Note 1 - Formation and Business of the Company

9 Months Ended

Sep. 30, 2025

Notes to Financial Statements

Organization, Consolidation and Presentation of Financial Statements Disclosure [Text Block]

1. Formation and Business of the Company

Tivic Health Systems, Inc. (the “Company”) was incorporated in the state of California on September 22, 2016 for the purpose of developing and commercializing non-invasive bioelectronic medicine. In June 2021, the Company was reincorporated as a Delaware corporation and, in November 2021, it completed its initial public offering. In 2019, the Company commercially launched ClearUP, a handheld device for treatment of sinus pain and congestion and the Company's first FDA-regulated product, a business it is in the process of exiting. In 2021, the Company also began developing a novel platform directed to vagus nerve stimulation, which has undergone clinical evaluation and optimization studies. In February 2025, the Company acquired a worldwide exclusive license from Statera Biopharma, Inc. (“Statera”) to the late-stage toll-like receptor 5 agonist Entolimod™ for the treatment of Acute Radiation Syndrome (“ARS”). At the same time, the Company acquired an exclusive option to license five additional indications and clinical use cases for Entolimod and its immune-optimized derivative, Entolasta™, with buy-out rights to enable use across all indications. In March 2025, the Company exercised its option to license Entolimod and Entolasta for the treatment of neutropenia, one of the indications covered by the Statera license. With its entrance into the biopharmaceutical market in early 2025 and its impending exit from the consumer healthtech business, the Company is a late-stage prescription therapeutics company harnessing the power of the immune system to improve clinical outcomes and save lives. The Company is headquartered in Fremont, California and operates on a decentralized, virtual basis.