IDYA

Registrational OptimUM-02 trial of the darovasertib combination in metastatic uveal melanoma (mUM) met its primary endpoint; new drug application (NDA) filing is underway under the real-time oncology review program (RTOR) with completion expected in H2 2026 Updated data from Phase 2 OptimUM-01 trial (HLA*A2-positive mUM patient subset) and Phase 2 OptimUM-09 trial (neoadjuvant primary UM) to be presented at ESMO Updated data from Hengrui-sponsored Phase 1 trial of IDE849 (DLL3 TOP1 ADC) in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) patients to be presented at ESMO Announced clinical collaboration with Roche to evaluate IDE892 (PRMT5) in combination with RG6505 (pan-RAS) in MTAP-deleted, RAS-mutant pancreatic cancer; targeting to initiate a Phase 1 combination trial in H2 2026 IDEAYA to host an R&D Day in Q4 focused on MTAP/CDKN2A, KRAS, and pancreatic cancer ~$1.24 billion of cash, cash equivalents, and marketable securities as of June 30, 2026; cash runway guidance into 2030 is unchanged based on current operating plan SOUTH SAN FRANCISCO, Calif., Aug. 4, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery, development and commercialization of targeted therapeutics, today reported financial results for the second quarter ended June 30, 2026, and provided a business update. "This quarter marked another successful step forward in our mission to deliver new, potentially best-in-class precision therapies for people with cancer. We presented the positive topline results at ASCO from our registrational Phase 2/3 OptimUM-02 trial in HLA*A2:01-negative metastatic uveal melanoma while continuing to advance our NDA submission and pre-commercial activities to support a possible commercial launch. Additionally, our clinical pipeline is poised to deliver several key updates throughout the remainder of 2026, including updated data from IDE849, our DLL3 TOP1 ADC, in SCLC and NEC and clinical progress in MTAP-deleted cancers with IDE892, our PRMT5 inhibitor, as both a monotherapy and in combination with IDE397, our proprietary MAT2A inhibitor, and RG6505, Roche's Phase 1 pan-RAS inhibitor in NSCLC and PDAC, respectively. With over $1.2 billion in cash following our successful financing in June, IDEAYA is well-positioned to continue advancing our precision medicine pipeline through multiple key data updates," said Yujiro S. Hata, President and Chief Executive Officer of IDEAYA Biosciences. Selected Pipeline Developments and Corporate Updates Darovasertib for Uveal Melanoma IDEAYA presented complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois. Data were from a total of 313 patients with first line (1L) HLA*A2:01-negative mUM as of a January 23, 2026 cutoff date, randomized 2:1 to darovasertib in combination with crizotinib (the darovasertib combination) or an investigator's choice of therapy (ICT) arm reflective of real-world clinical practice that included ipilimumab plus nivolumab (anti-CTLA-4/PD-1) or pembrolizumab (anti-PD-1). The primary endpoint is median progression-free survival (PFS) as assessed by blinded independent central review (BICR). Secondary endpoints include safety and investigator assessed PFS, overall response rate (ORR), disease control rate (DCR) and duration of response. IDEAYA has completed enrollment of approximately 100 HLA*A2:01-positive mUM patients in the single-arm, Phase 2 OptimUM-01 trial of the darovasertib combination. The company plans to present updated ORR, PFS and OS results from approximately 85 efficacy-evaluable HLA*A2:01-positive patients, including both first line and pre-treated patients, at the 2026 European Society of Medical Oncology (ESMO) Congress taking place in October in Madrid, Spain. Updated clinical data will also be presented 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 IDEAYA is assessing optimal capital allocation across its portfolio, including accelerating its investment into other high-value programs, such as the DLL3 registrational trial and MTAP/KRAS combination studies. As part of this assessment, the Company is 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. Following the successful completion of a Type C meeting with the FDA earlier this year, IDEAYA and its partner, Les Laboratoires Servier (Servier), initiated a global Phase 3 registrational trial (OptimUM-11) to evaluate the darovasertib combination in the adjuvant setting of primary uveal melanoma. OptimUM-11 will enroll approximately 450 patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to 12-months of treatment with the combination or observation. The primary endpoint of the trial is relapse-free survival. ADC / DDR combinations IDE849 (DLL3 TOP1 ADC): IDEAYA's partner in China, Jiangsu Hengrui Pharmaceuticals (Hengrui), plans to provide a clinical data update from their ongoing Phase 1 trial in SCLC and NEC at ESMO. The update will include updated ORR, PFS and safety data along with 12-month landmark OS data from approximately 100 patients enrolled in the trial. IDEAYA also plans to provide the first clinical data from its ongoing global Phase 1/2 trial of IDE849 in SCLC and NEC in the second half of 2026. IDE161 (PARG): IDEAYA is also conducting a Phase 1 combination trial of IDE849 with IDE161, a potential first-in-class poly(ADP-ribose) glycohydrolase (PARG) inhibitor in patients with DLL3-upregulated solid tumors, including SCLC, NEC and melanoma. IDEAYA has previously shared preclinical data demonstrating the mechanism of action and potential synergy of IDE161 in combination with TOP1-payload based ADCs in driving enhanced anti-tumor activity. IDE034 (B7H3/PTK7 bispecific TOP1 ADC): IDEAYA plans to provide initial clinical data from its ongoing Phase 1 dose escalation trial by the end of 2026 or early 2027, which is expected to include preliminary safety and efficacy data. IDE034 is a potentially 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. MTAP pathway IDE892 (PRMT5): monotherapy expansion has been initiated in the Phase 1/2 clinical trial evaluating IDE892 in MTAP-deleted solid tumors, with a focus on non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). The expansion has been initiated at projected efficacious target human exposures where 24-hour target EC90 coverage has been achieved. The IDE892 maximum tolerated dose (MTD) has not yet been reached in the ongoing dose escalation. IDE397 (MAT2A): a Phase 1/2 combination cohort was initiated to evaluate IDE892 with IDE397, IDEAYA's proprietary MAT2A inhibitor, in MTAP-deleted cancers. Expansion is planned by year end 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. In May, IDEAYA entered into a clinical trial collaboration with Roche to explore IDE892 in combination with RG6505, Roche's proprietary Phase 1 pan-RAS inhibitor, in MTAP-deleted, RAS-mutant PDAC to target the genetic co-alterations of MTAP and KRAS in this indication. IDEAYA plans to begin a Phase 1 combination trial in the second half of 2026. KAT6/7 IDE574 (KAT6/7): a Phase 1 dose escalation trial is underway in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which 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. Corporate In June, IDEAYA successfully completed a public offering of 7,222,225 shares of common stock and pre-funded warrants to purchase 5,555,576 shares of common stock, inclusive of the underwriters' full exercise of their option to purchase additional shares in the offering. Net proceeds from the offering were approximately $323.4 million, after deducting underwriting discounts, commissions and other expenses. IDEAYA is targeting to host an MTAP/CDKN2A, KRAS, and Pancreatic Cancer R&D Day in the fourth quarter of 2026. Topics will include rational combination strategies to target the underlying tumor heterogeneity and adaptive plasticity in PDAC and other solid tumor indications. Additional agenda details and key participants will be provided at a later date. As of June 30, 2026, IDEAYA had approximately $1.24 billion in cash, cash equivalents and marketable securities. IDEAYA's cash runway guidance into 2030 is unchanged based on the current operating plan. Financial Results for the Quarter Ended June 30, 2026 As of June 30, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.24 billion, compared to $972.9 million as of March 31, 2026. The increase was primarily attributable to $323.4 million in net proceeds from the underwritten public offering and pre-funded warrants to purchase common stock and $33.1 million from the sale of common stock shares through IDEAYA's at-the-market offering program, partially offset by net cash used in operations. Collaboration revenue for the three months ended June 30, 2026, totaled $8.9 million, compared to $6.6 million for the three months ended March 31, 2026. Collaboration revenue was recognized for the performance obligations satisfied through June 30, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of June 30, 2026, the remaining balance for the research and development services performance obligations is $147.0 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed. Research and development (R&D) expenses for the three months ended June 30, 2026 totaled $108.7 million, compared to $95.7 million for the three months ended March 31, 2026. The increase was primarily driven by higher clinical trial and personnel-related expenses to support IDEAYA's programs. General and administrative (G&A) expenses for the three months ended June 30, 2026 totaled $22.5 million, compared to $19.4 million for the three months ended March 31, 2026. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities. The net loss for the three months ended June 30, 2026, was $112.5 million compared to the net loss of $98.5 million for the three months ended March 31, 2026. Total stock compensation expense for the three months ended June 30, 2026, was $16.7 million compared to $14.5 million for the three months ended March 31, 2026. About IDEAYA Biosciences IDEAYA is 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 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. