Sarasota, FL and San Diego, CA — May 7, 2026 — Leads & Copy — Oragenics, Inc., a clinical-stage biopharmaceutical company focused on neurological therapeutics, and Sigyn Therapeutics, Inc., a developer of extracorporeal therapies, have announced the signing of a Letter of Intent (LOI) for Oragenics to license CardioDialysis™ from Sigyn. CardioDialysis™ is a blood purification technology designed to clear inflammatory and pathogenic molecules from the bloodstream.
Under the proposed license agreement, Oragenics would gain exclusive rights to develop and commercialize CardioDialysis™ for treating Traumatic Brain Injury (TBI) and other chronic neurodegenerative diseases.
Oragenics is currently conducting Phase IIa clinical trials for ONP-002, an intranasal neurosteroid, targeting concussion and mild traumatic brain injury (mTBI). ONP-002 aims to cross the blood-brain barrier to reduce neuroinflammation and oxidative stress within the brain.
CardioDialysis™ complements this approach by addressing TBI-induced inflammation outside the brain, purifying the bloodstream of inflammatory molecules that accumulate after a TBI event. The combined therapies would create a dual-modality strategy, targeting the inflammatory cascade of TBI at both central and peripheral levels.
There are no FDA-approved pharmacological treatments for concussion or mTBI. Oragenics anticipates that this multi-faceted strategy could significantly improve care for the estimated 69 million individuals worldwide who experience a brain injury annually.
Oragenics’ Chief Executive Officer, Janet Huffman, stated the LOI demonstrates commitment to building a comprehensive TBI platform, addressing the full biology of brain injury. She added that while ONP-002 directly targets neuroinflammation in the brain, CardioDialysis™ provides a complementary approach to clear the systemic inflammatory burden following a TBI event. Huffman believes combining these strategies could redefine recovery outcomes for patients lacking approved treatment options.
Sigyn Therapeutics CEO, Jim Joyce, stated the proposed transaction would position Oragenics as the only company with therapeutic strategies to directly target TBI-induced inflammation on both sides of the blood-brain barrier.
Joyce also envisions the potential for ONP-002 and CardioDialysis™ to be synergistically combined to accelerate TBI recovery and reduce long-term adverse events.
The proposed transaction involves an exclusive, assignable license of the CardioDialysis™ technology for agreed Target Markets. Oragenics expects to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible into Oragenics common stock on a one-to-one basis, subject to NYSE American rules and shareholder approval conditions.
Oragenics expects to pay a 3% royalty on revenue from sales of the licensed technology after FDA market clearance, for six years from the first commercial sale per approved indication and country.
The target closing date is within 90 days from the LOI’s effective date, pending due diligence, board approvals, an independent third-party valuation, and other customary closing conditions.
Sigyn has agreed to exclusivity, refraining from licensing CardioDialysis™ technology to third parties for the proposed Target Markets during the exclusivity period.
The LOI is non-binding except for exclusivity, confidentiality, and governing law provisions. A definitive agreement depends on due diligence satisfactory to Oragenics, board approvals from both companies, NYSE American continued listing compliance, and other customary closing conditions.
CardioDialysis™, developed by Sigyn Therapeutics, is an extracorporeal blood purification technology designed for broad-spectrum clearance of inflammatory cytokines, endotoxins, and other pathogenic molecules from the bloodstream. It uses pressure dynamics to filter and purify blood plasma via a proprietary cartridge system.
Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biopharmaceutical company focused on neurological therapeutics for unmet medical needs. Their lead asset, ONP-002, is in Phase IIa clinical trials for concussion and mild traumatic brain injury. ONP-002 is delivered via an intranasal device, bypassing the blood-brain barrier to reduce neuroinflammation and oxidative stress.
Sigyn Therapeutics develops CardioDialysis, a next-generation blood purification technology for continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream. CardioDialysis integrates plasma separation and therapeutic adsorption within a single device. Therapeutic opportunities include sepsis, life-threatening viral infections, neuroinflammatory disorders, and cardiovascular disease. The company’s development pipeline includes ImmunePrep™, ChemoPrep™, and ChemoPure™.
Source: Oragenics, Inc.
