Zentalis Pharmaceuticals, Inc.
For the period ended Mar 31, 2026. Filed May 12, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 12, 2026
ZNTL$1.72+0.6%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-09-30; filed 2025-11-10.
0001725160-25-000161
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-12.
0001725160-26-000042
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 143 previous paragraphs and 143 current paragraphs.
89 unchanged; 29 reworded; 24 added; 24 removed; 1 previous and 1 current paragraphs rearranged.
Tables are not compared: 4 previous and 3 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (24)
Current report
◦DENALI Part 2 is prospectively enrolling PROC patients with Cyclin E1 protein overexpression based on our proprietary IHC cutoff. Part 2 consists of three cohorts across a seamless design that may support accelerated approval in patients with Cyclin E1-positive PROC, pending positive study outcomes and further discussions with the FDA. The study design consists of the following parts:
Current report
▪Part 2a: Dose confirmation in patients with 1-3 prior lines of therapy, or up to 4 prior lines allowed in prior mirvetuximab treatment in patients with high FRα. Two doses were evaluated, 300mg QD 5:2 and 400mg QD 5:2, with approximately 30 patients enrolled per dose group. In April 2026, we announced that 400mg QD 5:2 was selected as the pivotal monotherapy dose and that recruitment at the 300mg QD 5:2 dose level has been discontinued. All patients enrolled in Part 2a will contribute to the overall safety database submitted to the FDA.
Current report
▪Part 2b: Enrollment expansion in the same patient population as Part 2a at the selected 400mg QD 5:2 dose up to approximately 100 patients, including patients at that dose in Part 2a. This cohort is currently enrolling.
Current report
▪Part 2c: Broadening study population, which is expected to include approximately 40 patients previously treated with a taxane-containing regimen for PROC, with 1-4 prior lines of therapy allowed, including prior mirvetuximab in patients with high FRα. This cohort is currently enrolling.
Current report
We expect to complete enrollment in all cohorts of DENALI Part 2 and provide a topline readout of the trial by year-end 2026. The FDA has granted Fast Track Designation to azenosertib for the treatment of patients with Cyclin E1-positive PROC.
Current report
•Monotherapy – Phase 3 Clinical Trial in Cyclin E1-positive PROC (ASPENOVA – ZN-c3-020)ASPENOVA is a Phase 3 randomized, confirmatory clinical trial designed to support full approval of azenosertib in patients with Cyclin E1-positive PROC. The trial is expected to enroll approximately 420 patients and compare azenosertib monotherapy at 400mg QD 5:2 to the investigator's choice of standard-of-care single-agent chemotherapy (paclitaxel, pegylated liposomal doxorubicin, gemcitabine, or topotecan). The trial design was based on feedback from the U.S. FDA regarding requirements for seeking approval under the accelerated approval pathway and requirements to support potential conversion to full approval, subject to data outcomes. In May 2026, we announced that the first patient had been dosed in the ASPENOVA trial.
Current report
◦Part 1: Enrolled patients with PROC treated with azenosertib in combination with one of four chemotherapy regimens: carboplatin, gemcitabine, pegylated liposomal doxorubicin, or paclitaxel. Primary objectives were safety and tolerability, with key secondary objectives including clinical activity assessed by objective response rate, duration of response, and progression-free survival per RECIST v1.1. In April 2026, we announced that data from MUIR Part 1 focusing on azenosertib in combination with paclitaxel in PROC have been accepted for presentation at the 2026 American Society for Clinical Oncology (ASCO) Annual Meeting in June 2026.
Current report
◦Part 2: Evaluating azenosertib in combination with bevacizumab as a maintenance regimen (in the first line, or 1L, or second line, or 2L, of treatment) in patients with advanced ovarian, peritoneal, or fallopian tube cancer following platinum-based chemotherapy. The dose escalation portion will determine the recommended dose for azenosertib orally once daily 5 days on, 2 days off in 21-day cycles in combination with bevacizumab 15mg/kg intravenously on Day 1 of each 21-day cycle. The dose expansion portion will evaluate azenosertib at the recommended dose determined from the dose escalation portion in combination with bevacizumab. The dose expansion portion is expected to enroll approximately 40 patients with platinum-sensitive ovarian cancer in 2L who progressed while on a PARP inhibitor for 1L maintenance. The primary objective is safety and tolerability; secondary objectives include preliminary clinical activity of the combination as assessed by progression-free survival for the dose expansion portion. The dose expansion portion is currently open for enrollment.
Current report
Recent Data and Presentations
Current report
In April 2026 at the AACR Annual Meeting, we presented a poster with preclinical data showing encouraging activity and tolerability of azenosertib combinations in treatment-naïve and ADC-resistant triple-negative breast cancer, or TNBC, supporting the potential for pipeline expansion beyond ovarian cancer. At this meeting, we also presented a poster with real-world data demonstrating that Cyclin E1-positive ovarian cancer patients have significantly worse outcomes, independent of CCNE1 gene amplification status, reinforcing the potential for azenosertib to address the unmet need for these patients.
Current report
Pfizer Development Agreement
Current report
In April 2022, we entered into a development agreement with Pfizer to collaborate to advance the clinical development of azenosertib. We did not grant Pfizer any economic ownership or control of azenosertib or the rest of our pipeline. In October 2022, we announced our first clinical development collaboration with Pfizer to initiate a Phase 1/2 dose escalation study of azenosertib, in combination with encorafenib and cetuximab (an FDA-approved standard of care known as the BEACON regimen) in patients with BRAF V600E-mutant mCRC. In January 2025, we announced that we would not advance to the dose expansion phase of the study due to resource prioritization and an evolving treatment landscape.
