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 projected cash runway into late 2027

SAN DIEGO, March 26, 2025 (GLOBE NEWSWIRE) -- Zentalis$(R)$ 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 $(ORR.AU)$ 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 meaningful response rates in other azenosertib clinical trials 
      disclosed on January 29, 2025. 
 
          -- In the monotherapy arm of the MAMMOTH (ZN-c3-006) study, which 
             evaluated azenosertib in patients with PARP-inhibitor resistant 
             ovarian cancer, Cyclin E1+ patients treated at the primary dose-of 
             interest 400mg QD 5:2 (n=16) had an ORR of 31.3% and an mDOR of 
             4.2 months as of the December 2, 2024 data cutoff. 
 
          -- In the ZN-c3-001 Phase 1, dose-escalation study evaluating 
             azenosertib monotherapy in solid tumors across continuous and 
             intermittent dosing schedules, patients with Cyclin E1+ PROC 
             treated at a total daily dose level >=300mg at an intermittent 
             schedule (n=23) demonstrated an encouraging ORR of 34.8% and an 
             mDOR of 5.2 months as of the December 2, 2024 data cutoff. 
 
   -- Azenosertib demonstrated strong and consistent therapeutic profile. 
      Across all of the above studies, azenosertib demonstrated meaningful 
      antitumor activity (ORR >30% at 400mg QD 5:2) and a manageable safety 
      profile in Cyclin E1+ PROC patients, with a significant sample size as of 
      the December 2, 2024 data cutoff. 
 
   -- Aligned with FDA on study design for DENALI Part 2. As previously 
      disclosed, the Company has aligned with the U.S. Food and Drug 
      Administration (FDA) on the design of its DENALI Part 2 study in patients 
      with Cyclin E1+ PROC, which allows for seamless enrollment across Parts 
      2a and 2b: Part 2a is designed to confirm the primary dose-of-interest, 
      400mg QD 5:2, with a target enrollment of approximately 30 patients at 
      each of two dose levels: 400mg QD 5:2 and 300mg QD 5:2. Part 2b is 
      designed to enroll approximately 70 additional patients at the selected 
      dose, which will be informed by the Part 2a results, subject to FDA 
      feedback. 
 
          -- The Company plans to initiate enrollment of DENALI Part 2 in the 
             first half of 2025 and to disclose topline data from DENALI Part 2 
             by year end 2026. DENALI Part 2, if successful, has the potential 
             to support an accelerated approval, subject to FDA review. 
 
          -- Zentalis plans to treat the same patient population in its Phase 3 
             randomized confirmatory study, which the Company plans to enroll 
             concurrently with Part 2b, subject to FDA feedback. 
 
   -- Continuing patient enrollment across clinical pipeline. The Company is 
      continuing to enroll patients in its ZN-c3-002 Phase 1b dose escalation 
      trial of azenosertib in the combination cohort with bevacizumab for the 
      treatment of patients with platinum sensitive ovarian cancer. 
      Additionally, the Company is continuing to enroll patients in its TETON 
      (ZN-c3-004) Phase 2 clinical trial of azenosertib as a monotherapy for 
      the treatment of uterine serous carcinoma and expects to present data 
      from this study in the first half of 2026. 
 
   -- Received Fast Track Designation for azenosertib. In January 2025, the 
      Company announced that the FDA has granted Fast Track Designation for 
      azenosertib for the treatment of patients with PROC who are positive for 
      Cyclin E1 based on immunohistochemistry for protein levels. The FDA 
      grants investigational medicines Fast Track Designation to facilitate the 
      development and expedite the review of medicines that demonstrate the 
      potential to treat serious conditions and fill an unmet medical need. 

Corporate Updates

   -- In November 2024, the Company strengthened its leadership and Board with 
      the appointment of Julie Eastland as Chief Executive Officer, Ingmar 
      Bruns, M.D. as Chief Medical Officer, Haibo Wang as Chief Business 
      Officer, Wendy Chang as Chief People Officer and Scott Myers as Chairman 
      of the Board. Together with the other members of the leadership team, the 
      Company refined and sharpened its pipeline. 
 
   -- In January 2025, the Company announced a strategic restructuring to 
      support late-stage clinical development of azenosertib. This 
      restructuring allows the Company to be more efficient in advancing the 
      clinical development of azenosertib and extended the Company's cash 
      runway into late 2027, beyond the Company's DENALI Part 2 topline data. 
      The workforce reduction associated with the restructuring is expected to 
      be substantially completed in the second quarter of 2025. 

Full Year 2024 Financial Results

   -- Cash, Cash Equivalents and Marketable Securities Position: As of December 
      31, 2024, the Company had cash, cash equivalents and marketable 
      securities of $371.1 million, which includes $19.2 million representing 
      the December 31, 2024 fair value of Immunome common stock received by the 
      Company from the sale of its ROR1 antibody-drug conjugate $(ADC)$ product 
      candidate and ADC platform to Immunome in October 2024. The Company 
      believes that its existing cash, cash equivalents and marketable 
      securities as of December 31, 2024 will be sufficient to fund its 
      operating expenses and capital expenditure requirements into late 2027. 
 
   -- Research and Development Expenses: Research and development, or R&D, 
      expenses for the year ended December 31, 2024 were $167.8 million, 
      compared to $189.6 million for the year ended December 31, 2023. The 
      decrease of $21.8 million was primarily due to a decrease of $10.7 
      million for personnel expense, of which $9.7 million is related to 
      non-cash stock-based compensation. There were also decreases of $5.8 
      million for clinical, $4.5 million for allocable expenses and $4.3 
      million for consulting, outside services and other expenses. These 
      decreases were partially offset by increases of $3.5 million as a result 
      from changes in cost sharing with Zentera. 
 
   -- General and Administrative Expenses: General and administrative expenses 
      for the year ended December 31, 2024 were $87.1 million, compared to 
      $64.4 million during the year ended December 31, 2023. The increase of 
      $22.8 million was primarily attributable to a $27.1 million increase 
      related to personnel expense, of which $22.2 million is related to 
      non-cash stock-based compensation. The Company also had an increase of 
      $3.1 million for facilities and allocable expenses. These increases were 
      partially offset by a decrease of $4.9 million for a non-cash operating 
      lease impairment charge during the twelve months ended December 31, 2023, 
      and $2.5 million for outside services and other expenses. 
 
   -- Operating Expenses: Total operating expenses were $258.6 million for the 
      year ended December 31, 2024, compared to $299.5 million for the year 
      ended December 31, 2023. Following the strategic restructuring announced 
      in January 2025, the Company expects to incur the non-recurring expenses 
      associated with the reorganization in the first quarter of 2025, and have 
      reduced operating expenses in the remainder of 2025, supporting the 
      anticipated cash runway into late 2027. 

About Azenosertib

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