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]

PresentationAll right. Good morning, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Ulz, one of the biotech analysts here, and it's my pleasure to introduce Julie Eastland, CEO, to my immediate right; and Ingmar Bruns, CMO to the far right from Zentalis. And before we get started, I just need to read a quick disclaimer. For important disclosures, please see the Morgan Stanley research disclosure website at www.morganstanley.com/researchdisclosures. And if yo ...

Zentalis Pharmaceuticals (NasdaqGM:ZNTL) FY Conference September 09, 2025 07:00 AM ET Company ParticipantsJulie Eastland - CEOConference Call ParticipantsMike Olds - Biotech AnalystMike OldsGood morning, everyone, and thanks for joining us at the Morgan Stanley Global Healthcare Conference. I'm Mike Olds, one of the biotech analysts here, and it's my pleasure to introduce Julie Eastland, CEO to my immediate right, and Ingmar Bruns, CMO to the far right from Zentali s. Before we get started, I just need to r ...

Summary of Zentalis Pharmaceuticals FY Conference Call Company Overview - **Company**: Zentalis Pharmaceuticals (NasdaqGM: ZNTL) - **Industry**: Biopharmaceuticals - **Lead Asset**: Azenosertib (ZN-c3), a WEE1 inhibitor for cancer treatment, specifically in platinum-resistant ovarian cancer [1][2] Core Points and Arguments - **Clinical Data**: Azenosertib has shown response rates over 30% and a duration of response exceeding six months in cyclin E1 positive patients, compared to standard chemotherapy response rates of 4% to 13% [3][8] - **Registration Trial**: The Denali study is currently enrolling for accelerated approval, with plans for a phase three confirmatory trial to follow [4][5][14] - **Biomarker Selection**: Cyclin E1 overexpression is a key focus, with proprietary assays developed to correlate expression levels with treatment efficacy [4][6] - **Market Opportunity**: Approximately 21,500 cyclin E1 positive patients could benefit from azenosertib, representing about 50% of the platinum-resistant ovarian cancer population [7][8] - **Unmet Need**: There is a significant unmet need in the PROC setting, where current treatment options yield low response rates and short progression-free survival [8][16] Additional Important Content - **Cash Runway**: The company has a cash runway of $300 million, expected to last until late 2027, supporting the advancement of azenosertib into the PROC setting [17][18] - **Future Plans**: Zentalis aims to explore azenosertib's potential in other tumor types and combinations after establishing its efficacy in the PROC setting [17][18] - **Regulatory Engagement**: Ongoing discussions with the FDA regarding trial designs and accelerated approval pathways are crucial for the company's strategy [5][14] This summary encapsulates the key insights from the conference call, highlighting Zentalis Pharmaceuticals' strategic focus on azenosertib and its potential impact on the treatment landscape for platinum-resistant ovarian cancer.

Financial Data and Key Metrics Changes - The company is focused on completing its registration trials, particularly the DENALI study for asenosertib in patients with cyclin E1 protein overexpression in platinum-resistant ovarian cancer [5][6] - The response rates observed in the DENALI trial were significantly higher than standard care chemotherapy, indicating a potential for better outcomes in a patient population with historically poor responses [12][13] Business Line Data and Key Metrics Changes - The primary focus is on the development of asenosertib, which is positioned as a first-in-class oral non-chemotherapy option for patients [5][6] - The company is conducting a seamless design for the DENALI trial, allowing for continuous enrollment while confirming the optimal dose [14][15] Market Data and Key Metrics Changes - The company estimates that at least 50% of the platinum-resistant ovarian cancer (PROC) setting would be eligible for treatment with asenosertib, indicating a substantial market opportunity [41] - The market opportunity for asenosertib is projected to be larger than that of mirvetuximab, with potential peak sales estimated at around $2 billion [42][43] Company Strategy and Development Direction - The company aims to focus resources on getting asenosertib to market while exploring opportunities for combination therapies with other agents, including antibody-drug conjugates (ADCs) [34][56] - There is a strategic emphasis on educating the market and physicians about the unique benefits of asenosertib, particularly in biomarker-selected populations [6][31] Management's Comments on Operating Environment and Future Outlook - Management expressed optimism about the ongoing enrollment in the DENALI trial and the enthusiasm from physicians regarding the non-chemotherapy oral option [28][29] - The company is committed to maintaining a clear narrative and strategy to address any concerns stemming from past clinical holds and to ensure investor confidence [50][51] Other Important Information - The company is preparing for top-line data from the DENALI trial in 2026, which is crucial for accelerated approval discussions with regulatory agencies [59][60] - There is ongoing interest in potential partnerships to expand the reach of asenosertib and explore combination therapies [56][57] Q&A Session Summary Question: What are the expectations for the DENALI trial data? - The company anticipates that the DENALI trial will yield response rates similar to or better than historical data, with a focus on biomarker-selected patients [17][24] Question: How does the company view the market opportunity for asenosertib? - The company believes that asenosertib could capture a significant portion of the PROC market, potentially exceeding the market share of mirvetuximab [41][42] Question: What is the company's strategy regarding combination therapies? - The company is exploring combinations with ADCs and other agents, emphasizing the importance of synergistic effects and managing tolerability profiles [32][34] Question: How is the company addressing past clinical holds? - Management is focused on improving communication and education regarding the safety profile of asenosertib to alleviate concerns from investors and the medical community [50][51] Question: What are the key milestones moving forward? - Key milestones include top-line data from the DENALI trial, discussions with regulatory agencies regarding phase three design, and updates on other ongoing studies [59][60]

