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IDEAYA Biosciences, Inc.

For the period ended Sep 30, 2025. Filed Nov 4, 2025.

View on SEC.gov

About 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 4, 2025

IDYA$31.24+1.9%Stored close · as of Nov 6, 2026

What changed in Management’s Discussion and Analysis?

Read the current filing

Previous report: 10-Q

Period ended 2025-06-30; filed 2025-08-05.

0000950170-25-102967

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

Current report: 10-Q

Period ended 2025-09-30; filed 2025-11-04.

0001193125-25-264632

Item 2. Management’s Discussion and Analysis of Financial Condition and Results of Operations

The 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 97 previous paragraphs and 104 current paragraphs.

60 unchanged; 31 reworded; 12 added; 6 removed; 0 previous and 1 current paragraphs rearranged.

Tables are not compared: 5 previous and 5 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 (12)

Current report

Darovasertib, an oral, small molecule inhibitor of protein kinase C is our most advanced program in development for uveal melanoma, or UM, an aggressive form of ocular cancer. We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor, for patients with metastatic UM. In October 2025 at the Society for Melanoma Research Congress in Amsterdam, Netherlands, we reported data from our single-arm Phase 2 trial (OptimUM-01) in patients with first-line, or 1L, metastatic UM, which included the first median overall survival data presented with the combination. We also expect to report topline data, including median progression free survival data, from our ongoing, potentially registration-enabling, Phase 2/3 trial (OptimUM-02) evaluating the combination of darovasertib and crizotinib in human leukocyte antigen-A*02:01 negative, or HLA-A2(-), patients with 1L metastatic UM by year-end 2025 to first quarter 2026. Based on our discussions with the U.S. Food and Drug Administration, or FDA, the data from OptimUM-02 may enable an accelerated approval filing.

Current report

We are also evaluating darovasertib as a single-agent in the neoadjuvant setting of primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy and potentially delay or prevent progression to metastatic disease. In October 2025 at the European Society for Medical Oncology Conference in Berlin, Germany, we presented updated data from more than 90 enucleation-eligible and plaque brachytherapy-eligible patients in our ongoing Phase 2 trial (OptimUM-09). We are currently conducting a randomized Phase 3 trial of darovasertib in the neoadjuvant setting of primary UM (OptimUM-10), which will enroll approximately 450 patients across two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients. Target enrollment in this trial was revised downward from the prior estimate of 520 patients based on additional FDA feedback on the statistical plan (alpha usage) across the two cohorts.

Current report

In August 2025, we entered into an exclusive licensing agreement with Les Laboratoires Servier, or Servier, for the regulatory and commercial rights to darovasertib outside of the United States. We received an upfront payment of $210.0 million and are eligible for up to $320.0 million in development, regulatory and commercial-based milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. Servier will be responsible for the regulatory and commercial activities for darovasertib outside the United States. We and Servier will collaborate on the development of darovasertib and share the associated costs. We retain all rights to darovasertib in the United States.

Current report

In addition to our clinical stage pipeline, we are advancing two pre-clinical development programs:

Current report

In August 2025, the Company entered into the Servier License Agreement for development and commercial rights to darovasertib in all countries worldwide except for the United States. The Company recognized revenue related to the D&C license performance obligation at a point in time during the three months ended September 30, 2025 upon execution of the contract. The Company recognizes revenue related to amounts allocated to research and development services over time, as the underlying services are performed over the period through the completion of program development activities. The timing of revenue recognition, billings, and cash collections results in accounts receivable, contract assets, and contract liabilities on the balance sheets.

Current report

The Company will also recognize revenue from development and regulatory milestones as they are achieved. Future net product sales may also result in royalty payments.

Current report

When consideration is received, or such consideration is unconditionally due, from a customer prior to transferring goods or services to the customer under the terms of a contract, a contract asset or contract liability is recorded. Contract liabilities are derecognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met.

Current report

Collaboration Revenue was $207.8 million for the three months ended September 30, 2025 as a result of revenue recognized from the Servier License Agreement. See Note 11. Revenue Recognition.

