PART 1. FINANCIAL INFORMATION

ITEM 1.FINANCIAL STATEMENTS

(Unaudited)

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED BALANCE SHEETS (UNAUDITED)

June 30, 2023 and December 31, 2022

The accompanying notes are an integral part of these condensed consolidated financial statements.

PART 1. FINANCIAL INFORMATION

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF OPERATIONS (UNAUDITED)

For the Three and NineSix Months Ended SeptemberJune 30, 20222023 and 20212022

The accompanying notes are an integral part of these condensed consolidated financial statements.

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)

For the Three and NineSix Months Ended SeptemberJune 30, 20222023

The accompanying notes are an integral part of these condensed consolidated financial statements.

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTSTATEMENTS OF STOCKHOLDERS’ EQUITY (UNAUDITED)

For the Three and NineSix Months Ended SeptemberJune 30, 20212022

The accompanying notes are an integral part of these condensed consolidated financial statements.

REVIVA PHARMACEUTICALS HOLDINGS, INC.

CONDENSED CONSOLIDATED STATEMENTS OF CASH FLOWS (UNAUDITED)

For the NineSix Months Ended SeptemberJune 30, 2022,2023 and 20212022

The accompanying notes are an integral part of these condensed consolidated financial statements.

REVIVA PHARMACEUTICALS HOLDINGS, INC.

NOTES TO CONDENSED CONSOLIDATED FINANCIAL STATEMENTS (UNAUDITED)

On December 14, 2020, Reviva Pharmaceuticals Holdings, Inc. (the “Company”), a Delaware corporation and the successor by re-domiciliation to Tenzing Acquisition Corp. (“Tenzing”), a British Virgin Islands exempted company, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiary), consummated a business combination (the “Business Combination”) through the merger of Merger Sub with and into Reviva Pharmaceuticals, Inc. (the “Merger”), contemplated byin accordance with the previously announced Agreement and Plan of Merger, dated as of July 20, 2020 (the “Merger Agreement”), by and among Tenzing, Merger Sub, Reviva Pharmaceuticals, Inc., and the other parties thereto. Pursuant to the Merger Agreement, at the effective time of the Merger, (the “Effective Time”), Merger Sub merged with and into Reviva Pharmaceuticals, Inc., with Reviva Pharmaceuticals, Inc. as the surviving company in the Merger and, after giving effect to such Merger, Reviva Pharmaceuticals, Inc. becoming a wholly-owned subsidiary of Reviva Pharmaceuticals Holdings, Inc. (together withIn these notes to the condensed consolidated financial statements, unless otherwise specified or the context indicates otherwise, references to the “Company,” “Reviva,” “we,” “us” and “our” refer to Reviva Pharmaceuticals Holdings, Inc. and its consolidated subsidiary).subsidiaries.

Reviva Pharmaceuticals, Inc. was originally incorporated in the state of Delaware and commenced operations on May 1, 2006 and its Indian subsidiary, Reviva Pharmaceuticals India Pvt. Ltd. was incorporated in 2014. The Company is an emerging research baseda late-stage pharmaceutical company focused on developing a portfolionew therapies that seek to address unmet medical needs in the areas of internally discovered next generation safe and effective therapeutic drugs by using an integrated chemical genomics technology platform and proprietary chemistries. The Company is currently focused on developing drugs for the central nervous system (CNS), cardiovascular (CV), metabolicinflammatory and inflammatorycardiometabolic diseases.

Basis of Presentation

The accompanying unaudited condensed consolidated financial statements have been prepared in accordance with the instructions to Form 10-Q and Article 8 of Regulation S-X. Certain footnotes and other financial information normally required by accounting principles generally accepted in the United States of America, or GAAP, have been condensed or omitted in accordance with such rules and regulations. In management’s opinion, these condensed consolidated financial statements have been prepared on the same basis as our annual consolidated financial statements and notes thereto and include all adjustments, consisting of normal recurring items, considered necessary for the fair presentation. The operating results for the ninethree and six months ended SeptemberJune 30, 2022,2023, are not necessarily indicative of the results that may be expected for the full year ending December 31, 2022.2023.

The condensed consolidated balance sheet as of December 31, 2021,2022, has been derived from our audited financial statements at that date but does not include all disclosures and financial information required by GAAP for complete financial statements. The information included in the quarterly report on Form 10-Q should be read in conjunction with our consolidated financial statements and notes thereto for the year ended December 31, 2021,2022, which were included in our annual report on Form 10-K, as filed with the Securities and Exchange Commission on March 15, 2022.30, 2023.

Liquidity and Going Concern

The Company has recognized recurring losses. Asincurred losses since inception and as of SeptemberJune 30, 20222023, the Company had a working capital of approximately $20.5$2.6 million, an accumulated deficit of $83.1$110.2 million and cash and cash equivalents on hand of approximately $23.2$11.2 million. The Company’s net loss for the three months ended SeptemberJune 30, 20222023 and 2021,2022, was approximately $3.5$12.4 million and $2.3$5.3 million, respectively. The Company’sCompany's net loss for the ninesix months ended SeptemberJune 30, 20222023 and 2021,2022, was approximately $16.2$19.0 million and $4.8$12.7 million, respectively. The Company expects to incur significant expenses and increased operating losses for the next several years. The Company expects its expenses to increase in connection with its ongoing activities to research, develop and commercialize its product candidates. The Company will need to generate significant revenues to achieve profitability, and it may never do so. The Company expects the balance of cash on hand to be sufficient to meet its obligations for the 12 months from the issuance of these consolidated financial statements.

The Company obtained financing for certain Director & Officer liability insurance policy premiums from First Insurance Funding (the “Lender”). The total premiums, taxes, and fees financed is $667,500 with an annual percentage interest rate of 8.735%. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on the condensed consolidated balance sheet, with the last quarterly installment payment due on October 1, 2023.

