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IDEAYA Biosciences, Inc. Reports Second Quarter 2025 Financial Results and Provides Business Update

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IDEAYA Biosciences (Nasdaq: IDYA) reported Q2 2025 financial results and significant pipeline progress. The company maintains a strong financial position with $992 million in cash, expected to fund operations into 2029. Key developments include the Phase 2/3 trial of darovasertib/crizotinib combination in metastatic uveal melanoma, with over 350 patients enrolled and median PFS data expected by year-end 2025.

The company plans three IND submissions by year-end 2025 and will present multiple clinical data updates across its pipeline. Notable upcoming milestones include Phase 2 data from over 90 primary uveal melanoma patients at ESMO and Phase 1 data from over 70 SCLC patients treated with IDE849 at WCLC. Financial results show R&D expenses of $74.2 million and a net loss of $77.5 million for Q2 2025.

[ "Strong cash position of $992 million expected to fund operations into 2029", "Phase 2/3 trial of darovasertib/crizotinib successfully enrolled over 350 patients", "Multiple near-term catalysts with six clinical data updates expected by year-end", "Three new IND submissions planned by year-end 2025", "Expansion of commercial and medical affairs team in preparation for potential product launch" ]

IDEAYA Biosciences (Nasdaq: IDYA) ha comunicato i risultati finanziari del secondo trimestre 2025 e importanti progressi nel proprio portafoglio pipeline. L'azienda mantiene una solida posizione finanziaria con 992 milioni di dollari in liquidità, sufficienti a finanziare le operazioni fino al 2029. Tra gli sviluppi chiave, il trial di Fase 2/3 della combinazione darovasertib/crizotinib nel melanoma uveale metastatico ha arruolato con successo oltre 350 pazienti e i dati mediana di PFS sono attesi entro la fine del 2025.

La società prevede tre nuove presentazioni IND entro fine 2025 e presenterà numerosi aggiornamenti clinici lungo tutto il suo portafoglio. Tra i traguardi imminenti, dati di Fase 2 da oltre 90 pazienti con melanoma uveale primario all'ESMO e dati di Fase 1 da oltre 70 pazienti con SCLC trattati con IDE849 al WCLC. I risultati finanziari mostrano spese per R&S pari a 74,2 milioni di dollari e una perdita netta di 77,5 milioni di dollari nel secondo trimestre 2025.

  • Solida posizione di cassa di 992 milioni di dollari, sufficiente a finanziare le operazioni fino al 2029
  • Trial di Fase 2/3 di darovasertib/crizotinib con oltre 350 pazienti arruolati con successo
  • Molteplici catalizzatori a breve termine con sei aggiornamenti clinici previsti entro fine anno
  • Tre nuove presentazioni IND pianificate entro fine 2025
  • Espansione del team commerciale e medico in vista di un potenziale lancio del prodotto

IDEAYA Biosciences (Nasdaq: IDYA) informó sus resultados financieros del segundo trimestre de 2025 y avances significativos en su cartera de desarrollo. La compañía mantiene una sólida posición financiera con 992 millones de dólares en efectivo, que se espera financien las operaciones hasta 2029. Entre los desarrollos clave, el ensayo de fase 2/3 de la combinación darovasertib/crizotinib en melanoma uveal metastásico ha inscrito con éxito a más de 350 pacientes, y se esperan datos medianos de PFS para finales de 2025.

La empresa planea tres nuevas presentaciones IND para finales de 2025 y presentará múltiples actualizaciones clínicas a lo largo de su cartera. Entre los hitos próximos, datos de fase 2 de más de 90 pacientes con melanoma uveal primario en ESMO y datos de fase 1 de más de 70 pacientes con SCLC tratados con IDE849 en WCLC. Los resultados financieros muestran gastos en I+D de 74,2 millones de dólares y una pérdida neta de 77,5 millones de dólares en el segundo trimestre de 2025.

  • Fuerte posición de caja de 992 millones de dólares, que se espera financie las operaciones hasta 2029
  • Ensayo de fase 2/3 de darovasertib/crizotinib con más de 350 pacientes inscritos con éxito
  • Múltiples catalizadores a corto plazo con seis actualizaciones clínicas previstas para fin de año
  • Tres nuevas presentaciones IND planeadas para finales de 2025
  • Expansión del equipo comercial y médico en preparación para un posible lanzamiento de producto

IDEAYA Biosciences (나스�: IDYA)� 2025� 2분기 재무 실적� 주요 파이프라� 진전� 보고했습니다. 회사� 9� 9,200� 달러� 현금� 보유하고 있어 2029년까지 운영 자금� 확보� 것으� 예상됩니�. 주요 개발 사항으로� 전이� 포도� 흑색종에� 다로바서티닙/크리조티� 병용 요법� 2/3� 임상 시험� 350� 이상� 환자 등록� 완료했으�, 2025� 말까지 중간 무진� 생존기간(PFS) 데이터가 발표� 예정입니�.

