Hansa Biopharma Ab · OMXSTO:HNSA

Hansa Biopharma Ab — Technical Presentation (May 2026)

28 slides from Hansa Biopharma Ab's technical presentation, May 27, 2026

  1. Slide 1: 20-HMedIdeS-19 Topline Results: Post Authorization Efficacy Study (PAES)

    ® 20-HMedIdeS-19 Topline Results Post Authorization Efficacy Study (PAES) 27th May 2026

  2. Slide 2: Forward-looking statements

    ® Forward-looking statements This presentation may contain certain forward-looking statements and forecasts based on our current expectations and beliefs regarding future events and are subject to significant uncertainties and risks since they relate to events and depend on circumstances that will o

  3. Slide 3: PAES Topline Results: Agenda

    PAES Topline Results: Agenda ® 27th of May, 2026 Introduction Renée Aguiar-Lucander CEO PAES Richard Philipson Topline Results Chief Medical Officer Close and Q&A Renée Aguiar-Lucander CEO © 2026, Hansa Biopharma AB 3

  4. Slide 4: Novel, first-in-class IgG-cleaving enzyme from proprietary technology platform

    Novel, first-in-class IgG-cleaving enzyme from proprietary technology platform ® What is IgG Hansa’s IgG-cleaving Platform  Immunoglobulin G (IgG): a protective antibody Imlifidase – proprietary, first in class IgG cleaving enzyme  Transplantation / Gene Therapy: High antibody (IgG)  Rapid and ta

  5. Slide 5: Transplantation: High Unmet Need with Significant Market Potential

    Transplantation: High Unmet Need with Significant Market Potential ®  Imlifidase represents a pioneering Desensitization  Around 10% of the waitlist is breakthrough for highly sensitized TRANSPLANTATION removed annually due to death / too patients Potential market opportunity > $2bn compromised to

  6. Slide 6: PAES Topline Results: Agenda

    PAES Topline Results: Agenda ® 27th of May, 2026 Introduction Renée Aguiar-Lucander CEO PAES Richard Philipson Topline Results Chief Medical Officer Close and Q&A Renée Aguiar-Lucander CEO © 2026, Hansa Biopharma AB 6

  7. Slide 7: Study 20-HMedIdeS-19 (PAES)

    ® Study 20-HMedIdeS-19 (PAES) A controlled, open-label post-authorisation efficacy and safety study in imlifidase desensitised kidney transplant patients with positive crossmatch against a deceased donor prior to imlifidase treatment, including non- comparative registry and concurrent reference coho

  8. Slide 8: Objectives

    Objectives ® Primary To determine the 1-year graft failure-free survival in highly sensitised kidney transplant patients, pre-treated with imlifidase to turn a positive crossmatch against a deceased donor into a negative crossmatch Secondary To evaluate, up to 1 year after transplantation: • Renal f

  9. Slide 9: Study Design

    ® Study Design Imlifidase treatment group Identify highly sensitized patients with the highest unmet medical need based Imlifidase- on the local allocation system Screening Tx Pre-screening Organ offer Positive XM Inclusion XM-conversion (pos to neg) Delisting of unacceptable antigen(s) 12 months No

  10. Slide 10: Eligibility

    ® Eligibility Imlifidase cohort Non-comparative concurrent Non-comparative historical reference cohort reference cohort Male or female patient aged 18-75 years Male or female patient aged 18-75 years Male or female patient aged 18-75 years with ABO-compatible deceased donor with ABO-compatible decea

  11. Slide 11: Disposition, demographics and exposure

    ® Disposition, demographics and exposure © 2026, Hansa Biopharma AB 11

  12. Slide 12: Disposition

    Disposition ® Imlifidase Concurrent reference Accepted organ offer 51 63 Dosed, n (%) 51 N/A Transplanted, n (%) 50 63 Analysis sets, n (%) Safety 51 (100) 61 Intention to treat (ITT) 48 (94.1) 61 Completed trial, n (%) 48 (94.1) 55 (90.2) © 2026, Hansa Biopharma AB 12

  13. Slide 13: Demographics

    Demographics ® Imlifidase Concurrent reference (N=48) (N=61) Age, years (mean) 49.8 55.4 Male, n (%) 29 (60.4) 37 (60.7) Race, n (%) White 37 (77.1) 51 (83.6) Black 6 (12.5) 5 (8.2) Asian 1 (2.1) 2 (3.3) Other 1 (2.1) 1 (1.6) Not reported 3 (6.3) 2 (3.3) BMI (mean) 24.5 26.7 © 2026, Hansa Biopharma

  14. Slide 14: Baseline characteristics

    Baseline characteristics ® Imlifidase Concurrent reference (N=48) (N=61) Currently on dialysis, n (%) 48 (100) 54 (88.5) Duration of dialysis, years (mean) 8.5 2.3 Dialysis modality, n (%) Peritoneal 4 (8.3) 12 (22.2) Hemodialysis 44 (91.7) 42 (77.8) Number of previous transplants 0 6 (12.5) 55 (90.

