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Recent press releases and 8-K filings for OGEN.
Oragenics Partners with DUCK FLATS Pharma for Concussion Program's FDA IND Readiness
OGEN
New Projects/Investments
- Oragenics, Inc. has engaged DUCK FLATS Pharma as its U.S. Investigational New Drug (IND) readiness and regulatory execution partner for its novel intranasal concussion therapy.
- The collaboration aims to align the company's upcoming Phase 2a clinical trial in Australia with its U.S. regulatory strategy for ONP-002, a potential first-in-class treatment for concussion and mild traumatic brain injury.
- DUCK FLATS Pharma brings extensive experience, having contributed to the development and approval of approximately 40 drug programs, including high-impact intranasal therapies.
- The global concussion market is projected to reach over $9 billion by 2027, addressing a significant unmet medical need as there are currently no FDA-approved therapies for this condition.
4 days ago
Oragenics Reports Q3 2025 Operational and Financial Achievements
OGEN
Delisting/Listing Issues
Convertible Preferred Issuance
New Projects/Investments
- Oragenics regained full compliance with NYSE American's continued listing standards on October 20, 2025, by resolving its stockholder equity deficiency.
- The company secured $16.5 million in gross proceeds from a July 2025 capital raise, resulting in approximately $15.2 million net proceeds and the elimination of a $3 million note payable. For the nine months ended September 30, 2025, operational efficiency included a 30% reduction in research and development expenses and a 5% decrease in total operating expenses year-over-year.
- Clinical trial infrastructure for the Phase IIa trial in Australia is secured, with Human Research Ethics Committee (HREC) approval in Q2 2025 and HREC protocol amendments under review, targeting trial initiation in Q4 2025/Q1 2026.
- A strategic collaboration with Receptor.AI was formalized in Q3 2025 to accelerate pipeline development using artificial intelligence.
Nov 12, 2025, 1:30 PM
Oragenics Regains NYSE Compliance and Advances Clinical Trials in Q3 2025
OGEN
Delisting/Listing Issues
Convertible Preferred Issuance
New Projects/Investments
- Oragenics, Inc. regained full compliance with NYSE American's listing standards on October 20, 2025, resolving a stockholder equity deficiency.
- The company completed a $16.5 million capital raise in July 2025 through Series H Convertible Preferred Stock and Warrants, which allowed for the elimination of $3 million in debt and restored stockholder equity above the $6 million threshold.
- Oragenics established the operational infrastructure for its Phase IIa clinical trial in Australia for ONP-002 and anticipates first patient dosing in Q4 2025/Q1 2026 ,.
- In Q3 2025, Oragenics formalized a strategic collaboration with Receptor.AI to accelerate its molecule portfolio development using AI-driven drug discovery.
Nov 12, 2025, 1:15 PM
Oragenics Regains NYSE American Compliance
OGEN
Delisting/Listing Issues
Convertible Preferred Issuance
New Projects/Investments
- Oragenics, Inc. regained full compliance with NYSE American's continued listing standards, effective October 20, 2025, by resolving its stockholder equity deficiency.
- This was achieved through a $16.5 million public offering of Series H Convertible Preferred Stock that closed on July 2, 2025.
- The capital raise provides funding to advance its lead candidate, ONP-002, for concussion and mild traumatic brain injury, through Phase II clinical trials in Australia and planned U.S. Phase IIb trials.
Oct 21, 2025, 12:00 PM
Oragenics Regains NYSE American Compliance and Settles Claims
OGEN
Delisting/Listing Issues
Convertible Preferred Issuance
Legal Proceedings
- Oragenics, Inc. regained full compliance with NYSE American's continued listing standards, effective October 20, 2025, by meeting the $6 million stockholders' equity requirement.
- This compliance was achieved through a $16.5 million public offering of Series H Convertible Preferred Stock that closed on July 2, 2025, which restored equity to compliant levels.
- On October 16, 2025, the company settled claims with Ladenburg Thalmann & Co., Inc. by paying $700,000, resolving a dispute where Ladenburg had claimed $2.5 million was due.
- With capital secured and compliance restored, Oragenics will now focus on advancing ONP-002, its lead candidate for concussion and mild traumatic brain injury, into Phase IIa clinical trials in Australia and planning for U.S. Phase IIb trials.
Oct 21, 2025, 11:45 AM
Oragenics Partners with Receptor.AI for AI-Driven Drug Development
OGEN
New Projects/Investments
- Oragenics has formed a strategic collaboration with Receptor.AI to utilize artificial intelligence for accelerating the development of pharmaceutical candidates targeting brain health conditions, aiming to expand its drug pipeline beyond ONP-002.
- Its primary candidate, ONP-002, a fully synthetic neurosteroid, is currently in Phase IIa clinical trials in Australia, with plans to commence Phase IIb trials in the US.
- Following the announcement of the partnership, Oragenics' shares rose by 2.30% in premarket trading, reaching $1.33.
- The company currently has no revenue or sales, reflecting its focus on research and development, and faces significant financial challenges.
Oct 7, 2025, 12:43 PM
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