ZNTL

400mg QD 5:2 selected as azenosertib monotherapy pivotal study dose based on favorable benefit-risk profile in DENALI Part 2a, supporting advancement in registration-intended trials DENALI Phase 2 trial topline readout expected by year-end 2026, with potential to support accelerated approval pathway, pending data outcomes and FDA feedback ASPENOVA Phase 3 confirmatory trial in Cyclin E1-positive PROC initiated with first patient dosed; designed to support conversion to PROC full approval and ex-US registrations $211.8 million in cash, cash equivalents and marketable securities as of March 31, 2026, providing runway into late 2027 with funding to support execution of key milestones SAN DIEGO, May 12, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced financial results for the first quarter ended March 31, 2026, and highlighted recent clinical progress. "This quarter, we built momentum with achievement of key milestones advancing azenosertib in our registration-intended Phase 2 and Phase 3 trials for patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC),” said Julie Eastland, Chief Executive Officer of Zentalis. "Our core focus is on bringing a convenient, oral, non-chemotherapy treatment option to approximately 50% of PROC patients who are Cyclin E1-positive and may experience poorer prognosis and limited benefit from standard-of-care therapies. Pivotal dose selection supports our regulatory strategy, positioning us to pursue accelerated approval through the DENALI Part 2 trial while simultaneously advancing ASPENOVA as our confirmatory trial—together charting a pathway to bring a potential first-in-class therapy to market for this underserved patient population. Following dose selection, we initiated pre-commercial launch preparedness activities to add commercial capabilities to the organization, scale manufacturing capacity and advance Cyclin E1 companion diagnostic market development. Beyond the lead indication, we see substantial opportunity for strategic expansion of azenosertib into platinum-sensitive or first-line maintenance settings of ovarian cancer, additional tumor types, and combination approaches." "With a...

On track for DENALI Part 2a dose confirmation in 1H 2026 DENALI Part 2 trial topline readout expected by year end 2026; potential to support accelerated approval On track to initiate the ASPENOVA Phase 3, randomized, confirmatory trial in 1H 2026 Expanding azenosertib potential in ovarian cancer with the ongoing MUIR Part 2 trial evaluating the combination of azenosertib and bevacizumab as maintenance therapy $245.9 million cash, cash equivalents and marketable securities balance as of December 31, 2025, with projected cash runway into late 2027 SAN DIEGO, March 26, 2026 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical oncology innovator advancing late-stage development of investigational first-in-class WEE1 inhibitor azenosertib as a biomarker-driven treatment approach for ovarian cancer, today announced financial results for the year ended December 31, 2025, and highlighted recent corporate accomplishments and milestones expected for 2026. “The completion of enrollment for DENALI Part 2a represented a key milestone to enable dose confirmation in the first half of 2026, with topline DENALI Part 2 trial readout anticipated by year-end. Results from the DENALI Part 2 trial could potentially support accelerated approval, pending study outcome,” said Julie Eastland, Chief Executive Officer. “In parallel, we expect to initiate the randomized Phase 3 confirmatory trial to support potential full approval, known as ASPENOVA, in the first half of 2026. The ASPENOVA trial will compare azenosertib to the current standard-of-care single, agent chemotherapy in the Cyclin E1+ PROC population. Beyond the lead indication Cyclin E1-positive platinum-resistant ovarian cancer (PROC), Zentalis is investigating azenosertib in combination with bevacizumab in earlier treatment settings for ovarian cancer in our MUIR study, and we plan to explore additional tumor types where WEE1 inhibition may have therapeutic relevance.” “2026 is expected to be a defining year for Zentalis. With a strong financial foundation, we continue to focus on advancing azenosertib, a potentially first-in-class, non-chemotherapy, oral treatment for patients with Cyclin E1-positive PROC – a group with substantial unmet medical needs.” Ms. Eastland added. Program Updates DENALI: Completed enrollment in DENALI Part 2a, supporting registration-intended development of azenosertib i...

DENALI Phase 2 trial evaluating azenosertib in patients with Cyclin E1-positive PROC remains on track with topline data anticipated by year end 2026, with the potential to support an accelerated approval, subject to FDA feedback $280.7 million cash, cash equivalents and marketable securities supports runway into late 2027 SAN DIEGO, Nov. 10, 2025 (GLOBE NEWSWIRE) -- Zentalis® Pharmaceuticals, Inc. (Nasdaq: ZNTL), a clinical-stage biopharmaceutical company developing a potentially first-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, announced financial results for the third quarter 2025 and highlighted recent operational progress. "We are pleased with our continued disciplined execution of the DENALI clinical trial this quarter, supporting late-stage development of azenosertib as a potential treatment for Cyclin E1-positive platinum-resistant ovarian cancer, and positioning us for an anticipated topline data readout by year end 2026. Our engagement with trial investigators and presence at medical conferences is very encouraging and continues to support our development strategy," said Julie Eastland, Chief Executive Officer of Zentalis. "With $280.7 million in cash providing runway into late 2027, we maintain a robust financial foundation to deliver on our azenosertib objectives." Business Updates Phase 2 DENALI clinical trial remains on track and has the potential to support an accelerated approval, subject to FDA feedback. Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results. The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. We believe that DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. Poster Presentations at AACR-NCI-EORTC International Conference on Molecular Targets and Cancer Therapeutics support Cyclin E1 biomarker...