Current report

Comparison of Nine Months Ended September 30, 2025 and September 30, 2024

Current report

Collaboration Revenue was $207.8 million for the nine months ended September 30, 2025 as a result of revenue recognized from the Servier License Agreement. See Note 11. Revenue Recognition.
Removed paragraphs (6)

Previous report

Darovasertib, a small molecule inhibitor of protein kinase C, or PKC, is our most advanced program in development for uveal melanoma, or UM, an aggressive form of ocular cancer. We expect to report data from two clinical trials evaluating the combination of darovasertib and crizotinib in patients with metastatic UM, including median progression free survival, or PFS, data from our potentially registrational-enabling Phase 2/3 trial in human leukocyte antigen-A*02:01 negative, or HLA-A2(-), patients with 1L metastatic UM by the end of 2025, and median overall survival, or OS, data from our ongoing single-arm Phase 2 trial in HLA-A2(-) and HLA-A2(+) patients in 1L metastatic UM at a medical conference in the fourth quarter of 2025. We are also evaluating neoadjuvant darovasertib in primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy, and potentially slow disease progression and metastasis. We expect to report initial safety and visual benefit data from our Phase 2 clinical trial from over 20 patients in the plaque brachytherapy-eligible cohort at the Company’s R&D Day on September 8 th, followed by updated data from over 90 patients in both the enucleation-eligible and plaque brachytherapy-eligible cohorts at the European Society for Medical Oncology (ESMO) Conference taking place from October 17 to October 21, 2025 in Berlin, Germany. Following a successful Type D meeting with the U.S. Food and Drug Administration (FDA), we initiated a Phase 3 registration-enabling trial of darovasertib in the neoadjuvant setting for primary UM, referred to as OptimUM-10, in the third quarter of 2025. The trial will enroll a total of approximately 520 patients in two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients.

Previous report

We are also advancing three pre-clinical development programs towards the submission of investigational new drug, or IND, applications:

Previous report

Comparison of Six Months Ended June 30, 2025 and June 30, 2024

Previous report

In June 2023, we entered into a lease agreement for approximately 44,000 square feet of laboratory and office facilities at 5000 Shoreline Court, South San Francisco, California. The lease term is 120 months, and we have an option to extend the lease term for a total of two consecutive five-year periods. The lease commenced in August 2024.

Previous report

In May 2024, we amended our 5000 Shoreline Court facility lease agreement to expand the size of the original premises by adding approximately 11,321 rentable square feet of additional space. The amendment to the lease term commenced in January 2025.

Previous report

In November 2023, we entered into a lease agreement for approximately 5,700 square feet of space at 11710 El Camino Real, San Diego, California for corporate office space. The lease commenced in December 2023 and expires in March 2028. We have an option to renew the lease for three years.
Reworded paragraphs (31)

Previous wording

Our clinical pipeline currently consists of six potential first-in-class product candidates, as follows:

Current wording

Our clinical pipeline currently consists of seven potential first-in-class product candidates, as follows:

Previous wording

IDE397, a small molecule inhibitor of methionine adenosyltransferase 2a, or MAT2A, which we are developing for patients with solid tumors with methylthioadenosine phosphorylase, or MTAP, gene deletion. We are conducting a Phase 1/2 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or CSCSA, with Gilead to evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. We plan to present initial data from the combination in MTAP-deletion UC patients at the Company’s R&D Day on September 8 th, with additional data at a medical conference in the first half of 2026.

Current wording

IDE397, a small molecule inhibitor of methionine adenosyltransferase 2a, or MAT2A, which we are developing for patients with solid tumors with methylthioadenosine phosphorylase, or MTAP, gene deletion. We are conducting a Phase 1/2 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or CSCSA, with Gilead to evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. We presented initial data from the combination in MTAP-deletion UC patients at our R&D Day on September 8, 2025 and are targeting to provide the next clinical data update at a medical conference in the first half of 2026.

Previous wording

IDE849, a potential first-in-class DLL3 TOP1i ADC, is being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in small-cell lung cancer, or SCLC, patients. Clinical efficacy and safety data from over 70 patients will be presented by Hengrui at the International Association for the Study of Lung Cancer (“IASLC”) 2025 World Conference on Lung Cancer taking place from September 6 to September 9, 2025 in Barcelona, Spain. We initiated a Phase 1 trial of IDE849 in SCLC in the U.S. in May 2025, and expect to begin dosing patients in NETs and other DLL3 expressing tumors by year-end 2025.

