Zentalis Pharmaceuticals Provides Corporate Update and Highlights Key Milestones and Expected Momentum in the Azenosertib Development Program for 2026

Core Insights - Zentalis Pharmaceuticals is advancing the development of azenosertib, a first-in-class WEE1 inhibitor, targeting Cyclin E1-positive platinum-resistant ovarian cancer (PROC) with significant unmet medical needs [2][8] Company Updates - The completion of enrollment in DENALI Part 2a is a significant milestone, with dose confirmation expected in the first half of 2026 and a topline readout anticipated by the end of 2026, which could support accelerated approval from the FDA [2][6] - The initiation of the ASPENOVA Phase 3 trial is planned for the first half of 2026, comparing azenosertib to standard-of-care chemotherapy in a biomarker-selected population [2][5] - Zentalis maintains a strong financial position with cash, cash equivalents, and marketable securities totaling $280.7 million as of September 30, 2025, providing a runway into late 2027 [3][6] Clinical Development - Azenosertib is being evaluated in clinical studies for ovarian cancer and other tumor types, with a focus on its role in earlier lines of ovarian cancer and additional indications [2][5] - The DENALI clinical trial is designed for accelerated approval, with Part 2 focusing on patients with Cyclin E1 protein overexpression, which is a predictive biomarker for treatment benefit [9][8] - Strong data from three trials in PROC have established a solid foundation for azenosertib as a lead indication, demonstrating clinically meaningful results and a manageable safety profile [6][9]