IDYA

EX-99.1

2 idya-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

IDEAYA Biosciences Reports Second Quarter 2026 Financial Results and Provides Business Update

• 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

Exhibit 99.1

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.

o The trial met its primary endpoint, with patients receiving the darovasertib combination demonstrating a statistically significant improvement in median PFS of 6.9 months versus 3.1 months in the ICT arm by BICR (HR: 0.42; 95% CI: 0.30, 0.59; p-value: <0.0001). A similar result was observed based on investigator assessment, with the combination leading to a median PFS of 6.7 months versus 2.7 months in the ICT arm (HR: 0.36; 95% CI: 0.26, 0.50, p-value: <0.0001).

o Patients receiving the darovasertib combination also had clinically meaningful and statistically significant improvements across all key secondary endpoints.

o Overall survival (OS) data was still immature as of the January 23, 2026 cutoff date; however, there was an early trend in OS improvement in the darovasertib combination arm relative to the ICT arm. IDEAYA plans to provide an update on the OS data as part of the pre-specified interim analysis expected in mid-2027.

o Overall, the darovasertib combination was generally well-tolerated with a manageable safety profile, consistent with previous results and known side-effects of each agent.

• 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 result

EX-99.1

2 idya-ex99_1.htm

EX-99.1

EX-99.1

Exhibit 99.1

IDEAYA Biosciences Reports First Quarter 2026 Financial Results and Provides Business Update

• 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).

o 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).

o 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.

o Overall survival (OS) data were not yet mature, however the darovasertib combination did show an early trend in OS improvement versus the ICT arm.

o 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.

o 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.

o 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 pat

8-K

false000167672500016767252026-02-172026-02-17

UNITED STATES

SECURITIES AND EXCHANGE COMMISSION

Washington, D.C. 20549

FORM 8-K

CURRENT REPORT

Pursuant to Section 13 or 15(d) of the Securities Exchange Act of 1934 Date of Report (Date of earliest event reported): February 17, 2026

IDEAYA Biosciences, Inc. (Exact name of registrant as specified in its charter)

Delaware

001-38915

47-4268251

(State or other jurisdiction of incorporation)

(Commission File Number)

(IRS Employer Identification Number)

5000 Shoreline Court, Suite 300 South San Francisco, California 94080 (Address of principal executive offices, including Zip Code)

Registrant’s telephone number, including area code: (650) 443-6209

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the registrant under any of the following provisions:

☐ Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425) ☐ Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12) ☐ Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)) ☐ Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))

Securities registered or to be registered pursuant to Section 12(b) of the Act.

Title of each class

Trading Symbol

Name of each exchange on which registered

Common Stock, $0.0001 par value per share

IDYA

The Nasdaq Global Select Market

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-2 of this chapter). Emerging growth company ☐ If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐

Item 2.02 Results of Operations and Financial Condition. On February 17, 2026, IDEAYA Biosciences, Inc. (the “Company”) announced its financial results for the fourth quarter and full year ended December 31, 2025. The full text of the press release issued in connection with the announcement is furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information in this Item 2.02 and the attached Exhibit 99.1 are being furnished and shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall they be deemed to be incorporated by reference in any filing made by the Company under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. Item 9.01 Financial Statements and Exhibits. (d) Exhibits.

Exhibit No.

Description

99.1

Press Release dated February 17, 2026.

104

Cover Page Interactive Data File (embedded within the Inline XBRL document).

SIGNATURES

Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.

IDEAYA BIOSCIENCES, INC.

Date: February 17, 2026

By:

/s/ Yujiro Hata

Yujiro Hata

President and Chief Executive Officer