Oruka Therapeutics, Inc. · NASDAQ:ORKA

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

30 slides from Oruka Therapeutics's merger presentation, Jun 6, 2024

  1. Slide 1: Company Overview June 2024

    ©2024 Oruka Therapeutics 1 Company Overview June 2024 ©2024 Oruka Therapeutics 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 biopharm

  2. Slide 2: This presentation is strictly and being made to you solely as a prospective investor

    ©2024 Oruka Therapeutics 2 This presentation is strictly confidential and being made to you solely as a prospective investor in the proposed offering (t he “ Offering ”) of common stock, par value $0.001 per share, or, in lieu thereof, pre - funded warrants (together, the “ Securities ”) of Oruka Th

  3. Slide 3: Important Additional Information About the Proposed Offering

    ©2024 Oruka Therapeutics 3 Important Additional Information About the Proposed Offering Will be Filed with the SEC This presentation is not a substitute for the registration statement or for any other document that Atlas may file with the C omm ission in connection with the Offering or Proposed Tran

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

    ©2024 Oruka Therapeutics 4 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

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

    ©2024 Oruka Therapeutics 5 5 13 7 14 9 11 15 18 25 20 2 4 4 6 7 10 25 32 0 20 40 60 80 100 120 140 2022 2028 Sales ($B) 0 2 4 6 8 10 Humira Sotyktu Other Bimzelx Taltz Cosentyx Ilumya Stelara Tremfya Skyrizi Co - lead programs target a $50B+ total market opportunity ​ ORKA - 001/002 target the domin

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

    ©2024 Oruka Therapeutics 6 ORKA - 001: potentially best - in - class anti - IL - 23p19

  7. Slide 7: Biologics have raised the bar in PsO, but there is ample room for improvement

    ©2024 Oruka Therapeutics 7 0 10 20 30 40 50 60 70 80 90 Biologics have raised the bar on standard of care in PsO, but there is ample room for improvement 2 4 8 12 26 Time Between Doses (Weeks) Placebo - adjusted PASI 100 (Week 16) (%) ORKA - 001 target range Sources: FDA and EMA Approval Labels 52 L

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

    ©2024 Oruka Therapeutics 8 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 St

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

    ©2024 Oruka Therapeutics 9 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) • K D < 20 pM • Predicted equivalent safety • Predict

  10. Slide 10: Clinical experience with YTE predicts significant half-life extension for ORKA-001

    ©2024 Oruka Therapeutics 10 0 10 20 30 40 0 50 100 150 Cyno Half-Life (Days) H u m a n H a l f - L i f e ( D a y s ) Clinical experience with YTE predicts significant half - life extension for ORKA - 001 Notes & Sources: Internal data (left); NHP datapoints associated with ADA excluded from analysis

  11. Slide 11: ORKA-001 could exceed Skyrizi exposures at fewer doses per year

    ©2024 Oruka Therapeutics 11 ORKA - 001 could exceed Skyrizi exposures at 1 - 2 doses per year 0 26 52 0 20 40 60 Weeks [ A b ] g / m L 0 10 20 30 40 Cavg (0-16 wks) Cavg (SS) Ctrough (SS) [Ab] ( μ g/mL) Base case – 2 maintenance doses per year Upside case – 1 maintenance dose per year 0 10 20 30 40

  12. Slide 12: KNOCKOUT study tested higher anti-IL-23 exposures in PsO

    ©2024 Oruka Therapeutics 12 KNOCKOUT study tested higher anti - IL - 23 exposures in PsO Double - blind follow - up (Weeks 16 - 52) Double - blind dosing (Weeks 0 - 16) Screening KNOCKOUT ​inclusion criteria • Adults • Chronic, stable plaque psoriasis – ≥ 6 months – PASI ≥ 12 – ≥ 10% BSA • No prior

  13. Slide 13: KNOCKOUT extended exposure-response relationship

    ©2024 Oruka Therapeutics 13 KNOCKOUT extended exposure - response relationship – higher exposures drove higher PASI 100 0 10 20 30 40 50 60 70 80 90 0 2 4 6 8 10 12 14 16 18 20 22 24 26 28 Time (Weeks) PASI 100 (%) UltIMMa - 1/2 combined (Skyrizi at approved 150 mg SC dose; W0 , 4, Q12W ) VOYAGE - 1