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding IDEAYA Biosciences, Inc.'s (IDEAYA) expectations with respect to the timing, progress, and results of its clinical trials and preclinical programs; the potential safety, efficacy, and therapeutic benefits of its product candidates; the planned presentation and publication of clinical data; the timing and likelihood of regulatory submissions, including the planned NDA for darovasertib and participation in the FDA's RTOR program; the potential for accelerated approval and label expansion; the initiation, design, and enrollment of current and future clinical trials; the development, advancement and potential termination of IDEAYA's pipeline programs, including IDE849, IDE034, IDE892, IDE397, IDE161, and IDE574; the expected timing of clinical updates and milestones; the potential benefits of collaborations; and IDEAYA's financial position, including its expected cash runway. These forward-looking statements are based on management's current expectations and assumptions and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks related to the timing, progress, and results of clinical trials and preclinical studies; the ability of IDEAYA to obtain and maintain regulatory approvals; uncertainties regarding the regulatory review process, including participation in the RTOR program; the potential for clinical data to differ from preliminary or interim results; the ability to successfully develop, manufacture, and commercialize product candidates; competition from other biotechnology and pharmaceutical companies; the impact of global economic conditions; the ability to maintain and realize the potential benefits of collaborations; IDEAYA's ability to successfully establish, protect and defend its intellectual property; and other matters that could affect the sufficiency of existing cash to fund operations and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements speak only as of the date of this press release, and IDEAYA undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor and Media Contact IDEAYA BiosciencesJoshua Bleharski, Ph.D.Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-reports-second-quarter-2026-financial-results-and-provides-business-update-302841723.html

Boston-headquartered Tango Therapeutics (TNGX) stock surged on Monday, driven by encouraging results from a pancreatic cancer trial. TNGX is a clinical-stage biotech firm focused on discovering and delivering next-gen precision cancer medicines, and the pancreatic cancer trial appears to have validated its therapeutic approach in a particularly difficult-to-treat cancer type. Billionaire Jeff Bezos Says America Needs to ‘Fix It at the Root’ Like Amazon Does Instead of Picking Villains — Bottom 50% Should Pay ‘Zero’ Taxes Ahead of Oracle Earnings, Here's What Barchart Data Says Comes Next for ORCL Stock Dear Nvidia Stock Fans, Mark Your Calendars for June 11 Our exclusive Barchart Brief newsletter is your FREE midday guide to what's moving stocks, sectors, and investor sentiment - delivered right when you need the info most. Subscribe today! Pancreatic cancer remains one of the most lethal malignancies worldwide, with limited treatment options — making any positive clinical signal extremely valuable. Including recent gains, Tango Therapeutics shares are up more than 200% versus the start of 2026. Tango’s management moved swiftly to capitalize on the post-results momentum by announcing a major capital raise. The biotech firm launched an underwritten public offering worth $500 million on June 8, with an additional 30-day option for underwriters to purchase up to $75 million in additional shares. The timing of this offering is highly strategic, as TNGX is leveraging enthusiasm following its pancreatic cancer clinical trial data to raise capital at what it presumably views as favorable terms. Note that TNGX shares are now trading at an all-time high. The $500 million offering looks substantial for a clinical-stage biotech and signals management’s confidence in advancing its pipeline aggressively. All shares in the offering are being sold directly by the company, meaning the proceeds will fund continued clinical development and potential expansion into additional indications. This capital raise places Tango within a broader wave of biotech dealmaking and financing activity visible in the current market environment, where oncology assets continue to command premium valuations. Companies like Roche (RHHBY), Johnson & Johnson (JNJ), and Incyte (INCY) have recently made multi-billion-dollar acquisitions of cancer-focused biotechs, underscoring exceptional demand for innovative oncology pipelines. Investors should also note that while the TNGX stock surge reflects genuine clinical excitement, the $500 million equity issuance will result in meaningful shareholder dilution. The market reaction to competitor Ideaya Biosciences (IDYA), which saw its share price drop nearly 8% on a similar $300 million offering announcement on the same day, illustrates that dilution concerns can quickly temper initial enthusiasm. Whether TNGX sustains its elevated valuation will depend on the durability of the pancreatic cancer data, the company's ability to execute the offering at favorable terms, and continued progress through later-stage clinical development. That said, Wall Street has a consensus “Moderate Buy” rating on Tango Therapeutics, wth price targets as high as $55, indicating potential upside of about 70% from here. On the date of publication, Wajeeh Khan did not have (either directly or indirectly) positions in any of the securities mentioned in this article. All information and data in this article is solely for informational purposes. This article was originally published on Barchart.com

Find your next quality investment with Simply Wall St's easy and powerful screener, trusted by over 7 million individual investors worldwide. IDEAYA Biosciences (IDYA) is back in focus after reporting positive topline Phase 2/3 OptimUM-02 data for its darovasertib plus crizotinib regimen in first line metastatic uveal melanoma and securing FDA Real-Time Oncology Review. See our latest analysis for IDEAYA Biosciences. The positive darovasertib data and Real-Time Oncology Review sit against a mixed share price picture, with recent 1-month and year-to-date share price declines but a 1-year total shareholder return of 61.19% suggesting longer term holders have still seen strong gains. If this kind of oncology catalyst has your attention, it could be a good moment to scan for other precision medicine and biotech opportunities through a curated list of 32 healthcare AI stocks With IDEAYA shares down 11.1% over the past month and 15.1% year to date, yet still up 61.19% over 1 year and trading below some analyst value estimates, you have to ask: is there still a buying opportunity here or is the market already pricing in future growth? IDEAYA currently trades on a P/S of 11.2x, which looks rich when you set it against both peers and an estimated fair level for the stock. P/S compares the company’s market value to its revenue and is often used for unprofitable biotechs where earnings are still negative. At 11.2x sales, investors are paying a high dollar amount for each dollar of current revenue while the company remains loss making, with a net loss of $140.06m and a negative Return on Equity of 14.94%. Relative to similar companies, IDEAYA screens as expensive. Its 11.2x P/S stands above the peer average of 6.7x and is also higher than the broader US Biotechs industry at 10.8x. Against an estimated fair P/S of 2.4x, the current multiple also sits well above a level the market could move toward if expectations or sentiment cool. Explore the SWS fair ratio for IDEAYA Biosciences Result: Price-to-Sales of 11.2x (OVERVALUED) However, investors still face real risks if clinical trial timelines slip or partnerships with larger pharma companies change, which could quickly reset sentiment around the stock. Find out about the key risks to this IDEAYA Biosciences narrative. The rich 11.2x P/S multiple clashes with our DCF model, which points to a fair value of about $288.65 per share versus the current $28.74. This implies the stock trades roughly 90% below that estimate. When two methods disagree this much, which signal should you take more seriously? Look into how the SWS DCF model arrives at its fair value. Simply Wall St performs a discounted cash flow (DCF) on every stock in the world every day (check out IDEAYA Biosciences for example). We show the entire calculation in full. You can track the result in your watchlist or portfolio and be alerted when this changes, or use our stock screener to discover 44 high quality undervalued stocks. If you save a screener we even alert you when new companies match - so you never miss a potential opportunity. With sentiment clearly split between rich valuation signals and upbeat clinical milestones, it makes sense to look at the numbers yourself and decide quickly where you stand by weighing up the 2 key rewards and 1 important warning sign If IDEAYA has you thinking about where to put fresh capital next, it is worth casting a wider net across other stocks that may fit your style. Target potential mispricings by scanning a curated set of 44 high quality undervalued stocks that combine quality traits with attractive valuations. Lock in income-focused ideas by reviewing a group of 12 dividend fortresses that concentrate on higher yielding payouts. Prioritize resilience by filtering for companies in the 74 resilient stocks with low risk scores that aim to keep risk scores in check. This article by Simply Wall St is general in nature. We provide commentary based on historical data and analyst forecasts only using an unbiased methodology and our articles are not intended to be financial advice. It does not constitute a recommendation to buy or sell any stock, and does not take account of your objectives, or your financial situation. We aim to bring you long-term focused analysis driven by fundamental data. Note that our analysis may not factor in the latest price-sensitive company announcements or qualitative material. Simply Wall St has no position in any stocks mentioned. Companies discussed in this article include IDYA. Have feedback on this article? Concerned about the content? Get in touch with us directly. Alternatively, email [email protected]

