See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Changes in Shareholders’ Equity

(Unaudited)

See accompanying notes.

Oragenics, Inc.

Consolidated Statements of Cash Flows

(Unaudited)

See accompanying notes.

Oragenics, Inc.

Notes to Consolidated Financial Statements

(Unaudited)

1. Organization

Oragenics, Inc. (formerly known as Oragen, Inc.) (the “Company” or “we”) was incorporated in November, 1996; however, operating activity did not commence until 1999. We are focused on becoming a leader in developingthe development of the NT-CoV2-1 intranasal vaccine candidate to combat the novel Severe Acute Respiratory Syndrome coronavirus (“SARS-CoV-2”) coronavirus pandemic and the further development of effective treatments for novel antibiotics against infectious disease and on developing effective treatments for oral mucositis.disease.

2. Basis of Presentation

The accompanying unaudited interim consolidated financial statements as of September 30, 2017March 31, 2022 and December 31, 20162021 (audited) and for the three and nine months ended September 30, 2017March 31, 2022 and 20162021, have been prepared in accordance with accounting principles generally accepted in the United States of America (“US GAAP”) for interim consolidated financial information and with the instructions to Form 10-Q and Article 8 of Regulation S-X. Accordingly, they do not include all of the information and footnotes required by US GAAP for complete consolidated financial statements. In the opinion of management, the accompanying consolidated financial statements include all adjustments, consisting of normal recurring accruals, necessary for a fair presentation of the financial condition, results of operations and cash flows for the periods presented. The results of operations for the interim period ending September 30, 2017ended March 31, 2022, are not necessarily indicative of the results of operations that may be expected for the year endingended December 31, 20172022, or any future period.

These consolidated financial statements should be read in conjunction with the audited financial statements and notes thereto for the year ended December 31, 2016,2021, which are included in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on February 27, 2017.March 24, 2022. The Company has incurred recurring losses and negative cash flows from operations since inception. To date, the Company has not generated significant revenues from operations. The Company sold its consumer probiotics business in 2016 and, as a result, has generated $-0- revenues, incurred a net loss of $5,270,292,$6,035,394 and used cash of $5,005,050$5,636,952 in its operating activities during the ninethree months ended September 30, 2017.March 31, 2022. As of September 30, 2017,March 31, 2022, the Company had an accumulated deficit of $99,940,064.$177,309,522.

The Company expects to incur substantial expenditures to further develop each of its technologies. The Company believes the working capital at September 30, 2017,March 31, 2022 will be sufficient to meet the business objectives as presently structured through Decemberthe fourth quarter of 2017.2022. As such, there is substantial doubt that we can continue as a going concern beyond that date.

The Company’s ability to continue operations after its current cash resources are exhausted depends on its ability to obtain additional financing or achieve profitable operations, as to which no assurances can be given. Cash requirements may vary materially from those now planned because of changes in the Company’s focus and direction of its research and development programs, competitive and technical advances, or other developments. Additional financing will be required to continue operations after the Company exhausts its current cash resources and to continue its long-term plans for clinical trials and new product development. There can be no assurance that any such financing can be realized by the Company, or if realized, what the terms thereof may be, or that any amount that the Company is able to raise will be adequate to support the Company’s working capital requirements until it achieves profitable operations.

The Company intends to seek additional funding through sublicensing arrangements, joint venturing or partnering, sales of rights to technology, government grants and public or private financings. The Company’s future success depends on its ability to raise capital and ultimately generate revenue and attain profitability. The Company cannot be certain that additional capital, whether through selling additional debt or equity securities or obtaining a line of credit or other loan, will be available to it or, if available, will be on terms acceptable to the Company. If the Company issues additional securities to raise funds, these securities may have rights, preferences, or privileges senior to those of its common stock, and the Company’s current shareholders may experience dilution. If the Company is unable to obtain funds when needed or on acceptable terms, the Company may be required to curtail its current development programs, cut operating costs and forego future development and other opportunities.

3. Significant Accounting Policies

Recently Issued Accounting Pronouncements

In March 2016,Basis of Consolidation

The consolidated financial statements include the Financialaccounts of Oragenics, Inc. and our wholly-owned subsidiary Noachis Terra, Inc. All intercompany balances and transactions have been eliminated.

New Accounting Standards Board issued guidance on Compensation—Stock Compensation (Topic 718) Improvements to Employee Share-Based Payment Accounting, to simplify the accounting for share-based payment transactions, including the income tax consequences, classification of awards as either equity or liabilities, and classification on the statement of

cash flows. Some of the areas for simplification apply only to nonpublic entities. The guidance is effective for annual and interim periods beginning after December 15, 2016. This guidance has not had a material impact on its results of operations, financial position or disclosures.

There are no otheradditional accounting pronouncements issued or effective during the three or nine months ended September 30, 2017March 31, 2022, that have had, or are expected to have, ana material impact on our consolidated financial statements.

Use of Estimates

The preparation of consolidated financial statements in conformity with US GAAP requires management to make estimates and assumptions that affect the reported amounts of assets and liabilities and disclosure of contingent assets and liabilities at the date of the consolidated financial statements, as well as the reported amounts of expenses during the reporting period. Actual results could differ from those estimates. The principal areasarea of estimation reflected in the consolidated financial statements are anticipated milestone payments, stock based compensation, valuation of warrants, and income tax valuation allowance. Inventory obsolescence reserve, sales returns and allowances and the allowance for doubtful accounts were the principal areas of estimation that had been reflected in the financial statements related to discontinued operations.is stock-based compensation.

Restricted Cash

The Company has cash that is restricted pursuant to the terms of the Note Purchase Agreement with Intrexon Corporation (“Intrexon”). Proceeds from the note are to be used to fund the Company’s AG013 research and clinical trials.

Stock-Based Payment Arrangements

Generally, all forms of stock-based payments, including stock option grants, warrants, and restricted stock grantswarrants are measured at their fair value on the awards’ grant date typically using a Black-Scholes pricing model. Stock-based compensation awards issued to non-employees for services rendered are recorded at the fair value of the stock-based payment. The expense resulting from stock-based payments are recorded in research and development expense or selling, general and administrative expense in the consolidated statement of operations, depending on the nature of the services provided. Stock-based payment expense is recorded over the requisite service period in which the grantee provides services to us. To the extent the stock option grants, warrants, or restricted stock grantswarrants do not vest at the grant date they are subject to forfeiture.

Stock-Based Compensation

US GAAP requires all stock-based payments to employees, including grants of employee stock options, to be recognized in the consolidated financial statements based on their fair values as of the grant date. Stock-based compensation expense is recorded over the requisite service period in which the grantee provides services to us, to the extent the options do not vest at the grant date and are subject to forfeiture. For performance-based awards that do not include market-based conditions, we record share-based compensation expense only when the performance-based milestone is deemed probable of achievement. We utilize both quantitative and qualitative criteria to judge whether milestones are probable of achievement. For awards with market-based performance conditions, we recognize the grant-date fair value of the award over the derived service period regardless of whether the underlying performance condition is met. In connection with adopting ASU 2016-09, the Company made an accounting policy election to account for forfeitures in compensation expense as they occur.

