Zentalis Pharmaceuticals Announces Corporate Update and Key Milestones for Azenosertib in 2026

On January 6, 2026, Zentalis Pharmaceuticals, Inc. (Nasdaq: ZNTL), a leader in clinical oncology, provided a pivotal corporate update regarding its investigational WEE1 inhibitor, azenosertib. The update highlighted substantial progress in the development program for azenosertib, particularly in its approach to treating platinum-resistant ovarian cancer, and outlined expected momentum for the year ahead.

Significant Developments Ahead

2026 is set to be a transformative year for Zentalis as it aims for potential regulatory approval of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer (PROC). Julie Eastland, Chief Executive Officer of Zentalis, expressed optimism regarding the upcoming milestones:

"The completion of DENALI Part 2a enrollment marks significant progress, positioning us for dose confirmation in the first half of 2026, followed by an expected topline readout by year-end that could support accelerated approval, subject to FDA feedback."

Additionally, Zentalis plans to initiate the ASPENOVA Phase 3 trial in the first half of 2026, which will compare azenosertib to standard-of-care chemotherapy in a biomarker-selected patient population.

Changes and Accomplishments in 2025

• DENALI Part 2a Enrollment Completed: Zentalis successfully enrolled patients in the second part of its Phase 2 DENALI clinical trial, focusing on dose confirmation of azenosertib.
• Alignment with the FDA: The company aligned on the design for the ASPENOVA Phase 3 trial with the FDA, ensuring the study meets regulatory expectations.
• Strong Clinical Data: Prior trials provided a strong foundation for azenosertib as a leading candidate in Cyclin E1-positive PROC. Interim results indicated a manageable safety profile and clinically significant benefits.
• Robust Financial Position: Zentalis reported cash and securities totaling $280.7 million as of September 30, 2025, giving it a projected financial runway into late 2027 to support ongoing developments.

Key Milestones Anticipated in 2026

• Dose Confirmation: Expected in the first half of 2026 following DENALI Part 2a.
• ASPENOVA Trial Initiation: Set for the first half of 2026, this trial will further validate azenosertib against established treatments.
• Topline Readout from DENALI Part 2: Anticipated by year-end 2026, with the potential to support accelerated FDA approval based on favorable outcomes.

Understanding Azenosertib

Azenosertib is an investigational, first-in-class inhibitor of WEE1, designed to target key cell cycle checkpoints to enhance anti-cancer activity. It is being studied in a range of tumor types, with a focus on ovarian cancer where traditional chemotherapy options are often ineffective.

Details on the DENALI Clinical Trial

The DENALI trial is structured to examine azenosertib's safety and efficacy in PROC patients. Part 1b involved treatment at 400mg QD 5:2, while Part 2 focuses on reinforcing the data by enrolling patients expressing Cyclin E1 protein.

About Zentalis Pharmaceuticals

Zentalis Pharmaceuticals is committed to innovating cancer treatment options, particularly for ovarian cancer. By leveraging cutting-edge science and extensive biomarker research, Zentalis aims to deliver highly effective, non-chemo oral therapies to meet critical patient needs.

Forward-Looking Statements

This release contains forward-looking statements regarding Zentalis' potential to advance azenosertib as a first-in-class therapy. Actual outcomes may vary significantly based on various factors, including regulatory feedback and trial results.

For more information about Zentalis Pharmaceuticals and its groundbreaking research, visit www.zentalis.com or follow them on LinkedIn.