  15. Slide 15: Exposure

    Exposure ® Imlifidase (N=48) One dose, n (%) 44 (91.7) Two doses, n (%) 4 (8.3) © 2026, Hansa Biopharma AB 15

  16. Slide 16: Efficacy and Safety Outcomes

    ® Efficacy and Safety Outcomes © 2026, Hansa Biopharma AB 16

  17. Slide 17: Graft failure-free survival

    Graft failure-free survival ® Imlifidase Imlifidase (N=48) Events, n (%) 5 (10.4) Kaplan-Meier survival estimate at 1 year (95% CI) 89.6 (76.8, 95.5) Concurrent reference Concurrent reference (N=61) Events, n (%) 5 ( 8.2) Kaplan-Meier survival estimate at 1 year (95% CI) 91.7 (81.3, 96.5) © 2026, Ha

  18. Slide 18: Patient survival

    Patient survival ® Imlifidase Imlifidase (N=48) Events, n (%) 1 ( 2.1) Kaplan-Meier survival estimate at 1 year (95% CI) 97.9 (86.1, 99.7) Concurrent reference Concurrent reference (N=61) Events, n (%) 2 ( 3.3) Kaplan-Meier survival estimate at 1 year (95% CI) 96.7 (87.4, 99.2) © 2026, Hansa Biophar

  19. Slide 19: Graft survival

    Graft survival ® Imlifidase Imlifidase (N=48) Events, n (%) 4 ( 8.3) Kaplan-Meier survival estimate at 1 year (95% CI) 91.6 (79.2, 96.8) Concurrent reference Concurrent reference (N=61) Events, n (%) 3 ( 4.9) Kaplan-Meier survival estimate at 1 year (95% CI) 95.0 (85.3, 98.4) © 2026, Hansa Biopharma

  20. Slide 20: Kidney function

    Kidney function ® Imlifidase Imlifidase (N=48) eGFR (mL/min/1.73 m2) at 1 year, Mean 52.4 95% CI (45.4, 59.4) Concurrent reference Concurrent reference (N=61) eGFR (mL/min/1.73 m2) at 1 year, Mean 56.5 95% CI (50.4, 62.5) © 2026, Hansa Biopharma AB 20

  21. Slide 21: Safety

    ® Safety Imlifidase was generally well tolerated, with a safety profile consistent with previous clinical trial experience There were no new safety findings © 2026, Hansa Biopharma AB 21

  22. Slide 22: Conclusions

    ® Conclusions © 2026, Hansa Biopharma AB 22

  23. Slide 23: Conclusions

    ® Conclusions • >90% of patients completed the trial • Demographics and baseline characteristics in keeping with a kidney transplant population • Efficacy outcomes at 12 months in imlifidase-treated patients were excellent: • Graft failure-free survival = 89.6% • Patient survival = 97.9% • Graft sur

  24. Slide 24: PAES Topline Results: Agenda

    PAES Topline Results: Agenda ® 27th of May, 2026 Introduction Renée Aguiar-Lucander CEO PAES Richard Philipson Topline Results Chief Medical Officer Close and Q&A Renée Aguiar-Lucander CEO © 2026, Hansa Biopharma AB 24

  25. Slide 25: Summary

    ® Summary  Clinically meaningful outcome  Consistent with previous results  High unmet need  Supports filing for conversion to full approval with EMA  Filing planned for Q4 2026  An exciting time for highly sensitized patients with limited or no options to receive an organ transplant © 2026, H

  26. Slide 26: Hansa Biopharma Capital Markets Day

    Hansa Biopharma Capital Markets Day ® Thursday 25th of June, 2026 from 9:00 AM to 12:00 PM EDT Location: The St. Regis Hotel, New York, & Live Webcast Featuring: Matthew Cooper, MD Nassim Kamar, MD, PhD Roslyn Mannon, MD Annette Jackson, PhD, F(ACHI) • Discussions with KOLs on the medical need in th

  27. Slide 27: Q&A

    ® Q&A © 2026, Hansa Biopharma AB 27

  28. Slide 28: HAN Sar

    IZ HAN Sar BIOPHARMA

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