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BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a clinical-stage biotechnology firm with a market capitalization of approximately $35 million, has received authorization from the U.S. Food and Drug Administration (FDA) to proceed with a Phase 2 clinical trial for TPST-1495, a potential treatment for Familial Adenomatous Polyposis (FAP). The company announced today that the Cancer Prevention Clinical Trials Network will commence the study this year, with financial backing from the National Cancer Institute’s Division of Cancer Prevention. According to InvestingPro data, the stock has seen significant price movement over the past year, with shares down over 76%.
TPST-1495 is a novel dual receptor inhibitor designed to disrupt prostaglandin (PGE2) signaling. The Phase 2 trial will assess the drug’s efficacy and safety in patients with FAP who have undergone colectomy. The primary goal is to evaluate TPST-1495’s ability to reduce the duodenal polyp burden over six months. Secondary objectives include the reduction of polyp burden in the retained rectum or IPAA and assessing the overall safety of the treatment. InvestingPro analysis shows that while the company maintains a current ratio of 1.69, indicating adequate short-term liquidity, its overall financial health score is categorized as weak. Notably, three analysts have recently revised their earnings expectations upward for the upcoming period.
Familial Adenomatous Polyposis is a condition that carries a high risk for developing multiple gastrointestinal cancers. The study aims to offer new treatment options for patients grappling with this challenging disease.
Sam Whiting M.D., Ph.D., chief medical officer and head of R&D at Tempest, expressed the importance of this development in providing innovative approaches for cancer prevention. The collaboration with the Cancer Prevention Clinical Trials Network highlights the urgent need for new therapies in this area.
Tempest Therapeutics is engaged in developing a diverse portfolio of small molecule product candidates that target tumor cells or modulate the immune system to treat various tumors. Their programs range from early research to later-stage investigations, including a randomized global study for first-line cancer patients.
This news is based on a press release statement and contains forward-looking statements. These statements are not guarantees of future performance and are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Investors are cautioned not to place undue reliance on these forward-looking statements. InvestingPro data reveals that while the company holds more cash than debt on its balance sheet, it is quickly burning through its cash reserves. Subscribers to InvestingPro can access 8 additional key insights about Tempest Therapeutics, along with detailed financial metrics and analyst forecasts.
In other recent news, Tempest Therapeutics, Inc. has received a notification from The Nasdaq Stock Market LLC regarding noncompliance with the minimum bid price requirement. The company’s stock has fallen below the $1.00 per share threshold for 30 consecutive business days, violating Nasdaq Listing Rule 5550(a)(2). As of December 27, 2024, Tempest Therapeutics has been given a 180-day period, ending on June 25, 2025, to regain compliance by maintaining a closing bid price of at least $1.00 per share for 10 consecutive business days. If the company fails to meet this requirement, it may qualify for an additional 180-day period, provided it meets all other initial listing standards, excluding the bid price requirement. Tempest Therapeutics has already secured stockholder approval to implement a reverse stock split if necessary, with a ratio ranging from 1-for-2 to 1-for-15. The company has expressed its intention to monitor its stock price closely and is exploring options to address the deficiency. Investors are encouraged to keep an eye on the company’s filings and announcements for further updates on this issue.
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