Zentalis Pharmaceuticals, Inc.
For the period ended Sep 30, 2026. Filed Nov 9, 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.
Sep 30, 2026 · Filed Nov 9, 2026
ZNTL$1.74+1.2%Stored close · as of Nov 9, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2026-06-30; filed 2026-08-06.
0001725160-26-000062
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2026-09-30; filed 2026-11-09.
0001725160-26-000070
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 146 previous paragraphs and 150 current paragraphs.
121 unchanged; 18 reworded; 11 added; 7 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 4 previous and 4 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 (11)
Current report
•Combination - Triple-Negative Breast Cancer Combination Study Planning Based on encouraging preclinical data, we are actively planning a combination clinical study of azenosertib in triple-negative breast cancer.
Current report
European Society for Medical Oncology (ESMO) 2026. In October 2026, we presented an overall survival, or OS, analysis from DENALI Part 1b at the ESMO Annual Meeting, the first OS analysis for azenosertib. As of the May 22, 2026 data cutoff, in patients with Cyclin E1-postive PROC tumors (n=48), a median OS of 15.9 months (95% CI, 8.7-21.2), with 31 events (65%), was observed. In patients with Cyclin E1-negative PROC tumors (n=46), a median OS of 7.5 months (95% CI, 5.8-12.3), with 34 events (74%), was observed. The Cyclin E1 status of 94 patients was retrospectively determined by our IHC cutoff.
Current report
In patients with Cyclin E1-postive PROC tumors who were response-evaluable (patients who had at least one scan after receiving azenosertib), an overall response rate, or ORR, of 37.2% (95% CI, 23.0-53.3) was observed. In all patients with Cyclin E1-positive PROC tumors, an ORR of 33.3% (95% CI, 20.4-48.4) was observed. As of the May 22, 2026 data cutoff, the median duration of response, or mDOR, was approximately 5.5 months (95% CI, 4.5-15.9), including two patients with responses exceeding 15 and 20 months.
Current report
The median relative dose intensity was 84.6%, confirming high overall exposure to azenosertib.
Current report
The safety profile was consistent with what was previously disclosed in March 2025. The most common treatment-related adverse events, or TRAEs, were nausea, fatigue, diarrhea, thrombocytopenia, decreased appetite, anemia, and neutropenia. The most common non-hematologic Grade 3+ TRAEs was fatigue (16%). The most common hematologic TRAEs were thrombocytopenia (12%), anemia (11%), and neutropenia (11%). There were two previously reported treatment-related Grade 5 events in the study (2.0%).
Current report
College of American Pathologists 2026 Annual Meeting. In October 2026, we presented a poster at the College of American Pathologists 2026 Annual Meeting on the development and analytical validation of a laboratory-developed test, or LDT, for detecting Cyclin E1 protein expression by IHC in high-grade serous ovarian cancer, or HGSOC, tumor samples. The validation, conducted under College of American Pathologists/Clinical Laboratory Improvement Amendments, or CAP/CLIA, standards, demonstrated high specificity for nuclear Cyclin E1 detection, epitope stability for at least 52 weeks, and high concordance across laboratories and readers throughout prospective clinical study execution. We believe these data support the suitability of the LDT for prospective biomarker screening in HGSOC patients.
Current report
Research and development expenses for the three months ended September 30, 2026 were $22.3 million, compared to $23.0 million for the three months ended September 30, 2025. The $0.7 million decrease was primarily attributable to a $6.2 million decrease in clinical trial expenses for certain studies that reached or are near completion, partially offset by a $3.8 million increase in expenses for ongoing clinical trials open for enrollment, a $0.8 million increase in companion diagnostic development expenses and a $0.9 million increase in personnel-related expenses and allocated overhead.
Current report
General and administrative expenses for the three months ended September 30, 2026 were $8.8 million, compared to $10.8 million during the three months ended September 30, 2025. The $2.0 million decreasewas primarily attributable to a $2.7 million decrease in personnel-related expenses partially offset by a $0.7 million increase primarily related to consulting and outside services.
