Oruka Therapeutics, Inc. · NASDAQ:ORKA

Oruka Therapeutics — Investor Presentation (May 2025)

33 slides from Oruka Therapeutics's investor presentation, May 2025

  1. Slide 1: Corporate Overview

    Corporate Overview NASDAQ: ORKA May 2025 ©2025 ORUKA THERAPEUTICS

  2. Slide 2: Disclaimers

    Disclaimers The information contained in this presentation has been prepared by Oruka Therapeutics, Inc. (the “Company”) and contains information pertaining to the business and operations of the Company. The information contained in this presentation: (a) is provided as at the date hereof, is subjec

  3. Slide 3: Fully funded through a potential psoriasis breakthrough

    Fully funded through a potential psoriasis breakthrough 2024 was a year of • Raised >$475M in two oversubscribed transactions and went public via reverse merger superb execution... • Lead program ORKA-001 entered the clinic in December 2024, well ahead of schedule • Better biologics overdeliver in P

  4. Slide 4: On a mission to enable freedom from chronic skin disease

    On a mission to enable freedom from chronic skin disease Our goal Our approach Help patients with chronic Advance potentially best-in-class antibodies targeting mechanisms with skin conditions experience the proven efficacy and safety greatest possible freedom POTENTIAL from disease PROGRAM DISCOVER

  5. Slide 5: Bimzelx launch shows that better biologics will win in psoriasis

    Bimzelx launch shows that better biologics will win in psoriasis Bimzelx versus Sotyktu performance validates our thesis Script volume from recent U.S. launches in psoriasis1 • UCB’s Bimzelx launch has exceeded expectations, 1,800 driven by strong demand – consensus sales of Bimzelx (approved Oct ’2

  6. Slide 6: The psoriasis market will continue to reward biologic innovation

    The psoriasis market will continue to reward biologic innovation Psoriasis is a massive, growing market where biologics are still underpenetrated $30B+ growing market today with further potential in mild-to-moderate disease Shown by major investments Pharma believes in the in orals, which sacrifice

  7. Slide 7: ORKA-001 & -002 complement each other to address all PsO/PsA

    ORKA-001 & -002 complement each other to address all PsO/PsA ORKA-001 ORKA-002 For patients with joint involvement, For patients with purely skin disease including PsA, or recalcitrant skin disease Majority of dermatologists Anti-IL-17 preferred, and IL-17A/F prefer an anti-IL-23p19 emerging as the

  8. Slide 8: Multiple orthogonal paths for Oruka to maximize differentiation

    Multiple orthogonal paths for Oruka to maximize differentiation Greater efficacy KNOCKOUT demonstrates potential for highest ever efficacy from higher IL-23 antibody exposure Maximizes odds of Long-term “remissions” having a strong value Ultra-long dosing High exposures of anti-IL-23 could lead to p

  9. Slide 9: Clinical data catalysts coming every six months going forward

    Clinical data catalysts coming every 6 months going forward 2025 2026 Beyond ORKA-001 PsO Ph2a: FIH Ph1 Interim PK Final PK PASI 100 & (Q4 2024) in HVs in HVs response (Q3 2025) duration Major clinical catalyst planned every six months ORKA-002 Interim PK FIH Ph1 Final PK in HVs (Q2 2025) in HVs (~Y

  10. Slide 10: ORKA-001: potentially best-in-class anti-IL-23p19

    ORKA-001: potentially best-in-class anti-IL-23p19

  11. Slide 11: Biologics have raised the bar in PsO, but there is ample room for improvement

    Biologics have raised the bar on standard of care in PsO, but there is ample room for improvement 80 60 PASI 100 (Week 16) (%) ORKA-001 target range 40 20 0 0 4 8 12 16 20 24 28 32 36 40 44 48 52 Time Between Doses (Weeks) Anti-IL-23 Anti-IL-17A/F Anti-TNF Highly safe; no AEs / SAEs of note Black bo

