Tempest Therapeutics(TPST) - 2025 Q1 - Quarterly Results

First Quarter 2025 Financial Results and Business Update This section provides an overview of Tempest Therapeutics' Q1 2025 financial performance and key business developments Business and Corporate Highlights Tempest Therapeutics advanced key drug candidates with FDA designations and pursued strategic alternatives including a workforce reduction - Amezalpat (TPST-1120) received both Orphan Drug and Fast Track designations from the FDA for the treatment of hepatocellular carcinoma (HCC)[4][7] - New mechanism-of-action data for amezalpat was presented at the 2025 AACR Annual Meeting, supporting its potential as a novel cancer treatment by showing it reduces immunosuppression and activates the immune system[3][4][7] - TPST-1495 was granted Orphan Drug designation by the FDA for treating familial adenomatous polyposis (FAP) and received a "Study May Proceed" letter for its Phase 2 trial, which is expected to begin in 2025[4][7] - The company announced it is exploring a full range of strategic alternatives to advance its clinical programs and maximize stockholder value, completing a related reduction in force on April 30, 2025[3][7] Financial Results Tempest Therapeutics reported an increased net loss in Q1 2025, driven by higher R&D expenses, with a decrease in cash and cash equivalents Key Financial Metrics Key financial metrics for Q1 2025 show decreased cash, an increased net loss, and the full repayment of a $3.5 million loan | Financial Metric | Q1 2025 (Millions USD) | Q1 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Cash and Cash Equivalents | $21.5 | N/A | -$8.8 (vs. Q4 2024) | | Net Loss | $10.9 | $7.9 | +$3.0 | | Net Loss Per Share (USD) | $3.16 | $4.62 | -$1.46 | - The decrease in cash was primarily due to operating activities, partially offset by $1.5 million in proceeds from the at-the-market offering program[7] - In April 2025, the company repaid $3.5 million, fully satisfying its Loan and Security Agreement with Oxford Finance LLC[7] Operating Expenses Operating expenses rose in Q1 2025, primarily due to increased R&D costs for Phase 3 trial preparations, while G&A expenses slightly decreased | Expense Category | Q1 2025 (Millions USD) | Q1 2024 (Millions USD) | Change (Millions USD) | | :--- | :--- | :--- | :--- | | Research and Development | $7.6 | $4.3 | +$3.3 | | General and Administrative | $3.3 | $3.6 | -$0.3 | - The increase in R&D expenses was primarily due to costs from contract research and manufacturing organizations in preparation for the pivotal Phase 3 trial of amezalpat for first-line HCC[10] Consolidated Balance Sheets The balance sheet as of March 31, 2025, shows decreases in total assets, liabilities, and stockholders' equity compared to year-end 2024 | Item | March 31, 2025 (Thousands USD) | December 31, 2024 (Thousands USD) | | :--- | :--- | :--- | | Assets | | | | Cash and cash equivalents | $21,511 | $30,268 | | Total current assets | $22,433 | $31,474 | | Total assets | $32,164 | $41,488 | | Liabilities and Stockholders' Equity | | | | Total current liabilities | $13,177 | $14,220 | | Total liabilities | $21,031 | $22,362 | | Total stockholders' equity | $11,133 | $19,126 | | Total liabilities and stockholders' equity | $32,164 | $41,488 | Consolidated Statements of Operations The consolidated statements of operations show increased operating and net losses for the three months ended March 31, 2025, compared to the prior year | Item | Three months ended March 31, 2025 | Three months ended March 31, 2024 | | :--- | :--- | :--- | | Research and development (Thousands USD) | $7,627 | $4,340 | | General and administrative (Thousands USD) | $3,309 | $3,634 | | Operating loss (Thousands USD) | ($10,936) | ($7,974) | | Net loss (Thousands USD) | ($10,860) | ($7,904) | | Net loss per share (USD) | ($3.16) | ($4.62) | Company Overview and Forward-Looking Statements Tempest Therapeutics is a clinical-stage biotechnology company focused on cancer treatment, with forward-looking statements subject to inherent risks and uncertainties - Tempest Therapeutics is a clinical-stage biotechnology company focused on advancing a diverse portfolio of small molecule product candidates with tumor-targeted and/or immune-mediated mechanisms[8] - The report contains forward-looking statements regarding strategic alternatives and the therapeutic potential of its product candidates, which are based on current management beliefs and are subject to significant risks and uncertainties[9][11]