Oragenics Stock Price, News & Analysis

Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biotechnology company focused on brain-targeted therapeutics delivered through proprietary intranasal technology. According to the company’s public disclosures, Oragenics is developing intranasal pharmaceutical medications for neurological disorders and infectious diseases, with a primary emphasis on mild traumatic brain injury (mTBI), commonly known as concussion. The company describes itself as pioneering intranasal therapeutics for brain-related conditions and as a development-stage biotechnology company centered on nasal delivery of pharmaceutical medications in neurology and fighting infectious diseases.

Core business and lead program

Oragenics’ lead drug candidate is ONP-002, an intranasal, neuroprotective and anti-inflammatory investigational therapy targeting concussion and mTBI. Company materials state that ONP-002 is designed to interrupt biological pathways involved in inflammation, oxidative stress, and swelling after head trauma. It is described as an intranasal neurosteroid with a novel delivery mechanism intended to enhance drug delivery to the brain while minimizing systemic exposure. Oragenics reports that ONP-002 has demonstrated safety and tolerability in Phase I clinical trials and is being advanced into Phase IIa clinical trials in Australia, with U.S. Phase IIb trials planned to follow, subject to regulatory processes.

Public communications from Oragenics further note that ONP-002 is being developed as a potential first-in-class pharmacological treatment for concussion and mild traumatic brain injury. The company highlights that there are no FDA-approved pharmacological treatments for concussion and positions ONP-002 as a candidate that may represent a shift from symptom management toward active neurological intervention, based on its preclinical and early clinical profile as described by the company.

Intranasal delivery platform

Beyond its lead asset, Oragenics emphasizes a proprietary intranasal delivery platform intended to enable targeted, non-invasive delivery of therapeutics to the brain. Company disclosures describe this platform as designed to provide rapid brain delivery, bypass aspects of systemic circulation, and offer patient- and caretaker-friendly administration. Oragenics has stated that it holds proprietary rights to a dry powder formulation and a novel intranasal delivery device, which it believes may support scalable manufacturing and delivery of intranasal therapies.

In its shareholder updates and press releases, the company indicates that while ONP-002 for concussion is the immediate focus, the intranasal platform is being evaluated for potential applications across multiple neurological and psychiatric conditions. Examples cited by Oragenics include Parkinson’s disease, Alzheimer’s disease, post-traumatic stress disorder (PTSD), anxiety disorders, opioid addiction, and other acute and chronic neurological conditions. These potential indications are presented by the company as areas where its intranasal, brain-targeted approach could be applied in future development.

Pipeline expansion and AI collaboration

Oragenics has disclosed a strategic collaboration with Receptor.AI, an artificial intelligence–driven drug profiling company. Under this collaboration, Receptor.AI is expected to apply computational models to analyze molecule structures acquired by Oragenics, with the goal of predicting receptor binding profiles and informing laboratory validation. The company describes this partnership as a way to accelerate development of an expanded pharmaceutical-candidate portfolio for conditions affecting brain health and to move beyond a single-asset focus on ONP-002.

According to Oragenics, AI-generated data from this collaboration is intended to guide preclinical work and help identify potential therapeutic applications across multiple neurological and psychiatric indications. The company characterizes this approach as a means to use advanced modeling to prioritize candidates for further testing, while maintaining focus on ONP-002 clinical development.

Clinical development and operational infrastructure

In its public updates, Oragenics reports that it has put in place key elements of clinical and manufacturing infrastructure to support ONP-002 development. The company has disclosed:

• Human Research Ethics Committee (HREC) approval in Australia for a Phase IIa clinical trial in adults with mild traumatic brain injury.
• The selection of Southern Star Research, a full-service Clinical Research Organization, as CRO for the Phase IIa ONP-002 trial in Australia, with responsibilities that include site selection, investigator agreements, and trial site initiation.
• A manufacturing agreement with Sterling Pharma Solutions, an established contract development and manufacturing organization, for cGMP production of ONP-002 to support clinical development, including planned Phase IIb trials.

Company communications explain that the Australian Phase IIa trial is designed as a randomized, double-blind, placebo-controlled study evaluating safety, tolerability, pharmacokinetics, and early pharmacodynamic effects of self-administered intranasal ONP-002 in adults with mTBI. Oragenics has also cited advantages of conducting clinical work in Australia, such as streamlined regulatory and ethics processes, experienced concussion trial sites, and access to that country’s R&D tax incentive program.

Market context as described by the company

In its shareholder updates, Oragenics references published projections for the nasal drug delivery and concussion markets to frame the potential opportunity for its platform and lead candidate. The company cites external estimates that the nasal drug delivery market could exceed a substantial value by 2030 and that the global concussion/mTBI market may represent a multibillion-dollar opportunity within a defined time frame. Oragenics also emphasizes, in its own statements, the absence of FDA-approved pharmacological treatments for concussion and the large number of concussions occurring annually in the United States, positioning concussion care as a significant unmet medical need.

These market references are presented by Oragenics as part of its rationale for focusing on intranasal neurotrauma therapeutics and for characterizing its intranasal platform as having potential applications across acute neurological emergencies and chronic neurodegenerative diseases. The company also discusses the concept of “brain-first recovery” and the possibility that early treatment of concussion could influence long-term neurological outcomes, describing this as a guiding theme for its development strategy.

Corporate and listing information

Oragenics is incorporated in Florida and lists its principal executive offices in Sarasota, Florida, in its SEC registration statements. The company’s common stock trades on the NYSE American under the ticker symbol OGEN. In SEC filings, Oragenics identifies itself as a smaller reporting company and a non-accelerated filer.

The company has disclosed a history of capital-raising activities, including a public offering of Series H Convertible Preferred Stock and Warrants. According to its Form 8-K and registration statements, this financing involved the issuance of Series H preferred shares convertible into common stock, together with associated warrants, with proceeds intended to fund ONP-002 clinical trials, related research and development, repayment of a bridge note, and general corporate purposes. The company has also noted that the terms of the preferred stock include conversion features and cumulative dividends payable in common stock, as described in its Certificate of Designation.

Oragenics has reported that it previously received deficiency letters from the NYSE American regarding stockholders’ equity requirements and submitted a plan of compliance. Subsequent company disclosures state that, following capital raises and expense reductions, Oragenics received notice that it had regained compliance with the NYSE American continued listing standards related to stockholders’ equity, and that the below-compliance indicator would be removed.

Governance and equity incentives

In its SEC filings, Oragenics describes equity incentive plans and option awards used to compensate directors, officers, employees, and consultants. The company has a 2021 Equity Incentive Plan, as amended, under which it grants stock options and other equity awards. An 8-K filed in December 2025 details option grants to the Chief Executive Officer and non-employee directors, including vesting schedules and exercise prices based on the market price of the company’s common stock on the grant date. The company has also reported the appointment of additional board members, along with related compensation arrangements consistent with its non-employee director compensation program.

These disclosures indicate that Oragenics uses stock-based compensation as part of its approach to aligning management and director incentives with shareholder interests, within the framework of its equity plans as filed with the SEC.

Summary of business focus

Overall, Oragenics presents itself, in its public communications and regulatory filings, as a development-stage, clinical-stage biotechnology company concentrating on intranasal therapeutics for neurological disorders, with a lead focus on concussion and mild traumatic brain injury. The company’s strategy, as described in its own materials, combines a proprietary intranasal delivery platform, the ONP-002 concussion program, AI-enabled pipeline expansion through a collaboration with Receptor.AI, and partnerships with specialized clinical and manufacturing organizations to support clinical development and potential future commercialization.