Tivic Health Acquires Exclusive Worldwide Rights to Statera Biopharma’s Phase III TLR5 Agonist

February 12, 2025

DENVER, Colo., Feb 12, 2025 (247marketnews.com)- Tivic Health Systems (NASDAQ:TIVC) announced the acquisition of worldwide exclusive license rights from Statera Biopharma (OTC:STAB) for Entolimod, a Toll-like Receptor 5 (TLR5) agonist that is in late-stage development for the treatment of acute radiation syndrome (ARS). In addition, Tivic secured an exclusive option to license five other indications and clinical use cases for Entolimod and its derivative Entalasta. This move significantly expands Tivic’s pipeline, positioning the company as a diversified therapeutics entity, incorporating both bioelectronic and biologic products.

Tivic made an initial payment of $1.5 million to Statera, $1.2 million in equity consideration and $300,000 in cash. Tivic has the option to expand its licensing rights and explore additional indications, with future payments tied to royalties and milestones. The agreement also includes exclusive rights to more than 60 patents and associated know-how, further strengthening Tivic’s biopharmaceutical space position.

Entolimod is a TLR5 agonist that has shown promising results in treating ARS, a potentially fatal condition caused by exposure to high doses of radiation. Tivic now holds the exclusive rights to develop Entolimod for this indication, with the FDA Fast Track and Orphan Drug designations already granted for its use in ARS treatment and radiation disaster scenarios.

Entalasta, an immunologically optimized derivative of Entolimod, is also part of the deal, with Tivic obtaining an exclusive option for its future use across multiple indications.

Jennifer Ernst, Tivic’s CEO, commented, “Today, we have aggressively accelerated Tivic’s strategic transformation from a single-product, direct-to-consumer company to a diversified therapeutics company—one with a growing pipeline of clinically validated product candidates. Statera’s TLR5 immunotherapy program strongly complements our work on non-invasive vagus nerve stimulation, positioning us to address immune and autonomic dysregulation—and associated diseases—through both neural and molecular pathways.”

TLRs are essential components of the innate immune system and play a critical role in immune responses to infection, cancer, and radiation. Entolimod works by activating TLR5 to enhance immune system activity, showing strong potential for treating radiation-related illnesses and other immune-related conditions.

In preclinical studies, Entolimod demonstrated three-fold increases in survival in animal models exposed to lethal radiation levels. It also has shown effectiveness in gastrointestinal protection and has exhibited no dose-limiting toxicity, even at high doses.

Michael K. Handley, Statera’s CEO, stated, “Based on extensive prior research, development and numerous clinical trials of Entolimod, this important immunotherapy drug will now be advanced through the final steps toward a BLA filing and potential FDA approval under the skilled execution of the Tivic team. We believe this agreement has the potential to provide considerable value for both Statera and Tivic shareholders.”

According to CoherentMI, the global ARS market is projected to reach USD 5.2 billion in 2024, growing at a 5% CAGR through 2031. This represents a significant opportunity for Entolimod, especially with the increasing risk of radiation-related incidents due to medical treatments or potential disasters.

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