Oric Pharmaceuticals (ORIC) investor relations material

Regulatory and clinical program updates

• Fulcrum discontinued its PRC2 inhibitor for sickle cell disease due to FDA concerns, but no similar issues have arisen for rinzimetostat in oncology, with over 100 patients dosed and no secondary malignancies observed in preclinical or clinical studies.

• Recent FDA interactions have not altered plans for the phase III study of rinzimetostat; protocol and dose (400 mg with darolutamide) are finalized, and the study is set to start imminently.

• The phase III study (Himalayas-1) will enroll 600 patients, with a control arm of physician's choice AR inhibitor or docetaxel, and aims for top-line data in early 2028.

Differentiation and clinical data

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

• Efficacy at five months (PFS ~84%) is competitive with Pfizer's data, but rinzimetostat shows a more favorable safety profile, with significantly fewer Grade 3 adverse events.

• Non-specific discontinuations in phase I are consistent with other prostate cancer studies and are expected to resolve in phase III as endpoints shift to efficacy.

Market opportunity and strategic positioning

• The target market for post-abiraterone metastatic prostate cancer is estimated at $3.5 billion in the U.S. and $7 billion globally, with safety differentiation expected to drive market share.

• Market research suggests safety is a key differentiator, especially for long-term therapy in earlier lines of prostate cancer.