Core Insights - Zentalis Pharmaceuticals has appointed James B. Bucher as Chief Legal Officer and Corporate Secretary, effective September 18, 2025, following the departure of Andrea Paul [1][3] - Bucher brings over 30 years of legal experience in the life sciences sector, with expertise in corporate strategy, governance, capital raising, and mergers and acquisitions [2][3] - The company is focused on advancing its clinical development of azenosertib, a WEE1 inhibitor for ovarian cancer, and aims to build shareholder value [3][4] Company Overview - Zentalis Pharmaceuticals is a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a potentially first-in-class and best-in-class WEE1 inhibitor for patients with Cyclin E1-positive platinum-resistant ovarian cancer [4] - Azenosertib is being evaluated in clinical trials as both a monotherapy and in combination across multiple tumor types, demonstrating anti-tumor activity and good tolerability [4] - The company is leveraging its capabilities to explore additional research opportunities for azenosertib beyond ovarian cancer [4]

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended June 30, 2025 or ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from ___________________ to ___________________ Commission File Number: 001-39263 Zentalis Pharmaceuticals, Inc. (Exact name of registrant as specified in its charter ...

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]

Azenosertib Clinical Development & Strategy - Azenosertib, a WEE1 inhibitor, is being developed as a potential first-in-class and best-in-class therapy for Cyclin E1+ platinum-resistant ovarian cancer (PROC) patients[10] - Zentalis plans to seek FDA feedback on Phase 3 study design in the second half of 2025, initiate a Phase 3 confirmatory trial in 2026 following FDA feedback, and anticipates topline data from DENALI Part 2 by the end of 2026, with potential for FDA accelerated approval in Cyclin E1+ PROC patients[11] - The company has established Cyclin E1 as a predictive biomarker for azenosertib in Cyclin E1+ PROC[11] - Clinical data demonstrates clinically meaningful results and a manageable safety profile across multiple azenosertib monotherapy studies, with over 200 PROC patients treated at 300mg and 400mg QD 5:2[11] Market Opportunity & Data - Approximately 50% of PROC patients are Cyclin E1+ representing a significant opportunity in PROC, with ~21,500 patients in the US, UK, and EU4[13, 18] - In Cyclin E1+ patients at a monotherapy dose of 400mg QD 5:2, azenosertib demonstrated an ORR greater than 30% and a median duration of response (mDOR) of approximately 6 months, which is substantially superior to current standard of care (SOC)[12, 16] - The company has treated over 350 patients at active doses in monotherapy, including over 200 PROC patients treated at 300mg and 400mg 5:2, demonstrating a manageable safety profile[16] Financial Position - As of March 31, 2025, Zentalis had $332.5 million in cash, cash equivalents, and marketable securities, projecting a runway into late 2027 beyond anticipated DENALI Part 2 topline data[11] Safety and Efficacy - Safety profiles at 300mg and 400mg 5:2 are broadly comparable, with low frequency of previously reported Grade 5 treatment-related adverse events (TRAEs), Grade 3+ febrile neutropenia, and sepsis observed at 400mg 5:2[27] - In Cyclin E1+ PROC patients treated at 400mg QD 5:2, the ORR in response evaluable patients was 33.8% (23/68), with a median duration of response (mDOR) of 5.5 months[30]

Zentalis Pharmaceuticals (ZNTL) Conference June 04, 2025 09:55 AM ET Speaker0 So good morning, everyone. I appreciate it. Thanks for joining us for the Jefferies Healthcare Conference. I have the pleasure of hosting the Zentales management team, and Ingmar, the chief medical officer, is joining us today. I think the Zentales team is gonna start with a brief overview on their end, and then we'll get started with questions. Speaker1 Alright. Thank you, Akash, and thank you to the Jefferies team for having us. ...