ORAGENICS INC 8K

Oragenics, Inc. provided an update on its ONP-002 Phase IIa trial and FDA interactions and disclosed receipt of an NYSE American deficiency letter regarding noncompliance with stockholders’ equity listing standards, requiring a remediation plan to avoid potential future delisting.

On August 28, 2026, Oragenics, Inc. reported continued progress in its Australian Phase IIa feasibility trial of ONP-002 for mild traumatic brain injury, noting three active clinical sites and nine participants dosed, and disclosed it had received FDA feedback on its July 2026 Type B meeting request as it works toward submitting an IND application by the end of 2026. The company also announced that on August 26, 2026, it received a deficiency letter from NYSE American stating it is not in compliance with the stockholders’ equity continued listing standards under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide and must submit a compliance plan within 45 days. If NYSE American accepts the plan, Oragenics’ listing may continue during a cure period subject to ongoing review, but failure to submit or execute an acceptable plan, or to regain compliance by February 25, 2028, could result in delisting. Management expressed confidence that execution of clinical and regulatory milestones and potential future transactions may enable the company to regain full compliance, while cautioning there are no assurances.

Filing Facts

CIK

1174940

Ticker

-

Form

8K

Source Type

sec

Accession

0001493152-26-040645

Alert Tier

7