Oruka Therapeutics Reports $83.7 Million Net Loss and Initiates Phase 1 Trials

Oruka Therapeutics, Inc. (formerly ARCA biopharma, Inc.) reported a net loss of $83.7 million for the period from its February 6, 2024 inception to December 31, 2024. Research and development expenses totaled $75.1 million, primarily driven by external costs including $18.3 million for Paragon Therapeutics services related to ORKA-001 and $13.3 million for ORKA-002. General and administrative expenses reached $13.1 million. The company had $393.7 million in cash, cash equivalents, and marketable securities as of December 31, 2024, and anticipates these resources will fund operations for at least twelve months.

Significant changes occurred during the fiscal period, most notably the August 29, 2024 acquisition of Oruka Therapeutics, Inc. This merger, accounted for as a reverse recapitalization, resulted in a name change and a 1-for-12 reverse stock split of the common stock. The company also completed a private placement (PIPE Financing) raising approximately $188.7 million in net proceeds. The company's name changed from ARCA biopharma, Inc. to Oruka Therapeutics, Inc., and its Nasdaq ticker symbol changed from "ABIO" to "ORKA."

Key operational developments include the initiation of a Phase 1 trial for ORKA-001, a high-affinity, extended half-life monoclonal antibody targeting IL-23p19 for psoriasis treatment, in the fourth quarter of 2024. Interim data from this trial is expected in the second half of 2025, with initial efficacy data anticipated in the second half of 2026. A Phase 1 trial for ORKA-002, targeting IL-17A/F, is planned for the third quarter of 2025, with interim data expected in the first half of 2026. The company also has a third monoclonal antibody program, ORKA-003, targeting an undisclosed pathway. As of February 28, 2025, the company employed 36 full-time employees.

The company's strategy centers on applying antibody engineering and format innovations to validated modes of action to improve efficacy and dosing regimens while reducing risk. The company anticipates that its programs could take six to seven years from first-in-human trials to biologics license application (BLA) filing, though this timeline is subject to FDA review. The company's financial performance is heavily reliant on the success of its clinical trials and subsequent regulatory approvals and commercialization of its product candidates. The company acknowledges significant risks related to drug development, regulatory approval, financial condition, intellectual property, reliance on third parties, and market competition.

The company's outlook is contingent upon successful clinical development, regulatory approvals, and commercialization of its product candidates. The company expects to continue incurring substantial losses for the foreseeable future, with profitability dependent on achieving sufficient revenue to support its cost structure. The company's financial statements and supplementary data are included in the filing, along with detailed disclosures regarding related party transactions, accounting policies, and risk factors.