The Company’s current cash on hand is not sufficient to satisfy its operating cash needs for the 12 months from the filing of this Quarterly Report on Form 10-Q. The Company believes that it has adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding the Company’s ability to continue as a going concern for a period of one year after the date the financial statements are issued. Management’s plan to alleviate the conditions that raise substantial doubt include raising additional working capital through public or private equity or debt financings or other sources, which may include collaborations with third parties as well as disciplined cash spending. Adequate additional financing may not be available to the Company on acceptable terms, or at all. Should the Company be unable to raise sufficient additional capital, the Company may be required to undertake cost-cutting measures including delaying or discontinuing certain clinical activities. These factors among others create a substantial doubt about the Company’s ability to continue as a going concern.

Use of estimates

The preparation of consolidated financial statements in conformity with GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities as of the date of the financial statements and the reported amounts of expenses during the reporting periods covered by the financial statements and accompanying notes. Significant areas requiring the use of management estimates include, but are not limited to, valuation of intangible assets, depreciative and amortization useful lives, assumptions used to calculate the fair value of the contingent share consideration, stock-based compensation, beneficial conversion features, warrant values, deferred taxes, and the assumptions used to calculate derivative liabilities.related valuation allowances. Actual results could differ materially from such estimates under different assumptions or circumstances.

Concentration of credit risk and other risks and uncertainties

Financial instruments that potentially subject the Company to a concentration of credit risk consist of cash. Substantially,Currently, substantially all the Company’s cash isand cash equivalents are held in demand deposit form by oneat two financial institution.institutions. Deposits in financial institutions may, from time to time, exceed federally insured limits. The Company has not experienced any losses on its deposits of cash.

The Company is subject to all of the risks inherent in an early-stage company developing new pharmaceutical products. These risks include, but are not limited to, limited management resources, dependence upon medical acceptance of the productproducts in development, regulatory approvals, successful clinical trials, availability and willingness of patients to participate in human trials, and competition in the pharmaceutical industry. The Company’s operating results may be materially affected by the foregoing factors.

Impact of COVID-19

In response to the spread of COVID-19, the Company has taken temporary precautionary measures intended to help minimize the risk of the virus to its employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for the Company’s employees.

As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, the Company may experience disruptions that could adversely impact the Company’s business. TheEffects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. TheEffects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that the Company intends to rely upon to assist it in conducting its clinical trials and the contract manufacturers who manufacture the Company’s drug candidates.

The Company is continuing to assess the potential impact of the continuing and lasting effects of the COVID-19 pandemic on its business and operations as of SeptemberJune 30, 2022.

On June 1, 2021, the Company completed a public offering (the “Offering”) of Units (each, a “Unit”), with each Unit consisting of (a) one share of common stock (or pre-funded warrant to purchase one share of common stock in lieu thereof, with an exercise price of $0.0001 per share, each a “Pre-Funded Warrant”) and (b) one warrant to purchase 0.75 of a share of our common stock, with an exercise price of $4.125 per share (each, an “Investor Warrant”). Pursuant to the Offering, the Company sold 4,133,400 Units consisting of (a) one share of common stock and (b) one Investor Warrant (inclusive the underwriter’s overallotment option of 1,200,000 of such Units), and 5,066,600 Units consisting of (a) one Pre-Funded Warrant and (b) one Investor Warrant. The Units had no stand-alone rights and were not certificated or issued as stand-alone securities. Accordingly, as result of the sale of such Units in the Offering, the Company issued in aggregate 4,133,400 shares of common stock, Pre-Funded Warrants exercisable for 5,066,600 shares of common stock, and Investor Warrants exercisable for 6,900,000 shares of common stock. The offering price was $3.75 for each Unit consisting of (a) one share of common stock and (b) one Investor Warrant, and $3.7499 for each Unit consisting of (a) one Pre-Funded Warrant and (b) one Investor Warrant. Net proceeds from the Offering were approximately $31.5 million, after underwriter discounts, commissions, legal and accounting fees, and certain other costs of approximately $3.0 million.

On September 8, 2022, the Company completed a registered direct offering and concurrent private placement (together, the “September 2022 Offering”). In the registered direct offering, the Company issued 1,976,285 shares of common stock at a purchase price per share of $2.53, for aggregate gross proceeds to the Company of approximately $5.0 million, before deducting certain transaction expenses payable by the Company. The transaction expenses were net against the proceeds received and were included in additional paid-in capital.

The Company issued to the investors in the September 2022 Offering warrants to purchase up to 3,359,684 shares of common stock (the “Private Placement Warrants”). The Private Placement Warrants were immediately exercisable upon issuance at an exercise price of $2.40 per share and will expire on September 8, 2027.

In a concurrent private placement the Company issued pre-funded warrants (the “Private Pre-Funded Warrants”) to purchase up to an aggregate of 1,383,399 shares of common stock at a purchase price of $2.5299 per Private Pre-Funded Warrant, for aggregate gross proceeds to the Company of approximately $3.5 million, before deducting transaction expenses payable by the Company, which were net against the proceeds received and were included in additional paid-in capital. The Private Pre-Funded Warrants were immediately exercisable at an exercise price of $0.0001 per share and will expire when the Private Pre-Funded Warrants are fully exercised. No Private Pre-Funded Warrants or Private Placement Warrants have been exercised as of September 30, 2022 (see Note 7).

The September 2022 Offering resulted in aggregate gross proceeds of approximately $8.5 million before deducting transaction expenses. The total net proceeds totaled approximately $7.8 million after deducting transaction costs of $0.7 million.2023.

In January 2022,2014, Reviva Pharmaceuticals, Inc. implemented a tax deferred savings plan, commonly referred to as a 401(k) plan. Employee’s contributions are withheld from standard payroll checks and are automatically withdrawn from the Company enteredchecking account and deposited into an At The Market Offering Agreement (the “ATM Agreement”) with H.C. Wainwright & Co., LLC, as sales agent (“Wainwright”), pursuant to whichindividual employee retirement accounts a few days following each payroll period. Employees can defer or contribute the statutory legal limits. There has been no Company may offer and sell, from time to time through Wainwright, sharesmatching of its common stock for aggregate gross proceeds of up to $12.9 million.