Current report
GSK Clinical Trial Collaboration and Supply Agreement
Current report
In April 2021, we entered into a clinical trial collaboration and supply agreement with GSK under which we have evaluated the combination of azenosertib and niraparib, GSK’s poly (ADP-ribose) polymerase (PARP) inhibitor, in patients with PROC. In January 2025, we announced that the trial was fully enrolled and that we were not proceeding further with the development of the combination of azenosertib with niraparib as efficacious exposures of azenosertib were not reached. Pursuant to this agreement, we were responsible for the conduct and cost of the study, under the supervision of a joint development committee made up of our representatives and representatives of GSK. GSK supplied niraparib for use in the collaboration, at no cost to us.
Current report
This agreement does not grant any right of first negotiation to participate in future clinical trials, and neither party granted the other any additional right or ability to evaluate their respective compounds in any other clinical studies, either as monotherapy or in combination with any other product or compound, in any therapeutic area.
Current report
The agreement with GSK will expire upon completion of all obligations of the parties thereunder or upon termination by either party. In addition, there are standard early termination provisions under this agreement.
Current report
Research and Development Expenses
Current report
General and Administrative Expenses
Current report
Research and Development Expenses
Current report
Research and development expenses for the three months ended March 31, 2026 were $28.7 million, compared to $27.2 million for the three months ended March 31, 2025. The increase of $1.5 million was primarily due to an increase of $6.8 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. This increase was partially offset by decreases of $3.9 million for personnel expense, of which $1.2 million was non-cash stock-based compensation, a decrease of $1.2 million related to a one time impairment charge recorded during the quarter ended March 31, 2025, and a decrease of $0.2 million for allocated overhead.
Current report
General and Administrative Expenses
Current report
Restructuring expenses for the three months ended March 31, 2026 were zero, compared to $7.8 million during the three months ended March 31, 2025.
Current report
Stock Purchase Agreement
Current report
On December 15, 2025, the Company entered into a Stock Purchase Agreement (the “Stock Purchase Agreement”) with Matrix Capital Master Fund, LP ("Matrix"), one of our then-stockholders. Pursuant to the Stock Purchase Agreement, the Company agreed to repurchase 7,500,000 shares of the Company’s common stock from Matrix at a price of $1.33 per share, representing a discount from the Company’s closing share price of $1.40 on December 12, 2025 (the “Repurchase”). The Repurchase closed on December 15, 2025.
Removed paragraphs (24)
Previous report
◦DENALI Part 2 is designed to enroll approximately 100 patients with Cyclin E1-positive PROC at the selected dose who have received one to three prior lines of therapy, or for patients whose tumors are also FRα-high and who have received mirvetuximab soravtansine, one to four prior lines of therapy. We have aligned with the FDA on the design of our DENALI Part 2 study in patients with Cyclin E1-positive PROC, which allows for seamless enrollment across Parts 2a and 2b. DENALI Part 2a is designed to confirm 400 mg QD 5:2 as the primary dose-of-interest by enrolling approximately 30 patients at each of two dose levels, 400 mg QD 5:2 and 300 mg 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 Part 2a and FDA feedback. In April 2025, we announced that the first patient was dosed in DENALI Part 2a. We anticipate disclosing topline data from DENALI Part 2 by year end 2026. We believe that DENALI Part 2, if successful, has the potential to support an accelerated approval, subject to FDA review. The FDA has granted Fast Track Designation to azenosertib for the treatment of patients with PROC who are positive via IHC for Cyclin E1 protein levels.
Previous report
•Monotherapy – Phase 3 Clinical Trial in Cyclin E1-positive PROC. We plan to conduct a randomized, controlled Phase 3 confirmatory clinical trial of azenosertib versus standard-of-care chemotherapy for the treatment of patients with Cyclin E1-positive PROC, with the goal of supporting an application seeking full approval of azenosertib in this setting, which we plan to conduct concurrently with DENALI Part 2b, subject to FDA feedback.
Previous report
•Monotherapy – Phase 2 Clinical Trial in Uterine Serous Carcinoma, or USC (TETON - ZN-c3-004). Azenosertib is currently being evaluated as a monotherapy in a Phase 2 clinical trial in patients with USC. The FDA granted Fast Track Designation to azenosertib in patients with advanced or metastatic USC who have received at least one prior platinum-based chemotherapy regimen for management of advanced or metastatic disease. Enrollment in this trial is complete. We plan to publish results from this trial in the first half of 2026. Consistent with our previously announced strategic prioritization of azenosertib for the treatment of patients with Cyclin E1-positive PROC, further development in USC will be limited to partnering or our ability to allocate capital to this indication. We will continue to support an investigator-initiated study to explore potential biomarker enrichment strategy in USC.
Previous report
Clinical Data – DENALI Part 1b
Previous report
In January 2025, we announced data from DENALI Part 1b (n=102). As of the December 2, 2024 data cutoff, in patients with Cyclin E1-positive PROC tumors who were response-evaluable (patients who had at least one scan after receiving azenosertib), an objective response rate, or ORR, of 34.9% (15/43; 95% confidence interval, or CI: 21.0 - 50.9) was observed. In the intent-to-treat patients with Cyclin E1-positive PROC (patients who received at least one dose of azenosertib), the ORR was 31.3% (15/48; 95% CI: 18.7 - 46.3). As of the December 2, 2024 data cutoff, the median duration of response, or mDOR, for the intent-to-treat population was still maturing and was approximately 5.5 months (95% CI: 2.7 - not estimable).
Previous report
As of the December 2, 2024 data cutoff, azenosertib was observed to have a safety and tolerability profile that is favorable compared to published data from standard-of-care single-agent chemotherapy. Treatment-related serious adverse events occurred in 22 patients (21.6%).
