Core Insights - IDEAYA Biosciences, Inc. reported financial results for Q4 and the full year ended December 31, 2024, highlighting significant advancements in its clinical pipeline and financial position [1][9]. Financial Performance - As of December 31, 2024, IDEAYA had approximately $1.1 billion in cash, cash equivalents, and marketable securities, an increase from $632.6 million as of December 31, 2023, primarily due to $379.9 million in net proceeds from common stock sales and $283.8 million from an underwritten public offering [9]. - Collaboration revenue for Q4 2024 was $7.0 million, up from $3.9 million in Q4 2023, driven by a milestone payment from GSK for IND clearance of IDE275 [11]. - Research and development expenses for Q4 2024 totaled $140.2 million, significantly higher than $38.8 million in Q4 2023, mainly due to a $75.0 million upfront payment for IDE849 and increased clinical trial expenses [12]. - The net loss for Q4 2024 was $130.3 million, compared to a net loss of $34.0 million in Q4 2023 [13]. Clinical Pipeline Updates - The company is targeting multiple clinical data readouts in 2025, including updates on darovasertib for neoadjuvant UM and IDE275 at major medical conferences [2][3]. - Over 230 patients have been enrolled in a registration-enabling trial for darovasertib in 1L HLA-A2-negative MUM, with a median PFS readout expected by year-end 2025 [5][7]. - IDEAYA plans to advance its IDE397 and IDE892 combination into clinical trials in the second half of 2025, following promising results in MTAP-deletion cancers [3][5]. - The company has made significant progress with the in-licensing of IDE849 and received FDA clearance for the Phase 1 trial of IDE275, with updates expected in 2025 [3][5]. Corporate Developments - IDEAYA appointed Joshua Bleharski as Chief Financial Officer and Stu Dorman as Chief Commercial Officer, both bringing extensive experience in the biopharmaceutical sector [14]. - The company is advancing three programs into IND-enabling studies, targeting IND filings for IDE892, IDE034, and IDE251 in the second half of 2025 [5][14].

Core Insights - IDEAYA Biosciences has entered into a clinical study collaboration and supply agreement with Gilead Sciences to evaluate the efficacy and safety of IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy in MTAP-deletion non-small cell lung cancer (NSCLC) [1][10] - The combination aims to target two distinct and complementary mechanisms related to MTAP-deletion in solid tumors [10] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [8] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [8] Clinical Development - IDE397 is a selective small molecule inhibitor targeting methionine adenosyltransferase 2a (MAT2A), with an estimated prevalence of MTAP-deletion at approximately 15% in NSCLC, translating to around 48,000 cases annually in the U.S. [3][10] - The ongoing Phase 1 trial is expanding to include patients with MTAP-deletion NSCLC, in addition to those with MTAP-deletion urothelial cancer [2][5] Trodelvy Overview - Trodelvy is currently approved in over 50 countries for second-line or later metastatic triple-negative breast cancer (TNBC) and in more than 40 countries for certain pre-treated HR+/HER2-metastatic breast cancer patients [4]

Company Overview - Ideaya Biosciences, Inc. (NASDAQ: IDYA) is making significant progress with its pipeline, particularly with its lead candidate darovasertib, which is currently in a potential ongoing phase 2/3 study [2] Investment Analysis - The Biotech Analysis Central service offers a comprehensive analysis of various pharmaceutical companies, including a library of over 600 biotech investing articles and a model portfolio of more than 10 small and mid-cap stocks [2]

Core Viewpoint - IDEAYA Biosciences, Inc. (IDYA) has received a Zacks Rank 2 (Buy) upgrade, indicating a positive outlook on its earnings estimates, which is a significant factor influencing stock prices [1][4]. Earnings Estimates and Ratings - The Zacks rating system is based solely on a company's changing earnings picture, tracking the Zacks Consensus Estimate for EPS from sell-side analysts [2]. - The Zacks rating upgrade reflects an improvement in IDEAYA's earnings outlook, which could lead to increased buying pressure and a rise in stock price [4][6]. Impact of Earnings Estimate Revisions - Changes in a company's future earnings potential, as indicated by earnings estimate revisions, are strongly correlated with near-term stock price movements, particularly due to institutional investors' reliance on these estimates for valuation [5]. - IDEAYA's rising earnings estimates and the subsequent rating upgrade suggest an enhancement in the company's underlying business, likely resulting in higher stock prices as investors respond positively to this trend [6]. Zacks Rank System - The Zacks Rank system classifies stocks into five groups based on earnings estimates, with a proven track record of Zacks Rank 1 stocks generating an average annual return of +25% since 1988 [8]. - IDEAYA's upgrade to Zacks Rank 2 places it in the top 20% of Zacks-covered stocks, indicating a strong potential for market-beating returns in the near term [11]. Current Earnings Estimates for IDEAYA - IDEAYA is projected to earn -$2.45 per share for the fiscal year ending December 2024, reflecting a year-over-year change of -25% [9]. - Over the past three months, the Zacks Consensus Estimate for IDEAYA has increased by 1.4%, indicating a positive trend in earnings expectations [9].

