IDEAYA Biosciences, Inc.
For the period ended Mar 31, 2026. Filed May 5, 2026.
View on SEC.govAbout this filing
A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Mar 31, 2026 · Filed May 5, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious 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 OperationsCurrent report: 10-Q
Period ended 2026-03-31; filed 2026-05-05.
0001193125-26-206357
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 104 previous paragraphs and 108 current paragraphs.
52 unchanged; 34 reworded; 18 added; 14 removed; 4 previous and 4 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 (18)
Current report
Darovasertib for Uveal Melanoma
Current report
Darovasertib is an oral, potent and selective small molecule inhibitor of protein kinase C and our most advanced clinical program. We are developing darovasertib for uveal melanoma (UM), a rare, aggressive form of ocular cancer in both the metastatic and pre-metastatic settings of UM, as described below.
Current report
Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor, in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) for human leukocyte antigen-A02:01 negative (HLAA2(-)), patients with first line mUM. In April 2026, we reported positive topline data from OptimUM-02, which demonstrated a statistically significant improvement in the primary endpoint of progression free survival, as well as a statistically significant improvement in the secondary endpoint of overall survival rate as assessed by blinded independent central review. We plan to provide complete data from the primary analysis of OptimUM-02 trial in a late-breaking oral presentation at the 2026 American Society for Clinical Oncology meeting in Chicago, Illinois.
Current report
We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. accelerated approval. The FDA has agreed to review our NDA under the Oncology Center of Excellence Real-Time Oncology Review program, which allows an applicant to pre-submit components of its NDA for review before the complete filing is submitted to provide a more efficient review process and ensure safe and effective treatments are available to patients as early as possible.
Current report
We are also evaluating the combination of darovasertib and crizotinib in HLAA2:01 positive (HLAA2(+)), mUM patients in our ongoing, single-arm Phase 2 OptimUM-01 trial. We have completed enrollment of approximately 100 patients in this trial and plan to present updated clinical data at a medical conference in the second half of 2026 to support a potential regulatory submission to the FDA. This submission has the potential to expand the labeled use of darovasertib and/or guideline inclusion to enable use of the combination in these HLA*A2(+) patients.
Current report
Adjuvant UM. In collaboration with our partner, Servier, we plan to initiate a global Phase 3 registrational trial (OptimUM-11) of darovasertib and crizotinib in the adjuvant setting of primary UM in the first half of 2026.
Current report
We have successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment with darovasertib combined with crizotinib for 12-months or observation. The primary endpoint is superiority by relapse-free survival.
Current report
Antibody-Drug Conjugates / DNA Damage Response (DDR) Combinations
Current report
IDE034 is a potential first-in-class, B7H3/PTK7 bispecific TOP1 ADC. We initiated a Phase 1 dose escalation trial in the first quarter of 2026 and are targeting to provide a clinical data update by the end of 2026. Dosing of the first patient with IDE034 triggered a $5.0 million milestone payment to Biocytogen, pursuant to our Option and License Agreement.
Current report
IDE705 is a potential first-in-class, oral small molecule inhibitor of the helicase domain of Pol Theta that had been in a Phase 1 combination trial with niraparib, GSK’s small molecule inhibitor of PARP, in patients with BRCA+ or other HRD-positive tumors. In December 2025, GSK notified us of its intention to terminate the GSK Collaboration Agreement, which became effective on March 9, 2026. We plan to discontinue development of IDE705 and are currently evaluating strategic options for this asset.
Current report
MTAP Pathway
Current report
IDE397 is a potential first-in-class, oral small molecule inhibitor of methionine adenosyltransferase 2a (MAT2A), which we are developing for patients with solid tumors with methylthioadenosine phosphorylase (MTAP) gene deletion. In March 2026, we made the strategic decision to prioritize our proprietary MTAP-deleted pipeline, including IDE397 and IDE892, and the advancement of our CDKN2A-deficiency program and deprioritize our clinical activity with Gilead evaluating the combination of IDE397 and Trodelvy. Based on preliminary data from these trials supporting the mechanistic rationale of the combination in MTAP-deleted cancers, we may evaluate additional combinations between IDE397 and other TOP1 payload ADCs, including IDE034, our B7H3/PTK7 bispecific TOP1 ADC.
