IDEAYA Biosciences Announces Participation at the 43rd Annual J.P. Morgan Healthcare Conference and 2025 Corporate Guidance

Rhea-AI Summary

IDEAYA Biosciences (NASDAQ: IDYA) announced its participation at the 43rd Annual J.P. Morgan Healthcare Conference and provided 2025 corporate guidance. The company reported $1.2 billion in cash as of September 30, 2024, expected to fund operations into at least 2028.

Key program updates include: darovasertib Phase 2/3 trial progression with over 200 patients enrolled; IDE397 Phase 1/2 study developments; IDE849 clinical program updates in SCLC and NETs; and planned expansion of IDE161 in combination with KEYTRUDA®. The company targets three IND filings in 2025, potentially bringing their clinical-stage precision medicine oncology programs to nine.

Notable milestones include median progression-free survival readout for darovasertib by year-end 2025, Phase 3 trial initiation in first half 2025, and multiple clinical program updates across their pipeline throughout the year.

Positive

• $1.2 billion cash position funding operations through 2028
• Strong enrollment of over 200 patients in darovasertib Phase 2/3 trial
• Three new IND filings planned for 2025
• Multiple potential milestone payments from GSK collaboration

Negative

• None.

Insights

Financial Analyst

The financial position of IDEAYA Biosciences appears robust with $1.2 billion in cash reserves as of September 2024, providing an extended runway into 2028. This substantial cash position significantly de-risks the company's extensive clinical development pipeline, allowing for multiple value-creating catalysts without immediate financing concerns.

The company's diversified pipeline includes several potential first-in-class drug candidates targeting significant market opportunities. The darovasertib program's progression, with over 200 patients enrolled in the Phase 2/3 trial, represents a near-term catalyst with the survival data readout expected by year-end 2025. The potential $10 million milestone payment from GSK for IDE705's Phase 2 expansion provides additional near-term revenue potential.

The ambitious plan for 3 IND filings in 2025 demonstrates strong R&D execution capability and pipeline expansion, potentially creating multiple shots on goal for future revenue streams. The strategic partnerships with major pharmaceutical companies (GSK, Merck) validate the platform technology and provide additional financial flexibility.

Oncology Research Analyst

The clinical development strategy shows sophisticated pipeline prioritization across multiple cancer indications. The darovasertib program in uveal melanoma is particularly noteworthy, with a dual approach targeting both metastatic and neoadjuvant settings. The planned Phase 3 initiation in neoadjuvant UM represents a strategic expansion of the addressable patient population.

The company's focus on precision medicine is evident in the targeted approach for IDE397 in MTAP-deletion tumors, especially the planned combination with IDE892 in NSCLC. The IDE849 program's early clinical data showing tumor reduction per RECIST criteria suggests promising efficacy in SCLC, an area with significant unmet medical need.

The diversification into multiple therapeutic modalities, including kinase inhibitors, ADCs and synthetic lethality approaches, demonstrates a comprehensive understanding of cancer biology and resistance mechanisms. The planned combinations with established therapies like Keytruda and Trodelvy indicate a thoughtful clinical development strategy aimed at improving treatment outcomes.

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

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
investor@ideayabio.com 

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SOURCE IDEAYA Biosciences, Inc.

FAQ

What is IDEAYA's (IDYA) cash runway projection as of 2025?

IDEAYA reported $1.2 billion in cash, cash equivalents, and marketable securities as of September 30, 2024, which is expected to fund operations into at least 2028.

How many patients are enrolled in IDEAYA's (IDYA) darovasertib Phase 2/3 trial?

As of January 6, 2025, enrollment has exceeded over 200 patients in the darovasertib and crizotinib combination trial.

When will IDEAYA (IDYA) initiate the Phase 3 trial for darovasertib in neoadjuvant UM?

IDEAYA plans to initiate the Phase 3 registration-enabling trial for darovasertib in neoadjuvant UM in the first half of 2025.

How many new IND filings is IDEAYA (IDYA) targeting for 2025?

IDEAYA is targeting 3 IND filings in 2025, which would bring their clinical-stage precision medicine oncology programs to nine.

What is the timeline for IDEAYA's (IDYA) darovasertib Phase 2/3 trial progression-free survival readout?

The median progression-free survival readout for the darovasertib and crizotinib combination trial is targeted by year-end 2025, pending enrollment status and data maturity.