Zentalis Pharmaceuticals (ZNTL) Corporate presentation summary

Strategic focus and market opportunity

• Targeting approximately 20,000 Cyclin E1-positive platinum-resistant ovarian cancer (PROC) patients lacking specifically targeted therapies, with azenosertib positioned as a first-in-class, oral, non-chemotherapy option.

• Clear regulatory path: DENALI Part 2 topline readout expected in 1H 2027 for potential accelerated approval; ASPENOVA Phase 3 trial enrolling to support full approval.

• Expansion plans include earlier lines of ovarian cancer and other tumor types, leveraging industry-leading WEE1 expertise and a $175M cash runway into late 2027.

Clinical development and trial progress

• Completed enrollment in DENALI Part 2a and 2b, confirming 400mg QD 5:2 as the monotherapy dose for pivotal studies in Cyclin E1-positive PROC.

• ASPENOVA Phase 3 trial aligned with FDA, enrolling patients to compare azenosertib with standard chemotherapy, with primary endpoint of progression-free survival.

• MUIR study ongoing for azenosertib in combination with bevacizumab in platinum-sensitive ovarian cancer maintenance settings.

Clinical efficacy and safety profile

• Integrated analysis across multiple studies shows >30% overall response rate (ORR) and ~6 month median duration of response (mDOR) at 400mg QD 5:2 in Cyclin E1-positive PROC.

• Safety profile at 400mg QD 5:2 is manageable, with most common adverse events being nausea, diarrhea, and fatigue; enhanced trial management reduced discontinuations and treatment-related deaths.

• Cyclin E1 identified as a predictive biomarker for response, with durable responses observed regardless of CCNE1 amplification status.