Full Press Release Details
SOUTH SAN FRANCISCO, Calif. , Jan. 12, 2025 /PRNewswire/ -- IDEAYA Biosciences, Inc. (NASDAQ: IDYA ), a precision medicine oncology company committed to the discovery and development of targeted therapeutics, announced its participation at the 43rd Annual J.P. Morgan Healthcare Conference and provided 2025 corporate guidance and program updates.
43rd Annual J.P. Morgan Healthcare Conference Monday, January 13 th , 2025, at 5:15 PM PT ( 8:15 PM ET )
• Presentation by Yujiro S. Hata , Chief Executive Officer, IDEAYA Biosciences, followed by analyst-hosted Q&A with Anupam Rama , Managing Director, US SMID Biotechnology Equity Research, J.P. Morgan
2025 Corporate Guidance to be Presented at the 43 rd Annual J.P. Morgan Healthcare Conference:
• Corporate financial guidance $1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024 , is anticipated to fund operations into at least 2028
• Darovasertib, a potential first-in-class Phase 2/3 PKC inhibitor program targeting Metastatic Uveal Melanoma (MUM) and Uveal Melanoma (UM) Median progression free survival readout for potential Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in first-line (1L) patients with HLA-A2-negative MUM targeted by year-end 2025, pending enrollment status and data maturity. Enrollment has exceeded over 200 patients as of January 6, 2025 Phase 2 1L MUM median overall survival readout for the darovasertib and crizotinib combination in approximately 38 1L MUM patients targeted in 2025 Targeting Phase 2 neoadjuvant UM clinical data update for darovasertib in over 75 patients and a regulatory update in 2025 Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for the first half of 2025
• IDE397, a potential first-in-class Phase 2 MAT2A Inhibitor program targeting MTAP-deletion solid tumors Clinical program update(s) for Phase 1/2 study of IDE397 in combination with Trodelvy ® in MTAP-deletion urothelial cancer (UC) in 2025 Target to enable wholly owned IDE397 + IDE892 (IDEAYA PRMT5) clinical combination in the second half of 2025 to target MTAP-deletion non-small cell lung cancer (NSCLC)
• IDE849 (SHR-4849), a potential first-in-class Phase 1 DLL3 TOP1i ADC targeting Small Cell Lung Cancer (SCLC) and Neuroendocrine Tumors (NETs) Clinical program update(s) targeted in 2025 Updated IDE849 clinical program slides have been provided in the JPM 2025 corporate presentation, including preclinical product profile, CT-scan tumor size waterfall plot by RECIST 1.1, and SCLC patient case study
• IDE275 (GSK959), a potential first-in-class Phase 1 Werner Helicase program targeting MSI-high solid tumors Targeting presentation at a medical conference with GSK, highlighting IDE275's differentiated potential best-in-class profile, in the first half of 2025
• IDE161, a potential first-in-class Phase 1 PARG inhibitor program targeting solid tumors Targeting Phase 1 expansion of IDE161 in combination with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in MSI-high and MSS endometrial cancer in 2025 Targeting clinical combination(s) of IDE161 with Topo-ADCs in 2025
• IDE705 (GSK101), a potential first-in-class Phase 1 Pol Theta Helicase Inhibitor targeting homologous recombination deficiency (HRD) solid tumors Targeting Phase 2 expansion in HRD solid tumors, enabling a potential $10 million milestone payment from GSK
• 3 IND-filings targeted in 2025, representing IDEAYA's 7 th , 8 th , and 9 th potential clinical stage precision medicine oncology program targeting solid tumors IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025. Combination potential with IDE397 IDE034, a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, in the second half of 2025. Combination potential with IDE161 IDE251, a potential first-in-class KAT6/7 dual inhibitor development candidate, in the second half of 2025. Combination potential with multiple programs in IDEAYA's pipeline
• $1.2 billion of cash, cash equivalents and marketable securities as of September 30, 2024 , is anticipated to fund operations into at least 2028
• Median progression free survival readout for potential Phase 2/3 registration-enabling trial of the darovasertib and crizotinib combination in first-line (1L) patients with HLA-A2-negative MUM targeted by year-end 2025, pending enrollment status and data maturity. Enrollment has exceeded over 200 patients as of January 6, 2025
• Phase 2 1L MUM median overall survival readout for the darovasertib and crizotinib combination in approximately 38 1L MUM patients targeted in 2025
• Targeting Phase 2 neoadjuvant UM clinical data update for darovasertib in over 75 patients and a regulatory update in 2025
• Initiation of the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM is planned for the first half of 2025
• Clinical program update(s) for Phase 1/2 study of IDE397 in combination with Trodelvy ® in MTAP-deletion urothelial cancer (UC) in 2025
• Target to enable wholly owned IDE397 + IDE892 (IDEAYA PRMT5) clinical combination in the second half of 2025 to target MTAP-deletion non-small cell lung cancer (NSCLC)
• Clinical program update(s) targeted in 2025
• Updated IDE849 clinical program slides have been provided in the JPM 2025 corporate presentation, including preclinical product profile, CT-scan tumor size waterfall plot by RECIST 1.1, and SCLC patient case study
• Targeting presentation at a medical conference with GSK, highlighting IDE275's differentiated potential best-in-class profile, in the first half of 2025
• Targeting Phase 1 expansion of IDE161 in combination with KEYTRUDA ® (pembrolizumab), Merck's anti-PD-1 therapy, in MSI-high and MSS endometrial cancer in 2025
• Targeting clinical combination(s) of IDE161 with Topo-ADCs in 2025
• Targeting Phase 2 expansion in HRD solid tumors, enabling a potential $10 million milestone payment from GSK
• IDE892, a potential best-in-class MTA-cooperative PRMT5 inhibitor, in mid-year 2025. Combination potential with IDE397
• IDE034, a potential first-in-class B7H3/PTK7 TOP1i bispecific ADC, in the second half of 2025. Combination potential with IDE161
• IDE251, a potential first-in-class KAT6/7 dual inhibitor development candidate, in the second half of 2025. Combination potential with multiple programs in IDEAYA's pipeline
IDEAYA's updated JPM 2025 corporate presentation reflecting its 2025 corporate guidance is available on its website under the Investor Relations section: https://ir.ideayabio.com/ .
A live audio webcast of the presentation and Q&A session will be available under the "Investors/Events" section of the IDEAYA website at https://ir.ideayabio.com/events and/or through the conference host. A replay of the webcast will be accessible for 30 days following the live event.
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 capabilities in identifying and validating translational biomarkers with drug discovery to select patient populations most likely to benefit from its targeted therapies. IDEAYA is applying its early research and drug discovery capabilities to synthetic lethality – which represents an emerging class of precision medicine targets.
Forward-Looking Statements
This press release contains forward-looking statements, including, but not limited to, statements related to (i) participation in and/or presentation at certain investor relations events and (ii) 2025 corporate guidance regarding the extent to which IDEAYA's existing cash, cash equivalents, and marketable securities will fund its planned operations and (iii) program updates regarding the potential timing of various activities. IDEAYA undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of IDEAYA in general, see IDEAYA's current and future filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K filed on February 20, 2024 .
Investor and Media Contact IDEAYA Biosciences Andres Ruiz Briseno Senior Vice President, Head of Finance and Investor Relations [email protected]