Oruka Therapeutics Reports $20.999 Million Net Loss in Q1 2025 Amid Increased R&D Expenses

Oruka Therapeutics, Inc. reported a net loss of $20.999 million for the first quarter of 2025, a significant increase from the $7.077 million loss recorded during the same period in 2024. The company's total operating expenses surged to $25.086 million, up from $6.863 million in the prior year, primarily driven by a 284% increase in research and development costs, which reached $19.925 million. General and administrative expenses also rose to $5.161 million, reflecting the company's ongoing investments in its operational infrastructure and personnel.

The financial results reflect substantial changes compared to the previous fiscal period, particularly in the context of Oruka's recent merger with Pre-Merger Oruka, which was completed in August 2024. This merger, along with a reverse stock split, has positioned the company for growth in the biopharmaceutical sector, focusing on developing monoclonal antibody therapeutics for psoriasis and other inflammatory conditions. The company has not yet generated any revenue from product sales, as it remains in the clinical development phase.

Operationally, Oruka has made significant strides in its research programs, particularly with its lead candidates, ORKA-001 and ORKA-002, which target interleukin-23 and interleukin-17A/F, respectively. The company initiated a Phase 1 trial for ORKA-001 in late 2024 and plans to begin a Phase 1 trial for ORKA-002 in mid-2025. As of March 31, 2025, Oruka had cash, cash equivalents, and marketable securities totaling $373 million, which management believes will be sufficient to fund operations for at least the next twelve months.

The company has also expanded its workforce, with a notable increase in employee headcount to support its research and development efforts. As of the end of the first quarter, Oruka had incurred significant expenses related to external research and development, including costs associated with contract research organizations and clinical trial sites. The increase in operational costs is expected to continue as the company advances its clinical programs and prepares for potential commercialization.

Looking ahead, Oruka anticipates ongoing substantial losses as it invests in the development of its product candidates. The company is focused on achieving regulatory approvals and generating revenue from product sales in the future. However, it acknowledges the inherent uncertainties in clinical development and the need for additional financing to support its long-term growth strategy.