Previous report
The most common treatment-related adverse events of special interest or clinical significance for azenosertib and this class of molecules, were nausea (65.7% all grades; 3.9% Grade 3+), fatigue (59.8% all grades, 15.7% Grade 3+), diarrhea (50.0% all grades; 6.9% Grade 3+), thrombocytopenia (34.3% all grades; 11.8% Grade 3+), and anemia (30.4% all grades, 10.8% Grade 3+). In addition, Grade 3+ sepsis occurred in 3 patients (2.9%), Grade 3+ febrile neutropenia occurred in 3 patients (2.9%), and Grade 3+ pancytopenia occurred in 1 patient (1.0%). Treatment-related adverse events led to dose reductions in 43 patients (42.2%), dose interruptions in 60 patients (58.8%) and discontinuations in 22 patients (21.6%). There were two previously reported treatment-related Grade 5 events in the study (2.0%). The DENALI Part 2 protocol contains measures for enhanced patient monitoring, guidance and supportive care, which could potentially improve discontinuation rates.
Previous report
In March 2025 at the Society of Gynecologic Oncology 2025 Annual Meeting on Women’s Cancer, or SGO, we disclosed updated data from DENALI Part 1b reflecting a January 13, 2025 data cutoff. As of the January 13, 2025 data cutoff, the ORR in patients with Cyclin E1-positive PROC tumors who were response-evaluable remained at 34.9% (15/43; 95% CI: 21.0 - 50.9). The safety and tolerability profile presented at SGO reflected treatment-related adverse events occurring in 10% or greater of patients and was consistent with the safety and tolerability profile reflected in the December 2, 2024 data cutoff, with no new safety findings. As previously disclosed in January 2025, the mDOR for the intent-to-treat population in DENALI Part 1b was still maturing. As of the January 13, 2025 data cutoff, the ongoing mDOR had increased to approximately 6.3 months (95% CI: 2.7 - not estimable) and continues to mature as patients remained on study as of the data cutoff.
Previous report
Government Shutdown
Previous report
On October 1, 2025, the U.S. government shut down and certain regulatory agencies, such as the FDA and the SEC, have had to furlough critical government employees and stop critical activities. If a prolonged government shutdown occurs, it could significantly impact the ability of the FDA to timely review and process our regulatory submissions, which could have a material adverse effect on the Company’s business. It could also impact the Company’s ability to access the public markets and obtain necessary capital in order to fund its operations. See Risk Factors—Risks Related to Regulatory Approval and Other Legal Compliance Matters— Changes and/or disruptions at the FDA, the SEC and other government agencies, including as a result of government shutdowns, funding shortages, staffing changes or limitations, or global health concerns could prevent those agencies from performing business functions as they were previously performed, which could negatively impact our business.
Previous report
Immunome Agreements
Previous report
In January 2024, we entered into an exclusive, worldwide license agreement with Immunome, or the Immunome License Agreement, under which Immunome licensed from us ZPC-21 (now known as IM-1021), a preclinical ROR1 ADC with best-in-class potential, and our proprietary ADC platform technology, or the ADC Assets. Under the terms of the deal, we received an up-front payment of $35 million in cash and Immunome common stock (with the stock valued at the trailing 30-day volume-weighted average price). In October 2024, we entered into an asset purchase agreement with Immunome, pursuant to which Immunome purchased the ADC Assets, or the Immunome Purchase Agreement. We received $25 million worth of Immunome common stock, with the shares valued at the trailing 30-day volume-weighted average price of Immunome's common stock. On the date of execution of the transaction, the Immunome common stock was valued at $21.9 million based on the closing price of Immunome's common stock on that date. In the first quarter of 2025, we also received $5.0 million of contingent consideration following the achievement of a developmental milestone in December 2024. The Immunome License Agreement terminated upon the parties’ entry into the Immunome Purchase Agreement. During the three months ended September 30, 2024, the Company divested 2.3 million shares of Immunome common stock acquired through the Immunome License Agreement resulting in net proceeds of $33.5 million. During the three months ended September 30, 2025, the Company divested 1.6 million shares of Immunome common stock acquired through the Immunome Purchase Agreement resulting in net proceeds of $17.9 million. As of September 30, 2025 the Company held 0.2 million shares of Immunome common stock. In October 2025, the Company divested all of these remaining shares, resulting in net proceeds of $2.6 million.
Previous report
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. Following the strategic restructuring announced in January 2025, we incurred certain associated non-recurring expenses in the first quarter of 2025. As a result of the strategic restructuring, we have realized a decrease in research and development expenses through the third quarter ended September 30, 2025. If our azenosertib development program continues to advance successfully, we expect our research and development expenses to increase as we initiate and execute our planned Phase 3 confirmatory study and prepare for potential commercialization.
Previous report
Following the strategic restructuring announced in January 2025 for which we incurred certain associated non-recurring expenses in the first quarter of 2025. Through September 30, 2025 we have realized a decrease in general and administrative expenses excluding one-time charges; however, if our azenosertib development program continues to advance successfully, we expect our general and administrative expenses to increase as we initiate and execute our planned Phase 3 confirmatory study and prepare for potential commercialization. We also expect to continue to incur expenses associated with being a public company, including costs of accounting, audit, legal, regulatory and tax-related services associated with maintaining compliance with Nasdaq and SEC requirements; director and officer insurance costs; and investor and public relations costs.
Previous report
Research and development expenses for the three months ended September 30, 2025 were $23.0 million, compared to $36.8 million for the three months ended September 30, 2024. The decrease of $13.8 million was primarily due to decreases of $7.6 million for personnel expense, of which $2.7 million was non-cash stock-based compensation. Decreases of $4.2 million for lab services, $1.2 million for clinical expenses, and $0.8 million for supplies, overhead, and other expense also contributed to the overall reduction in research and development expenses.
