IDEAYA Biosciences, Inc.
For the period ended Jun 30, 2025. Filed Aug 5, 2025.
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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.
Jun 30, 2025 · Filed Aug 5, 2025
IDYA$31.24+1.9%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-03-31; filed 2025-05-06.
0000950170-25-064438
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-06-30; filed 2025-08-05.
0000950170-25-102967
Item 2. Management’s Discussion and Analysis of Financial Condition and Results of 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 228 previous paragraphs and 97 current paragraphs.
58 unchanged; 26 reworded; 12 added; 142 removed; 2 previous and 1 current paragraphs rearranged.
Tables are not compared: 5 previous and 5 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (12)
Current report
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 report
Our clinical pipeline currently consists of six potential first-in-class product candidates, as follows:
Current report
Darovasertib, a small molecule inhibitor of protein kinase C, or PKC, is our most advanced program in development for uveal melanoma, or UM, an aggressive form of ocular cancer. We expect to report data from two clinical trials evaluating the combination of darovasertib and crizotinib in patients with metastatic UM, including median progression free survival, or PFS, data from our potentially registrational-enabling Phase 2/3 trial in human leukocyte antigen-A*02:01 negative, or HLA-A2(-), patients with 1L metastatic UM by the end of 2025, and median overall survival, or OS, data from our ongoing single-arm Phase 2 trial in HLA-A2(-) and HLA-A2(+) patients in 1L metastatic UM at a medical conference in the fourth quarter of 2025. We are also evaluating neoadjuvant darovasertib in primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy, and potentially slow disease progression and metastasis. We expect to report initial safety and visual benefit data from our Phase 2 clinical trial from over 20 patients in the plaque brachytherapy-eligible cohort at the Company’s R&D Day on September 8 th, followed by updated data from over 90 patients in both the enucleation-eligible and plaque brachytherapy-eligible cohorts at the European Society for Medical Oncology (ESMO) Conference taking place from October 17 to October 21, 2025 in Berlin, Germany. Following a successful Type D meeting with the U.S. Food and Drug Administration (FDA), we initiated a Phase 3 registration-enabling trial of darovasertib in the neoadjuvant setting for primary UM, referred to as OptimUM-10, in the third quarter of 2025. The trial will enroll a total of approximately 520 patients in two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients.
Current report
IDE849, a potential first-in-class DLL3 TOP1i ADC, is being evaluated by our partner, Hengrui Pharma, in a multi-site, open label Phase 1 clinical trial in China in small-cell lung cancer, or SCLC, patients. Clinical efficacy and safety data from over 70 patients will be presented by Hengrui at the International Association for the Study of Lung Cancer (“IASLC”) 2025 World Conference on Lung Cancer taking place from September 6 to September 9, 2025 in Barcelona, Spain. We initiated a Phase 1 trial of IDE849 in SCLC in the U.S. in May 2025, and expect to begin dosing patients in NETs and other DLL3 expressing tumors by year-end 2025.
Current report
IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is continuing with Phase 1 dose optimization to inform future combination studies with IDE849 and other TOP1i-based ADCs where PARG inhibition may synergize with the payload to deepen responses. We plan to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. We will also have a poster presentation at the IASLC 2025 World Conference on Lung Cancer, providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161.
Current 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.
Current 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.
Current report
We are also advancing three pre-clinical development programs towards the submission of investigational new drug, or IND, applications:
Current report
IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025; and
Current 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.
Current report
Comparison of Six Months Ended June 30, 2025 and June 30, 2024
Current report
Interest income decreased by $0.1 million during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to lower interest rates.
Removed paragraphs (142)
Previous report
We are a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. Our approach integrates small molecule drug discovery with extensive capabilities in identifying and validating translational biomarkers to develop targeted therapies for select patient populations that are most likely to benefit from these targeted therapies. Our small molecule drug discovery expertise includes discovery and development of small molecule therapeutics. We are applying these capabilities and approach to develop a robust pipeline in precision medicine oncology.
Previous report
Darovasertib – PKC Inhibitor Clinical Candidate in Uveal Melanoma (UM)
Previous report
Darovasertib (IDE196) is our most advanced clinical-stage product candidate, which we in-licensed from Novartis. Darovasertib is a potent, selective small molecule inhibitor of protein kinase C, or PKC, which we are developing for genetically defined cancers having GNAQ or GNA11 gene mutations. PKC is a protein kinase that functions downstream of the GTPases GNAQ and GNA11.
