Jefferies Global Life Sciences Conference Ingmar Bruns, M.D., CMO June 2025 Nasdaq: ZNTL Forward Looking Statements and Disclaimer Zentalis Pharmaceuticals, Inc. ("we," "us," "our," "Zentalis" or the "Company") cautions that this presentation (including oral commentary that accompanies this presentation) contains forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. All statements contained in this presentation that do not relate to matters of historical ...

First patient dosed in DENALI Part 2a clinical trial of azenosertib in patients with Cyclin E1+ PROC Topline data from DENALI Part 2 anticipated by year end 2026 with the potential to support an accelerated approval, subject to FDA feedback $332.5 million cash, cash equivalents and marketable securities supports operational runway into late 2027 SAN DIEGO, May 14, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially fir ...

Core Insights - Zentalis Pharmaceuticals has initiated dosing for the first patient in Part 2 of the Phase 2 DENALI clinical trial for azenosertib, targeting Cyclin E1+ platinum-resistant ovarian cancer [1][3] - The company anticipates topline data from DENALI Part 2 by the end of 2026, which could support accelerated approval from the FDA [2][3] - Azenosertib is a novel WEE1 inhibitor being evaluated as a monotherapy and in combination therapies across multiple tumor types [5][6] Clinical Trial Details - The DENALI trial is designed in two parts, with seamless enrollment; Part 2a aims to confirm the primary dose of azenosertib with approximately 30 patients at two dose levels: 400mg QD 5:2 and 300mg QD 5:2 [7] - Part 2b will enroll around 70 additional patients based on the results from Part 2a, pending FDA feedback [7] Clinical Data and Biomarkers - Previous data from Part 1b of the DENALI study indicated an objective response rate (ORR) of 34.9% among 43 response-evaluable patients, with a median duration of response (mDOR) of 6.3 months [3][4] - Cyclin E1 protein overexpression has been identified as a predictive biomarker for patient selection, with an estimated 50% of PROC patients overexpressing this protein [4] Company Overview - Zentalis Pharmaceuticals is focused on developing azenosertib as a potentially first-in-class and best-in-class treatment for Cyclin E1+ PROC, with ongoing research into additional applications [6] - The company has demonstrated that azenosertib is well tolerated and shows anti-tumor activity across various tumor types [6]

SAN DIEGO, April 23, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, today announced that an abstract has been accepted for poster presentation at the 2025 American Society of Clinical Oncology (ASCO) Annual Meeting, taking place May 30 to June 3, 2025 in Chicago, IL. The poster will include clinical data as of an ...

Core Insights - Zentalis Pharmaceuticals has reported positive clinical data for azenosertib, a WEE1 inhibitor, showing meaningful results in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC) [1][2] - The company anticipates topline data from the registration-intent DENALI Part 2 study by the end of 2026 [1][3] - Zentalis has strengthened its management team to support its focused strategy and has a cash position projected to last into late 2027 [1][2] Clinical Development - Updated clinical data from the DENALI Part 1b study showed an objective response rate (ORR) of 34.9% in patients with Cyclin E1+ PROC tumors, with a median duration of response (mDOR) of 6.3 months as of January 13, 2025 [3] - In the MAMMOTH study, Cyclin E1+ patients treated with azenosertib had an ORR of 31.3% and an mDOR of 4.2 months [3] - The ZN-c3-001 Phase 1 study reported an ORR of 34.8% and an mDOR of 5.2 months for patients treated with azenosertib [3] - The company has aligned with the FDA on the study design for DENALI Part 2, which will begin enrollment in the first half of 2025 [3] Financial Performance - As of December 31, 2024, Zentalis had cash, cash equivalents, and marketable securities totaling $371.1 million, sufficient to fund operations into late 2027 [1][5] - Research and development expenses for 2024 were $167.8 million, a decrease from $189.6 million in 2023, primarily due to reduced personnel expenses [5][12] - General and administrative expenses increased to $87.1 million in 2024 from $64.4 million in 2023, largely due to higher personnel costs [5][12] Corporate Updates - The company received Fast Track Designation from the FDA for azenosertib for treating PROC patients who are Cyclin E1 positive [4][6] - A strategic restructuring was announced in January 2025 to enhance efficiency in clinical development, which is expected to be completed by the second quarter of 2025 [4][6] - Zentalis has continued patient enrollment in various clinical trials, including studies for uterine serous carcinoma and in combination with bevacizumab [4][6]