Current report
IDE892 is a potential first-in-class, oral small molecule MTA-cooperative inhibitor of PRMT5 being developed for patients with high priority MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). We initiated a Phase 1 dose escalation trial with IDE892 in MTAP-deleted NSCLC and PDAC in the first quarter of 2026 and, pending completion, will target to initiate a Phase 1 combination cohort with IDE397 in MTAP-deleted cancers in mid-2026 with expansion in the second half of 2026.
Current report
Next Generation Therapies
Current report
IDE574 is a potential first-in-class, oral small molecule equipotent dual inhibitor of the lysine acetyltransferase (KAT) 6 and 7, both of which have been shown to support cancer cell survival. We initiated a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers in the first quarter of 2026.
Current report
IDE275 is a potential first-in-class, oral small molecule inhibitor of the helicase domain of the Werner protein, a RecQ enzyme involved in the maintenance of genome integrity. In December 2025, GSK notified us of its intention to terminate the GSK Collaboration Agreement, which became effective on March 9, 2026. We plan to discontinue development of IDE275 and are currently evaluating strategic options for this asset.
Current report
Collaboration Revenue decreased by $4.3 million, or 40%, during the three months ended March 31, 2026 compared to the three months ended December 31, 2025 as a result of revenue recognized from the Servier License Agreement. In connection with the Servier License Agreement, we recognized revenue related to amounts allocated to the two research and development service performance obligations over time, as the underlying services are performed over the period through the completion of program development activities.
Current report
General and administrative expenses increased by $0.5 million, or 3%, during the three months ended March 31, 2026 compared to the three months ended December 31, 2025 primarily due to increases of $1.3 million in personnel-related expenses, including salaries, benefits and stock-based compensation, partially offset by a decrease of $0.8 million in consulting fees.
Removed paragraphs (14)
Previous 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.
Previous report
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 report
IDE275/GSK959, a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline, or GSK. A Phase 1 clinical trial in patients with MSI-High solid tumors is ongoing.
Previous report
IDE705/GSK101, a potential first-in-class small molecule inhibitor of DNA Polymerase Theta Helicase, or Pol Theta, is being developed in collaboration with GSK. A Phase 1 clinical trial in combination with niraparib, GSK’s small molecule inhibitor of PARP, is ongoing in patients with BRCA+ or other HRD-positive tumors. We are targeting Phase 2 expansion in HRD-positive solid tumors, which would trigger a $10 million milestone payment from GSK.
Previous report
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 report
In addition to our clinical stage pipeline, we are advancing two pre-clinical development programs:
Previous report
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 report
IDE574, a potential first-in-class KAT6/7 dual inhibitor, which is on track for IND submission by the end of the year.
Previous report
Since our inception, we have invested significantly in capabilities for identifying and validating new precision medicine targets and biomarkers for patient selection and have established multiple research collaborations to support our internal discovery and development efforts. We have also partnered with leading pharmaceutical companies, including GSK, Pfizer and Gilead to support clinical development activities for our pipeline programs.
Previous report
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 report
IDE397 includes costs from Amgen CTCSA.
Previous report
Comparison of Nine Months Ended September 30, 2025 and September 30, 2024
Previous report
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 report
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.
Reworded paragraphs (34)
Previous wording
We are a precision medicine oncology company committed to the discovery, development, and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates, or ADCs, for molecularly defined solid tumor indications. Our clinical development strategy is to evaluate our product candidates in rational combinations, where appropriate, and earlier in the course of disease in the adjuvant and neoadjuvant settings which we believe has the potential to maximize their impact. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Current wording
We are a precision medicine oncology company committed to the discovery, development and commercialization of transformative therapies for cancer. Our approach integrates expertise in small-molecule drug discovery, structural biology and bioinformatics with robust internal capabilities in identifying and validating translational biomarkers to develop tailored, potentially first-in-class targeted therapies aligned to the genetic drivers of disease. We have built a deep pipeline of product candidates focused on synthetic lethality and antibody-drug conjugates (ADCs), for molecularly defined solid tumor indications. Our clinical development strategy is to evaluate our product candidates in rational combinations, where appropriate, and earlier in the course of disease in the adjuvant and neoadjuvant setting, which we believe has the potential to maximize their impact. Our mission is to bring forth the next wave of precision oncology therapies that are more selective, more effective, and deeply personalized with the goal of altering the course of disease and improving clinical outcomes for patients with cancer.