Effective July 28, 2022, the Company terminated the ATM Agreement. Prior to termination, the Company had not sold any shares of its Common Stock pursuantemployee contributions to the ATM Agreement.plan through June 30, 2023.

Basic and diluted net loss per share is computed by dividing the net loss for the period by the weighted average number of shares of common stock outstanding during the period. Diluted loss per share includes potentially dilutive securities such as stock options, warrants to purchase common stock, and other convertible instruments unless the result of inclusion would be anti-dilutive. These securities have been excluded from the calculation of diluted net loss per sharesshare for the three and ninesix months ended SeptemberJune 30, 20222023 and September 30, 20212022, because all such securities are anti-dilutive for all periods presented.

The following table summarizes the Company’s potentially dilutive securities, in common share equivalents, which have been excluded from the calculation of dilutive loss per share as their effect would be anti-dilutive:

The diluted loss per share computation equals basic loss per share for the three and ninesix months ended SeptemberJune 30, 20222023 and September 30, 20212022 because the Company had a net loss and the impact of the assumed exercise of stock options and warrants would have been anti-dilutive.

As of SeptemberJune 30, 2022,2023, there were public warrants outstanding to purchase an aggregate of 6,325,000 shares of common stock, and private warrants outstanding to purchase an aggregate of 3,915,9971,939,712 shares of common stock, investor warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock, private pre-funded warrants to purchase an aggregate of 1,383,399 shares of common stock, and assumed warrants outstanding to purchase an aggregate of 120,456 shares of common stock.

2020 Business Combination

In connection with the closing of our Business Combination in 2020, our predecessor company, Tenzing, issued public warrants to purchase 6,325,000 shares and private placement warrants to purchase 556,313 shares.

Further, there were assumed warrants to purchase an aggregate of 126,268 shares of common stock, of which 5,812 expired during fiscal year 2022. These warrants were classified as equity as of June 30, 2023 and June 30, 2022. The fair value of these warrants on the date of issuance was $1,279,182.

Each public warrant entitles the holder thereof to purchase one share of common stock at a price of $11.50 per share, subject to adjustment. No public warrants will be exercisable for cash unless we have an effective and current registration statement covering the issuance of the shares of common stock issuable upon exercise of the public warrants and a current prospectus relating to such shares of common stock.

We may call the public warrants for redemption, in whole and not in part, at a price of $0.01 per warrant;

The private warrants are substantially similar to the public warrants except such private warrants;

In no event will the Company be required to net cash settle either the public or the private warrants.

The exercise price and number of shares of common stock issuable on exercise of the warrants may be adjusted in certain circumstances including in the event of a share dividend, extraordinary dividend or a recapitalization, reorganization, merger or consolidation.

Further, there were assumed warrants outstanding to purchase an aggregate of 126,268 shares of common stock. These The private warrants were classified as equity as of September 30, 2022, and December 31, 2021. The fair value of these warrants on the date of issuance was $1,279,182.derivative liabilities pursuant to ASC 815 (see to Note 9).

2021 Public Offering

In connection with the September 2022 Offering,Company’s public offering of units completed on June 1, 2021, the Company issued pre-funded warrants (“2021 Pre-Funded WarrantsWarrants”) exercisable for 5,066,600 shares of common stock. Total proceeds from the sale of Units including the Pre-Funded Warrants were approximately $19.0 millionstock and the Pre-Funded Warrants are exercisable into one share of common stock at an exercise price of $0.0001 per share at any time after issuance. Additionally, in connection with the Offering, the Company issuedwarrants (“2021 Investor WarrantsWarrants”) exercisable for 6,900,000 shares of common stock with an exercise price of $4.125 per share of common stock any time after issuance. The Investor Warrants expire on June 1, 2026. No Investor Warrants were exercised during the nine months ended September 30, 2022. The Company has determined that as the Pre-Funded Warrants and Investor Warrants were issued at fair value in a public offering of Units with no debt funding included in the offering, the Pre-Funded Warrants and Investor Warrants should be classified as equity. stock.

During fiscal year 2021, 1,033,300 of the 2021 Pre-Funded Warrants were exercised for $103 in proceeds, resulting in the issuance of 1,033,300 common shares. During the nine months ended September 30,fiscal year 2022, 4,033,300 of the 2021 Pre-Funded Warrants were exercised for $403 in proceeds, resulting in the issuance of 4,033,300 common shares. There were no 2021 Pre-Funded Warrants outstanding as of SeptemberJune 30, 2022.2023.

During fiscal year 2022, 6,000 of the 2021 Investor Warrants were exercised for $18,563 in proceeds, resulting in the issuance of 4,500 shares of common stock. During the three months ended June 30, 2023, 295,816 of the 2021 Investor Warrants were exercised for $915,173 in proceeds, resulting in the issuance of 221,860 shares of common stock. During the six months ended June 30, 2023, 302,150 of the 2021 Investor Warrants were exercised for $934,766 in proceeds, resulting in the issuance of 226,610 shares of common stock. As of June 30, 2023, there are 2021 Investor Warrants outstanding to purchase an aggregate of 6,645,041 shares of common stock.

2022 Registered Direct Offering and Private Placement

On September 8, 2022, the Company completed a registered direct offering and concurrent private placement (the “September 2022 Offering”). In connection with the September 2022 Offering (see note 4),this offering, the Company issued to investors warrants (the “2022 Private Placement WarrantsWarrants”) to purchase up to 3,359,684 shares of Common Stock, whichcommon stock. The 2022 Private Placement Warrants were immediately exercisable at an exercise price of $2.40 per share and will expire on September 8, 2027. Additionally,upon issuance.

In a concurrent private placement, the Company issued pre-funded warrants (the “2022 Private Pre-Funded WarrantsWarrants”) to purchase up to an aggregate of 1,383,399 shares of common stock at a purchase price of $2.5299 per share.stock. The 2022 Private Pre-Funded Warrants were immediately exercisableexercisable.

