Core Insights - IDEAYA Biosciences has initiated a Phase 1/2 expansion clinical trial for IDE397, a potential first-in-class MAT2A inhibitor, in combination with Gilead's Trodelvy for treating MTAP-deletion urothelial cancer based on preliminary safety and efficacy data [1][10]. Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, aiming to discover and develop targeted therapeutics using molecular diagnostics to identify patient populations that would benefit most from its therapies [8]. Clinical Development - The combination of IDE397 and Trodelvy is being explored due to the high unmet medical need in MTAP-deletion urothelial cancer, where no approved therapies currently exist [3]. - The prevalence of MTAP-deletion in urothelial cancer is estimated to be around 26% [2][10]. - A clinical program update regarding the IDE397 and Trodelvy combination is expected in 2025, alongside other studies for IDE397 as a monotherapy in MTAP-deletion non-small cell lung cancer (NSCLC) and urothelial cancer [5]. Collaboration and Rights - IDEAYA and Gilead retain commercial rights to their respective compounds under a clinical study collaboration and supply agreement, with IDEAYA acting as the study sponsor [6].

Recently, I got a complaint from a frustrated reader who pointed out that since my bullish December coverage of Ideaya Biosciences, Inc. (NASDAQ: IDYA ), the stock has gone down relentlessly and is now down ~50%. A numberAbout the TPT serviceThanks for reading. At the Total Pharma Tracker, we offer the following:-Our Android app and website features a set of tools for DIY investors, including a work-in-progress software where you can enter any ticker and get extensive curated research material. For investor ...

SOUTH SAN FRANCISCO, Calif., April 1, 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. 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 ca ...

SOUTH SAN FRANCISCO, Calif., March 31, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, today announced that the U.S. Food and Drug Administration (FDA) has granted Breakthrough Therapy designation (BTD) for darovasertib, a potential first-in-class protein kinase C (PKC) inhibitor, for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has bee ...

Core Insights - IDEAYA Biosciences announced the publication of abstracts for presentations on IDE275 (GSK959) at the AACR Annual Meeting, highlighting its potential as a best-in-class Werner Helicase inhibitor for treating high microsatellite instability (MSI-H) solid tumors [1][2][3] Company Overview - IDEAYA Biosciences is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [9] - The company collaborates with GSK, which is responsible for 80% of the global research and development costs for IDE275 (GSK959) [4] Product Development - IDE275 (GSK959) has shown selective preclinical efficacy in MSI-H solid tumors, with significant prevalence rates of approximately 31% in endometrial, 20% in colorectal, and 19% in gastric cancers [3][7] - The drug is currently in a Phase 1 dose escalation trial in partnership with GSK, with the potential for further clinical development as both a monotherapy and in combination with PD1 inhibitors [2][7] Financial Aspects - IDEAYA could earn a $10 million milestone payment upon the initiation of Phase 1 clinical dose expansion and is eligible for up to $465 million in future milestone payments [4] - Upon commercialization, IDEAYA stands to receive up to $475 million in commercial milestones, 50% of U.S. net profits, and tiered royalties on global non-U.S. net sales of IDE275 [4] Upcoming Presentations - At the AACR 2025, IDEAYA will present a total of 8 presentations across various programs, including 4 focused on IDE275 (GSK959) [5][7]

Core Insights - IDEAYA Biosciences has announced a research collaboration with ATTMOS to develop a physics-based computational small molecule discovery platform targeting undruggable oncology targets [1][2] - The partnership aims to integrate IDEAYA's structural biology and drug discovery capabilities with ATTMOS's computational chemistry and software development expertise [2][3] - The collaboration will utilize the Amber molecular dynamics suite for free energy simulations and aims to enhance the efficiency of drug discovery for novel oncology therapeutics [4] Company Overview - IDEAYA Biosciences focuses on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [5] - The company is committed to identifying and validating translational biomarkers to select patient populations that will benefit from its therapies [5] ATTMOS Overview - ATTMOS was founded in early 2022 by a team of academics from Michigan State, Rutgers, and UC San Diego [6] - The company's mission is to integrate novel technologies into the drug discovery process, making them affordable and accessible [6]

