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. 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.
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 pre-effective amendment to its S-3 registration statement (File No. 333-292880) on March 19, 2026 to furnish an updated auditor consent as Exhibit 23.1. The amendment is exhibits-only; the prospectus text is unchanged.
Oragenics, Inc. is a development-stage biopharmaceutical company focused on intranasal therapies for neurological conditions and infectious diseases. Its lead candidate, ONP-002, targets mild traumatic brain injury (concussion) using a breath-powered nasal delivery device designed for rapid brain exposure.
ONP-002 has completed pre-clinical toxicology in rats and dogs and a Phase 1 trial in healthy volunteers, where it was safe and well tolerated. The company plans a Phase 2a feasibility trial in Australia starting in the first quarter of 2026, followed by U.S.-based Phase 2b development under an IND.
Oragenics holds issued U.S. patents on ONP-002 and related C-20 steroid compositions with expirations up to 2040, and on the breath-powered nasal device with an exemplary expiration in 2042. The company reports no approved products and highlights significant ongoing losses, substantial capital needs, and reliance on maintaining NYSE American listing.
As of June 30, 2025, non-affiliate equity market value was about $3.1 million, and as of March 13, 2026, there were 4,336,029 common shares outstanding, after a 1-for-30 reverse stock split effected on June 3, 2025.
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. has filed a shelf registration statement that would allow it to offer and sell up to $100,000,000 of common stock, warrants and units from time to time. This total includes $34,156,040 of unsold securities carried forward from a prior shelf registration under SEC Rule 415(a)(6).
The company is using this flexible structure so it can complete one or more offerings, with specific terms and prices to be set in future prospectus supplements. As of January 21, 2026, Oragenics’ public float was about $4,222,535, based on 4,265,187 shares of common stock held by non‑affiliates at a last reported price of $0.99 per share. Because it is relying on General Instruction I.B.6 for smaller issuers, Oragenics is limited to selling no more than one‑third of its public float in primary offerings under this shelf in any twelve‑month period unless its public float increases to at least $75.0 million.