Zentalis Pharmaceuticals (NasdaqGM:ZNTL) 2026 Conference February 11, 2026 03:30 PM ET Company ParticipantsIngmar Bruns - CMOJulie Eastland - President and CEOConference Call ParticipantsMichael Schmidt - Senior Biotech AnalystMichael SchmidtKicking off the next fireside chat here. My name is Michael Schmidt, Senior Biotech Analyst with Guggenheim, and I'm really happy to welcome, Julie Eastland, President and CEO of Zentalis, and she's joined by, Ingmar Bruns, Chief Medical Officer. Welcome. Thanks for joi ...

Core Insights - Zentalis Pharmaceuticals is advancing the late-stage development of its first-in-class WEE1 inhibitor, azenosertib, as a biomarker-driven treatment for ovarian cancer [1][3] - The management team will participate in a fireside discussion at Guggenheim's Emerging Outlook: Biotech Summit 2026 on February 11 in New York [1] Company Overview - Zentalis Pharmaceuticals focuses on developing innovative oncology treatments, particularly for ovarian cancer and various tumor types [3] - The company aims to provide a targeted, non-chemotherapy, orally available medicine that enhances treatment experience and outcomes for cancer patients [3] Event Information - A live webcast of the upcoming event will be available for at least 30 days after the event concludes, accessible under the "Events & Presentations" tab on the company's website [2]

Summary of Zentalis Pharmaceuticals Conference Call Company Overview - **Company**: Zentalis Pharmaceuticals (NasdaqGM:ZNTL) - **Lead Candidate**: Azenosertib, an orally available non-chemotherapy treatment for Cyclin E1-positive platinum-resistant ovarian cancer [2][3] Industry Context - **Market Need**: High unmet need in the PROC (platinum-resistant ovarian cancer) setting, with no approved therapies for patients with Cyclin E1 overexpression [8][11] - **Current Standard of Care**: Single-agent chemotherapy with response rates between 4% and 13% [11] Key Points on Azenosertib - **Efficacy**: - Response rates over 30% and duration of response exceeding six months at a dose of 400 mg [3][12] - Over 350 patients treated at doses of 300 mg and above, with over 200 in the PROC setting [3] - **Safety Profile**: Manageable safety profile with tolerability comparable between 300 mg and 400 mg doses [4][12] - **Biomarker Development**: Companion diagnostic developed to identify patients for enrollment in trials [9][32] Clinical Trials - **Denali Trial**: - Part 2 designed for registration and accelerated approval pathway [5][14] - Focus on patients with one to three prior lines of therapy [14] - Expected top-line data by the end of 2026 [17][18] - **Phase 3 Trial**: Planned concurrent enrollment with Denali Part 2B, aiming for at least 80% enrollment for accelerated approval [16][25] Market Opportunity - **Patient Population**: Approximately 21,500 patients in the PROC setting with Cyclin E1 overexpression, representing about 50% of the market [8][10] - **Financial Potential**: Comparison to Elahere, which generated over $330 million in sales in the first half of the year, indicating strong market demand for biomarker-selected therapies [10] Competitive Landscape - **Other Treatments**: Acknowledgment of competition from antibody-drug conjugates (ADCs) and CDK2 inhibitors [26][27] - **Differentiation**: Azenosertib offers a non-chemotherapy option for patients who have had limited success with existing treatments [27][34] Regulatory and Development Strategy - **FDA Interaction**: Ongoing discussions with the FDA regarding trial design and accelerated approval pathways [15][24] - **Funding**: Cash runway supports development through late 2027, ensuring continued progress towards trial milestones [19] Conclusion - Zentalis Pharmaceuticals is focused on addressing a significant unmet need in the treatment of platinum-resistant ovarian cancer with azenosertib, leveraging a strong clinical development strategy and a clear understanding of the patient population and market dynamics [18][19]

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]

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]