Azenosertib (ZN-c3) - (TETON)

Nov. 10, 2025: Zentalis Pharmaceuticals, Inc. (NASDAQ: ZNTL) reported Q3 2025 financial results and provided pipeline updates for azenosertib (ZN-c3), an investigational oral WEE1 inhibitor.

Azenosertib – DENALI Phase 2 (NCT05128825) in Cyclin E1-positive platinum-resistant ovarian cancer (PROC): Enrollment is ongoing in Part 2a (dose confirmation) targeting up to ~30 patients per arm at 400 mg QD 5:2 and 300 mg QD 5:2; Part 2b is planned to enroll ~70 patients at a single dose selected based on Part 2a. The company expects to disclose topline data from DENALI Part 2 (Parts 2a+2b) by year-end 2026. DENALI Part 2 is intended to potentially support accelerated approval, subject to FDA feedback/review. The company also noted poster presentations at the AACR-NCI-EORTC Molecular Targets and Cancer Therapeutics conference featuring Phase 1 biomarker findings supporting its Cyclin E1 strategy.

Azenosertib – TETON Phase 2 in uterine serous carcinoma (USC): Enrollment is complete; development in USC will be limited to partnering or available capital. Results are planned for publication in 1H 2026.

Financials: Cash/cash equivalents/marketable securities were $280.7M as of Sept. 30, 2025, projected to fund operations into late 2027.