1vavageord

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C.WASHINGTON, DC 20549

FORM 10-K

☒  Annual Report Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934

For the year ended December 31, 2020

Commission File Number 001-39603

PETRA ACQUISITION INC.

(Exact name of registrant as specified in its charter)

Mark One)

Delaware84-3898466
(State or Other Jurisdiction
of Incorporation)
(I.R.S. Employer
Identification No.)

5 West 21st Street

New York, NY

ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the fiscal year ended December 31, 2022

OR

10010

TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934

For the transition period from to

Commission File Number: 001-39603

REVELATION BIOSCIENCES, INC.

(Exact Name of Registrant as Specified in its Charter)

Delaware

84-3898466

( State or other jurisdiction of

incorporation or organization)

(I.R.S. Employer
Identification No.)

4660 La Jolla Village Drive, Suite 100,

San Diego, CA

92122

(Address of principal executive offices)

(zip code)Zip Code)

Registrant’s telephone number, including area code: (650) 800-3717

(971) 622-5800

(Issuer’s Telephone Number, Including Area Code)

Securities registered pursuant to Section 12(b) of the Act:

Title of Each Classeach class

Trading

Symbol(s)

Name of Each Exchangeeach exchange on Which Registeredwhich registered

Units, each consisting of one share of common stock and one redeemable warrantPAICUThe Nasdaq Stock Market LLC

Common stock, par value $0.001 per share

PAIC

REVB

The Nasdaq Stock Market LLC

Redeemable warrants, each exercisable for sharesa 1/35th share of common stock at an exercise price of $11.50$402.50 per share

PAICW

REVBW

The Nasdaq Stock Market LLC

Securities registered pursuant to Section 12(g) of the Act: None

Indicate by check mark if the registrant is a well-known seasoned issuer, as defined in Rule 405 of the Securities Act. Yes ☐ No

Indicate by check mark if the registrant is not required to file reports pursuant to Section 13 or 15(d) of the Exchange Act. Yes ☐ No

Indicate by check mark whether the registrant (1) has filed all reports required to be filed by Section 13 or 15(d) of the Securities Exchange Act of 1934 during the pastpreceding 12 months (or for such shorter period that the registrant was required to file such reports), and (2) has been subject to such filing requirementrequirements for the past 90 days. Yes ☒ No ☐

Indicate by check mark whether the registrant has submitted electronically every Interactive Data File required to be submitted pursuant to Rule 405 of Regulation S-T (§232.405 of this chapter) during the preceding 12 months (or for such shorter period that the registrant was required to submit such files). Yes No ☐

Indicate by check mark whether the registrant is a large accelerated filer, an accelerated filer, a non-accelerated filer, a smaller reporting company, or an emerging growth company. See the definitions of “large accelerated filer,” “accelerated filer,” “smaller reporting company,” and “emerging growth company” in Rule 12b-2 of the Exchange Act.

Large accelerated filer

Accelerated filer

Non-accelerated filer

Smaller reporting company

Emerging growth company

If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act.

Indicate by check mark whether the registrant has fi led a report on and attestation to its management’s assessment of the effectiveness of its internal control over financial reporting under Section 404(b) of the Sarbanes-Oxley Act (15 U.S.C. 7262(b)) by the registered public accounting fi rm that prepared or issued its audit report.


If securities are registered pursuant to Section 12(b) of the Act, indicate by check mark whether the financial statements of the registrant included in the filing reflect the correction of an error to previously issued financial statements. ☐

Indicate by check mark whether any of those error corrections are restatements that required a recovery analysis of incentive-based compensation received by any of the registrant’s executive officers during the relevant recovery period pursuant to §240.10D-1(b). ☐

Indicate by check mark whether the registrant is a shell company (as defined in Rule 12b-2 of the Exchange Act). Yes No

AsThe aggregate market value of voting common equity held by non-affiliates of the registrant was $13,305,377 as of June 30, 2020, the last business day of the registrant’s most recently completed second fiscal quarter, the registrant’s common stock was not publicly traded. Accordingly, there was no market value for the registrant’s common stock on such date.2022.

As of March 31, 2021, 9,097,68921, 2023, the registrant had 4,511,839 shares of common stock, $0.001 par value $0.001 per share, wereoutstanding.


EXPLANATORY NOTE

On January 10, 2022, Petra Acquisition, Inc., a Delaware corporation and our predecessor company (“Petra”), consummated the business combination (the “Business Combination”), pursuant to the terms of the agreement and plan of merger, dated as of August 29, 2021 (the “Business Combination Agreement”), by and among Petra, Petra Acquisition Merger, Inc., a Delaware corporation and wholly-owned subsidiary of Petra (“Merger Sub”), and Revelation Biosciences, Inc. (“Old Revelation”). Pursuant to the Business Combination Agreement, on the Closing Date, (i) Merger Sub merged with and into Old Revelation (the “Merger”), with Old Revelation as the surviving company in the Merger, and, after giving effect to such Merger, Old Revelation was renamed Revelation Biosciences Sub, Inc. and became a wholly-owned subsidiary of Petra (“Revelation Sub”) and (ii) Petra changed its name to “Revelation Biosciences, Inc.” (“Revelation” or the “Company” f/k/a Petra Acquisition, Inc.).

Except where the context requires otherwise, references herein to “Revelation” refers to its operating subsidiary.

On January 30, 2023, the Company filed a Certificate of Amendment of Third Amended and Restated Certificate of Incorporation (the “Certificate of Amendment”) reflecting the change in authorized shares of common stock from 100,000,000 to 500,000,000 and effecting a reverse stock split as of 12:01 a.m. Eastern Standard Time on February 1, 2023 with a ratio of 1-for-35 (the “Reverse Split”). As a result of the Reverse Split, every 35 shares of the Company’s issued and outstanding.outstanding common stock automatically converted into one share of common stock, without any change in the par value per share. No fractional shares are outstanding following the Reverse Split. Any holder who would have received a fractional share of common stock automatically received an additional fraction of a share of common stock to round up to the next whole share. In addition, effective as of the same time as the Reverse Split, proportionate adjustments were made to all then-outstanding equity awards and warrants with respect to the number of shares of common stock subject to such award or warrant and the exercise price thereof. Furthermore, the number of shares of common stock available for issuance under the Company’s equity incentive plans were proportionately adjusted for the Reverse Split ratio, such that fewer shares will be subject to such plans. All share numbers and preferred stock conversion numbers included herein have been retroactively adjusted to reflect the Reverse Split.


FREQUENTLY USED TERMS

References in this Annual Report on Form 10-K, unless otherwise noted, “we,” “us,” “our,” “Revelation” and the “Company” refer to Revelation Biosciences, Inc. and its subsidiary.

In this document:

ACEII” means Angiotensin Converting Enzyme II receptor.

AKI” means acute kidney injury.

ANDA” means abbreviated new drug application.

API” means Active Pharmaceutical Ingredient.

ARDS” means acute respiratory distress syndrome.

AUC” means area under the curve.

BLA” refers to the Biologics License Application.

BPCIA” means the Biologics Price Competition and Innovation Act of 2009.

Business Combination” means the business combination pursuant to the Business Combination Agreement.

Business Combination Agreement” means the Agreement and Plan of Merger, dated as of August 29, 2021, by and among Petra, Merger Sub and Old Revelation.

CCPA” means California Consumer Privacy Act.

CDC” means Centers for Disease Control and Prevention.

CDHS” means California Department of Health Services.

CE” means Conformitè Europëenne.

Certificate of Amendment” means the Certificate of Amendment of Third Amended and Restated Certificate of Incorporation filed January 30, 2023, reflecting the change in authorized shares of common stock from 100,000,000 to 500,000,000 and effecting a 1-35 reverse stock split as of 12:01 a.m.

Charter” means Revelation’s current third amended and restated certificate of incorporation as filed with the Secretary of State of the State of Delaware on January 10, 2022, including for references after January 30, 2023, the Certificate of Amendment.

CKD” means chronic kidney disease.

Class A Common Stock Warrant” means warrants issued as part of a private placement in January 2022 which are exercisable for one share of common stock at an exercise price of $115.15 per share until July 25, 2027.

Class A Placement Agent Common Stock Warrant” means warrants issued as part of a private placement in January 2022 which are exercisable for one share of common stock at an exercise price of $115.15 per share until July 25, 2027.

Class B Common Stock Warrant” means warrants issued as part of the July 2022 Public Offering which are exercisable for 1/35 of a share of common stock at an exercise price of $21.00 per share until July 28, 2027.

Class B Placement Agent Common Stock Warrant” means warrants issued as part of the July 2022 Public Offering which are exercisable for one share of common stock at an exercise price of $26.25 per share until July 25, 2027.


Class C Common Stock Warrant” means warrants issued as part of the February 2023 Public Offering which are exercisable for one share of common stock at an exercise price of $5.36 per share until February 14, 2028.

CMS” means Centers for Medicare & Medicaid Services.

Common Stock” means common stock of Revelation, $0.001 par value.

cGCP” or “GCP” means the current Good Clinical Practices.

cGLP” or “GLP” means the current Good Laboratory Practices.

cGMP” or “GMP” means the current Good Manufacturing Practices.

CMO” means contract manufacturing organization.

Code” means the Internal Revenue Code of 1986, as amended.

COPD” means chronic obstructive pulmonary disease.

CRO” means contract research organization.

DAMP” means damage-associated molecular patterns.

DGCL” means the Delaware General Corporation Law.

DSMB” means data safety monitoring board.

EEA” means the European Economic Area.

ELISA” means enzyme-linked immunosorbent assay.

EMA” means the European Medicines Agency.

EU” means the European Union.

Exchange Act” means the Securities Exchange Act of 1934, as amended.

FCA” means the False Claims Act.

FDA” means the U.S. Food and Drug Administration.

FDASIA” means Food and Drug Administration Safety and Innovation Act.

FD&C Act” means Federal Food, Drug, and Cosmetic Act.

FINRA” means Financial Industry Regulatory Authority.

GAAP” refers to the generally accepted accounting principles in the United States.

GDPR” means the General Data Protection Regulation ((EU) 2016/679).

GLA” means glucopyranosyl lipid A.

HAI” means healthcare associated infection.

HHS” means the U.S. Department of Health and Human Services.

HIPAA” means the Health Insurance Portability and Accountability Act of 1996.


IDE” means Investigational Device Exemption.

IFN” means interferon.

IM” means intramuscular.

IND” means Investigational New Drug Application.

IPO” means our initial public offering, which was consummated on October 13, 2020.

IRB” means institutional review board.

IVD” means in vitro diagnostic.

JOBS Act” means the Jumpstart Our Business Startup Act of 2012, as amended.

July 2022 Public Offering” means the Company’s public offering pursuant to the registration statement filed on Form S-1, and subsequently amended (File No. 333-266108), that closed on July 28, 2022 in which it sold 238,096 shares of its common stock for a price of $21.00 per share, 8,333,334 Class B Common Stock Warrants and 16,667 Class B Placement Agent Common Stock Warrants.

February 2023 Public Offering” means the Company’s public offering pursuant to the registration statement filed on Form S-1, and subsequently amended (File No. 333-268576), that closed on February 13, 2023 in which it sold an aggregate of 2,888,600 shares of its Common Stock, pre-funded warrants to purchase up to an aggregate of 336,400 shares of Common Stock and 6,450,000 Class C Common Stock Warrants, at a combined offering price of $4.83 per share of Common Stock and two Class C Common Stock Warrants, or $4.8299 per pre-funded warrant and two Class C Common Stock Warrants.

LOD” means limit of detection.

LPS” means a major component of gram-negative bacterial cell membrane, lipopolysaccharide.

MMID” means mild to moderate influenza disease.

MPLA” means monophosphoryl lipid A.

MRSA” means methicillin-resistant Staphylococcus aureus resistant infection.

Nasdaq” means The Nasdaq Stock Market, LLC.

Nasdaq Capital Market” means The Nasdaq Stock Market, LLC’s Nasdaq Capital Market listing tier.

NASH” means non-alcoholic steatohepatitis.

NDA” means New Drug Application.

PAMP” means pathogen-associated molecular patterns.

Petra” means Petra Acquisition, Inc., our predecessor, prior to the Business Combination.

PCR” means polymerase chain reaction.

PCT” means

PHAD®” means phosphorylated hexaacyl disaccharide.

PMA” means Premarket Approval Application.

Private Warrants” means the warrants sold by Petra prior to its IPO.


Program Products” refers to Revelation’s product candidates (REVTx-99b, REVTx-100, REVTx-200 and REVTx-300) and Revelation’s diagnostic device program (REVDx-501).

Public Warrants” means the warrants underlying the Units sold in the IPO.

QSR” means Quality System Regulation.

DAMP” means damage associated molecular pattern receptors.

Reverse Split” means a 1-for-35 reverse stock split effective February 1, 2023.

REVDx-501” means Revelation’s diagnostic device program.

REVTx-99a” means Revelation’s therapeutic product candidate that was being developed for the prevention and treatment of respiratory viral infections until June 2022.

REVTx-99b” means Revelation’s therapeutic product candidate being developed as a treatment for food allergies; and was being developed for prevention or treatment for chronic nasal congestion and allergic rhinitis until July 2022.

REVTx-100” means Revelation’s therapeutic product candidate being developed for the prevention and treatment of infections.

REVTx-200” means Revelation’s intranasal adjunct vaccine product candidate.

REVTx-300” means Revelation’s therapeutic product candidate being developed as a treatment for chronic organ disease including CKD and NASH.

RSU” means restricted stock unit.

SARS-CoV-2” means severe respiratory syndrome coronavirus 2.

SEC” means the United States Securities and Exchange Commission.

Securities Act” means the Securities Act of 1933, as amended.

Sunshine Act” means the Physician Payment Sunshine Act.

TEAEs” means treatment emergent adverse events.

TLR” means Toll-like receptors.

TLR-4” means Toll-like receptor 4.

Units” means units of Petra issued in our IPO consisting of one share of Common Stock and one Public Warrant, which traded on the Nasdaq Capital Market with the ticker symbol “REVBU” until their mandatory separation on January 13, 2023.

USPTO” means U.S. Patent and Trademark Office.


CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS AND RISK FACTORS SUMMARY

This annual report, including, without limitation, statements under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations,” includesAnnual Report contains forward-looking statements withinas defined in the meaningPrivate Securities Litigation Reform Act of Section 27A of the Securities Act and Section 21E of the Exchange Act. These forward-looking1995, as amended. Forward-looking statements can be identified by the use of forward-looking terminology, including the words “believes,” “estimates,” “anticipates,” “expects,” “intends,” “plans,” “may,” “will,” “potential,” “projects,” “predicts,” “continue,” or “should,” or, in each case, their negative or other variations or comparable terminology. There can be no assurance that actual results will not materially differ from expectations. Such statements include, but are not limited to, any statements relating to our ability to consummate any acquisition or other business combination and any other statements that are not statements of current or historical facts. These forward-looking statements are generally identified by the words “anticipate”, “believe”, “expect”, “estimate”, “plan”, “outlook”, and “project” and other similar expressions. We caution investors that forward-looking statements are based on management’s current expectations but actual results may differ materially due to various factors, including, but not limited to our:

ability to complete our initial business combination;
success in retaining or recruiting, or changes required in, our officers, key employees or directors following an initial business combination;
officers and directors allocating their time to other businesses and potentially having conflictsand are only predictions or statements of interest with our business or in approving our initial business combination, as a result of which they would then receive expense reimbursements;
potential ability to obtain additional financing to complete an initial business combination;
pool of prospective target businesses;
failure to maintain the listing on, or the delisting of our securities from, Nasdaq or an inability to have our securities listed on Nasdaq or another national securities exchange following our initial business combination;
the ability of our officers and directors to generate a number of potential investment opportunities;
potential change in control if we acquire one or more target businesses for stock;
public securities’ potential liquidity and trading;
lack of a market for our securities;
use of proceeds not held in the trust account or available to us from interest income on the trust account balance; or
our financial performance.

The forward-looking statements contained in this annual report are based on our current expectations and beliefs concerning future developmentsinvolve known and their potential effects on us. Future developments affecting us may not be those that we have anticipated. These forward-looking statements involve a number ofunknown risks, uncertainties (some of which are beyond our control) and other assumptionsfactors that may cause actual results or performance to be materially different from those expressed or impliedanticipated by thesethe forward-looking statements. These risks and uncertainties include, but areRevelation cautions readers not limited to thoseplace undue reliance on any such forward-looking statements, which speak only as of the date they were made. The following factors, described under the heading “Risk Factors.” Should one or more of these risks or uncertainties materialize, or should any of our assumptions prove incorrect,among others, could cause actual results may vary in material respects from those projected in these forward-looking statements. We undertake no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as may be required under applicable securities laws. These risks and others described under “Risk Factors” may not be exhaustive.

By their nature, forward-looking statements involve risks and uncertainties because they relate to events and depend on circumstances that may or may not occur in the future. We caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and developments in the industry in which we operate may differ materially from those madedescribed in these forward-looking statements: the ability of Revelation to meet its financial and strategic goals, due to, among other things, competition; the ability of Revelation to grow and manage growth profitability and retain its key employees; the possibility that the Revelation may be adversely affected by other economic, business, and/or suggestedcompetitive factors; risks relating to the successful development of Revelation’s product candidates; the clinical utility of an increase in intranasal cytokine levels as a biomarker of viral infections; the ability to successfully complete planned clinical studies of its product candidates; the risk that we may not fully enroll our clinical studies or enrollment will take longer than expected; risks relating to the occurrence of adverse safety events and/or unexpected concerns that may arise from data or analysis from our clinical studies; changes in applicable laws or regulations; expected initiation of the clinical studies, the timing of clinical data; the outcome of the clinical data, including whether the results of such study is positive or whether it can be replicated; the outcome of data collected, including whether the results of such data and/or correlation can be replicated; the timing, costs, conduct and outcome of our other clinical studies; the anticipated treatment of future clinical data by the forward-looking statements containedFDA, the EMA or other regulatory authorities, including whether such data will be sufficient for approval; the success of future development activities for REVTx-99a, REVTx-99b, REVTx-100, REVTx-200, REVTx-300, REVDx-501, or any other product candidates; potential indications for which product candidates may be developed; the potential impact that COVID-19 may have on Revelation’s suppliers, vendors, regulatory agencies, employees and the global economy as a whole; the ability of Revelation to maintain the listing of its securities on NASDAQ; investor sentiment relating to SPAC related going public transactions; the expected duration over which Revelation’s balances will fund its operations; and other risks and uncertainties described herein, as well as those risks and uncertainties discussed from time to time in this annual report. In addition, even if our results or operations, financial conditionother reports and liquidity, and developments in the industry in which we operate are consistentother public filings with the forward-looking statements contained in this annual report, those results or developments may not be indicativeSEC by Revelation.

Risks Related to Our Business

We have a limited operating history and no products approved for commercial sale. We have incurred net losses since our inception, we anticipate that we will continue to incur significant losses for the foreseeable future, and even if we were to generate revenue, we may never achieve or maintain profitability.

Risks Related to the Product Development, Regulatory Approval, Manufacturing and Commercialization of results or developments in subsequent periods.Our Program Products and Product Candidates

If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed, we will be unable to meet our future development goals.

The results of prior preclinical or clinical studies are not necessarily predictive of our future results.

The Clinical Studies of our Program Products’ have been and are planned to be conducted outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies.

Our Program Products and the administration of our Program Products may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

Our business depends on the success of our Program Products, including obtaining regulatory approval to market our product candidates in the United States and/or other major foreign markets such as the European Union.

i


i

Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

Legislative or regulatory healthcare reforms in the United States or other countries may make it more difficult and costly for us to obtain regulatory clearance or approval of our Program Products and to produce, market and distribute our Program Products after clearance or approval is obtained.

We face intense competition in an environment of rapid technological change and the possibility that our competitors may develop products and drug delivery systems that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our Program Products.

PETRA ACQUISITION INC.Risks Related to our Reliance on Third Parties

FORM 10-K

We rely on third parties to conduct certain elements of our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our Program Products.

We rely on third parties to manufacture the raw materials, including the active pharmaceutical ingredients that we use to create our therapeutic product candidate, and to manufacture the diagnostic devices, including the antibodies used for testing.

TABLE OF CONTENTSRisks Related to Our Intellectual Property

If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.

We may not be able to protect our intellectual property rights throughout the world.

We may not have sufficient patent lifespan to effectively protect our products and business.

If we are unable to maintain effective proprietary rights for our Program Products or any future product candidates, we may not be able to compete effectively in our markets.

Risks Related to Our Business Operations

Our future success depends in part on our ability to retain our senior management team, directors and other key employees and to attract, retain and motivate other qualified personnel.

Risks Related to Commercialization of Our Program Products and Product Candidates

As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully.

We may seek to establish commercial collaborations for our Program Products and future product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development plans.

We currently have no Program Products approved for marketing. We do not have a marketing and sales organization. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our Program Products, we may be unable to generate any product revenue.

ii


It may be difficult for us to profitably sell our Program Products, if and when approved, if coverage and reimbursement for these Program Products are limited by government authorities and/or third-party payor policies.

We face the risk of product liability claims and may not be able to obtain insurance.

Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.

General Risk Factors

We are subject to several other risks of which other public companies are subject, including without limitation, the volatility of our Common Stock price; our ability to comply with corporate governance laws and financial reporting standards; and our ability to maintain an effective system of internal controls.

iii


Table of Contents

 

PART I

Item 1.

Business.1

Page

Item 1A.Risk Factors.11

PART I

Item 1.

Business

1

Item 1A.

Risk Factors

36

Item 1B.

Unresolved Staff Comments.Comments

27

72

Item 2.

Properties.Properties

27

72

Item 3.

Legal Proceedings.Proceedings

27

72

Item 4.

Mine Safety Disclosures.Disclosures

27

73

PART II

Item 5.

Market for Registrant’s Common Equity, Related Stockholder Matters and Issuer Purchases of Equity Securities.Securities

28

73

Item 6.

Selected Financial Data.[RESERVED]

29

74

Item 7.

Management’s Discussion and Analysis of Financial Condition and Results of Operations.Operations

29

75

Item 7A.

Quantitative and Qualitative Disclosures About Market Risk.Risk

33

84

Item 8.

Financial Statements and Supplementary Data.Data

33

84

Item 9.

Changes in and Disagreements withWith Accountants on Accounting and Financial Disclosures.Disclosure

33

84

Item 9A.

Controls and Procedures.Procedures

33

84

Item 9B.

Other Information.Information

86

Item 9C.

Disclosure Regarding Foreign Jurisdictions that Prevent Inspections

87

PART III

PART III

Item 10.

Directors, Executive Officers and Corporate Governance.Governance

35

87

Item 11.

Executive Compensation.Officer and Director Compensation

39

92

Item 12.

Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.Matters

40

94

Item 13.

Certain Relationships and Related Transactions, and Director Independence.Independence

42

96

Item 14.

Principal Accounting Fees and Services.Services

43

98

PART IV

Item 15.

Exhibits, Financial Statement Schedules.Schedules

44

99

Item 16.

Form 10-K Summary.Summary

45

101

iv


ii

PART I

References in this Annual Report on Form 10-K, unless otherwise noted, “we,” “us,” “our,” “Revelation” and the “Company” refer to Revelation Biosciences, Inc. and its subsidiary.

ITEMItem 1. BUSINESSBusiness.

In this Annual Report

Overview

Revelation is a clinical-stage biopharmaceutical company founded in May 2020. We are focused on Form 10-K (the “Form 10-K”), referencesthe development or commercialization of innate immune system therapeutics and diagnostics. On January 10, 2022, we consummated our previously announced Business Combination. Prior to the “Company” and to “we,” “us,” and “our” refer toBusiness Combination, Petra Acquisition Inc.

We arewas a blank check company formedincorporated under the laws of the State of Delaware on November 20, 2019. We were formed for the purpose of entering intoeffecting a merger, sharecapital stock exchange, asset acquisition, stock purchase, recapitalization, reorganization, or other similar business combination with one or more businesses or entities. Our efforts to identify a prospective target business will not be limited to a particular industry or geographic location, although we intend to focus our search for target businesses in the healthcare or a healthcare-related industry. However, we are not limited to this industry and we may pursue a business combination opportunity in any business or industry we choose and we may pursue a company with operations or opportunities outside of the United States.

On January 21, 2020, we issued an aggregate of 3,593,750 shares of our common stock (“founders’ shares”) for an aggregate purchase price of $25,000, or approximately $0.007 per share, to Petra Investment Holdings, LLC (the “Sponsor). On August 24, 2020, pursuant to amendment to the terms of the Company’s offering our sponsor agreed to cancel 1,437,500 shares, resulting in an aggregate amount of 2,156,250 founders shares outstanding.

businesses. In May 2020, our sponsor agreed to transfer 25,000 founder shares to each of Messrs. Dobkin, Hayes, and Nicholson, our director nominees, and in August 2020 our sponsor transferred 25,000 founder shares to director nominee, Barry Dennis. However, on September 9, 2020, in connection with the amendment to the Company’s offering terms, each of our existing directors and nominees at the time agreed to have the number of shares assigned to them reduced to 10,000 shares and, concurrently, the Sponsor agreed to transfer 10,000 shares to director nominee, Kimon Angelides.

On October 13, 2020, we consummated an initial public offering (“IPO”) of 7,000,000 units (“Units”). Each Unit consists of one share of common stock of the Company, par value $0.001 per share (“Common Stock”), and one redeemable warrant of the Company (“Warrant”), with each Warrant entitling the holder thereof to purchase one share of Common Stock for $11.50 per share. The Units were sold at a price of $10.00 per Unit, generating gross proceeds to the Company of $70,000,000.

Simultaneously with the consummation of the IPO, the Company completed the private sale of an aggregate of 3,150,000 private warrants (the “Private Warrants”)Business Combination, Petra changed its name to the Sponsor at a purchase price of $1.00 per Private Warrant, generating gross proceeds to the Company of $3,150,000.

The Private Warrants are identical to the units and warrants sold in the IPO, except that the Private Warrants: (i) will not be redeemable by us and (ii) may be exercised for cash or on a cashless basis, as described in this prospectus, in each case so long as they are held by the initial purchasers or any of their permitted transferees. If the private warrants are held by holders other than the initial purchasers or any of their permitted transferees, the private warrants will be redeemable by us and exercisable by the holders on the same basis as the warrants included in the units being sold in this offering.Revelation Biosciences, Inc. Our initial stockholders have agreed not to transfer, assign or sell any of the private warrants and underlying securities (except to certain permitted transferees) until after the completion of our initial business combination. Furthermore, they have agreed (A) to vote the shares in favor of any proposed business combination, (B) not to convert any shares in connection with a stockholder vote to approve a proposed initial business combination or sell any shares to us in a tender offer in connection with a proposed initial business combination and (C) that the private warrants shall not participate in any liquidating distribution from our trust account upon winding up if a business combinationCommon Stock is not consummated. In the event of a liquidation prior to our initial business combination, the private warrants will likely be worthless.

Additionally, the purchasers of Private Warrants have agreed not to transfer, assign or sell any of the securities purchased in the Private Placement, including the underlying common stock and warrants (except to certain permitted transferees), for certain periods of time.


On October 16, 2020, we consummated the sale of an additional 278,151 Units (the “Over-Allotment Option Units”) at $10.00 per Unit, generating gross proceeds of $2,781,510. Simultaneously with the closing of the sale of additional units, the Company consummated the sale of an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446. Following the closing of the over-allotment option and sale of additional Private Warrants, an aggregate amount of $73,509,325 was placed in the Company’s trust account established in connection with the IPO. 

In addition, the shares of common stock of the Company (the “Founder Shares”) held by the Sponsor (prior to the exercise of the over-allotment) included an aggregate of up to 262,500 Founder Shares subject to forfeiture by the Sponsor to the extent that the underwriters’ over-allotment option was not exercised in full. Since the underwriters exercised the over-allotment option in part, 192,962 Founder Shares were subject to forfeiture and were cancelled by our Sponsor on December 30, 2020.

Effecting a Business Combination

General

We are not presently engaged in, and we will not engage in, any substantive commercial business for an indefinite period of time. We intend to utilize cash derived from the proceeds of our IPO and the Private Placement, our capital stock, debt or a combination of these in effecting a business combination which has not yet been identified. Accordingly, investors in our securities are investing without first having an opportunity to evaluate the specific merits or risks of any one or more business combinations. A business combination may involve the acquisition of, or merger with, a company which does not need substantial additional capital but which desires to establish a public trading market for its shares, while avoiding what it may deem to be adverse consequences of undertaking a public offering itself. These include time delays, significant expense, loss of voting control and compliance with various federal and state securities laws. In the alternative, we may seek to consummate a business combination with a company that may be financially unstable or in its early stages of development or growth. While we may seek to effect simultaneous business combinations with more than one target business, we will probably have the ability, as a result of our limited resources, to effect only a single business combination.

Sources of Target Businesses

We expect that our principal means of identifying potential target businesses will be through the extensive contacts and relationships of our Sponsor, initial stockholders, officers and directors. While our officers and directors are not required to commit any specific amount of time in identifying or performing due diligence on potential target businesses, our officers and directors believe that the relationships they have developed over their careers and their access to our Sponsor’s contacts and resources will generate a number of potential business combination opportunities that will warrant further investigation. We also anticipate that target business candidates will be brought to our attention from various unaffiliated sources, including investment bankers, venture capital funds, private equity funds, leveraged buyout funds, management buyout funds and other members of the financial community. Target businesses may be brought to our attention by such unaffiliated sources as a result of being solicited by us through calls or mailings. These sources may also introduce us to target businesses they think we may be interested in on an unsolicited basis, since many of these sources will have read our prospectus and know what types of businesses we are targeting. Our Sponsor, initial stockholders, officers and directors, as well as their affiliates, may also bring to our attention target business candidates that they become aware of through their business contacts as a result of formal or informal inquiries or discussions they may have, as well as attending trade shows or conventions. Our officers and directors must present to us all target business opportunities that have a fair market value of at least 80% of the assets held in the trust account (excluding deferred underwriting commissions and taxes payable on the income accrued in the trust account) at the time of the agreement to enter into the initial business combination, subject to any pre-existing fiduciary or contractual obligations. We may also engage the services of professional firms or other individuals that specialize in business acquisitions in which case we may pay a finder’s fee, consulting fee or other compensation to be determined in an arm’s length negotiation based on the terms of the transaction.


Selection of Target Business and Structuring of a Business Combination

Subject to the limitations that a target business have a fair market value of at least 80% of the balance in the trust account (excluding taxes payable on the income earned on the trust account) at the time of the execution of a definitive agreement for our initial business combination, as described below in more detail, and that we must acquire a controlling interest in the target business, our management has virtually unrestricted flexibility in identifying and selecting a prospective target business. We have not established any specific attributes or criteria (financial or otherwise) for prospective target businesses. In evaluating a prospective target business, our management may consider a variety of factors, including one or more of the following:

financial condition and results of operation;
growth potential;
brand recognition and potential;
experience and skill of management and availability of additional personnel;
capital requirements;
competitive position;
barriers to entry;
stage of development of the products, processes or services;
existing distribution and potential for expansion;
degree of current or potential market acceptance of the products, processes or services;
proprietary aspects of products and the extent of intellectual property or other protection for products or formulas;
impact of regulation on the business;
regulatory environment of the industry;
the target business’s compliance with U.S. Federal laws and regulations;
costs associated with effecting the business combination;
industry leadership, sustainability of market share and attractiveness of market industries in which a target business participates; and
macro competitive dynamics in the industry within which the company competes.

These criteria are not intended to be exhaustive. Any evaluation relating to the merits of a particular business combination will be based, to the extent relevant, on the above factors as well as other considerations deemed relevant by our management in effecting a business combination consistent with our business objective. In evaluating a prospective target business, we will conduct an extensive due diligence review which will encompass, among other things, meetings with incumbent management and inspection of facilities, as well as review of financial and other information which is made available to us. This due diligence review will be conducted either by our management or by unaffiliated third parties we may engage, although we have no current intention to engage any such third parties.


The time and costs required to select and evaluate a target business and to structure and complete the business combination cannot presently be ascertained with any degree of certainty. Any costs incurred with respect to the identification and evaluation of a prospective target business with which a business combination is not ultimately completed will result in a loss to us and reduce the amount of capital available to otherwise complete a business combination.

We may enter into a business combination with a target business that is affiliated with any of our officers, directors or Sponsor. However, we would only do so if (i) such transaction is approved by a majority of our disinterested independent directors and (ii) we obtain an opinion from an independent investment banking firm, or another independent entity that commonly renders valuation opinions, that the business combination is fair to our unaffiliated stockholders from a financial point of view.

Fair Market Value of Target Business

Nasdaq listing rules require that the target business or businesses that we acquire must collectively have a fair market value equal to at least 80% of the balance of the funds in the trust account (excluding taxes payable on the income earned on the trust account) at the time of the execution of a definitive agreement for our initial business combination, although we may acquire a target business whose fair market value significantly exceeds 80% of the trust account balance.

We currently anticipate structuring a business combination to acquire 100% of the equity interests or assets of the target business or businesses. We may, however, structure our initial business combination where we merge directly with the target business or where we acquire less than 100% of such interests or assets of the target business in order to meet certain objectives of the target management team or shareholders or for other reasons, but we will only complete such business combination if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment Company Act. Even if the post-transaction company owns or acquires 50% or more of the voting securities of the target, our stockholders prior to the business combination may collectively own a minority interest in the post-transaction company, depending on valuations ascribed to the target and us in the business combination transaction. For example, we could pursue a transaction in which we issue a substantial number of new shares in exchange for all of the outstanding capital stock of a target. In this case, we could acquire a 100% controlling interest in the target; however, as a result of the issuance of a substantial number of new shares, our stockholders immediately prior to our initial business combination could own less than a majority of our outstanding shares subsequent to our initial business combination. If less than 100% of the equity interests or assets of a target business or businesses are owned or acquired by the post-transaction company, the portion of such business or businesses that is owned or acquired is what will be valued for purposes of the 80% of trust account balance test. Notwithstanding the foregoing, if we are not then listed on Nasdaq for whatever reason, we would no longer be requiredunder the ticker symbol “REVB” and Public Warrants are listed on Nasdaq under the ticker symbol “REVBW.”

Recent Developments

Change in Authorized Shares and Reverse Stock Split

On January 30, 2023, at a special meeting of stockholders, our stockholders approved a Certificate of Amendment to meetour Third Amended and Restated Certificate of Incorporation to change the foregoing 80% fair market value test.

In orderauthorized common stock from 100,000,000 to consummate such an acquisition, we may issue a significant amount of our debt or equity securities to the sellers of such businesses and/or seek to raise additional funds through a private offering of debt or equity securities. Since we have no specific business combination under consideration, we have not entered into any such fund raising arrangement500,000,000 shares and have no current intention of doing so. The fair market value of the target will be determined by our board of directors based upon one or more standards generally accepted by the financial community (such as actual and potential sales, earnings, cash flow and/or book value). The proxy solicitation materials or tender offer documents used by us in connection with any proposed transaction will provide public stockholders with our analysis of the fair market value of the target business, as well as the basis for our determinations. If our board is not able to independently determine that the target business has a sufficient fair market value, we will obtain an opinion from an unaffiliated, independent investment banking firm, or another independent entity that commonly renders valuation opinions, with respect to the satisfaction of such criteria.


We will not be required to obtain an opinion from an investment banking firm as to the fair market value if our board of directors independently determines that the target business complies with the 80% threshold.

Lack of Business Diversification

We may seek to effect a business combination with more than one target business, and there is no required minimum valuation standard for any single target at the timereverse stock split of such acquisition. We expect to complete only a single business combination, although this process may entail the simultaneous acquisitions of several operating businesses. Therefore, at least initially, the prospects for our success may be entirely dependent upon the future performance of a single business operation. Unlike other entities which may have the resources to complete several business combinations of entities operating in multiple industries or multiple areas of a single industry, it is probable that we will not have the resources to diversify our operations or benefit from the possible spreading of risks or offsetting of losses. By consummating a business combination with only a single entity, our lack of diversification may:

subject us to numerous economic, competitive and regulatory developments, any or all of which may have a substantial adverse impact upon the particular industry in which we may operate subsequent to a business combination, and
result in our dependency upon the performance of a single operating business or the development or market acceptance of a single or limited number of products, processes or services.

If we determine to simultaneously acquire several businesses and such businesses are owned by different sellers, we will need for each of such sellers to agree that our purchase of its business is contingent on the simultaneous closings of the other acquisitions, which may make it more difficult for us, and delay our ability, to complete the business combination. With multiple acquisitions, we could also face additional risks, including additional burdens and costs with respect to possible multiple negotiations and due diligence investigations (if there are multiple sellers) and the additional risks associated with the subsequent assimilation of the operations and services or products of the acquired companies in a single operating business.

Limited Ability to Evaluate the Target Business’ Management

Although we intend to scrutinize the management of a prospective target business when evaluating the desirability of effecting a business combination, we cannot assure you that our assessment of the target business’ management will prove to be correct. In addition, we cannot assure you that the future management will have the necessary skills, qualifications or abilities to manage a public company. Furthermore, the future role of our officers and directors, if any, in the target business following a business combination cannot presently be stated with any certainty. While it is possible that some of our key personnel will remain associated in senior management or advisory positions with us following a business combination, it is unlikely that they will devote their full time efforts to our affairs subsequent to a business combination. Moreover, they would only be able to remain with the company after the consummation of a business combination if they are able to negotiate employment or consulting agreements in connection with the business combination. Such negotiations would take place simultaneously with the negotiation of the business combination and could provide for them to receive compensation in the form of cash payments and/or our securities for services they would render to the company after the consummation of the business combination. While the personal and financial interests of our key personnel may influence their motivation in identifying and selecting a target business, their ability to remain with the company after the consummation of a business combination will not be the determining factor in our decision as to whether or not we will proceed with any potential business combination. Additionally, we cannot assure you that our officers and directors will have significant experience or knowledge relating to the operations of the particular target business.

Following a business combination, we may seek to recruit additional managers to supplement the incumbent management of the target business. We cannot assure you that we will have the ability to recruit additional managers, or that any such additional managers we do recruit will have the requisite skills, knowledge or experience necessary to enhance the incumbent management.

5

Stockholders May Not Have the Ability to Approve an Initial Business Combination

In connection with any proposed business combination, we will either (1) seek stockholder approval of our initial business combination at a meeting called for such purpose at which stockholders may seek to convert their shares, regardless of whether they vote for or against the proposed business combination or don’t vote at all, into their pro rata share of the aggregate amount then on deposit in the trust account (net of taxes payable), or (2) provide our stockholders with the opportunity to sell their shares to us by means of a tender offer (and thereby avoid the need for a stockholder vote) for an amount equal to their pro rata share of the aggregate amount then on deposit in the trust account (net of taxes payable), in each case subject to the limitations described herein. If we determine to engage in a tender offer, such tender offer will be structured so that each stockholder may tender all of his, her or its shares rather than some pro rata portion of his, her or its shares. The decision as to whether we will seek stockholder approval of a proposed business combination or will allow stockholders to sell their shares to us in a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors such as the timing of the transaction and whether the terms of the transaction would otherwise require us to seek stockholder approval. Unlike other blank check companies which require stockholder votes and conduct proxy solicitations in conjunction with their initial business combinations and related conversions of public shares for cash upon consummation of such initial business combination even when a vote is not required by law, we will have the flexibility to avoid such stockholder vote and allow our stockholders to sell their shares pursuant to Rule 13e-4 and Regulation 14E of the Exchange Act which regulate issuer tender offers. In that case, we will file tender offer documents with the SEC which will contain substantially the same financial and other information about the initial business combination as is required under the SEC’s proxy rules. We will consummate our initial business combination only if we have net tangible assets of at least $5,000,001 upon such consummation and, if we seek stockholder approval, a majority of the outstanding shares of common stock votedat a specific ratio within a range of one-for-twenty (1-for-20) to a maximum of a one-for-one hundred (1-for-100) split. Additionally, on January 30, 2023, we filed the Certificate of Amendment which set the authorized common stock to 500,000,000 and effected a 1-for-35 reverse stock split of our outstanding shares of common stock as of 12:01 a.m. Eastern Standard Time on February 1, 2023.

Business Strategy

Our current product candidates are voted in favorbeing developed by Revelation to potentially modulate the activity of the business combination.immune system through stimulation of TLR-4. Our current programs consist of: REVTx-300, which is being developed as a potential therapy for the prevention and treatment of acute organ injury (e.g. AKI, MI) and chronic organ disease including CKD; REVTx-100, which is being developed for the prevention and treatment of infections including healthcare-associated bacterial infection resulting from surgery, severe burns, and antibiotic resistance; REVTx-200, which is being developed as a potential intranasal therapy that will be administered concurrently with a traditional commercially available IM vaccine and REVTx-99b, which is being developed as a potential treatment for food allergies.

REVTx-99a was being developed for the prevention or treatment of a wide array of viral infections and REVTx-99b was being developed as a prevention or treatment for chronic nasal congestion and allergic rhinitis until July of 2022. Our diagnostic, REVDx-501 (REVIDTM Rapid Test Kit), was being developed as a rapid point of care diagnostic that can be used to detect IP-10 as a surrogate biomarker for any type of respiratory infection, without the need for specialized instrumentation.

Our Pipeline

Revelation is currently leveraging the human body’s innate immune response to develop therapeutics to prevent and treat disease. Revelation’s pipeline is summarized in the table below:

1


img38676523_0.jpg

The Therapeutic Platform

Our current therapeutic candidates are all based on the active ingredient PHAD®, a synthetic version of MPLA, that is known to stimulate TLR-4. Stimulation of TLR-4 leads to the production of multiple types of cytokines and chemokines which modulate the activity of the innate and adaptive immune response. Modulated activities may include stimulation and recruitment of infection fighting immune cells, down-regulation of inflammation, and/or upregulation of inflammation depending on the degree and nature of the stimulation which enables the multiple potential product candidates in development.

REVTx-300

REVTx-300 is being developed as a potential therapy for the prevention of acute organ injury such as AKI and as a treatment of chronic organ disease including CKD. Acute organ injury may be caused by many different events, including blood or fluid loss (such as with bleeding or severe diarrhea), low blood pressure or shock leading to hypotension, heart failure or heart attack, overuse of certain pain medications including NSAIDs, ibuprofen, etc., toxicity due to chemotherapy, contrast agents, etc., burns, or major surgery. During surgery, ischemia or deprivation of blood supply to a tissue followed by the reperfusion or re-introduction of blood to prevent tissue necrosis can result in further damage and/or dysfunction to the organ. Chronic disease of an organ, due to chronic inflammation and subsequent fibrosis, follows a pattern of perpetual and ongoing destruction of living functional cells and subsequent replacement by the non-functional protein, collagen, resulting in fibrosis (scar tissue) (Wilson 2015). The establishment of fibrosis and subsequent death of the organ is driven by ongoing inflammatory processes and reactive oxygen species associated with the innate immune response. We chosebelieve redirection of the innate immune response with REVTx-300 from a pro-inflammatory state to an anti-inflammatory (protective) state may rebalance the innate immune response to slow down or halt the progressive destruction and scarring of organ tissue, allowing the healing process to take place.

Revelation conducted a nonclinical study to evaluate the anti-fibrotic activity of REVTx-300. Specifically, a range of daily systemic dosing levels of REVTx-300 were tested in a rat Unilateral Ureteral Obstruction model. The unilateral ureteral obstruction (UUO) model is appropriate for studying the anti-inflammatory and anti-fibrotic effects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the affected kidney over a 7-day period.

The present study consisted of 6 groups with the following outcomes on renal cortical fibrosis as measured by detection of collagen deposition using picosirius red stained histology sections assessed at three different sampling depths.

Group 1 animals had no UUO surgery and received vehicle only (collagen deposition: 2.36 ± 0.44%).

Group 2 animals had UUO surgery and received vehicle only (collagen deposition: 4.88 ± 0.51%).

2


Group 3 animals had UUO surgery and received SB-525334, a known TGF-β inhibitor of fibrosis (collagen deposition: 3.02 ± 0.37%, 75% reduction vs Group 2 minus background from group 1, p < 0.05).

Group 4 animals had UUO surgery and received 0.1 mg/kg REVTx-300 (collagen deposition: 4.96 ± 0.95 %, 1% reduction vs Group 2 minus background from group 1).

Group 5 animals had UUO surgery and received 0.3 mg/kg REVTx-300 (collagen deposition: 3.82 ± 0.91%, 44% reduction vs Group 2 minus background from group 1, p < 0.05).

Group 6 animals had UUO surgery and received 0.9 mg/kg REVTx-300 (collagen deposition: 3.45 ± 0.54%, 58% reduction vs Group 2 minus background from group 1, p < 0.05).

Revelation will continue evaluating the potential of REVTx-300 in additional preclinical models including AKI, CKD, nonalcoholic steatohepatitis (NASH) and myocarditis to identify optimal dosing conditions required for prevention and resolution of inflammation and fibrosis.

Revelation plans to initiate a Phase 1a clinical study in the second half of 2023 in healthy volunteers to evaluate the safety of systemically delivered REVTx-300, and investigate biomarkers to elucidate the pharmacokinetic/pharmacodynamic relationship. For efficiency, this phase 1a clinical study will be the same one conducted for REVTx-100. This study will be followed by a Phase 1b study in patients to further evaluate the safety and activity of REVTx-300 in preparation for Phase 2.

REVTx-100

REVTx-100 is being developed, through a license agreement with Vanderbilt University, as a potential therapy for the prevention or treatment of healthcare-associated bacterial infection including post-surgical infection, post-burn infection, urinary tract infection (e.g. as a result of hospital-based or outpatient catheterization), sepsis, antibiotic-resistant infection, etc. We hypothesize controlled stimulation of TLR-4 will selectively prime the body’s immune system to be able to better respond to subsequent pathogen exposure.

Multiple preclinical studies have shown that systemic pretreatment with PHAD results in significantly increased immune response leading to significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria.

Revelation plans to initiate a Phase 1a clinical study in the second half of 2023 in healthy volunteers to evaluate the safety of systemically delivered REVTx-100 and investigate biomarkers to elucidate the pharmacokinetic/pharmacodynamic relationship. The Phase 1a study will be followed by a phase 1b study in patients undergoing colorectal surgery to establish proof-of-concept in preparation for phase 2.

REVTx-200

REVTx-200 is being developed as a potential intranasal therapy that will be administered concurrently with a commercially available traditional IM vaccine. We believe concurrent stimulation of the nasal mucosa with REVTx-200 upon IM vaccination may provide a more complete immunization.

We believe optimal protection from a vaccine requires both a systemic immune response elicited by the IM vaccine injection and a mucosal immune response elicited by the intranasal administration of REVTx-200. We hypothesize that intranasal administration of REVTx-200 will result in improved recruitment of vaccine-specific activated adaptive immune cells (e.g. T cells and B cells) into the nasal mucosa. Biomarker data from our net tangible asset thresholdPhase 1 clinical study (RVL-NHV01) and Phase 2 virus challenge study (RVL-VRL01) supports this hypothesis. In particular, we were able to see increases in local (intranasal) IL-7 and MCP-1, as well as increased titers of $5,000,001antibodies specific to ensure that we would avoid being subjectthe viral challenge pathogen.

3


The adjuvant activity attributed to Rule 419 promulgated underREVTx-200 will likely benefit a number of vaccines by increasing mucosal immunity. For this reason, it can be paired with a variety of potential vaccine products. We plan to establish relationships with vaccine product development companies with the Securities Actintention of 1933, as amended. However, if we seekworking with one or more of these companies to consummate an initial businessdevelop REVTx-200. Initial development will include studying REVTx-200 using commercially available IM vaccines in nonclinical models unique to each potential partnering company. Initial clinical studies will likely evaluate the potential of REVTx-200 to improve the performance of influenza or SARS-CoV-2 vaccinations.

Since REVTx-200 will be used in combination with a target businesstraditional vaccine, and based on feedback from the FDA, we believe REVTx-200 will be regulated as a biologic, and the approval process will require its own unique development pathway.

REVTx-99b for Food Allergies

REVTx-99b is being developed as a treatment for food allergies. According to research performed by the Food Allergy Research & Education group, approximately 11% of adults in the United States have one or more food allergies with different levels of severity (FARE 2020). Most food allergies are diagnosed early in life and sometimes resolve over time, while other allergies develop later in life.

As a Type I hypersensitivity, food allergies induce a Th2-biased response, resulting in allergen-specific IgE antibodies, which bind to mast cell and basophil receptors upon challenge with antigen, resulting in degranulation and release of inflammatory mediators (e.g., histamine, leukotrienes, tryptase) (Bousquet 2020). Systemic responses, e.g., anaphylaxis, may also occur within minutes or hours post-challenge. Accordingly, there remains a significant need for effective therapies for treating and preventing allergic disease.

REVTx-99b potentially engages three different aspects of the allergic response via stimulation of the TLR-4 pathway. These include (i) the possible induction of a physical barrier to allergens, (ii) the possible reduction of IgE secretion as a result of IFN upregulation and (iii) by secretion of IP-10 which competes for the native eotaxin receptor.

Revelation intends to explore the potential for treatment of food allergies with REVTx-99b in several preclinical models, minimally including an anaphylaxis model, in which administration of allergen will be followed by treatment with multiple dose levels of intranasal REVTx-99b. Resolution of symptoms will be assessed through the evaluation of local and systemic allergic endpoints including IgE and/or IgG4 titers, tryptase, histamine, and eotaxin levels.

REVTx-99a for Prevention of Viral infection and REVTx-99b for Allergic Rhinitis

REVTx-99a was being developed as a broad anti-viral nasal drop solution for the potential prevention or treatment of respiratory viral infection until June of 2022. We conducted a Phase 1 study in 2020 and Phase 2b study, on March 30, 2022 we announced that imposes any typethe primary endpoint of working capital closingthe Phase 2b study, reduction in AUC of viral load measured by RT-PCR from nasopharyngeal swabs, did not meet statistical significance. We received the full data package during the second quarter of 2022 and have determined to stop all future clinical development of REVTx-99a.

REVTx-99b was being developed as a prevention or treatment for chronic nasal congestion and allergic rhinitis until July of 2022. We conducted a Phase 1b allergen challenge study and on July 22, 2022 we announced that the primary endpoint to evaluate the effects of REVTx-99b versus placebo on safety and tolerability was met but exploratory endpoints for efficacy were not met. This includes no reduction in allergy symptoms (Total Nasal Symptom Score) and no increase in peak nasal inspiratory flow versus placebo. We have determined to stop all future clinical development of REVTx-99b for this indication.

REVDx-501

Our diagnostic, REVDx-501 (REVIDTM Rapid Test Kit) is being developed as a rapid point of care in vitro diagnostic test (or diagnostic device) that has the potential to detect IP-10 as a surrogate marker of respiratory viral infections including SARS-CoV-2, Influenza A, Influenza B, Parainfluenza, or Respiratory syncytial virus. REVDx-501 is currently being developed as a point of care test kit with a simple to read visual readout which provides a result

4


in less than 15 minutes without the need for specialized instrumentation. Preliminary evaluation of clinical samples demonstrated good correlation between REVID and PCR for SARS-CoV-2 (100% positive agreement for replicating SARS-CoV-2 virus, 86% negative agreement for non-replicating or inactive SARS-CoV-2 virus). We have suspended development of REVTx-501 at this time to focus our resources on development of our therapeutic candidates.

Our Strategy

Our goal is to become a leading biopharmaceutical company focused on the development of therapeutics that modulate the immune system to prevent and treat conditions with significant unmet. The key components of our strategy are to:

Advance the development of REVTx-300 for the prevention of acute organ injury (including AKI) an treatment of chronic organ disease (including CKD).

Advance the development of REVTx-100 for the prevention and treatment of healthcare associated infection.

Advance the development of our intranasal product candidate, REVTx-200 for improving the immunity and durability of traditional IM vaccinations.

Advance the development of our intranasal product candidate, REVTx-99b for the treatment of food allergies.

Our Corporate History and Team

Revelation Biosciences, Inc. was formed on May 4, 2020 and is a Delaware corporation. We have assembled a management team of biopharmaceutical experts with extensive experience in drug development, manufacturing and commercialization of pharmaceutical products along with broad experience in building companies from inception, including La Jolla Pharmaceutical Company, Pluromed, Inc., and Horizon Pharma, Inc. We are also supported by a group of directors and leading investors whose collective experience will assist us in realizing our corporate strategy.

BACKGROUND

Infection Overview

Acute Organ Injury Overview

Acute organ injury may be caused by many different events, including blood or fluid loss (such as with bleeding or severe diarrhea), low blood pressure or shock leading to hypotension, heart failure or heart attack, overuse of certain pain medications including NSAIDs, ibuprofen, etc., toxicity due to chemotherapy, contrast agents, etc., burns, or major surgery. During surgery, ischemia or deprivation of blood supply to a tissue followed by the reperfusion or reintroduction of blood to prevent tissue necrosis can result in further damage and/or dysfunction to the organ.

AKI, also known as acute renal failure, is rapid loss of kidney function that onsets within a few hours or a few days. AKI causes a build-up of waste products in your blood and makes it hard for your kidneys to keep the right balance of fluid in your body. AKI can also affect other organs such as the brain, heart, and lungs. Due its severe nature, AKI an important contributor to increased hospital stay duration and patient morbidity as well as significantly increased healthcare costs.

AKI is a significant health problem that continues to grow especially in patients with co-existing conditions such as diabetes. Approximately 1% of all hospitalized patients having AKI upon admission. During all hospitalization, the approximate incidence rate of acute kidney injury is 2 to 5%. Development of AKI is even worse for patients admitted to the intensive care unit occurring in up to 67% of patients admitted.

5


AKI can have many different causes including decreased blood flow to the kidneys, direct damage to the kidneys or blockage of the kidney. AKI inducing events may include shock (low blood pressure), blood or fluid loss (such as bleeding, severe diarrhea), heart attack, heart failure, and other conditions leading to decreased heart function, organ failure (e.g., heart, liver), overuse of pain medicines such as NSAIDs, severe allergic reactions, burns, injury, infection (sepsis), cancer, toxicity (e.g. chemotherapies), hereditary factors or major surgery.

AKI is of particular concern after cardiac surgery and published evidence suggests that even slight postoperative increases in serum creatinine levels are associated with a significant increase in the risk of death. Up to 31% of patients undergoing cardiac surgery with no prior CKD develop post operative AKI with a high mortality rate. The average cost to treat AKI is about $46,000 and results in about a 4-7 day increase in hospitalization time.

Chronic Organ Disease Overview

Organ damage, due to chronic disease, is a pervasive problem in the United States and world-wide. Organ disease (due to chronic inflammation and subsequent fibrosis, for example) is progressive and ultimately results in loss of function of the organ. Examples of chronic organ and tissue disease include CKD through end-stage renal disease, liver diseases such as NASH, osteoarthritis, rheumatoid arthritis, pulmonary fibrotic disease, heart disease, pancreatitis, cancer, and irritable bowel syndrome.

In addition, acute organ stress may lead to reduced functionality and eventual decline, contributing to a chronic organ disease. One example of this is acute kidney toxicity (the stress) associated with platinum-based chemotherapy which could lead to the development of chronic kidney disease.

Kidney disease is a major public health problem, affecting ~10% of populations in industrialized countries. AKI, which affects 13.3 million people per year, may lead to CKD. Both AKI and CKD are increasing worldwide. Progression of chronic kidney damage often leads to end stage renal disease with the need for renal replacement therapy (dialysis or transplantation), resulting in significant morbidity and mortality for affected patients.

CKD can be initiated and propagated in several ways. One prevalent condition is the high blood sugar levels associated with diabetes (either Type 1 or requires usType 2). High blood sugar is toxic to kidney cells creating stress which imitates the inflammatory process leading to the demise of these cells with subsequent fibrosis ultimately resulting in continuous loss of kidney function over time. High arterial blood pressure is another source of stress that initiates the inflammatory process leading to CKD. Other risk factors include heart disease, obesity family history of CKD or older age.

Every day more than 360 people begin treatment for kidney failure (dialysis or transplant). According to the CDC, more than 1 in 7, that is 15% of US adults or 37 million people are estimated to have CKD. As many as 9 to 10 adults with CKD as well as about 2 in 5 adults with severe CKD do not know they have the disease. Kidney diseases are the leading cause of death in the United States. The CDC estimates Medicare costs in excess of $87 billion and continues to promote reduced costs including better management of CKD.

Other causes for CKD include: Glomerulonephritis (inflammation in the glomerulus), polycystic kidney disease, autoimmune diseases (such as systemic lupus erythematosus), vesicoureteral reflux (a condition where urine flows back up to the kidneys, pyelonephritis, interstitial nephritis (inflammation of the tubules), kidney stones, obstruction in kidney or cancer can lead to kidney failure over a minimum amountperiod of fundstime, overuse of certain medications, drug (heroin or cocaine) abuse, chemotherapy (such as cisplatin).

Healthcare Associated Infection Overview

Despite efforts to monitor and prevent infection in hospital care settings, HAI arise from a range of different causes including surgery, burn wounds, central line catheters or urinary catheters, and sepsis, as well as long courses of antibiotic treatment, which may lead to the development of MRSA. According to the most recent prevalence study data published by the Center for Disease Control and Prevention in 2015, approximately 3% of hospital patients suffered at least one HAI, and there were approximately 687,000 HAI cases in acute care settings resulting in approximately 72,000 deaths. According to the CDC, on any given day about 31 hospital patients has at least one healthcare-associated infection. A World Health Organization cooperative study which included 55 hospitals in 14

6


countries from four regions, approximately 8.7% of hospitalized patients developed infection within 48 hours of hospitalization (Tikhomirov 1987). The most common healthcare-associated infection are bloodstream infection, pneumonia, urinary tract infections, and surgical site infections.

Influenza Disease Overview

Influenza, or the flu, is caused by the influenza virus. There are four strains of influenza virus: influenza A (Alphainfluenzavirus), B (Betainfluenzavirus), C (Gammainfluenzavirus), and D (Deltainfluenzavirus). Through the hemagglutinin on the surface exterior, the influenza virus binds to sialic acid molecules attached to many proteins on the cell surface. Sialic acid is expressed ubiquitously on cell surface receptors throughout the body, which allows the virus to infect many different cell types.

Typically, influenza infects 5-15% of the global population each year. The majority of influenza infections are mild to moderate and symptoms include runny nose, cough, headache, muscle aches, fever, and chills. However, approximately 5% of all severe pneumonia cases in hospitals are due to influenza, which is also the most common cause of ARDS in adults.

The current prevalence of influenza worldwide is at 3 to 5 million cases per year, with 290,000 to 650,000 reported deaths according to the World Health Organization. While the impact of flu varies, it places a substantial burden on the health of people in the United States each year. CDC estimates that influenza has resulted in 9 to 45 million illnesses, 140,000 – 810,000 hospitalizations, and 12,000 – 61,000 deaths annually since 2010.

COVID-19 Disease Overview

COVID-19 is caused by the severe respiratory syndrome coronavirus 2, or SARS-CoV-2 virus. The SARS-CoV-2 virus is a positive sense, single stranded RNA virus. Through the spike protein subunit on the surface exterior, the SARS-CoV-2 virus binds to the ACEII receptor. Although the ACEII receptor is expressed on a wide range of tissues throughout the body, it appears the majority of the transmission of SARS-CoV-2 occurs in the nose, through the ciliated nasal goblet cells, and the nasal epithelial cells, where expression levels of ACEII are most prevalent (Sungnak 2020).

The majority of infections with SARS-CoV-2 are mild to moderate, and in some cases are completely asymptomatic. The symptoms associated with SARS-CoV-2 infection include shortness of breath or difficulty breathing, runny nose, dry cough, headache, diarrhea, muscle aches, fever, chills, and loss of smell and/or taste. In a small percentage (0.5-2%) of cases, serious illness occurs, leading to major complications including pneumonia and or trouble breathing, organ failure in several organs, heart problems, ARDS, blood clots, acute kidney injury, and potential further viral and bacterial infection.

As of October 2022 there have been over 96 million confirmed cases of COVID-19 and over one million deaths in the United States according to the CDC and there have been over 623 million confirmed cases of COVID-19 and over 6.5 million deaths worldwide according to the World Health Organization.

Food Allergy Overview

According to research performed by the Food Allergy Research & Education group, approximately 11% of adults in the United States have one or more food allergies with different levels of severity, which equates to approximately 32 million Americans, including 5.6 million children under age 18, and these numbers are increasing (FARE 2020). Each year in the US, 200,000 people require emergency medical care for allergic reactions to food. Most food allergies are diagnosed early in life and sometimes resolve over time, while other allergies develop later in life. It is estimated that caring for children with food allergies costs US families nearly $25 billion annually (FARE 2022).

As a Type I hypersensitivity, food allergies result in activation of a Th2-biased response to an antigen, resulting in allergen-specific IgE antibody production (Bousquet 2020). Allergen-specific IgE antibodies bind to mast cell and basophil receptors upon subsequent challenge with antigen, resulting in degranulation and release of inflammatory mediators (e.g., histamine, leukotrienes, tryptase). These mediators cause mobilization of basophils,

7


eosinophils, and T lymphocytes to the site of insult, as well as activation of T cells, which compound symptomology and enhance inflammation. Systemic responses, e.g., anaphylaxis, may also occur within minutes or hours post-challenge. Accordingly, there remains a significant need for effective therapies for treating and preventing allergic disease.

Current Prevention, Treatment, and Detection Options

Prevention and treatment of AKI

There are currently no therapeutics to prevent or treat AKI. Treatment for AKI requires hospitalization and intensive supportive care until kidney function recovers. In more serious cases, dialysis may be needed to help replace kidney function until your kidneys recover. The main treatment is to address what is causing your acute kidney injury.

Prevention and Treatment of Chronic Organ Disease

There are currently no effective therapies for treating chronic organ disease or therapies for preventing loss of function due to acute organ dysfunction, outside of steroidal treatment or organ transplantation. There is no cure for CKD but treatments may help manage symptoms or stop it from progressing. These treatments include life style changes to control health and weight, medications to control associated diseases such as high blood pressure or high cholesterol and for later stages, filtering the blood with a machine known as dialysis. Avoiding conditions or exposures that can harm the kidneys like certain medications or kidney infections is also beneficial.

In April 2021, The FDA approved the use of Farxiga (Dapagliflozin) to reduce the risk of kidney function decline, kidney failure, cardiovascular death and hospitalization for heart failure in adults who are at risk of disease progression. Farxiga was originally approved in 2014 for diabetic control in adults in addition to diet and exercise.

Still, at this time, there is a significant unmet need for therapies that slow disease progression and improve outcomes of patients with chronic kidney disease.

Prevention of Bacterial Infection

There are no recommended anti-bacterial prescriptions currently available for the prevention of infection. Measures commonly recommended for the prevention of bacterial infection are typically focused on the prevention of transmission, including regular hand washing, mask wearing, social distancing and/or self-isolation/self-quarantine, and cleaning potentially contaminated surfaces.

Treatment and Management of Bacterial Infection

Because the presence of bacteria in humans is ubiquitous, not all bacterial growth is considered pathogenic. Therefore, interpretation of patient bacterial cultures needs to take into account clinical presentation, patient immune status, reason for performing patient culture test, the testing procedure, and any alternate evidence of infection. Based on the source of infection and patient results, medical care may include administration of antibiotics, administration of anti-fungal or anti-viral medication, line removal, or surgical debridement as necessary.

In the case of antibiotic treatment, the typical course of treatment may require an initial empiric broad-spectrum antibiotic, later targeted to the organism detected, with consideration for the presence of multidrug resistant pathogens, specifically MRSA. Antibiotic resistance has become a major consideration in the treatment of yet-to-be diagnosed infections, as the number of antibiotic resistant strains have increased, and the over prescription of antibiotics further contributes to resistance.

Prevention and Treatment of Respiratory Viral Infection

Current therapies for preventing respiratory viral infections are limited. The main prophylaxis for preventing respiratory viral infections are vaccines. Each year, vaccines are developed and administered to prevent influenza. The effectiveness of these vaccines can be quite variable due to the ability of the influenza virus to mutate. According to the CDC, in some years, the influenza vaccine has been as low as 19% effective. Several vaccines have been developed

8


and approved for emergency use for the prevention of SARS-CoV-2. The main drawback to intramuscular vaccines is the durability of their imparted protection and their poor ability to provide a strong mucosal immunity.

Prevention or Treatment of Food Allergies

Prevention of food allergies is currently limited to the practice of active avoidance of known allergens. This can have a highly negative impact on patient’s quality of life, especially in the case of severe food allergies, in which avoidance may dictate declining normal social activities in which foods with knows allergens may be present.

Although several therapies are being developed, there is no cure for food allergies. The current standard of care for food allergies is allergen immunotherapy, which involves the progressive increase in exposure to allergens under controlled clinical conditions, which is time consuming and has as yet provided unpredictable efficacy. Palforzia is the only approved medication for food allergy, which has varied degrees of efficacy, dependent on age (Perkin, 2022), and peanut avoidance is recommended during treatment with Palforzia.

Detection Methods

While multiple test methods exist for the detection of respiratory viral infections, they have many limitations. These limitations include their inability to detect multiple virus types, turn-around time, sample collection and cost. The current gold-standard is the PCR assay. PCR testing is highly sensitive and can detect extremely low levels of genetic material of a specific organism, such as a virus, thus identifying the specific virus type. However, PCR tests are expensive, time-consuming, and can only detect virus types based on a specific “primer sequence” used when running the test. Because the PCR test requires this primer sequence, its utility in detecting new viral variants may be limited. PCR tests may also detect inactive, non-proliferating virus, leading to false positive results, in some cases several weeks after resolution of active infection. These limitations make the PCR test non-ideal for at-home testing or as a screening tool for respiratory viral infections.

Other methods for detecting viral infection include the rapid antigen test kits. While these methods can be performed relatively inexpensively and in an at-home test format, they also suffer from the trust accountsame limitation as PCR tests in that they are specific for the detection of a single virus type.

This limitation is illustrated in the following example: if you test a person infected with influenza using a SARS-CoV-2 test kit or a PCR test, the result would be limited to solely showing the individual is not infected with SARS-CoV-2, even though they actually are infected with a respiratory viral infection and should seek medical attention and/or self-quarantine.

REVELATION’S PROGRAMS

Scientific Rationale/Mechanism of Action

The innate immune system is our first line of defense against invading pathogens such as bacteria and viruses. The innate immune system defends against infection by producing and releasing various types of cytokines. Cytokines are proteins that direct different activities in cells to combat the invading pathogen, as well as stimulating recruitment of the adaptive immune system which ultimately leads to the production of antibodies. Cytokines can be inflammatory or protective, meaning they may be able to modulate certain established cellular activities. TLRs serve a vital role in initiating the innate immune system response by recognizing different molecular patterns associated with pathogens such as bacteria and viruses. For example, TLRs are associated with cells (e.g., macrophage, dendritic cells) found in the nasal mucosal tissue, and when a pathogen, such as a bacteria, invades through the nose, TLRs recognize the pathogen as foreign and activate the innate immune response, producing cytokines. Stimulation of TLR-4 by PHAD may modulate the cellular response, leading to the production of protective (non-inflammatory and regulatory) cytokines that have multiple therapeutic applications as illustrated in the following Figure.

Interaction of PHAD with TLR-4

9


img38676523_1.jpg

The active ingredient PHAD®, may interact with TLR-4 to stimulate the TRIF pathway leading to the production of protective and regulatory cytokines, including IP-10, IL-7, MCP-1, and TGF-b. Source: Revelation Biosciences

REVTx-300

Overview

REVTx-300 is being developed as a potential therapy for the prevention of acute organ injury such as AKI and as a treatment of chronic organ disease including CKD. REVTx-300 utilizes the active ingredient PHAD® and is formulated as a liquid for intravenous administration.

Acute organ injury may be caused by many different events, including blood or fluid loss (such as with bleeding or severe diarrhea), low blood pressure or shock leading to hypotension, heart failure or heart attack, overuse of certain pain medications including NSAIDs, ibuprofen, etc., toxicity due to chemotherapy, contrast agents, etc., burns, or major surgery. During surgery, ischemia or deprivation of blood supply to a tissue followed by the reperfusion or re-introduction of blood to prevent tissue necrosis can result in further damage and/or dysfunction to the organ. Chronic disease of an organ, due to chronic inflammation and subsequent fibrosis, follows a pattern of perpetual and ongoing destruction of living functional cells and subsequent replacement by the non-functional protein, collagen, resulting in fibrosis (scar tissue) (Wilson 2015). The establishment of fibrosis and subsequent death of the organ is driven by ongoing inflammatory processes and reactive oxygen species associated with the innate immune response. We believe redirection of the innate immune response with REVTx-300 from a pro-inflammatory state to an anti-inflammatory (protective) state may rebalance the innate immune response to slow down or halt the progressive destruction and scarring of organ tissue, allowing the healing process to take place.

Nonclinical

Revelation conducted a nonclinical study to evaluate the anti-fibrotic activity of REVTx-300. Specifically, a range of daily systemic dosing levels of REVTx-300 were tested in a rat Unilateral Ureteral Obstruction (UUO) model. The unilateral ureteral obstruction (UUO) model is appropriate for studying the anti-inflammatory and anti-fibrotic effects of potential new therapies for acute and chronic kidney disease as complete ureteral obstruction of one kidney results in significant inflammation and subsequent fibrosis of the affected kidney over a 7-day period.

The present study consisted of 6 groups with the following outcomes on renal cortical fibrosis as measured by detection of collagen deposition using picosirius red stained histology sections assessed at three different sampling depths.

10


img38676523_2.jpg

Revelation will continue evaluating the potential of REVTx-300 in additional preclinical models including CKD and myocarditis to identify optimal dosing conditions required for prevention and resolution of inflammation and fibrosis.

Clinical Development Plan

Revelation plans to initiate a Phase 1a clinical study in the second half of 2023 in healthy volunteers to evaluate the safety of systemically delivered REVTx-300 and investigate biomarkers to elucidate the pharmacokinetic/pharmacodynamic relationship. The proposed study will consist of cohorts of single ascending doses of REVTx-300. The primary readout will be safety with exploratory endpoints evaluating biomarkers.

The Phase 1a study will be followed by a phase 1b study in 2024 in patients undergoing cardiac surgery to establish proof-of-concept in preparation for phase 2. The proposed Phase 1b study will consist of a placebo group and low and high dose REVTx-300 groups. The primary readout will be safety with exploratory endpoints to evaluate biomarkers and rate, duration and severity of AKI.