Phase 2/3 registrational trial (OptimUM-02) of darovasertib combination met its primary endpoint; complete data will be provided in a late-breaking oral presentation at ASCO IDEAYA to initiate RTOR submission process with first pre-submission in May; targeting completion of the NDA filing in H2 2026 Clinical updates from Phase 2 OptimUM-01 trial in HLA*A2-positive mUM, Phase 2 OptimUM-09 in neoadjuvant primary UM and Phase 1/2 trials with IDE849 (DLL3 TOP1 ADC) and IDE034 (B7H3/PTK7 bispecific TOP1 ADC) planned for H2 2026 Initiation of registrational trial for IDE849 monotherapy in DLL3-positive solid tumors planned by year-end 2026; Phase 1 combination cohort of IDE892 (PRMT5) + IDE397 (MAT2A) in MTAP-deleted cancers to begin in mid-2026 ~$973 million of cash, cash equivalents, and marketable securities as of March 31, 2026; current cash runway guidance into 2030 remains unchanged SOUTH SAN FRANCISCO, Calif., May 5, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the first quarter ended March 31, 2026. "This was a transformational quarter for IDEAYA, with positive topline results from the OptimUM-02 registrational trial in first line HLA*A2-negative metastatic uveal melanoma to enable the company's first NDA submission for potential U.S. accelerated approval. We look forward to a catalyst rich second half of 2026, including targeted clinical data updates for the darovasertib combination in HLA*A2-positive mUM, IDE849 in DLL3-positive solid tumors, and IDE034, our potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, in multiple large solid tumor indications. Finally, clinical dose escalation is advancing rapidly for our potential first-in-class KAT6/7 dual inhibitor, IDE574, and our PRMT5 inhibitor, IDE892, with the goal of initiating clinical expansion and combination trials with IDE892 in MTAP-deleted PDAC and NSCLC in the second half of this year," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Pipeline Developments and Corporate Updates Darovasertib in Uveal Melanoma On April 13th IDEAYA reported positive topline data from the Phase 2/3 OptimUM-02 trial of darovasertib in combination with crizotinib (darovasertib combination) in first line (1L) HLA*A2-negative metastatic uveal melanoma (mUM). The trial met its primary endpoint, with the combination reducing the risk of disease progression by 58% (Hazard Ratio of 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001) and achieving a statistically significant improvement in median progression-free survival (PFS) of 6.9 months versus 3.1 months in the investigator choice of therapy (ICT) arm as assessed by blinded independent central review (BICR). On secondary endpoints, an overall response rate (ORR) of 37.1%, including 5 complete responses, was observed in patients treated with the darovasertib combination versus 5.8% in the ICT arm (p-value: <0.0001) with a median duration of response (DOR) of 6.8 months. Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm. The combination was generally well-tolerated with a manageable safety profile consistent with previously reported results and known side-effects of each drug. IDEAYA will provide complete data from the primary analysis of OptimUM-02 in a late-breaking oral presentation at the 2026 American Society of Clinical Oncology (ASCO) meeting in Chicago, Illinois, and plans to submit a manuscript for publication in the second half of 2026. A new drug application (NDA) submission to the U.S. Food and Drug Association (FDA) is planned in the second half of 2026 to support a potential U.S. accelerated approval. The FDA has agreed to review IDEAYA's NDA under the Oncology Center of Excellence (OCE) Real-Time Oncology Review (RTOR) program, which allows an applicant to pre-submit components of its NDA for review before the complete filing is submitted to provide a more efficient review process and ensure safe and effective treatments are available to patients as early as possible. IDEAYA has completed enrollment of approximately 100 HLA*A2-positive mUM patients in the single-arm Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib. The company plans to present data at a major medical conference from over 85 efficacy-evaluable HLA*A2-positive mUM patients in the second half of 2026. Data will include updated ORR, PFS, and OS results, which will be used to support a potential regulatory submission to the FDA to expand the labeled use of darovasertib and/or guideline inclusion to enable the use of the darovasertib combination in HLA*A2-positive mUM patients. In collaboration with Servier, IDEAYA successfully completed a Type C meeting with the U.S. FDA to align on the Phase 3 registrational design of the OptimUM-11 trial evaluating darovasertib in combination with crizotinib in the adjuvant setting of primary uveal melanoma. The trial will enroll approximately 450 primary uveal melanoma patients with increased risk of metastasis, irrespective of HLA status, randomized 1:1 to treatment with darovasertib combined with crizotinib for 12-months or observation. The primary endpoint is superiority by relapse-free survival (RFS). OptimUM-11 is a global trial being conducted as part of IDEAYA's partnership with Servier and is expected to initiate in the first half of 2026. IDEAYA is continuing site activation and patient enrollment in the Phase 3 OptimUM-10 trial of neoadjuvant darovasertib in primary uveal melanoma. Full enrollment in the trial is estimated to be complete by the end of 2027, revised from prior guidance of first half of 2027. IDEAYA is targeting to provide a clinical data update from the ongoing Phase 2 OptimUM-09 trial at a medical conference in the second half of 2026. ADC / DDR combinations IDE849 (DLL3 TOP1 ADC): targeting to provide a clinical data update from the ongoing IDEAYA-sponsored global Phase 1/2 trial of IDE849 in small-cell lung cancer (SCLC) and neuroendocrine carcinomas (NEC) by the end of 2026. The company is planning to initiate a monotherapy registrational trial by the end of 2026. In April, IDEAYA entered into a clinical collaboration agreement with AstraZeneca plc to evaluate the efficacy and safety of IDE849 in combination with Imfinziﾮ (durvalumab), a programmed death-ligand 1 (PD-L1) inhibitor, in extensive-stage SCLC. IDEAYA will sponsor the clinical combination trial; AstraZeneca will supply Imfinziﾮ at no cost. Achieved first-patient-in (FPI) in Phase 1 combination trial of IDE849 and IDE161, IDEAYA's proprietary inhibitor of poly(ADP-ribose) glycohydrolase (PARG). Data from this trial are intended to help evaluate the potential synergy between TOP1 and PARG inhibition to drive deeper, more durable anti-tumor responses in patients IDEAYA's China-region partner, Jinagsu Hengrui Pharmaceuticals Co. Ltd., is targeting to initiate Phase 3 registrational trials in China in 2027 for IDE849 in SCLC and provide a clinical update from their Phase 1 trial in SCLC and NEC at a medical conference in the second half of 2026. IDE034 (B7H3/PTK7 bispecific TOP1 ADC): achieved FPI in Phase 1 dose escalation trial to evaluate IDE034 in solid tumors, and is targeting to provide a clinical data update by the end of 2026. IDE034 is a potentially 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. Patient dosing triggered a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies. MTAP pathway IDE892 (PRMT5): achieved FPI in Phase 1 dose escalation trial of IDE892 in MTAP-deleted solid tumors, including non-small cell lung cancer (NSCLC) and pancreatic ductal adenocarcinoma (PDAC). IDEAYA is planning to initiate a Phase 1 combination cohort with IDE397, its proprietary MAT2A inhibitor, in MTAP-deleted cancers in mid-2026 and expansion in the second half of 2026. Dual inhibition of IDE892 and IDE397 has demonstrated durable and well-tolerated tumor regressions in preclinical MTAP-deleted tumor models, including in NSCLC. In March, IDEAYA announced it will deprioritize clinical activity with Gilead evaluating the combination of IDE397 and Trodelvy and conclude enrollment in the Phase 1/2 trial in MTAP-deleted urothelial and lung cancers. Other programs IDE574 (KAT6/7): achieved FPI in Phase 1 dose escalation trial of IDE574 in solid tumors including breast, prostate, colorectal and lung cancer. IDE574 is a selective, equipotent dual inhibitor of both KAT6 and KAT7 which spares other structurally similar paralogs, including KAT5 and KAT8, which 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. Following termination of the Collaboration, Option and License Agreement with GlaxoSmithKline in 2025, IDEAYA plans to discontinue development of IDE275, a small molecule inhibitor of Werner helicase (WRN), and IDE705, a small molecule inhibitor of Pol-Theta helicase (POLQ). The company is currently evaluating strategic options for these assets. Corporate In February, IDEAYA announced the appointment of Dr. Theodora (Theo) Ross into the newly created role of Chief Development Officer. Dr. Ross will be responsible for leading early clinical development for IDEAYA's emerging oncology pipeline and play a crucial role in guiding the company's long-term R&D strategy. She joins IDEAYA from AbbVie, where she served as Vice President, Head of Early Oncology R&D and Site Head for the Bay Area. As of March 31, 2026, IDEAYA had $972.9 million of cash, cash equivalents and marketable securities; current cash runway guidance into 2030 remains unchanged. Financial Results for the Quarter Ended March 31, 2026 As of March 31, 2026, IDEAYA had cash, cash equivalents and marketable securities of approximately $972.9 million, compared to $1.05 billion as of December 31, 2025. The decrease was primarily driven by net cash used in operations. Collaboration revenue for the three months ended March 31, 2026, totaled $6.6 million compared to $10.9 million for the three months ended December 31, 2025. Collaboration revenue was recognized for the performance obligations satisfied through March 31, 2026 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of March 31, 2026, the remaining balance for the research and development services performance obligations is $155.3 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed. Research and development (R&D) expenses for the three months ended March 31, 2026 totaled $95.7 million compared to $86.6 million for the three months ended December 31, 2025. The increase was primarily driven by higher clinical trial and personnel-related expenses to support our programs. General and administrative (G&A) expenses for the three months ended March 31, 2026 totaled $19.4 million compared to $18.8 million for the three months ended December 31, 2025. The increase was primarily due to higher personnel-related expenses to support company growth and darovasertib commercial preparation activities. The net loss for the three months ended March 31, 2026, was $98.5 million compared to the net loss of $83.3 million for the three months ended December 31, 2025. Total stock compensation expense for the three months ended March 31, 2026, was $14.5 million compared to $11.8 million for the three months ended December 31, 2025. About IDEAYA Biosciences IDEAYA is 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 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. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements, including, without limitation, statements regarding IDEAYA Biosciences, Inc.'s ("IDEAYA") expectations with respect to the timing, progress, and results of its clinical trials and preclinical programs; the potential safety, efficacy, and therapeutic benefits of its product candidates; the planned presentation and publication of clinical data; the timing and likelihood of regulatory submissions, including the planned new drug application (NDA) for darovasertib and participation in the FDA's Real-Time Oncology Review (RTOR) program; the potential for accelerated approval and label expansion; the initiation, design, and enrollment of current and future clinical trials; the development and advancement of IDEAYA's pipeline programs, including IDE849, IDE034, IDE892, IDE397, and IDE574; the expected timing of clinical updates and milestones; the potential benefits of collaborations; and IDEAYA's financial position, including its expected cash runway. These forward-looking statements are based on management's current expectations and assumptions and are subject to a number of risks, uncertainties, and other factors that could cause actual results to differ materially from those described in the forward-looking statements. Such risks and uncertainties include, but are not limited to: risks related to the timing, progress, and results of clinical trials and preclinical studies; the ability of IDEAYA to obtain and maintain regulatory approvals; uncertainties regarding the regulatory review process, including participation in the RTOR program; the potential for clinical data to differ from preliminary or interim results; the ability to successfully develop, manufacture, and commercialize product candidates; competition from other biotechnology and pharmaceutical companies; the impact of global economic conditions; IDEAYA's ability to successfully establish, protect and defend its intellectual property: and other matters that could affect the sufficiency of existing cash to fund operations and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission (SEC), including its most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K. Forward-looking statements speak only as of the date of this press release, and IDEAYA undertakes no obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise, except as required by law. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-reports-first-quarter-2026-financial-results-and-provides-business-update-302762088.html

SOUTH SAN FRANCISCO, Calif., March 22, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in upcoming investor relations events and provided updated guidance related to the timing of its upcoming topline data release from the Phase 2/3 OptimUM-02 trial in first-line HLA-A2*-negative metastatic uveal melanoma. Darovasertib Phase 2/3 OptimUM-02 Trial Topline Results Investor and Analyst Webcast: Updated Topline Results Guidance: The database lock is projected in the first half of April, followed by the topline data analysis thereafter Live investor and analyst webcast will be hosted by IDEAYA management and a guest key opinion leader Pre-registration will be available prior to the event through IDEAYA's investor relations events page at https://ir.ideayabio.com/events Bank of America Merrill Lynch Health Care Conference Tuesday, May 12th, 2026 Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Bank of America Stifel 2026 Targeted Oncology Virtual Forum Tuesday, May 19th, 2026 Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Laura Prendergast, Managing Director, PhD A live audio webcast of the events will be available under the "Investors/Events" section of the IDEAYA website at https://ir.ideayabio.com/events and/or through the conference host. A replay of the webcasts will be accessible for 30 days following the live events. About IDEAYA Biosciences IDEAYA is 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 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. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to the expected timing of database lock, analysis and topline results from the Phase 2/3 OptimUM-02 trial; the anticipated timing and content of and participation in and/or presentation at investor and analyst events and webcasts; and IDEAYA's expectations regarding its clinical development activities. Forward-looking statements are based on IDEAYA's current expectations and are subject to a number of risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, but are not limited to, risks related to the timing, progress, and results of clinical trials, including the OptimUM-02 trial; the timing of data readouts, database analysis; the risk that topline results may not be predictive of final results; the potential for delays in clinical development; regulatory developments; and other risks described in IDEAYA's filings with the U.S. Securities and Exchange Commission, including its most recent Annual Report on Form 10-K and subsequent Quarterly Reports on Form 10-Q. IDEAYA undertakes no obligation to update or revise any forward-looking statements, except as required by law. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-upcoming-investor-relations-events-and-updated-darovasertib-topline-results-guidance-from-phase-23-optimum-02-trial-302721438.html

130 required PFS events confirmed by BICR in the Phase 2/3 OptimUM-02 trial of darovasertib and crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM); topline results expected by approximately the last week of March Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials in uveal melanoma, including the metastatic, neoadjuvant and adjuvant settings, by H1 '26 Initiation of IDE849 (DLL3 TOP1 ADC) monotherapy registrational study in the second line/refractory setting (2L+) of small cell lung cancer (SCLC) and/or neuroendocrine carcinomas (NEC) targeted by the end of 2026 Preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial of IDE849 expected by the end of 2026 ~$1.05 billion of cash, cash equivalents, and marketable securities as of December 31, 2025; expected to fund operations into 2030 SOUTH SAN FRANCISCO, Calif., Feb. 17, 2026 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the fourth quarter and full year ended December 31, 2025. "We had a strong quarter of clinical execution, clinical pipeline expansion and commercial readiness activities. The key highlights include completing full enrollment of 437 patients in OptimUM-02, our Phase 2/3 registrational trial in first line HLA*A2-negative mUM, submission of IND filings for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1 ADC, and IDE574, a KAT6/7 dual inhibitor, and continued build out of our U.S. commercial organization in anticipation of our upcoming topline PFS results," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Recent Developments and Upcoming Milestones Darovasertib in Uveal Melanoma (UM) Topline results, including progression free survival (PFS) data, from ongoing registrational Phase 2/3 OptimUM-02 trial of the darovasertib and crizotinib combination in first line (1L) patients with HLA*A2-negative metastatic UM are expected by approximately the last week of March, pending completion of ongoing data collection, cleaning and analysis. 130 PFS events required to trigger the topline readout have been confirmed by blinded independent central review (BICR); Randomized PFS analysis will be based on the intent-to-treat population (ITT) enrolled in the Phase 2b/3 portion of the trial, which comprises a total of approximately 313 patients randomized 2:1 to the treatment arm versus control; Topline PFS results, if positive, are anticipated to enable a potential accelerated approval filing in the United States. Darovasertib is anticipated to be in three randomized, Phase 3 registrational trials across all stages of uveal melanoma by H1 '26: OptimUM-02 (mUM): full enrollment of 437 patients is complete; overall survival (OS) data from these patients, when available, are expected to support a filing for full approval in 1L HLA*A2-negative mUM; OptimUM-10 (neoadjuvant): targeting to complete full enrollment of approximately 450 patients across enucleation and plaque brachytherapy cohorts by H1 '27; OptimUM-11 (adjuvant): trial initiation in collaboration with Servier planned in Q2 '26. Enrollment of approximately 100 HLA*A2-positive mUM patients in single-arm, Phase 2 OptimUM-01 trial of darovasertib in combination with crizotinib is expected to be complete by Q2 '26. Data may support a potential future submission to the U.S. Food and Drug Administration (FDA) to expand the labeled use of darovasertib and/or a national comprehensive cancer network (NCCN)/compendia listing to enable use of the combination in these patients. Targeting to submit two manuscripts for publication with data from 1) treatment na￯ve mUM patients and 2) HLA*A2-positive mUM patients enrolled in the OptimUM-01 trial in H1 '26 and H2 '26, respectively. Antibody-drug Conjugates (ADC) / DNA Damage Response (DDR) Combinations IDE849 (DLL3 TOP1 ADC): targeting to provide a preliminary clinical data update from IDEAYA-sponsored global Phase 1 trial and initiate a monotherapy registrational study in the second line/refractory setting (2L+) of SCLC and/or NEC by the end of 2026. IDE034 (B7H3/PTK7 bispecific TOP1 ADC): received investigational new drug (IND) clearance from the U.S. FDA in Q4 '25; expect to achieve first-patient-in (FPI) in Phase 1 dose escalation trial in Q1 '26; Dosing