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FREMONT, Calif. - Tivic Health Systems, Inc. (NASDAQ:TIVC), currently trading at $3.05 and showing a -64.82% decline over the past six months, announced Wednesday it has received two investigational new drug applications (INDs) from Statera Biopharma for its lead candidate, Entolimod.
The transferred INDs cover Entolimod’s use in treating acute radiation syndrome (ARS), including both hematopoietic and gastrointestinal sub-syndromes, as well as advanced cancers. The transfer allows Tivic to formally engage with the FDA regarding Entolimod’s regulatory pathway. According to InvestingPro analysis, while the company maintains a healthy current ratio of 2.24, indicating strong short-term liquidity, it faces challenges with rapid cash burn and weak profit margins.
Jennifer Ernst, Tivic’s CEO, stated that while the IND for advanced cancers permits exploration of Entolimod’s anti-tumor activity, the company remains focused on acute radiation syndrome as the first indication. With a market capitalization of just $4.1 million and significant revenue decline of -58.49% in the last twelve months, InvestingPro data suggests the stock may be undervalued based on its Fair Value analysis. Subscribers can access 12 additional ProTips and comprehensive financial metrics for deeper insight into TIVC’s potential.
Entolimod is a TLR5 agonist that triggers NF-kB signaling, activating antiapoptotic and cell protective mechanisms. Under the FDA’s Animal Rule, the drug has undergone extensive trials for ARS treatment, demonstrating survival benefits, enhanced GI tract recovery, and improved hematopoiesis in animal models. The FDA has granted Entolimod Fast Track Designation for ARS.
Tivic also holds exclusive rights for Entolimod in treating neutropenia and has options to license additional indications including lymphocyte exhaustion, immunosenescence, and chronic radiation syndrome.
The company employs a dual platform strategy utilizing both biopharmaceutical and bioelectronic approaches to target the immune system. Besides Entolimod, Tivic is developing a non-invasive medical device targeting neural pathways implicated in various diseases. Despite reporting negative EBITDA of -$6.35 million, the company maintains more cash than debt on its balance sheet, according to InvestingPro analysis.
The information in this article is based on a company press release statement.
In other recent news, Tivic Health Systems reported a significant decline in revenue for the second quarter of 2025 compared to the previous year. Despite this drop, the company is shifting its focus towards the biopharmaceutical sector, particularly in immune system therapies, which it views as promising for future growth. Additionally, Tivic Health announced progress in discussions with key U.S. government agencies regarding the potential use of its Entolimod product as a radiation countermeasure for military personnel. This development follows the company’s participation in the 2025 Military Health System Research Symposium, where executives met with representatives from the Biomedical Advanced Research and Development Authority, the Armed Forces Radiobiology Research Institute, and the Medical CBRN Defense Consortium. These discussions indicate Tivic Health’s strategic pivot and engagement with government bodies to explore new applications for its products. While the revenue decline is notable, the company’s recent activities suggest a strategic realignment towards emerging opportunities in the health sector.
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