Zentalis Pharmaceuticals (ZNTL) Wells Fargo 20th Annual Healthcare Conference 2025 summary

Strategic focus and clinical priorities

• Emphasis on advancing registration-directed studies for azenasertib in cyclin E1 overexpressing, platinum-resistant ovarian cancer, with a clear focus on market education and clinical execution over the next 6–12 months.

• Strategic decision to prioritize azenasertib as a first-in-class, non-chemo oral option for a biomarker-selected population with high unmet need.

• Ongoing engagement with regulators to ensure a clear path to accelerated approval and initiation of a phase III confirmatory study.

• Enrollment and trial execution are on track, with strong investigator enthusiasm and active patient screening.

Differentiation and clinical data

• Azenasertib offers a differentiated, non-chemo oral therapy compared to standard non-platinum chemo, with strong correlation to outcomes in cyclin E1 overexpressers.

• Historical trials show azenasertib nearly doubles or triples response rates versus standard care in a population with poor outcomes.

• DENALI trial uses a seamless design to compare 300mg and 400mg doses, with 400mg showing higher efficacy in cross-trial comparisons.

• Dose selection will be finalized in consultation with regulators, with top-line data expected at the end of 2026.

Expansion and combination strategies

• Over 700 patients have been treated with azenasertib, demonstrating a well-characterized safety profile in both single-agent and combination settings.

• Ongoing and planned studies include combinations with chemotherapy, bevacizumab, and antibody-drug conjugates (ADCs), with preclinical data showing synergy across multiple tumor types.

• Future expansion opportunities include earlier lines of ovarian cancer and other tumor types, contingent on resource allocation and clinical signals.