Clinical Development Pipeline - The company has a clinical pipeline with six potential first-in-class product candidates, including darovasertib, IDE397, and IDE849, with all commercial rights owned or controlled outside of Greater China for IDE849[21]. - As of February 7, 2025, over 230 patients have been enrolled in the Phase 2/3 clinical trial for darovasertib, targeting a median progression-free survival readout by year-end 2025[25]. - The IDE397 program is being evaluated in a Phase 1/2 clinical trial, with preliminary clinical efficacy demonstrated in heavily pre-treated MTAP-deletion patients[28]. - The company is targeting IND filings for several development candidates, including IDE892 and IDE034, in the second half of 2025[21]. - The company plans to initiate a neoadjuvant UM trial with approximately 400 patients randomized for treatment in the first half of 2025[25]. - The IDE705 program is in Phase 1 dose escalation, targeting solid tumors with BRCA or other HRD mutations, in collaboration with GSK[31]. - The company aims to enable a clinical combination of IDE397 and IDE892 in the second half of 2025 for MTAP-deletion NSCLC[28]. - The company is targeting a clinical data update for darovasertib in over 75 patients in the first half of 2025, including vision data in plaque brachytherapy patients[25]. - IDE849 is currently in a Phase 1 trial in China for small cell lung cancer, with 8 out of 11 evaluable patients achieving partial response[32]. - A U.S. IND submission for IDE849 as a monotherapy in SCLC is planned for the first half of 2025, with a combination evaluation targeted for the second half of 2025[32]. - GSK initiated a Phase 1 clinical trial for IDE275 (GSK959) in October 2024, with a milestone payment of $7.0 million received for IND clearance[32]. - IDE161 is progressing in a Phase 1/2 clinical trial, with an initial expansion dose selected for endometrial cancer and a Phase 1 expansion targeted for 2025[32]. - The company received Fast Track Designations from the FDA for IDE161 in September 2023 for specific advanced cancer treatments[32]. - IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, is targeted for IND submission in mid-2025[36]. - The company has selected IDE034 as a development candidate, with a potential IND submission targeted for the second half of 2025[36]. - Darovasertib (IDE196) has enrolled over 230 patients in a Phase 2/3 trial, with a median overall survival readout targeted for 2025[40]. - The Phase 2 portion of the clinical trial for darovasertib will randomize approximately 230 patients on a 2:1 basis for treatment with darovasertib and crizotinib or control[52]. - The primary endpoint for the Phase 2 trial is median progression-free survival (PFS), with a goal of supporting potential accelerated approval based on efficacy data from approximately 200 patients[52]. - The FDA has granted darovasertib Orphan Drug designation for uveal melanoma (UM) and Fast Track designation for the development program in metastatic uveal melanoma (MUM)[59][60]. - The Phase 2 clinical trial for darovasertib in neoadjuvant UM is projected to enroll approximately 400 patients, with primary endpoints focused on time to vision loss and eye preservation rate[65][66]. - The company has expanded its relationship with Pfizer to support the Phase 2/3 registrational trial, with Pfizer providing crizotinib at no cost for a defined quantity[55]. - The Phase 2 clinical trial for darovasertib as neoadjuvant therapy has enrolled 95 patients as of December 31, 2024, with ongoing enrollment across multiple clinical sites[62]. - The favorable adverse event profile at the 30 mg QD dose of IDE397 showed only 5.6% of patients experienced Grade 3 or higher drug-related adverse events[73]. - The company anticipates initiating the registrational trial for neoadjuvant UM in the first half of 2025, with a targeted move-forward dose of 300 mg BID for darovasertib[67]. - In the Phase 1 expansion data for IDE397, an overall response rate of approximately 33% was reported among 27 evaluable MTAP-deletion patients, with a disease control rate of 93%[74]. - For MTAP-deletion UC patients, the confirmed overall response rate was 40%, while for squamous NSCLC patients it was approximately 38%, and for adenocarcinoma NSCLC patients it was approximately 22%[74]. - The ctDNA minimal response rate was 81%, with 17 of 21 reportable patients showing a 50% or greater ctDNA reduction, and 33% showing a deep 90% or greater ctDNA reduction[74]. - Approximately 18% of patients experienced a Grade 3 or higher drug-related adverse event at the 30 mg QD dose, with no drug-related serious adverse events observed[75]. - The collaboration with Gilead aims to evaluate IDE397 in combination with Trodelvy for MTAP-deletion UC patients, with the first patient dosed in June 2024[76][77]. - The IDE849 program, licensed from Hengrui Pharma, has shown an overall response rate of approximately 73% in SCLC patients, with 8 partial responses observed among 11 evaluable subjects[86]. - IDE161, a PARG inhibitor, is being evaluated in a Phase 1/2 clinical trial for tumors with homologous recombination deficiency, with a focus on endometrial cancer[96][101]. - The IDE161 development program has received Fast Track Designation from the FDA for advanced ovarian and breast cancer patients with BRCA mutations[98][99]. - The company is targeting a Phase 1 expansion for IDE161 in MSI-High and MSS endometrial cancer in 2025[101]. Collaborations and Partnerships - The company has established collaborations with leading pharmaceutical companies, including Pfizer and Gilead, to support clinical development activities[21]. - An exclusive license agreement with Hengrui Pharma for IDE849 includes potential payments totaling $1.045 billion, with a $75 million upfront fee and milestone payments[28]. - The company has expanded its relationship with