Financial Performance - Net loss for the three months ended March 31, 2025, was $72.178 million, compared to a net loss of $39.572 million for the same period in 2024, indicating an increase of 82.5%[18] - The company reported a comprehensive loss of $71.405 million for the three months ended March 31, 2025, compared to a comprehensive loss of $41.057 million for the same period in 2024, reflecting an increase of 74.0%[18] - For the three months ended March 31, 2025, the company reported a net loss of $72.2 million, compared to a net loss of $39.6 million for the same period in 2024, representing an increase of 82.5%[24] - Net loss attributable to common stockholders for Q1 2025 was $72,178,000, compared to $39,572,000 in Q1 2024, resulting in a net loss per share of $(0.82) for Q1 2025 versus $(0.53) for Q1 2024[144] Assets and Liabilities - Total current assets increased to $707.872 million as of March 31, 2025, compared to $689.713 million as of December 31, 2024, reflecting a growth of approximately 2.4%[16] - Total liabilities increased to $76.506 million as of March 31, 2025, from $64.944 million as of December 31, 2024, marking a rise of approximately 17.8%[16] - Total stockholders' equity decreased to $1.024 billion as of March 31, 2025, from $1.059 billion as of December 31, 2024, a decline of approximately 3.3%[16] - The company had cash, cash equivalents, and marketable securities totaling approximately $1.05 billion as of March 31, 2025, which is expected to fund operations for at least the next 12 months[33] Research and Development - Research and development expenses rose to $70.886 million for the three months ended March 31, 2025, up from $42.805 million in the same period of 2024, representing a significant increase of 65.5%[18] - External clinical development expenses for the drug Darovasertib rose to $23,018,000 in Q1 2025 from $10,869,000 in Q1 2024, indicating increased investment in this area[147] - The company plans to continue its clinical trials for multiple product candidates, including darovasertib and IDE397, with ongoing Phase 2/3 and Phase 1/2 trials[12] - IDEAYA is focused on expanding its strategic collaborations and partnerships to enhance its research and development capabilities and market reach[12] Cash Flow and Financing - Net cash used in operating activities for the three months ended March 31, 2025, was $60.3 million, up from $43.8 million in the prior year, indicating a 37.5% increase in cash outflow[24] - During the three months ended March 31, 2025, the company raised $25.0 million through the sale of 984,000 shares of common stock at an average price of approximately $26.00 per share under its at-the-market offering program[29] - The company completed a follow-on offering on July 11, 2024, raising approximately $283.8 million in net proceeds from the sale of 8,355,714 shares of common stock[27] - The company has significant risks and uncertainties related to its ability to obtain future financing and the success of its product candidates in clinical trials[38] Stock and Equity - The weighted-average common shares outstanding increased to 88,356,335 for the three months ended March 31, 2025, compared to 75,108,484 for the same period in 2024, an increase of 17.6%[18] - The total number of shares available for future issuance was 17,275,354, an increase from 13,027,922 as of December 31, 2024[80] - The number of options to purchase common stock increased to 10,220,556 as of March 31, 2025, up from 7,874,924 in the previous year[145] - The company has reserved 1,000,000 shares for the 2023 Inducement Plan, which was amended to increase the number of shares available for issuance by an additional 1,000,000[82] Tax and Regulatory Matters - The company did not record a federal or state income tax provision for the three months ended March 31, 2025, due to recurring net losses[74] - The company has a full valuation allowance against its net deferred tax assets, indicating it is not likely to realize the benefit[74] Future Outlook and Risks - The company has not generated any revenue from commercial products since its inception, and management expects operating losses to continue and increase as clinical development progresses[32] - The company has limited experience in the field, which contributes to uncertainty regarding the outcome of clinical trials and regulatory approvals[142] - Despite ongoing geopolitical events, the company does not believe inflation or exchange rate fluctuations have significantly impacted its operations[317]

