Slide 1: ConfIdeS US Phase 3 Pivotal Trial Topline Results
® ConfIdeS US Phase 3 Pivotal Trial Topline Results September 25, 2025 © 2025, Hansa Biopharma AB
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
Slide 3: ConfIdeS Topline Results Conference Call Agenda
® ConfIdeS Topline Results Conference Call Agenda 25 September 2025 Introduction Renée Aguiar-Lucander CEO ConfIdeS Richard Philipson Topline data CMO Market opportunity Maria Törnsén COO, President US Next step Renée Aguiar-Lucander Q&A and Close CEO © 2025 Hansa Biopharma AB 3
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 Autoimmune Disease: IgG becomes harmful and Imlifidase – proprietary, first in class IgG cleaving enzyme attacks the body’s cel
Slide 5: Significant Unmet Medical Need
® Significant Unmet Medical Need Over 800,000 people have End Stage Kidney transplant is the treatment Renal Disease (ESRD) in the US1. of choice for ESRD. It is a medical condition in which It provides higher quality of life, less kidneys no longer adequately filter societal impact, and lower morta
Slide 6: ConfIdeS Topline Results Conference Call Agenda
® ConfIdeS Topline Results Conference Call Agenda 25 September 2025 Introduction Renée Aguiar-Lucander CEO ConfIdeS Richard Philipson Topline data CMO Market opportunity Maria Törnsén COO, President US Next step Renée Aguiar-Lucander Q&A and Close CEO © 2025, Hansa Biopharma AB 6
Slide 7: An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function
® An open-label, controlled, randomized Phase 3 trial evaluating 12-month kidney function in highly sensitized (cPRA>99,9%) kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with standard of care Renal function in highly sensitiz
Slide 8: Study Design
® Study Design © 2025, Hansa Biopharma AB 8
Slide 9: Study Design
Study Design ® Imlifidase Organ offer R Pre-screening Screening Delisting of Eligibility unacceptable assessment antigen(s) Control 12 months Imlifidase arm: accept organ offer; if treatment results in xm-conversion from positive to negative, then proceed to transplant Control arm: EITHER accept org
Slide 10: Disposition & Demographics
® Disposition & Demographics © 2025, Hansa Biopharma AB 10
Slide 11: Disposition and Demographics
Disposition and Demographics ® Imlifidase Control Total Disposition n (%) (N=32) (N=32) (N=64) Randomized 32 (100) 32 (100) 64 (100) Treated with imlifidase 30 (93.8) 0 (0) 30 (46.9) Discontinued study 2 (6.3) 4 (12.5) 6 (9.4) Completed study 30 (93.8) 28 (87.5) 58 (90.6) Sex, n (%) Female 18 (56.3)
Slide 12: Demographics and Baseline Characteristics
Demographics and Baseline Characteristics ® Treatment groups were balanced with respect to race and ethnicity, and representative of a highly sensitised waitlist population Imlifidase Control Total Demographic (N=32) (N=32) (N=64) Race, n (%) Asian 1 (3.1) 2 (6.3) 3 (4.7) Black or African American 1
Slide 13: Analysis Sets
Analysis Sets ® Analysis set n (%) Imlifidase Control Total Comment (N=32) (N=32) (N=64) Full analysis set 32 (100) 32 (100) 64 (100) All patients randomised (FAS) Safety analysis set 30 (93.8) 32 (100) 62 (96.9) Excludes patients who did not receive (SAF) randomised imlifidase treatment © 2025, Han
Slide 14: Efficacy Outcomes
Efficacy Outcomes ® Imlifidase Control Imlifidase eGFR Control p-value n n (mean) eGFR (mean) Primary endpoint 32 32 51.5 19.3 <0.0001 eGFR at 12 months in FAS Rank-based non-parametric analysis of 32 32 50.0* 0* 0.0001 eGFR at 12 months eGFR at 12 months in patients transplanted 27 3 59.3 23.1 0.01
Slide 15: Safety Outcomes in Imlifidase-Treated Patients
Safety Outcomes in Imlifidase-Treated Patients ® • Tolerability of imlifidase was good • There was a low incidence of infusion reactions, and no infusions were interrupted due to an infusion reaction • Infections observed in imlifidase-treated patients were typically not related to treatment • The A
Slide 16: Conclusions
Conclusions ® • The treatment arms were well-balanced at baseline, and the demographic characteristics reflected a highly sensitised, dialysis-dependent population wait-listed for transplantation • Retention in the study was excellent; 58/64 patients (90.6%) completed the study • The primary endpoin
Slide 17: ConfIdeS Topline Results Conference Call Agenda
ConfIdeS Topline Results Conference Call Agenda ® 25 September 2025 Introduction Renée Aguiar-Lucander CEO ConfIdeS Richard Philipson Topline data CMO Market opportunity Maria Törnsén COO, President US Next step Renée Aguiar-Lucander Q&A and Close CEO © 2025, Hansa Biopharma AB 17
Slide 18: US represents a significant market opportunity
US represents a significant market opportunity ® Significant Unmet Medical Need US Transplant Waitlist Inability to match or effectively desensitize patients remains a barrier for transplantation in highly sensitized patients ~100,000 ~ 15% of patients are on the wait list highly sensitized (cPRA >
Slide 19: The US transplant market is highly concentrated
The US transplant market is highly concentrated ® Northwestern U of Iowa Mayo Rochester Barnes Jewish U of Chicago U of Minnesota U Wash MC Wisconsin Mass General NYU Langone Columbia Cornell Cedars Sinai USC U Penn UCSF Johns Hopkins Mayo AZ St Barnabas CPMC Banner Phoenix UAB Methodist SA Houston
Slide 20: Robust commercialization strategy established
Robust commercialization strategy established ® Concentrated Market Pricing and Reimbursement Experienced US Team ~200 adult transplant centers ~55% paid by Medicare Medical Affairs Field team with multiple years in the transplant market; SVP Medical Affairs has recent nephrology launch experience 1
Slide 21: ConfIdeS Topline Results Conference Call Agenda
ConfIdeS Topline Results Conference Call Agenda ® 25 September 2025 Introduction Renée Aguiar-Lucander CEO ConfIdeS Richard Philipson Topline data CMO Market opportunity Maria Törnsén COO, President US Next step Renée Aguiar-Lucander Q&A and Close CEO © 2025, Hansa Biopharma AB 21
Slide 22: Next Steps
Next Steps ® A Biologic License Application (BLA) under the accelerated approval pathway to the US Food and Drug Administration (FDA) remain on track Validation 2 months Accelerated approval pathway 6 months Validation 2 months Standard approval pathway 10 months The FDA instituted its Accelerated A
Slide 23: Q&A
® Q&A © 2025, Hansa Biopharma AB 23
Slide 24: HAN Sar
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