Previous report
Investment and Other Income, Net
Previous report
Comparison of Nine Months Ended September 30, 2025 to Nine Months Ended September 30, 2024
Previous report
License Revenue
Previous report
License revenue for the nine months ended September 30, 2025 was zero compared to $40.6 million for the nine months ended September 30, 2024. The license revenue for the nine months ended September 30, 2024 relates to the License Agreement with Immunome.
Previous report
Research and development expenses for the nine months ended September 30, 2025 were $77.8 million, compared to $134.8 million for the nine months ended September 30, 2024. The decrease of $57.0 million was primarily due to decreases of $24.6 million for clinical expenses, $12.2 million for lab services,$8.3 million for drug manufacturing, and $0.7 million for supplies and other expense. A decrease of $12.3 million from personnel expense, of which $5.2 million was non-cash stock-based compensation, also contributed to the overall reduction in research and development expenses. These decreases were partially offset by an increase of $1.1 million from a one-time impairment charge related to the disposal of research and development equipment.
Previous report
General and administrative expenses for the nine months ended September 30, 2025 were $29.8 million, compared to $47.1 million during the nine months ended September 30, 2024. This decrease of $17.3 million was attributable to a decrease of $15.8 million of personnel expense, of which $14.0 was non-cash stock-based compensation. Decreases of $1.2 million related to consulting and outside services and $0.3 million in other expenses also contributed to the overall reduction in general and administrative expenses.
Previous report
Restructuring expenses for the nine months ended September 30, 2025 were $7.8 million, compared to zero during the nine months ended September 30, 2024.
Previous report
Investment and Other Income, Net
Previous report
Investment and other income, net was $13.6 million for the nine months ended September 30, 2025, compared to $23.3 million for the nine months ended September 30, 2024. The decrease of $9.8 million was primarily driven by decreases in the fair value of Immunome common stock of $7.0 million and a decrease of $6.4 million in returns on invested cash and marketable debt securities. The decreases were partially offset by a $0.6 million gain on fixed asset disposals as well as a reduction of one-time miscellaneous expenses incurred in 2024.
Reworded paragraphs (29)
Previous wording
The following discussion and analysis of financial condition and operating results should be read together with our interim unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q, as well as our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2024. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q contains forward-looking statements based upon current plans, expectations and beliefs that involve significant risks and uncertainties. As a result of many important factors, including those set forth under “Risk Factors” in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. For convenience of presentation some of the numbers have been rounded in the text below.
Current wording
You should read the following discussion and analysis of financial condition and operating results together with our interim unaudited condensed consolidated financial statements and the related notes and other financial information included elsewhere in this Quarterly Report on Form 10-Q, as well as our audited consolidated financial statements and the related notes included in our Annual Report on Form 10-K for the year ended December 31, 2025. Some of the information contained in this discussion and analysis or set forth elsewhere in this Quarterly Report on Form 10-Q contains forward-looking statements based upon current plans, expectations and beliefs involving significant risks and uncertainties. As a result of many important factors, including those set forth under “Risk Factors” and elsewhere in this Quarterly Report on Form 10-Q, our actual results may differ materially from those anticipated in these forward-looking statements. For convenience of presentation some of the numbers have been rounded in the text below.
Previous wording
We are a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), an investigational, potentially first-in-class and best-in-class WEE1 inhibitor, for patients with ovarian cancer and across other solid tumor types. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. We are currently focused on advancing the clinical development of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer, or PROC. We believe that our DENALI (ZN-c3-005) Part 2 clinical trial of azenosertib in patients with Cyclin E1-positive PROC, if successful, has the potential to support an application seeking accelerated approval, subject to U.S. Food and Drug Administration, or FDA, review. Azenosertib also has broad franchise potential beyond Cyclin E1-positive PROC. We exclusively in-license or solely own worldwide development and commercialization rights to azenosertib.
Current wording
We are a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), an investigational, potentially first-in-class and best-in-class WEE1 inhibitor, for patients with ovarian cancer and other tumor types. In clinical trials, azenosertib has been well tolerated and has demonstrated anti-tumor activity as a single agent across multiple tumor types. We are currently focused on advancing the clinical development of azenosertib in Cyclin E1-positive platinum-resistant ovarian cancer, or PROC. We believe that our DENALI (ZN-c3-005) Part 2 clinical trial of azenosertib in patients with Cyclin E1-positive PROC, if successful, has the potential to support an accelerated approval, subject to U.S. Food and Drug Administration, or FDA, review. Our Phase 3 ASPENOVA clinical trial is designed as a confirmatory trial to support conversion to potential full approval, subject to data outcomes. We also believe that azenosertib has broad franchise potential beyond Cyclin E1-positive PROC. We exclusively in-license or solely own worldwide development and commercialization rights to azenosertib.
Previous wording
Azenosertib is an investigational, potentially best-in-class and first-in-class oral, small molecule WEE1 inhibitor. The inhibition of WEE1, a DNA damage response kinase, drives cancer cells into mitosis without being able to repair damaged DNA, resulting in cell death and thereby preventing tumor growth and potentially causing tumor regression. We have designed azenosertib to have advantages over other investigational therapies targeting WEE1, including superior selectivity and pharmacokinetic properties.
Current wording
Azenosertib is an investigational, potentially first-in-class and best-in-class oral, small molecule WEE1 inhibitor. The inhibition of WEE1, a DNA damage response kinase, drives cancer cells into mitosis without being able to repair damaged DNA, resulting in cell death and thereby preventing tumor growth and potentially causing tumor regression. We have designed azenosertib to have advantages over other investigational therapies targeting WEE1, including superior selectivity and pharmacokinetic, or PK, properties.