[Executive Summary & Business Update](index=1&type=section&id=Executive%20Summary%20%26%20Business%20Update) IDEAYA Biosciences reported strong Q1 2025 progress, extending cash runway into 2029 and advancing oncology programs [Company Overview and Strategic Highlights](index=1&type=section&id=Company%20Overview%20and%20Strategic%20Highlights) IDEAYA, a precision oncology company, extended its cash runway to 2029 and achieved FDA Breakthrough for darovasertib - IDEAYA Biosciences is a **precision medicine oncology company** focused on discovering and developing targeted therapeutics[2](index=2&type=chunk) - The company has updated its cash runway guidance **into 2029**[3](index=3&type=chunk)[5](index=5&type=chunk) - Significant progress was made on the darovasertib program, including U.S. FDA **Breakthrough Therapy Designation** and enrollment of **over 300 patients** in the 1L HLA-A2-negative MUM registrational trial[3](index=3&type=chunk)[5](index=5&type=chunk) [Recent Key Developments and Upcoming Milestones](index=1&type=section&id=Recent%20Key%20Developments%20and%20Upcoming%20Milestones) Significant clinical pipeline advancements and strategic corporate developments, including collaborations and leadership [Research and Clinical Development](index=1&type=section&id=Research%20and%20Clinical%20Development) Clinical pipeline updates highlight darovasertib's rapid advancement and progress across multiple other programs [Darovasertib Program](index=1&type=section&id=Darovasertib%20Program) Darovasertib, a PKC inhibitor, advances in Phase 2/3 trials for MUM and neoadjuvant UM, with FDA Breakthrough - Darovasertib is a potential **first-in-class PKC inhibitor** in **Phase 2/3 clinical testing** for metastatic uveal melanoma (MUM) and neoadjuvant treatment for primary uveal melanoma (UM)[4](index=4&type=chunk) - **Over 300 patients** enrolled in darovasertib and crizotinib registrational 1L HLA-A2-negative MUM trial, targeting median PFS results by **YE 2025** to enable potential accelerated approval filing[5](index=5&type=chunk)[6](index=6&type=chunk) - U.S. FDA granted **Breakthrough Therapy Designation** for single agent darovasertib for the neoadjuvant treatment of adult patients with primary uveal melanoma (UM) for whom enucleation has been recommended[5](index=5&type=chunk)[6](index=6&type=chunk) [Other Clinical Programs](index=3&type=section&id=Other%20Clinical%20Programs) Updates on IDE397, IDE849, IDE275, and other pipeline assets, including new collaborations, Phase 1 initiations, and targeted IND filings in 2025 - **IDE397 (MAT2A inhibitor)** entered into an additional **clinical study collaboration** and supply agreement with Gilead to evaluate its combination with Trodelvy® in MTAP-deletion NSCLC[7](index=7&type=chunk)[11](index=11&type=chunk) - **IDE849 (DLL3 TOP1 ADC) Phase 1 initiated** in U.S., and partner Hengrui targeting clinical data update in over 40 SCLC patients at a medical conference in **Q3 2025**[5](index=5&type=chunk)[8](index=8&type=chunk)[11](index=11&type=chunk) - Oral presentation of potential best-in-class **Phase 1 WRN inhibitor IDE275** at **AACR 2025**, demonstrating selectivity to treat MSI-H solid tumors[5](index=5&type=chunk)[9](index=9&type=chunk)[11](index=11&type=chunk) - **Three additional IND-filings targeted in 2025**: PRMT5 (IDE892), B7H3/PTK7 ADC (IDE034), and KAT6/7 (IDE574)[5](index=5&type=chunk)[13](index=13&type=chunk)[16](index=16&type=chunk) [Corporate Development and Operations](index=4&type=section&id=Corporate%20Development%20and%20Operations) IDEAYA formed a research collaboration with ATTMOS and strengthened its leadership team with key executive appointments - Formed a **research collaboration with ATTMOS** to develop a physics-based computational platform for small molecule discovery, aimed at swiftly unlocking oncology targets traditionally considered undruggable[14](index=14&type=chunk) - **Joshua Bleharski**, Ph.D., joined IDEAYA as **Chief Financial Officer** from J.P. Morgan[20](index=20&type=chunk) - **Shanthakumar Tyavanagimatt**, Ph.D., joined IDEAYA as **Senior Vice President, Technical Operations**, to lead IDEAYA's darovasertib global commercial supply chain