aibioOragenics signs letter of intent to license CardioDialysis for TBI
Oragenics signed a non-binding letter of intent to license certain indications of CardioDialysis from Sigyn Therapeutics for traumatic brain injury. The proposed terms include 3,250,000 restricted preferred shares and a 3% royalty for six years.
Key facts
- Companies
- Oragenics Inc. (AMEX: OGEN), Sigyn Therapeutics Inc. (OTC: SIGY)
- News type
- Company Updates
- Primary source
- Oragenics Inc. 8-K (2026-05-07)
Oragenics, Inc. (NYSE American: OGEN) signed a letter of intent to license certain disease indications of CardioDialysis from Sigyn Therapeutics, Inc. (OTCQB: SIGY), according to a press release dated May 7, 2026, filed as Exhibit 99.1 to a Form 8-K. The license would cover treatment of traumatic brain injury (TBI) and other chronic neurodegenerative diseases. The letter is non-binding except for certain provisions, including exclusivity, confidentiality and governing law.
The proposed license is exclusive and assignable. 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. It expects to pay Sigyn a 3% royalty on revenue from sales of the licensed technology after FDA market clearance, for six years from the date of first commercial sale per approved indication and country.
The terms and conditions
The target closing is 90 days or sooner from the effective date of the letter. Closing is subject to due diligence satisfactory to Oragenics, board approvals by both companies, an independent third-party valuation and other customary conditions. The release says completion of a definitive agreement remains subject to NYSE American continued listing compliance.
Sigyn has agreed not to license CardioDialysis to third parties for the proposed target markets during the exclusivity period. The release notes that certain provisions of the letter are binding on the parties, but that the letter does not obligate them to complete the transaction.
Why Oragenics wants the technology
Oragenics says the transaction would position it to target TBI-induced inflammation on both sides of the blood-brain barrier. Its lead candidate, ONP-002, is designed to cross the blood-brain barrier and address neuroinflammation and oxidative stress within the brain. CardioDialysis would address inflammation from outside the brain, by clearing inflammatory and pathogenic molecules from the bloodstream.
The company cites an estimated 69 million individuals worldwide who suffer a brain injury each year, and says there is no FDA-approved pharmacological treatment for concussion or mild traumatic brain injury.
Sigyn describes CardioDialysis as an extracorporeal blood purification technology that uses plasma separation and therapeutic adsorption within a single device. The release says Sigyn sees potential uses in sepsis, life-threatening viral infections, neuroinflammatory disorders and cardiovascular disease. Sigyn's other development programs are ImmunePrep, ChemoPrep and ChemoPure.
Background from the 10-K
The 10-K describes ONP-002 as a fully synthetic, non-naturally occurring neurosteroid that the company believes can cross the blood-brain barrier. It is manufactured as a powder and filled into a breath-propelled intranasal device.
The 10-K reports national patents covering the C-20 steroid compounds granted in 9 different countries, and says multiple nasal delivery device patent applications have been filed in the U.S. and in more than 60 countries. Net loss was $9.8 million in 2025 against $10.6 million in 2024, and research and development expense was $2.4 million against $4.1 million.
Financial position
Cash used in operations was $9.2 million in 2025 and $8.6 million in 2024, according to the 10-K. Year-end cash and cash equivalents were $864,840 at December 31, 2024. This story uses only figures from filings made on or before May 7, 2026, so it does not cite later quarterly balances.
What comes next
The letter of intent is the step before a definitive license agreement. Oragenics targets a closing within 90 days or sooner from the letter's effective date, subject to the conditions above. Sigyn's chief executive said the companies envision the possibility of combining ONP-002 and CardioDialysis in the future, which the release presents as a possibility, not a plan. The release gives no clinical data for CardioDialysis in brain injury, and the royalty is payable only after FDA market clearance, which has not occurred. The claim that the deal would make Oragenics the only company working on both sides of the blood-brain barrier is the two companies' own. The preferred shares would add to the share count, and ONP-002 is still in Phase IIa. The company reported $864,840 of cash at the end of 2024 and used $9.2 million in operations in 2025; the release warns that due diligence may turn up unfavorable results and that no definitive agreement may follow.