Pfizer to support the Phase 2/3 registrational trial, with Pfizer providing crizotinib at no cost for a defined quantity[55]. - The company has established strategic partnerships for clinical evaluations, including an exclusive license agreement with Novartis for darovasertib and collaborations with Gilead and Merck for IDE397 and IDE161, respectively[161]. - The company has entered into strategic collaborations with Hengrui Pharma for IDE849 and Biocytogen for IDE034, focusing on selective evaluations of partnerships for targeted product candidates[139]. - The company has formed joint development committees with Pfizer and Gilead to coordinate regulatory and other activities under their respective agreements[168][180]. - The company will bear all internal and external costs associated with the conduct of the combination studies with Gilead and Amgen[179][180]. - The company has a license agreement with Novartis for darovasertib, which includes an upfront payment of $2.5 million and potential milestone payments totaling up to $29 million[176]. - The company entered into a collaboration agreement with GSK, receiving $100 million upfront and being eligible for up to $485 million in development and regulatory milestones for Pol Theta products[192][194]. - The company has the potential to achieve an additional $10.0 million development milestone upon initiation of Phase 1 clinical dose expansion, with further aggregate late-stage development and regulatory milestones of up to $465.0 million[197]. - Under the GSK Collaboration Agreement, the company is eligible to receive total development milestones of up to $485.0 million for each WRN product, along with up to $475.0 million in commercial milestones[199]. - In October 2023, the company earned a $3.0 million milestone from GSK for IND-enabling studies and a $7.0 million milestone for IND clearance of IDE275, with potential for an additional $10.0 million milestone[200]. - The Biocytogen Option and License Agreement includes total potential milestone payments of $400.0 million, with development and regulatory milestones of up to $100.0 million[206]. - The Hengrui Pharma License Agreement includes upfront and milestone payments totaling $1.045 billion, with a $75.0 million upfront fee and up to $200.0 million in development and regulatory milestones[209]. Financial and Regulatory Milestones - The company incurred an obligation to pay milestone payments totaling £750,000 to CRT for achieving specific milestones in the Phase 1 clinical trial of IDE161-001[104]. - The company has the potential to earn up to $10.0 million in milestone payments upon the initiation of Phase 1 clinical dose expansion, with a recent achievement of a $7.0 million milestone based on FDA IND acceptance[111]. - The company is eligible to receive up to $475.0 million in commercial milestones and tiered royalties on global net sales of GSK101, ranging from high single-digit to sub-teen double-digit percentages[112]. - The company is obligated to make milestone payments totaling up to £19.5 million to CRT based on specific development events for PARG inhibitors[188]. Market Position and Competition - The company faces substantial competition from major pharmaceutical and biotechnology companies, with many competitors having significantly greater financial and technical resources[140]. - For darovasertib, the company is not aware of other companies developing clinical-stage therapeutics directed to PKC as a target for solid tumors, indicating a unique position in this area[142]. Intellectual Property - The patent portfolio includes approximately 59 distinct patent families, with 18 issued U.S. patents and 35 pending U.S. applications, protecting technology across the pipeline[154]. - As of January 26, 2025, the PKC program includes approximately six issued U.S. patents and 33 issued foreign patents, with expiration dates ranging from 2035 to 2045[155]. - The MAT2A program has approximately four issued U.S. patents and 50 pending foreign applications, with expiration dates between 2039 and 2044[157]. Research and Development Strategy - The company has established a robust precision medicine research platform, integrating drug discovery with biomarker identification to develop targeted therapies[125]. - The company has established collaborative relationships for access to proprietary databases and genetic screening services, supporting its research and development activities[164]. - The company has various agreements with service providers for research and development activities, including chemistry, compound synthesis, and clinical trial support[165]. - The company plans to selectively evaluate strategic collaborations with biopharmaceutical partners to accelerate development timelines and maximize commercial potential[166]. - In May 2023, the company entered into Amendment No. 4 to the Pfizer Agreement for the supply of crizotinib in support of a Phase 2 clinical trial, with Pfizer providing additional crizotinib at no cost[170]. Manufacturing and Commercialization - The company plans to build its own sales force to commercialize approved medicines in the U.S. and potentially in Europe and other selected countries[212]. - The company currently relies on third parties for the manufacture of product candidates and biomarker diagnostics, with plans to establish agreements with contract manufacturing organizations[213]. - The company intends to retain significant rights in key markets for its products, including worldwide commercialization rights for darovasertib, IDE397, and IDE161[211]. - The GSK Collaboration Agreement will continue until the expiration of payment obligations for each product in each country, unless terminated earlier by either party[203]. - The company has the right to terminate the Biocytogen Option and License Agreement for any reason upon ninety days written notice[207].