Current wording

IDE849, a potential first-in-class DLL3 TOP1i ADC, is being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in small-cell lung cancer, or SCLC, patients. Clinical efficacy and safety data from over 70 patients was presented by Hengrui at the International Association for the Study of Lung Cancer (IASLC) 2025 World Conference on Lung Cancer taking place from September 6 to September 9, 2025 in Barcelona, Spain. In May 2025 we initiated a global Phase 1 trial of IDE849 and have achieved first-patient-in (FPI) in the United States. We continue to enroll patients with SCLC and plan to expand into patients with neuroendocrine tumors (NETs) and other DLL3-expressing tumors by the end of 2025.

Previous wording

IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is continuing with Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We plan to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. We will also have a poster presentation at the IASLC 2025 World Conference on Lung Cancer, providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161.

Current wording

IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is continuing with Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We plan to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025.

Previous wording

IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025;

Current wording

IDE892, a potential best-in-class MTA-cooperative inhibitor of PRMT5, is being developed for patients with MTAP-deleted lung cancer and other high priority MTAP-deleted solid tumor indications. We received an investigational new drug, or IND, clearance from the FDA in the third quarter and expect to begin a Phase 1 dose escalation trial by the end of the year with the goal of advancing into combination trials with IDE397 in the first half of 2026.

Previous wording

IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025; and

Current wording

IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, for which an investigational new drug application (IND) was submitted in the fourth quarter; and

Previous wording

IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025.

Current wording

IDE574, a potential first-in-class KAT6/7 dual inhibitor, which is on track for IND submission by the end of the year.

Previous wording

We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.

Current wording

We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK and Servier. As of September 30, 2025, we had cash, cash equivalents and marketable securities of approximately $1.14 billion, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.

Previous wording

Our net losses were $149.7 million and $92.3 million for the six months ended June 30, 2025 and June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $772.5 million.

Current wording

Our net losses were $30.4 million and $144.2 million for the nine months ended September 30, 2025 and September 30, 2024, respectively. As of September 30, 2025, we had an accumulated deficit of $653.3 million.

Previous wording

As of June 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $991.9 million.

Current wording

As of September 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $1.14 billion.

Previous wording

We believe that our cash, cash equivalents, and short-term and long-term marketable securities will be sufficient to fund our planned operations for at least twelve months from the date of the issuance of our Quarterly Report on Form 10-Q filed August 5, 2025.

Current wording

We believe that our cash, cash equivalents, and short-term and long-term marketable securities will be sufficient to fund our planned operations for at least twelve months from the date of the issuance of our Quarterly Report on Form 10-Q filed on November 4, 2025.

Previous wording

To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales unless and until we are able to initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement, including amounts that are recognized related to previously received upfront payments and amounts due and payable to us for research and development services. The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of June 30, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration Agreement. The future revenue recognition is contingent on additional milestones earned, profit sharing and royalties on any net product sales under our collaborations. We expect that any revenue we recognize or generate under the GSK Collaboration Agreement will fluctuate from period to period due to period to period variability in milestone payments and other payments.

Current wording

The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of September 30, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration Agreement. The future revenue recognition is contingent on additional milestones earned, profit sharing and royalties on any net product sales under our collaborations. We expect that any revenue we recognize or generate under the GSK Collaboration Agreement will fluctuate from period to period due to period to period variability in milestone payments and other payments.

Previous wording

Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include certain payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expenses for our research and product development employees, fees to third parties to conduct certain research and development activities on our behalf including fees to CMOs and CROs in support of manufacturing and clinical activity for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK 101, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.

Current wording

Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include certain payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expenses for our research and product development employees, fees to third parties to conduct certain research and development activities on our behalf including fees to CMOs and CROs in support of manufacturing and clinical activity for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK 101 and IDE892, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.

