Tempest Reports Year End 2024 Financial Results and Provides Business Update

Core Insights - Tempest Therapeutics has made significant progress in 2024, achieving key milestones in the development of its drug candidates, particularly Amezalpat for Hepatocellular Carcinoma (HCC) and TPST-1495 for Familial Adenomatous Polyposis (FAP) [2][3] Drug Development Progress - Amezalpat (TPST-1120) received both Orphan Drug and Fast Track designations from the FDA for the treatment of HCC [3] - The company has secured regulatory agreement with the FDA and EMA on the Phase 3 plan for Amezalpat and received a "Study May Proceed" letter for a pivotal Phase 3 trial [3] - An agreement with Roche has been established to advance Amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for first-line treatment of unresectable or metastatic HCC [3] - New survival data indicates that Amezalpat combined with atezolizumab and bevacizumab shows a six-month improvement in median overall survival compared to the standard of care [3] - TPST-1495 has received a "Study May Proceed" letter from the FDA for a Phase 2 trial targeting FAP, with data expected in 2026 [3][8] Financial Performance - For the year ended December 31, 2024, Tempest reported a net loss of $41.8 million, or $1.50 per share, compared to a net loss of $29.5 million, or $1.91 per share, in 2023 [11] - Research and development expenses increased to $28.5 million from $17.5 million in the previous year, primarily due to costs associated with preparing for the pivotal Phase 3 trial of Amezalpat [8][11] - The company ended 2024 with $30.3 million in cash and cash equivalents, down from $39.2 million at the end of 2023 [8][10] Corporate Developments - The leadership team has been expanded to enhance global clinical expertise, with new appointments in key positions [3]