Warrants

Warrants

The Company used the Black Scholes Option Pricing Model in calculating the relative fair value of any warrants that have been issued.

Derivative Liabilities

In accordance with ASC 480-10-25 Liabilities-Distinguishing from Equity, warrants are accounted for as liabilities at their fair value during periods where they can be net cash settled in case of a change in control transaction.

The warrants are accounted for as a liability at their fair value at each reporting period. The value of the derivative warrant liability will be re-measured at each reporting period with changes in fair value recorded as a change in the value of derivative liability. To derive an estimate of the fair value of these warrants, a Black Scholes Option Pricing Model is utilized.

Net Loss Per Share

During all periods presented, the Company had securities outstanding that could potentially dilute basic earnings per share in the future but were excluded from the computation of diluted net loss per share, as their effect would have been antidilutive because the Company reported a net loss for all periods presented. Basic and diluted net loss per share amounts are the same for the periods presented. Net loss per share is computed using the weighted average number of shares of common stock outstanding.

Revenue Recognition

During the quarter ended June 30, 2016, the Company sold its consumer probiotic business, from which it had historically generated revenues. As a result of this sale, the Company is no longer generating revenues.Concentrations

Concentrations

In June of 2016, the Company sold its consumer probiotics business, as such the Company is no longer dependent on key suppliers to continue to operate the consumer probiotics business.

Financial instruments which potentially subject the Company to concentrations of credit risk consist principally of cash and cash equivalents. The Company maintains cash accounts in commercial banks, which may, at times, exceed federally insured limits. The Company has not experienced any losses in such accounts. The Company believes it is not exposed to any significant credit risk on cash and cash equivalents. As of September 30, 2017,March 31, 2022, the uninsured portion of this balance was $4,081,569.$21,122,463. As of December 31, 2016,2021, the uninsured portion of this balance was $3,830,618.$27,015,703.

Grant Revenue

Grant revenues are derived from a small business innovation research grant in the amount of $250,000 (“Computer-aided Design for Improved Lantibiotics” R41GM136034. The Company recognizes grant revenue as reimbursable grant costs are incurred up to the pre-approved award limits within the budget period. The costs associated with these reimbursements are reflected as a component of research and development expenses in the accompanying consolidated statement of operations.

4. Stock-based Compensation

The Company recognized stock-based compensation on all employee and non-employee awards as follows:

Schedule of Stock Based Compensation Expenses Recognized

The following table summarizes the stock option activity during the three months ended March 31, 2022:

Summary of Stock Option Activity

Total unrecognized compensation cost related to unvested stock options was $311,534 as of March 31, 2022 and is expected to be recognized over a weighted-average period of less than two years.

On February 25, 2022, the Company held its reconvened Annual Meeting. At our annual meeting on May 4, 2017, ourthe Annual Meeting, the shareholders of the Company approved an amendment to our 2012and ratified the Company’s 2021 Equity Incentive Plan to increase the shares available for awards thereunder by 1,500,000 shares.

The Company granted -0- and 1,056,000 stock options, with(the “2021 Plan”) Which is a weighted-average grant date fair value of -0- and $0.37 per share, during the three and nine months ended September 30, 2017, respectively. The Company granted -0- and 700,000 stock options, with a weighted-average grant date fair value of -0- and $0.72 per share, during the three and nine months ended September 30, 2016, respectively.

During the nine months ended September 30, 2017, 386,666 stock options previously granted have vested and 71,200 stock options were forfeited and no stock options were exercised.

On June 22, 2017, in connection with, and in furtherance of, the non-employee director compensation program, the Board approved stock option awards in the amount of 140,000successor to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, and Robert Koski under the Company’s 2012 Equity Incentive Plan at an exercise price(the “2012 Plan”). The 2021 Plan was originally approved by the Company’s Board of $0.37 per share,Directors on March 13, 2021. The 2021 Plan provides the closing price on June 22, 2017, the dateaggregate number of the grant.

In addition, on June 22, 2017, in connection with, and in furtheranceshares of the new equity based award program, the Board approved stock option awards in the amount of 455,000 to management and 41,000 to staffCommon Stock that may be issued under the Company’s2021 Plan will not exceed the sum of (i) 10,000,000 new shares, (ii) the number of shares remaining available for the grant of new awards under the 2012 Equity Incentive Plan at an exercise price(the “2012 Plan”) as of $0.37 per share,immediately prior to the closing price on June 22, 2017, theeffective date of the grant.

On February 9, 2017, in connection with,2021 Plan, and in furtherance(iii) certain shares subject to outstanding awards granted under the 2012 Plan that may become available for issuance under the 2021 Plan, as such shares become available from time to time. As of the non-employee director compensation program, the Board approved the award of 40,000 restrictedMarch 31, 2022, 10,582,806 shares of the Company’s common stock to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, and Robert Koskiare available for future awards under the Company’s 2012 Equity Incentive Plan, of which, 10,000 restricted shares vest at the end of each calendar quarter in 2017, provided the recipient remains a director through the vesting date.

On February 15, 2016, in connection with, and in furtherance of, the new, the non-employee director compensation program, the Board approved stock option awards in the amount of 80,000, to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, Robert Koski and former director Christine Koski under the Company’s 2012 Equity Incentive Plan at an exercise price of $0.84 per share, the closing price on the February 16, 2016, the date of grant. Dr. Telling, Mr. Pope, Dr. Dunton, Robert Koski and former director Christine Koski were each also awarded 40,000 restricted shares of the Company’s common stock under the Company’s 2012 Plan, of which 10,000 restricted shares vested at the end of each calendar quarter in 2016. Dr. Telling, Mr. Pope, Dr. Dunton, Robert Koski vested fully in the restricted shares awarded to them in 2016. Former director Christine Koski vested in 20,000 restricted shares due to her resignation as a director in June of 2016.

Each executive officer and non-employee director receiving equity basedequity-based awards is subject to a minimum dollar value stock ownership holding requirement with respect to the awards received as well as all prior equity awards under the 2012 Equity Incentive Plan which requirements are intended to align the ability to sell shares with the performance of the Company’s stock price. The executive officer recipients each have a minimum dollar value stock ownership holding requirement threshold equal to two times (2x) their then base salaries below which dollar threshold they would be precluded from selling any shares of Company stock obtained from the Company under its 2012 Equity Incentive Plan. Also, the non-employee directors are each subject to a minimum dollar value stock ownership holding requirement threshold equal to six times the annual Board retainer ($270,000)270,000) below which dollar threshold they would be precluded from selling shares of Company stock acquired from the Company under its 2012 Equity Incentive Plan.

