Tempest Q1 2024 Financial Results and Business Update

Tempest Therapeutics, Inc., a clinical-stage biotechnology firm focusing on targeted and immune-mediated cancer treatments, has released its financial results for the first quarter of 2024, ending March 31st, and provided a corporate update.

Stephen Brady, president and CEO, expressed strong optimism about the evolving data for TPST-1120, emphasizing its potential in treating liver and kidney cancers and other malignancies. He confirmed that the program is advancing toward a pivotal Phase 3 study for first-line Hepatocellular Carcinoma (HCC).

Key Developments:
TPST-1120, a clinical PPARα antagonist, showcased promising new preclinical data at the 2024 American Association for Cancer Research (AACR) Annual Meeting. This data demonstrated TPST-1120's ability to inhibit kidney cancer (RCC) growth as a standalone treatment and in combination with chemotherapy and immunotherapy. This reinforces the clinical benefits previously noted in the TPST-1120 Phase 1 data presented at ASCO 2022.

Additionally, positive outcomes from a Phase 1 trial of TPST-1120 in patients with advanced solid tumors were published in the Journal of Cancer Research Communications. The data indicated that TPST-1120 exhibited clinical activity, including tumor reduction, even in cancers resistant to PD-1 inhibitors and in immune-compromised conditions. The treatment was well tolerated both alone and when combined with nivolumab. This complements prior positive Phase 1b/2 data from a global randomized study of TPST-1120 in conjunction with atezolizumab and bevacizumab for first-line advanced HCC patients reported in October 2023.

At the Society for Immunotherapy of Cancer (SITC) 2024 Spring Scientific Meeting, new preclinical data highlighted TPST-1120’s potent anti-tumor activity across various cancer models, both as a monotherapy and combined with immune checkpoint inhibitors. The presentation also covered experimental results that validated clinical biomarker data from patients with advanced solid tumors treated in the Phase 1 trial of TPST-1120. Statistically significant increases in immune-related gene expression and elevated circulating free fatty acids (FFA) in responding patients aligned with the proposed mechanism of action for TPST-1120.

Future Milestones:
TPST-1120 is expected to have updated data from the ongoing randomized study in first-line HCC patients released in 2024. Pending FDA feedback, the company plans to advance TPST-1120 into a registrational Phase 3 study for first-line HCC patients.

Another agent, TPST-1495, a clinical dual EP2/4 prostaglandin receptor antagonist, is poised to enter a Phase 2 study in 2024 for patients with Familial Adenomatous Polyposis (FAP) under the Cancer Prevention Clinical Trials Network and funded by the National Cancer Institute (NCI) Division of Cancer Prevention, subject to final NCI approval. Additionally, data from the combination arm at the two highest TPST-1495 doses in patients with advanced endometrial cancer will be reported in 2024.

Financial Overview:
As of March 31, 2024, Tempest concluded the quarter with $32.3 million in cash and cash equivalents, down from $39.2 million on December 31, 2023. The net loss for this quarter was $7.9 million, or $0.36 per share, compared to $7.6 million, or $0.55 per share, in the same period in 2023. Research and development expenses totaled $4.3 million, a decrease from $4.7 million in the previous year, primarily due to reduced costs from contract research organizations and third-party vendors. General and administrative expenses rose to $3.6 million from $2.9 million, mainly due to increased share-based compensation and consulting services. Tempest anticipates having enough resources to continue operations into the second quarter of 2025.

About Tempest Therapeutics:
Headquartered in Brisbane, California, Tempest Therapeutics is dedicated to developing a diverse portfolio of small molecule product candidates with tumor-targeted and immune-mediated mechanisms, aiming to treat a wide array of tumors. The company's innovative programs span early research to late-stage investigations in randomized global studies for first-line cancer patients.