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Zentalis Pharmaceuticals (ZNTL) investor relations material

Zentalis Pharmaceuticals Morgan Stanley 23rd Annual Global Healthcare Conference summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Morgan Stanley 23rd Annual Global Healthcare Conference summary9 Sep, 2025

Strategic focus and clinical development

  • Lead asset azenosertib is being advanced in platinum-resistant ovarian cancer, targeting patients with cyclin E1 protein overexpression.

  • The Denali trial is a registration-intent study aiming for accelerated approval, with a phase 3 confirmatory trial planned.

  • A clear strategic focus was established to prioritize azenosertib in ovarian cancer, with capital allocated to this path and ongoing trials in other indications.

  • The company underwent restructuring to ensure sufficient capital, reporting $303 million in cash and equivalents, providing runway into late 2027.

Clinical data and trial design

  • Integrated analysis across multiple studies showed consistent response rates and durability for azenosertib, with a 35% response rate and 6.3 months duration in Denali part 1.

  • The selected dosing regimen is 400 mg, five days on, two days off, based on efficacy and tolerability.

  • Cyclin E1 biomarker enrichment improved response rates by over 10%, and prospective enrichment is being used in Denali part 2.

  • Denali part 2A is a randomized dose confirmation (300 mg vs 400 mg), with part 2B expanding to a registrational size; top-line data expected end of 2026.

  • The FDA has aligned with the trial design, including the need for a confirmatory phase 3 trial in the same patient population.

Safety, regulatory, and market positioning

  • Safety profile is considered manageable, with protocol updates and site management to address adverse events.

  • A brief clinical hold was resolved without changes to dose or schedule, and the FDA expressed confidence in the program.

  • The target market is about 21,500 patients annually in the US, representing 50% of the platinum-resistant ovarian cancer population.

  • Expansion opportunities include earlier lines of ovarian cancer, combinations with other agents, and other tumor types such as HER2-positive and triple-negative breast cancer.

  • The company remains focused on its lead indication but is open to further development if additional capital becomes available.

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Frequently asked questions

Zentalis Pharmaceuticals Inc., operating under the ticker ZNTL on the NASDAQ, is a clinical-stage biopharmaceutical company with a dedicated focus on the discovery and development of small molecule therapeutics aimed at various cancer types. Its pipeline includes a variety of compounds in different stages of clinical trials, targeting key biological pathways in cancer. Zentalis Pharmaceuticals is headquartered in NYC and its shares are listed on the Nasdaq.

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