Previous wording
Our clinical pipeline currently consists of seven potential first-in-class product candidates, as follows:
Current wording
Our current clinical pipeline consists of nine potential first-in-class product candidates across four clinical focus areas, as described below.
Previous wording
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 wording
In August 2025, we entered into an exclusive license agreement with Servier, for the development and commercialization of darovasertib outside of the United States. We received an upfront payment of $210.0 million and are eligible to receive up to $320.0 million in milestone payments, clinical trial cost sharing and clinical trial cost reimbursement, as well as double-digit royalties on net sales in all territories outside of the United States
Previous wording
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 wording
Neoadjuvant UM. We are also evaluating darovasertib as a monotherapy 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. Enrollment and site activation is continuing in our randomized Phase 3 trial of neoadjuvant darovasertib (OptimUM-10), which will include approximately 450 patients across plaque brachytherapy-eligible and enucleation-eligible cohorts. We expect to reach full enrollment in the trial by the end of 2027. We are also conducting a Phase 2 trial of neoadjuvant darovasertib (OptimUM-09) and are targeting to provide a clinical data update from this trial at a medical conference in the second 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 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.
Current wording
IDE849 is a potential first-in-class, DLL3 TOP1 ADC being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in patients with small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC). Hengrui Pharma is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and to provide a clinical data update on this program in the second half of 2026. We are currently conducting a global Phase 1/2 trial of IDE849 in SCLC and NEC with the goal of providing a clinical update and initiating a monotherapy registrational trial by the end of 2026.
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.
Current wording
IDE161 is a potential first-in-class, oral small molecule poly (ADP-ribose) glycohydrolase (PARG) inhibitor in a Phase 1 dose optimization trial to inform future combination studies with IDE849 and other TOP1-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We initiated a Phase 1 clinical combination trial of IDE161 with IDE849 in SCLC, NEC, and potentially other DLL3-overexpressing solid tumors in the first quarter of 2026. We may also evaluate clinical combinations of IDE161 with IDE034 (B7H3/PTK7) and potentially other TOP1 ADCs in collaboration with third parties.
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 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.
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 the upfront payment received from Servier. As of March 31, 2026, we had cash, cash equivalents and marketable securities of approximately $972.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.
Previous 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.
Current wording
Our net losses were $98.5 million and $72.2 million for the three months ended March 31, 2026 and March 31, 2025, respectively. As of March 31, 2026, we had an accumulated deficit of $835.1 million.
Previous wording
Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, ourselves, or for some programs, in collaboration with our strategic partners.
Current wording
Our ability to generate product revenue will depend on the successful development, regulatory approval and eventual commercialization of one or more of our product candidates, by ourselves or, for some programs, in collaboration with our strategic partners.
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 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.
Current 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 obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the Servier License Agreement, including amounts that are recognized related to previously received upfront payments, development and regulatory milestone payments and amounts due and payable to us for research and development services.
Previous wording
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 wording
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 recognized as revenue after control of the products or services is transferred to the customer and all revenue recognition criteria have been met. Contract assets are recorded when revenue has been recognized for services performed that are not yet billable to a customer.
Previous wording
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 wording
In August 2025, we entered into the Servier License Agreement for development and commercial rights to darovasertib in all countries worldwide except for the United States. We recognized revenue related to the D&C license performance obligation at a point in time upon execution of the contract. We recognize 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. We will also recognize revenue from regulatory milestones as they are achieved. Future net product sales may also result in royalty 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 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.