5. Warrants

In connection with

During the Preferred Stock financing (See Note 11), three months ended March 31, 2021,the Company has issued an additional 2,472,573 shares of common stock as a result of the exercise of certain outstanding warrants as follows: (i) warrants to purchase 10,645,161acquire 360,000 shares of the Company’s Common stock. The warrants have a term of seven years from the date of issuance and are non-exercisable until six months after issuance, and haveStock at an exercise price of $0.31$1.00 per share. In addition, the Company issued a warrantshare were exercised and (ii) warrants to purchase 483,870acquire 2,112,573 shares of the Company’s Common stock pursuant to the terms of a financial advisory services agreement. The warrant has a term of five years from the date of issuance and is non-exercisable until six months after issuance, and hasStock at an exercise price of $0.31$0.90 per share. share were exercised. The warrant exercises provided aggregate gross proceeds to the Company of $2,261,336.

A summary of warrant activity for the year ended December 31, 20162021 and the ninethree months ended September 30, 2017March 31, 2022 is as follows:

Schedule of Warrants Activity

The warrants outstanding as of September 30, 2017March 31, 2022 are as follows:

Schedule of Warrants Outstanding

All outstanding warrants are classified as equity on the Company’s Consolidated Balance Sheets.

6. Short-Term Notes Payable

As of September 30, 2017March 31, 2022 and December 31, 2016,2021, the Company had $128,070$122,175 and $66,377,$303,416, respectively, in short-term notes payable for the financing of various insurance policies.

Products Liability Insurance

The product liability insurance policy has been renewed in subsequent periods without premium financing.

Directors’ and Officers’ Insurance

On March 1, 2016,July 24, 2021, the Company entered into a short-term note payable for $49,395$600,169 bearing interest at 5.93% per annum to finance the product liability insurance. Principal and interest payments on this note began April 10, 2016 and were made evenly based on a straight line amortization over a 10-month period with the final payment being made on January 4, 2017.

On March 10, 2017, the Company entered into a short-term note payable for $31,985 bearing interest at 6.18% per annum to finance the product liability insurance. Principal and interest payments on this note began April 10, 2017 and are made evenly based on a straight line amortization over a 10-month period with the final payment due on January 10, 2018.

On July 24, 2016, the Company entered into a short-term note payable for $111,730 bearing interest at 4.89%5.34% to finance a portion of the directors’ and officers’ liability insurance and employment practices liability insurance premiums. Principal and interest payments on this note began August 24, 20162021 and wereare made evenly based on a straight linestraight-line amortization over an 11-montha 10-month period with the final payment being madedue on June 21, 2017.May 24, 2022.

On July 21, 2017,24, 2020, the Company entered into a short-term note payable for $140,062$413,784 bearing interest at 5.09%5.39% to finance a portion of the directors’ and officers’ liability insurance and employment practices liability insurance premiums. Principal and interest payments on this note began August 24, 20172020 and arewere made evenly based on a straight linestraight-line amortization over an 11-month period with the final payment being duemade on June 24, 2018.28, 2021.

7. Note Payable to StockholderCommitments and Contingencies

On May 10, 2017 the Company entered into a Note Purchase Agreement

Additional Consideration-NTI Acquisition

In connection with Intrexon pursuant to which the Company issued a $2,400,000 unsecured non-convertible promissory note to Intrexon and amended the first milestone in its oral mucositis Exclusive Channel Collaboration Agreement (“Oral Mucositis ECC”) with Intrexon. The note matures in two (2) years and has a simple interest rate of 12% per annum. Proceeds from the note are to be used to fund the Company’s AG013 research and clinical trials.

8. Commitments and Contingencies

The Universityacquisition of Florida Research Foundation Licenses

UFRF-MU1140 License. In the Company’s University of Florida Research Foundation (“UFRF”) amended license agreement for MU1140,NTI, the Company is obligated to pay 5%the former sole shareholder of NTI contingent consideration based upon the exercise of certain of the sellingCompany’s outstanding warrants as follows: (i) twenty percent (20%) of the cash proceeds received by the Company upon exercise of the Company’s warrants carrying an exercise price of $0.75 and $0.90 and (ii) forty-five percent (45%) of the cash proceeds received by the Company upon exercise of the Company’s warrants carrying an exercise price of $1.00, in each case, for so long as the warrants remain outstanding. The Company’s previously issued warrants carrying an exercise price of $0.75 have expired by their terms. As a result, no additional consideration will be due to the former sole shareholder of NTI relating to these warrants.

During the three months ended March 31, 2021, 2,472,573 warrants were exercised as follows: (i) 360,000 shares at an exercise price of $1.00 per share and (ii) 2,112,573 at an exercise price of $0.90 per share. See Note 8. Shareholders’ Equity.

As a result of the warrant exercises in 2021, the Company paid $542,263 of additional consideration to the sole former shareholder of NTI. The additional consideration payment is included in research and development expenses.

During the three months ended March 31, 2022, no warrants were exercised that resulted in the payment of additional consideration to the sole former shareholder of NTI.

NIH License

Through NTI, the Company is a party to a Patent License and Biological Materials License Agreement (the “License Agreement” or “NIH License”), dated March 23, 2020, with the United States Department of Health and Human Services (the “HHS”), as represented by the National Institute of Allergy and Infectious Diseases (“NIAID”), an Institute within the National Institutes of Health (“NIH”). Under the terms of the License Agreement, we hold a nonexclusive, worldwide license to certain specified patent rights (including patent applications, provisional patent applications and Patent Cooperation Treaty (“PCT”) patent applications) and biological materials relating to the use of pre-fusion coronavirus spike proteins to exploit products (“Licensed Products”) and practice processes (“Licensed Processes”) that are covered by the licensed patent rights and biological materials for the purpose of developing and commercializing a vaccine product candidate for SARS-CoV-2.

Under the terms of the License Agreement, the NIAID is entitled to receive a non-creditable, nonrefundable upfront license issue royalty of $30,000 and reimbursement of $11,739 for our pro rata share of the NIAID’s past and future patent prosecution-related expenses (which amounts have already been paid). Additionally, the NIAID is entitled to receive lump sum nonrefundable minimum annual royalties, which increase in the year after the first commercial sale of any products developedLicensed Products or the practice of any Licensed Processes, as well as lump sum benchmark royalties following our completion of certain commercial development and sales-related benchmarks. The NIH is entitled to receive earned royalties on the annual net sales of Licensed Products and the practice of any Licensed Processes (subject to certain reductions), at certain low- to mid-single digit royalty rates, which rates vary based on the total amount of annual net sales and the geographic market in which those sales occur. We must provide regular written reports to the NIAID on the development status of and royalty payments relating to the Licensed Products and the Licensed Processes.

The License Agreement will expire upon (a) twenty (20) years from the UFRFfirst commercial sale where no licensed technology thatpatent rights exist or have ceased to exist or (b) the Companyexpiration of the last patent contained in the licensed patent rights, unless terminated earlier. None of the applications included in the NIH licensed patent rights have issued yet. The NIH may sell as royalty toterminate or modify the UFRF. In addition,license in the event of a material breach, including if the Company sublicenses any rights granteddoes not meet certain milestones by the amended license agreement, the Company is obligated to pay to the UFRF 22% of all revenues received from the sublicenses, excluding monies received solely for development costs. The Company is also obligated to make thecertain dates, or upon certain insolvency events that remain uncured following payments to UFRF as follows: a one-time commercialization fee, post-commercialization minimum royalty payments, and a one-time cumulative royalty payment. The one-time commercialization fee would be due on the first anniversary of first commercial sale and is calculated at $5,000 per month between (1) April 1, 2013 for the MU1140 license agreement and (2) the month of the first anniversary of a commercial sale. The post-commercialization minimum royalty payments of $50,000 annually would be due following payment of a commercialization fee. The one-time additional royalty payment would be due when total cumulative royalties paid to UFRF exceed $2.0 million, upon which we would be obligated to make a one-time additional payment to UFRF of 10% of the total royalties due to UFRF in the calendar year in which cumulative royalties exceeded $2.0 million.

