"2024 was another year filled with significant progress and milestone achievements that position Tempest for a successful future," said Stephen Brady, president and chief executive officer of Tempest. "Despite challenging capital markets, our lean team excelled, reporting key OS data from the ongoing randomized Phase 2 trial of amezalpat in first-line hepatocellular carcinoma. As previously announced, we have secured broad regulatory agreement with both the FDA and EMA on the Phase 3 plan and received both ...

Clinical data supporting mechanism of action reinforce potential as a novel cancer treatmentBRISBANE, Calif., March 25, 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 an abstract highlighting data supporting the immune component of amezalpat’s purported mechanism of action has been accepted for poster presentation at the 2025 American Associat ...

Second clinical program entering Phase 2 with data expected 2026BRISBANE, Calif., March 13, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the Cancer Prevention Clinical Trials Network received a “Study May Proceed” letter from the U.S. Food and Drug Administration (FDA) to evaluate TPST-1495, the company’s novel dual receptor inhibitor of pro ...

Fast Track Designation highlights potential of amezalpat to address unmet need for patients with HCC Amezalpat builds momentum with both Fast Track and Orphan Drug Designations BRISBANE, Calif., Feb. 10, 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 the U.S. Food and Drug Administration (FDA) has granted Fast Track Designation (FTD) to ameza ...

BRISBANE, Calif., Jan. 06, 2025 (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company developing first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today announced that the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation (ODD) to amezalpat (TPST-1120), an oral, small molecule, selective PPAR⍺ antagonist for the treatment of patients with hepatocellular carcinoma (HCC). “Receiving orphan drug designation for a ...

BRISBANE, Calif., Nov. 25, 2024 (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 members of senior management will participate in a fireside chat at the Piper Sandler 36th Annual Healthcare Conference on Tuesday, December 3, 2024 at 9:00 a.m. ET. To access the live or archived recording of the discussion, please visit the investor section of the Temp ...

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 September 30, 2024 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(D) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from to . | --- | --- | |----------------------------------------------------------------------------------------------------------------------|-------- ...

Building upon a successful end-of-Phase 2 meeting, received FDA “Study May Proceed” letter for pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line HCCAnnounced agreement with Roche to support advancement of amezalpat into first-line HCC pivotal Phase 3 trialReceived final funding approval from NCI to move TPST-1495 into a Phase 2 trial in FAPExpanded leadership team to strengthen global clinical expertise BRISBANE, Calif., Nov. 12, 2024 (GLOBE NEWSWIRE) -- Tempest Therape ...

Financial Performance - Tempest ended Q3 2024 with $22.1 million in cash and cash equivalents, down from $39.2 million on December 31, 2023[11] - Net loss for Q3 2024 was $10.6 million, or $0.41 per share, compared to a net loss of $6.8 million, or $0.48 per share, in Q3 2023[11] - Research and development expenses for Q3 2024 were $7.6 million, an increase of $3.4 million from $4.2 million in Q3 2023[11] - General and administrative expenses for Q3 2024 were $3.0 million, up from $2.4 million in Q3 2023, primarily due to increased stock-based compensation[11] - Cash used in operating activities for the nine months ended September 30, 2024, was $22.9 million[11] - Total liabilities as of September 30, 2024, were $22.4 million, down from $24.8 million on December 31, 2023[15] Clinical Development - The company received FDA approval to proceed with a pivotal Phase 3 trial for amezalpat in combination with atezolizumab and bevacizumab for first-line HCC treatment[3] - Tempest announced an agreement with Roche to advance amezalpat into the pivotal Phase 3 trial, with Roche supplying atezolizumab globally[4] - The company plans to advance TPST-1495 into a Phase 2 study in patients with Familial Adenomatous Polyposis (FAP) in 2024 or early 2025[9] Leadership and Team Expansion - The company expanded its leadership team to enhance global clinical expertise with new appointments[8]

Tempest Therapeutics Inc. TPST stock is trading higher on Thursday, with a strong session volume of over 23 million as per data from Benzinga Pro. The company entered into an agreement with Roche Holdings AG RHHBY to advance the evaluation of amezalpat (TPST-1120) in combination with atezolizumab (Tecentriq) and bevacizumab, the current standard of care for unresectable or metastatic hepatocellular carcinoma (HCC), into a Phase 3 trial for the first-line treatment of liver cancer. Under the agreement, Roche ...