Oragenics Signs Letter of Intent to License CardioDialysis™ Technology from Sigyn Therapeutics to Target TBI-Induced Systemic Inflammation

Rhea-AI Summary

Oragenics (NYSE American: OGEN) signed a non-binding Letter of Intent to license Sigyn Therapeutics' CardioDialysis™ blood‑purification technology for TBI and other neurodegenerative indications. The LOI contemplates 3,250,000 convertible restricted preferred shares to Sigyn, a 3% royalty for six years post-clearance, and a target close within 90 days subject to due diligence and approvals.

Strategic rationale: combining ONP-002 intranasal neurosteroid (crosses the blood‑brain barrier) with CardioDialysis™ (systemic inflammation clearance) to address TBI inflammation both centrally and peripherally.

Positive

• Exclusive license targeting TBI and neurodegenerative indications
• 3,250,000 convertible preferred shares expected as consideration
• Planned 3% royalty for six years post-market clearance
• Dual-modality approach pairing ONP-002 with CardioDialysis

Negative

• Issuance of 3,250,000 convertible preferred shares may dilute shareholders
• LOI is non-binding; definitive deal requires due diligence and approvals
• Closing conditional on NYSE American continued listing compliance

News Market Reaction – OGEN

-1.13%

5 alerts

-1.13% Session close to close

-20.0% Trough in 31 hr 44 min

$2.69M Market Cap

0.4x Rel. Volume

In the May 7 session, OGEN declined 1.13%, reflecting a mild negative market reaction. Argus tracked a trough of -20.0% from its starting point during tracking. Our momentum scanner triggered 5 alerts that day, indicating moderate trading interest and price volatility.

Data tracked by StockTitan Argus on the day of publication.

Market Context

This announcement expands Oragenics’ TBI strategy by pairing ONP-002, now in a 40-patient Phase IIa ...

Analysis

This announcement expands Oragenics’ TBI strategy by pairing ONP-002, now in a 40-patient Phase IIa trial, with Sigyn’s CardioDialysis™ to address inflammation on both sides of the blood-brain barrier. The non-binding LOI outlines 3,250,000 preferred shares, a 3% royalty over 6 years, and a targeted 90-day closing. Recent filings highlight an active shelf registration and at-the-market facility, so monitoring capital-raising activity, ONP-002 trial progress, and any definitive licensing agreement will be important.

Key Figures

Preferred shares to Sigyn: 3,250,000 shares Royalty on sales: 3% Royalty term: 6 years +5 more

8 metrics

Preferred shares to Sigyn 3,250,000 shares Restricted preferred stock, convertible 1:1 into common, as LOI consideration

Royalty on sales 3% Royalty on revenue from licensed CardioDialysis™ technology post-FDA clearance

Royalty term 6 years From first commercial sale per approved indication and country

Target closing period 90 days Target closing timeline from LOI effective date, subject to conditions

Annual brain injury cases 69 million individuals Estimated worldwide yearly brain injury incidence referenced for TBI market

Planned trial size 40 patients ONP-002 Phase IIa clinical trial enrollment target

Initial dosing window 12 hours Time from concussion/mTBI to first dosing in ONP-002 Phase IIa trial

Treatment duration 30 days Maximum treatment period in ONP-002 Phase IIa trial design

Historical Context

5 past events · Latest: May 05 (Positive)

Pattern 5 events

Date	Event	Sentiment	24h Move	Catalyst
May 05	Phase IIa site activation	Positive	+3.4%	Activated second ONP-002 Phase IIa site with initial patients already dosed.
Apr 20	Trial dosing update	Positive	-1.1%	Reported early ONP-002 Phase IIa dosing progress and trial design details.
Apr 13	First patient dosed	Positive	+12.9%	Dosed first ONP-002 Phase IIa patient for concussion and mild TBI.
Mar 25	Audit going-concern note	Negative	-7.3%	Unqualified audit opinion including going-concern explanation in 2025 10-K.
Mar 17	10-K and update	Neutral	-3.0%	Filed 2025 10-K with capital raise, expense cuts and program updates.

24h Move is the share-price change in the day after each event; other market factors may also have contributed.

Pattern Detected

Recent news flow has centered on ONP-002’s Phase IIa trial progress and corporate/financial disclosures. Clinical milestones often saw positive price alignment, while some operational or incremental trial updates produced muted or negative reactions. A going-concern audit explanation in March corresponded with a notable decline, underscoring sensitivity to financing and viability disclosures.