REVTx-100

Overview

REVTx-100 is being developed, through a license agreement with Vanderbilt University, as a potential therapy for the prevention or treatment of healthcare-associated bacterial infection including post-surgical infection, post-burn infection, urinary tract infection (e.g. as a result of hospital-based or outpatient catheterization), sepsis, antibiotic-resistant infection, etc. We hypothesize controlled stimulation of TLR-4 will selectively prime the body’s immune system to be able to better respond to subsequent pathogen exposure.

As illustrated in the following figure, we hypothesize REVTx-100 will prime the body’s immune response to be able to better respond upon consummationexposure to a pathogen.

img38676523_3.jpg

11


Nonclinical studies

Multiple preclinical studies have shown that systemic pretreatment with PHAD results in significantly increased immune response with significantly reduced duration and severity of infection following bacterial challenge with either gram-positive or gram-negative bacteria as indicated in the following figures.

Pretreatment with PHAD Impart Protection from Gram Negative Bacterial Infection

img38676523_4.jpg

Pretreatment with PHAD Impart Protection from Gram Positive Bacterial Infection

img38676523_5.jpg

Clinical Development Plan

Revelation plans to initiate a Phase 1a clinical study in the second half of 2023 in healthy volunteers to evaluate the safety of systemically delivered REVTx-100 and investigate biomarkers to elucidate the pharmacokinetic/pharmacodynamic relationship. The proposed study will consist of cohorts of single ascending doses of REVTx-100. The primary readout will be safety with exploratory endpoints evaluating biomarkers.

The Phase 1a study will be followed by a phase 1b study in 2024 in patients undergoing colorectal surgery to establish proof-of-concept in preparation for phase 2. The proposed Phase 1b study will consist of a placebo group

12


and low and high dose REVTx-100 groups. The primary readout will be safety with exploratory endpoints to evaluate biomarkers, infection rate, duration and severity.

REVTx-200

Overview

REVTx-200 is being developed as a potential intranasal therapy that will be administered concurrently with a commercially available IM vaccine. We believe concurrent stimulation of the nasal mucosa with REVTx-200 upon IM vaccination will provide a more complete immunization. REVTx-200 utilizes the active ingredient PHAD®. Based on feedback from the FDA, we believe REVTx-200 will be regulated as a biologic, and not as a therapeutic, since it is concurrently administered with another vaccine. As such initial business combination, we believe the approval process will require its own unique development pathway to be approved for this use.

Most vaccinations for respiratory viruses (influenza, SARS-CoV-2) are being developed or have been developed for IM administration. It has been shown that IM vaccination results in a strong systemic immune response, but a weak mucosal immune response. Contrary to this, intranasal vaccination (e.g., FluMist®) has been shown to elicit a strong mucosal response and a moderate systemic response. We hypothesize that optimal protection from a vaccine requires both a systemic immune response elicited by the IM injection and a mucosal immune response developed by recruiting immune cells into the mucosal immune system.

Optimal protection from a vaccine requires both a systemic immune response elicited by the IM vaccine injection and a mucosal immune response elicited by the intranasal administration of REVTx-200. We hypothesize that intranasal administration of REVTx-200 will result in improved recruitment of vaccine-specific activated adaptive immune cells (e.g. T cells and B cells) into the nasal mucosa.

Biomarker data from our Phase 1 clinical study (RVL-NHV01) and Phase 2 virus challenge study (RVL-VRL01) supports this hypothesis. In particular, we were able to see increases in local (intranasal) IL-7 and MCP-1 as well as increased titers of antibodies specific to the viral challenge pathogen. IL-7 is a cytokine that induces the differentiation of hematopoietic stem cells into T cells, B cells, and NK cells. MCP-1 is a chemokine that recruits B cells and T cells to the site of application. In addition, MPLA has been reported to improve expression of T cell stimulatory co-factors such as CD80 to improve the engagement of the adaptive immune system. This data suggest intranasal REVTx-200 will traffic antigen activated B cells and T cells to the intranasal space.

Nonclinical studies

Revelation is currently conducting a preclinical study to evaluate improved mucosal immunity against a SARS-CoV-2 trimeric peptide vaccination administered intranasally or IM. Vaccine administered in conjunction with REVTx-200 will be evaluated relative to vaccination alone, through improved systemic and mucosal antibody titers, including the detection of an antigen specific antibody response. Additional endpoints will be evaluated to provide additional clarity on the impact of REVTx-200 on immune cell recruitment and activation. Additional nonclinical studies will be necessary to optimize the formulation and dosing regimen for REVTx-200.

REVTx-99b

Overview

REVTx-99b potentially engages three different aspects of the allergic response via stimulation of the TLR-4 pathway. These include (i) the possible induction of a physical barrier to allergens, (ii) the possible reduction of IgE secretion as a result of IFN upregulation and (iii) by secretion of IP-10 which competes for the native eotaxin receptor.

Stimulation of TLR-4 results in mobilization of exosomes from epithelia which can release antimicrobial peptides and nitric oxide that can destroy invading pathogens/antigens (Nocera 2018). TLR-4 stimulation also leads to generation of Type I interferons which block activation of Th2 cellular activity, resulting in reduced IgE secretion and reduction in allergic symptoms (Gonzalez-van Horn 2015). Type I IFN response results in the generation of IP-10, which is capable of binding to CCR3, the native receptor for eotaxin and is present on cells involved in the allergic

13


response, including eosinophils, basophils, and mast cells (Loetscher 2001). IP-10 binding to CCR3 prevents eotaxin from binding and recruiting immune cells, thereby reducing recruitment of Th2 cells and attenuating the allergic response.

Future development activities will include formulation development and optimization which is a key aspect for intranasal delivery. This formulation development will be done in conjunction with preclinical models (including an anaphylaxis model, in which administration of allergen will be followed by treatment with multiple dose levels of intranasal REVTx-99b. Resolution of symptoms will be assessed through the evaluation of local and systemic allergic endpoints, likely including IgE and IgG4 titers, tryptase, histamine, and eotaxin levels.

REVDx-501 (Diagnostic) Overview

REVDx-501 (REVIDTM Rapid Test Kit) is being developed as a rapid point of care in vitro diagnostic test (or diagnostic device) that has the potential to detect IP-10 as a surrogate marker of respiratory viral infections including SARS-CoV-2, Influenza A, Influenza B, parainfluenza, or respiratory syncytial virus. REVDx-501 is currently being developed as a point of care test kit with a simple to read visual readout which provides a result in less than 15 minutes without the need for specialized instrumentation. Sample collection is simply a swab of the anterior nares (nostrils) making sample collection easy. If approval is obtained, we anticipate the commercial version of the kit to be a self-contained, portable kit that can be shipped anywhere. The instructions will direct users with a positive result to seek confirmatory testing and/or medical treatment.

While the kit could potentially be used universally at home as a self-screening method a more practical and potential early use would be as a screening tool in healthcare facilities (e.g. hospitals and nursing homes) to allow for rapid triage and appropriate isolation of patients with potential respiratory infection.

In addition, the diagnostic can be used to increase the efficiency of PCR testing by eliminating wasted testing on subjects who are not infected with a viral infection. The figure below explains the concept of increasing the efficiency of PCR testing. The left panel shows the current state of PCR testing with most patients (>80%) being PCR negative for infection. The right panel shows the effect of the addition of the REVID screening test to rule out virus negative patients resulting in better utilization of the PCR test.

img38676523_6.jpg

The diagnostic is based on the knowledge that respiratory viral infection results in elevated nasal mucosal secretions containing specific cytokines (e.g., IP-10, IFN), which can be detected rapidly after exposure. One or more of these cytokines can be detected using a lateral flow assay format (e.g., home pregnancy kit) from a mucosal sample collected from the anterior nares.

Device Testing and Data supporting the potential utility of REVDx-501

Clinical samples were collected under protocol and with consent from volunteers presenting at a COVID-19 testing center. Participants included those presenting with symptoms including fever, cough, loss of taste or loss of smell as well as asymptomatic (no symptoms) subjects. For each subject, a sample was collected using the nasopharyngeal method and tested by PCR for SARS-CoV-2 and a second sample of the lower nose was collected using the REVDx-501 swab and tested using the REVDx-501 test method. The results shown below from this testing

14


showed REVDx-501 to have excellent correlation with PCR for replicating SARS-CoV-2 virus (100% positive agreement for replicating SARS-CoV-2 virus, 86% negative agreement for no replicating SARS-CoV-2 virus).

PCR vs. REVDx-501 Test Kit

 

PCR
POSITIVE

 

 

PCR
NEGATIVE

 

Test Kit POSITIVE

 

 

37

 

 

 

21

 

Test Kit NEGATIVE

 

 

0

 

 

 

132

 

TOTAL SAMPLES

 

 

37

 

 

 

153

 

Patients who reported symptoms of fever, cough, loss of taste or loss of smell were tested by REVDx-501 and PCR. REVDx-501 had a 0% false negative rate for replicating SARS-CoV-2. These results include patients who reported onset of symptoms within 24 hours of the test, which may make the diagnostic an earlier detection method than even PCR. In addition, the positive REVDx-501 results that were PCR negative for COVID-19 were likely caused by other viral infections. Source.

In addition to the clinical evaluation described above, the FDA recommends a series of validation studies for IVD devices prior to submission for approval. These studies are planned and ongoing and include limit of detection, inclusivity, cross-reactivity, flex, usability, and clinical evaluation studies.

The LOD, inclusivity, cross-reactivity, and flex test studies are generally analytical laboratory-based (“bench”) studies to test how well the diagnostic device can detect the chemical or pathogen the device is intended to measure, as well as under different conditions. Usability (human factors) studies are investigations that enable a device design team to improve the usability of their device to meet acceptable standards of risk — it informs the development team if the device kit and instructions for use are appropriate for typical users.

Generally, the final study is the clinical evaluation study, which is the largest study (at least 100 users). This study is considered the “real-world” testing of the product. Study participants will use the test kit as recommended in a clinical setting or a simulated clinical environment. The device test kit results are compared to a PCR assay, as the reference standard test. Overall, in order to be considered for marketing approval by FDA, users should have minimal issues using the test and the device test results should align very closely with the reference test.

We have suspended development of REVDx-501 to focus our resources on development of our therapeutic candidates.

Competition

The biopharmaceutical industry is intensely competitive and subject to rapid innovation and significant technological advancements. We believe the key competitive factors that will affect the development and commercial success of REVTx-300, REVTx-100, REVTx-200, REVTx-99b, and any future Program Product candidates are efficacy, safety and tolerability profile, reliability, convenience of dosing, price, the level of generic competition and reimbursement. We believe the key competitive factors that will affect the development and commercial success of REVDx-501 and any future product candidates are reliability, convenience, and price. Our competitors include multinational pharmaceutical companies, specialized biotechnology companies, universities, and other research institutions. A number of biotechnology and pharmaceutical companies are pursuing the development or marketing of pharmaceuticals that target the same diseases that we are targeting. A number of device companies are pursuing the development or marketing of devices in the same or similar space. Smaller or earlier-stage companies may also prove to be significant competitors, particularly through collaborative arrangements with large, established companies. Given the high incidence of respiratory viral infections, it is likely that the number of companies seeking to develop products and therapies for the prevention or treatment of viral infection, will increase.

If REVTx-300 is approved is approved for prevention or treatment for chronic kidney disease, we would face competition from currently approved and marketed products including Farxiga®. We would also have future competition that could arise from products currently in development.

15


If REVTx-100 is approved for prevention or treatment of infection, we would face competition from currently approved and marketed products including many antibiotics that are effective against non-resistant strains of bacteria. We would also have future competition that could arise from products currently in development.

If REVTx-200 is approved is approved as an intranasal adjunct for intramuscular vaccination, we would face competition from currently approved and marketed products including most intramuscular vaccine adjuvants, such as CpG 1018 (Dynavax). We would also have future competition that could arise from products currently in development.

If REVTx-99b is approved is approved is approved for prevention or treatment of food allergies, we would face competition from currently approved and marketed products including Palforzia® for prophylactic desensitization and epinephrine for acute anaphylactic shock due to exposure to a peanut allergen. We would also have future competition that could arise from products currently in development.

If REVDx-501 is approved, it will need to have more than $5,000,001 in net tangible assets upon consummationbe a stand alone test and this may force us to seek third party financing which maywill not be available on terms acceptableable to usbe combined with other diagnostic test and competition would arise from various companies and partnerships currently engaged in clinical studies with competing device concepts including: Quest Diagnostics, Inc., Laboratory Corporation of America Holdings, and Eurofins Advantar Laboratories. As well as from currently approved COVID-19 home test from Ellume Limited, MeMed, Abbot Laboratories, and Lucira Health.

Many of our competitors have substantially greater financial, technical, human and other resources than we do and may be better equipped to develop, manufacture and market technologically superior products. Mergers and acquisitions in the biotechnology and pharmaceutical industries may result in even more resources being concentrated among a smaller number of competitors. In addition, many of these competitors have significantly longer operating histories and greater experience than we have in undertaking nonclinical studies and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Many of our competitors have established distribution channels for the commercialization of their products, whereas we have no such channel or at all.capabilities. In addition, many competitors have greater name recognition and more extensive collaborative relationships. As a result, our competitors may obtain regulatory approval of their products more rapidly than we do or may obtain patent protection or other intellectual property rights that limit our ability to develop or commercialize our Program Products or any future product candidates. Our competitors may also develop and succeed in obtaining approval for drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than we are in manufacturing and marketing their products. If we are unable to compete effectively against these companies, then we may not be able to consummatecommercialize our product candidate or any future product candidates or achieve a competitive position in the market. This would adversely affect our ability to generate revenue. Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical study sites and enrolling patients for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs.

Manufacturing and Supply

We do not own or operate manufacturing facilities for the production of our Program Products or any other product candidates, nor do we have plans to develop our own manufacturing operations in the foreseeable future. We currently rely, and expect to continue to rely, on third parties for the manufacturing of our Program Products or any other product candidates for preclinical and clinical testing, as well as for commercial manufacturing if REVTx-300, REVTx-100, REVTx-200 or any future product candidate receives marketing approval. Also, we currently rely and continue to rely on third parties for the manufacturing and development of our diagnostic devices for clinical testing, as well as for commercial manufacturing if REVDx-501 gets marketing approval. Also, there is only one supplier for PHAD®, Avanti Polar Lipids, Inc., with whom we do not have a long-term supply agreement. Currently we have purchased enough material for our planned clinical studies through purchase orders.

Strategic Acquisitions and In-Licensing

We are working to deepen the pipeline of Revelation through both internal organic development of new technologies along with portfolio additions from acquisitions, strategic partnerships and in-licensing of new therapeutic product candidates. From time to time we enter into discussions regarding potential transactions; however,

16


our focus is on development of our existing pipeline and discussions with third parties to date have not progressed beyond the preliminary stage.

Vanderbilt License

On September 29, 2022, we entered into an exclusive worldwide license agreement with Vanderbilt University to develop and commercialize PHAD, for treating or preventing infections. The license grants Revelation the use of issued US patent 11,389,465.

We are obligated to use commercially reasonable efforts to (i) develop, commercialize, market and sell licensed products in a manner consistent with a development plan submitted to Vanderbilt by April 2023 and (ii) achieve certain financing, development, regulatory and clinical milestone events, including, among other things, raising $5 million in financing to advance the development program, commencement of various clinical trials by target dates according to the development plan and the filing of an IND by the end of 2032.

Under the license agreement we are obligated to make payments to Vanderbilt based upon achievement of certain milestones including achievement of various clinical trial events, regulatory approval and sales levels. In addition, we will pay royalties on sales of products using the licensed patent.

Vanderbilt has the right to terminate the license agreement if the development milestones are not made, subject to a six-month grace period.

Global Health

We entered into a Global Health Agreement (“GHA”) with AXA IM Prime Impact Fund on December 31, 2020. As part of the GHA for six years from December 31, 2020 (the “Term”) we will (i) provide REVTx-99a/b and REVDx-501 (the “GHA Program Products”), if approved by the FDA and/or the EMA, to non-profit organizations and public-sector purchasers (“Global Health Purchasers”) in certain low and middle income countries (as defined by the World Bank) (“Target Countries”), to be determined by the Global Access Committee (the “GAC”), at a price of no more than 30% above the cost of goods sold, (ii) make available up to 20% of the annual unit sales volume, (iii) allocate $50,000 per year to the GAC to work on training programs, and (iv) work with global health authorities to have the products added to protocols and treatment guidelines.

In the event that the GHA Program Products are acquired directly or through an acquisition of the Company by a third party the GHA shall continue to survive for the Term and shall be assumed by the acquirer. In the event that the Company (i) fails to use commercially reasonable efforts to obtain regulatory approvals as agreed by the GAC, (ii) fails to cure a non-compliance within the GHA, (iii) if we transfer the intellectual property and the successor fails to assume the GHA, or (iv) if the Company institutes any bankruptcy, reorganization, dissolution, liquidation, or similar proceeding, the Company will grant a nonexclusive, perpetual, irrevocable, non-terminable, fully paid up, royalty free license in the Target Countries for Global Health Purchasers.

Sales and Marketing

We currently have no marketing, sales or distribution capabilities. In order to commercialize any products that are approved for commercial sale, we must either develop a sales and marketing infrastructure or collaborate with third parties that have sales and marketing experience.

We may elect to establish our own sales force to market and sell a product for which we obtain regulatory approval if we expect that the geographic market for a product, we develop on our own is limited or that the prescriptions for the product will be written principally by a relatively small number of physicians. If we decide to market and sell any products ourselves, we do not expect to establish direct sales capability until shortly before the products are approved for commercial sale.

We plan to seek third-party support from established pharmaceutical and biotechnology companies for those products that would benefit from the promotional support of a large sales and marketing force. In these cases, we

17


might seek to promote our products in collaboration with marketing partners or rely on relationships with one or more companies with large established sales forces and distribution systems.

Intellectual Property

Our success depends in part on our ability to obtain and maintain proprietary protection for our product candidates, technology, and know-how, to operate without infringing upon the proprietary rights of others and to prevent others from infringing upon our proprietary rights. Our policy is to seek to protect our proprietary position by, among other methods, pursuing and obtaining patent protection in the United States and in jurisdictions outside of the United States related to our proprietary technology, inventions, improvements, and product candidates that are important to the development and implementation of our business. Our patent portfolio is intended to cover our product candidates and components thereof, their methods of use and processes for their manufacture, our kit designs, our proprietary reagents and assays, and any other inventions that are commercially important to our business. We also rely on trade secret protection of our confidential information and know-how relating to our proprietary technology, platforms, and product candidates.

As of March 21, 2023, our patent portfolio includes three U.S. provisional patent applications – one for REVTx-300, one for REVTx-99b and one for a new drug program. These provisional patent applications will be converted to utility patent applications prior to their respective 1-year anniversaries. Our portfolio includes three international PCT patent applications, two for REVTx-99b, and one for REVDx-501. In regard to our REVTx-99b program, one PCT patent application is directed to MPLA formulations including REVTx-99b and one PCT patent application is directed to the use of REVTx-99b for the treatment of allergic rhinitis and chronic nasal congestion. In regard to our REVDx-501 program, the PCT patent application has claims directed to the rapid detection kit and methods for detecting a signal of viral infection of the respiratory tract. The provisional application for REVTx-300 is directed to the use of MPLA formulations for the prevention of loss of function associated with chronic organ disease. The provisional application for REVTx-99b is directed to nasal administration of MPLA formulations as an adjuvant to traditional allergy immunotherapy, such as oral allergy immunotherapy.

We expect to file a non-provisional patent application prior to the twelve-month convention date for each provisional patent application. Our pending and future patent applications may not result in patents being issued which protect our technology or product candidates, or which effectively prevent others from commercializing competitive technologies and product candidates. Additionally, any U.S. provisional patent application that we file is not eligible to become an issued patent until, among other things, we file a non-provisional patent application within 12 months of filing the related provisional patent application. If we do not file a non-provisional patent application in a timely manner, we may lose our priority date with respect to the provisional patent application, and may lose the ability to obtain any associated patent protection on the inventions disclosed in the provisional patent application.

Generally, issued patents are granted a term of 20 years from the earliest claimed non-provisional filing date. In certain instances, patent term can be adjusted to recapture a portion of delay incurred by the USPTO in examining the patent application (patent term adjustment, or PTA) or extended to account for term effectively lost as a result of the FDA regulatory review period (patent term extension, or PTE), or both. In addition, we cannot provide any assurance that any patents will be issued from our pending or future applications or that any issued patents will adequately protect our products or product candidates.

We believe that we have certain know-how and trade secrets relating to our technology and product candidates. We rely on trade secrets to protect certain aspects of our technology related to our current and future product candidates. However, trade secrets can be difficult to protect. We seek to protect our trade secrets, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors, service providers, and contractors. We also seek to preserve the integrity and confidentiality of our data and trade secrets by maintaining physical security of our premises and physical and electronic security of our information technology systems.

Employees

As of March 21, 2023, we had 6 full-time employees, 2 of whom are engaged in research and development activities or operations and 4 of whom are engaged in general and administrative activities or operations. None of our

18


employees are represented by a labor union or covered by a collective bargaining agreement. We consider our relationship with our employees to be good.

Legal Proceedings

On February 18, 2022, LifeSci Capital LLC filed an action against the Company in the U.S. District Court for the Southern District of New York seeking damages in the amount of approximately $2.7 million in cash and $2.6 million in equity for unpaid banking and advisory fees. These fees arise under contracts which were entered into prior to the Business Combination and the Company is disputing the amount owed under those contracts and has asserted affirmative defenses including the defense that the amount of the fees sought exceeded the $8.5 million cap on transaction expenses in the Business Combination Agreement. This action remains pending as of the date of this report. On March 2, 2023, the court denied the plaintiff’s motion for summary judgment. As of the date of this report, the court has not set any schedule for discovery or a timetable for any trial.

Of the LifeSci Capital LLC claim, $1.5 million relates to deferred underwriting fees from the Petra initial public offering. In addition, but separate from the claim, one of the underwriters in the Petra initial public offering who is not a participant in the litigation with LifeSci Capital LLC recently issued a demand letter seeking repayment for $655 thousand in fees owed from the Petra initial public offering that remain unpaid. Both of these amounts are recorded as a current liability in the financial statements as of December 31, 2022 under deferred underwriting commissions. No other liabilities are reflected in the financial statements as the amount of any additional liability cannot be determined at this time.

On September 27, 2022, A-IR Clinical Research Ltd. (“A-IR”) filed a claim against the Company in the High Court of Justice, in the Business and Property Courts of England and Wales, seeking £1.6 million in unpaid invoices, plus interest and costs, relating to the Company’s viral challenge study. The Company is disputing the claim because many of the invoices relate to work that was not performed and A-IR had misrepresented its qualifications to perform the contracted work. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

On January 30, 2023, Marwood Advisory Group, LLC filed an action in the Supreme Court of New York for the County of New York seeking damages in the amount of $150,000 plus interest in respect of a contract agreed by the sponsors of Petra allegedly relating to a due diligence report with another target considered by Petra prior to the Business Combination. The Company believes it has defenses to this claim and as of the date of this report no answer is due. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

Government Regulation

The FDA and other regulatory authorities at federal, state and local levels, as well as in foreign countries, extensively regulate, among other things, the research, development, testing, manufacture, quality control, import, export, safety, effectiveness, labeling, packaging, storage, distribution, recordkeeping, approval, advertising, promotion, marketing, post-approval monitoring and post-approval reporting of drugs. We, along with our vendors, contract research organizations, or CROs, clinical investigators and contract manufacturing organizations, or CMOs will be required to navigate the various preclinical, clinical, manufacturing and commercial approval requirements of the governing regulatory agencies of the countries in which we wish to conduct studies or seek approval of our product candidates. The process of obtaining regulatory approvals of drugs and ensuring subsequent compliance with appropriate federal, state, local and foreign statutes and regulations requires the expenditure of substantial time and financial resources.

In the United States, the FDA regulates drug products under the FD&C Act, its implementing regulations, and other federal, state and local statutes and regulations. Drugs are also subject to other federal, state and local statutes and regulations. If we fail to comply with applicable FDA or other requirements at any time with respect to product development, clinical testing, approval or any other regulatory requirements relating to product manufacture, processing, handling, storage, quality control, safety, marketing, advertising, promotion, packaging, labeling, export, import, distribution, or sale, we may become subject to administrative or judicial sanctions or other legal consequences. These sanctions or consequences could include, among other things, the FDA’s refusal to approve

19


pending applications, issuance of clinical holds for ongoing studies, suspension or revocation of approved applications, warning or untitled letters, product withdrawals or recalls, product seizures, relabeling or repackaging, total or partial suspensions of manufacturing or distribution, injunctions, fines, civil penalties or criminal prosecution.

Our product candidates must be approved for therapeutic indications by the FDA before they may be marketed in the United States. For drug product candidates regulated under the FD&C Act, FDA must approve a NDA. The process generally involves the following:

completion of extensive preclinical studies in accordance with applicable regulations, including studies conducted in accordance with good laboratory practice, or GLP, requirements;

completion of the manufacture, under current Good Manufacturing Practices (“cGMP”), conditions, of the drug substance and drug product that the sponsor intends to use in human clinical trials along with required analytical and stability testing;

submission to the FDA of an investigational new drug application, or IND, which must become effective before clinical trials may begin and must be updated annually and when certain changes are made;

approval by an institutional review board, or IRB, or independent ethics committee at each clinical trial site before each trial may be initiated;

performance of adequate and well-controlled clinical trials in accordance with applicable IND regulations, good clinical practice, or GCP, requirements and other clinical trial-related regulations to establish the safety and efficacy of the investigational product for each proposed indication;

preparation and submission to the FDA of an NDA;

a determination by the FDA within 60 days of its receipt of an NDA to file the application for review;

satisfactory completion of one or more FDA pre-approval inspections of the manufacturing facility or facilities where the drug will be produced to assess compliance with cGMP requirements to assure that the facilities, methods and controls are adequate to preserve the drug’s identity, strength, quality and purity;

satisfactory completion of FDA audit of the clinical trial sites that generated the data in support of the NDA;

payment of user fees for FDA review of the NDA; and

FDA review and approval of the NDA, including, where applicable, consideration of the views of any FDA advisory committee, prior to any commercial marketing or sale of the drug in the United States.

Preclinical studies and the IND process — Therapeutics

Preclinical studies include laboratory evaluation of product chemistry and formulation, as well as in vitro and animal studies to assess the potential for adverse events and in some cases to establish a rationale for therapeutic use. The conduct of preclinical studies is subject to federal regulations and requirements, including GLP regulations. An IND sponsor must submit the results of the preclinical tests, together with manufacturing information, analytical data, any available clinical data or literature and a proposed protocol for clinical studies, among other things, to the FDA as part of an IND. An IND is an exemption from the FD&C Act that allows an unapproved product candidate to be shipped in interstate commerce for use in an investigational clinical study and is a request for FDA authorization to administer such investigational product to humans. Such authorization must be secured prior to interstate shipment and administration of any product candidate that is not the subject of an approved application. Some long-term preclinical testing, such as animal tests of reproductive adverse events and carcinogenicity, may continue after the IND is submitted. An IND automatically becomes effective 30 days after receipt by the FDA, unless before that time the FDA raises concerns or questions related to one or more proposed clinical studies and places the study on clinical

20


hold. In such a case, the IND sponsor and the FDA must resolve any outstanding concerns before the clinical study can begin. As a result, submission of an IND may not necessarily result in the FDA allowing clinical studies to commence.

Clinical studies — Therapeutics

Clinical studies involve the administration of the investigational new drug to human subjects — healthy volunteers or patients — under the supervision of qualified investigators in accordance with GCP requirements, which include, among other things, the requirement that all research subjects provide their informed consent in writing before their participation in any clinical study. Clinical studies are conducted under written study protocols detailing, among other things, the objectives of the study, the parameters to be used in monitoring safety and the effectiveness criteria to be evaluated. A protocol for each clinical study and any subsequent protocol amendments must be submitted to the FDA as part of the IND. In addition, an IRB at each institution participating in the clinical study must review and approve the plan for any clinical study before it commences at that institution, and the IRB must conduct continuing review and reapprove the study at least annually. The IRB must review and approve, among other things, the study protocol and informed consent information to be provided to study subjects. An IRB may also require the clinical study at the site to be halted, either temporarily or permanently, for failure to comply with the IRB’s requirements, or may impose other conditions. For clinical studies involving an IND, an IRB must operate in compliance with FDA regulations. Additionally, some studies are overseen by an independent group of qualified experts organized by the study sponsor, known as a DSMB. This group provides authorization as to whether or not a study may move forward at designated check points based on access that only the DSMB maintains to available data from the study.

Human clinical studies are typically conducted in three sequential phases, which may overlap or be combined:

Phase 1: The investigational drug or biological product is initially introduced into healthy human subjects or patients with the target disease or condition and tested for safety, side effects associated with increasing doses, pharmacological action, absorption, metabolism, distribution, excretion and, if possible, to gain an early indication of its effectiveness.

Phase 2: The investigational drug or biological product is administered to a limited patient population to identify common adverse effects and safety risks, to preliminarily evaluate the efficacy of the product for specific targeted diseases and to determine dosage tolerance and optimal dosage. This phase may include administration of the investigational drug to patients with concomitant disease conditions.

Phase 3: The investigational drug or biological product is administered to an expanded patient population in adequate and well-controlled clinical studies, typically at geographically dispersed clinical study sites, to generate sufficient data to statistically confirm the efficacy and safety of the product for approval, to permit the FDA to evaluate the overall risk-benefit profile of the product and to provide adequate information for the labeling of the product. More than one adequate and well-controlled Phase 3 clinical study may be required by the FDA for approval of an NDA.

Progress reports detailing the results of clinical studies involving an IND must be submitted at least annually to the FDA and more frequently if serious adverse events occur. Phase 1, Phase 2 and Phase 3 clinical studies may not be completed successfully within any specified period, or at all. Furthermore, the FDA or the sponsor may suspend or terminate a clinical study at any time on various grounds, including a finding that the research subjects are being exposed to an unacceptable health risk. Similarly, an IRB can suspend or terminate approval of a clinical study at its institution if the clinical study is not being conducted in accordance with the IRB’s requirements or if the drug or biologic product has been associated with unexpected serious harm to patients.

Concurrent with clinical studies, the company usually complete additional animal studies, develop additional information about chemistry and physical characteristics of the product candidate, and finalize a process for manufacturing the drug product in commercial quantities in accordance with cGMP requirements. The manufacturing must be capable of consistently producing quality batches of the product candidate and manufacturers must develop, among other things, methods for testing the identity, strength, quality and purity of the final drug product.

21


Additionally, appropriate packaging must be selected and tested, and stability studies must be conducted to demonstrate that the product candidate does not undergo unacceptable deterioration over its shelf life.

In some cases, the FDA may approve an application for a product candidate but require the sponsor to conduct additional clinical studies to further assess the product candidate’s safety and effectiveness after approval. Such post-approval studies are typically referred to as Phase 4 clinical studies. These studies are used to gain additional experience from the treatment of a larger number of patients in the intended treatment group and to further document a clinical benefit in the case of drugs approved under accelerated approval regulations.

Clinical studies — Device

Clinical studies are almost always required to support pre-market approval and are sometimes required for 510(k) clearance or de novo clearance. In the United States, for significant risk devices, these studies require submission of an application for an IDE to the FDA. The IDE application must be supported by appropriate data, such as animal and laboratory testing results, showing it is safe to test the device in humans and that the testing protocol is scientifically sound. The IDE must be approved in advance by the FDA for a specific number of patients at specified study sites. During the study, the sponsor must comply with the FDA’s IDE requirements for investigator selection, study monitoring, reporting and recordkeeping. The investigators must obtain patient informed consent, rigorously follow the investigational plan and study protocol, control the disposition of investigational devices and comply with all reporting and recordkeeping requirements. Clinical studies for significant risk devices may not begin until the IDE application is approved by the FDA and the appropriate IRBs at the clinical study sites. An IRB is an appropriately constituted group that has been formally designated to review and monitor medical research involving subjects and which has the authority to approve, require modifications in, or disapprove research to protect the rights, safety, and welfare of human research subjects. A nonsignificant risk device does not require FDA approval of an IDE; however, the clinical study must still be conducted in compliance with various requirements of FDA’s IDE regulations and be approved by an IRB at the clinical study sites. The FDA or the IRB at each site at which a clinical study is being performed may withdraw approval of a clinical study at any time for various reasons, including a belief that the risks to study subjects outweigh the benefits or a failure to comply with FDA or IRB requirements. Even if a study is completed, the results of clinical testing may not demonstrate the safety and effectiveness of the device, may be equivocal or may otherwise not be sufficient to obtain approval or clearance of the product.

Sponsors of clinical studies of devices are required to register with clinicaltrials.gov, a public database of clinical study information. Information related to the device, patient population, phase of investigation, study sites and investigators and other aspects of the clinical study is made public as part of the registration.

U.S. Marketing approval — Therapeutics

Assuming successful completion of the required clinical testing, the results of the preclinical and clinical studies, together with detailed information relating to the product’s pharmacology chemistry, manufacture, controls and proposed labeling, among other things, are submitted to the FDA as part of an NDA or BLA requesting approval to market the product for one or more indications. FDA approval of the NDA or BLA is required before marketing of the product may begin in the United States. Under federal law, the submission of most NDAs and BLAs is subject to a substantial application user fee, and the sponsor of an approved NDA or BLA is also subject to annual product or program fees. These fees may be increased or decreased annually.

The FDA conducts a preliminary review of all NDAs and BLAs within the first 60 days after receipt before accepting them for filing based on the agency’s threshold determination that they are sufficiently complete to permit substantive review. The FDA may request additional information rather than accept an NDA or BLA for filing. In this event, the application must be resubmitted with the additional information, which would also be subject to review before the FDA accepts it for filing. Once the submission is accepted for filing, the FDA begins an in-depth substantive review. The FDA has agreed to specified performance goals in the review of NDAs and BLAs. Most such applications for non-priority products are reviewed within ten to twelve months after filing, and most applications for priority review products, that is, drugs and biologics that the FDA determines represent a significant improvement over existing therapy, are reviewed in six to eight months after filing. The review process may be extended by the FDA for three additional months to consider certain late-submitted information or clarification regarding information already provided in the submission. The FDA may also refer applications for novel drugs or biological products or products that present difficult questions of safety or efficacy to an advisory committee, typically a panel that includes clinicians

22


and other experts, for review, evaluation and a recommendation as to whether the application should be approved. The FDA is not bound by the recommendations of an advisory committee, but it considers such recommendations carefully when making decisions.

Before approving an NDA or BLA, the FDA typically will inspect the facility or facilities where the product is manufactured. The FDA will not approve an application unless it determines that the manufacturing processes and facilities are in compliance with cGMP requirements and adequate to assure consistent production of the product within required specifications. In addition, before approving an NDA or BLA, the FDA will typically inspect one or more clinical sites to assure compliance with GCP and integrity of the clinical data submitted.

The testing and approval process requires substantial time, effort and financial resources, and each may take many years to complete. Data obtained from clinical activities are not always conclusive and may be susceptible to varying interpretations, which could delay, limit or prevent regulatory approval. We may encounter difficulties or unanticipated costs in our efforts to develop our product candidates and secure necessary governmental approvals, which could delay or preclude us from marketing our products.

After the FDA’s evaluation of the NDA or BLA and inspection of the manufacturing facilities, the FDA may issue an approval letter or a complete response letter. An approval letter authorizes commercial marketing of the drug or biological product with specific prescribing information for specific indications. A complete response letter generally outlines the deficiencies in the submission and may require substantial additional testing or information in order for the FDA to reconsider the application. If and when those deficiencies have been addressed to the FDA’s satisfaction in a resubmission of the NDA, the FDA will issue an approval letter. The FDA has committed to reviewing such resubmissions in two or six months depending on the type of information included. Even with submission of this additional information, the FDA ultimately may decide that the application does not satisfy the regulatory criteria for approval.

Even if the FDA approves a product, the agency may limit the approved indications for use for the product, require that contraindications, warnings or precautions be included in the product labeling, require that post-approval studies be conducted to further assess a drug’s safety after approval, require testing and surveillance programs to monitor the product after commercialization, or impose other conditions, including distribution restrictions through a Risk Evaluation and Mitigation Strategy or other risk management mechanisms, which can materially affect the potential market and profitability of the product. The FDA may prevent or limit further marketing of a product based on the results of post-market studies or surveillance programs. After approval, some types of changes to the approved product, such as changes in indications, manufacturing changes and labeling, are subject to further testing requirements and FDA review and approval.

FDA’s Pre-market Clearance and Approval Requirements — Device

In vitro diagnostic tests such as our REVDx-501 diagnostic program is regulated as medical devices. Each medical device we seek to commercially distribute in the United States will require either a prior 510(k) clearance, de novo classification or PMA, unless it is exempt, or a pre-market approval from the FDA. In the United States, the FD&C Act, and its implementing regulations, and other federal and state statutes and regulations govern, among other things, medical device design and development, preclinical and clinical testing, premarket clearance or approval, registration and listing, manufacturing, labeling, storage, advertising and promotion, sales and distribution, export and import, and post-market surveillance. Unless an exemption or FDA exercise of enforcement discretion applies, diagnostic tests generally require marketing clearance or approval from the FDA prior to commercialization. The primary types of FDA marketing authorization applicable to a medical device are clearance of a premarket notification, 510(k), or de novo classification, and approval of a PMA.

To obtain 510(k) clearance for a medical device, or for certain modifications to devices that have received 510(k) clearance, a manufacturer must submit a premarket notification demonstrating that the proposed device is substantially equivalent to a previously cleared 510(k) device or to a pre-amendment device that was in commercial distribution before May 28, 1976, or a predicate device, for which the FDA has not yet called for the submission of a PMA. In making a determination that the device is substantially equivalent to a predicate device, the FDA compares the proposed device to the predicate device and assesses whether the subject device is comparable to the predicate device with respect to intended use, technology, design and other features which could affect safety and effectiveness. If the FDA determines that the subject device is substantially equivalent to the predicate device, the subject device

23


may be cleared for marketing. The 510(k) premarket notification pathway generally takes from three to twelve months from the date the application is completed, but can take significantly longer.

The de novo classification process, provides a pathway to classify novel medical devices for which general controls alone, or general and special controls, provide reasonable assurance of safety and effectiveness for the intended use, but for which there is no legally marketed predicate device. A de novo classification is a risk-based classification process through which devices are classified into class I or class II. Devices classified in response to a de novo classification request may be marketed and used as predicates for future premarket notification 510(k) submissions.

A PMA must be supported by valid scientific evidence, which typically requires extensive data, including technical, preclinical, clinical and manufacturing data, to demonstrate to the FDA’s satisfaction the safety and effectiveness of the device. For diagnostic tests, a PMA typically includes data regarding analytical and clinical validation studies. As part of its review of the PMA, the FDA will conduct a pre-approval inspection of the manufacturing facility or facilities to ensure compliance with the quality system regulation, or QSR, which requires manufacturers to follow design, testing, control, documentation and other quality assurance procedures. The FDA’s review of an initial PMA is required by statute to take between six to ten months, although the process typically takes longer, and may require several years to complete. If the FDA evaluations of both the PMA and the manufacturing facilities are favorable, the FDA will either issue an approval letter or an approvable letter, which usually contains a number of conditions that must be met in order to secure the final approval of the PMA. If the FDA’s evaluation of the PMA or manufacturing facilities is not favorable, the FDA will deny the approval of the PMA or issue a not approvable letter. A not approvable letter will outline the deficiencies in the application and, where practical, will identify what is necessary to make the PMA approvable. Once granted, PMA approval may be withdrawn by the FDA if compliance with post-approval requirements, conditions of approval or other regulatory standards is not maintained or problems are identified following initial marketing.

We expect that REVDx-501 will be subject to review as a de novo clearance. A de novo clearance pathway may be a lengthier and a more rigorous process than the 510(k) clearance pathway, which may delay or terminate this program down the road, which could adversely affect our ability to grow our business.

Ongoing Regulation by the FDA — Device

Even after a device receives clearance or approval and is placed on the market, numerous regulatory requirements apply. These include:

establishment registration and device listing;

the QSR, which requires manufacturers, including third-party manufacturers, to follow stringent design, testing, control, documentation and other quality assurance procedures during all aspects of the manufacturing process;

labeling regulations and the FDA prohibitions against the promotion of products for uncleared, unapproved or “off-label” uses, and other requirements related to promotional activities;

medical device reporting regulations, which require that manufactures report to the FDA if their device may have caused or contributed to a death or serious injury, or if their device malfunctioned and the device or a similar device marketed by the manufacturer would be likely to cause or contribute to a death or serious injury if the malfunction were to recur;

corrections and removal reporting regulations, which require that manufactures report to the FDA field corrections or removals if undertaken to reduce a risk to health posed by a device or to remedy a violation of the FD&C Act that may present a risk to health; and

post market surveillance regulations, which apply to certain Class II or III devices when necessary to protect the public health or to provide additional safety and effectiveness data for the device.

24


After a device receives 510(k) clearance or de novo classification, any modification that could significantly affect its safety or effectiveness, or that would constitute a major change in its intended use, will require a new clearance or possibly a pre-market approval. The FDA requires each manufacturer to make this determination initially, but the FDA can review any such decision and can disagree with a manufacturer’s determination. If the FDA disagrees with our determination not to seek a new 510(k) clearance, the FDA may retroactively require us to seek 510(k) clearance or possibly a pre-market approval. The FDA could also require us to cease marketing and distribution and/or recall the modified device until 510(k) clearance or pre-market approval is obtained. Also, in these circumstances, we may be subject to significant regulatory fines and penalties.

Some changes to an approved PMA device, including changes in indications, labeling or manufacturing processes or facilities, require submission and FDA approval of a new PMA or PMA supplement, as appropriate, before the change can be implemented. Supplements to a PMA often require the submission of the same type of information required for an original PMA, except that the supplement is generally limited to that information needed to support the proposed change from the device covered by the original PMA. The FDA uses the same procedures and actions in reviewing PMA supplements as it does in reviewing original PMAs.

FDA regulations require us to register as a medical device manufacturer with the FDA. Additionally, the CDHS, requires us to register as a medical device manufacturer within the state. Because of this, the FDA and the CDHS inspect us on a routine basis for compliance with the QSR. These regulations require that we manufacture our products and maintain related documentation in a prescribed manner with respect to manufacturing, testing and control activities. We have undergone and expect to continue to undergo regular QSR inspections in connection with the manufacture of our products at our facilities. Further, the FDA requires us to comply with various FDA regulations regarding labeling. Failure by us or by our suppliers to comply with applicable regulatory requirements can result in enforcement action by the FDA or state authorities, which may include any of the following sanctions:

warning or untitled letters, fines, injunctions, consent decrees and civil penalties;

customer notifications, voluntary or mandatory recall or seizure of our products;

operating restrictions, partial suspension or total shutdown of production;

delay in processing submissions or applications for new products or modifications to existing products

withdrawing approvals that have already been granted; and

criminal prosecution.

The Medical Device Reporting laws and regulations require us to provide information to the FDA when we receive or otherwise become aware of information that reasonably suggests our device may have caused or contributed to a death or serious injury as well as a device malfunction that likely would cause or contribute to death or serious injury if the malfunction were to recur. In addition, the FDA prohibits an approved device from being marketed for off-label use. The FDA and other agencies actively enforce the laws and regulations prohibiting the promotion of off-label uses, and a company that is found to have improperly promoted off-label uses may be subject to significant liability, including substantial monetary penalties and criminal prosecution.

Newly discovered or developed safety or effectiveness data may require changes to a product’s labeling, including the addition of new warnings and contraindications, and also may require the implementation of other risk management measures. Also, new government requirements, including those resulting from new legislation, may be established, or the FDA’s policies may change, which could delay or prevent regulatory clearance or approval of our products under development.

We are also subject to other federal, state and local laws and regulations relating to safe working conditions, laboratory and manufacturing practices.

European Union

25


We anticipate that our products will be regulated in the European Union as medical devices per the European Union Directive (93/42/EEC), also known as the Medical Device Directive. An authorized third party, Notified Body, must approve products for CE marking. The CE Mark is contingent upon continued compliance to the applicable regulations and the quality system requirements of the ISO 13485 standard.

Other Regions

Most major markets have different levels of regulatory requirements for medical devices. Modifications to the cleared or approved products may require a new regulatory submission in all major markets. The regulatory requirements, and the review time, vary significantly from country to country. Products can also be marketed in other countries that have minimal requirements for medical devices.

Other U.S. Healthcare Laws and Compliance Requirements

In the United States, our current and future operations are subject to regulation by various federal, state and local authorities in addition to the FDA, including but not limited to, the CMS, other divisions of the HHS (such as the Office of Inspector General, Office for Civil Rights and the Health Resources and Service Administration), the U.S. Department of Justice, and state and local governments. For example, our clinical research, sales, marketing and scientific/educational grant programs may have to comply with the anti-fraud and abuse provisions of the Social Security Act, the false claims laws, the privacy and security provisions of HIPAA, and similar state laws, each as amended, as applicable.

The federal Anti-Kickback Statute prohibits, among other things, any person or entity from knowingly and willfully offering, paying, soliciting or receiving any remuneration, directly or indirectly, overtly or covertly, in cash or in kind, to induce or in return for purchasing, leasing, ordering or arranging for the purchase, lease or order of any item or service reimbursable, in whole or in part, under Medicare, Medicaid or other federal healthcare programs. The term remuneration has been interpreted broadly to include anything of value. The Anti-Kickback Statute has been interpreted to apply to arrangements between therapeutic product manufacturers on one hand and prescribers, purchasers, and formulary managers on the other.

There are a number of statutory exceptions and regulatory safe harbors protecting some common activities from prosecution. The exceptions and safe harbors are drawn narrowly and practices that involve remuneration that may be alleged to be intended to induce prescribing, purchasing or recommending may be subject to scrutiny if they do not qualify for an exception or safe harbor. Failure to meet all of the requirements of a particular applicable statutory exception or regulatory safe harbor does not make the conduct per se illegal under the Anti-Kickback Statute. Instead, the legality of the arrangement will be evaluated on a case-by-case basis based on a cumulative review of all of its facts and circumstances. Our practices may not in all cases meet all of the criteria for protection under a statutory exception or regulatory safe harbor. The statutory exceptions and regulatory safe harbors are also subject to change.

Additionally, the intent standard under the Anti-Kickback Statute was amended by the Affordable Care Act, to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. In addition, the Affordable Care Act also codified case law that a claim including items or services resulting from a violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the federal FCA (discussed below).

The federal false claims and civil monetary penalty laws, including the FCA, which imposes significant penalties and can be enforced by private citizens through civil qui tam actions, prohibit any person or entity from, among other things, knowingly presenting, or causing to be presented, a false or fraudulent claim for payment to, or approval by, the federal government, including federal healthcare programs, such as Medicare and Medicaid; knowingly making, using, or causing to be made or used a false record or statement material to a false or fraudulent claim to the federal government; or knowingly making a false statement to improperly avoid, decrease or conceal an obligation to pay money to the federal government. A claim includes “any request or demand” for money or property presented to the U.S. government. Although we would not submit claims directly to payors, manufacturers can be held liable under these laws if they are deemed to “cause” the submission of false or fraudulent claims by, for example, providing inaccurate billing or coding information to customers or promoting a product off-label. In addition, our future activities relating to the reporting of wholesaler or estimated retail prices for our products, the reporting of

26


prices used to calculate Medicaid rebate information and other information affecting federal, state, and third-party reimbursement for our products, and the sale and marketing of our products, are subject to scrutiny under this law. For example, pharmaceutical companies have been prosecuted under the FCA in connection with their alleged off-label promotion of drugs, purportedly concealing price concessions in the pricing information submitted to the government for government price reporting purposes, and allegedly providing free product to customers with the expectation that the customers would bill federal health care programs for the product.

HIPAA created additional federal criminal statutes that prohibit, among other things, knowingly and willfully executing, or attempting to execute, a scheme to defraud or to obtain, by means of false or fraudulent pretenses, representations or promises, any money or property owned by, or under the control or custody of, any healthcare benefit program, including private third-party payors, willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up by trick, scheme or device, a material fact or making any materially false, fictitious or fraudulent statement in connection with the delivery of or payment for healthcare benefits, items or services. Like the Anti-Kickback Statute, the Affordable Care Act amended the intent standard for certain healthcare fraud statutes under HIPAA such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation.

Also, many states have similar, and typically more prohibitive, fraud and abuse statutes or regulations that apply to items and services reimbursed under Medicaid and other state programs, or, in several states, apply regardless of the payor.

In addition, we may be subject to data privacy, data security and data breach notification laws, regulations, standards, and codes of conduct by both the U.S. federal government and the states. These laws, regulations, standards, and codes of conduct may govern the collection, use, disclosure and protection of health-related and other personal information. HIPAA, as amended by the HITECH, imposes requirements relating to the privacy, security and transmission of individually identifiable health information. HIPAA requires covered entities to limit the use and disclosure of protected health information to specifically authorized situations and requires covered entities to implement security measures to protect health information that they maintain in electronic form. The federal government may impose civil, criminal, and administrative fines and penalties and/or additional reporting or oversight obligations for a violation of HIPAA’s requirements. Among other things, HITECH makes HIPAA’s privacy and security standards directly applicable to business combinationassociates that receive or obtain protected health information in connection with providing a service on behalf of a covered entity.

HITECH also created four new tiers of civil monetary penalties, amended HIPAA to make civil and criminal penalties directly applicable to business associates, and gave state attorneys general new authority to file civil actions for damages or injunctions in federal courts to enforce HIPAA and seek attorneys’ fees and costs associated with pursuing federal civil actions. In addition to HIPAA and HITECH, many state laws govern the privacy and security of health information in specified circumstances, many of which differ from each other in significant ways, are often not pre-empted by federal law, and may have a more prohibitive effect than federal law, thus complicating compliance efforts.

We may develop products that, once approved, may be administered by a physician. Under currently applicable U.S. law, certain products not usually self-administered (including injectable drugs) may be eligible for coverage under Medicare through Medicare Part B. Medicare Part B is the part of Medicare that covers outpatient services and supplies, including certain pharmaceutical products, that are medically necessary to treat a beneficiary’s health condition. As a condition of receiving Medicare Part B reimbursement for a manufacturer’s eligible drugs, the manufacturer is required to participate in other government healthcare programs, including the Medicaid Drug Rebate Program and the 340B Drug Pricing Program. The Medicaid Drug Rebate Program requires pharmaceutical manufacturers to enter into and have in effect a national rebate agreement with the Secretary of HHS as a condition for states to receive federal matching funds for the manufacturer’s outpatient drugs furnished to Medicaid patients. Under the 340B Drug Pricing Program, the manufacturer must extend discounts to entities that participate in the program.

In addition, many pharmaceutical manufacturers must calculate and report certain price reporting metrics to the government, such as average sales price and best price. Penalties may apply in some cases when such metrics are not submitted accurately and timely.

27


Additionally, the Sunshine Act within the Affordable Care Act, and its implementing regulations, require that certain manufacturers of drugs, devices, biological and medical supplies for which payment is available under Medicare, Medicaid or the Children’s Health Insurance Program (with certain exceptions) report annually to CMS information related to certain payments or other transfers of value made or distributed to physicians and teaching hospitals, or to entities or individuals at the request of, or designated on behalf of, the physicians and teaching hospitals and to report annually certain ownership and investment interests held by physicians and their immediate family members. This information is made publicly available on a CMS website, and failure to report accurately could result in penalties. In addition, many states also govern the reporting of payments or other transfers of value, many of which differ from each other in significant ways, are often not pre-empted, and may have a more prohibitive effect than the Sunshine Act, thus further complicating compliance efforts.

In order to distribute products commercially, we must comply with state laws that require the registration of manufacturers and wholesale distributors of drug and biological products in a state, including, in certain states, manufacturers and distributors who ship products into the state even if such manufacturers or distributors have no place of business within the state. Some states also impose requirements on manufacturers and distributors to establish the pedigree of product in the chain of distribution, including some states that require manufacturers and others to adopt new technology capable of tracking and tracing product as it moves through the distribution chain. Several state and local laws have been enacted requiring pharmaceutical and biotechnology companies to establish marketing compliance programs, file periodic reports with the state, make periodic public disclosures on sales, marketing, pricing, clinical studies and other activities, and/or register their sales representatives, as well as to prohibit pharmacies and other healthcare entities from providing certain physician prescribing data to pharmaceutical and biotechnology companies for use in sales and marketing, and to prohibit certain other sales and marketing practices. In addition, all of our activities are potentially subject to federal and state consumer protection and unfair competition laws.

Ensuring business arrangements with third parties comply with applicable healthcare laws and regulations is a costly endeavor. If our operations are found to be in violation of any of the federal and state healthcare laws described above or any other current or future governmental regulations that apply to us, we may be subject to significant penalties, including without limitation, civil, criminal and/or administrative penalties, damages, fines, disgorgement, imprisonment, exclusion from participation in government programs, such as Medicare and Medicaid, injunctions, private “qui tam” actions brought by individual whistleblowers in the name of the government, or refusal to allow us to enter into government contracts, contractual damages, reputational harm, administrative burdens, diminished profits and future earnings, additional reporting obligations and oversight if we become subject to a corporate integrity agreement or other agreement to resolve allegations of non-compliance with these laws, and the curtailment or restructuring of our operations, any of which could adversely affect our ability to operate our business and our results of operations.

Coverage, Pricing and Reimbursement

Significant uncertainty exists as to the coverage and reimbursement status of any product candidates for which we may obtain regulatory approval. In the United States and in foreign markets, sales of any products for which we receive regulatory approval for commercial sale will depend, in part, on the extent to which third-party payors provide coverage and establish adequate reimbursement levels for such products. In the United States, third-party payors include federal and state healthcare programs, private managed care providers, private health insurers and other organizations.

Adequate coverage and reimbursement from governmental healthcare programs, such as Medicare and Medicaid in the United States, and commercial payors are critical to new product acceptance.

Our ability to commercialize any products successfully also will depend in part on the extent to which coverage and adequate reimbursement for these products and related treatments will be available from government health administration authorities, private health insurers and other organizations. Government authorities and third-party payors, such as private health insurers and health maintenance organizations, decide which therapeutics they will pay for and establish reimbursement levels. Coverage and reimbursement by a third-party payor may depend upon a number of factors, including the third-party payor’s determination that use of a therapeutic is:

28


a covered benefit under its health plan;

safe, effective and medically necessary;

appropriate for the specific patient;

cost-effective; and

neither experimental nor investigational.

We cannot be sure that reimbursement will be available for any product that we commercialize and, if coverage and reimbursement are available, what the level of reimbursement will be. Coverage may also be more limited than the purposes for which the product is approved by the FDA or comparable foreign regulatory authorities. Reimbursement may impact the demand for, or the price of, any product for which we obtain regulatory approval.

Third-party payors are increasingly challenging the price, examining the medical necessity, and reviewing the cost-effectiveness of medical products, therapies, and services, in addition to questioning their safety and efficacy. Obtaining reimbursement for our products may be particularly difficult because of the higher prices often associated with branded drugs and drugs administered under the supervision of a physician. We may need to conduct expensive pharmacoeconomic studies in order to demonstrate the medical necessity and cost-effectiveness of our products, in addition to the costs required to obtain FDA approvals. Our product candidates may not be considered medically necessary or cost-effective. Obtaining coverage and reimbursement approval of a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide to each payor supporting scientific, clinical and cost-effectiveness data for the use of our product on a payor-by-payor basis, with no assurance that coverage and adequate reimbursement will be obtained. A payor’s decision to provide coverage for a product does not imply that an adequate reimbursement rate will be approved. Further, one payor’s determination to provide coverage for a product does not assure that other payors will also provide coverage for the product. Adequate third-party reimbursement may not be available to enable us to maintain price levels sufficient to realize an appropriate return on our investment in product development. If reimbursement is not available or is available only at limited levels, we may not be able to locate another suitable targetsuccessfully commercialize any product candidate that we successfully develop.

Different pricing and reimbursement schemes exist in other countries. In the European Union, governments influence the price of pharmaceutical products through their pricing and reimbursement rules and control of national health care systems that fund a large part of the cost of those products to consumers. Some jurisdictions operate positive and negative list systems under which products may only be marketed once a reimbursement price has been agreed. To obtain reimbursement or pricing approval, some of these countries may require the completion of clinical studies that compare the cost effectiveness of a particular product candidate to currently available therapies. Other member states allow companies to fix their own prices for medicines but monitor and control company profits. The downward pressure on health care costs has become intense. As a result, increasingly high barriers are being erected to the entry of new products. In addition, in some countries, cross-border imports from low-priced markets exert a commercial pressure on pricing within the applicable time period, if at all.a country.

Our Sponsor, initial stockholders, officers and directors have agreed (1) to vote any shares of common stock owned by them in favorThe marketability of any proposed business combination, (2) notproduct candidates for which we receive regulatory approval for commercial sale may suffer if the government and third-party payors fail to convert any sharesprovide adequate coverage and reimbursement. In addition, emphasis on managed care, the increasing influence of common stock in connection with a stockholder vote to approve a proposed initial business combinationhealth maintenance organizations, and (3) not sell any shares of common stock in any tender in connection with a proposed initial business combination.

If we hold a meeting to approve a proposed business combination and a significant number of stockholders vote, or indicate an intention to vote, against such proposed business combination, our officers, directors, Sponsor, initial stockholders or their affiliates could make purchases of our securitiesadditional legislative changes in the open marketUnited States has increased, and we expect will continue to increase, the pressure on healthcare pricing. The downward pressure on the rise in healthcare costs in general, particularly prescription medicines, medical devices and surgical procedures and other treatments, has become very intense. Coverage policies and third-party reimbursement rates may change at any time. Even if favorable coverage and reimbursement status is attained for one or more products for which we receive regulatory approval, less favorable coverage policies and reimbursement rates may be implemented in the future.

Healthcare Reform

In the United States and some foreign jurisdictions, there have been, and continue to be, several legislative and regulatory changes and proposed changes regarding the healthcare system that could prevent or delay marketing

29


approval of product candidates, restrict or regulate post-approval activities, and affect the ability to profitably sell product candidates for which marketing approval is obtained. Among policy makers and payors in the United States and elsewhere, there is significant interest in promoting changes in healthcare systems with the stated goals of containing healthcare costs, improving quality and/or expanding access. In the United States, the pharmaceutical industry has been a particular focus of these efforts and has been significantly affected by major legislative initiatives.

For example, the Affordable Care Act has substantially changed healthcare financing and delivery by both governmental and private transactionsinsurers. The Affordable Care Act and its implementing regulations, among other things, revised the methodology for calculating rebates for covered outpatient drugs and certain biologics owed by manufacturers to the state and federal government under the Medicaid Drug Rebate Program, increased the minimum Medicaid rebates owed by most manufacturers under the Medicaid Drug Rebate Program, extended the Medicaid Drug Rebate program to utilization of prescriptions of individuals enrolled in orderMedicaid managed care organizations, subjected manufacturers to influencenew annual fees and taxes for certain branded prescription drugs, and expanded programs designed to test innovative payment models, service delivery models, or value-based arrangements, and fund comparative effectiveness research.

Some of the vote. Notwithstandingprovisions of the Affordable Care Act have yet to be implemented, and there have been legal and political challenges to certain aspects of the Affordable Care Act. We anticipate that the Affordable Care Act, if substantially maintained in its current form, will continue to result in additional downward pressure on coverage and the price that we receive for any approved product, and could seriously harm our business. Any reduction in reimbursement from Medicare and other government programs may result in a similar reduction in payments from private payors. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our products. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition and ability to develop product candidates.

In addition, further legislation or regulation could be passed that could harm our business, financial condition and results of operations. Other legislative changes have been proposed and adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2027 unless additional Congressional action is taken. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, after some pharmacy benefit managers and insurers adopted policies stating that the amount of a copay coupon would not be applied to the enrollee’s deductible or out-of-pocket maximum (referred to as “accumulator adjustment programs”), some states passed legislation banning these policies. Based on a rule that will take effect in the 2020 plan year, CMS will allow accumulator adjustment programs only when used for a branded drug that has a generic equivalent. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates, if approved.

30


Future legislation or regulation

Other legislative changes have been adopted since the Affordable Care Act was enacted. For example, in August 2011, President Obama signed into law the Budget Control Act of 2011, which, among other things, created the Joint Select Committee on Deficit Reduction to recommend to Congress proposals in spending reductions. The Joint Select Committee on Deficit Reduction did not achieve a targeted deficit reduction of at least $1.2 trillion for fiscal years 2012 through 2021, triggering the legislation’s automatic reduction to several government programs. This includes aggregate reductions to Medicare payments to providers of up to 2% per fiscal year, which went into effect beginning on April 1, 2013 and will stay in effect through 2029 unless additional Congressional action is taken. The Coronavirus Aid, Relief and Economic Security Act, or CARES Act, which was signed into law in March 2020 and was designed to provide financial support and resources to individuals and businesses affected by the COVID-19 pandemic, suspended the 2% reductions from May 1, 2020 through December 31, 2020, and extended the sequester by one year, through 2030. In January 2013, the American Taxpayer Relief Act of 2012 was signed into law, which, among other things, further reduced Medicare payments to several types of providers, including hospitals, imaging centers and cancer treatment centers, and increased the statute of limitations period for the government to recover overpayments to providers from three to five years.

Additionally, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. Congressional inquiries and proposed federal legislation designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs, and reform government program reimbursement methodologies for drugs.

Individual states in the United States have also become increasingly active in passing legislation and implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing. For example, after some pharmacy benefit managers and insurers adopted policies stating that the amount of a copay coupon would not be applied to the enrollee’s deductible or out-of-pocket maximum (referred to as “accumulator adjustment programs”), some states passed legislation banning these policies. Based on a rule that will take effect in the 2020 plan year, CMS will allow accumulator adjustment programs only when used for a branded drug that has a generic equivalent. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate revenue, attain profitability, or commercialize our product candidates, if approved.

Additional Regulation

In addition to the foregoing, local, state and federal laws, including such matters as safe working conditions, manufacturing practices, environmental protection, fire hazard control and hazardous substances, including, in the United States, the Occupational Safety and Health Act, the Resource Conservancy and Recovery Act and the Toxic Substances Control Act, affect our officers, directors, Sponsor, initial stockholdersbusiness. These and their affiliates will not make purchasesother laws govern our use, handling and disposal of shares of common stock if the purchases would violate Section 9(a)(2) or Rule 10b-5various biological, chemical and radioactive substances used in, and wastes generated by, our operations. If our operations result in contamination of the Exchange Act, whichenvironment or expose individuals to hazardous or biohazardous substances, we could be liable for damages, environmental remediation, and/or governmental fines. We believe that we are rules designed to stop potential manipulation of a company’s stock.

Conversion Rights

At any meeting called to approve an initial business combination, public stockholders may seek to convert their shares, regardless of whether they vote for or against the proposed business combination or do not vote at all, into their pro rata share of the aggregate amount then on deposit in the trust account as of two business days prior to the consummation of the initial business combination, less any taxes then due but not yet paid. Alternatively, we may provide our public stockholdersmaterial compliance with the opportunity to sell their shares of our common stock to us through a tender offer (and thereby avoid the need for a stockholder vote) for an amount equal to their pro rata share of the aggregate amount then on deposit in the trust account, less any taxes then due but not yet paid.


Our sponsor, initial stockholdersapplicable environmental laws and our officersoccupational health and directorssafety laws that continued compliance therewith will not have conversion rightsa material adverse effect on our business. We cannot predict, however, how changes in these laws may affect our future operations. We may incur significant costs to comply with respect to any shares of common stock owned by them, directly or indirectly, whether acquired prior to this offering or purchased by them in this offeringsuch laws and regulations now or in the aftermarket.future.

We may require public stockholders, whether theyGovernment Regulation and Product Approval

Government authorities in the United States, at the federal, state and local level, and in other countries extensively regulate, among other things, the research, development, testing, manufacture, including any manufacturing changes, packaging, storage, recordkeeping, labeling, advertising, promotion, distribution, marketing,

31


post-approval monitoring and reporting, import and export of pharmaceutical products, biological products and medical devices, such as those we are a record holder or hold their shares in “street name,”developing.

Disclosure of clinical study information

Sponsors of applicable clinical studies of FDA regulated products, including drugs, are required to either (i) tender their certificates to our transfer agent or (ii) deliver their sharesregister and disclose certain clinical study information. Information related to the transfer agent electronically using Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System,product, patient population, phase of investigation, study sites and investigators, and other aspects of the clinical study is then made public on the ClinicalTrials.gov website as part of the registration. Sponsors are also obligated to disclose the results of their clinical studies after completion. Disclosure of the results of these studies can be delayed until the new product or new indication being studied has been approved. Competitors may use this publicly available information to gain knowledge regarding the progress of development programs.

Expedited Programs for Serious Conditions

The FDA maintains several programs intended to facilitate and expedite development and review of new drugs and biologics to address unmet medical needs in the treatment of serious or life-threatening diseases or conditions. These programs include Fast Track designation, Breakthrough Therapy designation, Priority Review and Accelerated Approval. These programs can significantly reduce the time it takes for the FDA to review a BLA or NDA, but they do not guarantee that a product will receive FDA approval. Even if a product qualifies initially, the FDA may later decide that the product no longer meets the conditions for qualification or decide that the time period for FDA review will not be shortened. In May 2018, the Right to Try Act also established a program to increase access to unapproved, investigational treatments for patients diagnosed with life-threatening diseases or conditions who have exhausted approved treatment options and who are unable to participate in a clinical study.

A new drug or biologic is eligible for Fast Track designation if it is intended to treat a serious or life-threatening disease or condition and demonstrates the potential to address unmet medical needs for such disease or condition. Fast Track designation provides increased opportunities for sponsor interactions with the FDA during preclinical and clinical development, in addition to the potential for rolling review once a marketing application is filed, meaning that the agency may review portions of the marketing application before the sponsor submits the complete application, as well as Priority Review, discussed below. In addition, a new drug or biologic may be eligible for Breakthrough Therapy designation if it is intended to treat a serious or life-threatening disease or condition and preliminary clinical evidence indicates that the drug may demonstrate substantial improvement over existing therapies on one or more clinically significant endpoints, such as substantial treatment effects observed early in clinical development. Breakthrough Therapy designation provides all the features of Fast Track designation in addition to intensive guidance on an efficient drug development program beginning as early as Phase 1, and FDA organizational commitment to expedited development, including involvement of senior managers and experienced review staff in a cross-disciplinary review, where appropriate.

Any product submitted to the FDA for approval, including a product with Fast Track or Breakthrough Therapy designation, may also be eligible for additional FDA programs intended to expedite the review and approval process, including Priority Review designation and accelerated approval. A product is eligible for Priority Review if it has the potential to provide a significant improvement in safety or effectiveness in the treatment, diagnosis or prevention of a serious disease or condition. Under priority review, FDA will review an application in six months compared to ten months for a standard review. Products are eligible for accelerated approval if they can be shown to have an effect on a surrogate endpoint that is reasonably likely to predict clinical benefit, or an effect on a clinical endpoint that can be measured earlier than an effect on irreversible morbidity or mortality which is reasonably likely to predict an effect on irreversible morbidity or mortality or other clinical benefit, taking into account the severity, rarity, or prevalence of the condition and the availability or lack of alternative treatment. Accelerated approval is usually contingent on a sponsor’s agreement to conduct additional post-approval studies to verify and describe the product’s clinical benefit. In addition, unless otherwise informed by the FDA, the FDA currently requires, as a condition for accelerated approval, that all advertising and promotional materials that are intended for dissemination or publication be submitted to FDA for review before the initial dissemination or publication.

Orphan drugs

32


Under the Orphan Drug Act, the FDA may grant orphan drug designation to drugs or biologics intended to treat a rare disease or condition, which is generally defined as a disease or condition that affects fewer than 200,000 individuals in the United States. Orphan drug designation must be requested before submitting an NDA or BLA. After the FDA grants orphan drug designation, the generic identity of the drug or biologic and its potential orphan use are disclosed publicly by the FDA. Orphan drug designation is taken into consideration but generally does not convey any advantage in, or shorten the duration of, the regulatory review and approval process. The first NDA or BLA applicant to receive FDA approval for a particular active ingredient to treat a particular disease with FDA orphan drug designation is entitled to a seven-year exclusive marketing period in the United States for that product, for that indication. During the seven-year exclusivity period, the FDA may not approve any other applications to market the same drug or biologic for the same orphan indication, except in limited circumstances, such as a showing of clinical superiority to the product with orphan drug exclusivity in that it is shown to be safer, more effective or makes a major contribution to patient care. This is the case despite an earlier court opinion holding that the Orphan Drug Act unambiguously required the FDA to recognize orphan exclusivity regardless of a showing of clinical superiority. Orphan drug exclusivity does not prevent the FDA from approving a different drug or biologic for the same disease or condition, or the same drug or biologic for a different disease or condition. Among the other benefits of orphan drug designation are tax credits for certain research and a waiver of the NDA or BLA application user fee.

Pediatric information and exclusivity

Under the Pediatric Research Equity Act of 2003, an NDA, BLA or supplement to an NDA or BLA must contain data from pediatric studies that are adequate to assess the safety and effectiveness of the drug or biological product for the claimed indications in all relevant pediatric subpopulations, and to support dosing and administration for each pediatric subpopulation for which the product is safe and effective. The FDA may, on its own initiative or at the holder’s option,request of the applicant, grant deferrals for submission of some or all pediatric data until after approval of the product for use in each case prioradults, or full or partial waivers from the pediatric data requirements. Under the FDASIA, the FDA has additional authority to take action against manufacturers not adhering to pediatric study requirements. Unless otherwise required by regulation, the pediatric data requirements do not apply to products with orphan drug designation.

Pediatric exclusivity is a type of non-patent exclusivity in the United States and, if granted, provides for the attachment of an additional six months of marketing protection to the term of any existing regulatory exclusivity or patent protection, including the non-patent and orphan exclusivity. This six-month exclusivity may be granted if an application sponsor submits pediatric data that fairly respond to a date set forthwritten request from the FDA for such data. The data do not need to show the product to be effective in the proxy materials sent in connectionpediatric population studied; rather, if the clinical study is deemed to fairly respond to the FDA’s request, the additional protection is granted.

The Hatch-Waxman Act

Abbreviated new drug applications

In seeking approval for a drug through an NDA, applicants are required to list with the proposalFDA each patent that claims to approvecover the business combination.

