IDEAYA Biosciences (IDYA) 2025 Conference Transcript

Summary of IDEAYA Biosciences (IDYA) Conference Call Company Overview - IDEAYA Biosciences is a leading precision medicine oncology company founded about a decade ago with six clinical programs and a target of nine by the end of the year [4][5] Key Clinical Programs - Durovacertib: Currently in a pivotal registration enabling trial targeting frontline approval in HLA A2 negative metastatic melanoma, with a potential readout for accelerated approval by year-end based on median progression-free survival (PFS) [5][7] - Clinical Data: Historical median PFS in metastatic uveal melanoma is 2-3 months; IDEAYA reported a median PFS of approximately 7 months at ESMO 2023, aiming for a PFS of over 5.5 months in their study [7][21] - Enrollment: Target enrollment for the PFS study was 250 patients, but over 320 patients have been enrolled, with expectations to complete full enrollment by year-end [9][10] Upcoming Data and Regulatory Plans - OS Readout: The overall survival (OS) readout is expected to occur concurrently with the PFS readout, with preliminary data anticipated by mid-2026 [14][15] - NDA Filing: Fast track designation in the metastatic setting and breakthrough therapy designation in the neoadjuvant setting will facilitate NDA submission post-results [19][20] Market Opportunity - HLA A2 Negative Population: The company sees a significant commercial opportunity in the HLA A2 negative patient population, with approximately 70% of screened patients being HLA A2 negative [26][29] - Chemtrac Comparison: Chemtrac from Immunocor has shown strong growth with a run rate of $375 million, indicating a robust market potential for IDEAYA's products [26] Neoadjuvant Study - Phase III Study Design: The study includes two cohorts (enucleation and plaque therapy) with primary endpoints focused on eye preservation and vision tests, respectively [34][35] - Enrollment Timeline: Anticipated enrollment of 520 patients over five quarters, with the first readout expected within a year [38][40] DLL3 Topical ADC - Differentiation: IDEAYA's DLL3 ADC is expected to differentiate based on its tetrapeptide cleavable linker, which cleaves upon internalization, compared to competitors [49][50] - Data Expectations: A medical conference update is expected in the third quarter, with data on response rates and adverse event profiles [51][56] MAT2A Inhibitor and Combination Studies - Combination with Trodelvy: IDEAYA is optimistic about achieving a response rate above 40% in combination studies with Gilead's Trodelvy in urothelial carcinoma [65] - PRMT5 Inhibitor: The company plans to submit an IND for a combination therapy with its PRMT5 inhibitor, aiming for greater response rates compared to monotherapy [67][70] Financial Position - Cash Reserves: As of March, the company reported over $1 billion in cash, providing runway into 2029 and flexibility for continued investment in its pipeline [78][79] Upcoming Catalysts - Data Readouts: IDEAYA anticipates four data readouts for durovacertib and a substantial update on DLL3 in the third quarter, along with plans for an R&D day by year-end [82][83]