Oruka Therapeutics (ORKA) investor relations material

Strategic vision and clinical progress

• Focused on developing best-in-class therapies for psoriatic disease, targeting IL-23 and IL-17A/F to maximize disease clearance with minimal dosing.

• EVERLAST-A phase II data for the IL-23 antibody (001) showed high rates of disease clearance, potentially matching or exceeding current market leaders.

• EVERLAST-B is underway to provide dose-ranging data, critical for phase III dose selection and regulatory discussions.

• 002 program (IL-17A/F) is in phase II, targeting both psoriasis and expansion into hidradenitis suppurativa (HS).

• Strategic amendment with Paragon/Spyre opens future IBD opportunities for 001 after a delay period.

Data readouts and regulatory planning

• 16-week EVERLAST-A data exceeded expectations; 28-week and one-year follow-up data expected in the second half of the year.

• Phase III planning is contingent on EVERLAST-B dose-ranging results, with high confidence in the 600 mg dose.

• Regulatory strategy considers both six-month and annual dosing for label flexibility, with potential for initial approval based on one-year data.

• Ongoing CMC and clinical operations preparation ensures rapid phase III initiation post-EVERLAST-B.

Commercial and market positioning

• Annual and six-month dosing regimens planned, with equivalent annual pricing for both to align with payer expectations.

• Medical benefit channel seen as a strong entry point, referencing ILUMYA’s success despite lower efficacy.

• Self-administration at home is planned post-launch, following initial in-office format.

• Pricing strategy will consider potential for off-treatment remission, a first in the field if demonstrated.