SOUTH SAN FRANCISCO, Calif., Feb. 10, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced the appointment of Joshua Bleharski, Ph.D. as Chief Financial Officer.  Dr. Bleharski joins IDEAYA from J.P. Morgan, where he spent nearly 17 years advising clients in the biopharma sector on capital markets transactions, corporate strategy and other investment banking services. IDEAYA an ...

SOUTH SAN FRANCISCO, Calif., Jan. 27, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation in the upcoming investor relations events. Oppenheimer 35th Annual Healthcare Life Sciences ConferenceTuesday, February 11th, 2025 at 1:20 PM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Matthew Biegler, Executive Director and Senior ...

Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on discovering and developing targeted therapeutics for patient populations selected using molecular diagnostics [2] - The company integrates translational biomarker identification and validation with drug discovery to select patient populations most likely to benefit from its targeted therapies [2] - IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality, an emerging class of precision medicine targets [2] Upcoming Events - IDEAYA will participate in the 43rd Annual J P Morgan Healthcare Conference on January 13, 2025, with a presentation by CEO Yujiro S Hata followed by an analyst-hosted Q&A session [5] - A live audio webcast of the presentation and Q&A session will be available on the IDEAYA website, with a replay accessible for 30 days [1] 2025 Corporate Guidance - As of September 30, 2024, IDEAYA has $1 2 billion in cash, cash equivalents, and marketable securities, which is anticipated to fund operations into at least 2028 [5] - The company plans to make 3 IND filings in 2025, representing its 7th, 8th, and 9th potential clinical stage precision medicine oncology programs targeting solid tumors [5] Pipeline Updates Darovasertib Program - Darovasertib is a potential first-in-class Phase 2/3 PKC inhibitor targeting Metastatic Uveal Melanoma (MUM) and Uveal Melanoma (UM) [5] - Median progression-free survival readout for the Phase 2/3 trial of darovasertib and crizotinib combination in first-line MUM patients is targeted by year-end 2025, with enrollment exceeding 200 patients as of January 6, 2025 [5] - Phase 2 median overall survival readout for the combination in approximately 38 first-line MUM patients is targeted in 2025 [5] - Phase 2 neoadjuvant UM clinical data update for darovasertib in over 75 patients and a regulatory update are targeted in 2025 [5] - Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for the first half of 2025 [5] IDE397 Program - IDE397 is a potential first-in-class Phase 2 MAT2A Inhibitor targeting MTAP-deletion solid tumors [5] - Clinical program updates for the Phase 1/2 study of IDE397 in combination with Trodelvy in MTAP-deletion urothelial cancer are targeted in 2025 [5] - The company aims to enable a wholly owned IDE397 + IDE892 (PRMT5) clinical combination in the second half of 2025 to target MTAP-deletion non-small cell lung cancer [5] IDE849 Program - IDE849 is a potential first-in-class Phase 1 DLL3 TOP1i ADC targeting Small Cell Lung Cancer and Neuroendocrine Tumors [5] - Clinical program updates are targeted in 2025, with updated slides provided in the JPM 2025 corporate presentation [5] IDE275 Program - IDE275 is a potential first-in-class Phase 1 Werner Helicase program targeting MSI-high solid tumors [5] - A presentation highlighting IDE275's differentiated potential best-in-class profile is targeted in the first half of 2025 in collaboration with GSK [5] IDE161 Program - IDE161 is a potential first-in-class Phase 1 PARG inhibitor targeting solid tumors [5] - Phase 1 expansion of IDE161 in combination with KEYTRUDA in MSI-high and MSS endometrial cancer is targeted in 2025 [5] - Clinical combinations of IDE161 with Topo-ADCs are also targeted in 2025 [5] IDE705 Program - IDE705 is a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor targeting homologous recombination deficiency solid tumors [5] - Phase 2 expansion in HRD solid tumors is targeted, enabling a potential $10 million milestone payment from GSK [5] IDE892 Program - IDE892 is a potential best-in-class MTA-cooperative PRMT5 inhibitor, with combination potential with IDE397, targeted for mid-year 2025 [5][6] IDE034 Program - IDE034 is a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, with combination potential with IDE161, targeted for the second half of 2025 [5][6] IDE251 Program - IDE251 is a potential first-in-class KAT6/7 dual inhibitor development candidate, with combination potential with multiple programs in IDEAYA's pipeline, targeted for the second half of 2025 [6]

