Core Insights - Tempest Therapeutics has received approval from the National Medical Products Administration (NMPA) in China to initiate a pivotal trial for amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [1][2][3] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing targeted and immune-mediated therapeutics for cancer treatment [8] - The company is headquartered in Brisbane, California, and has a diverse portfolio of small molecule product candidates [8] Drug Development - Amezalpat is an oral, small molecule, selective PPAR⍺ antagonist that shows promise in treating cancer by targeting tumor cells and modulating the tumor microenvironment [7] - The planned Phase 3 study will be a global, blinded, 1:1 randomized trial comparing amezalpat plus atezolizumab and bevacizumab against a placebo combination for first-line treatment of HCC [3] - The company has received agreement from both the FDA and EMA on the study design and statistical plan for the Phase 3 trial [3] Hepatocellular Carcinoma (HCC) Insights - HCC is an aggressive cancer with over 900,000 new diagnoses globally each year, and it is projected to become the third leading cause of cancer death by 2030 [4] - The highest incidence and mortality rates of HCC are found in East Asia, with increasing rates in Europe and the US [4] - Chronic liver diseases, including hepatitis B and C, NAFLD, NASH, and cirrhosis, account for 90% of HCC cases [5] Clinical Trial Context - The ongoing global randomized Phase 1b/2 study of amezalpat in combination with atezolizumab and bevacizumab has shown clinical superiority in overall survival compared to the standard of care [7] - Early-stage HCC patients face a 70-80% recurrence rate post-surgery, which is associated with poorer prognosis [6]

EMA Orphan Drug Designation (ODD) builds on U.S. Food & Drug Administration (FDA) ODD and Fast Track Designation, underscoring the urgent need for new treatment optionsThe multiple regulatory designations were granted following strong positive results from a global randomized Phase 1b/2 study in first-line HCC demonstrating superior outcomes for amezalpat combination therapy across multiple study endpoints, including overall survival in both the entire population and key subpopulations, when compared to sta ...

Core Viewpoint - Tempest Therapeutics, Inc. reported promising developments in its clinical-stage oncology programs, particularly highlighting the amezalpat program's potential as a cancer therapy and ongoing efforts to maximize stockholder value through strategic alternatives [2][5]. Recent Highlights - The amezalpat program demonstrated its ability to reduce immunosuppression and activate the immune system against tumors, supported by positive randomized Phase 2 data [2]. - Tempest received Orphan Drug designation from the FDA for TPST-1495 for familial adenomatous polyposis (FAP) and for amezalpat for hepatocellular carcinoma (HCC) [5][6]. - The company is preparing for a Phase 2 trial of TPST-1495, expected to begin in 2025, emphasizing innovative cancer prevention strategies [6]. Financial Results - For the first quarter of 2025, Tempest reported a net loss of $10.9 million, or $3.16 per share, compared to a net loss of $7.9 million, or $4.62 per share, in the same period of 2024 [6][15]. - Research and development expenses increased to $7.6 million from $4.3 million year-over-year, primarily due to costs associated with preparing for a pivotal Phase 3 trial of amezalpat [6][7]. - The company ended the quarter with $21.5 million in cash and cash equivalents, down from $30.3 million at the end of 2024, mainly due to cash used in operating activities [6][12]. Corporate Developments - The company announced plans to explore a full range of strategic alternatives to advance its clinical-stage programs and maximize stockholder value [6]. - A reduction in force was completed on April 30, 2025, as part of its strategic initiatives [6].

BRISBANE, Calif., April 28, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that a presentation of new data supporting the immune component of amezalpat’s purported dual mechanism of action that reinforces its potential as a novel cancer treatment at the 2025 American Association for Cancer Research (AACR) Annual Meeting. “The data presented at the ...