Previous wording
Cyclin E1 Protein Expression as a Sensitive and Specific Predictive Biomarker
Current wording
Cyclin E1 Expression as a Sensitive and Specific Predictive Biomarker in PROC
Previous wording
Cells with Cyclin E1 protein overexpression are exquisitely sensitive to WEE1 inhibition via azenosertib because Cyclin E1 overexpression further accelerates cancer cells into the DNA replication phase without adequate DNA repair. As a result, we have used retrospective analyses to establish Cyclin E1 as a sensitive and specific predictive biomarker that can be used to identify patients who might benefit from azenosertib. In addition, based on published retrospective analyses, Cyclin E1 protein overexpression is a biomarker of poor prognosis and low benefit from standard-of-care single-agent chemotherapy in PROC patients.
Current wording
Cells with Cyclin E1 activation are exquisitely sensitive to WEE1 inhibition via azenosertib because Cyclin E1 activation further accelerates cancer cells into the DNA replication phase without adequate DNA repair. As a result, we have used retrospective analyses to establish Cyclin E1 as a sensitive and specific predictive biomarker that can be used to identify patients who might benefit from azenosertib. Based on published retrospective analyses, Cyclin E1 alteration is a biomarker of poor prognosis and low benefit from standard-of-care single-agent chemotherapy in PROC patients. Additionally, real-world data from two independent cohorts (Tempus Lens Ovarian cancer dataset and our historical clinical studies) presented at the 2026 American Association for Cancer Research, or AACR, annual meeting, consistently demonstrated that Cyclin E1-positive ovarian cancer patients experience worse clinical outcomes.
Previous wording
We are working with a diagnostic partner to develop a companion diagnostic test that will identify patients with PROC that overexpress the Cyclin E1 protein using our proprietary immunohistochemistry, or IHC, cutoff. A prototype of this test is being used in DENALI Part 2.
Current wording
We are working with a diagnostic partner to validate a companion diagnostic test that will identify patients with PROC that overexpress the Cyclin E1 protein using our proprietary immunohistochemistry, or IHC, cutoff. A prototype of this test is being used in DENALI Part 2 and our Phase 3 ASPENOVA clinical trial.
Previous wording
In 2022, the global ovarian cancer market was approximately $3 billion, with significant growth expected over the next several years. PROC is a subset of the ovarian cancer market. Based on our analysis utilizing our IHC cutoff, we estimate that approximately 50% of PROC patients overexpress Cyclin E1 protein, which accounts for approximately 21,500 patients on an annual basis in the United States, EU4 (France, Germany, Italy, Spain) and the United Kingdom, based on 2024 estimates. As a result, we believe there is a large market opportunity for azenosertib in Cyclin E1-positive PROC patients. Moreover, the successful launch of mirvetuximab soravtansine in PROC patients with high folate receptor alpha, or FRα-high, expression underscores the demand for biomarker-directed therapies for PROC patients. The limited overlap between FRα-high PROC patients and those that have Cyclin E1 overexpression is estimated to be less than 20%, which highlights the significant unmet need in patients with Cyclin E1-positive PROC.
Current wording
In 2022, the global ovarian cancer market was approximately $3 billion, with significant growth expected over the next several years. PROC is a subset of the ovarian cancer market. Based on our retrospective, historical analysis utilizing our IHC cutoff, we estimate that approximately 50% of PROC patients overexpress Cyclin E1 protein, which accounts for approximately 21,500 patients on an annual basis in the United States, EU4 (France, Germany, Italy, Spain) and the United Kingdom, based on 2024 estimates. As a result, we believe there is a significant opportunity for azenosertib in Cyclin E1-positive PROC patients. Moreover, the successful launch of mirvetuximab in PROC patients with high folate receptor alpha, or FRα-high, expression underscores the demand for biomarker-directed therapies for PROC patients. The limited overlap between FRα-high PROC patients and those that have Cyclin E1 overexpression is estimated to be less than 20% of all PROC patients, which highlights the significant unmet need in patients with Cyclin E1-positive PROC.
Previous wording
We believe there is additional market opportunity for azenosertib as a combination therapy, in earlier lines of treatment for ovarian cancer, and across other solid tumor types.
Current wording
We believe there is additional market opportunity for azenosertib in earlier lines of treatment for ovarian cancer, and across other solid tumor types.
Previous wording
◦DENALI Part 1b is a single-arm study that evaluated azenosertib monotherapy at our primary dose-of-interest, 400 mg QD 5:2 (intermittent daily dosing with a five days on, two days off dosing schedule), in 102 patients with PROC. Tissue collection for biomarker assessment was mandated in the study and upon a retrospective analysis, approximately 50% of the patients were Cyclin E1-positive per our proprietary IHC cutoff. In January and March of 2025, we announced clinical data from this study, which is described in the next section below titled “Clinical Data – DENALI Part 1b.”
Current wording
◦DENALI Part 1b is a single-arm study that evaluated azenosertib monotherapy at 400 mg QD 5:2 (single daily dose on an intermittent schedule of five days on and two days off), in 102 patients with PROC. Tissue collection for biomarker assessment was mandated in the study and upon a retrospective analysis, approximately 50% of the patients were Cyclin E1-positive per our IHC cutoff. In 2025, we announced clinical data from this study.
Previous wording
•Combination – Phase 1b Clinical Trial of Azenosertib and Chemotherapy or Bevacizumab in Ovarian Cancer (ZN-c3-002). We are currently enrolling patients in an arm of our ZN-c3-002 Phase 1b clinical trial that is evaluating azenosertib in combination with bevacizumab in platinum sensitive ovarian cancer.
