readthroughSign in
Aug 28, 2026Clinical readout

Oragenics gets NYSE American deficiency notice, updates trial and FDA progress

Oragenics disclosed a stockholders' equity shortfall triggering a listing compliance deadline, alongside continued Phase IIa dosing for ONP-002 and an ongoing FDA review of its Type B meeting package.

Oragenics, Inc. (NYSE American: OGEN) disclosed on August 28, 2026 that it received a deficiency letter from NYSE American LLC on August 26, 2026, citing noncompliance with continued listing standards under Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide. The company's stockholders' equity stood at $3.7 million as of June 30, 2026, after five straight years of net losses through fiscal year 2025.1 Oragenics does not currently qualify for any exemption from the equity requirements under Section 1003(a) of the Company Guide.1

The company faces a compliance timeline: it must file a plan with NYSE American by September 25, 2026, laying out how it will meet listing standards again before a February 25, 2028 deadline.1 That plan must include specific milestones, quarterly financial projections, and details of any strategic initiatives.1 Oragenics said it has already begun preparing the plan ahead of the deadline.1 The company noted that it faced and resolved an identical listing standard issue once before, restoring compliance in October 2025.1 Trading will continue under the ticker "OGEN" but with a ".BC" designation added to signal below-compliance status.1

On the clinical side, Oragenics said it continues to advance ONP-002, its intranasal candidate for mTBI (concussion), through a Phase IIa feasibility trial in Australia, having dosed nine participants so far across active sites.1 On the U.S. regulatory front, the company said it received FDA responses tied to its Type B meeting briefing package submitted in July 2026, and is reviewing them while still aiming to submit an IND application by the end of 2026.1

Written by readthrough’s AI from the linked primary sources and fact-checked against them automatically before publishing. Not investment advice.