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IDEAYA Biosciences, Inc.

For the period ended Sep 30, 2026. Filed Nov 3, 2026.

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, 2026 · Filed Nov 3, 2026

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 2026-06-30; filed 2026-08-04.

0001193125-26-332774

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

Current report: 10-Q

Period ended 2026-09-30; filed 2026-11-03.

0001193125-26-445294

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 105 previous paragraphs and 105 current paragraphs.

66 unchanged; 31 reworded; 8 added; 6 removed; 2 previous and 0 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 (8)

Current report

Metastatic UM (mUM). We are evaluating darovasertib in combination with crizotinib, Pfizer’s oral c-MET inhibitor (the darovasertib combination), in a potentially registration-enabling, Phase 2/3 trial (OptimUM-02) in patients with first line, human leukocyte antigen-A02:01 negative (HLAA2(-)) mUM. We are also evaluating the darovasertib combination in HLA-A02:01 positive (HLAA2(+)) mUM patients in our single-arm Phase 2 OptimUM-01 trial, and presented updated clinical data from these trials at the 2026 European Society for Medical Oncology (ESMO) Congress in Madrid, Spain. Collectively, we believe the data presented at ESMO supports the broad potential of the darovasertib combination to drive meaningful clinical benefits for patients with mUM, irrespective of HLA*A2 allele status or line of therapy.

Current report

Due to ongoing site activation and enrollment challenges, we have decided to stop enrollment and close the Phase 3 OptimUM-010 trial. We remain committed to enabling patient access to neoadjuvant darovasertib, and plan to submit published data from OptimUM-09 to support potential inclusion in clinical practice guidelines. If successful, guideline inclusion is intended to provide evidence to support the potential clinical benefit of neoadjuvant darovasertib and may allow payor coverage for eligible patients in the United States.

Current report

We are conducting a global Phase 1/2 trial of IDE849 in extensive-stage SCLC (ES-SCLC) and NEC and plan to provide our first clinical data from this trial by the end of 2026 or early in 2027. Following successful Type C meetings with the U.S. FDA, we plan to initiate two Phase 3 registrational trials with IDE849 in ES-SCLC and NEC by the end of 2026.

Current report

IDE034 is a potential first-in-class, B7H3/PTK7 bispecific TOP1 ADC designed to be internalized only when its target antigens are co-expressed on the same tumor cell, which may enhance its selectivity and tolerability profile relative to monovalent antibody formats. We are conducting a Phase 1 dose escalation trial and are targeting to provide a clinical data update in 2027.

Current report

Comparison of Nine Months Ended September 30, 2026 and September 30, 2025

Current report

Collaboration revenue decreased by $182.2 million, or 88% for the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025, primarily due to the recognition of upfront license revenue associated with the Servier collaboration in the prior-year period.

Current report

General and administrative expenses increased by $23.7 million, or 53%, during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 primarily due to increases of $15.2 million in personnel-related expenses, including salaries, benefits and stock-based compensation, $4.8 million in commercial preparation activities for darovasertib, $3.1 million in audit, tax, consulting and other external services for continued company growth, and $0.6 million in legal expenses, including contracting and patent support.
Removed paragraphs (6)

Previous 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 the OptimUM-02, which met its primary endpoint demonstrating as statistically significant improvement in median progression free survival as assessed by blinded independent central review. We presented complete data from the primary analysis of the OptimUM-02 trial in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology meeting in Chicago, Illinois.

Previous 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 plan to present updated clinical data from this trial at the 2026 European Society for Medical Oncology (ESMO) Congress being held in October in Madrid, Spain. These data will be included as part of our NDA submission to the FDA to support regulatory discussions that have the potential to expand the labeled indication of darovasertib. We also plan to publish data from OptimUM-01 for potential inclusion in clinical practice guidelines to support potential use of the combination in certain HLA*A2(+) mUM patients. Inclusion in the clinical practice guidelines, if achieved, is intended to provide healthcare professionals with an evidence-based rationale to consider use of darovasertib in appropriate patients, and may support payer coverage for such patients.

