BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ: TPST), a clinical-stage biotechnology company, announced today that it is preparing to advance its cancer treatment candidate TPST-1120 to a pivotal Phase 3 trial in Hepatocellular Carcinoma (HCC) after observing positive results in earlier phases of clinical trials. The decision follows the publication of encouraging data from a Phase 1 trial in Cancer Research Communications.
TPST-1120, an oral, selective PPARα antagonist, displayed clinical activity including tumor shrinkage in PD-1 inhibitor refractory and immune-compromised cancers. The drug was well-tolerated both as monotherapy and in combination with nivolumab. These findings complement October 2023 data from a global randomized study, which indicated clinical superiority of TPST-1120 in combination with atezolizumab and bevacizumab over the standard care for advanced HCC.
The Phase 1 study treated 35 patients with escalating doses of TPST-1120. In monotherapy, stable disease was observed in 53% of evaluable patients, with a subset experiencing treatment durations over five months. In combination therapy, objective response rates were 23% across all dose levels, suggesting a dose-responsive anti-cancer activity.
Dr. Sam Whiting, Chief Medical Officer and Head of R&D at Tempest, expressed optimism about the potential of TPST-1120, noting the first evidence of anti-tumor activity across multiple cancer types. He highlighted the link between changes in PPARα-associated immune genes and clinical outcomes, which was observed in patients who responded to the treatment.
Tempest Therapeutics is focused on developing targeted and immune-mediated therapeutics to combat cancer. TPST-1120 is entirely owned by Tempest and represents a novel approach to cancer treatment by targeting tumor cells and modulating immune suppressive cells and angiogenesis within the tumor microenvironment.
This news is based on a press release statement from Tempest Therapeutics. The company cautions that the press release contains forward-looking statements, which 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 advised not to place undue reliance on these forward-looking statements.
InvestingPro Insights
As Tempest Therapeutics, Inc. (NASDAQ: TPST) gears up for a pivotal Phase 3 trial of its cancer treatment candidate TPST-1120, investors are closely monitoring the company's financial health and stock performance. Here are some key insights from InvestingPro that may be of interest:
InvestingPro Data shows that TPST has a market capitalization of $113.73 million USD, indicating the company's size in the biotechnology sector. Despite the challenges of drug development, TPST has shown a remarkable 1-year price total return of 122.83%, which could reflect investor confidence in the company's pipeline and its future prospects.
However, the financial metrics reveal a more complex picture. The company's P/E Ratio stands at -2.70, and it has an adjusted P/E Ratio for the last twelve months as of Q4 2023 of -3.86. This negative P/E ratio suggests that TPST is not currently profitable, a common situation for clinical-stage biotech companies investing heavily in research and development.
InvestingPro Tips highlight that TPST holds more cash than debt on its balance sheet, which is a positive sign for its financial stability. Nevertheless, analysts are not expecting the company to be profitable this year, indicating that the road to financial success may still be long for Tempest Therapeutics.
For investors seeking a deeper dive into Tempest Therapeutics' prospects, InvestingPro offers additional insights, including 13 more InvestingPro Tips. These tips can provide a more nuanced understanding of TPST's financial position, stock performance, and market behavior. To access these tips, visit: https://www.investing.com/pro/TPST.
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