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]

Core Insights - Tivic Health® Systems, Inc. has acquired the strategic manufacturing and development assets of Scorpius Holdings, Inc. and is launching a new subsidiary, Velocity Bioworks™, to provide contract development and manufacturing services [1] Group 1: Acquisition Details - The acquisition is financed by 3i, LP, which includes $16 million in debt financing for asset purchase and up to $75 million in preferred convertible equity for therapeutics commercialization and corporate growth initiatives [1] - The formation of Velocity Bioworks™ secures a robust US-based manufacturing site for Tivic's lead drug candidate, Entolimod™, as the company prepares for a Biologics License Application (BLA) with the U.S. Food & Drug Administration [1]

Core Viewpoint - Tivic Health Systems, Inc. will report its third quarter financial results for 2025 on November 14, 2025, via a pre-recorded conference call and webcast [1]. Company Overview - Tivic Health is a diversified immunotherapeutics company that utilizes both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [2][3]. - The company's lead drug candidate, Entolimod™, is a novel TLR5 agonist aimed at treating acute radiation syndrome and has received Fast Track and Orphan Drug designations, currently in late-stage development [3]. Product Development - Tivic's biologics compounds are designed to activate an innate immune pathway to prevent cell death in bone marrow and epithelial tissues affected by radiation and aging [3]. - The bioelectronic program is focused on developing a non-invasive medical device targeting neural pathways associated with various prevalent diseases, showing promising early trial results [4]. Upcoming Events - CEO Jennifer Ernst will participate in the 8th Annual Northwell Health Innovation Constellation Forum on October 23, discussing advancements in bioelectronic medicine [8]. - Jennifer Ernst will also present at the Emerging Growth virtual conference on September 25, 2025, detailing the company's strategic transformation [9]. Manufacturing Progress - Tivic has completed the verification of its Entolimod™ cell line, marking the first step towards establishing Current Good Manufacturing Practices (CGMP) in preparation for a Biologics License Application (BLA) [10][11].

Core Insights - Tivic Health Systems, Inc. is participating in the eighth annual Northwell Health Innovation Constellation Forum, focusing on bioelectronic medicine and its potential to transform healthcare delivery [1][4] - CEO Jennifer Ernst will join a panel to discuss collaboration across the healthcare ecosystem to drive the adoption of bioelectronic medicine [2][3] Company Overview - Tivic Health is a diversified immunotherapeutics company utilizing both biopharmaceutical and bioelectronic systems to address unmet medical needs by targeting the immune system [5] - The company's lead drug candidate, Entolimod™, is in late-stage development for acute radiation syndrome and has received Fast Track and Orphan Drug designations [6] Industry Context - Bioelectronic medicine is positioned as a transformative frontier that integrates science, technology, and patient care, with the potential to disrupt traditional disease management [2][4] - The upcoming program at the Constellation Forum will highlight breakthroughs, commercialization strategies, and challenges in scaling bioelectronic medicine into everyday healthcare [4]