During the three and six months ended June 30, 2023, an aggregate of 1,976,285 of the 2022 Private Placement Warrants were exercised for $4,743,084 in proceeds, resulting in the issuance of 1,976,285 shares of common stock. As of June 30, 2023, there are 1,383,399 of the 2022 Private Placement Warrants outstanding to purchase an aggregate of 1,383,399 shares of common stock. No 2022 Private Pre-Funded Warrants issued during the September 2022 Offering have been exercised as of June 30, 2023.

The Company has determined that as the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants were issued at fair value in an exercise priceoffering transaction in tandem with shares of $0.0001 per share.equity with no debt funding included in the offering, the 2022 Private Pre-Funded Warrants and 2022 Private Placement Warrants should be classified as equity.

The fair value of the 2022 Private Placement Warrants and 2022 Private Pre-Funded Warrants was determined utilizing a Black-Scholes model considering all relevant assumptions current at the date of issuance (i.e., Company share price of $2.20, exercise price of $2.40 for the 2022 Private Placement Warrants and $0.0001 for the 2022 Private Pre-Funded Warrants, term of 5 years, volatility of 111%, risk-free rate of 3.4%, and expected dividend rate of 0%). The grant date relative fair value of these warrants was estimated to be $5,712,592 on September 8, 2022 and are classified as equity.

The Company evaluated the 2022 Private Placement Warrants and the 2022 Private Pre-Funded Warrants in accordance with the guidance at ASC 480, Distinguishing Liabilities from Equity and ASC 815-40, Derivatives and Hedging, and determined that they should be classified as equity instruments, with no recurring fair value measurement required. The warrants are indexed to the Company’s common stock and are required to be settled through physical settlement or net share settlement, if exercised. Accordingly, the warrants were recorded at their grant date fair value with no subsequent remeasurement.

Stock-Based Compensation Expense

On April 25, 2023, the Compensation Committee of the Company's Board of Directors (the “Compensation Committee”) approved the grant of option awards to certain of the Company's officers and employees in accordance with the terms of the Company’s 2020 Equity Incentive Plan ("2020 Plan"). The Compensation Committee's approval included options granted to purchase a total of 1,303,000 shares of common stock to the Company's executive officers and other employees of the Company. All of the options were granted pursuant to the 2020 Plan and have an exercise price of $6.74 per share, based on the closing price of the common stock on the grant date in accordance with the terms of the 2020 Plan. The options granted to the named executive officers and Vice President for Program & Portfolio Management were immediately vested as to 50% of the shares subject thereto on the grant date, and will vest as to an additional 1.389% of the shares subject thereto on the last day of each month thereafter and have a ten-year expiration date. The options granted to the other employees have varying vesting terms between three and four years.

The Company records stock-based compensation expense in connection with the amortization of the fair value of stock options granted to employees, non-employee consultants and non-employee directors. During the three months ended SeptemberJune 30, 20222023 and 2021,2022, the Company recorded stock-based compensation of $40,587$2,620,819 and $27,590$39,876 respectively. During the ninesix months ended SeptemberJune 30, 2022,2023 and 2021,2022, the Company recorded stock-based compensation of $120,149$2,672,346 and $44,679$79,562 respectively. As of SeptemberJune 30, 2022,2023, the Company had unrecognized stock-based compensation expense of $163,779,$4,188,195, which is expected to be recognized over a weighted-average period of 1.53.0 years. As of SeptemberJune 30, 2022,2023, there are 0 and 2,695,6631,297,063 shares of common stock available for issuance under the 2006 Equity Incentive Plan and the 2020 Equity Incentive Plan.Plan, respectively.

Determining Fair Value

Valuation and Recognition – The fair value of each option award is estimated on the date of grant using the Black-Scholes option-pricing model. The Black-Scholes pricing model utilizes the following assumptions:

Expected Term – Expected life of an option award is the average length of time over which the Company expects employees will exercise their options, which is based on historical experience with similar grants.

Expected Volatility - Expected volatility is based on the Company’s historical stock volatility data over the expected term of the awards.

Risk-Free Interest Rate - The Company bases the risk-free interest rate on the implied yield currently available on U.S. Treasury zero-coupon issues with an equivalent expected term.

Dividend Yield – The Company has not paid a dividend and does not anticipate paying a dividend in the foreseeable future.

There were no options granted during the six months ended June 30, 2022. The value of option grants is calculated using the Black-Scholes option pricing model with the following assumptions for options granted during the ninesix months ended SeptemberJune 30, 2022 and 2021:2023:

Activity under the stock plans for the ninesix months ending Septemberended June 30, 2022,2023, is as follows:

The options granted had a $4.90 weighted average grant date fair value during the six months ended June 30, 2023.

7.SHORT-TERM DEBT

Insurance Funding

The Company obtained financing for certain Director & Officer liability insurance policy premiums. The governing agreement assigns the Lender a first priority lien on and security interest in the financed policies and any additional premium required in the financed policies.

The total premiums, taxes and fees financed is $667,500 with an annual interest rate of 8.735%. In consideration of the premium payment by the Lender to the insurance companies or the agent or broker, the Company unconditionally promises to pay the Lender the amount financed plus interest and other charges permitted under the governing agreement. As of June 30, 2023, the Company has repaid $445,000 towards the short-term debt and has recorded at such date the remaining insurance financing debt payable balance of $222,500, as short-term debt, on its condensed consolidated balance sheet. The Company will pay the remaining insurance financing through the last quarterly installment payment on October 1, 2023.

Clinical trials

Since 2010, the Company has entered into multiple clinical trial agreements with medical institutions in the United States, Europe and Asia for the purpose of enrolling patients into various clinical trials. The agreements are substantially similar by trial and include a detailed listing of the clinical trial services for which the Company will pay, how much willthe amount to be paid for each service, a set-up charge (if any), Investigational Review Board fees, contractual term, and other provisions. The clinical trial services provided by each site generally include the screening of prospective patients and, for those patients to be enrolled in the study, administration of the Company’s investigation drug according to the trial protocol, any required hospitalization, ancillary medical supplies, and 2-week patient follow-up. Further, each agreement requires the Company to indemnify each respective clinical site against any and all liability, loss, or damage it may suffer as a result of third-party claims; the Company maintains product liability insurance of not less than $10 million in conjunction with this indemnification. The agreements may be terminated upon 30 days’ written notice, subject to conditions of paying all liabilities incurred through the date of termination. Additionally, with each screened patient, the Company incurs expense with other entities engaged to provide independent review of patient medical records.

