Company demonstrates commercial-scale production of its Toll-like Receptor 5 (TLR5) agonist for Acute Radiation Syndrome (ARS) and Neutropenia through wholly owned contract development manufacturing organization (CDMO). Velocity Bioworks Company's next step is to initiate production under current Good Manufacturing Practice (cGMP), a critical milestone moving towards filing a Biologics License Application (BLA) with the U.S. Food and Drug Administration (FDA) Milestone achieved in advance of January 26 Tech ...

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]