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Zentalis Pharmaceuticals Reports Third Quarter 2025 Financial Results and Operational Progress
Globenewswire· 2025-11-10 21:05
Core Insights - Zentalis Pharmaceuticals is progressing with the DENALI Phase 2 trial for azenosertib, targeting Cyclin E1-positive platinum-resistant ovarian cancer, with topline data expected by the end of 2026, which may support accelerated approval pending FDA feedback [1][5][7] - The company reported a cash position of $280.7 million as of September 30, 2025, which is projected to sustain operations into late 2027 [2][5] - Research and development expenses decreased to $23.0 million in Q3 2025 from $36.8 million in Q3 2024, reflecting cost management efforts [5][10] Clinical Trial Updates - The DENALI trial is ongoing, with Part 2a enrolling approximately 30 patients at two dose levels (400mg and 300mg) to confirm the primary dose of interest [5][7] - Part 2b of the DENALI trial aims to enroll around 70 patients based on results from Part 2a, with the overall design intended for potential accelerated approval [5][7] - The TETON Phase 2 trial in uterine serous carcinoma has completed enrollment, but further development will be limited to partnerships or available capital [5][8] Financial Performance - Total operating expenses for Q3 2025 were $33.7 million, down from $51.4 million in Q3 2024, indicating a significant reduction in costs [10] - The net loss attributable to Zentalis for Q3 2025 was $26.7 million, compared to a net loss of $40.2 million in Q3 2024 [14] - The company reported no license revenue for the three months ended September 30, 2025, consistent with the previous year [14] Company Overview - Zentalis Pharmaceuticals is focused on developing azenosertib, a novel WEE1 inhibitor, for various tumor types, with a strong emphasis on Cyclin E1-positive platinum-resistant ovarian cancer [6][8] - Azenosertib is being evaluated in both monotherapy and combination studies, demonstrating anti-tumor activity across multiple tumor types [6][8]
Zentalis Pharmaceuticals Announces Four Azenosertib Posters Presentations at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics
Globenewswire· 2025-10-13 20:05
Core Insights - Zentalis Pharmaceuticals is advancing the development of azenosertib, a WEE1 inhibitor, with four abstracts accepted for presentation at the AACR-NCI-EORTC International Conference, highlighting its potential in treating ovarian cancer and other tumor types [1][2] Company Overview - Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company focused on developing azenosertib, a potentially first-in-class WEE1 inhibitor targeting Cyclin E1-positive platinum-resistant ovarian cancer [7] - Azenosertib is being evaluated in both monotherapy and combination therapies across various tumor types, demonstrating anti-tumor activity and good tolerability in clinical trials [7] Clinical Trial Details - The DENALI clinical trial is a multi-part Phase 2 study assessing azenosertib in platinum-resistant ovarian cancer patients, with ongoing enrollment focusing on those with Cyclin E1 protein overexpression [5][6] - Part 1b of the DENALI trial has already enrolled patients treated with azenosertib at a dose of 400mg, with interim results presented at the SGO 2025 Annual Meeting [5] Presentation Highlights - The presentations at the conference will cover various aspects of azenosertib, including its use in early-line treatment for Cyclin E1-positive high-grade serous ovarian cancer and its potential as a combination therapy [2][3] - Specific presentations include results from the Phase 1 study and the rationale for using azenosertib in specific patient populations [3]
Zentalis Pharmaceuticals Reports Second Quarter 2025 Financial Results and Operational Progress
Globenewswire· 2025-08-06 20:05
Core Insights - Zentalis Pharmaceuticals is advancing the late-stage clinical development of azenosertib for Cyclin E1-positive platinum-resistant ovarian cancer (PROC), with topline data from the DENALI Phase 2 trial expected by the end of 2026, potentially supporting accelerated approval [1][2][5] - The company reported a cash position of $303.4 million as of June 30, 2025, which is projected to fund operations into late 2027 [1][5][16] Business Updates - The DENALI Phase 2 trial is ongoing, with Part 2a enrolling approximately 30 patients at two dose levels, and Part 2b designed to enroll around 70 patients based on Part 2a results [5][8] - Azenosertib is being evaluated as a monotherapy and in combination studies across multiple tumor types, demonstrating potential as a first-in-class WEE1 inhibitor [7][9] Financial Results - Research and development expenses for Q2 2025 were $27.6 million, a decrease from $48.4 million in Q2 2024, primarily due to reduced clinical and lab service costs [4][6] - General and administrative expenses for Q2 2025 were $8.4 million, down from $16.7 million in Q2 2024, reflecting a decrease in personnel and consulting expenses [4][6] - Total operating expenses for Q2 2025 were $36.1 million, compared to $65.1 million in Q2 2024 [6][14]