Oragenics Signs License Intent with Sigyn Therapeutics for CardioDialysis Technology in TBI

With no FDA-approved pharmacological treatment for concussion or mild traumatic brain injury on the market, Oragenics is structuring a pipeline that targets TBI-induced inflammation from two anatomically distinct fronts. The company has signed a Letter of Intent to license Sigyn Therapeutics' CardioDialysis™ blood purification technology for TBI and other chronic neurodegenerative indications.

Oragenics is currently running ONP-002, a first-in-class intranasal neurosteroid, through Phase IIa trials for concussion and mTBI. ONP-002 crosses the blood-brain barrier to address neuroinflammation and oxidative stress centrally. CardioDialysis™ operates extracorporeally, clearing inflammatory and pathogenic molecules from the systemic circulation, the peripheral inflammatory burden that accumulates following a TBI event. The proposed combination would constitute a dual-modality strategy acting simultaneously on both sides of the blood-brain barrier, a position Oragenics would hold exclusively under the proposed license terms.

Under the LOI, Oragenics expects to issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn, convertible to common stock on a one-to-one basis and subject to NYSE American rules and shareholder approval. A 3% royalty on net sales would apply for six years from first commercial sale per approved indication and country, commencing after FDA market clearance. Target closing is set at 90 days from the LOI effective date, contingent on due diligence completion and execution of a definitive agreement.

For drug development and regulatory teams, the structure is notable: the LOI covers an exclusive, assignable license scoped to agreed target markets, meaning the eventual IND and regulatory pathway for CardioDialysis™ in TBI would sit entirely within Oragenics' development infrastructure. Sigyn retains rights outside those target markets. The extracorporeal modality will require its own FDA clearance pathway, distinct from the NDA or BLA route applicable to ONP-002, adding a parallel regulatory workstream to Oragenics' existing clinical obligations.

The transaction's close remains subject to standard conditions, and the definitive license agreement has not yet been executed; the 90-day target closing window will be the first measurable checkpoint for both development and regulatory planning teams tracking this program.

Source: Sigyn Therapeutics, Inc. via GlobeNewswire, May 7, 2026.