Thereapplicant’s product. Upon approval of a drug, each of the patents listed in the application for the drug is then published in the FDA’s Approved Drug Products with Therapeutic Equivalence Evaluations, commonly known as the Orange Book. Drugs listed in the Orange Book can, in turn, be cited by potential competitors in support of approval of an ANDA. Generally, an ANDA provides for marketing of a nominal cost associated withdrug product that has the above-referenced delivery processsame active ingredients in the same strengths and dosage form as the act of certificating the shares or delivering themlisted drug and has been shown through the DWAC System. The transfer agent will typically charge the tendering broker $45.00 and it wouldbioequivalence testing to be uptherapeutically equivalent to the broker whetherlisted drug. Other than the requirement for bioequivalence testing, ANDA applicants are not required to conduct or submit results of preclinical or clinical tests to prove the safety or effectiveness of their drug product. Drugs approved in this way are commonly referred to as “generic equivalents” to the listed drug and can often be substituted by pharmacists under prescriptions written for the original listed drug.

The ANDA applicant is required to certify to the FDA concerning any patents listed for the approved product in the FDA’s Orange Book. Specifically, the applicant must certify that:

the required patent information has not been filed;

33


the listed patent has expired;

the listed patent has not expired, but will expire on a particular date and approval is sought after patent expiration; or

the listed patent is invalid or will not be infringed by the new product.

A certification that the new product will not infringe the already approved product’s listed patents or that such patents are invalid is called a Paragraph IV certification. If the ANDA applicant does not challenge the listed patents, the ANDA will not be approved until all the listed patents claiming the referenced product have expired.

If the ANDA applicant has provided a Paragraph IV certification to the FDA, the applicant must also send notice of the Paragraph IV certification to the NDA and patent holders once the ANDA has been accepted for filing by the FDA. The NDA and patent holders may then initiate a patent infringement lawsuit in response to the notice of the Paragraph IV certification. The filing of a patent infringement lawsuit within 45 days after the receipt of a Paragraph IV certification automatically prevents the FDA from approving the ANDA until the earlier of a 30-month period, expiration of the patent, settlement of the lawsuit or a decision in the infringement case that the patent involved is deemed invalid or not to pass this cost on to the holder. However, this fee wouldinfringed.

The ANDA also will not be incurred regardlessapproved until any applicable non-patent exclusivity, such as exclusivity for obtaining approval of whether or not we require holders seeking to exercise conversion rights. The need to deliver shares is a requirement of exercising conversion rights regardless of the timing of when such delivery must be effectuated. However,new chemical entity, listed in the event we require stockholders seeking to exercise conversion rights prior toOrange Book for the consummationreferenced product has expired. Federal law provides a period of five years following approval of a drug containing no previously approved active ingredients during which ANDAs for generic versions of those drugs cannot be received by the proposed business combination andFDA, except that the proposed business combinationapplication may be submitted in four years if it contains a Paragraph IV certification. If there is no listed patent in the Orange Book, there may not consummated this may result in an increased cost to stockholders.

Any proxy solicitation materials we furnish to stockholders in connection withbe a vote for any proposed business combination will indicate whether we are requiring stockholders to satisfy suchParagraph IV certification, and delivery requirements. Accordingly, a stockholder would have from the time the stockholder received our proxy statement up until the vote on the proposal to approve the business combination to deliver his shares if he wishes to seek to exercise his conversion rights. This time period varies depending on the specific facts of each transaction. However, as the delivery process can be accomplished by the stockholder, whether or not he is a record holder or his shares are held in “street name,” in a matter of hours by simply contacting the transfer agent or his broker and requesting delivery of his shares through the DWAC System, we believe this time period is sufficient for an average investor. However, we cannot assure you of this fact. Please see the risk factor titled “In connection with any stockholder meeting called to approve a proposed initial business combination, we may require stockholders who wish to convert their shares in connection with a proposed business combination to comply with specific requirements for conversion that may make it more difficult for them to exercise their conversion rights prior to the deadline for exercising their rights” for further information on the risks of failing to comply with these requirements.

The foregoing is different from the procedures historically used by some blank check companies. Traditionally, in order to perfect conversion rights in connection with a blank check company’s business combination, the company would distribute proxy materials for the stockholders’ vote on an initial business combination, and a holder could simply vote against a proposed business combination and check a box on the proxy card indicating such holder was seeking to exercise his conversion rights. After the business combination was approved, the company would contact such stockholder to arrange for him to deliver his certificate to verify ownership. As a result, the stockholder then had an “option window” after the consummation of the business combination during which he could monitor the price of the company’s stock in the market. If the price rose above the conversion price, he could sell his shares in the open market before actually delivering his shares to the company for cancellation. As a result, the conversion rights, to which stockholders were aware they needed to commit before the stockholder meeting, would become a “continuing” right surviving past the consummation of the business combination until the holder delivered its certificate. The requirement for physical or electronic delivery prior to the meeting ensures that a holder’s election to convert his shares is irrevocable once the business combination is approved.

Any request to convert such shares once made,thus, no ANDA may be withdrawn at any time up to the vote on the proposed business combination orfiled before the expiration of the tender offer. Furthermore, ifexclusivity period. Federal law provides for a holderperiod of three years of exclusivity following approval of a public sharelisted drug that contains previously approved active ingredients but is approved in a new dosage form, route of common stock delivered his certificate in connection with an election of their conversion and subsequently decides prior to the applicable date not to elect to exercise such rights, he may simply request that the transfer agent return the certificate (physicallyadministration or electronically).

If the initial business combination, is not approved or completed for any reason, then our public stockholders who elected to exercise their conversion rights would not be entitled to convert their shares for the applicable pro rata share of the trust account as of two business days prior to the consummation of the initial business combination. In such case, we will promptly return any shares delivered by public holders.


Liquidation if No Business Combination

Our amended and restated certificate of incorporation provides that we will have only until October 13, 2021, to complete an initial business combination. If we have not completed an initial business combination by such date, we will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem 100% of the outstanding public shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including any interest not previously released to us but net of taxes payable, divided by the number of then outstanding public shares, which redemption will completely extinguish public stockholders’ rights as stockholders (including the right to receive further liquidation distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject tonew use, the approval of our remaining stockholders and our board of directors, dissolve and liquidate, subject (inwhich was required to be supported by new clinical studies conducted by or for the case of (ii) and (iii) above) to our obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law.

Our Sponsor, initial stockholders, officers and directors have agreed that they will not propose any amendment to our amended and restated certificate of incorporation that would affect our public stockholders’ ability to convert or sell their shares to us in connection with a business combination as described herein or affect the substance or timing of our obligation to redeem 100% of our public shares if we do not complete a business combination by October 13, 2021 unless we provide our public stockholders with the opportunity to convert their shares of common stock upon such approval at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the trust account, including interest not previously released to us but net of franchise and income taxes payable, divided by the number of then outstanding public shares. This redemption right shall apply in the event of the approval of any such amendment, whether proposed by our Sponsor, initial stockholders, executive officers, directors or any other person.

Under the Delaware General Corporation Law, stockholders may be held liable for claims by third parties against a corporation to the extent of distributions received by them in a dissolution. The pro rata portion of our trust account distributed to our public stockholders upon the redemption of 100% of our outstanding public shares in the event we do not complete our initial business combination within the required time period may be considered a liquidation distribution under Delaware law. If the corporation complies with certain procedures set forth in Section 280 of the Delaware General Corporation Law intended to ensure that it makes reasonable provision for all claims against it, including a 60-day notice period during which any third-party claims can be brought against the corporation, a 90-day periodsponsor, during which the corporationFDA cannot grant effective approval of an ANDA based on that listed drug.

The FDA must establish a priority review track for certain generic drugs, requiring the FDA to review a drug application within eight months for a drug that has three or fewer approved drugs listed in the Orange Book and is no longer protected by any patent or regulatory exclusivities, or is on the FDA’s drug shortage list. The FDA must also expedite review of “competitor generic therapies” or drugs with inadequate generic competition, including holding meetings with or providing advice to the drug sponsor prior to submission of the application.

Patent term extension

After NDA approval, owners of relevant drug patents may reject any claims brought, and an additional 150-day waiting period before any liquidating distributions are made to stockholders, any liability of stockholders with respectapply for up to a liquidating distributionfive year patent term extension. The allowable patent term extension is limitedcalculated as half of the drug’s testing phase, based on the time between IND application and submission of the NDA, and all of the review phase, based on the time between the NDA submission and approval up to a maximum of five years. The time can be shortened if the FDA determines that the applicant did not pursue approval with due diligence. The total patent term after the extension may not exceed 14 years.

For patents that might expire during the application phase, the patent owner may request an interim patent term extension. An interim patent term extension increases the patent term by one year and may be renewed up to four times. For each interim patent term extension granted, the post-approval patent term extension is reduced by one year. The director of the USPTO must determine that approval of the drug covered by the patent for which a patent term extension is being sought is likely.

Interim patent term extensions are not available for a drug for which an NDA has not been submitted.

Section 505(b)(2) new drug applications

34


Most drug products obtain FDA marketing approval pursuant to an NDA or an ANDA. A third alternative is a special type of NDA, commonly referred to as a Section 505(b)(2) NDA, which enables the applicant to rely, in part, on the FDA’s previous approval of a similar product, or published literature, in support of its application.

Section 505(b)(2) NDAs often provide an alternate path to FDA approval for new or improved formulations or new uses of previously approved products. Section 505(b)(2) permits the filing of an NDA where at least some of the information required for approval comes from studies not conducted by or for the applicant and for which the applicant has not obtained a right of reference. If the Section 505(b)(2) applicant can establish that reliance on the FDA’s previous approval is scientifically appropriate, it may eliminate the need to conduct certain preclinical or clinical studies of the new product. The FDA may also require companies to perform additional studies or measurements to support the change from the approved product. The FDA may then approve the new product for all or some of the label indications for which the referenced product has been approved, as well as for any new indication sought by the Section 505(b)(2) applicant.

To the extent that the Section 505(b)(2) applicant is relying on studies conducted for an already approved product, the applicant is required to certify to the lesser of such stockholder’s pro rata share ofFDA concerning any patents listed for the claim orapproved product in the amount distributedOrange Book to the stockholder, andsame extent that an ANDA applicant would. As a result, approval of a Section 505(b)(2) NDA can be stalled until all the listed patents claiming the referenced product have expired, until any liabilitynon-patent exclusivity, such as exclusivity for obtaining approval of the stockholder would be barred after the third anniversary of the dissolution.

Furthermore, if the pro rata portion of our trust account distributed to our public stockholders upon the redemption of 100% of our public sharesa new chemical entity, listed in the event we do not complete our initial business combination withinOrange Book for the required time period is not considered a liquidation distribution under Delaware lawreferenced product has expired, and, such redemption distribution is deemed to be unlawful, then pursuant to Section 174 of the Delaware General Corporation Law, the statute of limitations for claims of creditors could then be six years after the unlawful redemption distribution, instead of three years, as in the case of a liquidation distribution. If we are unable to completeParagraph IV certification and subsequent patent infringement suit, until the earlier of a business combination within the prescribed time frame, we will (i) cease all operations except for the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem 100%30-month period, settlement of the outstanding public shares, atlawsuit or a per-share price, payabledecision in cash, equalthe infringement case that the patent involved is deemed invalid or not infringed.

Post-Approval Requirements

Any products manufactured or distributed by us pursuant to FDA approvals are subject to pervasive and continuing regulation by the FDA, including, among other things, requirements relating to record-keeping, reporting of adverse experiences, periodic reporting, product sampling and distribution, and advertising and promotion of the product. After approval, most changes to the aggregate amount thenapproved product, such as adding new indications or other labeling claims, are subject to prior FDA review and approval. There also are continuing user fee requirements, under which FDA assesses an annual program fee for each product identified in an approved BLA or NDA. Biologic manufacturers and their subcontractors are required to register their establishments with the FDA and certain state agencies and are subject to periodic unannounced inspections by the FDA and certain state agencies for compliance with cGMP, which impose certain procedural and documentation requirements upon us and our third-party manufacturers. Changes to the manufacturing process are strictly regulated, and, depending on depositthe significance of the change, may require prior FDA approval before being implemented. FDA regulations also require investigation and correction of any deviations from cGMP and impose reporting requirements upon us and any third-party manufacturers that we may decide to use. Accordingly, manufacturers must continue to expend time, money and effort in the trust account,area of production and quality control to maintain compliance with cGMP and other aspects of regulatory compliance.

The FDA may withdraw approval if compliance with regulatory requirements and standards is not maintained or if problems occur after the product reaches the market. Later discovery of previously unknown problems with a product, including any interest but netadverse events of franchiseunanticipated severity or frequency, or with manufacturing processes, or failure to comply with regulatory requirements, may result in revisions to the approved labeling to add new safety information; imposition of post-market studies or clinical studies to assess new safety risks; or imposition of distribution restrictions or other restrictions under a Risk Evaluation and income taxes payable, dividedMitigation Strategy program. Other potential consequences include, among other things:

restrictions on the marketing or manufacturing of a product, complete withdrawal of the product from the market or product recalls;

fines, warning letters or holds on post-approval clinical studies;

refusal of the FDA to approve pending applications or supplements to approved applications, or suspension or revocation of existing product approvals;

35


product seizure or detention, or refusal of the FDA to permit the import or export of products; or

injunctions or the imposition of civil or criminal penalties.

The FDA closely regulates the marketing, labeling, advertising and promotion of biologic regulations prohibiting the promotion of off-label uses. Failure to comply with these requirements can result in, among other things, adverse publicity, warning letters, corrective advertising and potential civil and criminal penalties. Physicians may prescribe legally available products for uses that are not described in the product’s labeling and that differ from those tested by us and approved by the FDA. Such off-label uses are common across medical specialties. Physicians may believe that such off-label uses are the best treatment for many patients in varied circumstances. The FDA does not regulate the behavior of physicians in their choice of treatments. The FDA does, however, restrict manufacturer’s communications on the subject of off-label use of their products.

Biosimilars and Reference Product Exclusivity

The Patient Protection and Affordable Care Act, as amended by the Affordable Care Act, signed into law in 2010, includes a subtitle called the BPCIA, which created an abbreviated approval pathway for biological products that are biosimilar to or interchangeable with an FDA-approved reference biological product. To date, a number of then outstanding public shares,biosimilars have been licensed under the BPCIA, and numerous biosimilars have been approved in Europe. The FDA has issued several guidance documents outlining an approach to review and approval of biosimilars.

Biosimilarity, which redemption will completely extinguish public stockholders’ rightsrequires that there be no clinically meaningful differences between the biological product and the reference product in terms of safety, purity, and potency, can be shown through analytical studies, animal studies, and a clinical study or studies. Interchangeability requires that a product is biosimilar to the reference product and the product must demonstrate that it can be expected to produce the same clinical results as stockholders (including the rightreference product in any given patient and, for products that are administered multiple times to receive further liquidation distributions, if any), subjectan individual, the biologic and the reference biologic may be alternated or switched after one has been previously administered without increasing safety risks or risks of diminished efficacy relative to applicable lawexclusive use of the reference biologic. Complexities associated with the larger, and (iii)often more complex, structures of biological products, as promptlywell as reasonably possiblethe processes by which such products are manufactured, pose significant hurdles to implementation of the abbreviated approval pathway that are still being worked out by the FDA.

Under the BPCIA, an application for a biosimilar product may not be submitted to the FDA until four years following such redemption, subject tothe date that the reference product was first licensed by the FDA. In addition, the approval of our remaining stockholdersa biosimilar product may not be made effective by the FDA until 12 years from the date on which the reference product was first licensed. During this 12-year period of exclusivity, another company may still market a competing version of the reference product if the FDA approves a full BLA for the competing product containing that applicant’s own preclinical data and our boarddata from adequate and well-controlled clinical studies to demonstrate the safety, purity and potency of directors, dissolve and liquidate, subject (in the case of (ii) and (iii) above) to our obligations under Delaware law to provideits product. The BPCIA also created certain exclusivity periods for claims of creditors and the requirements of other applicable law. Accordingly,biosimilars approved as interchangeable products. At this juncture, it is our intentionunclear whether products deemed “interchangeable” by the FDA will, in fact, be readily substituted by pharmacies, which are governed by state pharmacy law.

The BPCIA is complex and continues to redeem our public shares as soon as reasonably possible following our 12th month,be interpreted and therefore, we do not intendimplemented by the FDA. In addition, recent government proposals have sought to comply with those procedures. As such, our stockholders could potentially be liable for any claims toreduce the extent of distributions received by them (but no more) and any liability of our stockholders may extend well beyond the third anniversary of such date.


Because we will not be complying with Section 28012-year reference product exclusivity period. Other aspects of the Delaware General Corporation Law, Section 281(b)BPCIA, some of which may impact the Delaware General Corporation Law requires us to adopt a plan, based on facts known to us at such time that will provide for our paymentBPCIA exclusivity provisions, have also been the subject of all existing and pending claims or claims that may be potentially brought against us within the subsequent ten years. However, because we are a blank check company, rather than an operating company, and our operations will be limited to searching for prospective target businesses to acquire, the only likely claims to arise would be from our vendors (such as lawyers, investment bankers, etc.) or prospective target businesses.

We are required to seek to have all third parties (including any vendors or other entities we engage after this offering) and any prospective target businesses enter into agreements with us waiving any right, title, interest or claim of any kind they may have in or to any monies held in the trust account.recent litigation. As a result, the claims that could be made against us will be limited, thereby lessening the likelihood that any claim would result in any liability extending to the trust. We therefore believe that any necessary provision for creditors will be reducedultimate impact, implementation, and should not have a significant impact on our ability to distribute the funds in the trust account to our public stockholders. Nevertheless, dbbmckennon, our independent registered public accounting firm, and the underwriters of the offering, will not execute agreements with us waiving such claims to the monies held in the trust account. Furthermore, thereBPCIA is no guarantee that other vendors, service providers and prospective target businesses will execute such agreements. Nor is there any guarantee that, even if they execute such agreements with us, they will not seek recourse against the trust account. Our sponsor has agreed that it will be liable to ensure that the proceeds in the trust account are not reduced below $10.10 per share by the claims of target businesses or claims of vendors or other entities that are owed money by us for services rendered or contracted for or products sold to us, but we cannot assure you that it will be able to satisfy its indemnification obligations if it is required to do so. We have not asked our sponsor to reserve for such indemnification obligations, nor have we independently verified whether our sponsor has sufficient funds to satisfy its indemnity obligations and believe that our sponsor’s only assets are securities of our company. Therefore, we believe it is unlikely that our sponsor will be able to satisfy its indemnification obligations if it is required to do so. Additionally, the agreement our sponsor entered into specifically provides for two exceptions to the indemnity it has given: it will have no liability (1) as to any claimed amounts owed to a target business or vendor or other entity who has executed an agreement with us waiving any right, title, interest or claim of any kind they may have in or to any monies held in the trust account, or (2) as to any claims for indemnification by the underwriters of this offering against certain liabilities, including liabilities under the Securities Act. As a result, if we liquidate, the per-share distribution from the trust account could be less than $10.10 due to claims or potential claims of creditors. We will distribute to all of our public stockholders, in proportion to their respective equity interests, an aggregate sum equal to the amount in the trust account, inclusive of any interest (subject to our obligations under Delaware law to provide for claims of creditors as described below).

We anticipate notifying the trustee of the trust account to begin liquidating such assets promptly after such date and anticipate it will take no more than 10 business days to effectuate such distribution. The holders of the founders’ shares and private shares have waived their rights to participate in any liquidation distribution from the trust account with respect to such shares. There will be no distribution from the trust account with respect to our warrants, which will expire worthless. We will pay the costs of any subsequent liquidation from our remaining assets outside of the trust account. If such funds are insufficient, our Sponsor has contractually agreed to advance us the funds necessary to complete such liquidation (currently anticipated to be no more than approximately $15,000) and has contractually agreed not to seek repayment for such expenses.

If we are unable to complete an initial business combination and expend all of the net proceeds of the IPO, other than the proceeds deposited in the trust account, and without taking into account interest, if any, earned on the trust account, the initial per-share redemption price would be $10.10. The proceeds deposited in the trust account could, however, become subject to claims of our creditors that are in preference to the claims of public stockholders.significant uncertainty.

Our public stockholders shall be entitled to receive funds from the trust account only in the event of our failure to complete a business combination within the required time period, if the stockholders seek to have us convert or purchase their respective shares upon a business combination which is actually completed by us or upon certain amendments to our amended and restated certificate of incorporation prior to consummating an initial business combination. In no other circumstances shall a stockholder have any right or interest of any kind to or in the trust account.

If we are forced to file a bankruptcy case or an involuntary bankruptcy case is filed against us which is not dismissed, the proceeds held in the trust account could be subject to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of third parties with priority over the claims of our stockholders. To the extent any bankruptcy claims deplete the trust account, we cannot assure you we will be able to return to our public stockholders at least $10.00 per share.


If we are forced to file a bankruptcy case or an involuntary bankruptcy case is filed against us which is not dismissed, any distributions received by stockholders could be viewed under applicable debtor/creditor and/or bankruptcy laws as either a “preferential transfer” or a “fraudulent conveyance.” As a result, a bankruptcy court could seek to recover all amounts received by our stockholders. Furthermore, because we intend to distribute the proceeds held in the trust account to our public stockholders promptly after October 13, 2021, this may be viewed or interpreted as giving preference to our public stockholders over any potential creditors with respect to access to or distributions from our assets. Furthermore, our board may be viewed as having breached their fiduciary duties to our creditors and/or may have acted in bad faith, and thereby exposing itself and our company to claims of punitive damages, by paying public stockholders from the trust account prior to addressing the claims of creditors. We cannot assure you that claims will not be brought against us for these reasons.

Competition

We may encounter intense competition from other entities having a business objective similar to ours when identifying, evaluating and selecting a target business. Many of these entities are well established and have extensive experience identifying and effecting business combinations directly or through affiliates. Many of these competitors possess greater technical, human and other resources than us and our financial resources will be relatively limited when contrasted with those of many of these competitors. While we believe there may be numerous potential target businesses that we could acquire with the net proceeds of this offering, our ability to compete in acquiring certain sizable target businesses may be limited by our available financial resources. This inherent limitation gives others an advantage in pursuing the acquisition of a target business. Furthermore, our obligation to pay cash to our public stockholders who exercise their redemption rights may reduce the resources available to us for an initial business combination. In addition, the number of our outstanding warrants, and the future dilution they potentially represent, may not be viewed favorably by certain target businesses. Either of these factors may place us at a competitive disadvantage in successfully negotiating an initial business combination.

If we succeed in effecting a business combination, there will be, in all likelihood, intense competition from competitors of the target business. We cannot assure you that, subsequent to a business combination, we will have the resources or ability to compete effectively.

Employees

We currently have two executive officers. These individuals are not obligated to devote any specific number of hours to our affairs but they intend to devote as much of their time as they deem necessary to our affairs until we have completed our initial business combination. The amount of time they will devote in any time period will vary based on whether a target business has been selected for our initial business combination and the stage of the business combination process we are in. We do not intend to have any full time employees prior to the consummation of our initial business combination.

Facilities

We currently maintain our executive offices at 5 West 21st Street, New York, NY. Our sponsor is making this space available to us free of charge. We consider our current office space, combined with the other office space otherwise available to our executive officers, adequate for our current operations.

10

ITEMItem 1A. RISK FACTORSRisk Factors

The following risk factors are not exhaustive and investors are encouraged to perform their own investigation with respect to the business, prospects, financial condition and operating results of Revelation and our business, prospects, financial condition and operating results. You should carefully consider the following risk factors in addition to the other information included in this Annual Report on Form 10-K, including our audited financial statements and related notes and “Management’s Discussion and Analysis of Financial Condition and Results of Operations.” We may face additional risks and uncertainties that are not presently known to us, or that we currently deem immaterial, which may also impair our business, prospects, financial condition or operating results. The

36


following discussion should be read in conjunction with our audited financial statements and notes to the financial statements included herein.

Unless the context otherwise requires, references herein to “Program Products” refers to Revelation’s REVTx-300, REVTx-100, REVTx-200, REVTx-99a, REVTx-99b and REVDx-501 programs.

Risks RelatingRelated to Our Business

Although our Searchfinancial statements have been prepared on a going concern basis, we have a limited operating history and no products approved for Consummation of, or Inability to Consummate, a Business Combination and Post-Business Combination Risks

If we are unable to consummate a business combination, our public stockholders may be forced to wait more than 12 months before receiving distributions from the trust account.

commercial sale. We have until October 13, 2021incurred net losses since our inception, we anticipate that we will continue to complete a business combination. We have no obligation to return funds to investors prior to such date unless we consummate a business combination prior theretoincur significant losses for the foreseeable future, and only then in cases where investors have sought to convert or sell their shares to us. Only after the expiration of this full time period will public security holders be entitled to distributions from the trust accounteven if we were to generate revenue, we may never achieve or maintain profitability.

We are unablea clinical stage biopharmaceutical company with a limited operating history may make it difficult to complete aevaluate the success of our business combination. Accordingly, investors’ funds may be unavailable to them until after such date and to liquidate your investment, public security holdersassess our future viability. We commenced our operations in May 2020, and, to date, our operations have been limited to organizing and staffing our Company, business planning, raising capital, conducting research and development activities, including early clinical study, and providing general and administrative support for these operations. Investment in biopharmaceutical product development and diagnostic device is highly speculative because it entails substantial upfront capital expenditures and significant risk that any potential product candidate and/or diagnostic device will fail to demonstrate adequate effect and/or an acceptable safety profile, gain regulatory approval or become commercially viable. We currently have no products approved for commercial sale, we have not generated any revenue from product sales to date and we continue to incur significant research and development and other expenses related to our ongoing operations. We have limited experience as a Company conducting clinical studies and no experience as a Company commercializing any products.

We are not profitable and have incurred net losses since our inception. As of December 31, 2022, we had an accumulated deficit of $25.3 million. Consequently, predictions about our future success or viability may not be forcedas accurate as they would be if we had a longer operating history or a history of successfully developing and commercializing pharmaceutical products. We have spent, and expect to sell their public shares or warrants, potentially at a loss.

Our searchcontinue to spend, significant resources to fund research and development of, conduct clinical studies, and seek regulatory approvals for, a business combination,our Program Products, and any target business with which we ultimately consummatefuture product candidates. We expect to incur substantial and increasing operating losses over the next several years as our research, development, preclinical testing and clinical study activities increase. As a business combination,result, our accumulated deficit will also increase significantly. We may be materially adversely affected by the recent coronavirus (COVID-19) outbreak. 

The significant outbreak of COVID-19 has resulted in a widespread health crisisencounter unforeseen expenses, difficulties, complications, delays and other unknown factors that couldmay adversely affect the economies and financial markets worldwide, and the businessour business. The size of any potential target business with which we consummate a business combination could be materially and adversely affected. Furthermore, we may be unable to complete a business combination if continued concerns relating to COVID-19 restrict travel, limit the ability to have meetings with potential investors or the target company’s personnel, vendors and services providers are unavailable to negotiate and consummate a transaction in a timely manner. The extent to which COVID-19 impacts our search for a business combinationfuture net losses will depend, in part, on the rate of future developments, which are highly uncertaingrowth of our expenses and cannot be predicted, including new information which may emerge concerning the severity of COVID-19 and the actions to contain COVID-19 or treat its impact, among others. If the disruptions posed by COVID-19 or other matters of global concern continue for an extensive period of time, our ability to consummategenerate revenue. Our prior losses and expected future losses have, had and will continue to have a business combination, or the operations of a target business with which we ultimately consummate a business combination, may be materially adversely affected.

Our public stockholders may not be afforded an opportunity to votematerial adverse effect on our proposed business combination.stockholders’ equity and working capital.

We will either (1) seek stockholder approval of our initial business combination at a meeting called for such purpose at which public stockholders may seek to convert their shares, regardless of whether they vote for or against the proposed business combination or don’t vote at all,Additionally, taking into their pro rata share of the aggregate amount then on deposit in the trust account (net of taxes payable), or (2) provide our public stockholders with the opportunity to sell their shares to us by means of a tender offer (and thereby avoid the need for a stockholder vote) for an amount equal to their pro rata share of the aggregate amount then on deposit in the trust account (net of taxes payable), in each case subject to the limitations described elsewhere in this prospectus. Accordingly, it is possible that we will consummate our initial business combination even if holders of a majority of our public shares do not approve of the business combination we consummate. The decision as to whether we will seek stockholder approval of a proposed business combination or will allow stockholders to sell their shares to us in a tender offer will be made by us, solely in our discretion, and will be based on a variety of factors such as the timing of the transaction and whether the terms of the transaction would otherwise require us to seek stockholder approval. For instance, Nasdaq rules currently allow us to engage in a tender offer in lieu of a stockholder meeting but would still require us to obtain stockholder approval if we were seeking to issue more than 20% of our outstanding shares to a target business as consideration in any business combination. Therefore, if we were structuring a business combination that required us to issue more than 20% of our outstanding shares, we would seek stockholder approval of such business combination instead of conducting a tender offer.


We may issue shares of our capital stock or debt securities to complete a business combination, which would reduce the equity interest of our stockholders and likely cause a change in control of our ownership.

Our second amended and restated certificate of incorporation authorizes the issuance of up to 100,000,000 shares of common stock, par value $0.001 per share, and 1,000,000 shares of preferred stock, par value $0.001 per share. Although we have no commitment as of the date of this Form 10-K, we may issue a substantial number of additional shares of common stock or shares of preferred stock, or a combination of common stock and preferred stock, to complete a business combination. The issuance of additional shares of common stock will not reduce the per-share conversion amount in the trust account. The issuance of additional shares of common stock or preferred stock:

may significantly reduce the equity interest of investors in our common stock;
may subordinate the rights of holders of shares of common stock if we issue shares of preferred stock with rights senior to those afforded to our shares of common stock;
may cause a change in control if a substantial number of shares of common stock are issued, which may affect, among other things, our ability to use our net operating loss carry forwards, if any, and could result in the resignation or removal of our present officers and directors; and
may adversely affect prevailing market prices for our shares of common stock.

Similarly, if we issue debt securities, it could result in:

default and foreclosure on our assets if our operating revenues after a business combination are insufficient to repay our debt obligations;
acceleration of our obligations to repay the indebtedness even if we make all principal and interest payments when due if we breach certain covenants that require the maintenance of certain financial ratios or reserves without a waiver or renegotiation of that covenant;
our immediate payment of all principal and accrued interest, if any, if the debt security is payable on demand; and
our inability to obtain necessary additional financing if the debt security contains covenants restricting our ability to obtain such financing while the debt security is outstanding.

If we incur indebtedness, our lenders will not have a claim on the cash in the trust account and such indebtedness will not decrease the per-share conversion amount in the trust account.

If the net proceeds of our IPO not being heldapproximately $14.0 million received in trust, togetherconnection with the interest earned on the fundspublic offering completed in the trust account available to us, are insufficient to allow us to operate until least October 13, 2021,February of 2023, we may be unable to complete a business combination.

Of the net proceeds fromdo not anticipate that our IPO, we have $537,021 available to us outside the trust account as of December 31, 2020 to fund our working capital requirements. We will also have access to interest earned on the funds held in the trust account for taxescurrent cash and subject to a limit of $250,000 per 12-month period, for our working capital needs. We believe that such fundscash equivalents balance will be sufficient to allow us to operate until at least October 13, 2021; however, we cannot assure yousustain operations within one year after the date that our estimateaudited financial statements for December 31, 2022 were issued, which raises substantial doubt about our ability to continue as a going concern. In our own required quarterly assessments, we may continue to conclude that there is accurate. Accordingly,substantial doubt about our ability to continue as a going concern, and the current and future reports from our independent registered public accounting firm contains and may also contain statements expressing substantial doubt about our ability to continue as a going concern.

If we seek additional financing to fund our business activities in the future and there remains substantial doubt about going concern, investors or other financing sources may be unwilling to provide additional funding on commercially reasonable terms or at all. Our ability to raise more equity capital will depend in part on our ability to amend our certificate of incorporation to authorize additional shares of Common Stock.

The net losses we incur may fluctuate significantly from quarter-to-quarter such that a period-to-period comparison of our results of operations may not be a good indication of our future performance.

37


We have no products approved for marketing in any jurisdiction, our Program Products are in early stages of development. We have never generated any revenue from product sales. Our ability to generate revenue and achieve profitability depends on our ability, alone or with strategic collaboration partners, to successfully complete the development of and obtain the regulatory and marketing approvals necessary to commercialize one or more of our Program Products. We do not anticipate generating revenue from product sales in the next couple of years. Even if we use all of the funds held outside of the trust account and all interest available to us,eventually generate product revenue, we may not have sufficient funds available with which to structure, negotiate or close an initial business combination. In such event, we would need to borrow funds from our sponsor, officers or directors or their affiliates to operate or maynever be forced to liquidate. Our sponsor, initial stockholders, officers, directorsprofitable and, their affiliates may, but are not obligated to, loan us funds, from time to time or at any time, in whatever amount that they deem reasonable in their sole discretion for our working capital needs. Each loan would be evidenced by a promissory note. The notes would either be paid upon consummation of our initial business combination, without interest, or, at holder’s discretion, up to $1,500,000 of the notes may be converted into warrants at a price of $1.00 per warrant.


If third parties bring claims against us, the proceeds held in trust could be reduced and the per-share redemption price received by stockholders may be less than $10.10.

Our placing of funds in trust may not protect those funds from third party claims against us. Although we will seek to have all vendors and service providers we engage and prospective target businesses we negotiate with execute agreements with us waiving any right, title, interest or claim of any kind in or to any monies held in the trust account for the benefit of our public stockholders, they may not execute such agreements. Furthermore, even if such entities execute such agreements with us, they may seek recourse against the trust account. A court may not uphold the validity of such agreements. Accordingly, the proceeds held in trust could be subject to claims which could take priority over those of our public stockholders. If we are unable to complete a business combination and distribute the proceeds held in trust to our public stockholders, our Sponsor has agreed (subject to certain exceptions described elsewhere in this Form 10-K) that it will be liable to ensure that the proceeds in the trust account are not reduced below $10.10 per share by the claims of target businesses or claims of vendors or other entities that are owed money by us for services rendered or contracted for or products sold to us. However, we have not asked our Sponsor to reserve for such indemnification obligations, nor have we independently verified whether our Sponsor has sufficient funds to satisfy its indemnity obligations and believe that our Sponsor’s only assets are securities of our company. Therefore, we believe it is unlikely that our Sponsor will be able to satisfy its indemnification obligations if it is required to do so. As a result, the per-share distribution from the trust account may be less than $10.10, plus interest, due to such claims.

Additionally, if we are forced to file a bankruptcy case or an involuntary bankruptcy case is filed against us which is not dismissed, the proceeds held in the trust account could be subject to applicable bankruptcy law, and may be included in our bankruptcy estate and subject to the claims of third parties with priority over the claims of our stockholders. To the extent any bankruptcy claims deplete the trust account,do achieve profitability, we may not be able to returnsustain or increase profitability on a quarterly or annual basis.

We may not be able to raise additional funding on acceptable terms, or at all. Failure to obtain funding on acceptable terms and on a timely basis may require us to curtail, delay or discontinue our product development efforts or other operations. Raising additional funding may cause dilution to our stockholders.

Developing our Program Products is expensive, and we expect our research and development expenses to increase substantially in connection with our ongoing activities, particularly as we advance our Program Products through clinical studies, manufacturing and regulatory approval. We expect to finance future cash needs through public stockholdersor private equity or debt offerings or product collaborations. We do not have any committed external source of funds. We cannot guarantee that future financing will be available in sufficient amounts or on terms acceptable to us, if at least $10.10.all, and the terms of any financing may adversely affect the interests or rights of our stockholders. Even if we believe that we have sufficient funds for our current or future operating plans, we may seek additional capital if market conditions are favorable or if we have specific strategic considerations. The issuance of additional securities, whether equity or debt, by us, or the possibility of such issuance, may affect the value of your investment.

To the extent that we raise additional capital through the sale of equity or convertible debt securities, your ownership interest will be diluted, and the terms of such securities may include liquidation or other preferences that adversely affect your rights as a stockholder. Debt financing, if available, may involve covenants restricting our operations or our ability to incur additional debt.

If we do not raise additional capital, we may not be able to expand our operations or otherwise capitalize on our business opportunities, our business and financial condition will be negatively impacted, and we may need to:

significantly delay, scale back or discontinue research and discovery efforts and the development or commercialization of our Product Programs and future program candidates or cease operations altogether;

seek strategic alliances for research and development programs when we otherwise would not, or at an earlier stage than we would otherwise desire or on terms less favorable than might otherwise be available; or

relinquish, or license on unfavorable terms, our rights to technologies or any product candidates that we otherwise would seek to develop or commercialize ourselves.

Risks Related to the Product Development, Regulatory Approval, Manufacturing and

Commercialization of Our stockholdersProgram Products and Product Candidates

If preclinical studies or clinical studies for our Program Products are unsuccessful or delayed, we will be unable to meet our future development goals.

Conducting clinical studies for any product candidates for approval in the United States requires filing an IND and reaching agreement with the FDA on clinical protocols, finding appropriate clinical sites and clinical investigators, securing approvals for such studies from the IRB at each such site, manufacturing clinical quantities of product candidates and supplying drug product or devices to clinical sites. Currently, we do not have an active IND with the FDA in the United States for our Program Products. If our IND is not approved by the FDA, our clinical development timeline may be held liablenegatively impacted, and any future clinical programs may be delayed or terminated.

Even if the clinical studies are approved by FDA or other regulatory agencies, clinical study is expensive and can take many years to complete, and its outcome is inherently uncertain. A failure of one or more of our clinical

38


studies can occur at any time during the clinical study process. We do not know whether future clinical studies, if any, will begin on time, need to be redesigned, enroll an adequate number of patients on time or be completed on schedule, if at all. Clinical studies can be delayed, suspended or terminated for claims by third parties against usa variety of reasons, including failure to (i) generate sufficient positive preclinical and clinical data; (ii) recruit CROs, clinical investigators and patients in a timely manner; (iii) manufacture sufficient quantities at the required quality of Program Products for use in clinical studies; (iv) raise sufficient capital to fund a study; (v) comply with all applicable regulatory requirements, whether in the United States or elsewhere, and (vi) obtain successful regulatory approval from regulatory authorities like the FDA.

If we experience delays in completing any clinical study of our Program Products or successfully obtaining regulatory approval, the commercial prospects of our Program Products may be harmed, and our ability to generate product revenues from any of these product candidates will be delayed. In addition, any delays in completing our clinical studies will increase our costs, slow down the development and approval process of our Program Products, and jeopardize our ability to commence product sales and generate revenues. Any of these occurrences may significantly harm our business and financial condition. In addition, many of the factors that cause, or lead to, a delay in the commencement or completion of clinical studies may also ultimately lead to the extentdenial of distributions receivedregulatory approval of our product candidates.

Drug development involves a lengthy and expensive process with uncertain timelines and uncertain outcomes, and the results of prior preclinical or clinical studies are not necessarily predictive of our future results. Our clinical studies may fail to adequately demonstrate the safety and efficacy of our Program Products or any future product candidates.

To date, the primary focus of our product development has been on the development of REVTx-300, REVTx-100, REVTx-200 and REVTx-99a/b, our therapeutic products and REVDx-501, our diagnostic device.

Our near-term focus is on the development of REVTx-300, REVTx-100 and REVTx-200, which are in pre-clinical development working towards early clinical trials.

There is a high failure rate for product candidates proceeding through clinical studies. Failure can occur at any time during the clinical study process. Many companies in the pharmaceutical industry have suffered significant setbacks in late-stage clinical studies even after achieving promising results in preclinical testing and earlier-stage clinical studies. Data obtained from preclinical and clinical activities are subject to varying interpretations, which may delay, limit or prevent regulatory approval. In addition, we may experience regulatory delays or rejections as a result of many factors, including changes in regulatory policy during the development period of our Program Products. Success in preclinical testing and early clinical studies does not ensure that later clinical studies will generate the same results or otherwise provide adequate data to demonstrate the efficacy and safety of a product candidate. Frequently, product candidates that have shown promising results in early clinical studies have subsequently suffered significant setbacks in later clinical studies. If we are unable to successfully demonstrate the safety and efficacy of our Program Products or other future product candidates and receive the necessary regulatory approvals, our business will be materially harmed.

The Clinical Studies of our Program Products’ have been and are planned to be conducted outside the United States, and the FDA or comparable foreign regulatory authorities may not accept data from such studies.

We currently have not conducted any clinical studies in the United States to date. We have conducted and we plan to conduct additional clinical studies outside the United States, including Europe, Australia, or other foreign jurisdictions. The acceptance of clinical study data by them.the FDA from clinical studies conducted outside the United States may be subject to certain conditions. In cases where data from clinical studies conducted outside the United States are intended to serve as the sole bases for regulatory approval in the United States, the FDA will generally not approve the application on the basis of foreign data alone unless (i) the data are applicable to the United States population and United States medical practices, (ii) the studies were performed by clinical investigators of recognized competence and (iii) the data may be considered valid without the need for an on-site inspection by the FDA or, if the FDA considers such an inspection to be necessary, the FDA is able to validate the data through an on-site inspection or other appropriate means. Additionally, the FDA’s clinical study requirements, including sufficient size of patient populations and statistical powering, must be met. Many foreign regulatory bodies have similar approval requirements.

39


In addition, such foreign studies would be subject to the applicable local laws of the foreign jurisdictions where the studies are conducted. There can be no assurance that the FDA or any comparable foreign regulatory authority will accept data from studies conducted outside of the United States or the applicable jurisdiction. If the FDA or any comparable foreign regulatory authority does not accept such data, it would result in the need for additional studies, which would be costly and time-consuming and delay aspects of our business plan, and may result in our Program Products’ not receiving regulatory approval or clearance for commercialization in the applicable jurisdiction.

Our second amended

As an organization, we have never conducted pivotal clinical studies, and restated certificatewe may be unable to do so for any Program Products we may develop.

We will need to successfully complete pivotal clinical studies in order to obtain the approval of incorporation provides that we will continue in existence only until October 13, 2021. Ifthe FDA, the EMA or other regulatory agencies to market any of our Program Products. Carrying out later-stage clinical studies and the submission to the FDA of a successful NDA, BLA, 510(k) Clearance, De Novo Clearance or PMA is a complicated process. As an organization, we have not completedpreviously conducted any later stage or pivotal clinical studies and have limited experience in preparing, submitting and prosecuting regulatory filings. We may be unable to conduct clinical studies at preferred sites, enlist clinical investigators, enroll sufficient numbers of participants or begin or successfully complete clinical studies in a business combination by such date,timely fashion, if at all. In addition, the design of a clinical study can determine whether its results will support approval of a product, and flaws in the design of a clinical study may not become apparent until the clinical study is well advanced. Because we will (i) cease all operations excepthave limited experience as a company designing clinical studies, we may be unable to successfully and efficiently execute and complete necessary clinical studies in a way that leads to successful regulatory submission and approval. We may require more time and incur greater costs than our competitors and may not succeed in obtaining regulatory approvals of product candidates that we develop. Failure to commence or complete, or delays in, our planned clinical studies, could prevent us from or delay us in commercializing our Program Products. We rely on third parties to conduct certain elements of our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our Program Products.

We may find it difficult to enroll patients in our clinical studies, which could delay or prevent us from proceeding with clinical studies.

Identifying and qualifying patients to participate in clinical studies of our product candidates is critical to our success. The timing of our clinical studies depends in part on the speed at which we can recruit patients to participate in testing our Program Products, and we may experience delays in our clinical studies if we encounter difficulties in enrollment. Patient enrollment and retention in clinical studies depends on many factors, including the size of the patient population, number and location of the clinical sites, significant adverse events or other side effects observed, if any, the nature of the study protocol, our ability to recruit clinical study investigators with the appropriate competencies and experience, the existing body of safety and efficacy data with respect to the study drug, the number and nature of competing treatments and ongoing clinical studies of competing drugs for the purposesame indication, the proximity of winding up, (ii)patients to clinical sites, clinicians’ and patients’ perceptions as promptly as reasonably possible but not more than ten business days thereafter, redeem 100%to the potential advantages of the outstanding public shares, at a per-share price, payableProgram Products being studied in cash, equalrelation to the aggregate amount then on deposit in the trust account,other available therapies, including any interest not previously releaseddrugs that may be approved for the indications we are investigating, the eligibility criteria for the study, our ability to us but netobtain and maintain patient consents and the risk that patients enrolled in clinical studies will drop out of franchisethe studies before completion.

In addition, our competitors, some of whom have significantly greater resources than we do, are conducting clinical studies for the same indications and income taxes payable, divided byseek to enroll patients in their studies that may otherwise be eligible for our clinical studies or studies, which could lead to slow recruitment and delays in our clinical programs. Further, since the number of then outstanding public shares,qualified clinical investigators is limited, we expect to conduct some of our clinical studies at the same clinical study sites that some of our competitors use, which redemptioncould further reduce the number of patients who are available for our clinical studies in these sites.

Our inability to enroll sufficient number of patients for our clinical studies would result in significant delays or may require us to abandon one or more clinical studies altogether. If we are unable to enroll sufficient number of patients that will completely extinguish public stockholders’ rightscomplete clinical testing, we will be unable to seek or gain marketing approval for our Program Products and any future product candidates and our business will be harmed. Even if we are able to enroll a sufficient number of patients in our clinical studies or studies, delays in patient enrollment may result in increased costs or may

40


affect the timing or outcome of our clinical studies, which could prevent completion of these studies and adversely affect our ability to advance the development of our Program Products and any future product candidates.

Our Program Products and the administration of our Program Products may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit the commercial profile of an approved label or result in significant negative consequences following marketing approval, if any.

The severity and frequency of undesirable side effects caused by our Program Products, could cause us or regulatory authorities to interrupt, delay or halt clinical studies and could result in a more restrictive label, delay or denial of regulatory approval by the FDA or other regulatory agencies. Results of our studies could reveal a high and unacceptable severity and prevalence of these or other side effects. In such an event, our clinical studies could be suspended or terminated, and the FDA or other regulatory agencies could order us to cease further development of or deny or withdraw approval of our product candidates for any or all targeted indications. Moreover, during the conduct of clinical studies, patients report changes in their health, including illnesses, injuries and discomforts, to their study doctor. Often, it is not possible to determine whether or not the product candidate being studied caused these conditions.

Drug-related, drug product-related, formulation-related and administration-related side effects could affect patient recruitment, the ability of enrolled patients to complete the clinical study or result in potential product liability claims, which could exceed the insurance coverage. Additionally, if one or more of our Program Products receives marketing approval, and we or others later identify undesirable side effects caused by such products, a number of potentially significant negative consequences could result.

If we or others identify undesirable or unacceptable side effects caused by our Program Products or any future product candidates or products:

we may be required to modify, suspend or terminate our clinical studies;

we may be required to modify or include additional dosage and administration instructions, warnings and precautions, contraindications, boxed warnings, limitations, restrictions or other statements in the product label for our approved products, or issue field alerts to physicians and pharmacies;

we may be required to conduct costly additional clinical studies;

we may be subject to limitations on how we may promote our approved products;

sales of our approved products may decrease significantly;

regulatory authorities may require us to take our approved products off the market;

we may be subject to regulatory investigations, government enforcement actions, litigation or product liability claims; and

our products may become less competitive, or our reputation may suffer.

Interim, topline and preliminary data from our clinical studies that we announce or publish from time to time may change as stockholders (including the right to receive further liquidation distributions, if any),more patient data become available and are subject to applicable law,audit and (iii)verification procedures that could result in material changes in the final data.

From time to time, we may publicly disclose preliminary or topline data from our clinical studies, which are based on a preliminary analysis of then-available data, and the results and related findings and conclusions are subject to change following a more comprehensive review of the data related to the particular study or studies. We also make assumptions, estimations, calculations and conclusions as promptly as reasonably possible followingpart of our analyses of data, and we may not have received or had the opportunity to fully and carefully evaluate all data. As a result, the topline results that we report may differ from future results of the same studies, or different conclusions or considerations may qualify such redemption,results, once additional data have been received and fully evaluated. Topline data also remain subject to audit and verification

41


procedures that may result in the final data being materially different from the preliminary data we previously published. As a result, topline data should be viewed with caution until the final data are available. From time to time, we may also disclose interim data from our clinical studies. In addition, we may report interim analyses of only certain endpoints rather than all endpoints. Interim data from clinical studies that we may complete are subject to the risk that one or more of the clinical outcomes may materially change as patient enrollment continues and more patient data become available.

In addition, adverse changes between interim data and final data could significantly harm our business and prospects. Additional disclosure of interim data by us or by our competitors in the future could also result in volatility in the price of our Common Stock after this offering. Further, others, including regulatory agencies, may not accept or agree with our assumptions, estimates, calculations, conclusions or analyses or may interpret or weigh the importance of data differently, which could impact the value of the particular program, the approvability or commercialization of the particular product candidate or product and our Company in general. In addition, the information we choose to publicly disclose regarding a particular study or clinical study is based on what is typically extensive information, and you or others may not agree with what we determine is the material or otherwise, appropriate information to include in our disclosure, and any information we determine not to disclose may ultimately be deemed significant with respect to future decisions, conclusions, views, activities or otherwise regarding a particular drug, drug candidate or our business. If the topline data that we report differ from actual results, or if others, including regulatory authorities, disagree with the conclusions reached, our ability to obtain approval for, and commercialize, our Program Products or any future product candidates may be harmed, which could harm our business, financial condition, results of operations and prospects.

Even if we complete the necessary clinical studies, we cannot predict when, or if, we will obtain regulatory approval to commercialize any of our Program Products, and the approval may be for a more narrow indication than we seek or be subject to other limitations or restrictions that limit its commercial profile.

Our Program Products have not received regulatory approval. We do not expect our Program Products or any future product candidate to be commercially available for years, if at all. Our Program Products are, and any future product candidate will be subject to strict regulation by regulatory authorities in the United States and in other countries. We cannot commercialize a product candidate or diagnostic device until the appropriate regulatory authorities have reviewed and approved such product candidate or diagnostic device. Even if our current or future Program Products meet safety and efficacy endpoints in pivotal clinical studies, the regulatory authorities may not complete their review processes in a timely manner, or we may not be able to obtain regulatory approval. Additional delays may result if an FDA Advisory Committee or other regulatory authority recommends non-approval or restrictions on approval. This may include approval of a product candidate for more limited indications than requested or they may impose significant limitations in the form of warnings. In addition, we may experience delays or rejections based upon additional government regulation from future legislation or administrative action, or changes in regulatory authority policy during the period of product development, clinical studies and the review process.

Our business depends on the success of our Program Products, including obtaining regulatory approval to market our product candidates in the United States and/or other major foreign markets such as the EU.

We have invested, and will continue to invest, a significant portion of our time and financial resources in the clinical development of REVTx-300, REVTx-100 and REVTx-200. Historically we have invested in REVDx-501 and REVTx-99a/b until June of 2022. If we cannot successfully develop, obtain regulatory approval for, and commercialize our Program Products, we may not be able to continue our operations. The future regulatory approval and commercial success of our Program Products are subject to a number of risks, including the following:

we may not have sufficient financial and other resources to complete the necessary clinical studies for our Program Products, including, but not limited to, the clinical studies needed to obtain regulatory approval for commercialization;

we may not be able to obtain regulatory authorization to proceed with various clinical studies in the United States, and even if we are able to proceed with clinical studies, the regulatory authorities may limit, delay, or put our clinical studies on hold;

42


we may not be able to obtain adequate evidence from our clinical studies for our Program Products;

the results of our clinical studies may not meet the level of statistical or clinical significance required by the FDA or comparable foreign regulatory authorities for marketing approval;

we cannot be certain of the number of types of clinical studies and non-clinical studies that the regulatory agencies will require in order to approve our Program Products;

the data from clinical studies conducted outside of the United States may not be accepted by the FDA or other regulatory authorities;

patients in our clinical studies may suffer serious adverse events for reasons that may or may not be related to our Program Products, which could delay or prevent further clinical development;

the regulatory agencies may find deficiencies without manufacturing processes or facilities;

the CROs, that we retain to conduct our clinical studies may take actions outside of our control that materially adversely impact our clinical studies;

the regulatory agencies may not approve the formulation, labeling or specifications of REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or other future product candidates;

the regulatory agencies may change their approval policies or adopt new regulations;

if approved, our Program Products will likely compete with products that may reach approval for the same indication or use prior to our Program Products, products that are currently approved and the products that are currently marketed products; and

we may not be able to obtain, maintain or enforce our patents and other intellectual property rights.

Of the large number of drugs and devices in development in the pharmaceutical industry, only a small percentage results in the submission of a marketing authorization to the FDA or comparable foreign regulatory authorities and even fewer are approved for commercialization. Furthermore, even if we do receive regulatory approval to market our Program Products, any such approval may be subject to limitations on the indicated uses or patient populations for which we may market the products. Accordingly, even if we are able to obtain the requisite financing to continue to fund our development programs, we may be unable to successfully develop or commercialize our Program Products. If we or any of our future development collaborators are unable to develop, or obtain regulatory approval for, or, if approved, successfully commercialize our Program Products, we may not be able to generate sufficient revenue to continue our business.

Even if we obtain regulatory approval for a product candidate, our products and business will remain subject to ongoing regulatory obligations and review.

Even if our Program Products are approved, they will be subject to ongoing regulatory requirements for manufacturing, labeling, packaging, storage, advertising, distribution, promotion, sampling, record-keeping, conduct of post-marketing studies and submission of safety, efficacy and other post-market information, including both federal and state requirements in the United States and comparable requirements outside of the United States. Accordingly, we and others with whom we work must continue to expend time, money and effort in all areas of regulatory compliance, including manufacturing, production and quality control. If a regulatory agency discovers previously unknown problems with a product, such as adverse events of unanticipated severity or frequency, quality of product or disagrees with the promotion, marketing or labeling of a product, such regulatory agency may impose restrictions on that product or us, including requiring recall or withdrawal of the product from the market.

In addition, manufacturers of drug products and their facilities are subject to continual review and periodic inspections by the FDA and other regulatory authorities for compliance with cGMP, regulations and standards. If we or a regulatory agency discover previously unknown problems with a product, such as adverse events of unanticipated

43


severity or frequency, or problems with the facility where the product is manufactured, a regulatory agency may impose restrictions on that product, the manufacturing facility or us, including requiring recall or withdrawal of the product from the market or suspension of manufacturing. If we, our product candidates or the manufacturing facilities for our product candidates fail to comply with applicable regulatory requirements, or undesirable side effects caused by such products are identified, a regulatory agency may:

issue safety alerts, Dear Healthcare Provider letters, press releases or other communications containing warnings about such product;

mandate modification to promotional materials or require us to provide corrective information to healthcare practitioners;

require that we conduct post-marketing studies;

require us to enter into a consent decree, which can include imposition of various fines, reimbursements for inspection costs, required due dates for specific action and penalties for noncompliance;

seek an injunction or impose civil or criminal penalties or monetary fines;

suspend marketing of, withdraw regulatory approval of or recall such product;

suspend any ongoing clinical studies;

refuse to approve pending applications or supplements to applications filed by us;

suspend or impose restrictions on operations, including costly new manufacturing requirements; or

seize or detain products, refuse to import or export products or require us to initiate a product recall.

The occurrence of any event or penalty described above may inhibit our ability to commercialize our products and generate product revenue.

If one or more of our Program Products is approved for marketing in the United States or other countries, we may be subject, directly or indirectly, to United States or other countries equivalent federal and state healthcare fraud and abuse laws, false claims laws, physician payment transparency laws and health information privacy and security laws. If we are unable to comply, or have not fully complied, with such laws, we could face substantial penalties.

Even if we obtain FDA or other comparable regulatory agencies approval for any of our Program Products and begin commercializing those products in the United States or other countries, our operations may be directly or indirectly through our relationships with physicians, patients, third-party payors and customers, subject to broadly applicable fraud and abuse and other healthcare laws and regulations that may constrain our business or financial arrangements and relationships through which we research, market, sell and distribute our Program Products. In addition, we may be subject to patient privacy regulation by both the federal government and the states in which we conduct our business. The laws that may affect our ability to operate include, among others, the United States Anti-Kickback Statute, the False Claims Act, the United States Health Insurance Portability and Accountability Act of 1996, and the Sunshine Act and analogous state laws. Ensuring that our internal operations and business arrangements with third parties comply with all applicable healthcare laws and regulations will likely be costly.

Legislative or regulatory healthcare reforms in the United States or other countries may make it more difficult and costly for us to obtain regulatory clearance or approval of our remaining stockholdersProgram Products and to produce, market and distribute our Program Products after clearance or approval is obtained.

From time to time, legislation is drafted and introduced in Congress that could significantly change the statutory provisions governing the regulatory clearance or approval, manufacture and marketing of regulated products or the reimbursement thereof. In addition, FDA or other comparable regulatory agencies regulations and guidance are

44


often revised or reinterpreted by the FDA or other comparable regulatory agencies in ways that may significantly affect our business and our boardproducts. Any new regulations or revisions or reinterpretations of directors, dissolveexisting regulations may impose additional costs or lengthen review times of our Program Products. We cannot determine what effect changes in regulations, statutes, legal interpretation or policies, when and liquidate, subject (inif promulgated, enacted or adopted may have on our business in the casefuture.

We face intense competition in an environment of (ii) and (iii) above) to our obligations under Delaware law to provide for claims of creditorsrapid technological change and the requirementspossibility that our competitors may develop products and drug delivery systems that are similar, more advanced or more effective than ours, which may adversely affect our financial condition and our ability to successfully market or commercialize our Program Products.

The pharmaceutical industry in which we operate is intensely competitive and subject to rapid and significant technological change. We are currently aware of other applicable law. We cannot assure youvarious existing therapies in the market and in development that may in the future compete with our Program Products.

Even if approved, we will properly assess all claims thatcompete with currently approved therapies and therapies further along in development. Our competitors both in the United States and abroad include large, well-established pharmaceutical and generic companies with significantly greater name recognition and an established market share. Our competitors may be potentially brought against us. As such,able to charge lower prices than we can, which may adversely affect our stockholders could potentiallymarket acceptance. Many of these competitors have greater resources than we do, including financial, product development, marketing, personnel and other resources.

If our competitors market products that are more effective, safer or cheaper than our products or that reach the market sooner than our products, we may not achieve commercial success. In addition, the biopharmaceutical industry is characterized by rapid technological change. Because our research approach integrates many technologies, it may be liabledifficult for any claimsus to stay abreast of the extentrapid changes in other technologies. If we fail to stay at the forefront of distributions receivedtechnological change, we may be unable to compete effectively. Technological advances or products developed by them (but no more) and any liabilityour competitors may render our technologies, products or product candidates obsolete, less competitive or not economical. Many of our stockholderscompetitors have substantially greater financial, technical, human and other resources than we do and may extend well beyondbe better equipped to develop, manufacture and market technologically superior products. In addition, many of these competitors have significantly longer operating histories and greater experience than we have in undertaking nonclinical studies and human clinical studies of new pharmaceutical products and in obtaining regulatory approvals of human therapeutic products. Many of our competitors have established distribution channels for the third anniversarycommercialization of the datetheir products, whereas we have no such channel or capabilities. In addition, many competitors have greater name recognition and more extensive collaborative relationships.

As a result, our competitors may obtain regulatory approval of distribution. Accordingly,their products more rapidly than we cannot assure youdo or may obtain patent protection or other intellectual property rights that third parties will not seeklimit our ability to recover fromdevelop or commercialize our stockholders amounts owed to them by us.

product candidate or any future product candidates. Our competitors may also develop and succeed in obtaining approval for drugs that are more effective, more convenient, more widely used and less costly or have a better safety profile than our products and these competitors may also be more successful than we are in manufacturing and marketing their products. If we are unable to compete effectively against these companies, then we may not be able to commercialize our product candidate or any future product candidates or achieve a competitive position in the market. This would adversely affect our ability to generate revenue. Our competitors also compete with us in recruiting and retaining qualified scientific, management and commercial personnel, establishing clinical study sites and enrolling patients for clinical studies, as well as in acquiring technologies complementary to, or necessary for, our programs. Our inability to compete effectively in any of these aspects of our business could harm our business, financial condition, results of operations and prospects.

Risks Related to COVID-19 and our Reliance on Third Parties

COVID-19 related disruptions have had an adverse impact on the Company’s business, operations and financial performance. The Company is unable to predict the full extent to which the COVID-19 pandemic or any future pandemic, epidemic or similar public health threat will adversely impact its business, operations, financial performance, results of operations, and financial condition.

45


During the COVID-19 public health emergency our business was adversely affected by the inability to timely enroll patients in our clinical trials, limitations in employee resources that would otherwise be focused on the conduct of our clinical studies, including because of sickness of employees or their families or the desire of employees to avoid contact with large groups of people; delays or difficulties in clinical site initiation, including difficulties in recruiting clinical site investigators, and clinical site staff, due to competition with other pharmaceutical companies starting their clinical studies that have been delayed or paused due to the COVID-19 pandemic for limited resources such as clinical sites, site investigators, clinical site staff, as well as various other resources would or the overwork of existing investigators and staff; delays in necessary interactions with local regulators, ethics committees and other important agencies and contractors due to limitations in employee resources or forced furlough of government employees, and others. While we believe the global health systems and patients have largely adapted to file a bankruptcy casethe impact of COVID-19, the continued duration and severity of the COVID-19 pandemic is uncertain and difficult to predict. The degree to which COVID-19 related disruptions impact the Company’s results in 2023 will depend on future developments, beyond the Company’s knowledge or an involuntary bankruptcy case is filed againstcontrol, including governmental and third-party actions taken to contain or prevent the spread and treatment of the virus and mitigate its public health and economic effects. In addition, any future pandemic, epidemic or similar public health threat could present similar risks to the Company’s business, cash flow, results of operations, financial condition and prospects.

We rely on third parties to conduct certain elements of our preclinical and clinical studies and perform other tasks for us. If these third parties do not successfully carry out their contractual duties, meet expected deadlines or comply with regulatory requirements, we may not be able to obtain regulatory approval for or commercialize our Program Products.

We currently rely on, and expect to continue to rely on, third parties, such as CROs, clinical data management organizations, medical institutions, consultants and clinical investigators, to conduct our clinical studies and certain aspects of our research and preclinical testing. Any of these third parties may terminate their engagements with us which isat any time. If we need to enter into alternative arrangements, it will delay our product development activities and such alternative arrangements may not dismissed, any distributions received by stockholdersbe available on terms acceptable to us.

Our reliance on these third parties for research and development activities will reduce our control over these activities but will not relieve us of our responsibilities. For example, we will remain responsible for ensuring that each of our clinical studies are conducted in accordance with the general investigational plan and protocols for the study. Moreover, the FDA and other regulatory agencies requires us to comply with standards, commonly referred to as current Good Clinical Practices or equivalent, for conducting, recording and reporting the results of clinical studies to assure that data and reported results are credible and accurate and that the rights, integrity and confidentiality of study participants are protected. We also are required to register ongoing clinical studies and post the results of completed clinical.

We rely on third parties to manufacture the raw materials, including the active pharmaceutical ingredients that we use to create our therapeutic product candidate, and to manufacture the diagnostic devices, including the antibodies used for testing. Our business could be viewed under applicable debtor/creditor and/harmed if existing and prospective third parties fail to provide us with sufficient quantities of these materials and products or bankruptcy laws as eitherfail to do so at acceptable quality levels or prices.

We rely on third party suppliers for certain raw materials necessary to manufacture our product candidates for our preclinical studies and clinical studies and to manufacture our diagnostic tests for our clinical studies. Some of these raw materials and test components are difficult to source. Because there are a “preferential transfer” orlimited number of suppliers for these raw materials and components, we may need to engage alternate suppliers to prevent a “fraudulent conveyance.” As a result, a bankruptcy court could seek to recover all amounts received by our stockholders. Furthermore, because we intend to distribute the proceeds held in the trust account to our public stockholders promptly after expirationpossible disruption of the timemanufacture of the materials necessary to produce our Program Products for our clinical studies, and if approved, ultimately for commercial sale. In particular, there is only one supplier for PHAD®, Avanti Polar Lipids, Inc. Although we have secured enough material through a purchase order for our planned clinical trials, we do not have a long-term supply agreement with Avanti Polar Lipids, Inc. We do not have any control over the availability of raw materials and components. If we or our manufacturers are unable to complete an initial business combination, this maypurchase these raw materials or components on acceptable terms, at sufficient quality levels, or in adequate quantities, if at all, the development and commercialization of our product candidates or any future product candidates, would be vieweddelayed or interpreted as giving preferencethere would be a shortage in supply, which would impair our ability to meet our public stockholders over any potential creditors with respect to access todevelopment objectives for our Program Products or distributions from our assets. Furthermore, our board may be viewed as having breached their fiduciary duties to our creditors and/or may have acted in bad faith, and thereby exposing itself and our company to claims of punitive damages, by paying public stockholdersgenerate revenues from the trust account priorsale of any approved products.

46


Until such time, if ever, as we establish a manufacturing facility that has been properly validated to addressing the claims of creditors. We cannot assure you that claimscomply with FDA or other comparable regulatory agencies cGMP requirements, we will not be brought against usable to independently manufacture Program Products for these reasons.

13

Our directorsour planned preclinical and clinical programs. We currently rely on a third-party manufacturer for the production of our clinical study materials. And to date, REVTx-300, REVTx-100, REVTx-200 and REVTx-99a/b have been manufactured by a single third-party manufacturer. This manufacturer may decide not be able to enforce our Sponsor’s indemnification obligations, resulting inscale production to the larger quantities required for large clinical studies and to commercialize REVTx-300, REVTx-100, REVTx-200 and REVTx-99b, if approved. REVDx-501 has also been manufactured and developed by a reduction insingle third-party manufacturer. This manufacturer may not be able to scale production to the amount of funds inlarger quantities required for a clinical study and to commercialize, if approved. Also, the trust account available for distributionthird-party manufacturers may not be able to our public stockholders.

produce Program Products that meet the quality requirements. In the event that the proceedsthis third-party manufacturer does not successfully carry out its contractual duties, meet expected deadlines or manufacture our products in the trust accountaccordance with regulatory requirements or if there are reduced below $10.00 per public sharedisagreements between us and our Sponsor asserts that it is unable to satisfy its obligations or that it has no indemnification obligations related to a particular claim, our independent directors would determine whether to take legal action against our Sponsor to enforce such indemnification obligations. It is possible that our independent directors in exercising their business judgment may choose not to do so in any particular instance. If our independent directors choose not to enforce these indemnification obligations, the amount of funds in the trust account available for distribution to our public stockholders may be reduced below $10.00 per share.

Ifthis third-party manufacturer, we do not file and maintain a current and effective prospectus relating to the common stock issuable upon exercise of the warrants, holders will only be able to exercise such warrants on a “cashless basis.”

If we do not file and maintain a current and effective prospectus relating to the common stock issuable upon exercise of the warrants at the time that holders wish to exercise such warrants, they will only be able to exercise them on a “cashless basis” provided that an exemption from registration is available. As a result, the number of shares of common stock that holders will receive upon exercise of the warrants will be fewer than it would have been had such holder exercised his warrant for cash. Further, if an exemption from registration is not available, holders would not be able to exercisecomplete, or may be delayed in completing, the clinical studies required. In such instances, we may need to locate an appropriate replacement third-party relationship, which may not be readily available or on a cashless basisacceptable terms, which would cause additional delay or increased expense and would onlythereby have a material adverse effect on our business, financial condition, results of operations and prospects.

We do not have a long-term supply agreement with any third-party manufacturer. Reliance on third-party manufacturers entails risks to which we would not be subject if we manufacture product candidates or products ourselves. For example, if we do not maintain our key manufacturing relationships, we may fail to find replacement manufacturers or develop our own manufacturing capabilities in a timely manner or at all, which could delay or impair our ability to obtain regulatory approval for our products and substantially increase our costs or deplete profit margins, if any. If we do find replacement manufacturers, we may not be able to exercise their warrantsenter into agreements with them on terms and conditions favorable to us, and there could be a substantial delay before new facilities could be qualified and registered with the FDA and other comparable foreign regulatory authorities. Even if we are able to establish agreements with third-party manufacturers, reliance on third-party manufacturers entails additional risks, including:

the possible failure of the third party to manufacture product candidates according to our schedule, or at all, including if our third-party contractors give greater priority to the supply of other products over our product candidates or otherwise do not satisfactorily perform according to the terms of the agreements between us and them;

the possible breach of the manufacturing agreement by the third party because of factors beyond our control (including a failure to manufacture product candidates in accordance with our product specifications);

the possible mislabeling of clinical supplies, potentially resulting in the wrong dose amounts being supplied or active drug or placebo not being properly identified;

the possibility of clinical supplies not being delivered to clinical sites on time, leading to clinical study interruptions, or of drug supplies not being distributed to commercial vendors in a timely manner, resulting in lost sales;

the possible misappropriation of our proprietary information, including our trade secrets and know-how;

the possible termination or nonrenewal of the agreement by the third party at a time that is costly or inconvenient for us; and

reliance on the third party for regulatory compliance, quality assurance and safety and pharmacovigilance reporting.

Certain raw materials necessary for cashthe manufacture of REVTx-300, REVTx-100, REVTx-200 and REVTx-99b under our current manufacturing process, such as our API, are available only from a single supplier. Any significant delay in the acquisition or decrease in the availability of these raw materials from our supplier could considerably delay the manufacture of REVTx-300, REVTx-100, REVTx-200 and REVTx-99b, which could adversely impact the timing of any planned studies or the regulatory approvals of REVTx-300, REVTx-100,

47


REVTx-200 and REVTx-99b. The FDA and other comparable foreign regulatory authorities require manufacturers to register manufacturing facilities. The FDA and other comparable foreign regulatory authorities also inspect these facilities to confirm compliance with cGMP.

Contract manufacturers may face manufacturing or quality control problems causing drug substance, drug product, diagnostic test kit production and shipment delays or a situation where the contractor may not be able to maintain compliance with the applicable cGMP requirements. We may have little to no control regarding the occurrence of third-party manufacturer incidents. Any failure to comply with cGMP requirements or other FDA or comparable foreign regulatory requirements could adversely affect our clinical research activities and our ability to develop our Program Products or any future product candidates and market our Program Products following approval.

If our Program Products or any future product candidates are approved by the FDA or other comparable foreign regulatory authorities for commercial sale, we may need to manufacture such product candidate in larger quantities. We intend to use third-party manufacturers for commercial quantities of our Program Products to the extent we advance this product candidate and other product candidates. Our manufacturers may not be able to successfully increase the manufacturing capacity for any of our product candidates in a timely or efficient manner, or at all. If we are unable to successfully increase the manufacturing capacity for a product candidate, the regulatory approval or commercial launch of that product candidate may be delayed or there may be a shortage in the supply of the product candidate.

In addition, the operations of our third-party manufacturers may be subject to earthquakes, power shortages, telecommunications failures, failures or breaches of information technology systems, water shortages, floods, hurricanes, typhoons, fires, extreme weather conditions, medical epidemics, and other natural or man-made disasters or business interruptions. Damage or extended periods of interruption to our facilities due to fire, natural disaster, power loss, communications failure, unauthorized entry or other events could cause us to cease or delay development of some or all of our product candidates. Our ability to obtain clinical supplies of our product candidates could be disrupted if the operations of these suppliers are affected by a man-made or natural disaster or other business interruption.

