ORKA-001 / Oruka Therapeutics - LARVOL DELTA

The company is simultaneously expanding the broader pipeline. (Pulse 2.0) - "ORKA-004, a half-life extended monoclonal antibody targeting TL1A, is expected to enter clinical development during the fourth quarter of 2026. Oruka plans Phase 2 studies combining ORKA-004 with ORKA-001 and ORKA-002 beginning in 2027."

New P2 trial • Immunology

EVERLAST-B: Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=160 | Active, not recruiting | Sponsor: Oruka Therapeutics, Inc. | Recruiting ➔ Active, not recruiting

Enrollment closed • Dermatology • Immunology • Psoriasis

Oruka Therapeutics Expands Into IBD As $1.1 Billion Cash Position Funds ORKA-001 Through BLA Filing (Pulse 2.0)

Financing • Inflammatory Bowel Disease

Oruka expects Week 28 data at the end of Q3 2026 and 52-week data in December, which will help assess whether the therapy can support dosing only once or twice per year. (Pulse 2.0) - "Oruka has also fully enrolled the 187-patient EVERLAST-B Phase 2b trial and plans to begin a Phase 3 ORKA-001 program in the first half of 2027."

Enrollment closed • New P3 trial • P2a data • Immunology • Plaque Psoriasis • Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=240 | Recruiting | Sponsor: Oruka Therapeutics, Inc. | N=80 ➔ 240 | Trial completion date: Jan 2029 ➔ Jul 2030 | Trial primary completion date: Nov 2028 ➔ May 2030

Enrollment change • Trial completion date • Trial primary completion date • Dermatology • Immunology • Psoriasis

In April 2026, the Company announced the pricing of an upsized $700 million public offering (GlobeNewswire) - "Proceeds from this offering, including existing cash, are expected to fund operations through an anticipated BLA filing for ORKA-001 and continued development of ORKA-002."

Financing • Hidradenitis Suppurativa • Psoriasis

ORKA-001-114: Dose Ranging Study of ORKA-001 in Patients with Moderate-to-Severe Plaque Psoriasis (EVERLAST-B) (clinicaltrialsregister.eu) - P1/2 | N=16 | Not yet recruiting | Sponsor: Oruka Therapeutics Inc.

New P1/2 trial • Dermatology • Immunology • Psoriasis

Halozyme and Oruka Announce Global Collaboration and License Agreement to Develop ORKA-001 with Hypercon Technology (PRNewswire) - "Under the agreement, Oruka has licensed Halozyme's Hypercon technology for use with ORKA‑001, in development for psoriasis and related inflammatory diseases, and up to one additional target....Under the terms of the agreement, Oruka will make an upfront payment to Halozyme and potential future milestone payments. Halozyme will also be eligible to receive mid-single digit royalties on net sales of products developed using the Hypercon technology."

Licensing / partnership • Inflammation • Psoriasis

Upcoming Milestones for ORKA-001 (GlobeNewswire) - "Oruka plans to share longer-term data from EVERLAST-A, including efficacy at Week 28 for all patients and 52-week follow-up for a subset of the cohort, in the second half of 2026. The Company also continues to advance the Phase 2b EVERLAST-B trial, with data expected in 2027."

P2a data • Trial status • Plaque Psoriasis • Psoriasis

Oruka Therapeutics Announces Positive Week 16 Data for ORKA-001 from the Ongoing EVERLAST-A Phase 2a Trial in Moderate-to-Severe Plaque Psoriasis (GlobeNewswire) - "40 of 63 participants (63.5%) treated with ORKA-001 achieved the primary endpoint of PASI 100 at Week 16, representing complete skin clearance. Identical results were observed for IGA 0. Other key secondary endpoints included PASI 90 at Week 16, achieved by 83% of participants, and IGA 0/1 at Week 16, achieved by 84% of participants. One of 21 participants receiving placebo reached PASI 100, IGA 0, PASI 90, and IGA 0/1 at Week 16, in line with historical psoriasis trials...ORKA-001 was well tolerated...Following a single 600 mg dose, ORKA-001 concentrations remained well above effective trough levels for an entire year, with sustained inhibition of IL-23 pathway signaling observed throughout that time period....Oruka Therapeutics’ live webcast of the EVERLAST-A results will begin today at 8:00 a.m. ET."

P2a data • PK/PD data • Plaque Psoriasis • Psoriasis

ORKA-001-111: ORKA-001 in Healthy Volunteers (clinicaltrials.gov) - P1 | N=24 | Completed | Sponsor: Oruka Therapeutics, Inc. | Active, not recruiting ➔ Completed

First-in-human • Trial completion

EVERLAST-A: ORKA-001 Versus Placebo in Patients With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=80 | Active, not recruiting | Sponsor: Oruka Therapeutics, Inc. | Recruiting ➔ Active, not recruiting | Trial primary completion date: Sep 2026 ➔ Apr 2026

Enrollment closed • Trial primary completion date • Dermatology • Immunology • Psoriasis

ORKA-001: A novel half-life extended IL-23p19 monoclonal antibody (GlobeNewswire) - "Enrollment in EVERLAST-A was completed in December 2025. As a result, the Company now expects to report Week 16 data for all patients in the second quarter of 2026. In addition, the Company plans to provide longer-term data, including Week 28 for all patients and 52-week follow-up for a portion of the cohort in the second half of 2026....EVERLAST-B is evaluating multiple induction regimens of ORKA-001, with a primary endpoint of PASI 100 at Week 16. Data from EVERLAST-B is anticipated in 2027 and will be used to support initiation of a Phase 3 program."

Enrollment closed • P2 data • Psoriasis

An Open-Label Extension Study of ORKA-001 in Participants With Plaque Psoriasis (clinicaltrials.gov) - P2 | N=80 | Recruiting | Sponsor: Oruka Therapeutics, Inc.

