Tempest Therapeutics reports Q2 2025 financial results, receives HCC trial clearance.

• Tempest Therapeutics received clearance for pivotal trial of amezalpat in China for HCC. • EMA granted orphan drug designation for amezalpat in HCC treatment. • AACR Annual Meeting presented new mechanism-of-action data for amezalpat. • FDA granted orphan drug designation for TPST-1495 in FAP treatment.

Tempest Therapeutics, a clinical-stage biotechnology company, has made significant strides in its quest to develop innovative cancer treatments. The company recently received clearance to proceed with a pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China [2]. This approval follows similar clearances obtained from the U.S. Food and Drug Administration (FDA) and the European Medicines Agency (EMA) [2].

In addition to the trial clearance, Tempest Therapeutics has also been granted orphan drug designation for amezalpat by the EMA for the treatment of patients with HCC [2]. The company presented new mechanism-of-action data for amezalpat at the 2025 American Association for Cancer Research (AACR) Annual Meeting, reinforcing its potential as a novel cancer treatment [2]. Furthermore, the FDA has granted orphan drug designation for TPST-1495 to treat patients with familial adenomatous polyposis (FAP) [2].

These developments are part of Tempest Therapeutics' ongoing efforts to maximize the value of its promising clinical-stage programs and advance its pipeline of first-in-class targeted and immune-mediated therapeutics. The company's strategic alternatives process aims to explore various options to maximize stockholder value while continuing to invest in its therapeutic innovations.

The company's financial results for the second quarter of 2025 reflect a cash position of $14.3 million, compared to $30.3 million at the end of 2024 [2]. Net loss and net loss per share for the quarter were $7.9 million and $2.07, respectively, compared to $9.6 million and $5.52 for the same period in 2024 [2]. The decrease in cash was primarily due to cash used in operating activities, offset by net proceeds from a registered direct offering and the company's at-the-market offering program [2].

Tempest Therapeutics continues to strengthen its cash position and explore strategic alternatives to advance its clinical-stage programs and maximize stockholder value. The company's recent regulatory milestones and financial results underscore its commitment to innovation and its potential to contribute to advancements in cancer treatment.

References:
[1] https://onco-this-week.com/post-content/gi-cancers/hcc/
[2] https://www.streetinsider.com/Globe+Newswire/Tempest+Reports+Second+Quarter+2025+Financial+Results+and+Provides+Business+Update/25181079.html