Zentalis Pharmaceuticals, Inc.

The company is a clinical-stage biopharmaceutical company focused on developing azenosertib (ZN-c3), an investigational WEE1 inhibitor, for patients with ovarian cancer and other tumor types. Azenosertib has demonstrated anti-tumor activity as a single agent across multiple tumor types in clinical trials. The company is currently advancing the clinical development of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). The DENALI (ZN-c3-005) Part 2 clinical trial of azenosertib in patients with Cyclin E1-positive PROC, if successful, may support an accelerated approval, subject to U.S. Food and Drug Administration (FDA) review. The company exclusively in-licenses or solely owns worldwide development and commercialization rights to azenosertib. Its strategy includes rapidly advancing azenosertib as a monotherapy toward first regulatory approval in Cyclin E1-positive PROC. In January 2025, clinical data showed an objective response rate (ORR) of over 30% and a manageable safety profile in patients with Cyclin E1-positive PROC who received azenosertib at 400 mg QD 5:2. Enrollment in Part 2a of the Phase 2 DENALI clinical trial was completed in 2025, with a topline readout anticipated by year end 2026. The company also plans to advance the development of azenosertib outside of Cyclin E1-positive PROC, as resources allow.