Previous report

Antibody-Drug Conjugates / DNA Damage Response Combinations

Previous report

IDE034 is a potential first-in-class, B7H3/PTK7 bispecific TOP1 ADC. We are currently conducting a Phase 1 dose escalation trial and are targeting to provide a clinical data update by the end of 2026 or early 2027. Dosing of the first patient with IDE034 in the first quarter of 2026 triggered a $5.0 million milestone payment to Biocytogen, pursuant to our Option and License Agreement.

Previous report

Comparison of Six Months Ended June 30, 2026 and June 30, 2025

Previous report

General and administrative expenses increased by $13.8 million, or 49%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025. The increase in general and administrative expenses was primarily due to increases of $6.4 million in personnel-related expenses, including salaries, benefits and stock-based compensation, $6.1 million in consulting services primarily related to support darovasertib commercial preparation activities and company growth, and $1.3 million in legal patent expenses.
Reworded paragraphs (31)

Previous wording

We plan to complete a new drug application (NDA) submission in the second half of 2026 to support a potential U.S. approval. Pursuant to Food and Drug Administration's (FDA) authorization, we have begun pre-submitting components of the NDA under the Oncology Center of Excellence Real-Time Oncology Review program (RTOR), 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 wording

During the third quarter, we successfully submitted a new drug application (NDA) to the U.S. Food and Drug Administration (FDA) under the Oncology Center of Excellence Real-Time Oncology Review (RTOR) program to support a potential U.S. approval of the darovasertib combination in mUM. The RTOR program is designed to enable a more efficient NDA submission and review process to make safe and effective treatments available to patients as early as possible.

Previous wording

Neoadjuvant UM. We are evaluating single-agent darovasertib 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. We plan to present updated clinical data at ESMO from the ongoing Phase 2 OptimUM-09 trial of neoadjuvant darovasertib. Based on ongoing patient recruitment considerations for the global Phase 3 OptimUM-10 trial we are assessing optimal capital allocation across our portfolio, including accelerating investment into other high-value programs. As part of this assessment, we are evaluating whether published data from the OptimUM-09 trial could provide a pathway for inclusion in clinical practice guidelines, supporting the use and payer coverage of darovasertib in the neoadjuvant setting of primary uveal melanoma. If successful, this approach has the potential to accelerate patient access while reducing the investment required to support clinical utility in this setting.

Current wording

Neoadjuvant UM. We are evaluating single-agent darovasertib 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. We presented updated data from our Phase 2 OptimUM-09 trial at ESMO in 2026 showing that treatment with neoadjuvant darovasertib continued to drive robust tumor shrinkage in primary UM patients, resulting in meaningful improvements in eye preservation rate and predicted vision loss in enucleation-eligible and plaque brachytherapy-eligible patients, respectively.

Previous wording

Adjuvant UM. In collaboration with our partner, Servier, we have initiated a global Phase 3 registrational trial (OptimUM-11) of darovasertib and crizotinib in the adjuvant setting of primary UM. The trial is expected to enroll approximately 450 primary UM patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to 12 months treatment with the combination or observation. The primary endpoint of the trial is relapse-free survival.

Current wording

Adjuvant UM. In collaboration with Servier we initiated our OptimUM-011 trial, a global, Phase 3 registrational trial evaluating the darovasertib combination in the adjuvant setting of primary UM. The trial is expected to enroll approximately 450 primary UM patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to either 12 months of treatment with the combination or observation. The primary endpoint of the trial is relapse-free survival.

Previous 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 plans to provide a clinical data update from this trial at ESMO, and is targeting to initiate a Phase 3 registrational trial in China in refractory SCLC by the end of 2026. We are also conducting a global Phase 1/2 trial of IDE849 in SCLC and NEC and plan to provide our first clinical data from this trial in the second half of the year. We are also having discussions with the FDA to align on the design of a Phase 3 registrational trial of IDE849 in refractory SCLC and/or NEC, and plan to provide more detail on the proposed trial design with our data update in the second half of the year, with the goal of initiating the registrational trial by the end of 2026.

