Tempest报告2025年第二季度财务业绩并提供业务更新

• Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line hepatocellular carcinoma (HCC) in China

• Granted orphan drug designation from the European Medicines Agency (EMA) for amezalpat for the treatment of patients with HCC

• Presented new amezalpat mechanism-of-action data reinforcing its potential as a novel cancer treatment at the 2025 AACR Annual Meeting

• Granted Orphan Drug designation by FDA for TPST-1495 for the treatment of familial adenomatous polyposis (FAP)

BRISBANE, Calif., Aug.  11, 2025  (GLOBE NEWSWIRE) -- Tempest Therapeutics, Inc. (Nasdaq: TPST), a clinical-stage biotechnology company with a pipeline of first-in-class1 targeted and immune-mediated therapeutics to fight cancer, today reported financial results for the quarter ended June 30, 2025 and provided a corporate update.

"We are pleased to see the continued progress of our clinical oncology portfolio, including the recent clearance in China to initiate a pivotal trial of amezalpat combination therapy in first-line HCC, expanding on similar clearances we received in the U.S. and Europe from the FDA and EMA," said Stephen Brady, president and chief executive officer of Tempest. "We believe these milestones reflect both the promise of our therapies and the dedication of the team who brought the programs to this point. We remain actively engaged in our strategic alternatives process with the goal of maximizing value for stockholders and patients."

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1 If approved by the U.S. Food and Drug Administration (FDA).

Recent Highlights

• Amezalpat (TPST-1120) (clinical PPARα antagonist):

  • Received clearance to proceed with pivotal trial of amezalpat combination therapy for first-line HCC in China.

  • Granted orphan drug designation from the EMA for amezalpat for the treatment of patients with HCC.

  • Reported new data at the 2025 American Association for Cancer Research (AACR) Annual Meeting, supporting the immune component of amezalpat's dual mechanism of action and reinforcing its potential as a novel cancer treatment.

  • Granted both Orphan Drug and Fast Track designations by the U.S. Food and Drug Administration (FDA) for amezalpat for the treatment of patients with HCC.

• TPST-1495 (clinical dual EP2/4 prostaglandin receptor antagonist):

  • Granted Orphan Drug designation by the FDA to treat patients with FAP.

• Corporate:

  • Announced cost-cutting measures and plans to explore a full range of strategic alternatives to advance the company's promising clinical-stage programs and maximize stockholder value.

  • Strengthened cash position with completion of $4.6 million registered direct offering of common stock in June 2025.

Financial Results

Second Quarter 2025

• Tempest ended the quarter with $14.3 million in cash and cash equivalents, compared to $30.3 million on December 31, 2024. The decrease was primarily due to cash used in operating activities, offset by $4.1 million in net proceeds from the June 2025 registered direct offering, as well as $2.8 million in net proceeds from the company's at-the-market offering program.

• 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, respectively, for the same period in 2024.

• Research and development expenses for the quarter were $3.9 million, compared to $5.8 million for the same period in 2024. The $1.9 million decrease was primarily due to a decrease in costs incurred as a result of re-prioritizing efforts towards exploring strategic alternatives.

• General and administrative expenses for the quarter were $4.1 million, compared to $3.7 million for the same period in 2024. The $0.4 million increase was primarily related to one-time separations costs for employees terminated during the period.

Year-to-Date

• Cash used in operating activities for the six months ended June 30, 2025 was $16.5 million.

• Net loss and net loss per share for the six months ended June 30, 2025 were $18.7 million and $5.17, respectively, compared to $17.5 million and $10.15, respectively, for the same period in 2024.

• Research and development expenses for the six months ended June 30, 2025 were $11.5 million, compared to $10.2 million for the same period in 2024. The $1.3 million increase was primarily due to an increase in costs incurred from contract research and manufacturing organizations in preparation for the company's pivotal Phase 3 trial of amezalpat for the treatment of first-line HCC.

• General and administrative expenses for the six months ended June 30, 2025 were $7.4 million, compared to $7.4 million for the same period in 2024, and were primarily related to employee compensation costs, inclusive of one-time separation costs for employees terminated during the quarter ended June 30, 2025, as well as consulting, professional services and facilities costs.

(1) Results have been adjusted to reflect the one-for-thirteen reverse stock split effected in April 2025.