Recent Company History

Over the past several months, Oragenics has progressed ONP-002 through key Phase IIa milestones, including first patient dosing on Apr 13, 2026, additional dosing updates, and activation of a second trial site. These clinical steps generally supported a TBI-focused strategy but elicited varied price reactions. Concurrently, the company filed its 2025 Form 10-K, raised capital, reduced operating expenses, and disclosed a going-concern explanation. Today’s LOI to license CardioDialysis™ extends that TBI platform beyond intranasal ONP-002 into systemic blood purification.

Key Terms

letter of intent, extracorporeal, blood-brain barrier, restricted preferred stock, +4 more

8 terms

letter of intent financial

"today announced the signing of a Letter of Intent ("LOI") under which Oragenics"

A letter of intent is a document that shows an agreement in principle between parties to work towards a future deal or transaction. It outlines their intentions and key terms, acting like a roadmap before a formal contract is signed. For investors, it signals serious interest and helps clarify expectations early in the process.

extracorporeal medical

"Sigyn Therapeutics, Inc. (OTCQB: SIGY) (“Sigyn”), a developer of extracorporeal therapies"

Extracorporeal describes medical treatments or devices that act on blood, organs, or tissues outside the body for a period of time, such as filtering, oxygenating, or warming blood using a machine. Investors care because extracorporeal technologies form a distinct product market with specific regulatory paths, manufacturing needs, and recurring revenue from disposables; think of it like a laundromat for the body's fluids—specialized equipment doing work externally that patients and hospitals must repeatedly buy or use.

blood-brain barrier medical

"strategies targeting TBI-Induced Inflammation on Both Sides of the Blood-Brain Barrier"

A protective barrier of tightly packed cells and supporting tissue that controls what substances in the blood can enter the brain, acting like a security checkpoint that keeps out most pathogens and many drugs while allowing essential nutrients through. For investors, the barrier matters because whether a therapy can cross or safely bypass it often determines clinical success, regulatory approval and commercial potential for treatments of brain disorders.

restricted preferred stock financial

"issue 3,250,000 shares of a new class of restricted preferred stock to Sigyn"

Preferred shares that carry priority for dividend payments and claims on assets but come with limits on transferability or resale. Think of them as a special coupon that pays before common shares but you can’t freely sell it on the open market; those restrictions reduce liquidity and can change the price investors are willing to pay. Investors care because restricted preferred stock combines steady income and higher claim priority with added risk from limited ability to sell or trade.

royalty financial

"expects to pay a 3% royalty on revenue from sales of the licensed technology"

A royalty is a payment made to the owner of a resource or asset—such as a patent, mineral rights, or creative work—whenever others use or profit from it. For investors, royalties provide a steady stream of income without owning the entire asset, similar to earning a small commission each time a product is sold or a service is used. This makes royalties an important factor in valuing certain types of investments.

FDA regulatory

"from sales of the licensed technology following FDA market clearance"

The FDA is the U.S. federal agency that evaluates and approves medical drugs, devices, biological therapies and certain foods; think of it as the gatekeeper that decides whether a medical product is safe and effective for patients. For investors, FDA decisions determine whether a company can sell a product, affect expected revenue and introduce regulatory risk, so approvals, rejections or safety warnings can quickly move a company's valuation and stock price.

phase IIa medical

"ONP-002, a first-in-class intranasal neurosteroid in Phase IIa clinical trials"

Phase IIa is an early mid-stage clinical study that tests whether a new drug or treatment shows the intended biological effect in patients and helps identify the best dose. Think of it as a focused test-drive to see if a medicine does what it’s supposed to and what dose is tolerable before larger trials. Investors watch Phase IIa results because positive findings reduce technical risk and can materially increase the program’s value, while negative results raise the likelihood of costly delays or failure.

NYSE American regulatory

"subject to NYSE American rules and shareholder approval conditions"

NYSE American is a stock exchange where companies can list their shares to be bought and sold by investors. It functions like a marketplace, helping businesses raise money and providing investors with opportunities to buy ownership in these companies. Its role is important because it facilitates the trading of smaller or emerging companies, offering investors access to a broader range of investment options.

AI-generated analysis. How Rhea-AI works. Not financial advice.

