Oruka Therapeutics Reports Third Quarter 2025 Financial Results and Provides Corporate Update

Core Insights - Oruka Therapeutics, Inc. has reported promising Phase 1 results for ORKA-001, indicating potential for once-per-year dosing, higher efficacy, and extended off-treatment remission for chronic skin diseases like plaque psoriasis [1][6][12] - The company has a strong cash position of approximately $500.9 million, providing a runway beyond key upcoming clinical readouts [1][7] - ORKA-001 and ORKA-002 are both advancing in clinical trials, with ORKA-001's Phase 2a trial expected to provide data in the second half of 2026 [1][2][6] Financial Performance - For Q3 2025, Oruka reported a net loss of $30.3 million, compared to a net loss of $28.6 million in Q3 2024, with R&D expenses increasing to $29.0 million from $25.7 million year-over-year [7][8][11] - General and administrative expenses rose to $5.1 million in Q3 2025 from $3.8 million in Q3 2024, primarily due to increased employee compensation and consulting fees [9] - Other income increased significantly to $3.8 million in Q3 2025, up from $0.8 million in Q3 2024, attributed to higher interest income from marketable securities [10] Clinical Development Updates - ORKA-001 demonstrated a half-life of approximately 100 days, significantly longer than risankizumab, enhancing the potential for less frequent dosing [6] - The Phase 2a trial, EVERLAST-A, is currently enrolling participants, with results expected in 2H 2026, while a Phase 2b trial, EVERLAST-B, is set to begin in 1H 2026 [6][14] - ORKA-002 is in a Phase 1 trial, with interim data anticipated around the end of 2025, and a Phase 2 trial planned for 1H 2026 [1][6][14] Strategic Outlook - The company aims to establish a new standard for treating chronic skin diseases, focusing on achieving high rates of complete disease clearance with infrequent dosing [12] - Oruka is also exploring a sequential combination regimen of ORKA-002 and ORKA-001, which could enhance treatment efficacy for psoriatic disease [14] - The company is progressing ORKA-003 through preclinical development, indicating a robust pipeline for future growth [14]