Full Press Release Details
Q3 2025 Shareholder Update
on Solid Ground: From Vision to Execution
Compliance, Advancing Innovation, Preparing for Clinical Milestones
Fla., November 12, 2025 - Oragenics, Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted
therapeutics through proprietary intranasal delivery technology, today reported key operational, financial, and strategic achievements
for the third quarter of 2025. These milestones reflect the Company's evolution from vision to execution as it advances toward
critical clinical trial initiation in Q4 2025/Q1 2026.
EXCELLENCE: FOUNDATION RESTORED
American Compliance Regained
October 20, 2025, Oragenics regained full compliance with NYSE American's continued listing standards, resolving the stockholder
equity deficiency that had placed the Company on noncompliant status. The below-compliance indicator has been removed, and Oragenics
has been removed from the NYSE American noncompliant issuers roster.
compliance represents more than checking a regulatory box-it demonstrates our commitment to financial discipline, operational accountability,
and transparent investor relations," said CEO Janet Huffman. "We addressed the equity deficiency head-on, executed
a strategic capital raise, and emerged with a balance sheet that supports our clinical objectives. That's the kind of execution
investors should expect from this management team."
Trial Infrastructure Secured
has established the critical operational infrastructure required for successful Phase IIa trial execution in Australia:
| Human Research Ethics Committee (HREC) approval secured in Q2 2025 | ||
| Southern Star Research appointed as Clinical Research Organization (CRO) | ||
| Sterling Pharma Solutions contracted for cGMP manufacturing at their Cary, North Carolina facility | ||
| HREC protocol amendments submitted to update sponsor, principal investigator, and clinical protocol-currently under regulatory review |
trial execution requires meticulous attention to regulatory detail. We're working through HREC amendments methodically and properly-not
cutting corners to meet arbitrary deadlines," said Huffman. "Once these final amendments are approved, we anticipate
that we will onboard clinical sites, enroll patients, and dose our first patient. We believe that milestone will represent the first
drug Oragenics has ever advanced into clinical trials-a transformational moment for this company."
INNOVATION: BEYOND A SINGLE ASSET
Partnership: Accelerating Pipeline Development
Q3 2025, Oragenics formalized a strategic collaboration with Receptor.AI, an artificial intelligence-driven drug discovery platform,
with the goal of accelerating the development of the Company's expanded molecule portfolio beyond ONP-002. We believe this partnership
leverages advanced AI modeling to identify optimal receptor binding profiles for molecules Oragenics acquired in previous years, enabling
more efficient laboratory validation and potential therapeutic applications across multiple neurological conditions.
not building a one-drug company-we're building a neurological therapeutics platform," said Huffman. "The
Receptor.AI partnership demonstrates how we're thinking strategically about capital efficiency. Instead of blindly testing molecules
in the lab, we're hoping to use AI to predict which candidates have the highest probability of success. That's smart science
and smart business."
believe the Company's intranasal delivery platform has potential applications beyond concussion treatment, including Parkinson's
disease, Alzheimer's disease, PTSD, anxiety disorders, and other acute and chronic neurological conditions. The AI-driven partnership
positions Oragenics to systematically explore these opportunities while maintaining focus on ONP-002 clinical development.
Opportunity: Platform Technology Leadership
proprietary intranasal delivery technology positions the Company at the forefront of a rapidly expanding market:
| Nasal drug delivery market projected to exceed $40 billion by 2030 | ||
| Concussion/mTBI market estimated at $8.9 billion globally by 2027 | ||
| No FDA-approved pharmacological treatments currently exist for concussion | ||
| 3.8 million concussions occur annually in the United States alone |
DISCIPLINE: CAPITAL EFFICIENCY AND RUNWAY
believe the Company's July 2025 capital raise of $16.5 million (gross proceeds) through Series H Convertible Preferred Stock and
Warrants provides meaningful runway to advance ONP-002 through Phase IIa clinical trials in Australia and prepare for U.S. Phase IIb
trials. Post-capital raise:
| Net proceeds: ~$15.2 million after fees and expenses | ||
| Debt eliminated: $3 million note payable paid in full | ||
| NYSE compliance: Stockholder equity restored above $6 million threshold |
the nine months ended September 30, 2025, Oragenics demonstrated continued operational discipline:
| 30% reduction in research and development expenses (year-over-year) | ||
| 5% decrease in total operating expenses (year-over-year) |
As Oragenics advances toward Phase IIa initiation and subsequent U.S. Phase IIb trials, the Company anticipates strategic increases in
R&D investment to support clinical excellence and accelerated development timelines. The current expense reductions reflect the transition
period between asset acquisition, regulatory preparation, and active clinical trial execution.
