TIVC News & Events

Tivic Health Systems announced it has entered into an agreement with the National Institute of Allergy and Infectious Diseases, NIAID, part of the National Institutes of Health, to sponsor and conduct a series of preclinical studies evaluating Entolimod for gastrointestinal acute radiation syndrome, GI-ARS. The program is expected to support Tivic's development strategy for Entolimod as a medical countermeasure for acute radiation syndrome. Under the agreement, NIAID will fund and conduct GI-ARS studies, the first of which will be performed at the Armed Forces Radiobiology Research Institute

Tivic CEO Michael Handley sent a letter to shareholders, which said in part, "As I assume the role of CEO 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 confidence and support. Some of you recognize me from my time as CEO of Statera Biopharma, where I led the advancement of Entolimod, our Toll-like Receptor 5 agonist. Over the past year, as Tivic's COO and President of Biopharma, I have continued to advance the program strategically and operationally. Tivic is now a biopharmaceutical company solely focused on the Entolimod and our TLR5 platform with our second-generation TLR5 molecule, Entolasta. To maximize our impact and resources, we have made the deliberate decision to discontinue commercial sales of the ClearUP sinus device and suspend development of the non-invasive vagus nerve stimulation platform. While those assets remain the property of the company, we have made the deliberate decision to concentrate our resources on the significant opportunity represented by our biotherapeutic programs. With our pivot into biopharmaceuticals, we are aggressively pursuing the multi-billion-dollar oncology market. Entolimod's mechanism of action shows significant potential in preventing cell death in bone marrow and gastrointestinal epithelial tissues thereby addressing conditions like neutropenia, which affects up to half of all cancer patients, and radiation-induced mucosal necrosis. While we are currently developing the injectable form, we are also exploring oral formulations to significantly broaden our clinical applications.A primary pillar of our corporate strategy is our collaboration with the Biomedical Advanced Research and Development Authority. Following our second meeting with the agency two weeks ago, we are encouraged by our progress. Our objective is to secure BARDA funding to advance Entolimod as a medical countermeasure for Acute Radiation Syndrome. We believe Entolimod's highly differentiated profile makes it a superior candidate for the Strategic National Stockpile compared to existing treatments. In parallel, we are engaging with allied governments interested in independent stockpiling for their own national preparedness programs. Our speed is driven by our vertical integration. Through Velocity Bioworks, our wholly owned Contract Development & Manufacturing Organization or CDMO, we successfully demonstrated a 200-fold manufacturing scale-up of Entolimod using 50-liter fermentation. This milestone was achieved on time and within budget, meeting all purity and potency specifications. Controlling our domestic supply chain is not only an operational advantage but a critical requirement for U.S. government procurement. Tivic is uniquely positioned at the intersection of critical macro trends: the urgent need for national preparedness, the demand for domestic biomanufacturing, and an investor preference for scalable, high value assets. By combining late-stage therapeutics with in-house manufacturing, we are building a profit center designed to serve both our internal pipeline and the broader biotech industry. We will provide a comprehensive update during our year-end call tomorrow, March 25, held in conjunction with our Form 10-K filing. I look forward to speaking with you then."

Tivic Health Systems announced that its Board of Directors has appointed Michael Handley as CEO of Tivic, effective immediately. Mr. Handley succeeds Jennifer Ernst, who has served as CEO since its founding in 2016 and is stepping down from the CEO role as the Company enters its next chapter. Ms. Ernst will continue to support the Company through this strategic transition. Mr. Handley brings over two decades of executive leadership in the biopharmaceutical and medical device industries

Tivic announced that a second, follow-up meeting with the Biomedical Advanced Research and Development Authority has been scheduled for March 10, to continue discussions focused on clinical data and the potential for funding and, ultimately, stockpiling Entolimod for Acute Radiation Syndrome. On January 26, Tivic attended an initial TechWatch meeting with BARDA and presented clinical data for Tivic's Toll-like Receptor 5 agonist, Entolimod, to potentially be used as a radiation countermeasure. The presentation discussed characteristics of Entolimod that are expected to distinguish it mechanistically from currently approved ARS therapies. Tivic also highlighted the company's manufacturing readiness, enabled through Tivic's newly formed biomanufacturing subsidiary Velocity Bioworks. Following this meeting, key government attendees recommended a follow-up meeting as soon as possible. "We see this invitation by the U.S. government to return for further discussions on the differentiated properties of Entolimod as a promising sign," said CEO Jennifer Ernst. "Our goal for this meeting is to explore potential government support for continued development of Entolimod, including activities necessary to pursue FDA approval and potentially incorporating Entolimod into the Strategic National Stockpile."