Our current and effective prospectus relatinganticipated future dependence upon others for the manufacture of our product candidates may adversely affect our future profit margins and our ability to develop our product candidates and commercialize any products that receive regulatory approval on a timely basis.

In some cases, the technical skills or technology required to manufacture our product candidates may be unique or proprietary to the common stock issuable upon exerciseoriginal manufacturer, we may have difficulty transferring such skills or technology to another third party and a feasible alternative many not exist. These factors would increase our reliance on such manufacturer or require us to obtain a license from such manufacturer in order to have another third party manufacture our product candidates. If we are required to change manufacturers for any reason, we will be required to verify that the new manufacturer maintains facilities and procedures that comply with quality standards and with all applicable regulations and guidelines. The delays associated with the verification of a new manufacturer, if we are able to identify an alternative source, could negatively affect our ability to develop product candidates in a timely manner or within budget.

We may not be able to obtain and maintain the warrants is available. Under the termsthird-party relationships that are necessary to develop, commercialize and manufacture some or all of the warrant agreement, we have agreedour product candidates.

We expect to usedepend on collaborators, partners, licensees, clinical investigators, CROs, manufacturers and other third parties to support our bestdiscovery efforts, to meet these conditionsformulate product candidates, to conduct clinical studies for some or all of our Program Products, to manufacture clinical and commercial scale quantities of our drug substance, drug product, diagnostic test and to filemarket, sell and maintain a currentdistribute any products we successfully develop. Any problems we experience with any of these third parties could delay the development, commercialization and effective prospectus relating to the common stock issuable upon exercisemanufacturing of the warrants until the expirationour product candidates, which could harm our results of the warrants. However, weoperations.

We cannot assure youguarantee that we will be able to successfully negotiate agreements for, or maintain relationships with, collaborators, partners, licensees, clinical investigators, CROs, manufacturers and other third parties on favorable terms, if at all. If we are unable to obtain or maintain these agreements, we may not be able to clinically

48


develop, formulate, manufacture, obtain regulatory approvals for or commercialize our Program Products and any future product candidates, which will in turn adversely affect our business.

We expect to expend substantial management time and effort to enter into relationships with third parties and, if we successfully enter into such relationships, to manage these relationships. In addition, substantial amounts will be paid to third parties in these relationships. However, we cannot control the amount or timing of resources our future contract partners will devote to our research and development programs, product candidates or potential product candidates, and we cannot guarantee that these parties will fulfill their obligations to us under these arrangements in a timely fashion, if at all. In addition, while we manage the relationships with third parties, we cannot control all of the operations of, and any outsourcing used by such third parties. We rely on third parties’ knowledge regarding specific local laws and regulatory requirements in foreign jurisdictions, where applicable.

We depend on our information technology systems and those of our third-party collaborators, service providers, contractors or consultants. Our internal computer systems, or those of our third-party collaborators, service providers, contractors or consultants, may fail or suffer security breaches, disruptions, or incidents, which could result in a material disruption of our development programs or loss of data or compromise the privacy, security, integrity or confidentiality of sensitive information related to our business and have a material adverse effect on our reputation, business, financial condition or results of operations.

In the ordinary course of our business, we collect, store and transmit large amounts of confidential information, including intellectual property, proprietary business information and personal information. Our internal technology systems and infrastructure, and those of our current or future third-party collaborators, service providers, contractors and consultants are vulnerable to damage from computer viruses, unauthorized access or use resulting from malware, natural disasters, terrorism, war and telecommunication and electrical failures, denial-of-service attacks, cyber-attacks or cyber-intrusions over the Internet, hacking, phishing and other social engineering attacks, persons inside our organizations (including employees or contractors), loss or theft, or persons with access to systems inside our organization. Attacks on information technology systems are increasing in their frequency, levels of persistence, sophistication and intensity, and they are being conducted by increasingly sophisticated and organized foreign governments, groups and individuals with a wide range of motives and expertise. In addition to extracting or accessing sensitive information, such attacks could include the deployment of harmful malware, ransomware, denial-of-service attacks, social engineering and other means to affect service reliability and threaten the security, confidentiality, integrity and availability of information. The prevalent use of mobile devices that access sensitive information also increases the risk of data security incidents which could lead to the loss of confidential information or other intellectual property. While to our knowledge we have not experienced any material system failure, accident or security breach to date, if such an event were to occur and cause interruptions in our operations or the operations of third-party collaborators, service providers, contractors and consultants, it could result in a material disruption of our development programs and significant reputational, financial, legal, regulatory, business or operational harm. The costs to us to mitigate, investigate and respond to potential security incidents, breaches, disruptions, network security problems, bugs, viruses, worms, malicious software programs and security vulnerabilities could be significant, and while we have implemented security measures to protect our data security and information technology systems, our efforts to address these problems may not be successful, and these problems could result in unexpected interruptions, delays, cessation of service and other harm to our business and our competitive position.

For example, the loss of clinical study data from completed, ongoing or planned clinical studies for our product candidates could result in delays in our regulatory approval efforts and significantly increase our costs to recover or reproduce the data. To the extent that any real or perceived security breach affects our systems (or those of our third-party collaborators, service providers, contractors or consultants), or results in the loss of or accidental, unlawful or unauthorized access to, use of, release of, or other processing of personally identifiable information or damage to our data or applications or other data or applications relating to our technology or product candidates, or inappropriate disclosure of confidential or proprietary information, we could incur liabilities and the further development of our product candidates could be delayed. Such a breach may require notification to governmental agencies, the media or individuals pursuant to various foreign, domestic (federal and state) privacy and security laws, if applicable, including HIPAA, as amended by HITECH, and its implementing rules and regulations, as well as regulations promulgated by the Federal Trade Commission and state breach notification laws. In addition, our liability insurance may not be sufficient in type or amount to cover us against claims related to security breaches, cyberattacks and other related incidents.

49


Any failure or perceived failure by us or any third-party collaborators, service providers, contractors or consultants to comply with our privacy, confidentiality, data security or similar obligations, or any data security incidents or other security breaches that result in the accidental, unlawful or unauthorized access to, use of, release of, processing of, or transfer of sensitive information, including personally identifiable information, may result in negative publicity, harm to our reputation, governmental investigations, enforcement actions, regulatory fines, litigation or public statements against us, could cause third parties to lose trust in us or could result in claims by third parties, including those that assert that we have breached our privacy, confidentiality, data security or similar obligations, any of which could have a material adverse effect on our reputation, business, financial condition or results of operations. To the extent we maintain individually identifiable health information, we could be subject to fines and penalties (including civil and criminal) under HIPAA for any failure by us or our business associates to comply with HIPAA’s requirements. Moreover, data security incidents and other security breaches can be difficult to detect, and any delay in identifying them may lead to increased harm. While we have implemented data security measures intended to protect our information, data, information technology systems, applications and infrastructure, there can be no assurance that such measures will successfully prevent service interruptions or data security incidents.

Risks Related to Our Intellectual Property

If we are unable to obtain and maintain effective patent rights for our product candidates or any future product candidates, we may not be able to compete effectively in our markets. If we are unable to protect the confidentiality of our trade secrets or know-how, such proprietary information may be used by others to compete against us.

Our success will depend in significant part on our and our future licensors’, licensees’ or collaborators’ ability to establish and maintain adequate protection of our owned and licensed intellectual property covering the product candidates we plan to develop, and the ability to develop these product candidates and commercialize the products resulting therefrom, without infringing the intellectual property rights of others. Our Program Products have been developed in-house and are not subject to any third-party license. In addition to taking other steps to protect our intellectual property, we file patent applications to protect inventions we have developed, seeking to protect compositions, methods of use, manufacturing methods, and other aspects of our technology. There can be no assurance that any of these patent applications will issue as patents or, for those applications that do mature into patents, that the claims of these patents will exclude others from making, using or selling our product candidates or products that compete with or are similar to our product candidates.

With respect to patent rights, we cannot be certain whether any of the technology described in our patent applications for any of our product candidates will remain relevant to our future commercial products, whether any of our patent applications will issue as patents, whether any patents that may be issued to us will effectively protect our commercial processes and product candidates, or whether any patents that may be issued to us will effectively prevent others from competing with our products.

In countries where we have not sought and do not seek patent protection, third parties may be able to manufacture and sell our product candidates without our permission, and we may not be able to stop them from doing so.

Publications of discoveries in the scientific literature often lag behind the actual discoveries, and patent applications in the United States and other jurisdictions are typically not published until 18 months after filing or in some cases not at all, until they are issued as a patent. Therefore, we cannot be certain that we or future licensors, licensees or collaborators were the first to make the inventions claimed in our owned or licensed patents or pending patent applications, or that we or future licensors, licensees or collaborators were the first to file for patent protection of such inventions.

Any changes we make to our Program Products or any future product candidates to cause them to have what we view as more advantageous properties may fall outside the coverage of our existing patent applications, and we may need to file new patent applications and/or seek other forms of protection for any such altered product candidates. The patent landscape surrounding the technology underlying our product candidates is crowded, and there can be no assurance that we will be able to secure patent protection that would adequately cover such altered Program Products or any future product candidates.

50


The patent prosecution process is expensive and time-consuming, and we and our future licensors, licensees or collaborators may not be able to prepare, file and prosecute all necessary or desirable patent applications at a reasonable cost or in a timely manner. It is also possible that we or our future licensors, licensees or collaborators will fail to identify patentable aspects of inventions made in the course of development and commercialization activities before it is too late to obtain patent protection for them. Moreover, in some circumstances, we may not have the right to control the preparation, filing and prosecution of patent applications, or to maintain or enforce the patents, covering technology that we license from or license to third parties and may be reliant on our current or future licensors, licensees or collaborators to perform these activities, which means that these patent applications may not be prosecuted, and these patents may not be enforced or maintained, in a manner consistent with the best interests of our business. If our future licensors, licensees or collaborators fail to establish, maintain, protect or enforce such patents and other intellectual property rights, such rights may be reduced or eliminated. If our future licensors, licensees or collaborators are not fully cooperative or disagree with us as to the prosecution, maintenance or enforcement of any patent rights, such patent rights could be compromised.

Similar to the patent rights of other biotechnology companies, the scope, validity and enforceability of our owned and licensed patent rights generally are highly uncertain and involve complex legal and factual questions. The issuance of a patent is not conclusive as to its inventorship, scope, validity or enforceability, and our patents may be challenged in the courts or patent offices in the United States and abroad. In recent years, these areas have been the subject of much litigation in the industry. As a result, the issuance, scope, validity, enforceability and commercial value of our and our current or future licensors’, licensees’ or collaborators’ patent rights are highly uncertain. Our and our future licensors’, licensees’ or collaborators’ future patent applications may not result in patents being issued that protect our technology or product candidates, or that effectively prevent others from commercializing competitive technologies and products. The patent examination process may require us or our future licensors, licensees or collaborators to narrow the scope of the claims of our patent applications, which would limit the scope of patent protection that is obtained, if any. Our and our future licensors’, licensees’ or collaborators’ patent applications cannot be enforced against third parties practicing the technology that is currently claimed in such applications unless and until a patent issues from such applications, and then only to the extent the claims that issue are broad enough to cover the technology being practiced by those third parties.

We may not be able to protect our intellectual property rights throughout the world.

Filing, prosecuting, enforcing and defending patents on product candidates in all countries throughout the world would be prohibitively expensive, and we may not protect our intellectual property in some countries outside the United States to the same extent as in the United States. In addition, the laws of some foreign countries do not protect intellectual property rights to the same extent as federal and certain state laws in the United States.

Consequently, we may not be able to prevent third parties from practicing our inventions in all countries outside the United States, or from selling or importing products made using our inventions in and into the United States or other jurisdictions. Competitors may use technologies in jurisdictions where we have not obtained patent protection to develop their own products and, further, may export otherwise infringing products to territories where we do not have patent protection, or where we do have patent protection, but enforcement is not as strong as that in the United States. These products may compete with our Program Products or any future product candidates and our patents or other intellectual property rights may not effectively prevent them from competing.

Many companies have encountered significant problems in protecting and defending intellectual property rights in foreign jurisdictions. The legal systems of certain countries, particularly certain developing countries, do not favor the enforcement of patents and other intellectual property protection, particularly those relating to biopharmaceuticals. This could make it difficult for us to stop the infringement of our patents or the marketing of competing products in violation of our proprietary rights. Proceedings to enforce our patent rights in foreign jurisdictions could result in substantial costs and divert our efforts and attention from other aspects of our business, could put our patents at risk of being revoked, invalidated or interpreted narrowly, and could provoke third parties to assert claims against us or our collaborator. We may not prevail in any lawsuits that we initiate, and the damages or other remedies awarded, if any, may not adequately compensate us for the harm to our business.

51


Different countries impose different requirements for patentability and certain countries have heightened requirements for patentability, requiring more disclosure in the patent application or disfavoring the issuance of broad claims. In addition, certain countries have compulsory licensing laws under which a patent owner may be compelled to grant licenses to third parties. In such countries, we may have limited remedies if patents are infringed or if we are compelled to grant a license to a third party, which could materially diminish the value of those patents. This could limit our potential revenue opportunities. In addition, many countries limit the enforceability of patents against government agencies or government contractors. In these countries, the patent owner may have limited remedies, which could materially diminish the value of such patent. Accordingly, our efforts to enforce intellectual property rights around the world may be inadequate to obtain a significant commercial advantage from the intellectual property that we own or license.

We may not have sufficient patent lifespan to effectively protect our products and business.

All of our patents are in early stages. Patents have a limited lifespan. In the United States, the natural expiration of a patent is generally 20 years after its priority date. Given the amount of time required for the development, testing and regulatory review of new product candidates, patents protecting such candidates might expire before or shortly after the resulting products are commercialized. As a result, our owned and future in-licensed patents may not provide us with sufficient rights to exclude others from commercializing products similar or identical to ours. We expect to seek extensions of patent terms for our issued patents, where available. This includes in the United States under the Hatch-Waxman Act, which permits a patent term extension of up to five years beyond the original expiration date of the patent as compensation for regulatory delays. However, such a patent term extension cannot lengthen the remaining term of a patent beyond a total of 14 years from the product’s approval date. Only one patent applicable to an approved drug is eligible for the extension and the application for the extension must be submitted prior to the expiration of the patent. During the period of patent term extension, the claims of a patent are not enforceable for their full scope but are instead limited to the scope of the approved product. In addition, the applicable authorities, including the FDA in the United States, and any comparable foreign regulatory authorities, may not agree with our assessment of whether such extensions are available, and may refuse to grant extensions to our patents, or may grant more limited extensions than we request. In addition, we may not be granted an extension because of, for example, failing to apply within applicable deadlines, failing to apply prior to the expiration of relevant patents or otherwise failing to satisfy applicable requirements. If this occurs, any period during which we have the right to exclusively market our product will be shorter than we would otherwise have expected, and our competitors may obtain approval of and launch products earlier than might otherwise have been the case.

If we are unable to maintain effective proprietary rights for our Program Products or any future product candidates, we may not be able to compete effectively in our markets.

In addition to the protection afforded by any patents that may be granted, we rely on trade secret protection and confidentiality agreements to protect proprietary know-how that is not patentable or that we elect not to patent, processes for which patents are difficult to enforce and any other elements of our product candidate discovery and development processes that involve proprietary know-how, information or technology that is not covered by patents. However, trade secrets can be difficult to protect. We protect our proprietary technology and processes, in part, by entering into confidentiality agreements with our employees, consultants, scientific advisors and contractors. We also seek to preserve the integrity and confidentiality of our data, trade secrets and intellectual property by maintaining the physical security of our premises and physical and electronic security of our information technology systems. While we have confidence in these individuals, organizations and systems, agreements or security measures may be breached, and we may not have adequate remedies for any breach. In addition, our trade secrets and intellectual property may otherwise become known or be independently discovered by competitors.

Additionally, our reliance on third parties, including CROs and outside consultants, requires us to share our trade secrets and intellectual property, which increases the possibility that a competitor will discover them or that our trade secrets and intellectual property will be misappropriated or publicly disclosed. The steps that we have already taken to protect our intellectual property may not be sufficient or effective, and our confidentiality, non-disclosure, or invention assignment agreements with employees, consultants, partners, or other parties may be breached and may otherwise not be effective in establishing our rights in intellectual property and in controlling access to our proprietary information. Even if we do detect violations, we may need to engage in litigation to enforce our rights, and such

52


litigation, even if successful, may not restore our proprietary rights or adequately compensate us for the damage to our rights or our business.

We may be involved in lawsuits to protect or enforce our intellectual property, which could be expensive, time-consuming and unsuccessful.

Third parties may infringe our patents or misappropriate or otherwise violate our intellectual property rights. In the future, we may initiate legal proceedings to enforce or defend our intellectual property rights, to protect our trade secrets or to determine the validity or scope of intellectual property rights we own or control. Also, third parties may initiate legal proceedings against us to challenge the validity or scope of intellectual property rights we own, control or license. For example, generic or biosimilar drug manufacturers or other competitors or third parties may challenge the scope, validity or enforceability of our patents, requiring us to engage in complex, lengthy and costly litigation or other proceedings. These proceedings can be expensive and time-consuming and many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can. Accordingly, despite our efforts, we may not be able to prevent third parties from infringing upon or misappropriating intellectual property rights we own, control or license, particularly in countries where the laws may not protect those rights as fully as in the United States. Litigation could result in substantial costs and diversion of management resources, which could harm our business and financial results. In addition, if we initiated legal proceedings against a third party to enforce a patent covering a product candidate, the defendant could assert that such patent is invalid or unenforceable, or does not cover their product candidate. Grounds for a validity challenge could be an alleged failure to meet any of several statutory requirements, including lack of novelty, obviousness or non-enablement. Grounds for an unenforceability assertion could be an allegation that someone connected with prosecution of the patent withheld relevant information from the USPTO, or made a misleading statement, during prosecution. In an infringement or declaratory judgment proceeding, a court may decide that a patent owned by or licensed to us is invalid or unenforceable or may refuse to stop the other party from using the subject matter alleged to be infringing on the grounds that our patents do not cover that subject matter. An adverse result in any litigation proceeding could put one or more of our patents at risk of being invalidated, narrowed, held unenforceable or interpreted in such a manner that would allow third parties to enter the market with competing products.

Third-party pre-issuance submission of prior art to the USPTO, or opposition, derivation, revocation, reexamination, inter parties review, post-grant review or interference proceedings, or other patent office proceedings or litigation in the United States or other jurisdictions provoked by third parties or brought by us, may be necessary to determine the inventorship, priority, patentability or validity of inventions with respect to our patents or patent applications. An unfavorable outcome could leave our technology or product candidates without patent protection, could allow third parties to commercialize our technology or product candidates and compete directly with us, or without payment to us. In addition, if the breadth or strength of protection provided by our patents and patent applications is threatened, it could dissuade companies from collaborating with us to license, develop or commercialize current or future product candidates. Even if we successfully defend such litigation or proceeding, we may incur substantial costs and our defense may distract our management and other employees.

Furthermore, because of the substantial amount of discovery required in connection with intellectual property litigation, there is a risk that some of our confidential information could be compromised by disclosure during this type of litigation. In addition, many foreign jurisdictions have rules of discovery that are different than those in the United States and that may make defending or enforcing our patents extremely difficult. There could also be public announcements of the results of hearings, motions or other interim proceedings or developments. If securities analysts or investors perceive these results to be negative, it could have a material adverse effect on the price of shares of our Common Stock.

We may infringe the intellectual property rights of others, which could increase our costs and delay or prevent our development efforts.

Our commercial success depends upon our ability to develop, manufacture, market and sell our Program Products and any future product candidates that we may develop and use our proprietary technologies without infringing, misappropriating or otherwise violating the intellectual property and proprietary rights of third parties. The biotechnology and pharmaceutical industries are characterized by extensive litigation regarding patents and other intellectual property rights. Third parties may initiate legal proceedings against us alleging that we infringe their

53


intellectual property rights, or we may initiate legal proceedings against third parties to challenge the validity or scope of intellectual property rights controlled by third parties, including in oppositions, interferences, revocations, reexaminations, inter parties review, post-grant review or derivation proceedings before the USPTO or its counterparts in other jurisdictions. These proceedings can be expensive and time-consuming and many of our adversaries in these proceedings may have the ability to dedicate substantially greater resources to prosecuting these legal actions than we can.

We could be found liable for monetary damages, including treble damages and attorneys’ fees, if we are found to have willfully infringed a patent of a third party. A finding of infringement could prevent us from commercializing our Program Products or any future product candidates or force us to cease some of our business operations, which could materially harm our business.

We may not be aware of all third-party intellectual property rights potentially relating to our Program Products or any future product candidates. As to pending third-party applications, we cannot predict with any certainty which claims will issue, if any, or the scope of any claims that may issue. Even if we believe third-party intellectual property claims are without merit, there is no assurance that a court would find in our favor on questions of infringement, validity, enforceability or priority. A court of competent jurisdiction could hold that these third-party patents are valid, enforceable and infringed, which could materially and adversely affect our ability to commercialize any product candidates we may develop and any other product candidates covered by the asserted third-party patents. In order to successfully challenge the validity of any such U.S. patent in federal court, we would need to overcome a presumption of validity. As this burden is a high one requiring us to present clear and convincing evidence as to the invalidity of any such U.S. patent claim, there is no assurance that a court of competent jurisdiction would invalidate the claims of any such U.S. patent. If any third-party patents were successfully asserted against us or our commercialization partners and we were unable to successfully challenge the scope, validity or enforceability of any such asserted patents, then we and our commercialization partners may be prevented from commercializing our product candidates, or may be required to pay significant damages, including treble damages and attorneys’ fees if we are found to willfully infringe the asserted patents, or obtain a license to such patents, which may not be available on commercially reasonable terms, or at all. Even if we were able to obtain a license, it could be non-exclusive, thereby giving our competitors and other third parties’ access to the same technologies licensed to us, and it could require us to make substantial licensing and royalty payments. Any of the foregoing would have a material adverse effect on our business, financial condition and operating results.

Although we have reviewed certain third-party patents and patent filings that we believe may be relevant to our therapeutic candidates or products, we have not conducted a freedom-to-operate search or analysis for any of our therapeutic candidates or products, and we may not be aware of patents or pending or future patent applications that, if issued, would block us from commercializing our therapeutic candidates or products. Thus, we cannot guarantee that our therapeutic candidates or products, or our commercialization thereof, do not and will not infringe any third party’s intellectual property.

Changes in United States and international patent law could diminish the value of patents in general, thereby impairing our ability to protect our products.

As is the case with other biotechnology companies, our success is heavily dependent on IP, particularly patents. Obtaining and enforcing patents in the biotechnology industry involve both technological and legal complexity, and therefore obtaining and enforcing biotechnology patents is costly, time-consuming and inherently uncertain. Recent U.S. Supreme Court rulings have narrowed the scope of patent protection available in certain circumstances and weakened the rights of patent owners in certain situations, which may diminish our ability to obtain and enforce patents for our inventions. Depending on decisions by the U.S. Congress, the federal courts, and the USPTO, the laws and regulations governing patents could change in unpredictable ways that would weaken our ability to obtain new patents or to enforce our existing patents and patents that we might obtain in the future. Furthermore, depending on the Supreme Court’s review of the Patient Protection and Affordable Care Act, as amended by the Health Care and Education Reconciliation Act of 2010 (the “Affordable Care Act”), or legislation to repeal or amend the Affordable Care Act, the twelve years of regulatory exclusivity currently provided to certain biologic products in the United States may be reduced or eliminated. Any such reduction or elimination could impair the length of exclusivity against similar products.

54


Our inability to protect our trade secrets would harm our business and competitive position.

In addition to seeking patents for some of our technology and product candidates, we also rely substantially on trade secrets, including unpatented know-how, technology and other proprietary materials and information, to maintain our competitive position. We protect these trade secrets, in part, by entering into non-disclosure and confidentiality agreements with parties who have access to them, such as our employees, corporate collaborators, outside scientific collaborators, contract manufacturers, consultants, advisors and other third parties. However, these steps may be inadequate, we may fail to enter into agreements with all such parties or any of these parties may breach the agreements and disclose our trade secrets and there may be no adequate remedy available for such breach of an agreement. We cannot assure you that our trade secrets will not be disclosed or that we can meaningfully protect our trade secrets. Enforcing a claim that a party illegally disclosed or misappropriated a trade secret is difficult, expensive and time-consuming, and the outcome is unpredictable. In addition, some courts both within and outside the United States may be less willing, or unwilling, to protect trade secrets. If a competitor lawfully obtained or independently developed any technology or information that we protect as trade secret, we would have no right to prevent such competitor from using that technology or information to compete with us, which could harm our competitive position.

Intellectual property rights do not necessarily address all potential threats.

The degree of future protection afforded by our intellectual property rights is uncertain because intellectual property rights have limitations and may not adequately protect our business or permit us to maintain our competitive advantage. For example:

others may be able to make products that are similar to our Program Products and any future product candidates we may develop but that are not covered by the claims of the patents that we may own or license in the future;

we, or our future collaborators, might not have been the first to make the inventions covered by the issued patents and pending patent applications that we may own or license in the future;

we, or our future collaborators, might not have been the first to file patent applications covering certain of our or their inventions;

others may independently develop similar or alternative technologies or duplicate any of our technologies without infringing our owned or licensed intellectual property rights;

it is possible that our pending patent applications or those that we may file in the future will not result in issued patents;

patents that we may own or license in the future may be held invalid or unenforceable, including as a result of legal challenges by our competitors;

our competitors might conduct research and development activities in countries where we do not have patent rights and then use the resulting information to develop competitive products for sale in major commercial markets in which we do not have sufficient patent rights to stop such sales;

we may not develop additional proprietary technologies that are patentable;

third-party patents may be asserted against our product candidates and technologies in a manner that threatens or harms our business; and

we may choose not to file a patent application in order to maintain certain trade secrets or know-how, and a third party may subsequently file a patent covering such trade secrets or know-how.

Should any of these events occur, they could have a material adverse effect on our business, financial condition, results of operations and prospects.

55


If our trademarks and trade names are not maintained and adequately protected, we may not be able to build name recognition in our markets of interest, and our business may be adversely affected.

Failure to obtain trademark registrations in the future could limit our ability to protect and enforce our trademarks and impede our marketing efforts in the countries in which we intend to operate. We may not be able to protect our rights to trademarks and trade names which we may need to build name recognition with potential partners or customers in our markets of interest. As a means to enforce any future trademark rights and prevent infringement, we may be required to file trademark claims against third parties or initiate trademark opposition proceedings. This can be time-consuming and expensive and may strain the financial resources of a company of our size, and we may not ultimately be successful in enforcing our trademark rights. In addition, our registered or unregistered trademarks or trade names may be challenged, infringed, circumvented, declared generic or determined to be infringing on other marks.

Future trademark applications in the United States and in other foreign jurisdictions where we may file may not be allowed or may subsequently be opposed. Even if these applications result in registration of trademarks, third parties may challenge our use or registration of these trademarks in the future. Over the long term, if we are unable to establish name recognition based on our trademarks and trade names, then we may not be able to compete effectively, and our business may be adversely affected.

Risks Related to Our Business Operations

Our future success depends in part on our ability to retain our senior management team, directors and other key employees and to attract, retain and motivate other qualified personnel.

We may not be able to attract or retain qualified directors, personnel and consultants due to the intense competition for such individuals among in the biotechnology and pharmaceutical industries. If we are not able to attract and retain necessary personnel and consultants to accomplish our business objectives, we may experience constraints that will significantly impede the achievement of our development objectives, our ability to raise additional capital and our ability to implement our business strategy.

Our industry has experienced a high rate of turnover of management personnel in recent years. We are highly dependent on the development, regulatory, commercialization and business development expertise of the members of our executive team, as well as other key employees and consultants. If we lose one or more of our executive officers or other key employees or consultants, our ability to implement our business strategy successfully could be seriously harmed. Any of our executive officers or other key employees or consultants may terminate their employment or consultancy arrangements with us at any time and replacing such individuals may be difficult and time-consuming because of the limited number of individuals in our industry with the necessary breadth of skills and experience. Competition to hire and retain employees and consultants from this limited pool is intense, and we may be unable to hire, train, retain or motivate such individuals. Additionally, we do not currently maintain “key person” life insurance on the lives of our executives or any of our employees. This lack of insurance means that we may not receive adequate compensation for the loss of the services of these individuals. If we are unable to continue to attract and retain high-quality personnel, the rate and success with which we can discover and develop product candidates and our business will be limited.

We will need to expand our organization, and we may experience difficulties in managing this growth, which could disrupt our operations.

We are in the early stages of building the full management team and employee base that we anticipate we will need to complete the development of our Program Products and other future product candidates. As of March 21, 2023, we had 6 employees.

As we advance our preclinical and clinical development programs for our product candidates, seek regulatory approval in the United States and elsewhere and increase the number of ongoing product development programs, we anticipate that we will need to increase our product development, scientific and administrative headcount. We will also need to establish commercial capabilities in order to commercialize any product candidates that may be approved.

56


Such an evolution may impact our strategic focus and our deployment and allocation of resources. Our management, personnel and systems may experience difficulty in adjusting to our growth and strategic focus.

Our ability to manage our operations and growth effectively depends upon the continual improvement of our procedures, reporting systems and operational, financial and management controls. We may not be able to implement administrative and operational improvements in an efficient or timely manner and may discover deficiencies in existing systems and controls. If we do not meet these challenges, we may be unable to execute our business strategies and may be forced to expend more resources than anticipated addressing these issues.

We may acquire additional technology and complementary businesses in the future. Acquisitions involve many risks, any of which could materially harm our business, including the diversion of management’s attention from core business concerns, failure to effectively exploit acquired technologies, failure to successfully integrate the acquired business or realize expected synergies or the loss of key employees from either our business or the acquired businesses.

In addition, in order to continue to meet our obligations as a public company and to support our anticipated long-term growth, we will need to increase our general and administrative capabilities. Our management, personnel and systems may not be adequate to support this future growth.

If we are unable to successfully manage our growth and the increased complexity of our operations, our business, financial position, results of operations and prospects may be materially and adversely affected.

We may not be successful in our efforts to identify, discover or license additional product candidates.

Although a substantial amount of our effort will focus on the continued clinical testing, potential approval and commercialization of our lead Program Products, the success of our business also depends upon our ability to identify, discover or license additional product candidates. Our research programs or licensing efforts may fail to yield additional product candidates for clinical development for a number of reasons, including (i) lack of financial or personnel resources to acquire or discover additional product candidates; (ii) product candidates may not succeed in preclinical or clinical testing; (iii) product candidates may be shown to have harmful side effects or may have other characteristics that may make the products unmarketable or unlikely to receive marketing approval; (iv) competitors may develop alternatives that render our product candidates obsolete or less attractive; (v) the market for a product candidate may change during our development program so that such product may become unprofitable to continue to develop; (vi) product candidates may not be capable of being produced in commercial quantities at an acceptable cost, or at all; and (vii) product candidates may not be accepted as safe and effective by patients, the medical community, or third-party payors.

We may be forced to abandon our development efforts for a program or programs that are unsuccessful, or we may not be able to identify, license, or discover additional product candidates, which would have a material adverse effect on our business and could potentially cause us to cease operations. Further, research programs to identify new product candidates require substantial technical, financial and human resources. We may focus our efforts and resources on potential programs or product candidates that ultimately prove to be unsuccessful.

If we fail to comply with environmental, health and safety laws and regulations, we could become subject to fines or penalties or incur costs that could have a material adverse effect on the success of our business.

Our research, development and manufacturing activities and our third-party manufacturers’ and suppliers’ activities involve the controlled storage, use and disposal of hazardous materials, including the components of our product candidates and other hazardous compounds. We and our manufacturers and suppliers are subject to laws and regulations governing the use, manufacture, storage, handling and disposal of these hazardous materials. In some cases, these hazardous materials and various wastes resulting from their use are stored at our and our manufacturers’ facilities pending their use and disposal. We cannot eliminate the risk of contamination, which could cause an interruption of our commercialization efforts, research and development efforts and business operations, environmental damage resulting in costly clean-up and liabilities under applicable laws and regulations governing the use, storage, handling and disposal of these materials and specified waste products. Although we believe that the safety procedures utilized by our third-party manufacturers for handling and disposing of these materials generally comply

57


with the standards prescribed by these laws and regulations, we cannot guarantee that this is the case or eliminate the risk of accidental contamination or injury from these materials. In such an event, we may be held liable for any resulting damages, such liability could exceed our resources, and state or federal or other applicable authorities may curtail our use of certain materials and/or interrupt our business operations. Furthermore, environmental laws and regulations are complex, change frequently and have tended to become more stringent. We cannot predict the impact of such changes and cannot be certain of our future compliance. We do not currently carry biological or hazardous waste insurance coverage.

Healthcare reform in the United States may negatively impact our ability to profitably sell our product candidates, if approved, and to recoup the upfront investment needed to obtain regulatory approval of our product candidates.

Third-party payors, whether domestic or foreign, or governmental or commercial, are continually developing and advancing new methods of controlling healthcare costs. The United States and many foreign jurisdictions have enacted or proposed legislative and regulatory changes affecting the healthcare system that could prevent or delay marketing approval of our product candidates, restrict or regulate post-approval activities and affect our ability to profitably sell any product for which we obtain marketing approval.

Affordable Care Act for example, contains provisions that have significantly changed the way health care is financed by both governmental and private insurers. We expect that current laws, as well as other healthcare reform measures that may be adopted in the future, may result in more rigorous coverage criteria and in additional downward pressure on the price that we, or any strategic collaborators, may receive for any approved products.

Since its enactment, there have been numerous judicial, administrative, executive, and legislative challenges to certain aspects of the Affordable Care Act, and we expect there will be additional challenges and amendments to the Affordable Care Act in the future. By way of example, on January 28, 2021, President Biden issued the “Executive Order on Strengthening Medicaid and the Affordable Care Act,” which, among other things revoked certain executive orders of the previous administration that had eliminated cost sharing subsidies and various other provisions of the Affordable Care Act, stating that it is the current administration’s policy “to protect and strengthen Medicaid and the ACA and to make high-quality healthcare accessible and affordable for every American,” and directing heads of relevant executive departments and agencies immediately to review agency actions to determine whether any such actions are inconsistent with this policy. And, on June 24, 2021, the U.S. Supreme Court dismissed a challenge to the Affordable Care Act in a decision that leaves the law intact. We cannot predict what effect further changes to the Affordable Care Act would have on our business.

It is also possible that additional governmental action is taken in response to the COVID-19 pandemic. Individual states in the United States have also become increasingly active in implementing regulations designed to control pharmaceutical product pricing, including price or patient reimbursement constraints, discounts, restrictions on certain product access and marketing cost disclosure and transparency measures, and, in some cases, designed to encourage importation from other countries and bulk purchasing.

At the same time, there has been increasing legislative and enforcement interest in the United States with respect to specialty drug pricing practices. Specifically, there have been several recent U.S. congressional inquiries and proposed bills designed to, among other things, bring more transparency to drug pricing, reduce the cost of prescription drugs under Medicare, review the relationship between pricing and manufacturer patient programs and reform government program reimbursement methodologies for drugs.

There have been, and likely will continue to be, legislative and regulatory proposals at the foreign, federal and state levels directed at broadening the availability of healthcare and containing or lowering the cost of healthcare. The implementation of cost containment measures or other healthcare reforms may prevent us from being able to generate product revenue, attain profitability, or commercialize our products. Such reforms could have an adverse effect on anticipated revenue from product candidates that we may successfully develop and for which we may obtain regulatory approval and may affect our overall financial condition, including our ability to recoup the upfront investment needed to obtain regulatory approval for our product candidates.

Risks Related to Commercialization of Our Program Products and Product Candidates

58


As we evolve from a company that is primarily involved in clinical development to a company that is also involved in commercialization, we may encounter difficulties in expanding our operations successfully.

As we advance our Program Products through clinical studies, we will need to expand our development, regulatory, manufacturing, and marketing and sales capabilities and may need to further contract with third parties to provide these capabilities, such as collaborators, distributors, marketers and additional suppliers. We currently have no experience as a Company in or infrastructure for sales, marketing and distribution, and our operations are currently limited to clinical development activities and as our operations expand, we likely will need to manage additional relationships with such third parties.

If our Program Products or any future product candidate is approved, we intend either to establish a sales organization with technical expertise and supporting distribution capabilities to commercialize our Program Products or any future product candidate or to outsource such functions to one or more third parties. Either of these options would be expensive and time-consuming. Some or all of these costs may be incurred in advance of any approval of our Program Products or any future product candidate. In addition, we may not be able to hire a sales force that is sufficient in size or has adequate expertise in the medical markets that we intend to target. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely affect the commercialization of our Program Products and other future product candidates.

Maintaining third-party relationships for these purposes will impose significant added responsibilities on members of our management and other personnel. We must be able to effectively manage our development efforts, recruit and train sales and marketing personnel, effectively manage our participation in the clinical studies in which our product candidates are involved and improve our managerial, development, operational and finance systems, all of which may impose a strain on our administrative and operational infrastructure.

If we enter into arrangements with third parties to perform sales, marketing or distribution services, any product revenues that we receive, or the profitability of these product revenues to us, are likely to be lower than if we were to market and sell any products that we develop without the involvement of these third parties. In addition, we may not be successful in entering into arrangements with third parties to sell and market our products or in doing so on terms that are favorable to us. We likely will have little control over such third parties, and any of them may fail to devote the necessary resources and attention to sell and market our products effectively. If we do not establish sales and marketing capabilities successfully, either on our own or in collaboration with third parties, we will not be successful in commercializing our products.

We may seek to establish commercial collaborations for our Program Products and future product candidates, and, if we are not able to establish them on commercially reasonable terms, we may have to alter our development plans.

Our drug development programs, and the potential commercialization of our product candidates will require substantial additional cash to fund expenses. We may decide to collaborate with other pharmaceutical and biotechnology companies for the development and potential commercialization of our product candidates. For example, we have recently licensed a patent from Vanderbilt University which is the basis of REVTx-100.

We face significant competition in seeking appropriate collaborators. Whether we reach a definitive agreement for a collaboration will depend, among other things, upon our assessment of the collaborator’s resources and expertise, the terms and conditions of the proposed collaboration and the proposed collaborator’s evaluation of a number of factors. Those factors may include the design or results of clinical studies, the likelihood of approval by the FDA or comparable foreign regulatory authorities, the potential market for the subject product candidate, the costs and complexities of manufacturing and delivering such product candidate to patients, the potential of competing products and the existence of uncertainty with respect to our ownership of technology, which can exist if there is a challenge to such ownership without regard to the merits of the challenge and industry and market conditions generally. The collaborators may also consider alternative product candidates or technologies for similar indications that may be available to collaborate on and whether such a collaboration could be more attractive than the one with us for our product candidate.

59


Collaborations are complex and time-consuming to negotiate and document. In addition, there have been a significant number of business combinations among large pharmaceutical companies that have resulted in a reduced number of potential future collaborators.

We may not be able to negotiate collaborations on a timely basis, on acceptable terms, or at all. If we are unable to do so, we may have to curtail the potential “upside”development of the holder’s investment inproduct candidate for which we are seeking to collaborate, reduce or delay its development program or one or more of our companyother development programs, delay its potential commercialization or reduce the scope of any sales or marketing activities or increase our expenditures and undertake development or commercialization activities at our own expense. If we elect to increase our expenditures to fund development or commercialization activities on our own, we may need to obtain additional capital, which may not be reducedavailable to us on acceptable terms, or the warrantsat all. If we do not have sufficient funds, we may expire worthless.

An investor will onlynot be able to exercisefurther develop our product candidates or bring them to market and generate product revenue.

We currently have no Program Products approved for marketing. We do not have a warrant if the issuancemarketing and sales organization. If we are unable to establish sales and marketing capabilities or enter into agreements with third parties to market and sell our Program Products, we may be unable to generate any product revenue.

We have no experience selling and marketing our Program Products, and we currently have no marketing or sales organization. To successfully commercialize any product candidates that may result from our development programs, we will need to develop these capabilities, either on our own or with others. If our product candidates receive regulatory approval, we intend to establish a sales and marketing organization independently or by utilizing experienced third parties with technical expertise and supporting distribution capabilities to commercialize our Program Products in major markets, all of shares of common stock upon such exercise has been registered or qualified or is deemed exempt under the securities laws of the state of residence of the holder of the warrants.

No warrantswhich will be exercisableexpensive, difficult and time consuming. Any failure or delay in the development of our internal sales, marketing and distribution capabilities would adversely impact our ability to commercialize our Program Products.

Our efforts to educate the medical community, including physicians, hospital pharmacists and third-party payors on the benefits of our Program Products may require significant resources and may never be successful. If any of our Program Products are approved but fail to achieve market acceptance among physicians, patients or third-party payors, we will not be obligatedable to issue sharesgenerate significant revenues from such product, which could have a material adverse effect on our business, financial condition, results of common stock unlessoperations and prospects.

It may be difficult for us to profitably sell our Program Products, if and when approved, if coverage and reimbursement for these Program Products are limited by government authorities and/or third-party payor policies.

In addition to any healthcare reform measures which may affect reimbursement, market acceptance and sales of our Program Products, if approved, will depend on, in part, the shares of common stock issuable upon such exercise has been registered or qualified or deemedextent to be exempt under the securities laws of the state of residence of the holder of the warrants. If the shares of common stock issuable upon exercise of the warrants are not qualified or exempt from qualification in the jurisdictions in which the holdersprocedures utilizing our Program Products, performed by health care providers, will be covered by third party payors, such as government health care programs, commercial insurance and managed care organizations. In the event health care providers and patients accept our Program Products as medically useful, cost effective and safe, there is uncertainty regarding whether our Program Products will be directly reimbursed, reimbursed through a bundled payment or if the product candidates will be included in another type of value-based reimbursement program. Third party payors determine the warrants reside,extent to which new products will be covered as a benefit under their plans and the warrantslevel of reimbursement for any covered product or procedure which may be deprived of any value,utilize a covered product. It is difficult to predict at this time what third party payors will decide with respect to the marketcoverage and reimbursement for our Program Products.

Obtaining coverage and reimbursement approval for a product from a government or other third-party payor is a time-consuming and costly process that could require us to provide supporting scientific, clinical and cost effectiveness data for the warrants may be limited and they may expire worthless if they cannot be sold.

The private warrants may be exercised at a time whenuse of our products to the public warrantspayor. Additionally, we may not be exercised.able to provide data sufficient to gain acceptance with respect to coverage and reimbursement. We cannot be sure that coverage or adequate reimbursement will be available for our product candidates, if approved. Also, we cannot be sure that reimbursement amounts will not reduce the demand for, or the price of, our future products. If reimbursement is not available, or is available only to limited levels, we may not be able to commercialize our product candidates, or achieve profitably at all, even if approved.

Once60


Our business entails a significant risk of clinical study and/or product liability and our ability to obtain sufficient insurance coverage could have a material effect on our business, financial condition, results of operations or prospects.

Our business exposes us to significant clinical study and/or product liability risks inherent in the private warrants become exercisable, such warrants may immediately be exercised on a cashless basis, at the holder’s option, so long as they are held by the initial purchasersdevelopment, testing, manufacturing and marketing of therapeutic treatments. Clinical study liability claims could delay or their permitted transferees. The public warrants, however, will only be exercisable on a cashless basis at the optionprevent completion of our development programs. If we succeed in marketing products, product liability claims could result in an FDA investigation of the holderssafety and effectiveness of our products, our manufacturing processes and facilities or our marketing programs and potentially a recall of our products or more serious enforcement action, limitations on the approved indications for which they may be used or suspension or withdrawal of approvals. Regardless of the merits or eventual outcome, liability claims may also result in decreased demand for our products, injury to our reputation, costs to defend the related litigation, a diversion of management’s time and our resources, substantial monetary awards to study participants or patients and a decline in our Company valuation. We currently carry insurance coverage to the limit required by clinical sites for our clinical study. We do not anticipate carrying product liability insurance until such time we have a commercially available product. Our current insurance coverage or any other insurance coverage that we may obtain in the future may not provide sufficient coverage against potential liabilities. Furthermore, clinical study and product liability insurance are becoming increasingly expensive. As a result, we may be unable to obtain sufficient insurance at a reasonable cost to protect us against losses caused by clinical study and product liability claims that could have a material adverse effect on our business.

Product liability lawsuits against us could cause us to incur substantial liabilities and to limit commercialization of any products that we may develop.

We face an inherent risk of product liability exposure related to the testing of our product candidates in human clinical studies and will face an even greater risk if we failcommercialize any resulting products. Product liability claims may be brought against us by subjects enrolled in our clinical studies, patients, or others using our products. If we cannot successfully defend ourselves against claims that our product candidates or products that we may develop caused injuries, we could incur substantial liabilities. Regardless of merit or eventual outcome, liability claims may result in:

decreased demand for any product candidates or products that we may develop;

product recalls or a change in the indications for which products may be used;

termination of clinical study sites or entire study programs;

injury to our reputation and significant negative media attention;

withdrawal of clinical study participants;

significant costs to defend the related litigation;

substantial monetary awards to study subjects or patients;

loss of revenue;

diversion of management and scientific resources from our business operations; and

the inability to commercialize any products that we may develop.

Our clinical study liability insurance coverage may not adequately cover all liabilities that we may incur. We may not be able to registermaintain insurance coverage at a reasonable cost or in an amount adequate to satisfy any liability that may arise. Our inability to obtain product liability insurance at an acceptable cost or to otherwise protect against potential product liability claims could prevent or delay the shares issuable upon exercisecommercialization of any products or product candidates that we develop. We intend to expand our insurance coverage for products to include the warrants under the Securities Act within 90 days following the closingsale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain

61


commercially reasonable product liability insurance for any products approved for marketing. Large judgments have been awarded in class action lawsuits based on drugs that had unanticipated side effects. If we are sued for any injury caused by our products, product candidates or processes, our liability could exceed our product liability insurance coverage and our total assets. Claims against us, regardless of their merit or potential outcome, may also generate negative publicity or hurt our ability to obtain physician endorsement of our initialproducts or expand our business.

Our employees, contractors, vendors, principal investigators, consultants and future partners may engage in misconduct or other improper activities, including noncompliance with regulatory standards and requirements and insider trading.

We are exposed to the risk of fraud or other misconduct by our employees, contractors, vendors, principal investigators, consultants or future partners. Misconduct by these parties could include failures to comply with FDA regulations, to provide accurate information to the FDA, to comply with federal and state healthcare fraud and abuse laws and regulations, to report financial information or data timely, completely or accurately, or to disclose unauthorized activities to us. In particular, sales, marketing and business combination. Accordingly,arrangements in the healthcare industry are subject to extensive laws and regulations intended to prevent fraud, misconduct, kickbacks, self-dealing and other abusive practices. These laws and regulations may restrict or prohibit a wide range of pricing, discounting, marketing and promotion, sales commission, customer incentive programs and other business arrangements. Third-party misconduct could also involve the improper use of information obtained in the course of clinical studies, which could result in regulatory sanctions and serious harm to our reputation. Although we have adopted a Code of Business Conduct and Ethics, it is not always possible thatto identify and deter misconduct, and the holdersprecautions we take to detect and prevent this activity may not be effective in controlling unknown or unmanaged risks or losses or in protecting us from governmental investigations or other actions or lawsuits stemming from a failure to comply with these laws or regulations. If any such actions are instituted against us resulting from this misconduct and we are not successful in defending ourselves or asserting our rights, those actions could have a significant impact on our business, including the imposition of the private warrants could exercise such warrants at a time when the holders of public warrants could not.

We may amend the terms of the warrantssignificant fines or other sanctions. If we or our future partners market products in a manner that violates fraud and abuse and other healthcare laws, or if we or our future partners violate government price reporting laws, we or our future partners may be adversesubject to holdersadministrative civil and/or criminal penalties, among other sanctions.

Pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting inflated best price information to the Medicaid Rebate Program to reduce liability for Medicaid rebates. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will involve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and abuse or other healthcare laws and regulations.

Our business operations and relationships with investigators, healthcare professionals, consultants, third-party payors, patient organizations and customers are subject to broadly applicable healthcare regulatory laws, which could expose us to penalties.

Healthcare providers, physicians and third-party payors will play a primary role in the approval byrecommendation and prescription of any product candidate for which we obtain regulatory approval. Our current and future arrangements may expose us to broadly applicable fraud and abuse and other healthcare laws that may constrain the holdersbusiness or financial arrangements and relationships through which we would market, sell and distribute our products. Even though we will not control referrals of at least 50% of the then outstanding public warrants.

Our warrantshealthcare services or bill directly to Medicare, Medicaid or other third-party payors, federal and state healthcare laws pertaining to fraud and abuse are and will be issued in registered form under a warrant agreement between Continental Stock Transfer & Trust Company, as warrant agent, and us. The warrant agreement provides thatapplicable to our business. Such laws include, but are not limited to, the terms of the warrants may be amended without the consent of any holder to cure any ambiguity or correct any defective provision. The warrant agreement requires the approval by the holders of at least 50% of the then outstanding public warrants in order to make any change that adversely affects the interests of the registered holders.following:

14

A provision of our warrant agreement may make it more difficult for us to consummate an initial business combination.

If:

we issue additional shares

Federal false claims, false statements and civil monetary penalties laws, including the federal civil FCA, which can be enforced through civil whistleblower or qui tam actions, prohibit, among others, any person from knowingly presenting, or causing to be presented, a false claim for payment to the federal government or knowingly making, or causing to be made, a false statement to get a false claim paid.

62


The federal Anti-Kickback Statute prohibits, among other things, knowingly and willfully offering, paying, soliciting or receiving remuneration to induce, or in return for, purchasing, leasing, ordering or arranging for the purchase, lease or order of any healthcare item or service reimbursable under Medicare, Medicaid or other federally financed healthcare programs. This statute has been interpreted to apply to arrangements between pharmaceutical manufacturers, on the one hand, and prescribers, purchasers and formulary managers, on the other. Although there are several statutory exceptions and regulatory safe harbors protecting certain common stockactivities from prosecution, the exceptions and safe harbors are drawn narrowly, and practices that involve remuneration intended to induce prescribing, purchasing or equity-linked securitiesrecommending may be subject to scrutiny if they do not qualify for capital raisingan exception or safe harbor. In addition, the intent standard under the federal Anti-Kickback Statute was amended by the Affordable Care Act to a stricter standard such that a person or entity no longer needs to have actual knowledge of the statute or specific intent to violate it in order to have committed a violation. Moreover, the government may assert that a claim including items or services resulting from violation of the federal Anti-Kickback Statute constitutes a false or fraudulent claim for purposes of the FCA.

The federal HIPAA, which prohibits, among other things, knowingly and willfully executing, or attempting to execute, a scheme or artifice to defraud any healthcare benefit program or obtain, by means of false or fraudulent pretenses, representations, or promises, any of the money or property owned by, or under the custody or control of, any healthcare benefit program, regardless of the payor (e.g., public or private), willfully obstructing a criminal investigation of a healthcare offense, and knowingly and willfully falsifying, concealing or covering up by any trick or device a material fact or making any materially false, fictitious or fraudulent statements in connection with the closingdelivery of, our initial business combination at an issue price or effective issue pricepayment for, healthcare benefits, items or services relating to healthcare matters. Similar to the federal Anti-Kickback Statute, a person or entity does not need to have actual knowledge of less than $9.50 per share of common stock,the statute or specific intent to violate it in order to have committed a violation.

Patient data privacy and security regulation, including, in the United States, HIPAA, as amended by the Health Information Technology for Clinical Health Act of 2009 (“HITECH”), and their respective implementing regulations, which impose specified requirements on “covered entities,” including healthcare providers, health plans, and healthcare clearinghouses, as well as their respective “business associates” that perform services for them that involve the use, or disclosure of, individually identifiable health information relating to the privacy, security and transmission of individually identifiable health information.

The federal transparency requirements under the aggregate gross proceeds from such issuances represent more than 60%Physician Payments Sunshine Act, enacted as part of the total equity proceeds,Affordable Care Act, that require applicable manufacturers of covered drugs, devices, biologics and interest thereon,medical supplies for which payment is available forunder Medicare, Medicaid, or the fundingChildren’s Health Insurance Program, with specific exceptions, to track and annually report to CMS payments and other transfers of our initial business combinationvalue provided to physicians and teaching hospitals and certain ownership and investment interests held by physicians or their immediate family members in the applicable manufacturer, and disclosure of such information will be made by CMS on the date of the consummation of our initial business combination (net of redemptions), anda publicly available website.

Analogous state, local or foreign laws, such as state anti-kickback and false claims laws, which may apply to items or services reimbursed by any third-party payor, including commercial insurers; state and local marketing and/or transparency laws applicable to manufacturers that may be broader in scope than the volume weighted average trading pricefederal requirements; state laws that require biopharmaceutical companies to comply with the biopharmaceutical industry’s voluntary compliance guidelines and the relevant compliance guidance promulgated by the federal government; state and local laws that require licensure or registration by sales and marketing agents of our common stock duringa pharmaceutical company; state laws that require disclosure of information related to drug pricing; and state and foreign laws governing the 20 trading day period starting onprivacy and security of health information in certain circumstances, many of which differ from each other in significant ways and may not have the trading day prior to the day on which we consummate our initial business combination (such price, the “Market Value”) is below $9.50 per share,same effect as HIPAA.

Pharmaceutical and other healthcare companies have been prosecuted under these laws for a variety of promotional and marketing activities, such as: providing free trips, free goods, sham consulting fees and grants and other monetary benefits to prescribers; reporting to pricing services inflated average wholesale prices that were then

63


used by federal programs to set reimbursement rates; engaging in off-label promotion; and submitting inflated best price information to the exercise price of the warrantsMedicaid Rebate Program to reduce liability for Medicaid rebates. Ensuring that our internal operations and future business arrangements with third parties comply with applicable healthcare laws and regulations will be adjusted to be equal to 115% of the higher of the Market Valueinvolve substantial costs. It is possible that governmental authorities will conclude that our business practices do not comply with current or future statutes, regulations, agency guidance or case law involving applicable fraud and the price at which we issue the additional shares of common stockabuse or equity-linked securities. This may make it more difficult for us to consummate an initial business combination with a target business.other healthcare laws and regulations.

Since we have not yet selected a particular industry or target business with which to complete a business combination, we are unable to currently ascertain the merits or risks of the industry or business in which we may ultimately operate.

We may pursue an acquisition opportunity in any business industry or sector, although we intend to focus on companies in the healthcare or a healthcare-related industry as described in this prospectus. Accordingly, thereThe global data protection landscape is no current basis for you to evaluate the possible merits or risks of the particular industry in which we may ultimately operate or the target business which we may ultimately acquire. To the extent we complete a business combination with a financially unstable company or an entity in its development stage,rapidly evolving, and we may be affected by numerous risks inherentor subject to new, amended or existing laws and regulations in the businessfuture, including as our operations continue to expand or if we operate in foreign jurisdictions. Several foreign jurisdictions, including the EU, its member states, the United Kingdom, Japan and Australia, among others, have adopted legislation and regulations that increase or change the requirements governing the collection, use, disclosure and transfer of those entities. the personal information of individuals in these jurisdictions. Additionally, certain countries have passed or are considering passing laws that require local data residency and/or restrict the international transfer of data. These laws have the potential to increase costs of compliance, risks of noncompliance and penalties for noncompliance.

If we complete a business combination with an entityour operations are found to be in an industry characterized by a high levelviolation of risk,any of these laws or any other governmental regulations that may apply to us, we may be affectedsubject to significant civil, criminal and administrative penalties, damages, disgorgement, fines, imprisonment, exclusion from government funded healthcare programs, such as Medicare and Medicaid, additional oversight and reporting obligations, contractual damages, reputational harm, diminished profits and future earnings, and the curtailment or restructuring of our operations. If any of the physicians or other healthcare providers or entities with whom we expect to do business is found not to be in compliance with applicable laws, that person or entity may be subject to significant criminal, civil or administrative sanctions, including exclusions from government funded healthcare programs.

Data collection is governed by restrictive regulations governing the currently unascertainable riskscollection, use, processing and cross-border transfer of that industry. Although our management will endeavor to evaluate the risks inherentpersonal information.

We have completed a Phase 2b clinical study in a particular industry or target business, we cannot assure you thatEurope and we will properly ascertaincontinue to collect, process, use or assess all oftransfer personal information from individuals located in the significant risk factors. We also cannot assure you that an investmentEEA in connection with our units will not ultimately prove to be less favorable to investorsbusiness, including in this offering than a direct investment,connection with conducting clinical studies in the EEA. Additionally, if an opportunity were available, in a target business. 

Our ability to successfully effect a business combination and to be successful thereafter will be totally dependent upon the efforts of our key personnel, some of whom may join us following a business combination. While we intend to closely scrutinize any individuals we engage after a business combination, we cannot assure you that our assessment of these individuals will prove to be correct.

Our ability to successfully effect a business combination is dependent upon the efforts of our key personnel. We believe that our success depends on the continued service of our key personnel, at least until we have consummated our initial business combination. We cannot assure you that any of our key personnel will remainproduct candidates are approved, we may seek to commercialize those products in the EEA. The collection and use of personal health data in the EEA is governed by the provisions of the GDPR, along with usother European Union and country-specific laws and regulations. The United Kingdom and Switzerland have also adopted data protection laws and regulations. These legislative acts (together with regulations and guidelines) impose requirements relating to having legal bases for processing personal data relating to identifiable individuals and transferring such data outside of the immediateEEA, including to the United States, providing details to those individuals regarding the processing of their personal data, keeping personal data secure, having data processing agreements with third parties who process personal data, responding to individuals’ requests to exercise their rights in respect of their personal data, reporting security breaches involving personal data to the competent national data protection authority and affected individuals, appointing data protection officers or foreseeable future. In addition, none of our officers arecorporate representatives, conducting data protection impact assessments and record-keeping. The GDPR imposes additional responsibilities and liabilities in relation to personal data that we process and we may be required to commit any specified amount of timeput in place additional mechanisms ensuring compliance with the new data protection rules. Failure to our affairs and, accordingly, our officers will have conflicts of interest in allocating management time among various business activities, including identifying potential business combinations and monitoring the related due diligence. We do not have employment agreements with, or key-man insurance on the life of, any of our officers. The unexpected loss of the services of our key personnel could have a detrimental effect on us.

The role of our key personnel after a business combination, however, cannot presently be ascertained. Although some of our key personnel serve in senior management or advisory positions following a business combination, it is likely that most, if not all, of the management of the target business will remain in place. While we intend to closely scrutinize any individuals we engage after a business combination, we cannot assure you that our assessment of these individuals will prove to be correct. These individuals may be unfamiliarcomply with the requirements of operating a public companythe GDPR and related national data protection laws of the member states of the EEA and other states in the EEA may result in substantial fines, other administrative penalties and civil claims being brought against us, which could causehave a material adverse effect on our business, financial condition and results of operations. European data protection authorities may interpret the GDPR and national laws differently and may impose additional requirements, which adds to the complexity of processing personal data in or from the EEA or United Kingdom. Guidance on implementation and compliance practices are often updated or otherwise revised. Compliance with the GDPR will be a rigorous and time-intensive process that may increase our cost of doing business or require us to change our business practices, and despite those efforts, there is a risk that we may be subject to fines and penalties, litigation, and reputational harm in connection with our European activities.

In addition, in 2018 California enacted the California Consumer Privacy Act (“CCPA”), which created new individual privacy rights for California consumers (as defined in the law) and places increased privacy and security obligations on entities handling personal data of consumers or households. The CCPA requires covered companies to

64


provide new disclosure to consumers about such companies’ data collection, use and sharing practices, provide such consumers new ways to opt-out of certain sales or transfers of personal information, and provide consumers with additional causes of action. The CCPA went into effect on January 1, 2020, and the California Attorney General commenced enforcement actions for violations on July 1, 2020. Moreover, the California Privacy Rights Act, or CPRA, which was passed in November 2020 and will go into effect on January 1, 2023, with a “look-back” period to January 1, 2022. The CPRA significantly modified the CCPA, resulting in further uncertainty and requiring us to incur additional costs and expenses in an effort to comply. The CCPA and the CPRA, may impact our business activities and exemplifies the vulnerability of our business to the evolving regulatory environment related to personal data and protected health information.

Compliance with U.S. and international data protection laws and regulations could require us to take on more onerous obligations in our contracts, restrict our ability to collect, use and disclose data, or in some cases, impact our ability to operate in certain jurisdictions. Any actual or alleged failure to comply with U.S. or international laws and regulations relating to privacy, data protection, and data security could result in governmental investigations, proceedings and enforcement actions (which could include civil or criminal penalties), private litigation or adverse publicity, harm to our reputation, and could negatively affect our operating results and business. Moreover, clinical study subjects about whom we or our potential collaborators obtain information, as well as the providers who share this information with us, may contractually limit our ability to use and disclose the information or impose other obligations or restrictions in connection with our use, retention and other processing of information, and we may otherwise face contractual restrictions applicable to our use, retention, and other processing of information. Claims that we have violated individuals’ privacy rights, failed to expend time and resources helping them become familiarcomply with such requirements. Thisdata protection laws, or breached our contractual obligations, even if we are not found liable, could be expensive and time-consumingtime consuming to defend and could leadresult in adverse publicity that could harm our business.

Unstable market and economic conditions may have serious adverse consequences on our business and financial condition.

Global credit and financial markets have experienced extreme disruptions at various points over the last few decades, characterized by diminished liquidity and credit availability, declines in consumer confidence, declines in economic growth, increases in unemployment rates and uncertainty about economic stability. If another such disruption in credit and financial markets and deterioration of confidence in economic conditions occurs, our business may be adversely affected. If the equity and credit markets were to deteriorate significantly in the future, it may make any necessary debt or equity financing more difficult to complete, more costly, and more dilutive. Failure to secure any necessary financing in a timely manner and on favorable terms could have a material adverse effect on our growth strategy, financial performance and share price and could require us to delay or abandon development or commercialization plans. In addition, there is a risk that one or more of our service providers, manufacturers or other partners would not survive or be able to meet their commitments to us under such circumstances, which could directly affect our ability to attain our operating goals on schedule and on budget.

We are subject to U.S. and certain foreign export and import controls, sanctions, embargoes, anti-corruption laws, and anti-money laundering laws and regulations. Compliance with these legal standards could impair our ability to compete in domestic and international markets. We can face criminal liability and other serious consequences for violations, which can harm our business.

We are subject to export control and import laws and regulations, including the U.S. Export Administration Regulations, U.S. Customs regulations, various economic and trade sanctions regulations administered by the U.S. Treasury Department’s Office of Foreign Assets Controls, the U.S. Foreign Corrupt Practices Act of 1977, as amended, the U.S. domestic bribery statute contained in 18 U.S.C. § 201, the U.S. Travel Act, the USA PATRIOT Act, and other state and national anti-bribery and anti-money laundering laws in the countries in which we conduct activities. Anti-corruption laws are interpreted broadly and prohibit companies and their employees, agents, contractors, and other collaborators from authorizing, promising, offering, or providing, directly or indirectly, improper payments or anything else of value to recipients in the public or private sector. We may engage third parties to sell our products sell our products outside the United States, to conduct clinical studies, and/or to obtain necessary permits, licenses, patent registrations, and other regulatory issues whichapprovals. We have direct or indirect interactions with officials and employees of government agencies or government-affiliated hospitals, universities, and other organizations. We can be held liable for the corrupt or other illegal activities of our employees, agents, contractors,

65


and other collaborators, even if we do not explicitly authorize or have actual knowledge of such activities. Any violations of the laws and regulations described above may result in substantial civil and criminal fines and penalties, imprisonment, the loss of export or import privileges, debarment, tax reassessments, breach of contract and fraud litigation, reputational harm, and other consequences.

Changes in our effective income tax rate could adversely affect our results of operations.


Risks RelatingWe are subject to income taxes in the United States. Various factors may have favorable or unfavorable effects on our effective income tax rate. These factors include, but are not limited to, interpretations of existing tax laws, changes in tax laws and rates, the accounting for stock options and other stock-based compensation, changes in accounting standards, future levels of research and development spending, changes in the mix and level of pre-tax earnings in different jurisdictions, the outcome of audits or other examinations by the U.S. Internal Revenue Service and tax regulators in other jurisdictions, the accuracy of our estimates for unrecognized tax benefits, the realization of deferred tax assets and changes to our Sponsor and Management Team

Our officers and directors may not have significant experienceownership or knowledge regarding the jurisdiction or industrycapital structure. The impact of the target business weabove-mentioned factors and others on our effective income tax rate may seek to acquire.

We may consummate a business combination with a target business in any geographic location or industry we choose, although we intend to focus on companies or assets in the healthcare or a healthcare-related industry. We cannot assure you that our officers and directors will have enough experience or have sufficient knowledge relating to the jurisdiction of the target or its industry to make an informed decision regarding a business combination.

Our key personnel may negotiate employment or consulting agreements with a target business in connection with a particular business combination. These agreements may provide for them to receive compensation following a business combination and as a result, may cause them to have conflicts of interest in determining whether a particular business combination is the most advantageous.

Our key personnel will be able to remain with the company after the consummation of a business combination only if they are able to negotiate employment or consulting agreements or other appropriate arrangements in connection with the business combination. Such negotiations would take place simultaneously with the negotiation of the business combinationsignificant and could provide for such individuals to receive compensationadversely affect our results of operations.

Our future growth may depend, in the form of cash payments and/or our securities for services they would render to the company after the consummation of the business combination. The personal and financial interests of such individuals may influence their motivation in identifying and selecting a target business.

Our officers and directors will allocate their time to other businesses thereby causing conflicts of interest in their determination as to how much time to devote to our affairs. This could have a negative impactpart, on our ability to consummate a business combination.

Our officers and directors will not commit their full time to our affairs. We presently expect each of our officers and directors to devote such amount of time as they reasonably believe is necessary to our business. We do not intend to have any full time employees prior to the consummation of our initial business combination. The foregoing could have a negative impact on our ability to consummate our initial business combination.

Our officers and directors may have a conflict of interest in determining whether a particular target business is appropriate for a business combination.

Our sponsor has waived its right to convert its founders’ shares or any other shares purchased in this offering or thereafter, or to receive distributions from the trust account with respect to its founders’ shares upon our liquidation if we are unable to consummate a business combination. Accordingly, the shares acquired prior to this offering, as well as the warrants purchased by our officers or directors in the aftermarket, will be worthless if we do not consummate a business combination. The personal and financial interests of our directors and officers may influence their motivation in timely identifying and selecting a target business and completing a business combination. Consequently, our directors’ and officers’ discretion in identifying and selecting a suitable target business may result in a conflict of interest when determining whether the terms, conditions and timing of a particular business combination are appropriate and in our stockholders’ best interest.

Our officers and directors or their affiliates have pre-existing fiduciary and contractual obligations and may in the future become affiliated with other entities engaged in business activities similar to those intended to be conducted by us. Accordingly, they may have conflicts of interest in determining to which entity a particular business opportunity should be presented.

Our officers and directors or their affiliates have pre-existing fiduciary and contractual obligations to other companies. Accordingly, they may participate in transactions and have obligations that may be in conflict or competition with our consummation of our initial business combination. As a result, a potential target business may be presented by our management team to another entity prior to its presentation to us and we may not be afforded the opportunity to engage in a transaction with such target business. Additionally, our officers and directors may in the future become affiliated with entities that are engaged in a similar business, including another blank check company that may have acquisition objectives that are similar to ours. Accordingly, they may have conflicts of interest in determining to which entity a particular business opportunity should be presented. These conflicts may not be resolved in our favor and a potential target business may be presented to other entities prior to its presentation to us, subject to our officers’ and directors’ fiduciary duties under Delaware law.

16

Certain of our officers and directors are affiliated with entities engaged in business activities similar to those intended to be conducted by us and, accordingly, may have conflicts of interest in allocating their time and determining to which entity a particular business opportunity should be presented. 

Certain of our executive officers and directors are affiliated with entities that are engaged in a similar business. Our officers may become aware of business opportunities which may be appropriate for presentation to us and the other entities to which they owe certain fiduciary duties. Accordingly, they may have conflicts of interest in determining to which entity a particular business opportunity should be presented. For example, some of our directors are affiliated with LifeSci Capital LLC, which is also the underwriter in this offering. Additionally, Mr. Dobkin and Mr. Dennis are also the directors of another SPAC and as such may present opportunities to the other SPAC prior to presenting them to us. This may limit the number of potential targets they present to us for purposes of completing a business combination. Any conflict of interest may not be resolved in our favor and potential target businesses may be presented to another entity prior to its presentation to us.

LifeSci Capital LLC may have a conflict of interest in rendering services to us in connection with our initial business combination.

We have engaged LifeSci Capital LLC to assist us in connection with our initial business combination. We will pay LifeSci Capital LLC a cash fee for such services in an aggregate amount equal to up to 4% of the total gross proceeds raised in the offering only if we consummate our initial business combination. These financial interests may result in LifeSci Capital LLC having a conflict of interest when providing the services to us in connection with an initial business combination. 

General Risk Factors

We are a company with no operating history and no revenue and, accordingly, you have no basis on which to evaluate our ability to achieve our business objective.

We are a company with no operating history and no revenue. We will not commence operations until we consummate our initial business combination. Because we lack an operating history, you have no basis upon which to evaluate our ability to achieve our business objective of acquiring one or more operating businesses or entities. If we fail to complete a business combination, we will never generate any operating revenues.

Nasdaq may delist our securities from quotation on its exchange which could limit investors’ ability to make transactions in our securities and subject us to additional trading restrictions.

Our securities are listed on Nasdaq, a national securities exchange. Although we expect to meet on a pro forma basis Nasdaq’s minimum initial listing standards, which generally only requires that we meet certain requirements relating to stockholders’ equity, market capitalization, aggregate market value of publicly held shares and distribution requirements, we cannot assure you that our securities will continue to be listed on Nasdaq in the future prior to an initial business combination. Additionally, in connection with our initial business combination, it is likely that Nasdaq will require us to file a new initial listing application and meet its initial listing requirements as opposed to its more lenient continued listing requirements. We cannot assure you that we will be able to meet those initial listing requirements at that time. Nasdaq will also have discretionary authority to not approve our listing if Nasdaq determines that the listing of the company to be acquired is against public policy at that time.

