Tempest Therapeutics Inc Stock Price, News & Analysis

Tempest (Nasdaq: TPST) agreed to acquire Factor Bioscience’s clinical dual‑CAR T programs in an all‑stock transaction announced Nov 19, 2025, expected to close in early 2026 subject to shareholder approval and closing conditions.

The deal issues 8,268,495 shares (65% of outstanding) to a Factor affiliate, grants Tempest global rights outside China/India/Turkey/Russia to TPST-2003, and includes a Factor investment commitment expected to extend Tempest’s runway to mid 2027. TPST-2003 has a completed Phase 1 in rrMM with China BLA planned for 2027 and additional program milestones and trials slated for 2026–2028. Leadership changes and warrants to existing holders are included.

Tempest Therapeutics (Nasdaq: TPST) reported third quarter 2025 results and a corporate update on Nov 5, 2025. The company said it is pursuing a strategic alternatives process and expects to start the TPST-1495 Phase 2 in collaboration with the NCI and Cancer Prevention Clinical Trials Network. Cash and equivalents were $7.5 million at Sept 30, 2025, down from $30.3 million at Dec 31, 2024, after operating cash use and net proceeds of $4.1M (June registered direct offering) and $2.8M (ATM program). Net loss was $3.5M (Q3) and $22.2M year-to-date; R&D expenses declined due to reprioritization.

Tempest Therapeutics (NASDAQ: TPST) reported Q2 2025 financial results and significant clinical developments. The company received clearance for a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China, complementing existing FDA and EMA approvals. Amezalpat secured orphan drug designation from both the EMA and FDA, along with Fast Track designation for HCC treatment.

Financially, Tempest ended Q2 with $14.3 million in cash, down from $30.3 million in December 2024. The company reported a net loss of $7.9 million ($2.07 per share) and completed a $4.6 million registered direct offering in June 2025. The company is actively exploring strategic alternatives to maximize stockholder value while implementing cost-cutting measures.

Tempest Therapeutics (NASDAQ: TPST) has received approval from China's National Medical Products Administration (NMPA) to proceed with a pivotal trial for its drug candidate amezalpat (TPST-1120). The trial will evaluate amezalpat in combination with atezolizumab and bevacizumab, compared to the standard of care alone, for first-line treatment of unresectable or metastatic hepatocellular carcinoma (HCC).

The regulatory clearance follows previous approvals from the FDA and EMA, marking a significant expansion into China, which has the world's largest population of HCC patients. According to Dr. Sam Whiting, Chief Medical Officer and Head of R&D at Tempest, this approval represents a crucial milestone for reaching global markets with high HCC prevalence.

Tempest Therapeutics (NASDAQ: TPST), a clinical-stage biotech company focused on cancer therapeutics, has secured a registered direct offering agreement with a single institutional investor. The offering includes 739,000 shares of common stock at $6.25 per share, expected to generate gross proceeds of $4.6 million. The closing is anticipated for June 12, 2025, with H.C. Wainwright & Co. serving as the exclusive placement agent. The company plans to use the proceeds to support its previously announced strategic alternative process and for working capital purposes. The offering is being conducted under a shelf registration statement that became effective on January 27, 2025.

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.