As part of the Company's agreement with one of its clinical research organizations, the Company is required to maintain a 7% upfront float for fees related to expenses incurred in clinical studies. When the float has depleted to 15% (i.e. 85% of the float has been used) the Company will receive an invoice to replenish the float up to 7% of the remaining estimated budget for the studies. During the three months ended June 30, 2023, the Company did not make any additional payments to replenish the float and expensed approximately $0.7 million. During the six months ended June 30, 2023, the Company paid approximately $0.9 million to replenish the float and expensed approximately $1.0 million. As of June 30, 2023, the Company has no remaining prepaid float balance.

Indemnification

From time to time, in its normal course of business, the Company may indemnify other parties, with whom it enters into contractual relationships, including lessors and parties to other transactions with the Company. The Company may agree to hold other parties harmless against specific losses, such as those that could arise from a breach of representation, covenant or third-party infringement claims. It may not be possible to determine the maximum potential amount of liability under such indemnification obligations due to the unique facts and circumstances that are likely to be involved in each particular claim and indemnification provision. Historically, there have been no such indemnification claims. The Company has also indemnified its directors and executive officers, to the extent legally permissible, against all liabilities reasonably incurred in connection with any action in which such individual may be involved by reason of such individual being or having been a director or executive officer.

Operating Leases

The Company adopted ASC 842, Leases, on January 1, 2020.2019. The Company has elected to apply the short-term lease exception to leases of one year or less. Presently, the Company has a single twelve-month lease on its Corporate Office located at 19925 Stevens Creek Blvd., Suite 100, Cupertino, CA 95014. The monthly lease payment is approximately $1,300$1,447 and the lease was renewed in February 20212022 and again on February 1, 2022,2023, for another 12-month term.

Fair value is defined as the price that would be received to sell an asset or paid to transfer a liability in an orderly transaction between market participants at the measurement date. To increase the comparability of fair value measures, the following hierarchy prioritizes the inputs to valuation methodologies used to measure fair value:

The determination of where assets and liabilities fall within this hierarchy is based upon the lowest level of input that is significant to the fair value measurement.

The following is a listing of the Company’s warrant liabilities required to be measured at fair value on a recurring basis and where they are classified within the fair value hierarchy as of SeptemberJune 30, 20222023 and December 31, 2021:2022:

The following table summarizes the changes in the fair value of the warrant liabilities measured at fair value on a recurring basis using significant unobservable inputs (Level 3):

The Company classifiesclassified the private warrants pursuant to ASC 815 as derivative liabilities, as the warrants have terms which are modified upon any future transfer of ownership, with subsequent changes in their fair values to be recognized in the consolidated financial statements at each reporting date. The Company calculated the fair value of the private warrants as of SeptemberJune 30, 20222023 as $105,699$1,012,490 using a Black-Scholes model. The key inputs used in the Black-Scholes calculation were the risk-free interest rate, expected volatility, expected life, exercise price and stock price. The risk-free interest rate was estimated to be 4.23%4.70%, the expected volatility was estimated to be 76.8%77.90%, and the expected life was estimated to be 3.212.46 years. The exercise price was $11.50,$11.50, and the stock price $1.59.$5.86.

The Company recorded a gainloss on remeasurement of warrant liabilities of $0$456,177 and $200,273a gain of 178,021 for the three months ended SeptemberJune 30, 20222023 and 2021,2022, respectively. The Company recorded a gainloss on remeasurement of warrant liabilities of $267,031$445,051 and $1,312,899a gain of $267,031 for the ninesix months ended SeptemberJune 30, 2023 and 2022, and 2021, respectively.

In connection with the September 2022 Offering, on October 6, 2022, the Company filed a registration statement on Form S-1 with the Securities and Exchange Commission (the “SEC”) under the Securities Act of 1933, as amended, relating to the resale from time to time, by the selling stockholders identified in the prospectus of (i) up to 3,359,684 shares of common stock, which the selling stockholders may acquire upon the exercise the Private Placement Warrants and (ii) up to 1,383,399 shares of common stock which the selling stockholders may acquire upon the exercise of the Private Pre-Funded Warrants. The Company issued the Private Placement Warrants and the Private Pre-Funded Warrants to the selling stockholders in the September 2022 Offering on September 8, 2022. On October 17, 2012, the SEC issued the Company a Notice of Effectiveness for the registration statement on Form S-1. The Company will not receive any proceeds from the sale of the shares by the selling stockholders.

ITEM 2.    MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

All statements other than statements of historical fact included in this section regarding our financial position, business strategy and the plans and objectives of management for future operations, are forward- looking statements. When used in this section, words such “anticipate,” “believe,” “estimate,” “expect,” “intend” and similar expressions, as they relate to our management, identify forward-looking statements. Such forward-looking statements are based on the beliefs of management, as well as assumptions made by, and information currently available to, our management. Actual results could differ materially from those contemplated by the forward- looking statements as a result of certain factors detailed herein. All such forward-looking statements, and all subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are qualified in their entirety by this paragraph.paragraph and the "Cautionary Note Regarding Forward-Looking Statements" below.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

This reportQuarterly Report on Form 10-Q contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 under Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.amended (the “Exchange Act”). Forward-looking statements include statements with respect to our beliefs, plans, objectives, goals, expectations, anticipations, assumptions, estimates, intentions and future performance, and involve known and unknown risks, uncertainties and other factors, which may be beyond our control, and which may cause our actual results, performance or achievements to be materially different from future results, performance or achievements expressed or implied by such forward-looking statements. All statements other than statements of historical fact are statements that could be forward-looking statements. You can identify these forward-looking statements through our use of words such as “may,” “can,” “anticipate,” “assume,” “should,” “indicate,” “would,” “believe,” “contemplate,” “expect,” “seek,” “estimate,” “continue,” “plan,” “point to,” “project,” “predict,” “could,” “intend,” “target,” “potential” and other similar words and expressions of the future.