readiness activities[20](index=20&type=chunk) [Financial Results](index=5&type=section&id=Financial%20Results) The company reported a strong cash position extending into 2029, with a reduced net loss driven by lower R&D expenses [Cash Position and Runway](index=5&type=section&id=Cash%20Position%20and%20Runway) IDEAYA maintained a strong cash position of approximately $1.05 billion as of March 31, 2025, extending its runway into 2029 Cash, Cash Equivalents and Marketable Securities | Metric | March 31, 2025 | December 31, 2024 | | :----- | :------------- | :---------------- | | Cash, cash equivalents and marketable securities | ~$1.05 billion | ~$1.08 billion | - The cash balance is projected to be sufficient to fund planned operations **into 2029**, based on the current operating plan and pipeline prioritization[3](index=3&type=chunk)[5](index=5&type=chunk)[18](index=18&type=chunk) - The decrease in the cash balance was primarily driven by net cash used in operations, partially offset by **$25.0 million** in net proceeds from at-the-market financings during the quarter[17](index=17&type=chunk) [Condensed Statements of Operations Analysis](index=5&type=section&id=Condensed%20Statements%20of%20Operations%20Analysis) Q1 2025 saw no collaboration revenue, a significant decrease in R&D expenses, and an improved net loss Key Financials (Three Months Ended) | Metric | March 31, 2025 | December 31, 2024 | Change (QoQ) | | :-------------------------- | :------------- | :---------------- | :----------- | | Collaboration revenue | $0 | $7.0 million | -$7.0 million | | Research and development | $70.9 million | $140.2 million | -$69.3 million | | General and administrative | $13.5 million | $11.0 million | +$2.5 million | | Net loss | $(72.2) million | $(130.3) million | +$58.1 million | | Net loss per share (basic & diluted) | $(0.82) | $(1.49) | +$0.67 | - The decrease in R&D expenses was primarily due to a one-time **$75.0 million** upfront payment under the license agreement for IDE849 with Hengrui Pharma that occurred in December 2024, offset by higher clinical trial, consulting and personnel-related expenses[21](index=21&type=chunk) - The increase in G&A expenses was primarily due to higher personnel-related, consulting and legal patent expenses to support our growth[22](index=22&type=chunk) [Condensed Balance Sheet Highlights](index=9&type=section&id=Condensed%20Balance%20Sheet%20Highlights) Total assets slightly decreased to $1.10 billion, while total liabilities increased to $76.5 million as of March 31, 2025 Condensed Balance Sheet Data | Metric | March 31, 2025 (in thousands) | December 31, 2024 (in thousands) | | :----------- | :---------------------------- | :------------------------------- | | Total assets | $1,100,641 | $1,124,091 | | Total liabilities | $76,506 | $64,944 | [Company Information and Disclosures](index=6&type=section&id=Company%20Information%20and%20Disclosures) This section provides an overview of IDEAYA Biosciences, outlines forward-looking statements, and lists investor contact information [About IDEAYA Biosciences](index=6&type=section&id=About%20IDEAYA%20Biosciences) IDEAYA Biosciences is a precision medicine oncology company focused on targeted therapeutics and synthetic lethality targets - IDEAYA is a **precision medicine oncology company** committed to the discovery and development of targeted therapeutics for patient populations selected using molecular diagnostics[24](index=24&type=chunk) - IDEAYA is applying its research and drug discovery capabilities to **synthetic lethality** – which represents an emerging class of precision medicine targets[24](index=24&type=chunk) [Forward-Looking Statements](index=6&type=section&id=Forward-Looking%20Statements) This section details forward-looking statements, highlighting inherent risks and uncertainties in drug development and financial projections - This press release contains **forward-looking statements** related to clinical program updates, therapeutic benefits, regulatory approvals, development and regulatory milestones, and the extent to which IDEAYA's existing cash will fund its planned operations[26](index=26&type=chunk) - Such forward-looking statements involve **substantial risks and uncertainties** inherent in the drug development process, including early stage development, trial design, regulatory processes, manufacturing, intellectual property, and financial sufficiency[27](index=27&type=chunk) [Investor and Media Contact](index=7&type=section&id=Investor%20and%20Media%20Contact) Contact information for investor and media inquiries is provided, directed to Andres Ruiz Briseno, Chief Accounting Officer - For investor and media inquiries, contact **Andres Ruiz Briseno, Chief Accounting Officer**, at investor@ideayabio.com[28](index=28&type=chunk)

