Zentalis Pharmaceuticals
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Zentalis Pharmaceuticals (ZNTL) investor relations material

Zentalis Pharmaceuticals Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Guggenheim Securities Emerging Outlook: Biotech Summit 2026 summary11 Feb, 2026

Strategic priorities and trial focus

  • Strategy centers on rapid development of azenosertib for platinum-resistant ovarian cancer with high cyclin E1 expression, prioritizing the DENALI registration trial and the ASPENOVA confirmatory Phase 3 trial.

  • DENALI Part 2 is enrolling, with dose selection between 300 mg and 400 mg ongoing; final dose selection and trial readout expected by year-end 2026.

  • ASPENOVA Phase 3 trial mirrors DENALI eligibility, is randomized against standard-of-care, and includes an adaptive dose confirmation arm to accelerate timelines.

  • Biomarker-driven patient selection uses a validated IHC assay for cyclin E1, with about 50% of eligible patients expected to be positive.

  • Prioritization remains on ovarian cancer, with other indications or combinations considered secondary and dependent on resource availability.

Clinical profile and differentiation

  • Azenosertib is an oral, non-chemo option, offering a differentiated profile from ADCs and chemotherapy, targeting a specific biomarker-defined population.

  • Demonstrates a favorable tolerability and safety profile, with low rates of high-grade neutropenia and manageable GI side effects.

  • Data-driven clinical oversight and proactive site support are used to optimize safety and management during trials.

  • Dose selection is based on overall risk-benefit, response rate, and PKPD modeling, with both doses showing similar tolerability.

  • Efficacy bar for accelerated approval is around 30% ORR and 5–6 months duration of response, with current data exceeding these thresholds.

Trial design and regulatory strategy

  • DENALI is a single-arm trial for accelerated approval, while ASPENOVA is a randomized controlled trial, both using the same biomarker criteria.

  • Adaptive design in ASPENOVA allows for rapid initiation and dose confirmation, minimizing delays between trials.

  • Regulatory engagement has aligned trial designs with FDA preferences, supporting a clear path for both accelerated and full approval.

  • Changes in eligibility criteria between DENALI parts include prospective biomarker selection and limits on prior lines of therapy.

  • Cross-trial evidence suggests cyclin E high expressors have poorer prognosis, supporting the need for targeted therapy.

Impact of DENALI dose selection on adoption
Azenosertib's niche amid ADC competition
Criteria for future assets beyond azenosertib
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Q4 202527 Feb, 2026
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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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