Oric Pharmaceuticals (ORIC) investor relations material

Regulatory and clinical program updates

• Recent discontinuation of a competitor's PRC2 inhibitor in sickle cell disease has limited implications for the prostate cancer program due to different risk-benefit profiles and no observed secondary malignancies in over 100 patients dosed to date.

• End of phase I meeting completed with FDA; protocol and dose (400 mg rinzimetostat with darolutamide) for phase III study finalized, with no prerequisites remaining for study initiation.

• Phase III study (Himalayas-1) will enroll 600 patients, with a control arm of physician's choice (AR inhibitor or docetaxel), primary endpoint of radiographic PFS, and expected top-line data in early 2028.

• Dose selection based on exposure-response analysis prioritized safety without compromising efficacy, aligning with Project Optimus requirements.

Differentiation and clinical data

• Rinzimetostat offers a 20-hour half-life, enabling once-daily dosing and potentially reducing Cmax-driven toxicities compared to competitors requiring BID dosing.

• Efficacy at five months (PFS ~84%) is highly competitive with leading agents, while safety profile shows significantly fewer Grade 3 adverse events.

• Early phase I discontinuations are consistent with other prostate cancer studies and often unrelated to drug safety or efficacy.

• Upcoming program updates may include progress on phase III studies, additional data, and insights from external trials.

Market opportunity and strategy

• U.S. market for post-abiraterone metastatic prostate cancer estimated at $3.5 billion, with global opportunity near $7 billion; safety differentiation seen as key to capturing market share.

• Market research suggests safety profile could drive significant share, especially in earlier lines of therapy.

• Commercial opportunity is substantial due to high unmet need and potential for long therapy duration.