Core Insights - IDEAYA Biosciences, Inc. provided a business update and announced financial results for Q1 2025, highlighting significant progress in its clinical programs and financial position [1][2]. Financial Overview - As of March 31, 2025, IDEAYA had approximately $1.05 billion in cash, cash equivalents, and marketable securities, down from $1.08 billion at the end of 2024, primarily due to operational cash usage [4][16]. - The company projects that its current cash balance will fund operations into 2029 based on its updated operating plan [17]. - The net loss for Q1 2025 was $72.2 million, a decrease from a net loss of $130.3 million in Q4 2024 [22]. Clinical Development Highlights - The darovasertib program received U.S. FDA breakthrough therapy designation, with over 300 patients enrolled in the registrational trial for HLA-A2-negative metastatic uveal melanoma (MUM) [2][4]. - The company is targeting a median progression-free survival (PFS) readout by the end of 2025 to enable a potential accelerated approval filing [4][5]. - IDEAYA is advancing multiple clinical programs, including IDE849 for lung cancer, IDE275 for MSI-high colorectal and endometrial cancer, and IDE397 for MTAP-deletion lung and urothelial cancer [2][4]. Research and Development Updates - The Phase 3 trial for darovasertib as neoadjuvant therapy for primary uveal melanoma is expected to enroll approximately 520 patients, with a focus on eye preservation and visual acuity outcomes [5][6]. - IDEAYA plans to present clinical data updates at medical conferences throughout 2025, including results from darovasertib and other pipeline candidates [4][5]. - The company has initiated a Phase 1 study for IDE849 in small cell lung cancer (SCLC) and is collaborating with Gilead to evaluate IDE397 in combination with Trodelvy® [12][19]. Corporate Developments - IDEAYA appointed Joshua Bleharski as Chief Financial Officer and Shanthakumar Tyavanagimatt as Senior Vice President of Technical Operations, enhancing its leadership team [21]. - The company formed a collaboration with ATTMOS to develop a computational platform for small molecule discovery, aiming to unlock oncology targets [21].

Core Insights - IDEAYA Biosciences has received FDA clearance for an IND application to initiate a Phase 1 clinical trial for IDE849, a potential first-in-class DLL3-targeting Topo-I-payload ADC in solid tumors [1][2] Group 1: Clinical Development - IDE849 is advancing into a Phase 1 study in the U.S., targeting DLL3, which is upregulated in various solid tumors such as SCLC, NETs, and NSCLC, indicating a strong potential for a single asset pipeline [2][6] - The ongoing multi-site open label Phase 1 clinical trial for IDE849 has shown multiple partial responses, with treatment-related adverse events primarily being Grade 1 or 2, and no drug-related discontinuations reported [4][8] - IDEAYA plans to present clinical efficacy and safety data on IDE849 from over 40 SCLC patients at a medical conference in Q3 2025 [4][10] Group 2: Combination Therapies - IDE849 aligns with IDEAYA's strategy to develop rational combination therapies, particularly with the potential first-in-class Phase 1 PARG inhibitor IDE161, which has shown preclinical synergy with TOP1-based ADCs [3][5] - The company aims to evaluate IDE849 in combination with IDE161/PARG to enhance the durability of its ADC pipeline [5][7] Group 3: Market Potential - DLL3's limited expression in normal tissues and its upregulation in multiple solid tumor types highlight its promise as a therapeutic target, addressing significant unmet medical needs in oncology [6][11] - IDEAYA's approach integrates capabilities in identifying translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies [11]