Current wording

IDE849 is a potential first-in-class, DLL3 TOP1 ADC being evaluated by our partner, Jiangsu Hengrui Pharmaceuticals Co., Ltd. (Hengrui) in a multi-site, open label Phase 1 clinical trial in China in patients with relapsed small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC). Hengrui provided a clinical data update from this trial at ESMO which continued to demonstrate the robust anti-tumor activity of IDE849 that was consistent with data previously shared from this trial at the 2025 World Conference on Lung Cancer. Hengrui plans to initiate a Phase 3 registrational trial in China in relapsed SCLC by the end of 2026.

Previous 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 combination studies with IDE849 and other TOP1-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We are conducting a Phase 1 clinical combination trial of IDE161 with IDE849 in SCLC, NEC, and potentially other DLL3-overexpressing solid tumors. We may also evaluate clinical combinations of IDE161 with IDE034 (B7H3/PTK7) and potentially other TOP1 ADCs in collaboration with third parties.

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 combination studies with IDE849 and other TOP1-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We are evaluating IDE161 in a Phase 1 combination cohort with IDE849 in ES-SCLC, NEC, and other DLL3-overexpressing solid tumors. We may also evaluate clinical combinations of IDE161 with IDE034 (B7H3/PTK7) or other TOP1 ADCs in collaboration with third parties.

Previous wording

IDE892 is a potential first-in-class, oral small molecule MTA-cooperative inhibitor of protein arginine methyltransferase 5 (PRMT5) being developed for patients with MTAP-deleted solid tumors. We are currently evaluating IDE892 both as a monotherapy and in combination with IDE397, our proprietary inhibitor of MAT2A, in Phase 1/2 dose escalation trials in MTAP-deleted cancers, with a focus on pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). In May 2026, we entered into a Clinical Supply Collaboration Agreement with Roche to evaluate IDE892 in combination with RG6505, Roche's Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC. We are targeting to begin a Phase 1 combination trial in the second half of 2026.

Current wording

IDE892 is a potential first-in-class, oral small molecule MTA-cooperative inhibitor of protein arginine methyltransferase 5 (PRMT5) being developed for patients with MTAP-deleted solid tumors. We are evaluating IDE892 both as a monotherapy and in combination with IDE397, our proprietary inhibitor of MAT2A, in a Phase 1/2 trial in MTAP-deleted cancers, with a focus on pancreatic ductal adenocarcinoma (PDAC) and non-small cell lung cancer (NSCLC). In May 2026 we entered into a Clinical Supply Collaboration Agreement with Roche to evaluate IDE892 in combination with RG6505, their Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC. We will sponsor and conduct the clinical trial and Roche will provide clinical supply of RG6505, with a goal of initiating a Phase 1 combination trial by the end of the year. In August 2026 we entered into a Clinical Supply Collaboration Agreement with Genentech to evaluate IDE892 in combination with RG6620, a Phase 1 KRAS G12D inhibitor, in MTAP-deleted, KRAS G12D-mutant PDAC. Genentech will sponsor and conduct the trial and we will provide clinical supply of IDE892.

Previous wording

IDE397 is a potential first-in-class, oral small molecule inhibitor of methionine adenosyltransferase 2a (MAT2A), which we are developing for patients with MTAP-deleted solid tumors. IDE397 is currently being evaluated in a Phase 1/2 combination cohort with IDE892 in MTAP-deleted cancers. Expansion is planned by the end of 2026 or early 2027, with an initial clinical focus on MTAP-deleted NSCLC. Dual inhibition of MAT2A and PRMT5 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC.

Current wording

IDE397 is a potential first-in-class, oral small molecule inhibitor of methionine adenosyltransferase 2a (MAT2A), which we are developing for patients with MTAP-deleted solid tumors. IDE397 is currently being evaluated in a Phase 1/2 combination cohort with IDE892 in MTAP-deleted cancers. Expansion is planned by the first half of 2027, with an initial clinical focus on MTAP-deleted NSCLC. Dual inhibition of MAT2A and PRMT5 has demonstrated durable tumor regressions in several preclinical MTAP-deleted tumor models, including in NSCLC.

Previous wording

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 are currently conducting a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers.

