Hansa Biopharma Ab · OMXSTO:HNSA

Hansa Biopharma Ab — Investor Day (June 2026)

64 slides from Hansa Biopharma Ab's investor day presentation, Jun 25, 2026

  1. Slide 1: Hansa Capital Markets Day

    Hansa Capital Markets Day June 25, 2026

  2. Slide 2: Welcome and Strategic Outlook

    Welcome and Strategic Outlook Renée Aguiar-Lucander, Chief Executive Officer Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB

  3. Slide 3: 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

  4. Slide 4: Hansa Capital Markets Day Agenda

    Welcome and Strategic Outlook 01 Renée Aguiar-Lucander, CEO Kidney Transplantation -- Clinical Data Validation 02 Richard Philipson, CMO • Dr. Matthew Cooper • Dr. Nassim Kamar Hansa Capital Kidney Transplantation -- Transforming Outcomes 03 Markets Day Jennifer Leonard, Sr. Director US Medical Affa

  5. Slide 5: 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

  6. Slide 6: Addressing Orphan / Rare Indications

    Addressing Orphan / Rare Indications ® THERAPEUTIC FOCUS Desensitization IDEFIRIX conditionally approved in the EU & the UK For desensitization prior to kidney transplantation deceased donor Enabling Transplantation Paradigm shift for highly sensitized kidney transplant patients Out-licensing Agreem

  7. Slide 7: European Out-licensing Creates Strong Financial Position

    European Out-licensing Creates Strong Financial Position ® Cash Position o Transaction (upfront €110M or 1.3 BSEK) significantly increases Hansa’s cash position o Pro forma cash based on Q1 2026 cash on hand ~1.9 BSEK (~ $195m) Pro Forma Q1 2026 Cash with Out Licensing Agreement* o Upon EMA acceptan

  8. Slide 8: Focused Pipeline in Desensitization and Autoimmune Diseases

    Focused Pipeline in Desensitization and Autoimmune Diseases ® Preclinical Phase 1 Phase 2 Phase 3 Marketed Partner Upcoming Milestone Desensitization Kidney Transplantation Q4 2026: filing for full approval Desensitization Kidney Transplantation PDUFA* date Dec 19, 2026 Desensitization Gene Therapy

  9. Slide 9: Experienced and Proven Leadership Team

    Experienced and Proven Leadership Team Proven track record delivering growth, approvals, and launches across renal, rare disease, and immunology ® Renée Aguiar-Lucander Maria Törnsén Chief Executive Officer Chief Operating Officer, President US 20+ yrs rare disease leader and former investor, Succes

  10. Slide 10: Hansa Capital Market Day June 25, 2026

    02 ® Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB 10

  11. Slide 11: Topline European Post Authorization Efficacy Study (PAES)

    Topline European Post Authorization Efficacy Study (PAES) Richard Philipson, MD, Chief Medical Officer Hansa Capital Market Day June 25, 2026 ©© 2026, 2026, Hansa Hansa Biopharma Biopharma ABAB

  12. Slide 12: 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 cohort

  13. Slide 13: Objectives

    Objectives Primary To determine the 1-year graft failure-free survival in highly sensitized 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 fun

  14. Slide 14: Study Design

    Study Design Imlifidase treatment group PRE-SCREENING IMLIFIDASE-TX Identify highly sensitized patients with the SCREENING XM-conversion (pos to highest unmet medical need based on the Positive XM Organ offer Inclusion neg) local allocation system Delisting of unacceptable antigen(s) 12 months Non-c

  15. Slide 15: Eligibility

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

  16. Slide 16: © 2026, Hansa Biopharma AB

    01 ® © 2026, Hansa Biopharma AB 16

  17. Slide 17: Disposition

    Disposition Imlifidase Concurrent reference cohort Accepted organ offer 51 63 Dosed, n (%) 51 N/A Transplanted, n (%) 50 (98.0) 63 (100) Analysis sets, n (%) Safety 51 (100) 63 (100) Intention to treat 50 (98.0) 63 (100) Completed trial, n (%) 48 (94.1) 57 (90.5) Early terminated, n (%) 3 (5.9) 6 (9