Previous report
We have enrolled over 300 patients as of May 5, 2025, and have opened multiple clinical sites, including international sites, in our potential registration-enabling Phase 2/3 clinical trial, designated as IDE196-002. The purpose of the clinical trial is to evaluate darovasertib in combination with crizotinib, Pfizer’s investigational cMET inhibitor, in patients having metastatic uveal melanoma, or MUM, with human leukocyte antigen-, or HLA-A*02:01 negative, or HLA-A2(-), serotype, as part of a second Clinical Trial Collaboration and Supply Agreement, or the Second Pfizer Agreement, with Pfizer.
Previous report
In December 2024, we announced the recommendation of a move-forward dose and the completion of the Part 2a dose optimization for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the first-line, or 1L, setting in patients with HLA-A2(-) MUM. We are continuing enrollment in Part 2b with the selected optimal dose.
Previous report
We are targeting a median progression free survival, or PFS, readout for the Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in 1L HLA-A2(-) MUM by year-end 2025.
Previous report
We are enrolling additional HLA-A*02:01 positive, or HLA-A2(+), patients as an independent clinical strategy to address HLA-A2(+) MUM patients, in our ongoing Phase 2 clinical trial, designated as IDE196-001.
Previous report
We are targeting a median overall survival, or OS, readout from our Phase 2 clinical trial, designated as IDE196-001, in over 40 1L MUM patients at a medical conference in the second half of 2025. The readout will include both 1L HLA-A2(-) and HLA-A2(+) MUM patients.
Previous report
We are also supporting evaluation of darovasertib as single-agent neoadjuvant and adjuvant therapy in primary uveal melanoma, or UM, in an ongoing investigator-sponsored clinical trial, or IST, captioned as “Neoadjuvant / Adjuvant trial of Darovasertib in Ocular Melanoma,” or NADOM, led by St. Vincent’s Hospital in Sydney with the participation of Alfred Health and the Royal Victorian Eye and Ear Hospital in Melbourne.
Previous report
We enrolled 95 patients as of December 31, 2024 in our Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary uveal melanoma, or UM, with ongoing enrollment and multiple clinical sites open. We are targeting two clinical data updates from this Phase 2 clinical trial to be presented at medical conferences in mid-2025 and the second half of 2025. The mid-2025 update will be focused on vision data and the plaque brachytherapy patients, and the update in the second half of 2025 is expected to include over 90 UM patients from both the enucleation and plaque brachytherapy eligible cohorts.
Previous report
In September 2024, we announced interim clinical data from the ongoing Phase 2 Company-sponsored trial and provided a regulatory update on a potential Phase 3 registration-enabling clinical trial in neoadjuvant UM patients based on a Type C meeting held with the U.S. Food and Drug Administration, or FDA. In April 2025, we provided a further regulatory update on the potential Phase 3 registrational trial design for darovasertib in neoadjuvant UM patients based on a Type D meeting held with the FDA. Based on the Type D meeting, we currently project approximately 520 patients will be randomized 2:1 to receive darovasertib or control in two cohorts. The two cohorts include enucleation-eligible UM patients (n=120) and plaque brachytherapy, or PB,-eligible UM patients (n=400). Primary endpoints, which are supportive of full approval based on the FDA Type D Meeting, include eye preservation rate for enucleation patients and proportion of patients with best corrected visual acuity 15-letter loss from time of randomization and time of completion of PB for the PB cohort, with event-free survival (EFS) as a required secondary endpoint for both cohorts. Commencement of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is targeted for the first half of 2025.
Previous report
In June 2024, we announced interim clinical data from the ongoing investigator-sponsored Phase 2 trial of darovasertib as neoadjuvant/adjuvant treatment in UM, which was included in an oral presentation at the American Society of Clinical Oncology, or ASCO, 2024 Annual Meeting, and preliminary clinical data from our Phase 2 trial of darovasertib for neoadjuvant UM.