The Company is required to make minimum annual maintenance payments to the UFRF for the term of the amended license agreement in the amount of $10,000 for the license agreement. The aggregate minimum annual payments are required to be paid in advance on a quarterly basis (i.e. $2,500 per quarter) for the license. The Company must also pay all patent costs and expenses incurred by the UFRF for the preparation, filing, prosecution, issuance and maintenance of the patents.

The terms of the UFRF amended license agreement expire upon the earlier of (i) the date that no patents covered by the amended license agreement remain enforceable or (ii) the payment of earned royalties under the amended license agreement, once begun, ceases for more than three calendar quarters. The Company may voluntarily terminate the license agreement uponis 90 days written notice to UFRF. UFRF may terminate the amended license agreement if the Company breaches its obligations to timely pay any amounts due under the amended license agreement, to submit development reports as required under the amended license agreement or commit any other breach of any other covenants contained in the amended license agreement and the Company fails to remedy such breach within 90 days afterfollowing written notice of such breach by UFRF.or insolvency event. The Company may terminate the license, or any portion thereof, at its sole discretion at any time upon 60 days written notice to the NIH.

Texas A&M

NRC License

On July 26, 2021, the Company entered into a non-exclusive Technology License Agreement

Under (the “License Agreement”) with the termsNational Research Council of Canada (“NRC”) pursuant to which the NRC grants to the Company a license to use NRC’s inventions, patents, trade secrets, know-how, copyright, biological material, designs, and/or technical information created by or on behalf of the Texas A&M license agreement,NRC (the “NRC Technologies”) relating to the derivatives of CHO ^{2353 TM} Cell Line listed in the License Agreement (the “Stable Cells”) to: (i) make, research, and develop SARS-CoV-2 spike protein manufactured by a Stable Cell (the “Drug Substance”) within Canada, Australia, the United Kingdom, the European Union and the United States (U.S.) (collectively the “Territory”); (ii) file regulatory approval, export and sell the final formulation of the Drug Substance (“Products”) and (iii) engage contractors to use the Stable Cells to make Drug Substance or Products on behalf of the Company made an initial paymentto be used and sold, worldwide, by the Company. The License Agreement was subsequently amended to include the Delta and Omicron variants. In addition, the Company subsequently amended the License Agreement to broaden the non-exclusive field of five thousand dollars ($5,000)use to Texas A&M. Theinclude all diseases caused by coronaviruses and any genetic variants thereof.

As consideration for the grant of the license, the Company must alsowill pay to Texas A&M a royaltythe NRC an annual (low five digits) license fee, with the initial portion of five percent (5%)the fee covering the first three years of net salesthe license. Additionally, we will pay certain milestone payments (a) upon transfer of products that includeeach Stable Cell listed in the licensed technology, subjectAgreement and (b) with regard to royalty stacking provisions with a two percent (2%) minimum royalty. Additionally, in order to maintain the exclusive license, commencing in 2014 and each year thereafter prior to the calendar year of the first sale of products using the licensed technology, the Company was to pay Texas A&M $15,000 as minimum annual consideration for the continuationthree Products, (i) upon submission of the license agreement. In October of 2016Investigational New Drug application (IND) related thereto, (ii) upon dosing the Texas A&M license agreement was amended to provide for a payment of $25,000 commencing in 2017 and each year thereafter prior to the calendar year of the first sale of products using the licensed technology, as minimum annual consideration for the continuation of the license agreement. Once the Company commences the sale of products that include the technology the Company licenses from Texas A&M the Company must pay a minimum annual amount of $100,000 to

Texas A&M and every year thereafter through the expiration of the Agreement. However, once sales begin, any royalty payments the Company makes on net sales will be credited against the $100,000 required maintenance payment.

The Company must also pay all patent costs and expenses for the preparation, filing, prosecution, issuance and maintenance of the patent rights. Sales by sublicensees are subject to the royalty rate above, and the Company is responsible for certain payments to Texas A&M for any other consideration received that are not in the form of a royalty.

Pursuant to the amended Texas A&M license agreement, the Company is obligated to meet the following milestones and make milestone payments: (i) enrollment of first patient in a Phase 1 clinical trial using the licensed technology, to occur on or before June 1, 2019, with a milestone achievement payment of $50,000, (ii) completion of Phase 2 clinical trial, using(iii) upon dosing the licensed technology to occur on or before June 1, 2022, withfirst patient in a milestone achievement payment of $100,000, (iii) completion of Phase 3 clinical trial of the licensed technology to occur on or before June 1, 2025, with a milestone achievement payment of $150,000, and (iv) upon first sale ofregulatory approval. Milestone payments range from the licensed technologylow five digits to occur on or before June 1, 2026 with a milestone achievement payment of $400,000. If we fail to accomplish the milestones or fail to achieve net sales of products including the licensed technology for two consecutive calendar years Texas A&M at its sole option may waive the requirement, negotiate the missed milestones or terminate the license agreement. None of the Texas A&M milestones had been achieved as of September 30, 2017.

The Lantibiotic ECC

Under the Lantibiotic ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of lantibiotics toward the goal of commercialization, conducting nonclinical and clinical development of candidate lantibiotics, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, certain aspects of the manufacturing process, and costs of filing, prosecution and maintenance of Intrexon’s patents.

Subject to certain expense allocations and other offsets provided in the Lantibiotic ECC, the Companyhigh six digits. In addition, Oragenics will pay Intrexon on a quarterly basis 25% of gross quarterly profits derived in that quarter fromlow single-digit royalty to the NRC for the sale of products developedProducts, based on sales revenue, commencing after the first commercial sale.

Pursuant to the License Agreement, the NRC is required to bear the responsibility and pay the costs to obtain and maintain patents related to the NRC Technologies in the U.S., Canada, Brazil, European Union, Japan, South Korea, Singapore, Australia, China, and India, and the NRC shall use reasonable efforts to obtain and maintain those patents. Additional countries may be requested by us, in which event, the NRC will file and maintain such patents, at our expense.

Pursuant to the License Agreement, we are required to indemnify and hold the NRC and its employees and agents harmless from and against all liability and damages in connection with or arising out of all claims, demands, losses, damages, costs including solicitor and client costs, actions, suits or proceedings brought by any third party that are in any manner based upon, arising out of, related to, occasioned by, or attributable to the manufacturing, distribution, shipment, offering for sale, sale, or use of Products, services based on the NRC Technologies and product liability and infringement of intellectual property rights other than copyright, if any, licensed under the License Agreement.