  18. Slide 18: Demographics

    Demographics Imlifidase Concurrent reference cohort (N=50) (N=63) Age (mean) 50.1 55.6 Female, n (%) 20 (40.0) 26 (41.3) Pregnancy, n (% of female) 12 (60.0) 21 (80.8) Male, n (%) 30 (60.0) 37 (58.7) Race, n (%) White 39 (78.0) 53 (84.1) Black 6 (12.0) 5 (7.9) Asian 1 (2.0) 2 (3.2) Other 1 (2.0) 1 (

  19. Slide 19: Baseline Characteristics

    Baseline Characteristics Imlifidase Concurrent reference (N=63) (N=50) Currently on dialysis, n (%) 50 (100) 56 (88.9) Years on dialysis, mean 8.7 2.3 Dialysis modality, n (%) Peritoneal 4 (8.0) 12 (21.4) Hemodialysis 46 (92.0) 44 (78.6) Number of previous transplants 0 6 (12.0) 56 (88.9) 1 25 (50.0

  20. Slide 20: Exposure

    Exposure Imlifidase (N=50) One dose, n (%) 46 (92.0) Two doses, n (%) 4 (8.0) © 2026, Hansa Biopharma AB 20

  21. Slide 21: © 2026, Hansa Biopharma AB

    02 ® © 2026, Hansa Biopharma AB 21

  22. Slide 22: Graft Failure-Free Survival

    Graft Failure-Free Survival Primary endpoint – Imlifidase arm Imlifidase (N=50) Events, n (%) 5 (10.0) Kaplan-Meier survival estimate at 1 year (95% CI) 90.0 (77.6, 95.7) Secondary endpoint – Concurrent reference cohort Concurrent reference cohort (N=63) Events, n (%) 5 (7.9) Kaplan-Meier survival e

  23. Slide 23: Patient Survival

    Patient Survival Imlifidase arm Imlifidase (N=50) Events, n (%) 1 ( 2.0) Kaplan-Meier survival estimate at 1 year (95% CI) 98.0 (86.6, 99.7) Concurrent reference cohort Concurrent reference cohort (N=63) Events, n (%) 2 (3.2) Kaplan-Meier survival estimate at 1 year (95% CI) 96.8 (87.8, 99.2) © 2026

  24. Slide 24: Graft survival

    Graft survival Imlifidase arm Imlifidase (N=50) Events, n (%) 4 ( 8.0) Kaplan-Meier survival estimate at 1 year (95% CI) 92.0 (80.0, 96.9) Concurrent reference cohort Concurrent reference cohort (N=63) Events, n (%) 3 (4.8) Kaplan-Meier survival estimate at 1 year (95% CI) 95.2 (85.7, 98.4) © 2026,

  25. Slide 25: Kidney Function

    Kidney Function Imlifidase arm Imlifidase (N=50) eGFR (mL/min/1.73 m2) at 1 year, Mean 51.6 n 44 95% CI (44.7, 58.5) Concurrent reference cohort Concurrent reference cohort (N=63) eGFR (mL/min/1.73 m2) at 1 year, Mean (SD) 55.9 n 56 95% CI (50.0, 61.9) © 2026, Hansa Biopharma AB 25

  26. Slide 26: Safety

    Safety Imlifidase (N=51) At least one TEAE, n (%) 51 (100) Relationship, n (%) At least one possibly or probably related TEAE 3 (5.9) At least one TESAE, n (%) 28 (54.9) At least one AESI, n (%) 13 (25.5) At least one TEAE leading to study withdrawal, n (%) 0 (0.0) At least one TEAE leading to death

  27. Slide 27: © 2026, Hansa Biopharma AB

    03 ® © 2026, Hansa Biopharma AB 27

  28. Slide 28: 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 = 90.0% Patient survival = 98.0% Graft survival = 92.0%

