Oruka Therapeutics, Inc.

What they do

Oruka develops novel monoclonal antibody therapeutics for psoriasis (PsO) and other inflammatory and immunology (I&I) indications. Its lead program ORKA-001 targets IL-23p19, and its co-lead ORKA-002 targets IL-17A/F; ORKA-004 targets TL1A. The company has never generated product revenue and has funded operations primarily through convertible preferred stock, common stock, a convertible note, and pre-funded warrants.

Revenue drivers

• ORKA-001 (IL-23p19) — Lead program for moderate-to-severe plaque psoriasis; no product sales to date and no revenue recognized, as the company is clinical-stage.
• ORKA-002 (IL-17A/F) — Co-lead program being studied in psoriasis and hidradenitis suppurativa; remains pre-commercial and generates no revenue.
• ORKA-004 (TL1A) — Discovery-stage half-life extended antibody planned for clinic entry in Q4 2026 and eventual combination studies; no revenue.

Recent performance

Annual revenue has been $0.00 every year from 2019 through 2023, and the company reported no revenue from product sales. Net losses were $83.7 million in 2024 and $105.4 million in 2025, with operating cash use of $57.8 million and $88.2 million in those years. For the three and six months ended June 30, 2026, net losses were $41.2 million and $73.0 million, respectively, and net cash used in operating activities was $56.7 million in the first half of 2026. As of June 30, 2026, total assets were $1.14 billion, total liabilities $24.8 million, and shareholder equity $1.11 billion, with $268.5 million in cash and equivalents and $1.1 billion in cash, cash equivalents and marketable securities.

Strategy

Oruka applies antibody engineering and format innovations to validated modes of action, aiming to improve on the efficacy and dosing regimens of standard-of-care medicines. It intends to target mechanisms with proven efficacy and safety involving pathogenic tissue-resident memory T cells. In April 2026 the company priced an upsized $700 million public offering to fund operations through an anticipated BLA filing for ORKA-001 and continued ORKA-002 development. In May 2026 it amended its IL-23 license agreement with Paragon Therapeutics to include all therapeutic areas, adding inflammatory bowel disease. It also plans Phase 2 combination studies of ORKA-004 with ORKA-001 and ORKA-002 beginning in 2027.

Risks

• Limited operating history and no approved products — The company is clinical-stage with ongoing trials, has no products approved for sale, and has never generated revenue from product sales.
• Recurring losses and cash consumption — Net losses were $83.7 million in 2024 and $105.4 million in 2025, with $88.2 million of operating cash used in 2025 and $56.7 million used in the first half of 2026.
• Need to raise additional capital — The company may not be able to raise needed capital, and additional raises could dilute stockholders, restrict operations, or require relinquishing rights to technologies or product candidates.
• Clinical and regulatory uncertainty — Success of product candidates depends on factors the company does not fully control, including aspects of clinical development and the regulatory submission process.

Outlook

Management expects Week 28 EVERLAST-A data at the end of Q3 2026 and 52-week data in December 2026. EVERLAST-B Week 16 data is now expected in Q4 2026, and a Phase 3 program for ORKA-001 is expected to begin in the first half of 2027. ORCA-SURGE Week 16 data is accelerated to Q1 2027, and ORKA-004 is expected to enter the clinic in Q4 2026. Cash, cash equivalents and marketable securities of $1.1 billion are expected to fund the company through a BLA filing for ORKA-001.