Core Insights - Oruka Therapeutics is advancing its clinical programs ORKA-001 and ORKA-002, which target chronic skin diseases like plaque psoriasis, with the potential to set a new treatment standard [2][12] Pipeline Developments - ORKA-001, targeting IL-23p19, has completed Phase 1 trial dosing, with data expected in Q3 2025. Phase 2a initiation is anticipated in 2H 2025, with efficacy readout expected in 2H 2026 [1][5] - ORKA-002, targeting IL-17A/F, has accelerated its Phase 1 initiation to Q2 2025, with initial pharmacokinetic (PK) data expected by the end of 2025 [1][5] - The Phase 2a study for ORKA-001 will enroll approximately 80 patients and aims for a primary endpoint of PASI 100 at week 16, which is more ambitious than previous studies [5] Financial Position - As of March 31, 2025, Oruka has a strong cash position of 373 million, providing a runway through 2027 [1][7] - Research and Development (R&D) expenses for Q1 2025 totaled 19.9 million, reflecting increased investment in clinical development [8] - General and Administrative (G&A) expenses for Q1 2025 were $5.2 million, driven by employee compensation and operational growth [9] Clinical Data and Efficacy - Interim data from the ORKA-001 Phase 1 trial is expected in Q3 2025, with a focus on safety, tolerability, and pharmacokinetics [5] - ORKA-002 has shown a half-life in non-human primates of over 30 days, supporting a dosing interval of two to three times per year [5] Market Potential - The company aims to achieve high rates of complete disease clearance for patients with chronic skin diseases, with dosing as infrequently as once or twice a year [12]
Oruka Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update