Tempest Therapeutics(US:TPST)2025-11-05 14:12Financial Position - As of September 30, 2025, the company had cash and cash equivalents totaling $7.5 million, down from $30.3 million as of December 31, 2024[96]. - The accumulated deficit as of September 30, 2025, is $229.3 million, indicating ongoing financial challenges[96]. - As of September 30, 2025, the company had $3.5 million in material cash requirements payable within 12 months, including $1.1 million related to the Brisbane Lease[136]. - The primary use of cash is to fund operating expenses, primarily research and development expenditures, headcount costs, and lease expenses[135]. - The company has no long-term debt and no material non-cancelable purchase commitments with service providers[137]. - The company is classified as a "smaller reporting company," with a market value of shares held by non-affiliates less than $700 million[140]. Research and Development - Research and development expenses for Q3 2025 were $570,000, a decrease of 92% compared to $7.6 million in Q3 2024[108]. - Total research and development expenses for the nine months ended September 30, 2025, were $12.1 million, a decrease of $5.6 million (32%) from $17.7 million in the same period in 2024[114]. - Amezalpat research costs for the nine months ended September 30, 2025, were $5.3 million, down 24% from $7.0 million in 2024[116]. - Research and development expenses decreased by $7.0 million to $0.6 million for the three months ended September 30, 2025, compared to $7.6 million for the same period in 2024, primarily due to re-prioritizing efforts towards exploring strategic alternatives[110]. Clinical Trials and Designations - Amezalpat is set to begin a pivotal Phase 3 study in first-line hepatocellular carcinoma (HCC), with positive feedback received from the FDA on the trial design[90]. - The FDA granted Orphan Drug Designation for amezalpat in January 2025, and Fast Track Designation in February 2025, which may provide regulatory advantages[91][92]. - TPST-1495 is expected to enter a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in late 2025, pending potential delays due to the U.S. government shutdown[94]. Expenses and Losses - General and administrative expenses for Q3 2025 were $3.0 million, a slight increase of 1% from $2.99 million in Q3 2024[108]. - The net loss for Q3 2025 was $3.5 million, a reduction of 67% compared to a net loss of $10.6 million in Q3 2024[108]. - General and administrative expenses remained stable at $3.0 million for the three months ended September 30, 2025, compared to the same period in 2024[112]. - Interest expense related to the Oxford Loan was eliminated in the three months ended September 30, 2025, compared to $329 thousand in the same period in 2024[113]. - Cash used in operating activities for the nine months ended September 30, 2025, was $23.2 million, compared to $22.9 million in 2024[128]. - Cash used in operating activities for the nine months ended September 30, 2024, was $22.9 million, with a net loss of $28.0 million[130]. Financing Activities - The company repaid the Oxford Loan in full in April 2025, which had a total outstanding amount of $3.5 million[123]. - The company sold 312,830 shares of common stock for proceeds of $2.8 million under the ATM Program as of September 30, 2025[125]. - The net proceeds from a registered direct offering on June 11, 2025, were approximately $4.1 million after deducting fees and expenses[127]. - Cash provided by financing activities for the nine months ended September 30, 2025, included net proceeds from a registered direct offering of $4.1 million[133]. - Cash provided by financing activities for the nine months ended September 30, 2024, included proceeds from the issuance of common stock totaling $8.8 million[134]. Stock and Corporate Actions - A one-for-thirteen reverse stock split was executed on April 8, 2025, adjusting the number of shares and options accordingly[101]. - There have been no significant changes to critical accounting policies since December 31, 2024[138].