Previous report
ASCO Clinical Data from Investigator-Sponsored Phase 2 Trial
Previous report
In our ongoing investigator-sponsored Phase 2 trial of darovasertib as neoadjuvant/adjuvant treatment in UM, 15 patients planned for enucleation with localized UM were treated twice daily with a 300 mg dose of darovasertib in the Phase 2 investigator-sponsored clinical trial as of May 14, 2024. An initial safety cohort of three patients was treated for one month, and the remaining 12 patients were treated in an expansion cohort for up to six months with darovasertib as neoadjuvant treatment prior to their primary intervention (enucleation, plaque brachytherapy or external beam radiotherapy, or EBRT) across three Australian centers. As of May 14, 2024, 13 patients had completed neoadjuvant darovasertib treatment, 11 patients received adjuvant darovasertib treatment after primary treatment of UM, with five patients completing the planned six months of therapy. As of May 14, 2024, 75% (nine out of 12 enucleation patients) had confirmed preservation of the eye, by conversion from planned enucleation to plaque brachytherapy or EBRT, and approximately 67% (eight out of 12 enucleation patients) observed greater than 30% tumor shrinkage (maximum tumor volume change) after six months. Median tumor shrinkage (maximum tumor volume change) in the 12 enucleation patients was approximately 47% after six months. The darovasertib monotherapy neoadjuvant treatment had a manageable adverse event, or AE, profile with no drug-related serious adverse events, or SAEs, observed in the investigator-sponsored Phase 2 trial. Drug-related AEs in the trial were predominantly Grade 1 or Grade 2, and 20% of patients reported at least one drug-related Grade 3 AE.
Previous report
Company-Sponsored Phase 2 Trial
Previous report
In September 2024, we provided a clinical data update in which we observed encouraging clinical activity in our Phase 2 Company-sponsored trial. Collectively with the IST trial, the clinical efficacy data from the Phase 2 Company-sponsored trial substantiate clinical proof of concept for the use of darovasertib in the neoadjuvant uveal melanoma setting. The Phase 2 Company-sponsored trial used a data cutoff date of August 15, 2024, with an enrollment cutoff date of May 13, 2024.
Previous report
We evaluated 31 enucleation and 18 plaque brachytherapy UM patients who were treated with darovasertib neoadjuvant therapy in the Phase 2 Company-sponsored and IST trials. We observed approximately 59%, or 29 of the 49 total evaluable patients, with greater than or equal to 20% ocular tumor shrinkage by product of diameters and approximately 49%, or 24 of the 49 total evaluable patients, with greater than or equal to 30% ocular tumor shrinkage by product of diameters. We also observed an approximately 61% eye preservation rate in enucleation patients. We found evidence predicting visual preservation by reducing the amount of radiation associated with plaque brachytherapy. We observed a manageable AE profile from the Phase 2 Company-sponsored trial. In 38 patients, 11% of patients experienced a Grade 3 or higher AE and 5% of patients experienced a serious AE rate. We also observed a discontinuation rate of 3%. The most common AEs observed included diarrhea, nausea, vomiting and fatigue.
Previous report
We are pursuing a clinical strategy for darovasertib to broadly address UM, alternatively referred to as ocular melanoma, in both primary and metastatic settings. Greater than 90% of UM patients have tumors harboring GNAQ or GNA11 mutations. There are no FDA-approved systemic therapies for primary UM as either neoadjuvant or adjuvant therapies. There are likewise no FDA-approved therapies for patients having MUM with HLA-A02:01 negative, or HLA-A2(-), serotype. These primary UM patients and HLA-A2(-) MUM patients collectively represent approximately 85% of all ocular melanoma patients. We have a separate, independent clinical strategy to address HLA-A02:01 positive, or HLA-A2(+), MUM patients.
Previous report
The potentially addressable patient population for MUM is estimated to include an annual incidence of approximately 4,500 patients across the United States and Europe. (Neo)Adjuvant UM represents a significant expansion opportunity for darovasertib – with a potential annual incidence of approximately 12,000 patients aggregate in North America, Europe and Australia.
Previous report
We own or control all commercial rights in our darovasertib program in UM, including in MUM and in primary UM, subject to certain economic obligations pursuant to our exclusive, worldwide license to darovasertib with Novartis.
Previous report
Darovasertib – Potential Registration-Enabling Clinical Trial in First-Line HLA-A2(-) MUM
Previous report
The protocol of the Phase 2/3 clinical trial design incorporates guidance and feedback following our Type C meeting with the FDA in March 2023. This protocol includes an integrated Phase 2/3 open-label study-in-study design in first-line MUM patients with an HLA-A2(-) serotype. The clinical trial design employs a Phase 2 portion with median progression free survival, or PFS, as a primary endpoint for potential accelerated approval. Patients enrolled in Phase 2 will continue on treatment within the same study and will be considered, together with additional enrolled patients, to evaluate OS as the primary endpoint of the Phase 3 confirmatory portion of the clinical trial to support a potential full approval.