Unless terminated earlier, the License Agreement will terminate twenty (20) years from the Lantibiotic ECC, calculated on an Oragenics Product-by-Oragenics Product basis.effective date of the License Agreement. Either party may terminate the License Agreement, by giving written notice to the other party, if the other party defaults or is in breach of the License Agreement, provided that if the defaulting party cures the breach within 60 days after the notice is given, the License Agreement shall continue in full force and effect. The NRC may terminate the License Agreement if the Company becomes bankrupt, or insolvent, or has likewise agreeda receiver appointed to pay Intrexon oncontinue its operations, or passes a quarterly basis 50% of revenue obtained in that quarter from a sublicensor in the event of a sublicensing arrangement.resolution for winding up. The License Agreement contains customary confidentiality obligations.

In addition, in partial consideration for each party’s execution and delivery ofconnection with the Lantibiotic ECC, the Companyinitiative to develop its vaccine, we also previously entered into a Stock Issuance Agreementmaterial transfer agreement with Intrexon. Pursuantthe NRC for SARS-CoV-2 trimeric spike protein Wuhan variant and SARS-CoV-2 trimeric spike protein South African variant to the Stock Issuance Agreement, the Company issued to Intrexon 4,392,425 shares of the Company’s common stock as an initial technology access fee, in consideration for the execution and delivery of the Lantibiotic ECC and granted Intrexon certain equity participation rights and registration rights. Under the Stock Issuance Agreement and as part of the Lantibiotic ECC, the Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones in the form of shares of Company common stock or, at the Company’s option, make a cash payment to Intrexon (based upon the fair market value of the shares otherwise required to be issued). The milestone events and amounts payable are as follows:move forward with pre-clinical testing.

Leases

Base SharesLab Facility-Alachua. The Company’s Alachua facility is defined in the Stock Issuance Agreement to mean (i) the number of shares of Company common stock together with any securities or instruments convertible or exercisable for shares of common stock issued and outstanding at the time of the applicable milestone event, (ii) minus any shares issuable upon conversion of Capital Inducement Securities. Capital Inducement Securities is defined in the Stock Issuance Agreement to mean warrants or other convertible securities of the Company issued to investors in connection with a debt or equity investment in the Company that are issued in addition to the primary investment

securities and in an amount not to exceed 10% of the overall number of shares issued in the investment (on an as-converted to common stock basis).

None of the Lantibiotic ECC milestones had been achieved as of September 30, 2017.

The Oral Mucositis ECC

Under the Oral Mucositis ECC, and subject to certain exceptions, the Company is responsible for, among other things, funding the further anticipated development of products toward the goal of commercialization, conducting preclinical and clinical development of candidate products, as well as for other aspects of manufacturing and the commercialization of the product(s). Among other things, Intrexon is responsible for technology discovery efforts, cell-engineering development, and certain aspects of the manufacturing process.

The Company will pay Intrexon on a quarterly basis 12% of the net sales derived from the sale of products developed from the exclusive channel collaboration. The Company has likewise agreed to pay Intrexon on a quarterly basis 50% of revenue obtained in that quarterbeing leased from a sublicensor in the event of a sublicensing arrangement.

The Company has also agreed to make certain payments to Intrexon upon the Company’s achievement of designated milestones in the form of shares of Company Common Stock (based upon the fair market value of the shares otherwise required to be issued) unless the issuance of such shares would reasonably likely cause Intrexon to consolidate the Company’s financial statements with Intrexon’s financial statements, or at the Company’s option make a cash payment to Intrexon. The Commercialization Milestone Events and amounts payable are as follows:

None of the Oral Mucositis ECC milestones had been achieved as of September 30, 2017.

The Oral Mucositis ECC provides that in the event (i) Oragenics is required to make a milestone payment in cash as an issuance of shares would cause Intrexon to consolidate the Company’s financial statements with Intrexon’s financial statements, and (ii) Oragenics reasonably concludes that a cash milestone payment would have an adverse effect on its working capital needs over the next twelve (12) months, then such cash payment shall be in the form of an interest bearing promissory note with a maturity date of less than twelve (12) months and include other conventional market terms that would not be expected to unreasonably have an adverse effect on Oragenics working capital needs over such twelve (12) month period.

9. Related Party Transactions

On May 10, 2017 the Company entered into a Note Purchase Agreement with Intrexon pursuant to which the Company issued a $2.4 million unsecured non-convertible promissory note to Intrexon and amended the first milestone in its Oral Mucositis ECC with Intrexon. The note matures in two (2) years and has a simple interest rate of 12% per annum. Proceeds from the note will be used to fund the Company’s AG013 research and clinical trials.

During the three and nine months ended September 30, 2017, we paid $-0- and $524,620 respectively; and during the three and nine months ended September 30, 2016 we paid $253,646 and $1,187,021 respectively, to Intrexon under the Oral Mucositis and Lantibiotic ECC agreements (See Note 8). Included in accounts payable and accrued expenses at September 30, 2017 and December 31, 2016 was $894,922 and $524,620, respectively, related to unpaid invoices received from Intrexon relating to work performed under the ECC Agreements and accrued interest relating to unpaid invoices and the unsecured non-convertible promissory note. As of September 30, 2017 and 2016 Intrexon beneficially owned approximately 31.4% and 31.5% of our outstanding common stock.

On June 27, 2016, the Company completed the sale of its consumer probiotics business to ProBiora Health, LLC, (“ProBiora Health”) an entity owned by Ms. Christine L. Koski, a director at the time of the transaction. The purchase price was $1,700,000 in cash of which $1,250,000 was paid at closing and $450,000 was payable on or before July 31, 2016. The note accrued interest at the rate of 1% per annum and was paid in full on July 29, 2016. In connection with the sale, ProBiora Health assumed certain liabilities. ProBiora Health is obligated to pay the Company contingent consideration annually over a 10 year period based on a percentage of sales of products using the Purchased Assets, in excess of $2,000,000 annually over the contingent contribution period, with a maximum obligation to the Company of $2,000,000. No payments were made by or due from ProBiora Health for post-closing sales in 2016.

The activities related to the consumer probiotic business are reflected as part of “Discontinued Operations” for the periods presented.

10. Common Stock

On February 9, 2017, in connection with and in furtherance of the non-employee director compensation program (See Note 4), the Board approved the award of 40,000 restricted shares of the Company’s common stock to each of the Company’s non-employee directors, Frederick Telling, Charles Pope, Alan Dunton, and Robert Koski under the Company’s 2012 Equity Incentive Plan of which a total of 30,000 restricted shares vested on September 30, 2017 for each non-employee director and the remainder will vest at the end of each calendar quarter in 2017 provided the recipient remains a director through the vesting date. The awards are considered issued and outstanding as of the date of the grant and are eligible to be voted by the recipient. At September 30, 2017, the Company has $8,624 in unrecognized compensation expense relating to these awards that will be recognized through the remainder of 2017.