Previous wording

A discussion regarding our financial condition and results of operations for the three months ended June 30, 2025 compared to the three months ended March 31, 2025 and six months ended June 30, 2025 compared to the six months ended June 30, 2024 is presented below.

Current wording

A discussion regarding our financial condition and results of operations for the three months ended September 30, 2025 compared to the three months ended June 30, 2025 and the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 is presented below.

Previous wording

Research and development expenses increased by $3.3 million, or 5%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025 primarily due to $1.5 million in personnel-related expenses and $1.8 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies.

Current wording

Research and development expenses increased by $8.8 million, or 12%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025 primarily due to $8.8 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies.

Previous wording

General and administrative expenses increased by $1.1 million, or 8%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025. The increase in general and administrative expense was primarily due to $1.1 million in personnel-related expenses to support our growth.

Current wording

General and administrative expenses increased by $1.8 million, or 12%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025. The increase in general and administrative expense was primarily due to $1.8 million in consulting and legal patent expenses to support our growth.

Previous wording

Interest income decreased by $0.9 million, or 7%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025, primarily due to lower investment balances.

Current wording

Interest income decreased by $0.5 million, or 5%, during the three months ended September 30, 2025 compared to the three months ended June 30, 2025 primarily due to lower interest rates.

Previous wording

Research and development expenses increased by $47.8 million, or 49%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to $37.4 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $6.2 million in personnel-related expenses and $4.2 million in costs for laboratory supplies, facilities and information technology costs to support our research and development programs.

Current wording

Research and development expenses increased by $73.6 million, or 48%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to $59.4 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $9.0 million in personnel-related expenses and $5.2 million in costs for laboratory supplies, facilities and software license costs to support our research and development programs.

Previous wording

General and administrative expenses increased by $9.5 million, or 51%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due $5.2 million in personnel-related expenses and $4.3 million in consulting services and legal patent expenses to support our growth.

Current wording

General and administrative expenses increased by $16.1 million, or 57%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to increases in $8.4 million in personnel-related expenses and $7.7 million in consulting services and legal patent expenses to support our growth.

Previous wording

Interest income decreased by $0.1 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to lower interest rates.

Current wording

Interest income decreased by $4.4 million, or 11%, during the nine months ended September 30, 2025 compared to the nine months ended September 30, 2024 primarily due to lower interest rates.

Previous wording

We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.

Current wording

We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK and Servier. As of September 30, 2025, we had cash, cash equivalents and marketable securities of approximately $1.14 billion, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.

Previous wording

During the six months ended June 30, 2025, we sold an aggregate of 984,000 shares of our common stock for an aggregate net proceeds of $25.0 million at a weighted average sales price of approximately $26.00 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of June 30, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.

Current wording

During the nine months ended September 30, 2025, we sold an aggregate of 984,000 shares of our common stock for an aggregate net proceeds of $25.0 million at a weighted average sales price of approximately $26.00 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of September 30, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.

Previous wording

We have incurred net losses since our inception. For the six months ended June 30, 2025 and June 30, 2024, we had net losses of $149.7 million and $92.3 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2025, we had an accumulated deficit of $772.5 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.

Current wording

We have primarily incurred net losses since our inception. For the nine months ended September 30, 2025 and September 30, 2024, we had net losses of $30.4 million and $144.2 million, respectively, and we expect to incur substantial additional losses in future periods. As of September 30, 2025, we had an accumulated deficit of $653.3 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.

Previous wording

For more information see also Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements, each in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Current wording

For more information see Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements, each in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.

Previous wording

Net cash used in operating activities was $122.8 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $149.7 million, adjusted for net non-cash charges of $18.0 million and changes in net operating assets and liabilities of $8.9 million. Our non-cash charges consisted of $22.1 million in stock-based compensation, $1.3 million in depreciation and $1.0 million of the amortization of right of use assets, partially offset by $6.5 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $2.4 million in accounts payable, $7.7 million accrued and other liabilities in support of research and manufacturing activities and $1.2 million in lease liabilities, partially offset by outflows of $2.5 million in prepaid and other assets.