If Nasdaq delists our securities from trading on its exchange, or we are not listed in connection with our initial business combination, we could face significant material adverse consequences, including:

a limited availability of market quotations for our securities;
reduced liquidity with respect to our securities;
a determination that our shares of common stock are “penny stock” which will require brokers trading in our shares of common stock to adhere to more stringent rules, possibly resulting in a reduced level of trading activity in the secondary trading market for our shares of common stock;
a limited amount of news and analyst coverage for our company; and
a decreased ability to issue additional securities or obtain additional financing in the future.

The National Securities Markets Improvement Act of 1996, which is a federal statute, prevents or preempts the states from regulating the sale of certain securities, which are referred to as “covered securities.” Because our units, common stock and warrants are listed on Nasdaq, our units, common stock and warrants will be covered securities. Although the states are preempted from regulating the sale of our securities, the federal statute does allow the states to investigate companies if there is a suspicion of fraud, and, if there is a finding of fraudulent activity, then the states can regulate or bar the sale of covered securities in a particular case. While we are not aware of a state having used these powers to prohibit or restrict the sale of securities issued by blank check companies, certain state securities regulators view blank check companies unfavorably and might use these powers, or threaten to use these powers, to hinder the sale of securities of blank check companies in their states. Further, if we were no longer listed on Nasdaq, our securities would not be covered securities andpenetrate foreign markets, where we would be subject to regulationadditional regulatory burdens and other risks and uncertainties.

Our future profitability may depend, in each statepart, on our ability to commercialize our product candidates in foreign markets for which we offermay rely on collaboration with third parties. We are evaluating the opportunities for the development and commercialization of our securities.

17

product candidates in foreign markets. We are not permitted to market or promote any of our product candidates before we receive regulatory approval from the applicable regulatory authority in that foreign market, and we may never receive such regulatory approval for any of our product candidates. To obtain separate regulatory approvals in other countries, we may be required to comply with numerous and varying regulatory requirements of such countries regarding the safety and efficacy of our product candidates and governing, among other things, clinical studies and commercial sales, pricing and distribution of our product candidates, and we cannot predict success in these jurisdictions. We may not obtain foreign regulatory approvals on a timely basis, if at all. If we obtain approval of our product candidates and ultimately commercialize our product candidates in foreign markets, we would be subject to additional risks and uncertainties, including:

our customers’ ability to obtain reimbursement for our product candidates in foreign markets;

our inability to directly control commercial activities if we are relying on third parties; the burden of complying with complex and changing foreign regulatory, tax, accounting and legal requirements;

different medical practices and customs in foreign countries affecting acceptance in the marketplace;

import or export licensing requirements;

longer accounts receivable collection times;

our ability to supply our product candidates on a timely and large-scale basis in local markets;

longer lead times for shipping which may necessitate local manufacture of our product candidates;

language barriers for technical training and the need for language translations;

reduced protection of patent and other intellectual property rights in some foreign countries;

the existence of additional potentially relevant third-party intellectual property rights;

foreign currency exchange rate fluctuations; and

the interpretation of contractual provisions governed by foreign laws in the event of a contract dispute.

66


Foreign sales of our product candidates could also be adversely affected by the imposition of governmental controls, political and economic instability, trade restrictions and changes in tariffs.

If any of our product candidates is approved for commercialization, we may selectively partner with third parties to market it in certain jurisdictions outside the United States. We expect that we will be subject to additional risks related to international pharmaceutical operations, including:

different regulatory requirements for drug approvals and rules governing drug commercialization in foreign countries, including requirements specific to biologics or cell therapy products;

reduced protection for patent and other intellectual property rights;

foreign reimbursement, pricing and insurance regimes;

potential noncompliance with the U.S. Foreign Corrupt Practices Act, the U.K. Bribery Act 2010 and similar anti-bribery and anticorruption laws in other jurisdictions; and

production shortages resulting from any events affecting raw material supply or manufacturing capabilities abroad.

We have no prior experience in these areas. In addition, there are complex regulatory, tax, labor and other legal requirements imposed by both the EU and many of the individual countries in Europe with which we will need to comply. Many U.S.-based biotechnology companies have found the process of marketing their own products in Europe to be very challenging.

Certain legal and political risks are also inherent in foreign operations. There is a risk that foreign governments may nationalize private enterprises in certain countries where we may operate. In certain countries or regions, terrorist activities and the response to such activities may threaten our operations more than in the United States. Social and cultural norms in certain countries may not support compliance with our corporate policies, including those that require compliance with substantive laws and regulations. Also, changes in general economic and political conditions in countries where we may operate are a risk to our financial performance and future growth. Additionally, the need to identify financially and commercially strong partners for commercialization outside the United States who will comply with the high manufacturing and legal and regulatory compliance standards we require is a risk to our financial performance. As we operate our business globally, our success will depend, in part, on our ability to anticipate and effectively manage these and other related risks. There can be no assurance that the consequences of these and other factors relating to our international operations will not have an adverse effect on our business, financial condition or results of operations.

In some countries, particularly in Europe, the pricing of prescription pharmaceuticals is subject to governmental control. In these countries, pricing negotiations with governmental authorities can take considerable time after the receipt of marketing approval for a drug. To obtain reimbursement or pricing approval in some countries, we may be required to conduct clinical studies that compare the cost-effectiveness of our product candidates to other available therapies. If reimbursement of our products is unavailable or limited in scope or amount, or if pricing is set at unsatisfactory levels, our business could be harmed, possibly materially.

We face the risk of product liability claims and may not be able to obtain insurance.

Our business exposes us to the risk of product liability claims that are inherent in the development of drugs and diagnostic devices. We may be subject to costly and damaging product liability claims brought against us by clinical study participants, consumers, health care providers, pharmaceutical companies or others selling our products. Our inability to obtain sufficient product liability insurance at an acceptable cost to protect against potential product liability claims could prevent or inhibit the commercialization of pharmaceutical products we develop, alone or with collaborators. While we currently carry clinical study insurance and product liability insurance, the amount of insurance coverage we hold now may not be adequate to cover all liabilities we might incur. We intend to expand our insurance coverage to include the sale of commercial products if we obtain marketing approval for our product candidates in development, but we may be unable to obtain commercially reasonable product liability insurance for

67


any products approved for marketing. If we are unable to obtain insurance at an acceptable cost or otherwise protect against potential product liability claims, we will be exposed to significant liabilities, which may materially and adversely affect our business and financial position. If we are sued for any injury allegedly caused by our Program Products, our liability could exceed our total assets and our ability to pay the liability. A product liability claim or series of claims brought against us would decrease our cash and could cause our stock price to fall.

Our insurance policies are expensive and protect us only from some business risks, which will leave us exposed to significant uninsured liabilities.

We carry insurance for most categories of risk that our business may encounter; however, we may not have adequate levels of coverage. We currently maintain general liability, property, workers’ compensation, clinical study, products liability and directors’ and officers’ insurance, along with an umbrella policy. We may not be able to maintain existing insurance at current or adequate levels of coverage. Any significant uninsured liability may require us to pay substantial amounts, which would adversely affect our cash position and results of operations.

We have no current plans to pay dividends on our Shares of Common Stock.

We do not anticipate paying any cash dividends in the foreseeable future. If we incur indebtedness in the future to fund our future growth, our ability to pay dividends may be further restricted by the terms of such indebtedness.

If we fail to maintain proper and effective internal control over financial reporting in the future, our ability to produce accurate and timely financial statements could be impaired, which could harm our operating results, investors’ views of us and, as a result, the value of our Common Stock.

Pursuant to Section 404 of the Sarbanes-Oxley Act, our management will be required to report upon the effectiveness of our internal control over financial reporting beginning with the Annual Report on Form 10-K for our fiscal year ending December 31, 2022. When and if we are a “large accelerated filer” or an “accelerated filer” and are no longer an “emerging growth company” or “smaller reporting company,” each as defined in the Exchange Act, our independent registered public accounting firm will be required to attest to the effectiveness of our internal control over financial reporting. However, for so long as we remain an emerging growth company or smaller reporting company, we intend to take advantage of an exemption available to emerging growth companies and smaller reporting companies from these auditor attestation requirements. The rules governing the standards that must be met for management to assess our internal control over financial reporting are complex and require significant documentation, testing, and possible remediation. To comply with the requirements of being a reporting company under the Exchange Act, we cannot be certainwill need to upgrade our systems including information technology; implement additional financial and management controls, reporting systems, and procedures; and hire additional accounting and finance staff. If we or, if required, our auditors are unable to conclude that our internal control over financial reporting is effective, investors may lose confidence in our financial reporting, and the trading price of our Common Stock may decline.

We are an emerging growth company, and the reduced disclosurereporting requirements applicable to emerging growth companies willmay make our shares of common stockCommon Stock less attractive to investors.

We are an “emerging growth company,” as defined in the JOBS Act. We will remain an “emerging growth company” for up to five years. However, if our non-convertible debt issued within a three year period or revenues exceeds $1.07 billion, or the market value of our shares of common stock that are held by non-affiliates exceeds $700 million on the last day of the second fiscal quarter of any given fiscal year, we would cease to be an emerging growth company asand are eligible to take advantage of the following fiscal year. As ancertain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth company, we arecompanies, including, but not limited to, only two years of audited financial statements in addition to any required unaudited interim financial statements with correspondingly reduced “Management’s Discussion and Analysis of Financial Condition and Results of Operations” disclosure, not being required to comply with the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act we haveof 2002 reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements, and we are exemptexemptions from the requirements of holding a nonbindingnon-binding advisory votevotes on executive compensation and seeking stockholder approval of any golden parachute payments not previously approved. Additionally,approved and not being required to adopt certain accounting standards until those standards would otherwise apply to private companies. We could be an emerging growth company until the last day of the fiscal year following the fifth anniversary of the IPO, although circumstances could cause us to lose that status earlier, including if we become a large accelerated filer (in which case we will cease to be an emerging company as of the date we become a large accelerated filer, which, generally, would occur if, at the end of a fiscal year, among other things, the

68


market value of our Common Stock that is held by non-affiliates exceeds $700 million as of the last business day of our most recently completed second fiscal quarter), if we have total annual gross revenue of $1.07 billion or more during any fiscal year (in which cases we would no longer be an emerging growth company as of March 31 of such fiscal year), or if we issue more than $1.0 billion in non-convertible debt during any three year period before that time (in which case we would cease to be an emerging growth company immediately). Even after we no longer qualify as an emerging growth company, we have electedmay still qualify as a “smaller reporting company,” which would allow us to delaytake advantage of many of the adoption of new or revised accounting standards that have different effective dates for public and private companies until those standards applysame exemptions from disclosure requirements including not being required to private companies. As such, our financial statements may not be comparable to companies that comply with public company effective dates.the auditor attestation requirements of Section 404 of the Sarbanes-Oxley Act and reduced disclosure obligations regarding executive compensation in our periodic reports and proxy statements. We cannot predict if investors will find our shares of common stockCommon Stock less attractive because we may rely on these provisions.exemptions. If some investors find our shares of common stockCommon Stock less attractive as a result, there may be a less active trading market for our sharesCommon Stock and our sharestock price may be more volatile.

WeOur Common Stock price may only be ablevolatile and as a result you could lose all or part of your investment.

In addition to complete one business combinationvolatility associated with equity securities in general, the proceeds fromvalue of your investment could decline due to the impact of any of the following factors upon the market price of our IPO, which will cause us to be solely dependent on a single business which may have a limited numbershares of products or services.Common Stock:

It is likely we will consummate a business combination with a single target business, although we have the ability to simultaneously acquire several target businesses. By consummating a business combination with only a single entity, our lack of diversification may subject us to numerous economic, competitive and regulatory developments. Further, we would not be able to diversify our operations or benefit from the possible spreading of risks or offsetting of losses, unlike other entities which may have the resources to complete several business combinations in different industries or different areas of a single industry. Accordingly, the prospects for our success may be:

solely dependent upon the performance of a single business, or

disappointing results from our development efforts;

dependent upon the development or market acceptance

decline in demand for our shares of a single or limited number of products, processes or services.Common Stock;

downward revisions in securities analysts’ estimates or changes in general market conditions;

technological innovations by competitors or in competing products;

investor perception of our industry or our prospects; and

general economic trends.

This lack of diversification may subject us to numerous economic, competitiveStock markets in general have experienced extreme price and regulatory developments, any or all of which may have a substantial adverse impact upon the particular industry in which we may operate subsequent to a business combination.

Alternatively, if we determine to simultaneously acquire several businesses and such businesses are owned by different sellers, we will need for each of such sellers to agree that our purchase of its business is contingent on the simultaneous closings of the other business combinations, which may make it more difficult for us, and delay our ability, to complete the business combination. With multiple business combinations, we could also face additional risks, including additional burdens and costs with respect to possible multiple negotiations and due diligence investigations (if there are multiple sellers)volume fluctuations, and the additional risks associated withmarket prices of securities have been highly volatile. These fluctuations are often unrelated to operating performance and may adversely affect the subsequent assimilation of the operations and services or products of the acquired companies in a single operating business. If we are unable to adequately address these risks, it could negatively impact our profitability and results of operations.

18

The abilitymarket price of our stockholders to exercise their conversion rights or sell their shares to us in a tender offer may not allow us to effectuate the most desirable business combination or optimize our capital structure.

If our business combination requires us to use substantially all of our cash to pay the purchase price, because we will not know how many stockholders may exercise conversion rights or seek to sell their shares to us in a tender offer, we may either need to reserve part of the trust account for possible payment upon such conversion, or we may need to arrange third party financing to help fund our business combination. In the event that the acquisition involves the issuance of our stock as consideration, we may be required to issue a higher percentage of our stock to make up for a shortfall in funds. Raising additional funds to cover any shortfall may involve dilutive equity financing or incurring indebtedness at higher than desirable levels. This may limit our ability to effectuate the most attractive business combination available to us.

In connection with any vote to approve a business combination, we will offer each public stockholder the option to vote in favor of a proposed business combination and still seek conversion of his, her or its shares.

In connection with any vote to approve a business combination, we will offer each public stockholder (but not our Sponsor, officers or directors) the right to have his, her or its shares of common stock convertedCommon Stock.

Potential future sales pursuant to cash (subject toregistration rights granted by the limitations described elsewhere in this Form 10-K) regardless of whether such stockholder votes for or against such proposed business combination or does not vote at all. The ability to seek conversion while voting in favor of our proposed business combinationCompany and under Rule 144 may make it more likely that we will consummate a business combination.

In connection with any stockholder meeting called to approve a proposed initial business combination, we may require stockholders who wish to convert their shares in connection with a proposed business combination to comply with specific requirements for conversion that may make it more difficult for them to exercise their conversion rights prior todepress the deadline for exercising their rights.

In connection with any stockholder meeting called to approve a proposed initial business combination, each public stockholder will have the right, regardless of whether he is voting for or against such proposed business combination or does not vote at all, to demand that we convert his shares into a pro rata share of the trust account as of two business days prior to the consummation of the initial business combination. We may require public stockholders who wish to convert their shares in connection with a proposed business combination to either (i) tender their certificates to our transfer agent or (ii) deliver their shares to the transfer agent electronically using the Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System, at the holders’ option, in each case prior to a date set forth in the tender offer documents or proxy materials sent in connection with the proposal to approve the business combination. In order to obtain a physical stock certificate, a stockholder’s broker and/or clearing broker, DTC and our transfer agent will need to act to facilitate this request. It is our understanding that stockholders should generally allot at least two weeks to obtain physical certificates from the transfer agent. However, because we do not have any control over this process or over the brokers or DTC, it may take significantly longer than two weeks to obtain a physical stock certificate. While we have been advised that it takes a short time to deliver shares through the DWAC System, we cannot assure you of this fact. Accordingly, if it takes longer than we anticipate for stockholders to deliver their shares, stockholders who wish to convert may be unable to meet the deadline for exercising their conversion rights and thus may be unable to convert their shares.

If, in connection with any stockholder meeting called to approve a proposed business combination, we require public stockholders who wish to convert their shares to comply with specific requirements for conversion, such converting stockholders may be unable to sell their securities when they wish to in the event that the proposed business combination is not approved.

If we require public stockholders who wish to convert their shares to comply with specific requirements for conversion and such proposed business combination is not consummated, we will promptly return such certificates to the tendering public stockholders. Accordingly, investors who attempted to convert their shares in such a circumstance will be unable to sell their securities after the failed acquisition until we have returned their securities to them. The market price for our shares of common stock may decline during this time and you may not be ableCommon Stock.

The Company has granted a number of its stockholders’ registration rights with respect to sell your securities when you wish to, even while other stockholders that did not seek conversion may be able to sell their securities.

19

Becauseshares of Common Stock. See the section titled “Registration Rights.” Such future sales of our structure, other companiesshares of Common Stock by our existing stockholders, pursuant to and in accordance with the provisions of any registration statement, may have a competitive advantage and we may not be able to consummate an attractive business combination.

We expect to encounter intense competition from entities other than blank check companies having a business objective similar to ours, including venture capital funds, leveraged buyout funds and operating businesses competing for acquisitions. Many of these entities are well established and have extensive experience in identifying and effecting business combinations directly or through affiliates. Many of these competitors possess greater technical, human and other resources than we do and our financial resources will be relatively limited when contrasted with those of many of these competitors. While we believe that there are numerous potential target businesses that we could acquire with the net proceeds of our IPO, our ability to compete in acquiring certain sizable target businesses will be limited by our available financial resources. This inherent competitive limitation gives others an advantage in pursuing the acquisition of certain target businesses. Furthermore, seeking stockholder approval or engaging in a tender offer in connection with any proposed business combination may delay the consummation of such a transaction. Additionally, our outstanding warrants, and the future dilution they potentially represent, may not be viewed favorably by certain target businesses. Any of the foregoing may place us at a competitive disadvantage in successfully negotiating a business combination.

We may be unable to obtain additional financing, if required, to complete a business combination or to fund the operations and growth of the target business, which could compel us to restructure or abandon a particular business combination.

Although we believe that the net proceeds of our IPO, together with interest earned on the funds held in the trust account available to us, will be sufficient to allow us to consummate a business combination, because we have not yet identified any prospective target business, we cannot ascertain the capital requirements for any particular transaction. If the net proceeds of our IPO prove to be insufficient, either because of the size of the business combination, the depletion of the available net proceeds in search of a target business, or the obligation to convert into cash a significant number of shares from dissenting stockholders, we will be required to seek additional financing. Such financing may not be available on acceptable terms, if at all. To the extent that additional financing proves to be unavailable when needed to consummate a particular business combination, we would be compelled to either restructure the transaction or abandon that particular business combination and seek an alternative target business candidate. In addition, if we consummate a business combination, we may require additional financing to fund the operations or growth of the target business. The failure to secure additional financing could have a material adverse effect on the continued development or growth of the target business. None of our Sponsor, officers, directors or stockholders is required to provide any financing to us in connection with or after a business combination.

Our initial stockholders control a substantial interest in us and thus may influence certain actions requiring a stockholder vote.

Our initial stockholders own approximately 20% of our issued and outstanding shares of common stock. Our Sponsor, officers, directors, initial stockholders or their affiliates could determine in the future to make purchases of our securities in the open market or in private transactions, to the extent permitted by law, in order to influence the vote or magnitude of the number of shareholders seeking to tender their shares to us. In connection with any vote for a proposed business combination, our initial stockholders, as well as all of our officers and directors, have agreed to vote the shares of common stock owned by them immediately before our IPO as well as any shares of common stock acquired in the IPO or in the aftermarket in favor of such proposed business combination.

Our board of directors is and will be divided into three classes, each of which will generally serve for a term of three years with only one class of directors being elected in each year. It is unlikely that there will be an annual meeting of stockholders to elect new directors prior to the consummation of a business combination, in which case all of the current directors will continue in office until at least the consummation of the business combination. Accordingly, you may not be able to exercise your voting rights under corporate law for up to 24 months. If there is an annual meeting, as a consequence of our “staggered” board of directors, only a minority of the board of directors will be considered for election and our Sponsor, because of their ownership position, will have considerable influence regarding the outcome. Accordingly, our initial stockholders will continue to exert control at least until the consummation of a business combination.


Our outstanding warrants may have an adverse effect on the market price of our common stock and make it more difficult to effect a business combination.

We issued warrants to purchase 7,278,151 shares of common stock as part of the units offered in our IPO and private warrants to purchase 3,233,446 shares of common stock, inclusive of Underwriters partial allotment exercise. We may also issue other warrants to our sponsor, initial stockholders, officers, directors or their affiliates in payment of working capital loans made to us as described in this prospectus. To the extent we issue shares of common stock to effect a business combination, the potential for the issuance of a substantial number of additional shares upon exercise of these warrants could make us a less attractive acquisition vehicle in the eyes of a target business. Such securities, when exercised, will increase the number of issued and outstanding shares of common stock and reduce the value of the shares issued to complete the business combination. Accordingly, our warrants may make it more difficult to effectuate a business combination or increase the cost of acquiring the target business. Additionally, the sale, or even the possibility of sale, of the shares underlying the warrants could have an adverse effect on the market price for our securities or on our ability to obtain future financing. If and to the extent these warrants are exercised, you may experience dilution to your holdings.

We may redeem your unexpired warrants prior to their exercise at a time that is disadvantageous to you, thereby making your warrants worthless.

We have the ability to redeem outstanding warrants (excluding the private warrants and any warrants underlying additional units issued to our sponsor, officers or directors in payment of working capital loans made to us) at any time after they become exercisable and prior to their expiration, at a price of $0.01 per warrant, provided that the last reported sales price of the common stock equals or exceeds $18.00 per share (as adjusted for stock splits, stock dividends, reorganizations and recapitalizations) for any 20 trading days within a 30 trading-day period ending on the third business day prior to proper notice of such redemption provided that on the date we give notice of redemption and during the entire period thereafter until the time we redeem the warrants, we have an effective registration statement under the Securities Act covering the shares of common stock issuable upon exercise of the warrants and a current prospectus relating to them is available. If and when the warrants become redeemable by us, we may exercise our redemption right even if we are unable to register or qualify the underlying securities for sale under all applicable state securities laws. Redemption of the outstanding warrants could force you (i) to exercise your warrants and pay the exercise price therefor at a time when it may be disadvantageous for you to do so, (ii) to sell your warrants at the then-current market price when you might otherwise wish to hold your warrants or (iii) to accept the nominal redemption price which, at the time the outstanding warrants are called for redemption, is likely to be substantially less than the market value of your warrants. None of the private warrants will be redeemable by us so long as they are held by the initial purchasers or their permitted transferees.

Our management’s ability to require holders of our warrants to exercise such warrants on a cashless basis will cause holders to receive fewer shares of common stock upon their exercise of the warrants than they would have received had they been able to exercise their warrants for cash.

If we call our public warrants for redemption after the redemption criteria described above have been satisfied, our management will have the option to require any holder that wishes to exercise his warrant (including any private warrants) to do so on a “cashless basis.” If our management chooses to require holders to exercise their warrants on a cashless basis, the number of shares of common stock received by a holder upon exercise will be fewer than it would have been had such holder exercised his warrant for cash. This will have the effect of reducing the potential “upside” of the holder’s investment in our company.

If our security holders exercise their registration rights, it may have an adversedepressive effect on the market price of our shares of common stockCommon Stock. Further, in general, under Rule 144 under the Securities Act, a person who has satisfied a minimum holding period of between six months and one-year and any other applicable requirements of Rule 144, may thereafter sell such shares publicly. A significant number of our currently issued and outstanding shares of Common Stock held by existing stockholders, including officers and directors and other principal stockholders are currently eligible for resale pursuant to and in accordance with the existenceprovisions of Rule 144. The possible future sale of our shares by our existing stockholders, pursuant to and in accordance with the provisions of Rule 144, may have a depressive effect on the price of our Shares of Common Stock in the applicable trading marketplace.

FINRA has adopted sales practice requirements, which may also limit a stockholder’s ability to buy and sell our Common Stock.

FINRA has adopted rules that require that in recommending an investment to a customer, a broker-dealer must have reasonable grounds for believing that the investment is suitable for that customer. Prior to recommending speculative low-priced securities to their non-institutional customers, broker-dealers must make reasonable efforts to obtain information about the customer’s financial status, tax status, investment objectives and other information.

69


Under interpretations of these rights mayrules, FINRA believes that there is a high probability that speculative low-priced securities will not be suitable for at least some customers. FINRA requirements make it more difficult for broker-dealers to effect a business combination.

The holdersrecommend that their customers buy our shares of Common Stock, which may limit your ability to buy and sell our founders’ sharesstock and private warrants issued and outstanding on the date of this prospectus, as well as the holders of the private warrants our sponsor, initial stockholders, officers, directors or their affiliates may be issued in payment of working capital loans made to us (and all underlying securities), are entitled to demand that we register the resale of the private warrants and any other units and warrants we issue to them (and the underlying securities) commencing at any time after we consummate an initial business combination. The presence of these additional securities trading in the public market may have an adverse effect on the market price of our securities. In addition, the existence of these rights may make it more difficult to effectuate a business combination or increase the cost of acquiring the target business, as the stockholders of the target business may be discouraged from entering into a business combination with us or will request a higher price for their securities because of the potential effect the exercise of such rights may have on the trading market for our shares of common stock.Common Stock.


If we are deemedWe face risks related to be an investment company, we may be required to institute burdensome compliance requirementswith corporate governance laws and our activities may be restricted, which may make it difficult for us to complete a business combination.financial reporting standards.

A company that, among other things, is or holds itself outThe Sarbanes-Oxley Act, as being engaged primarily, or proposes to engage primarily,well as related new rules and regulations implemented by the SEC and the Public Company Accounting Oversight Board, require changes in the business of investing, reinvesting, owning, trading or holding certain types of securities would be deemed an investment company under the Investment Company Act, as amended, or the Investment Company Act. Since we will invest the proceeds held in the trust account, it is possible that we could be deemed an investment company. Notwithstanding the foregoing, we do not believe that our anticipated principal activities will subject us to the Investment Company Act. To this end, the proceeds held in trust may be invested by the trustee only in United States “government securities” within the meaning of Section 2(a)(16) of the Investment Company Act having a maturity of 185 days or less or in money market funds meeting certain conditions under Rule 2a-7 promulgated under the Investment Company Act which invest only in direct U.S. government treasury obligations. By restricting the investment of the proceeds to these instruments, we intend to meet the requirementscorporate governance practices and financial reporting standards for the exemption provided in Rule 3a-1 promulgated under the Investment Company Act.

If we are nevertheless deemed to be an investment company under the Investment Company Act, we may be subject to certain restrictions that may make it more difficult for us to complete a business combination, including:

restrictions on the nature of our investments; and
restrictions on the issuance of securities.

In addition, we may have imposed upon us certain burdensome requirements, including:

registration as an investment company;
adoption of a specific form of corporate structure; and
reporting, record keeping, voting, proxy,public companies. These laws, rules and regulations, including compliance policies and procedures and disclosure requirements and other rules and regulations.

Compliance with these additional regulatory burdens would require additional expense for which we have not allotted.

If we do not conduct an adequate due diligence investigation of a target business, we may be required to subsequently take write-downs or write-offs, restructuring, and impairment or other charges that could have a significant negative effect on our financial condition, results of operations and our stock price, which could cause you to lose some or all of your investment.

We must conduct a due diligence investigation of the target businesses we intend to acquire. Intensive due diligence is time consuming and expensive due to the operations, accounting, finance and legal professionals who must be involved in the due diligence process. Even if we conduct extensive due diligence on a target business, this diligence may not reveal all material issues that may affect a particular target business, and factors outside the control of the target business and outside of our control may later arise. If our diligence fails to identify issues specific to a target business, industry or the environment in which the target business operates, we may be forced to later write-down or write-off assets, restructure our operations, or incur impairment or other charges that could result in our reporting losses. Even though these charges may be non-cash items and not have an immediate impact on our liquidity, the fact that we report charges of this nature could contribute to negative market perceptions about us or our common stock. In addition, charges of this nature may cause us to violate net worth or other covenants to which we may be subject as a result of assuming pre-existing debt held by a target business or by virtue of our obtaining post-combination debt financing.


The requirement that we complete an initial business combination by October 13, 2021 may give potential target businesses leverage over us in negotiating a business combination.

We have until October 13, 2021 to complete an initial business combination. Any potential target business with which we enter into negotiations concerning a business combination will be aware of this requirement. Consequently, such target business may obtain leverage over us in negotiating a business combination, knowing that if we do not complete a business combination with that particular target business, we may be unable to complete a business combination with any other target business. This risk will increase as we get closer to the time limit referenced above.

We may not obtain a fairness opinion with respect to the target business that we seek to acquire and therefore you may be relying solely on the judgment of our board of directors in approving a proposed business combination.

We will only be required to obtain a fairness opinion with respect to the target business that we seek to acquire if it is an entity that is affiliated with any of our Sponsor, initial stockholders, officers, directors or their affiliates. In all other instances, we will have no obligation to obtain an opinion. Accordingly, investors will be relying solely on the judgment of our board of directors in approving a proposed business combination.

Resources could be spent researching acquisitions that are not consummated, which could materially adversely affect subsequent attempts to locate and acquire or merge with another business.

It is anticipated that the investigation of each specific target business and the negotiation, drafting, and execution of relevant agreements, disclosure documents, and other instruments will require substantial management time and attention and substantial costs for accountants, attorneys and others. If a decision is made not to complete a specific business combination, the costs incurred up to that point for the proposed transaction likely would not be recoverable. Furthermore, even if an agreement is reached relating to a specific target business, we may fail to consummate the business combination for any number of reasons including those beyond our control. Any such event will result in a loss to us of the related costs incurred which could materially adversely affect subsequent attempts to locate and acquire or merge with another business.

Compliance with the Sarbanes-Oxley Act of 2002 will require substantial financial and management resources and may increase the time and costs of completing an acquisition.

Section 404 of the Sarbanes-Oxley Act of 2002 requires that we evaluate and report on our system ofrelating to internal controls and may require that we have such system of internal controls audited beginning with our Annual Report on Form 10-K for the year ending December 31, 2021. If we failcontrol over financial reporting, referred to maintain the adequacy of our internal controls, we could be subject to regulatory scrutiny, civil or criminal penalties and/or stockholder litigation. Any inability to provide reliable financial reports could harm our business.as Section 404, of the Sarbanes-Oxley Act also requires thatmaterially increased our independent registered public accounting firm report on management’s evaluation oflegal and financial compliance costs and made some activities more time-consuming and more burdensome,

Anti-takeover provisions contained in our system of internal controls. A target company may not be in compliance with theCharter and bylaws, as well as provisions of the Sarbanes-Oxley Act regarding adequacy of their internal controls. The development of the internal controls of any such entity to achieve compliance with the Sarbanes-Oxley Act may increase the time and costs necessary to complete any such acquisition. Furthermore, any failure to implement required new or improved controls, or difficulties encountered in the implementation of adequate controls over our financial processes and reporting in the future, could harm our operating results or cause us to fail to meet our reporting obligations. Inferior internal controls could also cause investors to lose confidence in our reported financial information, which could have a negative effect on the trading price of our stock.


If we effect a business combination with a company located in a foreign jurisdiction, we would be subject to a variety of additional risks that may negatively impact our operations.

If we are successful in consummating a business combination with a target business in a foreign country, we would be subject to any special considerations or risks associated with companies operating in the target business’ home jurisdiction, including any of the following:

rules and regulations or currency conversion or corporate withholding taxes on individuals;
tariffs and trade barriers;
regulations related to customs and import/export matters;
longer payment cycles;

tax issues, such as tax law changes and variations in tax laws as compared to the United States;
currency fluctuations and exchange controls;
challenges in collecting accounts receivable;
cultural and language differences;
employment regulations;
crime, strikes, riots, civil disturbances, terrorist attacks and wars; and
deterioration of political relations with the United States.

We cannot assure you that we would be able to adequately address these additional risks. If we were unable to do so, our operations might suffer.

If we effect a business combination with a company located outside of the United States, the laws applicable to such company will likely govern all of our material agreements and we may not be able to enforce our legal rights.

If we effect a business combination with a company located outside of the United States, the laws of the country in which such company operates will govern almost all of the material agreements relating to its operations. We cannot assure you that the target business will be able to enforce any of its material agreements or that remedies will be available in this new jurisdiction. The system of laws and the enforcement of existing laws in such jurisdiction may not be as certain in implementation and interpretation as in the United States. The inability to enforce or obtain a remedy under any of our future agreements could result in a significant loss of business, business opportunities or capital. Additionally, if we acquire a company located outside of the United States, it is likely that substantially all of our assets would be located outside of the United States and some of our officers and directors might reside outside of the United States. As a result, it may not be possible for investors in the United States to enforce their legal rights, to effect service of process upon our directors or officers or to enforce judgments of United States courts predicated upon civil liabilities and criminal penalties of our directors and officers under federal securities laws.

Provisions in our amended and restated certificate of incorporation and bylaws and Delaware law, may inhibitcould impair a takeover of us, which could limit the price investors might be willing to pay in the future for our common stock and could entrench management.attempt.

Our amended and restated certificate of incorporation and bylaws containCharter contains provisions that may discourage unsolicited takeover proposals that stockholders may consider to be in their best interests. Our board of directors is divided into three classes, each of which will generally serve for a term of three years with only one class of directors being elected in each year. As a result, at a given annual meeting only a minority of the board of directors may be considered for election. Since our “staggered board” may prevent our stockholders from replacing a majority of our board of directors at any given annual meeting, it may entrench management and discourage unsolicited stockholder proposals that may be in the best interests of stockholders. Moreover, our board of directors has the ability to designate the terms of and issue new series of preferred stock.


We are also subject to anti-takeover provisions under Delaware law, which could delay or prevent a change of control. Together, these provisions may make more difficult the removal of management and may discourage transactions that otherwise could involve payment of a premium over prevailing market prices for our securities. These provisions will include:

no cumulative voting in the election of directors, which limits the ability of minority stockholders to elect director candidates;

a classified board of directors with three-year staggered terms, which could delay the ability of stockholders to change the membership of a majority of the Board;

the right of our Board to elect a director to fill a vacancy created by the expansion of our Board or the resignation, death or removal of a director in certain circumstances, which prevents stockholders from being able to fill vacancies on our Board; and

a prohibition on stockholder action by written consent, which forces stockholder action to be taken at an annual or special meeting of our stockholders.

Because we must furnish our stockholders with target business financial statements prepared in accordance with U.S. generally accepted accounting principles or international financial reporting standards, we will not be able to complete a business combination with prospective target businesses unless their financial statements are prepared in accordance with U.S. generally accepted accounting principles or international financial reporting standards.

The federal proxy rules require that a proxy statement with respect to a vote on a business combination meeting certain financial significance tests include historical and/or pro forma financial statement disclosure in periodic reports. These financial statements may be required to be prepared in accordance with, or be reconciled to, accounting principles generally accepted in the United States of America, or GAAP, or international financial reporting standards, or IFRS, depending on the circumstances, and the historical financial statements may be required to be audited in accordance with the standards of the Public Company Accounting Oversight Board (United States), or PCAOB. We will include the same financial statement disclosure in connection with any tender offer documents we use, whether or not they are required under the tender offer rules. Additionally, to the extent we furnish our stockholders with financial statements prepared in accordance with IFRS, such financial statements will need to be audited in accordance with U.S. GAAP at the time of the consummation of the business combination. These financial statement requirements may limit the pool of potential target businesses we may acquire.

Changes in laws or regulations, or a failure to comply with any laws and regulations, may adversely affect our business, investments and results of operations.

We are subject to laws and regulations enacted by national, regional and local governments. In particular, we will be required to comply with certain SEC and other legal requirements. Compliance with, and monitoring of, applicable laws and regulations may be difficult, time consuming and costly. Those laws and regulations and their interpretation and application may also change from time to time and those changes could have a material adverse effect on our business, investments and results of operations. In addition, a failure to comply with applicable laws or regulations, as interpreted and applied, could have a material adverse effect on our business and results of operations.

There may be tax consequences to our business combinations that may adversely affect us.

While we expect to undertake any merger or acquisition so as to minimize taxes both to the acquired business and/or asset and us, such business combination might not meet the statutory requirements of a tax-free reorganization, or the parties might not obtain the intended tax-free treatment upon a transfer of shares or assets. A non-qualifying reorganization could result in the imposition of substantial taxes.

Our amended and restated certificate of incorporation will provide, subject to limited exceptions,Charter provides that the Court of Chancery of the State of Delaware and the federal district courts of the United States of America will be the soleexclusive forums for substantially all disputes between us and exclusive forum for certain stockholder litigation matters,our stockholders, which could limit our stockholders’ ability to obtain a favorable judicial forum for disputes with us or our directors, officers, or employees.

Our Charter provides that, subject to limited exceptions, any (i) derivative action or proceeding brought on our behalf of under Delaware law, (ii) any action asserting a claim of breach of a fiduciary duty owed by any current or former director, officer or other employee of Revelation to its stockholders, (iii) any action asserting a claim against Revelation or any of its directors, officers or other employees arising pursuant to any provision of the DGCL, the Charter or stockholders.

Ourthe Bylaws of Revelation (in each case, as may be amended and restated certificatefrom time to time), (iv) any action asserting a claim against Revelation or any of incorporation requires,its directors, officers or other employees governed by the internal affairs doctrine of the State of Delaware or (v) any other action asserting an “internal corporate claim,” as defined in Section 115 of the DGCL, in all cases subject to the court’s having personal jurisdiction over all indispensable parties named as defendants shall, to the fullest extent permitted by law, that derivative actionsbe exclusively brought in our name, actions against directors, officers and employees for breach of fiduciary duty and other similar actions may be brought only in the Court of Chancery inof the State of Delaware and,or, if brought outside of Delaware, the stockholder bringing the suit will be deemed to have consented to service of process on such stockholder’s counsel except any action (A) as to which the Court of Chancery in the State of Delaware determines that there is an indispensable party not subject to the jurisdiction of the Court of Chancery (and the indispensable party does not consent to the personal jurisdiction of the Court of Chancery within ten days following such determination), (B) which is vested in the exclusive jurisdiction of a court or forum other than the Court of Chancery, (C) for which the Court of Chancery does not have subject matter jurisdiction thereof, another state or (D)federal court located within the State of Delaware. The Charter also provides that unless a majority of the Board of Revelation, acting on behalf of Revelation, consents in writing to the selection of an alternative forum (which consent may be given at any time, including during the pendency of litigation), the federal district courts of the United States of America, to the fullest extent permitted by law, will be the sole and exclusive forum for the resolution of any action asserting a cause of action arising under the Securities Act, as to which the Court of Chancery and the federal district court for the District of Delaware shall have concurrent jurisdiction.Act. Any person or entity purchasing or otherwise acquiring any interest in shares

70


of ourRevelation’s capital stock shall be deemed to have notice of and to have consented to the forum provisions in our amended and restated certificate of incorporation.


This choice of forum provision may limit a stockholder’s ability to bring a claim in a judicial forum that it finds favorable for disputes with us or any of our directors, officers or employees, which may discourage lawsuits with respect to such claims, although our stockholders will not be deemed to have waived our compliance with federal securities laws and the rules and regulations thereunder and may therefore bring a claim in another appropriate forum. We cannot be certain that a court will decide that this provision is either applicable or enforceable, and if a court were to find the choice of forum provision contained in our amended and restatedRevelation’s certificate of incorporation to be inapplicable or unenforceable in an action, we may incur additional costs associated with resolving such action in other jurisdictions, which could harm our business, operating results and financial condition.

Our amended and restated certificate of incorporation provides that the exclusive forum provision will be applicable to the fullest extent permitted by applicable law.described above. Section 27 of the Exchange Act creates exclusive federal jurisdiction over all suits brought to enforce any duty or liability created by the Exchange Act or the rules and regulations thereunder. As a result, the exclusive forum provision will not apply to suits brought to enforce any duty or liability created by the Exchange Act or any other claim for which the federal courts have exclusive jurisdiction.

Because we intend to seek a business combination with a target business in Section 22 of the healthcare industry, we expect our future operations to be subject to risks associated with this industry.

Healthcare-related companies are generally subject to greater governmental regulation than most other industries at U.S.Securities Act creates concurrent jurisdiction for state and federal levels,courts over all suits brought to enforce any duty or liability created by the Securities Act or the rules and internationally. In recent years, both localregulations thereunder.

This choice of forum provision may limit a stockholders ability to bring a claim in a judicial forum that it finds favorable for disputes with Revelation or its directors, officers, or other employees, which, along with potential increased costs of litigating the courts provided by the choice of forum provision, may discourage such lawsuits against Revelation and national governmental budgets have been subjectits directors, officers, and employees. Alternatively, if a court were to pressurefind these provisions of Revelation’s Charter inapplicable to, reduce spending and control healthcareor unenforceable in respect of, one or more of the specified types of actions or proceedings, Revelation may incur additional costs associated with resolving such matters in other jurisdictions, which could adversely affect both regulatory processesRevelation’s business and financial condition.

If Revelation is not able to comply with the applicable continued listing requirements or standards of Nasdaq, Nasdaq could delist our Common Stock.

Revelation’s Common Stock and Public Warrants are listed on the Nasdaq Capital Market under the symbols “REVB” and “REVBW,” respectively. If Nasdaq delists the Revelation Common Stock and Public Warrants from trading on its exchange for failure to meet the listing standards such as the minimum public funding availablestockholders equity requirement or for healthcare products, servicesfailure to hold an annual stockholders meeting, we and facilities. our stockholders could face significant material adverse consequences including:

limited availability of market quotations for our securities;

reduced liquidity for Revelation’s securities;

a determination that the Revelation Common Stock is a “penny stock” which will require brokers trading in the Revelation Common Stock to adhere to more stringent rules and possibly result in a reduced level of trading activity in the secondary trading market for Revelation’s securities;

a limited amount of news and analyst coverage; and

a decreased ability to issue additional securities or obtain additional financing in the future.

Revelation will continue to incur significant increased expenses and administrative burdens as a public company, which could negatively impact its business, financial condition and results of operations.

As a public company, we are subject to the reporting requirements of the Exchange Act, the listing standards of the Nasdaq Capital Market, and other applicable securities rules and regulations. We expect that the requirements of these rules and regulations will continue to increase our legal, accounting, and financial compliance costs, make some activities more difficult, time-consuming and costly, and place significant strain on our personnel, systems, and resources. For example, the Exchange Act requires, among other things, that we file annual, quarterly, and current reports with respect to our business and results of operations. As a result of the complexity involved in complying with the rules and regulations applicable to public companies, our management’s attention may be diverted from other business concerns, which could harm our business, results of operations, and financial condition. Additionally, as a public company subject to additional rules and regulations and oversight, we may not have the same flexibility we had as a private company.

Revelation’s business and operations could be negatively affected if it becomes subject to any securities litigation or stockholder activism, which could cause Revelation to incur significant expense, hinder execution of business and growth strategy and impact its stock price.

71


In March 2010, comprehensive healthcare reform legislation was enactedthe past, following periods of volatility in the United States throughmarket price of a company’s securities, securities class action litigation has often been brought against that company. Stockholder activism, which could take many forms or arise in a variety of situations, has been increasing recently. Volatility in the Health Care Reform Act. These laws are intendedstock price of Revelation Common Stock or other reasons may in the future cause it to increase health insurance coverage through individualbecome the target of securities litigation or stockholder activism. Securities litigation and employer mandates, subsidies offeredstockholder activism, including potential proxy contests, could result in substantial costs and divert management’s and board of directors’ attention and resources from the Revelation’s business. Additionally, such securities litigation and stockholder activism could give rise to lower income individuals, tax credits availableperceived uncertainties as to smaller employersthe Combined Entity’s future, adversely affect its relationships with service providers and broadening of Medicaid eligibility. 

While one intent of healthcare reform ismake it more difficult to expand health insurance coverageattract and retain qualified personnel. Also, Revelation may be required to more individuals, it may also involve additional regulatory mandatesincur significant legal fees and other measures designedexpenses related to constrain medical costs, including coverageany securities litigation and reimbursementactivist stockholder matters. Further, its stock price could be subject to significant fluctuation or otherwise be adversely affected by the events, risks and uncertainties of any securities litigation and stockholder activism.

Our financial condition will be adversely affected if we are unsuccessful in our defense in our litigation with LifeSci Capital LLC

The investment banking firm for healthcare services. The Health Care Reform Actthe SPAC into which we merged has hadbrought suit against us for unpaid investment banking fees relating to the merger and deferred underwriting fees, which claims damages of $5.3 million, payable in a significant impact on the healthcare sectorcombination of cash and shares of common stock. See “Legal Proceedings.” While we have defenses which we believe are meritorious, if we were to be unsuccessful in the U.S. and consequently has the ability to affect companies that operate within the healthcare industry. The ultimate effects of federal healthcare reform or any future legislation or regulation, or healthcare initiatives, if any, on the healthcare sector, whether implemented at the federal or state level, or internationally, cannot be predicted with certainty and such reform, legislation, regulation or initiatives, including the Health Care Reform Act or any successor legislation, may adversely affect the performance of a potential business combination.

Changes in governmental policies may have a material effect on the demand for or costs of certain products and services. A healthcare-related company must receive government approval before introducing new drugs and medical devices or procedures. This process may delay the introduction of these products and services to the marketplace, resulting in increased development costs, delayed cost recovery and loss of competitive advantage to the extent that rival companies have developed competing products or procedures, adversely affecting the company’s revenues and profitability. Failure to obtain governmental approval of a key drug or device or other regulatory action couldproceeding it would have a material adverse effect on the business of a portfolio company. Additionally, expansion of facilities by healthcare-related providers is subject to “determinations of need” by the appropriate government authorities. This process not only increases the timeour financial condition and cost involved in these expansions, but also makes expansion plans uncertain, limiting the revenue and profitability growth potential of healthcare-related facilities operators. 

Some healthcare-related companies depend on the exclusive rights or patents for the products they develop and distribute. Patents have a limited duration and, upon expiration, other companies may market substantially similar “generic” products that are typically sold at a lower price than the patented product, causing the original developer of the product to lose market share and/or reduce the price charged for theavailable funds to advance our product resulting in lower profits for the original developer. As a result, the expiration of patents may adversely affect the profitability of these companies. The profitability of healthcare-related companies may also be affected by such things as restrictions on government reimbursement for medical expenses, rising or falling costs of medical products and services, pricing pressure, an increased emphasis on outpatient services, a limited product offering, industry innovation, changes in technologies and other market developments. Finally, because the products and services of healthcare-related companies affect the health and well-being of many individuals, these companies are especially susceptible to product liability lawsuits. development.

Some healthcare-related industry products are subject to regulation as medical devices. Among other things, pursuant to the Federal Food, Drug and Cosmetic Act (the “FDC Act”) and its implementing regulations, the FDA regulates the research, testing, manufacturing, safety, labeling, storage, recordkeeping, premarket clearance or approval, marketing and promotion, and sales and distribution of medical devices in the United States to ensure that medical products distributed domestically are safe and effective for their intended uses. In addition, the FDA regulates the import and export of medical devices. These regulations are complex and can be costly to ensure compliance with.

Additionally, in the healthcare or healthcare related industry we may, in the future, collect and store sensitive data, including protected health information (“PHI”), personally identifiable information (“PII”), credit card and other financial information, intellectual property, and proprietary business information owned or controlled by ourselves or customers, payors, and other parties. We will be responsible for the secure processing, storage, maintenance, and transmission of this critical information. Any breach, or other loss of information could result in legal claims or proceedings, liability under federal or state laws that protect the privacy of personal information, such as the Health Insurance Portability and Accountability Act of 1996 (“HIPAA”) and the Health Information Technology for Economic and Clinical Health Act (“HITECH”), and regulatory penalties


The healthcare industry spends heavily on research and development. Research findings (e.g., regarding side effects or comparative benefits of one or more particular treatments, services or products) and technological innovation (together with patent expirations) may make any particular treatment, service or product less attractive if previously unknown or underappreciated risks are revealed, or if a more effective, less costly or less risky solution is or becomes available. Any such development could have a material adverse effect on the companies that are target businesses for investment.

There are additional risks related to the healthcare industry to which we may be subject.

Business combinations with companies with operations in the healthcare industry entail special considerations and risks. If we are successful in completing a business combination with a target business with operations in the healthcare industry, we will be subject to, and possibly adversely affected by, the following risks, including but not limited to:

Competition could reduce profit margins.

An inability to license or enforce intellectual property rights on which our business may depend.

The success of our planned business following consummation of our initial business combination may depend on maintaining a well-secured business and technology infrastructure.

Continuing government and private efforts to contain healthcare costs, including through the implementation of legal and regulatory changes, may reduce our future revenue and our profitability following such business combination.

Changes in the healthcare related wellness industry and markets for such products affecting our customers or retailing practices could negatively impact customer relationships and our results of operations.

The healthcare industry is susceptible to significant liability exposure. If liability claims are brought against us following a business combination, it could materially adversely affect our operations.

Dependence of our operations upon third-party suppliers, manufacturers or contractors whose failure to perform adequately could disrupt our business.

A disruption in supply could adversely impact our business.

Any of the foregoing could have an adverse impact on our operations following a business combination. However, our efforts in identifying prospective target businesses will not be limited to the healthcare industry. Accordingly, if we acquire a target business in another industry, these risks will likely not affect us and we will be subject to other risks attendant with the specific industry in which we operate or target business which we acquire, none of which can be presently ascertained.

ITEMItem 1B. UNRESOLVED STAFF COMMENTSUnresolved Staff Comments.

None.

 

Not applicable.Item 2. Property.

ITEM 2. PROPERTY

We lease laboratory space located at 11011 Torreyana Rd., Suite 102, San Diego, California, which consists of approximately 2,140 square feet. The lease expires on December 31, 2023. Our corporate headquarters is located at 4660 La Jolla Village Dr., Suite 100, San Diego, California, where we currently maintain our principal executive offices at 5 West 21st Street, New York, NY 10010. Our sponsor is making thishave access to office space available to us free of charge.on an as-needed basis. We considerbelieve that our current office space combined with the other office space otherwise available to our executive officers,is adequate for our current operations.needs. We also believe we will be able to obtain additional space, as needed, on commercially reasonable terms.

ITEMItem 3. LEGAL PROCEEDINGSLegal Proceedings

None.On February 18, 2022, LifeSci Capital LLC filed an action against the Company in the U.S. District Court for the Southern District of New York seeking damages in the amount of approximately $2.7 million in cash and $2.6 million in equity for unpaid banking and advisory fees. These fees arise under contracts which were entered into prior to the Business Combination and the Company is disputing the amount owed under those contracts and has asserted affirmative defenses including the defense that the amount of the fees sought exceeded the $8.5 million cap on transaction expenses in the Business Combination Agreement. This action remains pending as of the date of this report. On March 2, 2023, the court denied the plaintiff’s motion for summary judgment. As of the date of this report, the court has not set any schedule for discovery or a timetable for any trial.

Of the LifeSci Capital LLC claim, $1.5 million relates to deferred underwriting fees from the Petra initial public offering. In addition, but separate from the claim, one of the underwriters in the Petra initial public offering who is not a participant in the litigation with LifeSci Capital LLC recently issued a demand letter seeking repayment for $655 thousand in fees owed from the Petra initial public offering that remain unpaid, Both of these amounts are recorded as a current liability in the financial statements as of December 31, 2022 under deferred underwriting commissions. No other liabilities are reflected in the financial statements as the amount of any additional liability cannot be determined at this time.

On September 27, 2022, A-IR Clinical Research Ltd. (“A-IR”) filed a claim against the Company in the High Court of Justice, in the Business and Property Courts of England and Wales, seeking £1.6 million in unpaid invoices, plus interest and costs, relating to the Company’s viral challenge study. The Company is disputing the claim because

72


many of the invoices relate to work that was not performed and A-IR had misrepresented its qualifications to perform the contracted work. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

On January 30, 2023, Marwood Advisory Group, LLC filed an action in the Supreme Court of New York for the County of New York seeking damages in the amount of $150,000 plus interest in respect of a contract agreed by the sponsors of Petra allegedly relating to a due diligence report with another target considered by Petra prior to the Business Combination. The Company believes it has defenses to this claim and as of the date of this report no answer is due. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

 

ITEMItem 4. MINE SAFETY DISCLOSURESMine Safety Disclosures.

Not applicable.


PART II

ITEMItem 5. MARKET FOR COMMON EQUITY AND RELATED STOCKHOLDER MATTERS AND ISSUER PURCHASES OF EQUITY SECURITIESSECURITIES.

Market Information

Our units, common stock and warrants are listedtraded on the Nasdaq Capital Markets (“Nasdaq”)Market under the symbols PAICU, PAIC“REVB” and PAICW,“REVBW”, respectively.

Holders of Record

As of March 31, 2021,21, 2023, there was one holder of record of our units, seven holderswere approximately 78 stockholders of record of our common stock and two28 holders of record of our warrants. Because many of our securities are held by brokers and other institutions on behalf of stockholders, we are unable to estimate the total number of stockholders represented by these record holders.

Dividends

We have notnever paid any cash dividends on our shares of our common stock, to date and we do not intendhave any plans to pay cash dividends prior to the completion of a business combination. The payment of cash dividends in the futureforeseeable future. Any determination to pay dividends to holders of shares of our common stock will be contingent upon our revenues and earnings, if any, capital requirements, and general financial condition subsequent to completion of a business combination. The payment of any dividends subsequent to a business combination will be withinat the discretion of our then board of directors. It is the present intention of our board of directors to retain alland will depend on many factors, including our financial condition, results of operations, projections, liquidity, earnings, iflegal requirements, restrictions in the agreements governing any for use in our business operationsindebtedness we may enter into and accordingly,other factors that our board does not anticipate declaring any dividends in the foreseeable future. Further, if we incur any indebtedness in connection with our initial business combination, our ability to declare dividends may be limited by restrictive covenants we may agree to in connection therewith.of directors deems relevant.

Recent SalesIssuer Purchases of Unregistered Securities; Use of Proceeds from RegisteredEquity Securities

On October 13, 2020, we consummated the IPO of 7,000,000 units. Each unit consists of one share of common stockThe following table summarizes all of the Company, par value $0.001 per share, and one redeemable warrantrepurchases of the Company, with each warrant entitlingCompany’s equity securities during the holder thereof to purchase one share of common stock for $11.50 per share. The units were sold at a price of $10.00 per Unit, generating gross proceeds to the Company of $70,000,000.

LifeSci Capital LLC and Ladenburg Thalmann & Co. Inc. acted as joint book-running managers and as representatives of the underwriters, with Northland Securities, Inc. and Ingalls and Snyder LLC acted as co-managers of the offering. The securities sold in the IPO were registered under the Securities Act on registration statements on Form S-1 (No. 333-240175) which was declared effective by the Securities Exchange Commission on October 7, 2020.


Simultaneously with the consummation of the IPO, the Company completed the private sale of an aggregate of 3,150,000 private warrants (the “Private Warrants”) to the Sponsor at a purchase price of $1.00 per Private Warrant, generating gross proceeds to the Company of $3,150,000. The Private Warrants are identical to the units and warrants sold in the IPO, except that the Private Warrants are non-redeemable and may be exercised on a cashless basis, in each case so long as they continue to be held by the initial purchasers or their permitted transferees.

On October 16, 2020, we consummated the sale of an additional 278,151 units that were subject to the underwriter’s partial exercise of the over-allotment option at $10.00 per Unit, generating gross proceeds of $2,781,510. Simultaneously with the closing of the sale of additional units, the Company consummated the sale of an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446. Following the closing of the over-allotment option and sale of additional Private Warrants, an aggregate amount of $73,509,325 was placed in the Company’s trust account established in connection with the IPO. 

On November 16, 2020, the shares of common stock and warrants included in the units began separate trading. Units not separated will continue to be listed on the Nasdaq Capital Market.

Shares of common stock of the Company (the “Founder Shares”) held by the Sponsor (prior to the exercise of the over-allotment) included an aggregate of up to 262,500 Founder Shares subject to forfeiture by the Sponsor to the extent that the underwriters’ over-allotment option was not exercised in full. Since the underwriters exercised the over-allotment option in part, 192,962 Founder Shares were subject to forfeiture and were cancelled by our Sponsor on December 30, 2020.

Transaction costs amounted to $4,682,736, consisting of $4,366,890 of underwriting fees and $315,846 of other offering costs. In addition, $11,734 of cash and $525,287 of marketable securities atyear ended December 31, 2020 was held outside of the Trust Account and is available for working capital purposes.2022:

 

 

 

 

 

Period

 

 

 

 

Total number of shares purchased

 

 

 

 

 

Average price paid per share

 

Total number of shares purchased as part of publicly announced plans or programs

 

Maximum number of shares that may yet be purchased under the plans or programs

January 1, 2022 to January 31, 2022

 

 

 

 

February 1, 2022 to February 28, 2022

 

21,429(1)

 

$ 357.10

 

21,429

 

March 1, 2022 to March 31, 2022

 

 

 

 

April 1, 2022 to April 30, 2022

 

 

 

 

May 1, 2022 to May 31, 2022

 

 

 

 

73


June 1, 2022 to June 30, 2022

 

 

 

 

July 1, 2022 to July 31, 2022

 

 

 

 

August 1, 2022 to August 31, 2022

 

 

 

 

September 1, 2022 to September 30, 2022

 

 

 

 

October 1, 2022 to October 31, 2022

 

 

 

 

November 1, 2022 to November 30, 2022

 

 

 

 

December 1, 2022 to December 31, 2022

 

 

 

 

Total

 

21,429

 

$ 357.10

 

21,249

 

1.

Shares repurchased as part of the February 4, 2022 exercise of the Forward Share Purchase Agreement dated December 21, 2021, with a total repurchase amount of $7,652,325. The Forward Share Purchase Agreement expired 30 days after the Closing Date of the Business Combination. The shares of common stock repurchased have been retired.

ITEMItem 6. SELECTED FINANCIAL DATA[RESERVED]

Not applicable.

74


ITEMItem 7. MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

Special Note Regarding Forward-Looking Statements

All statements other than statements of historical fact included in this Form 10-K including, without limitation, statements under “Management’sManagement’s Discussion and Analysis of Financial Condition and Results of Operations” regardingOperations

You should read the Company’sfollowing discussion of our financial position, business strategycondition and results of operations in conjunction with our audited financial statements and the plans and objectives of management for future operations, are forward-looking statements. When usednotes included elsewhere in this Form 10-K, words such as “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to us or the Company’s management, identify forward-looking statements. Such10-K. The following discussion contains forward-looking statements are based on the beliefs of management, as well as assumptions made by,that involve certain risks and information currently available to, the Company’s management. Actualuncertainties. Our actual results could differ materially from those contemplateddiscussed in these statements. Factors that could cause or contribute to these differences include those discussed below and elsewhere in this Form 10-K, particularly under the “Risk Factors” and “Cautionary Note Regarding Forward-Looking Statements and Risk Factors Summary” sections.

Overview

Revelation is a clinical-stage biopharmaceutical company founded in May 2020. We are focused on the development or commercialization of innate immune system therapeutics and diagnostics. Our current product candidates were developed by us to potentially prevent, treat and detect disease. Our therapeutic product candidates are based on our therapeutic platform and consist of REVTx-300, which is being developed as a potential therapy for the forward-lookingprevention and treatment of acute organ injury (e.g. AKI, MI) and chronic organ disease including CKD; REVTx-100, which is being developed for the prevention and treatment of infections including healthcare-associated bacterial infection resulting from surgery, severe burns, and antibiotic resistance; REVTx-200, which is being developed as a potential intranasal therapy that will be administered concurrently with a traditional commercially available IM vaccine; and REVTx-99b, which is being developed for the treatment of food allergies. REVTx-99a was being developed as a broad anti-viral nasal drop solution for the potential prevention or potential treatment of respiratory viral infections and REVTx-99b was being developed as a prevention or treatment for chronic nasal congestion and allergic rhinitis until June of 2022. Our diagnostic, REVDx-501 (REVIDTM Rapid Test Kit), was being developed as a rapid point of care diagnostic product that can potentially be used to detect various respiratory viral infections.

Since our inception in May 2020, we have devoted substantially all of our resources to organizing and staffing our Company, business planning, raising capital, and research and development of REVTx-300, REVTx-100, REVTx-200, REVTx-99a/b and REVDx-501, our product candidates.

We have funded our operations since our inception in May 2020 to December 31, 2022 through the issuance and sale of our capital stock, from which we have raised net proceeds of $29.9 million. Additionally, taking into consideration the net proceeds of approximately $14.0 million received in connection with the public offering completed in February of 2023, our current cash and cash equivalents balance will not be sufficient to complete all necessary product development or future commercialization efforts. We anticipate that our current cash and cash equivalents balance will not be sufficient to sustain operations within one year after the date that our audited financial statements for December 31, 2022 were issued, which raises substantial doubt about our ability to continue as a going concern.

We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.

We have incurred recurring losses since our inception, including a net loss of $10.8 million for the year ended December 31, 2022 and $12.0 million for the year ended December 31, 2021, respectively. As of December 31, 2022 we had an accumulated deficit of $25.3 million. We expect to continue to generate operating losses and negative operating cash flows for the foreseeable future if and as we:

continue the research and development of our product candidates;
initiate clinical studies for, or preclinical development of, our product candidates;
further develop and refine the manufacturing processes of our product candidates;

75


change or add manufacturers or suppliers of product candidate materials;
seek regulatory and marketing authorizations for any of our product candidates that successfully complete development;
acquire or license other product candidates, technologies or biological materials;
make milestone, royalty or other payments under future license agreements;
obtain, maintain, protect and enforce our intellectual property portfolio;
seek to attract and retain new and existing skilled personnel;
create additional infrastructure to support our operations as a public company and incur increased legal, accounting, investor relations and other expenses; and
experience delays or encounter issues with any of the above.

Our net losses may fluctuate significantly from quarter-to-quarter and year-to-year, depending on the timing of our clinical studies and our expenditures on other research and development activities.

We have never generated revenue and do not expect to generate revenue from product sales unless and until we successfully complete development and obtain regulatory approval for REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or other product candidates, which we expect will not be for at least several years, if ever. Accordingly, until such time as we can generate significant revenue from sales of REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or other product candidates, if ever, we expect to finance our cash needs through a combination of public or private equity offerings, debt financings or other capital sources, including potential collaborations, licenses and other similar arrangements. However, we may be unable to raise additional funds or enter into such other arrangements when needed on favorable terms or at all. Our failure to raise capital or enter into such other arrangements when needed would have a negative impact on our financial condition and could force us to delay, limit, reduce or terminate our product development or future commercialization efforts or grant rights to develop and market product candidates that we would otherwise prefer to develop and market ourselves.

Recent Developments

Change in Authorized Shares and Reverse Stock Split

On January 30, 2023, at a special meeting of stockholders, our stockholders approved a Certificate of Amendment to our Third Amended and Restated Certificate of Incorporation to change the authorized common stock from 100,000,000 to 500,000,000 shares and effect a reverse stock split of our outstanding shares of common stock at a specific ratio within a range of one-for-twenty (1-for-20) to a maximum of a one-for-one hundred (1-for-100) split. On January 30, 2023, we filed the Certificate of Amendment which set the authorized common stock to 500,000,000 and effected a 1-for-35 reverse stock split of our outstanding shares of common stock as of 12:01 a.m. Eastern Standard Time on February 1, 2023.

Business Combination

On January 10, 2022, we consummated the previously announced Business Combination, pursuant to the terms of the agreement and plan of merger, dated as of August 29, 2021 with Petra and Merger Sub. Pursuant to the Business Combination Agreement, on the Closing Date, (i) Merger Sub merged with and into Revelation Sub, with Revelation Sub as the surviving company in the Business Combination, and became a wholly-owned subsidiary of Petra and (ii) Petra changed its name to “Revelation Biosciences, Inc.”

Research and Development

Research and development expenses consist primarily of costs incurred for the development of our product candidates, REVTx-300, REVTx-100, REVTx-200, REVTx-99a/b and REVDx-501. Our research and development

76


expenses consist primarily of external costs related to clinical development, costs related to contract research organizations, costs related to consultants, costs related to acquiring and manufacturing clinical study materials, costs related to contract manufacturing organizations and other vendors, costs related to the preparation of regulatory submissions, costs related to laboratory supplies and services, and personnel costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in research and development efforts.

We expense all research and development expenses in the periods in which they are incurred. We accrue for costs incurred as the services are being provided by monitoring the status of specific activities and the invoices received from our external service providers. We adjust our accrual as actual costs become known.

We expect our research and development expenses to increase substantially for the foreseeable future as we continue the development of REVTx-300, REVTx-100, REVTx-200, REVTx-99b and REVDx-501 and continue to invest in research and development activities. The process of conducting the necessary clinical research and product development to obtain regulatory approval is costly and time consuming, and the successful development of REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 and any future product candidates is highly uncertain. To the extent that our product candidates continue to advance into larger and later stage clinical studies, our expenses will increase substantially and may become more variable.

The actual probability of success for REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or any future product candidate may be affected by a variety of factors, including the safety and efficacy of our product candidates, investment in the development of REVDx-501, investment in our clinical programs, manufacturing capability and competition with other products. As a result, we are unable to determine the timing of initiation, duration and completion costs of our research and development efforts or when and to what extent we will generate revenue from the commercialization and sale of REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or any future product candidate.

General and Administrative

Our general and administrative expenses consist primarily of personnel costs, expenses for outside professional services, including financial advisory, legal, human resource, audit and accounting services and consulting costs. Personnel and related costs consist of salaries, employee benefits and stock-based compensation for personnel involved in executive, finance and other administrative functions. We expect our general and administrative expenses to increase for the foreseeable future as we increase the size of our administrative function to support the growth of our business and support our continued research and development activities. We also anticipate increased expenses as a result of certain factors detailedoperating as a public company, including increased expenses related to financial advisory services, audit, legal, regulatory, investor relations costs, director and officer insurance premiums associated with maintaining compliance with exchange listing and SEC requirements.

Other Income (Expense), Net

Other income (expense), net primarily consists of foreign currency transaction gains and losses, interest expense for the Promissory Notes Payable and Convertible Note and interest income from our cash balances in savings accounts.

Results of Operations

The following table summarizes our results of operations for the periods presented:

77


 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

 

Change

 

Operating expenses:

 

 

 

 

 

 

 

 

 

Research and development

 

$

5,377,400

 

 

$

6,914,756

 

 

$

(1,537,356

)

General and administrative

 

 

5,487,111

 

 

 

5,035,729

 

 

 

451,382

 

Total operating expenses

 

 

10,864,511

 

 

 

11,950,485

 

 

 

(1,085,974

)

Loss from operations

 

 

(10,864,511

)

 

 

(11,950,485

)

 

 

1,085,974

 

Total other income (expense), net

 

 

34,962

 

 

 

(36,352

)

 

 

71,314

 

Net loss

 

$

(10,829,549

)

 

$

(11,986,837

)

 

$

1,157,288

 

Research and Development Expenses

The following table summarizes our research and development expenses for the periods presented:

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

 

Change

 

REVTx-99a clinical study expenses

 

$

3,104,727

 

 

$

2,787,193

 

 

$

317,534

 

REVTx-99b clinical study expenses

 

 

450,464

 

 

 

452,982

 

 

 

(2,518

)

REVTx-99a/b manufacturing expenses

 

 

225,578

 

 

 

460,488

 

 

 

(234,910

)

REVDx-501 diagnostic development

 

 

27,660

 

 

 

1,285,143

 

 

 

(1,257,483

)

Personnel expenses (including stock-based compensation)

 

 

1,136,811

 

 

 

1,615,622

 

 

 

(478,811

)

Other expenses

 

 

432,160

 

 

 

313,328

 

 

 

118,832

 

Total research and development expenses

 

$

5,377,400

 

 

$

6,914,756

 

 

$

(1,537,356

)

Research and development expenses decreased by $1.5 million, from $6.9 million for the year ended December 31, 2021 to $5.4 million for the year ended December 31, 2022. The decrease was primarily due to decreases of $1.3 million in diagnostic development expenses related to REVDx-501, $0.5 million in personnel expenses and $0.2 million in REVTx-99a/b manufacturing expenses. The decrease in personnel expenses is primarily due to the release of employees in July 2022, including a decrease of $0.1 million due to the reversal of accrued bonus expense and share-based compensation expense related to forfeited, unvested equity awards, offset by an increase in severance expense. These decreases were offset by an increase of $0.3 million in clinical study expenses related to REVTx-99a.

General and Administrative Expenses

The following table summarizes our general and administrative expenses for the periods presented:

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

 

Change

 

Personnel expenses (including employee stock-based compensation)

 

$

1,874,706

 

 

$

2,564,122

 

 

$

(689,416

)

Legal and professional fees (including non-employee stock-based compensation)

 

 

2,073,561

 

 

 

2,338,732

 

 

 

(265,171

)

Other expenses

 

 

1,538,844

 

 

 

132,875

 

 

 

1,405,969

 

Total general and administrative expenses.

 

$

5,487,111

 

 

$

5,035,729

 

 

$

451,382

 

General and administrative expenses increased by $0.5 million, from $5.0 million for the year ended December 31, 2021 to $5.5 million for the year ended December 31, 2022. The increase was primarily due to an increase of $1.4 million in other expense as a result of an increase in D&O Insurance. These increases were offset by a decrease of $0.7 million in personnel expenses and $0.3 million in financial advisory fees, legal fees and professional consulting service fees. The decrease in personnel expenses is primarily due to the release of employees

78


in July 2022, including a decrease of $0.1 million due to the reversal of accrued bonus expense and share-based compensation expense related to forfeited, unvested equity awards, offset by an increase in severance expense.

Other Income (Expense), Net

Other income (expense), net was $36,352 for the year ended December 31, 2021 and $34,962 for the year ended December 31, 2022, related to interest expense for the Promissory Notes Payable and Convertible Note, foreign currency transaction gains and losses, and interest income from our cash balances in savings accounts.

Liquidity and Capital Resources

Since our inception to December 31, 2022, we have funded our operations from the issuance and sale of our common stock, preferred stock and warrants, from which we have raised net proceeds of $29.9 million, of which $16.0 million was received during the year ended December 31, 2022. As of December 31, 2022, we had available cash and cash equivalents of $5.3 million and an accumulated deficit of $25.3 million.

Our use of cash is to fund operating expenses, which consist primarily of research and development expenditures related to our therapeutic product candidate, REVTx-300, REVTx-100 and REVTx-200. We plan to increase our research and development expenses substantially for the foreseeable future as we continue the clinical development of our current and future product candidates. At this time, due to the inherently unpredictable nature of product development, we cannot reasonably estimate the costs we will incur and the timelines that will be required to complete development, obtain marketing approval, and commercialize our current product candidate, diagnostic product or any future product candidates. For the same reasons, we are also unable to predict when, if ever, we will generate revenue from product sales or any future license agreements which we may enter into or whether, or when, if ever, we may achieve profitability. Clinical and preclinical development timelines, the probability of success, and development costs can differ materially from expectations. In addition, we cannot forecast the timing and amounts of milestone, royalty and other revenue from licensing activities, which future product candidates may be subject to future collaborations, when such arrangements will be secured, if at all, and to what degree such arrangements would affect our development plans and capital requirements.