11. Convertible Preferred Stock

On May 10, 2017 the Company entered into a securities purchase agreement with three accredited investors, to purchase up to $3,000,000 of Series A Convertible Preferred Stock (the “Preferred Stock Financing”). The sale of the preferred stock took place in two separate closings. At the first closing which occurred on May 10, 2017, the Company received gross proceeds of approximately $1.302 million. At the second closing, which occurred on July 25, 2017, the Company received $1.698 million. The full $3,000,000 of preferred stock is convertible into twelve million shares of the Company’s common stock, based on a fixed conversion price of $0.25 per share on an as-converted basis. In addition, the Company issued warrants to purchase an aggregate of 4,621,037 shares of common stock at the first closing and an aggregate of 6,024,124 shares of common stock at the second closing. The warrants have a term of sevenfive years beginning in December 2019. Under the amended lease agreement, the rental payments range from $12,870 per month to $13,338 per month. The lease may be terminated prior to its stated expiration date upon the datepayment of issuance, are non-exercisable until 6 months after issuance, and have an exercise pricenine-months rent.

Corporate Office – Tampa. In November of $0.31 per share.

On July 27, 2017,2016, the Company entered into an amendment for the leased office space for corporate personnel located in Tampa, FL. The amended lease is for approximately 2,207 square feet. The lease period for the office space is for thirty-six months commencing on March 1, 2017. Lease payments range from $4,138 per month to $4,392 per month inclusive of insurance, taxes and utilities. The lease expired on February 29, 2020. In November of 2019, the Company entered into an amendment for the Tampa facility for a term of three years beginning in March of 2020. Under the amended lease agreement, the rental payments range from $4,524 per month to amend the warrants issued in connection with the Preferred$4,800 per month.

Supplemental balance sheet information related to leases is as follows:

Schedule of Supplemental Balance Sheet Information Related to Leases

Maturities of operating lease liabilities are as follows:

Schedule of Maturities of Operating Lease Liabilities

The cost component of operating leases is as follows:

Schedule of Cost Component of Operating Leases

Supplemental cash flow information related to operating leases is as follows:

Schedule of Supplemental Cash Flow Information Related to Operating Leases

8. Shareholders’ Equity

Common Stock Financing to provide notification

The Company’s Board of Directors and objection requirements with respect to the change of control provisions. The change of control provisions in the warrants had previously caused the warrants to be treated as a derivative liability as opposed to being treated as equity on the Company’s balance sheet. The warrants have been replaced by amended and restated warrants containing such notification and objection requirements (the “Amended and Restated Common Stock Purchase Warrants”) so that theshareholders, at its reconvened 2020 Annual Meeting on February 25, 2022, approved an amendment to our Amended and Restated Common Stock Purchase Warrants are now treated as equity on the Company’s balance sheet. All other termsArticles of the original warrants remain unchanged by the Amended and Restated Common Stock Purchase Warrants.

In connection with the Preferred Financing, the Company filed a Certificate of Designations of Preferences, Rights and Limitations of Series A Preferred Stock with the Secretary of State of the State of Florida,Incorporation to be effective May 10, 2017. The number of shares of Preferred Stock designated as Series A Preferred Stock is 12,000,000.

In connection with the issuance and sale of the Preferred Stock and Warrants, the Company granted certain demand registration rights and piggyback registration rights with respect to the shares of the Company’s Common Stock issuable upon conversion of the Preferred Stock and exercise of the Warrants, pursuant to a Registration Rights Agreement.

Except as otherwise required by law, the Series A Preferred Stock has no voting rights. However, as long as any shares of Series A Preferred Stock are outstanding, the Company shall not, without the affirmative vote of the holders of a majority of the then outstanding shares of the Series A Preferred Stock, (a) alter or change adversely the powers, preferences or rights given to the Series A Preferred Stock or alter or amend the Certificate of Designation, (b) amend its articles of incorporation or other charter documents in any manner that adversely affects any rights of the holders of Series A Preferred Stock, (c)(i) increase the number of authorized shares of common stock from 200,000,000 shares to 250,000,000 shares.

During the three months ended March 31, 2022, the Company issued no shares of common stock.

During the three months ended March 31, 2021, the Company issued an aggregate of 23,871,338 shares of common stock comprised of (i) 21,398,765 shares of common stock issued in connection with sales under its ATM Program which generated gross proceeds of approximately $27.8 million and (ii) 2,472,573 shares of common stock issued as the result of the exercise of certain outstanding warrants which generated gross proceeds of approximately $2.3 million as a result of the exercise of certain outstanding.

Preferred Stock

Series AC Non-Voting, Non-Convertible, Preferred Stock or (d) enter into any agreement with respectDividend and Redemption

During the three months ended March 31, 2021, the Company provided a notice of redemption, to anythe holder of the foregoing. Upon any liquidation, dissolution or winding-up of the Company, whether voluntary or involuntary that is not a Fundamental Transaction (as defined in the Certificate of Designation), the holders ofCompany’s Series AC Preferred Stock shall be entitled to receive out of the assets, the greater of (i) the product of the number of shares ofredeem all outstanding Series AC Preferred Stock then held by such holder, multiplied by(which included the Original Issue Price;dividend of 26.697 shares paid on January 28, 2021 and (ii)any accrued dividends due through the amount that would be payable to such holder in the Liquidation in respectredemption date of Common Stock issuable upon conversion of such shares ofMarch 13, 2021). The Series AC Preferred Stock ifredemption amount of approximately $5.6 million was paid on March 15, 2021 and all outstanding shares of Series AC Preferred Stock were converted into Common Stock immediately prior to the Liquidation. The preferred stock is classified as permanent equity.cancelled.

ITEM 2.

ITEM 2.

MANAGEMENT’S DISCUSSION AND ANALYSIS OF FINANCIAL CONDITION AND RESULTS OF OPERATIONS

The following information should be read in conjunction with the Consolidated Financial Statements, including the notes thereto, included elsewhere in thisForm 10-Q.10-Q as well as our Annual Report on Form 10-K for the year ended December 31, 2021 filed on March 24, 2022.

As used in this quarterly report the terms “we”, “us”, “our”, “Oragenics” and the “Company” mean Oragenics, Inc. and its wholly owned subsidiary Noachis Terra Inc., unless the context otherwise requires.