There are a number of important factors that could cause the actual results to differ materially from those expressed in any forward-looking statement made by us. These factors include, but are not limited to:

The foregoing does not represent an exhaustive list of matters that may be covered by the forward-looking statements contained herein or risk factors that we are faced with that may cause our actual results to differ from those anticipated in such forward-looking statements. Please see “Risk Factors” for additional risks which could adversely impact our business and financial performance.

All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this report or the date of the document incorporated by reference into this report. We have no obligation, and expressly disclaims any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. We have expressed our expectations, beliefs and projections in good faith and believe they have a reasonable basis. However, we cannot assure you that our expectations, beliefs or projections will result or be achieved or accomplished.

Company Overview

We are a clinical-stage biopharmaceuticallate-stage pharmaceutical company that discovers, develops, and seeks to commercialize next-generation therapeutics for diseases representing significant unmet medical needs and burdenburdens to society, patients, and their families. Our current pipeline focuses on the central nervous system, respiratory,inflammatory, and metaboliccardiometabolic diseases. We use a chemical genomics driven technology platform and proprietary chemistry to develop new medicines. Our pipeline currently has two drug candidates, RP5063 (brilaroxazine)brilaroxazine (RP5063) and RP1208. Both are new chemical entities discovered in-house. We have been granted composition of matter patents for both RP5063brilaroxazine and RP1208 in the United States (U.S.), Europe, and several other countries.

Our lead drug candidate, RP5063,brilaroxazine, is ready for continuedin clinical development forand is intended to treat multiple neuropsychiatric indications. These include schizophrenia, bipolar disorder (BD), major depressive disorder (MDD), attention–deficit/hyperactivity disorder (ADHD), behavioral and psychotic symptoms of dementia or Alzheimer’s disease (BPSD), and Parkinson’s disease psychosis. Furthermore, RP5063brilaroxazine is also ready for clinical development for two respiratory indications —  pulmonary arterial hypertension (PAH) and idiopathic pulmonary fibrosis (IPF). The U.S. Food and Drug Administration (FDA) has granted Orphan Drug designationDesignation to RP5063brilaroxazine for the treatment of PAH in November 2016 and IPF in April 2018. Brilaroxazine also is in preclinical development for the treatment of psoriasis.

On January 10, 2022, the FDA notified us that we maycould proceed with our Phase 3 RECOVER trial for RP5063.(the “RECOVER Trial”), which is a global Phase 3, randomized, double-blind, placebo-controlled, multicenter study designed to assess the safety and efficacy of brilaroxazine in approximately 400 patients with acute schizophrenia compared to placebo. On February 1, 2022, we announced that the first patients havein the RECOVER Trial had been dosed in our Phase 3 RECOVER trial to assess RP5063 for the treatment of subjects with an acute exacerbation of schizophrenia.dosed. On July 27, 2022, we announced that we had enrolled patients in 15 geographically diverse sites across the US. RECOVER is a global Phase 3, randomized, double-blind, placebo-controlled, multicenterU.S.

The Company received regulatory approval for initiating the study designed to assess the safetyin Asia (India) on October 11, 2022 and efficacy of RP5063multiple sites were initiated in approximately 400 patients with acute schizophrenia compared to placebo. India in November and December 2022.

On October 31, 2022, we announced over 30% enrollment in our Phase 3the RECOVER trialTrial in the United States and the initiation and ongoing enrollment across sites in Europe. TheEurope, and we finished 2022 with about 40% enrollment. On June 22, 2023, the Company has received regulatory approvalreported that over 80% of patients have been enrolled in the RECOVER Trial, and on August 14, 2023, the Company reported that enrollment was near completion for initiating the study in Asia (India), with enrollment atapproximately 400 patients across multiple sites in Indiathe Unites States, Europe and Asia for the RECOVER Trial with topline data expected in 2022.October 2023.

Our primary focus is to complete the clinical development of RP5063brilaroxazine for the treatment of acute and maintenance schizophrenia.

We are currently developing Phase 2 trial protocols for studies of brilaroxazine in ADHD and PAH and anticipate submitting the protocols to regulatory agencies in the firstsecond half of 2023 and initiating the Phase 2 studies in the second half of 2023.

Subject to the receipt of additional financing, we may also continue the clinical development of RP5063brilaroxazine for the treatment of BD, MDD, BPSD, PDP, and IPF. Moreover, subject to the receipt of additional financing, we may also advance the development of our second drug candidate, RP1208, for the treatment of depression and obesity.

Impact of COVID-19

In response to the spread of COVID-19, we have taken temporary precautionary measures intended to help minimize the risk of the virus to our employees and community, including temporarily requiring employees to work remotely and suspending all non-essential travel for our employees.

As a result of the COVID-19 pandemic, the effects of which are still being felt in the U.S. and around the world, we may experience disruptions that could adversely impact our business. TheEffects of the COVID-19 pandemic may negatively affect clinical site initiation, patient recruitment and enrollment, patient dosing, distribution of drug to clinical sites and clinical trial monitoring for our clinical trials. TheEffects of the COVID-19 pandemic may also negatively affect the operations of the third-party contract research organizations that we intend continue to rely upon to assist us in conducting our clinical trials and the contract manufacturers who manufacture our drug candidates.

We are continuing to assess the potential impact of the COVID-19continuing and lasting effects of theCOVID-19 pandemic on our business and operations. For additional information on the various risks posed by the COVID-19 pandemic, refer to Part I—Item 1A—Risk Factors of our Annual Report on Form 10-K, as filed with the Securities and Exchange Commission (the “SEC”) on March 15, 2022.30, 2023.