We expect to continue to generate substantial operating losses for the foreseeable future as we expand our research and development activities. We will continue to fund our operations primarily through utilization of our current financial resources and through additional raises of capital.

To the extent that we raise additional capital through partnerships or licensing arrangements with third parties, we may have to relinquish valuable rights to our product candidates, future revenue streams or research programs or to grant licenses on terms that may not be favorable to us. If we raise additional capital through public or private equity offerings, the ownership interest of our then-existing stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect our stockholders’ rights. If we raise additional capital through debt financing, we may be subject to covenants limiting or restricting our ability to take specific actions, such as incurring additional debt, making capital expenditures or declaring dividends. If we are unable to obtain adequate financing when needed, we may have to delay, reduce the scope of or suspend one or more of our clinical studies or preclinical studies, research and development programs or commercialization efforts or grant rights to develop and market our product candidates or diagnostic product even if we would otherwise prefer to develop and market such product candidates or diagnostic product ourselves.

Going Concern

We have incurred recurring losses since our inception, including a net loss of $10.8 million for the year ended December 31, 2022. As of December 31, 2022 we had an accumulated deficit of $25.3 million, a stockholders’ equity of $1.1 million and available cash and cash equivalents of $5.3 million. Additionally, taking into consideration the net proceeds of approximately $14.0 million received in connection with the public offering completed in February of 2023, we expect to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as we continue to complete all necessary product development or future commercialization efforts. We have never generated revenue and do not expect to generate

79


revenue from product sales unless and until we successfully complete development and obtain regulatory approval for REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or other product candidates, which we expect will not be for at least several years, if ever. We do not anticipate that our current cash and cash equivalents balance will be sufficient to sustain operations within one year after the date that our audited financial statements for December 31, 2022 were issued, which raises substantial doubt about our ability to continue as a going concern.

To continue as a going concern, we will need, among other things, to raise additional capital resources. We plan to seek additional funding through public or private equity or debt financings. We may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the holdings or the rights of our stockholders. If we are unable to obtain funding we could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect our business operations.

The audited consolidated financial statements for December 31, 2022, have been prepared on the basis that we will continue as a going concern, and do not include any adjustments to reflect the possible future effects on the recoverability and classification of assets or the amounts and classification of liabilities that may result from the possible inability for us to continue as a going concern.

Cash Flows

The following table summarizes our cash flows for the periods presented:

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

Net cash used in operating activities

 

$

(11,219,396

)

 

$

(11,090,573

)

Net cash used in investing activities

 

 

 

 

 

(131,963

)

Net cash provided by financing activities.

 

 

15,197,646

 

 

 

8,004,865

 

Net increase (decrease) in cash and cash equivalents

 

$

3,978,250

 

 

$

(3,217,671

)

Net Cash Used in Operating Activities

During the year ended December 31, 2022, net cash used in operating activities was $11.2 million, which consisted of a net loss of $10.8 million and a net change of $0.7 million in our filingsnet operating assets and liabilities, offset by non-cash charges of $0.3 million comprised of stock-based compensation expense, non-cash lease expense and depreciation expense.

During the year ended December 31, 2021, net cash used in operating activities was $11.1 million, which consisted of a net loss of $12.0 million, offset by a net change of $0.4 million in our net operating assets and liabilities and non-cash charges of $0.5 million comprised of stock-based compensation expense, non-cash lease expense and depreciation expense.

Net Cash Used in Investing Activities

During the year ended December 31, 2022, there was no cash used in investing activities.

During the year ended December 31, 2021, net cash used in investing activities consisted of $0.1 million for purchases of lab equipment.

Net Cash Provided by Financing Activities

During the year ended December 31, 2022, net cash provided by financing activities was $15.2 million, from net proceeds of $4.2 million received in connection with the SEC.Business Combination, after exercise of the

80


Forward Share Purchase Agreement of $7.7 million, net proceeds of $7.3 million received from the PIPE, and net proceeds of approximately $4.5 million received from the July 2022 Public Offering, offset by $0.8 million in repayments of Promissory Notes Payable, including interest expense.

During the year ended December 31, 2021, net cash provided by financing activities was $8.0 million, from the sale of our common stock, Series A Preferred Stock and Series A-1 Preferred Stock.

Contractual Obligations and Other Commitments

We enter into contracts in the normal course of business with third party service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments. We believe that our non-cancelable obligations under these agreements are not material.

Off-Balance Sheet Arrangements

As of December 31, 2022, we did not have any off-balance sheet arrangements as defined in Item 303(a)(4)(ii) of Regulation S-K.

Interest Rate Risk

Our cash and cash equivalents consist primarily of highly liquid investments in money market funds and cash on hand and have an original maturity date of 90 days or less. The followingfair value of our cash and cash equivalents would not be significantly affected by either an increase or decrease in interest rates due mainly to the short-term nature of these instruments.

Foreign Currency Risk

Our expenses are generally denominated in the currencies in which our operations are located, which is primarily in the United States and Australia. We make payments to vendors for research and development services with payments denominated in foreign currencies including Australian Dollars and British Pounds. We are subject to foreign currency transaction gains or losses on our payments denominated in foreign currencies. To date, foreign currency transaction gains and losses have not been material and we have not had a formal hedging program with respect to foreign currency; however, we may consider doing so in the future. A 10% increase or decrease in currency exchange rates would not have a material effect on our financial results.

Critical Accounting Policies and Significant Judgements and Estimates

Our management’s discussion and analysis of our financial condition and results of operations should be readis based on our financial statements, which have been prepared in conjunctionaccordance with the financial statements and the notes thereto contained elsewhere in this Report. Certain information contained in the discussion and analysis set forth below includes forward-looking statements that involve risks and uncertainties.


Overview

We are a blank check company formed under the laws of the State of Delaware on November 20, 2019 for the purpose of effecting a merger, capital stock exchange, asset acquisition, stock purchase, reorganization or other similar Business Combination with one or more businesses. We intend to effectuate our Business Combination using cash from the proceeds of the IPO and the sale of the private securities, our capital stock, debt or a combination of cash, stock and debt.

All activity through December 31, 2020 relates to our formation, IPO, and search for a prospective initial business combination target.

Results of Operations

We have neither engaged in any operations nor generated any revenues to date. Our only activities from November 20, 2019 (inception) through December 31, 2020 were organizational activities, those necessary to prepare for the IPO, described below, and, after our IPO, identifying a target company for a Business Combination. We do not expect to generate any operating revenues until after the completion of our Business Combination. We generate non-operating income in the form of interest income on marketable securities held after the IPO. We incur expenses as a result of being a public company (for legal, financial reporting,U.S. generally accepted accounting and auditing compliance), as well as for due diligence expenses.

For the year ended December 31, 2020, we had a net loss of $136,408, which consisted of interest income of $9,325 and unrealized loss on marketable securities of $1,831, as well as interest income from cash held in the Trust Account of $1,590, offset by operating costs of $145,492 which were primarily professional fees and insurance expense.

For the period from November 20, 2019 (inception) to December 31, 2019, our net loss of $3,638 consisted of professional fees.

Liquidity and Capital Resources

On October 13, 2020, we consummated the IPO of 7,000,000 units. Each unit consists of one share of common stock of the Company, par value $0.001 per share, and one redeemable warrant of the Company, with each warrant entitling the holder thereof to purchase one share of common stock for $11.50 per share. The units were sold at a price of $10.00 per Unit, generating gross proceeds to the Company of $70,000,000.

On October 16, 2020, we consummated the sale of an additional 278,151 units that were subject to the underwriter’s partial exercise of the over-allotment option at $10.00 per Unit, generating gross proceeds of $2,781,510. Simultaneously with the closing of the sale of additional units, the Company consummated the sale of an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446.

Following the IPO, the exercise of the over-allotment option and sale of additional Private Warrants, an aggregate amount of $73,509,325 was placed in the Company’s trust account established in connection with the IPO.   Transaction costs amounted to $4,366,890, consisting of $3,450,000 of underwriting fees and $315,846 of other offering costs.

As of December 31, 2020, we had cash held in the Trust Account of $73,510,915 (including approximately $1,590 of interest income) consisting of U.S. treasury bills with a maturity of 185 days or less. Interest income on the balance in the trust account may be used by us to pay taxes. Through December 31, 2020, we withdrew $0 of interest earned on the Trust Account to pay our income taxes.

For the period from November 20, 2019 (inception) through December 31, 2019, cash used in operating activities was $0. For the year ended December 31, 2020, cash used in operating activities was $218,713. Net loss of $136,408 was affected by an unrealized loss on marketable securities of $1,831. Changes in operating assets and liabilities used $84,136 of cash from operating activities.


We intend to use substantially all of the funds held in the trust account, to acquire a target business and to pay our expenses relating thereto, including a fee payable to LifeSci Capital LLC, Ladenburg Thalmann, and Ingalls & Snyder LLC, and Northland Securities, Inc., upon consummation of our initial business combination for assisting us in connection with our initial business combination. To the extent that our capital stock is used in whole or in part as consideration to effect a business combination, the remaining funds held in the trust account will be used as working capital to finance the operations of the target business. Such working capital funds could be used in a variety of ways including continuing or expanding the target business’ operations, for strategic acquisitions and for marketing, research and development of existing or new products. Such funds could also be used to repay any operating expenses or finders’ fees which we had incurred prior to the completion of our business combination if the funds available to us outside of the trust account were insufficient to cover such expenses.

As of December 31, 2020, we had cash of $11,734 and marketable securities of $525,287. We intend to use the funds held outside the trust account for identifying and evaluating prospective acquisition candidates, performing business due diligence on prospective target businesses, traveling to and from the offices, plants or similar locations of prospective target businesses, reviewing corporate documents and material agreements of prospective target businesses, selecting the target business to acquire and structuring, negotiating and consummating the business combination.

In order to fund working capital deficiencies or finance transaction costs in connection with a Business Combination, the Insiders, or certain of our officers and directors or their affiliates may, but are not obligated to, loan us funds as may be required. If we complete a Business Combination, we would repay such loaned amounts. In the event that a Business Combination does not close, we may use a portion of the working capital held outside the Trust Account to repay such loaned amounts but no proceeds from our Trust Account would be used for such repayment. Up to $1,500,000 of such loans may be convertible into warrants identical to the Private Warrants, at a price of $1.00 per warrant at the option of the lender.

We do not believe we will need to raise additional funds in order to meet the expenditures required for operating our business. However, if our estimate of the costs of identifying a target business, undertaking in-depth due diligence and negotiating a Business Combination are less than the actual amount necessary to do so, we may have insufficient funds available to operate our business prior to our Business Combination. Moreover, we may need to obtain additional financing either to complete our Business Combination or because we become obligated to redeem a significant number of our public shares upon consummation of our Business Combination, in which case we may issue additional securities or incur debt in connection with such Business Combination. Subject to compliance with applicable securities laws, we would only complete such financing simultaneously with the completion of our Business Combination. If we are unable to complete our Business Combination because we do not have sufficient funds available to us, we will be forced to cease operations and liquidate the Trust Account. In addition, following our Business Combination, if cash on hand is insufficient, we may need to obtain additional financing in order to meet our obligations.

Related Party Transactions

Our Sponsor, Petra Investment Holdings LLC, has loaned us an aggregate of $140,000 on a non-interest bearing basis for payment of expenses related to the IPO pursuant to a promissory note issued to Sponsor by us, which allows us to borrow up to an aggregate principal amount of $150,000. The note was repaid on October 16, 2020, including prior advances of $10,000 converted into the note, less $25,000 applied to the purchase of Founder Shares.

Concurrent with the IPO, our sponsor purchased 3,150,000 Private Placement Warrants at a price of $1.00. Simultaneously with the closing of the sale of the Over-Allotment Option Units, the Company consummated the sale of an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446.

In addition, in order to finance transaction costs in connection with a business combination, Petra Investment Holdings LLC, or certain of the Company’s officers and directors or their affiliates may, but are not obligated to, loan the us funds as may be requiredprinciples (“Working Capital Loans”GAAP”). If we complete a business combination, the we would repay the Working Capital Loans out of the proceeds of the trust account released to the Company. Otherwise, the Working Capital Loans would be repaid only out of funds held outside the trust account. In the event that a business combination does not close, the we may use a portion of proceeds held outside the trust account to repay the Working Capital Loans but no proceeds held in the trust account would be used to repay the Working Capital Loans. Except for the foregoing, the terms of such Working Capital Loans, if any, have not been determined and no written agreements exist with respect to such loans. The Working Capital Loans would either be repaid upon consummation of a Business Combination, without interest, or, at the lender’s discretion, up to $1,500,000 of such Working Capital Loans may be converted into warrants of the post Business Combination entity at a price of $1.00 per warrant. There have been no Working Capital Loans to date.


Off-balance sheet financing arrangements

We did not have any off-balance sheet arrangements as of December 31, 2020.

Contractual obligations

We do not have any long-term debt, capital lease obligations, operating lease obligations or long-term liabilities.

We have engaged to LifeSci Capital LLC, Ladenburg Thalmann, and Ingalls & Snyder LLC, and Northland Securities, Inc.  (collectively, the “Advisors��) as advisors in connection with a Business Combination to assist us in holding meetings with our shareholders to discuss the potential Business Combination and the target business’ attributes, introduce us to potential investors that are interested in purchasing our securities in connection with a Business Combination, assist us in obtaining shareholder approval for the Business Combination and assist us with our press releases and public filings in connection with the Business Combination. We will pay the Advisors a cash fee for such services upon the consummation of a Business Combination in an amount equal to 4% of the gross proceeds received by the Company in the IPO (“Fee”) (exclusive of any applicable finders’ fees which might become payable). The Company will allocate 52.5% of the Fee to LifeSci, 10% of the Fee to Ingalls, 22.5% of the Fee to Ladenburg and 15% of the Fee to Northland.

Critical Accounting Policies

The preparation of the consolidated financial statements and related disclosures in conformityaccordance with accounting principles generally accepted in the United States of AmericaGAAP requires management to make estimates and assumptions about future events that affect the reported amounts of assets and liabilities disclosure ofreported, disclosures about contingent assets and liabilities, and reported amounts of revenue and expenses. These estimates and assumptions are based on management’s best estimates and judgment. Management regularly evaluates its estimates and assumptions using industry experience and other factors; however, actual results could differ materially from these estimates and could have an adverse effect on our consolidated financial statements. While our significant accounting policies are more fully described in the notes to our consolidated financial statements, we believe that the accounting policies discussed below are most critical to understanding and evaluating our historical and future performance.

Research and Development Expenditures

81


We record accrued expenses for estimated preclinical and clinical study and research expenses related to the services performed but not yet invoiced pursuant to contracts with research institutions, contract research organizations and clinical manufacturing organizations that conduct and manage preclinical studies, and clinical studies, and research services on our behalf. Payments for these services are based on the terms of individual agreements and payment timing may differ significantly from the period in which the services were performed. Our estimates are based on factors such as the work completed, including the level of patient enrollment. We monitor patient enrollment levels and related activity to the extent reasonably possible and make judgments and estimates in determining the accrued balance in each reporting period. Our estimates of accrued expenses are based on the facts and circumstances known at the time. If we underestimate or overestimate the level of services performed or the costs of these services, our actual expenses could differ from our estimates. As actual costs become known, we adjust our accrued expenses. To date, we have not experienced significant changes in our estimates of clinical study accruals.

Stock-based Compensation

We recognize the compensation expense related to stock options, third-party warrants, and RSU awards granted, based on the estimated fair value of the awards on the date of grant. The fair value of employee stock options and third-party warrants are generally determined using the Black-Scholes option-pricing model using various inputs, including estimates of historic volatility, term, risk-free rate, and future dividends. The grant date fair value of the stock-based awards, which have graded vesting, is recognized using the straight-line method over the requisite service period of each stock-based award, which is generally the vesting period of the respective stock-based awards. The Company recognizes forfeitures as they occur.

As of December 31, 2022, there were 7,290 Rollover RSU awards unvested and unissued and 9,581 stock options outstanding.

Determination of the Fair Value of Common Stock

Prior to the Business Combination, given the absence of a public trading market for our shares of common stock, our board of directors exercises its judgment and considers a number of objective and subjective factors to determine the best estimate of the fair value of our shares of common stock, including timely valuations of our shares of common stock prepared by an unrelated third-party valuation firm, important developments in our operations, sales of common stock and convertible preferred shares, actual operating results and financial performance, the conditions in the biotechnology industry and the economy in general, the stock price performance and volatility of comparable public companies, and the lack of liquidity of our shares of common stock, among other factors. After the Business Combination, the fair value of each share of common stock is based on the closing price of our shares of common stock as reported on the date of grant.

Recent Accounting Pronouncements

See Note 2 to our audited consolidated financial statements for more information about recent accounting pronouncements, the timing of their adoption, and our assessment, to the extent we have made one yet, of their potential impact on our financial condition of results of operations.

JOBS Act Accounting Election

We are an “emerging growth company,” as defined in the JOBS Act. Under the JOBS Act, emerging growth companies can delay adopting new or revised accounting standards issued subsequent to the enactment of the JOBS Act until such time as those standards apply to private companies.

We have elected to use this extended transition period to enable us to comply with new or revised accounting standards that have different effective dates for public and private companies until the earlier of the date we (i) are no longer an emerging growth company or (ii) affirmatively and irrevocably opt out of the extended transition period provided in the JOBS Act. As a result, our financial statements and income and expenses during the periods reported. Actual results could materially differ from those estimates. We have identified the following critical accounting policies:our interim financial statements

82


Common stock subjectmay not be comparable to possible redemption

We account for common stock subject to possible redemption in accordancecompanies that comply with the guidance in Accounting Standards Codification (“ASC”) Topic 480 “Distinguishing Liabilities from Equity.” Common stock subject to mandatory redemption is classified as a liability instrument and is measured at fair value. Conditionally redeemable common stock (including common stock that feature redemption rights that is either within the control of the holdernew or subject to redemption upon the occurrence of uncertain events not solely within our control) is classified as temporary equity. At all other times, common stock is classified as stockholders’ equity. Our common stock features certain redemption rights that are considered to be outside of our control and subject to occurrence of uncertain future events. Accordingly, common stock subject to possible redemption is presented at redemption value as temporary equity, outside of the stockholders’ equity section of our condensed balance sheet.

Net loss per common share

We apply the two-class method in calculating earnings per share. Common stock subject to possible redemption which is not currently redeemable and is not redeemable at fair value, have been excluded from the calculation of basic net loss per common share since such shares, if redeemed, only participate in their pro rata share of the trust account earnings. Our net income is adjusted for the portion of income that is attributable to common stock subject to possible redemption, as these shares only participate in the earnings of the Trust Account and not our income or losses.

Recent accounting standards

Management does not believe that any other recently issued, but not yet effective,revised accounting pronouncements if currently adopted, would have a material effect on our financial statements.as of public company effective dates.


83


ITEMItem 7A. QUANTITATIVE AND QUALITATIVE DISCLOSURES ABOUT MARKET RISKQuantitative and Qualitative Disclosures About Market Risk.

AsWe are a smaller reporting company as defined by Rule 12b-2 of December 31, 2020, we werethe Exchange Act and are not subjectrequired to any market or interest rate risk. Followingprovide the consummation of our IPO, the net proceeds of our IPO, including amounts in the Trust Account, have been invested in U.S. government treasury bills, notes or bonds with a maturity of 185 days or less or in certain money market funds that invest solely in U.S. treasuries. Due to the short-term nature of these investments, we believe there will be no associated material exposure to interest rate risk.information otherwise required under this item.

 

ITEMItem 8. FINANCIAL STATEMENTS AND SUPPLEMENTARY DATAFinancial Statements and Supplementary Data.

This information appears following Item 15The financial statements required by this item are set forth at the end of this Annual Report on Form 10-K beginning on page F-1 and is includedare incorporated herein by reference.

ITEMItem 9. CHANGES IN AND DISAGREEMENTS WITH ACCOUNTANTS ON ACCOUNTING AND FINANCIAL DISCLOSURE.Changes in and Disagreements With Accountants on Accounting and Financial Disclosure.

None.

 

ITEMItem 9A. CONTROL AND PROCEDURESControls and Procedures.

Evaluation of Disclosure Controls and Procedures

DisclosureOur management, with the participation of our principal executive officer and our principal financial officer, evaluated, as of the end of the period covered by this Annual Report on Form 10-K, the effectiveness of our disclosure controls and procedures. Based on that evaluation of our disclosure controls and procedures as of December 31, 2022, our principal executive officer and principal financial officer concluded that our disclosure controls and procedures as of such date are effective at the reasonable assurance level. The term “disclosure controls and procedures,” as defined in Rules 13a-15(e) and 15d-15(e) under the Securities Exchange Act of 1934 (the “Exchange Act”), means controls and other procedures of a company that are designed with the objective of ensuringto ensure that information required to be disclosed by a company in ourthe reports filedthat it files or submits under the Exchange Act such as this Report, isare recorded, processed, summarized and reported within the time periodperiods specified in the SEC’sU.S. Securities and Exchange Commission’s rules and forms. Disclosure controls are alsoand procedures include, without limitation, controls and procedures designed withto ensure that information required to be disclosed by us in the objective of ensuring that such informationreports we file or submit under the Exchange Act is accumulated and communicated to our management, including the chiefour principal executive officer and chiefprincipal financial officer, as appropriate to allow timely decisions regarding required disclosure. Our management evaluated, with the participation of our principal executive officer and principal financial and accounting officer (our “Certifying Officers”), the effectiveness of our disclosure controls and procedures as of December 31, 2020, as defined in Rules 13a-15(e) and 15d-15(e) under the Exchange Act. Based uponManagement recognizes that evaluation, our Certifying Officers concluded that, as of December 31, 2020, our disclosure controls and procedures were effective.

We do not expect that our disclosure controls and procedures will prevent all errors and all instances of fraud. Disclosureany controls and procedures, no matter how well conceiveddesigned and operated, can provide only reasonable not absolute, assurance thatof achieving their objectives, and our management necessarily applies its judgment in evaluating the objectivescost-benefit relationship of the disclosurepossible controls and procedures are met. Further, the design of disclosure controls and procedures must reflect the fact that there are resource constraints, and the benefits must be considered relative to their costs. Because of the inherent limitations in all disclosure controls and procedures, no evaluation of disclosure controls and procedures can provide absolute assurance that we have detected all our control deficiencies and instances of fraud, if any. The design of disclosure controls and procedures also is based partly on certain assumptions about the likelihood of future events, and there can be no assurance that any design will succeed in achieving its stated goals under all potential future conditions.procedures.

Management’s Annual Report on Internal Controls OverControl over Financial Reporting

Our management is responsible for establishing and maintaining adequate internal control over our financial reporting as defined in Rules 13a-15(f) and 15d-15(f) under the Exchange Act. Our internal control over financial reporting is designed to provide reasonable assurance regarding the reliability of financial reporting and the presentation of financial statements for external purposes in accordance with U.S. generally accepted accounting principles. Internal control over financial reporting includes those policies and procedures that:

Pertain to the maintenance of records that in reasonable detail accurately and fairly reflect the transactions and dispositions of the assets of the Company;


Provide reasonable assurance that transactions are recorded as necessary to permit preparation of financial statements in accordance with generally accepted accounting principles, and that receipts and expenditures of the Company are being made only in accordance with authorizations of management and directors of the Company; and

Provide reasonable assurance regarding prevention or timely detection of unauthorized acquisition, use or disposition of the Company’s assets that could have a material effect on the financial statements.

84


Because of its inherent limitations, internal control over financial reporting may not prevent or detect misstatements. Also, projections of any evaluation of effectiveness to future periods are subject to the risk that controls may become inadequate because of changes in conditions, or that our degree of compliance with the policies or procedures may deteriorate.

In connection with the preparation of this Annual Report, our management assessed the effectiveness of our internal control over financial reporting as of December 31, 2020.2022. In making this assessment, it used the criteria set forth by the Committee of Sponsoring Organizations of the Treadway Commission in Internal Control—Integrated Framework (2013 framework). Based on such assessment, our management concluded that, as of December 31, 2020,2022, our internal control over financial reporting was effective based on those criteria.

This report does not include an attestation report of our independent registered public accounting firm due to a transition period established by the rules of the SEC for newly public companies.

Changes in Internal Control over Financial Reporting

There werewas no changeschange in our internal control over financial reporting (as such term is defined in Rules 13a-15(f) and 15d-15(f) of the Exchange Act)that occurred during theour most recent fiscal quarter that havehas materially affected, or areis reasonably likely to materially affect, our internal control over financial reporting.

85



Item 9B. Other Information.

None.

86


Item 9C. Disclosure Regarding Foreign Jurisdictions that Prevent Inspections.

Not applicable.

PART III

ITEMItem 10. DIRECTORS AND EXECUTIVE OFFICERS OF THE REGISTRANTDirectors, Executive Officers and Corporate Governance.

Executive Officers and Directors

The following table sets forth information regarding our executive officers and directors, including their ages as of March 21, 2023:

Name

Age

Position

BOARD OF DIRECTORS

George Tidmarsh, M.D., Ph.D.

63

Chairman and Director

James Rolke

54

Director and Chief Executive Officer

Jennifer Carver, BSN, MBA

69

Director

Jess Roper

58

Director

Curt LaBelle, MD

52

Director

EXECUTIVE OFFICERS

James Rolke

54

Director and Chief Executive Officer

Chester S. Zygmont, III

42

Chief Financial Officer

Our Director and Executive Officers

Our current directorsGeorge Tidmarsh, M.D., Ph.D. — Chairman. Dr. Tidmarsh has been Chairman of the Company since its inception in May 2020. Dr. Tidmarsh received his M.D. and executive officers are as follows:

NameAgePosition
Andreas Typaldos 75 Chairman of the Board, Chief Executive Officer, Secretary 
Sean Fitzpatrick 55 Chief Financial Officer, Director 
David Dobkin 42 Director 
Anthony Hayes 53 Director 
Robert Nicholson 47 Director 
Barry Dennis 56 Director 
William Carson 73Director 

Andreas Typaldos hasPh.D. from Stanford University, where he also completed his fellowship training in Pediatric Oncology and Neonatology and is currently Adjunct Faculty of Pediatrics and Neonatology since 2018. He served as our Chairman and Chief Executive Officer since inception. Andreas has been a software and technology entrepreneur from the inception of the industry, as well as a private equity investor through a Family Office. His entrepreneurial activities and companies extend over both the US and international and primarily European venues. In the past, he was founder, founding investor, Board Member, and Chief Executive ofclinical faculty at Stanford for a number of software, technology, consulting services, and internet companies, including AXS-One, an early international enterprise software company; Enikia LLC (subsequently known as Arkados and Iota Communications Inc.), which was a fabless semiconductor company in the powerline-based communications space at the inception of that market and whose Homeplug-compliant technology was sold to one of the largest semiconductor companies (ST Micro) before evolving into the IoT space; Xandros Inc., a Linux operating system company that provided the operating system used by Asus and Intel on the eeePC netbook mobile device to create that spaceyears after his fellowship prior to its domination by Apple’s iPad tablet;devoting his full time to clinical research and a number of other companiesdevelopment in order to bring new treatments through the technology, software, AI, and lifestyle markets. Currently, he is the Executive Chairman of BCII Enterprises Inc., a publicly traded holding company with a number of software, CLOUD, and AI operating subsidiaries including Soteria Health, a digital health and virtual care company of which he acts as Chairman; and Executive Chairman of Scalix Inc., a Linux-based enterprise email server company developed through funding and technology support by Microsoft. In the lifestyle and life sciences related industries, he is Board Member of an early cancer detection biotech company, QCDx; and owner of Merakia, a hospitality holding company. In April 2020 he became an Advisory Board Member, for AI/ML (artificial intelligence/machine learning), of AIkido Pharma (NASDAQ:AIKI). A native of Greece, Andreas came to the US in 1963 on scholarship from Columbia University where he received a Bachelors degree in Mathematical Methods for Engineering and Operations Research and where he has funded a named scholarship program since 1996. He also received a graduate degree in Computer Science from Pratt Institute. He is married and is the father of four.

Sean Fitzpatrick has been our Chief Financial Officer and Board Member since inception. He is the Founding Partner of Fidem Advisors, a boutique advisory firm that offers services in raising equity, debt, and bridge capital. Sean has over 25 years of Wall Street experience, spanning several major investment banks. He began his career in 1990 with Shearson Lehman Brothers as a Financial Advisor. Sean has held various positions of increasing responsibility at Alex Brown and Sons, Hambrecht & Quist, JP Morgan and Credit Suisse. The majority of his work experience has focused on the managing and raising capital from private wealth, family offices and institutional clients. Throughout the course of his career, Sean has raised or managed in excess of $2 billion dollars on behalf of a diverse base of clients. He holds a BBA in Finance from Loyola University in Baltimore, MD.

David DobkinFDA approval process. Since 2018 Dr. Tidmarsh has served as a memberdirector and chairman of audit committee of Lucile Packard Foundation for Children’s Health. Since the Board of Directors since inception. He is an experienced healthcare capital markets investment banker with a career focused on helping high-growth life science, medical device, and healthcare IT companies achieve their financial and strategic goals. DavidCompany’s inception in 2020 he has worked with companies developing a wide range of technologies and brings extensive strategic advisory and execution capability to his clients. David has experience with both traditional and non-traditional forms of equity and debt offerings in both the U.S. and abroad. He is a regular speaker on growth capital formationalso served as chairman at conferences across the United States and Canada.Revelation Biosciences Inc. Prior to joining LifeSci Capital in 2018, David founded Dobkin &Revelation, Dr. Tidmarsh was President, Chief Executive Officer, Secretary and a Director of La Jolla Pharmaceutical Company an investment bank tailored(“La Jolla”) from January 2012 until November 2019. While at La Jolla, Dr. Tidmarsh helped discover the use of angiotensin II for entrepreneur-lead companies focused on seedthe treatment of shock and growth equityled all aspects of development including approval by the FDA and capital, in 2015. Previously,the EMA for the treatment of patients suffering from 2010 to 2015, David worked in various capacities withdistributive shock. He also led the New Zealand Government facilitating capital formation on behalfdevelopment of regional companies and government agencies with a focus on securing strategic foreign direct investment. Davidartesunate for the treatment of severe malaria, which was approved by the FDA. Dr. Tidmarsh has tremendous experience conducting cross-border transactions. Prior to October 2010, David worked for Lazard Frères, oneover 30 years of the world’s preeminent financial advisory and asset management firms, where he facilitated and advised on cross-border mergers and acquisitions transactions in excess of $2.5 billion. Prior to joining for Lazard Frères, David began his career in in the Healthcare investment banking group for Wasserstein Perella based in New York. At Wasserstein Perella, David advised healthcare companies on capital formation as well as strategic alternatives. David conducted graduate research in stem cell bioengineering and received a Master of Science, Biomedical Engineering, from the University of Southern California. David also received a Bachelor of Science, Biomedical Engineering, from Columbia University. David holds the Series 63, 79, and 82 licenses. We believe David is qualified to sit on our board due to his extensive experience in mergers and acquisitions.


Anthony Hayes hasbiotechnology, including the successful clinical development of seven FDA-approved drugs. He previously served as a member of the Board of Directors since inception. He is the Chief Executive Officer of AlkidoHorizon Pharma, Inc. fka Spherix Incorporated,, a NASDAQ-traded technology commercialization company (NASDAQ:AIKI)he founded in 2005, where he continued as CEO until 2008 and Director until 2010. While at Horizon, he invented and led all aspects of development of Duexis, which was approved by the FDA for the treatment of rheumatoid arthritis. He also founded Threshold Pharmaceuticals, Inc. and held senior positions at Coulter Pharmaceutical, Inc. (acquired by GlaxoSmithKline) and SEQUUS Pharmaceuticals, Inc. (acquired by Johnson & Johnson). He beganWhile at Coulter and SEQUUS, Dr. Tidmarsh led the clinical development of BEXXAR and Doxil, respectively, two FDA-approved anti-cancer agents. We believe that Dr. Tidmarsh is qualified to serve as a director based on his tenure byextensive management experience in the biotechnology industry.

James Rolke — Director and Chief Executive Officer. Mr. Rolke cofounded and has been the Chief Executive Officer and a director of Revelation since its inception in May 2020. Mr. Rolke has over 30 years of experience in the biotechnology industry, spanning all areas and phases of drug development. Prior to joining the Company, beginning in 2012, Mr. Rolke was employed at La Jolla in various leadership roles overseeing Alkido’s transformationResearch and Development and serving as Chief Scientific Officer from a biotechnology company into a diversified corporate entity, committed2017 to advancing innovation by participating in2020. While at La Jolla, Mr. Rolke oversaw the development of newmultiple technologies acrossincluding six INDs and two marketing approvals: Giapreza for the treatment of distributive shock (US FDA and EMEA) and artesunate for the treatment of severe malaria. Prior to La Jolla, from July 2009 to January 2012 Mr. Rolke was Chief Technology Officer at Pluromed, Inc. (acquired by Sanofi) and played a key role in the approvals of two medical devices via the 510(k) and PMA approval pathways. Prior to Pluromed,

87


Mr. Rolke held several sectors. Anthony identifiedkey positions at biotechnology companies, including Director of Operations at Prospect Therapeutics, Inc., Associate Director of Pharmaceutical Development at Mersana Therapeutics, Inc., Manager of Process Development at GlycoGenesys, Inc., Principal Scientist at Surgical Sealants, Inc., Scientist at GelTex, Inc., and brought about multimillion-dollar M&A acquisitions that resulted in some of the largest transactions in technology patents. He is also involved in all aspects of investor relations, representing Alkido in shareholder meetings,Associate Scientist at domestic and international conferences, and in television and print media, including Bloomberg Television and Forbes. Anthony is an attorney and a former partner of an Am Law 100 firm, and is the previous co-founder and managing member of JaNSOME IP Management LLC, an intellectual property monetization firm. AnthonyAlpha-Beta Technology, Inc. Mr. Rolke received his Juris DoctorB.S. in chemistry from Tulane University Law School, and his Bachelor of Arts in Economics from Mary WashingtonKeene State College.

Robert Nicholson Since 2022, Mr. Rolke has served as a memberdirector at Plum Tree Therapeutics. We believe that Mr. Rolke is qualified to serve as a director based on his role as our Chief Executive Officer and his extensive management experience in the biotechnology industry.

Jennifer Carver, BSN, MBA — Director. Ms. Carver has been a director of the Board of DirectorsCompany since inception. Robert has manyMay 2020. Ms. Carver brings over 20 years of leadership and investingindustry experience in investment banking and private equity with a focus on publicsmall biotech companies and private Capital Markets transactions, Real Estate, Mergers and Acquisitions, and Mid-Market Credit. He is currently a principal owner and Managing Director of Archon, responsible for general management of the firm’s operations, mergers and acquisitions, financial advisory, capitaltheir evolution from early development and strategic growth. He joined Archon in 2019 from Deutsche Bank where he focused on Private Equity and Alternative Investments. Robert began his career as an analyst at Morgan Stanley before moving into buy-side analysis with Oxford, and eventually into acquisitions for Wells Real Estate Funds. Over the last 15 years he has worked in a capital markets role directly or through joint ventures with some of the largest Private Equity firms in the industry including Hines, Cole Capital, Apollo, and Ares Management. He has a BA in Economics from the University of Texas at Austin, a Masters from London Business School with a concentration in Private Equity, and an MBA from Columbia Business School with a concentration in Finance.

Barry Dennis, CFA,commercialization. From 2020 to 2021, Ms. Carver has served as Chief Operating Officer at Kartos Therapeutics (Kartos). Prior to Kartos from 2014, Ms. Carver was employed at La Jolla Pharmaceutical Company in various leadership roles providing leadership through the clinical development, approval and launch of Giapreza and serving as Chief Operating Officer from 2017 to 2019. Prior to La Jolla, Ms. Carver held positions at Spectrum Pharmaceuticals and Allos Therapeutics, leading teams through the development and approval of Belionostat and Folotyn respectively. Her experience in the healthcare industry spans multiple therapeutic areas including oncology, inflammatory disease, shock, iron overload, and anti-infectives. Ms. Carver has played a membercritical role in negotiating key alliances, evaluation of financing opportunities, and overseeing rapid organizational growth. Ms. Carver earned her B.S.N. and M.B.A. from University of Colorado. We believe that Ms. Carver’s extensive experience working in the Board Memberbiotechnology industry makes her well-qualified to serve as of the IPO. Barry is a Managing Director of Investment Banking and Strategic Consulting at WaveCrest Securities and since March 2020 Barrydirector.

Jess Roper — Director. Mr. Roper has been a director since October 2020. Mr. Roper has considerable financial and audit experience in the sectors of medical device, life sciences, technology, manufacturing, and financial institutions. He currently serves as a Board Member and Audit Chair for Biolase, a publicly traded company that is the global leader in the manufacturing of dental laser systems. Mr. Roper previously served as Senior Vice President and Chief Financial Officer of Dexcom, retiring in 2017 following a fulfilling and rewarding career. During his 12-year tenure, Dexcom transitioned from a pre-revenue privately held medical device company to a multi-national publicly traded entity. Mr. Roper previously held financial management positions with two other publicly traded companies and one venture funded company. He has played key roles in two initial public offerings, acquisitions/divestitures, and numerous equity and debt financings. Earlier in his career, Mr. Roper was an auditor with PricewaterhouseCoopers, and a bank and information systems examiner with the Office of the Comptroller of the Currency. He earned a Master of Science in Corporate Accountancy and a Bachelor of Science in Finance. Mr. Roper is a certified public accountant in the state of California. We believe that Mr. Roper is qualified to serve as a director based on his extensive financial and audit experience.

Curt LaBelle, MD — Director. Dr. LaBelle has been a director since January 2021. Dr. LaBelle has been investing in and working with life science companies for over 20 years. Since 2015, he has been President of the Global Health Investment Fund (“GHIF”). GHIF is a pioneering impact fund with a proven record of generating attractive financial returns and tangible impact. The fund works to facilitate access to therapeutics and diagnostics among low-income populations. Dr. LaBelle also works with the AXA Prime Impact Fund and serves as a Board member for Alydia Health, Atomo Diagnostics, Atticus Medical, Eyenovia, and Z Optics. He holds MD and MBA degrees from Columbia University. Dr. LaBelle is the designee of the AXA Prime Impact Fund, the holder of the outstanding shares of our Series A Preferred Stock. We believe that Dr. LaBelle’s significant experience as an investor in life science companies makes him well-qualified to serve as a director.

Chester S. Zygmont, III — Chief Financial Officer. Mr. Zygmont has been the Company’s Chief Financial Officer since inception. Mr. Zygmont brings over 17 years of experience in finance to the company with a wide range of industry applications. In 2016, Mr. Zygmont Co-Founded Jivanas, a social enterprise that owns and operates a factory in Nepal, that is focused on creating jobs for people at risk for human trafficking. Jivanas has operations in Nepal, Hong Kong, and the USA. During 2013, Mr. Zygmont Co-Founded oOxesis Biotechnology, LLC, a biologics lab that worked on developing therapies for unmet needs. From June 2012 to January 2016, Mr. Zygmont was the Senior Director of Finance, at La Jolla Pharmaceutical Company. During Mr. Zygmont’s tenure at La Jolla, he brought the company to its Nasdaq listing. Prior to La Jolla, Mr. Zygmont served as Managing Director at Z3 Capital, LLC from March 2009 to June 2012. Z3 Capital, LLC, a privately held investment firm, focused on investment acquisition and venture funding for multiple startup companies in real estate, medical device and biotechnology. Mr. Zygmont also served as Vice President at Symmetry Advisors, Inc. a private equity leveraged buyout firm. While at Symmetry,

88


he managed all finance and accounting for its SPAC, was a key player on a $600 million buyout of a portfolio company, and subsequently led the restructuring of its manufacturing division. Mr. Zygmont earned his M.S. in Finance from Baruch College, Zicklin School of Business and his B.A. from Eastern University.

Number and Terms of Office of Officers and Directors

Our Board is divided into three classes, designated Class A, Class B and Class C, with only one class of directors being elected in each year and each class serving a three-year term.

Our officers are appointed by the Board and serve until such person’s successor is appointed or until such person’s earlier resignation, death or removal. Our Board is authorized to appoint persons to the offices set forth in our bylaws as it deems appropriate. Our bylaws provide that our officers may consist of a Chief Executive Officer, President, Secretary, Treasurer, Chief Financial Officer, Vice Presidents and such other offices as may be determined by the Board.

Family Relationships

There are no family relationships among our directors or executive officers.

Involvement in Certain Legal Proceedings

None of our directors, executive officers, promoters or control persons has been involved in any events requiring disclosure under Item 401(f) of Regulation S-K.

Board Composition

Classified Board of Directors

In accordance with our amended and restated certificate of incorporation, our board of directors is divided into three classes with staggered three-year terms. At each annual general meeting of stockholders, the successors to the directors whose terms then expire will be elected to serve from the time of election and qualification until the third annual meeting following their election. Our directors are divided among the three classes as follows:

The Class A directors are Dr. LaBelle and Ms. Carver, and their terms will expire at the first annual meeting of stockholders following the Business Combination;

The Class B directors are Messrs. Rolke and Roper, and their terms will expire at the second annual meeting of stockholders following the Business Combination; and

The Class C director is Dr. Tidmarsh, and his term will expire at the third annual meeting of stockholders following the Business Combination.

We expect that any additional directorships resulting from an increase in the number of directors will be distributed among the three classes so that, as nearly as possible, each class will consist of one-third of the directors. The division of our board of directors into three classes with staggered three-year terms may delay or prevent a change of our management or a change in control.

Leadership Structure of the Board

Our bylaws and corporate governance guidelines provide our board of directors with flexibility to combine or separate the positions of Chairman of the board of directors and Chief Executive Officer.

Our board of LifeSci Acquisition Corp (NASDAQ: LSAC), a blank check companydirectors has concluded that raised approximately $65,600,000 in its initial public offeringour current leadership structure is appropriate at this time. However, our board of directors will continue to periodically review our leadership structure and is currently seeking to consummate an initial business combinationmay make such changes in the healthcare industry. Priorfuture as it deems appropriate.

89


Role of Board in Risk Oversight Process

Risk assessment and oversight are an integral part of our governance and management processes. Our board of directors encourages management to joining WaveCrest, from January 2018 to December 2019 Barry served as Chairmanpromote a culture that incorporates risk management into our corporate strategy and day-to-day business operations. Management discusses strategic and operational risks at regular management meetings, and conducts specific strategic planning and review sessions during the year that include a focused discussion and analysis of the Risk Committee Strategos Capital Markets, a structured products hedge fund, and as President from April 2015 to March 2017. From August 2013 to February 2015, Mr. Dennis served as Senior Managing Director of Institutional Structured Products for Canaccord Genuity, a full-service financial services firm and he served on Canaccord’s US Executive Management Committee in New York City. From 1993 to 2013, Barry worked for such firms as Merrill Lynch, TD Securities, and BMO. Barry received his Bachelor’s of Commerce fromrisks facing us. Throughout the University of British Columbia and his M.B.A from the University of Western Ontario and is a holder of the Charter of Financial Analysts.

William H. Carson, of Texas, has been a director since February 22, 2021, and is a forty year, senior management veteran in the prescription and OTC drug industriesreviews these risks with broad exposure to product licensing, new product R&D, manufacturing, Rx-to-OTC switches, company acquisition and new business entity development. He has held Leadership roles at Novartis, Bayer, Galderma, in MTO (Plant Management, New Facility Construction, Compliance), Product Development and Regulatory Affairs (NDA, ANDA, RX to OTC Switch, OTC Monographs), and LMA (Due Diligence, Organizational Review, Post Merger/Acquisition Integration).  For the past 9 years, Carson has operated his own consulting business taking on consulting assignments in: compliance, production, licensing and acquisition product development and FDA/regulatory strategy. Carson started his career with Dorsey Laboratories Division, Sandoz Pharmaceuticals where he remained employed from 1972-1994 ; he served in a variety of director roles such as Director of Regulatory Affairs, and Director of New Products. He last served as Vice President of Scientific Affairs, managing the FDA approval process for the switches of Tavist-1 and Tavist-D from Rx to OTC status. From 1994-1996, he served as Senior Vice President of OTC Products at Goldline Pharmaecuticals. From 1996-2004 he was Vice President, Scientific Affairs with Bayer Consumer Care Division (NYSE: BAYRY). From 2004-2011 he served as Senior Vice-President, Medical &Regulatory Affairs at Galderma Laboratories, a skin health pharma company. There he built departments to support a period of rapid sales growth, new product approvals and acquisitions. He also was the team leader for the integration of two major acquisitions, Collagenix in the U.S. and Q-Med in Europe.  Mr. Carson has a BS and MS from University of Nebraska in Physiology and Biochemistry.

Director Independence

Nasdaq rules require that a majority of the board of directors at regular board meetings as part of a company listedmanagement presentations that focus on Nasdaq must be composed of “independent directors.” An “independent director” is defined generally as a person other than an officerparticular business functions, operations or employee ofstrategies, and presents the companysteps taken by management to mitigate or its subsidiaries or any other individual having a relationship, which, in the opinion of the company’s board of directors, would interfere with the director’s exercise of independent judgment in carrying out the responsibilities of a director. We have determined that Anthony Hayes, Robert Nicholson, Barry Dennis, and William Carson are independent directors under the Nasdaq Listing rules. Our independent directors will have regularly scheduled meetings at which only independent directors are present.eliminate such risks.

Any affiliated transactions will be on terms no less favorable to us than could be obtained from independent parties. Our board of directors will reviewdoes not have a standing risk management committee, but rather administers this oversight function directly through our board of directors as a whole, as well as through various standing committees of our board of directors that address risks inherent in their respective areas of oversight. While our board of directors is responsible for monitoring and approve all affiliated transactions withassessing strategic risk exposure, our audit committee is responsible for overseeing our major financial risk exposures and the steps our management has taken to monitor and control these exposures. The audit committee also approves or disapproves any interested director abstaining from such reviewrelated person transactions. Our nominating and approval.corporate governance committee monitors the effectiveness of our corporate governance guidelines. Our compensation committee assesses and monitors whether any of our compensation policies and programs has the potential to encourage excessive risk-taking.


CommitteesAttendance of Directors at Board Meetings and Annual Meeting of Stockholders

During 2022, the Board of Directors met 11 times and the Audit Committee met 4 times. Each director who was on the Board during this timeframe attended at least 93% of the aggregate number of meetings held during his or her term of service. The Company has not yet held an Annual Meeting of Stockholders. The Company does not have a policy requiring its directors to attend the Annual Meeting of Stockholders.

We have three standing committees:Board Committees

Our board of directors has established an audit committee, a nominatingcompensation committee and a compensationnominating and corporate governance committee. Our board of directors may establish other committees to facilitate the management of our business. The composition and functions of each committee are described below. Members serve on these committees until their resignation or until otherwise determined by our board of directors. Each such committee is composed of solely independent directors

Audit Committee

Effective October 13, 2020, we established an audit committeehas adopted a written charter that satisfies the applicable rules and regulations of the boardSEC rules and regulations and the Nasdaq Listing Rules, which are posted on our website. The reference to our website address does not constitute incorporation by reference of directors,the information contained at or available through our website.

Audit Committee

Revelation has a separately-designated standing Audit Committee established in accordance with Section 3(a)(58)(A) of the Exchange Act. Under theAct and Nasdaq listing standards and applicable SEC rules, werules. In addition, the board of directors adopted a written charter for the Audit Committee. The Audit Committee’s duties, will include, but are required to have at least three membersnot limited to:

appoints our independent registered public accounting firm;

evaluates the independent registered public accounting firm’s qualifications, independence, and performance;

determines the engagement of the independent registered public accounting firm;

reviews and approves the scope of the annual audit and pre-approves the audit and non-audit fees and services;

reviews and approves all related party transactions on an ongoing basis;

90


establishes procedures for the receipt, retention and treatment of any complaints received by us regarding accounting, internal accounting controls or auditing matters;

discusses with management and the independent registered public accounting firm the results of the annual audit and the review of our quarterly financial statements;

approves the retention of the independent registered public accounting firm to perform any proposed permissible non-audit services;

discusses on a periodic basis, or as appropriate, with our management’s policies and procedures with respect to risk assessment and risk management;

consults with management to establish procedures and internal controls relating to cybersecurity;

is responsible for reviewing our financial statements and our management’s discussion and analysis of financial condition and results of operations to be included in our annual and quarterly reports to be filed with the SEC;

investigates any reports received through the ethics helpline and reports to the board of directors periodically with respect to any information received through the ethics helpline and any related investigations; and

reviews the audit committee charter and the audit committee’s performance on an annual basis.

The composition of the Audit Committee is comprised of Mr. Roper, Dr. Tidmarsh and Ms. Carver, with Mr. Roper as Chair. Mr. Roper qualifies as an audit committee all of whom must be independent. Each of Messrs. Anthony Hayes, Robert Nicholson, and Barry Dennis meet the independent director standard under Nasdaq listing standards and under Rule 10-A-3(b)(1) of the Exchange Act.

The audit committee will at all times be composed exclusively of “independent directors” who are “financially literate”financial expert, as defined under Nasdaq’s listing standards. Nasdaq listing standards define “financially literate” as being able to read and understand fundamental financial statements, including a company’s balance sheet, income statement and cash flow statement.by the SEC rules. In addition, we must certifyRevelation certified to Nasdaq that the committeeAudit Committee has, and will continue to have, at least one member who has past employment experience in finance or accounting, requisite professional certification in accounting, or other comparable experience or background that results in the individual’s financial sophistication.sophistication, including being or having been a chief executive officer, chief financial officer or other senior officer with financial oversight responsibilities. It has been determined that each of each of Mr. Roper, Dr. Tidmarsh and Ms. Carver satisfy such requirements.

EachNominating and Governance Committee

Revelation’s Nominating and Governance Committee is comprised of Ms. Carver and Drs. Tidmarsh and LaBelle, each of whom has been determined to be independent under the Nasdaq Listing Rules. The Nominating and Governance Committee adopted a written charter.

Specific responsibilities of the Nominating and GovernanceCommittee include:

identifying, evaluating and selecting, or recommending that board of directors approve, nominees for election to board of directors;

evaluating the performance of board of directors and of individual directors;

reviewing developments in corporate governance practices;

evaluating the adequacy of corporate governance practices and reporting;

reviewing management succession plans; and

developing and making recommendations to board of directors regarding corporate governance guidelines and matters.

Compensation Committee

91


Revelation has a Compensation Committee established in accordance with the Nasdaq Listing Rules. The Compensation Committee is comprised of Drs. Tidmarsh and LaBelle and Mr. Roper, each of whom has been determined to be independent under the Nasdaq Listing Rules and is a “non-employee director” as defined in Rule 16b-3 promulgated under the Exchange Act. The chair of Revelation’s compensation committee is Dr. LaBelle.

The Compensation Committee oversees Revelation’s policies relating to compensation and benefits of its officers and employees. The Compensation Committee reviews and approves or recommends corporate goals and objectives relevant to compensation of its executive officers (other than the Chief Executive Officer), evaluates the performance of these officers in light of those goals and objectives and approves the compensation of these officers based on such evaluations. The Compensation Committee also reviews and approves or makes recommendations to the board of directors regarding the issuance of stock options and other awards under Revelation’s stock plans to its executive officers (other than the Chief Executive Officer). The Compensation Committee reviews the performance of the Chief Executive Officer and makes recommendations to the board of directors with respect to his compensation, and the board of directors retains the authority to make compensation decisions relative to the Chief Executive Officer. The Compensation Committee reviews and evaluates, on an annual basis, the compensation committee charter and the compensation committee’s performance.

Compensation Committee Interlocks and Insider Participation

No member of the auditCompensation Committee has ever been an officer or employee of Revelation. None of Revelation’s executive officers serve, or have served during the last fiscal year, as a member of the compensation committee or other board committee performing equivalent functions of any other entity that has one or more executive officers serving as one of Revelation’s directors or on the Compensation Committee.

Code of Conduct and Ethics

The Revelation Board adopted a Code of Ethics that applies to all its employees including its principal executive and financial officers.

Item 11. Executive Officer and Director Compensation.

Executive Compensation Overview

Each of the Company’s executive officers receives a base salary to compensate them for services rendered to the Company. The base salary is financially literateintended to provide a fixed component of compensation reflecting the executive’s skill set, experience, position and responsibilities.

Effective as of July 27, 2021, the Company entered into separate Executive Employment Agreements with Messrs. Rolke and Zygmont for their service as Chief Executive Officer and Chief Financial Officer, respectively (collectively, the “Executive Employment Agreements”). The Executive Employment Agreements provide for a term of three years, unless terminated earlier in accordance with their terms.

The Executive Employment Agreements provide for an annual base salary of $400,000 for Mr. Rolke and $320,000 for Mr. Zygmont. Messrs. Rolke and Zygmont are also eligible to receive an annual performance bonus targeted at 40% for Mr. Rolke and 35% for Mr. Zygmont of their respective base salaries or as otherwise determined in the sole discretion of the board (each, an “Annual Bonus”), as well as equity incentive grants as determined by the Board in its sole discretion.

Pursuant to the Executive Employment Agreements, if his employment is terminated as a result of a “Covered Termination Event” that is not in connection with a change in control of the Company, then each of Messrs. Rolke and Zygmont will be entitled to receive a lump sum payment equal to twelve months of severance payments at his then current base salary, plus a pro-rata portion of his Annual Bonus for the fiscal year in which his termination occurs based on actual achievement of the applicable bonus objectives and/or conditions for such year, plus continuation of medical benefits. If Mr. Rolke’s or Mr. Zygmont’s employment is terminated as a result of a “Covered Termination Event” in connection with a change in control of the Company, then each of Messrs. Rolke and Zygmont will be

92


entitled to receive a lump sum payment equal to one times the sum of his then current base salary, plus his target bonus in effect for the year in which his termination of employment occurs, plus a pro-rata portion of his Annual Bonus for the fiscal year in which his termination occurs based on actual achievement of the applicable bonus objectives and/or conditions for such year, continuation of medical benefits and acceleration of vesting of all outstanding and unvested equity-based awards. “Covered Termination Event” means (i) a dismissal or discharge other than for Cause and other than by reason of death or disability, or (ii) a voluntary termination for Good Reason.

Historically, our executive compensation program has reflected our growth and development-oriented corporate culture. To date, the compensation of our Chief Executive Officer and President and our other executive officers identified in the 2022 and 2021 Summary Compensation Table below, who we refer to as the named executive officers, has consisted of a combination of base salary, bonuses and long-term incentive compensation in the form of restricted common stock awards and incentive stock options. Our named executive officers who are full-time employees, like all other full-time employees, are eligible to participate in our retirement and health and welfare benefit plans. As we transition from a private company to a publicly traded company, we will evaluate our compensation values and philosophy and compensation plans and arrangements as circumstances merit. At a minimum, we expect to review executive compensation annually with input from a compensation consultant. As part of this review process, we expect the board of directors has determined that Robert Nicholson and Barry Dennisthe compensation committee to apply our values and philosophy, while considering the compensation levels needed to ensure our executive compensation program remains competitive with our peers. In connection with our executive compensation program, we will also review whether we are meeting our retention objectives and the potential cost of replacing a key employee.

Summary Compensation Table

The following table shows the total compensation awarded to, earned by, or paid to during the years ended December 31, 2022 and 2021 to our executive officers who earned more than $100,000 during each qualifyof the fiscal years ended December 31, 2022 and 2021 and were serving as an “audit committee financial expert”named executive officers as definedof such date.

Our named executive officers for 2022 and 2021 who appear in applicable SEC rules and has accounting or related financial management expertise.the Summary Compensation Table are:

The audit committee’s duties, which are specified in our Audit Committee Charter, include, but are not limited to:

reviewing

James Rolke, our President and discussing with managementChief Executive Officer; and the independent auditor the annual audited financial statements, and recommending to the board whether the audited financial statements should be included in our Form 10-K;

discussing with management and the independent auditor significant financial reporting issues and judgments made in connection with the preparation of

Chester S. Zygmont, III, our financial statements;Chief Financial Officer.

The following table sets forth, for the years ended December 31, 2022 and 2021, all compensation paid, distributed or earned for services, including salary and bonus amounts, rendered in all capacities by the Company’s named executive officers. The information contained below represents compensation earned by the Company’s officers for their work related to the Company:

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Non-equity
incentive plan
compensation
($)

 

 

 

 

 

 

 

Name and Position

 

Year

 

 

Salary
($)

 

 

Bonus
($)

 

 

Stock-
based
awards
($)
(1)

 

 

Option-
based
awards
($)
(2)

 

 

Annual
incentive
plans

 

 

Long
term
incentive
plans

 

 

All other
compensation
($)

 

 

Total
compensation
($)

 

James Rolke

 

 

2022

 

 

 

400,000

 

 

 

 

 

 

 

 

 

79,591

 

 

 

 

 

 

 

 

 

 

 

 

479,591

 

CEO

 

 

2021

 

 

 

400,000

 

 

 

66,630

 

 

 

151,813

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

618,443

 

Chester S. Zygmont, III

 

 

2022

 

 

 

320,000

 

 

 

 

 

 

 

 

 

19,138

 

 

 

 

 

 

 

 

 

 

 

 

339,138

 

CFO

 

 

2021

 

 

 

320,000

 

 

 

46,641

 

 

 

36,379

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

403,020

 

(1)

discussing with management major risk assessment and risk management policies;

Amounts shown in this column represent the aggregate grant date fair value of RSU awards granted during the year. The assumptions used in calculating the fair value of the RSU awards can be found under Note 11 to the audited Financial Statements appearing in this Annual Report on Form 10-K. These amounts reflect the grant date

93


fair value for these RSU’s and do not necessarily correspond to the actual value that will be realized by the named executive officers.

(2)

monitoring

Amounts shown in this column represent the independenceaggregate grant date fair value of stock options granted during the year. The assumptions used in calculating the fair value of the independent auditor;stock options can be found under Note 11 to the audited Financial Statements appearing elsewhere in this Annual Report on Form 10-K. These amounts reflect the grant date fair value for these stock options and do not necessarily correspond to the actual value that will be realized by the named executive officers.

OUTSTANDING EQUITY AWARDS AT FISCAL YEAR END

Outstanding Equity Awards

The following table provides information regarding the 2021 Equity Incentive Plan awards and the 2020 Equity Incentive Plan awards for each named executive officer outstanding as of December 31, 2022:

 

 

 

 

Option-based Awards

 

 

Stock-based Awards

 

Name

 

Date of Grant

 

Number of securities
underlying
unexercised
options
(#)

 

 

Option
exercise
price
($)

 

 

Option
expiration
date

 

Value of
unexercised
in-the-money
options at
December 31,
2022
($)

 

 

Number of
shares or
units of
shares that
have not
vested
(#)

 

 

Market or
payout value of
share awards
that have not
vested
($)

 

James Rolke

 

2/25/2022(1)

 

 

2,542

 

 

$

49.00

 

 

2/25/2032

 

 

 

 

 

 

 

 

 

CEO

 

2/23/2021(2)

 

 

 

 

 

 

 

 

 

 

 

 

1,006

 

 

 

81,609

 

 

 

10/31/2020(3)

 

 

 

 

 

 

 

 

 

 

 

 

122

 

 

 

9,151

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Chester S. Zygmont, III

 

2/25/2022(1)

 

 

611

 

 

$

49.00

 

 

2/25/2032

 

 

 

 

 

 

 

 

 

CFO

 

2/23/2021(2)

 

 

 

 

 

 

 

 

 

 

 

 

241

 

 

 

19,556

 

 

 

10/31/2020(3)

 

 

 

 

 

 

 

 

 

 

 

 

97

 

 

 

7,320

 

(1)

verifying

The stock options vest 25% on the rotationone-year anniversary of the lead (or coordinating) audit partner having primary responsibility for the auditgrant date, and the audit partner responsible for reviewing the audit as required by law;thereafter quarterly over a three-year period, subject to continued service through each such vesting date.

(2)

reviewing

The RSU awards vest 25% on the one-year anniversary of the grant date, and approving all related-party transactions;thereafter quarterly over a three-year period, subject to continued service through each such vesting date.

(3)

inquiring and discussing with management our compliance with applicable laws and regulations;

The RSU awards vest quarterly over four years, subject to continued service through each such vesting date.

pre-approving all audit services and permitted non-audit services to be performed by our independent auditor, including the fees and terms of the services to be performed;

appointing or replacing the independent auditor;

determining the compensation and oversight of the work of the independent auditor (including resolution of disagreements between management and the independent auditor regarding financial reporting) for the purpose of preparing or issuing an audit report or related work;

establishing procedures for the receipt, retention and treatment of complaints received by us regarding accounting, internal accounting controls or reports which raise material issues regarding our financial statements or accounting policies; and

approving reimbursement of expenses incurred by our management team in identifying potential target businesses.

DIRECTOR COMPENSATION

The general policy of the Board is that compensation for independent directors should be a fair mix between cash and equity-based compensation. Additionally, the Company reimburses directors for reasonable expenses incurred during the course of their performance. There are no long-term incentive or medical reimbursement plans. The Company does not pay directors who are part of management for Board service in addition to their regular employee compensation. The Board determines the amount of director compensation. The Board may delegate such authority to the compensation committee. During the fiscal year ended December 31, 2020,2022, there was no cash or equity compensation paid to our audit committee held 1 meeting. Each of the audit committee members attended all of the meetings of the audit committee in fiscal year 2020.


Nominating Committee

Effective October 13, 2020, we established a nominating committee of the board ofnon-employee directors which consists of Robert Nicholson, Anthony Hayes, and Barry Dennis, each of whom is an independent director under Nasdaq’s listing standards. The nominating committee is responsible for overseeing the selection of persons to be nominated to serveservice on our board of directors. The nominating committee considers persons identified by its members, management, shareholders, investment bankers and others.

During the fiscal year ended December 31, 2020 the nominating committee did not hold any meetings.

Guidelines for Selecting Director Nominees

The guidelines for selecting nominees, which are specified in the Nominating Committee Charter, generally provide that persons to be nominated:

should have demonstrated notable or significant achievements in business, education or public service;
should possess the requisite intelligence, education and experience to make a significant contribution to the board of directors and bring a range of skills, diverse perspectives and backgrounds to its deliberations; and
should have the highest ethical standards, a strong sense of professionalism and intense dedication to serving the interests of the shareholders.

The Nominating Committee will consider a number of qualifications relating to management and leadership experience, background, and integrity and professionalism in evaluating a person’s candidacy for membership on the board of directors. The nominating committee may require certain skills or attributes, such as financial or accounting experience, to meet specific board needs that arise from time to time and will also consider the overall experience and makeup of its members to obtain a broad and diverse mix of board members. The nominating committee does not distinguish among nominees recommended by shareholders and other persons.

There have been no material changes to the procedures by which security holders may recommend nominees to our board of directors.

Compensation Committee

Effective October 13, 2020, we established a compensation committee of the board of directors which consists of Robert Nicholson, Anthony Hayes, and Barry Dennis, each of whom is an independent director under Nasdaq’s listing standards. The compensation committee’s duties, which are specified in our Compensation Committee Charter, include, but are not limited to:during 2022.

reviewing and approving on an annual basis the corporate goals and objectives relevant to our Chief Executive Officer’s compensation, evaluating our Chief Executive Officer’s performance in light of such goals and objectives and determining and approving the remuneration (if any) of our Chief Executive Officer based on such evaluation;
reviewing and approving the compensation of all of our other executive officers;
reviewing our executive compensation policies and plans;


implementing and administering our incentive compensation equity-based remuneration plans;
assisting management in complying with our proxy statement and annual report disclosure requirements;
approving all special perquisites, special cash payments and other special compensation and benefit arrangements for our executive officers and employees;
if required, producing a report on executive compensation to be included in our annual proxy statement; and
reviewing, evaluating, and recommending changes, if appropriate, to the remuneration for directors.

No compensation of any kind, including finders, consulting or other similar fees, will be paid to any of our existing stockholders, including our directors, or any of their respective affiliates, prior to, or for any services they render in order to effectuate, the consummation of a business combination. Accordingly, it is likely that prior to the consummation of an initial business combination, the compensation committee will only be responsible for the review and recommendation of any compensation arrangements to be entered into in connection with such initial business combination.

During the fiscal year ended December 31, 2020 the compensation committee did not hold any meetings.

Code of Ethics

Effective October 13, 2020, we adopted a code of ethics that applies to all of our executive officers, directors, and employees. The code of ethics codifies the business and ethical principles that govern all aspects of our business. We will provide, without charge, upon request, copies of our code of ethics. Requests for copies of our code of ethics should be sent in writing to 5 West 21st Street, New York, NY 10010.

ITEM 11. EXECUTIVE COMPENSATION

Executive Compensation

No executive officer has received any cash compensation for services rendered to us.

Other than the repayment of the loan from Petra Investment Holdings LLC (none of which payments will be made from the proceeds of this offering held in the trust account prior to the completion of our initial business combination), no compensation or fees of any kind, including finder’s, consulting fees and other similar fees, will be paid to our sponsor, initial stockholders, members of our management team or their respective affiliates, for services rendered prior to or in connection with the consummation of our initial business combination (regardless of the type of transaction that it is). However, they will receive reimbursement for any out-of-pocket expenses incurred by them in connection with activities on our behalf, such as identifying potential target businesses, performing business due diligence on suitable target businesses and business combinations as well as traveling to and from the offices, plants or similar locations of prospective target businesses to examine their operations. There is no limit on the amount of out-of-pocket expenses reimbursable by us.

After our initial business combination, members of our management team who remain with us may be paid consulting, management or other fees from the combined company with any and all amounts being fully disclosed to stockholders, to the extent then known, in the proxy solicitation materials furnished to our stockholders. It is unlikely the amount of such compensation will be known at the time of a stockholder meeting held to consider an initial business combination, as it will be up to the directors of the post-combination business to determine executive and director compensation. In this event, such compensation will be publicly disclosed at the time of its determination in a Current Report on Form 8-K, as required by the SEC.

Since our formation, we have not granted any stock options or stock appreciation rights or any other awards under long-term incentive plans to any of our executive officers or directors.


ITEM 12. SECURITY OWNERSHIP OF CERTAIN BENEFICIAL OWNERS AND MANAGEMENT AND RELATED SHAREHOLDER MATTERS

 

Item 12. Security Ownership of Certain Beneficial Owners and Management and Related Stockholder Matters.

94


The following table also sets forth information known to us regarding the beneficial ownership of our common stock by:Common Stock as of March 21, 2023:

each person known by uswho is, or is expected to be, the beneficial owner of more than 5% of ourthe outstanding shares of common stock;our Common Stock;

each of our current officers and directors; and

all of ourcurrent executive officers and directors of the Company, as a group.

Beneficial ownership is determined according to the rules of the SEC, which generally provide that a person has beneficial ownership of a security if he, she or it possesses sole or shared voting or investment power over that security, including options and warrants that are currently exercisable or exercisable within 60 days. Shares of Common Stock issuable pursuant to options or warrants are deemed to be outstanding for purposes of computing the beneficial ownership percentage of the person or group holding such options or warrants but are not deemed to be outstanding for purposes of computing the beneficial ownership percentage of any other person.

The beneficial ownership of our Common Stock is based on 4,511,839 shares of Common Stock issued and outstanding as of March 21, 2023.

Unless otherwise indicated, we believe that all persons named in the table have sole voting and investment power with respect to all shares of common stock beneficiallyCommon Stock owned by them. The following table does not reflect record of beneficial ownership of the warrants included in the units offered in the IPO or the Private Warrants as the warrants are not exercisable within 60 days of the date hereof.

  After Offering(2) 
Name and Address of Beneficial Owner(1) Amount and
Nature of
Beneficial
Ownership
  Approximate
Percentage of
Outstanding
Shares of
Common Stock
 
Petra Investment Holdings, LLC(2)  1,769,538   19.45%
Andreas Typaldos(2)  1,769,538   19.45%
Sean Fitzpatrick(2)  1,769,538   19.45%
David Dobkin  10,000   * 
Anthony Hayes  10,000   * 
Robert Nicholson  10,000   * 
Barry Dennis  10,000   * 
William Carson(3)  0(1)  0%
All directors and executive officers as a group (seven individuals)  1,819,538   20%
Glazer Capital LLC(4)  1,035,652   11.38%

Hudson Bay Capital Management LP(5)

  693,000   7.61%

Polar Asset Management Partners Inc. (6)

  700,000   7.69%
Linden Capital L.P. (7)  679,000   7.46%

Name

 

Number of Shares
Beneficially Owned

 

 

Beneficial
Ownership Prior
to the Offering (%)

 

 

Beneficial Ownership
After the Offering
(%)

 

Directors and Officers of Revelation(1):

 

 

 

 

 

 

 

 

 

James Rolke(2)

 

 

21,321

 

 

 

*

 

 

 

 

 

George Tidmarsh M.D., Ph.D.(3)

 

 

58,097

 

 

 

1.3

%

 

 

 

 

Jennifer Carver, BSN, MBA(4)

 

 

3,171

 

 

 

*

 

 

 

 

 

Jess Roper(5)

 

 

1,224

 

 

 

*

 

 

 

 

 

Curt LaBelle, M.D.(6)

 

 

612

 

 

 

*

 

 

 

 

 

Chester S. Zygmont, III(7)

 

 

20,048

 

 

 

*

 

 

 

 

 

All Directors and Officers as a Group (Six Individuals)

 

 

104,473

 

 

 

2.3

%

 

 

 

 

*

*

Less than 1%.one percent.

(1)

(1)

Unless otherwise indicated, the business address of each of the individuals is 5 West 21st Street, New York, NY 10010.c/o Revelation Biosciences, Inc., 4660 La Jolla Village Dr., Suite 100, San Diego, CA 92122.

(2)

Represents securities held by Petra Investment Holdings, LLC, our sponsor,Consists of which Mr. Typaldos is sole managing member have voting and investment discretion with respect to the common stock held by our sponsor. Mr. Fitzpatrick is also a member(i) 20,232 shares of our Sponsor. As such, they may be deemed to have beneficial ownership of the common stockCommon Stock held directly by our sponsor. Each such person disclaims any beneficial ownership of the reported shares other than to the extent of any pecuniary interest they may have therein, directly or indirectly.