Current wording

Net cash provided by operating activities was $19.4 million for the nine months ended September 30, 2025. Cash provided by operating activities was primarily due to the use of funds in our operations to develop our product candidates, partially offset by the upfront payment from Servier License Agreement resulting in a net loss of $30.4 million, adjusted for net non-cash charges of $29.3 million and changes in net operating assets and liabilities of $20.6 million. Our non-cash charges consisted of $34.3 million in stock-based compensation, $2.0 million in depreciation and $1.4 million of the amortization of right of use assets, partially offset by $8.5 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $3.6 million in accounts payable, $15.2 million accrued and other liabilities in support of the advancement of our lead product candidates, $2.2 million in contract liabilities related to the Servier License Agreement, $1.9 million in lease liabilities, partially offset by outflows of $2.3 million in prepaid and other assets.

Previous wording

Net cash used in operating activities was $76.7 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $92.3 million, adjusted for net non-cash charges of $5.3 million and changes in net operating assets and liabilities of $10.4 million. Our non-cash charges consisted of $16.0 million in stock-based compensation, $1.2 million in depreciation and $0.9 million of the amortization of right of use assets, partially offset by $13.0 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $9.2 million in accounts payable and $5.6 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows from $3.5 million in prepaid and other assets and $1.0 million in lease liabilities.

Current wording

Net cash used in operating activities was $125.9 million for the nine months ended September 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $144.2 million, adjusted for net non-cash charges of $10.1 million and changes in net operating assets and liabilities of $8.1 million. Our non-cash charges consisted of $25.3 million in stock-based compensation, $1.8 million in depreciation and $1.4 million of the amortization of right of use assets, partially offset by $18.3 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $5.3 million in accounts payable and $8.5 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows of $4.4 million in prepaid and other assets and $1.3 million in lease liabilities.

Previous wording

Net cash provided by investing activities was $125.7 million for the six months ended June 30, 2025, which consisted primarily of $232.8 million used to purchase marketable securities and $2.0 million used to purchase property and equipment, offset by $360.5 million provided by maturities of marketable securities.

Current wording

Net cash provided by investing activities was $167.5 million for the nine months ended September 30, 2025, which consisted primarily of $371.8 million used to purchase marketable securities and $2.0 million used to purchase property and equipment, offset by $541.3 million provided by maturities of marketable securities.

Previous wording

Net cash used in investing activities was $285.4 million for the six months ended June 30, 2024, which consisted primarily of $640.5 million used to purchase marketable securities and $2.3 million used to purchase property and equipment, partially offset by $357.4 million provided by maturities of marketable securities.

Current wording

Net cash used in investing activities was $305.5 million for the nine months ended September 30, 2024, which consisted primarily of $854.3 million used to purchase marketable securities and $2.8 million used to purchase property and equipment, partially offset by $551.6 million provided by maturities of marketable securities.

Previous wording

Net cash provided by financing activities was $27.3 million for the six months ended June 30, 2025, which consisted primarily of $25.0 million in net proceeds from at-the-market offerings, $1.5 million in proceeds from exercise of common stock options and $0.8 million in proceeds from ESPP purchase.

Current wording

Net cash provided by financing activities was $27.6 million for the nine months ended September 30, 2025, which consisted primarily of $24.9 million in net proceeds from at-the-market offerings, $1.9 million in proceeds from exercise of common stock options and $0.8 million in proceeds from ESPP purchases.

Previous wording

Net cash provided by financing activities was $388.3 million for the six months ended June 30, 2024, which consisted primarily of $380.0 million of net proceeds from at-the-market offerings and $7.5 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchases.

Current wording

Net cash provided by financing activities was $674.8 million for the nine months ended September 30, 2024, which consisted primarily of $379.9 million of net proceeds from at-the-market offerings, $274.7 million of proceeds from issuance of common stock upon public offering, $9.4 million of proceeds from issuance of pre-funded warrants, $10.0 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchases.

Previous wording

For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 18, 2025. For the six months ended June 30, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.

Current wording

For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 18, 2025. For the nine months ended September 30, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.
Rearranged current paragraphs (1)

Current report — wording carried from elsewhere

To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales unless and until we are able to initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement and Servier License Agreement, including amounts that are recognized related to previously received upfront payments, development milestone payments and amounts due and payable to us for research and development services.