Business Combination and Domestication

On December 14, 2020, our predecessor company, formerly known as Tenzing Acquisition Corp., a British Virgin Islands exempted company (“Tenzing”), and Reviva Pharmaceuticals, Inc., a Delaware corporation (together with its consolidated subsidiaries, “Old Reviva”), consummated the transactions (the “Business Combination”) contemplated by the Agreement and Plan of Merger, dated as of July 20, 2020 (as amended, the “Merger Agreement”), by and among Tenzing, Tenzing Merger Subsidiary Inc., a Delaware corporation and wholly-owned subsidiary of Tenzing (“Merger Sub”), Old Reviva, and the other parties thereto. Pursuant to the Merger Agreement, Merger Sub merged with and into Old Reviva, with Old Reviva surviving as our wholly owned subsidiary. We refer to this transaction as the Business Combination. In connection with and one day prior to the completion of the Business Combination, Tenzing re-domiciled out of the British Virgin Islands and continued as a company incorporated in the State of Delaware, and changed its name to Reviva Pharmaceuticals Holdings, Inc. Prior to the completion of the Business Combination, the Company was a shell company. Following the Business Combination, the business of Old Reviva is the business of the Company.

Old Reviva was incorporated in the state of Delaware on May 1, 2006 and its subsidiary, Reviva Pharmaceuticals India Pvt. Ltd., was incorporated on December 23, 2014. Tenzing was formed pursuant to the laws of the British Virgin Islands on March 20, 2018.

Financial Overview

We are a clinical-stage biopharmaceutical company and have not generated any revenues from the sale of products. We have never been profitable, and our accumulated deficit as of SeptemberJune 30, 2022,2023, was $83.1$110.2 million. Our net loss for the three months ended SeptemberJune 30, 20222023 and 2021,2022, was approximately $3.5$12.4 million and $2.3$5.3 million, respectively. Our net loss for the ninesix months ended SeptemberJune 30, 20222023 and 2021,2022, was approximately $16.2$19.0 million and $4.8$12.7 million, respectively. We expect to incur significant expenses and increased operating losses for the next several years. We expect our expenses to increase in connection with our ongoing activities to research, develop and commercialize our product candidates. Furthermore, we expect to incur additional costs associated with operating as a public company. We will need to generate significant revenues to achieve profitability, and we may never do so.

We expect our expenses will increase substantially in connection with our ongoing activities, as we:

We have funded our operations to date primarily from the issuance and sale of our equity and convertible equity securities. As of SeptemberJune 30, 2022,2023, we had cash and cash equivalents of approximately $23.2$11.2 million. To fund our current operating plans, we will need to raise additional capital. Our existing cash and cash equivalents will not be sufficient for us to complete development of our product candidates and, if applicable, to prepare for commercializing any product candidate that may receive approval. Accordingly, we will continue to require substantial additional capital beyond our existing cash to continue our clinical development and potential commercialization activities, however, weactivities. We believe that we have adequate cash on hand to cover anticipated outlays well into the fourth quarter of 2023, but will need additional fundraising activities and cash on hand during the fourth quarter of fiscal year 2023. These conditions raise substantial doubt regarding our existing cash, will be sufficientability to fund our current operating plans through at least November 2023.continue as a going concern for a period of one year after the date the financial statements are issued. The amount and timing of our future funding requirements will depend on many factors, including the pace and results of our clinical development efforts. We will seek to fund our operations through public or private equity or debt financings or other sources, which may include collaborations with third parties. Adequate additional financing may not be available to us on acceptable terms, or at all. Our failure to raise capital as and when needed would have a negative impact on our financial condition, and our ability to pursue our business strategy.strategy, and our ability to continue as a going concern. We cannot assure you that we will ever be profitable or generate positive cash flow from operating activities.

Research and Development Expenses

We focus our resources on research and development activities, including the conduct of preclinical and clinical studies and product development and expense such costs as they are incurred. We have not historically tracked or recorded research and development expenses on a project-by-project basis, primarily because we use our employee and infrastructure resources across multiple research and development projects, and it is not practical for us to allocate such costs on a project-by-project basis. Our research and development expenses primarily consist of employee-related expenses, including deferred salaries, salaries, benefits and taxes for personnel in research and development functions.

The largest recurring component of our total operating expenses has historically been research and development activities. weWe expect our research and development expenses will increase for the next several years as we advance our development programs, pursues regulatory approval of our product candidates in the U.S. and other jurisdictions and prepare for potential commercialization, which would require a significant investment in costs related to contract manufacturing, inventory buildup and sales and marketing activities.

Our primary product candidates and their current status is as follows:

** We completed the Phase 1 clinical study for RP5063 (Brilaroxazine)brilaroxazine prior to starting the Phase 2 study in schizophrenia and schizoaffective disorder. We collected safety data for RP5063 (Brilaroxazine)brilaroxazine in over 200 patients, including healthy subjects and patients with stable schizophrenia, acute schizophrenia and schizoaffective disorder. Generally, no separate Phase 1 study is required for conducting a Phase 2 study for an additional indication, provided the treatment doses in the Phase 2 study for an additional indication are within the range of doses tested in the previously completed Phase 1 study.

The successful development of our platform and product candidates is highly uncertain, and we may never succeed in achieving marketing approval for our product candidates RP5063 (Brilaroxazine), RP1208, or any future product candidates. We estimate that initialexpect the remaining costs to conductin connection with our ongoing Phase 3 clinical study for RP5063 could totalbrilaroxazine to be approximately $26$9.2 million as of June 30, 2023, with approximately $1.0 million having been paid over the course of calendar 2021, with approximately $16.2$5.5 million payable during calendar 2022, approximately $6.6 million payable duringthe rest of calendar 2023, and approximately $2.5$3.7 million payable during calendar 2024. At this time, other than our estimates for conducting our Phase 3 clinical study for RP5063,brilaroxazine, we cannot reasonably estimate the nature, timing, or costs of the efforts necessary to finish developing any of our product candidates or the period in which material net cash, if any, from these product candidates may commence. This is due to the numerous risks and uncertainties associated with developing therapeutics, including the uncertainty of:

General Administrative Expenses

General and administrative expenses primarily consist of payroll and related costs for employees in executive, business development, finance, and administrative functions. Other significant general and administrative expenses include professional fees for accounting and legal services.

