Zentalis Pharmaceuticals (ZNTL) investor relations material

Clinical development and trial updates

• Focused on developing azenosertib, a WEE1 inhibitor, for platinum-resistant ovarian cancer in Cyclin E1 high patients, with the DENALI trial aiming for accelerated approval and ASPENOVA as a confirmatory global trial.

• DENALI trial uses a five-on, two-off oral dosing schedule, showing favorable tolerability and efficacy at 400 mg, with consistent response rates above 30% and duration of response over five months across studies.

• Cohort 2C was added to DENALI to reflect real-world treatment paradigms, shifting the integrated data readout to the first half of next year to allow for comprehensive analysis.

• FDA interactions confirmed the appropriateness of the trial design, dosing, and integrated analysis for accelerated approval, with the agency supportive of the approach.

• ASPENOVA is enrolling 420 patients globally, using investigator's choice chemotherapy as control, and is designed to support full approval.

Expansion opportunities and strategic focus

• Exploring azenosertib in earlier ovarian cancer lines and in combination with bevacizumab for second-line maintenance, targeting patients progressing on PARP inhibitors.

• Preclinical data suggest potential in triple-negative breast cancer and HPV-driven diseases, with future expansion decisions guided by biology and combination partners.

• Strategic focus remains on maximizing capital efficiency, prioritizing platinum-resistant ovarian cancer, and expanding to broader indications as data matures.

Market landscape and commercial planning

• Cyclin E1 high PROC population represents about 20,000 patients across the U.S., EU5, U.K., and Japan, with about half eligible for targeted therapy.

• Current standard of care is chemotherapy, often associated with significant toxicities; azenosertib offers an oral, non-chemotherapy alternative with a differentiated safety profile.

• Pre-commercial activities include market research, development of companion diagnostics, and payer strategy, with commercial investments staged post-data.