Previous report
In the Phase 2 portion of the clinical trial, approximately 260 patients will be randomized on a 2:1 basis for treatment with the darovasertib and crizotinib combination in the treatment arm or investigators choice in the control arm, selected from (a) a combination of ipilimumab (ipi) and nivolumab (nivo), (b) PD1-targeted monotherapy or (c) dacarbazine. The treatment arm of the Phase 2 portion of the clinical trial includes a nested study to confirm the move forward combination dose for the integrated Phase 2/3 clinical trial – including cohorts at the Phase 2 expansion doses of (i) darovasertib 300 mg BID + crizotinib 200 mg BID and (ii) darovasertib 200 mg BID + crizotinib 200 mg BID. Under the nested study design, patients enrolled in the cohort at the move forward dose will be included within the Phase 2/3 registrational clinical trial. The Phase 2 portion of the clinical trial contemplates an efficacy and safety data set of approximately 200 patients randomized 2:1 with the treatment arm at the move forward dose to support a potential accelerated approval based on median PFS by blinded independent central review, or BICR, as a primary endpoint. Accelerated approval is intended to allow for earlier approval of drugs that treat serious conditions and fill an unmet medical need based on a demonstration of effectiveness on a surrogate endpoint.
Previous report
Patients enrolled in Phase 2 at the selected dose would continue on treatment and be included in the Phase 3 study analysis, supplemented by enrollment of approximately 120 additional patients into the Phase 3 portion of the clinical trial, with 2:1 randomization on the same basis as the Phase 2 portion. Efficacy data from the Phase 3 could support potential full approval using median OS as a primary endpoint.
Previous report
In December 2024, we announced the recommendation of a move-forward dose and the completion of the Part 2a dose optimization for the potential registration-enabling Phase 2/3 trial evaluating the combination of darovasertib and crizotinib in the 1L setting in patients with HLA-A2(-) MUM. We are continuing enrollment in Part 2b with the selected optimal dose.
Previous report
In May 2023, we expanded our relationship with Pfizer to support the Phase 2/3 registrational trial to evaluate darovasertib and crizotinib as a combination therapy in MUM by entering into Amendment No. 1 to the Second Pfizer Agreement. Under Amendment No. 1 to the Second Pfizer Agreement, Pfizer will provide us with a first defined quantity of crizotinib at no cost, as well as an additional second defined quantity of crizotinib at a lump-sum cost.
Previous report
In December 2024, we entered into Amendment No. 5 to the Pfizer Agreement for the supply of crizotinib in the Phase 1/2 clinical trial for Pfizer to provide us a defined quantity of crizotinib at defined costs.
Previous report
Prevalence of HLA-A2*02:01 Negative Serotype in MUM
Previous report
Data from darovasertib clinical trials in MUM demonstrate that approximately 70% of MUM patients with known HLA-A*02:01, or HLA-A2 status were HLA-A2(-). As reported at ESMO 2023, the HLA-A2 status was known in subsets of patients enrolled in clinical trials evaluating darovasertib. Prevalence of HLA-A2(+) and HLA-A2(-) in MUM patients was determined from a first data set of n=149 MUM patients treated with darovasertib as monotherapy or in a combination arm of a clinical trial, and separately in a second data set of n=118 MUM patients treated with the darovasertib and crizotinib combination. These data include 102 of 149 (68%) of patients in the all-treatment subset and 81 of 118 (69%) patients in the darovasertib and crizotinib combination treatment subset.
Previous report
Darovasertib – Strategy for HLA-A*02:01 Positive MUM
Previous report
Based on clinical data from the Phase 2 clinical trial evaluating darovasertib and crizotinib in MUM as reported at ESMO 2023, and based on the darovasertib mechanism of action, we anticipate darovasertib will have clinical activity independent of HLA-A2 status in GNAQ/11-mutation cancers.
Previous report
We are enrolling additional HLA-A2(+) MUM patients as an independent clinical strategy to address HLA-A2(+) MUM patients, in our ongoing Phase 2 clinical trial, designated as IDE196-001. This strategy demonstrates our commitment to fully address the high unmet medical need in MUM. Such clinical trial data from darovasertib and crizotinib combination treatment in HLA-A2(+) MUM could support publication and potential inclusion in NCCN Clinical Practice Guidelines in Oncology.
Previous report
Darovasertib – Orphan Drug Designation in UM, Fast Track Designation in MUM and Breakthrough Therapy Designation in Neoadjuvant UM
Previous report
In April 2022, the FDA designated darovasertib as an Orphan Drug in UM, including primary and metastatic disease. Under an Orphan Drug designation, darovasertib may be entitled to certain tax credits for qualifying clinical trial expenses, exemption from certain user fees and, subject to FDA approval of a New Drug Application, or NDA, for darovasertib in UM, eligibility for seven years of statutory marketing exclusivity during which the FDA is prohibited from approving a subsequent same drug for the same rare disease or condition except in limited circumstances, such as a subsequent drug that demonstrates clinical superiority. As an FDA-designated Orphan Drug, darovasertib may also be excluded from certain mandatory price negotiation provisions of the 2022 Inflation Reduction Act, if approved for a single indication only.
