Tempest Therapeutics Inc Stock Price, News & Analysis

Tempest Therapeutics (TPST) has received Orphan Drug Designation from the European Medicines Agency for amezalpat, their oral PPAR⍺ antagonist drug candidate for hepatocellular carcinoma (HCC) treatment. This follows previous FDA Orphan Drug and Fast Track Designations, highlighting the significant unmet need in liver cancer treatment. The designations were granted after positive Phase 1b/2 clinical trial results, where amezalpat combined with standard-of-care therapy (atezolizumab and bevacizumab) demonstrated superior outcomes. Key results include a six-month improvement in median overall survival with a hazard ratio of 0.65 compared to standard care alone. Notably, the survival benefit was maintained in key subpopulations, including PD-L1 negative disease patients, aligning with amezalpat's dual mechanism targeting both tumor cells and the immune system.

Tempest Therapeutics (NASDAQ: TPST) reported Q1 2025 financial results and corporate updates. The company presented new data for amezalpat at AACR, demonstrating its potential in cancer treatment by reducing immunosuppression. Key developments include: FDA granting both Orphan Drug and Fast Track designations for amezalpat in hepatocellular carcinoma (HCC) treatment, and Orphan Drug designation for TPST-1495 in familial adenomatous polyposis (FAP). Financially, Tempest ended Q1 with $21.5 million in cash, down from $30.3 million in December 2024. The company reported a net loss of $10.9 million ($3.16 per share) compared to $7.9 million in Q1 2024. R&D expenses increased to $7.6 million, primarily due to preparation for amezalpat's Phase 3 trial. The company announced plans to explore strategic alternatives and completed a workforce reduction in April 2025.

Tempest Therapeutics presented new data for their cancer treatment candidate amezalpat at the 2025 AACR Annual Meeting, showcasing promising results in its dual mechanism of action.

Key findings include:

• Amezalpat reduces tumor-promoting immunosuppression by targeting M2 macrophages and T regulatory cells
• The drug works by inhibiting PPAR-alpha, which controls fatty acid oxidation (FAO)
• Shows promising clinical results in multiple cancers including HCC, RCC, and CCA when combined with immunotherapy
• Demonstrates ability to decrease anti-inflammatory cytokine production

According to Dr. Sam Whiting, Chief Medical Officer at Tempest, the data supports amezalpat's potential as a first-in-class cancer therapy. The treatment's effectiveness is linked to its ability to block immune suppression, which has been observed in clinical trials.

Tempest Therapeutics (TPST) has received Orphan Drug Designation (ODD) from the FDA for TPST-1495, its dual receptor inhibitor of prostaglandin signaling, for treating Familial Adenomatous Polyposis (FAP). The designation marks a significant milestone for the company's second clinical program.

A Phase 2 study of TPST-1495 in FAP patients is scheduled to commence in 2025, led by the Cancer Prevention Clinical Trials Network with National Cancer Institute Division of Cancer Prevention funding. Study results are anticipated in 2026.

Tempest Therapeutics (NASDAQ: TPST) has announced plans to explore strategic alternatives to advance its clinical-stage oncology programs and maximize stockholder value. The company has retained MTS Health Partners as financial advisor for this process.

Key highlights include:

• Their lead drug amezalpat (TPST-1120) is Phase 3-ready for first-line hepatocellular carcinoma (HCC) treatment, having received both Orphan Drug and Fast Track designations
• Phase 1b/2 clinical study showed amezalpat improved median overall survival by six months when combined with atezolizumab and bevacizumab
• FDA has issued "Study May Proceed" letter for TPST-1495 in Phase 2 trial for familial adenomatous polyposis (FAP) treatment, with data expected in 2026
• The company has established an agreement with Roche for evaluating amezalpat in combination therapy

Tempest Therapeutics (NASDAQ: TPST) reported significant progress in 2024, highlighted by key developments for their cancer therapeutics. Their lead drug Amezalpat received both Orphan Drug and Fast Track designations from the FDA for Hepatocellular Carcinoma (HCC) treatment. The company secured an agreement with Roche to advance Amezalpat into a Phase 3 trial.

Clinical results showed Amezalpat delivered a six-month improvement in median overall survival when combined with standard treatments for HCC. For TPST-1495, the company received FDA clearance for a Phase 2 trial in Familial Adenomatous Polyposis.

Financial results showed cash position of $30.3 million at year-end, down from $39.2 million in 2023. Net loss increased to $41.8 million ($1.50 per share) compared to $29.5 million ($1.91 per share) in 2023. R&D expenses rose to $28.5 million from $17.5 million, while G&A expenses increased to $13.6 million from $11.7 million.

Tempest Therapeutics (NASDAQ: TPST) has announced that data supporting the immune component of amezalpat's mechanism of action will be presented at the 2025 American Association for Cancer Research (AACR) Annual Meeting. The presentation, which will be in poster format, is scheduled to take place during the conference running from April 25-30, 2025 in Chicago, IL. The abstract highlights clinical data that reinforces amezalpat's potential as a novel cancer treatment.

Tempest Therapeutics (TPST) has received FDA clearance to proceed with a Phase 2 clinical trial for TPST-1495, their novel dual receptor inhibitor of prostaglandin signaling, to treat Familial Adenomatous Polyposis (FAP). This marks the company's second clinical program entering Phase 2, with data expected in 2026.

The study will be conducted by the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute's Division of Cancer Prevention. The trial aims to develop new treatment options for FAP, a high-risk condition that significantly increases the risk of multiple GI cancers. The Phase 2 study is scheduled to begin in 2025.

Tempest Therapeutics (NASDAQ: TPST) has received Fast Track Designation (FTD) from the FDA for amezalpat, their oral PPAR⍺ antagonist drug for treating hepatocellular carcinoma (HCC). This follows the Orphan Drug Designation (ODD) granted in January after positive Phase 1b/2 clinical trial results.

The global randomized study evaluated amezalpat combined with standard-of-care atezolizumab and bevacizumab versus atezolizumab and bevacizumab alone in first-line treatment of unresectable or metastatic HCC. Key results showed a six-month improvement in median overall survival with a hazard ratio of 0.65 for patients receiving the combination therapy. The survival benefit was maintained in key sub-populations, including PD-L1 negative disease patients, supporting amezalpat's proposed mechanism targeting both tumor cells and the patient's immune system.