of the first patient with IDE034 will trigger a $5 million milestone payment from IDEAYA to Biocytogen, pursuant to the Option and License Agreement between the companies. IDE161 (PARG): initiation of clinical combination studies with IDE849 in SCLC, NEC and other DLL3-overexpressing solid tumors in Q2 '26. MTAP Pathway IDE397 (MAT2A): planning to provide updated data from Phase 1/2 combination trial with Trodelvy in MTAP-deleted urothelial cancer (UC) at a medical conference in 2026. IDE892 (PRMT5): targeting initiation of Phase 1 monotherapy dose escalation trial in Q1 '26 to enable a combination trial with IDE397 in MTAP-deleted solid tumors in Q2 '26. Nomination of a development candidate for a potential first-in-class program targeting CDKN2A, the most common co-alteration of MTAP, expected in H2 '26 followed by IND submission to the U.S. FDA in H1 '27. Next Generation Therapies IDE574 (KAT6/7): obtained IND clearance from the U.S. FDA in January 2026; targeting to initiate a Phase 1 dose escalation trial in patients with breast, lung, prostate and colorectal cancers Q1 '26. Corporate Darovasertib commercial readiness activities are advancing in the United States and globally with our partner, Servier. In December 2025, GlaxoSmithKline (GSK) notified IDEAYA of its intention to terminate the Collaboration, Option and License Agreement, dated June 15, 2020. Pursuant to the terms of the Agreement, GSK will transfer the Werner Helicase (IDE275) and Pol Theta (IDE705) clinical programs to IDEAYA in accordance with the applicable provisions of the Agreement. Fourth Quarter and Full Year 2025 Financial Results As of December 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion, compared to $1.08 billion as of December 31, 2024. The decrease was primarily driven by net cash used in operations, offset by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib during the year ended December 31, 2025. Collaboration revenue for the three months ended December 31, 2025, totaled $10.9 million compared to $7.0 million for the three months ended December 31, 2024. Collaboration revenue was recognized for the performance obligations satisfied through December 31, 2025 related to the research and development services that are recognized over time under the Servier exclusive license agreement for darovasertib. As of December 31, 2025, the remaining balance for the research and development services performance obligations is $161.8 million related to the clinical trial cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed. Research and development (R&D) expenses for the three months ended December 31, 2025 totaled $86.6 million compared to $140.2 million for the three months ended December 31, 2024. The decrease was primarily driven by a $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma during the three months ended December 31, 2024, offset by higher clinical trial and CMC manufacturing expenses to support our programs and personnel-related expenses during the three months ended December 31, 2025. General and administrative (G&A) expenses for the three months ended December 31, 2025 totaled $18.8 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related expenses, higher consulting and legal patent fees to support company growth and darovasertib commercial preparation activities. The net loss for the three months ended December 31, 2025, was $83.3 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended December 31, 2025, was $11.8 million compared to $9.5 million for the three months ended December 31, 2024. The net loss for the year ended December 31, 2025, was $113.7 million compared to the net loss of $274.5 million for the year ended December 31, 2024. Total stock compensation expense for the year ended December 31, 2025, was $46.1 million compared to $34.7 million for the year ended December 31, 2024. About IDEAYA Biosciences IDEAYA is 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 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. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements regarding the expected timing and results of clinical trials, including patient enrollment, and data readouts; the potential for accelerated approval or full regulatory approval of darovasertib, alone or in combination with crizotinib; the anticipated design, initiation, enrollment, timing and outcomes of IDEAYA's ongoing and planned Phase 1, Phase 2, and Phase 3 clinical trials across its pipeline programs, including IDE849, IDE034, IDE161, IDE397, IDE892 and IDE574; the therapeutic potential, safety, tolerability, efficacy, and combination potential of IDEAYA's product candidates; the expected prevalence of target patient populations; commercial readiness activities and future commercialization efforts; anticipated collaboration activities and transfers of clinical programs; and IDEAYA's expectations regarding its cash runway and ability to fund operations into 2030. Such forward-looking statements are based on management's current expectations, assumptions and beliefs and involve substantial risks and uncertainties that could cause actual results, including, but not limited to, those related to IDEAYA's clinical programs, commercial activities, and performance and/or achievements, to differ significantly and/or materially from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including the process of designing and conducting preclinical and clinical trials, enrollment rates, safety outcomes, efficacy results, regulatory interactions and decisions, and the ability to translate preclinical findings into clinical benefit, manufacturing and supply risks, competition, changes in standard of care, the timing and success of commercialization efforts, the outcome of collaborations and licensing arrangements, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of financial resources to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. A further description of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, are in IDEAYA's filings with the Securities and Exchange Commission, including IDEAYA's most recent Annual Report on Form 10-K and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-reports-fourth-quarter-and-full-year-2025-financial-results-and-provides-a-business-update-302688513.html

Phase 2/3 trial (OptimUM-02) of the darovasertib/crizotinib combination in 1L HLA*A2-negative metastatic uveal melanoma (mUM) to report median PFS data by year-end 2025 to 1Q 2026; on track to complete enrollment by year-end 21.1 month median OS and 7.0 month median PFS reported from single-arm Phase 2 trial (OptimUM-01) evaluating the darovasertib/crizotinib combination in 1L mUM Phase 1 data reported in SCLC for IDE849 (DLL3 TOP1i ADC) at the World Conference on Lung Cancer. Preliminary evidence of clinical efficacy was also observed in NETs patients, including Partial Responses by RECIST 1.1 Go-forward dose selected for IDE397 and Trodelvy® clinical combination in MTAP-deleted urothelial cancer (UC), and FPI achieved in non-small cell lung cancer (NSCLC); next clinical update planned for a medical conference in the first half of 2026 IND clearance for IDE892 (PRMT5) received in 3Q 2025; IND filing for IDE034 (B7H3/PTK7 bispecific TOP1i ADC) complete, with IND filing for IDE574 (KAT6/7) on track for year-end 2025 Entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States; IDEAYA received $210 million upfront and is eligible for up to $320 million in milestone payments ~$1.14 billion of cash, cash equivalents, and marketable securities as of September 30, 2025; expected to fund operations into 2030 SOUTH SAN FRANCISCO, Calif., Nov. 4, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a leading precision medicine oncology company, provided a business update and announced financial results for the third quarter ended September 30, 2025. "This quarter we continued to make significant progress across the pipeline and broader business, including the partnership with Servier that extends our runway into 2030 and enables potential commercialization of darovasertib outside of the United States. We have also provided multiple major medical conference clinical data updates at WCLC, ESMO and SMR, and completed our third IND filing in 2025 to further extend our industry leadership in precision medicine oncology," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Pipeline Developments and Upcoming Milestones Darovasertib Metastatic uveal melanoma (mUM) Median progression-free survival (PFS) data from the Phase 2/3 trial (OptimUM-02) of darovasertib in combination with crizotinib in first line (1L) HLA*A2:01-negative mUM is on track to be reported by year-end 2025 to 1Q 2026; this data has the potential to enable an accelerated approval filing in the United States. The trial is nearing full enrollment, which remains on track to be completed by year-end. In October 2025, data from the single-arm, Phase 2 trial (OptimUM-01) of darovasertib in combination with crizotinib were presented at the Society for Melanoma Research (SMR) Congress in Amsterdam, Netherlands. Data were from a total of 44 1L mUM patients, including both HLA*A2:01-negative and HLA*A2:01-positive patient subsets. Highlights include: 21.1 month median overall survival (OS) and 7.0 month median progression free survival (PFS) across all patients In 41 efficacy-evaluable patients, confirmed overall response rate (ORR) of 34% (14/41) with a 9.0 month median duration of response (mDOR) Disease control rate (DCR) of 90% (37/41), with 85% (35/41) of patients achieving 'any reduction' in target lesions The combination continued to be well-tolerated with the most common treatment-related adverse events (TRAEs >30%) of diarrhea, nausea, edema, vomiting, dermatitis, hypoalbuminemia, and fatigue Neoadjuvant therapy for primary uveal melanoma (UM) In October 2025, the company presented positive data from the randomized Phase 2 trial (OptimUM-09) in a Proffered Paper Oral Presentation at the European Society for Medical Oncology (ESMO) in Berlin, Germany. Data were from a total of 95 patients, including 56 recommended for enucleation (EN) and 39 eligible for plaque brachytherapy (PB). Highlights include: Ocular tumor shrinkage in ~83% (78/94) of patients assessed, the majority of whom achieved ≥20% tumor shrinkage Among