Previous report
In November 2022, the FDA granted Fast Track designation to our development program investigating darovasertib in combination with crizotinib in adult patients being treated for MUM. The Fast Track designation makes our darovasertib and crizotinib development program eligible for various expedited regulatory review processes, including generally more frequent FDA interactions, such as meetings and written communications, potential eligibility for rolling review of a future NDA and potential accelerated approval and priority review of an NDA.
Previous report
In March 2025, the FDA granted Breakthrough Therapy Designation, or BTD, for darovasertib for the neoadjuvant treatment of adult patients with primary UM for whom enucleation has been recommended. Under the license agreement with Novartis, we paid Novartis a $1.0 million milestone payment in April 2025. BTD is designed to expedite the development and regulatory review of promising therapies for serious or life-threatening conditions where preliminary clinical evidence suggests substantial improvement over existing treatments. The designation facilitates more intensive FDA guidance, cross-disciplinary collaboration, and eligibility for rolling submission and priority review.
Previous report
Darovasertib – Phase 2 Trials in Neoadjuvant and Adjuvant Therapy in UM
Previous report
We are clinically evaluating the potential for darovasertib as neoadjuvant or adjuvant therapy, or both, also referred to as (neo)adjuvant therapy, in primary, non-metastatic UM patients. We previously reported preliminary clinical data in the neoadjuvant setting showing evidence of anti-tumor activity that we believe supports further clinical evaluation of darovasertib to determine its potential as a neoadjuvant therapy to either save the eye by avoiding enucleation, or to reduce the tumor thickness in the eye, enabling treatment with less radiation to preserve vision, and as an adjuvant therapy, to potentially extend relapse free survival.
Previous report
We enrolled 95 patients as of December 31, 2024 in our Phase 2 clinical trial, designated as IDE196-009, evaluating darovasertib as single-agent neoadjuvant and adjuvant therapy in patients having primary UM with ongoing enrollment and multiple clinical sites open. The purpose of the clinical trial is to evaluate single-agent darovasertib as neoadjuvant treatment of primary UM prior to primary interventional treatment of enucleation or radiation therapy and also as adjuvant therapy following the primary treatment. An amendment to the study protocol was submitted to the FDA in July 2024 to enable dosing of darovasertib therapy up to 12 months.
Previous report
We are additionally supporting evaluation of darovasertib as (neo)adjuvant therapy in primary UM in the ongoing NADOM IST. Pursuant to an as-amended protocol for the NADOM study, UM patients who would otherwise undergo enucleation are instead treated with single agent darovasertib as neoadjuvant treatment for up to six months or maximum benefit. This reflects an increase in potential treatment duration versus the initial approach of one month neoadjuvant therapy, following which these patients will undergo a primary interventional treatment. Patients will subsequently be treated with darovasertib for up to six months as follow-up adjuvant therapy after the primary interventional treatment.
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Reworded paragraphs (26)
Previous wording
We are collaborating with Gilead Sciences, Inc., or Gilead, to clinically evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients having MTAP-deletion UC, in our Phase 1 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or CSCSA, with Gilead.
Current wording
IDE397, a small molecule inhibitor of methionine adenosyltransferase 2a, or MAT2A, which we are developing for patients with solid tumors with methylthioadenosine phosphorylase, or MTAP, gene deletion. We are conducting a Phase 1/2 clinical trial pursuant to a Clinical Study Collaboration and Supply Agreement, or CSCSA, with Gilead to evaluate IDE397 in combination with Trodelvy (sacituzumab govitecan-hziy), Gilead’s Trop-2 directed antibody drug conjugate, or ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. We plan to present initial data from the combination in MTAP-deletion UC patients at the Company’s R&D Day on September 8 th, with additional data at a medical conference in the first half of 2026.
