Oragenics Inc. filings document the regulatory record of a clinical-stage biotechnology company focused on intranasal CNS therapeutics. The company’s 8-K reports include clinical and regulatory disclosures for ONP-002, including materials related to its Phase IIa program for concussion and mild traumatic brain injury, along with Regulation FD presentations and other public updates.
The filing record also covers capital-structure matters such as at-the-market common stock sales arrangements, shareholder meeting and proposal deadlines, executive compensation and equity awards, governance matters, risk factors, operating results and financial-condition disclosures, including going-concern language in the annual report.
Oragenics, Inc. (OGEN) reported that its Chief Medical Officer, Dr. James P. Kelly, is scheduled to present on September 17, 2026 at the IPAC-RS 2026 Nasal Innovation Forum, highlighting clinical progress for ONP-002, its first-in-class intranasal neurosteroid candidate for concussion. The presentation and a related investor presentation deck dated September 16, 2026 will be made available on the company’s website and are furnished, not filed, under Regulation FD. ONP-002 is being advanced through an ongoing Phase IIa feasibility trial in Australia following Phase I safety studies and is supported by a proprietary breath-powered intranasal delivery device designed to target the brain while minimizing systemic exposure. Oragenics also disclosed plans to submit an Investigational New Drug application in the United States in the fourth quarter of 2026 to enable further clinical development, including anticipated U.S. Phase IIb trials.
Oragenics, Inc. (OGEN) disclosed that NYSE American has notified the company it is no longer in compliance with continued listing standards requiring stockholders’ equity of $4 million under Section 1003(a)(ii) and $6 million under Section 1003(a)(iii). Oragenics reported $3.7 million of stockholders’ equity at June 30, 2026 and net losses in each of its last five fiscal years, making it ineligible for available exemptions.
The company must submit a detailed compliance plan by September 25, 2026, outlining how it will regain compliance by February 25, 2028. During this period, OGEN shares will continue trading on NYSE American with a “.BC” below-compliance marker, and normal SEC reporting and business operations continue. Failure to submit or execute an acceptable plan could trigger delisting, which Oragenics states could reduce liquidity, constrain equity financing, limit use of registration statements, and impair equity incentive programs.
Separately, Oragenics reported ongoing progress for ONP-002, its intranasal candidate for mild traumatic brain injury. Three Australian Phase IIa trial sites are active, with nine participants dosed, and the company is working toward a U.S. IND submission by year-end 2026 following FDA feedback on its Type B meeting package.
Oragenics, Inc. is a development-stage biopharmaceutical company focused on intranasal ONP-002 for concussion. A Phase IIa trial in Australia has enrolled 9 participants with 34 doses administered and no serious adverse events; a Type B FDA meeting request has been submitted, with an IND targeted by end of 2026.
For the six months ended June 30, 2026, the company generated no revenue, incurred a net loss of $4.7 million, and used $4.4 million in operating cash. R&D rose to $1.8 million, and G&A was $3.0 million. Cash and cash equivalents were $3.9 million within $5.5 million of total assets and no short-term debt.
The accumulated deficit reached $231.4 million, and the auditor’s prior report and management disclosures state substantial doubt about the company’s ability to continue as a going concern, with liquidity expected to fund operations only through December 31, 2026. Capital needs are significant, and the capital structure is highly dilutive, including Series F and Series H preferred stock with anti-dilution features and warrants that could convert into tens of millions of common shares. During the quarter, John Spencer was appointed Chief Financial Officer with a base salary of $200,000.
Oragenics Inc reported that its Chief Financial Officer, John Spencer, received a grant of stock options. The award covers 55,900 options to buy Oragenics common stock at an exercise price of $0.59 per share under the company’s 2021 Equity Incentive Plan.
According to the terms, one fifth of the options vest on the grant date, with the remaining options vesting in equal annual installments on the first through fourth anniversaries of the grant date, contingent on continued service. Following this grant, Spencer holds 55,900 derivative securities related to this award, which expire on July 1, 2036. The filing shows no open-market purchases or sales of common stock.