Current wording
•Combination – Phase 1b Clinical Trial of Azenosertib and Chemotherapy or Bevacizumab in Ovarian Cancer (MUIR - ZN-c3-002) MUIR is a multi-part, open-label Phase 1b clinical trial evaluating the safety, efficacy and preliminary clinical activity of azenosertib in combination in patients with ovarian cancer. The study design consists of the following parts:
Previous wording
Since inception, we have incurred significant operating losses. Our net losses were $165.9 million for the year ended December 31, 2024. We had net losses of $101.8 million and $118.4 million for the nine months ended September 30, 2025 and September 30, 2024, respectively. We had an accumulated deficit of $1.2 billion as of September 30, 2025. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We had cash, cash equivalents and marketable securities of $280.7 million as of September 30, 2025. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our operating expenses and capital expenditure requirements into late 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Current wording
Since inception, we have incurred significant operating losses. Our net losses were $137.1 million for the year ended December 31, 2025. We had net losses of $35.4 million and $48.3 million for the three months ended March 31, 2026 and March 31, 2025, respectively. We had an accumulated deficit of $1.2 billion as of March 31, 2026. We expect to continue to incur significant expenses and operating losses for the foreseeable future. We had cash, cash equivalents and marketable securities of $211.8 million as of March 31, 2026. We believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into late 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Previous wording
In December 2014, our wholly owned subsidiary, Zeno Pharmaceuticals, Inc., entered into a license agreement, or the Recurium Agreement, with Recurium IP Holdings, LLC, or Recurium IP, which was subsequently amended, under which Zeno Pharmaceuticals, Inc. was granted an exclusive worldwide license to certain intellectual property rights owned or controlled by Recurium IP to develop and commercialize pharmaceutical products for the treatment or prevention of disease, other than for providing pain relief. Following certain historical corporate restructuring as disclosed in our Annual Report on Form 10-K for the year ended December 31, 2024, our wholly owned subsidiary, Zeno Management, Inc., or ZMI, became the Zentalis contracting party to the Recurium Agreement. The intellectual property rights exclusively licensed by ZMI under the Recurium Agreement include certain intellectual property covering azenosertib. ZMI has the right to sublicense its rights under the Recurium Agreement, subject to certain conditions. ZMI is required to use commercially reasonable efforts to develop and commercialize at least one product that comprises or contains a compound modulating one of ten specific biological targets and to execute certain development activities.
Current wording
In December 2014, our wholly owned subsidiary, Zeno Pharmaceuticals, Inc., entered into the Recurium Agreement, with Recurium IP Holdings, LLC, or Recurium IP, which was subsequently amended, under which Zeno Pharmaceuticals, Inc. was granted an exclusive worldwide license to certain intellectual property rights owned or controlled by Recurium IP to develop and commercialize pharmaceutical products for the treatment or prevention of disease, other than for providing pain relief. Following a corporate restructuring, our wholly owned subsidiary, ZMI, became the Zentalis contracting party to the Recurium Agreement. The intellectual property rights exclusively licensed by ZMI under the Recurium Agreement include certain intellectual property covering azenosertib. ZMI has the right to sublicense its rights under the Recurium Agreement, subject to certain conditions. ZMI is required to use commercially reasonable efforts to develop and commercialize at least one product that comprises or contains a compound modulating one of ten specific biological targets and to execute certain development activities.
Previous wording
Under the terms of the Recurium Agreement, ZMI is obligated to make development and regulatory milestone payments, pay royalties on net sales, and make certain sublicensing payments with respect to products that comprise or contain a compound modulating one of ten specific biological targets, including azenosertib. ZMI is obligated to make development and regulatory milestone payments for each such licensed product of up to $44.5 million. In addition, ZMI is obligated to make milestone payments of up to $150,000 for certain licensed products used in animals. ZMI is also obligated to pay royalties on sales of such licensed products at a mid- to high-single digit percentage. In addition, if ZMI chooses to sublicense or assign to any third parties its rights under certain patents exclusively in-licensed under the Recurium Agreement, ZMI must pay to Recurium IP 20% of certain sublicensing income received in connection with such transaction.
Current wording
Under the terms of the Recurium Agreement, ZMI is obligated to make development and regulatory milestone payments, pay royalties on net sales, and make certain sublicensing payments with respect to products that comprise or contain a compound modulating one of ten specific biological targets, including azenosertib. ZMI is obligated to make development and regulatory milestone payments for each such licensed product of up to $44.5 million, which covers the first two indications for which such licensed product receives regulatory approval and includes a $7.0 million milestone payment payable as a result of the commencement of our Phase 3 ASPENOVA clinical trial. In the event that a licensed product receives regulatory approval in any additional indications beyond the first two, ZMI would be obligated to pay an additional one-time milestone payment for each such approval. In addition, ZMI is obligated to make milestone payments of up to $150,000 for certain licensed products used in animals. ZMI is also obligated to pay royalties on sales of such licensed products at a mid- to high-single digit percentage. In addition, if ZMI chooses to sublicense or assign to any third parties its rights under certain patents exclusively in-licensed under the Recurium Agreement, ZMI must pay to Recurium IP 20% of certain sublicensing income received in connection with such transaction.
Previous wording
•expenses incurred under agreements with third parties, including contract research organizations, or CROs, and other third parties that conduct research, preclinical activities and clinical trials on our behalf as well as contract manufacturing organizations, or CMOs, that manufacture drug material for use in our preclinical studies and clinical trials;
Current wording
•expenses incurred under agreements with third parties, including CROs and other third parties that conduct research, preclinical activities and clinical trials on our behalf as well as CMOs that manufacture drug material for use in our preclinical studies and clinical trials;
Previous wording
The successful development of our product candidates is highly uncertain. At this time, we cannot determine with certainty the duration and costs of our existing and future clinical trials of azenosertib or any other product candidate we may develop or if, when, or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing approval. We may never succeed in obtaining marketing approval for any product candidate. The duration, costs and timing of clinical trials and development of azenosertib and any other product candidate we may develop in the future will depend on a variety of factors, including:
Current wording
Research and development activities are central to our business model. Product candidates in later stages of clinical development generally have higher development costs than those in earlier stages of clinical development, primarily due to the increased size and duration of later-stage clinical trials. The successful development of azenosertib, and any of our future product candidates is highly uncertain. At this time, we cannot determine with certainty the duration and costs of our existing and future clinical trials of azenosertib or any other product candidate we may develop or if, when, or to what extent we will generate revenue from the commercialization and sale of any product candidate for which we obtain marketing approval. We may never succeed in obtaining marketing approval for azenosertib, or any future product candidate. The duration, costs and timing of clinical trials and development of our product candidates and any other product candidate we may develop in the future will depend on a variety of factors, including:
Previous wording
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to incur significant additional expenses and time on the completion of clinical development.
