ORKA — what changed in the latest 10-Q

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

• We initiated a Phase 1 trial of ORKA-001 in the fourth quarter of 2024. In September 2025, we announced interim results and updated those results in April 2026. The data showed that ORKA-001 has a human half-life of approximately 100 days and was well tolerated at all dose levels, with a favorable s…

• In the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-A”). EVERLAST-A enrolled 84 patients randomized 3:1 to receive 600 mg of ORKA-001 at Weeks 0 and 4 or matching placebo. At Week 28, patients who…

• 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…

• In January 2026, we announced interim findings from the Phase 1 trial of ORKA-002 in healthy volunteers. The results showed that ORKA-002 has a half-life of approximately 75-80 days, which supports the potential for twice-yearly maintenance dosing in PsO and quarterly maintenance dosing in HS. Singl…

• Based on these Phase 1 results, we initiated ORCA-SURGE, a Phase 2 trial of ORKA-002 in patients with moderate-to-severe PsO, in February 2026. ORCA-SURGE is designed to enroll approximately 160 patients randomized 1:1:1:1 to receive 40 mg, 160 mg or 320 mg of ORKA-002 at Weeks 0 and 4, or matching …

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• We initiated a Phase 1 trial of ORKA-001 in the fourth quarter of 2024 and in September 2025, we announced the interim results at the European Academy of Dermatology and Venereology (EADV) Congress. ORKA-001 showed a half-life of approximately 100 days. Single doses of ORKA-001 demonstrated complete…

• In the third quarter of 2025, we commenced dosing in a Phase 2a clinical trial of ORKA-001 in patients with moderate-to-severe PsO (also known as “EVERLAST-A”). We expect to share efficacy and response duration data from this study in the second half of 2026. EVERLAST-A is expected to enroll approxi…

• Additionally, in the third quarter of 2025, we announced our plans to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients (also known as “EVERLAST-B”) in the first half of 2026. EVERLAST-B will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Wee…

• We view ORKA-002 and ORKA-001 as highly complementary. Patients with moderate-to-severe PsO that have purely skin manifestations are most often treated with IL-23 inhibitors due to the high efficacy and tolerability of this mechanism. However, for patients who also have joint involvement, or signs a…

• We have a third mAb 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 creat…

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

• ● Future sales of shares, or the anticipation of such sales, by existing stockholders could cause our stock price to decline.

• ● progress our chemistry, manufacturing and control development, registration, and validation, including the manufacture of our product candidates by third parties, including increasing volumes manufactured by third parties;

• Even if we are successful in raising additional capital, the amount of capital we raise may be limited or restricted due to investor demand, market conditions, or other factors.

• To the extent that we raise additional capital through the sale of equity securities or convertible debt securities, the ownership interest of our stockholders will be diluted, and the terms of these securities may include liquidation or other preferences that adversely affect the rights of holders …

• ● The number of subjects required for clinical trials of any product candidates may be larger than we anticipate, especially if regulatory bodies require completion of non-inferiority or superiority trials.

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• ● Our patents and our ability to protect our products may be impaired by changes to patent laws, and our patent protection could be reduced or eliminated for non-compliance with legal requirements.

• ● We may fail to identify or interpret relevant third-party patents.

• ● Patent terms may be inadequate to protect our competitive position of our programs.

• ● Third parties we rely on for the execution of nonclinical studies and clinical trials may fail to carry out their contractual duties.

• ● In order to successfully implement our plans and strategies, we will need to grow the size of our organization, and we may experience difficulties in managing this growth.

Text added 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…

Text removed vs the prior filing · source: 10-Q · 2025-11-12

• On September 19, 2025, Joana Goncalves, our Chief Medical 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 151,000 shares of our common stock over a period ending upon the earlier of when all shares under the plan …