Oruka Therapeutics (ORKA) investor relations material

Strategic vision and pipeline overview

• Focused on psoriatic disease, including plaque psoriasis, psoriatic arthritis, and hidradenitis suppurativa, with two co-lead monoclonal antibody programs: ORKA-001 (IL-23p19) and ORKA-002 (IL-17A/F).

• Both programs are modeled after gold standard antibodies, aiming for improved efficacy and ultra-long dosing intervals (once yearly for ORKA-001, twice yearly for ORKA-002).

• 2026 is positioned as a pivotal year, with ongoing phase II studies and key data readouts expected in the second half of the year.

• The company is well-funded, with over $500 million in cash and a runway extending beyond upcoming clinical milestones.

Clinical development and differentiation

• ORKA-001 shows a 100-day half-life, potentially enabling annual dosing and higher efficacy through increased antibody exposure.

• EVERLAST-A and EVERLAST-B phase II studies in plaque psoriasis use a novel design, including PASI 100 as a primary endpoint and a maintenance arm to assess off-treatment remission.

• Data suggest the possibility of 20–30% of patients maintaining clear skin for two years or more after induction dosing.

• ORKA-002 demonstrates a 75–80-day half-life, supporting twice-yearly dosing in psoriasis and quarterly in HS, with predictable PK and no ADA evidence.

Market opportunity and competitive landscape

• Psoriatic disease represents a $30 billion and growing market, with recent blockbusters validating the potential for biologic innovation.

• ORKA-001 and ORKA-002 are designed to differentiate from current standards (Skyrizi, Bimzelx) through longer dosing intervals and potential for off-treatment remission.

• Higher antibody exposures, as seen in the KNOCKOUT study, correlate with increased skin clearance, supporting the rationale for ORKA-001’s dosing strategy.

• The company believes small firms can commercialize effectively, citing examples like Ilumya and Arcutis, but remains open to strategic partnerships.