Current wording
A change in the outcome of any of these variables with respect to the development of a product candidate could mean a significant change in the costs and timing associated with the development of that product candidate. For example, if the FDA or another regulatory authority were to require us to conduct clinical trials beyond those that we anticipate will be required for the completion of clinical development of a product candidate, or if we experience significant delays in our clinical trials due to patient enrollment or other reasons, we would be required to expend significant additional financial resources and time on the completion of clinical development.
Previous wording
General and administrative expenses for the three months ended September 30, 2025 were $10.8 million, compared to $14.6 million during the three months ended September 30, 2024. This decrease of $3.8 million was attributable to a decrease of $3.8 million in personnel expense, of which $2.8 million was non-cash stock-based compensation.
Current wording
General and administrative expenses for the three months ended March 31, 2026 were $9.1 million, compared to $10.6 million during the three months ended March 31, 2025. This decrease of $1.5 million was attributable to a decrease of $2.0 million in personnel expense, of which $1.2 million was non-cash stock-based compensation. The decrease was partially offset by an increase of $0.5 million related to consulting, outside services and other allocated costs.
Previous wording
Investment and other income, net was $7.0 million for the three months ended September 30, 2025, compared to $11.2 million for the three months ended September 30, 2024. The decrease of$4.2 million was primarily driven by the change in the fair value of Immunome common stock of $2.2 million, a decrease of $2.1 million in returns on invested cash and marketable debt securities partially offset by a $0.1 million increase on gain of fixed assets sold.
Current wording
Investment and other income (expense), net was $2.6 million for the three months ended March 31, 2026, compared to $(2.7) million for the three months ended March 31, 2025. The increase of$5.3 million was primarily driven by a non-cash recognized loss of $7.0 million on the mark to market adjustment for equity securities during the three months ended March 31, 2025 partially offset by a decrease of $1.7 million in returns on invested cash and marketable debt securities.
Previous wording
As a result, we will need to raise substantial additional capital to support our continuing operations and pursue our strategy. Until such time as we can generate significant revenue from product sales, if ever, we plan to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of the global macroeconomic environment and fluctuating inflation and interest rates. If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of one or more product candidates or delay our pursuit of potential in-licenses or acquisitions.
Current wording
As a result, we will need to raise substantial additional capital to support our continuing operations and pursue our strategy. Until such time as we can generate significant revenue from product sales, if ever, we plan to finance our operations through the sale of equity, debt financings or other capital sources, which may include collaborations with other companies or other strategic transactions. There are no assurances that we will be successful in obtaining an adequate level of financing as and when needed to finance our operations on terms acceptable to us or at all, particularly in light of the global macroeconomic environment, including the ongoing trade tensions between the United States and certain ex-U.S. governments, ongoing military conflicts, and fluctuating inflation and interest rates. If we are unable to secure adequate additional funding as and when needed, we may have to significantly delay, scale back or discontinue the development and commercialization of azenosertib or delay our pursuit of potential in-licenses or acquisitions.
Previous wording
We do not currently have any approved products and have never generated any revenue from product sales. To date, we have financed our operations primarily through the sale of equity securities. From inception through September 30, 2025, we raised a total of $1.2 billion in gross proceeds from the sale of shares of our common stock and convertible preferred units. We have also financed ongoing operations through the out license in January 2024 and subsequent sale in October 2024 to Immunome of one of our preclinical programs, through which Immunome paid us $20.0 million in cash proceeds in the aggregate and issued to us 4.1 million shares in the aggregate of of its common stock valued at approximately $47.4 million at the time of the transactions. Through September 30, 2025, we have sold 3.9 million of these shares in the public markets yielding gross proceeds of $51.3 million. As of September 30, 2025 we held 0.2 million shares of Immunome common stock, which we sold in October 2025. As of September 30, 2025, we had $39.1 million in cash and cash equivalents, $239.2 million in marketable debt securities, $2.4 in marketable equity securities, and an accumulated deficit of $1.2 billion. We maintain the majority of our cash and cash equivalents in accounts with major financial institutions, and our deposits at these institutions exceed insured limits. Market conditions can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. We had no indebtedness as of September 30, 2025.
Current wording
We do not currently have any approved products and have never generated any revenue from product sales. To date, we have financed our operations primarily through the sale of equity securities. From inception through March 31, 2026, we raised a total of $1.2 billion in gross proceeds from the sale of shares of our common stock and convertible preferred units. As of March 31, 2026, we had $31.9 million in cash and cash equivalents, $179.8 million in marketable debt securities, and an accumulated deficit of $1.2 billion. We maintain the majority of our cash and cash equivalents in accounts with major financial institutions, and our deposits at these institutions exceed insured limits. Market conditions can impact the viability of these institutions. In the event of failure of any of the financial institutions where we maintain our cash and cash equivalents, there can be no assurance that we would be able to access uninsured funds in a timely manner or at all. Any inability to access or delay in accessing these funds could adversely affect our business and financial position. We had no indebtedness as of March 31, 2026.