(3)Mr. Carson joined the Board of Directors on February 22, 2021. Mr. Carson will receive ten thousand (10,000)Rolke, (ii) 62 shares of the Company’s common stockCommon Stock held by Mr. Rolke’s spouse, (iii) 391 shares of Common Stock from the Company’s Sponsor, Petra Investment Holdings, LLC, as compensation for his service on the Board; however, theRollover RSU’s vesting and issuable within 60 days to Mr. Rolke, and (iv) 636 shares have not yet been transferred.
(4)

According to the Schedule 13G filed with the SEC on November 10, 2020, as amended February 16, 2021of Common Stock underlying Stock Options exercisable within 60 days by Glazer Capital, LLC (“Glazer”), on behalf of Glazer, certain funds and managed accounts to which Glazer Capital serves as investment manager (collectively, the “Glazer Funds”) and Paul J. Glazer (“Mr. Glazer”). Mr. Glazer has beneficial ownership by virtue of his role as a control person of Glazer.  The principal business address of each of Glazer, Glazer Funds and Mr. Glazer is 250 West 55th Street, Suite 30A, New York, New York 10019. Rolke.


 (5)

(3)

According to the Schedule 13G filed with the SEC on February 10, 2021, by Hudson Bay Capital Management LP (the “Hudson Bay”) and Mr. Sander Gerber (“Mr. Gerber”). The Investment Manager serves as the investment manager to HB Strategies LLC, in whose name the securities reported herein are held. As such, the Investment Manager may be deemed to be the beneficial ownerConsists of all securities(i) 43,525 shares of Common Stock held by HB Strategies LLC. Mr. Gerber serves as the managing memberGeorge Tidmarsh, Trustee George Francis Tidmarsh 2021 Irrevocable Trust, (ii) 13,348 shares of Hudson Bay Capital GP LLC, which is the general partnerCommon Stock held directly by Dr. Tidmarsh, and (iii) 1,224 shares of the Investment Manager. Mr. Gerber disclaims beneficial ownership of these securities.  The principal business address of each of Hudson BayCommon stock from Rollover RSU’s vesting and Mr. Gerber is 777 Third Avenue, 30th Floor, New York, NY 10017.

(6)Accordingissuable within 60 days to the Schedule 13G filed with the SEC on February 10, 2021 by Polar Asset Management Partners Inc. (“Polar”), on behalf of Polar Asset Management Partners Inc., a company incorporated under the laws of Ontario, Canada, which serves as the investment advisor to Polar Multi-Strategy Master Fund, a Cayman Islands exempted company (“PMSMF”). The principal business address of Polar and PMSMF is 401 Bay Street, Suite 1900, PO Box 19, Toronto, Ontario M5H 2Y4, Canada.
(7)

According to the Schedule 13G filed with the SEC on October 16, 2020, as amended February 4, 2021 by Linden Capital L.P., a Bermuda limited partnership (“Linden Capital”), Linden Advisors LP, a Delaware limited partnership (“Linden Advisors”), Linden GP LLC, a Delaware limited liability company (“Linden GP”), and Mr. Siu Min (Joe) Wong (“Mr. Wong,” and collectively, the “Reporting Persons”). As of December 31, 2020, each of Linden Advisors and Mr. Wong may be deemed the beneficial owner of 679,000 Shares. This amount consists of 614,101 Shares held by Linden Capital and 64,899 Shares held by separately managed accounts. As of December 31, 2020, each of Linden GP and Linden Capital may be deemed the beneficial owner of the 614,101 Shares held by Linden Capital. The principal business address for Linden Capital is Victoria Place, 31 Victoria Street, Hamilton HM10, Bermuda. The principal business address for each of Linden Advisors, Linden GP and Mr. Wong is 590 Madison Avenue, 15th Floor, New York, New York 10022.Dr. Tidmarsh.

(4)

Consists of (i) 1,947 shares of Common Stock held directly by Ms. Carver and (ii) 1,224 shares of Common stock from Rollover RSU’s vesting and issuable within 60 days to Ms. Carver.

(5)

Consists of 1,224 shares of Common stock from Rollover RSU’s vesting and issuable within 60 days to Mr. Roper.

All95


(6)

Consists of 612 shares of Common stock from Rollover RSU’s vesting and issuable within 60 days to Dr. LaBelle.

(7)

Consists of (i) 13,481 shares of Common Stock held by The Zygmont Family Trust Dated October 25, 2016, (ii) 6,230 shares of Common Stock held by Czeslaw Capital Fund, LLC, (iii) 62 shares held by Mr. Zygmont’s spouse, (iv) 122 shares of Common stock from Rollover RSU’s vesting and issuable within 60 days to Mr. Zygmont, and (v) 153 shares of Common Stock underlying Stock Options exercisable within 60 days by Mr. Zygmont.

Item. 13. Certain Relationships and Related Person Transactions, and Director Independence.

Backstop Agreements

On December 21, 2021, Petra entered into certain backstop agreements (the “Backstop Agreements”) with AXA Prime Impact Master Fund (“AXA”) (through a backstop agreement with Old Revelation, LifeSci Venture Partners (“LifeSci”) and other Petra and Old Revelation institutional, and individual investors, including Dr. Tidmarsh, chairman of the founders’ shares outstanding priorCompany (such additional institutional and individual investors, together with LifeSci and Old Revelation collectively, the “Backstop Subscribers”). Pursuant to the IPO have been placedBackstop Agreements, the Backstop Subscribers agreed to subscribe for and purchase, in escrowthe aggregate, up to $4.5 million of shares of Petra’s common stock, par value $0.001 per share (the “Petra Common Stock”), in the event that more than $31.5 million of shares of Petra Common Stock are submitted for redemption in connection with ContinentalPetra’s proposed business combination with Old Revelation (the “Business Combination”). On January 6, 2022, pursuant to the Backstop Agreements, the Backstop Subscribers purchased an aggregate of 12,345 shares of Petra Common Stock.

Old Revelation obtained the financing for its Backstop Agreement through a convertible note financing in an amount of up to $2.5 million from an AXA (the “Convertible Note”), the proceeds of which may be used by Old Revelation solely to purchase shares of Petra Common Stock Transfer & Trust Company,from redeeming Petra stockholders who redeem shares of Petra Common Stock in connection with the Business Combination. On January 6, 2022, Old Revelation purchased 7,001 shares of Petra Common Stock with the proceeds from the Convertible Note. Repayment of the Convertible Note is in process in accordance with the exchange terms of the Convertible Note, by which the shares of Petra’s Common Stock purchased by Old Revelation are transferred to AXA.

Forward Share Purchase Agreement

On December 21, 2021, Petra also entered into a forward share purchase agreement (the “Purchase Agreement”) with Meteora Capital Partners and its affiliates (collectively, “Meteora”) pursuant to which Meteora has committed, subject to certain customary closing conditions, to purchase additional shares of Petra Common Stock in open market transactions or from redeeming stockholders so that Meteora holds at least 21,429 shares of Petra common stock as escrow agent, until (i) with respectof the closing of the Business Combination, and to 50%not redeem any of such 21,429 shares for a period endingof Petra Common Stock, in connection with the business combination.

The Purchase Agreement provides that Meteora may elect to sell and transfer to Petra, and that Petra will purchase from Meteora, on the earlier of the threeone month anniversary of the closing of the Business Combination up to 21,429 shares of Petra Common Stock (the “Petra Share Repurchase”) held by Meteora at the time of closing of the Business Combination (the “Meteora Shares”). The price at which Meteora has the right to sell the Meteora Shares to the Petra is $357.10 per share. Meteora will notify the Petra in writing not less than five business days prior to the closing date of the consummationPetra Share Repurchase (the “Closing Date”), specifying the number of our initial business combination and the date on which the closing price of our common stock equals or exceeds $12.50 per share (as adjusted for share splits, share dividends, reorganizations and recapitalizations) for any 20 trading days within a 30-trading day period following the consummation of our initial business combination and (ii) with respectMeteora Shares that Petra will be required to purchase.

Pursuant to the remaining 50% of such shares, for a period ending on the six month anniversaryPurchase Agreement, Meteora is also permitted at its election to sell any or all of the date ofMeteora Shares in the consummation of our initial business combination, or earlier if, subsequent to our initial business combination, we consummate a liquidation, merger, stock exchange or other similar transaction which results in all of our stockholders having the right to exchange their shares of common stock for cash, securities or other property.


During the escrow period, the holders of these shares will not be able to sell or transfer their securities except for transfers, assignments or sales (i) among our initial stockholders or to our initial stockholders’ members, officers, directors, consultants or their affiliates, (ii) to a holder’s stockholders or members upon its liquidation, (iii) by bona fide gift to a member of the holder’s immediate family or to a trust, the beneficiary of which is the holder or a member of the holder’s immediate family, for estate planning purposes, (iv) by virtue of the laws of descent and distribution upon death, (v) pursuant to a qualified domestic relations order, (vi) to us for no value for cancellation in connection with the consummation of our initial business combination, or (vii) in connection with the consummation of a business combination at prices no greater than the price at which the shares were originally purchased, in each case (except for clause (vi) or with our prior consent) where the transferee agrees to the terms of the escrow agreement and to be bound by these transfer restrictions, but will retain all other rights as our stockholders, including, without limitation, the right to vote their shares of common stock and the right to receive cash dividends, if declared. If dividends are declared and payable in shares of common stock, such dividends will also be placed in escrow. If we are unable to effect a business combination and liquidate, there will be no liquidation distribution with respect to the founders’ shares. Our executive officers and our Sponsor are our “promoters,” as that term is defined under the federal securities laws.

Equity Compensation Plans

As of December 31, 2020, we had no compensation plans (including individual compensation arrangements) under which equity securities of the registrant were authorized for issuance.

ITEM 13. CERTAIN RELATIONSHIPS AND RELATED TRANSACTIONS, AND DIRECTOR INDEPENDENCE

On January 21, 2020 we issued an aggregate of 3,593,750 shares of our common stock (“founders’ shares”) for an aggregate purchase price of $25,000, or approximately $0.007 per share, to Petra Investment Holdings, LLC (the “Sponsor). On August 24, 2020, pursuant to amendment to the terms of the Company’s offering our sponsor agreed to cancel 1,437,500 shares, resulting in an aggregate amount of 2,156,250 founders shares outstanding.

Simultaneously with the consummation of the IPO, the Company completed the private sale of an aggregate of 3,150,000 private warrants (the “Private Warrants”) to the Sponsor at a purchase price of $1.00 per Private Warrant, generating gross proceeds to the Company of $3,150,000.

On October 16, 2020, we consummated the sale of an additional 278,151 Units (the “Over-Allotment Option Units”) at $10.00 per Unit, generating gross proceeds of $2,781,510. Simultaneously withopen market commencing after the closing of the Business Combination, so long as the sale of additional units,price exceeds $357.10 per share.

On February 4, 2022, Meteora exercised the Forward Share Purchase Agreement entered into by and between the Company. 21,429 shares were repurchased by the Company consummatedand approximately $7.7 million that was escrowed was paid to Meteora.

96


Series A Preferred Stock

On December 19, 2022, the sale ofCompany entered into a Subscription and Investment Representation Agreement (the “Subscription Agreement”) with James Rolke, its Chief Executive Officer, who is an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446. Followingaccredited investor (the “Purchaser”), pursuant to which the closingCompany agreed to issue and sell one (1) share of the over-allotment optionCompany’s Series A Preferred Stock, par value $0.001 per share (the “Preferred Stock”), to the Purchaser for $5,000.00 in cash. The sale closed on December 19, 2022.

The Series A Preferred Stock will have 50,000,000 votes and salewill vote together with the outstanding shares of additional Private Warrants, an aggregate amount of $73,509,325 was placed in the Company’s trust account established in connectioncommon stock as a single class exclusively with respect to any proposal to amend the IPO. 

In addition,Company’s Restated Certificate of Incorporation to effect a reverse stock split of the Company’s common stock and to increase the number of authorized shares of common stock of the Company (the “Founder Shares”) heldCompany. The Series A Preferred Stock will be voted, without action by the Sponsor (priorholder, on any such proposal in the same proportion as shares of common stock are voted. The Series A Preferred Stock otherwise has no voting rights except as otherwise required by the General Corporation Law of the State of Delaware.

The Series A Preferred Stock is not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Series A Preferred Stock has no rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Series A Preferred Stock will not be entitled to receive dividends of any kind.

The outstanding share of Series A Preferred Stock was automatically redeemed upon the effectiveness of the amendment to the exerciseCertificate of Incorporation implementing the reverse stock split and the increase in authorized shares of common stock of the over-allotment) included an aggregate of up to 262,500 Founder Shares subject to forfeiture byCompany. Upon such redemption, the Sponsor to the extent that the underwriters’ over-allotment option was not exercised in full. Since the underwriters exercised the over-allotment option in part, 192,962 Founder Shares were subject to forfeiture and were cancelled by our Sponsor on December 30, 2020.

Other than the repaymentholder of the $150,000loan to our Sponsor, no compensation or feesSeries A Preferred Stock received the redemption price of any kind, including finder’s, consulting fees and other similar fees, will be paid to our Sponsor, initial stockholders, members of our management team or their respective affiliates, for services rendered prior to or$5,000.00 in connection with the consummation of our initial business combination (regardless of the type of transaction that it is). However, such individuals will receive reimbursement for any out-of-pocket expenses incurred by them in connection with activities on our behalf, such as identifying potential target businesses, performing business due diligence on suitable target businesses and business combinations as well as traveling to and from the offices, plants or similar locations of prospective target businesses to examine their operations. There is no limit on the amount of out-of-pocket expenses reimbursable by us.cash.


Related Party Policy

Our Code of Ethics requires us to avoid, wherever possible, all related party transactions that could result in actual or potential conflicts of interests, except under guidelines approved by the board of directors (or the audit committee). Related-party transactions are defined as transactions in which (1) the aggregate amount involved will or may be expected to exceed $120,000 in any calendar year, (2) we or any of our subsidiaries is a participant, and (3) any (a) executive officer, director or nominee for election as a director, (b) greater than 5% beneficial owner of our sharesShares of common stock,Common Stock, or (c) immediate family member, of the persons referred to in clauses (a) and (b), has or will have a direct or indirect material interest (other than solely as a result of being a director or a less than 10% beneficial owner of another entity). A conflict of interest situation can arise when a person takes actions or has interests that may make it difficult to perform his or her work objectively and effectively. Conflicts of interest may also arise if a person, or a member of his or her family, receives improper personal benefits as a result of his or her position.

Our audit committee, pursuant to its written charter, will be responsible for reviewing and approving related-party transactions to the extent we enter into such transactions. The audit committee will consider all relevant factors when determining whether to approve a related party transaction, including whether the related party transaction is on terms no less favorable to us than terms generally available from an unaffiliated third-party under the same or similar circumstances and the extent of the related party’s interest in the transaction. No director may participate in the approval of any transaction in which he is a related party, but that director is required to provide the audit committee with all material information concerning the transaction. We also require each of our directors and executive officers to complete a directors’ and officers’ questionnaire that elicits information about related party transactions.

These procedures are intended to determine whether any such related party transaction impairs the independence of a director or presents a conflict of interest on the part of a director, employee or officer.

To further minimize conflicts of interest, we have agreed not to consummate an initial business combination with an entity that is affiliated with any of our sponsor, officers or directors including (i) an entity that is either a portfolio company of, or has otherwise received a material financial investment from, any private equity fund or

97


investment company (or an affiliate thereof) that is affiliated with any of the foregoing, (ii) an entity in which any of the foregoing or their affiliates are currently passive investors, (iii) an entity in which any of the foregoing or their affiliates are currently officers or directors, or (iv) an entity in which any of the foregoing or their affiliates are currently invested through an investment vehicle controlled by them, unless we have obtained an opinion from an independent investment banking firm, or another independent entity that commonly renders valuation opinions, and the approval of a majority of our disinterested independent directors that the business combination is fair to us and to our unaffiliated stockholders from a financial point of view.

Director Independence

Our board of directors currently consists of five members. Our board of directors has determined that all of our directors, other than Mr. Rolke, qualify as “independent” directors in accordance with the rules of the SEC and the Nasdaq, Marketplace Rules, or the Nasdaq Listing Rules, which the Company has adopted as its independence standards. Mr. Rolke is not considered independent because he is an executive officer of the Company. Under the

Nasdaq Listing Rules, the definition of independence includes a series of objective tests, such as that the director is not, and has not been for at least three years, one of our employees and that neither the director nor any of his or her family members has engaged in various types of business dealings with us. In addition, as required by the Nasdaq Listing Rules, our board of directors has made a subjective determination as to each independent director that no relationships exist that, in the opinion of our board of directors, would interfere with the exercise of independent judgment in carrying out the responsibilities of a director. In making these determinations, our board of directors reviewed and discussed information provided by the directors and us with regard to each director’s relationships as they may relate to us and our management.

Item 14. Principal Accountant Fees and Services

ITEM 14. PRINCIPAL ACCOUNTING FEES AND SERVICES.

Baker Tilly US, LLP acted as the Company’s independent registered public accounting firm for the years ended December 31, 2022 and 2021 and for the interim periods in such fiscal years. The following is a summary oftable shows the fees paid or to be paid to dbbmckennonthat were incurred by the Company for audit and other services rendered.provided by Baker Tilly US, LLP for the years ended December 31, 2022 and 2021.

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

Audit Fees(a)

 

$

144,730

 

 

$

147,567

 

Tax Fees(b)

 

 

19,756

 

 

 

38,869

 

Other Fees(c)

 

 

126,016

 

 

 

107,959

 

Total

 

$

290,502

 

 

$

294,395

 

____________

Audit Fees.(a) Audit fees consist ofrepresent fees billed for professional services rendered forprovided in connection with the audit of our year-endthe Company’s annual financial statements and the review of its financial statements included in the Company’s Quarterly Reports on Form 10-Q and services that are normally provided by dbbmckennon in connection with statutory or regulatory filings. The aggregate

(b) Tax fees billed by dbbmckennonrepresent fees for professional services related to tax compliance, tax advice and tax planning.

(c) Other fees represent fees related to our filing of certain Registration Statements.

Pre-Approval Policies and Procedures

All audit related services, tax services and other services rendered by Baker Tilly US, LLP were pre-approved by the Company’s Board of Directors. Commencing in 2020, the Audit Committee was charged with all pre-approval activities with respect to the Company’s independent registered public accounting firm. The Audit Committee has adopted a pre-approval policy that provides for the auditpre-approval of our annual financial statements, review of the financial information included in our Forms 10-Qall services performed for the respective periodsCompany by its independent registered public accounting firm. Our independent registered public accounting firm and othermanagement are required filingsto periodically report to the Audit Committee regarding the extent of services provided by the independent registered public accounting firm in accordance with this pre-approval policy, and the SECfees for the period from November 20, 2019 (inception) through December 31, 2020 totaled $72,969. services performed to date.

98


PART IV

Item 15. Exhibits, Financial Statement Schedules.

The above amounts include interim procedures and audit fees,following documents are filed as well as attendance at audit committee meetings.part of this Annual Report:

Audit-Related Fees. Audit-related services consist of fees billed for assurance and related services that are reasonably related to performance of the audit or review of our financial statements and are not reported under “Audit Fees.” These services include attest services that are not required by statute or regulation and consultations concerning financial accounting and reporting standards. We did not pay dbbmckennon for consultations concerning financial accounting and reporting standards for the period from November 20, 2019 (inception) through December 31, 2020. 


Tax Fees. We did not pay dbbmckennon for tax planning and tax advice for the period from November 20, 2019 (inception) through December 31, 2020. 

All Other Fees. We did not pay dbbmckennon for other services for the period from November 20, 2019 (inception) through December 31, 2020

Pre-Approval Policy

Our audit committee was formed upon the consummation of our IPO. As a result, the audit committee did not pre-approve all of the foregoing services, although any services rendered prior to the formation of our audit committee were approved by our board of directors. Since the formation of our audit committee, and on a going-forward basis, the audit committee has and will pre-approve all auditing services and permitted non-audit services to be performed for us by our auditors, including the fees and terms thereof (subject to the de minimis exceptions for non-audit services described in the Exchange Act which are approved by the audit committee prior to the completion of the audit).

ITEM 15. EXHIBITS, FINANCIAL STATEMENTS, AND SCHEDULES

(a)The following documents are filed as part of this report:

(1)Financial Statements:

Page

EXHIBIT

DESCRIPTION

Report Of Independent Registered Public Accounting Firm

2.1(3)

F-2

Agreement and Plan of Merger, dated as of August 29, 2021 by and among Petra Acquisition, Inc., Petra Acquisition Merger Inc., and Revelation Biosciences, Inc.

Balance Sheets

3.1(3)

F-3

Statements of Operations

F-4
Statement of Changes in Stockholders’ Equity (Deficit)F-5
Statements of Cash FlowsF-6
Notes to Financial StatementsF-7-F-16

(2)Financial Statement Schedules:

None.


(b)The following Exhibits are filed as part of this report:

ExhibitDescription
3.1Certificate of Incorporation(2)
3.2SecondThird Amended and Restated Certificate of Incorporation(1)Incorporation

3.3

3.2*

Bylaws(2)Amendment to the Third Amended and Restated Certificate of Incorporation dated January 30, 2023

4.1 

3.3(3)

Specimen Unit Certificate.(2)Second Amended and Restated Bylaws.

4.2 

4.1(3)

Specimen Common Stock Certificate.(2)Certificate

4.3 

4.2(3)

Specimen Warrant Certificate.(2)Certificate

4.4

4.3(2)

Warrant Agreement, dated October 7, 2020, between Continental Stock Transfer & Trust Company and the Company(1)Company

4.5

4.4(5)

DescriptionForm of Registrant’s Securities.Unregistered Pre-Funded Common Stock Purchase Warrant dated January 25, 2022

10.1

4.5(5)

Investment Management TrustForm of Unregistered Common Stock Purchase Warrant dated January 25, 2022

4.6(5)

Form of Unregistered Placement Agent Warrant dated January 25, 2022

4.7(6)

Form of Common Stock Warrant dated July 28, 2022

4.8(6)

Form of Placement Agent Common Stock Purchase Warrant dated July 28, 2022

4.9(6)

Warrant Agency Agreement dated October 7, 2020, betweenwith Continental Stock Transfer & Trust Company and the Company.(1)Co. dated July 28, 2022

10.2

4.10(7)

EscrowForm of Class C Common Stock Warrant dated February 13, 2023

4.11(7)

Form of Pre-Funded Common Stock Purchase Warrant dated February 13, 2023

4.12(7)

Form of Warrant Agency Agreement dated October 7, 2020, by and among the Company,with Continental Stock Transfer & Trust Company and the Company’s Initial Stockholders.(1)Co. dated February 13, 2023

10.3

4.13(6)

Description of Securities

10.1(1)

Form of Letter Agreement from each of the Registrant’s sponsor, initial stockholder, officers and directors.

10.2(2)

Registration Rights Agreement, dated October 7, 2020, between the Company and Investors.(1)

10.4

10.3(2)

Subscription Agreement, dated October 7, 2020, between the Company and Petra Investment Holdings LLC(1)LLC

10.5

10.4(2)

Business Combination Marketing Agreement, dated October 7, 2020, by and among the Company, LifeSci Capital LLC, Ladenburg Thalmann & Co. Inc., Northland Securities, Inc., and Ingalls & Snyder LLC(1)LLC

10.6

10.5(2)

Escrow Agreement, dated October 7, 2020, by and among the Company, Continental Stock Transfer & Trust Company and the Company’s Initial Stockholders.

10.6(1)

Promissory Note

10.7†(3)

Revelation Biosciences, Inc. 2021 Equity Incentive Plan.

10.8(3)

Global Health Agreement by and between Revelation and AXA IM Prime Impact Fund dated December 31, 2020

10.9(3)

Executive Employment Agreement between Revelation Biosciences, Inc. and James Rolke, effective July 27, 2021

10.10(3)

Executive Employment Agreement between Revelation Biosciences, Inc. and Chester S. Zygmont, III, effective July 27, 2021

10.11(3)

Revelation Common Stock Warrant Issued to National Securities Corporation

10.12(5)

Securities Purchase Agreement dated January 23, 2022 by and between the Company and Armistice Capital Master Fund Ltd.

10.13(5)

Registration Rights Agreement dated January 23, 2022 by and between the Company and Armistice Capital Master Fund Ltd.

10.14(6)

Form of LetterSecurities Purchase Agreement from each of the Registrant’s initial shareholders, officers and directors.**dated July 28, 2022

14

10.15(6)

Form of Placement Agency Agreement dated July 28, 2022

10.16(7)

Form of Securities Purchase Agreement dated February 13, 2023

10.17(6)

Form of Lock-Up Agreement

99


10.18(7)

Form of Placement Agency Agreement Dated February 13, 2023

14.1*

Code of Ethics.(2)Ethics

31.1*

21.1(4)

List of Subsidiaries.

23.1*

Consent of Baker Tilly US, LLP, independent registered public accounting firm of Revelation Biosciences, Inc.

31.1*

Certification of Principal Executive Officer Pursuant to Securities Exchange Act Rules 13a-14(a)13a_14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

31.2*

Certification of Principal Financial Officer Pursuant to Securities Exchange Act Rules 13a-14(a)13a_14(a) and 15(d)-14(a), as adopted Pursuant to Section 302 of the Sarbanes-Oxley Act of 2002

32.1**

Certification of Principal Executive Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

32.2**

Certification of Principal Financial Officer Pursuant to 18 U.S.C. Section 1350, as adopted Pursuant to Section 906 of the Sarbanes-Oxley Act of 2002

101.INS*

99.1*

Audit Committee Charter

99.2*

Compensation Committee Charter

99.3*

Nominating Committee Charter

101.INS*

XBRL Instance Document – the instance document does not appear in the interactive data file because its XBRL tags are embedded within the Inline XBRL document.

101.CAL*

101.SCH*

Inline XBRL Taxonomy Extension Scema Document

101.CAL*

Inline XBRL Taxonomy Extension Calculation Linkbase Document

101.SCH*

101.DEF*

XBRL Taxonomy Extension Schema Document
101.DEF*

Inline XBRL Taxonomy Extension Definition Linkbase Document

101.LAB*

Inline XBRL Taxonomy Extension LabelsLabel Linkbase Document

101.PRE*

Inline XBRL Taxonomy Extension Presentation Linkbase Document

104*

Cover Page Interactive Data File (formatted as Inline XBRL and contained in Exhibit 101)

The annexes, schedules, and certain exhibits to the Agreement and Plan of Merger have been omitted pursuant to Item 601(b)(2) of Regulation S-K. Revelation hereby agrees to furnish supplementally a copy of any omitted annex, schedule or exhibit to the SEC upon request.

(1)

Previously filed as an exhibit to ourPetra Acquisition Inc.’s Registration Statement on Form S-1, as amended (File No. 333-240175).

(2)

Previously filed as an exhibit to Petra Acquisition Inc.’s Current Report on Form 8-K filed on October 13, 2020.

(2)

(3)

Previously filed as an exhibit to ourPetra Acquisition Inc.’s Current Report on Form S-4 filed, as amended (File No. 333- 259638).

(4)

Previously filed as an exhibit to Revelation Biosciences, Inc.’s Current Report on Form 8-K filed on January 14, 2022.

(5)

Previously filed as an exhibit to Revelation Biosciences, Inc.’s Current Report on Form 8-K filed on January 27, 2022.

(6)

Previously filed as an exhibit to Revelation Biosciences, Inc.’s Registration Statement on Form S-1, as amended (File No. 333-268076).

(7)

Previously filed as an exhibit to Revelation Biosciences, Inc.’s Current Report on Form 8-K filed on September 21, 2020February 13, 2023.

*Filed herewith.

+

Previously filed.

**Furnished.

*

Filed herewith.

Indicates a management contract or compensatory plan.

100


Item 16. FORMForm 10-K SUMMARYSummary.

None.Not applicable.


SIGNATURES

SIGNATURES

Pursuant to the requirements of the Section 13 or 15 or 15(d) of the Securities Exchange Act of 1934, the registrantRegistrant has duly caused this reportAnnual Report on Form 10-K to be signed on its behalf by the undersigned, thereunto duly authorized on the 31 day of March, 2021.

authorized.

PETRA ACQUISITION INC.

REVELATION BIOSCIENCES, INC.

By:

/s/ Andreas Typaldos

Date: March 30, 2023

Andreas Typaldos

By:

/s/ James Rolke

James Rolke

Chief Executive Officer

(principal executive officer)

In accordance

KNOW ALL PERSONS BY THESE PRESENTS, that each person whose signature appears below constitutes and appoints Chester S. Zygmont, III and Joseph P. Galda, jointly and severally, his or her attorney-in-fact, with the power of substitution, for him or her in any and all capacities, to sign any amendments to this Annual Report on Form 10-K and to file the same, with exhibits thereto and other documents in connection therewith, with the Securities and Exchange Commission, hereby ratifying and confirming all that each of said attorneys-in-fact, or his or her substitute or substitutes, may do or cause to be done by virtue hereof.

Pursuant to the requirements of the Securities Exchange Act of 1934, this reportAnnual Report on Form 10-K has been signed below by the following persons on behalf of the registrantRegistrant and in the capacities and on the dates indicated.

NameTitleDate

 Date: March 30, 2023

By:

/s/ James Rolke

/s/ Andreas Typaldos

Chairman and

Chief Executive Officer

and Director

Andreas Typaldos

(Principal Executive Officer)March 31, 2021

 Date: March 30, 2023

By:

/s/ George Tidmarsh

Chairman and Director

  Date: March 30, 2023

By:

/s/ Sean FitzpatrickChester S. Zygmont, III

Chief Financial Officer

and Principal Accounting Officer

Sean Fitzpatrick

(Principal Financial and Accounting Officer) and DirectorMarch 31, 2021

  Date: March 30, 2023

By:

/s/ Jennifer Carver

/s/ Anthony Hayes

Director

Anthony Hayes

March 31, 2021

  Date: March 30, 2023

By:

/s/ Jess Roper

/s/ Robert Nicholson

Director

Robert Nicholson

March 31, 2021

  Date: March 30, 2023

By:

/s/ Curt LaBelle

/s/ Barry Dennis

Director

Barry Dennis

101


INDEX TO CONSOLIDATED FINANCIAL STATEMENTS

REVELATION BIOSCIENCES, INC.

March 31, 2021
/s/ David DobkinDirector
David DobkinMarch 31, 2021
/s/ William CarsonDirector
William CarsonMarch 31, 2021


PETRA ACQUISITION, INC.

INDEX TO FINANCIAL STATEMENTS

Page
Report Ofof Independent Registered Public Accounting Firm (PCAOB ID 23)

F-2

Financial Statements:

Consolidated Balance Sheets

F-3

Balance Sheets

F-3
Consolidated Statements of Operations

F-4

StatementConsolidated Statements of Changes in Stockholders’ Equity (Deficit)

F-5

Consolidated Statements of Cash Flows

F-6

Consolidated Notes to the Financial Statements

F-7-F-16

F-7 – F-26

F-1

F-1


REPORT OF INDEPENDENT REGISTERED PUBLIC ACCOUNTING FIRM

To the Board of Directors and Stockholders of Revelation Biosciences, Inc.

Petra Acquisition, Inc.

Opinion on the Financial Statements

We have audited the accompanying consolidated balance sheetssheet of Petra Acquisition,Revelation Biosciences, Inc. (the “Company”)Company) as of December 31, 20202022 and 2019, and2021, , the related consolidated statements of operations, stockholders’changes in stockholders' equity (deficit), and cash flows for each of the yeartwo years in the period ended December 31, 2020 and the period from November 20, 2019 (inception) to December 31, 2019,2022, and the related notes (collectively, referred to as the “financial statements”)consolidated financial statements). In our opinion, the consolidated financial statements present fairly, in all material respects, the financial position of the Company as of December 31, 20202022 and 2019,2021,, and the results of its operations and its cash flows for each of the two years thenin the period ended December 31, 2022, in conformity with accounting principles generally accepted in the United States of America.

Going Concern Uncertainty

The accompanying financial statements have been prepared assuming that the Company will continue as a going concern. As discussed in Note 1 to the financial statements, the Company has incurred recurring operating losses and has no revenue sources. These conditions raise substantial doubt about the Company’s ability to continue as a going concern. Management’s plans in regard to these matters are also described in Note 1. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.

Basis for Opinion

These consolidated financial statements are the responsibility of the Company’sCompany's management. Our responsibility is to express an opinion on the Company’s consolidated financial statements based on our audits.audit. We are a public accounting firm registered with the Public Company Accounting Oversight Board (United States) (“PCAOB”)(PCAOB) and are required to be independent with respect to the Company in accordance with the U.S. federal securities laws and the applicable rules and regulations of the Securities and Exchange Commission and the PCAOB.

We conducted our audits in accordance with the standards of the PCAOB. Those standards require that we plan and perform the audit to obtain reasonable assurance about whether the consolidated financial statements are free of material misstatement, whether due to error or fraud. The Company is not required to have, nor were we engaged to perform, an audit of its internal control over financial reporting. As part of our audits, we are required to obtain an understanding of internal control over financial reporting but not for the purpose of expressing an opinion on the effectiveness of the Company’s internal control over financial reporting. Accordingly, we express no such opinion.

Our audits included performing procedures to assess the risks of material misstatement of the consolidated financial statements, whether due to error or fraud, and performing procedures that respond to those risks. Such procedures included examining, on a test basis, evidence regarding the amounts and disclosures in the consolidated financial statements. Our audits also included evaluating the accounting principles used and significant estimates made by management, as well as evaluating the overall presentation of the consolidated financial statements. We believe that our audits provide a reasonable basis for our opinion.

/s/ dbbmckennonBAKER TILLY US, LLP

We have served as the Company’s auditor since 2019.2021.

Newport Beach,San Diego, California

March 31, 202130, 2023

F-2



PETRA ACQUISITION, INC.PART I—FINANCIAL INFORMATION

BALANCE SHEETSItem 1. Consolidated Financial Statements

  December 31,
2020
  December 31,
2019
 
       
ASSETS      
Current assets:      
Cash and cash equivalents $11,734  $- 
Marketable securities  525,287   - 
Prepaid insurance  114,270   - 
Deferred offering costs  -   22,671 
Total current assets  651,291   22,671 
         
Cash held in Trust Account  73,510,915   - 
Total assets $74,162,206  $22,671 
         
LIABILITIES AND STOCKHOLDER’S EQUITY        
Current liabilities:        
Accounts payable and accrued liabilities $33,772  $16,309 
Related party advances  -   10,000 
Total current liabilities  33,772   26,309 
         
Deferred underwriting commissions  2,911,260   - 
Total liabilities  2,945,032   26,309 
         
Commitments and Contingencies  (Note 5)        
         
Common stock subject to possible redemption, 6,556,156 shares at redemption value  66,217,172   - 
         
Stockholder’s equity (deficit):        
Preferred stock, par value $0.001, 1,000,000 shares authorized; 0 issued and outstanding  -   - 
Common stock, par value $0.001, 100,000,000 shares authorized; 2,541,533 shares issued and outstanding (excluding 6,556,156 shares subject to possible redemption) as of December 31, 2020  2,542   - 
Additional paid-in capital  5,137,506   - 
Accumulated deficit  (140,046)  (3,638)
Total stockholder’s equity (deficit)  5,000,002   (3,638)
Total liabilities and stockholder’s equity $74,162,206  $22,671 

REVELATION BIOSCIENCES, INC.

TheConsolidated Balance Sheets

 

 

December 31,
2022

 

 

December 31,
2021

 

ASSETS

 

 

 

 

 

 

Current assets:

 

 

 

 

 

 

Cash and cash equivalents

 

$

5,252,979

 

 

$

1,274,729

 

Deferred offering costs

 

 

87,171

 

 

 

 

Prepaid expenses and other current assets

 

 

73,132

 

 

 

637,342

 

Total current assets

 

 

5,413,282

 

 

 

1,912,071

 

Property and equipment, net

 

 

90,133

 

 

 

115,181

 

Right-of-use lease asset

 

 

 

 

 

14,960

 

Total assets

 

$

5,503,415

 

 

$

2,042,212

 

LIABILITIES AND STOCKHOLDERS’ EQUITY (DEFICIT)

 

 

 

 

 

 

Current liabilities:

 

 

 

 

 

 

Accounts payable

 

$

554,205

 

 

$

596,261

 

Accrued expenses

 

 

985,497

 

 

 

1,528,669

 

Lease liability

 

 

 

 

 

16,752

 

Deferred underwriting commissions

 

 

2,911,260

 

 

 

 

Total current liabilities

 

 

4,450,962

 

 

 

2,141,682

 

Total liabilities

 

 

4,450,962

 

 

 

2,141,682

 

Commitments and Contingencies (Note 5)

 

 

 

 

 

 

Stockholders’ equity (deficit):

 

 

 

 

 

 

Series A Preferred Stock, $0.001 par value; one and zero shares authorized, issued and outstanding at December 31, 2022 and December 31, 2021, respectively; liquidation preference of $5,000 and $0 at December 31, 2022 and December 31, 2021, respectively

 

 

 

 

 

 

Revelation Sub Series A Preferred Stock, $0.001 par value; zero shares authorized, issued and outstanding at December 31, 2022 and December 31, 2021

 

 

 

 

 

 

Revelation Sub Series A-1 Preferred Stock, $0.001 par value; zero and 1,100,000 shares authorized at December 31, 2022 and December 31, 2021, respectively, and zero shares issued and outstanding at December 31, 2022 and December 31, 2021

 

 

 

 

 

 

Common Stock, $0.001 par value; 500,000,000 and 11,000,000 shares authorized and 682,882 and 282,039 issued and outstanding at December 31, 2022 and December 31, 2021, respectively

 

 

683

 

 

 

282

 

Additional paid-in-capital

 

 

26,398,618

 

 

 

14,417,547

 

Accumulated deficit

 

 

(25,346,848

)

 

 

(14,517,299

)

Total stockholders’ equity (deficit)

 

 

1,052,453

 

 

 

(99,470

)

Total liabilities and stockholders’ equity (deficit)

 

$

5,503,415

 

 

$

2,042,212

 

See accompanying footnotes are an integral part ofnotes to the consolidated financial statements.

F-3


REVELATION BIOSCIENCES, INC.

Consolidated Statements of Operations

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

Operating expenses:

 

 

 

 

 

 

Research and development

 

$

5,377,400

 

 

$

6,914,756

 

General and administrative

 

 

5,487,111

 

 

 

5,035,729

 

Total operating expenses

 

 

10,864,511

 

 

 

11,950,485

 

Loss from operations

 

 

(10,864,511

)

 

 

(11,950,485

)

Other income (expense):

 

 

 

 

 

 

Other income (expense)

 

 

34,962

 

 

 

(36,352

)

Total other income (expense), net

 

 

34,962

 

 

 

(36,352

)

Net loss

 

$

(10,829,549

)

 

$

(11,986,837

)

 

 

 

 

 

 

 

Net loss per share, basic and diluted

 

$

(20.09

)

 

$

(42.50

)

Weighted-average shares used to compute net loss per share, basic and diluted

 

 

539,037

 

 

 

282,035

 

See accompanying notes to the consolidated financial statements.

F-4


REVELATION BIOSCIENCES, INC.

Consolidated Statements of Changes in Stockholders’ Equity (Deficit)

 

 

Series A
Preferred Stock

 

 

Series A-1
Preferred Stock

 

 

Common Stock

 

 

Additional
Paid-in

 

 

Accumulated

 

 

Total
Stockholders’
Equity

 

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Shares

 

 

Amount

 

 

Capital

 

 

Deficit

 

 

(Deficit)

 

Balance as of December 31, 2020 (as previously reported)

 

 

628,930

 

 

$

403,733

 

 

 

 

 

$

 

 

 

65,519

 

 

$

66

 

 

$

5,538,287

 

 

$

(2,530,462

)

 

$

3,411,624

 

Retrospective application of reverse recapitalization

 

 

(628,930

)

 

 

(3,903,730

)

 

 

(684,450

)

 

 

(3,578,197

)

 

 

205,658

 

 

 

206

 

 

 

7,481,721

 

 

 

 

 

 

 

Reverse stock split fractional stock round up

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,412

 

 

 

10

 

 

 

(10

)

 

 

 

 

 

 

Balance at December 31, 2020, after effect of the Business Combination

 

 

 

 

$

(3,499,997

)

 

 

(684,450

)

 

$

(3,578,197

)

 

 

281,589

 

 

$

282

 

 

$

13,019,998

 

 

$

(2,530,462

)

 

$

3,411,624

 

Issuance of common stock

 

 

 

 

 

 

 

 

 

 

 

 

 

 

450

 

 

 

 

 

 

99,998

 

 

 

 

 

 

99,998

 

Issuance of Revelation Sub Series A-1 Preferred Stock, net

 

 

 

 

 

 

 

 

684,450

 

 

 

3,904,872

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,904,872

 

Issuance of Warrants in connection with the issuance of the Revelation Sub Series A-1 Preferred Stock

 

 

 

 

 

 

 

 

 

 

 

(326,675

)

 

 

 

 

 

 

 

 

326,675

 

 

 

 

 

 

 

Payment for Revelation Sub Series A Preferred Stock subscribed

 

 

 

 

 

3,499,997

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,499,997

 

Payment for common stock subscribed

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

499,998

 

 

 

 

 

 

499,998

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

470,878

 

 

 

 

 

 

470,878

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(11,986,837

)

 

 

(11,986,837

)

Balance as of December 31, 2021, after effect of the Business Combination

 

 

 

 

$

 

 

 

 

 

$

 

 

 

282,039

 

 

$

282

 

 

$

14,417,547

 

 

$

(14,517,299

)

 

$

(99,470

)

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Balance as of December 31, 2021 (as previously reported)

 

 

628,930

 

 

$

3,903,730

 

 

 

684,450

 

 

$

3,578,197

 

 

 

65,969

 

 

$

66

 

 

$

6,935,836

 

 

$

(14,517,299

)

 

$

(99,470

)

Retrospective application of reverse recapitalization

 

 

(628,930

)

 

 

(3,903,730

)

 

 

(684,450

)

 

 

(3,578,197

)

 

 

205,658

 

 

 

206

 

 

 

7,481,721

 

 

 

 

 

 

 

Reverse stock split fractional stock round up

 

 

 

 

 

 

 

 

 

 

 

 

 

 

10,412

 

 

 

10

 

 

 

(10

)

 

 

 

 

 

 

Balance at December 31, 2021, after effect of the Business Combination

 

 

 

 

$

 

 

 

 

 

$

 

 

 

282,039

 

 

$

282

 

 

$

14,417,547

 

 

$

(14,517,299

)

 

$

(99,470

)

Issuance of common stock in connection with the Business Combination, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

98,209

 

 

 

98

 

 

 

6,864,229

 

 

 

 

 

 

6,864,327

 

Issuance of common stock for fees in connection with the Business Combination

 

 

 

 

 

 

 

 

 

 

 

 

 

 

8,572

 

 

 

9

 

 

 

291

 

 

 

 

 

 

300

 

Proceeds from the PIPE Investment, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

36,947

 

 

 

37

 

 

 

7,262,182

 

 

 

 

 

 

7,262,219

 

Rollover Warrant exercise

 

 

 

 

 

 

 

 

 

 

 

 

 

 

54

 

 

 

 

 

 

5,074

 

 

 

 

 

 

5,074

 

Repurchase for the Forward Share Purchase Agreement exercise

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(21,429

)

 

 

(21

)

 

 

(7,652,304

)

 

 

 

 

 

(7,652,325

)

Pre-Funded Warrants exercise

 

 

 

 

 

 

 

 

 

 

 

 

 

 

36,959

 

 

 

37

 

 

 

(24

)

 

 

 

 

 

13

 

Proceeds from the July 2022 Public Offering, net

 

 

 

 

 

 

 

 

 

 

 

 

 

 

238,096

 

 

 

238

 

 

 

4,450,810

 

 

 

 

 

 

4,451,048

 

RSU awards issued

 

 

 

 

 

 

 

 

 

 

 

 

 

 

3,435

 

 

 

3

 

 

 

(3

)

 

 

 

 

 

 

Issuance of common stock for Accrued Expenses in connection with the Business Combination

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

749,700

 

 

 

 

 

 

749,700

 

Issuance of Series A Preferred Stock

 

 

1

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

Stock-based compensation expense

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

301,116

 

 

 

 

 

 

301,116

 

Net loss

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

 

(10,829,549

)

 

 

(10,829,549

)

Balance as of December 31, 2022

 

 

1

 

 

$

 

 

 

 

 

$

 

 

 

682,882

 

 

$

683

 

 

$

26,398,618

 

 

$

(25,346,848

)

 

$

1,052,453

 

See accompanying notes to the consolidated financial statements.

F-5


REVELATION BIOSCIENCES, INC.

Consolidated Statements of Cash Flows

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

Cash flows from operating activities:

 

 

 

 

 

 

Net loss

 

$

(10,829,549

)

 

$

(11,986,837

)

Adjustments to reconcile net loss to net cash used in operating activities:

 

 

 

 

 

 

Stock-based compensation expense

 

 

301,116

 

 

 

470,878

 

Depreciation expense

 

 

25,048

 

 

 

16,782

 

Non-cash lease expense

 

 

14,960

 

 

 

52,384

 

Changes in operating assets and liabilities:

 

 

 

 

 

 

Prepaid expenses and other current assets

 

 

569,044

 

 

 

(509,342

)

Deferred offering costs

 

 

(61,154

)

 

 

 

Accounts payable

 

 

(666,042

)

 

 

(269,640

)

Accrued expenses

 

 

(592,987

)

 

 

1,185,794

 

Operating lease liability

 

 

(16,752

)

 

 

(50,592

)

Accrued interest on Promissory Notes Payable & Convertible Note

 

 

36,920

 

 

 

 

Net cash used in operating activities

 

 

(11,219,396

)

 

 

(11,090,573

)

Cash flows from investing activities:

 

 

 

 

 

 

Purchase of property and equipment

 

 

 

 

 

(131,963

)

Net cash used in investing activities

 

 

 

 

 

(131,963

)

Cash flows from financing activities:

 

 

 

 

 

 

Proceeds from the Convertible Note

 

 

2,500,000

 

 

 

 

Repayment of the Convertible Note

 

 

(2,500,000

)

 

 

 

Proceeds from the Business Combination, net

 

 

11,923,499

 

 

 

 

Proceeds from the PIPE Investment, net

 

 

7,262,219

 

 

 

 

Proceeds from Rollover Warrant exercise

 

 

5,074

 

 

 

 

Repurchase for the Forward Share Purchase Agreement exercise

 

 

(7,652,325

)

 

 

 

Repayments of Promissory Notes Payable, including interest

 

 

(796,882

)

 

 

 

Proceeds from Pre-Funded Warrants exercise

 

 

13

 

 

 

 

Proceeds from the July 2022 Public Offering, net

 

 

4,451,048

 

 

 

 

Proceeds from issuance of common stock, net

 

 

 

 

 

599,996

 

Proceeds from issuance of Series A Preferred Stock

 

 

5,000

 

 

 

 

Proceeds from issuance of Revelation Sub Series A Preferred Stock, net

 

 

 

 

 

3,499,997

 

Proceeds from issuance of Revelation Sub Series A-1 Preferred Stock, net

 

 

 

 

 

3,904,872

 

Net cash provided by financing activities

 

 

15,197,646

 

 

 

8,004,865

 

Net increase (decrease) in cash and cash equivalents

 

 

3,978,250

 

 

 

(3,217,671

)

Cash and cash equivalents at beginning of period

 

 

1,274,729

 

 

 

4,492,400

 

Cash and cash equivalents at end of period

 

$

5,252,979

 

 

$

1,274,729

 

 

 

 

 

 

 

 

Supplemental disclosure of non-cash investing and financing activities:

 

 

 

 

 

 

Deferred offering costs included in accounts payable and accrued expenses

 

$

26,017

 

 

$

 

Current liabilities assumed in the Business Combination

 

$

2,149,432

 

 

$

 

Deferred underwriting commissions assumed in the Business Combination

 

$

2,911,260

 

 

$

 

Conversion of Revelation Sub Series A Preferred Stock to common stock

 

$

3,903,730

 

 

$

 

Conversion of Revelation Sub Series A-1 Preferred Stock to common stock

 

$

3,578,197

 

 

$

 

Equity Issuance for fees in connection with the Business Combination

 

$

300

 

 

$

 

Issuance of Class A Common Stock Warrants in connection with the PIPE Investment

 

$

3,634,262

 

 

$

 

Issuance of Class A Placement Agent Common Stock Warrants in connection with the PIPE Investment

 

$

508,797

 

 

$

 

Conversion of Accrued Expenses to Equity in connection with the Business Combination

 

$

749,700

 

 

$

 

Issuance of Class B Common Stock Warrants in connection with the July 2022 Public Offering

 

$

4,490,457

 

 

$

 

Issuance of Class B Placement Agent Common Stock Warrants in connection with the July 2022 Public Offering

 

$

310,137

 

 

$

 

Acquisition of right-of-use asset through operating lease obligation

 

$

 

 

$

67,344

 

Issuance of warrants in connection with Revelation Sub Series A-1 Preferred Stock

 

$

 

 

$

326,675

 

 

 

 

 

 

 

 

See accompanying notes to the consolidated financial statements.

F-6


REVELATION BIOSCIENCES, INC.

Notes to the Consolidated Financial Statements

F-3

PETRA ACQUISITION, INC.

STATEMENTS OF OPERATIONS

  For the Year Ended  For the Period from Inception (November 20,
2019) Through
 
  December 31,
2020
  December 31,
2019
 
       
Operating expenses:      
General and administrative $145,492  $3,638 
Loss from operations  (145,492)  (3,638)
         
Other income (expense):        
Interest income  9,325   - 
Unrealized loss on marketable securities  (1,831)  - 
Interest earned on cash held in Trust Account  1,590   - 
Other income, net  9,084   - 
         
Loss before income taxes  (136,408)  (3,638)
Benefit from  income taxes  -   - 
         
Net loss $(136,408) $(3,638)
         
Weighted-average common shares outstanding, basic and diluted  4,373,660   - 
Basic and diluted net income per common share $(0.03) $- 

The accompanying footnotes are an integral part of the financial statements.

F-4

PETRA ACQUISITION, INC.

STATEMENT OF STOCKHOLDERS’ DEFICIT

              Total 
        Additional     Stockholder’s 
  Common Stock  Paid-in  Accumulated  Equity 
  Shares  Amount  Capital  Deficit  (Deficit) 
                
Balance at November 20, 2019 (Inception)  -  $-  $-  $-  $- 
Net loss              (3,638)  (3,638)
Balance at December 31, 2019  -   -   -   (3,638)  (3,638)
Sale of common stock to sponsors (Note 4)  3,593,750   3,594   21,406       25,000 
Cancellation of founders’ shares  (1,774,212)  (1,774)  1,774       - 
Sale of common stock in public offering  7,278,151   7,278   68,202,756       68,210,034 
Sale of private placement warrants          3,233,446       3,233,446 
Common stock subject to possible redemption  (6,556,156)  (6,556)  (66,321,876)      (66,328,432)
Net loss              (136,408)  (136,408)
Balance at December 31, 2020  2,541,533  $2,542  $5,137,506  $(140,046) $5,000,002 

The accompanying footnotes are an integral part of the financial statements.

F-5

PETRA ACQUISITION, INC.

STATEMENT OF CASH FLOWS

  For the Year Ended  For the Year Ended 
  December 31,
2020
  December 31,
2019
 
       
CASH FLOWS FROM OPERATING ACTIVITIES:      
Net loss  (136,408) $(3,638)
Adjustments to reconcile net loss to net cash used in operating activities:        
Unrealized loss on marketable securities  1,831   - 
Changes in operating assets and liabilities:        
Changes in prepaid insurance  (114,270)    
Changes in accounts payable and accrued liabilities  30,134   3,638 
Net cash used in operating activities  (218,713)  - 
         
CASH FLOWS FROM INVESTING ACTIVITIES:        
Investment of cash in Trust Account  (73,510,915)  - 
Investment in marketable securities  (527,118)    
Net cash used in investing activities  (74,038,033)  - 
         
CASH FLOWS FROM FINANCING ACTIVITIES:        
Proceeds from related party advances  150,000   10,000 
Repayments of advances  (150,000)  - 
Proceeds from notes payable - related party  140,000   - 
Repayments of notes payable - related party  (125,000)  - 
Cash proceeds received for private warrants  3,233,446   - 
Cash proceeds received for public offering  71,325,880   - 
Offering costs  (305,846)  (10,000)
   74,268,480   - 
         
NET CHANGE IN CASH  11,734   - 
Cash - Beginning of period  -   - 
Cash - End of period  11,734  $- 
         
SUPPLEMENTAL CASH FLOW INFORMATION:        
Non-cash investing and financing activities:        
Deferred offering costs in accrued liabilities $-  $12,671 
Common stock issued in partial relief of related party note payable $25,000  $- 
Cancellation of founders’ shares $1,774  $- 
Deferred underwriting commissions $2,911,260  $- 
Advance converted to related party note payable $10,000  $- 

The accompanying footnotes are an integral part of the financial statements.

F-6

PETRA ACQUISITION, INC.

NOTES TO FINANCIAL STATEMENTS

DECEMBER 31, 2020

Note 1 –Nature of Operations,1. Organization and Basis of Presentation and Summary of Significant Accounting Policies

Revelation Biosciences, Inc. (collectively with its wholly-owned subsidiaries, the “Company” or “Revelation”), formerly known as Petra Acquisition, Inc. (the “Company” or “Petra”(“Petra”), was incorporated in Delaware on November 20, 2019. The Company was formed for the purpose of entering into a merger, share exchange, asset acquisition, stock purchase, recapitalization, reorganization or similar business combination with one or more businesses or entitiesentities. On January 10, 2022 (the “Closing Date”) the Company consummated its business combination, with Revelation Biosciences Sub, Inc. (“Old Revelation” or “Revelation Sub”), the Company's wholly owned subsidiary (the “Business Combination”). The Company is not limited to a particular industry or sector for purposes of consummating aSince the Business Combination. The Company is an early stage and emerging growth company and, as such,Combination, the Company is subject toa clinical-stage biopharmaceutical company and has been focused on the development and commercialization of immunologic therapeutics and diagnostics.

The Business Combination was accounted for as a reverse recapitalization with Revelation Sub as the accounting acquirer and Petra as the acquired company for accounting purposes. Accordingly, all historical financial information presented in the audited consolidated financial statements represents the accounts of Revelation Sub as if Revelation Sub is the risks associated with early stage and emerging growth companies.

As of December 31, 2020, the Company had not commenced any operations. All activity for the period from November 20, 2019 (Inception) through December 31, 2020 relatespredecessor to the Company’s formationCompany. The common stock and net loss per share, prior to the initial public offering (“Initial Public Offering”), which is described below. The Company will not generate any operating revenues until afterMerger, have been retroactively restated as common stock and net loss per share reflecting the completion of aexchange ratio established in the Business Combination at(the “Common Stock Exchange Ratio”).

Petra’s Common Stock, Public Warrants and Units were historically listed on the earliest. The Company will generate non-operating income inNasdaq Capital Market under the form of interest income from the proceeds derived from the Initial Public Offering. The Company has selected December 31 as its fiscal year end.

The registration statement forsymbols “PAIC,” “PAICW” and “PAICU,” respectively. On January 10, 2022, the Company’s Initial Public Offering became effectiveunits, common stock and warrants were listed on October 7, 2020. the Nasdaq Capital Market under the symbols “REVBU”, “REVB” and “REVBW”, respectively, (see Note 3).

On OctoberJanuary 13, 2020,2023, the Company consummated the Initial Public Offering of 7,000,000Company’s units (the “Units” and, with respect to the shareswere mandatorily separated into one share of common stock included inand one Public Warrant and ceased trading on the Units sold,Nasdaq Capital Market.

On January 30, 2023, the “Public Shares”) at $10.00 per Unit, generating gross proceedsCompany filed a Certificate of $70,000,000, which is described in Note 3.

Simultaneously with the closingAmendment of the Initial Public Offering, the Company consummated the sale of 3,150,000 warrants (the “Private Placement Warrants”) at a price of $1.00 per Private Placement Warrant in a private placement to Petra Investment Holdings, LLC, a Delaware limited liability company (the “Sponsor”), for gross proceeds of $3,150,000. The funds for the Private Placement Warrants had been placed in our Trust account in anticipation of the exercise prior to September 30, 2020.

Transaction costs amounted to $4,682,736, consisting of $4,366,980 of underwriting discounts ($2,911,260 of which payment is deferred) and $315,846 of professional fees, printing, filing, regulatory and other costs which have been charged to additional paid in capital upon completion of the Initial Public Offering.

Following the closing of the Initial Public Offering on October 13, 2020, an amount of $70,700,000 ($10.00 per Unit, plus $700,000 trust deposit premium) from the net proceeds of the sale of the Units in the Initial Public Offering and the sale of the Private Placement Warrants was placed in a trust account (the “Trust Account”) which are to be invested in U.S. government securities, within the meaning set forth in Section 2(a)(16) of the Investment Company Act, with a maturity of 185 days or less or in any open-ended investment company that holds itself out as a money market fund selected by the Company meeting the conditions of Rule 2a-7 of the Investment Company Act of 1940, as amended (the “Investment Company Act”), as determined by the Company, until the earlier of: (i) the consummation of a Business Combination and (ii) the distribution of the funds in the Trust Account, as described below.

The Company’s management has broad discretion with respect to the specific application of the net proceeds of the Initial Public Offering and the sale of the private warrants, although substantially all of the net proceeds are intended to be applied generally toward consummating a Business Combination. There is no assurance that the Company will be able to complete a Business Combination successfully. The Company must complete a Business Combination having an aggregate fair market value of at least 80% of the assets held in the Trust Account (as defined below) (excluding taxes payable on income earned on the Trust Account) at the time of the agreement to enter into an initial Business Combination. The Company will only complete a Business Combination if the post-transaction company owns or acquires 50% or more of the outstanding voting securities of the target or otherwise acquires a controlling interest in the target sufficient for it not to be required to register as an investment company under the Investment Company Act 1940, as amended (the “Investment Company Act”).


The Company will provide its holders of the outstanding Public Shares (the “Public Stockholders”) with the opportunity to redeem all or a portion of their Public Shares upon the completion of a Business Combination either (i) in connection with a stockholder meeting called to approve the Business Combination or (ii) by means of a tender offer. The decision as to whether the Company will seek stockholder approval of a Business Combination or conduct a tender offer will be made by the Company, solely in its discretion. The Public Stockholders will be entitled to redeem their Public Shares for a pro rata portion of the amount then in the Trust Account (initially anticipated to be $10.10 per Public Share, plus any pro rata interest earned on the funds held in the Trust Account and not previously released to the Company to pay its franchise and income tax obligations and up to $250,000 per 12-month period for working capital requirements). There will be no redemption rights upon the completion of a Business Combination with respect to the Company’s warrants.

The Company will proceed with a Business Combination if the Company has net tangible assets of at least $5,000,001 upon such consummation of a Business Combination and, if the Company seeks stockholder approval, a majority of the shares voted are voted in favor of the Business Combination. If a stockholder vote is not required by law and the Company does not decide to hold a stockholder vote for business or other legal reasons, the Company will, pursuant to itsThird Amended and Restated Certificate of Incorporation (the “Amended“Certificate of Amendment”) reflecting the change in authorized shares of common stock from 100,000,000 to 500,000,000 and Restated Certificateeffecting a reverse stock split as of Incorporation”12:01 a.m. Eastern Standard Time on February 1, 2023 with a ratio of 1-for-35 (the “Reverse Split”), conduct. As a result of the redemptions pursuantReverse Split, every 35 shares of the Company’s issued and outstanding common stock automatically converted into one share of common stock, without any change in the par value per share. No fractional shares will be outstanding following the Reverse Split. Any holder who would have received a fractional share of common stock will automatically be entitled to receive an additional fraction of a share of common stock to round up to the tender offer rulesnext whole share. In addition, effective as of the U.S. Securitiessame time as the Reverse Split, proportionate adjustments were made to all then-outstanding equity awards and Exchange Commission (“SEC”) and file tender offer documents with the SEC prior to completing a Business Combination. If, however, stockholder approval of the transaction is required by law, or the Company decides to obtain stockholder approval for business or legal reasons, the Company will offer to redeem shares in conjunction with a proxy solicitation pursuant to the proxy rules and not pursuant to the tender offer rules. If the Company seeks stockholder approval in connection with a Business Combination, the Company’s Sponsor have agreed to vote their Founder Shares (See Notes 4 and 6), and any Public Shares purchased during or after the Initial Public Offering in favor of approving a Business Combination and not to convert any shares in connection with a stockholder vote to approve a Business Combination or sell any shares to the Company in a tender offer in connection with a Business Combination. Additionally, each public stockholder may elect to redeem their Public Shares irrespective of whether they vote for or against the proposed transaction or don’t vote at all.

The Sponsor has agreed (a) to waive their redemption rightswarrants with respect to their Founder Sharesthe number of shares of common stock subject to such award or warrant and Public Shares held bythe exercise price thereof. Furthermore, the number of shares of common stock available for issuance under the Company’s equity incentive plans were proportionately adjusted for the Reverse Split ratio, such that fewer shares will be subject to such plans. All share numbers and preferred stock conversion numbers included herein have been retroactively adjusted to reflect the 1-for-35 Reverse Split. (See Note 10).

The Company has incurred recurring losses since its inception, including a net loss of $10.8 million for the year ended December 31, 2022. As of December 31, 2022, the Company had an accumulated deficit of $25.3 million, a stockholders’ equity of $1.1 million and available cash and cash equivalents of $5.3 million. The Company expects to continue to incur significant operating and net losses, as well as negative cash flows from operations, for the foreseeable future as it continues to complete all necessary product development or future commercialization efforts. The Company has never generated revenue and does not expect to generate revenue from product sales unless and until it successfully completes development and obtains regulatory approval for REVTx-300, REVTx-100, REVTx-200, REVTx-99b, REVDx-501 or other product candidates, which the Company expects will not be for at least several years, if ever. Additionally, taking into consideration the net proceeds of approximately $14.0 million received in connection with the completionpublic offering completed in February of a Business Combination, (b) to waive their rights to liquidating distributions from the Trust Account with respect to the Founder Shares if the Company fails to consummate a Business Combination, and (c) not to propose an amendment to the Amended and Restated Certificate of Incorporation that would affect a public stockholder’s ability to convert or sell their shares to the Company in connection with a Business Combination or affect the substance or timing of the Company’s obligation to redeem 100% of its Public Shares if2023, the Company does not completeanticipate that its current cash and cash equivalents balance will be sufficient to sustain

F-7


operations within one year after the date that the Company’s audited financial statements for December 31, 2022 were issued, which raises substantial doubt about its ability to continue as a Business Combination, unlessgoing concern.

To continue as a going concern, the Company provides the public stockholders with the opportunitywill need, among other things, to redeem their Public Shares in conjunction with any such amendment.

raise additional capital resources. The Company will have until 12 months fromplans to seek additional funding through public or private equity or debt financings. The Company may not be able to obtain financing on acceptable terms, or at all. The terms of any financing may adversely affect the closingholdings or the rights of the Initial Public Offering to complete a Business Combination (the “Combination Period”).Company’s stockholders. If the Company is unable to complete a Business Combination withinobtain funding, it could be required to delay, reduce or eliminate research and development programs, product portfolio expansion or future commercialization efforts, which could adversely affect the Combination Period,Company’s business operations.

The audited consolidated financial statements for December 31, 2022, have been prepared on the basis that the Company will (i) cease all operations except forcontinue as a going concern, and does not include any adjustments to reflect the purpose of winding up, (ii) as promptly as reasonably possible but not more than ten business days thereafter, redeem the Public Shares, at a per-share price, payable in cash, equal to the aggregate amount then on deposit in the Trust Account including interest earnedfuture effects on the funds held inrecoverability and classification of assets or the Trust Accountamounts and not previously released toclassification of liabilities that may result from the possible inability for the Company to pay franchise and income taxes, divided by the number of then outstanding Public Shares, which redemption will completely extinguish public stockholders’ rightscontinue as stockholders (including the right to receive further liquidating distributions, if any), subject to applicable law, and (iii) as promptly as reasonably possible following such redemption, subject to the approval of the Company’s remaining stockholders and the Company’s board of directors, dissolve and liquidate, subject in each case to the Company’s obligations under Delaware law to provide for claims of creditors and the requirements of other applicable law. There will be no redemption rights or liquidating distributions with respect to the Company’s warrants, which will expire worthless if the Company fails to complete a Business Combination within the Combination Period.going concern.


In order to protect the amounts held in the Trust Account, the Sponsor has agreed to be liable to the Company if and to the extent any claims by a third party for services rendered or products sold to the Company, or a prospective target business with which the Company has discussed entering into a transaction agreement, reduce the amount of funds in the Trust Account to below $10.10 per Public Share, except as to any claims by a third party who executed a valid and enforceable agreement with the Company waiving any right, title, interest or claim of any kind they may have in or to any monies held in the Trust Account and except as to any claims under the Company’s indemnity of the underwriters of Initial Public Offering against certain liabilities, including liabilities under the Securities Act of 1933, as amended (the “Securities Act”). Moreover, in the event that an executed waiver is deemed to be unenforceable against a third party, the Insiders will not be responsible to the extent of any liability for such third-party claims. The Company will seek to reduce the possibility that the Insiders will have to indemnify the Trust Account due to claims of creditors by endeavoring to have all vendors, service providers, prospective target businesses or other entities with which the Company does business, execute agreements with the Company waiving any right, title, interest or claim of any kind in or to monies held in the Trust Account.

Basis of Presentation

The accompanying financial statement is presentedstatements are prepared in in conformityaccordance with U.S. generally accepted accounting principles generally accepted(“GAAP”). All inter-company transactions and balances have been eliminated in consolidation. Certain amounts previously reported in the United States of America (“GAAP”) and pursuantfinancial statements have been reclassified to conform to the rules and regulationscurrent year presentation. Such reclassifications did not affect net loss, stockholders’ deficit or cash flows.

2. Summary of the SEC.Significant Accounting Policies

Emerging Growth Company

The Company is an “emerging growth company,” as defined in Section 2(a) of the Securities Act, as modified by the Jumpstart Our Business Startups Act of 2012 (the “JOBS Act”), and it may take advantage of certain exemptions from various reporting requirements that are applicable to other public companies that are not emerging growth companies including, but not limited to, not being required to comply with the independent registered public accounting firm attestation requirements of Section 404 of the Sarbanes-Oxley Act, reduced disclosure obligations regarding executive compensation in its periodic reports and proxy statements, and exemptions from the requirements of holding a nonbinding advisory vote on executive compensation and stockholder approval of any golden parachute payments not previously approved.

Further, Section 102(b)(1) of the JOBS Act exempts emerging growth companies from being required to comply with new or revised financial accounting standards until private companies (that is, those that have not had a Securities Act registration statement declared effective or do not have a class of securities registered under the Exchange Act) are required to comply with the new or revised financial accounting standards. The JOBS Act provides that a company can elect to opt out of the extended transition period and comply with the requirements that apply to non-emerging growth companies but any such election to opt out is irrevocable. The Company has elected not to opt out of such extended transition period which means that when a standard is issued or revised and it has different application dates for public or private companies, the Company, as an emerging growth company, can adopt the new or revised standard at the time private companies adopt the new or revised standard. This may make comparison of the Company’s financial statement with another public company which is neither an emerging growth company nor an emerging growth company which has opted out of using the extended transition period difficult or impossible because of the potential differences in accounting standards used.

Use of Estimates

The preparation of the consolidated financial statementstatements in conformityaccordance with GAAP requires the Company’s management to make estimates and assumptions about future events that affect the reported amounts of assets and liabilities and disclosure ofreported, disclosures about contingent assets and liabilities, at the date of the financial statement and the reported amounts of revenuesexpenses. These estimates and expenses duringassumptions are based on the reporting period.

MakingCompany’s best estimates requires management to exercise significantand judgment. It is at least reasonably possible that the estimate of the effect of a condition, situation or set of circumstances that existed at the date of the financial statement, which management considered in formulatingThe Company regularly evaluates its estimate, could change in the near term due to one or more future confirming events. Accordingly, theestimates and assumptions using historical and industry experience and other factors; however, actual results could differ significantlymaterially from those estimates.these estimates and could have an adverse effect on the Company’s consolidated financial statements.

Cash and cash equivalentsCash Equivalents

The Company considers all short-termhighly liquid investments purchased with an original maturitymaturities of three months or less when purchasedfrom the purchase date to be cash equivalents. AssetsThe Company maintains its cash in checking and savings accounts. Income generated from cash held in the Trust Account are held in cashsavings accounts is recorded as of December 31, 2020.


Marketable Securities Held in Trust and Operating Account

At December 31, 2020, the assets held in the Trust Account were substantially held in U.S. Treasury Bills. During the year ended December 31, 2020, the Company withdrew no interest income or withdrawals from the Trust Account Common Stock Subject to Possible Redemption.

At December 31, 2020, the marketable securities held in the Company’s operating account were investments that substantially hold bonds and fixed income securities.

Common Stock Subject to Possible Redemption

income. The Company accounts for its common stock subject to possible redemption in accordance with the guidance in Accounting Standards Codification (“ASC”) Topic 480 “Distinguishing Liabilities from Equity.” Common stock subject to mandatory redemption is classified as a liability instrument and is measured at fair value. Conditionally redeemable common stock (including common stock that feature redemption rights that is either within the control of the holder or subject to redemption upon the occurrence of uncertain events not solely within the Company’s control) is classified as temporary equity. At all other times, common stock is classified as stockholders’ equity. The Company’s common stock features certain redemption rights that are considered to be outsidecarrying value of the Company’s controlsavings accounts is included in cash and approximates the fair value.

Concentrations of Credit Risk

Financial instruments that potentially subject the Company to occurrencea concentration of uncertain future events. Accordingly, common stock subject to possible redemption is presentedcredit risk consist primarily of cash and cash equivalents. Bank deposits are held by accredited financial institutions and these deposits may at redemption valuetimes be in excess of federally insured limits. The Company limits its credit risk associated with cash and cash equivalents by placing them with financial institutions that it believes are of high quality. The Company has not experienced any losses on its deposits of cash or cash equivalents.

Deferred Offering Costs

The Company capitalizes certain legal, professional accountingand other third-party fees that are directly associated with in-process equity financings as temporary equity, outsidedeferred offering costs until such financings are consummated. After consummation of the stockholders’ equity sectionfinancing, these costs are recorded as a reduction of the proceeds generated as a result of the offering. Should the planned equity financing be abandoned, the deferred offering costs will be expensed immediately as a charge to operating expenses in the statements of operations.

F-8


Property and Equipment, Net

Property and equipment are stated at cost less accumulated depreciation. Depreciation is computed using the straight-line method over the estimated useful lives of the assets, which is five years. Maintenance and repairs are charged to operating expense as incurred. When assets are sold, or otherwise disposed of, the cost and related accumulated depreciation are removed from the accounts, and any gain or loss is included in other income (expense).