Company Overview - IDEAYA Biosciences, Inc. is a precision medicine oncology company focused on discovering and developing targeted therapeutics using molecular diagnostics [12] - Jiangsu Hengrui Pharmaceuticals Co., Ltd. is an innovative global pharmaceutical company with a strong emphasis on unmet clinical needs and has invested over $5.4 billion in R&D since 2011 [4] Licensing Agreement - IDEAYA has entered into an exclusive license agreement with Hengrui Pharma for SHR-4849, a DLL3-targeting Topo-I-payload ADC program, for development and commercialization outside of Greater China [1][8] - Hengrui Pharma is eligible to receive total payments of $1.045 billion, including a $75 million upfront fee and up to $200 million in development and regulatory milestone payments [8] Clinical Development - SHR-4849 is currently in a Phase 1 clinical trial for advanced solid tumors in China, showing promising antitumor activity with an overall response rate of approximately 73% in evaluable small cell lung cancer subjects [7][11] - The drug targets DLL3, which is highly expressed in small cell lung cancer (85%) and neuroendocrine tumors (20-40%), making it a significant therapeutic target [6][11] Strategic Objectives - IDEAYA aims to file a US IND for SHR-4849 in the first half of 2025, aligning with its strategic objective to develop rational clinical combinations with its PARG inhibitor IDE161 [2][6] - The collaboration with Hengrui Pharma supports IDEAYA's goal of delivering innovative medicines globally, addressing significant unmet medical needs in DLL3-expressing solid tumors [2][6]

Independent Data Monitoring Committee (IDMC) recommends move-forward dose in Part 2a of potential registration-enabling trial in 1L HLA-A2-Negative MUM, based on clinical efficacy and safety observed Over 185 patients enrolled in potential registration-enabling trial in 1L HLA-A2-Negative MUM, and the darovasertib and crizotinib combination has received U.S. Food and Drug Administration (FDA) Fast Track designation in MUM SAN FRANCISCO, Dec. 17, 2024 /PRNewswire/ -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA) ...

Development Candidate IDE251 - IDE251 is a potential first-in-class KAT6/7 dual inhibitor, designed to selectively target both KAT6 and KAT7 while sparing other structurally similar KAT family members [1][3] - The molecule demonstrates robust and durable monotherapy anti-tumor activity in preclinical models, particularly in biomarker-positive breast and lung cancer xenografts with 8p11 amplification [1][3] - IDE251 is targeted for evaluation in breast cancer and squamous non-small cell lung cancer (NSCLC) with 8p11 amplification, which occurs in approximately 15% of breast cancer patients and up to 17.5% in squamous NSCLC [1][2][4] Preclinical and Clinical Development - IND-enabling studies for IDE251 are progressing as planned, with the company targeting an Investigational New Drug (IND) submission to the FDA in 2025 [5] - The preclinical profile of IDE251 suggests an enriched response in 8p11 amplified cancers, with dual KAT6/7 inhibition showing superior anti-tumor activity compared to KAT6 inhibition alone [3][4] - IDE251 is being developed as a monotherapy for patients with breast and lung cancers with 8p11 amplification, with additional opportunities in lineage addiction settings [4] Company Overview - IDEAYA Biosciences is a precision medicine oncology company focused on the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics [6] - The company integrates translational biomarker identification and validation with drug discovery to select patient populations most likely to benefit from its targeted therapies [6] - IDEAYA is applying its research and drug discovery capabilities to synthetic lethality, an emerging class of precision medicine targets [6]