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BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotech with a market capitalization of $28.2 million and strong cash position relative to debt, announced Monday it has received approval from China’s National Medical Products Administration to proceed with a pivotal trial for its liver cancer drug candidate amezalpat. According to InvestingPro analysis, while the company maintains a healthy current ratio of 1.7, it faces challenges with rapid cash burn - one of several key insights available to Pro subscribers.
The Phase 3 study will evaluate amezalpat in combination with atezolizumab and bevacizumab versus the standard of care alone for first-line treatment of patients with unresectable or metastatic hepatocellular carcinoma (HCC).
This approval follows previous clearances from the U.S. Food and Drug Administration and European Medicines Agency for the trial design.
"This regulatory clearance to proceed with a pivotal trial in China is a significant milestone towards reaching global markets where HCC has high prevalence," said Sam Whiting, chief medical officer and head of R&D at Tempest.
The planned Phase 3 study will be a global, blinded, randomized trial with a 1:1 ratio testing the drug combination against placebo plus the standard of care. The company noted that the trial includes a pre-specified efficacy analysis that could potentially shorten the time to primary analysis.
Hepatocellular carcinoma is projected to become the third leading cause of cancer death globally by 2030, with over 900,000 people diagnosed worldwide annually. China has the largest population of HCC patients in the world.
In an ongoing Phase 1b/2 study, the amezalpat combination showed clinical superiority across multiple endpoints, including overall survival, when compared to the standard of care alone, according to the company’s press release statement.
Tempest Therapeutics is a clinical-stage biotechnology company developing small molecule product candidates for various tumor types. Trading at $6.90 per share, the stock has shown strong momentum recently with a positive return over the last month, despite being down 76% over the past year. InvestingPro analysis suggests the stock may be undervalued based on its Fair Value metrics, though investors should note the company’s weak overall financial health score of 1.55 out of 5.
In other recent news, Tempest Therapeutics has announced a registered direct offering expected to raise approximately $4.6 million. This move involves the issuance of 739,000 shares of common stock at $6.25 per share, with H.C. Wainwright & Co. serving as the exclusive placement agent. The company plans to use the proceeds to support its strategic alternative process and for general corporate purposes. Additionally, Tempest has terminated its automatic teller machine prospectus supplement with Jefferies LLC, halting any further sales of its securities under the existing agreement.
Tempest Therapeutics also received Orphan Drug Designation from the European Medicines Agency for its cancer treatment drug, amezalpat, aimed at treating hepatocellular carcinoma. This recognition follows similar designations from the U.S. Food and Drug Administration, highlighting the drug’s potential benefits. Furthermore, the FDA granted Orphan Drug Designation to Tempest’s TPST-1495 for Familial Adenomatous Polyposis, a rare condition, which may expedite its development process. Tempest has also regained compliance with Nasdaq’s minimum bid price requirement, securing its listing on the exchange. These developments reflect the company’s ongoing efforts to advance its clinical programs and maintain regulatory compliance.
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