Valion Bio, Inc. (NASDAQ: TIVC)

Tivic Health Systems, Inc. is a late stage therapeutics company that harnesses the power of the immune system to improve clinical outcomes and save lives. Its lead product candidate is the Toll like receptor 5 agonist Entolimod™, which is being developed for the prevention and treatment of acute radiation syndrome and for mitigating side effects of medical radiation and chemotherapy. In parallel, the company maintains a bioelectronic medicine program that develops non invasive cervical vagus nerve stimulation devices to modulate autonomic functions in neurologic, cardiac and autoimmune conditions. While it previously commercialized the over the counter sinus device ClearUP, Tivic Health is winding down that consumer health business to focus resources on its biologic and bioelectronic pipelines.

The company currently generates revenue solely from the sale of ClearUP and related accessories, including expedited shipping charges, sold directly to consumers through its own website and through resellers such as Simply Medical, Cardinal Health, Amazon, McKesson, Optum Store, Walmart, Target, Best Buy and FSA/HSA Store. Revenue is net of return reserves and reflects the company’s efforts to liquidate existing inventory before exiting the consumer business. Tivic Health does not anticipate meaningful product sales until it obtains regulatory approval for Entolimod or its bioelectronic candidates and can commercialize those products.

The company operates through the following segments: Biologics Program and Bioelectronic Medicine.

• Biologics Program: This segment is advancing the Toll like receptor 5 agonist Entolimod™ for acute radiation syndrome and neutropenia indications, supporting manufacturing validation, preparing a biologics license application for the FDA, and conducting IND enabled Phase 2 oncology studies for Entolimod and the second generation candidate Entolasta.

• Bioelectronic Medicine: This segment focuses on proprietary non invasive cervical vagus nerve stimulation technology, having completed feasibility and optimization studies with the Feinstein Institutes for Medical Research, and is preparing intellectual property filings while evaluating further clinical applications in post traumatic stress, cardiac disease, inflammatory conditions and ischemic stroke.

Within the biodefense and medical countermeasure sector, Tivic Health holds a differentiated position through its FDA granted Fast Track and Orphan Drug designations for Entolimod, which few competitors possess for acute radiation syndrome. Its bioelectronic approach leverages patent pending precision stimulation parameters that aim to improve reproducibility and clinical effect compared with earlier non invasive vagus nerve devices, giving it a potential edge in a crowded neuromodulation market.

The company’s customer base for its current ClearUP product includes individual consumers purchasing online and a range of retail and pharmacy partners such as Simply Medical, Cardinal Health, Amazon, Walmart, Target, Best Buy and FSA/HSA Store. For its future biologics, Tivic Health anticipates selling to federal agencies, hospital systems and oncology clinics, while its bioelectronic devices would target physicians, health systems and direct to consumer channels pending regulatory clearance.