ORKA — what changed in the latest 10-Q
A section-by-section comparison of ORKA's newest periodic SEC filing (10-K/10-Q) against the prior same-form filing: paragraphs added and removed per section, with verbatim excerpts. Purely a deterministic text diff — no similarity scores, no directional read, not investment advice.
Comparing 10-Q · 2026-08-10 vs the prior 10-Q · 2026-05-13
| Section | Outcome | Added | Removed | Minor | Unchanged |
|---|---|---|---|---|---|
| MD&A | Text added/removed | +27 | −11 | ~42 | 23 |
| Market risk (Item 3) | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Controls & procedures | Text added/removed | 0 | 0 | ~1 | 4 |
| Legal proceedings | No paragraph-level changes | 0 | 0 | 0 | 1 |
| Risk factors | Text added/removed | 0 | 0 | ~15 | 250 |
| Other information | Text added/removed | +1 | −1 | ~2 | 0 |
Counts are paragraphs; added/removed means text added or removed vs the prior filing — no direction or judgement implied.
Representative excerpts
Up to 5 excerpts of about 300 characters per section, quoted verbatim from the two SEC filings.
MD&A
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.
Other information
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…
How to read Risk Factors (Item 1A) in a 10-Q
A 10-Q risk-factor section usually takes one of three forms; this page classifies it as one of:
- Pointer — the filer states there have been no material changes and points back to the annual 10-K risk factors; there is no own risk text to compare this quarter.
- Partial update — the filer carves out specific updated risks ("except as set forth below"); the excerpts show exactly what is new this quarter.
- Restated in full — the quarter carries the complete risk-factor text. When the prior quarter was only a pointer there is no prior full text to diff against, so the page flags the section as restated instead.
This describes the filing structure only — it is never a judgement on whether risk went up or down.
Source: text-level diff of the two SEC EDGAR filings · deterministic (no AI-generated content) · for reference only · not investment advice