Earlier this month, Tempest Therapeutics announced that it would explore strategic alternatives for its oncology pipeline of assets. Specifically, it has a phase 3 ready drug in its pipeline known as Amezalpat (TPST-1120), which had already been studies in a phase 2 study for the treatment of patients with first-line hepatocellular carcinoma (liver cancer).
The biotech has been struggling to find a suitor who would be willing to put up the cash to fund its endeavor of running a phase 3 study to get Amezalpat to the finish line. The hope is that a strategic alternative will be established to boost shareholder value, as no trial has yet been initiated to move this program forward.
Things looked very good back in October of 2023, when the stock price soared as much as a historic 1,500% in one day after the Amezalpat combination was shown to be superior to that of Roche’s current standard of care (SOC) atezolizumab (TECENTRIQ) + bevacizumab (AVASTIN) in targeting such 1st-line liver cancer patients. In essence, it was shown in a phase 1b/2 study that Amezalpat (TPST-1120) in combination with atezolizumab + bevacizumab achieved a confirmed objective response rate (ORR) of 30%. Compared to that of current SOC allowing patients to typically achieve a confirmed ORR of only 13.3%.
With the company now looking towards some type of strategic transaction to take place, it has gone one step further last Friday. In an 8-K SEC filing, which was filed on April 18th, it was revealed that it would remove about 21 of 26 of its full-time employees in an effort to conserve cash. Whether such a move is a smart one highly depends on if Tempest can garner some type of merger or transaction or be bought out before it runs out of cash.
In a press release today, the company noted that it had received Orphan Drug Designation for its other oncology candidate from its pipeline, known as TPST-1495. This particular novel dual receptor inhibitor of prostaglandin (PGE2) signaling is being developed for the treatment of patients with Familial Adenomatous Polyposis (FAP).
A phase 2 trial for this program is set to kick off in 2025, and clinical data from it is expected to be released at some point in 2026. Of course, while not guaranteed, it is possible that the company could have achieved its strategic alternative by then. However, this remains to be seen, as thus far, it has not fared well in capturing a suitor who is willing to fund its phase 3 study of Amezalpat.