Tempest Therapeutics(TPST) - 2025 Q2 - Quarterly Results

Business Highlights Tempest Therapeutics achieved significant clinical and regulatory milestones for its oncology pipeline, including pivotal trial clearances and orphan drug designations, while pursuing strategic alternatives and strengthening its cash position - Received clearance to proceed with a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China, expanding on previous clearances from the FDA (U.S.) and EMA (Europe)[3][5][6] - Amezalpat was granted orphan drug designation by the European Medicines Agency (EMA) for treating HCC[5][7] - TPST-1495 received Orphan Drug designation from the FDA for the treatment of familial adenomatous polyposis (FAP)[5][7] - The company is actively engaged in a strategic alternatives process and has implemented cost-cutting measures to maximize stockholder value[3][7] - Strengthened its cash position with a $4.6 million registered direct offering of common stock in June 2025[7] Financial Results Tempest Therapeutics reported an improved net loss in Q2 2025, ending with $14.3 million cash, driven by reduced R&D expenses and strategic reprioritization Second Quarter 2025 Q2 2025 financial performance is detailed, focusing on cash position, net loss, and shifts in R&D and G&A expenses - Ended Q2 2025 with $14.3 million in cash and cash equivalents, a decrease from $30.3 million at the end of 2024. The decrease was primarily due to cash used in operations, partially offset by proceeds from stock offerings[7] Q2 2025 vs Q2 2024 Financial Performance | Metric | Q2 2025 (USD) | Q2 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Loss | $7.9 million | $9.6 million | Decreased | | Net Loss Per Share | $2.07 | $5.52 | Decreased | | R&D Expenses | $3.9 million | $5.8 million | Decreased | | G&A Expenses | $4.1 million | $3.7 million | Increased | - The $1.9 million decrease in R&D expenses was primarily due to a reduction in costs as the company re-prioritized efforts towards exploring strategic alternatives[7] - The $0.4 million increase in G&A expenses was mainly related to one-time separation costs for terminated employees[7] Year-to-Date (Six Months Ended June 30, 2025) Year-to-date financial performance is presented, detailing cash usage, net loss, and changes in R&D and G&A expenses - Cash used in operating activities for the first six months of 2025 was $16.5 million[11] YTD 2025 vs YTD 2024 Financial Performance | Metric | YTD 2025 (USD) | YTD 2024 (USD) | Change | | :--- | :--- | :--- | :--- | | Net Loss | $18.7 million | $17.5 million | Increased | | Net Loss Per Share | $5.17 | $10.15 | Decreased | | R&D Expenses | $11.5 million | $10.2 million | Increased | | G&A Expenses | $7.4 million | $7.4 million | Unchanged | - The $1.3 million increase in YTD R&D expenses was primarily due to costs from contract research and manufacturing organizations in preparation for the pivotal Phase 3 trial of amezalpat[11] Financial Statements Consolidated financial statements detail the balance sheet, showing $24.5 million in total assets, and the statement of operations Consolidated Balance Sheets Consolidated balance sheets summarize key asset, liability, and equity figures for June 30, 2025, and December 31, 2024 Balance Sheet Summary (in thousands) | Account | June 30, 2025 | Dec 31, 2024 | | :--- | :--- | :--- | | Cash and cash equivalents | $14,280 | $30,268 | | Total current assets | $15,103 | $31,474 | | Total assets | $24,484 | $41,488 | | Total current liabilities | $7,141 | $14,220 | | Total liabilities | $14,701 | $22,362 | | Total stockholders' equity | $9,783 | $19,126 | - Total assets decreased by 41% from December 31, 2024, to June 30, 2025, primarily driven by a 53% reduction in cash and cash equivalents[14] Consolidated Statements of Operations Consolidated statements of operations detail R&D, G&A expenses, operating loss, and net loss for Q2 and YTD 2025 and 2024 Statement of Operations Summary (in thousands) | Account | Three Months Ended June 30, 2025 | Three Months Ended June 30, 2024 | Six Months Ended June 30, 2025 | Six Months Ended June 30, 2024 | | :--- | :--- | :--- | :--- | :--- | | Research and development | $3,871 | $5,837 | $11,498 | $10,177 | | General and administrative | $4,095 | $3,745 | $7,404 | $7,379 | | Operating loss | ($7,966) | ($9,582) | ($18,902) | ($17,556) | | Net loss | ($7,870) | ($9,570) | ($18,730) | ($17,474) | | Net loss per share | ($2.07) | ($5.52) | ($5.17) | ($10.15) | About Tempest Therapeutics Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule cancer treatments via tumor-targeted and immune-mediated mechanisms - Tempest is a clinical-stage biotechnology company developing small molecule product candidates for cancer treatment[9] - The company's portfolio utilizes tumor-targeted and/or immune-mediated mechanisms[9] - Programs range from early research to a later-stage randomized global study in first-line cancer patients[9] Forward-Looking Statements This section provides a legal disclaimer for forward-looking statements, outlining risks for future plans and product development - The press release includes forward-looking statements concerning the company's evaluation of strategic alternatives and the anticipated therapeutic benefit and regulatory development of its product candidates[10][12] - Identified risks include capital market volatility, the company's ability to operate as a going concern, the availability and success of strategic transactions, and unexpected safety or efficacy data from clinical trials[12]