Tempest Therapeutics Reports $41.8 Million Net Loss for Fiscal Year 2024

Tempest Therapeutics, Inc. reported a net loss of $41.8 million for the fiscal year ending December 31, 2024, compared to a net loss of $29.5 million in the previous year, marking a 42% increase in losses. The company's total revenue remains at zero, as it has not yet commercialized any products. Research and development expenses surged by 63% to $28.5 million, primarily due to increased costs associated with preparing for a pivotal Phase 3 trial of its lead product candidate, amezalpat, for the treatment of hepatocellular carcinoma (HCC). General and administrative expenses also rose by 16% to $13.6 million, driven by higher stock-based compensation and legal consulting fees.

In terms of operational developments, Tempest is advancing its clinical programs, with amezalpat poised to enter a pivotal Phase 3 study after receiving positive feedback from the FDA regarding its trial design. The company also announced that it received Orphan Drug Designation and Fast Track Designation for amezalpat, which could expedite its development and regulatory review process. Additionally, Tempest's second clinical candidate, TPST-1495, is expected to begin a Phase 2 trial in 2025 for Familial Adenomatous Polyposis (FAP), a rare genetic disorder.

As of December 31, 2024, Tempest had cash and cash equivalents of $30.3 million, down from $39.2 million the previous year. The company has raised a total of $232.1 million since its inception, primarily through equity sales. However, it anticipates needing significant additional capital to fund ongoing operations and clinical trials, particularly for the Phase 3 trial of amezalpat. The company has entered into an at-the-market offering program, allowing it to sell shares of common stock to raise funds, with approximately $13.4 million available for sale as of March 21, 2025.

The company’s workforce consisted of 25 employees as of December 31, 2024, with plans to expand its team to support its growing clinical development efforts. Tempest's strategy includes enhancing its pipeline through in-licensing opportunities and exploring partnerships to maximize the potential of its product candidates. The company operates in a highly competitive environment, facing challenges from larger biopharmaceutical firms with more resources.

Looking ahead, Tempest remains focused on advancing its clinical programs and securing the necessary funding to support its operations. The company acknowledges the inherent risks in drug development, including the potential for delays in clinical trials and regulatory approvals, which could impact its ability to generate revenue and achieve profitability in the future.