Oragenics Inc (NYSE American: OGEN) is a clinical-stage biopharmaceutical company focused on developing treatments for neurological conditions, with its lead program targeting mild traumatic brain injury (mTBI). The company generates no product revenue, funding operations entirely through equity and debt issuances. As of December 31, 2025, Oragenics had three full-time and part-time employees and was headquartered in Lakewood Ranch, Florida. Its lead candidate, ONP-002, is an intranasal formulation under preclinical and early clinical development, with a 14-day repeat-dose GLP study in beagle dogs completed as of the 10-K filed March 16, 2026. Unregistered trademarks include SMaRT Replacement Therapy, MU1140, and LPT3-04, and the USPTO issued a Notice of Allowance for the ORAGENICS mark in November 2025. The company relies on a single third-party manufacturer for ONP-002 synthetic chemistry and manufacturing. Oragenics competes for capital and personnel against larger, better-resourced biotechnology companies and research institutions.

Revenue model

Oragenics generates no product revenue as of the 10-K filed March 16, 2026. Operations are financed through issuances of common stock, preferred stock, warrants, and short-term notes payable, as reflected in the FY2025 cash flow statement.

Products and services

ONP-002: intranasal treatment candidate for mild traumatic brain injury (mTBI), in preclinical/early clinical development as of FY2025. Additional pipeline referred to as Neurology Assets. Historic trademarks include SMaRT Replacement Therapy, MU1140, and LPT3-04.

Customers and end markets

No commercial customers as of the 10-K filed March 16, 2026. Target end markets, if products reach commercialization, include global public and private payers for mTBI treatment.

Value-chain role

Clinical-stage drug developer with no internal manufacturing capability. Outsources clinical trials, manufacturing, and regulatory activities to third-party contract organizations. Relies on a single manufacturer for ONP-002.

Geographic exposure

Headquartered in Lakewood Ranch, Florida. Filing indicates intent to market globally, but no commercial operations in any geography as of the 10-K filed March 16, 2026.

Source: SEC 10-K, filed 2026-03-16

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