Core Viewpoint - IDEAYA Biosciences, Inc. (IDYA) has experienced significant selling pressure, resulting in an 8.6% decline in stock price over the past four weeks, but analysts anticipate improved earnings in the near future [1] Group 1: Stock Performance and Technical Indicators - IDYA's stock is currently in oversold territory, indicated by a Relative Strength Index (RSI) reading of 29.84, suggesting a potential trend reversal [5] - The RSI is a momentum oscillator that helps identify whether a stock is oversold, typically when the reading falls below 30 [2][3] Group 2: Earnings Estimates and Analyst Sentiment - Over the last 30 days, the consensus EPS estimate for IDYA has increased by 1.3%, reflecting a positive trend in earnings estimate revisions [6] - A Zacks Rank of 2 (Buy) places IDYA in the top 20% of over 4,000 ranked stocks, indicating strong potential for a turnaround based on earnings estimate trends [7]

Core Viewpoint - IDEAYA Biosciences reported a quarterly loss of $1.49 per share, significantly worse than the Zacks Consensus Estimate of a loss of $0.67, marking an earnings surprise of -122.39% [1] Financial Performance - The company posted revenues of $7 million for the quarter ended December 2024, which aligns with the Zacks Consensus Estimate and represents an increase from $3.92 million in the same quarter last year [2] - Over the last four quarters, IDEAYA has only surpassed consensus EPS estimates once and has not beaten consensus revenue estimates during this period [2] Stock Performance - IDEAYA shares have declined approximately 14.6% since the beginning of the year, contrasting with the S&P 500's gain of 2.9% [3] - The company's near-term stock movements will largely depend on management's commentary during the earnings call [3] Future Outlook - The current consensus EPS estimate for the upcoming quarter is -$0.72 on revenues of $8.38 million, and for the current fiscal year, it is -$2.80 on revenues of $25.94 million [7] - The estimate revisions trend for IDEAYA is currently favorable, resulting in a Zacks Rank 2 (Buy), indicating expected outperformance in the near future [6] Industry Context - The Medical - Biomedical and Genetics industry, to which IDEAYA belongs, is currently ranked in the top 27% of over 250 Zacks industries, suggesting a positive outlook for stocks within this sector [8]

