Tivic Health Systems (NASDAQ:TIVC) outlined its strategy to advance what it described as late-stage, “highly de-risked” biopharma assets over the next 12 to 24 months, with a primary focus on Entolimod, a Toll-like receptor 5 (TLR5) agonist. Speaking during the event, company executive Michael said the company is focused on immune therapies intended to improve survival, with efforts spanning immuno-oncology, supportive cancer care, and acute radiation syndrome (ARS).
Platform focus: TLR5 agonist Entolimod
Michael described TLR5 as a receptor involved in immune activation pathways, and said the company’s approach is designed to activate multiple biological effects, including “anti-apoptotic pathway, hematopoiesis, innate immune activation,” as well as “activation of some stem cells and endothelial repair.” He characterized Entolimod as a “pleiotropic drug,” meaning it targets one receptor while producing multiple downstream effects.
Key indications discussed: ARS and neutropenia
The company highlighted ARS as its most advanced program. Michael said Entolimod has completed Phase III pivotal studies for ARS and that the company is preparing for a future biologics license application (BLA) submission intended for use in patients exposed to acute ionizing radiation. He added that Tivic is currently working on manufacturing validation for commercial launch, including bioequivalence testing of newly manufactured material to demonstrate comparability to earlier product batches.
Neutropenia was presented as a secondary indication. Michael described it as the loss of neutrophils due to myelosuppression, which can result from radiation or chemotherapy, and said the neutropenia program is expected to be ready for Phase II. He also stated that the company believes Entolimod could address multiple supportive-care complications associated with cancer treatment, including:
- Neutropenia (reduced infection-fighting capacity)
- Cachexia (difficulty absorbing nutrients and calories)
- Thrombocytopenia (loss of platelets and reduced clotting ability)
In discussing treatment-related toxicity, Michael said radiation side effects can be a limiting factor in cancer therapy, potentially leading to hospitalizations, incomplete treatment, and noncompliance. He positioned Entolimod as a potential tool to mitigate side effects of radiation and chemotherapy, citing effects including support for neutrophil growth, bone marrow regeneration, and “GI crypt preservation and regeneration.”
Regulatory and manufacturing timeline
During a Q&A segment, the moderator asked about Entolimod’s stage and regulatory path. Michael replied that Entolimod has “passed its phase III” and that the company is conducting manufacturing validation for a BLA. He said additional bioequivalence testing will be required for newly manufactured material and added that the company’s interactions with the FDA have been “very positive,” leading him to say the company feels good about the prospects for approval.
Michael also provided a timeline expectation, stating that the BLA “should occur sometime late 2027, early 2028,” and that the company anticipates interacting with the FDA over the coming months as it advances manufacturing and regulatory preparations.
National stockpile potential and government discussions
Michael said the company has had multiple meetings with BARDA and described discussions with the U.S. government regarding Entolimod’s potential use as a national stockpiling agent for radiation countermeasures. Asked directly whether Entolimod could become a National Stockpile drug, he said the company believes it could, while noting that additional government testing would be required.
He also referenced an agreement with the National Institute of Allergy and Infectious Diseases (NIAID), saying NIAID would help fund studies intended to demonstrate that Entolimod works as intended in protecting the gastrointestinal tract and bone marrow.
Company overview and resources
Michael said the company has been operating since 2016 and became public in 2021. He added that Tivic has 50 employees and recently acquired a commercial manufacturing organization in San Antonio, which he said can manufacture Entolimod and potentially provide biologics manufacturing services for other companies as an additional revenue opportunity.
Closing the presentation, Michael reiterated the company’s focus on “harnessing the immune system to save lives and improve clinical outcomes,” and said Tivic expects “high value inflection points” over the next 18 to 24 months as it advances its programs.
About Tivic Health Systems (NASDAQ:TIVC)
Tivic Health Systems is a commercial-stage medical technology company that develops and markets non-drug, neuromodulation-based therapies for nasal and sinus health. The company’s solutions are designed to alleviate sinus pain, pressure and congestion through gentle microcurrent and vibration stimulation. By targeting the underlying nerve pathways in the nasal passages, Tivic Health aims to provide an alternative to over-the-counter and prescription medications without introducing systemic side effects.
The flagship product, ClearUP™ Sinus Pain Relief, is an FDA-cleared, hand-held device intended for home use.
