Oragenics Locks Exclusive CardioDialysis™ License with Sigyn for TBI, Issues 3.25 M Shares
OGEN•Oragenics will issue 3.25 million convertible preferred shares to Sigyn for exclusive rights to CardioDialysis™ blood purification technology in TBI and neurodegenerative indications, with a 3% royalty on sales for six years post-commercialization. The deal complements Oragenics’ ONP-002 Phase IIa intranasal neurosteroid, forming a dual-modality TBI treatment platform.
1. Transaction Details
Oragenics will issue 3.25 million restricted preferred shares convertible into common stock to Sigyn for an exclusive license to CardioDialysis™ technology targeting TBI and other neurodegenerative diseases. The nonbinding letter of intent includes a 3% royalty on revenue for six years, exclusivity provisions and aims to close within 90 days, subject to due diligence, board and shareholder approvals and NYSE American compliance.
2. Strategic Rationale
CardioDialysis™ extracorporeal blood purification targets systemic inflammation post-TBI while ONP-002, an intranasal neurosteroid in Phase IIa trials, directly addresses neuroinflammation within the brain. This dual-modality strategy positions Oragenics as the only company tackling TBI-induced inflammation on both sides of the blood-brain barrier.
3. Market Opportunity
An estimated 69 million global TBI cases occur annually with no FDA-approved pharmacological treatments for concussion or mild TBI, representing a substantial unmet medical need. Oragenics’ combined approach could redefine standard of care, open new revenue channels and enhance its competitive positioning in neurological therapeutics.
4. Next Steps
Completion of a definitive agreement depends on satisfactory due diligence, an independent valuation, board and shareholder approvals and continued listing compliance. The companies target finalizing terms within 90 days, after which Oragenics will advance CardioDialysis™ development alongside its existing neurological pipeline.