회사� 2025� 말까지 � 건의 IND 제출� 계획하고 있으�, 파이프라� 전반� 걸쳐 여러 임상 데이� 업데이트� 발표� 예정입니�. 주목� 만한 향후 이정표로� ESMO에서 90� 이상� 원발� 포도� 흑색� 환자 대� 2� 데이�, WCLC에서 IDE849� 치료받은 70� 이상� 소세포폐�(SCLC) 환자 대� 1� 데이터가 있습니다. 재무 결과� 2025� 2분기 연구개발비가 7,420� 달러, 순손실이 7,750� 달러임을 보여줍니�.

  • 2029년까지 운영 자금 확보가 기대되는 9� 9,200� 달러� 강력� 현금 보유
  • 다로바서티닙/크리조티� 2/3� 임상 시험에서 350� 이상 환자 성공� 등록
  • 연말까지 6건의 임상 데이� 업데이트 � 다수� 단기 촉매� 예정
  • 2025� 말까지 � 건의 신규 IND 제출 계획
  • 잠재� 제품 출시 준비를 위한 상업 � 의료팀 확장

IDEAYA Biosciences (Nasdaq : IDYA) a publié ses résultats financiers du deuxième trimestre 2025 ainsi que des avancées significatives dans son portefeuille de développement. L'entreprise dispose d'une solide position financière avec 992 millions de dollars en liquidités, suffisantes pour financer ses opérations jusqu'en 2029. Parmi les développements clés, l'essai de phase 2/3 de la combinaison darovasertib/crizotinib dans le mélanome uvéal métastatique a recruté avec succès plus de 350 patients, avec des données médianes de survie sans progression (PFS) attendues d'ici fin 2025.

La société prévoit trois nouvelles soumissions IND d'ici la fin 2025 et présentera plusieurs mises à jour cliniques sur l'ensemble de son pipeline. Parmi les jalons à venir, des données de phase 2 issues de plus de 90 patients atteints de mélanome uvéal primitif lors de l'ESMO, ainsi que des données de phase 1 de plus de 70 patients atteints de SCLC traités avec IDE849 lors du WCLC. Les résultats financiers indiquent des dépenses de R&D de 74,2 millions de dollars et une perte nette de 77,5 millions de dollars pour le deuxième trimestre 2025.

  • Position de trésorerie solide de 992 millions de dollars, suffisante pour financer les opérations jusqu'en 2029
  • Essai de phase 2/3 de darovasertib/crizotinib avec plus de 350 patients recrutés avec succès
  • Plusieurs catalyseurs à court terme avec six mises à jour cliniques attendues d'ici la fin de l'année
  • Trois nouvelles soumissions IND prévues d'ici fin 2025
  • Extension des équipes commerciales et médicales en préparation d'un lancement potentiel de produit

IDEAYA Biosciences (Nasdaq: IDYA) meldete die Finanzergebnisse für das zweite Quartal 2025 sowie bedeutende Fortschritte in der Pipeline. Das Unternehmen verfügt über eine starke finanzielle Position mit 992 Millionen US-Dollar in bar, die voraussichtlich die Geschäftstätigkeit bis 2029 finanzieren werden. Zu den wichtigen Entwicklungen zählt die Phase-2/3-Studie der Kombination Darovasertib/Crizotinib beim metastasierten Uveamelanom, bei der über 350 Patienten eingeschlossen wurden und mediane PFS-Daten bis Ende 2025 erwartet werden.

Das Unternehmen plant drei IND-Einreichungen bis Ende 2025 und wird mehrere klinische Datenupdates aus seiner Pipeline präsentieren. Bedeutende bevorstehende Meilensteine sind Phase-2-Daten von über 90 Patienten mit primärem Uveamelanom auf dem ESMO sowie Phase-1-Daten von über 70 SCLC-Patienten, die mit IDE849 auf dem WCLC behandelt wurden. Die Finanzergebnisse zeigen F&E-Ausgaben von 74,2 Millionen US-Dollar und einen Nettoverlust von 77,5 Millionen US-Dollar im zweiten Quartal 2025.

  • Starke Barreserve von 992 Millionen US-Dollar, die voraussichtlich die Geschäftstätigkeit bis 2029 finanzieren wird
  • Phase-2/3-Studie von Darovasertib/Crizotinib mit erfolgreich eingeschlossenen über 350 Patienten
  • Mehrere kurzfristige Katalysatoren mit sechs klinischen Datenupdates bis Jahresende erwartet
  • Drei neue IND-Einreichungen bis Ende 2025 geplant
  • Ausbau des Vertriebs- und medizinischen Teams zur Vorbereitung auf eine mögliche Produkteinführung
Positive
  • None.
Negative
  • Increased net loss to $77.5 million in Q2 2025 from $72.2 million in Q1 2025
  • Higher R&D expenses at $74.2 million compared to $70.9 million in previous quarter
  • Cash position decreased from $1.05 billion to $991.9 million quarter-over-quarter

Insights

IDEAYA reports strong cash position with multiple near-term catalysts across its oncology pipeline, particularly for its lead darovasertib program.

IDEAYA Biosciences is approaching several critical inflection points in the coming months that could significantly impact its valuation. The company has approximately $992 million in cash as of June 30, 2025, providing runway into 2029—an exceptionally strong financial position that gives them substantial operational flexibility.

The most immediate value driver is their darovasertib program, where topline data from a Phase 2/3 trial in first-line HLA-A2-negative metastatic uveal melanoma (MUM) is expected by year-end. This data could potentially support an accelerated approval filing with the FDA, representing IDEAYA's first commercial opportunity. With over 350 patients already enrolled out of a targeted 400, the trial is progressing well. The company is simultaneously generating supportive overall survival data in both HLA-A2-negative and positive patients, potentially broadening darovasertib's market opportunity.

Particularly noteworthy is IDEAYA's expansion into the neoadjuvant setting for primary uveal melanoma. This indication represents a significantly larger market opportunity than metastatic disease, as it targets preserving vision and preventing surgical eye removal in newly diagnosed patients. The company has already initiated a Phase 3 registration trial (OptimUM-10) with approximately 520 patients after successful FDA interactions.

Beyond darovasertib, IDEAYA's pipeline is maturing with multiple data readouts expected across programs. The IDE849 (DLL3 TOP1i ADC) program will feature first-in-human data at an upcoming lung cancer conference, while the IDE397 (MAT2A inhibitor) combination with Trodelvy in MTAP-deletion urothelial cancer will report initial data at their R&D Day. Additionally, three IND submissions are targeted before year-end, including IDE892 (PRMT5), IDE034 (B7H3/PTK7 bispecific TOP1i ADC), and IDE574 (KAT6/7).

The operating expenses have increased to $74.2M for R&D and $14.6M for G&A in Q2, with a quarterly net loss of $77.5M. This burn rate is appropriate given their extensive clinical development activities across multiple programs. The company is also building commercial infrastructure in preparation for potential darovasertib approval, with key hires in medical affairs, commercial, and market access functions.

IDEAYA's darovasertib shows promise in rare uveal melanoma with potential approval pathway, while their novel targeted therapies advance through clinical development.

IDEAYA's clinical pipeline demonstrates significant advancement in targeting rare and difficult-to-treat cancers. Their lead program, darovasertib, addresses a critical unmet need in uveal melanoma (UM)—a rare eye cancer with limited treatment options and poor prognosis once metastasized.

The upcoming readout of median progression-free survival (PFS) data from the Phase 2/3 trial of darovasertib plus crizotinib in first-line HLA-A2-negative metastatic UM could be practice-changing if positive. This combination targets the PKC and MET pathways simultaneously, which are key oncogenic drivers in UM. The trial's robust enrollment (>350 patients) suggests strong investigator interest and confidence in the mechanism.

Particularly innovative is their neoadjuvant approach in primary UM. Current standard of care for primary UM typically involves radiation (plaque brachytherapy) or surgical removal of the eye (enucleation), both associated with significant morbidity. Darovasertib's potential to preserve vision and prevent enucleation represents a paradigm shift in treatment approach. The Phase 3 OptimUM-10 trial's size (520 patients) is impressive for such a rare disease and indicates the company's commitment to this indication.

Beyond UM, IDEAYA's rational combinations deserve attention. The IDE397 (MAT2A inhibitor) plus Trodelvy combination in MTAP-deletion tumors leverages synthetic lethality principles by targeting a specific genetic vulnerability while adding the targeted cytotoxicity of an antibody-drug conjugate. This approach could provide a precision therapy option for patients with this specific deletion.

The IDE849 (DLL3 TOP1i ADC) program for small cell lung cancer targets DLL3, which is highly expressed in SCLC but minimally expressed in normal tissues, potentially offering improved efficacy and safety over current therapies. With clinical data from over 70 patients to be presented soon, this program could provide early validation of their ADC platform.

IDEAYA's pipeline breadth is notable, with multiple synthetic lethality targets (PARG, Werner Helicase, Pol Theta, PRMT5) and novel approaches like dual-targeting ADCs (B7H3/PTK7). The upcoming data releases across several programs will better define which have the most promising clinical profiles and highest probability of reaching patients.

  • 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 datafrom 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 andTrodelvy® (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 endedJune 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 plaquebrachytherapy-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 , 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 millionmilestone 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 .

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 ofJune 30, 2025, IDEAYA had cash, cash equivalents and marketable securities of approximately $991.9 million, compared to $1.05 billion as ofMarch 31, 2025.The decreasewas primarily driven by net cash used in operations.

Research and development (R&D) expenses for the three months endedJune 30, 2025 totaled$74.2Dz compared to$70.9 millionfor the three months endedMarch 31, 2025.The increase was primarily due to higher clinical trial expensesto support our clinical pipeline and personnel-related expenses.

General and administrative (G&A) expenses for the three months endedJune 30, 2025 totaled $14.6million compared to$13.5 millionfor the three months endedMarch 31, 2025. The increase was primarily due to higher personnel-related expenses to support our growth.

The net loss for the three months endedJune 30, 2025, was$77.5Dz compared to the net loss of$72.2 millionfor the three months endedMarch 31, 2025. Total stock compensation expense for the three months endedJune 30, 2025, was$11.9Dz compared to$10.2 millionfor 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 andbioinformatics 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, orADCs, 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 datedFebruary 18, 2025and 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]

IDEAYA Biosciences, Inc.


Condensed Statements of Operations and Comprehensive Loss


(in thousands, except share and per share amounts)










Three Months Ended



Six Months Ended




June 30, 2025



March 31, 2025



June 30, 2025



June 30, 2024




(Unaudited)



(Unaudited)


Operating expenses:













Research and development


$

74,226



$

70,886



$

145,112



$

97,338


General and administrative



14,580




13,503




28,083




18,606


Total operating expenses



88,806




84,389




173,195




115,944


Loss from operations



(88,806)




(84,389)




(173,195)




(115,944)


Interest income and other income,
net



11,315




12,211




23,526




23,600


Net loss



(77,491)




(72,178)




(149,669)




(92,344)


Unrealized (losses) gains on
marketable securities



(64)




773




709




(1,978)


Comprehensive loss


$

(77,555)



$

(71,405)



$

(148,960)



$

(94,322)


Net loss per share
attributable to common
stockholders, basic and diluted


$

(0.88)



$

(0.82)



$

(1.69)



$

(1.21)


Weighted-average number of shares
outstanding, basic and diluted



88,472,197




88,356,335




88,414,586




76,535,607


IDEAYA Biosciences, Inc.


Condensed Balance Sheet Data


(in thousands)










June 30,



December31,




2025



2024




(Unaudited)


Cash and cash equivalents and short-term and
long-term marketable securities


$

991,869



$

1,082,151


Total assets



1,041,270




1,124,091


Total liabilities



81,617




64,944


Total liabilities and stockholders' equity


$

1,041,270



$

1,124,091


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SOURCE IDEAYA Biosciences, Inc.

FAQ

What is IDEAYA Biosciences' (IDYA) current cash position and runway?

IDEAYA has $991.9 million in cash, cash equivalents, and marketable securities as of June 30, 2025, which is expected to fund operations into 2029.

What are the key milestones expected for IDYA's darovasertib program in 2025?

Key milestones include median PFS data from Phase 2/3 trial by year-end 2025, Phase 2 data from over 90 primary UM patients at ESMO in Q4, and median OS data from over 40 1L MUM patients in Q4 2025.

How many IND submissions does IDEAYA (IDYA) plan for 2025?

IDEAYA plans three IND submissions by year-end 2025: IDE892 (PRMT5) in mid-2025, IDE034 (B7H3/PTK7 bispecific TOP1i ADC) in Q4, and IDE574 (KAT6/7) in Q4.

What were IDEAYA's (IDYA) Q2 2025 financial results?

IDEAYA reported R&D expenses of $74.2 million, G&A expenses of $14.6 million, and a net loss of $77.5 million for Q2 2025.

How many patients are enrolled in IDYA's Phase 2/3 darovasertib trial?

Over 350 patients are enrolled as of August 4, 2025, with full enrollment of approximately 400 patients expected by year-end.
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2.13B
86.79M
0.91%
116.53%
13.4%
Biotechnology
Pharmaceutical Preparations
United States
SOUTH SAN FRANCISCO