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ORAGENICS INC

For the period ended Sep 30, 2025. Filed Nov 7, 2025.

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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.

Sep 30, 2025 · Filed Nov 7, 2025

OGEN$0.35+1.6%Stored close · as of Nov 9, 2026

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Notes to Condensed Consolidated Financial Statements

Notes to Consolidated Financial Statements

Note 1. Basis of Presentation and Nature of Operations

Basis of Presentation

The accompanying condensed consolidated financial information of Oragenics, Inc. and its wholly-owned subsidiaries Noachis Terra Inc. and Oragenics Australia Pty Ltd (collectively, the “Company”), is unaudited and has been prepared in accordance with accounting principles generally accepted in the United States of America (“GAAP”) and pursuant to the rules and regulations of the Securities and Exchange Commission (“SEC”) applicable to interim financial reporting. All intercompany balances and transactions have been eliminated in consolidation.

In the opinion of management, all adjustments (consisting solely of normal recurring adjustments) considered necessary for a fair presentation of the Company’s consolidated financial position, results of operations, and cash flows for the interim period presented have been included in consolidation. The condensed consolidated balance sheet as of December 31, 2024, has been derived from the audited financial statements included in the Company’s annual report on Form 10-K for the year ended December 31, 2024, filed with the SEC on March 14, 2025.

These interim financial statements should be read in conjunction with the audited consolidated financial statements and accompanying notes included in the Company’s Annual Report on the Form 10-K for the year ended December 31, 2024. The results of operations for the three and nine months ended September 30, 2025, are not necessarily indicative of the results that may be expected for the full fiscal year ending December 31, 2025.

On June 3, 2025, the Company effected a 1-for-30 reverse stock split of its outstanding common stock. All share and per share amounts in these consolidated financial statements and related footnotes have been retroactively adjusted to reflect the reverse stock split for all periods presented in the accompanying financial statements, unless otherwise indicated.

Significant Accounting Policies

There have been no material changes to the Company’s significant accounting policies during the nine-months ended September 30, 2025, as compared to those disclosed in the consolidated financial statements included in the Company’s Annual Report on the Form 10-K for the year ended December 31, 2024.

Nature of Operations

Oragenics, Inc. (the “Company”) is a development-stage biopharmaceutical company dedicated to the research and development of nasally delivered pharmaceutical therapies targeting neurological conditions and infectious diseases. The Company is currently focused on advancing the development and commercialization of its lead product candidate, ONP-002, a novel formulation intended for the treatment of mild traumatic brain injury (“mTBI” or “concussion”). ONP-002 is being developed as a potential first-in-class therapeutic targeting the unmet medical need for effective concussion treatment.

Going Concern

Considering our recurring losses, accumulated deficit, and negative cash flows, the report of our independent registered public accounting firm on our consolidated financial statements for the year ended December 31, 2024, included an explanatory paragraph raising substantial doubt about our ability to continue as a going concern.

We have incurred operating losses and negative cash flow from operations since inception. To date, we have not generated significant revenues from our operations. We incurred a net loss of $7.6 million and used $6.4 million cash resources in operating activities during the nine months ending September 30, 2025. As of September 30, 2025, we had an accumulated deficit of $224 million and cash and cash equivalents of $11.4 million.

Historically, our primary sources of liquidity have included proceeds from public and private offerings of our common and preferred stock, warrant exercises, debt financings, grant income, and interest income. During the nine months ending September 30, 2025, we raised approximately $2.6 million in net proceeds from private placements and sales of our common stock, $15.2 million in net proceeds from the issuance of Series H preferred stock and warrants and received approximately $2.2 million in net proceeds from the issuance of debt.

We expect to continue to incur substantial expenses as we advance the development of ONP-002, our lead product candidate for the treatment of mild traumatic brain injury. Based on our available cash of September 30, 2025, we believe our current working capital will be sufficient to fund planned operations for at least the next twelve months from the date of this filing, taking into account the net proceeds from the July 2025 financing.

On July 2, 2025, we completed a public offering of Series H Preferred Stock and warrants to purchase additional shares of Series H Preferred Stock, resulting in net proceeds of approximately $15.2 million. We believe that this financing meaningfully extends our ability to execute on our near-term operating objectives, including continued development of ONP-002.

While this financing mitigates some of the liquidity risk, substantial doubt about our ability to continue as a going concern continues to exist unless and until we obtain additional capital to fund operations beyond the current planning horizon. There can be no assurance that we will be able to obtain such financing on acceptable terms, or at all. If we are unable to raise sufficient capital in the future, we may be forced to delay, reduce, or eliminate our research and development programs or future commercialization efforts, which would adversely affect our business prospects and ability to continue as a going concern.

