Zentalis Pharmaceuticals, Inc.
For the period ended Sep 30, 2025. Filed Nov 10, 2025.
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, 2025 · Filed Nov 10, 2025
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-06.
0001725160-25-000149
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 138 previous paragraphs and 143 current paragraphs.
105 unchanged; 31 reworded; 6 added; 2 removed; 0 previous and 1 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 (6)
Current report
Government Shutdown
Current 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.
Current 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.
Current report
Investment and Other Income, Net
Current report
Comparison of Nine Months Ended September 30, 2025 to Nine Months Ended September 30, 2024
Current report
Investment and Other Income, Net
Removed paragraphs (2)
Previous report
Research and development expenses for the three months ended June 30, 2025 were $27.6 million, compared to $48.4 million for the three months ended June 30, 2024. The decrease of $20.8 million was primarily due to decreases of $15.9 million for clinical expenses, $3.6 million for lab services, $3.4 million for drug manufacturing, $0.6 million related to personnel expenses and $0.4 million of miscellaneous expenses. These decreases were partially offset by an increase in companion diagnostic expense of $3.1 million.
Previous report
Comparison of Six Months Ended June 30, 2025 to Six Months Ended June 30, 2024
Reworded paragraphs (31)
Previous wording
We are a clinical-stage biopharmaceutical company developing azenosertib (ZN-c3), a 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. 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 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.
Previous wording
Azenosertib is a 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 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.
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 account 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 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.
Previous wording
We believe there is additional market opportunity for azenosertib outside of ovarian cancer across other solid tumor types, including uterine serous carcinoma, or USC, triple negative breast cancer, HER2+ solid tumors, and osteosarcoma. Some of these tumor types are being studied in a Company sponsored trial (TETON (ZN-c3-004) in USC) or investigator initiated clinical trials.
Current 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.
Previous wording
◦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 the Part 2a results subject to 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. 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.
Current wording
◦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 wording
•Monotherapy – Phase 3 Clinical Trial in Cyclin E1-positive PROC. We plan to conduct a randomized Phase 3 clinical trial of azenosertib versus standard-of-care chemotherapy for the treatment of patients with Cyclin E1-positive PROC designed to support a full approval of azenosertib in this setting, which we plan to conduct concurrently with DENALI Part 2b, subject to FDA feedback.
Current wording
•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 wording
•Monotherapy – Phase 2 Clinical Trial in 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. We plan to disclose data from this trial in the first half of 2026.
Current wording
•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 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 $75.2 million and $78.2 million for the six months ended June 30, 2025 and June 30, 2024, respectively. We had an accumulated deficit of $1.1 billion as of June 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 $303.4 million as of June 30, 2025. We believe that our existing cash, cash equivalents and marketable securities as of June 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 $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.
Previous wording
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 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.
Current wording
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 wording
To date, we have not generated any revenue, and we do not expect to generate any revenue in the foreseeable future from product sales. We have generated, and may in the future generate, revenue from payments received under our licensing, collaboration and asset sale agreements, which included payments of upfront fees, license fees, milestone-based payments and reimbursements for research and development efforts.
Current wording
To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue in the foreseeable future. We have generated, and may in the future generate, revenue from payments received under our licensing, collaboration and asset sale agreements, which included payments of upfront fees, license fees, milestone-based payments and reimbursements for research and development efforts.
Previous 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. Following the strategic restructuring announced in January 2025 for which we incurred certain associated non-recurring expenses in the first quarter of 2025, we expect an initial decrease in research and development expenses; however, if our azenosertib development program continues to advance successfully, we expect our research and development expenses to increase as we initiate and execute our Phase 3 confirmatory study and prepare for commercialization.
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. 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 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.
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 incur significant additional expenses and time on the completion of clinical development.
Previous wording
Following the strategic restructuring announced in January 2025 for which we incurred certain associated non-recurring expenses in the first quarter of 2025, we expect an initial decrease in general and administrative expenses; 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 Phase 3 confirmatory study and prepare for 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.
Current wording
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 wording
General and administrative expenses for the three months ended June 30, 2025 were $8.4 million, compared to $16.7 million during the three months ended June 30, 2024. This decrease of $8.3 million was attributable to a decrease of $6.8 million in personnel expense, $1.1 million related to consulting and $0.4 million miscellaneous expenses.
Current 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.
