Oruka Therapeutics, Inc. · NASDAQ:ORKA

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

31 slides from Oruka Therapeutics's merger presentation, Aug 9, 2024

  1. Slide 1: Corporate Overview August 2024

    © 2 0 2 4 O R U K A T H E R A P E U T I C S Corporate Overview August 2024 Filed by ARCA biopharma, Inc. Pursuant to Rule 425 under the Securities Act of 1933, as amended, and deemed filed pursuant to Rule 14a - 12 of the Securities Exchange Act of 1934, as amended Subject Company: ARCA biopharma, I

  2. Slide 2: Confidential notice to prospective investors

    © 2024 Oruk a Therapeutics 2 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 T

  3. Slide 3: On a mission to enable freedom from chronic skin disease

    © 2024 Oruk a Therapeutics 3 Notes: Oruka has an option to acquire exclusive worldwide rights from Paragon Therapeutics, Inc., for all programs, with IL - 23 rights for all therapeutic indications outside of IBD. Abbreviations: FIH, first - in - human; HV, healthy volunteer; MoA, mechanism of action

  4. Slide 4: Large, well-validated market with proven ability for new entrants to gain share

    © 2024 Oruk a Therapeutics 4 Large, well - validated market with proven ability for differentiated new entrants to gain share Best targets established with IL - 23p19 and IL - 17A/F – unlikely that new mechanisms can improve on the standard of care Physicians want new and better biologics – the fiel

  5. Slide 5: ORKA-001 and ORKA-002 complement each other

    © 2024 Oruk a Therapeutics 5 ORKA - 001 and ORKA - 002 complement each other Majority of dermatologists prefer an anti - IL - 23p19 For patients with purely skin disease For patients with joint involvement, including PsA, or recalcitrant skin disease Anti - IL - 17 preferred, and IL - 17A/F emerging

  6. Slide 6: ORKA-001/002 target dominant mechanisms in the largest I&I market

    © 2024 Oruk a Therapeutics 6 ORKA - 001/002 target the dominant mechanisms in the largest I&I market 5 13 7 14 9 11 15 18 25 20 2 4 6 10 25 32 2022 2028 Notes: Asthma sales represent biologic treatments only Sources: EvaluatePharma; GlobalData; Barclays; TD Cowen; Oruka analysis 0 20 40 60 80 100 12

  7. Slide 7: ORKA-001: potentially best-in-class anti-IL-23p19

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

  8. Slide 8: Biologics have raised the bar in PsO, but room for improvement

    © 2024 Oruk a Therapeutics 8 0 20 40 60 80 0 4 8 12 16 32 36 40 44 48 52 20 24 28 Time Between Doses (Weeks) Anti - IL - 23 Anti - TNF Anti - IL - 17A/F Black box warning / significant safety concerns Highly safe; no AEs / SAEs of note Anti - IL - 12/23 Anti - IL - 17A Oral (various mechanisms) Mixe

  9. Slide 9: Best-in-class profile and paradigm-changing scenarios

    © 2024 Oruk a Therapeutics 9 Best - in - class profile Paradigm - changing Dosing interval Once per six months Once per year and/or patient - specific Efficacy Comparable PASI 100 to Skyrizi Better PASI 100 than Skyrizi (as in KNOCKOUT study) Base case is best - in - class, upside could be paradigm

  10. Slide 10: ORKA-001 could be the last word in IL-23p19 inhibitors

    © 2024 Oruk a Therapeutics 10 ORKA - 001 could be the last word in IL - 23p19 inhibitors Notes: Oruka holds worldwide rights to all therapeutic indications outside of IBD Similar epitope to Skyrizi (risankizumab) with equal or better potency • Validated mechanism of action • Binds specifically to IL

  11. Slide 11: Half-life 2.4x longer than Skyrizi precursor mAb in NHPs

    © 2024 Oruk a Therapeutics 11 Notes & Sources: (left) Internal data; NHP datapoints associated with ADA excluded from analysis. (right) Sources on file for other wildtype (WT) and YTE mAbs; Skyrizi BLA review notes a ~7.2 - to 7.7 - day half - life in NHPs, which translated to ~28 - day half - life

  12. Slide 12: Q6M dosing projected to give higher exposure than Skyrizi

    © 2024 Oruk a Therapeutics Base 0 10 20 30 40 50 12 Notes & Sources: Oruka modeling based on internal data and published pharmacokinetic model for Skyrizi; steady - state (SS) C avg and C trough projected using the dosing interval ending at W160 1.7x 2.9x C avg (0 - 16W) C avg (SS) C trough (SS) 1.2

  13. Slide 13: Skyrizi UC regimen establishes safety of very high exposures

    © 2024 Oruk a Therapeutics 0 4 8 16 20 24 0 100 200 300 400 12 Weeks [Ab] (μg/mL) ORKA - 001: 600 mg W0 (SC) Skyrizi: 1200 mg W0, 4, 8 (IV) then 360 mg Q8W (SC) 13 ORKA - 001 benefits from a large body of clinical evidence with IL - 23 inhibition Notes & Sources: Oruka modeling based on internal dat

  14. Slide 14: Dermatologists view the base case as highly attractive

    © 2024 Oruk a Therapeutics 14 Sources: Weighted average of multiple independent surveys; N=32 practicing dermatologists for question on new patients; N=90 practicing dermatologists for question on current patients. Abbreviations: wAMD, wet age - related macular degeneration In the “base case,” derma