  29. Slide 29: US Phase 3 ConfIdeS Study

    US Phase 3 ConfIdeS Study Matthew Cooper, MD, Chief of Transplantation and Director of Solid Organ Transplant Medical College of Wisconsin​ Hansa Capital Market Day June 25, 2026 ©© 2026, 2026, 2026, Hansa Hansa Hansa Biopharma Biopharma BiopharmaAB AB AB

  30. Slide 30: Report from ConfIdeS, a Randomized Desensitization Trial

    Report from ConfIdeS, a Randomized Desensitization Trial Superior 1-year eGFR Among Highly-Sensitized Patients Desensitized with Imflifidase Compared with the Control Arm © 2026, Hansa Biopharma AB 30 Extract from data presented at American Transplant Congress (ATC) 2026 by R. Montgomery, MD, DPhil

  31. Slide 31: Background

    Background Highly sensitized US patients have low rates of transplantation leading to an indefinite dependency on dialysis Number of Highly Sensitized Patients ~15,000 with cPRA >80% Based on cPRA Threshold Inability to match or effectively ~7,000 with cPRA >98% desensitize patients remains a barrie

  32. Slide 32: Imlifidase

    Imlifidase An IgG-degrading enzyme of Streptococcus pyogenes as a novel desensitization treatment Imlifidase cleaves human, intra- and extravascular, Rapid Cleavage Return to IgG within 2-6 hours of administration. Baseline d, day; F(ab’)2, antigen-binding fragment; Fc, fragment crystallizable; h, h

  33. Slide 33: ConfIdeS Trial Design

    ConfIdeS Trial Design Randomized controlled trial in highly sensitized patient population with a cPRA value ≥99.90% Imlifidase n=32 Randomization Organ offer Pre-screening Screening Delisting of Eligibility unacceptable assessment Control n=32 antigen(s) 12 months Accept organ offer  Imlifidase tre

  34. Slide 34: ConfIdeS Results Presented

    ConfIdeS Results Presented Demographics Other secondary endpoints and baseline characteristics Graft survival Primary endpoint, kidney function Delayed graft function (DGF) (eGFR at 12 months) Antibody-mediated reaction (AMR) Key secondary endpoints Donor-specific antibodies (DSAs) • Dialysis depend

  35. Slide 35: Demographics & Baseline Characteristics

    Demographics & Baseline Characteristics Characteristics Imlifidase (n=32) Control (n=32) p-values Mean patient age (SD) — yr 45.8 (12.3) 44.7 (12.5) ns Female — no. (%) 18 (56.3) 15 (46.9) ns Race — no. (%) Asian 1 (3.1) 2 (6.3) Black 16 (50.0) 14 (43.8) ns White 14 (43.8) 13 (40.6) Other 0 (0) 2 (6

  36. Slide 36: Primary Endpoint – eGFR at 12 Months

    Primary Endpoint – eGFR at 12 Months eGFR was 51.5 mL/min/1.73 m2 in imlifidase arm compared with 19.3 mL/min/1.73 m2 in the control arm, resulting in a clinical and significant difference of 32.2 mL/min/1.73 m2 (p<0.0001) eGFR, estimated glomerular filtration rate; MDRD, modification of diet in ren

  37. Slide 37: Dialysis Dependency & CKD at 1 Year

    Dialysis Dependency & CKD at 1 Year Dialysis dependency was lower in the imlifidase arm (5 patients) than in the control arm (17 patients) (p=0.0007) CKD stage at 12 months for transplanted patients eGFR Imlifidase (n=28) Control (n=15) (mL/min/1.73 m2) no. (%) no. (%) >90 4 (14) 0 ≥60 8 (28) 4 (27)

  38. Slide 38: Patient Survival & AEs

    Patient Survival & AEs Patient survival was 97% with imlifidase compared with 100% in the control arm AEs and SAEs reflect post-transplant complications per current immunosuppressive practice and are consistent with previous clinical trial experience No imlifidase infusion was discontinued due to an

  39. Slide 39: DSA Over Time

    DSA Over Time Patients in the imlifidase arm maintained a low DSA during the first week; DSA peaked on day 15, then decreased thereafter DSA, donor-specific antibody; MFI, mean fluorescence intensity. © 2026, Hansa Biopharma AB 39 Extract from data presented at American Transplant Congress (ATC) 202

