Tivic Health CEO Letter to Shareholders ELEMENT-- Back to the Newsroom Tivic Health CEO Letter to Shareholders SAN ANTONIO, TX / ACCESS Newswire/ March 24, 2026 / Tivic Health Systems (Nasdaq:TIVC) Dear Valued Shareholders, As I assume the role of Chief Executive Officer at Tivic, my immediate priority is to establish a transparent dialogue with you regarding our current standing, our strategic pivot, and the long-term vision we are executing. First, I want to thank the Board of Directors for their confiden ...

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.

Core Viewpoint - Tivic Health Systems, Inc. has appointed Michael K. Handley as the new Chief Executive Officer, effective immediately, indicating a strategic leadership change within the company [1] Company Summary - Tivic Health Systems, Inc. is identified as a late-stage immunotherapeutics company, suggesting its focus on advanced therapeutic solutions in the healthcare sector [1]

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].

Summary of Tivic Health Conference Call Company Overview - **Company**: Tivic Health - **Ticker Symbol**: TIVC (Nasdaq) - **Focus**: Transitioning into a biopharmaceutical company with late-stage assets, particularly in radiation treatment and oncology [1][2] Core Points and Arguments - **Transformation**: Tivic Health has completed a major overhaul, focusing on harnessing the immune system to improve clinical outcomes, particularly in radiation treatment [2] - **Intolamod**: - Licensed drug with significant prior investment ($140 million) and government support ($36 million) aimed at treating acute radiation syndrome [3] - Potential applications in oncology, with a well-characterized mechanism of action supported by over 40 studies [4] - **Market Opportunity**: - Current standard of care in the acute radiation syndrome market is valued at $9.4 billion, primarily addressing blood disorders from radiation exposure [5] - Intolamod could replace existing G-CSF drugs and provide protective benefits while supporting regeneration of fast-growing cells [6] - **Commercialization Milestones**: - Successful scaling of manufacturing from small batch to 200x, maintaining or exceeding purity and potency levels [8] - Plans to file a Biologics License Application (BLA) with the FDA, with Fast Track and Orphan Drug Designation already secured [8] - **Government Interest**: Significant interest from the U.S. government as a medical countermeasure for nuclear disasters, alongside oncology applications [9] - **Strategic Moves**: - Acquisition of manufacturing assets to bring production in-house, ensuring cGMP manufacturing access and reducing time to market [10] - Establishment of a contract development and manufacturing organization (CDMO) for phase one and two biologics, creating an additional revenue stream [11] - **Financial Position**: Recently closed a financing package allowing access to up to $75 million, targeting multiple high-value therapeutic inflection points within the next 18 to 24 months [12] Additional Important Content - **Regulatory Pathway**: The company is drafting its BLA and anticipates starting investigator-led trials in oncology applications this year [9] - **Partnership Opportunities**: Intolamod's unique position in both acute radiation syndrome and oncology creates real partnering opportunities as the company progresses [10] - **Location Advantage**: The San Antonio facility is strategically positioned to serve U.S. government requirements, with proximity to military bases and airports for emergency product transport [11]

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]

Core Viewpoint - Tivic Health Systems held a special conference call on January 7th to discuss company updates and future expectations [1]. Group 1: Company Overview - The call featured Tivic's Chief Executive Officer, Jennifer Ernst, who provided insights into the company's current status and future plans [3]. Group 2: Forward-Looking Statements - Management made various forward-looking statements during the call, emphasizing that these statements are based on current expectations and are subject to risks and uncertainties [2]. - Investors were reminded to review the safe harbor statement in the press release and the risk factors in Tivic Health's SEC filings, including the annual report for the year ending December 31, 2024 [2].

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.

Core Insights - The company has successfully demonstrated commercial-scale production of its TLR5 agonist for Acute Radiation Syndrome (ARS) and Neutropenia through its wholly owned contract development manufacturing organization (CDMO) [1] - The next step for the company is to initiate production under current Good Manufacturing Practice (cGMP), which is a critical milestone towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) [1] - This milestone was achieved ahead of the January 26 TechWatch meeting with the Biomedical Advance Research and Development Authority (BARDA) to discuss federal strategic reliance on Entolimod for ARS [1] Company Developments - Tivic Health® Systems, Inc. has announced a 200x scale-up in manufacturing volume for its lead drug candidate Entolimod [1] - Entolimod is a TLR5 agonist being developed to treat ARS, Neutropenia, and other cancer-related conditions [1]