Tivic Health Systems Stock Price, News & Analysis
Company Description
Tivic Health Systems, Inc. (Nasdaq: TIVC) is described in its public disclosures as a diversified immunotherapeutics and health technology company. According to recent company statements, Tivic focuses on harnessing the body’s biopharmaceutical and bioelectronic systems to target the immune system and address unmet medical needs. The company is classified under surgical and medical instrument manufacturing in the manufacturing sector, and its business has evolved from consumer health technology into late-stage therapeutics and bioelectronic medicine.
Tivic’s mission, as stated in multiple press releases, is to harness the immune system to improve clinical outcomes and save lives. Its biologics compounds are designed to activate an innate immune pathway that helps prevent cell death in bone marrow and epithelial tissues across systems impacted by radiation and age. This focus underpins a pipeline centered on immune modulation in settings such as radiation injury, neutropenia, and other cancer-related conditions.
Biologics Platform and Entolimod™
The company identifies Entolimod™ as its lead drug candidate. Entolimod is described as a novel Toll-like Receptor 5 (TLR5) agonist that triggers NF‑kappaB signaling, activating anti‑apoptotic and cell‑protective mechanisms. Tivic’s disclosures state that Entolimod for acute radiation syndrome (ARS) has been the subject of extensive trials under the U.S. Food and Drug Administration’s Animal Rule. In animal models, Entolimod has demonstrated robust survival, enhanced gastrointestinal tract recovery, and improved hematopoiesis when administered after exposure to ionizing radiation.
Company communications note that Entolimod for ARS has received Fast Track and Orphan Drug designations from the FDA and is characterized as being in late-stage development. Tivic also reports holding rights to Entolimod for the treatment of neutropenia and lymphocyte exhaustion, and references options or rights to additional indications, including advanced cancers and other radiation- and age-related conditions. In various filings and press releases, Tivic emphasizes the potential role of Entolimod as a military or government stockpile countermeasure for radiation exposure and as part of host-directed medical countermeasures.
Expansion into Biologics and Licensing Agreements
In its SEC filings, Tivic describes an exclusive license agreement, later amended and restated, with Statera Biopharma, Inc. Under this agreement, Tivic obtained an exclusive worldwide license to Statera’s TLR5 agonist program known as Entolimod for the ARS indication, along with an exclusive option to license additional indications such as lymphocyte exhaustion, immunosenescence, neutropenia, and vaccine adjuvant uses, as well as the related TLR5 agonist program known as Entolasta. An amended and restated license agreement adjusted certain payment and royalty terms but maintained Tivic’s focus on this TLR5 agonist portfolio.
Company updates further note that investigational new drug applications (INDs) for Entolimod covering ARS sub‑syndromes and advanced cancers have been transferred to Tivic, enabling the company to initiate clinical trials in neutropenia, lymphocyte exhaustion, and certain cancer-related conditions. Tivic describes this portfolio as providing a late-stage, de‑risked biologic asset with a Phase III indication and multiple additional opportunities.
Manufacturing Strategy and Velocity Bioworks™
Tivic’s recent disclosures highlight a strategic emphasis on manufacturing readiness for Entolimod. The company reports completing verification of its Entolimod cell line, a key step in establishing current Good Manufacturing Practice (cGMP) processes ahead of a planned Biologics License Application (BLA). Cell line verification work, initially conducted with Scorpius Biomanufacturing, confirmed that newly produced Entolimod proteins met structural and yield requirements suitable for larger-batch production.
Subsequently, Tivic announced the acquisition of strategic manufacturing and development assets from Scorpius Holdings, Inc. Through a newly formed wholly owned subsidiary, Velocity Bioworks™, Tivic acquired facilities, equipment, inventory, contract rights, IT systems, intellectual property and other assets related to Scorpius’ contract development and manufacturing organization (CDMO) business. According to the company’s Form 8‑K and related press releases, Velocity Bioworks is intended to serve both as Tivic’s in‑house manufacturing resource for Entolimod and as a CDMO serving third-party biotechnology clients.
Tivic characterizes Velocity Bioworks as a full‑service CDMO based in San Antonio, Texas, with a purpose-built facility focused on rapidly advancing biologic programs to the clinic. The subsidiary is described as offering analytical testing, process development and manufacturing services, with an emphasis on speed, value and high‑quality production of cellular and biologic therapies. Tivic states that bringing these capabilities in‑house is expected to lower development costs, remove outsourcing delays, and create additional revenue opportunities through third‑party manufacturing contracts.