Current wording

IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8 that are required for normal cell function. KAT6 and KAT7 are epigenetic modulators of cell identity and lineage commitment programs that are corrupted by oncogenic transformation. We are currently conducting a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers. In October, we dosed our first patient in a Phase 1 combination cohort of IDE574 with fulvestrant in estrogen receptor positive (ER+) metastatic breast cancer.

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 under our former collaboration agreement with GSK and the upfront payment received from Servier under the Servier License Agreement. As of June 30, 2026, we had cash, cash equivalents and marketable securities of approximately $1.24 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 under our former collaboration agreement with GSK and the upfront payment received from Servier under the Servier License Agreement. As of September 30, 2026, we had cash, cash equivalents and marketable securities of approximately $1.15 billion, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.

Previous wording

Our net losses were $211.0 million and $149.7 million for the six months ended June 30, 2026 and June 30, 2025, respectively. As of June 30, 2026, we had an accumulated deficit of $947.5 million.

Current wording

Our net losses were $336.7 million and $30.4 million for the nine months ended September 30, 2026 and September 30, 2025, respectively. As of September 30, 2026, we had an accumulated deficit of $1,073.3 million.

Previous wording

A discussion regarding our financial condition and results of operations for the three months ended June 30, 2026 compared to the three months ended March 31, 2026 and the six months ended June 30, 2026 compared to the six months ended June 30, 2025 is presented below.

Current wording

A discussion regarding our financial condition and results of operations for the three months ended September 30, 2026 compared to the three months ended June 30, 2026 and the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 is presented below.

Previous wording

Collaboration revenue increased by $2.3 million, or 35%, during the three months ended June 30, 2026 compared to 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 service performance obligations over time, as the underlying services are performed over the period through the completion of program development activities.

Current wording

Collaboration revenue increased by $1.4 million, or 16%, during the three months ended September 30, 2026 compared to the three months ended June 30, 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 service 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 $13.0 million, or 14% during the three months ended June 30, 2026 compared to the three months ended March 31, 2026 primarily due to $11.2 million in fees paid to CROs and consultants related to the advancement of our lead product candidates through preclinical and clinical studies and $1.8 million in personnel-related expenses, including salaries, benefits and stock-based compensation, to support our growth and research and development programs.

Current wording

Research and development expenses increased by $12.9 million, or 12% during the three months ended September 30, 2026 compared to the three months ended June 30, 2026 primarily due to increases of $11.4 million in fees paid to CROs, consultants and milestone payments related to the advancement of our lead product candidates through preclinical and clinical studies, including a $2.0 million milestone payment to Novartis triggered by the submission of the darovasertib NDA for mUM to the FDA in the third quarter of 2026, $1.5 million in personnel-related expenses, including salaries, benefits and stock-based compensation and other expenses, to support our growth and research development programs.

Previous wording

General and administrative expenses increased by $3.1 million, or 16%, during the three months ended June 30, 2026 compared to the three months ended March 31, 2026 primarily due to increases of $1.7 million in personnel-related expenses, including salaries, benefits and stock-based compensation, $0.8 million in facilities and information technology expenses, to support our growth, and $0.6 million in consulting fees primarily related to support darovasertib commercial preparation activities.

Current wording

General and administrative expenses increased by $3.8 million, or 17%, during the three months ended September 30, 2026 compared to the three months ended June 30, 2026 primarily due to increases of $1.7 million in personnel-related expenses, including salaries, benefits and stock-based compensation, $1.5 million in facilities and information technology expenses to support our continued growth, and $0.6 million in consulting fees primarily related to commercial preparation activities for darovasertib.

Previous wording

Interest income decreased by $0.2 million, or 2%, during the three months ended June 30, 2026 compared to the three months ended March 31, 2026, primarily due to lower average investment balances during the three months ended June 30, 2026.

Current wording

Interest income increased by $2.0 million, or 21%, during the three months ended September 30, 2026 compared to the three months ended June 30, 2026 primarily due to higher average investment balances during the three months ended September 30, 2026.