We expect general and administrative expenses to increase as we expand infrastructure and continue the development of our clinical programs. Other increases could potentially include increased costs for director and officer liability insurance, costs related to the hiring of additional personnel, and increased fees for directors, outside consultants, lawyers, and accountants. We expect to incur significant costs to comply with corporate governance, internal controls, and similar requirements applicable to public companies.

Interest Income and Other Income

Interest income and other, net consists largely of interest earned on our cash & cash equivalents.

Critical Accounting Policies and Use of Estimates

Our critical accounting policies are disclosed in our Annual Report on Form 10-K for the year ended December 31, 2021,2022, as filed with the SEC on March 15, 2022.30, 2023. Since the date of the Annual Report on Form 10-K, there have been no material changes in our critical accounting policies.

Results of Operations

Comparison of the three months ended SeptemberJune 30, 2022,2023 and 2021:2022:

The following table summarizes our results of operations for the three months ended SeptemberJune 30, 2022,2023 and 2021:2022:

Research and Development Expenses

We incurred approximately $2.3$9.0 million and $1.4$4.5 million in research and development expenses for the three months ended SeptemberJune 30, 20222023 and 2021,2022, respectively. The primary reason for the increase of $0.9$4.5 million, or 62%99%, was attributable to an increase in Phase 3 clinical trial activity, higherexpenses and drug development costs of approximately $0.4$3.0 million for our product candidate RP5063,brilaroxazine. This is coupled with an increase of approximately $0.4 million related to preclinical expenditures, other clinical expenses, and increases in salary. Our research and development expenses are expected to increase for the foreseeable future as we continue to advance our platform and product candidates. 

General and Administrative Expenses

We incurred approximately $1.3 million and $1.1$0.9 million in general and administrative expenses for the three months ended September 30, 2022 and 2021, respectively. The increase of $0.2 million, or 19%, was primarily attributable to an increase in consultant and professional fees of $0.2 million.

Gain on Remeasurement of Warrant Liabilities

The gain on remeasurement of warrant liabilities of $0 million and $0.2 million for the three months ended September 30, 2022 and 2021, respectively, resulted from the decrease in calculated fair value principally as a result of the decline in stock price during the three months ended September 30, 2021.

Interest and Other Income (Expense), Net

Interest and other income (expense), net was approximately $49,509 and $(547) for the three months ended September 30, 2022 and 2021, respectively. The increase is primarily due to higher interest income of approximately $50,000 due to an increase in market interest rates in 2022 as compared to 2021.

Provision for Income Taxes

The provision for income taxes was approximately $1,864 and $2,102 for the three months ended September 30, 2022 and 2021, respectively. The increase was primarily due to an increase of taxable income related to subsidiary revenue operations.

Comparison of the nine months ended September 30, 2022, and 2021:

The following table summarizes our results of operations for the nine months ended September 30, 2022, and 2021:

Research and Development Expenses

We incurred approximately $12.7 million and $2.2 million in research and development expenses for the nine months ended September 30, 2022 and 2021, respectively. The primary reason for the increase of $10.5 million, or 478%, was attributable to an increase in Phase 3 clinical trial activity and higher drug development costs of approximately $6.7 million for our product candidate RP5063,stock-based compensation, an increase of approximately $1.0 million related to preclinical expenditures and other clinical expenses, an increase of approximately $2.0 million related to manufacturing, testing, and delivery of chemicals, approximately $0.4$0.6 million related to safety and toxicology studies and other increasesan increase in salary.salaries of approximately $0.5 million. This is slightly offset by a decrease of approximately $0.4 million related to manufacturing and testing expenses, a decrease of approximately $0.1 million related to preclinical expenditures and a decrease of approximately $0.1 million related to recruiting expenses. Our research and development expenses are expected to increase for the foreseeable future as we continue to advance our platform and product candidates.

General and Administrative Expenses

We incurred approximately $3.9$3.1 million and $4.0$1.0 million in general and administrative expenses for the ninethree months ended SeptemberJune 30, 20222023 and 2021,2022, respectively. The decreaseincrease of $0.1$2.1 million, or 2%206%, was primarily attributable to a decreaseincreases in stock-based compensation of approximately $1.6 million, legal expenseexpenses of approximately $0.3 million, offset by an increase inrecruiting expenses of approximately $0.1 million, consultant and professional feesexpenses of approximately $0.1 million and recruiting expensessalary and board of director compensation totaling approximately $0.1 million. This is slightly offset by a decrease in health and commercial insurance of approximately $0.1 million.

Gain(Loss) gain on Remeasurement of Warrant Liabilities

The remeasurement of warrant liabilities loss of $0.5 million and gain of $0.2 million for the three months ended June 30, 2023 and 2022, respectively, resulted from the increase in calculated fair value principally as a result of the increase in our stock price during the three months ended June 30, 2023. The gain on remeasurement of warrant liabilities of approximately $0.3 million and $1.3$0.2 million for the ninethree months ended SeptemberJune 30, 2022, and 2021, respectively, resulted from the smaller decrease in calculated fair value principally as a result of the smaller decline in stock price during those nine month periodthe three months ended SeptemberJune 30, 2022 versus 2021.2022.

Interest and Other Income (Expense), Net

The interest and other income (expense), netInterest Income increased primarily due to the Company moving funds to an interest-bearing account in the final months of approximately $56,961 and $(3,948) for the nine months ended September 30,fiscal year 2022, and 2021, respectively. The increase is primarily a result of higher interest income of approximately $67,000 due tocoupled with an increase in market interest rates in 20222023 as compared to 2021.2022.

Provision for Income TaxesComparison of the six months ended June 30, 2023 and 2022:

The provision for income taxes was approximately $12,414 and $6,004following table summarizes our results of operations for the ninesix months ended SeptemberJune 30, 2023 and 2022: