Tivic Health Systems (NasdaqCM:TIVC) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsLisa Wolf - CFOMichael Handley - CEOOperatorWelcome to Tivic's conference call to discuss fiscal year and fourth quarter 2025 financial results. This call has been pre-recorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, please note that during today's call, management will make various forward-looking statem ...

Tivic Health Systems (NasdaqCM:TIVC) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Company ParticipantsLisa Wolf - CFOMichael Handley - CEOOperatorWelcome to Tivic's conference call to discuss fiscal year and fourth quarter 2025 financial results. This call has been pre-recorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, please note that during today's call, management will make various forward-looking statem ...

Tivic Health Systems (NasdaqCM:TIVC) Q4 2025 Earnings call March 25, 2026 04:30 PM ET Speaker2Welcome to Tivic's conference call to discuss fiscal year and fourth quarter 2025 financial results. This call has been pre-recorded. This call is being webcast, and the replay will be available on the IR section of the company's website for three months. Before we begin, please note that during today's call, management will make various forward-looking statements. Investors are cautioned that these forward-looking ...

Tivic Health Systems Conference Call Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Industry**: Biopharmaceuticals, specifically focusing on immunotherapeutics and contract development and manufacturing organization (CDMO) services Key Points and Arguments Transformation and Strategic Shift - In 2025, Tivic transitioned from a consumer health tech company to a late-stage, vertically integrated immunotherapeutics company, culminating in the acquisition of manufacturing and development assets in December 2025 [3][4] - The new subsidiary, Velocity Bioworks, was established to support both Tivic and third-party customers, marking a significant transformation for the company [3][8] Acquisition Details - Tivic acquired cGMP manufacturing and development assets from Scorpius Holdings for approximately $16 million, significantly lower than the estimated $30 million-$32 million for outsourcing [6][9] - The acquisition allows Tivic to produce tens of millions of doses of Entolimod annually, enhancing its operational capabilities [7][10] Financial Implications - The acquisition is expected to generate substantial cost savings, estimated at around $10 million before filing a biologics application, with potential for greater savings across the product lifecycle [23][24] - Velocity Bioworks is projected to generate up to $70 million in annual revenue at full capacity, serving 15-20 concurrent client programs [15][19] Market Opportunities - The biologic CDMO market is projected to reach approximately $145 billion by 2037, with a compound growth rate of over 15% [13] - The phase one and phase two segment is growing even faster at 17%-19% annually, driven by over 1,200 biotechnology companies advancing biologics through early clinical development [13][14] Product Development and Regulatory Strategy - Tivic is advancing its TLR5 agonist program with Entolimod, aiming for pivotal regulatory milestones and establishing a strong position with government agencies [11][12] - The company is preparing for a meeting with BARDA to discuss Entolimod as a radiation countermeasure, which is critical for securing government funding [28] Future Outlook - The company anticipates significant revenue generation opportunities through both Entolimod and Velocity Bioworks, with a focus on accelerating clinical and product development timelines [29] - The transformation has positioned Tivic Health to create shareholder value through its proprietary TLR5 platform and secured manufacturing capabilities [29][30] Additional Important Information - The aging population and increasing prevalence of chronic diseases are driving pharmaceutical demand growth, with the number of people aged 65 and older expected to double by 2050 [17] - The facility at Velocity Bioworks is designed to meet government security requirements, enhancing Tivic's likelihood of securing customer funding from U.S. government agencies [25][12] This summary encapsulates the critical insights from the conference call, highlighting Tivic Health Systems' strategic transformation, market opportunities, and future growth potential.

Initial presentation on January 26, 2026 s howcased Entolimod's potential to mitigate and prevent both gastrointestinal and hematopoietic injury from ionizing radiation exposure. FREMONT, CA / ACCESS Newswire / February 18, 2026 / Tivic (Nasdaq:TIVC), a late-stage immuno-therapeutics company, today announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority (BARDA) has been scheduled for March 10, 2026, to continue discussions focused on clinical data and the p ...

Core Insights - Tivic Health Systems, Inc. will present at the 3rd Annual DealFlow Discovery Conference, focusing on updates regarding its lead drug candidate, Entolimod, and its commercialization strategy [2][3]. Company Updates - The presentation will cover key milestones such as the successful scale-up of Entolimod manufacturing and progress towards cGMP manufacturing for a Biologics License Application (BLA) submission to the FDA [3]. - The strategic integration of Velocity Bioworks, a contract development and manufacturing organization (CDMO), is expected to enhance commercial readiness [3][12]. - Outcomes from a recent TechWatch meeting with the Biomedical Advanced Research and Development Authority (BARDA) will also be discussed [3]. Product Information - Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist aimed at treating Acute Radiation Syndrome (ARS), showing promising results in animal trials, including improved survival rates and gastrointestinal recovery [10][11]. - The drug is in late-stage development, with additional applications being explored for conditions like Neutropenia and lymphocyte exhaustion [11]. Conference Details - The DealFlow Discovery Conference is a significant event for connecting high-growth companies with the investment community, featuring presentations, networking, and opportunities for capital raising [4][5]. - The conference will take place on January 28-29, 2026, at the Borgata Hotel, Casino & Spa in Atlantic City, NJ [7].

Core Insights - Tivic Health Systems, Inc. is set to provide a corporate update on its immunotherapeutic candidate Entolimod during the Emerging Growth Virtual Conference on January 21-22, 2026, highlighting recent advancements in manufacturing readiness [1][2] Company Developments - The CEO, Jennifer Ernst, will discuss the scale-up validation for Entolimod manufacturing and the vertical integration of Velocity Bioworks, which enhances in-house manufacturing capabilities and introduces new revenue streams [1] - The acquisition of Velocity Bioworks is expected to lower production costs, eliminate outsourcing delays, and accelerate the validation of current Good Manufacturing Practice (cGMP) for Entolimod [1] Product Information - Entolimod is a novel Toll-like Receptor 5 (TLR5) agonist that activates the NF-kappaB pathway, showing promising results in animal trials for Acute Radiation Syndrome (ARS), including improved survival rates and gastrointestinal recovery [5][6] - The drug is in late-stage development and aims to prevent cell death in bone marrow and epithelial tissues affected by radiation and age [6] Conference Details - The Emerging Growth Virtual Conference serves as a platform for public companies to present their innovations and major announcements to a broad audience of investors and analysts [3][4]

Tivic Health Systems Conference Call Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Industry**: Biopharmaceuticals, specifically focusing on immunotherapeutics and contract development and manufacturing organization (CDMO) services Key Points Strategic Transition - In 2025, Tivic transitioned from a consumer health tech company to a late-stage vertically integrated immunotherapeutics company through a licensing agreement and acquisition of manufacturing assets [3][4] - The acquisition of Scorpius Holdings Inc.'s biomanufacturing assets enhances operational capabilities and supports the commercialization of drug candidates [4][6] Acquisition Details - The acquisition cost approximately $16 million, significantly lower than the estimated $30-$32 million for outsourcing cGMP production [6][20] - Tivic can now produce tens of millions of doses of Entolimod annually, enhancing its capacity for various indications [7][8] Velocity BioWorks - A new subsidiary, Velocity BioWorks, was established to manage in-house manufacturing and development, reducing costs and wait times associated with outsourcing [9][11] - Velocity BioWorks aims to serve both Tivic and third-party biotech companies, with potential annual revenue of up to $70 million at full capacity [10][14] Market Opportunity - The biologics CDMO market is projected to reach approximately $145 billion by 2037, with a compound growth rate of over 15% [13] - The phase I and II segment is growing even faster at 17%-19% annually, driven by the demand for monoclonal antibodies and biosimilars [13][14] Financial Implications - The acquisition and financing package includes $60 million in debt, with expectations that revenue from Entolimod and Velocity BioWorks will cover debt obligations [18][23] - The potential revenue from Entolimod is estimated at $1.6-$2 billion, with production capacity for over 20 million doses [23][24] Regulatory and Government Engagement - Upcoming meetings with BARDA are critical for securing government interest and funding for Entolimod as a radiation countermeasure [25] - The ability to control manufacturing and supply chain enhances Tivic's position with government agencies, particularly in light of national security concerns [12][23] Future Outlook - 2026 is focused on execution, with plans to accelerate clinical and product development timelines across Tivic's oncology portfolio [27] - The transformation positions Tivic to create significant shareholder value through its proprietary TLR5 platform and secured manufacturing capabilities [28] Additional Insights - The aging population and increasing prevalence of chronic diseases are driving pharmaceutical demand, presenting further opportunities for Tivic [15] - Velocity BioWorks is designed to address the capacity gap faced by small to mid-sized biotech companies, which often encounter long wait times for manufacturing slots [14][22] This summary encapsulates the strategic direction, operational enhancements, market opportunities, and financial implications for Tivic Health Systems as discussed in the conference call.

