Zentalis Pharmaceuticals Inc (ZNTL) News & EventsZNTLZentalis Pharmaceuticals Inc

Zentalis Presents Overall Survival Data for Azenosertib in DENALI Study

Zentalis presented results from an interim analysis of the DENALI Part 1b study as of a May 22 data cutoff, including the first overall survival analysis for azenosertib, at the European Society for Medical Oncology Congress 2026 in Madrid, Spain. As of the May 22 data cutoff, DENALI Part 1b enrolled 102 patients with PROC regardless of Cyclin E1 protein expression who had received between one and five prior lines of therapy, with prior bevacizumab required. This was a heavily pretreated population: 97% had received a taxane, 91% bevacizumab, 55% a PARP inhibitor, and 15% mirvetuximab soravtansine, with a median of three prior lines of therapy. Cyclin E1 status was retrospectively determined by immunohistochemistry using a proprietary cutoff, with 94 patients evaluable: Overall Survival: Cyclin E1 IHC-positive: median OS of 15.9 months; 31 events had occurred; Cyclin E1 IHC-negative: median OS of 7.5 months; 34 events had occurred. Objective Response Rate and Duration of Response: ORR in response-evaluable Cyclin E1 IHC-positive patients: 37.2%. ORR in all Cyclin E1 IHC-positive patients: 33.3%. Median DOR: 5.5 months/ The updated ORR includes a patient with a confirmed response after the prior cutoff. The current median DOR of 5.5 months reflects a more mature dataset with less censoring than the prior cutoff, including two patients with particularly durable responses exceeding 15 and 20 months. The safety profile was consistent with prior reporting. The most common treatment-related adverse events were nausea, fatigue, diarrhea, thrombocytopenia, decreased appetite, anemia, and neutropenia. The most common non-hematologic Grade greater than or equal to3 TRAE was fatigue. Grade greater than or equal to3 hematologic TRAEs included thrombocytopenia, anemia and neutropenia. The median relative dose intensity was 84.6%, confirming that overall exposure to azenosertib remained high despite dose modifications. TRAEs led to dose interruption in 56.9% of patients, dose reduction in 43.1%, and discontinuation in 19.6%. Serious TRAEs occurred in 21.6% of patients.

Zentalis Publishes Interim Survival Data from DENALI Study

Zentalis Pharmaceuticals announced that overall survival, OS, data from an interim analysis of the DENALI Part 1b study, GOG-3066, have been published in the abstract for the upcoming rapid oral presentation at the European Society for Medical Oncology, ESMO, Congress 2026. The published abstract reports results for OS, a secondary endpoint of DENALI Part 1b in patients with platinum-resistant ovarian cancer, PROC, from an interim analysis. As of the September 2, 2025 data cutoff: In the Cyclin E1-positive subgroup: median OS of 15.8 months; In the Cyclin E1-negative subgroup: median OS of 7.5 months; No new safety signals were observed.

Zentalis Pharmaceuticals Launches Public Offering

Zentalis Pharmaceuticals announced the commencement of a proposed underwritten public offering of shares of its common stock and in lieu of common stock to certain investors that so choose, pre-funded warrants to purchase shares of its common stock. All of the securities to be sold in the proposed offering will be sold by the company. The company intends to use the net proceeds from the offering, together with the company's existing cash, cash equivalents and marketable securities, to fund clinical trials, preclinical studies, regulatory filings, manufacturing and the Company's companion diagnostic in support of its programs, as well as for pre-commercial activities, capital expenditures, working capital and other general corporate purposes. TD Cowen, Guggenheim Securities and Oppenheimer & Co. are acting as joint bookrunners for the offering.