Tivic Health Systems (TIVC -1.43%), a company specializing in healthtech and biopharmaceutical development, reported its financial results for the quarter ended June 30, 2025, on August 14, 2025. Revenue (GAAP) for Q2 2025 was $86,000, a 38.6% decrease compared to $140,000 in Q2 2024, with a net loss of $1.9 million (GAAP). These results landed without analyst estimates for direct comparison. The quarter underscored shrinking sales for its legacy ClearUP device business, alongside a ramp-up in research and development costs related to new immunotherapeutic and bioelectronic pipeline programs. Management’s overall assessment pointed to a challenging transition quarter, driven by reduced focus on the legacy device line and expanded investment in late-stage drug development.
| Metric | Q2 2025 | Q2 2024 | Y/Y Change |
|---|---|---|---|
| EPS (GAAP) | $(2.19) | $(5.37) | 59.2% |
| Revenue | $86,000 | $140,000 | -38.6% |
| Gross Profit | $54,000 | $30,000 | 80.0% |
| Operating Expenses | $2,000,000 | $1,296,000 | 54.3% |
| Net Loss | $(1,931,000) | $(1,266,000) | -52.6% |
Business Overview and Strategic Direction
Tivic Health Systems delivers technology-based solutions for treating disorders linked to immune system dysfunction. The business originated with ClearUP, a U.S. Food and Drug Administration (FDA)-cleared handheld bioelectronic device designed for over-the-counter relief of sinus pain and congestion. Its recent transformation centers on building a pipeline of biopharmaceutical drugs and non-invasive medical devices targeting more complex health conditions. The company’s newer focus areas include late-stage immunotherapies, such as the toll‑like receptor 5 (TLR5) agonist Entolimod, and advanced neuromodulation devices for regulating immune and nervous system function.
Over the past year, Tivic has shifted its priorities sharply. It is moving away from consumer product marketing and investing resources in medical device research, drug commercialization, and manufacturing readiness. The most crucial factors for success now hinge on the advancement of Entolimod into regulatory and commercial milestones, the protection and expansion of its intellectual property, and maintaining sufficient capital for continued development activities.
Quarter Highlights and Notable Developments
The quarter was marked by a rapid contraction in legacy device revenue and execution of critical steps in the company’s business pivot. Sales of the ClearUP device fell off as the company intentionally reduced advertising and commercial focus, a strategy management said was necessary to free resources for its biopharmaceutical ambitions. Tivic confirmed its plan to exit the ClearUP business by the end of 2025, effectively ending near-term recurring revenue from this product family. This shift aligns with earlier indications that the board and leadership would direct investment away from direct-to-consumer product sales and toward high-potential programs in its new pipeline.
Gross profit (GAAP) increased to $54,000, Gross profit for the three months ended June 30, 2025, was $54,000, up 80% from $30,000 for the same period in 2024, despite a steeper revenue decline, reflecting a notable improvement in gross margin for the six months ended June 30, 2025. Management credited this margin expansion to reduced product support and fulfillment costs. Operating expenses rose to $2.0 million, a 53.8% increase compared to $1.3 million in Q2 2024. The increase in operating expenses was primarily due to the addition of the biopharma programs in February 2025, topping $655,000 for the quarter, with additional increases in sales and marketing, and general and administrative spending.
Tivic made material progress on advancing its new strategic priorities during the quarter. Key highlights include the completion of all study visits for its non-invasive cervical vagus nerve stimulation (ncVNS) device optimization study. The company expects to announce clinical results over the summer, marking a foundational step for this bioelectronic technology. In the biopharma space, Tivic expanded its Entolimod license to cover both acute radiation syndrome (ARS) and neutropenia, and entered a manufacturing agreement to pave the way for a Biologics License Application (BLA) submission to the FDA. Importantly, management stated: We have rapidly begun advancing Entolimod along its commercialization pathway. For clarity, Phase 3 trials are already complete under the FDA's animal pathway rules.
The period also saw further capital formation. Tivic raised $1.4 million across two tranches of preferred equity under an $8.4 million investment facility and established a $25 million equity line of credit. About $7.0 million remains available through these funding agreements, which should support manufacturing validation for Entolimod. Cash and equivalents as of June 30, 2025, stood at $1.2 million, down from $2.0 million (GAAP) at December 31, 2024, with no debt on the balance sheet. After Q2 2025, the company raised an additional $0.9 million. While the new funding is significant for near-term operations, the company acknowledged that ongoing capital needs are likely, given the resource demands of late-stage pharmaceutical and device development.
Organizationally, Tivic’s transformation took shape as it added regulatory, clinical, and business development talent to support its new direction. The appointment of Lisa Wolf as chief financial officer after nine months in an interim capacity marked another step in solidifying executive leadership during a period of rapid change. Shareholders approved several measures at the annual meeting to facilitate the company’s platform transition to immunotherapeutics and strengthen support for strategic realignment.
Looking Ahead: Guidance and Key Watchpoints
Management did not issue numerical financial guidance for future quarters or the full year. Instead, leadership directed attention to anticipated progress on Entolimod manufacturing validation and the significance of completing clinical data readouts for the ncVNS device. The company highlighted qualitative milestones, including completing regulatory steps for Entolimod, possible FDA application submissions, and review of study results from its bioelectronic pipeline in upcoming quarters.
Investors should monitor Tivic’s ability to secure additional capital and reach meaningful project milestones. As the current portfolio of wellness and consumer device products is phased out, future performance will hinge entirely on progress in its drug and advanced device programs. No dividend is paid at this time. TIVC does not currently pay a dividend.
Revenue and net income presented using U.S. generally accepted accounting principles (GAAP) unless otherwise noted.