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, IDE705, IDE892, IDE034, and IDE574 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
We have entered into various agreements with CMOs and CROs. Our research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on the condensed balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, we will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Current wording
We have entered into various agreements with CMOs and CROs. Our research and development accruals are estimated based on the level of services performed, progress of the studies, including the phase or completion of events, and contracted costs. The estimated costs of research and development provided, but not yet invoiced, are included in accrued liabilities on our balance sheet. If the actual timing of the performance of services or the level of effort varies from the original estimates, we will adjust the accrual accordingly. Payments made to CMOs and CROs under these arrangements in advance of the performance of the related services are recorded as prepaid expenses and other current assets until the services are rendered.
Previous wording
Costs of certain activities, such as preclinical studies, are generally recognized based on an evaluation of the progress to completion of specific tasks. Nonrefundable payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets on our condensed balance sheet. The capitalized amounts are recognized as expense as the goods are delivered or the related services are performed.
Current wording
Costs of certain activities, such as preclinical studies, are generally recognized based on an evaluation of the progress to completion of specific tasks. Nonrefundable payments made prior to the receipt of goods or services that will be used or rendered for future research and development activities are deferred and capitalized as prepaid expenses and other current assets on our balance sheet. The capitalized amounts are recognized as expense as the goods are delivered or the related services are performed.
Previous wording
We anticipate that our general and administrative expenses will increase, as a result of increased personnel costs, including salaries, benefits and stock-based compensation expense, patent costs for our product candidates, expanded infrastructure and higher consulting, legal and accounting services associated with maintaining compliance with our Nasdaq stock exchange listing and requirements of the Securities and Exchange Commission, or the SEC, investor relations costs and director and officer insurance policy premiums associated with being a public company.
Current wording
We anticipate that our general and administrative expenses will increase, as a result of increased personnel costs, including salaries, benefits and stock-based compensation expense, patent costs for our product candidates, expanded infrastructure and higher consulting, legal and accounting services associated with maintaining compliance with our Nasdaq stock exchange listing and requirements of the SEC, investor relations costs and director and officer insurance policy premiums associated with being a public company.
Previous 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.
Current wording
A discussion regarding our financial condition and results of operations for the three months ended March 31, 2026 compared to the three months ended March 31, 2025 and the three months ended March 31, 2026 compared to the three months ended December 31, 2025 is presented below.
Previous wording
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 wording
Collaboration Revenue was $6.6 million for the three months ended March 31, 2026 as a result of revenue recognized from the Servier License Agreement. In connection with the Servier License Agreement, we recognized revenue related to amounts allocated to the two research and development services performance obligations over time, as the underlying services are performed over the period through the completion of program development activities.
Previous 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.
Current wording
Research and development expenses increased by $24.8 million, or 35%, during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 primarily due to increases of $19.5 million in fees paid to CROs and consultants and milestone fees related to the advancement of our lead product candidates through preclinical and clinical studies, $4.3 million in personnel-related expenses, including salaries, benefits and stock-based compensation, to support our growth and $1.0 million in costs for laboratory supplies, facilities and information technology costs to support our research and development programs.
Previous 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.
Current wording
General and administrative expenses increased by $5.9 million, or 44%, during the three months ended March 31, 2026 compared to the three months ended March 31, 2025. The increase in general and administrative expenses was primarily due to increases of $2.9 million in personnel-related expenses, including salaries, benefits and stock-based compensation and $3.0 million in consulting services related to company growth.
Previous 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.
Current wording
Interest income decreased by $2.2 million, or 18%, during the three months ended March 31, 2026 compared to the three months ended March 31, 2025 primarily due to lower interest rates and lower investment balances.
Previous 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.
Current wording
Research and development expenses increased by $9.1 million, or 11%, during the three months ended March 31, 2026 compared to the three months ended December 31, 2025 primarily due to $6.0 million in fees paid to CROs and consultants and milestone fees related to the advancement of our lead product candidates through preclinical and clinical studies and $3.1 million in personnel-related expenses, including salaries, benefits and stock-based compensation, to support our growth.
Previous 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.
Current wording
Interest income decreased by $1.3 million, or 11%, during the three months ended March 31, 2026 compared to the three months ended December 31, 2025, primarily due to lower interest rates and lower investment balances.
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 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.
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 the upfront payment received from Servier. As of March 31, 2026, we had cash, cash equivalents and marketable securities of approximately $972.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Previous 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.