Previous wording

Research and development expenses increased by $59.3 million, or 41%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 primarily due to increases of $47.5 million in fees paid to CROs, consultants and milestone fees related to the advancement of our lead product candidates through preclinical and clinical studies, $8.9 million in personnel-related expenses, including salaries, benefits and stock-based compensation, $2.9 million in costs for facilities and information technology to support our growth and research and development programs.

Current wording

Research and development expenses increased by $97.9 million, or 43%, during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 primarily due to increases of $80.1 million in fees paid to CROs and consultants, clinical trial and manufacturing costs and milestone payments related to the advancement of our lead product candidates through preclinical and clinical studies, $14.9 million in personnel-related expenses, including salaries, benefits and stock-based compensation, to support our growth, and $2.9 million in facilities and information technology costs to support our research and development programs.

Previous wording

Interest income decreased by $3.7 million, or 16%, during the six months ended June 30, 2026 compared to the six months ended June 30, 2025 primarily due to lower interest rates and lower investment balances during the six months ended June 30, 2026.

Current wording

Interest income decreased by $2.6 million, or 8%, during the nine months ended September 30, 2026 compared to the nine months ended September 30, 2025 primarily due to lower investment yields.

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 under our former collaboration agreement with GSK and the upfront payment received from Servier under the Servier License Agreement. As of June 30, 2026, we had cash, cash equivalents and marketable securities of approximately $1.24 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 under our former collaboration agreement with GSK and the upfront payment received from Servier under the Servier License Agreement. As of September 30, 2026, we had cash, cash equivalents and marketable securities of approximately $1.15 billion, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.

Previous wording

On January 19, 2024, we entered into a new Open Market Sales Agreement, or the January 2024 Sales Agreement, with Jefferies LLC, or Jefferies, relating to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock, par value $0.0001 per share, or common stock, having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.

Current wording

On January 19, 2024, we entered into an Open Market Sales Agreement, or the January 2024 Sales Agreement, with Jefferies LLC, or Jefferies, relating to an at-the-market offering program under which we may offer and sell, from time to time at our sole discretion, shares of common stock, par value $0.0001 per share, or common stock, having aggregate gross proceeds of up to $350.0 million through Jefferies as sales agent.

Previous wording

During the six months ended June 30, 2026, we sold an aggregate of 1,196,423 shares of our common stock for aggregate net proceeds of $33.1 million at a weighted average sales price of approximately $28.38 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent.

Current wording

During the nine months ended September 30, 2026, we sold an aggregate of 1,196,423 shares of our common stock for aggregate net proceeds of $32.9 million at a weighted average sales price of approximately $28.38 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent.

Previous wording

As of June 30, 2026, approximately $122.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.

Current wording

As of September 30, 2026, approximately $122.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement. We may cancel our at-the-market program at any time upon written notice, pursuant to its terms.

Previous wording

On June 10, 2026, we completed an underwritten public follow-on offering. The offering consisted of 7,222,225 shares of common stock at an offering price to the public of $27.00 per share, including 1,666,669 shares of common stock upon the exercise in full of the overallotment option by the underwriters, as well as pre-funded warrants to purchase 5,555,576 shares of common stock at a public offering price of $26.9999 per underlying share, in each case before underwriting discounts and commissions. Pursuant to the offering, we received aggregate gross proceeds of approximately $345.0 million and net proceeds of $323.4 million, after deducting underwriting discounts and commissions and other offering expenses.

Current wording

On June 10, 2026, we completed an underwritten public follow-on offering. The offering consisted of 7,222,225 shares of common stock at an offering price to the public of $27.00 per share, including 1,666,669 shares of common stock issued upon the exercise in full of the overallotment option by the underwriters, as well as pre-funded warrants to purchase 5,555,576 shares of common stock at a public offering price of $26.9999 per underlying share, in each case before underwriting discounts and commissions. Pursuant to the offering, we received aggregate gross proceeds of approximately $345.0 million and net proceeds of $323.4 million, after deducting underwriting discounts and commissions and other offering expenses.

