Tivic Health briefs White House, FDA on biotech programs

FREMONT, Calif. - Tivic Health Systems, Inc. (NASDAQ:TIVC), a micro-cap therapeutics company currently valued at $2.17 million, recently held meetings with senior officials at the White House and the U.S. Food and Drug Administration (FDA) on Monday to discuss its biologic and bioelectronic product candidates, including potential defense applications. According to InvestingPro data, while the stock has experienced significant volatility with an 82% decline over the past year, the company maintains a strong liquidity position with a current ratio of 9.7x. The discussions on April 17th centered on the company’s TLR5 program and its non-invasive cervical vagus nerve stimulation (ncVNS) technology.

The TLR5 program, which includes the lead product candidate Entolimod™, has previously received substantial funding from various U.S. government agencies for development purposes. The White House briefing focused on the need for advanced treatments for acute radiation syndrome and the potential of targeting the TLR5 pathway, which plays a critical role in the immune system’s response to infections, autoimmune dysfunction, and cancer. While the company reported revenue of $0.78 million in the last twelve months, InvestingPro analysts project sales growth of 9.3% for the current fiscal year.

In a separate meeting, Tivic Health presented to the FDA the possibility of expedited approval pathways and support for export opportunities for Entolimod™, its second-generation TLR5 agonist Entolasta™, and its ncVNS technology. The ncVNS program is particularly noteworthy for its potential in treating post-traumatic stress disorder (PTSD), a condition of significant interest to military and defense organizations.

Jennifer Ernst, CEO of Tivic Health, expressed appreciation for the opportunity to discuss their clinical pipeline’s potential impact on military personnel, first responders, and civilians. Michael Handley, COO and President of Tivic Biopharma, highlighted the unique attributes of Entolimod in treating ionizing radiation exposure and the relevance of their ncVNS program for the veteran population.

Tivic Health’s bioelectronic program is focused on developing non-invasive medical devices for treating inflammatory, cardiac, and neurologic disorders. The company’s biopharma program’s lead product, Entolimod™, is in late-stage studies for treating acute radiation syndrome and has been granted Fast Track and Orphan Drug designation by the FDA. Additionally, Tivic is preparing to file an investigational new drug (IND) application for a phase 2 clinical study of Entolimod™ for Neutropenia treatment.

The company already markets ClearUP®, an FDA-approved device for sinus pain and pressure relief, available through online retailers and commercial distributors.

This article is based on a press release statement and contains information that is forward-looking and subject to risks and uncertainties. Based on InvestingPro’s Fair Value analysis, the stock appears to be undervalued at current levels, though investors should note its high volatility with a beta of 2.16. For deeper insights into Tivic Health’s financial health, growth prospects, and detailed valuation metrics, access the comprehensive Pro Research Report, available exclusively to InvestingPro subscribers along with 13 additional ProTips and extensive financial metrics.

In other recent news, Tivic Health Systems reported a 33% decline in revenue for Q1 2025, totaling $800,000 compared to $1.2 million in the previous year. Despite the revenue drop, the company improved its net loss to $5.7 million from $8.2 million. Tivic Health has entered an equity distribution agreement with Maxim Group LLC, allowing the company to sell up to $1,767,913 worth of shares, as detailed in a recent SEC filing. Additionally, Tivic Health has regained compliance with Nasdaq’s minimum bid price requirement, ensuring its continued listing on the Nasdaq Capital Market. The company has also expanded its licensing agreement with Statera Biopharma for the development of a treatment for Neutropenia, issuing additional equity securities as part of the milestone payment arrangement. Tivic Health acquired exclusive rights to a Phase Three drug, Entelimod, and is focusing on its commercialization. These recent developments highlight Tivic Health’s strategic efforts to manage capital and expand its bioelectronic medicine solutions.

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