Note 2. New Accounting Pronouncements

ASU 2023-09

In December 2023, the FASB issued ASU 2023-09 related to improvements to income tax disclosures. The amendments in this update require enhanced jurisdictional and other disaggregated disclosures for the effective tax rate reconciliation and income taxes paid. The amendments in this update are effective for fiscal years beginning after December 15, 2024. We plan to adopt this pronouncement and make the necessary updates to our disclosures for the year ending December 31, 2025, and, aside from these disclosure changes, we do not expect the amendments to have a material effect on our financial statements.

ASU 2024-03

In November 2024, the FASB issued ASU 2024-03 related to the disaggregation of certain income statement expenses. The amendments in this update require public entities to disclose incremental information related to purchases of inventory, team member compensation and depreciation, which will provide investors with the ability to better understand entity expenses and make their own judgements about entity performance. The amendments in this update are effective for fiscal years beginning after December 15, 2026. We plan to adopt this pronouncement and make the necessary updates to our disclosures for the year ending December 31, 2027, and, aside from these disclosure changes, we do not expect the amendments to have a material effect on our financial statements.

Note 3. Prepaid Expenses and Other Current Assets

Prepaid expenses and other current assets were $1.3 million as of September 30, 2025, compared to $0.6 million as of December 31, 2024. The increase was primarily due to the timing of insurance premium financing our new policy renewals and advance payments related to research and development service agreements associated with the ONP-002 program.

The Company’s prepaid balances typically consist of insurance premiums, research and development service agreements, and other vendor advances aligned with ongoing clinical, manufacturing, and regulatory activities.

Note 4. Accounts Payable and Accrued Expenses

Accounts payable and accrued expenses totaled $2.5 million as of September 30, 2025, compared to $1.4 million as of December 31, 2024. The increase was primarily attributable to the timing of vendor invoicing and payments and higher accrued research and development expenses related to ongoing ONP-002 program activities during the quarter.

These liabilities consist primarily of account payables to research and development vendors, payroll and benefits accruals, professional service fees, and other general corporate obligations. As of September 30, 2025, this balance also included a $700,000 accrual related to the Ladenburg Thalmann legal settlement, which was paid in October 2025 in full satisfaction of the matter (see Note 10. Commitments and Contingencies).

As of September 30, 2025, the Company had entered into several research and development service agreements not yet invoiced; such commitments are expected to be recognized as expenses in future periods as services are performed.

Note 5. Short-Term Notes Payable

On March 13, 2025, we issued a $3.0 million promissory note (the “Note”) to a single investor at an original issue discount of 17%. Net proceeds to us were approximately $2.2 million after placement agent fees of $175,000 and legal expenses of $98,437.

The Note was non-interest-bearing unless an event of a default occurred, at which time interest would accrue at a rate of 20% per annum. The Note was scheduled to mature on the earlier of July 14, 2025, or the closing of any subsequent offering with net proceeds equal to or exceeding all amounts due under the Note.

In connection with the issuance of the Note, we designated and issued 1,000,000 shares of our authorized but unissued Series G Mirroring Preferred Stock. For a description of the Series G terms, see Note 8. We used the net proceeds for working capital and general corporate purposes. Subsequently, in connection with the Reverse Stock Split the shares of Series G Preferred Stock were cancelled. See Note 8.

On July 2, 2025, the Company repaid in full the $3.0 million promissory note issued on March 13, 2025. The repayment was made using a portion of the net proceeds from the Company’s July 2, 2025, public offering of Series H Preferred Stock and warrants to purchase additional shares of Series H Preferred Stock.

Short-term notes payable consisted of the following:

September 30,December 31,
20252024
Insurance premium financing of $504,425, due in monthly installments of $58,314, which includes principal and annual interest at 8.75% through April 2026$394,836$—
Insurance premium financing of $328,528, due in monthly installments of $54,000, which include principal and annual interest at 9.55% through May 2025—328,528
Total short-term notes payable$394,836$328,528

Note 6. Stock-Based Compensation

2021 Equity Incentive Plan

Our 2021 Equity Incentive Plan (the “2021 Plan”) authorizes the grant of stock options (incentive and non-statutory), stock appreciation rights and restricted stock covering a total of 3,166,667 shares of our common stock. Options are granted at the fair value of our common stock on the date of grant and generally vest either immediately or over a period of up tothree years from the date of grant and expire 10 years from the date of grant. As of September 30, 2025,24,012 shares were reserved for issuance related to the 2021 Plan and 3,142,655 shares of our common stock remain available for awards.