Government and Strategic Engagements
Company news releases describe Tivic’s engagement with U.S. government agencies, particularly the Biomedical Advanced Research and Development Authority (BARDA) and the Department of Defense. Tivic has reported securing a TechWatch meeting with BARDA’s Radiological and Nuclear Medical Countermeasures Program staff to present clinical data on Entolimod, discuss manufacturing readiness, and outline preparations for a BLA. The TechWatch format is described as a mechanism for exchanging technical information, establishing program priorities, and exploring development pathways for potential deployment of Entolimod in mass‑casualty, stockpile, and field deployment scenarios.
Tivic has also referenced participation in the Military Health System Research Symposium, where it discussed Entolimod as a potential military medical countermeasure and stockpile drug. The company frames these interactions as part of a strategy to develop high‑value therapeutic assets with potential government partnership or acquisition pathways in areas with defined federal demand for medical countermeasures.
Bioelectronic Medicine and Vagus Nerve Stimulation
In addition to its biologics platform, Tivic describes a bioelectronic medicine program. The company reports developing a novel, non‑invasive medical device intended to target neural pathways implicated in prevalent and debilitating diseases. Early trials of Tivic’s non‑invasive cervical vagus nerve stimulation (ncVNS) device have, according to company statements, shown promising signals that its approach may regulate specific biologic responses.
A clinical optimization study conducted with The Feinstein Institutes for Medical Research at Northwell Health is cited by Tivic as demonstrating that personalizing stimulation parameters—such as frequency, amplitude, electrode positioning and duration—can significantly enhance autonomic effects, as measured by heart rate variability. The company notes that these findings support the importance of individualized stimulation settings and suggest potential clinical utility of its ncVNS approach in several large patient populations, while emphasizing that further development and funding decisions will shape how these opportunities are pursued.
Tivic describes its bioelectronic program as early-stage but aligned with its broader mission to modulate the immune system and nervous system through non‑invasive technologies. The company has also historically commercialized ClearUP Sinus Relief, a patented handheld device using ultra‑low current electrical waves to relieve sinus pain and congestion. More recent disclosures, however, indicate that Tivic has wound down its consumer health tech business, discontinued allocation of significant resources toward ClearUP sales, and written down related inventory as it shifts focus to its clinical pipeline in biologics and bioelectronic therapeutics.
Corporate Evolution and Capital Markets
Tivic’s SEC filings and press releases describe an ongoing strategic transformation from a consumer health technology business into a diversified immunotherapeutics and biopharmaceutical company. This evolution has included licensing the TLR5 agonist portfolio, transferring INDs, advancing manufacturing readiness for Entolimod, and acquiring CDMO assets to form Velocity Bioworks. The company has also reported financing arrangements, including preferred equity, convertible notes and equity purchase agreements, designed to support therapeutics commercialization and corporate growth initiatives.
The company’s common stock is registered on The Nasdaq Stock Market LLC under the symbol TIVC. Tivic identifies itself as an emerging growth company and smaller reporting company in its registration statements, which affects certain reporting and disclosure requirements. The company has also adopted and amended equity incentive plans, entered into executive employment agreements, and made governance disclosures through periodic and current reports filed with the U.S. Securities and Exchange Commission.
Business Model and Segment Focus
Based on the company’s public communications, Tivic’s business model integrates two main platforms:
- Biologics and immunotherapeutics: centered on Entolimod and related TLR5 agonist programs, with development aimed at ARS, neutropenia, lymphocyte exhaustion, advanced cancers and other radiation- and age-related conditions.
- Bioelectronic medicine: focused on non‑invasive vagus nerve stimulation and related device-based approaches to modulate neural and immune pathways.
The addition of Velocity Bioworks introduces a CDMO component, through which Tivic intends to manufacture its own biologics and, as stated in company releases, provide development and manufacturing services to other biotechnology companies. Together, these elements reflect Tivic’s stated dual‑platform strategy of using both biopharmaceutical and bioelectronic modalities to target the immune system.
Risk and Regulatory Considerations
Tivic’s filings and press releases emphasize that its therapeutic candidates remain subject to regulatory review, including requirements under the FDA’s Animal Rule for ARS indications and standard pathways for other indications. The company notes that Entolimod is in late-stage development but still requires successful completion of manufacturing validation, cGMP production, regulatory submissions such as a BLA, and potential government or commercial procurement decisions. As with other development-stage biopharmaceutical and medical device companies, Tivic’s progress depends on clinical results, regulatory outcomes, manufacturing execution, and access to capital.