OGEN News & Events

Oragenicsannounced that, as previously disclosed in its 2025 Annual Report filed on March 16, the audited consolidated financial statements contained an unqualified audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the company's ability to continue as a going concern. The announcement is made pursuant to NYSE Company Guide which requires public announcement of the receipt of an audit opinion containing a going concern paragraph.

Oragenics announced the filing of its Annual Report on Form 10-K for the fiscal year ended December 31, 2025, with the U.S. Securities and Exchange Commission. In conjunction with this filing, the Company is providing a shareholder update on key operational and clinical milestones achieved during 2025 and progress made in the first quarter of 2026. The company said, "2026 STRATEGIC PRIORITIES: Enroll and dose patients in the Phase IIa clinical trial of ONP-002 in Australia; File an IND with the FDA to enable a U.S.-based clinical trials; Advance CNS portfolio expansion strategy by evaluating and pursuing synergistic asset acquisition opportunities." "2025 was the year we reset this company - financially, operationally, and strategically," reported Janet Huffman, the Company's Chief Executive Officer. "We raised capital, restored compliance, resolved a material legacy liability, and built the partnerships and infrastructure to compete at a higher level. None of that was easy, and none of it was accidental. It was the result of disciplined execution by a team that believes deeply in what ONP-002 can do for the 69 million people worldwide who suffer concussions every year with no approved pharmacological treatment available to them. 2026 is not about resetting. It is about executing. We are in the clinic. Patients will be dosed. And we are actively exploring the expansion of our CNS platform."

Oragenics announced it has completed the first site initiation visit for its Phase IIa clinical trial of ONP-002 in Australia. The visit marks the formal launch of clinical trial operations at the first of three planned trial sites in Australia, including completion of site staff training, protocol orientation, and site regulatory documentation. The remaining two clinical trial sites are currently completing their Research Governance Office reviews - the final administrative step required following Human Research Ethics Committee approval before each site can activate to begin patient enrollment and dosing. The Company expects these reviews to be completed in the near term, at which point all three sites will be positioned to enroll patients. The Phase IIa trial initiation follows the Company's receipt of HREC approval earlier this year, which represented the final regulatory clearance required to commence clinical site contract finalization, activation, and onboarding.

Oragenics announced that it is exploring discussions with third parties regarding the potential acquisition of additional assets in the central nervous system space, with a specific focus on brain health and brain recovery indications that demonstrate strategic synergies with the Company's lead candidate ONP-002 and its proprietary intranasal drug delivery platform. No definitive agreements have been reached, and there can be no assurance that any transaction will be completed on terms acceptable to the Company, or at all. The Company will disclose any material transaction in accordance with applicable securities laws and regulations.