  15. Slide 15: Three potential upside scenarios for ORKA-001

    © 2024 Oruk a Therapeutics 15 Superior efficacy 1 - year dosing interval Disease modification Enabled by half - life extension Higher exposure could drive higher PASI 100 Patient - specific dosing to allow for treatment - free remissions Three potential upside scenarios for ORKA - 001 Upside

  16. Slide 16: Higher exposures drove higher efficacy in KNOCKOUT study

    © 2024 Oruk a Therapeutics 16 Notes: Cross - trial comparisons. Not placebo controlled. VOYAGE 1/2 Phase 3 trials tested Tremfya at 100 mg SC (W0, 4, Q8W) (FDA labeled dose) Sources: 2017 Blauvelt (JAAD); 2017 Reich (JAAD); 2018 Gordon (Lancet); 2023 Blauvelt (WCD presentation) KNOCKOUT evaluated 2

  17. Slide 17: Exposure-response trend could drive higher efficacy

    © 2024 Oruk a Therapeutics 0 20 40 60 80 100 0 10 20 C avg (µg/mL) 30 PASI 100 (%) KNOCKOUT Exposure deciles Phase 3 average Projected ORKA - 001 exposure & response 17 Notes & Sources: Adapted from 2019 Khatri (Clin Pharmacol Ther) and Skyrizi BLA Multi - disciplinary Review (Fig. 20); KNOCKOUT poo

  18. Slide 18: KNOCKOUT-like exposures possible with one dose per year

    © 2024 Oruk a Therapeutics 4 16 40 52 28 Weeks 0 20 40 60 [Ab] (μg/mL) 18 KNOCKOUT - like exposures are possible with one dose per year Notes & Sources: KNOCKOUT and ORKA - 001 exposure from Oruka modeling based on internal data and published pharmacokinetic model for Skyrizi; ORKA - 001 steady - st

  19. Slide 19: Disease modification potential of anti-IL-23

    © 2024 Oruk a Therapeutics 19 Anti - IL - 23 acts upstream of disease - causing TRMs, and has a unique ability to deplete them from tissue 5% 4% 5% 5% 0% 5% 10% 15% Leading to long - lasting remissions after treatment withdrawal – pointing to possibility of disease modification 0 10 20 30 Median Tim

  20. Slide 20: Development path sets up a catalyst-rich next 3 years

    © 2024 Oruk a Therapeutics Interim PK in HVs FPI Ph1a 16 - week PsO data Final PK in HVs Phase 2 top - line readout 20 ORKA - 001 development path sets up a catalyst - rich next 3 years Notes: Average time from FIH to BLA/NDA reflects average of Skyrizi, Tremfya, Bimzelx, and Sotyktu Abbreviations:

  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

    © 2024 Oruk a Therapeutics 22 IL - 17A/F shows superior efficacy to IL - 17A in PsO Bimzelx has had a very strong launch, validating both IL - 17A/F and the ability to differentiate in PsO 0 10 20 30 40 50 60 70 Cosentyx Taltz Bimzelx Sonelokimab PASI 100 (Week 16) (%) IL - 17As IL - 17A/Fs Addition

  23. Slide 23: The two leading IL-17A/Fs leave room for improvement

    © 2024 Oruk a Therapeutics 23 The two leading IL - 17A/Fs leave room for improvement Sources: 2020 Adams (Front Immunol.); 2017 Glatt (BJCP); 2019 Svecova (JAAD); FDA and EMA Approval Labels; Company disclosures ORKA - 002 Sonelokimab Target product profile No further development planned in PsO Full

  24. Slide 24: ORKA-002 could be the best-in-class IL-17A/F inhibitor

    © 2024 Oruk a Therapeutics 24 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

  25. Slide 25: ORKA-002 could be best-in-class in a $15B market

    © 2024 Oruk a Therapeutics 25 ORKA - 002 could be best - in - class in a $15B market Best target Best profile Limited competition Rapid development path • Dual IL - 17A/F inhibition has shown superior efficacy vs. IL - 17A • $15B+ in future market potential • Skyrizi - like dosing intervals or longe

  26. Slide 26: Corporate

    Corporate Beane S = QO

  27. Slide 27: Runway through multiple inflection points across the pipeline

    © 2024 Oruk a Therapeutics ORKA - 001 27 Runway through multiple inflection points across the pipeline Abbreviations: FPI, first patient in; OLE, open - label extension ORKA - 002 ORKA - 003 $275M raise supports company through multiple clinical inflection points Interim PK in HVs FPI Ph1a 16 - week

  28. Slide 28: Building rapidly with backing from Paragon

    © 2024 Oruk a Therapeutics 28 Board of Directors Joana Goncalves CMO Laura Sandler SVP, Operations Joe Senn SVP, Nonclinical R&D Lawrence Klein CEO Arjun Agarwal SVP, Finance Paul Quinlan General Counsel Andrew Blauvelt Chair, SAB Rajiv Panwar VP, Head of CMC Christopher Finch VP, Corp Dev & Strateg

  29. Slide 29: Estimated capitalization following close of transactions

    © 2024 Oruk a Therapeutics 29 Estimated capitalization following close of transactions Notes: (1) The percentage of the combined company owned by ARCA’s stockholders is subject to adjustment based on the amount of ARCA’s net cash at the closing date; (2) ARCA is expected to contribute $5M to the com

  30. Slide 30: coe tage

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  31. Slide 31: Overview: Post-Closing Ownership; Closing

    C O N F I D E N T I A L 31 Overview Post - Closing Ownership; Closing • 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. (

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