UPCOMING CATALYSTS AND MILESTONES
Value Drivers (Q4 2025/Q1 2026)
| Phase IIa clinical trial initiation with first patient dosed in Australia | ||
| IND submission preparations for U.S.-based Phase IIb clinical trials |
Strategic Goals (2026)
| Phase IIa data readout from Australia trials | ||
| IND submission to FDA for U.S. based clinical trials | ||
| Continued AI-driven pipeline expansion research | ||
| Strategic partnership development in concussion care ecosystem |
MESSAGE FROM OUR CEO
a Company Worth Believing In
past quarter represents a turning point for Oragenics-not because we made grand pronouncements, but because we delivered on operational
fundamentals that many biotech companies struggle to achieve.
regained NYSE compliance. We eliminated debt. We secured manufacturing partnerships. We established clinical trial infrastructure. We
formalized strategic collaborations that expand our platform beyond a single drug candidate. These aren't flashy milestones, but
they're the foundation upon which successful pharmaceutical companies are built.
regulatory process for clinical trials is complex, methodical, and sometimes frustrating. HREC amendments take time. Manufacturing agreements
require thorough vetting. CRO relationships demand careful coordination. We're working through these processes properly-not
cutting corners to meet arbitrary timelines that would compromise trial integrity or patient safety.
partnership with Receptor.AI demonstrates how we're thinking beyond ONP-002. While our lead program remains the immediate priority,
we're attempting to strategically position Oragenics as a neurological therapeutics platform company-not a one-asset bet.
The intranasal delivery technology we've developed has potential applications across multiple devastating brain conditions, and
we're using cutting-edge AI to identify the most promising opportunities.
our shareholders: You've supported us through capital raises, reverse splits, and operational pivots. The management team you're
backing today is fundamentally different from years past-more experienced, more disciplined, more focused. We're striving
to build a company capable of bringing breakthrough therapies to patients who desperately need them.
first patient dosed in our Phase IIa trial will mark a historic milestone-the first drug Oragenics has ever advanced into clinical
trials. But that milestone is just the beginning. We're building infrastructure, partnerships, and capabilities designed to sustain
multiple programs through clinical development, regulatory approval, and commercialization.
is what execution looks like. This is how you build a pharmaceutical company that lasts.
is an investigational neuroprotective, anti-inflammatory intranasal drug candidate targeting mild traumatic brain injury (mTBI) or concussion.
Designed to interrupt biological pathways involved in inflammation, oxidative stress, and swelling following head trauma, ONP-002 has
demonstrated safety and tolerability in Phase I clinical trials. The drug candidate utilizes Oragenics' proprietary intranasal
delivery platform to enable rapid brain delivery, potentially representing a paradigm shift from symptom management to active neurological
intervention. Oragenics is advancing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow
pending FDA IND approval.
Inc. is a clinical-stage biotechnology company developing brain-targeted therapeutics through proprietary intranasal delivery technology.
The Company's lead candidate, ONP-002, is being advanced as a potential first-in-class treatment for concussion and mild traumatic
brain injury. Oragenics is progressing ONP-002 through Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to
follow. The Company's intranasal delivery platform has potential applications across multiple neurological conditions, including
Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders. Oragenics is committed to developing innovative therapies
that address significant unmet medical needs in neurological care. For more information, visit www.oragenics.com.
communication contains "forward-looking statements" within the meaning of the safe harbor provisions of the U.S. Private
Securities Litigation Reform Act of 1995, including, but not limited to, statements regarding our future performance, business prospects,
events and product development plans. These forward-looking statements are not historical facts, but are based on current expectations,
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our strategies, objectives and our goals. To the extent statements in this Quarterly Report involve, without limitation, our expectations
for growth, estimates of future revenue, our sources and uses of cash, our liquidity needs, our current or planned clinical trials or
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