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The Expected License Agreement Would Position Oragenics as the Only Company with Therapeutic Strategies Targeting TBI-Induced Inflammation on Both Sides of the Blood-Brain Barrier

Sarasota, FL and San Diego, CA, May 07, 2026 (GLOBE NEWSWIRE) -- Oragenics, Inc. (NYSE American: OGEN) ("Oragenics" or the "Company"), a clinical-stage biopharmaceutical company pioneering neurological therapeutics, and Sigyn Therapeutics, Inc. (OTCQB: SIGY) (“Sigyn”), a developer of extracorporeal therapies, today announced the signing of a Letter of Intent ("LOI") under which Oragenics expects to license from Sigyn, certain disease indications of CardioDialysis^™, a blood purification technology that enables the broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream.

Under the terms of the proposed license agreement, Oragenics would receive an exclusive license from Sigyn to develop and commercialize CardioDialysis^™ for the treatment of Traumatic Brain Injury (TBI) and other chronic neurodegenerative diseases.

Strategic Rationale: Targeting TBI Inflammation on Both Sides of the Blood-Brain Barrier

Oragenics is currently advancing ONP-002, a first-in-class intranasal neurosteroid in Phase IIa clinical trials for concussion and mild traumatic brain injury (mTBI). ONP-002 is designed to cross the blood-brain barrier and directly address the neuroinflammation and oxidative stress that drive TBI-related damage within the brain.

CardioDialysis^™ addresses TBI-induced inflammation from a complementary direction — outside the brain — by purifying the bloodstream of inflammatory and pathogenic molecules that accumulate systemically following a TBI event. Together, the two therapeutic approaches would represent a dual-modality strategy designed to attack the inflammatory cascade of TBI at both the central and peripheral levels simultaneously.

There are currently no FDA-approved pharmacological treatments for concussion or mTBI. Oragenics believes this multi-pronged approach could represent a significant advancement in the standard of care for the estimated 69 million individuals worldwide who suffer a brain injury each year.

“This letter of intent reflects our commitment to building a comprehensive TBI platform — one that addresses the full biology of brain injury, not just symptoms. While ONP-002 targets neuroinflammation directly within the brain, CardioDialysis^™ offers a powerful complementary approach to clearing the systemic inflammatory burden that follows a TBI event. We believe combining these two strategies has the potential to redefine recovery outcomes for millions of patients who currently have no approved treatment options.” stated Oragenics’ Chief Executive Officer, Janet Huffman

“Beyond the benefit offered to our shareholders, we believe the proposed transaction will position Oragenics as the only Company with therapeutic strategies to directly target TBI-induced inflammation on both sides of the blood-brain barrier,” stated Sigyn Therapeutics CEO, Jim Joyce.

“In the future, we envision the possibility of ONP-002 and CardioDialysis^™ being synergistically combined to accelerate TBI recovery and reduce long-term adverse events,” concluded Joyce.

Summary of LOI Terms

The proposed transaction is structured as an exclusive, assignable license of the CardioDialysis^™ technology for use in the agreed Target Markets. Key terms of the LOI include:

Consideration: 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.

Royalty: Oragenics expects to pay a 3% royalty on revenue from sales of the licensed technology following FDA market clearance, for a period of six years from the date of first commercial sale per approved indication and country.

Target Closing: 90 days or sooner from the effective date of the LOI, subject to completion of due diligence, board approvals, an independent third-party valuation, and other customary closing conditions.

Exclusivity: Sigyn has agreed not to license the CardioDialysis^™ technology to third parties for the proposed Target Markets during the exclusivity period.

The LOI is non-binding except for certain provisions including exclusivity, confidentiality, and governing law. The completion of a definitive agreement remains subject to due diligence satisfactory to Oragenics, board approvals by both companies, NYSE American continued listing compliance, and other customary closing conditions.

About CardioDialysis^™

CardioDialysis^™, developed by Sigyn Therapeutics, is an extracorporeal blood purification technology engineered to enable broad-spectrum clearance of inflammatory cytokines, endotoxins, and other pathogenic molecules from the bloodstream. The technology is designed to leverage naturally occurring pressure dynamics to filter and purify blood plasma through a proprietary cartridge system, with a potential profile that distinguishes it from conventional large-scale plasmapheresis approaches. Sigyn Therapeutics is developing CardioDialysis^™ for a range of serious inflammatory conditions.

