aibioOragenics receives NYSE American deficiency letter on equity
Tickers OGEN
NYSE American notified Oragenics on August 26, 2026 that it is not in compliance with two continued listing standards on stockholders' equity. The company has 45 days to submit a compliance plan and says it intends to do so.
Key facts
- Company
- Oragenics Inc. (AMEX: OGEN)
- News type
- Listings
- Primary source
- Oragenics Inc. 8-K (2026-08-28)
Oragenics, Inc. (NYSE American: OGEN) received a deficiency letter from NYSE American LLC on August 26, 2026. The letter says the company is not in compliance with the continued listing standards in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. The company disclosed it in an August 28, 2026 press release, filed as Exhibit 99.1 to a Form 8-K.
Section 1003(a)(ii) requires stockholders' equity of $4 million or more if a listed company has reported losses from continuing operations and/or net losses in three of its four most recent fiscal years. Section 1003(a)(iii) requires stockholders' equity of $6 million or more if a company has reported such losses in its five most recent fiscal years. It previously regained compliance with this standard in October 2025.
The compliance timetable
Under NYSE American rules, the company has 45 days from receipt of the letter to submit a plan to regain compliance. If the plan is accepted, the company continues to list during a cure period, subject to periodic review by NYSE American staff. The company says it intends to submit a compliance plan within the required timeframe, and that it will endeavor to undertake a transaction or transactions in the future to achieve compliance. It also says there can be no assurances on that point.
If the plan is not timely submitted or not accepted, or if the company is not in compliance by February 25, 2028, or does not make progress consistent with the plan, it will be subject to delisting procedures under the Company Guide. The company believes that continued execution of its clinical and regulatory milestones will restore compliance, though it says there can be no assurances.
Clinical and regulatory progress
The company is advancing ONP-002, its lead intranasal candidate for mild traumatic brain injury (mTBI), also called concussion, through a Phase IIa feasibility trial in Australia. The release says nine participants have been dosed to date, and that three Australian sites are now active: Alfred Health, Mackay, and Royal Adelaide Hospital. The release reports no safety or efficacy results from those nine participants.
The company said it has received responses from the U.S. Food and Drug Administration (FDA) to its Type B meeting request briefing package, submitted in July 2026. Oragenics is reviewing those items and remains focused on submitting an Investigational New Drug (IND) application by the end of 2026. The release also refers to U.S. Phase IIb trials planned to follow the Phase IIa trial. With the IND not yet filed, those U.S. trials are still ahead, and the 10-K estimates a Q1 2027 start for the U.S. based clinical trial.
Background from the 10-K
The 10-K describes ONP-002 as a fully synthetic, non-naturally occurring neurosteroid, delivered as a powder in a breath-powered intranasal device.
Financial position
According to the 10-K, research and development expense was $2.4 million in 2025, compared with $4.1 million in 2024. Net loss was $9.8 million in 2025 and $10.6 million in 2024. Cash used in operations was $9.2 million in 2025 and $8.6 million in 2024. Year-end cash and cash equivalents were $864,840 at December 31, 2024.
The company's 10-Q filed August 13, 2026 reports year-end 2025 cash and cash equivalents of $4.4 million and short-term investments of $4.0 million, and $3.9 million of cash and cash equivalents at June 30, 2026. The materials used for this story do not state stockholders' equity, so this story does not compare the company's equity with the $4 million or $6 million thresholds.
The risks ahead
Oragenics has to submit an acceptable compliance plan and then fix its equity position, and it has no stated way to do that yet. It says it will endeavor to undertake a transaction or transactions, with no assurances. Delisting procedures follow if the plan is late or rejected, or if it is not in compliance by February 25, 2028. The company lost $9.8 million in 2025 and used $9.2 million of cash in operations, and reports $3.9 million of cash at June 30, 2026. It says it remains focused on filing an IND by the end of 2026.