Tivic Health Systems (NASDAQ:TIVC – Get Free Report) released its quarterly earnings data on Wednesday. The company reported ($1.03) EPS for the quarter, topping analysts’ consensus estimates of ($408.00) by $406.97, reports. Tivic Health Systems had a negative net margin of 1,557.26% and a negative return on equity of 202.20%.
Here are the key takeaways from Tivic Health Systems’ conference call:
- Entolimod has completed a pivotal Phase III for Acute Radiation Syndrome and the company is preparing a BLA with a GMP production run and bioequivalence testing targeting late 2027/early 2028.
- Management reports productive engagements with BARDA and NIAID, with NIAID agreeing to fund studies, supporting the drug’s candidacy for inclusion in the Strategic National Stockpile.
- The TLR5 platform shows broader opportunity — a Mayo Clinic Phase II indicated reversal of immunosenescence — and the pipeline includes a neutropenia program ready for Phase II plus immuno‑oncology and supportive‑care indications (cachexia, thrombocytopenia).
- The company acquired a commercial manufacturing facility in San Antonio that can produce Entolimod and offer contract biologics manufacturing, which could support commercialization and provide an additional revenue stream.
- Significant hurdles remain: new drug material must pass bioequivalence and other studies, regulatory interactions are ongoing, and approval or stockpile designation is not guaranteed — timelines and outcomes are uncertain.
Tivic Health Systems Stock Down 1.0%
TIVC stock opened at $1.00 on Friday. The business’s 50-day moving average price is $0.93 and its 200-day moving average price is $1.76. The stock has a market cap of $1.77 million, a P/E ratio of -0.15 and a beta of 1.84. Tivic Health Systems has a twelve month low of $0.72 and a twelve month high of $13.23.
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Tivic Health Systems Company Profile
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.
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