Zentalis(ZNTL)

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Zentalis Pharmaceuticals (ZNTL) Earnings Call Presentation
2025-07-03 12:57
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 ...
Zentalis Pharmaceuticals (ZNTL) Conference Transcript
2025-06-04 14:55
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. ...
Zentalis Pharmaceuticals (ZNTL) FY Conference Transcript
2025-05-27 16:00
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.
Zentalis(ZNTL) - 2025 FY - Earnings Call Transcript
2025-05-20 16:30
Zentalis Pharmaceuticals (ZNTL) FY 2025 Conference May 20, 2025 11:30 AM ET Speaker0 Great. I'd like to welcome everybody back to our morning session. I'd like to welcome everybody again to the H. C. Wainwright BioConnect Investor Conference at Nasdaq. Presenting, with us next is Zentalis Pharmaceuticals, and we have chief executive officer and president Julie Eastland, and we have Zentalis' CMO, Igmar Ber Burns Bruns. Welcome, and it's my pleasure to host you today. Speaker1 Thanks for having us as always ...
Zentalis(ZNTL) - 2025 Q1 - Quarterly Report
2025-05-14 20:13
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 March 31, 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 charte ...
Zentalis(ZNTL) - 2025 Q1 - Quarterly Results
2025-05-14 20:09
Exhibit 99.1 Zentalis Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Progress 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, Calif. — May 14, 2025 — Zentalis® Pharmaceuti ...
Zentalis Pharmaceuticals Reports First Quarter 2025 Financial Results and Operational Progress
Globenewswire· 2025-05-14 20:05
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 ...
Zentalis Pharmaceuticals Announces First Patient Dosed in DENALI Part 2 Clinical Trial of Azenosertib in Patients with Cyclin E1+ PROC
Globenewswire· 2025-04-28 12:00
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]
Zentalis Pharmaceuticals Announces Poster Presentation at 2025 ASCO Annual Meeting
Globenewswire· 2025-04-23 20:05
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 ...
Zentalis(ZNTL) - 2024 Q4 - Annual Results
2025-03-26 20:19
Exhibit 99.1 Zentalis Pharmaceuticals Reports Full Year 2024 Financial Results and Operational Updates Positive azenosertib clinical data demonstrated clinically meaningful results in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC) Topline data from registration-intent DENALI Part 2 anticipated by year end 2026 Strengthened management team to support execution of highly focused strategy $371.1 million cash, cash equivalents and marketable securities balance as of December 31, 2024, with pr ...