IDEAYA Biosciences (IDYA) Goldman Sachs 45th Annual Global Healthcare Conference summary

Pipeline and clinical program updates

• Four first-in-class clinical programs are active, including darovasertib for uveal melanoma, IDE397 (MAT2A inhibitor), a PARP inhibitor (IDE161), and Pol Theta, all targeting precision oncology indications.

• A fifth program, Werner helicase, is expected to enter the clinic by year-end, with two additional candidates targeted for delivery in the same timeframe.

• Over seven first-in-class programs could be in the clinic within the next few quarters.

• Recent ASCO data in neoadjuvant uveal melanoma showed 75% eye preservation, far exceeding the 10% benchmark considered a game changer.

• Company-sponsored phase II study update and regulatory feedback are expected in the second half of the year.

Regulatory and strategic outlook

• Preparing for a Type C FDA meeting in the second half of the year to seek endorsement for an accelerated approval study in neoadjuvant uveal melanoma.

• Plans to present both accelerated and full approval study designs, with adjuvant trial discussions to follow.

• In metastatic uveal melanoma, enrollment for the registrational trial is ahead of schedule, targeting a late 2026 launch.

• The primary endpoint for the metastatic trial is progression-free survival, with prior data showing PFS above seven months, significantly better than historical controls.

Market opportunity and competitive landscape

• Neoadjuvant and adjuvant uveal melanoma markets are estimated to be at least 10 times larger than the metastatic setting, with annual incidence of 8,000–10,000 patients.

• Duration of treatment could extend up to 12 months in both neoadjuvant and adjuvant settings.

• In metastatic uveal melanoma, the drug is being developed for both HLA-A2 positive and negative populations, with a total prevalence of 10,000–12,000 patients.

• The agent is also being explored in cutaneous melanoma, targeting GNAQ/11 mutations.