  14. Slide 14: ORKA-001 projected to extend exposure-response relationship

    ©2024 Oruka Therapeutics 14 0 20 40 60 80 100 0 10 20 30 PASI 100 (%) C avg (µg/mL) 0 20 40 60 80 100 0 10 20 30 PASI 100 (%) C avg (µg/mL) KNOCKOUT Notes & Sources: Adapted from 2019 Khatri (Clin Pharmacol Ther ) and Skyrizi BLA Multi - disciplinary Review (Fig. 20); KNOCKOUT pooled PASI 100 from 2

  15. Slide 15: ORKA-001 at one dose per year could match KNOCKOUT early exposures

    ©2024 Oruka Therapeutics 15 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 p

  16. Slide 16: Potential for disease modification or cure by depleting TRMs

    ©2024 Oruka Therapeutics 16 0 10 20 30 40 50 Siliq Taltz Cosentyx Bimzelx Tremfya Ilumya Skyrizi Loss of PASI 90 Loss of PASI 100 Potential for disease modification or cure by depleting TRMs 0% 5% 10% 15% % of T Cells in Tissue 12% 8% 8% 13% Leading to long - lasting remissions after treatment withd

  17. Slide 17: Safety of peak exposures established by Crohn's dose regimen

    ©2024 Oruka Therapeutics 17 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;

  18. Slide 18: Base case is best-in-class, upside could be paradigm changing

    ©2024 Oruka Therapeutics 18 .. Base case is best - in - class, upside could be paradigm changing Base case scenario Upside scenario Best - in - class profile Paradigm - changing Potential for patient - specific dosing to extend interval Modify and potentially cure disease in some patients Added bene

  19. Slide 19: Development path sets up a catalyst-rich next years

    ©2024 Oruka Therapeutics 19 Development path sets up a catalyst - rich next 3 years 2024 2025 2026 2027 Activity 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 di

  20. Slide 20: ORKA-002: potentially best-in-class anti-IL-17A/F

    ©2024 Oruka Therapeutics 20 ORKA - 002: potentially best - in - class anti - IL - 17A/F

  21. Slide 21: IL-17A/F dual blockade has emerged as the superior strategy

    ©2024 Oruka Therapeutics 21 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 Labe

  22. Slide 22: Bimzelx is showing signs of massive peak sales potential

    ©2024 Oruka Therapeutics 22 Bimzelx is showing signs of massive peak sales potential Notes: x - axis marks end of week Sources: Jefferies (based on IQVIA data); Cowen; GlobalData 0 100 200 300 400 500 600 700 800 900 1,000 1,100 Weekly Prescriptions (U.S.) Weeks after Launch W1 W6 W11 W26 Bimzelx (a

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

    ©2024 Oruka Therapeutics 23 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; Pr ess releases ORKA - 002 (TPP) Sonelokimab Format Full - length, dual targeting, half - life

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

    ©2024 Oruka 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 Oruka Therapeutics 25 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

  26. Slide 26: Corporate

    ©2024 Oruka Therapeutics 26 Corporate

  27. Slide 27: Single fundraise could support multiple inflection points

    ©2024 Oruka Therapeutics 27 Single fundraise could support multiple inflection points 1H – Final PK in HVs 2H – PsO 16 - week PoC 2H – Phase 2 FPI 1H – FPI 2H – Initial PK in HVs ORKA - 001 (SC, extended half - life IL - 23) 1H – Initial PK in HVs 2H – FPI ORKA - 002 (SC, extended half - life IL - 1

  28. Slide 28: Building rapidly with backing from Paragon

    ©2024 Oruka Therapeutics 28 Building rapidly with backing from Paragon Peter Harwin Managing Member, Fairmount Lawrence Klein CEO Board of Directors Laura Sandler SVP, Operations Joana Goncalves CMO Arjun Agarwal SVP, Finance Christina Liang Sr. EA & Operations Manager Andrew Blauvelt Chair, Scienti

  29. Slide 29: ARCA and Oruka transaction summary

    ©2024 Oruka Therapeutics 29 ARCA and Oruka 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

  30. Slide 30: Expected ownership of the combined company

    ©2024 Oruka Therapeutics 30 Please refer to ARCA’s SEC filings for additional information (1) The percentage of the combined company owned by ARCA’s stockholders is subject to adjustment based on the amount of ARCA’ s n et cash at the closing date; (2) ARCA is expected to contribute $5 million to th

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