About Oragenics, Inc.

Oragenics, Inc. (NYSE American: OGEN) is a clinical-stage biopharmaceutical company focused on pioneering neurological therapeutics for patients with unmet medical needs. The Company’s lead asset, ONP-002, is a first-in-class intranasal neurosteroid in Phase IIa clinical trials for the treatment of concussion and mild traumatic brain injury — a condition affecting an estimated 69 million people worldwide annually for which no FDA-approved pharmacological treatment currently exists. Delivered via a proprietary intranasal device, ONP-002 is designed to bypass the blood-brain barrier to directly reduce neuroinflammation and oxidative stress at the source of injury. For more information, visit www.oragenics.com.

About Sigyn Therapeutics^™

Sigyn Therapeutics is the developer of CardioDialysis, a next-generation blood purification technology that enables continuous broad-spectrum clearance of inflammatory and pathogenic molecules from the bloodstream. Within the emerging field of subtractive medicine, CardioDialysis is the first therapy to integrate plasma separation and therapeutic adsorption within a single device. Therapeutic opportunities for CardioDialysis include sepsis, life-threatening viral infections, neuroinflammatory disorders, and cardiovascular disease. The Company’s development pipeline is comprised of ImmunePrep^™ to optimize the delivery of therapeutic antibodies to treat cancer; ChemoPrep^™ to enhance the targeted delivery of chemotherapy; and ChemoPure^™ to reduce the toxicity of chemotherapy. To learn more about Sigyn Therapeutics, visit: www.SigynTherapeutics.com

Forward-Looking Statements

This press release contains “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements include, but are not limited to, statements regarding the Company’s expectations regarding the proposed transaction with Sigyn Therapeutics, including the execution of a definitive license agreement, the therapeutic potential of CardioDialysis^™, the potential clinical benefits of combining ONP-002 and CardioDialysis^™, and the Company’s broader CNS platform strategy. The words “believe,” “expect,” “anticipate,” “intend,” “estimate,” “project,” “potential,” “may,” “will,” “could,” “should,” and similar expressions identify forward-looking statements. These statements are subject to a variety of risks, uncertainties, and other factors that could cause actual results to differ materially, including the risk that a definitive agreement may not be executed, that due diligence may reveal unfavorable results, that required approvals may not be obtained, and other risks described in the Company’s most recent Form 10-K, Form 10-Q, and other filings with the U.S. Securities and Exchange Commission. The Company does not assume any obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future developments, or otherwise, except as required by law.

Although the letter of intent provides that certain provisions are binding on the parties, it does not obligate the parties to consummate the proposed transaction. The consummation of the proposed transaction remains subject to the negotiation, execution and delivery of a definitive license agreement and the satisfaction or waiver of applicable closing conditions. There can be no assurance that any definitive agreements will be entered into or that the proposed transaction will be consummated on the terms described herein or at all. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof and are not guarantees of future performance or outcomes.

Investor & Media Relations
irth Communications
800-383-4880
ir@oragenics.com

FAQ

What did Oragenics (OGEN) announce on May 7, 2026 about CardioDialysis?

Oragenics announced a non-binding LOI to license Sigyn's CardioDialysis™ for TBI and neurodegenerative uses. According to the company, the LOI outlines convertible preferred-share consideration, a 3% royalty, and a target 90-day close subject to approvals and due diligence.

How many shares will Oragenics (OGEN) issue to Sigyn under the proposed LOI?

Oragenics expects to issue 3,250,000 shares of restricted preferred stock convertible one-to-one into common stock. According to the company, conversion and issuance remain subject to NYSE American rules and shareholder approvals.

What are the commercial terms for royalties in the OGEN–Sigyn LOI?

The LOI contemplates a 3% royalty on revenue from licensed sales for six years after first commercial sale per approved indication and country. According to the company, royalties commence following FDA market clearance.

When would the Oragenics (OGEN) and Sigyn deal be expected to close?

The LOI targets closing within 90 days or sooner from the LOI effective date. According to the company, closing is conditional on satisfactory due diligence, board approvals, valuation, and customary closing conditions.

How does CardioDialysis complement Oragenics' ONP-002 for TBI treatment?

CardioDialysis purifies systemic inflammatory molecules while ONP-002 targets neuroinflammation inside the brain. According to the company, combining both therapies aims to address TBI inflammation on both sides of the blood‑brain barrier.