Current report
Comparison of Nine Months Ended September 30, 2026 to Nine Months Ended September 30, 2025
Current report
General and administrative expenses for the nine months ended September 30, 2026 were$27.2 million, compared to$29.8 million during the nine months ended September 30, 2025. The $2.6 million decrease was primarily attributable to a $5.5 million decrease in personnel-related expenses, partially offset by a $2.9 million increase primarily related to consulting and outside services.
Current report
Investment and other income, net was$7.3 million for the nine months ended September 30, 2026, compared to$13.6 million for the nine months ended September 30, 2025. The $6.3 million decrease was primarily attributable to a $4.5 million decrease in returns on invested cash and marketable debt securities, the absence of $1.1 million of other income recognized during the nine months ended September 30, 2025 resulting from a change in the fair value of marketable equity securities, and the absence of a $0.7 million miscellaneous gain recognized during the nine months ended September 30, 2025.
Removed paragraphs (7)
Previous 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.
Previous report
In May 2026, we presented data from Part 1 of the Phase 1b MUIR trial at the ASCO Annual Meeting. The findings reflect a December 1, 2025 data cutoff and include 46 patients who received azenosertib across four dose cohorts — 200 mg QD continuously or 200 mg, 250 mg, or 300 mg QD intermittently (5 days on, 2 days off) — in combination with paclitaxel 80 mg/m². All patients had received prior paclitaxel. The data showed combinability and activity of azenosertib in an all-comer PROC setting, demonstrating the potential for azenosertib in multiple lines of ovarian cancer and more broadly in combination with cytotoxic agents in other tumor types. For a summary of the data we presented at the ASCO Annual Meeting, please refer to the 8-K Current Report we filed with the SEC on May 21, 2026.
Previous report
Research and development expenses for the three months ended June 30, 2026 were $35.2 million, compared to $27.6 million for the three months ended June 30, 2025. The increase of $7.6 million was primarily due to a $7.0 million milestone payment to Recurium IP Holdings, LLC required as a result of the commencement of our Phase 3 ASPENOVA clinical trial and an increase of $5.2 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. This increase was partially offset by a decrease of $4.5 million for personnel expense, of which $2.1 million was non-cash stock-based compensation, and a decrease of $0.1 million related to allocated overhead.
Previous report
General and administrative expenses for the three months ended June 30, 2026 were $9.2 million, compared to $8.4 million during the three months ended June 30, 2025. This increase of $0.8 million was primarily attributable to an increase of $1.7 million for consulting and outside services. This increase was partially offset by a decrease of $0.9 million for non-cash stock-based compensation.
Previous report
Comparison of Six Months Ended June 30, 2026 to Six Months Ended June 30, 2025
Previous report
General and administrative expenses for the six months ended June 30, 2026 were$18.4 million, compared to$19.0 million during the six months ended June 30, 2025. This decrease of $0.6 million was attributable to a decrease of $2.8 million of personnel expense of which $2.2 million was non-cash stock-based compensation. This decrease was partially offset by an increase of $2.2 million related primarily to consulting and outside services.
Previous report
Investment and other income (expense), net was$4.9 million for the six months ended June 30, 2026, compared to$6.5 million for the six months ended June 30, 2025. The decrease of $1.6 million was primarily driven by a decrease of $3.5 million in returns on invested cash and marketable debt securities partially offset by a non-cash recognized loss of $2.4 million on the mark to market adjustment for equity securities during the six months ended June 30, 2025. A gain of $0.5 million on fixed assets sold during the six months ended June 30, 2025 also contributed to the overall decrease.
Reworded paragraphs (18)
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 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 (ZN-c3-020) 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.
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 and the treatment landscape at the time of regulatory action. Our Phase 3 ASPENOVA (ZN-c3-020) 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
◦DENALI Part 1b is a fully enrolled 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.
