Oruka Therapeutics, Inc. · NASDAQ:ORKA

Oruka Therapeutics — ARCA biopharma — Merger or Acquisition (April 2024)

30 slides from Oruka Therapeutics's merger presentation, Apr 3, 2024

  1. Slide 1: Company Overview April 2024

    Company Overview April 2024 ©2024 Oruka Therapeutics Exhibit 99.2

  2. Slide 2: Confidentiality and offering disclaimer

    This presentation is strictly confidential and being made to you solely as a prospective investor in the proposed offering (the “Offering”) of common stock, par value $0.001 per share, or, in lieu thereof, pre-funded warrants (together, the “Securities”) of Oruka Therapeutics, Inc (the “we,” “us,” “

  3. Slide 3: Transaction Summary

    Transaction Summary Transaction: Transaction between ARCA Biopharma, Inc. (ARCA), including its wholly owned subsidiaries Atlas Merger Sub Corp. (First Merger Sub), Atlas Merger Sub II, LLC (Second Merger Sub), and Oruka Therapeutics, Inc. (Oruka) Transaction Structure: ARCA to acquire 100% of Oruka

  4. Slide 4: Building best-in-class therapies for psoriasis and other diseases

    Building best-in-class therapies for psoriasis and other diseases Our name – derived from or, for “skin,” and arukah, for “restoration” – reflects our mission to deliver best-in-class therapies for inflammatory skin diseases Notes: Oruka has an option to acquire exclusive worldwide rights from Parag

  5. Slide 5: Co-lead programs target a $50B+ total market opportunity

    Co-lead programs target a $50B+ total market opportunity ORKA-001/002 target the dominant mechanisms in the largest I&I market 2028 PsO sales estimate ($B) Global I&I market IL-23s forecast to generate ~$15B in 2028 sales: >40% of market ~2x IL-17 sales ~6x TYK2 sales amongst top 10 therapies IL-17A

  6. Slide 6: ORKA-001: potentially best-in-class anti-IL-23p19

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

  7. Slide 7: Biologics have raised the bar on standard of care in PsO

    Biologics have raised the bar on standard of care in PsO, but there is ample room for improvement 8 26 Time Between -adjusted PASI 100 (Week 16) (%) ORKA-001 target range Sources: FDA and EMA Approval Labels 52 Legend Anti-IL-23 Anti-IL-12/23 Anti-IL-17A Anti-TNF Anti-IL-17A/F Black box warning / si

  8. Slide 8: Perfecting the product profile in plaque psoriasis

    Perfecting the product profile in plaque psoriasis Higher PASI 100 Higher exposure drives higher response 1-2 doses per year Enabled by half-life extension Disease modifying Evidence for disease modification via high exposure anti-IL-23 IL-23p19 safety profile Strong safety precedent even at high pe

  9. Slide 9: ORKA-001 could be the last word in IL-23p19 inhibitors

    ORKA-001 could be the last word in IL-23p19 inhibitors Similar epitope to Skyrizi (risankizumab) with equal or better potency Validated mechanism of action Binds specifically to IL-23p19 (not IL-12/23 p40) KD < 20 pM Predicted equivalent safety Predicted to meet or beat efficacy Novel IP for composi

  10. Slide 10: 2-3x longer half-life vs. Skyrizi achieved in NHPs

    2-3x longer half-life vs. Skyrizi achieved in NHPs with PoC mAb Notes: HLE indicates extended half-life; Skyrizi BLA review notes a ~7.2- to 7.7-day half-life in NHPs, which translated to ~28-day half-life in humans Sources: Internal data; NHP datapoints associated with ADA excluded from analysis. A

  11. Slide 11: Clinical experience with YTE predicts significant half-life extension

    Clinical experience with YTE predicts significant half-life extension for ORKA-001 WT mAbs YTE mAbs ORKA-001 ORKA-001 projected human half-life: ~74 days expected to enable once- or twice-yearly dosing vs. quarterly with Skyrizi Notes & Sources: Includes mAbs targeting soluble antigens with publicly

  12. Slide 12: ORKA-001 could exceed Skyrizi exposures at 1-2 doses per year

    ORKA-001 could exceed Skyrizi exposures at 1-2 doses per year Base case Upside case ORKA-001: 600 mg W0, 300 mg Q26W Skyrizi: 150 mg W0, 4, Q12W (standard dosing) ORKA-001: 600 mg W0, Q52W Skyrizi: 150 mg W0, 4, Q12W (standard dosing) Sources: Oruka modeling based on internal data and published phar

  13. Slide 13: KNOCKOUT study tested higher anti-IL-23 exposures in PsO

    KNOCKOUT study tested higher anti-IL-23 exposures in PsO Screening Double-blind dosing (Weeks 0-16) Double-blind follow-up (Weeks 16-52) KNOCKOUT ​inclusion criteria Adults Chronic, stable plaque psoriasis ≥ 6 months PASI ≥ 12 ≥ 10% BSA No prior Skyrizi use Skyrizi 600 mg SC (N=10, 4x approved dose)

  14. Slide 14: KNOCKOUT extended exposure-response relationship

    KNOCKOUT extended exposure-response relationship – higher exposures drove higher PASI 100 Time (Weeks) PASI 100 (%) UltIMMa-1/2 combined (Skyrizi at approved 150 mg SC dose; W0, 4, Q12W) VOYAGE-1/2 combined (Tremfya at approved 100 mg SC dose; W0, 4, Q8W) Notes: Cross-trial comparisons. Not placebo

