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 ...

Broad agreement on pivotal Phase 3 study plan, including use of current amezalpat dose and schedule Overall survival, the strongest result from the Phase 2 trial, will be the primary study endpoint Agreed-upon early efficacy analysis could reduce time to primary read-out significantly BRISBANE, Calif., Aug. 15, 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 ...

Unveiled new positive survival data for amezalpat (TPST-1120) in randomized first-line hepatocellular carcinoma ("HCC") study demonstrating: Survival benefit maintained across key subpopulations a six-month improvement over control arm in median survival a strong 0.65 hazard ratio, maintained since 0.59 observed 10 months earlier Advancing amezalpat towards a pivotal Phase 3 trial in first-line HCC Planning to move TPST-1495 into a Phase 2 in FAP BRISBANE, Calif., Aug. 08, 2024 (GLOBE NEWSWIRE) -- Tempest T ...

InvestorPlace is home to all of the hottest stock market coverage that traders need to know about on Thursday! Among this is what's going on with SMX (Security Matters) (NASDAQ:SMX) stock today, the biggest premarket stock movers this morning and more. All of this info is ready to go at the links below! Tempest Therapeutics will be holding a conference call at 8:30 a.m. Eastern Time today. This will cover its Phase 1b/2 combination study of amezalpat with atezolizumab and bevacizumab. How This Affects TPST ...

Core Insights - Tempest Therapeutics, Inc. is set to report new data from a global randomized Phase 1b/2 study involving amezalpat (TPST-1120) in combination with atezolizumab and bevacizumab for the first-line treatment of hepatocellular carcinoma (HCC) on June 20, 2024 [1] Company Overview - Tempest Therapeutics is a clinical-stage biotechnology company focused on developing first-in-class targeted and immune-mediated therapeutics for cancer treatment [3] - The company is advancing a diverse portfolio of small molecule product candidates that utilize tumor-targeted and/or immune-mediated mechanisms, with potential applications across a wide range of tumors [3] - Tempest Therapeutics is headquartered in Brisbane, California, and provides more information on its website [3]

About Tempest Therapeutics 1 If approved by the FDA BRISBANE, Calif., June 07, 2024 (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 Compensation Committee of the Company's Board of Directors granted one employee nonqualified stock options to purchase an aggregate of 14,000 shares of its common stock under the Company's 2023 Inducement Plan. Sylv ...

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, 2024 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 | | --- | ...

Financial Performance - Tempest ended Q1 2024 with $32.3 million in cash and cash equivalents, down from $39.2 million at the end of Q4 2023[13] - The net loss for Q1 2024 was $7.9 million, or $0.36 per share, compared to a net loss of $7.6 million, or $0.55 per share, in Q1 2023[13] - Total liabilities decreased to $23.7 million as of March 31, 2024, from $24.8 million at the end of 2023[16] - The accumulated deficit increased to $173.2 million as of March 31, 2024, compared to $165.3 million at the end of 2023[16] - Tempest anticipates having sufficient resources to fund operations into the second quarter of 2025 based on its current cash and operating plan[13] Expenses - Research and development expenses for Q1 2024 were $4.3 million, a decrease from $4.7 million in Q1 2023, primarily due to reduced costs from contract research organizations[13] - General and administrative expenses increased to $3.6 million in Q1 2024 from $2.9 million in Q1 2023, mainly due to share-based compensation and consulting services[13] Clinical Development - Tempest plans to advance TPST-1120 into a pivotal Phase 3 trial in first-line hepatocellular carcinoma (HCC) and TPST-1495 into a Phase 2 study in Familial Adenomatous Polyposis (FAP) in 2024[5] - New preclinical data for TPST-1120 demonstrated significant anti-tumor activity in kidney cancer, showing reduced growth as a monotherapy and enhanced inhibition when combined with chemotherapy[6] - The company expects to announce updated data from the ongoing randomized study in first-line HCC patients in 2024[9]