Tivic Health Systems, Inc. ((TIVC)) has held its Q2 earnings call. Read on for the main highlights of the call.
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Tivic Health Systems, Inc. recently held its second quarter 2025 earnings call, revealing a mixed sentiment among stakeholders. While the company showcased significant advancements in its biopharmaceutical endeavors, particularly with the promising drug candidate Entolimod and improved gross margins, it also faced hurdles such as declining revenue, increased operating expenses, and underperformance in ClearUP sales.
Expansion into Biopharmaceutical Sector
Tivic Health has made a strategic expansion into the biopharmaceutical sector by exclusively licensing Statera Biopharma’s TLR5 agonist assets. This includes the late-stage Phase III drug candidate, Entolimod, marking a significant shift in the company’s focus.
Entolimod’s Potential in ARS and Oncology
Entolimod has received Fast Track designation for Acute Radiation Syndrome (ARS) and orphan drug designation for pediatric ARS. It also shows potential in treating side effects of radiation and chemotherapy, targeting a market valued between $19 billion and $24 billion.
Gross Margin Improvement
Tivic Health reported a substantial increase in gross margins, rising to 63% in the second quarter from 21% a year ago, and to 67% for the first half of 2025 from 42% in the same period in 2024. This improvement is attributed to reductions in product support and fulfillment costs.
Strategic Pipeline Realignment
The company is strategically realigning its pipeline by exiting the Consumer Health Tech business to concentrate on its prescription-based therapeutic pipeline, which includes biologic and bioelectronic therapies.
Financial Stability and Fundraising
Tivic Health raised $0.9 million through equity and preferred stock sales, maintaining a debt-free balance sheet. This financial stability supports the company’s progress towards GMP manufacturing validation for Entolimod.
Decline in Revenue
Revenue for the quarter fell to $86,000 compared to $140,000 in the prior year, and $156,000 for the first half of 2025 compared to $474,000 for the first half of 2024. This decline is primarily due to decreased unit sales of ClearUP.
Increased Operating Expenses and Net Loss
Operating expenses increased to $2 million in Q2 2025 from $1.3 million in Q2 2024, leading to a net loss of $1.9 million compared to $1.3 million in the previous year. This rise in expenses is largely due to increased R&D investments.
ClearUP Sales Underperformance
Sales of ClearUP did not meet expectations, prompting Tivic Health to exit the Consumer Health Tech business and focus on more promising biopharmaceutical ventures.
Forward-Looking Guidance
Looking ahead, Tivic Health is strategically refocusing on the biopharmaceutical market, moving away from consumer devices. The company highlighted the potential of Entolimod in treating ARS, with opportunities for lucrative government contracts. Despite a decline in net revenue, gross margins improved due to cost reductions. The company plans to utilize its cash reserves and recent fundraising to advance GMP manufacturing validation for Entolimod, a crucial step towards commercialization.
In conclusion, Tivic Health Systems’ earnings call reflected a mixed sentiment, with promising developments in the biopharmaceutical sector counterbalanced by financial challenges. The company’s strategic pivot towards prescription-based therapies and improved gross margins are positive signs, but declining revenue and increased expenses remain areas of concern.