  15. Slide 15: ORKA-001 projected to extend exposure-response relationship

    KNOCKOUT Notes & Sources: Adapted from 2019 Khatri (Clin Pharmacol Ther) and Skyrizi BLA Multi-disciplinary Review (Fig. 20); KNOCKOUT pooled PASI 100 from 2023 Blauvelt (WCD presentation); gray dots represent observed PASI 100 rates within each Cavg decile for Skyrizi; gray lines represent model-es

  16. Slide 16: ORKA-001 at one dose per year could match KNOCKOUT early exposures

    ORKA-001 at one dose per year could match KNOCKOUT early exposures and greatly exceed trough levels Notes & Sources: KNOCKOUT efficacy data from 2023 Blauvelt (WCD presentation); KNOCKOUT and ORKA-001 exposure from Oruka modeling based on internal data and published pharmacokinetic model for Skyrizi

  17. Slide 17: Potential for disease modification or cure by depleting TRMs

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

  18. Slide 18: Safety of peak exposures established by Crohn's dose regimen

    Safety of peak exposures established by Crohn’s dose regimen “You literally can’t overdose this drug…patients take two shots on accident and they’re fine” – U.S. KOL Notes & Sources: Oruka modeling based on internal data and published pharmacokinetic model for Skyrizi; modeled Skyrizi exposure refle

  19. Slide 19: 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 Best-in-class profile Paradigm-changing Potential for Modify and potentially cure disease in some patients Added benefit Maintenance dosing Once yearly PASI 100 Highest observed to date (as in KNOCKOU

  20. Slide 20: Development path sets up a catalyst-rich next years

    Development path sets up a catalyst-rich next 3 years Phase 2 PsO Phase 1a/b HV & PsO ORKA-001 development Potential for rapid de-risking, value recognition, and path to BLA PoC PK data is highly validating, showing both basis for differentiation and early safety Validated clinical endpoints (e.g.,

  21. Slide 21: ORKA-002: potentially best-in-class anti-IL-17A/F

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

  22. Slide 22: IL-17A/F dual blockade has emerged as the superior strategy

    IL-17A/F dual blockade has emerged as the superior strategy Notes & Sources: Figure adapted from 2020 Brevi (Front Immunol.); PASI 100 reflects average of Ph3 trials (best-performing group in Ph2b trial for sonelokimab), not placebo adjusted; FDA and EMA Approval Labels; UCB Press Releases; 2023 Ven

  23. Slide 23: Bimzelx is showing signs of massive peak sales potential

    Bimzelx is showing signs of massive peak sales potential Notes: x-axis marks end of week Sources: Jefferies (based on IQVIA data); Cowen; GlobalData Weeks after Launch IL-23s IL-17As 16 Global IL-17 Class Sales ($B) 2020 Therapy Target DC-806 Sonelokimab Izokibep IL-17A IL-17A/F IL-17A/A IL-17A/F IL

  24. Slide 24: The two leading IL-17A/Fs leave room for improvement

    The two leading IL-17A/Fs leave room for improvement Sources: 2020 Adams (Front Immunol.); 2017 Glatt (BJCP); 2019 Svecova (JAAD); FDA / EMA Approval Labels; Company websites; Press releases ORKA-002 (TPP) Format Clear dose response similar to Bimzelx Minimal risk of neutralizing ADAs similar to Bim

  25. Slide 25: ORKA-002 could be the best-in-class IL-17A/F inhibitor

    ORKA-002 could be the best-in-class IL-17A/F inhibitor Similar epitope to Bimzelx (bimekizumab) with equal or better potency Validated mechanism of action Binds IL-17A and IL-17F to prevent homodimer and heterodimer signaling Equal or greater affinity vs. bimekizumab Predicted equivalent safety Pred

  26. Slide 26: ORKA-002 could be best-in-class in a $15B market

    ORKA-002 could be best-in-class in a $15B market Best target Dual IL-17A/F inhibition has shown superior efficacy vs. IL-17A inhibition, with $15B+ in future market potential Best profile Limited competition Skyrizi-like dosing intervals in a convenient single injection while minimizing biological r

  27. Slide 27: Corporate

    Corporate

  28. Slide 28: Single fundraise could support multiple inflection points

    Single fundraise could support multiple inflection points ORKA-001 (SC, extended half-life IL-23) 1H – FPI 2H – Initial PK in HVs 1H – Final PK in HVs 2H – PsO 16-week PoC 2H – Phase 2 FPI ORKA-002 (SC, extended half-life IL-17A/F) 2H – FPI 1H – Initial PK in HVs ORKA-003 (undisclosed) 1H – Target D

  29. Slide 29: Backed by Paragon and building rapidly

    Backed by Paragon and building rapidly Peter Harwin Managing Member, Fairmount Funds Evan Thompson COO Damon Banks Head of Legal Hussam Shaheen Head of Research Shawn Russell SVP, CMC Lawrence Klein CEO Board of Directors Laura Sandler SVP, Operations Christopher Finch VP, Corporate Development & St

  30. Slide 30: Thank You

    THANK YOU Exhibit 99.3 ARCA biopharma, Inc. and Oruka Therapeutics, Inc. Merger Agreement Announcement Webcast Call Transcript Wednesday, April 3, 2024 8:30 a.m. ET Operator Good morning, Ladies and Gentlemen. Thank you for standing by. Welcome to the ARCA Biopharma – Oruka Therapeutics Transaction

ARCA biopharma — Merger or Acquisition (April 2024) on 6ix