evaluable EN patients, the eye preservation rate was 57% (24/42), which increased to 95% (19/20) in patients achieving ≥20% tumor shrinkage In evaluable PB eligible patients, ~70% (26/37) achieved a reduction in predicted radiation dose to the eye from baseline, resulting in ~65% (24/37) having lower predicted risk of vision loss 3-years post-PB treatment During neoadjuvant treatment with darovasertib, ~55% (29/53) of EN and ~61% (23/38) of PB patients showed an improvement in baseline visual acuity scores (VAS), with a mean gain of 17 and 10 letters, respectively Darovasertib continued to be well-tolerated, with a low rate of serious adverse events and TRAEs leading to discontinuation IDEAYA has initiated a randomized Phase 3 registration-enabling trial of darovasertib as a single-agent in the neoadjuvant setting of primary UM. The trial, referred to as OptimUM-10, will enroll a total of approximately 450 patients in two cohorts of PB- and EN-recommended patients. Target enrollment was revised downward from our previous estimate of 520 patients due to a reduction of 70 patients in the PB cohort (prior guidance of 400, now 330 patients) based on additional FDA feedback on the statistical plan (alpha usage) across the two cohorts Adjuvant therapy for primary UM In collaboration with Servier, IDEAYA plans to initiate a global Phase 3 combination trial of darovasertib and crizotinib as an adjuvant therapy for primary UM in the first half of 2026. IDE397 (MAT2A) Positive data were reported from the ongoing Phase 1/2 trial of IDE397 in combination with Gilead's Trodelvy® (sacituzumab govitecan-hziy), a Trop2-directed antibody-drug conjugate (ADC), in patients with MTAP-deleted urothelial cancer (UC). 57% ORR (4/7; 4cPR) at 30 mg IDE397 plus 7.5mg/kg Trodelvy® (Dose level 2). Median PFS and mDOR were not yet reached. Manageable safety profile consistent with known adverse events of both drugs as single agents. IDEAYA has selected Dose level 2 as the go-forward dose for the IDE397 and Trodelvy clinical combination in MTAP-deleted UC and has achieved first-patient-in (FPI) in NSCLC. The next clinical update from the combination trial is planned for a medical conference in the first half of 2026. IDE849 (DLL3 TOP1i ADC) IDEAYA's partner, Hengrui Pharma, presented clinical safety and efficacy data from over 70 small-cell lung cancer (SCLC) patients from their Phase 1 clinical trial at the 2025 International Association for the Study of Lung Cancer ("IASLC") World Conference on Lung Cancer (WCLC) in Barcelona, Spain. Data included 87 patients with small-cell lung cancer (SCLC) and 13 patients with other neuroendocrine carcinomas (NEC) as of a cut-off date of June 20, 2025. A total of 71 refractory (2L+) SCLC patients were evaluated for efficacy at doses of IDE849 between 2.4mg/kg and 4.2 mg/kg. Highlights include: At the 2.4 mg/kg expansion dose of IDE849, 2L patients demonstrated an 80.0% (8/10) ORR and 70.0% (7/10) confirmed ORR; across all lines of therapy (2L+) at this dose the ORR and confirmed ORR decreased modestly to 73.7% (14/19) and 57.9% (11/19) (1 pending confirmation), respectively. Across all doses of IDE849 tested, 2L patients showed a 77.1% (27/35) ORR and 60.0% (21/35) confirmed ORR (4 pending confirmation) whereas a 73.2% (52/71) ORR and 47.9% (34/71) confirmed ORR (10 pending confirmation) was observed across all lines of therapy at all doses (≥2.4 mg/kg). Patients with baseline brain metastases had an 83.3% (5/6) confirmed ORR at the 2.4 mg/kg dose and a 66.7% (12/18) confirmed ORR (1 pending confirmation) across all doses (≥2.4 mg/kg). 6.7 month median PFS achieved across all lines and all doses (≥2.4 mg/kg); the median PFS was not reached in 2L patients. In May 2025, IDEAYA initiated a global Phase 1 trial of IDE849 and has achieved FPI in the United States. The company continues to enroll SCLC patients with plans to expand into patients with neuroendocrine tumors (NETs) and other DLL3-overexpressing tumors by the end of 2025. Other programs IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in 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. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing. 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 dose escalation in combination with niraparib, GSK's small molecule inhibitor of PARP, is ongoing in patients with solid tumors. Phase 2 dose expansion in BRCA-mutant solid tumors would trigger a $10 million milestone payment from GSK. IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, is being developed for patients with MTAP-deleted lung cancer and other high priority MTAP-deleted solid tumor indications. IDEAYA received IND clearance from the FDA in the third quarter and expects to begin a Phase 1 dose escalation trial by the end of the year with the goal of advancing into combination trials with IDE397 in the first half of 2026. In the fourth quarter IDEAYA submitted an IND for IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, and is on track to file an IND for IDE574, a potential first-in-class KAT6/7 dual inhibitor, by the end of the year. License agreement with Servier IDEAYA entered into an exclusive license agreement with Servier for rights to darovasertib outside the United States. The company received an upfront payment of $210 million, and is eligible for up to $100 million in regulatory approval-based milestone payments and up to $220 million in commercial milestone payments, as well as double-digit royalties on net sales in all territories outside of the United States. IDEAYA and Servier will collaborate on the development of darovasertib and share the associated costs. IDEAYA retains all rights to darovasertib in the United States. Financial Results for the Quarter Ended September 30, 2025 As of September 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.14 billion, compared to $991.9 million as of June 30, 2025. The increase was primarily driven by the $210.0 million upfront payment received from Servier related to the exclusive license agreement for darovasertib, offset by the net cash used in operations. Collaboration revenue for the three months ended September 30, 2025, totaled $207.8 million compared to zero for the three months ended June 30, 2025. Collaboration revenue was recognized for the performance obligations satisfied through September 30, 2025 related to the development and commercialization license recognized upon execution and the research and development services that will be recognized over time under the Servier exclusive license agreement for darovasertib. As of September 30, 2025, the remaining balance for the research and development services performance obligations is $143.1 million related to the clinical development cost reimbursements anticipated under the license agreement that will be recognized as IDEAYA collaboration revenue over time as the research and development services are completed. Research and development (R&D) expenses for the three months ended September 30, 2025 totaled $83.0 million compared to $74.2 million for the three months ended June 30, 2025. The increase was primarily driven by higher clinical trial and CMC manufacturing expenses to support our programs. General and administrative (G&A) expenses for the three months ended September 30, 2025 totaled $16.4 million compared to $14.6 million for the three months ended June 30, 2025. The increase was primarily due to higher legal expenses to support company growth and commercial expenses to support the darovasertib commercial preparation activities. The net income for the three months ended September 30, 2025, was $119.2 million compared to the net loss of $77.5 million for the three months ended June 30, 2025. Total stock compensation expense for the three months ended September 30, 2025, was $12.2 million compared to $11.9 million for the three months ended June 30, 2025. About IDEAYA Biosciences IDEAYA is 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 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. IDEAYA's corporate presentation is available on its website: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical trial programs and updates, including enrollment achievements, regulatory updates, clinical trial data readouts, including those at medical conferences; (ii) the potential for an accelerated approval filing for darovasertib; (iii) the potential therapeutic benefits of IDEAYA therapeutics; (iv) the translation of preliminary clinical trial results into future clinical trial results and/or regulatory approval; (v) timing of development and regulatory milestones; (vi) the timing of new IND application filings; (vii) the potential for milestone payments, royalties and clinical development cost sharing under the Servier License Agreement; and (viii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing and commercializing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-reports-third-quarter-2025-financial-results-and-provides-business-update-302603417.html

