Oragenics (NYSE: OGEN) faces NYSE listing warning as equity falls short
Rhea-AI Filing Summary
Oragenics, Inc. (OGEN) disclosed that NYSE American has notified the company it is no longer in compliance with continued listing standards requiring stockholders’ equity of $4 million under Section 1003(a)(ii) and $6 million under Section 1003(a)(iii). Oragenics reported $3.7 million of stockholders’ equity at June 30, 2026 and net losses in each of its last five fiscal years, making it ineligible for available exemptions.
The company must submit a detailed compliance plan by September 25, 2026, outlining how it will regain compliance by February 25, 2028. During this period, OGEN shares will continue trading on NYSE American with a “.BC” below-compliance marker, and normal SEC reporting and business operations continue. Failure to submit or execute an acceptable plan could trigger delisting, which Oragenics states could reduce liquidity, constrain equity financing, limit use of registration statements, and impair equity incentive programs.
Separately, Oragenics reported ongoing progress for ONP-002, its intranasal candidate for mild traumatic brain injury. Three Australian Phase IIa trial sites are active, with nine participants dosed, and the company is working toward a U.S. IND submission by year-end 2026 following FDA feedback on its Type B meeting package.
Positive
- None.
Negative
- NYSE American non-compliance and delisting risk: Oragenics reported stockholders’ equity of $3.7 million versus required thresholds of $4 million and $6 million, has incurred net losses for the last five fiscal years, and faces potential delisting by February 25, 2028 if its compliance plan is not accepted or successfully executed.
8-K Event Classification
3 items: 3.01, 8.01, 9.01
3 items
Item 3.01
Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing
Securities
The company received a delisting notice, failed to satisfy a continued-listing rule or standard, or transferred its listing.
Item 8.01
Other Events
Other
Voluntary disclosure of events the company deems important to shareholders but not covered by other items.
Item 9.01
Financial Statements and Exhibits
Exhibits
Financial statements, pro forma financial information, or exhibit attachments filed with this report.
Key Figures
Stockholders’ equity: $3.7 million
Stockholders’ equity requirement (Section 1003(a)(ii)): $4 million
Stockholders’ equity requirement (Section 1003(a)(iii)): $6 million
+5 more
8 metrics
Stockholders’ equity
$3.7 million
Reported at June 30, 2026
Stockholders’ equity requirement (Section 1003(a)(ii))
$4 million
Minimum equity if losses in three of four most recent fiscal years
Stockholders’ equity requirement (Section 1003(a)(iii))
$6 million
Minimum equity if losses in five most recent fiscal years
Net loss history
5 fiscal years
Net losses in last five fiscal years ended December 31, 2025
Compliance plan due date
September 25, 2026
Deadline to submit NYSE American plan of compliance
Compliance cure deadline
February 25, 2028
Date by which continued listing standards must be met
Phase IIa participants dosed
9 participants
ONP-002 feasibility trial in Australia
Active clinical sites
3 sites
Alfred Health, Mackay, and Royal Adelaide Hospital in Australia
Key Terms
stockholders’ equity, continued listing standards, NYSE American Company Guide, Investigational New Drug (IND) application, +2 more
6 terms
stockholders’ equity financial
"The Company reported stockholders’ equity of $3.7 million at June 30, 2026"
Stockholders’ equity is the portion of a company’s value that belongs to its owners after subtracting what the company owes from what it owns — like the equity in a house after paying the mortgage. For investors it shows the company’s net worth and can indicate financial strength, a cushion against losses, and the amount potentially available to support dividends or reinvestment; tracking changes helps assess whether the business is building or eroding owner value.
continued listing standards regulatory
"no longer in compliance with NYSE American’s continued listing standards"
Ongoing rules a stock exchange requires a listed company to meet to keep its shares trading publicly, such as minimum share price, market value, timely financial reports, and governance practices. Think of it as a membership checklist for a club: falling short can lead to warnings or removal from the exchange, which can sharply reduce liquidity, investor confidence, and a stock’s value. Investors watch these standards to gauge regulatory risk and the stability of their holdings.
NYSE American Company Guide regulatory
"standards set forth in Sections 1003(a)(ii) and 1003(a)(iii) of the NYSE American Company Guide"
A handbook of rules and requirements that govern companies listed on the NYSE American market, covering eligibility to list, ongoing disclosure duties, corporate governance expectations, and trading practices. It matters to investors because it sets the minimum standards companies must meet to join and remain on that exchange — like a routine safety inspection that signals basic reliability and transparency — helping investors judge regulatory compliance, quality of public information, and potential risks to a stock’s value.
Investigational New Drug (IND) application medical
"focused on its goal of submitting an Investigational New Drug (IND) application by the end of 2026"
An investigational new drug (IND) application is a formal request submitted to a drug regulator asking permission to begin testing a new medicine in people. It compiles lab results, manufacturing details and proposed human trial plans so regulators can judge safety before human studies start; for investors, an accepted IND is a key milestone that opens the clinical development pathway and can materially change a company’s risk profile and potential value, like getting a license to road-test a prototype.
Type B meeting regulatory
"received responses from the U.S. Food and Drug Administration (FDA) related to its Type B meeting request"
A Type B meeting is a formal, scheduled discussion between a drug or medical-device developer and a health regulator to resolve key mid‑ or late‑stage development issues such as clinical trial plans, interpretation of results, or steps needed for approval. Like a mid‑project review with an inspector, the meeting’s outcome can meaningfully change the timeline, cost and risk for a candidate: a clear, positive outcome lowers uncertainty for investors, while requests for more data or changes can signal delays and extra expense.
mTBI (concussion) medical
"its lead intranasal candidate for mTBI (concussion), through its Phase IIa feasibility trial"
FAQ
Why did Oragenics (OGEN) receive a NYSE American deficiency notice?
Oragenics received the notice because its stockholders’ equity was $3.7 million at June 30, 2026, below the NYSE American requirements of $4 million under Section 1003(a)(ii) and $6 million under Section 1003(a)(iii), and it reported net losses in its last five fiscal years.
What deadlines did NYSE American set for Oragenics (OGEN) to regain compliance?
Oragenics must submit a plan of compliance by September 25, 2026, detailing how it will meet continued listing standards by February 25, 2028. NYSE American staff will periodically review progress during this plan period.
How many participants have been dosed in Oragenics’ ONP-002 Phase IIa trial?
Oragenics reports that nine participants have been dosed in its Phase IIa feasibility trial of ONP-002 for mild traumatic brain injury in Australia, across three active clinical sites: Alfred Health, Mackay, and Royal Adelaide Hospital.
What regulatory milestone is Oragenics (OGEN) targeting for ONP-002 in the U.S.?
Oragenics is reviewing FDA responses to its Type B meeting briefing package and is focused on submitting an Investigational New Drug (IND) application for ONP-002 by the end of 2026, as part of its U.S. regulatory strategy.
AI-generated analysis. How Rhea-AI works. Not financial advice.