Investment Rating - The report does not explicitly provide an investment rating for the industry. Core Insights - The report emphasizes the importance of understanding the funding side of the U.S. innovative drug market, particularly how capital flows influence the industry dynamics [4][7]. - It highlights that large multinational corporations (MNCs) dominate the market due to their substantial cash reserves, enabling them to make significant upfront payments for innovative drug licenses [9][13]. - The report discusses the reliance of biotech companies on capital market financing, indicating that these firms often lack sufficient cash reserves to support their operations independently [18][30]. Summary by Sections Section 1: Where Does the Money for Innovative Drug Licensing Come From? - The report explores the sources of funding for innovative drug licensing, focusing on the role of MNCs and their financial capabilities [7][9]. Section 2: Financing Dependency - Biotech companies are heavily reliant on financing, with their cash flow primarily supported by capital market activities rather than product sales [18][30]. Section 3: U.S. Fiscal Support and Ecological Monopoly - The report discusses how the U.S. government and fiscal policies create an ecosystem that supports the dominance of MNCs in the innovative drug market [7][30]. Section 4: Liquidity Clock - The concept of a "liquidity clock" is introduced, illustrating how the interplay between funding and assets shapes the investment landscape in the U.S. innovative drug sector [4][7].

Company Participation in Investor Events - IDEAYA Biosciences, Inc. will participate in investor relations events including a fireside chat on May 8, 2025, and another on May 20, 2025 [1] - The events will feature Yujiro S. Hata, President and CEO, and will be hosted by notable analysts from Barclays and RBC Capital Markets [1] Company Overview - IDEAYA is a precision medicine oncology company focused on discovering and developing targeted therapeutics using molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]

Core Insights - IDEAYA Biosciences (NASDAQ: IDYA) is a developmental biotech company that has generated interesting data but may be overvalued based on previous assessments [1] Company Analysis - The company is involved in the biotech sector, focusing on clinical trials and innovative data generation [1] - The analyst has a background in biochemistry and extensive experience in analyzing biotech companies, indicating a strong foundation for evaluating IDEAYA's potential [1] Market Position - IDEAYA's valuation has been questioned, suggesting that while the company has promising data, its market price may not reflect its actual value [1]

Core Insights - IDEAYA Biosciences announced a successful FDA Type D meeting regarding the Phase 3 trial design for darovasertib as a neoadjuvant therapy for primary uveal melanoma (UM) [1][2] - The trial aims to assess safety and efficacy with primary endpoints focused on eye preservation and vision loss, alongside secondary endpoints related to Event-Free Survival (EFS) [2][6] Company Overview - IDEAYA Biosciences is a precision medicine oncology company dedicated to developing targeted therapeutics through molecular diagnostics [8] - The company integrates capabilities in identifying translational biomarkers with drug discovery to optimize patient selection for its therapies [8] Drug Development Details - Darovasertib is a selective protein kinase C (PKC) inhibitor targeting both primary and metastatic UM [3] - The drug has received Breakthrough Therapy Designation and Fast Track designation from the FDA for its use in neoadjuvant therapy and in combination with crizotinib for metastatic UM [3] Phase 3 Trial Design - The Phase 3 trial is projected to enroll approximately 520 patients, randomized in a 2:1 ratio between darovasertib and control [5][6] - Two cohorts will be included: 120 enucleation-eligible UM patients and 400 plaque brachytherapy (PB) eligible UM patients [5][6] Clinical Endpoints - Primary endpoints include eye preservation rate for enucleation patients and vision loss for PB patients, with no detriment to EFS as a secondary endpoint [6][7] - Additional secondary endpoints will assess overall response rate, macular edema, and vision loss metrics [7] Regulatory Pathway - The company plans to initiate the Phase 3 trial in the first half of 2025, with potential for earlier regulatory submission of enucleation cohort data [4][11]

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 ...