Phase 2/3 trial of the darovasertib and crizotinib combination in 1L HLA-A2-negative metastatic uveal melanoma (MUM) on track to report median PFS data by year-end 2025; potential to enable a U.S. accelerated approval filing First-reported median overall survival data in over 40 1L MUM patients from single-arm Phase 2 trial of the darovasertib and crizotinib combination to be provided at a medical conference in 4Q 2025 Phase 2 data from over 90 plaque brachytherapy and enucleation primary uveal melanoma (UM) patients treated with darovasertib in the neoadjuvant setting will be shared as a Proffered Paper Oral Presentation at the European Society of Medical Oncology (ESMO) in 4Q 2025 First-in-human Phase 1 clinical efficacy and safety data from over 70 SCLC patients treated with IDE849 (DLL3 TOP1i ADC) will be provided as an Oral Presentation at the IASLC 2025 World Conference on Lung Cancer on September 7th, 2025 IDEAYA 10-year Anniversary R&D Day will feature multiple clinical data updates, including from over 20 plaque brachytherapy patients in the Phase 2 trial of darovasertib as neoadjuvant therapy for primary UM and from two expansion cohorts in the Phase 1 combination trial of IDE397 and Trodelvy® (sacituzumab govitecan-hziy) in MTAP-deletion urothelial cancer Three IND submissions are on track by year-end 2025, including IDE892 (PRMT5), IDE034 (B7H3/PTK7 bispecific TOP1i ADC) and IDE574 (KAT6/7) ~$992 million of cash, cash equivalents, and marketable securities as of June 30, 2025; anticipated to fund operations into 2029 SOUTH SAN FRANCISCO, Calif., Aug. 5, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), an oncology company committed to advancing the discovery, development, and commercialization of transformative precision medicines to address unmet medical needs in cancer, provided a business update and announced financial results for the second quarter ended June 30, 2025. "We look forward to a catalyst rich period with six clinical data updates guided from now to year-end across three clinical stage programs, including two oral presentations that have been accepted at major medical conferences and our targeted top-line randomized median PFS results for the darovasertib and crizotinib combination in 1L HLA-A2 negative MUM to potentially enable our first accelerated approval filing in the U.S. We are also excited to host our 10-year Anniversary R&D Day in New York City on September 8th, where we will present multiple data updates across our potential first-in-class clinical pipeline and highlight our strategic vision and pioneering research in cancer biology and drug discovery," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Selected Pipeline Developments and Upcoming Milestones Darovasertib Metastatic uveal melanoma (MUM) Median progression-free survival (PFS) data from the Phase 2/3 trial of darovasertib in combination with crizotinib in first line (1L) HLA-A2-negative MUM is on track to be reported by year-end 2025; this data has the potential to enable an accelerated approval filing in the United States. Over 350 patients have been enrolled in the trial as of August 4, 2025, and the company expects to complete full enrollment of approximately 400 patients by year-end. Based on feedback from the U.S. Food and Drug Administration (FDA), IDEAYA plans to submit median overall survival (OS) data from this trial to support full U.S. approval in HLA-A2-negative MUM. Median OS data from a single-arm, Phase 2 trial of darovasertib in combination with crizotinib will be presented at a medical conference in the fourth quarter of 2025. The readout will include data in over 40 patients, including both HLA-A2-negative and HLA-A2-positive patients. IDEAYA continues to enroll HLA-A2-positive patients in this trial to assess the benefit of the darovasertib/crizotinib combination to support a potential real world evidence (RWE) regulatory submission and/or compendia listing. If granted, this has the potential to broaden the use of darovasertib in MUM patients, independent of HLA status. Neoadjuvant therapy for primary uveal melanoma (UM) IDEAYA is also evaluating darovasertib as a monotherapy in the neoadjuvant setting for primary UM, where the goal of treatment is to prevent enucleation (surgical eye removal), preserve vision prior to and post-plaque brachytherapy, and slow disease progression and metastasis. Initial safety and visual benefit data will be reported from the Phase 2 clinical trial from over 20 patients in the plaque brachytherapy-eligible cohort at IDEAYA's R&D Day on September 8th, followed by additional data from over 90 patients in both the enucleation-eligible and plaque brachytherapy-eligible cohorts in a Proffered Paper Oral Presentation at ESMO, taking place from October 17-21, 2025 in Berlin, Germany. Following a successful Type D meeting with the FDA in April 2025, the company initiated a randomized Phase 3 registration-enabling trial of darovasertib in the neoadjuvant setting for primary UM in the third quarter of 2025. The trial, referred to as OptimUM-10, will enroll a total of approximately 520 patients in two cohorts of plaque brachytherapy-eligible and enucleation-eligible patients. IDE397 (MAT2A) IDEAYA is conducting a Phase 1/2 clinical trial pursuant to a clinical study collaboration and supply agreement with Gilead to evaluate IDE397 in combination with Trodelvy® (sacituzumab govitecan-hziy), Gilead's Trop-2 directed ADC, in patients with MTAP-deletion urothelial cancer, or UC, and non-small cell lung cancer, or NSCLC. In April 2025, the companies announced expansion of the IDE397 and Trodelvy® (sacituzumab govitecan-hziy) combination trial in NSCLC. IDEAYA will provide initial Phase 1 safety and efficacy data from two expansion cohorts in the IDE397 and Trodelvy® (sacituzumab govitecan-hziy) combination trial in MTAP-deletion UC patients at the company's R&D Day September 8th, with additional data targeted for a medical conference in the first half of 2026. IDE849 (DLL3 TOP1i ADC) IDEAYA's partner, Hengrui Pharma, is conducting a multi-site, open label Phase 1 clinical trial for IDE849 in China for patients with small-cell lung cancer (SCLC). Hengrui will present clinical safety and efficacy data from over 70 patients in the trial at the International Association for the Study of Lung Cancer ("IASLC") 2025 World Conference on Lung Cancer (WCLC) taking place from September 6-9, 2025 in Barcelona, Spain. The presentation will include data from the dose escalation and multiple expansion doses. In May 2025, IDEAYA initiated a Phase 1 trial in the U.S. in SCLC. Patient dosing in NETs and other DLL3-expressing tumors is targeted by year-end 2025. Other programs IDE161, a potential first-in-class small molecule poly-(ADP-ribose) glycohydrolase, or PARG, inhibitor is currently in 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. IDEAYA plans to initiate a Phase 1 combination trial of IDE849 and IDE161 by the end of 2025. The company will also share preclinical data in a poster presentation at WCLC providing combination mechanism and pre-clinical synergy data between TOP1-payload based ADCs and IDE161. IDE275 (GSK959), a potential first-in-class small molecule inhibitor of Werner Helicase, is being developed in collaboration with GlaxoSmithKline (GSK). A Phase 1 dose escalation in patients with MSI-High solid tumors is ongoing. 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-positive or other HRD-positive tumors. Phase 2 expansion in HRD-positive solid tumors would trigger a $10 million milestone payment from GSK. IDEAYA also plans to submit three investigational new drug, or IND, applications before the end of the year: IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-2025; IDE034, a potential first-in-class B7H3/PTK7 bispecific TOP1i ADC, in the fourth quarter of 2025; and IDE574, a potential first-in-class KAT6/7 dual inhibitor, in the fourth quarter of 2025. R&D Day - September 8, 2025 IDEAYA will host an in-person and virtual R&D Day on September 8th, 2025 from 8:00-10:00 AM ET in New York City. The company will present multiple clinical data updates across the pipeline and highlight future growth drivers and upcoming milestones. Speakers will include members of IDEAYA's senior leadership team and key opinion leader(s). Additional agenda details will be provided by the end of August 2025. Registration for this event can be accessed here or at the investors section of the IDEAYA website at https://ir.ideayabio.com/events. Other corporate updates IDEAYA continues efforts to scale the organization in preparation for the potential U.S. launch of darovasertib, including key hires within the commercial, medical affairs and market access functions. Gary Palmer, M.D., joined as Senior Vice President, Medical Affairs, where he will lead the company's medical affairs activities. Gary joined IDEAYA with over 25 years of global leadership experience in medical affairs from biopharmaceutical companies of various sizes and stages, and across multiple therapeutic areas including oncology, pulmonary medicine, immunology and neurology. Most recently Gary was Senior Vice President of Medical Affairs at Pliant Therapeutics, and prior to that he was Senior Vice President of Global Medical Affairs Immunology & Neuroscience at Bristol-Myers Squibb Co (BMS) where he led the Worldwide Immunology, Fibrosis and Neuroscience Medical Affairs team covering a portfolio spanning four globally marketed medications and more than 15 development candidates across the areas of pulmonary fibrosis, dermatology, gastroenterology, rheumatology and neurology. Financial Results for the Quarter Ended June 30, 2025 As of June 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $991.9 million, compared to $1.05 billion as of March 31, 2025. The decrease was primarily driven by net cash used in operations. Research and development (R&D) expenses for the three months ended June 30, 2025 totaled $74.2 million compared to $70.9 million for the three months ended March 31, 2025. The increase was primarily due to higher clinical trial expenses to support our clinical pipeline and personnel-related expenses. General and administrative (G&A) expenses for the three months ended June 30, 2025 totaled $14.6 million compared to $13.5 million for the three months ended March 31, 2025. The increase was primarily due to higher personnel-related expenses to support our growth. The net loss for the three months ended June 30, 2025, was $77.5 million compared to the net loss of $72.2 million for the three months ended March 31, 2025. Total stock compensation expense for the three months ended June 30, 2025, was $11.9 million compared to $10.2 million for the same period in 2024. About IDEAYA Biosciences IDEAYA is 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 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. IDEAYA's corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical program updates, regulatory updates, clinical trial data readouts, including those at medical conferences and IDEAYA's R&D Day; (ii) the potential therapeutic benefits of IDEAYA therapeutics; (iii) the translation of preliminary clinical trial results into future clinical trial results and/or regulatory approval; (iv) timing of development and regulatory milestones; (v) the timing of new IND applications; and (vi) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Joshua Bleharski, Ph.D. Chief Financial Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-second-quarter-2025-financial-results-and-provides-business-update-302521444.html SOURCE IDEAYA Biosciences, Inc.

