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Tempest Therapeutics is a clinical-stage oncology company advancing two lead programs while conducting a strategic review to extend limited cash resources. The lead candidate, amezalpat, is positioned to begin a pivotal Phase 3 trial in first-line hepatocellular carcinoma and has received regulatory momentum including FDA Orphan Drug and Fast Track designations, a favorable end-of-Phase 2 meeting, and agency clearances to proceed in the U.S. and China; the company also reported EMA Orphan Drug designation. The second program, TPST-1495, received FDA authorization for an NCI-supported Phase 2 study in FAP and an FDA Orphan Drug designation.
Financially, Tempest reported $14.3 million in cash and cash equivalents and an accumulated deficit of $225.8 million. Net loss was $18.7 million for the six months ended June 30, 2025. The company expects existing cash to fund operations for less than 12 months, raising substantial doubt about its ability to continue as a going concern. In April 2025 Tempest launched a strategic alternatives process, reduced headcount (21 of 26 employees), transitioned key executives to consulting arrangements, completed a registered direct offering that raised net proceeds of ~$4.1 million, sold ~$2.8 million of stock via its ATM program year-to-date, and repaid its term loan in April 2025.
Tempest Therapeutics reported that it has issued a press release announcing its financial results for the quarter ended June 30, 2025. The press release is attached to this report as Exhibit 99.1. This Form 8-K indicates the company is furnishing the press release rather than "filing" it, meaning the release is provided for investor information in this report but is not subject to the liabilities of being formally filed or automatically incorporated by reference in other Securities Act filings. The 8-K itself does not include the numerical financial statements; those figures are contained in the attached press release.