Previous wording
Our clinical pipeline includes six potential first-in-class clinical-stage product candidates – darovasertib (PKC), IDE397 (MAT2A), IDE849 (DLL3), IDE275 / GSK959 (Werner Helicase), IDE161 (PARG), and IDE705 / GSK101 (Pol Theta Helicase). We own or control all commercial rights of three of these product candidates: darovasertib, IDE397, and IDE161, and own or control all commercial rights outside of greater China for IDE849. We are also advancing several development candidates, including IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor for which we are targeting an investigational new drug, or IND, filing in mid-year 2025; IDE034, a potential first-in-class B7H3/PTK7 topoisomerase-I-inhibitor-payload bispecific antibody drug conjugate, or BsADC, program for which we are targeting an IND filing in the second half of 2025; and IDE574, a potential first-in-class KAT6/7 dual inhibitor program for which we are targeting an IND filing in the second half of 2025. We also have multiple earlier-stage preclinical programs. We have established selective, value-accretive collaborations with leading pharmaceutical companies to support our clinical development activities.
Current wording
IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025;
Previous wording
We do not have any products approved for sale and have not generated any product revenue since inception. We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of March 31, 2025, we had cash, cash equivalents and marketable securities of approximately $1.05 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. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper and corporate bonds.
Previous wording
Since our inception in June 2015, we have devoted substantially all of our resources to discovering and developing our product candidates. We have incurred significant operating losses to date and expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development; seek regulatory approval, and prepare for, and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. Certain program costs that contribute to our operating expenses have been and/or will be reimbursed by GSK pursuant to the GSK Collaboration Agreement, including 100% of costs we incur for research we perform in connection with the Pol Theta program and 80% of the aggregate program costs incurred by us and GSK for research each of us performs for the Werner Helicase program. We also incur costs in accordance with the Gilead CSCSA and Second CSCSA. Gilead bears internal or external costs incurred in connection with its supply of Trodelvy. We bear all internal and external costs and expenses associated with the conduct of the combination study. We also incur costs in accordance with the Merck CTCSA. Merck provides KEYTRUDA for the study at no cost to us. We bear all internal and external costs and expenses associated with the conduct of the study. We also entered into two in-licensing agreements for ADCs with topoisomerase-I-inhibitor-payloads to enable combinations with our synthetic lethality programs with Hengrui Pharma for IDE849 and Biocytogen for IDE034. See Note 10. Significant Agreements.
Current wording
Since our inception in June 2015, we have devoted substantially all of our resources to discovering and developing our product candidates. We have incurred significant operating losses to date and expect that our operating expenses will increase significantly as we advance our product candidates through preclinical and clinical development; seek regulatory approval, and prepare for, and, if approved, proceed to commercialization; acquire, discover, validate and develop additional product candidates; obtain, maintain, protect and enforce our intellectual property portfolio; and hire additional personnel. For information about our specific program costs and expenses, see Note 10. Significant Agreements.
Previous wording
Our net losses were $72.2 million and $39.6 million for the three months ended March 31, 2025 and March 31, 2024, respectively. As of March 31, 2025, we had an accumulated deficit of $695.0 million.
Current wording
Our net losses were $149.7 million and $92.3 million for the six months ended June 30, 2025 and June 30, 2024, respectively. As of June 30, 2025, we had an accumulated deficit of $772.5 million.
Previous wording
As of March 31, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $1.05 billion.
Current wording
As of June 30, 2025, we had cash, cash equivalents and short-term and long-term marketable securities of approximately $991.9 million.
Previous wording
To date, we have not generated any revenue from product sales, and we do not expect to generate any revenue from product sales unless and until we are able to initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement, including amounts that are recognized related to previously received upfront payments and amounts due and payable to us for research and development services. The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of March 31, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration
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 initiate a registrational clinical trial, obtain regulatory approval and commercialize one of our product candidates in the future. Our revenue consists exclusively of collaboration revenue under the GSK Collaboration Agreement, including amounts that are recognized related to previously received upfront payments and amounts due and payable to us for research and development services. The amount of revenue recognized related to the GSK Collaboration Agreement, including as related to the previously received upfront payment or to certain development milestone payments, may vary considerably by period and certain components thereof may generally decrease year-over-year as we satisfy remaining performance obligations, for example, relating to the Pol Theta and WRN R&D Services. Since December 31, 2023, we have fully recognized the contract liabilities related to the upfront payment and reimbursements for the research and development performance obligations under the GSK Collaboration Agreement. There are no remaining contract liabilities as of June 30, 2025 as we concluded all the research and development performance obligations under the GSK Collaboration Agreement. The future revenue recognition is contingent on additional milestones earned, profit sharing and royalties on any net product sales under our collaborations. We expect that any revenue we recognize or generate under the GSK Collaboration Agreement will fluctuate from period to period due to period to period variability in milestone payments and other payments.
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, IDE275 / GSK959, IDE161, IDE705 / GSK 101, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.