DENALI Phase 2 trial evaluating azenosertib in patients with Cyclin E1-positive PROC remains on track with topline data anticipated by year end 2026, with the potential to support an accelerated approval, subject to FDA feedback $303.4 million cash, cash equivalents and marketable securities supports operational runway into late 2027 SAN DIEGO, Aug. 06, 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, announced financial results for the second quarter 2025 and highlighted recent operational progress. “This quarter, we continued to execute on our focused strategy to advance the late-stage clinical development of azenosertib in patients with Cyclin E1-positive platinum-resistant ovarian cancer (PROC). There is no approved treatment option specifically for this biomarker selected population, which comprises approximately 50% of PROC patients,” said Julie Eastland, Chief Executive Officer of Zentalis. “We are maintaining momentum with the DENALI Phase 2 clinical trial and remain on track to disclose topline data from DENALI Part 2 by year end 2026.” Business Updates Phase 2 DENALI clinical trial remains on track. Enrollment is ongoing in DENALI Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1-positive PROC. DENALI Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of up to approximately 30 patients at each of two dose levels: 400mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule) and 300mg QD 5:2. DENALI Part 2b is designed to enroll approximately 70 patients at a single dose, the selection of which will be informed by the Part 2a results, subject to FDA feedback. The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. Completed strategic restructuring announced in January 2025, supporting late-stage clinical development of azenosertib. The Company has operationally completed the restructuring and does not expect to incur further associated related non-recurring expenses. This restructuring priorit...

Net loss: US$48.3m (down from US$10.1m profit in 1Q 2024). US$0.67 loss per share (down from US$0.14 profit in 1Q 2024). AI is about to change healthcare. These 20 stocks are working on everything from early diagnostics to drug discovery. The best part - they are all under $10bn in marketcap - there is still time to get in early. All figures shown in the chart above are for the trailing 12 month (TTM) period Looking ahead, revenue is forecast to grow 52% p.a. on average during the next 3 years, compared to a 17% growth forecast for the Biotechs industry in the US. Performance of the American Biotechs industry. The company's share price is broadly unchanged from a week ago. It is worth noting though that we have found 2 warning signs for Zentalis Pharmaceuticals that you need to take into consideration. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email editorial-team (at) simplywallst.com. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned.

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 first-in-class and best-in-class WEE1 inhibitor for patients with ovarian cancer and other tumor types, announced financial results for the first quarter 2025 and highlighted recent operational progress. "We continued advancement of azenosertib and made solid progress against our strategic goals in the first quarter. The initiation of DENALI Part 2 moves us into a new chapter as a late-stage development company focusing on a significant patient population in platinum-resistant ovarian cancer with limited choices," said Julie Eastland, Chief Executive Officer of Zentalis. “Our team remains focused on the enrollment and execution of DENALI. Zentalis is financially and organizationally well-positioned to continue advancing azenosertib as a potential treatment option for PROC patients.” Program Highlights First patient dosed in Part 2 of the Phase 2 DENALI clinical trial. In April 2025, the Company announced that the first patient had been dosed in Part 2a of the Phase 2 DENALI clinical trial (NCT05128825) of azenosertib in patients with Cyclin E1+ platinum-resistant ovarian cancer (PROC). Part 2a is designed to confirm the primary dose-of-interest with a target enrollment of approximately 30 patients at each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule). The Company expects to disclose topline data from DENALI Part 2 (Part 2a and Part 2b) by year end 2026. DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. Azenosertib clinical data demonstrated clinically meaningful response rates and a consistent therapeutic profile. Previously disclosed clinical data from Part 1b of the DENALI study showed clinically meaningful results in patients with Cyclin E1+ PROC. As of the January 13, 2025 data cutoff, patients who were response-evaluab...

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 projected cash runway into late 2027 SAN DIEGO, March 26, 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 financial results for the year ended December 31, 2024, and highlighted recent corporate accomplishments. "Zentalis reported significant progress in the development of azenosertib in 2024 and made important advancements this year. We plan to maintain strong execution on the late-stage development of azenosertib," said Julie Eastland, Chief Executive Officer of Zentalis. “The clinical data we recently presented supports rapid advancement of azenosertib as a monotherapy therapy for patients with Cyclin E1+ PROC, and the continued development of azenosertib in other settings of ovarian cancer and other tumor types. With a sharpened focus on clinical development, and strong cash position into late 2027, Zentalis is well-positioned to execute on our objectives with the goal of bringing azenosertib to patients as quickly as possible.” Program Updates and Highlights Updated azenosertib monotherapy clinical data in DENALI Part 1b. Earlier this month, at the Society of Gynecologic Oncology’s 2025 Annual Meeting on Women’s Cancer, Zentalis presented updated clinical data from the DENALI (ZN-c3-005) Part 1b single-arm study evaluating azenosertib monotherapy 400mg QD 5:2 (intermittent daily dosing on a five-day on, two-day off schedule) in patients with Cyclin E1+ PROC tumors. As of the January 13, 2025 data cutoff, patients who were response-evaluable (n=43) had an objective response rate (ORR) of 34.9%, consistent with the Company’s interim results disclosed in January 2025, and an updated median duration of response (mDOR) of 6.3 months. The mDOR is subject to change since there were patients with ongoing responses as of the cutoff date. Clinically meani...