Stock Option Activity

The following table summarizes stock option activity for the nine-months ended September 30, 2025.

Number of SharesWeighted Average Exercise Price per ShareWeighted Average Remaining Contractual Life (in years)Aggregate Intrinsic Value
Outstanding at December 31, 202433,150$142.716.72$—
Forfeited(9,138)105.90
Outstanding at September 30, 202524,012156.727.79—
Exercisable at September 30, 202524,012$156.727.79$—

Unrecognized Stock-Based Compensation Costs

As of September 30, 2025, there was no unrecognized stock-based compensation expense.

Note 7. Warrants

Outstanding and exercisable warrants as of September 30,2025, are summarized below.

Warrants OutstandingExercise PriceExpiration Date
2,341$56.252/27/2029
1,834$37.506/29/2029
13,512$20.709/4/2029
660,000$25.007/2/2030

During the nine months ended September 30, 2025,1,764 warrants expired on July 17, 2025, in accordance with their original terms. These expirations included warrants held by institutional and accredited investors, as well as a limited number of board members and other holders. No warrants were exercised or cancelled during the period.

Note 8. Shareholders’ Equity

At-The-Market Sales Agreement with Dawson James

On October 11, 2024, we entered into an At-the-Market Sales Agreement (the “ATM Agreement”) with Dawson James Securities Inc. (“Dawson James”) pursuant to which are allowed to issue and sell, from time to time, shares of our common stock (the “Shares”). Dawson James uses its commercially reasonable efforts to sell the shares requested by us to be sold, consistent with their normal trading and sales practices. We may instruct Dawson James not to sell the shares if the sales cannot be affected at or above the price designated by us and we may suspend sales pursuant to the ATM Agreement at any time. We pay Dawson James a commission of up to 3.0% of the gross proceeds from the sale of Shares under the ATM.

In February 2025, we sold 260,000 shares pursuant to the ATM Agreement for net proceeds of $2.6 million after commissions and legal expenses totaling $0.11 million.

Series F Convertible Preferred Stock

In December 2023, we issued 8,000,000 shares of our Series F Convertible Preferred Stock in connection with our purchase of assets from Odyssey Health, Inc. (“Odyssey”). The Series F Convertible Preferred Stock is convertible shares of our common stock in accordance with the Certificate of Designation for the Series F Convertible Preferred Stock. Upon issuance,511,308 shares of Series F Convertible Preferred Stock were converted to 17,044 shares of our common stock. As of September 30, 2025,7,488,692 shares of Series F Convertible Preferred Stock remain outstanding. Currently, such 7,488,692 shares of Series F preferred stock are convertible into 249,624 shares of our common stock, subject to the provisions and limitations contained in the Certificate of Designation for the Series F Convertible Preferred Stock, which provide that the following Subsequent Conversion Conditions must occur before such shares can be converted: (i) the Company must have applied for and been approved for initial listing on the NYSE American or another national exchange or shall have been delisted from the NYSE American, and (ii) if required by the rules of the NYSE American, the Corporation’s shareholder shall have approved any change of control that could be deemed to occur upon the conversion of the Series F Convertible Preferred Stock into Common Stock, based on the facts and circumstances existing at such time.

Series G Mirroring Preferred Stock

In March 2025, in connection with our issuance of a $3.0 million promissory note (see Note 5), we designated and issued 1,000,000 shares of our authorized but unissued shares of preferred stock as Series G Mirroring preferred stock, no par value and a stated value of $0.10 per share. On May 2, 2025, upon our shareholders’ approval, at our annual shareholders meeting, of a proposal authorizing the Company’s Board of Directors, in its discretion at any time within one year after shareholder approval is obtained, to effect a Reverse Stock Split of then-outstanding shares of the Company’s common stock, at a ratio of not less than one-for-five (1:5) and not greater than one-for-sixty (1:60), with the exact ratio to be determined by the Company’s Board and included in a public announcement (the “Reverse Split Proposal”), in accordance with the Certificate of Designation creating the Series G Mirroring Preferred Stock, all of the shares of Series G Mirroring Preferred Stock were automatically transferred to the Company and cancelled and such shares have resumed the status of authorized but unissued shares of preferred stock and are no longer designated as Series G Preferred Stock.

