The FDA’s move to lift the hold on Zentalis Pharmaceuticals’ sole clinical-stage drug may have been good news for the biotech—but it’s been bad news for some of its staff. The company is now laying off 40% of its employees as it gears up for registrational studies in ovarian cancer.
Trials of the synthetic lethal WEE1 inhibitor, called azenosertib, were placed on hold by the FDA in June 2024 in the wake of two patient deaths that were presumed to be from sepsis. The hold was lifted three months later, and, by November, the company was shaking up its C-suite in preparation for a potentially registrational readout expected by the end of 2026.
But that’s not all the changes Zentalis is making to pave azenosertib’s path to regulators. In a post-market release Jan. 28, the biotech said the 40% layoffs were needed to ensure its cash tap keeps running until late 2027.
“Zentalis is sharply focused on our goal of bringing azenosertib to patients with gynecological malignancies,” said CEO Julie Eastland, who joined Zentalis in November. Eastland had previously served as CEO of Harpoon Therapeutics, which was bought out by Merck & Co. last year.
“To support this goal, we have made the necessary decisions to efficiently organize our company and allocate our capital resources to extend cash runway beyond an anticipated azenosertib data readout that we believe has the potential to be registration-enabling,” Eastland added in the release.
Zentalis announced the layoffs—which should be completed in the second quarter—ahead of an event this morning to map out the plans for the registrational studies.
The biotech came to the American Society of Clinical Oncology conference in May 2024 armed with data from a phase 1 trial of azenosertib in combination with the chemotherapy gemcitabine in relapsed or refractory osteosarcoma. At the maximum tolerated dose, the most common adverse events of grade 3 or above were thrombocytopenia and lymphopenia, although the company pointed out that there were no grade 4 thrombocytopenia events or instances of febrile neutropenia at this dose.