Tivic Health Systems Inc Stock Price, News & Analysis

Tivic Health Systems (Nasdaq: TIVC) has acquired two investigational new drug applications (INDs) from Statera Biopharma for its lead candidate, Entolimod™. The first IND covers the treatment of acute radiation syndrome (ARS), including hematopoietic and gastrointestinal sub-syndromes. The second IND is for treating advanced cancers and related conditions.

The company plans to engage with the FDA regarding Entolimod's regulatory pathway and initiate clinical trials focusing on neutropenia, lymphocyte exhaustion, and cancer-related conditions. While Entolimod shows potential for anti-tumor activity, Tivic's immediate focus remains on developing it for acute radiation syndrome as the primary indication.

Tivic Health Systems (Nasdaq: TIVC) participated in the 2025 Military Health System Research Symposium (MHSRS) to advance discussions on Entolimod as a potential radiation countermeasure for military personnel. The company's President of Biopharma and COO, Michael Handley, engaged with key government agencies including BARDA, AFRRI, and MCDC to explore deployment pathways.

The symposium, held in Kissimmee, Florida from August 4-7, 2025, provided Tivic direct access to Department of Defense decision-makers and researchers. The discussions focused on Entolimod's potential to protect warfighters from radiation exposure, aligning with the participating agencies' missions in chemical, biological, radiological, and nuclear defense.

Tivic Health (NASDAQ: TIVC) reported Q2 2025 financial results, highlighting its strategic transformation from consumer healthtech to biopharmaceuticals. The company reported Q2 revenue of $86,000, down from $140,000 in Q2 2024, with a net loss of $1.9 million compared to $1.3 million in the prior year.

Key developments include advancing their TLR5 agonist program Entolimod™ for ARS treatment, securing military interest, and expanding its worldwide license to include neutropenia treatment. The company plans to exit its ClearUP business by year-end and has secured financing through a $25 million equity line of credit and a preferred equity purchase agreement worth up to $8.4 million.

Cash position stands at $1.2 million as of June 30, 2025, with $7.0 million remaining available through the preferred equity purchase agreement.

Tivic Health (Nasdaq: TIVC), a diversified immunotherapeutics company, will host its Q2 2025 earnings conference call on Thursday, August 14, 2025 at 1:30 PM PT / 4:30 PM ET. The company will present its financial results via a pre-recorded conference call and webcast.

Investors can access the call through the toll-free number (877-545-0523), international line (973-528-0016), or webcast using participant access code 793820.

Tivic Health Systems (Nasdaq: TIVC) announced key shareholder approvals supporting its strategic transformation into biopharmaceuticals. Shareholders approved equity issuance for the company's exclusive license agreement for Entolimod™ and Entolasta™, targeting acute radiation syndrome and neutropenia treatments.

The company made significant leadership changes, with Lisa Wolf being appointed permanent Chief Financial Officer after serving nine months as interim CFO. Additionally, Blake Gurfein, Chief Scientific Officer, is transitioning to a consultant role, continuing to support the Vagus Nerve Stimulation program.

The neutropenia treatment market is projected to reach $21 billion worldwide by 2032. The company reports strong customer interest in Entolimod's national defense applications for acute radiation syndrome treatment.

Tivic Health (Nasdaq: TIVC) has completed its Optimization Study for a non-invasive cervical vagus nerve stimulation (ncVNS) device. The study, conducted by The Feinstein Institute of Bioelectronic Medicine, focused on identifying optimal device parameters including frequency, amplitude, electrode positioning, and personalization.

Initial findings emphasize the importance of personalization for therapeutic efficacy. The company plans to release complete study results later this year, which will inform an upcoming Phase I clinical trial. The global VNS market is projected to grow from $8.59 billion in 2021 to $21.3 billion by 2030, with peripheral nerve stimulation expected to grow at a 35% CAGR.

Tivic Health (Nasdaq: TIVC), a diversified therapeutics company, has announced its 2025 Virtual Annual General Meeting of Shareholders scheduled for Monday, June 30, 2025 at 1:00 PM PT / 4:00 PM ET.

The meeting will be held virtually at www.virtualshareholdermeeting.com/TIVC2025. Only stockholders of record as of May 14, 2025 will be entitled to vote. Stockholders can submit questions through the virtual platform before and during the meeting. The company's proxy materials and Annual Report for 2024 are available on their website.

Tivic Health Systems (NASDAQ: TIVC) reported Q1 2025 financial results and business updates. The company reported revenue of $70,000, down from $334,000 in Q1 2024, with a net loss of $1.5 million. Gross margin improved to 72% from 50% year-over-year. Cash and equivalents stood at $669,000 as of March 31, 2025. Key developments include securing a $25 million equity line of credit and an agreement for up to $8.4 million in securities sales. The company executed a worldwide exclusive licensing agreement for Phase III TLR5 agonist Entolimod and Entolasta, with manufacturing validation initiated. Tivic provided briefings to White House and FDA leadership regarding military applications of their products and entered an agreement for GMP manufacturing process validation for Entolimod. The company also regained Nasdaq compliance following a 1-for-17 reverse stock split.

Tivic Health (NASDAQ: TIVC) has signed a definitive agreement with Scorpius BioManufacturing for GMP manufacturing validation of Entolimod™, its lead candidate for treating Acute Radiation Syndrome (ARS). The $4.1 million validation program will be conducted at Scorpius' San Antonio facility and includes cell line verification, process verification, GMP scale-up production, and analytical development. This partnership aims to prepare for Tivic's Biological Licensing Application (BLA) submission to the FDA. Entolimod™ stands out as potentially the only therapy capable of both preventing and treating radiation-related damage to hematopoietic and gastrointestinal cells. The domestic manufacturing arrangement through Scorpius promises a streamlined supply chain and ensures U.S.-based production.