  40. Slide 40: AMR Status & Effect on eGFR at 12 Months

    AMR Status & Effect on eGFR at 12 Months AMR occurred in 16/28 patients in the imlifidase arm (57%) vs. 6/13 in the control arm (46%) No grafts in the imlifidase arm were lost due to AMR AMR did not impact kidney function AMR, antibody-mediated rejection; eGFR, estimated glomerular filtration rate;

  41. Slide 41: Conclusion

    Conclusion At 1-year post-randomization, desensitization with imlifidase was associated with clinically meaningful and statistically significant kidney function measured as eGFR • 51.5 mL/min/1.73 m2 which was superior to 19.3 mL/min/1.73 m2 in control arm (p<0.0001) Imlifidase enabled successful tr

  42. Slide 42: On Behalf of the ConfIdeS Trial Group

    On Behalf of the ConfIdeS Trial Group Randomizing Centers M. Kapturczak, L. Ratner, D. Anderson, R. Wesson, B. Lonze, L. Riella, M. Cooper, A. O. Gaber, D. Christopher, N. Leca, A. Patel, S. Jordan, R. Parsons, J. Wellen, P. Witkowski, R. Montgomery Participating Centers D. Adey, D. Axelrod, K. Bodz

  43. Slide 43: French Real-World Data ISKIA Registry

    French Real-World Data ISKIA Registry Nassim Kamar, MD, PhD (Toulouse University Hospital, France) Dr Kamar’s slides are not currently available for public distribution and have been removed from this presentation.

  44. Slide 44: Hansa Capital Market Day June 25, 2026

    03 ® Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB 44

  45. Slide 45: Clinical Impact in the US

    Clinical Impact in the US Annette Jackson, PhD, Jennifer Leonard, Pharm D Roslyn Mannon, MD F(ACHI) © 2026, Hansa Biopharma AB 45

  46. Slide 46: Hansa Capital Market Day June 25, 2026

    04 ® Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB 46

  47. Slide 47: Kidney Transplantation – Q&A

    Kidney Transplantation – Q&A Annette Jackson, PhD, Richard Philipson, MD Matthew Cooper, MD Nassim Kamar MD, PhD Roslyn Mannon, MD F(ACHI) © 2026, Hansa Biopharma AB 47

  48. Slide 48: US Market Opportunity and Launch Preparations

    US Market Opportunity and Launch Preparations Maria Törnsén, COO & US President Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB

  49. Slide 49: Disclaimer

    Disclaimer ® This presentation is intended for an investor audience only. Imlifidase in not approved in the United States and is currently subject to review by the Food & Drug Administration (“FDA”). All references in the following slides regarding the potential market opportunity or product profile

  50. Slide 50: US Kidney Transplant: A Growing Market with High Unmet Needs

    US Kidney Transplant: A Growing Market with High Unmet Needs ® Significant unmet medical need with thousands of highly sensitized patients waiting for a transplant ~100,000 US Transplant Waitlist is growing people in the US are waiting for a kidney transplant ~45,000 added to the waitlist each year

  51. Slide 51: Launch Preparations Ongoing: Focused and Led by an Experienced US Team

    Launch Preparations Ongoing: Focused and Led by an Experienced US Team ® 1 2 3 Market Research Insights* Market Development Transplant Center Readiness • Strong clinical need for a quick and • Fully staffed market access and • Concentrated market with 200 effective product that can enable HLAi medic

  52. Slide 52: Financial Stakeholders Recognize the Value of Imlifidase

    Financial Stakeholders Recognize the Value of Imlifidase* ® Majority of patients have Medicare insurance; however Early adoption likely to come from large volume, operationally opportunity exists with Commercial plans sophisticated transplant centers  Approximately 2/3 of patients have Medicare  D

