BRISBANE, Calif. - Tempest Therapeutics, Inc. (NASDAQ:TPST), a biotechnology firm focused on cancer treatments, has reached an agreement with pharmaceutical giant Roche to progress a Phase 3 trial for a potential liver cancer therapy. The study, slated to begin in the first quarter of 2025, will examine the efficacy of amezalpat in combination with Roche's atezolizumab and bevacizumab, compared to the current standard care for patients with unresectable or metastatic hepatocellular carcinoma (HCC).
The collaboration is an extension of a previous clinical partnership where the combination of these drugs was tested against the standard treatment in a Phase 1b/2 study. Tempest retains all development and commercial rights to amezalpat, an oral, small molecule antagonist targeting cancer cell growth and immune suppression within the tumor microenvironment.
This move follows the release of positive survival data from the ongoing study, which showed a six-month median overall survival improvement for patients treated with the combination therapy. The benefits were consistent across key subpopulations and were particularly notable in patients with a specific gene mutation.
In August 2024, the U.S. Food and Drug Administration (FDA) agreed on the Phase 3 study design, amezalpat dosage, and primary endpoint. A pre-specified early efficacy analysis could potentially shorten the study's timeline by eight months.
Stephen Brady, president and CEO of Tempest, expressed optimism about the potential of amezalpat to improve first-line liver cancer treatment. The upcoming study aims to validate the Phase 2 findings on a larger scale and bring a new treatment option to patients with HCC, a condition with a high unmet medical need.
This announcement is based on a press release statement and should not be regarded as a prediction of future events. Investors are advised not to rely solely on forward-looking statements for making investment decisions.
In other recent news, Tempest Therapeutics has been making noteworthy strides in cancer treatment development. The company recently received approval from the U.S. Food and Drug Administration (FDA) for the Phase 3 clinical trial of its cancer drug, amezalpat, intended for treating hepatocellular carcinoma (HCC). This follows a successful Phase 2 trial, with the FDA acknowledging the appropriateness of the current dosage and schedule for the Phase 3 trial.
Tempest Therapeutics has also appointed Troy M. Wagner as Vice President of Quality Assurance, leveraging his three decades of experience in the pharmaceutical sector to oversee quality systems and support global regulatory filings. This strategic appointment comes as the company prepares for Phase 3 trials of its leading oncology candidate, amezalpat.
Scotiabank has reiterated its Sector Outperform rating on shares of Tempest Therapeutics, reflecting confidence in the company's strategic position and the expected swift patient recruitment for its clinical program for HCC treatment. These recent developments highlight the company's continued progress in the field of cancer treatment.
InvestingPro Insights
As Tempest Therapeutics (NASDAQ:TPST) gears up for its Phase 3 trial with Roche, investors should consider some key financial metrics and insights from InvestingPro.
According to InvestingPro data, Tempest holds more cash than debt on its balance sheet, which could be crucial for funding the upcoming clinical trial. This financial stability is further supported by the fact that the company's liquid assets exceed its short-term obligations. These factors may provide Tempest with the necessary financial flexibility to pursue its ambitious clinical program.
However, it's important to note that Tempest is quickly burning through its cash reserves, as indicated by an InvestingPro Tip. This rapid cash burn is not uncommon for biotechnology companies in the clinical development stage, but it underscores the importance of the company's partnership with Roche and the potential success of the Phase 3 trial.
Another InvestingPro Tip reveals that analysts do not anticipate the company will be profitable this year. This aligns with the article's focus on the future potential of amezalpat rather than current profitability. The company's stock price has also fallen significantly over the last three months, which could present an opportunity for investors who believe in the long-term potential of Tempest's pipeline.
For investors seeking a more comprehensive analysis, InvestingPro offers 11 additional tips for Tempest Therapeutics, providing a deeper understanding of the company's financial health and market position.
This article was generated with the support of AI and reviewed by an editor. For more information see our T&C.