Current wording
▪DENALI Part 1b is a fully enrolled 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 October 2026, we presented an overall survival analysis from this study at ESMO. These data are described in the next section below titled “Recent Data and Presentations.”
Previous wording
▪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 wording
▪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, further discussions with the FDA and the treatment landscape at the time of the regulatory action. The study design consists of the following parts:
Previous wording
◦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 wording
◦Part 2c: Broadening study population, which is expected to include up to 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. Enrollment in this cohort is scheduled to complete in November 2026.
Previous wording
The integrated dataset of DENALI Parts 2a, 2b, and 2c is designed to support accelerated approval in the Cyclin E1 biomarker-selected patient population, subject to regulatory review. We expect to provide a topline readout of DENALI Part 2 in the first half of 2027 to allow for data maturation post full enrollment.
Current wording
The integrated dataset of DENALI Parts 2a, 2b, and 2c is designed to support accelerated approval in the Cyclin E1 biomarker-selected patient population, subject to regulatory review. In light of an evolving landscape in PROC, we plan to discuss the DENALI data with the FDA in 2027 to assess the accelerated approval opportunity. We expect to provide a topline readout of DENALI Part 2 in the first half of 2027.
Previous wording
▪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 May 2026, we announced data from MUIR Part 1 focusing on azenosertib in combination with paclitaxel in PROC as paclitaxel is commonly used across multiple tumor types, including ovarian cancer. These data are described in the next section below titled “Recent Data and Presentations.” Data from the other combination arms will be presented at a later date.
Current wording
▪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 May 2026, we announced data from MUIR Part 1 focusing on azenosertib in combination with paclitaxel in PROC as paclitaxel is commonly used across multiple tumor types, including ovarian cancer.
Previous 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 $77.6 million and $75.2 million for the six months ended June 30, 2026 and June 30, 2025, respectively. We had an accumulated deficit of $1.3 billion as of June 30, 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 $174.6 million as of June 30, 2026. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 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.
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 $106.5 million and $101.8 million for the nine months ended September 30, 2026 and September 30, 2025, respectively. We had an accumulated deficit of $1.3 billion as of September 30, 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 $228.9 million as of September 30, 2026. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2028. 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
Investment and other income (expense), net was $2.2 million for the three months ended June 30, 2026, compared to $9.2 million for the three months ended June 30, 2025. The decrease of $7.0 million was primarily driven by a non-cash recognized gain of $4.6 million on the mark to market adjustment for equity securities during the three months ended June 30, 2025 and a decrease of $1.7 million in returns on invested cash and marketable debt securities. A gain of $0.5 million on fixed assets sold during the three months ended June 30, 2025 and a decrease of $0.2 million in other income and expense accounts also contributed to the overall decrease.
Current wording
Investment and other income, net was $2.4 million for the three months ended September 30, 2026, compared to $7.0 million for the three months ended September 30, 2025. The $4.6 million decrease was primarily attributable to the absence of$3.5 million of other income recognized in 2025 resulting from a change in the fair value of marketable equity securities, as well as a $1.1 million decrease in returns on invested cash and marketable debt securities.
Previous wording
Research and development expenses for the six months ended June 30, 2026 were$63.9 million, compared to$54.9 million for the six months ended June 30, 2025. The increase of $9.0 million was primarily due to a $7.0 million milestone payment to Recurium IP Holdings, LLC required as a result of the commencement of our Phase 3 ASPENOVA clinical trial and an increase of $11.5 million related to clinical expenses and drug manufacturing, including costs associated with advancing the DENALI and ASPENOVA trials. These increases were partially offset by a decrease of $8.4 million for personnel expense, of which $3.4 million was non-cash stock-based compensation and a decrease of $1.1 million related to a one time impairment charge recorded during the quarter ended March 31, 2025.
