ORKA — what changed in the latest 10-Q

Text added vs the prior filing · source: 10-Q · 2026-08-10

• Additionally, we commenced dosing in a Phase 2b clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-B”) in December 2025. EVERLAST-B enrolled 187 patients and is designed to evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, an…

• In addition, we expect to initiate the ORKA-001 Phase 3 program in the first half of 2027.

• In addition, we initiated ORCA-SPLASH, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe HS. ORCA-SPLASH is designed to enroll approximately 160 patients. Patients will be randomized 1:1 to receive 320 mg of ORKA-002 or placebo at Week 0, Week 4, Week 8, and Week 12. The primary endpoi…

• ORKA-004 is a novel, subcutaneously administered, extended half-life mAb designed to target TL1A. We anticipate initiating clinical development of ORKA-004 in the fourth quarter of 2026. We plan to pursue ORKA-004 in combination with ORKA-001 and ORKA-002, with Phase 2 combination trials planned to …

• In addition, we have a fourth program, ORKA-003, designed to target an undisclosed pathway. These additional programs provide the potential for indication expansion beyond PsO while maintaining our strategic focus in I&I diseases, and especially inflammatory dermatology conditions.

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• Additionally, the first patients were dosed in EVERLAST-B in December 2025. EVERLAST-B is designed to enroll approximately 160 patients into a dose-ranging Phase 2b trial of ORKA-001 in patients with moderate-to-severe PsO and will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at…

• Based on recent precedent in PsO, we anticipate that the overall development program, from first-in-human studies through biologics license application (“BLA”) submission, could take as little as six to seven years, based on averages observed for recently approved medicines. However, we have no cont…

• We have a third program, ORKA-003, designed to target an undisclosed pathway. Our strategy as a company is to remain highly focused on I&I diseases, and specifically on inflammatory dermatology conditions. Our third program provides the potential for indication expansion beyond PsO and may create co…

• Comparison of the Three Months Ended March 31, 2026 and 2025

• Research and development expenses increased by $9.2 million, from $19.9 million for the three months ended March 31, 2025 to $29.1 million for the three months ended March 31, 2026.

Text added vs the prior filing · source: 10-Q · 2026-08-10

• On May 14, 2026, Lawrence Klein, our President and Chief Executive Officer, adopted a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of up to 350,000 shares of our common stock over a period ending upon the earlier of when all shares under …

Text removed vs the prior filing · source: 10-Q · 2026-05-13

• On February 11, 2026, Arjun Agarwal, our Senior Vice President – Finance and Treasurer, adopted a Rule 10b5-1 trading arrangement intended to satisfy the affirmative defense of Rule 10b5-1(c) for the sale of shares of our common stock over a period ending upon the earlier of when all shares under th…