Previous wording
Investment and other income (expense), net was $9.2 million for the three months ended June 30, 2025, compared to $(22.9) million for the three months ended June 30, 2024. The increase of $32.1 million was primarily driven by the change in the fair value of Immunome stock of $33.6 million, a $0.5 million increase on gain of fixed assets sold offset by a decrease of $2.0 million in returns on invested cash and marketable debt securities.
Current 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.
Previous wording
License revenue for the six months ended June 30, 2025 was zero compared to $40.6 for the six months ended June 30, 2024. The license revenue for the six months ended June 30, 2024 relates to the License Agreement with Immunome.
Current wording
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 wording
Research and development expenses for the six months ended June 30, 2025 were $54.9 million, compared to $98.0 million for the six months ended June 30, 2024. The decrease of $43.1 million was primarily due to decreases of $26.6 million for clinical expenses, $8.2 million for drug manufacturing, $8.0 million for lab services, and $4.7 million related to personnel expenses. These decreases were partially offset by an increase in companion diagnostic expense of $3.2 million and the one-time impairment charge of $1.2 million related to the disposal of research and development equipment.
Current wording
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 wording
General and administrative expenses for the six months ended June 30, 2025 were $19.0 million, compared to $32.5 million during the six months ended June 30, 2024. This decrease of $13.5 million was attributable to a decrease of $11.9 million of personnel expense, $1.2 million related to consulting and outside services and $0.4 million in other expenses.
Current wording
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 wording
Restructuring expenses for the six months ended June 30, 2025 were $7.8 million, compared to zero during the six months ended June 30, 2024.
Current wording
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 wording
Investment and other income (expense), net was $6.5 million for the six months ended June 30, 2025, compared to $12.1 million for the six months ended June 30, 2024. The decrease of $5.6 million was primarily driven by decreases in the fair value of Immunome stock of $4.6 million and a decrease of $4.4 million in returns on invested cash and marketable debt securities. The decreases were partially offset by a $0.5 million gain on fixed asset disposals as well as a reduction of one-time miscellaneous expenses incurred in 2024.
Current wording
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.
Previous wording
Since our inception, our operations have been limited to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and performing research and development of our product pipeline. We do not have any products approved for commercial sale and have not generated any revenues from product sales and we have incurred significant operating losses. Following the strategic restructuring announced in January 2025 for which we incurred certain associated non-recurring expenses in the first quarter of 2025, we expect an initial decrease in expenses; however, if our azenosertib development program continues to advance successfully, we expect our expenses to increase as we initiate and execute our Phase 3 confirmatory study and prepare for commercialization.
Current wording
Since our inception, our operations have been limited to organizing and staffing our company, business planning, raising capital, establishing our intellectual property portfolio and performing research and development of our product pipeline. We do not have any products approved for commercial sale and have not generated any revenues from product sales and we have incurred significant operating losses.
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, 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. As of June 30, 2025, we had $37.6 million in cash and cash equivalents, $249.0 million in marketable debt securities, $16.8 in marketable equity securities, and an accumulated deficit of $1.1 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, 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 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.
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 candidate and general and administrative activities, as well as changes in operating assets and liabilities of $6.6 million and partially offset by 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 used in operating activities for the six months ended June 30, 2024 was $87.1 million, consisting primarily of our net loss of $78.2 million offset by 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 $2.2 million and non-cash adjustments of $6.7 million.
Current 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.
Previous wording
Net cash provided by investing activities for the six months ended June 30, 2025 of $70.9 million was attributable to proceeds of 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 provided by investing activities for the six months ended June 30, 2024 of $96.0 million was attributable to proceeds of maturities of marketable securities of $125.7 million, offset by net investment of excess cash of $29.5 million and purchases of property and equipment of $221 thousand.
Current 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.
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
Net cash provided by financing activities for the six months ended June 30, 2024 of $16 thousand consists of $257 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.
Current 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.
Previous wording
Following the strategic restructuring announced in January 2025 for which we incurred certain associated non-recurring expenses in the first quarter of 2025, we expect an initial decrease in expenses; however, if our azenosertib development program continues to advance successfully, we expect our expenses to increase as we initiate and execute our Phase 3 confirmatory study and prepare for commercialization. Our future capital requirements will depend on many factors, including:
Current wording
Our future capital requirements will depend on many factors, including:
Previous wording
•the clinical development of azenosertib for the treatment of oncology indications;
Current 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;
Previous wording
As of June 30, 2025, we have $3.6 million and $37.7 million in current and long-term lease liabilities, respectively. We believe that our existing cash, cash equivalents and marketable securities as of June 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 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.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
Investment and Other Income (Expense), Net