Current wording
Research and development expenses for the nine months ended September 30, 2026 were$86.2 million, compared to$77.8 million for the nine months ended September 30, 2025. The $8.4 million increasewas primarily attributable to a $7.0 million milestone payment to Recurium IP Holdings, LLC triggered by the commencement of our Phase 3 ASPENOVA clinical trial; an $8.8 million increase in clinical trial expenses, including costs associated with advancing the DENALI and ASPENOVA trials; a $1.5 million increase in drug manufacturing costs; and a $0.4 million increase in companion diagnostic development costs. These increases were partially offset by a $7.7 million decrease in personnel-related expenses, the absence of a $1.1 million one-time impairment charge recorded in 2025, and a $0.5 million decrease in allocated overhead and other miscellaneous costs.
Previous wording
Restructuring expenses for the six months ended June 30, 2026 were zero, compared to $7.8 million during the six months ended June 30, 2025.
Current wording
Restructuring expenses for the nine months ended September 30, 2026 were zero, compared to $7.8 million during the nine months ended September 30, 2025.
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 June 30, 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 June 30, 2026, we had $24.8 million in cash and cash equivalents, $149.8 million in marketable debt securities, and an accumulated deficit of $1.3 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 June 30, 2026.
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 September 30, 2026, we raised a total of $1.3 billion in gross proceeds from the sale of shares of our common stock and convertible preferred units, including a total of $92.6 million in gross proceeds from our follow-on offering in August 2026. As of September 30, 2026, we had $24.0 million in cash and cash equivalents, $204.9 million in marketable debt securities, and an accumulated deficit of $1.3 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, 2026.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2026 was $70.2 million, consisting primarily of our net loss of $77.6 million as we incurred expenses associated with research and development activities for our product candidate and general and administrative activities, partially offset by changes in operating assets and liabilities of $1.0 million and non-cash adjustments of $6.4 million.
Current wording
Net cash used in operating activities for the nine months ended September 30, 2026 was $102.9 million, consisting primarily of our net loss of $106.5 million as we incurred expenses associated with research and development activities for our product candidate and general and administrative activities as well as changes in operating assets and liabilities of $6.1 million, offset by non-cash adjustments of $9.7 million.
Previous wording
Net cash used in operating activities for the six months ended June 30, 2025 was $67.3 million, consisting primarily of our net loss of $75.2 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 $6.6 million and non-cash adjustments of $14.4 million.
Current 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.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2026 of $60.0 million was primarily attributable to proceeds from maturities of marketable securities of $120.0 million, offset by net investment of excess cash of $59.9 million.
Current wording
Net cash provided by investing activities for the nine months ended September 30, 2026 of $4.7 million was primarily attributable to proceeds from maturities of marketable securities of $180.0 million, offset by net investment of excess cash of $175.2 million.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 of $70.9 million was attributable to proceeds from maturities of marketable securities of $130.0 million and proceeds from sale of property and equipment of $0.6 million, offset by net investment of excess cash of $59.7 million.
Current 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.
Previous wording
Net cash used in financing activities for the six months ended June 30, 2026 of $1.1 million resulted from cash used for the net-settlement of restricted stock unit vesting of $1.5 million partially offset by proceeds of $0.4 million from the issuance of common stock under equity incentive plans .
Current wording
Net cash provided by financing activities for the nine months ended September 30, 2026 of $86.2 million primarily relates to the August 2026 follow-on offering, which provided net cash of $86.9 million as well as $0.7 million from the issuance of common stock under equity incentive plans offset by $1.4 million of cash used for the net-settlement of restricted stock unit vesting.
Previous wording
Net cash provided by financing activities for the six months ended June 30, 2025 of $189 thousand was provided from the issuance of common stock under equity incentive plans.
Current 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.
Previous wording
As of June 30, 2026, we have $4.1 million and $33.6 million in current and long-term lease liabilities, respectively. We believe that our existing cash, cash equivalents and marketable securities as of June 30, 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.
Current wording
As of September 30, 2026, we have $4.3 million and $32.4 million in current and long-term lease liabilities, respectively. We believe that our existing cash, cash equivalents and marketable securities as of September 30, 2026 will be sufficient to fund our operating expenses and capital expenditure requirements into the first half of 2028. 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.