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BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a biotech firm specializing in cancer therapeutics, is exploring strategic alternatives to enhance stockholder value, including potential mergers and partnerships. According to InvestingPro data, while the company maintains more cash than debt on its balance sheet, it faces capital market challenges as it seeks to advance its clinical programs, particularly its promising cancer treatments, amezalpat and TPST-1495.
Amezalpat, with Orphan Drug and Fast Track designations from the FDA, is poised for a pivotal Phase 3 trial in hepatocellular carcinoma (HCC), having shown a six-month improvement in median overall survival in a Phase 2 study. TPST-1495, also granted Orphan Drug status, targets familial adenomatous polyposis (FAP) and is expected to enter a Phase 2 trial with data anticipated in 2026.
Despite positive clinical data and the potential for significant impact in oncology, Tempest has not finalized any agreements and cautions that there is no certainty of a transaction resulting from its strategic review. The company's efforts to find a strategic partner are driven by the need for resources to develop these potential therapies fully. InvestingPro analysis reveals the company is quickly burning through cash, though its liquid assets currently exceed short-term obligations.
Stephen Brady, Tempest's CEO, highlighted the "rare opportunity" presented by the company's pipeline, citing FDA clearance for amezalpat's pivotal study and the drug's commercial potential in treating HCC. He emphasized the goal of securing a partnership to bring potentially life-saving therapies to patients.
Tempest's portfolio includes small molecule product candidates with tumor-targeted and immune-mediated mechanisms. Amezalpat, a PPARα antagonist, has shown clinical activity in advanced solid tumors, and TPST-1495, a dual EP2/4 prostaglandin receptor antagonist, has demonstrated preclinical efficacy in reducing kidney cancer growth.
This announcement is based on a press release statement, and Tempest has set no timetable for completing the strategic review process. The company will not provide further updates unless it deems additional disclosure appropriate or necessary. For investors seeking deeper insights, InvestingPro offers 13 additional key metrics and analysis points about Tempest Therapeutics, including detailed profitability trends and market performance indicators.
In other recent news, Tempest Therapeutics has announced a 1-for-13 reverse stock split, aiming to consolidate its shares and potentially increase the market price of its common stock. This move, approved by shareholders, will see the company's common stock begin trading on a split-adjusted basis on The Nasdaq Capital Market with a new CUSIP number. Additionally, Tempest Therapeutics reported financial results that missed expectations, with an earnings per share of ($0.34) for the fourth quarter and ($1.50) for the year, falling short of both H.C. Wainwright's and consensus estimates. Following these results, H.C. Wainwright revised its price target for Tempest Therapeutics to $16, down from $47, but maintained a Buy rating on the shares.
Tempest Therapeutics is progressing with its clinical programs, having received FDA authorization to proceed with a Phase 2 trial for TPST-1495, targeting Familial Adenomatous Polyposis (FAP). This trial, financially backed by the National Cancer Institute, will assess the drug's efficacy and safety in reducing duodenal polyp burden in patients. The company is also advancing its lead clinical program, amezalpat, for Hepatocellular Carcinoma, with a Phase 3 study set to start in late 2025, supported by a recent agreement with Roche. These developments highlight Tempest's ongoing efforts in cancer prevention and treatment, despite facing financial challenges.
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