Oragenics SEC Filings

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.

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. director Fred Telling filed an amended insider trading report covering a small stock sale and a new option grant. On 12/12/2025, he sold 210 shares of common stock at a weighted average price of $0.9446, and held 948 shares directly after the transaction. The filing notes that the shares were sold in multiple trades between $0.9440 and $0.9451.

The amendment also reports a grant of 125,000 non-employee director stock options on 12/11/2025 with an exercise price of $0.93 per share, vesting immediately and expiring on 12/11/2035. The company previously completed a 1-for-30 reverse stock split of its common stock, and this amendment corrects the amount of securities beneficially owned to reflect that corporate action.

Oragenics, Inc. received a Schedule 13G filing showing that Sabby Volatility Warrant Master Fund, Ltd., Sabby Management, LLC, and Hal Mintz together report beneficial ownership of 412,654 shares of Oragenics common stock. This position represents 9.9% of the outstanding common shares as of the filing. The reporting persons state they have shared voting and dispositive power over all 412,654 shares and no sole voting or dispositive power. They also certify that the securities were not acquired and are not held for the purpose of changing or influencing control of Oragenics, but instead are held on a passive basis consistent with a Schedule 13G filing.

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. reported an equity award to its CEO and CFO, Janet Huffman. On 12/11/2025 she was granted an employee stock option to buy 250,000 shares of Oragenics common stock at an exercise price of $0.93 per share under the Company's 2021 Equity Incentive Plan, as amended.

One third of the options vest on the first anniversary of the grant date, with the remaining two thirds vesting in equal annual installments on the second and third anniversaries, provided she continues to perform services for the company through each vesting date. The options are scheduled to expire on 12/11/2035, and the exercise price was set at the closing price of the common stock on the grant date.