~$1.05 billion of cash, cash equivalents and marketable securities as of March 31, 2025, and an updated cash runway guidance into 2029; commercial readiness activities ongoing Over 300 patients enrolled in darovasertib and crizotinib registrational 1L HLA-A2-negative MUM trial; targeting median PFS results by YE 2025 to enable potential accelerated approval filing Successful FDA Type D meeting completed to finalize darovasertib Ph3 registrational trial design and received U.S. FDA Breakthrough Therapy Designation in neoadjuvant UM Targeting three darovasertib program clinical data updates at medical conferences in 2025, including 1L MUM mOS results in >40 patients and neoadjuvant UM data in >90 patients IDE849 (DLL3 TOP1 ADC) Phase 1 initiated in U.S., and partner Hengrui targeting clinical data update in over 40 SCLC patients at a medical conference in Q3 2025 Oral presentation of potential best-in-class Phase 1 WRN inhibitor IDE275 at AACR 2025 Three additional IND-filings targeted in 2025: PRMT5, B7H3/PTK7 ADC, and KAT6/7 SOUTH SAN FRANCISCO, Calif., May 6, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the first quarter that ended March 31, 2025. "We have provided an updated cash runway guidance into 2029, and this past quarter we made significant progress on the darovasertib program, including receiving U.S. FDA breakthrough therapy designation, and enrollment is ahead of schedule with over 300 patients in the 1L HLA-A2-negative MUM registrational trial for a targeted median PFS readout by year-end to enable a potential accelerated approval filing next year. We also advanced a broad clinical pipeline of potential first-in-class programs to continue to drive forward our growth strategy, including DLL3 TOP1 ADC IDE849 in lung cancer, Werner Helicase inhibitor IDE275 in MSI-high colorectal and endometrial cancer, and MAT2A inhibitor IDE397 in MTAP-deletion lung and urothelial cancer," said Yujiro S. Hata, President and Chief Executive Officer, IDEAYA Biosciences. Recent Key Developments and Upcoming Milestones Research and Clinical Development Darovasertib: a potential first-in-class PKC inhibitor in Phase 2/3 clinical testing for the treatment of metastatic uveal melanoma (MUM) and as neoadjuvant treatment for primary uveal melanoma (UM). MUM Neoadjuvant UM IDE397: a potential first-in-class Phase 2 MAT2A inhibitor for the treatment of MTAP-deletion solid tumors. IDE849 (SHR-4849): a potential first-in-class Phase 1 DLL3 TOP1i antibody drug conjugate (ADC) targeting small cell lung cancer (SCLC) and neuroendocrine tumors (NETs). IDE275 (GSK959): a potential first-in-class and best-in-class Phase 1 Werner Helicase inhibitor for the treatment of high microsatellite instability (MSI-High) tumors. IDE161: a potential first-in-class Phase 1 PARG inhibitor for the treatment of solid tumors. IDE705 (GSK101): a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor in combination with PARP inhibitor for the treatment of HRD solid tumors. IDE892: a potential best-in-class MTA-cooperative PRMT5 inhibitor to enable wholly-owned combination with IDE397. IDE034: a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC with combination potential with IDE161. IDE574: a potential first-in-class KAT6/7 dual inhibitor development candidate with combination opportunities with multiple programs in the Company's pipeline. Corporate Development and Operations Formed a research collaboration with ATTMOS to develop a physics-based computational platform for small molecule discovery, aimed at swiftly unlocking oncology targets traditionally considered undruggable. The collaboration will integrate IDEAYA's differentiated and proven capabilities in structural biology and pharmaceutical drug discovery across multiple first-in-class oncology targets with ATTMOS's capabilities in computational chemistry method development, high performance computing, and software development. Joshua Bleharski, Ph.D., joined IDEAYA as Chief Financial Officer. Dr. Bleharski joins from J.P. Morgan, serving most recently as Managing Director and Global Co-Head of Biopharma in the Healthcare Investment Banking group. Josh spent nearly 17 years at J.P. Morgan advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services representing more than $65 billion of value for biotechnology companies worldwide. Shanthakumar Tyavanagimatt, Ph.D., joined IDEAYA as Senior Vice President, Technical Operations, where he will lead IDEAYA's darovasertib global commercial supply chain readiness activities, as well as the technical operations activities across IDEAYA's preclinical and clinical-stage pipeline. Prior to IDEAYA, Shanthakumar brings over 20-years of technical operations experience to IDEAYA, including approximately 9-years at CTI Biopharma (acquired by SOBI, Inc.) where he led the technical operations function for multiple commercial product launches. Updated cash runway guidance into 2029 based on current operating plan. Financial Results As of March 31, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $1.05 billion. This compared to cash, cash equivalents and marketable securities of approximately $1.08 billion as of December 31, 2024 The decrease in the balance as of March 31, 2025 was primarily driven by net cash used in operations which was offset by $25.0 million in net proceeds from the sale of common stock shares through at-the-market financings during the quarter. IDEAYA projects that the $1.05 billion in cash, cash equivalent and marketable securities balance as of March 31, 2025 will be sufficient to fund its planned operations into 2029 based on its current operating plan. We have updated our operating plan costs with further pipeline prioritization, including focusing: 1) the IDE161 clinical program on the combination study with DLL3 TOP1 ADC IDE849, 2) the IDE397 and PRMT5 mechanism clinical combination activities to wholly-owned PRMT5 inhibitor IDE892 (PRMT5MTA), and 3) the clinical dose escalation and expansion data for the IDE397 and Trodelvy® combination in MTAP-deletion UC, to be utilized for the MTAP-deletion NSCLC indication clinical expansion activities. There was no collaboration revenue for the three months ended March 31, 2025, compared to $7.0 million in collaboration for the three months ended December 31, 2024. Collaboration revenue for the three months ended December 31, 2024 was related to a milestone payment from GSK that was earned for the IND clearance of IDE275 (GSK959) in October 2024. Research and development (R&D) expenses for the three months ended March 31, 2025, totaled $70.9 million compared to $140.2 million for the three months ended December 31, 2024. The decrease was primarily due to a one-time $75.0 million upfront payment under the license agreement for IDE849 with Hengrui Pharma that occurred in December 2024, offset by higher clinical trial, consulting and personnel-related expenses to support our pipeline. General and administrative (G&A) expenses for the three months ended March 31, 2025 totaled $13.5 million compared to $11.0 million for the three months ended December 31, 2024. The increase was primarily due to higher personnel-related, consulting and legal patent expenses to support our growth. The net loss for the three months ended March 31, 2025, was $72.2 million compared to the net loss of $130.3 million for the three months ended December 31, 2024. Total stock compensation expense for the three months ended March 31, 2025, was $10.2 million compared to $9.5 million for the three months ended December 31, 2024. About IDEAYA Biosciences IDEAYA is a precision medicine oncology company committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics. IDEAYA's approach integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets. IDEAYA's updated corporate presentation is available on its website, at its Investor Relations page: https://ir.ideayabio.com/. Forward-Looking Statements This press release contains forward-looking statements, including, but not limited to, statements related to (i) the timing and content of clinical program updates, regulatory updates and clinical trial data readouts; (ii) the potential therapeutic benefits of IDEAYA therapeutics; (iii) the translation of preliminary clinical trial results into future clinical trial results and/or regulatory approval; (iv) timing of development and regulatory milestones; (v) the timing and potential of registration-enabling trial and readouts for darovasertib in 1L HLA-A2 negative MUM and potential for accelerated approval filing; (vi) the timing and potential for accelerated FDA approval of darovasertib in MUM; (vii) the timing of the initiation of registration-enabling Phase 3 trial for darovasertib in neoadjuvant UM; (viii) the timing of combination trial of IDE397 and IDE892 in patients with MTAP-deletion NSCLC; (ix) the timing and potential of a Phase 2 expansion monotherapy dose for IDE161; (x) the timing of initiating IDE161 and TOP1-payload ADC combination trial; (xi) timing of INDs for IDE892, IDE034, and IDE251; (xii) timing of data presentation for IDE275 and IDE849 at medical conferences; and (xiii) the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations. Such forward-looking statements involve substantial risks and uncertainties that could cause IDEAYA's preclinical and clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the drug development process, including IDEAYA's programs' early stage of development, the process of designing and conducting preclinical and clinical trials, the regulatory approval processes, the timing of regulatory filings, the challenges associated with manufacturing drug products, IDEAYA's ability to successfully establish, protect and defend its intellectual property, and other matters that could affect the sufficiency of existing cash to fund operations. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's Annual Report on Form 10-K dated February 18, 2025 and any current and periodic reports filed with the U.S. Securities and Exchange Commission. Investor and Media Contact IDEAYA Biosciences Andres Ruiz Briseno Chief Accounting Officer [email protected] View original content to download multimedia:https://www.prnewswire.com/news-releases/ideaya-biosciences-inc-reports-first-quarter-2025-financial-results-and-provides-business-update-302446500.html SOURCE IDEAYA Biosciences, Inc.