Slide 1: Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study
Hansa Biopharma announces positive full results from 15-HMedIdeS-09 Phase 2 study and indirect treatment comparison of imlifidase in Guillain-Barré Syndrome 18 December 2024 Søren Tulstrup, President and CEO Hitto Kaufmann, CR&DO
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 occ
Slide 3: GBS is a rare, acute inflammatory disease driven by IgG
GBS is a rare, acute inflammatory disease driven by IgG Guillain-Barré Syndrome IgG is a key driver of inflammatory attacks on peripheral nerves and has a rare, acute, paralyzing, inflammatory been clinically linked to the severity and progression of the disease. disease of the peripheral nervous sy
Slide 4: IgG cleaving technologies have the potential to transform the autoimmune treatment landscape
IgG cleaving technologies have the potential to transform the autoimmune treatment landscape 80 + types of autoimmune diseases, many of which In GBS, IgG is a key driver of inflammatory are chronic, unpredictable, and have debilitating, attacks on peripheral nerves and has been recurring symptoms. I
Slide 5: Hansa has conducted a Phase 2 single arm study and comparative analysis
Hansa has conducted a Phase 2 single arm study and comparative analysis to assess the potential of imlifidase in GBS Indirect treatment 15-HMedIdeS-09 Phase 2 comparison with IGOS real- single arm study to world comparator group evaluate single dose treated with IVIg to evaluate imlifidase (0.25 mg/
Slide 6: 15-HMedIdeS-09 Phase 2 Study Results
15-HMedIdeS-09 Phase 2 Study Results 6
Slide 7: The 15-HMedIdeS-09 Phase 2 Study demonstrated the role imlifidase may play in halting the progression of GBS
The 15-HMedIdeS-09 Phase 2 Study demonstrated the role imlifidase may play in halting the progression of GBS Rapid overall • Expedited muscle recovery 15-HMedIdeS-09 improvement in • Fast return to independently walking functional • Improvement by at least one grade on GBS disability • Open-label, s
Slide 8: Data underscore imlifidase ability to very rapidly and robustly reduce IgG
Data underscore imlifidase ability to very rapidly and robustly reduce IgG KEY TAKEAWAYS ✓ Imlifidase rapidly reduces total Pre imlifidase IgG including pathological 2 days post antibodies that causes GBS imlifidase pre IVIg ✓ Standard of care IVIg is initiated 48 h after imlifidase 1 day post imlif
Slide 9: Recovery of muscle strength is seen as early as week 1
Recovery of muscle strength is seen as early as week 1 in patients treated with imlifidase in combination with IVIg KEY TAKEAWAYS ✓ Muscle weakness is a primary symptom of GBS and can lead to paralysis ✓ Regaining muscle strength is a key factor in recovery and returning to daily activities ✓ Mean i
Slide 10: Phase 2 demonstrates imlifidase followed by IVIg lead to improvement in GBS DS
Phase 2 demonstrates imlifidase followed by IVIg lead to improvement in GBS DS at week 1 and 2 and continued improvement at later timepoints PERCENTAGE PERCENTAGE PERCENTAGE (number) (number) (number) ≤ 1 GBS DS ≤ 2 GBS DS ≤ 3 GBS DS KEY TAKEAWAYS Week 1 56% (15/27) 33 (9/27) 7% (2/27) ✓ Rapid impro
Slide 11: Increasing proportion of patients able to walk and run over time
Increasing proportion of patients able to walk and run over time Able to walk Able to run KEY TAKEAWAYS independently (GBS DS ≤ 1) (GBS DS ≤ 2) ✓ Rapid progression to independently walking Week 1 37% (10/27) 15% (4/27) ✓ Continuous improvement over time Week 2 48% (13/27) 19% (5/27) ✓ Additional imp
Slide 12: Comparison of imlifidase data to historical published data
Comparison of imlifidase data to historical published data illustrates benefit of imlifidase and IVIg in GBS patients Median Time to Median Time to Admission walking Improvement (reaching GBS DS2) (1 GBS DS grade or more) Patients treated with imlifidase + IVIg 16 days 6.0 days imlifidase + IVIg had
Slide 13: 15-HMedIdeS-09 indirect analysis to IGOS real-world comparator group treated with IVIg
15-HMedIdeS-09 indirect analysis to IGOS real-world comparator group treated with IVIg Confidential and prop rietary bu sine ss info rmatio n.
Slide 14: 15-HMedIdeS-09 patient data and IGOS real-world comparator data are similar
15-HMedIdeS-09 patient data and IGOS real-world comparator data are similar 15-HMedIdeS-09 IGOS IVIg, imlifidase, N=27 N=754 n (%) n (%) Media Age 60 60 KEY TAKEAWAYS Female Gender 13 (48) 319 (42) ✓ Propensity score weighting used all 6 (22) 218 (29) available patients (IGOS - IVIg treated) 3 Basel
Slide 15: Indirect treatment comparison demonstrates the robust, consistent benefit of imlifidase in GBS
Indirect treatment comparison demonstrates the robust, consistent benefit of imlifidase in combination with IVIg in GBS Weighted Prognostic Variables Time from weakness onset to treatment initiation and baseline values for: 15-HMedIdeS-09 data Age GBS DS Cranial Nerve Involvement MRC sum score Diarr
Slide 16: Imlifidase in combination with IVIg delivers clinically meaningful benefit to patients with severe GBS
Imlifidase in combination with IVIg delivers clinically meaningful benefit to patients with severe GBS Substantial early improvement in functional Significantly faster improvement in clinically status in Phase 2 study meaningful measures vs standard of care IVIg well tolerated/consistent safety prof
Slide 17: Hansa is addressing unmet medical need in IgG driven immune mediated diseases
Hansa is addressing unmet medical need in IgG driven immune mediated diseases Two IgG- cleaving compounds IMLIFIDASE HNSA-5487 first generation, first in class, single dose therapy second generation molecule with redosing potential with proven efficacy and safety F(ab’)2 imlifidase IgG Fc ❑ Conditio
Slide 18: Q&A Hansa Biopharma leadership
Q&A HANSA BIOPHARMA LEADERSHIP Søren Tulstrup Hitto Kaufmann President & CEO Chief R&D Officer