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 ...

Zentalis Pharmaceuticals (NasdaqGM:ZNTL) FY Conference September 08, 2025 02:30 PM ET Company ParticipantsJulie Eastland - CEO, President & DirectorCharles Wallace - Equity Research Associate - BiotechCharles Wallace207th Annual Global Investment Conference. My name is Charles Wallace, and I'm with the Equity Research Team. It's my pleasure to welcome Zentalis Pharmaceuticals, ticker ZNTL. Zentalis is a clinical-stage biopharmaceutical company, and their lead asset, azenosertib, or ZN-c3, is a potentially f ...

Zentalis Pharmaceuticals (ZNTL) FY 2025 Conference September 04, 2025 10:15 AM ET Speaker0I think we'll get started here with the next fireside discussion. So my name is Derek Archila. I'm one of the senior biotech analysts here at Wells. Very excited to have Zantalis Pharmaceuticals with us for the next discussion here from the company. We have Julie Eastland, CEO and president, as well as Ingmar Burns, the chief medical officer.Thank you so much for joining us.Speaker1Yep. Thanks for having us. Appreciate ...

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. ...

Summary of Zantalis Conference Call Company Overview - **Company**: Zantalis - **Lead Candidate**: Azinocertib - **Focus**: Treatment for cyclin E1 positive platinum resistant ovarian cancer (PROC) [5][6] Core Points and Arguments - **Transformative Therapy**: Azinocertib is positioned as a convenient oral non-chemotherapy treatment option for ovarian cancer patients, with potential applications in other tumor types [6][7] - **Clinical Data**: Recent data from the Denali Part 1b clinical study shows a 35% response rate in cyclin E1 positive PROC patients, compared to low single-digit response rates for standard non-platinum chemotherapy [10][19] - **Patient Population**: Cyclin E1 overexpression is found in nearly 50% of PROC patients, representing a significant commercial opportunity and addressing a substantial unmet medical need [9][10] - **Companion Diagnostic**: A proprietary IHC assay is being developed to identify eligible patients for treatment with Azinocertib, which is expected to facilitate patient access [12][13] - **Overlap with Other Treatments**: There is an estimated 20% overlap between folate receptor alpha patients and cyclin E1 patients, indicating potential for combination therapies [14][15] Clinical Trials and Development - **Ongoing Trials**: Enrollment for the DENALI Part 2 trial has begun, with expectations for data by the end of 2026 [23][24] - **Dose Selection**: The trial is comparing 300 mg and 400 mg doses to confirm the preferred dose in alignment with FDA guidelines [20][21] - **Patient Enrollment**: Focus on enrolling patients with 1-3 prior lines of therapy, which is expected to yield better outcomes compared to those with more extensive prior treatments [27][28] - **Safety and Tolerability**: Azinocertib is reported to have a favorable safety profile compared to standard chemotherapy, which is crucial for patients with prior treatment experiences [31][32] Market Opportunity - **Addressable Market**: Approximately 21,500 patients in the U.S. and EU4/UK are estimated to be cyclin E1 positive PROC patients, indicating a large market potential [38] - **Combination Therapies**: Interest in exploring combinations with ADCs and other therapies to enhance treatment options for cyclin E1 high expressers [44][45] Financials - **Cash Runway**: As of March 31, the company reported $330 million in cash, supporting operations into late 2027, primarily focused on the cyclin E1 positive PROC population [47] Additional Notes - **Future Discussions with FDA**: Plans to engage with the FDA regarding the Phase 3 confirmatory trial design and enrollment requirements are set for 2025 [35][36] - **Other Indications**: Ongoing trials for other tumor types, including USC and triple-negative breast cancer, are being monitored for potential expansion of the Azinocertib franchise [41][42] This summary encapsulates the key points discussed during the conference call, highlighting Zantalis' strategic focus on Azinocertib and its implications for the treatment of PROC.