Business
Oruka Therapeutics Reports First Quarter 2025 Financial Results and Provides Corporate Update
Continued operational excellence leading to acceleration of multiple timelines: ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data
About this update from Oruka Therapeutics, Inc.
[{"type":"text","content":"Continued operational excellence leading to acceleration of multiple timelines: ORKA-001, targeting IL-23p19, Phase 1 trial dosing complete, with data expected in 3Q 2025 ORKA-001 Phase 2a initiation expected in 2H 2025, with efficacy readout expected in 2H 2026 that will provide multiple opportunities to show differentiation over standard of care ORKA-002, targeting IL-17A/F, Phase 1 initiation accelerated to 2Q 2025, with initial PK data now expected around YE 2025; data will support both ORKA-002 and ORKA-021 psoriasis studies Strong cash position of $373 million provides runway through 2027, over one year past anticipated ORKA-001 Phase 2a data in psoriasis MENLO PARK, Calif., May 14, 2025 (GLOBE NEWSWIRE) -- Oruka Therapeutics, Inc. (“Oruka”) (Nasdaq: ORKA), a clinical-stage biotechnology company developing novel biologics designed to set a new standard for the treatment of chronic skin diseases including plaque psoriasis, today reported first quarter 2025 financial results and provided a corporate update. “We are thrilled with the continued rapid progress we are making to advance our co-lead programs, which we think could set a new standard in the treatment of psoriatic disease,” said Lawrence Klein, PhD, Chief Executive Officer of Oruka. “We’re excited to soon have both of our co-lead programs, ORKA-001 and ORKA-002, in the clinic and release our first clinical data on ORKA-001. As we ramp up preparations for our first psoriasis studies, we are energized by the reception from physicians who clearly see the potential to advance the treatment paradigm in this important disease.” First Quarter Business and Pipeline Updates ORKA-001: a novel half-life extended IL-23p19 monoclonal antibody Oruka’s Phase 1 trial of ORKA-001 is progressing, with dosing completed for all 24 subjects across three dose levels. The trial is a double-blind, placebo-controlled, single ascending dose study evaluating the safety, tolerability, and pharmacokinetics (PK) of ORKA-001. The Company expects to share interim data from this trial, including initial PK data, in 3Q 2025 (previously 2H 2025).Based on PK modeling, the Company expects that a human half-life of 50 days or more will support dosing every six months whereas a half-life of 75 days or more could support dosing once per year. In comparison, currently approved IL-23p19 inhibitors require ma...