Financial Data and Key Metrics Changes - Revenue net of returns for Q3 2025 totaled $146,000, an increase from $126,000 in Q3 2024, while for the nine-month period, it decreased to $302,000 from $600,000 in 2024 [12][13] - Cost of sales increased to $291,000 from $82,000 in the year-ago quarter, primarily due to a $230,000 inventory reserve recorded in Q3 2025 [13] - Gross margins, excluding the inventory reserve, were 42% for Q3 2025 compared to 35% for Q3 2024 [13] - Net loss for Q3 2025 was $2.6 million, compared to $1.4 million for Q3 2024, while the nine-month net loss was $6 million compared to $4.2 million in 2024 [14][15] - Cash and cash equivalents at September 30, 2025, totaled $3.5 million, up from $2 million at December 31, 2024 [15] Business Line Data and Key Metrics Changes - The company is transitioning from the consumer device market to biopharmaceuticals, with a focus on Entolimod and related assets [3][11] - The company recorded reserves for excess and obsolete inventory of $230,000 as part of its exit from the consumer device market [11] - The company has discontinued significant resources toward ClearUP sales, reflecting its strategic shift [12] Market Data and Key Metrics Changes - The company is focusing on building relationships with U.S. and allied governments for Entolimod as a military countermeasure [5][6] - Discussions with BARDA are anticipated to explore stockpiling opportunities for Entolimod [5] Company Strategy and Development Direction - The company has undergone a significant strategic transformation, expanding from bioelectronics to biologic pharmaceuticals with a focus on the immune system [3][4] - The primary commercial opportunity for Entolimod is as a countermeasure for acute radiation syndrome, with plans to advance clinical programs in neutropenia and lymphocyte exhaustion [6][7] - The company is also exploring alternative commercial opportunities for its non-invasive vagus nerve stimulation (VNS) program [10] Management's Comments on Operating Environment and Future Outlook - Management expressed confidence in the progress of the transformation and the potential of Entolimod to deliver clinical benefits across multiple organ systems [7][16] - The company aims to advance value creation activities for shareholders while bringing life-saving treatments to patients [17] Other Important Information - The company has completed the transfer of two INDs for Entolimod, enabling further clinical development [6][16] - A new corporate website has been launched to emphasize the transformed mission and expanded clinical pipeline [12] Q&A Session Summary - No specific Q&A session content was provided in the transcript, thus this section is not applicable.

Tivic Health Systems Conference Summary Company Overview - **Company**: Tivic Health Systems (NasdaqCM:TIVC) - **Focus**: Development of non-invasive medical devices targeting neural pathways and a strong late-stage pipeline in biopharmaceuticals, particularly in immunomodulation and cancer therapeutics [1][2] Key Points Transformation and Pipeline Development - Tivic Health has undergone a significant transformation by acquiring newly licensed assets, leading to a robust late-stage portfolio in biopharmaceuticals [2] - The company maintains a clean capital structure with no debt and anticipates significant value inflection points in the near future [2] Biopharmaceutical Focus - The company is focusing on immunomodulation, utilizing the immune system to combat diseases and improve health outcomes [3] - A biologic licensing agreement was established, including a phase three recombinant protein funded by BARDA for radiation countermeasures, with potential applications in cancer [3][4] Entolimod and Market Opportunities - **Entolimod**: A TLR5 agonist with dual capabilities to treat acute radiation syndrome and cancer-related conditions, showing a 300% increase in survival rates with a single dose [9][23] - The market for GCSF drugs, which Entolimod aims to compete against, is valued at approximately $7.2 billion in 2023, with a broader neutropenia market of around $20 billion [9][31] - Entolimod is positioned as a military countermeasure for nuclear disasters, with a potential market opportunity of $5.2 billion for stockpiling [9][10] Clinical and Regulatory Progress - The company has made significant strides in customer engagement and manufacturing agreements, moving towards a Biologics License Application (BLA) filing [5][10] - The FDA has granted fast track and orphan drug designations for Entolimod, facilitating expedited regulatory processes [11] Future Directions and Strategic Focus - The company plans to focus on Entolimod over the next 6 to 18 months while also exploring other high-potential areas, including cancer therapeutics and vagus nerve stimulation technologies [17][35] - By 2026, Tivic Health aims to have GMP materials ready, FDA meetings completed, and customer interest solidified [34] Additional Insights - The company operates with a capital-light model and has a strong team with extensive experience in drug launches and biopharmaceutical development [16][25] - There is potential for partnerships with larger organizations to scale production and market reach effectively [29] - The vagus nerve technology remains a promising area for future development, with established research backing its efficacy [13][12] Conclusion Tivic Health Systems is positioned for growth with its innovative biopharmaceutical pipeline, particularly through Entolimod, which addresses significant market needs in radiation countermeasures and cancer therapeutics. The company's strategic focus on regulatory pathways and partnerships will be crucial for its success in the coming years.