Tivic Health Systems(TIVC) - 2025 Q1 - Quarterly Results

CEO's Statement on Business Transformation The CEO highlighted a significant strategic shift towards immunotherapeutics, driven by the exclusive licensing of the Phase III drug Entolimod and its derivative, Entolasta. The company has received positive interest from the White House and FDA for defense applications, is advancing its non-invasive vagus nerve stimulation (VNS) program with new IP, and has secured financing to support these key initiatives - The company initiated a significant strategic shift to expand its clinical pipeline for restoring immune system health[3] - Executed a worldwide exclusive licensing agreement for the Phase III TLR5 agonist, Entolimod, and its derivative, Entolasta. Phase III validation for Entolimod for acute radiation syndrome (ARS) is complete, and manufacturing validation has been initiated[4] - Briefed senior leadership at the White House and FDA, receiving positive interest for potential military and defense applications of Entolimod for ARS and the non-invasive vagus nerve stimulation (VNS) program[5] - Created new intellectual property through patent filings covering breakthroughs in personalizing and optimizing the clinical effects of vagus nerve stimulation[6] - Entered into financing agreements expected to fund the company through Entolimod's manufacturing validation and upcoming VNS data readouts[7] Business and Operational Updates During and after Q1 2025, Tivic engaged with senior U.S. government leadership, secured significant financing through an equity line and purchase agreement, licensed a second indication for Entolimod, advanced its ncVNS technology, regained Nasdaq compliance through a reverse stock split, and initiated GMP manufacturing validation for Entolimod - Secured a $25 million equity line of credit and a separate purchase agreement for up to $8.4 million of company securities[11] - Licensed the Phase II drug candidate Entolimod for a second indication, the treatment of neutropenia, with Phase II trials expected to start later in the year[11] - Regained compliance with the Nasdaq Minimum Bid Price Listing rule following a 1-for-17 reverse stock split effective March 7[11] - Post-quarter, entered an agreement for GMP manufacturing process validation for Entolimod in preparation for a Biologics License Application (BLA) filing with the FDA[11] Q1 2025 Financial Performance In Q1 2025, revenue significantly decreased to $70,000 from $334,000 year-over-year, a result of a 92% reduction in advertising for the ClearUP™ device as the company pivoted resources to R&D. Despite the revenue drop, the net loss remained flat at $1.5 million, and gross margin improved to 72%. The company's cash position was $669,000 at quarter-end Q1 2025 vs. Q1 2024 Financial Comparison | Metric | Q1 2025 | Q1 2024 | Change | | :--- | :--- | :--- | :--- | | Revenue | $70,000 | $334,000 | -79.0% | | Gross Profit | $50,000 | $167,000 | -70.1% | | Gross Margin | 72% | 50% | +22 p.p. | | Operating Expenses | $1.6 million | $1.6 million | Flat | | Net Loss | $1.5 million | $1.5 million | Flat | - The decrease in revenue was attributed to lower unit sales of the ClearUP™ device, resulting from a 92% decrease in advertising expenses as the company reallocated resources to R&D programs[11] Cash Position | Date | Cash and Cash Equivalents | | :--- | :--- | | March 31, 2025 | $669,000 | | December 31, 2024 | $2.0 million | | Subsequent to Q1 | Raised net proceeds of $1.7 million under ATM | - The company has no debt on its balance sheet as of March 31, 2025[11] Financial Statements The financial statements for Q1 2025 show total assets increased to $3.8 million, while cash decreased to $0.7 million, and the net loss remained flat at $1.5 million despite a significant revenue decline Condensed Balance Sheets As of March 31, 2025, Tivic's total assets were $3.8 million, up from $2.8 million at year-end 2024, primarily due to an increase in noncurrent assets. Cash and cash equivalents decreased to $0.7 million from $2.0 million. The company reported no long-term debt, and total stockholders' equity increased to $3.0 million Condensed Balance Sheet (in thousands) | Account | March 31, 2025 (Unaudited) | December 31, 2024 (Audited) | | :--- | :--- | :--- | | ASSETS | | | | Cash and cash equivalents | $669 | $2,002 | | TOTAL CURRENT ASSETS | $1,261 | $2,639 | | TOTAL ASSETS | $3,777 | $2,807 | | LIABILITIES & EQUITY | | | | TOTAL CURRENT LIABILITIES | $741 | $272 | | TOTAL LONG-TERM LIABILITIES | $— | $— | | TOTAL STOCKHOLDERS' EQUITY | $3,036 | $2,535 | | TOTAL LIABILITIES AND STOCKHOLDERS' EQUITY | $3,777 | $2,807 | Condensed Statements of Operations For the three months ended March 31, 2025, Tivic reported revenues of $70,000, a sharp decline from $334,000 in the prior-year period. The net loss was stable at $1.5 million, or ($2.52) per share, compared to a net loss of $1.5 million, or ($17.15) per share, in Q1 2024. The significant change in EPS reflects a different number of weighted-average shares outstanding following a reverse stock split Condensed Statement of Operations (in thousands, except per share data) | Account | Three Months Ended March 31, 2025 | Three Months Ended March 31, 2024 | | :--- | :--- | :--- | | REVENUES | $70 | $334 | | GROSS PROFIT | $50 | $167 | | TOTAL OPERATING EXPENSES | $1,556 | $1,648 | | NET OPERATING LOSS | $(1,506) | $(1,481) | | NET LOSS | $(1,502) | $(1,481) | | NET LOSS PER SHARE - BASIC AND DILUTED | $(2.52) | $(17.15) | | WEIGHTED-AVERAGE NUMBER OF SHARES | 596,368 | 86,338 |