  12. Slide 12: Base case is best-in-class, upside could be paradigm changing

    Base case is best-in-class, upside could be paradigm changing Base case scenario Upside scenario Once per year and/or Dosing interval Once per six months patient-specific Comparable PASI 100 Better PASI 100 Efficacy to Skyrizi than Skyrizi Best-in-class profile Paradigm-changing ©2025 Oruka Therapeu

  13. Slide 13: ORKA-001 could be the last word in IL-23p19 inhibitors

    ORKA-001 could be the last word in IL-23p19 inhibitors Binds similar epitope to Skyrizi (risankizumab) with similar potency • Validated mechanism of action • Specific for IL-23p19 (not IL-12/23 p40) • KD < 5 pM • Predicted equivalent safety • Predicted to meet or beat efficacy Novel IP for compositi

  14. Slide 14: ORKA-001 binds a similar epitope as risa with similar potency

    ORKA-001 binds a similar epitope as risa with similar potency ORKA-001 binds a nearly identical epitope to risankizumab ORKA-001 shows comparable potency to risankizumab Inhibition of IL-17 release in human PBMCs 120 ORKA-001 100 Risankizumab IL23p40 80 % Inhibition 60 40 20 0 10 -2 10 -1 10 0 10 1

  15. Slide 15: Clinical experience with YTE predicts significant t1/2 extension

    Clinical experience with YTE predicts significant t1/2 extension ORKA-001 has a >3x longer half-life Implies ORKA-001 could have a than risankizumab in NHPs significantly longer half-life in humans ORKA-001 (IV) Risa (IV) For YTE mAbs, human t1/2 ≈ 2-4x NHP t1/2 based 1000 ORKA-001 (SC) Risa (SC) on

  16. Slide 16: Base case is achievable even at lower end of predicted half-life

    Base Base case is achievable even at lower end of predicted half-life ORKA-001 exposure could exceed Skyrizi under a variety of half-life scenarios ORKA-001 (~50d half-life): 300 mg W0, 4, Q6M Skyrizi: 150 mg W0, 4, Q12W (approved regimen) ORKA-001 (~75d half-life): 300 mg W0, 4, Q6M 50 50 Even at a

  17. Slide 17: ORKA-001 benefits from a large body of clinical evidence with IL-23 inhibition

    Base ORKA-001 benefits from a large body of clinical evidence with IL-23 inhibition Skyrizi regimen in UC establishes the safety of very high exposures Very uncommon to have clinical precedent in large numbers of patients for the safety of higher exposures 600 Skyrizi: 1200 mg W0, 4, 8 (IV) then 360

  18. Slide 18: Dermatologists view the base case as highly attractive

    Base Dermatologists view the “base case” as highly attractive In the “base case,” dermatologists would put half of new patients on Multiple examples support dosing as a ORKA-001 even when accounting for entry of new oral medicines major commercial differentiator: PsO vs. 75% Q12W Q8W % of patients t

  19. Slide 19: Three potential upside scenarios for ORKA-001

    Upside Three potential upside scenarios for ORKA-001 Superior efficacy 1-year dosing interval Disease modification Higher exposure could Enabled by half-life Patient-specific dosing to allow drive higher PASI 100 extension for treatment-free remissions ©2025 Oruka Therapeutics 19

  20. Slide 20: Higher exposures drove higher efficacy in KNOCKOUT study

    Upside Higher exposures drove higher efficacy in KNOCKOUT study KNOCKOUT evaluated 2-4x the approved Skyrizi dose… …and resulted in the highest PASI 100 rates observed to date 100 Double-blind Double-blind follow-up KNOCKOUT (pooled across dose levels) Screening dosing (W0-16) (W16-52) UltIMMa-1/2 (

  21. Slide 21: ORKA-001 could drive higher efficacy based on KNOCKOUT and exposure-response trend

    Upside ORKA-001 could drive higher efficacy based on KNOCKOUT and a consistent exposure-response trend across trials Risankizumab induction phase (0-16 weeks) Risankizumab steady-state phase (40-52 weeks) 100 100 80 80 Exposure KNOCKOUT deciles PASI 100 (%) PASI 100 (%) 60 Exposure 60 Projected deci

