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Oruka Therapeutics (ORKA) investor relations material

Oruka Therapeutics Study Presentation summary

Complete event summary combining all related documents: earnings call transcript, report, and slide presentation.
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Study Presentation summary18 Sep, 2025

Mechanism of action and molecular design

  • ORKA-001 is a humanized IgG1 monoclonal antibody targeting the p19 subunit of IL-23, inhibiting its receptor interaction.

  • Engineered Fc region ablates effector function and extends half-life via YTE substitutions, increasing FcRn binding and recycling.

  • Demonstrates similar epitope binding and potency to risankizumab in multiple assays.

Phase 1 trial design and participant characteristics

  • Double-blind, placebo-controlled, single ascending dose study in healthy adults, with 3 dose cohorts (300, 600, 1200 mg SC).

  • Primary endpoints: safety and tolerability; secondary: pharmacokinetics; exploratory: pharmacodynamics.

  • Baseline demographics were typical for healthy volunteers, with balanced age, sex, and BMI across cohorts.

Safety and tolerability

  • Safety profile consistent with IL-23p19 inhibitors; no serious adverse events or discontinuations due to adverse events.

  • Most common adverse events were headache, upper respiratory tract infection, and transient injection site erythema.

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Q3 202512 Nov, 2025
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Frequently asked questions

Oruka Therapeutics Inc. is a biopharmaceutical company focused on developing innovative treatments for various medical conditions. The company specializes in research and development activities, aiming to address unmet medical needs through advanced therapeutic solutions. Oruka Therapeutics operates within the healthcare sector, leveraging cutting-edge technologies to create potential treatments for patients worldwide. The company is headquartered in Westminster, Colorado, and its shares are listed on the Nasdaq.

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