  53. Slide 53: Launch Ready at PDUFA and Imlifidase Potentially Available in Q1 2027

    Launch Ready at PDUFA and Imlifidase Potentially Available in Q1 2027* ® Q4 2026 Q1 2027 US commercial Imlifidase potentially organization build available in the US* Q1-Q4 2026 Pre-launch activities Q2 Q3 Q4 Q1 2026 2026 2026 2027 JUNE 2026 DECEMBER 19, 2026 ConfIdeS data at ATC PDUFA *Subject to FD

  54. Slide 54: Hansa Pipeline Overview

    Hansa Pipeline Overview Richard Philipson, MD, Chief Medical Officer Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB

  55. Slide 55: Focused Pipeline in Desensitization and Autoimmune Diseases

    Focused Pipeline in Desensitization and Autoimmune Diseases ® Preclinical Phase 1 Phase 2 Phase 3 Marketed Partner Upcoming Milestone Desensitization Kidney Transplantation Q4 2026: filing for full approval Desensitization Kidney Transplantation PDUFA* date Dec 19, 2026 Desensitization Gene Therapy

  56. Slide 56: Guillain-Barré Syndrome Overview

    Guillain-Barré Syndrome Overview IgG is a key driver of inflammatory attacks on peripheral nerves and has been Guillain-Barré Syndrome clinically linked to the severity and progression of the disease. a rare, acute, paralyzing, inflammatory disease of the peripheral nervous system caused by the immu

  57. Slide 57: Overview of Imlifidase Phase 2 Study in GBS (15-HMedIdeS-09)

    Overview of Imlifidase Phase 2 Study in GBS (15-HMedIdeS-09) Visit 1 Visit 2 Visit 3 Visit 4 Visit 5 Visit 6 Visit 7 Visit 8 Visit 9 Visit 10 (phone call) Day 1-2 Day 3-7 Day 8 Day 15 Day 29 Day 57 Day 92 Day 180 Day 360 Day 3-7 IVIg End of study treatment Imlifidase Screening 0.25 mg/kg Assessments

  58. Slide 58: Demographics and Baseline Characteristics

    Demographics and Baseline Characteristics 15-HMedIdeS-09, N=27 n (%) During the trial, 3 patients were re-diagnosed Median Age 60 with other conditions*, leaving 27 patients with Female Gender 13 (48) confirmed severe GBS (GBS disability score 6 (22) 3-5) eligible for efficacy evaluation Baseline GB

  59. Slide 59: Total IgG was Rapidly Reduced by Imlifidase and Restored with IVIg Treatment

    Total IgG was Rapidly Reduced by Imlifidase and Restored with IVIg Treatment % IgG normalized to Predose Pre imlifidase 2 days post  Imlifidase rapidly reduces total IgG imlifidase pre IVIg  Standard of care IVIg is initiated 48 h after imlifidase and IgG levels return to normal 1 day post imlifid

  60. Slide 60: Mean Change in MRC Sum Score Over Time vs IGOS Cohort

    Mean Change in MRC Sum Score (+/-SEM) Over Time in Patients Treated with Imlifidase Followed by IVIg Compared to IGOS Cohort (Naïve Comparison) Imlifidase followed by IVIg (15-HMedIdes-09, n=27*) Mean change from baseline Baseline mean score = 39 MRC sum scores Reference cohort increase rapidly (IGO

  61. Slide 61: Current Status of HNSA-5487

    Current Status of HNSA-5487 • Phase 1 healthy volunteer study completed • Rapid and robust IgG reduction by more than 95% within a few hours • Significantly reduced ADA response • At least as efficacious as imlifidase in reducing total IgG levels • No tolerability or safety concerns • Design of clin

  62. Slide 62: Q&A and Closing Remarks

    Q&A and Closing Remarks Renée Aguiar-Lucander, Chief Executive Officer Hansa Capital Market Day June 25, 2026 © 2026, Hansa Biopharma AB

  63. Slide 63: Q&A and Closing Remarks

    Q&A and Closing Remarks Renée Aguiar-Lucander Maria Törnsén Richard Philipson, MD © 2026, Hansa Biopharma AB 63

  64. Slide 64: Thank You

    ® Thank You June 25, 2026 © 2026, Hansa Biopharma AB

Hansa Biopharma — Investor Day (June 2026) on 6ix