Tivic Health Systems, Inc., (TIVC) Wednesday announced the acquisition of global exclusive license rights from Statera Biopharma Inc. (STAB) to the phase 3 Toll-like Receptor 5 or TLR5 agonist Entolimod for the treatment of acute radiation syndrome or ARS.
In the pre-market hours, shares of Tivic are surging more than 71 percent at $0.40 on 140,007 shares in
The licensing agreement accelerates Tivic's transformation into a diversified therapeutics company and the late-stage product is target to a potential FDA approval within 24 months.
The company has also acquired an exclusive option to license five additional indications and clinical use cases for Entolimod and its derivative, Entalasta.
Jennifer Ernst, CEO of Tivic said, "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."
Entolimod and its immunologically optimized derivative, Entalasta, have undergone forty animal and human trials. The FDA has granted Fast Track and Orphan Drug designation to Entolimod for the prevention or treatment of ARS and to prevent death following a potential lethal dose of total body ionization irradiation.
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