Leases

The Company determines if an arrangement is a lease at inception. Lease right-of-use assets represent the right to use an underlying asset for the lease term and lease liabilities represent the obligation to make lease payments arising from the lease. For operating leases with an initial term greater than 12 months, the Company recognizes operating lease right-of-use assets and operating lease liabilities based on the present value of lease payments over the lease term at the commencement date. Operating lease right-of-use assets are comprised of the lease liability plus any lease payments made and excludes lease incentives. Lease terms include options to renew or terminate the lease when the Company is reasonably certain that the renewal option will be exercised or when it is reasonably certain that the termination option will not be exercised. For an operating lease, if the interest rate used to determine the present value of future lease payments is not readily determinable, the Company estimates the incremental borrowing rate as the discount rate for the lease. The Company’s incremental borrowing rate is estimated to approximate the interest rate on a collateralized basis with similar terms and payments, and in similar economic environments. Lease expense for lease payments is recognized on a straight-line basis over the lease term.

Research and Development Expenses

Research and development expenses consist primarily of costs incurred for the development of the Company’s condensed balance sheets.

Offering Costs

Offeringproduct candidates, REVTx-300, REVTx-100, REVTx-200, REVTx-99a/b and diagnostic product, REVDx-501. Research and development costs consist of underwriting discounts, professional fees, printing, filing, regulatoryare charged to expense as incurred. The Company records accrued expenses for estimated preclinical, clinical study and other costs incurred through the balance sheet date that are directlyresearch expenses related to the Initial Public Offering.services performed but not yet invoiced pursuant to contracts with research institutions, contract research organizations, and clinical manufacturing organizations that conduct and manage preclinical studies, clinical studies, research services, and development services on the Company’s behalf. Payments for these services are based on the terms of individual agreements and payment timing may differ significantly from the period in which the services were performed. Estimates are based on factors such as the work completed, including the level of patient enrollment. The deferred offeringCompany monitors patient enrollment levels and related activity to the extent reasonably possible and makes judgments and estimates in determining the accrued balance in each reporting period. The Company’s estimates of accrued expenses are based on the facts and circumstances known at the time. If the Company underestimates or overestimates the level of services performed or the costs were offset againstof these services, actual expenses could differ from estimates. As actual costs become known, the IPOCompany adjusts accrued expenses. To date, the Company has not experienced significant changes in estimates of clinical study and overallotment proceedsdevelopment services accruals.

Patent Costs

Legal costs in connection with approved patents and were reclassifiedpatent applications are expensed as incurred, as recoverability of such expenditures is uncertain. These costs are recorded in general and administrative expense in the statements of operations.

Stock-based Compensation

The Company recognizes compensation expense related to additional paid-in capital upon completionstock options, third-party warrants, and Restricted Stock Unit (“RSU”) awards granted, based on the estimated fair value of the IPOstock-based awards on the date of grant. The fair value of employee stock options and overallotment transaction duringthird-party warrants are generally determined using the year end December 31, 2020.Black-Scholes option-pricing model using various inputs, including estimates of historic volatility, term, risk-free rate, and future dividends. The grant date fair value of the stock-based awards, which have graded vesting, is recognized using the straight-line method over the requisite service period of each stock-based award, which is

F-9


Income Taxes

generally the vesting period of the respective stock-based awards. The Company followsrecognizes forfeitures as they occur.

Income Taxes

Income taxes are accounted for under the asset and liability method. Under this method, of accounting for income taxes under ASC 740, “Income Taxes.” Deferreddeferred tax assets and liabilities are recognized for the estimated future tax consequences attributable to differences between the financial statement carrying amounts of existing assets and liabilities and their respective tax bases.bases and operating loss and tax credit carryforwards. Deferred tax assets and liabilities are measured using enacted tax rates expected to applyapplied to taxable income in the years in which those temporary differences are expected to be recovered or settled.realized. The effect on deferred tax assets and liabilities of a change in tax rates is recognized inas income or loss in the period that includedincludes the enactment date. Valuation allowances areA valuation allowance is established when necessary to reduce deferred tax assets to the amount expected to be realized.

ASC 740 prescribes a recognition threshold and a measurement attribute for the financial statement recognition and measurement of tax positions taken or expected to be taken in a tax return. For those benefits to be recognized, a tax position must be more likely than not to be sustained upon examination by taxing authorities. The Company recognizes accrued interest Interest and penalties related to unrecognized tax benefits asare included within the provision of income tax expense. There were tax. To date, there have been no unrecognized tax benefits balances.

Basic and no amounts accrued for interest and penalties as of December 31, 2020 and 2019. The Company is currently not aware of any issues under review that could result in significant payments, accruals or material deviation from its position. The Company is subject to income tax examinations by major taxing authorities since inception.

On March 27, 2020, the CARES Act was enacted in response to COVID-19 pandemic. Under ASC 740, the effects of changes in tax rates and laws are recognized in the period which the new legislation is enacted. The CARES Act made various tax law changes including among other things (i) increasing the limitation under Section 163(j) of the Internal Revenue Code of 1986, as amended (the “IRC”) for 2019 and 2020 to permit additional expensing of interest (ii) enacting a technical correction so that qualified improvement property can be immediately expensed under IRC Section 168(k), (iii) making modifications to the federal net operating loss rules including permitting federal net operating losses incurred in 2019 and 2020 to be carried back to the five preceding taxable years in order to generate a refund of previously paid income taxes and (iv) enhancing the recoverability of alternative minimum tax credits.


Diluted Net Loss per Common Share

NetBasic net loss per common share is computedcalculated by dividing net loss by the weighted averageweighted-average number of common shares outstanding for the period. The Company applies the two-class method in calculating earnings per share. Shares of common stock subject to possible redemption at December 31, 2020, whichoutstanding during the period, without consideration of potential shares of common stock. Diluted net loss per share is calculated by dividing net loss by the weighted-average number of shares of common stock outstanding plus potential shares of common stock. Convertible preferred stock on an as converted basis, unvested and unissued RSU awards, warrants and stock options outstanding are not currently redeemableconsidered potential shares of common stock and are not redeemable at fair value, have beenincluded in the calculation of diluted net loss per share using the treasury stock method when their effect is dilutive. Potential shares of common stock are excluded from the calculation of basicdiluted net loss per share when their effect is anti-dilutive. As of December 31, 2022 and 2021, there were 660,956 and 17,946 potential shares of common stock, respectively, (see Note 10), that were excluded from the calculation of diluted net loss per share sincebecause their effect was anti-dilutive. The basic and diluted weighted-average shares used to compute net loss per share in the audited consolidated statements of operations excludes the shares issued from the reverse stock split fractional share round up.

Comprehensive Loss

The Company has no components of comprehensive loss other than net loss. Thus, comprehensive loss is the same as net loss for the periods presented.

Segment Reporting

Operating segments are defined as components of an entity about which separate discrete information is available for evaluation by the chief operating decision maker, or decision-making group, in deciding how to allocate resources in assessing performance.

The Company has one operating segment. The Company’s chief operating decision maker, its Chief Executive Officer, manages the Company’s operations for the purposes of allocating resources and evaluating financial performance.

Recent Accounting Pronouncements

In December 2019, the Financial Accounting Standards Board (“FASB”) issued Accounting Standards Update (“ASU”) 2019-12, Simplifying the Accounting for Income Taxes (Topic 740) (“ASU 2019-12”). ASU 2019-12 issued guidance on the accounting for income taxes that, among other provisions, eliminates certain exceptions to existing guidance related to the approach for intra-period tax allocation, the methodology for calculating income taxes in an interim period and the recognition of deferred tax liabilities for outside basis differences. This guidance also requires an entity to reflect the effect of an enacted change in tax laws or rates in its effective income tax rate in the first interim period that includes the enactment date of the new legislation, aligning the timing of recognition of the effects from enacted tax law changes on the effective income tax rate with the effects on deferred income tax

F-10


assets and liabilities. Under existing guidance, an entity recognizes the effects of the enacted tax law change on the effective income tax rate in the period that includes the effective date of the tax law. This guidance is effective for fiscal years beginning after December 15, 2021, and interim periods within the fiscal years beginning after December 15, 2022. Early adoption is permitted. The Company’s adoption of the ASU 2019-12 guidance did not have an effect on the Company’s consolidated financial statements.

3. Business Combination

As disclosed in Note 1, the Company consummated the Business Combination, pursuant to the terms of the agreement and plan of merger, dated as of August 29, 2021 (the “Business Combination Agreement”), by and among Petra, Petra Acquisition Merger, Inc., a Delaware corporation and wholly-owned subsidiary of Petra (“Merger Sub”), and Old Revelation. Pursuant to the Business Combination Agreement, on the Closing Date, (i) Merger Sub merged with and into Old Revelation (the “Merger”), with Old Revelation as the surviving company in the Merger, and, after giving effect to such Merger, Old Revelation was renamed Revelation Biosciences Sub, Inc. and became a wholly-owned subsidiary of the Company and (ii) the Company changed its name to “Revelation Biosciences, Inc.”

In accordance with the terms and subject to the conditions of the Business Combination Agreement, at the effective time of the Merger (the “Effective Time”), (i) each share of common stock and preferred stock of Old Revelation outstanding as of immediately prior to the Effective Time was exchanged for shares of common stock, par value $0.001 per share, of Revelation based on the agreed upon Common Stock Exchange Ratio; (ii) each Old Revelation RSU award outstanding as of immediately prior to the Effective Time was assumed by Revelation and was converted into that number of whole rollover RSU awards based on the Common Stock Exchange Ratio (“Rollover RSU”); and (iii) each Old Revelation warrant outstanding as of immediately prior to the Effective Time was assumed by Revelation and was converted into that number of whole rollover warrants based on the Common Stock Exchange Ratio, at an exercise price per share of common stock equal to (x) the exercise price per share of Old Revelation common stock of such Old Revelation warrant divided by (y) the Common Stock Exchange Ratio (“Rollover Warrant”).

At the Closing Date, up to 300,000 shares of common stock were to be issued constituting the merger consideration, (i) an aggregate of 282,039 shares of common stock, including conversion of all outstanding shares of the Revelation Sub Series A Preferred Stock and Revelation Sub Series A-1 Preferred Stock of Old Revelation, were issued in exchange for the Old Revelation stock outstanding as of immediately prior to the Effective Time, (ii) 4,792 shares of common stock were reserved for issuance for Rollover Warrants outstanding as of immediately prior to the Effective Time and (iii) 13,154 shares of common stock were reserved for issuance for Rollover RSU awards outstanding as of immediately prior to the Effective Time.

Immediately after giving effect to the Business Combination, there were 369,836 shares of common stock outstanding. The pre-merger stockholders of Petra retained an aggregate of 87,797 shares of common stock of Petra, representing 23.7% ownership of the post-Merger company. Therefore, upon consummation of the Business Combination, there was a change in control of Petra, with the former owners of Revelation Sub acquiring control of Petra. The common stock and net loss per share, prior to the Merger, have been retroactively restated as common stock and net loss per share reflecting the exchange ratio established in the Business Combination (the “Common Stock Exchange Ratio”).

Prior to the Closing Date, on December 21, 2021, Petra entered into certain backstop agreements (the “Backstop Agreements”) with AXA Prime Impact Master Fund (“AXA”) (through a backstop agreement with Old Revelation), LifeSci Venture Partners (“LifeSci”) and other Petra and Old Revelation institutional, and individual investors, including Dr. Tidmarsh, Chairman of Old Revelation and present Chairman of the Company (such additional institutional and individual investors, together with LifeSci and Old Revelation collectively, the “Backstop Subscribers”). Pursuant to the Backstop Agreements, the Backstop Subscribers agreed to purchase, in the aggregate, up to $4.5 million of shares of Petra’s common stock, par value $0.001 per share, in the event that more than $31.5 million was redeemed from the trust account in connection with the Business Combination. On January 6, 2022, pursuant to the Backstop Agreements, the Backstop Subscribers purchased an aggregate of 12,345 shares of Petra Common Stock that had been surrendered for redemption totaling $4.5 million. Petra also entered into a forward share purchase agreement (the “Forward Share Purchase Agreement”) with Meteora Capital Partners and its

F-11


affiliates (collectively, “Meteora”) pursuant to which Meteora committed, to purchase additional shares of the Company's common stock in open market transactions or from redeeming stockholders so that Meteora held at least 21,429 shares of common stock as of the closing of the Business Combination. The Forward Share Purchase Agreement provides that Meteora may elect to sell and transfer to the Company, on the one month anniversary of the closing of the Business Combination up to 21,429 shares of common stock held by Meteora at the time of closing of the Business Combination at a price of $357.10 per share.

On the Closing Date, in connection with the Business Combination, stockholders holding 99,449 shares of Petra common stock exercised their right to redeem such shares for cash at a price of approximately $357.10 per share for payments in the aggregate of approximately $35.5 million. Additionally, approximately $7.7 million was escrowed pursuant to the Forward Share Purchase Agreement entered into by and between Petra and Meteora and approximately $4.2 million was released to Revelation. On February 4, 2022, Meteora exercised the Forward Share Purchase Agreement entered into by and between the Company. 21,429 shares were repurchased by the Company and approximately $7.7 million that was escrowed was paid to Meteora.

At the closing of the Business Combination, Petra adopted the third amended and restated certificate of incorporation, which became effective upon filing with the Secretary of State of the State of Delaware on the Closing Date.

Subsequent to the Closing Date on February 10, 2022 and February 22, 2022 the Company paid $105,490 and $691,392, respectively, to the three holders of promissory notes made to Petra in connection with the Business Combination (“Promissory Notes Payable”). The Promissory Notes Payable had a total principal of $750,000, and had accrued interest of $46,882 at the time of repayment.

The Business Combination has been accounted for as a reverse recapitalization, in accordance with U.S. GAAP. Under this method of accounting, although Petra issued shares for outstanding equity interests of Old Revelation in the Business Combination, Petra was treated as the “acquired” company for financial reporting purposes. Accordingly, the Business Combination was treated as the equivalent of Old Revelation issuing stock for the net assets of Petra, accompanied by a recapitalization. The net assets of Petra have been stated at historical cost, with no goodwill or other intangible assets recorded. Operations prior to the Business Combination are those of Revelation.

4. Balance Sheet Details

Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets consisted of the following:

 

 

December 31,
2022

 

 

December 31,
2021

 

Prepaid clinical costs

 

$

 

 

$

488,614

 

Other prepaid expenses & current assets

 

 

73,132

 

 

 

148,728

 

Total prepaid expenses & current assets

 

$

73,132

 

 

$

637,342

 

Property and Equipment, Net

Property and equipment, net consisted of the following:

 

 

December 31,
2022

 

 

December 31,
2021

 

Lab equipment

 

$

131,963

 

 

$

131,963

 

Total property and equipment, gross

 

 

131,963

 

 

 

131,963

 

Accumulated depreciation

 

 

(41,830

)

 

 

(16,782

)

Total property and equipment, net

 

$

90,133

 

 

$

115,181

 

F-12


Depreciation expense was $25,048 for the year ended December 31, 2022 and $16,782 for the year ended December 31, 2021.

Accrued Expenses

Accrued expenses consisted of the following:

 

 

December 31,
2022

 

 

December 31,
2021

 

Accrued payroll and related expenses

 

$

618,014

 

 

$

756,729

 

Accrued clinical study expenses

 

 

175,061

 

 

 

327,244

 

Accrued professional fees

 

 

75,722

 

 

 

294,130

 

Accrued clinical development costs

 

 

111,700

 

 

 

145,566

 

Accrued other expenses

 

 

5,000

 

 

 

5,000

 

Total accrued expenses

 

$

985,497

 

 

$

1,528,669

 

In connection with the Business Combination the Company entered into a payment deferral of legal fees with Loeb & Loeb, LLP, which, deferred the legal fees for six months from the Closing Date of the Business Combination, or July 9, 2022. The agreement stated, if the fees were not paid by July 9, 2022, 8,572 shares of common stock that were issued in January 2022 as collateral to Loeb & Loeb, LLP would be retained in lieu of cash payment, as full payment for the legal fees. As a result, during the year ended December 31, 2022, $0.7 million of accrued professional fees recorded as of June 30, 2022 were converted to equity.

Included in accrued other expenses as of the year ended December 31, 2022, was the $5,000 redemption price of the Series A Preferred Stock that automatically redeemed only participateon January 30, 2023 upon the effectiveness of the Certificate of Amendment implementing the reverse stock split and an increase in their pro ratathe authorized shares of common stock of the Company.

5. Commitments and Contingencies

Lease Commitments

In February 2021, Revelation Sub entered into an agreement to lease 2,140 square feet of laboratory space located at 11011 Torreyana Road, Suite 102, San Diego, California (the “Original Lease”). The Original Lease had a term of 13 calendar months, plus any partial month at the beginning of the Original Lease (the “Original Lease Term”). Revelation Sub recorded a lease liability and right-of-use lease asset for the Original Lease based on the present value of Original Lease payments over the expected Original Lease Term, discounted using Revelation Sub’s incremental borrowing rate of 7.73%. There was no option to extend the Original Lease and the expiration date was March 31, 2022. In accordance with the Original Lease, Revelation Sub is required to maintain a security deposit of $5,564. Revelation Sub paid a total of $70,313 of rent expense over the life of the Original Lease.

In October 2021, Revelation Sub amended the Original Lease to expire on December 31, 2022, equal to an additional nine calendar months with a base monthly rent equal to the 13th month of the Original Lease (the “First Amendment”). Revelation Sub signed the First Amendment on October 14, 2021. In connection with the Business Combination, the First Amendment was assumed by the Company. The Company will pay $51,578 of rent expense over the life of the First Amendment. The Company has applied the short-term lease exception as the First Amendment is less than twelve months. In addition to rent, the Lease requires the Company to pay certain taxes, insurance and operating costs relating to the leased premises. The Lease contains customary default provisions, representations, warranties and covenants. The Lease is classified as an operating lease.

Rent expense was $66,645 for the year ended December 31, 2022 and $55,246 for the year ended December 31, 2021, respectively.

There are no future minimum lease payments under the First Amendment of the operating lease as of December 31, 2022.

Convertible Note Financing

F-13


On January 4, 2022, Revelation Sub entered into a convertible note financing in an amount of up to $2.5 million with a fixed 10% annual interest rate from AXA IM Prime Impact Fund (the “Convertible Note”), the proceeds of which were used by Revelation Sub to purchase shares of Petra common stock from redeeming Petra stockholders who redeemed shares of Petra common stock in connection with the Business Combination. On January 6, 2022, Old Revelation purchased 7,001 shares of Petra common stock with the proceeds from the Convertible Note. Repayment of the Convertible Note was made on January 6, 2022 in accordance with the exchange terms of the Convertible Note by which 7,001 shares of Petra’s common stock that had been purchased by Revelation Sub were transferred to AXA.

Total interest incurred under the Convertible Note was $14,383 during the year ended December 31, 2022.

Premium Finance Agreement - D&O Insurance

In order to obtain a public company directors and officers insurance policy (“D&O Insurance”), the Company entered into an agreement with a premium financing lender, where by the lender paid the D&O Insurance premium for the company (“Premium Finance Agreement”). If the Company were to not pay the lender monthly installment payments, the lender would cancel the D&O Insurance and the remaining D&O Insurance premium would be returned to the lender. In addition, if the Company were to cancel the D&O Insurance, the remaining D&O Insurance premium would be returned to the lender.

The Premium Finance Agreement is for $825,000 and accrues interest at a fixed rate of 3.57% per annum payable monthly for a total of $9,856 over the term of the Premium Finance Agreement. Monthly payments of $74,428, are to be paid in ninemonthly installments, which commenced on February 10, 2022 with a maturity date of October 10, 2022. Upon entering into the Premium Finance Agreement, an upfront payment of $165,000 was due and paid on February 14, 2022.

Total expense incurred under the Finance Agreement for upfront, monthly and interest payments was $834,856 during the year ended December 31, 2022. Total cash paid under the Finance Agreement for upfront, monthly and interest payments was $834,856 during the year ended December 31, 2022. There are no future obligations under the Premium Finance Agreement as of December 31, 2022.

Commitments

The Company enters into contracts in the normal course of business with third party service providers and vendors. These contracts generally provide for termination on notice and, therefore, are cancellable contracts and not considered contractual obligations and commitments.

Contingencies

From time to time, the Company may become subject to claims and litigation arising in the ordinary course of business. The Company is not a party to any material legal proceedings, nor is it aware of any material pending or threatened litigation other than described below.

Legal Proceedings

On February 18, 2022, LifeSci Capital LLC filed an action against the Company in the U.S. District Court for the Southern District of New York seeking damages in the amount of approximately $2.7 million in cash and $2.6 million in equity for unpaid banking and advisory fees. These fees arise under contracts which were entered into prior to the Business Combination and the Company is disputing the amount owed under those contracts and has asserted affirmative defenses including the defense that the amount of the fees sought exceeded the $8.5 million cap on transaction expenses in the Business Combination Agreement. This action remains pending as of the date of this report. On March 2, 2023, the court denied the plaintiff’s motion for summary judgment. As of the date of this report, the court has not set any schedule for discovery or a timetable for any trial.

Of the LifeSci Capital LLC claim, $1.5 million relates to deferred underwriting fees from the Petra initial public offering. In addition, but separate from the claim, one of the underwriters in the Petra initial public offering

F-14


who is not a participant in the litigation with LifeSci Capital LLC recently issued a demand letter seeking repayment for $655 thousand in fees owed from the Petra initial public offering that remain unpaid. Both of these amounts are recorded as a current liability in the financial statements as of December 31, 2022 under deferred underwriting commissions. No other liabilities are reflected in the financial statements as the amount of any additional liability cannot be determined at this time.

On September 27, 2022, A-IR Clinical Research Ltd. (“A-IR”) filed a claim against the Company in the High Court of Justice, in the Business and Property Courts of England and Wales, seeking £1.6 million in unpaid invoices, plus interest and costs, relating to the Company’s viral challenge study. The Company is disputing the claim because many of the invoices relate to work that was not performed and A-IR had misrepresented its qualifications to perform the contracted work. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

On January 30, 2023, Marwood Advisory Group, LLC filed an action in the Supreme Court of New York for the County of New York seeking damages in the amount of $150,000 plus interest in respect of a contract agreed by the sponsors of Petra allegedly relating to a due diligence report with another target considered by Petra prior to the Business Combination. The Company believes it has defenses to this claim and as of the date of this report no answer is due. Since this proceeding is at a very early stage, no liability is reflected in the financial statements as the amount of any liability cannot be determined at this time.

6. PIPE Investment

On January 23, 2022, the Company entered into a securities purchase agreement with an institutional investor (“the Purchaser”) pursuant to which the Purchaser agreed to purchase, and the Company agreed to issue and sell to the Purchaser in a private placement, 36,947 shares of common stock at a gross purchase price of $105.00 per share (the “Shares”) (the “PIPE Investment”), 36,959 unregistered pre-funded warrants to purchase common stock (the “Pre-Funded Warrants”) and 73,905 unregistered warrants to purchase common stock (the “Class A Common Stock Warrants”). The closing was consummated on January 25, 2022. The net proceeds to the Company was $7.3 million.

Each Pre-Funded Warrant was funded to the amount of $105.00, with $0.00035 per share of common stock payable upon exercise, was immediately exercisable, could have been exercised at any time until exercised in full and is subject to customary adjustments. The Pre-Funded Warrants may not be exercised if the aggregate number of shares of the Company’s common stock beneficially owned by the holder (together with its affiliates) would exceed 9.99% of the Company’s outstanding common stock immediately after exercise. On February 22, 2022, the Company received a notice of cash exercise for the total outstanding Pre-Funded Warrants issued in connection with the PIPE Investment for 36,959 shares of common stock at purchase price of $12.94.

Each Class A Common Stock Warrant has an exercise price of $115.15 per share of common stock, is exercisable at any time after the sixth month anniversary of the date of issuance, will expire five and one-half years from the date of issuance and is subject to customary adjustments. The Class A Common Stock Warrants may not be exercised if the aggregate number of shares of the Company’s common stock beneficially owned by the holder (together with its affiliates) would exceed 4.99% of the Company’s outstanding common stock immediately after exercise. However, the holder may increase (upon 61 days’ prior notice from the holder to the Company) or decrease such percentages, provided that in no event such percentage exceeds 9.99%.

Also on January 23, 2022 and in connection with the private placement, the Company entered into a registration rights agreement (the “Registration Rights Agreement”) with the Purchaser, pursuant to which the Company agreed to use its best efforts to file a registration statement on Form S-1 (the “Registration Statement”) to register for resale the Shares and any shares of the Company’s common stock issuable upon exercise of the Pre-Funded Warrants and Class A Common Stock Warrants by January 31, 2022, but in no event later than February 4, 2022. The company filed the Registration Statement on January 28, 2022 and it became effective on February 7, 2022.

Roth Capital Partners, LLC (the “Placement Agent”) was engaged by the Company to act as its exclusive placement agent for the private placement. The Company agreed to pay the Placement Agent a cash fee equal to 6.0% of the gross proceeds received by the Company in the private placement, totaling approximately $465,600. In

F-15


addition, the Company agreed to issue to the Placement Agent warrants to purchase up to 10,347 shares of common stock representing 7.0% of the aggregate number of shares of common stock sold in the private placement (including shares of common stock issuable upon the exercise of any of the Pre-Funded Warrants and Common Warrants) (the “Class A Placement Agent Common Stock Warrants”). The Class A Placement Agent Common Stock Warrants have substantially the same terms as the Class A Common Stock Warrants.

Using the Black-Scholes option pricing model, the Class A Common Stock Warrants were valued in the aggregate at $3.6 million and the Class A Placement Agent Common Stock Warrants were valued in the aggregate at $0.5 million. Both were included in the issuance costs of the private placement (see Note 12).

7. Public Offering

On July 28, 2022, the Company closed a public offering of 238,096 shares of its common stock (the “July 2022 Public Offering”), together with 8,333,334 warrants to purchase up to 238,095 shares of its common stock (the “Class B Common Stock Warrants”) at an offering price to the public of $21.00 per share and associated warrant. The Class B Common Stock Warrants have an exercise price of $21.00 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The net proceeds to the Company from the offering were $4.5 million. The shares of common stock, and the shares of common stock underlying the Class B Common Stock Warrants were registered with the SEC on Form S-1 (File No. 333-266108), and was declared effective by the SEC on July 25, 2022.

Roth Capital Partners, LLC (the “Placement Agent”) was engaged by the Company to act as its exclusive placement agent for the July 2022 Public Offering. The Company agreed to pay the Placement Agent a cash fee equal to 7.0% of the gross proceeds received by the Company in the public offering, totaling $350,000. In addition, the Company agreed to issue to the Placement Agent warrants to purchase up to 16,667 shares of common stock representing 7.0% of the aggregate number of shares of common stock sold in the public offering (the “Class B Placement Agent Common Stock Warrants”). The Class B Placement Agent Common Stock Warrants have an exercise price of $26.25 per share and expire five years following the date of issuance.

Using the Black-Scholes option pricing model, the Class B Common Stock Warrants were valued in the aggregate at $4.5 million and the Class B Placement Agent Common Stock Warrants were valued in the aggregate at $0.3 million. Both were included in the issuance costs of the July 2022 Public Offering (see Note 12).

8. Preferred Stock

Revelation Authorized Preferred Stock

The third amended and restated certificate of incorporation of the Company authorizes up to 5,000,000 shares of preferred stock, $0.001 par value per share, which may be issued as designated by the Board of Directors without stockholder approval. As of December 31, 2022 and as of the date of this Report, there was one share of preferred stock issued and outstanding.

Series A Preferred Stock

On December 19, 2022, the Company entered into a Subscription and Investment Representation Agreement (the “Subscription Agreement”) with James Rolke, its Chief Executive Officer, who is an accredited investor (the “Purchaser”), pursuant to which the Company agreed to issue and sell one (1) share of the Trust Account earnings.Company’s Series A Preferred Stock, par value $0.001 per share, to the Purchaser for $5,000.00 in cash. The Company has not consideredsale closed on December 19, 2022.

The Series A Preferred Stock had 50,000,000 votes and voted together with the outstanding shares of the Company’s common stock as a single class exclusively with respect to any proposal to amend the Company’s Restated Certificate of Incorporation to effect a reverse stock split of warrants soldthe Company’s common stock and to increase the number of authorized shares of common stock of the Company. The Series A Preferred Stock voted, without action by the holder, on any such proposal in the Initial Public Offeringsame proportion as shares of common stock voted. The Series A

F-16


Preferred Stock otherwise had no voting rights except as otherwise required by the General Corporation Law of the State of Delaware.

The Series A Preferred Stock was not convertible into, or exchangeable for, shares of any other class or series of stock or other securities of the Company. The Series A Preferred Stock had no rights with respect to any distribution of assets of the Company, including upon a liquidation, bankruptcy, reorganization, merger, acquisition, sale, dissolution or winding up of the Company, whether voluntarily or involuntarily. The holder of the Series A Preferred Stock was not entitled to receive dividends of any kind.

The outstanding share of Series A Preferred Stock was automatically redeemed on January 30, 2023 upon the effectiveness of the Certificate of Amendment implementing the reverse stock split and the private placementincrease in authorized shares of common stock of the Company. Upon such redemption, the holder of the Series A Preferred Stock received the redemption price of $5,000.00 in cash.

Revelation Sub Authorized Preferred Stock

Prior to purchase 3,233,446the Merger, in August 2020, Revelation Sub authorized the sale and issuance of up to 2,000,000 shares of preferred stock, par value $0.001 per share. At the Closing Date of the Business Combination, all outstanding shares of the Series A Preferred Stock and Series A-1 Preferred Stock were converted into 48,971 and 53,293, respectively, shares of common stock (see Note 3).

Revelation Sub Series A Preferred Stock

Prior to the Merger, in December 2020, Revelation Sub sold and issued 628,930 shares of Series A Preferred Stock for net proceeds of $3.9 million. All shares of the Series A Preferred Stock were exchanged on the Closing Date for 48,971 shares of common stock in connection with the calculationBusiness Combination.

Revelation Sub Series A-1 Preferred Stock

Prior to the Merger, in January 2021, Revelation Sub sold and issued 684,450 shares of diluted loss per share, since the exerciseSeries A-1 Preferred Stock for net proceeds of $3.9 million. All shares of the warrants intoSeries A-1 Preferred Stock were exchanged on the Closing Date for 53,293 shares of common stock is contingent upon the occurrence of future events. As a result, diluted net loss per common share is the same as basic net loss per common share for the period presented.

The effect of income attributable to shares subject to possible redemption was negligible and does not affect basic and diluted net loss per common share for the years ended December 31, 2020 and 2019.

Concentration of Credit Risk

Financial instruments that potentially subject the Company to concentrations of credit risk consist of a cash account in a financial institution, which, at times, may exceed the Federal Depository Insurance Coverage of $250,000. As of December 31, 2020, the Company has not experienced losses on this account and management believes the Company is not exposed to significant risks on such account.

Fair Value of Financial Instruments

The fair value of the Company’s assets and liabilities, which qualify as financial instruments under ASC 820, “Fair Value Measurements and Disclosures,” approximates the carrying amounts represented in the accompanying balance sheet, primarily due to their short-term nature.

Recent Accounting Pronouncements

Management does not believe that any recently issued, but not yet effective, accounting pronouncements, if currently adopted, would have a material effect on the Company’s financial statement.

Note 2 –Management’s Liquidity Plans

As of December 31, 2020, the Company had approximately $537,000 in cash and marketable securities in its operating bank account, and working capital of approximately $618,000.

The Company’s liquidity needs up to December 31, 2020 had been primarily satisfied through the Promissory Note from the Sponsor of for up to $150,000 (see Note 4) to the Company. In addition, in order to finance transaction costs in connection with a Business Combination, the Sponsor may, but is not obligated to, provide the Company Working Capital Loans (see Note 4). To date, there were no amounts outstanding under any Working Capital Loans.

Based on the foregoing and Public Offering, management believes that the Company will have sufficient working capital and borrowing capacity to meet its needs through the earlier of the consummation of a Business Combination or one year from this filing. Over this time period, the Company will be using these funds for paying operational expenses, identifying and evaluating prospective initial Business Combination candidates, performing due diligence on prospective target businesses, paying for travel expenditures, selecting the target business to merge with or acquire, and structuring, negotiating and consummating the Business Combination.

9. Units

Management continues to evaluateIn connection with the impactPetra's IPO, in October of the COVID-19 pandemic and has concluded2020, Petra issued unit's that the specific impact is not readily determinable as of the date of the financial statements. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.


Note 3 –Public Offering

Pursuant to the Initial Public Offering on October 13, 2020, the Company sold 7,000,000 units at a price of $10.00 per Unit for a total of $70,000,000. Each Unit consistsconsisted of one share of common stock and one warrant (“Public Warrant”with an exercise price of $402.50 per shares (the “Public Warrants”). Each whole

As of December 31, 2022 there were 48,246 units outstanding (not effected for the reverse split), which trade on the Nasdaq Capital Market under the ticker symbol “REVBU.” The Company includes each share of common stock and Public Warrant entitlesfrom the holderunit’s in its calculation of common stock and Public Warrants outstanding, respectively.

10. Common Stock

The Company is authorized under its articles of incorporation, as amended, to purchaseissue 500,000,000 shares of Common Stock, par value $0.001 per share.

Reverse Split

On January 30, 2023, the Company filed the Certificate of Amendment reflecting the change in authorized shares of common stock from 100,000,000 to 500,000,000 and effecting a reverse stock split as of 12:01 a.m. Eastern Standard Time on February 1, 2023 with a ratio of 1-for-35. As a result of the Reverse Split, every 35 shares of the Company’s issued and outstanding common stock automatically converted into one share of common stock, at

F-17


without any change in the par value per share. No fractional shares are outstanding following the Reverse Split. Any holder who would have received a fractional share of common stock automatically received an additional fraction of a share of common stock to round up to the next whole share. In addition, effective as of the same time as the Reverse Split, proportionate adjustments were made to all then-outstanding equity awards and warrants with respect to the number of shares of common stock subject to such award or warrant and the exercise price thereof. Furthermore, the number of shares of common stock available for issuance under the Company’s equity incentive plans were proportionately adjusted for the Reverse Split ratio, such that fewer shares will be subject to such plans.

Common Stock Issuance due to the Business Combination

At the Closing Date, the Company issued an aggregate of 282,039 shares of common stock in exchange for the Revelation Sub stock, outstanding as of immediately prior to the Effective Time.

On the Closing Date, the Company received net proceeds from the Business Combination of $11.9 million, of which $7.7 million was escrowed pursuant to a Forward Share Purchase Agreement entered into by Petra and $4.2 million was released to Revelation.

Common Stock Issuance during the year ended December 31, 2022

On January 23, 2022, the Company issued 36,947 shares of common stock in connection with the PIPE Investment. The Company received net proceeds of $7.3 million.

On January 31, 2022, the Company issued 8,572 shares of common stock as collateral to Loeb & Loeb, LLP as part of a payment deferral of legal fees in connection with the Business Combination.

On February 4, 2022, the Company cancelled 21,429 shares in connection with the exercise of the Forward Share Purchase Agreement and approximately $7.7 million that was in escrow was paid to Meteora.

On February 22, 2022, the Company issued 36,959 shares of common stock in connection with the notice of cash exercise for the Pre-Funded Warrants issued in connection with the PIPE Investment with a total purchase price of $11.50 per share, subject to adjustment (see Note 6)$12.94.

On February 2, 2022, the Company issued 54 shares of common stock in connection with a notice of cash exercise for the Company’s Rollover Warrants with a total purchase price of $5,073.

On October 14, 2020,July 28, 2022, the underwriters exercisedCompany issued 238,096 shares of its common stock in connection with the over-allotment option in part, and the closing of the issuance and sale of an additional 278,151 Units occurred (the “Over-Allotment Option Units”) on October 16, 2020 at $10.00 per Unit, generating grossJuly 2022 Public Offering. The Company received net proceeds of $2,781,510.$4.5 million.

Note 4 –Related Party Transactions

Sponsor Shares

On January 21, 2020,July 29, 2022, the Company’s sponsor, Petra Investment Holdings, LLC, (the “Sponsor”) purchased 3,593,750Company issued 3,435 shares (the “Founder Shares”) of the Company’s common stock for an aggregate price of $25,000. The $25,000 was paid through relief of the related party note disclosed below. Of the original Founder Shares, 1,774,212 were forfeited. in connection with vested Rollover RSU awards.

As of December 31, 2022 and December 31, 2021, 682,882 and 282,039 shares of common stock were issued and outstanding, respectively. As of December 31, 2022, no cash dividends have been declared or paid.

The total shares of common stock reserved for issuance are summarized as follows:

F-18


 

 

December 31,
2022

 

 

December 31,
2021

 

Revelation Sub Series A Preferred Stock

 

 

 

 

 

 

Series A-1 Preferred Stock

 

 

 

 

 

 

Public Warrants

 

 

300,332

 

 

 

 

Class A Common Stock Warrants

 

 

73,905

 

 

 

 

Class A Placement Agent Common Stock Warrants

 

 

10,347

 

 

 

 

Class B Common Stock Warrants

 

 

238,096

 

 

 

 

Class B Placement Agent Common Stock Warrants

 

 

16,667

 

 

 

 

Rollover Warrants

 

 

4,738

 

 

 

4,792

 

Unvested and unissued Rollover RSU awards

 

 

7,290

 

 

 

13,154

 

Stock options outstanding

 

 

9,581

 

 

 

 

Shares reserved for issuance

 

 

660,956

 

 

 

17,946

 

Shares available for future stock grants under the 2021 Equity Incentive Plan

 

 

58,707

 

 

 

 

Total common stock reserved for issuance

 

 

719,663

 

 

 

17,946

 

11. Stock-Based Compensation

2020 Equity Incentive Plan and 2021 Equity Incentive Plan

Prior to the Merger, Revelation Sub adopted the Revelation Biosciences, Inc. 2020 Equity Incentive Plan (the “2020 Plan”) on October 1, 2020 for the issuance of stock-based awards. There was a total of 13,154 shares that had been granted for RSU awards under the 2020 Plan. On the Closing Date of the Business Combination, the outstanding RSU awards from the 2020 Plan were exchanged for Rollover RSU awards and the 2020 Plan was cancelled and there are no additional Founder Shares are subject to forfeiture.shares available for grant under the 2020 Plan.

Related Party Advances

In order to finance transaction costsJanuary 2022, in connection with athe Business Combination, certainthe Board of Directors adopted the 2021 Equity Incentive Plan (the “2021 Plan”) and reserved 36,983authorized shares of common stock the Company could issue. The 2021 Plan is administered by the Board of Directors. Vesting periods and other restrictions for grants under the 2021 Plan are determined at the discretion of the Company’sBoard of Directors. Grants to employees, officers, directors, advisors, and directors,consultants of the Company typically vest over one to four years. In addition, the number of shares of stock available for issuance under the 2021 Plan will be automatically increased each January 1, beginning on January 1, 2022, by 10% of the aggregate number of outstanding shares of our common stock from the first day of the preceding calendar year to the first day of the current calendar year or their affiliates, may, butsuch lesser number as determined by our board of directors. On January 1, 2023, after effecting the Reverse Split the total shares available for issuance under the 2021 Equity Plan was increased to 68,288 authorized shares of common stock.

Under the 2021 Plan, stock options and stock appreciation rights are granted at exercise prices determined by the Board of Directors which cannot be less than 100% of the estimated fair market value of the common stock on the grant date. Incentive stock options granted to any stockholders holding 10% or more of the Company's equity cannot be granted with an exercise price of less than 110% of the estimated fair market value of the common stock on the grant date and such options are not obligatedexercisable after five years from the grant date.

As of December 31, 2022, there were 58,707 shares available for future grant under the 2021 Plan.

Restricted Stock Units

At the Closing Date of the Business Combination, all Revelation Sub RSU award holders received a Rollover RSU award in exchange for each RSU award of Revelation Sub that vest in accordance with the original terms of the award. The Company determined this to advance fundsbe a Type I modification but did not record any incremental stock-based compensation expense since the fair value of the modified awards immediately after the modification was not greater than the fair value of the original awards immediately before the modification.

The Rollover RSU awards have time-based and milestone-based vesting conditions. Under time-based vesting conditions, the Rollover RSU awards vest quarterly over one year for grants to the Company.Board of Directors and

F-19


quarterly over four years or 25% on the one year anniversary and the remainder vesting monthly thereafter for grants to officers, employees and consultants. The milestone-based vesting conditions vested on the Closing Date of the Business Combination.

As of December 31, 2022 and December 31, 2021, the Company has a total of 7,290 and 13,154 Rollover RSU awards for shares of common stock outstanding, respectively. During the year ended December 31, 2020, $150,000 in advances were received, $10,000 in prior advances were converted into the Promissory Note disclosed below2022, 3,435 Rollover RSU awards have fully vested and $150,000 was repaid.been issued and 2,429 Rollover RSU awards have been forfeited. As of December 31, 2020, there were no advances outstanding.2022, 7,290 Rollover RSU awards will vest and be issued over the next 2.4 years. Each Rollover RSU award converts to one share of common stock.

Stock Options

Promissory Note - Related PartyThe Company has granted stock options which vest 25% on the one year anniversary of the grant date or the employees hiring date, with the remainder vesting quarterly thereafter for grants to officers and employees. Stock options have a maximum term of 10 years.

On June 4, 2020,July 29, 2022, in connection with the Company issued an unsecured promissory noterelease of 9 employees, the Board of Directors granted 5,590 stock options for shares of common stock that vest 100% on the date of grant. The stock options have a maximum term of 3 years.

The activity related to the Sponsor (the “Promissory Note”), pursuant to which the Company may borrow up to an aggregate principal amount of $150,000. Duringstock options, during the year ended December 31, 2020, the Company received proceeds of $140,000 under the Promissory Note and converted $10,000 of prior advances into the Promissory Note. The Promissory note was relieved by $25,000 to pay of Founder Shares described above. The Promissory Note was non-interest bearing and payable on the earlier of (i) December 31, 2021 or (ii) within 15 days of written notice of demand for payment.2022 is summarized as follows:

On October 16, 2020, the $125,000 note payable to the Sponsor was repaid in full. 

Private Warrants

Concurrent with the Initial Public Offering, Our sponsor purchased 3,150,000 Private Placement Warrants at a price of $1.00, see Note 1. Simultaneously with the closing of the sale of the Over-Allotment Option Units, the Company consummated the sale of an additional 83,446 Private Warrants at a price of $1.00 per Private Warrant, generating total proceeds of $83,446.

Related Party Loans

In addition, in order to finance transaction costs in connection with a Business Combination, certain of the Company’s officers and directors or their affiliates may, but are not obligated to, loan the Company funds as may be required (“Working Capital Loans”).


 

 

Shares

 

 

Weighted-average Exercise Price

 

 

Weighted-average Remaining Contractual Term (Years)

 

Outstanding at December 31, 2021

 

 

 

 

$

 

 

 

 

Granted

 

 

15,708

 

 

 

38.57

 

 

 

 

Exercised

 

 

 

 

 

 

 

 

 

Expired and forfeited

 

 

(6,127

)

 

 

49.00

 

 

 

 

Outstanding at December 31, 2022

 

 

9,581

 

 

$

31.91

 

 

 

3.5

 

Exercisable at December 31, 2022

 

 

5,590

 

 

$

19.71

 

 

 

2.6

 

If the Company completes a Business Combination, the Company would repay the Working Capital Loans out of the proceeds of the Trust Account released to the Company. Otherwise, the Working Capital Loans would be repaid only out of funds held outside the Trust Account. In the event that a Business Combination does not close, the Company may use a portion of proceeds held outside the Trust Account to repay the Working Capital Loans but no proceeds held in the Trust Account would be used to repay the Working Capital Loans. Except for the foregoing, the terms of such Working Capital Loans, if any, have not been determined and no written agreements exist with respect to such loans. The Working Capital Loans would either be repaid upon consummation of a Business Combination, without interest, or, at the lender’s discretion, up to $1,500,000 of such Working Capital Loans may be converted into warrants of the post Business Combination entity at a price of $1.00 per warrant. There have been no Working Capital Loans to date.

Note 5 –Commitments and Contingencies

Registration Rights

The holders of the Founder Shares, private warrants, and warrants that may be issued upon conversion of Working Capital Loans (and all underlying securities) will be entitled to registration rights pursuant to a registration rights agreement to be signed prior to or on the effective date of the Initial Public Offering. The holders of the majority of these securities are entitled to make up to two demands that the Company register such securities. The holders of the majority of the Founder Shares can elect to exercise these registration rights at any time commencing three months prior to the date on which the Founder Shares are to be released from escrow.

Underwriting Agreement

The Company granted the underwriters a 45-day option from the date of the prospectus filed on October 13,2020 to purchase up to 1,050,000 additional units to cover over-allotments, if any, at the Initial Public Offering price less the underwriting discounts and commissions.

The underwriters are entitled to a cash underwriting discount of $0.20 per unit, or $ 1,400,000 in the aggregate (or $1,610,000 in the aggregate if the underwriters’ over-allotment option is exercised in full), payable upon the closing of the Proposed Public Offering, and deferred compensation of $0.40 per unit, or $2,800,000 upon completion of a business combination or $3,220,000 in the aggregate if the underwriters’ over-allotment option is exercised in full.

See Note 3 for partial exercise of over-allotment subsequent to the Initial Public Offering. The remaining portion of the over-allotments units expired.

Business Combination Marketing Agreement

The Company has engaged LifeSci Capital LLC as an advisor in connection with a Business Combination to assist the Company in holding meetings with its shareholders to discuss the potential Business Combination and the target business’ attributes, introduce the Company to potential investors that are interested in purchasing the Company’s securities in connection with a Business Combination, assist the Company in obtaining shareholder approval for the Business Combination and assist the Company with its press releases and public filings in connection with the Business Combination. The Company will pay LifeSci Capital LLC a cash fee for such services upon the consummation of a Business Combination in an amount equal to 4.0% of the gross proceeds of Initial Public Offering, exclusive of any applicable finders’ fees which might become payable.

Note 6 –Stockholder’s Deficit

Preferred Stock

On May 11, 2020, the Company amended and restated its articles of incorporation to authorize 1,000,000 shares of preferred stock with a par value of $0.001 per share with such designation, rights and preferences as may be determined from time to time by the Company’s board of directors. At December 31, 2020, there were no shares of preferred stock authorized, issued or outstanding.


Common Stock

The Company is authorized to issue 100,000,000 shares of common stock with a par value of $0.001 per share.

At December 31, 2020 and 2019, there were 2,541,533 and 0 shares of common stock issued and outstanding, respectively (excluding 6,556,156 shares subject to redemption as of December 31, 2020.

See Note 4 for initial issuance of Founder Shares and subsequent forfeitures.

DuringFor the year ended December 31, 2020,2022, the Sponsor assigned 10,000 of their Founders Shares to each memberweighted-average Black-Scholes value per stock option was $25.67. The fair value of the Boardstock options was estimated using the Black-Scholes option pricing model with the following weighted-average assumptions:

Volatility

96.5

%

Expected term (years)

5.00

Risk-free interest rate

2.27

%

Expected dividend yield

0.0

%

Expected volatility is based on the historical volatility of Directors, totaling 50,000 shares.shares of the Company’s common stock. In determining the expected term of stock options, the Company uses the “simplified” method. Under this method, the expected term is presumed to be the midpoint between the average vesting date and the end of the contractual term. The risk-free interest rate is based on the U.S. Treasury yield for a period consistent with the expected term of the stock options in effect at the time of the grants. The dividend yield assumption is based on the expectation of no future dividend payments by the Company. In addition to assumptions used in the Black-Scholes model, the Company reduces stock-based compensation expense based on actual forfeitures in the period that each forfeiture occurs.

F-20


Stock-Based Compensation Expense

For the years ended December 31, 2022 and 2021, the Company recorded stock-based compensation expense for the period indicated as follows:

Warrants

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

General and administrative:

 

 

 

 

 

 

RSU awards

 

$

130,689

 

 

$

412,214

 

Stock Options

 

 

44,000

 

 

 

 

General and administrative stock-based compensation expense

 

 

174,689

 

 

 

412,214

 

Research and development:

 

 

 

 

 

 

RSU awards

 

 

41,506

 

 

 

58,664

 

Stock Options

 

 

84,921

 

 

 

 

Research and development stock-based compensation expense

 

 

126,427

 

 

 

58,664

 

Total stock-based compensation expense

 

$

301,116

 

 

$

470,878

 

As of December 31, 2022, there was $204,030 and $98,633 of unrecognized stock-based compensation expense related to Rollover RSU awards and stock options, respectively. The unrecognized stock-based compensation expense is expected to be recognized over a period of 2.1 years and 3.2 years for Rollover RSU’s and stock options, respectively.

12. Warrants

The

Public Warrants

In connection with the Petra's IPO, Petra issued 10,511,597 Public Warrants will become exercisable on the laterto purchase an aggregate of (a) 30 days after the completion of a Business Combination or (b) 12 months from the closing of the Initial Public Offering. No warrants will be exercisable for cash unless the Company has an effective and current registration statement covering the300,332 shares of common stock issuable uponat an exercise price of the warrants$402.50 per share and a current prospectus relating to such shares of common stock. Notwithstanding the foregoing, if a registration statement covering the shares of common stock issuable upon exercise of the public warrants is not effective within a specified period following the consummation of a Business Combination, warrant holders may, until such time as there is an effective registration statement and during any period when the Company shall have failed to maintain an effective registration statement, exercise warrantsexpire on a cashless basis pursuant to the exemption provided by Section 3(a) (9) of the Securities Act, provided that such exemption is available. If that exemption, or another exemption, is not available, holders will not be able to exercise their warrants on a cashless basis.January 10, 2027. The Public Warrants will expire five years aftertrade on the completion of a Business Combination or earlier upon redemption or liquidation.Nasdaq Capital Market under the ticker symbol REVBW.

Once the warrants become exercisable, theThe Company may redeem the Public Warrants as follows:

in whole and not in part;

at a price of $0.01 per warrant;

upon not less than 30 days’ prior written notice of redemption;

if, and only if, the reported last sale price of the Company’s common stock equals or exceeds $18.00 per share for any 20 trading days within a 30-trading day period ending on the third business day prior to the notice of redemption to the warrant holders; and

if, and only if, there is a current registration statement in effect with respect to the shares of common stock underlying the warrants.

at a price of $0.01 per Public Warrant upon not less than 30 days’ prior written notice of redemption if, and only if, the reported last sale price of the Company’s common stock equals or exceeds $630.00 per share for any 20 trading days within a 30-trading day period ending on the third business day prior to the notice of redemption to the Public Warrant holders; and if, and only if, there is a current registration statement in effect with respect to the shares of common stock underlying the Public Warrants. If the Company calls the Public Warrants for redemption, management will have the option to require all holders that wish to exercise the Public Warrants to do so on a “cashless basis,” as described in the warrant agreement.

The PrivateRollover Warrants will be identical

Prior to the Public Warrants underlyingMerger, in connection with the Units being sold inissuance of the Initial Public Offering, except thatRevelation Sub Series A-1 Preferred Stock through a private placement, Revelation Sub issued warrants to the Private Warrants and theplacement agent to purchase an aggregate of 4,792 shares of common stock issuable uponat an exercise price of $93.80 per share, valued on the exerciseissuance date of the Private Warrants will not be transferable, assignableRevelation Sub Series A-1 Preferred Stock in the aggregate at $326,675 and included in the issuance costs of the Revelation Sub Series A-1 Preferred Stock. The warrants were exercisable immediately upon issuance, provide for a cash or salable until aftercashless exercise right and expire on January 31, 2027.

At the completionClosing Date of athe Business Combination, subject to certain limited exceptions. Additionally, the Private Warrants will beall warrant holders received a Rollover Warrant, which was exercisable for cash or on a cashless basis at the holder’s option, and be non-redeemable so long as they are held by the initial purchasers or their permitted transferees. If the Private Warrants are held by someone other than the initial purchasers or their permitted transferees, the Private Warrants will be redeemable byin accordance with its original issuance.

On February 2, 2022, the Company and exercisable by such holders onreceived a notice of cash exercise for the same basis as the Public Warrants.

The exercise price and number ofCompany’s Rollover Warrants for 54 shares of common stock issuable upon exercise of the warrants may be adjusted in certain circumstances including in the event of a stock dividend, or recapitalization, reorganization, merger or consolidation. However, the warrants will not be adjusted for issuance of common stock at a price below its exercise price. Additionally, in no event will the Company be required to net cash settle the warrants. If the Company is unable to complete a Business Combination within the Combination Period and the Company liquidates the funds held in the Trust Account, holders of warrants will not receive any of such funds with respect to their warrants, nor will they receive any distribution from the Company’s assets held outside of the Trust Account with the respect to such warrants. Accordingly, the warrants may expire worthless.


In addition, if (x) the Company issues additional shares of common stock or equity-linked securities for capital raising purposes in connection with the closing of an initial Business Combination at an issue price or effective issuepurchase price of less than $9.50 per share$5,073. As of common stock (with such issue price or effective issue priceDecember 31, 2022, there were 4,738 Rollover Warrants remaining to be determined in good faith by the Company’s board of directors, and in the case of any such issuance to our sponsor, initial stockholdersexercised or their affiliates, without taking into account any founders’ shares held by them prior to such issuance), (y) the aggregate gross proceeds from such issuances represent more than 60% of the total equity proceeds, and interest thereon, available for the funding of an initial Business Combination on the date of the consummation of an initial Business Combination (net of redemptions), and (z) the volume weighted average trading price of the common stock during the 20 trading day period starting on the trading day prior to the day on which the Company consummated an initial Business Combination (such price, the “Market Value”) is below $9.50 per share, the exercise price of the warrants will be adjusted (to the nearest cent) to be equal to 115% of the greater of (i) the Market Value or (ii) the price at which the Company issues the additional shares of common stock or equity-linked securities.exchanged.

F-21


See Note 4 for Private Warrants issued for cash.

Note 7 –Fair Value Measurements

The Company follows the guidance in ASC 820 for its financial assets and liabilities that are re-measured and reported at fair value at each reporting period, and non-financial assets and liabilities that are re-measured and reported at fair value at least annually.

The fair value of the Company’s financial assets and liabilities reflects management’s estimate of amounts thatRollover Warrants was estimated using the Black-Scholes option pricing model with the following assumptions:

Volatility

115

%

Expected term (years)

6

Risk-free interest rate

0.85

%

Expected dividend yield

0.0

%

Class A Common Stock Warrants

In connection with the PIPE Investment, the Company would haveissued warrants to the Purchaser to purchase an aggregate of 73,905 shares of common stock at an exercise price of $115.15 per share, valued on the PIPE Investment purchase date in the aggregate at $3,634,262 and included in the issuance costs of the PIPE Investment. The warrants were exercisable six months from the issuance date, provide for a cash or cashless exercise right and expire on July 25, 2027.

The fair value of the warrants was estimated using the Black-Scholes option pricing model with the following assumptions:

Volatility

47

%

Expected term (years)

5

Risk-free interest rate

1.54

%

Expected dividend yield

0.0

%

Pre-Funded Warrants

In connection with the PIPE Investment, the Company issued warrants to the Purchaser to purchase an aggregate of 36,959 shares of common stock at an exercise price of $0.00035 per share.

On February 22, 2022, the Company received a notice of cash exercise for the Pre-Funded Warrants issued in connection with the salePIPE Investment for 36,959 shares of the assets or paid incommon stock at purchase price of $12.94.

Class A Placement Agent Common Stock Warrants

In connection with the transferPIPE Investment, the Company issued warrants to the Placement Agent to purchase an aggregate of 10,347 shares of common stock at an exercise price of $115.15 per share, valued on the PIPE Investment purchase date in the aggregate at $508,797 and included in the issuance costs of the liabilities in an orderly transaction between market participants atPIPE Investment. The warrants were exercisable six months from the measurement date. issuance date, provide for a cash or cashless exercise right and expire on July 25, 2027.

The fair value of the warrants was estimated using the Black-Scholes option pricing model with the following assumptions:

Volatility

47

%

Expected term (years)

5

Risk-free interest rate

1.54

%

Expected dividend yield

0.0

%

Class B Common Stock Warrants

In connection with measuring the July 2022 Public Offering, the Company issued 8,333,334 warrants to purchase an aggregate of 238,095 shares of common stock at an exercise price of $21.00 per share, valued on the public offering purchase date in the aggregate at $4,490,457 and included in the issuance costs of the public offering. The warrants were exercisable immediately upon issuance, provide for a cash or cashless exercise right and expire on July 28, 2027.

F-22


The fair value of its assets and liabilities,the warrants was estimated using the Black-Scholes option pricing model with the following assumptions:

Volatility

144

%

Expected term (years)

5

Risk-free interest rate

2.69

%

Expected dividend yield

0.0

%

Class B Placement Agent Common Stock Warrants

In connection with the July 2022 Public Offering, the Company seeksissued warrants to maximize the usePlacement Agent to purchase an aggregate of observable inputs (market data obtained from independent sources)16,667 shares of common stock at an exercise price of $26.25 per share, valued on the public offering purchase date in the aggregate at $310,137 and to minimizeincluded in the useissuance costs of unobservable inputs (internal assumptions about how market participants would price assetsthe public offering. The warrants were exercisable immediately upon issuance, provide for a cash or cashless exercise right and liabilities)expire on July 25, 2027.

The following fair value hierarchy is used to classify assets and liabilities based on the observable inputs and unobservable inputs used in order to value the assets and liabilities:

Level 1: Quoted prices in active markets for identical assets or liabilities. An active market for an asset or liability is a market in which transactions for the asset or liability occur with sufficient frequency and volume to provide pricing information on an ongoing basis.

Level 2: Observable inputs other than Level 1 inputs. Examples of Level 2 inputs include quoted prices in active markets for similar assets or liabilities and quoted prices for identical assets or liabilities in markets that are not active.

Level 3: Unobservable inputs based on our assessment of the assumptions that market participants would use inwarrants was estimated using the Black-Scholes option pricing model with the asset or liability.following assumptions:

Volatility

144

%

Expected term (years)

5

Risk-free interest rate

2.69

%

Expected dividend yield

0.0

%

The following table presents information about the Company’s assets that are measured at fair value on a recurring basis at December 31, 2020 and 2019 and indicates the fair value hierarchy of the valuation inputs the Company utilized to determine such fair value:

    Year Ended December 31, 
Assets Level 2020  2019 
         
Assets:        
Marketable securities held in Trust Account Level 1 $73,510,915   - 
Marketable securities held outside of Trust Account Level 1  525,287   - 
         - 
Total   $74,036,202  - 

F-15

13. Income Taxes

Note 8 –Income Taxes

The Company accountsdid not record a provision for income taxes under ASC 740 - Income Taxes (“ASC 740”), which provides for an assetthe years ended December 31, 2022 and liability approach of accountingDecember 31, 2021 due to a full valuation allowance against its deferred tax assets.

The difference between the provision for income taxes. Under this approach, deferred tax assetstaxes and liabilities are recognized based on anticipated future tax consequences,income taxes computed using currently enacted tax laws, attributed to temporary differences between the carrying amounts of assets and liabilities for financial reporting purposes and the amounts calculated for income tax purposes.effective U.S. federal statutory rate is as follows:

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

 

 

 

 

 

 

 

Federal tax statutory rate

 

 

21.0

%

 

 

21.0

%

State tax, net of federal benefit

 

 

7.2

 

 

 

7.1

 

Research and development credits

 

 

0.6

 

 

 

1.9

 

Non-deductible expenses

 

 

2.9

 

 

 

(2.3

)

Change in valuation allowance

 

 

(31.7

)

 

 

(27.7

)

Effective tax rate

 

— %

 

 

— %

 

Significant components of the Company’s deferred tax assets are as follows:

 

 

Year Ended
December 31,

 

 

 

2022

 

 

2021

 

Net operating loss carryforwards

 

$

5,511,086

 

 

$

3,524,526

 

Research and development credits

 

 

324,661

 

 

 

255,656

 

Capitalized research and development costs

 

 

1,429,419

 

 

 

 

Capitalized start-up costs

 

 

860,853

 

 

 

 

Other, net

 

 

373,936

 

 

 

351,836

 

Total gross deferred tax assets

 

 

8,499,983

 

 

 

4,132,018

 

Valuation allowance

 

 

(8,499,983

)

 

 

(4,132,018

)

Net deferred tax assets

 

$

 

 

$

 

F-23


As of December 31, 2020 are summarized below.

  December 31,
2020
 
Deferred tax assets:   
Net operation loss carryforwards $35,000 
Total deferred tax asset  35,000 
Valuation allowance  (35,000)
  $- 

The Company recognizes deferred tax assets to the extent that it believes that these assets are more likely than not to be realized. In making such a determination, the Company considers all available positive2022 and negative evidence, including future reversals of existing taxable temporary differences, projected future taxable income, tax-planning strategies, and results of recent operations. The Company assessed the need for a valuation allowance against its net deferred tax assets and determined2021, a full valuation allowance is required asof $8,499,983 and $4,132,018, respectively, was established against its deferred tax assets due to the Company has no historyuncertainty surrounding the realization of generating taxable income. Therefore, asuch assets. The valuation allowance increased by $4,012,802 and $3,323,197 in 2022 and 2021, respectively, due to the increase in the deferred tax assets by the same amount; primarily due to net operating loss carryforwards and the mandatory capitalization of $35,000 was recorded asqualified research and development expenses in 2022.

As of December 31, 2020. Deferred tax assets were calculated using2022, the Company’s combined effective tax rate, which it estimated to be approximately 26%. The effective rate is reduced to 0% for 2020 due to the full valuation allowance on itsCompany had federal and state net deferred tax assets. Deferred tax assetsoperating loss carryforwards of $18,224,037 and related valuation allowance as$24,505,008, respectively. As of December 31, 2019 were negligible.

The Company’s ability to utilize2021, the Company had federal and state net operating loss carryforwards of $12,468,027 and $13,221,253, respectively. Federal net operating losses carryforward indefinitely. State net operating loss carryforwards will depend on its abilitybegin to generate adequate future taxable income. Future utilizationexpire in 2026.

The Company had estimated federal research and development credit carryforwards of the net operating loss carry forwards is subject$93,915 and $91,217 as of December 31, 2022 and 2021, respectively. The federal research tax credit carryforwards will begin to certain limitations underexpire in 2040. The Company had estimated state research and development credit carryforwards of $292,083 and $208,150 as of December 31, 2022 and 2021, respectively. The California state credits carryforward indefinitely.

Pursuant to Section 382 and 383 of the Internal Revenue Code. AsCode (“IRC”), utilization of December 31, 2020, the Company hadCompany’s federal net operating loss carryforwards availableand research and development credit carryforwards may be subject to offset future taxable incomeannual limitations in the amountsevent of approximately $135,000. Federalany significant future changes in its ownership structure. These annual limitations may result in the expiration of net operating loss and research and development credit carryforwards generated do not expire whereas state carryforwards beginprior to expire in 2039.

utilization. The Company has evaluated its income tax positionsnot completed an IRC Section 382 and has determined that it does not have any383 analyses regarding the limitation of net operating loss and research and development credit carryforwards.

No liability is recorded on the financial statements related to uncertain tax positions. There are no unrecognized tax benefits as of December 31, 2022 and 2021. The Company does not expect that uncertain tax benefits will recognizematerially change in the next 12 months.

The Company’s policy is to record estimated interest and penalties related to any uncertain tax positions through itsbenefits as income tax expense. As of December 31, 2022 and 2021, the Company had no accrued interest or penalties recorded related to uncertain tax positions.

The Company is subject to franchise tax filing requirementstaxation in the State of Delaware.U.S. and various state jurisdictions. The Company’s tax returns in all jurisdictions remain opensince inception are subject to examination.

Note 9 –Subsequent Events

examination by the U.S. and various state tax authorities. The Company hasis not currently undergoing a tax audit in any federal or state jurisdiction.

On March 27, 2020, the Coronavirus Aid, Relief and Economic Security (“CARES”) Act was enacted and signed into law and GAAP requires recognition of the tax effects of new legislation during the reporting period that includes the enactment date. The CARES Act includes changes to the tax provisions that benefits business entities and makes certain technical corrections to the 2017 Tax Cuts and Jobs Act. The tax relief measures for businesses in the CARES Act include a five-year net operating loss carryback for certain net operating losses, suspension of the annual deduction limitation of 80% of taxable income for certain net operating losses, changes in the deductibility of interest, acceleration of alternative minimum tax credit refunds, payroll tax relief, and a technical correction to allow accelerated deductions for qualified improvement property. The CARES Act also provides other non-tax benefits to assist those impacted by the pandemic. The Company evaluated subsequent events throughthe impact of the CARES Act and determined that there is no material impact to the income tax provision for the years ended December 31, 2022 and 2021.

The Consolidated Appropriation Act (“CAA”) of 2021 was signed into law by the President, December 27, 2020, containing the most recent COVID-19 relief provisions as well as many tax provisions including renewals of several popular tax extenders. The Company evaluated the impact of the CAA and determined that there is no material impact to the income tax provision for the years ended December 31, 2022 and 2021.

14. Subsequent Events

Unit Separation

On January 13, 2023, the Company’s units, which traded with the ticker symbol “REVBU” were mandatorily separated and cease to exist, further the units no longer trade on the Nasdaq Capital Market. Each unit was comprised of one share of the Company’s common stock and one Public Warrant. At the time of separation there were 1,688,598 units seperated, no new shares of common stock or Public Warrants were issued in connection with the speration.

F-24


Second Amendment to Lease

In January 2023, Revelation Sub amended the First Amendment to the Original Lease (the “Second Amendment”) to expire on December 31, 2023, equal to an additional 11 calendar months with a base monthly rent equal to $9,630.00. Revelation Sub signed the Second Amendment on January 17, 2023. The Company will pay $105,930 of rent expense over the life of the Second Amendment.

Change in Authorized Shares and Reverse Stock Split

On January 30, 2023, at a special meeting of stockholders, the Company’s stockholders approved a Certificate of Amendment to the Company’s Third Amended and Restated Certificate of Incorporation to change the authorized common stock from 100,000,000 to 500,000,000 shares and effect a reverse stock split of our outstanding shares of common stock at a specific ratio within a range of one-for-twenty (1-for-20) to a maximum of a one-for-one hundred (1-for-100) split. On January 30, 2023, the Company filed the Certificate of Amendment which set the authorized shares of common stock to 500,000,000 and effected a 1-for-35 reverse stock split of our outstanding shares of common stock as of 12:01 a.m. Eastern Standard Time on February 1, 2023.

Public Offering

On February 13, 2023, the Company closed a public offering of (i) an aggregate of 2,888,600 shares of its common stock, par value $0.001 per share and pre-funded warrants to purchase up to an aggregate of 336,400 shares of Common Stock (the “Pre-Funded Warrants”) and (ii) accompanying Class C Common Stock Purchase Warrants to purchase up to an aggregate of 6,450,000 shares of its Common Stock at a combined offering price of $4.83 per share of Common Stock and associated Class C Common Stock Warrants, or $4.8299 per Pre-Funded Warrant and associated Class C Common Stock Warrants, resulting in gross proceeds of approximately $15.6 million. As of December 31, 2022, the Company recorded $87,171 of deferred offering costs. The Pre-Funded Warrants do not expire and have an exercise price of $0.0001 per share. The Class C Common Stock Warrants will have an exercise price of $5.36 per share, are exercisable upon issuance, and will expire five years following the date of issuance. The net proceeds to the financial statements are availableCompany from the offering were approximately $14.0 million, after deducting the placement agent’s fees and other offering expenses payable by the Company. The Company intends to use the net proceeds from this offering to further the development of REVTx-300, REVTx-100, REVTx-200 and REVTx-99b; continue to develop other products and therapies; and fund working capital and general corporate purposes using any remaining amounts. A registration statement on Form S-1 (File No. 333-268576) relating to these securities has been filed with the SEC, and was declared effective by the SEC on February 9, 2023.

Roth Capital Partners, LLC (the “Placement Agent’) was engaged by the Company to act as its exclusive placement agent for the public offering. The Company agreed to pay the Placement Agent a cash fee equal to 8.0% of the gross proceeds received by the Company in the public offering, totaling approximately $1.2 million.

Using the Black-Scholes option pricing model, the Class C Common Stock Warrants were valued in the aggregate at $16.1 million and included in the issuance costs of the public offering.

As a result of the proceeds from the Public Offering, the Company believes it is now in compliance with Listing Rule 5550(b)(2) because it has stockholders’ equity in excess of $2.5 million as of the date of this filing.

Regaining NASDAQ Compliance

On February 16, 2023, the Company received formal notice from The Nasdaq Stock Market (“Nasdaq”) stating that the Company’s common stock will continue to be issued. There are no subsequent events identifiedlisted and traded on Nasdaq, due to the Company having regained compliance with the minimum bid price requirement and minimum stockholders’ equity requirement for continued listing on Nasdaq, as set forth in Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively, and all applicable listing standards.

As previously reported in 2022, Nasdaq issued delist letters based on the Company’s non-compliance with the bid price and stockholders’ equity requirements for continued listing on The Nasdaq Capital Market, as set forth in Nasdaq Listing Rules 5550(a)(2) and 5550(b)(1), respectively. The Company’s compliance plan was approved by a Nasdaq hearing panel giving the Company until April 18, 2023 to regain compliance. To regain compliance with the stockholders’ equity requirement, the Company must have achieved stockholders’ equity of at least $2.5 million

F-25


and demonstrated its ability to sustain compliance with that would require disclosurerequirement. In order to demonstrate compliance with the $1.00 bid price requirement, the Company must have demonstrated compliance for a minimum of ten consecutive business days.

Also, as previously reported on February 13, 2023, the Company closed a Public Offering on February 13, 2023, resulting in estimated net cash proceeds of approximately $14.0 million after accounting for estimated expenses incurred in connection with the financial statements.Public Offering. As a result, the Listing Qualifications staff determined that the Company has regained compliance with the minimum equity requirement. The staff also determined as of February 15, 2023, the Company has evidenced compliance with the $1.00 per share price requirement having traded for 11 consecutive trading days above $1.00.

Pre-Funded Warrant Exercise

On February 14, 2023, the Company received a notice of cash exercise for the Pre-Funded Warrants issued in connection with the February 2023 Public Offering for 33,000 shares of common stock at purchase price of $3.30.

F-16On March 2, 2023, the Company received a notice of cash exercise for the Pre-Funded Warrants issued in connection with the February 2023 Public Offering for 160,000 shares of common stock at purchase price of $16.00.

Class C Common Stock Warrant Exercise

As of March 20 2023, the Company received notices of alternative cash-less exercises for 1,868,390 Class C Common Stock Warrants issued in connection with the February 2023 Public Offering for 747,357 shares of common stock.

F-26