Oruka Therapeutics (ORKA) investor relations material

Pipeline and strategy

• ORKA-001, an ultra-long-acting IL-23p19 antibody, and ORKA-002, an IL-17A/F antibody, are co-lead programs in phase II; intended ORKA-001 dosing profile is potentially annual, with a six-month option.

• ORKA-004 is an extended half-life TL1A program; the leading strategy is a proprietary ORKA-002 plus ORKA-004 combination for HS, aimed at improving on monotherapy efficacy.

• ORKA-004 phase I is planned around year-end, with a TL1A combination study planned for next year; HS is the leading indication for the combination.

ORKA-001 results and readouts

• Two independent randomized, placebo-controlled phase II studies showed similar 600 mg results: low-60% PASI 100 and mid-80% PASI 90; efficacy was similar to the best observed with BIMZELX.

• Higher antibody exposure was cited as the rationale for stronger responses; ORKA-001 showed response rates close to 20 percentage points above other IL-23 agents at week 16.

• December week 52 data from EVERLAST-A will assess maintenance after induction without further dosing; PASI 100 maintenance is a key metric, with 50%-80% described as the range supporting annual dosing.

• PK supports potential year-long drug coverage, while the strict PASI 100 threshold and natural disease fluctuation may affect observed maintenance; 60% maintenance was described as a strong profile.

• EVERLAST-B includes a no-dose arm and more patients followed to one year; resident memory cell biopsy analyses may take longer, with two- or three-year follow-up potentially informative on durable responses.

ORKA-001 development plans

• Phase III is targeted for the first half of next year; end-of-phase discussions are being prepared following EVERLAST-B week 16 data, with CMC and site-start requirements advanced.

• Phase III is expected to include an active comparator, likely not an IL-23p19; STELARA was cited as a possible choice given its expected biosimilar timing.