Oragenics Regains NYSE Compliance, Advances Clinical Trial and Expands AI Neurology Pipeline

Oragenics Inc. (NYSE American: OGEN), a clinical-stage biotechnology company developing brain-targeted therapeutics via proprietary intranasal delivery technology, has regained full NYSE American compliance while reporting significant third quarter 2025 progress. The company has established clinical infrastructure in Australia and is preparing for its first-ever Phase IIa trial of ONP-002, its lead candidate for concussion treatment.

The company also announced a strategic collaboration with Receptor.AI to expand its neurological therapeutics pipeline using artificial intelligence to identify and validate next-generation candidates for conditions including Parkinson's disease, Alzheimer's disease, PTSD, and anxiety disorders. This partnership represents a significant advancement in Oragenics' approach to neurological drug development, leveraging AI technology to accelerate the discovery and validation process for potential treatments.

CEO Janet Huffman emphasized the company's broader vision, stating "We're not building a one-drug company—we're building a neurological therapeutics platform." This statement underscores Oragenics' commitment to developing a comprehensive approach to neurological care rather than focusing on single therapeutic candidates.

Oragenics is working to revolutionize neurological care through its proprietary intranasal delivery technology, which has the potential to enable targeted, non-invasive therapeutics for brain-related conditions. The company believes its platform technology could open pathways to address neurodegenerative diseases, CNS disorders, and other neurological conditions beyond its initial focus on concussion treatment.

The company's latest developments and updates are available through its newsroom at https://ibn.fm/OGEN, providing investors and stakeholders with ongoing information about the company's progress. The restoration of NYSE American compliance represents a significant milestone for the company, ensuring continued access to public markets while advancing its clinical programs.

The establishment of clinical infrastructure in Australia marks an important step in Oragenics' global development strategy, potentially accelerating the timeline for its Phase IIa trial of ONP-002. If successful, ONP-002 could become the first FDA-approved treatment for concussion, addressing a significant unmet medical need in neurological trauma care.

The collaboration with Receptor.AI demonstrates Oragenics' commitment to leveraging cutting-edge technology in drug discovery. By incorporating artificial intelligence into its pipeline development, the company aims to identify promising therapeutic candidates more efficiently while potentially reducing development timelines and costs associated with traditional drug discovery methods.

Oragenics describes its mission as creating "a movement around brain-first recovery that transforms how patients, clinicians, and healthcare systems approach neurological trauma." This comprehensive approach to neurological care could have far-reaching implications for treatment paradigms across multiple neurological conditions, potentially improving patient outcomes and expanding treatment options for conditions that currently have limited therapeutic interventions.