Oruka Widens Third-Quarter Loss as Clinical Spend Rises

The Tip Desk · November 12, 2026 · 3 min read

The clinical-stage biopharmaceutical company posted a $50.0 million net loss for the three months ended September 30, 2026, as research and development costs reached $53.7 million.

Oruka Therapeutics (ORKA), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for psoriasis and other inflammatory and immunology indications, reported a net loss of $50.0 million for the three months ended September 30, 2026, 65% wider than the $30.3 million loss a year earlier.

Research and development expenses rose to $53.7 million from $29.0 million a year earlier. General and administrative expenses were $8.4 million. Total operating expenses increased to $62.1 million. The company said it has not generated revenue from product sales and does not expect to in the foreseeable future.

Interest income was $12.2 million, compared with $3.8 million a year earlier. Cash, cash equivalents, and marketable securities were $1.2 billion as of September 30, 2026, versus $1.1 billion as of June 30, 2026. The accumulated deficit was $312.1 million. For the nine months ended September 30, 2026, the company used $101.0 million of net cash for operating activities. It said existing cash is expected to fund operating plans for at least twelve months from the filing date.

The quarter’s clinical news centered on the lead program ORKA-001, an extended half-life antibody targeting IL-23p19 for moderate-to-severe psoriasis. In September 2026, the company announced Week 28 data from the Phase 2a EVERLAST-A trial, showing efficacy that continued to deepen six months after the last dose: 71% of participants achieved PASI 100 and 87% achieved PASI 90, versus 63.5% PASI 100 at Week 16. Patients who initially received placebo and crossed over at Week 16 showed a similar response pattern; in that arm, 40% achieved PASI 100 at Week 28, compared with 43% of patients in the active arm at the equivalent timepoint. Two patients experienced serious adverse events, neither deemed drug related. The company said it expects to announce Week 52 data from EVERLAST-A in December 2026.

In October 2026, it announced Week 16 data from the Phase 2b EVERLAST-B trial, which enrolled 187 patients across four groups. In the 600 mg group, 61% of participants achieved the primary endpoint of PASI 100, a result the company said was highly consistent with EVERLAST-A. Efficacy increased in a dose-dependent manner, with the 600 mg group outperforming both lower dose groups on complete skin clearance. That group also showed 86% of patients achieving each of PASI 90 and IGA 0/1. Through Week 16, ORKA-001 was observed as well tolerated, with no injection-site reactions. Week 52 data from EVERLAST-B is expected in the second half of 2027.

Based on the EVERLAST program, the company said it intends to discuss Phase 3 plans with regulatory authorities. Pending those discussions, it plans to initiate Phase 3 trials of ORKA-001 in moderate-to-severe psoriasis in the first half of 2027 with the 600 mg dose.

Co-lead ORKA-002, targeting IL-17A/F, advanced on two fronts. ORCA-SURGE, the Phase 2 psoriasis trial started in February 2026, enrolled 171 patients, versus a prior design of approximately 160. Week 16 data from ORCA-SURGE is expected in the first quarter of 2027. In August 2026, the company initiated ORCA-SPLASH, a Phase 2 trial in hidradenitis suppurativa designed to enroll approximately 160 patients.

ORKA-004, an extended half-life antibody targeting TL1A, is still slated for clinical initiation in the fourth quarter of 2026, with Phase 2 combination trials planned for 2027. In August 2026, the company entered into the ORKA-003 license agreement with Paragon after having only an option agreement as of June 30, 2026. As of September 30, 2026, milestone payments incurred and expensed remained $7.0 million for each of ORKA-001 and ORKA-002, with no ORKA-003 milestones yet.

The company said it expects research and development and general and administrative expenses to increase substantially for the foreseeable future as it continues to invest in its programs, manufacturing, and clinical trials.