  22. Slide 22: KNOCKOUT-like exposures are possible with one dose per year

    Upside KNOCKOUT-like exposures are possible with one dose per year 80 ORKA-001 (~75d half-life): 600 mg Q12M Skyrizi: projected KNOCKOUT exposure (pooled) Skyrizi: steady-state (W52) Ctrough in Phase 3 trials 60 With a ~75-day half-life, [Ab] (μg/mL) ORKA-001 at one dose per year could match or 40 e

  23. Slide 23: Potential for disease modification or cure by depleting TRMs

    Upside Potential for disease modification or cure by depleting TRMs Anti-IL-23 acts upstream of disease-causing TRMs, Leading to long-lasting remissions after treatment and has a unique ability to deplete them from tissue withdrawal – pointing to possibility of disease modification 15% Loss of PASI

  24. Slide 24: ORKA-001 development path sets up a catalyst-rich next 2 years

    ORKA-001 development path sets up a catalyst-rich next 2 years 2025 2026 Phase 1 study to evaluate the safety, tolerability, and PK of ORKA-001 in Phase 1 in HVs healthy participants • Placebo-controlled, single ascending Phase 2a/b in PsO dose study (NCT06698939) 1200 mg SC FIH Ph1 Interim PK in HV

  25. Slide 25: Phase 2a to test KNOCKOUT-like exposures of ORKA-001

    Phase 2a to test KNOCKOUT-like exposures of ORKA-001 Phase 2a proof-of-concept study of ORKA-001 in moderate-to-severe psoriasis Induction Maintenance ORKA-001 ORKA-001 Q6M • Phase 2a expected to N ~80 OLE start in 2H 2025 Placebo ORKA-001 No dose until disease recurrence • Initial efficacy data exp

  26. Slide 26: ORKA-002: potentially best-in-class anti-IL-17A/F

    ORKA-002: potentially best-in-class anti-IL-17A/F

  27. Slide 27: IL-17A/F dual blockade has emerged as the superior strategy

    IL-17A/F dual blockade has emerged as the superior strategy Bimzelx has had a very strong launch, validating both IL-17A/F shows superior efficacy to IL-17A in PsO IL-17A/F and the ability to differentiate in PsO 70 1,800 Bimzelx (approved Oct ’23) 60 1,600 Additional 20-30% of Cosentyx PASI 100 (We

  28. Slide 28: ORKA-002 has a dramatically extended half-life vs. bimekizumab

    ORKA-002 has a dramatically extended half-life vs. bimekizumab ORKA-002 binds a nearly identical epitope ORKA-002 has a >3x longer half-life to bimekizumab with comparable potency than bimekizumab in NHPs ORKA-002 Bimekizumab ORKA-002 (IV) Bime (IV) ORKA-002 (SC) Bime (SC) 100 1000 IL-17A 75 Plasma

  29. Slide 29: Potential for 2-3 doses per year enabled by half-life extension

    Potential for 2-3 doses per year enabled by half-life extension Projected Ctrough of illustrative ORKA-002 regimens exceeds approved bimekizumab regimen ORKA-002 (~50d half-life): ORKA-002 (~75d half-life): Bimekizumab: 320 mg 320 mg W0, 4 then Q4M 320 mg W0, 4 then Q6M W0, 4, 8, 12, 16 then Q8W 80

  30. Slide 30: ORKA-021

    ORKA-021

  31. Slide 31: ORKA-021: Potential to combine the best of IL-17s and IL-23s

    ORKA-021: Potential to combine the best of IL-17s and IL-23s IL-17s: fastest onset and highest peak response IL-23s: less frequent dosing and best durability and safety Combining the two mechanisms sequentially could provide the “best of both worlds” Feedback from U.S. 100 dermatologists: 80 Possibl

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  33. Slide 33: Shares outstanding

    Shares outstanding As of Mar 31, 2025 Number of shares1 Common stock • Shares outstanding 37.4M • Preferred stock 11.4M Common stock (as-converted to common stock) equivalents • Pre-funded warrants 6.2M Common stock and common stock • Total outstanding2 55.1M equivalents Notes: Please refer to SEC f

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