Current wording
Substantially all of our research and development expenses consist of expenses incurred in connection with the discovery and development of our product candidates. These expenses include certain payroll and personnel-related expenses, including salaries, employee benefit costs and stock-based compensation expenses for our research and product development employees, fees to third parties to conduct certain research and development activities on our behalf including fees to CMOs and CROs in support of manufacturing and clinical activity for darovasertib, IDE397, IDE849, IDE161, IDE275 / GSK959, IDE705 / GSK 101, and consulting costs, costs for laboratory supplies, costs for product licenses and allocated overhead, including rent, equipment, depreciation, information technology costs and utilities. We expense both internal and external research and development expenses as they are incurred.
Previous wording
A discussion regarding our financial condition and results of operations for the three months ended March 31, 2025 compared to the three months ended December 31, 2024 and for the three months ended March 31, 2025 compared to the three months ended March 31, 2024 is presented below.
Current wording
A discussion regarding our financial condition and results of operations for the three months ended June 30, 2025 compared to the three months ended March 31, 2025 and six months ended June 30, 2025 compared to the six months ended June 30, 2024 is presented below.
Previous wording
Research and development expenses decreased by $69.3 million, or 49%, during the three months ended March 31, 2025 compared to the three months ended December 31, 2024 primarily due to the $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma that occurred in December 2024, partially offset by increases in $5.7 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 $3.3 million, or 5%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025 primarily due to $1.5 million in personnel-related expenses and $1.8 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies.
Previous wording
General and administrative expenses increased by $5.3 million, or 64%, during the three months ended March 31, 2025 compared to the three months ended March 31, 2024. The increase in general and administrative expenses was primarily due to increases of $2.6 million in personnel-related expenses and $2.7 million in consulting and legal patent expenses to support our growth.
Current wording
General and administrative expenses increased by $1.1 million, or 8%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025. The increase in general and administrative expense was primarily due to $1.1 million in personnel-related expenses to support our growth.
Previous wording
Interest income decreased by $1.6 million, or 12%, during the three months ended March 31, 2025 compared to the three months ended December 31, 2024, primarily due to lower investment balances.
Current wording
Interest income decreased by $0.9 million, or 7%, during the three months ended June 30, 2025 compared to the three months ended March 31, 2025, primarily due to lower investment balances.
Previous wording
Research and development expenses increased by $28.0 million, or 66%, during the three months ended March 31, 2025 compared to the three months ended March 31, 2024 primarily due to increases in $22.0 million in fees paid to CROs, CMOs and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $3.6 million in personnel-related expenses to support our growth, and $2.4 million in costs for laboratory supplies, facilities and information technology costs to support our research and development programs.
Current wording
Research and development expenses increased by $47.8 million, or 49%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due to $37.4 million in fees paid to CROs, CMOs, and consultants related to the advancement of our lead product candidates through preclinical and clinical studies, $6.2 million in personnel-related expenses and $4.2 million in costs for laboratory supplies, facilities and information technology costs to support our research and development programs.
Previous wording
General and administrative expenses increased by $2.5 million, or 23%, during the three months ended March 31, 2025 compared to the three months ended December 31, 2024. The increase in general and administrative expense was primarily due to increases of $1.2 million in personnel-related expenses and $1.3 million in consulting services and legal patent expenses.
Current wording
General and administrative expenses increased by $9.5 million, or 51%, during the six months ended June 30, 2025 compared to the six months ended June 30, 2024 primarily due $5.2 million in personnel-related expenses and $4.3 million in consulting services and legal patent expenses to support our growth.
Previous wording
We have funded our operations primarily through the sale and issuance of common stock and the upfront payment and certain milestone payments received from GSK. As of March 31, 2025, we had cash, cash equivalents and marketable securities of approximately $1.05 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. As of June 30, 2025, we had cash, cash equivalents and marketable securities of approximately $991.9 million, consisting primarily of money market funds, U.S. government securities, commercial paper, and corporate bonds.
Previous wording
During the three months ended March 31, 2025, we sold an aggregate 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. As of March 31, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
Current wording
During the six months ended June 30, 2025, we sold an aggregate of 984,000 shares of our common stock for an aggregate net proceeds of $25.0 million at a weighted average sales price of approximately $26.00 per share under the at-the-market offering pursuant to the January 2024 Sales Agreement with Jefferies as sales agent. As of June 30, 2025, approximately $156.6 million of common stock remained available to be sold pursuant to the January 2024 Sales Agreement.
Previous wording
We may cancel our at-the-market program at any time upon written notice, pursuant to its terms.
Current wording
The Company may cancel its at-the-market program at any time upon written notice, pursuant to its terms.
