Tivic Health Systems (TIVC) has made a strategic move into the immunotherapy space by acquiring exclusive global rights to Entolimod, a late-stage treatment for acute radiation syndrome (ARS), from Statera Biopharma. The acquisition of this Phase III Toll-like Receptor 5 (TLR5) agonist marks a significant expansion of Tivic's therapeutic portfolio.
Clinical Development and Regulatory Status
Entolimod has demonstrated promising results through an extensive development program encompassing forty animal and human trials. The U.S. Food and Drug Administration (FDA) has already granted both Fast Track and Orphan Drug designations to Entolimod for the prevention or treatment of ARS, specifically targeting the prevention of death following potentially lethal total body ionizing radiation exposure.
Strategic Expansion and Market Potential
The licensing agreement positions Tivic for potential market entry within 24 months, accelerating the company's transformation into a diversified therapeutics company. Beyond the primary indication, Tivic has secured an exclusive option to license five additional indications and clinical use cases for both Entolimod and its derivative, Entalasta.
Synergistic Integration with Existing Programs
Jennifer Ernst, CEO of Tivic, emphasized the strategic fit of the acquisition: "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."
Market Response
The market has responded positively to the announcement, with Tivic's shares surging more than 71 percent to $0.40 in pre-market trading, reflecting investor confidence in the strategic acquisition and its potential impact on the company's growth trajectory.
