Management Commentary & Strategic Transformation Tivic is strategically transforming, shifting resources from ClearUP to its biopharmaceutical pipeline to enhance shareholder value - Tivic is strategically transforming by expanding into biopharmaceuticals to treat diseases by addressing both biochemical and bioelectronic systems2 - The company is shifting resources away from its consumer healthtech device, ClearUP, and plans to exit that business by the end of 2025 to maximize focus on its clinical pipeline3 Corporate Highlights Tivic advanced Entolimod™ and ncVNS development, securing $1.4 million preferred equity and a $25 million credit line - Secured positive interest from the White House and FDA for potential military and defense applications of its drug candidate Entolimod™ to treat Acute Radiation Syndrome (ARS)3 - Extended the worldwide license of Entolimod™ to include the treatment of neutropenia, a condition that reduces the body's ability to fight infections3 - Completed all study visits in the Optimization Study for its patent-pending non-invasive cervical vagus nerve stimulation (ncVNS) device3 - Raised $1.4 million from a preferred equity purchase agreement that provides for up to $8.4 million in total financing and entered into a separate $25 million equity line of credit3 Financial Performance Summary Q2 2025 results show decreased revenue, improved gross margin, increased operating expenses, and net loss due to biopharma investments Q2 & H1 2025 Financial Highlights (in thousands) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | YTD 2025 (in thousands) | YTD 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Revenue | $86 | $140 | $156 | $474 | | Gross Profit | $54 | $30 | $104 | $197 | | Operating Expenses | $2,000 | $1,300 | $3,500 | $3,000 | | Net Loss | ($1,900) | ($1,300) | ($3,400) | ($2,700) | - The decrease in revenue is attributed to lower unit sales of ClearUP™, resulting from reduced advertising expenses as the company focuses resources on its TLR5 program8 - Gross margin for the first six months of 2025 improved to 67% compared to 42% in the same period of 20248 - As of June 30, 2025, the company held $1.2 million in cash and cash equivalents with no debt on its balance sheet. An additional $7.0 million remains available through a committed preferred equity purchase agreement8 Financial Statements This section presents Tivic's condensed balance sheets and statements of operations, outlining financial position and performance Condensed Balance Sheets Tivic's balance sheet as of June 30, 2025, shows total assets of $4.5 million, increased liabilities, and higher stockholders' equity Condensed Balance Sheet (in thousands) | Account | June 30, 2025 (Unaudited, in thousands) | December 31, 2024 (Audited, in thousands) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $1,184 | $2,002 | | Total Current Assets | $1,842 | $2,639 | | Total Assets | $4,508 | $2,807 | | Liabilities & Equity | | | | Total Current Liabilities | $821 | $272 | | Total Liabilities | $821 | $272 | | Total Stockholders' Equity | $3,687 | $2,535 | | Total Liabilities and Stockholders' Equity | $4,508 | $2,807 | Condensed Statements of Operations Q2 2025 saw a net loss of $1.9 million on $86,000 revenue, driven by increased R&D expenses for biopharma programs Condensed Statement of Operations (in thousands, except per share data) | Metric | Q2 2025 (in thousands) | Q2 2024 (in thousands) | H1 2025 (in thousands) | H1 2024 (in thousands) | | :--- | :--- | :--- | :--- | :--- | | Revenues | $86 | $140 | $156 | $474 | | Gross Profit | $54 | $30 | $104 | $197 | | Research and development | $655 | $302 | $990 | $558 | | Total Operating Expenses | $1,988 | $1,296 | $3,544 | $2,944 | | Net Loss | $(1,931) | $(1,266) | $(3,433) | $(2,747) | | Net Loss Per Share | $(2.19) | $(5.37) | $(4.64) | $(17.05) | - The increase in net operating loss was driven by higher operating expenses, particularly in Research and Development, which more than doubled year-over-year for the second quarter14 Business Overview Tivic is an immunotherapeutics company using dual biopharmaceutical and bioelectronic platforms to address unmet medical needs - Tivic's business model is a dual platform using the body's biopharmaceutical and bioelectronic systems to target the immune system7 - The lead drug candidate, Entolimod™, is a novel TLR5 agonist in late-stage development for acute radiation syndrome and has been granted Fast Track designation by the FDA9 - The bioelectronic program is developing a non-invasive vagus nerve stimulation device with the potential to deliver clinical outcomes comparable to surgically implanted devices10
Tivic Health Systems(TIVC) - 2025 Q2 - Quarterly Results