Previous wording
We have incurred net losses since our inception. For the three months ended March 31, 2025 and March 31, 2024, we had net losses of $72.2 million and $39.6 million, respectively, and we expect to incur substantial additional losses in future periods. As of March 31, 2025, we had an accumulated deficit of $695.0 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 incurred net losses since our inception. For the six months ended June 30, 2025 and June 30, 2024, we had net losses of $149.7 million and $92.3 million, respectively, and we expect to incur substantial additional losses in future periods. As of June 30, 2025, we had an accumulated deficit of $772.5 million. Based on our current business plan, we believe that our existing cash, cash equivalents and marketable securities will be sufficient to fund our planned operations for at least the next 12 months from the issuance date of this Quarterly Report on Form 10-Q.
Previous wording
See Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements.
Current wording
For more information see also Notes 5. Operating Leases, 6. Commitments and Contingencies, 7. Income Taxes and 10. Significant Agreements, each in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q.
Previous 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.
Current wording
Net cash used in operating activities was $122.8 million for the six months ended June 30, 2025. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $149.7 million, adjusted for net non-cash charges of $18.0 million and changes in net operating assets and liabilities of $8.9 million. Our non-cash charges consisted of $22.1 million in stock-based compensation, $1.3 million in depreciation and $1.0 million of the amortization of right of use assets, partially offset by $6.5 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $2.4 million in accounts payable, $7.7 million accrued and other liabilities in support of research and manufacturing activities and $1.2 million in lease liabilities, partially offset by outflows of $2.5 million in prepaid and other assets.
Previous wording
Net cash used in operating activities was $43.8 million for the three months ended March 31, 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 $39.6 million, adjusted for net non-cash charges of $1.1 million and changes in net operating assets and liabilities of $5.3 million. Our non-cash charges consisted of $6.3 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 $6.3 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily of $3.1 million in prepaid and other assets, $1.3 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, $0.5 million in lease liabilities, and $0.5 million in accounts payable.
Current wording
Net cash used in operating activities was $76.7 million for the six months ended June 30, 2024. Cash used in operating activities was primarily due to the use of funds in our operations to develop our product candidates resulting in a net loss of $92.3 million, adjusted for net non-cash charges of $5.3 million and changes in net operating assets and liabilities of $10.4 million. Our non-cash charges consisted of $16.0 million in stock-based compensation, $1.2 million in depreciation and $0.9 million of the amortization of right of use assets, partially offset by $13.0 million accretion of discounts on marketable securities. The net change in our operating assets and liabilities consisted primarily due to cash inflows from $9.2 million in accounts payable and $5.6 million accrued and other liabilities due to CRO fees in support of research and manufacturing activities, partially offset by outflows from $3.5 million in prepaid and other assets and $1.0 million in lease liabilities.
Previous 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.
Current 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.
Previous wording
Net cash used in investing activities was $354.0 million for the three months ended March 31, 2024, which consisted primarily of $475.8 million used to purchase marketable securities and $1.3 million used to purchase property and equipment, partially offset by $123.1 million provided by maturities of marketable securities.
Current wording
Net cash used in investing activities was $285.4 million for the six months ended June 30, 2024, which consisted primarily of $640.5 million used to purchase marketable securities and $2.3 million used to purchase property and equipment, partially offset by $357.4 million provided by maturities of marketable securities.
Previous 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.
Current 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.
Previous wording
Net cash provided by financing activities was $349.1 million for the three months ended March 31, 2024, which consisted primarily of $343.7 million of net proceeds from sales under our ATM facility and $5.5 million of proceeds from exercise of common stock options.
Current wording
Net cash provided by financing activities was $388.3 million for the six months ended June 30, 2024, which consisted primarily of $380.0 million of net proceeds from at-the-market offerings and $7.5 million of proceeds from exercise of common stock options and $0.8 million of proceeds from ESPP purchases.
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 three months ended March 31, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.
Current wording
For more detail on our critical accounting policies, refer to Note 2 in the unaudited interim condensed financial statements appearing elsewhere in this Quarterly Report on Form 10-Q, and the notes to the financial statements appearing elsewhere in our Annual Report on Form 10-K filed with the SEC on February 18, 2025. For the six months ended June 30, 2025, there were no material changes to our critical accounting policies from those disclosed in our Annual Report on Form 10-K filed with the SEC on February 18, 2025.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025.
Rearranged previous paragraphs (2)
Previous report — wording carried elsewhere
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 — wording carried elsewhere
Comparison of Three Months Ended March 31, 2025 and March 31, 2024