Current wording
During the year ended December 31, 2025, we sold an aggregate of 984,000 shares of our common stock for 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.
Previous wording
The Company may cancel its at-the-market program at any time upon written notice, pursuant to its terms.
Current wording
We may cancel our at-the-market program at any time upon written notice, pursuant to its terms.
Previous 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.
Current wording
We have primarily incurred net losses since our inception. For the three months ended March 31, 2026 and March 31, 2025, we had net losses of $98.5 million and $72.2 million, respectively, and we expect to incur substantial additional losses in future periods. As of March 31, 2026, we had an accumulated deficit of $835.1 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
We enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies and testing, manufacture and supply of our preclinical and clinical materials and providing other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore, we believe that our non-cancellable obligations under these agreements are not material.
Current wording
We enter into contracts in the normal course of business with third-party contract organizations for preclinical and clinical studies and testing, manufacture and supply of our preclinical and clinical materials and providing other services and products for operating purposes. These contracts generally provide for termination following a certain period after notice, and therefore, we believe that our non-cancelable obligations under these agreements are not material.
Previous 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.
Current wording
Net cash used in operating activities was $75.2 million for the three months ended March 31, 2026. 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 $98.5 million, adjusted for net non-cash charges of $14.5 million and changes in net operating assets and liabilities of $8.9 million. Our non-cash charges consisted of $14.5 million in stock-based compensation, $0.7 million in depreciation and $0.5 million of the amortization of right of use assets, partially offset by $1.2 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily of cash inflows resulting from a $0.7 million increase in lease liabilities, $3.1 million increase in accounts payable, $3.0 million decrease in prepaid expenses and other assets and $2.7 million increase in accrued and other liabilities due to fees paid to CROs, CMOs and consultants in support of research and manufacturing activities, partially offset by cash outflows resulting from a $0.6 million increase in contract assets related to the Servier License Agreement.
Previous 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.
Current wording
Net cash used in operating activities was $60.3 million for the three months ended March 31, 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 $72.2 million, adjusted for net non-cash charges of $7.6 million and changes in net operating assets and liabilities of $4.2 million. Our non-cash charges consisted of $10.2 million in stock-based compensation, $0.6 million in depreciation and $0.5 million of the amortization of right of use assets, partially offset by $3.8 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $2.7 million in accounts payable, $2.9 million accrued and other liabilities in support of research and manufacturing activities and $0.6 million in lease liabilities, partially offset by outflows of $2.0 million in prepaid and other assets.
Previous 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.
Current wording
Net cash provided by investing activities was $119.0 million for the three months ended March 31, 2026, which consisted primarily of $42.6 million used to purchase marketable securities and $1.0 million used to purchase property and equipment, partially offset by $162.5 million provided by maturities of marketable securities.
Previous 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.
Current wording
Net cash provided by investing activities was $79.8 million for the three months ended March 31, 2025, which consisted primarily of $105.2 million used to purchase marketable securities and $1.3 million used to purchase property and equipment, offset by $186.4 million provided by maturities of marketable securities.
Previous 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.
Current wording
Net cash provided by financing activities was $26.1 million for the three months ended March 31, 2025, which consisted primarily of $25.0 million in net proceeds from at-the-market offerings and $1.1 million in proceeds from exercise of common stock options.
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 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.
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 17, 2026. For the three months ended March 31, 2026, 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 17, 2026.
Rearranged current paragraphs (4)
Current report — wording carried from elsewhere
Comparison of Three Months Ended March 31, 2026 and December 31, 2025
Current report — wording carried from elsewhere
During the three months ended March 31, 2026, we sold no shares of common stock under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent.
Current report — wording carried from elsewhere
As of March 31, 2026, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
Current report — wording carried from elsewhere
Net cash provided by financing activities was $1.2 million for the three months ended March 31, 2026, which consisted primarily of $1.2 million in proceeds from exercise of common stock options, offset by costs related to the at-the-market offering program.
Rearranged previous paragraphs (4)
Previous report — wording carried elsewhere
As of September 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $1.14 billion.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
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.
Previous report — wording carried elsewhere
Adequate additional funding may not be available to us on acceptable terms or at all.