ORAGENICS INC Chief Financial Officer John Spencer filed an initial Form 3 reporting his beneficial ownership in company securities. The filing shows indirect ownership of 53 shares of common stock held by his spouse, and an employee stock option for 10,000 shares of common stock.
The option has an exercise price of $0.93 per share and expires on December 11, 2035. According to the award terms, one third of the options vest on the first anniversary of the grant date, with the remaining two thirds vesting in equal annual installments over the second and third anniversaries, subject to continued service.
Oragenics, Inc. appointed John Spencer, previously Senior Controller, as Chief Financial Officer effective July 1, 2026, under an Executive Employment Agreement providing a $200,000 base salary and customary confidentiality, non‑competition and non‑solicitation terms. He also received a stock option award valued at $25,000 with an exercise price equal to the NYSE American closing price immediately before the grant date.
At the June 29, 2026 annual meeting, shareholders re‑elected six directors and approved, on a non‑binding basis, the company’s executive compensation. Shareholders authorized the Board, in its sole discretion within one year, to implement a reverse stock split of outstanding common shares at a ratio between 1‑for‑2 and 1‑for‑50, and ratified Cherry Bekaert LLP as independent auditor for the year ending December 31, 2026.
Oragenics, Inc. is asking shareholders to vote on four key items at its June 29, 2026 virtual annual meeting. Investors will elect six directors, cast an advisory “Say on Pay” vote on executive compensation, and decide whether to authorize the board to implement a reverse stock split at a ratio between 1‑for‑2 and 1‑for‑50 at any time through June 29, 2027.
Shareholders are also being asked to ratify Cherry Bekaert LLP as independent auditor for 2026; that firm’s latest report included a going concern explanatory paragraph. As of April 27, 2026, there were 4,511,957 common shares outstanding, with significant additional common shares potentially issuable from preferred stock and warrants.
Oragenics, Inc. filed an update highlighting clinical, regulatory and financial progress. Its Phase IIa trial of ONP-002 for concussion and mild traumatic brain injury is active in Australia, with multiple hospital sites initiated, patients enrolled and dosed, and no serious adverse events reported so far.
The company is preparing a U.S. Investigational New Drug application, targeting an FDA Type C meeting request in Q2 2026 and full IND submission by the end of 2026. Oragenics reported a Q1 2026 cash balance of $6.1 million, higher research and development spending, slightly lower general and administrative costs, and noted an active at-the-market equity facility. It also signed a Letter of Intent to license a complementary CNS-related medical device and will present to investors at Sidoti’s Micro-Cap Virtual Investor Conference.
Oragenics, Inc. is soliciting proxies for its 2025 Annual Meeting to be held virtually on June 29, 2026. Shareholders will vote to elect six directors, approve a non-binding advisory vote on executive compensation, ratify Cherry Bekaert LLP as auditors, and approve a reverse stock split authorization (board may choose a ratio between 1:2 and 1:50 within one year of approval). The Board unanimously recommends voting FOR each proposal. The record date for voting is April 27, 2026, when 4,511,957 shares of common stock were issued and outstanding.
Oragenics, Inc. reported a Q1 2026 net loss of $2.2 million, roughly flat versus Q1 2025, as it continues developing its lead concussion drug ONP-002. Operating expenses rose to $2.3 million, driven by higher research and development spending of $0.6 million as the Phase IIa trial in Australia began enrolling patients.
Cash and cash equivalents were $6.1 million at March 31, 2026, after liquidating a $4.0 million short-term investment, which management believes funds operations through year-end 2026. The company’s auditor and management highlight substantial doubt about its ability to continue as a going concern without additional financing.
The filing details significant potential dilution from Series F and Series H preferred stock and associated warrants, including an anti-dilution reset that reduced the Series H conversion price to $1.00 per share. Oragenics also signed a non-binding letter of intent to license Sigyn Therapeutics’ CardioDialysis technology for traumatic brain injury and other neurodegenerative diseases, which could involve issuing 3,250,000 new preferred shares if a definitive agreement is reached.