Tempest Therapeutics: Navigating Growth and Challenges in Q3 2024

Tempest Therapeutics, Inc. (TPST) recently reported its financial results for the quarter ended September 30, 2024, and provided a corporate update, highlighting its progress in developing first-in-class targeted and immune-mediated therapeutics to fight cancer. The company's stock price reacted positively to the news, indicating investors' confidence in its strategic direction and future prospects.

Cash Position and Net Loss
Tempest ended the quarter with $22.1 million in cash and cash equivalents, compared to $39.2 million at the end of 2023. The decrease in cash position can be attributed to increased research and development (R&D) expenses, which rose to $7.6 million from $4.2 million in the same period last year. General and administrative expenses also increased, from $2.4 million to $3.0 million. Despite the increase in expenses, Tempest raised an additional $19.9 million in net proceeds through the sale of 17 million shares of common stock under its at-the-market (ATM) program, strengthening its financial position.



Amezalpat and Roche Agreement
Tempest received a "Study May Proceed" letter from the U.S. Food and Drug Administration (FDA) for a pivotal Phase 3 trial of amezalpat (TPST-1120) combination therapy to treat first-line hepatocellular carcinoma (HCC). The company also announced an agreement with F. Hoffmann-La Roche Ltd. (Roche) to advance the evaluation of amezalpat in combination with atezolizumab and bevacizumab into a pivotal Phase 3 trial for the first-line treatment of unresectable or metastatic HCC. Under the agreement, Roche will supply atezolizumab globally, while Tempest will sponsor and lead the pivotal study, retaining all development and commercial rights to amezalpat.

TPST-1495 and NCI Funding
Tempest received final funding approval from the National Cancer Institute (NCI) to move TPST-1495 into a Phase 2 trial in Familial Adenomatous Polyposis (FAP). This approval allows Tempest to advance TPST-1495 into a Phase 2 study in patients with FAP in 2024 or early 2025, under the auspices of the Cancer Prevention Clinical Trials Network and funded by the NCI Division of Cancer Prevention.

Expanding Leadership Team
Tempest expanded its leadership team to strengthen global clinical expertise by appointing Troy M. Wagner as Vice President of Quality Assurance and Sheldon Mullins as Vice President of Regulatory Affairs. These appointments will help Tempest maintain high-quality standards and ensure compliance with global regulatory requirements, ultimately strengthening the company's position in the competitive clinical-stage biotechnology landscape.

In conclusion, Tempest Therapeutics' Q3 2024 financial results and business update demonstrate the company's commitment to developing innovative cancer therapies and its strategic partnerships to advance its pipeline. Despite the challenges posed by increased expenses, Tempest's cash position remains strong, supported by a successful ATM offering. The company's progress in its lead drug candidate, amezalpat, and the receipt of NCI funding for TPST-1495 further solidify its position in the competitive biotechnology sector. As Tempest continues to navigate the complexities of clinical development and regulatory requirements, investors should remain optimistic about the company's long-term growth prospects.