Oruka Therapeutics (ORKA) TD Cowen 45th Annual Healthcare Conference summary

Strategic focus and market opportunity

• Advancing care in psoriatic disease with biologics targeting IL-23p19 and IL-17A/F, aiming for long-term remission and ultra-long dosing intervals of six months to one year.

• Biologics remain underpenetrated in a large, growing market, with potential to expand into mild to moderate disease and beyond psoriasis.

• Market research indicates strong patient and physician preference for infrequent injections over daily oral therapies.

• Combination and sequential use of ORKA-001 and ORKA-002 could offer best-in-class regimens for diverse patient needs.

• Cash runway extends through 2027, supporting multiple clinical milestones.

Clinical development and differentiation

• Phase I for ORKA-001 began in December, with phase II-A in psoriasis starting later this year, using PASI 100 as a primary endpoint at week 16.

• Phase II-A design includes maintenance and treat-to-relapse arms to assess duration of response, aiming to demonstrate multi-year remission in a subset of patients.

• ORKA-002 phase I starts in Q3, with PK data expected first half of next year; dosing may reach every four to six months.

• Evidence from KNOCKOUT trial suggests higher efficacy with increased IL-23 inhibitor exposure, supporting potential for superior outcomes with ORKA-001.

• Sequential induction with ORKA-002 followed by maintenance with ORKA-001 may optimize efficacy and safety.

Competitive landscape and future plans

• Recent BIMZELX launch demonstrates market rewards for innovative biologics with higher efficacy.

• ORKA-001 and ORKA-002 are positioned as the only pipeline with strong candidates against both IL-23 and IL-17 targets.

• Expansion into indications beyond psoriasis, such as hidradenitis suppurativa and psoriatic arthritis, is planned after initial psoriasis focus.

• Safety profile considerations include minimizing oral candidiasis by limiting IL-17 exposure to induction phase.

• Multiple clinical catalysts are expected every six months, with robust endpoints and reproducible data anticipated.