Basis of Presentation and Nature of Operations |
9 Months Ended |
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Sep. 30, 2025 | |
| Accounting Policies [Abstract] | |
| Basis of Presentation and Nature of Operations |
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.
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