Forward-Looking Statements

This Quarterly Report on Form 10-Q contains forward-looking includes “forward-looking” statements within the meaning of Section 27A of the Securities Act of 1933, as amended and Section 21E of the Securities Exchange Act of 1934, as amended. SuchThese forward-looking statements are not historical facts, but are based on current expectations, estimates and projections about our industry, our beliefs and our assumptions. These forward-looking statements include statements regarding, among other things, (a) our need for and availability of working capital, (b) our financing plans, (c)about our strategies, (d) our projected salesobjectives and profitability, (e) anticipated trends in our industry. Forward-looking statements, which involve assumptions and describe our future plans, strategies,achievement. To the extent statements in this Quarterly Report involve, without limitation, our expectations for growth, estimates of future revenue, our sources and expectations,uses of cash, our liquidity needs, our current or planned clinical trials or research and development activities, product development timelines, our future products, regulatory matters, expense, profits, cash flow balance sheet items or any other guidance on future periods, these statements are generally identifiable byforward-looking statements. These statements are often, but not always, made through the use of the words “may,word or phrases such as “believe,” “will,” “should,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or“plan,” and “would. “These forward-looking statements are not guarantees of future performance and concern matters that could subsequently differ materially from those described in the negative of these words or other variations on these words or comparable terminology. This information may involve known and unknown risks, uncertainties, and other factors that may cause our actual results, performance, or achievements to be materially different from the future results, performance, or achievements expressed or implied by any forward-looking statements. These statements may be found under “Management’s Discussion and Analysis of Financial Condition and Results of Operations as well as in this10-Q generally. Actual events or results may differ materially from those discussed in this Quarterly Report on Form 10-Q. Except as may be required by applicable law, we undertake no obligation to update any forward-looking statements as a resultor to reflect events or circumstances arising after the date of variousthis Report. Important factors including, without limitation,that could cause actual results to differ materially from those in these forward looking statements are in the risks outlined undersection entitled “Risk Factors” in the most recent Annual Report on Form 10- K, as updated by our recent Form10-K 8-K Report filed with the Securities and in this10-Q. In light of theseExchange Commission, and the other risks and uncertainties theredescribed elsewhere in this report as well as other risks identified from time to time in our filings with the Securities and Exchange Commission, press releases and other communications. In addition, the statements contained throughout this Quarterly Report concerning future events or developments or our future activities, including concerning, among other matters, current or planned clinical trials, anticipated research and development activities, anticipated dates for commencement of clinical trials, anticipated completion dates of clinical trials, anticipated meetings with the FDA or other regulatory authorities concerning our product candidates, anticipated dates for submissions to obtain required regulatory marketing approvals, anticipated dates for commercial introduction of products, and other statements concerning our future operations and activities, are forward-looking statements that in each instance assume that we are able to obtain sufficient funding in the near term and thereafter to support such activities and continue our operations and planned activities in a timely manner. There can be no assurance that this will be the forward-lookingcase. Also, such statements containedassume that there are no significant unexpected developments or events that delay or prevent such activities from occurring. Failure to timely obtain sufficient funding, or unexpected developments or events, could delay the occurrence of such events or prevent the events described in this filing will in fact occur. In additionany such statements from occurring.

Overview

We are a development-stage company dedicated to fighting infectious diseases including coronaviruses and multidrug-resistant organisms. Our lead product (NT-CoV2-1) is an intranasal vaccine candidate to prevent coronavirus disease 2019 (“COVID-19”) from the information expressly requiredSARS-CoV-2 virus and variants thereof. The NT-CoV2-1 program leverages coronavirus spike protein research licensed from the National Institute of Health and the National Research Council of Canada with a focus on reducing viral transmission and offering a more patient-friendly intranasal administration. Our lantibiotics program features a novel class of antibiotics against bacteria that have developed resistance to be included in this filing, we will provide such further material information, if any, as may be necessary to make the required statements, in lightcommercial antibiotics.

Our SARS-CoV-2 Vaccine Product Candidate - NT-CoV2-1

Following our May 2020 acquisition of one hundred percent (100%) of the circumstances under which they are made, not misleading.

Overview

Wetotal issued and outstanding common stock of Noachis Terra, Inc. (“Noachis Terra”) we are focused on becomingthe development and commercialization of a leadervaccine product candidate to provide long-lasting immunity from SARS-CoV-2, which causes COVID-19. Noachis Terra is a party to a worldwide, nonexclusive intellectual property and biological materials license agreement with the National Institute of Allergy and Infectious Diseases (“NIAID”), an institute within the National Institutes of Health (“NIH”), relating to certain research, patent applications and biological materials involving pre-fusion stabilized coronavirus spike proteins and their use in novel antibiotics against infectious diseasethe development and commercialization of a vaccine to provide specific, long lasting immunity from SARS-CoV-2. Since the acquisition we have conducted testing in animal models, including SARS-CoV-2 challenge studies in hamsters, using specific formulations for intramuscular administration (our Terra CoV-2 vaccine candidate) and intranasal administration (our NT-CoV2-1 vaccine candidate), both based on the NIAID pre-fusion stabilized spike protein antigens. Following consideration of a number of factors, including but not limited to the competitive landscape, we determined to bring the intranasal vaccine candidate NT-CoV2-1, into further development due to the greater differentiation versus current COVID-19 vaccines and the potential benefits of intranasal over intramuscular administration. We believe these benefits could include a higher reduction of transmission of SARS-CoV-2 and would offer a needle-free delivery option. We therefore are currently focusing our development efforts on our more highly differentiated NT-CoV2-1 vaccine candidate.

Coronaviruses are a family of viruses that can lead to upper-respiratory infections in humans. Recent clinical reports also suggest that the SARS-CoV-2 virus can affect other body-systems, including the nervous, cardiovascular, gastrointestinal and renal systems. Among the recent iterations of coronaviruses to move from animal to human carriers is SARS-CoV-2, which, beginning in Wuhan, China, in late 2019, caused a global pandemic due to its rapid spread and the relatively high mortality rate (as compared to the seasonal influenza). In late April of 2022, the World Health Organization’s estimates indicate the number of worldwide COVID-19 infections have exceeded 505 million and the number of deaths directly attributed to COVID-19 have exceeded 6.2 million. Pfizer/-BioNTech received FDA approval for their COVID-19 vaccines in August of 2021 and the Moderna vaccine in January 2022. The Janssen vaccine is currently available in the United States under Emergency Use Authorizations (“EUA”) by the FDA. We believe given the size of the worldwide pandemic that even with additional vaccines projected to be available in the months ahead, there will be demand for the highly differentiated NT-CoV2-1 vaccine, once development is successfully completed. We intend to combine the research, patent applications and biological materials covered by our NIAID license with our existing clinical research and manufacturing capabilities to respond rapidly to this ongoing, global, public health issue. We believe our NT-CoV2-1 vaccine holds the possibility of playing an important role in addressing this issue.

Coronaviruses, such as SARS-CoV-2, possess signature protein spikes on their outer capsule. The NIAID license covers patents and data on a vaccine candidate that were created based on a stabilized pre-fusion spike trimeric protein. By stabilizing the spike protein in the pre-fusion state, the number of immunogenic centers is increased thereby allowing for a greater likelihood of successful antibody binding, resulting in an improved immunogenic response. The genetic code, acquired from the NIH, for the stabilized pre-fusion spike protein was provided to Aragen Bioscience, Inc. (“Aragen”) for the purpose of insertion of the spike protein gene sequence into a Chinese Hamster Ovary (“CHO”) cell line. Aragen is a leading contract research organization focused on accelerating pre-clinical biologics product development, has extensive experience building CHO cell lines for recombinant proteins, such as monoclonal antibodies. Aragen has successfully inserted the NIH pre-fusion spike protein gene sequence into a CHO cell line and is currently developing both the analytical tests and identifying preliminary cell line growth conditions to optimize the spike protein titers. Currently, “mini-pool” production and analytical development is underway. The process to transfer to full-scale manufacture has begun.