Previous wording
In May 2021, we entered into a sales agreement, or the Sales Agreement, with Leerink Partners LLC, as sales agent, pursuant to which we may, from time to time, issue and sell common stock with an aggregate value of up to $75.0 million in “at-the-market” offerings, or the ATM, under our Registration Statement on Form S-3 (File No. 333-286122) filed with the U.S. Securities and Exchange Commission, or the SEC, on March 26, 2025. Sales of common stock, if any, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act of 1933, as amended, or the Securities Act, including sales made directly through The Nasdaq Global Market or any other existing trading market for our common stock. During the quarter ended September 30, 2025, we did not sell any shares of common stock under the Sales Agreement. As of September 30, 2025, there was $75.0 million of our common stock remaining available for sale under our ATM.
Current wording
In May 2021, the Company entered into a sales agreement, or the Sales Agreement, with SVB Leerink Partners LLC, or SVB Leerink, as sales agent (the “Sales Agreement”), pursuant to which the Company may, from time to time, issue and sell common stock with an aggregate value of up to $75.0 million in “at-the-market” offerings, or the ATM, under the Company’s Registration Statement on Form S-3 (File No. 333-286122) filed with the SEC, on March 26, 2025. Sales of common stock, pursuant to the Sales Agreement, may be made in sales deemed to be an “at the market offering” as defined in Rule 415(a) of the Securities Act, including sales made directly through the Nasdaq Global Market or any other existing trading market for the Company’s common stock. In December 2025, the Company sold 3,928,571 shares of common stock under the Sales Agreement at a price of $1.40 per share, raising aggregate gross proceeds of $5.5 million before fees and expenses of $0.1 million. As of March 31, 2026, there was $69.5 million of our common stock remaining available for sale under our ATM.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2025 was $94.3 million, consisting primarily of our net loss of $101.8 million as we incurred expenses associated with the restructuring event, research and development activities for our product candidate and general and administrative activities, as well as changes in operating assets and liabilities of $7.7 million and partially offset by non-cash adjustments of $15.2 million.
Current wording
Net cash used in operating activities for the three months ended March 31, 2026 was $33.0 million, consisting primarily of our net loss of $35.4 million as we incurred expenses associated with research and development activities for our product candidate and general and administrative activities, and changes in operating assets and liabilities of $0.7 million, partially offset by non-cash adjustments of $3.1 million.
Previous wording
Net cash used in operating activities for the nine months ended September 30, 2024 was $131.2 million, consisting primarily of our net loss of $118.4 million as we incurred expenses associated with research and development activities for our product candidates and incurred general and administrative expenses, as well as changes in operating assets and liabilities of $9.5 million and non-cash adjustments of $3.3 million.
Current wording
Net cash used in operating activities for the three months ended March 31, 2025 was $32.6 million, consisting primarily of our net loss of $48.3 million as we incurred expenses associated with the restructuring event, research and development activities for our product candidates and incurred general and administrative expenses, as well as changes in operating assets and liabilities of $1.8 million and non-cash adjustments of $13.9 million.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2024 of $144.3 million was attributable to proceeds of maturities of marketable securities of $199.7 million and the sale of marketable equity securities of $33.5 million, offset by net investment of excess cash of $88.7 million and purchases of property and equipment of $221 thousand and proceeds from sales of property and equipment of $65 thousand.
Current wording
Net cash provided by investing activities for the three months ended March 31, 2026 of $30.0 million was primarily attributable to proceeds from maturities of marketable securities of $60.0 million, offset by net investment of excess cash of $30.0 million.
Previous wording
Net cash provided by investing activities for the nine months ended September 30, 2025 of $99.2 million was attributable to proceeds of maturities of marketable securities of $190.0 million, the sale of marketable equity securities of $17.9 million, and proceeds from sale of property and equipment of $0.6 million, offset by net investment of excess cash of $109.3 million.
Current wording
Net cash provided by investing activities for the three months ended March 31, 2025 of $40.5 million was attributable to proceeds from maturities of marketable securities of $60.0 million, offset by net investment of excess cash of $19.5 million.
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2024 of $108 thousand consisted of $349 thousand provided from the issuance of common stock under equity incentive plans offset by cash used in the net-settlement of restricted stock unit vesting of $241 thousand.
Current wording
Net cash used in financing activities for the three months ended March 31, 2026 of $1.1 million resulted from cash used for the net-settlement of restricted stock unit vesting of $1.4 million partially offset by proceeds of $0.3 million from the issuance of common stock under equity incentive plans .
Previous wording
Net cash provided by financing activities for the nine months ended September 30, 2025 of $304 thousand was provided from the issuance of common stock under equity incentive plans.
Current wording
Net cash provided by financing activities for the three months ended March 31, 2025 of $189 thousand was provided from the issuance of common stock under equity incentive plans.
Previous wording
•the clinical development of azenosertib for the treatment of oncology indications, including, in particular, the initiation and execution of our planned Phase 3 confirmatory clinical trial of azenosertib versus standard-of-care chemotherapy for the treatment of patients with Cyclin E1-positive PROC;
Current wording
•the clinical development of azenosertib for the treatment of oncology indications;
Previous wording
As of September 30, 2025, we have $3.7 million and $36.7 million in current and long-term lease liabilities, respectively. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2025 will be sufficient to fund our operating expenses and capital expenditure requirements into late 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Current wording
As of March 31, 2026, we have $4.0 million and $34.7 million in current and long-term lease liabilities, respectively. We believe that our existing cash, cash equivalents and marketable securities as of March 31, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into late 2027. We have based these estimates on assumptions that may prove to be imprecise, and we could utilize our available capital resources sooner than we expect.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Investment and Other Income (Expense), Net
Rearranged previous paragraphs (1)
Previous report — wording carried elsewhere
The following table summarizes our results of operations for the periods indicated, together with the changes in those items in dollars: