Core Insights - IDEAYA Biosciences has received FDA clearance for an IND application to initiate a Phase 1 clinical trial for IDE034, a bispecific B7H3/PTK7 TOP1 antibody-drug conjugate, expected to start patient enrollment in Q1 2026 [1][2] - The drug targets solid tumors expressing B7H3 and PTK7, with co-expression rates in lung, colorectal, and head and neck cancers reported at approximately 30%, 46%, and 27% respectively [1][5] - IDE034 has shown strong anti-tumor activity in preclinical studies, supporting its advancement into clinical development [3][5] Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, aiming to develop targeted therapies that are aligned with the genetic drivers of cancer [4] - The company has a robust pipeline of product candidates, particularly in synthetic lethality and antibody-drug conjugates for molecularly defined solid tumor indications [4] Clinical Development Strategy - The company is advancing a differentiated clinical strategy with three potentially first-in-class clinical-stage programs aimed at enhancing the efficacy of TOP1 ADCs through a PARG DDR combination mechanism [2][3] - Preclinical studies suggest that combining IDE034 with IDE161, a PARG inhibitor, may enhance anti-tumor activity in patients with solid tumors co-expressing B7H3 and PTK7 [3][5]

Group 1 - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share [1] - The current stock valuation of Ideaya Biosciences is $35 per share, indicating significant appreciation since its IPO [1] - The investing group Haggerston BioHealth, led by biotech consultant Edmund Ingham, provides insights and analysis on over 1,000 companies in the biotech, healthcare, and pharma sectors [1] Group 2 - Haggerston BioHealth offers catalysts for investors to monitor, along with buy and sell ratings, product sales forecasts, and integrated financial statements [1] - The group also conducts discounted cash flow analysis and market-by-market analysis for major pharmaceutical companies [1]

Core Insights - Ideaya Biosciences, Inc. (IDYA) is a precision medicine oncology company that went public in May 2019, raising $57.5 million by issuing 5.75 million shares at $10 per share, with the current stock valued at $35 per share [1] Group 1 - Ideaya Biosciences focuses on precision medicine within the oncology sector [1] - The company has been supported by a biotech consultant with over 5 years of experience in the biotech, healthcare, and pharma industries [1] - The investing group Haggerston BioHealth provides insights and forecasts for major pharmaceutical companies, including product sales and integrated financial statements [1]

Core Insights - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events, showcasing its commitment to engaging with investors and stakeholders in the healthcare sector [1][5]. Company Overview - IDEAYA is a precision medicine oncology company focused on discovering, developing, and commercializing transformative cancer therapies. The company integrates expertise in small-molecule drug discovery, structural biology, and bioinformatics to create targeted therapies aligned with genetic disease drivers [2]. Upcoming Events - The company will participate in Citi's 2025 Global Healthcare Conference on December 2, 2025, at 9:00 AM ET, featuring a fireside chat with CEO Yujiro S. Hata [1]. - IDEAYA will also be present at the 8th Annual Evercore Healthcare Conference on December 3, 2025, at 10:50 AM ET, with another fireside chat led by CEO Yujiro S. Hata [1]. Communication Channels - A live audio webcast of the conference events will be available on the IDEAYA website, and a replay will be accessible for 30 days post-event [1].

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Industry**: Precision medicine oncology - **Lead Program**: Darovasertib, currently in a registrational trial for frontline metastatic uveal melanoma, with an expected median progression-free survival (PFS) readout by year-end 2025 to Q1 2026 [2][4] Key Clinical Programs - **Pipeline**: IDEAYA has a deep pipeline with eight clinical stage programs, targeting nine by year-end 2025 [2] - **MTAP Deletion Focus**: - ID397 (Phase 2 MAT2A inhibitor) - ID892 (Phase 1 MTAP-cooperative PRMT5 inhibitor) [3] - **Antibody-Drug Conjugates (ADC)**: - DLL3 topo ADC with recent presentations at major conferences - Bispecific B7H3 PTK7 ADC (Phase 1) - ID161 (PARG inhibitor) [3] Upcoming Data and Expectations - **PFS Events**: Approximately 130 PFS events are needed for top-line results, with expectations for results in early 2026 [4] - **Control Arm Expectations**: Anticipated PFS in the control arm is 2-3 months, while treatment arm results have shown consistent 7-month PFS [5][6] - **Overall Survival (OS) Data**: OS data from the Society of Melanoma Research (SMR) indicated potential for median OS to increase to 22 months, pending further patient follow-up [13] Regulatory and Market Considerations - **NDA Submission**: Plans for a pre-NDA meeting with the FDA are anticipated as PFS results are finalized [12] - **Pricing Strategy**: Expected pricing in the low $50,000s per month, with considerations for the robustness of the dataset and unmet medical needs in the market [14] - **Compendia Strategy**: Plans to submit HLA-A*02 positive data for potential inclusion in the label, which would enhance promotional capabilities [18][20] Neoadjuvant and Adjuvant Studies - **Neoadjuvant Study**: Enrollment is expected to accelerate with increased site activation, aiming for completion in approximately five quarters [21] - **Adjuvant Program**: Planning to start a phase three adjuvant study in collaboration with Servier, targeting 400-450 patients [26] ADC Programs and Future Directions - **DLL3 ADC**: Positive data supports a potential path for accelerated approval in small cell lung cancer and neuroendocrine tumors [28] - **Combination Studies**: Plans to explore combinations with standard care agents to enhance treatment durability [34] Additional Pipeline Developments - **MAT2A Program**: Updates on Trodalvy combo data in urothelial carcinoma expected in the first half of 2026 [39] - **CAT67 Program**: IND filing planned by year-end 2025, focusing on dual inhibition of CAT6 and CAT7 [45] Conclusion - **Key Catalysts**: Investors should focus on upcoming PFS results, NDA submission timelines, and ongoing clinical trials across various programs through 2026 [48]

Core Insights - The event features a virtual fireside chat with Yujiro Hata, CEO of IDEAYA, hosted by Yigal Nochomovitz, a biotech analyst at Citigroup [1][2] Group 1 - The discussion is part of a series aimed at engaging with C-suite executives in the biotech industry [1] - Participants are encouraged to submit questions for the CEO during the conversation [2]

Summary of IDEAYA Biosciences Conference Call Company Overview - **Company**: IDEAYA Biosciences (NasdaqGS:IDYA) - **Date**: November 06, 2025 - **Context**: Discussion led by CEO Yujiro Hata regarding recent developments in the company's pipeline and strategic direction. Key Industry and Company Insights Pipeline Developments - IDEAYA reported one of its most productive quarters since its founding, with significant updates presented at major medical conferences, including the World Conference on Lung Cancer and ESMO [3][4] - The lead program is nearing randomized progression-free survival (PFS) results, with expectations for an accelerated approval filing in the U.S. by year-end or early next year [3][4] - Enrollment for clinical trials is progressing well, with full enrollment expected soon for both overall survival (OS) and randomized OS studies [4] Uveal Melanoma Focus - IDEAYA aims for darovasertib to become the standard of care across the uveal melanoma patient journey, with plans for a phase three randomized study in the adjuvant setting in the first half of next year [7][9] - The annual incidence of metastatic uveal melanoma is estimated at 4,000-5,000 patients, with potential for higher numbers in neoadjuvant and adjuvant settings [7][8] - The company has received Breakthrough Therapy Designation from the FDA based on promising data from clinical cohorts [10] Clinical Trial Data and Expectations - In the enucleation cohort, the eye preservation rate exceeded the 10% threshold required for full approval, indicating strong efficacy [10][11] - The plaque therapy cohort showed a median vision improvement of 14 letters, significantly higher than previous reports [11] - The company anticipates that the first data from the enucleation cohort will be available in approximately five quarters, with visual acuity results expected 18 months after the last patient is enrolled [19][20] MTAP Deletion Market - IDEAYA is focusing on MTAP deletion across multiple tumor types, prioritizing lung cancer, urothelial cancer, and pancreatic ductal adenocarcinoma (PDAC) [35] - The confirmed response rate for ID 397 in monotherapy is in the 25-30% range, with combination therapy showing a response rate of approximately 50% [37][38] - The company is exploring co-alterations in MTAP, particularly with RAS and CDK N2A, to enhance treatment efficacy [50][51] DLL3 Asset Development - IDEAYA's DLL3 ADC has shown a confirmed response rate of 70% in the second-line setting, with a PFS of approximately 6.7 months [55] - The company is considering a monotherapy accelerated approval path, which could provide a competitive advantage over other companies requiring comparator arms [57] Other Assets and Future Directions - IDEAYA is advancing several other assets, including poltheta partnered with GSK, and a bispecific ADC targeting B7H3 and PTK7, which has shown promising preclinical results [63][64] - The company is leveraging machine learning to enhance drug discovery efficiency, aiming for a 30% acceleration in time to IND [73][74] Additional Important Points - The collaboration with the FDA has been positive, allowing for adjustments in trial design that reduce patient enrollment numbers without compromising study integrity [24] - The company is focused on building a world-class precision oncology portfolio and is actively seeking partnerships to advance its pipeline [66] This summary encapsulates the key points discussed during the conference call, highlighting IDEAYA Biosciences' strategic focus, pipeline advancements, and market opportunities.

Financial Performance - Total revenue for the three months ended September 30, 2025, was $207.834 million, compared to $0 for the same period in 2024[17] - Net income for the three months ended September 30, 2025, was $119.244 million, compared to a net loss of $51.821 million in the same period of 2024[17] - For the nine months ended September 30, 2025, the net loss was $30.4 million, compared to a net loss of $144.2 million for the same period in 2024[26] - Net income attributable to common stockholders for Q3 2025 was $119,244,000, compared to a loss of $51,821,000 in Q3 2024[162] - Basic net income per share for Q3 2025 was $1.35, while in Q3 2024 it was $(0.60)[162] Revenue and Collaboration - The company reported collaboration revenue of $207.834 million for the three months ended September 30, 2025[17] - The Company recognized $207.8 million in collaboration revenue related to the Servier License Agreement for the three and nine months ended September 30, 2025[141] - The remaining performance obligation under the Servier License Agreement was $143.1 million as of September 30, 2025, with $32.4 million expected to be satisfied over the next 12 months[146] - The Company has the potential to earn up to $475.0 million in commercial milestones from GSK upon commercialization of Pol Theta and Werner Helicase products[109][114] - The Company has the potential to achieve additional late-stage development and regulatory milestones of up to $465 million under the GSK Collaboration Agreement[156] Expenses and Costs - Research and development expenses for the nine months ended September 30, 2025, were $228.105 million, an increase of 47.5% from $154.490 million in 2024[17] - Operating expenses for the three months ended September 30, 2025, totaled $99.382 million, compared to $66.893 million in the same period of 2024[17] - Total research and development expenses for Q3 2025 were $82,993,000, an increase from $57,152,000 in Q3 2024, representing a 45% increase[166] - Stock-based compensation increased to $34.3 million for the nine months ended September 30, 2025, compared to $25.3 million for the same period in 2024[26] - Total stock-based compensation expense for the nine months ended September 30, 2025, was $34.3 million, compared to $25.3 million for the same period in 2024, a 35.7% increase[97] Assets and Cash Position - Total assets as of September 30, 2025, were $1.185 billion, an increase from $1.124 billion as of December 31, 2024[15] - Cash and cash equivalents increased to $298.927 million as of September 30, 2025, from $84.378 million as of December 31, 2024[15] - The company had cash, cash equivalents, and marketable securities of approximately $1.14 billion as of September 30, 2025[232] - The company had cash, cash equivalents, and marketable securities of approximately $1.14 billion as of September 30, 2025, which is expected to fund operations for at least 12 months[35] Liabilities and Deficits - The company had an accumulated deficit of $653.3 million as of September 30, 2025[33] - Accrued liabilities increased to $45.258 million as of September 30, 2025, compared to $30.352 million as of December 31, 2024, with significant increases in accrued research and development expenses from $19.956 million to $32.878 million[68] Stock and Shares - The weighted-average common shares outstanding, basic, for the three months ended September 30, 2025, were 88,526,781, compared to 86,188,510 for the same period in 2024[17] - As of September 30, 2025, the company had reserved a total of 19,174,198 shares of common stock for future issuance, an increase from 13,027,922 shares as of December 31, 2024[85] - The number of shares available for issuance under the 2023 Inducement Plan was 1,426,467 as of September 30, 2025, following amendments that increased the number of shares available[88] Regulatory and Market Risks - The Company operates in a highly competitive biotechnology industry and faces risks such as dependence on key personnel and the need for additional financing[40] - The Company is subject to regulatory approvals from the FDA and other agencies before commercial sales can occur, impacting the timeline for revenue generation[41] - Significant funds are required for research, development, and clinical testing of product candidates, with the Company unable to fully fund these efforts with current financial resources[43] Future Commitments and Agreements - The Company entered into a lease agreement for approximately 44,000 square feet of laboratory and office facilities, with a lease term of 120 months starting in August 2024[69] - Future minimum lease payments under operating leases total $46.455 million as of September 30, 2025, with total operating lease liabilities of $27.245 million after deducting imputed interest[72] - The Company is currently evaluating the impact of new accounting pronouncements, including ASU 2023-06 and ASU 2023-09, on its financial disclosures[50][51]

Financial Performance - IDEAYA reported collaboration revenue of $207.8 million for Q3 2025, compared to zero in Q2 2025, primarily due to the Servier license agreement[13] - The net income for Q3 2025 was $119.2 million, a significant improvement from a net loss of $77.5 million in Q2 2025[16] - Collaboration revenue for the three months ended September 30, 2025, was $207.834 million, with total revenue matching this figure[23] - Net income for the three months ended September 30, 2025, was $119.244 million, compared to a net loss of $77.491 million in the previous quarter[23] - Comprehensive income for the three months ended September 30, 2025, was $119.775 million, contrasting with a comprehensive loss of $77.555 million in the previous quarter[23] - The company reported a net income per share attributable to common stockholders of $1.35 for the three months ended September 30, 2025[23] Cash and Assets - As of September 30, 2025, IDEAYA had approximately $1.14 billion in cash, cash equivalents, and marketable securities, up from $991.9 million as of June 30, 2025[12] - Cash and cash equivalents, along with marketable securities, totaled $1.136 billion as of September 30, 2025, up from $1.082 billion at the end of 2024[25] - Total assets increased to $1.185 billion as of September 30, 2025, compared to $1.124 billion at the end of 2024[25] - Total liabilities rose to $93.102 million as of September 30, 2025, from $64.944 million at the end of 2024[25] Expenses - Research and development expenses for Q3 2025 totaled $83.0 million, an increase from $74.2 million in Q2 2025, driven by higher clinical trial costs[14] - General and administrative expenses for Q3 2025 were $16.4 million, up from $14.6 million in Q2 2025, mainly due to increased legal and commercial preparation expenses[15] - Research and development expenses for the same period were $82.993 million, an increase from $74.226 million in the previous quarter[23] Clinical Development - IDEAYA completed its third IND filing in 2025, further extending its leadership in precision medicine oncology[3] - The Phase 2/3 trial of darovasertib/crizotinib in metastatic uveal melanoma is on track to report median progression-free survival data by year-end 2025 to Q1 2026[5] - The company reported a median overall survival of 21.1 months and a median progression-free survival of 7.0 months in the Phase 2 trial of darovasertib[6] - IDEAYA plans to initiate a global Phase 3 trial of darovasertib and crizotinib as an adjuvant therapy for primary uveal melanoma in the first half of 2026[8] Licensing and Collaboration - IDEAYA entered into an exclusive license agreement with Servier for darovasertib outside the U.S., receiving an upfront payment of $210 million and potential milestone payments of up to $320 million[11] Risks and Uncertainties - IDEAYA's forward-looking statements highlight potential risks and uncertainties in drug development and regulatory processes[19]

Core Insights - IDEAYA Biosciences reported significant progress in its pipeline and business operations, including a partnership with Servier that extends its runway into 2030 and enables potential commercialization of darovasertib outside the U.S. [2] Pipeline Developments - The Phase 2/3 trial (OptimUM-02) of darovasertib/crizotinib in metastatic uveal melanoma is on track to report median progression-free survival (PFS) data by year-end 2025 to Q1 2026, with enrollment expected to be completed by year-end [4][5] - The single-arm Phase 2 trial (OptimUM-01) reported a median overall survival (OS) of 21.1 months and a median PFS of 7.0 months, with a confirmed overall response rate (ORR) of 34% [5] - IDEAYA has initiated a randomized Phase 3 trial (OptimUM-10) for darovasertib as a neoadjuvant therapy in primary uveal melanoma, targeting approximately 450 patients [8] Financial Highlights - As of September 30, 2025, IDEAYA had approximately $1.14 billion in cash, cash equivalents, and marketable securities, an increase from $991.9 million as of June 30, 2025, primarily due to a $210 million upfront payment from Servier [11] - Collaboration revenue for Q3 2025 totaled $207.8 million, compared to zero in the previous quarter, driven by the Servier license agreement [11] - The net income for Q3 2025 was $119.2 million, a significant improvement from a net loss of $77.5 million in Q2 2025 [14] License Agreement with Servier - IDEAYA entered into an exclusive license agreement with Servier for darovasertib outside the U.S., receiving an upfront payment of $210 million and being eligible for up to $320 million in milestone payments [10] Research and Development Expenses - R&D expenses for Q3 2025 totaled $83.0 million, an increase from $74.2 million in Q2 2025, primarily due to higher clinical trial and manufacturing expenses [12] General and Administrative Expenses - G&A expenses for Q3 2025 were $16.4 million, up from $14.6 million in Q2 2025, mainly due to increased legal and commercial preparation expenses [13]