Earnings summaries and quarterly performance for Zentalis Pharmaceuticals.
Executive leadership at Zentalis Pharmaceuticals.
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ZNTL Provides Update on Azenosertib Development for Ovarian Cancer
ZNTL
New Projects/Investments
Guidance Update
- Zentalis (ZNTL) is focused on the late-stage development of its lead candidate, azenosertib, a potentially best-in-class, orally available non-chemotherapy for Cyclin E1-positive platinum-resistant ovarian cancer (PROC). This patient population represents about 50% of the PROC market, or approximately 21,500 patients.
- Azenosertib has demonstrated encouraging efficacy with consistent response rates over 30% and a duration of response exceeding six months in these patients at the 400 milligram dose.
- The company has initiated Denali Part 2, a Phase 2 study designed for an accelerated approval pathway, with top-line data expected around year-end 2026.
- Key milestones for 2026 include dose selection for Denali and the initiation of the Phase 3 confirmatory trial.
- Zentalis's cash runway is projected to support development through late 2027, extending beyond the anticipated top-line data readout in 2026.
Nov 12, 2025, 1:00 PM
Zentalis Provides Update on Asenocertib Development for Platinum-Resistant Ovarian Cancer
ZNTL
New Projects/Investments
Guidance Update
- Zentalis (ZNTL) is focused on the late-stage development of its lead candidate, asenocertib, for cyclin E1 positive platinum-resistant ovarian cancer (PROC).
- The Phase 2 Denali Part 2 study is designed for an accelerated approval pathway, with reported response rates over 30% and duration of response exceeding six months in this patient population.
- The target market for asenocertib is estimated to be 50% of the PROC population, representing approximately 21,005 patients.
- Key upcoming milestones include initiating a Phase 3 confirmatory trial in 2026 and expecting top-line data from the Denali Part 2 trial by the end of 2026.
- Zentalis's cash runway is projected to support development through late 2027, extending beyond the 2026 top-line readout.
Nov 12, 2025, 1:00 PM
Zentalis Pharmaceuticals Updates on Azenosertib Progress in Ovarian Cancer Trials
ZNTL
New Projects/Investments
Guidance Update
Product Launch
- Zentalis Pharmaceuticals is prioritizing the development of azenosertib for platinum-resistant ovarian cancer (PROC) in patients with high cycling E1 protein expression, aiming for accelerated approval via the Denali part 2 study and a subsequent phase 3 confirmatory trial.
- Azenosertib is positioned as a differentiated oral, non-chemo, biomarker-directed therapy, demonstrating response rates greater than 35% and durable responses over six months in historical studies, significantly exceeding the 4-13% response rates of current standard-of-care chemotherapy.
- The tolerability profile of azenosertib is described as manageable, with significantly fewer high-grade cytopenias and reduced GI toxicities compared to other WEE1 inhibitors.
- Enrollment for the Denali trial (parts 2A and B combined) is on track to provide top-line data by the end of 2026. While the Teton trial (in USC) is fully enrolled with data expected in the first half of 2026, Zentalis's primary investment focus remains on PROC.
Nov 11, 2025, 8:30 PM
Zentalis Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Progress
ZNTL
Earnings
Guidance Update
New Projects/Investments
- Zentalis Pharmaceuticals reported $280.7 million in cash, cash equivalents, and marketable securities as of September 30, 2025, which is projected to fund operating expenses into late 2027.
- For the three months ended September 30, 2025, total operating expenses were $33.7 million, comprising $23.0 million in research and development expenses and $10.8 million in general and administrative expenses.
- The DENALI Phase 2 trial for azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer remains on track, with topline data anticipated by year end 2026 and potential for accelerated approval.
- The TETON Phase 2 trial in uterine serous carcinoma has completed enrollment, and results are planned for publication in the first half of 2026.
Nov 10, 2025, 9:11 PM
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