New P2 trial • Dermatology • Immunology • Psoriasis

High-Dose, Extended Half-Life IL-23 Inhibitors: the Next Big Step in Psoriasis Care? (PubMed, Dermatol Ther (Heidelb)) - "Phase 1 data demonstrate a terminal half-life of approximately 100 days, sustained pharmacodynamic suppression of IL-23 signaling, and a favorable safety profile. Ongoing clinical development aims to determine whether high-dose, long-acting IL-23 inhibition can enable prolonged remission with infrequent or no maintenance dosing, challenging current paradigms of lifelong continuous therapy in psoriasis."

Journal • Dermatology • Fatigue • Immunology • Psoriasis • IL17A • IL23A

ORKA-001 Updates (GlobeNewswire) - "The first patients were dosed in EVERLAST-B in December 2025, and enrollment is ongoing. EVERLAST-B is evaluating three induction dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo...Data from EVERLAST-B is anticipated in 2027....The EVERLAST-A study is ongoing, and the Company continues to expect to share PASI 100 data at Week 16 for all patients, as well as response duration data out to approximately one year for some patients, in 2H 2026."

P2 data • Trial status • Psoriasis

EVERLAST-B: Dose Ranging Study of ORKA-001 in Patients With Moderate-to-Severe Plaque Psoriasis (clinicaltrials.gov) - P2 | N=160 | Recruiting | Sponsor: Oruka Therapeutics, Inc.

New P2 trial • Dermatology • Immunology • Psoriasis

EVERLAST-A: A Phase 2a Study Design of ORKA-001, a Novel Half-Life Extended IL-23p19 Monoclonal Antibody for Plaque Psoriasis (ISDS 2025) - "ORKA-001 is a novel half-life extended monoclonal antibody targeting IL-23p19 with similar potency and epitope binding to risankizumab... EVERLAST-A is a Phase 2 proof-of-concept study evaluating efficacy and safety of ORKA-001 in adults with moderate-to-severe psoriasis. The study aims to investigate whether high induction doses of ORKA- 001 can lead to increased rates of skin clearance and prolonged durability of responses."

P2a data • Dermatology • Immunology • Psoriasis • IL23A

Additional…updates (GlobeNewswire) - "The Company completed a $180M PIPE financing, extending runway over one year past three Phase 2 catalysts: the ORKA-001 Phase 2a and 2b studies (EVERLAST-A and -B), and the ORKA-002 Phase 2 study in PsO."

Financing • Psoriasis

Additional programs… (GlobeNewswire) - "(i) ORKA-021 (ORKA-002 → ORKA-001): Oruka continues to advance a sequential combination regimen of ORKA-002 and ORKA-001, which could deliver rapid and deep responses with an ideal maintenance profile. ORKA-021 could create another opportunity for the Company to define the best possible regimen for the treatment of psoriatic disease; (ii) ORKA-003: The Company continues to progress ORKA-003 through preclinical development."

Pipeline update • Psoriasis

Oruka plans to initiate a dose-ranging Phase 2b trial of ORKA-001, EVERLAST-B, in 1H 2026 (GlobeNewswire) - "EVERLAST-B will evaluate three dose levels of ORKA-001: 37.5 mg at Week 0, 300 mg at Weeks 0 and 4, and 600 mg at Weeks 0 and 4, versus placebo. The primary endpoint is PASI 100 at Week 16. To expedite development, EVERLAST-B dosing is projected to begin enrolling before the completion of EVERLAST-A."

New P2b trial • Psoriasis

Enrollment is progressing well in EVERLAST-A, a randomized, double-blind, placebo-controlled Phase 2a trial of ORKA-001 in moderate to severe PsO (GlobeNewswire) - "The Company expects to share PASI 100 data at Week 16 for all patients, as well as response duration data out to approximately one year for some patients, in 2H 2026."

Enrollment status • P2a data • Psoriasis

Phase 1 clinical data of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody with potential for once-yearly dosing in plaque psoriasis (EADV 2025) - "Conclusion PK and PD results in this Phase 1 study of ORKA-001 support the potential for once-yearly dosing while maintaining trough antibody concentrations above approved IL-23 targeting antibodies like risankizumab...ORKA-001 was well-tolerated across all dose levels, with a favorable safety profile consistent with the IL-23p19 inhibitor class. These attributes are being further explored in an ongoing Phase 2a study, EVERLAST- A, which is evaluating efficacy and safety of ORKA-001 in adults with moderate-to-severe psoriasis."

Clinical data • Late-breaking abstract • P1 data • Dermatology • Immunology • Infectious Disease • Psoriasis • Respiratory Diseases • IL23A

EVERLAST-A: A phase 2a study design of ORKA-001, a novel half-life extended IL-23p19 monoclonal antibody for plaque psoriasis (EADV 2025) - "ORKA-001 is a novel half-life extended monoclonal antibody targeting IL-23p19 with similar potency and epitope binding to risankizumab... EVERLAST-A is a Phase 2 proof-of-concept study evaluating efficacy and safety of ORKA-001 in adults with moderate-to-severe psoriasis. The study aims to investigate whether high induction doses of ORKA-001, a novel IL-23p19 inhibitor with an extended half-life, can lead to increased rates of skin clearance and prolonged durability of responses. This dosing strategy could support infrequent individualized dosing and potentially lead to disease remission in some individuals."

P2a data • Dermatology • Immunology • Psoriasis • IL23A

…Oruka expects to initiate a dose-ranging Phase 2b trial of ORKA-001 in moderate-to-severe PsO patients, EVERLAST-B, in 1H 2026. (GlobeNewswire)

New P2b trial • Psoriasis