Builds on clearances already received by FDA and EMAChina has the largest population of patients with hepatocellular carcinoma in the world BRISBANE, Calif., June 30, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-classi targeted and immune-mediated therapeutics to fight cancer, today announced that the company received approval from the National Medical Products Administration (NMPA) in China to proceed with a pivotal t ...

BRISBANE, Calif., June 11, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that it has entered into a definitive agreement with a single institutional investor for the purchase and sale in a registered direct offering of 739,000 shares of its common stock (or common stock equivalents), at an offering price of $6.25 per share of common stock ...

Table of Contents UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . Commission File No. 001-35890 Tempest Therapeutics, Inc. (Exact Name of Registrant as Specified in its Charter) | Delaware | 45-1472564 | | --- | ...

Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual MeetingGranted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)Received FDA “Study May Proceed” letter for Phase 2 trial of TPST-1495 for the treatment of FAPGranted both Orphan Drug & Fast Track designations by FDA for Amezalpat (TPST-1120) for the treatment of patients with hepatocellular carcinoma (HCC) BRISBANE, Calif., May 1 ...

Exhibit 99.1 Tempest Reports First Quarter 2025 Financial Results and Provides Business Update Brisbane, CA, May 13, 2025 – Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended March 31, 2025 and provided a corporate update. "The amezalpat program continues to produce data that reinforce its potential as a cancer therapy, most recently in a ...

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 ...

Core Viewpoint - Tempest Therapeutics, Inc. is exploring strategic options to enhance stockholder value, which may include mergers, acquisitions, partnerships, or licensing arrangements [1] Company Development Plans - Tempest is developing amezalpat (TPST-1120), a PPAR-alpha antagonist, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC) [2] - The company is also working on TPST-1495, a selective EP2-EP4 dual antagonist, for treating familial adenomatous polyposis (FAP) [2] - Tempest has partnered with Roche to evaluate amezalpat in combination with Roche's Tecentriq and Avastin for HCC treatment [5] - The FDA has cleared Tempest to begin a pivotal phase III study for amezalpat in combination with Roche's therapy for HCC [6] - Ongoing studies have shown that amezalpat combined with Roche's therapy resulted in a six-month improvement in median overall survival compared to the standard therapy alone [7] - The FDA has granted Fast Track and Orphan Drug designations to amezalpat for HCC treatment [7] - Tempest has received a "Study May Proceed" letter from the FDA for a phase II study on TPST-1495, expected to start in 2025 [9] - The FDA has also granted Orphan Drug designation to TPST-1495 for FAP treatment [9] - Management believes that amezalpat has blockbuster potential in HCC, while TPST-1495 also shows promise [10] Stock Performance - Following the announcement of strategic options, Tempest's shares rose by 6.3% in after-hours trading on April 9 [2] - Year-to-date, Tempest's shares have decreased by 34.1%, compared to a 14.6% decline in the industry [3]

Amezalpat (TPST-1120) is Phase 3-ready: completed FDA and EMA interactions for first-line pivotal study in hepatocellular carcinoma (HCC); global investigator support in placeAwarded both Orphan Drug & Fast Track designations for amezalpat based on positive randomized Phase 2 data in first-line HCC Received FDA "Study May Proceed" letter for TPST-1495 in a Phase 2 trial for the treatment of familial adenomatous polyposis (FAP); data expected 2026 BRISBANE, Calif., April 09, 2025 (GLOBE NEWSWIRE) -- Tempest ...

(Exact Name of Registrant as Specified in its Charter) UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 _______________________________________________________________________________________________________________________________ FORM 10-K _______________________________________________________________________________________________________________________________ (Mark One) ☒ ANNUAL REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the fiscal year end ...

• Granted Both Orphan Drug & Fast Track designations for Amezalpat (TPST-1120) for the treatment of patients with Hepatocellular Carcinoma (HCC)• Announced Agreement with Roche to Support Advancement of Amezalpat Combination Therapy into First-Line HCC Pivotal Trial• Received FDA "Study May Proceed" letter for Phase 2 trial of TPST-1495 for the treatment of Familial Adenomatous Polyposis (FAP) BRISBANE, Calif., March 27, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage bio ...