The NIH’s pre-clinical study shows that this spike protein, adjuvanted with the mouse specific TLR-4-agonist Sigma Adjuvant System (“SAS”, a TLR-4 agonist) that induces T cell activation), generates neutralizing antibody titers in both a pseudovirus neutralization assay and a plaque reduction neutralization titer (PRNT) assay. Recently released information indicated that pretreatment of mice with the NIH-created COVID-19 spike protein in combination with the SAA adjuvant completely inhibited viral growth in the nasal cavities and lungs of infected animals compared to unvaccinated control animals. In October 2020, we received feedback to our Type B Pre-IND Meeting Request from the FDA. The response indicated that the FDA broadly supported our planned approach to the pre-clinical program that would support the clinical development of the Terra CoV-2 vaccine. Due to our current focus on our intranasal vaccine candidate, we have submitted a request to the FDA for a type B Pre-IND Meeting Request to discuss NT-CoV2-1, which is expected to occur by mid-July 2022.

We also entered into a material transfer agreement with Biodextris Inc. for the use of three intranasal mucosal adjuvants in our Terra CoV-2 and NT-CoV2-1 vaccine candidates. BDX100, BDX300 and BDX301 are proteosome-based adjuvants comprised of proteins and lipopolysaccharides with improved attributes including enhanced immune response, manufacturing efficiency and the benefits of intranasal vaccine administration. The agreement allows for the future collaboration regarding the intranasal delivery of vaccine during clinical development with the opportunity to enter into a commercial agreement upon regulatory approval of the intranasal vaccine.

The NT-CoV2-1 vaccine containing Inspirevax’s intranasal mucosal adjuvant BDX301 has been studied in pre-clinical animal studies, including hamster viral challenge studies and mouse immunogenicity studies. A rabbit toxicology study has been initiated and is required for regulatory approval prior to the Phase 1 clinical study. We believe the NT-CoV2-1 vaccine has the potential to lead to a higher reduction of transmission of SARS-CoV-2 and offers a needle-free delivery option. This vaccine could also permit cost effective treatments for oral mucositis.storage and distribution at refrigerated temperatures, which should facilitate distribution.

Our Oral Mucositis Product Candidate-Clinical

In June of 2015,On July 26, 2021, we entered into a worldwide Exclusive Channel Collaboration Agreement (“Oral Mucositis ECC”)licensing agreement with Intrexon Corporation (“Intrexon”)the NRC that enables us to pursue the rapid development of next-generation vaccines against the SARS-CoV-2 virus and Intrexon Actobiotics NV,its variants. The license was subsequently extended to include the Omicron variant. In addition, we broadened the non-exclusive field of use to include all diseases caused by coronaviruses and any genetic variants thereof. The NRC technologies, in combination with the U.S. NIH elements found in our NT-CoV2-1 vaccine candidates, provide us with a wholly-owned subsidiaryplatform that can generate cell lines for high-yield production of Intrexon, pursuantspike protein antigens for existing and emerging variants of concern. This platform should allow production of cell lines within six to eight weeks of spike gene sequence availability, compared with six to nine months for traditional production of such cell lines. The NRC technologies, developed with support from the NRC’s Pandemic Response Challenge Program, are expected to expedite the evaluation of SARS-CoV-2 antigen candidates in pre-clinical and clinical studies.

We began pre-clinical studies in June of 2021 through our collaboration and material transfer agreement with the NRC. We initiated an immunogenicity study in mice to evaluate several adjuvant candidates. On August 30, 2021, we announced the successful completion of these mouse immunogenicity studies that supported further development using either the intramuscular or intranasal routes of administration. A hamster challenge study was initiated in September of 2021 to assess inhibition of viral replication using adjuvants specific for intramuscular and intranasal administration. In December of 2021, we announced that both formulations generated robust immune responses and reduced the SARS-CoV-2 viral loads to undetectable levels in the nasal passages and lungs five days following a viral challenge. By contrast, hamsters in the control groups that had received saline or adjuvants alone had no detectable immune response and substantial viral loads. The vaccines delivered by intranasal and intramuscular routes generated immune responses as measured by multiple assays.

Through assessment of a variety of factors including evolving variants and available vaccines in use, we have determined to focus our development efforts on the intranasal delivery of our vaccine product candidate, NT-CoV2-1, which is more highly differentiated than the currently available and late-stage COVID-19 vaccines. As a result, we obtained certain exclusive rightsexpect to AG013 asfile an IND application with the FDA upon completion of our pending toxicology study and to thereafter commence a potential treatment of oral mucositis, or OMPhase 1 clinical study with NT-CoV2-1, the protocol for cancer patients, which we intendis currently under development.

We expect to use our currently available cash resources to continue to develop. AG013, is an oral rinsing solution designed to deliver human Trefoil Factor 1 (hTFF1) to protectadvance the development of NT-CoV2-1 through IND-enabling studies, including immunogenicity, viral challenge studies, toxicology studies, and regenerate damaged mucosal lining of the oral cavity.

OM results in a painful inflammation and mucosal ulceration in the lining of the oral cavity, throat and esophagus and is one of the most commonly reported adverse events associated with cancer chemotherapy affecting up to 500,000 patients annually. OM has a negative effect on patient well-being and if severe, negatively affects a patient’s cancer treatment regimen. At present, we are not aware of any drug that is approved to prevent the condition broadly and current therapies are primarily palliative in nature, only addressing symptom relief but not treating the underlying causes of the condition.

In a Phase 1b clinical trial in 25 cancer patients with OM, AG013 was safe and well tolerated. Data published in the journal Cancer showed a 35% reduction of the duration of ulcerative OM in the AG013-treated patients versus the placebo-treated patients. Furthermore, close to 30% of the patients treated with AG013 were full responders while all placebo-treated patients developed ulcerative OM. Additionally, in a Phase 1 pharmacokinetic (PK) study in 10 healthy volunteers, AG013 bacteria adheredtrial with further clinical development being contingent upon the receipt of additional funding, including non-dilutive government grant funding which we continue to the buccal mucosa and actively secrete protein locally, resulting in homogeneous exposure of the entire mucosal surface up to 24 hours after administration of the rinse. During the first quarter of 2016, we conducted a confirmatory animal study on AG013. AG013 has been granted Orphan Drug status in the European Union. In November of 2016, the United States Food and Drug Administration (the “FDA”) granted Fast Track designation for AG013, and we believe it may be eligible for Biologic License Application exclusivity as well.pursue, or partnering or out-licensing opportunities.

We have developed a Phase 2 protocol for AG013 with the FDA and it has received fast track designation. The study will be a double blind, placebo controlled, evaluation of daily AG013, administered three times a day, oral rinse for the duration of the cancer treatment. The study is expected to enroll between160-180 patients receiving chemoradiation over 7 to 9 weeks. The primary endpoint is a reduction, compared to the placebo, in the number of days of severe oral mucositis. In addition, a number of secondary endpoints will also be evaluated.