BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a biotechnology company focused on developing cancer treatments, has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 3 trial for amezalpat, a drug candidate for liver cancer. The trial will evaluate the efficacy of amezalpat in combination with standard care therapies atezolizumab and bevacizumab in patients with unresectable or metastatic hepatocellular carcinoma (HCC).
The Phase 3 study, referred to as TPST-1120-301 (NCT06680258), is designed to be a global, blinded, randomized study comparing the effects of the amezalpat combination therapy against the current standard of care alone. The FDA's agreement on the study design, dosage, and statistical plan was reached in August 2024, with the trial expected to commence in the first quarter of 2025.
Amezalpat is an oral, small molecule antagonist of PPARα, which is believed to target tumor cells and modulate the tumor microenvironment, potentially improving patient survival. The decision to advance to Phase 3 was supported by positive results from an earlier Phase 2 study, which indicated that amezalpat could enhance overall survival in patients with advanced HCC.
Chief Medical (TASE:PMCN) Officer of Tempest, Dr. Sam Whiting, expressed enthusiasm for the upcoming trial and the potential of amezalpat to improve outcomes for liver cancer patients. This optimism is based on the drug's performance in prior clinical studies, which showed promising results in terms of survival benefits.
Tempest Therapeutics is headquartered in Brisbane, California, and is engaged in developing a portfolio of small molecule product candidates aimed at a variety of tumors. The company has emphasized that the information provided in their press release contains forward-looking statements, which are not guarantees of future performance and are subject to risks and uncertainties.
As the company prepares for the Phase 3 trial, it has cautioned investors not to place undue reliance on these forward-looking statements. The news of the trial's approval is based on a press release statement from Tempest Therapeutics.
In other recent news, Tempest Therapeutics has maintained its positive stride in the development of cancer treatments. The biotech firm has entered into a supply agreement with Roche for its forthcoming Phase 3 study in first-line Hepatocellular Carcinoma (HCC). This agreement is expected to reduce the trial costs by an estimated $30-50 million. Scotiabank (TSX:BNS) has reaffirmed its Sector Outperform rating for Tempest, while H.C. Wainwright has maintained its Buy rating, both reflecting confidence in the company's strategic position.
In addition, the U.S. Food and Drug Administration (FDA) has approved the Phase 3 study plan for Tempest's drug, amezalpat. The study, which will commence patient enrollment in the first quarter of 2025, is expected to evaluate amezalpat in combination with Roche's atezolizumab/bevacizumab. This follows the success of the Phase 2 trial and the FDA's agreement on the current dosage and schedule for the Phase 3 trial.
Tempest Therapeutics has also appointed Troy M. Wagner as Vice President of Quality Assurance, a strategic move as the company prepares for the upcoming trials. Despite these positive developments, Tempest acknowledges the need for significant funding to support the Phase 3 study, with costs estimated around $100 million. These recent developments underscore the company's continued progress in the field of cancer treatment.
InvestingPro Insights
As Tempest Therapeutics (NASDAQ:TPST) gears up for its pivotal Phase 3 trial of amezalpat, investors may find value in examining the company's financial health and market performance. According to InvestingPro data, Tempest's market capitalization stands at a modest $29.22 million, reflecting its status as a small-cap biotech firm focused on cancer treatments.
The company's financial position aligns with its developmental stage. An InvestingPro Tip indicates that Tempest is "quickly burning through cash," which is typical for biotech companies investing heavily in research and development. This cash burn is evident in the company's adjusted operating income of -$31.66 million for the last twelve months as of Q2 2024. Despite this, another InvestingPro Tip notes that Tempest "holds more cash than debt on its balance sheet," suggesting a degree of financial stability as it moves into the costly Phase 3 trial stage.
Tempest's stock has shown volatility, with a significant 10% return over the last week, contrasting sharply with a 66.15% decline over the past six months. This recent uptick could be attributed to the FDA's authorization for the Phase 3 trial, highlighting the market's sensitivity to regulatory developments in the biotech sector.
For investors considering Tempest's potential, it's worth noting that InvestingPro offers 11 additional tips for TPST, providing a more comprehensive analysis of the company's financial health and market position. These insights could be particularly valuable as Tempest approaches this critical phase in its drug development pipeline.
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