Series H Preferred Stock and Warrants

On July 2, 2025, the Company completed a public offering of Series H Convertible Preferred Stock and warrants to purchase additional shares of Series H Convertible Preferred Stock, resulting in gross proceeds of approximately $16.5 million and net proceeds of approximately $15.2 million, after deducting placement agent fees and offering expenses. In connection with the offering, the Company issued 660,000 shares of Series H Preferred Stock, each with a stated value of $25.00, and 660,000 warrants to purchase an equal number of Series H Preferred Shares at an exercise price of $25.00 per warrant. Each share of Series H Preferred Stock is convertible into Common Stock at an initial conversion price of $2.50 per share. The warrants are exercisable immediately and expire on July 2, 2030.

The Series H Preferred Stock has a stated value of $25.00 per share and is convertible at the option of the holder into shares of the Company’s common stock at a conversion price of $2.50 per share, subject to customary adjustments for stock splits, combinations, dividends, and similar events. The Series H Preferred Stock does not accrue dividends, except that holders are entitled to participate on an as-converted basis if dividends are declared on the common stock. The shares rank “pari passu” with Company’s common stock with respect to rights upon liquidation, dissolution, or winding-up and do not carry voting rights, except as required under Florida law. The shares may be automatically converted into common stock upon certain events specified in the Certification of Designation, such as the effectiveness of a registration statement covering the underlying common shares or at the Company’s election if the specified trading-price and volume conditions are met. The Series H Preferred Stock is non-redeemable by the Company, except as provided in the Certificate of Designation.

As of September 30, 2025,432,122 shares of Series H Preferred Stock remained outstanding, and 227,878 shares had been converted into 3,304,246 shares of common stock. All conversions were made in accordance with the stated conversion terms, and no additional Series H warrants had been exercised as of the reporting date.

Note 9. Net Loss Per Share

Basic and diluted net loss per share is computed by dividing net loss attributable to common stockholders by the weighted-average number of shares of common stock outstanding during the period. Basic and diluted net loss per share is the same for all periods presented, as the inclusion of potentially dilutive securities would have been anti-dilutive.

The following potentially dilutive securities were excluded from the calculation of diluted net loss per share because their effect would have been antidilutive:

Nine Months Ended September 30,
20252024
Stock options24,0127,431
Warrants677,68711,628
Common shares issuable upon conversion of Series H Preferred Stock6,265,769—
Total6,967,46819,059

Note 10. Commitments and Contingencies

On December 7, 2022, the Company entered into an investment-banking engagement letter with Ladenburg Thalmann & Co. Inc. (“Ladenburg”), which was subsequently amended several times (collectively, the “Engagement Letter”). The Company terminated the Engagement Letter effective August 15, 2023. Following termination, Ladenburg asserted that it was entitled to a fee in connection with the Company’s purchase of assets from Odyssey Health, Inc., and issued an invoice for $2,500,000 The Company disputed that no such fee was due. Related proceedings were also filed in the United States District Court for the Southern District of Florida.

On October 16, 2025, the Company and Ladenburg executed a Settlement Agreement resolving all claims between the parties. Under the terms of the Settlement Agreement, the Company agreed to pay $700,000, which was wired on October 17, 2025, in full satisfaction of the matter. The Company has accrued $700,000 as of September 30, 2025, related to this contingency.

No other material legal proceedings are pending or known to be threatened against the Company as of the date of these financial statements.

Note 11. Subsequent Events

Settlement Agreement. Subsequent to September 30, 2025, the Company settled its previously disclosed dispute with Ladenburg Thalmann & Co. Inc. for $700,000, which was accrued as of quarter-end and paid on October 17, 2025.

NYSE Compliance. On October 20, 2025, the Company received a letter from the NYSE American informing the Company it has regained compliance with the stockholder’s equity requirements of the NYSE American continued listing standards. As such, on October 21, 2025, the below compliance (“.BC”) indicator was removed and the Company was removed from the list of NYSE American noncompliant issuers.

Note 12. Acquisition of Concussion Assets

On December 28, 2023, we entered into an Asset Purchase Agreement with Odyssey Health, Inc. to purchase their intellectual property assets for their neurology products ONP-001 and ONP-002.

The aggregate purchase price of the transaction was $10,273,506 as follows:

Cash$1,000,000
Assumed accounts payable325,672
8,000,000 shares of our Series F Convertible preferred stock8,947,834
Aggregate purchase price$10,273,506

We evaluated the transaction and determined that it should be accounted for as an asset purchase. Furthermore, it was determined that the assets acquired were in-process research and development and, accordingly, the entire purchase price was recorded as a component of Research and development expense in the fourth quarter of 2023.

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