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IDEAYA Biosciences (IDYA) FY Conference Transcript
2025-06-09 15:40
Summary of IDEA Biosciences Conference Call Company Overview - **Company**: IDEA Biosciences - **Focus**: Development of innovative therapies for cancer treatment, with six clinical programs currently and a target of nine by year-end [2][1]. Key Value Drivers - **Lead Program**: Derobicertib, targeting metastatic human melanoma, currently in a registrational trial [2][1]. - **Enrollment Status**: Completed enrollment for the trial, with over 320 patients enrolled, exceeding the target of 250 [12][13]. - **Primary Endpoint**: Median progression-free survival (PFS) is crucial for potential accelerated approval, with historical PFS around 2-3 months and a target of over 5.5 months for the current study [3][8]. Clinical Data and Updates - **PFS Results**: Previous studies showed a PFS of approximately 7 months, with a specific setting achieving nearly 11 months [10][11]. - **Overall Survival (OS)**: Anticipated update on OS data from the phase two study, with historical OS in treatment-naive settings around 12-13 months [17][18]. - **Market Opportunity**: Targeting the HLA A2 negative population, with an estimated annual incidence of 4,000 to 5,000 patients in the US and Europe [20][19]. Commercial Strategy - **Commercial Organization**: Building a commercial team with key hires, including a Chief Commercial Officer and heads of various departments [24][25]. - **Regulatory Strategy**: Fast track designation from the FDA for expedited review, with ongoing discussions regarding NDA submission [14][16]. Pipeline and Future Developments - **Additional Programs**: Focus on MTAP deletion space and DLL3, with several data catalysts expected [5][6][51]. - **Combination Therapies**: Emphasis on rational combinations, particularly with PRMT5 inhibitors in lung cancer [70][71]. - **IND Filings**: Targeting multiple INDs, with a goal of one IND per year, and a record of four INDs planned for the current year [86][87]. Financial Position - **Cash Reserves**: Reported over $1 billion in cash, providing a strong financial position for ongoing and future clinical activities [88][87]. Conclusion - IDEA Biosciences is positioned for significant growth with multiple clinical programs, a robust commercial strategy, and a strong financial foundation, aiming to address unmet needs in cancer treatment through innovative therapies and strategic partnerships.
IDEAYA Biosciences (IDYA) 2025 Conference Transcript
2025-06-04 13:12
IDEAYA Biosciences (IDYA) 2025 Conference June 04, 2025 08:10 AM ET Speaker0 Hi everyone. My name is Maury Raycroft and one of the biotech analysts at Jefferies. So it's a great pleasure that I'd like to welcome the IDEA team. We've got Yajiro Hata, CEO, and Josh Blaharski, the CFO. Thanks so much for joining us today. Speaker1 Great. Thanks so much Maury and thank you to Jeffries for the opportunity to participate this year and Josh and I will be talking today. Thanks again. Speaker0 And we're going do fir ...
IDEAYA Biosciences to Participate in Upcoming June 2025 Investor Relations Events
Prnewswire· 2025-06-02 10:00
Group 1 - IDEAYA Biosciences, Inc. is participating in two upcoming investor relations events: the 2025 Jefferies Global Healthcare Conference on June 4th and the Goldman Sachs 46th Annual Global Healthcare Conference on June 9th [1] - The CEO, Yujiro S. Hata, will be featured in fireside chats at both conferences, hosted by equity research analysts from Jefferies and Goldman Sachs [1] - A live audio webcast of the events will be available on the IDEAYA website, with replays accessible for 30 days post-event [1] Group 2 - IDEAYA is focused on precision medicine in oncology, developing targeted therapeutics based on molecular diagnostics [2] - The company integrates capabilities in identifying and validating translational biomarkers with drug discovery to optimize patient selection for its therapies [2] - IDEAYA is particularly focused on synthetic lethality, an emerging class of precision medicine targets [2]
IDEAYA Biosciences (IDYA) 2025 Conference Transcript
2025-05-20 13:30
IDEAYA Biosciences (IDYA) 2025 Conference May 20, 2025 08:30 AM ET Speaker0 To get started. Welcome back, everyone, to the twenty twenty five RBC Global Healthcare Conference. My name is Greg Renza, one of the, biotech equity research analysts, and we're very pleased to have Idea Biosciences with us today. And joining us from from the company, of course, is the CEO, Yuzuru Hata, as well as the the new CFO, Josh Blarsky. Guys, it's great great to have you. Speaker1 Thanks. Well, great, Greg. Thanks so much f ...
IDEAYA Biosciences(IDYA) - 2025 Q1 - Quarterly Report
2025-05-06 20:05
UNITED STATES SECURITIES AND EXCHANGE COMMISSION Washington, D.C. 20549 FORM 10-Q (Mark One) 5000 Shoreline Court, Suite 300 South San Francisco, California 94080 (Address of principal executive offices) (Zip Code) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES AND EXCHANGE ACT OF 1934 For the transition period from to Commission File Number: 0 ...
IDEAYA Biosciences(IDYA) - 2025 Q1 - Quarterly Results
2025-05-06 10:05
Exhibit 99.1 IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update SOUTH SAN FRANCISCO, Calif., May 6, 2025 -- IDEAYA Biosciences, Inc. (Nasdaq: IDYA), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, provided a business update and announced financial results for the first quarter that ended March 31, 2025. "We have provided an updated cash runway guidance into 2029, and this past quarter we made significa ...
IDEAYA Biosciences, Inc. Reports First Quarter 2025 Financial Results and Provides Business Update
Prnewswire· 2025-05-06 10:05
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].
IDEAYA Biosciences to Participate in Upcoming May 2025 Investor Relations Events
Prnewswire· 2025-04-28 10:00
SOUTH SAN FRANCISCO, Calif., April 28, 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.Barclays Hosted: Peter Lawson's Catalyst & Key Debate Calls & Investor 1x1'sThursday, May 8th, 2025 at 11:00 AM ET Fireside chat with Yujiro S. Hata, President and Chief Executive Officer, hosted by Peter Lawson, D.Phil., Managing Dir ...
Ideaya Biosciences: These Prices Are Probably Going To Look Cheap Sooner Than Later
Seeking Alpha· 2025-04-16 12:52
IDEAYA Biosciences (NASDAQ: IDYA ) is a developmental biotech I covered once back in mid-2024, although my impression at the time was that although they were generating interesting data with an interesting premise, they were valued a bit too highI have my PhD in biochemistry and have worked for years analyzing clinical trials and biotech companies. It is my passion to educate everyone possible on the science behind the businesses that we invest in, and it's my mission to help you do your due diligence and n ...
IDEAYA Biosciences Announces Successful FDA Type D Meeting on Phase 3 Registrational Trial Design for Darovasertib as Neoadjuvant Therapy for Primary Uveal Melanoma
Prnewswire· 2025-04-14 10:00
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]