Every 8-K that Oragenics Inc. (OGEN) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow OGEN and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full OGEN filings page.
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. 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. 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. has signed a non-binding Letter of Intent with Sigyn Therapeutics to license CardioDialysis™, an extracorporeal blood purification technology, for traumatic brain injury (TBI) and certain chronic neurodegenerative diseases.
Oragenics expects to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible into common stock on a one-to-one basis, as consideration. The proposed license also includes a 3% royalty on revenue from sales of the licensed technology for six years from the first commercial sale per approved indication and country. The parties are targeting closing within 90 days, subject to due diligence, board approvals, an independent valuation, listing compliance, and other customary conditions.
The strategy is to pair CardioDialysis™, which clears inflammatory and pathogenic molecules from the bloodstream, with Oragenics’ intranasal neurosteroid ONP-002, now in Phase IIa trials for concussion and mild TBI, to address TBI-induced inflammation on both sides of the blood-brain barrier.
Oragenics, Inc. has dosed the first patient in its ongoing Phase IIa clinical trial in Australia for ONP-002, an intranasal drug candidate for concussion and mild traumatic brain injury. The randomized, placebo-controlled study will enroll 40 patients, with treatment starting within 12 hours of injury and continuing for up to 30 days.
The trial will evaluate safety, tolerability and feasibility using nasal exams, physical assessments and neurocognitive testing, and is expected to support a planned investigational new drug application to the FDA in Q4 2026 for subsequent U.S. trials. Prior Phase 1 data in 40 patients showed zero serious adverse events, supporting advancement to this phase.
Oragenics, Inc. plans to hold its 2025 Annual Meeting of Shareholders on June 29, 2026. The board chose this date and is notifying investors because it is more than 30 days later than the prior year’s meeting date, triggering specific disclosure requirements under securities rules.
Shareholders who want their proposals included in the company’s proxy statement and form of proxy for the 2025 Annual Meeting must ensure Oragenics receives them by May 1, 2026, at its Lakewood Ranch, Florida principal executive offices, directed to the Corporate Secretary.
Oragenics, Inc. filed a report outlining several milestones for its lead concussion drug candidate, ONP-002, and its broader brain-health strategy. The company received final Human Research Ethics Committee approval in Australia to start a Phase IIa clinical trial of ONP-002 for concussion and mild traumatic brain injury.
All required approvals and filings are in place to onboard three Australian trial sites, and the first site initiation visit has been completed, marking the start of on-the-ground trial operations. The randomized, placebo-controlled Phase IIa study plans to enroll 40 patients, with first dosing expected within 12 hours of injury and treatment continuing for up to 30 days.
Earlier Phase 1 testing in 40 patients showed ONP-002 was safe and well tolerated with zero serious adverse events. Oragenics projects a Phase IIa data readout before year-end 2026 and expects the results to support an investigational new drug application to the FDA for U.S. trials. In parallel, the company is exploring potential acquisitions of additional central nervous system assets that align with its proprietary intranasal delivery platform and ONP-002 program.
Oragenics, Inc. entered into an amendment with Dawson James Securities Inc. to update its at-the-market common stock sales arrangement. The company already had an At-the-Market Sales Agreement that allows it to issue and sell shares of its common stock from time to time through Dawson James as sales agent or principal, in transactions deemed "at the market offerings" under securities regulations.
The new amendment, dated January 22, 2026, extends the term of this sales arrangement so that it will now expire at the earlier of either the sale of all shares covered by the agreement or the later of the expiration of Oragenics’ shelf registration statement on Form S-3 and any replacement registration statement filed under applicable Securities Act rules. All other terms, conditions, and covenants of the original Sales Agreement remain unchanged.
Oragenics, Inc. filed a current report to share that it will use an updated investor presentation, dated January 20, 2026, in a presentation by its CEO at the Sequire Investor Summit. The same presentation, furnished as Exhibit 99.1, will also be available on the company’s website under the “Presentations” tab in the “News and Media” section. The company notes that this information is being furnished under Regulation FD and is not deemed “filed” for liability purposes under the Exchange Act unless specifically stated otherwise.
Oragenics, Inc. updated compensation for its leadership. The board increased Chief Executive Officer Janet Huffman’s annual base salary by five percent from $325,000 to $341,250, effective January 1, 2026, and awarded her a cash bonus of $110,500 based on performance under the existing compensation program.
The board also granted Huffman stock options to purchase 250,000 shares of common stock at an exercise price of $0.93 per share, vesting in equal annual installments over three years, with earlier vesting upon a change in control. Each non-employee director received options for 125,000 shares at $0.93 per share that vested immediately, and director Natasha Giordano received an additional onboarding stock option award valued at $30,000 when she joined the board.
Oragenics, Inc. filed a current report to note that it has issued a new press release for shareholders. On November 12, 2025, the company released an update describing recent developments that took place during the third quarter of 2025 and shortly afterward. The report states that this press release is being furnished as an exhibit and incorporated by reference, directing readers to that document for the detailed business and operational update.
Oragenics, Inc. entered a Settlement Agreement with Ladenburg Thalmann, paying $700,000 for a mutual release of all claims related to a disputed fee tied to a prior asset purchase. This resolves arbitration between the parties.
The company also regained compliance with NYSE American continued listing standards, and the “.BC” indicator is expected to be removed at the open on October 21, 2025. Oragenics reports that stockholders’ equity exceeds $6.0 million as of October 18, 2025, satisfying Sections 1003(a)(i), (ii) and (iii).
Management cites recent financing actions: in July 2025, a public offering of Series H Convertible Preferred Stock generated $16.5 million in gross proceeds and is initially convertible into up to 9,570,000 shares of common stock, inclusive of dividends payable on the Series H Preferred Stock. Additional capital included an ATM sale on February 5, 2025 for $2.75 million gross and a September 2024 offering for $4.45 million gross.
Oragenics, Inc. appointed Natasha Giordano to its board of directors, effective September 1, 2025. She brings extensive leadership experience from prior CEO and board roles at multiple pharmaceutical and healthcare-related companies and holds a Bachelor of Science in nursing from Wagner College.
Under Oragenics’ non-employee director compensation program, which provides a $45,000 annual base fee for board service, the board agreed to pay Ms. Giordano $3,750 per month for September through December 2025. The company states there are no special arrangements or related-party transactions tied to her appointment, and she has agreed to stand for re-election at the next annual shareholder meeting.
Oragenics, Inc. filed a Current Report on Form 8-K dated August 11, 2025 stating the company issued a press release updating shareholders on developments in the second quarter of 2025 and shortly thereafter. The filing expressly attaches that press release as Exhibit 99.1 and includes the cover page Interactive Data File as Exhibit 104.
The 8-K lists Oragenics' state of incorporation as Florida, its trading symbol OGEN on NYSE American, the principal executive office address and phone number, and is signed by CEO Janet Huffman. The body of the filing notifies investors of the press release but does not include additional financial or operational detail beyond the exhibits referenced.