Financial Performance - As of December 31, 2024, IDEAYA had approximately $1.1 billion in cash, cash equivalents, and marketable securities, up from $632.6 million as of December 31, 2023, primarily due to $379.9 million in net proceeds from common stock sales[11]. - The net loss for Q4 2024 was $130.3 million, compared to a net loss of $34.0 million in Q4 2023, with total stock compensation expense rising to $9.5 million from $4.8 million[16]. - For the full year 2024, the net loss was $274.5 million, compared to $113.0 million in 2023, with total stock compensation expense increasing to $34.7 million from $18.5 million[17]. - Total operating expenses for Q4 2024 were $151,138,000, up from $45,838,000 in Q4 2023, indicating a significant increase of approximately 229.5%[23]. - Net loss for Q4 2024 was $130,312,000, compared to a net loss of $33,955,000 in Q4 2023, reflecting an increase in losses of approximately 284.5%[23]. - The comprehensive loss for Q4 2024 was $133,336,000, compared to $32,643,000 in Q4 2023, representing an increase of approximately 308%[23]. - Total assets increased to $1,124,091,000 in 2024 from $649,316,000 in 2023, representing a growth of approximately 73%[25]. Revenue and Collaboration - Collaboration revenue for Q4 2024 totaled $7.0 million, compared to $3.9 million in Q4 2023, driven by a $7.0 million milestone payment from GSK for IND clearance of IDE275[13]. - Collaboration revenue for Q4 2024 was $7,000,000, compared to $3,923,000 in Q4 2023, representing an increase of approximately 78.5%[23]. Research and Development - Research and development expenses for Q4 2024 were $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 costs[14]. - Research and development expenses for the year ended December 31, 2024, were $294,673,000, compared to $129,508,000 in 2023, marking an increase of approximately 128%[23]. - General and administrative expenses for the year ended December 31, 2024, were $39,302,000, up from $28,306,000 in 2023, indicating an increase of approximately 39%[23]. - Over 230 patients have been enrolled in the potential registration-enabling trial for 1L HLA-A2-negative MUM, with a median PFS readout targeted by year-end 2025[4]. - IDEAYA plans to initiate a Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM in the first half of 2025, with 95 patients already enrolled[6]. - The company is targeting clinical data updates for IDE397 in combination with Trodelvy in MTAP-deletion UC in 2025, following encouraging Phase 1 results presented at ENA 2024[7]. - IDEAYA aims to submit a U.S. IND for IDE849 as a monotherapy in SCLC in the first half of 2025, with preliminary results showing an overall response rate of approximately 73% in a Phase 1 trial[7]. - The company anticipates filing INDs for three new candidates: IDE892 (PRMT5) in mid-2025, IDE034 (B7H3/PTK7 ADC) in the second half of 2025, and IDE251 (KAT6/7) also in the second half of 2025[9]. Shareholder Information - The weighted-average number of shares outstanding increased to 87,340,758 in Q4 2024 from 65,246,361 in Q4 2023, reflecting an increase of approximately 33.9%[23]. Future Outlook - IDEAYA is focused on advancing its clinical programs and expects to provide updates on regulatory milestones and trial data in the near future[20].