Tivic Health Systems Inc Stock Price, News & Analysis

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.

Tivic Health Systems (NASDAQ: TIVC) has filed a new patent application (No. 63,801,058) titled "Vagus Nerve Stimulation System" with the USPTO, expanding its non-invasive VNS intellectual property portfolio. The patent protects methods for enhancing treatment efficacy through personalized stimulation parameters and electrode positioning, building on findings from their VNS optimization study.

According to CSO Blake Gurfein, this technology is expected to deliver superior and more consistent therapeutic effects compared to current solutions. CEO Jennifer Ernst emphasized that protecting their IP is crucial as they advance their VNS program, highlighting Tivic's diverse portfolio of bioelectronic VNS and biologic immunotherapies for treating immune system dysregulation-related conditions.

Tivic Health Systems (NASDAQ: TIVC), a diversified therapeutics company focused on immune and autonomic nervous systems, has scheduled its Q1 2025 financial results announcement for May 15, 2025 at 1:30 PM PT / 4:30 PM ET. The company will host a pre-recorded conference call and webcast, accessible via toll-free number 1-877-407-0779 (International: 1-201-389-0914) with Conference ID 13753498. A webcast link has been provided for online participation.

Tivic Health (NASDAQ: TIVC) has conducted briefings with senior leadership at the White House and FDA regarding potential military and defense applications of its product candidates. The meetings, held on April 17th in Washington D.C., focused on two key programs:

1. The TLR5 program, including lead candidate Entolimod™ and second-generation Entolasta™, which targets acute radiation syndrome treatment. This program has previously received significant funding from various U.S. government agencies including BARDA, NASA, and the Department of Defense.

2. The company's non-invasive cervical vagus nerve stimulation (ncVNS) technology, which shows promise in treating PTSD, inflammatory, cardiac, and neurologic disorders. The FDA discussions explored expedited approval pathways for both programs, with positive feedback received regarding potential breakthrough device designations following clinical work completion.

Tivic Health Systems (Nasdaq: TIVC), a diversified therapeutics company, has successfully regained compliance with Nasdaq's minimum bid price listing requirements under Rule 5550(a)(2). As a result, the company's common stock will maintain its listing and continue trading on the Nasdaq Capital Market under the ticker symbol 'TIVC'.

Tivic Health Systems (TIVC) reported its year-end 2024 financial results, marking a transformative period with strategic expansions in biotech. The company secured exclusive license rights to Entolimod™, a late-stage TLR5 agonist for treating acute radiation syndrome, and progressed in developing non-invasive cervical vagus nerve stimulation (ncVNS) devices.

Key financial metrics for 2024 include:

• Revenue of $0.8M (down from $1.2M in 2023)
• Gross profit decreased to $2,000 (from $287,000 in 2023)
• Operating expenses reduced to $5.7M (from $8.5M in 2023)
• Net loss decreased 30% to $5.7M (from $8.2M in 2023)
• Cash and equivalents at $2.0M (down from $3.4M in 2023)

Notable developments include securing a $25M equity line of credit, executing a 1-for-17 reverse stock split, and expanding their patent portfolio to 27 patents. The company plans to increase R&D investments in vagus nerve platform and advance TLR5 agonist programs.