Previous wording

We have primarily incurred net losses since our inception. For the six months ended June 30, 2026 and June 30, 2025, we had net losses of $211.0 million and $149.7 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2026, we had an accumulated deficit of $947.5 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, 2026 and September 30, 2025, we had net losses of $336.7 million and $30.4 million, respectively, and we expect to incur substantial additional losses in future periods. As of September 30, 2026, we had an accumulated deficit of $1,073.3 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

Net cash used in operating activities was $163.4 million for the six months ended June 30, 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 $211.0 million, adjusted for net non-cash charges of $31.2 million and changes in net operating assets and liabilities of $16.4 million. Our non-cash charges consisted of $31.2 million in stock-based compensation, $1.4 million in depreciation and $0.9 million of the amortization of right-of-use assets, partially offset by $2.2 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities was primarily of cash inflows resulting from a $1.4 million increase in lease liabilities, $11.9 million increase in accounts payable, $2.0 million decrease in prepaid expenses and other assets and $10.5 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 $9.4 million increase in contract assets related to the Servier License Agreement.

Current wording

Net cash used in operating activities was $256.9 million for the nine months ended September 30, 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 $336.7 million, adjusted for net non-cash charges of $48.8 million and changes in net operating assets and liabilities of $31.1 million. Our non-cash charges consisted of $48.9 million in stock-based compensation, $2.0 million in depreciation and $1.3 million of the amortization of right-of-use assets, partially offset by $3.4 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities was primarily of cash inflows resulting from a $1.8 million increase in lease liabilities, $4.4 million increase in accounts payable, $2.6 million decrease in prepaid expenses and other assets and $31.7 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 $4.3 million increase in contract assets related to the Servier License Agreement.

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 was 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 upfront payment from Servier License Agreement, partially offset by the use of funds in our operations to develop our product candidates, 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 was 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 investing activities was $37.0 million for the six months ended June 30, 2026, which consisted primarily of $356.0 million used to purchase marketable securities and $1.8 million used to purchase property and equipment, partially offset by $320.9 million provided by maturities of marketable securities.

Current wording

Net cash provided by investing activities was $41.7 million for the nine months ended September 30, 2026, which consisted primarily of $419.4 million used to purchase marketable securities and $2.1 million used to purchase property and equipment, partially offset by $463.2 million provided by maturities of marketable securities.

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 provided by financing activities was $360.4 million for the six months ended June 30, 2026, which consisted primarily of $183.2 million of net proceeds from issuance of common stock upon public offering, $141.0 million of proceeds from issuance of pre-funded warrants, $33.2 million in net proceeds from at-the-market offerings, $2.0 million in proceeds from exercise of common stock options and $0.9 million in proceeds from ESPP purchase.

Current wording

Net cash provided by financing activities was $364.1 million for the nine months ended September 30, 2026, which consisted primarily of $182.3 million of net proceeds from issuance of common stock upon public offering, $141.0 million of proceeds from issuance of pre-funded warrants, $32.9 million in net proceeds from at-the-market offerings, $6.9 million in proceeds from exercise of common stock options and $0.9 million in proceeds from ESPP purchase.

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

Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported revenue recognized and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions. We believe that the accounting policies discussed below are critical to understanding our historical and future performance, as these policies relate to the more significant areas involving management’s judgments and estimates.

Current wording

Our financial statements have been prepared in accordance with U.S. generally accepted accounting principles, or GAAP. The preparation of these financial statements requires us to make estimates and assumptions that affect the reported amounts of assets and liabilities, the disclosure of contingent assets and liabilities at the date of the financial statements and the reported revenue recognized and expenses incurred during the reporting periods. Our estimates are based on our historical experience and on various other factors that we believe are reasonable under the circumstances, the results of which form the basis for making judgments about the carrying value of assets and liabilities that are not readily apparent from other sources. Actual results may differ from these estimates under different assumptions or conditions.

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 17, 2026. For the six months ended June 30, 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.

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 nine months ended September 30, 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 previous paragraphs (2)

Previous report — wording carried elsewhere

Collaboration revenue increased by $15.4 million for the six months ended June 30, 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 report — wording carried elsewhere

We may cancel our at-the-market program at any time upon written notice, pursuant to its terms.