Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Investor Presentation (November 2025)
29 slides from Hansa Biopharma Ab's investor presentation, November 2025
Slide 1: Corporate Presentation
Corporate Presentation November 2025
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: 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 targ
Slide 4: Platform is uniquely positioned to treat serious immune mediated diseases
Platform is uniquely positioned to treat serious immune mediated diseases or challenges due to its rapid IgG reduction Provides unmatched speed in reducing IgG IgG cleaving enzymes cleave antibodies across all domains Extravascular Cell bound IgG lowering Intravascular IgG IgG IgG modalities Imlifid
Slide 5: Addressing Serious Immune Mediated Conditions
Addressing Serious Immune Mediated Conditions THERAPEUTIC FOCUS Desensitization Enabling Transplantation Paradigm shift for highly sensitized kidney transplant patients IDEFIRIX® conditionally approved in the EU For desensitization prior to kidney transplantation Enabling Gene Therapy Partnerships f
Slide 6: 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 CEO COO, President US 20+ yrs rare disease leader and former investor, Successfully launched multiple orphan drugs in t
Slide 7: Desensitization: Transplantation
DESENSITIZATION Transplantation © 2025 Hansa Biopharma AB
Slide 8: Transplantation: High Unmet Need with Significant Market Potential
Transplantation: High Unmet Need with Significant Market Potential ➢ Pioneering breakthrough for Desensitization ➢ Potentially significantly larger patients with significant unmet TRANSPLANTATION population as not all patients are medical need Potential market opportunity > $2bn referred to the wait
Slide 9: Thousands of highly sensitized U.S. patients face indefinite dialysis
Thousands of highly sensitized U.S. patients face indefinite dialysis US Transplant Waitlist ~ 15% of patients are highly sensitized The US represents a significant (cPRA > 80%) market opportunity Significant ~100,000 on the wait list Unmet ~15k highly sensitized patients with Medical Need cPRA >80%
Slide 10: Robust U.S. commercialization strategy established
Robust U.S. commercialization strategy established Concentrated Market Pricing and Reimbursement Experienced US Team ~200 adult transplant centers ~55% Medical Affairs paid by Medicare Field team with multiple years in the transplant market; SVP Medical Affairs has recent nephrology launch experienc
Slide 11: US ConfIdeS Phase 3 study supports BLA filing
US ConfIdeS Phase 3 study supports BLA filing Strong topline data reported in September 2025 Imlifidase Control Imlifidase Control p-value n n eGFR (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 eGFR at 32 32 50.0* 0* 0.0001
Slide 12: Long-term follow-up study showed durable graft and patient survival
Long-term follow-up study showed durable graft and patient survival Study Overview ➢ Extended pooled analysis from the 17-HMedIdeS-14 study ➢ A long-term follow-up study of patients who have received a kidney transplant following desensitization with imlifidase Key Takeaways ➢ 82% five-year graft su
Slide 13: Europe: Upcoming Milestones and Growth Initiatives
Europe: Upcoming Milestones and Growth Initiatives EU Market Challenges Current Status in Europe Accelerating Initiatives ➢ Fragmented market Reimbursement ➢ Focus on resolving regional market ➢ Limited KOL experience 21 markets across the EU access challenges representing 90% of the ➢ Phase 2 with
Slide 14: Desensitization: Gene Therapy
DESENSITIZATION Gene Therapy © 2025 Hansa Biopharma AB
Slide 15: Compelling opportunity in high-growth gene therapy sector
Compelling opportunity in high-growth gene therapy sector GENE THERAPY MARKET DESENSITIZATION ➢ Multiple gene therapy drugs SIGNIFICANT GROWTH EXPECTED GENE THERAPY with 10 – 40% of patients eligible who cannot be Existing $2bn+ market in 2024 treated due to AAV vector Expected to reach $23.9B by 20
Slide 16: Collaborating to bridge access to gene therapies for more patients
Collaborating to bridge access to gene therapies for more patients Indication exclusivity ➢ Duchenne Muscular Indication exclusivity Current Dystrophy (DMD) - 1/3,500 to ➢ Crigler-Najjar syndrome – partnerships 5,000 male births worldwide ultrarare condition with ➢ Limb-Girdle Muscular approximate i
Slide 17: Autoimmune Disease
AUTOIMMUNE DISEASE © 2025 Hansa Biopharma AB
Slide 18: Rare disease focus; IgG mediated conditions
Rare disease focus; IgG mediated conditions Autoimmune IVIg market growth $40B by 2032 Significant unmet medical need – nothing approved in Europe or the US for GBS & Anti-GBM Europe and US Strong Phase 2 data in both indications provided basis for 14,108 addressable further clinical development 18,
Slide 19: Anti-GBM is a rare, acute inflammatory disease driven by IgG
Anti-GBM is a rare, acute inflammatory disease driven by IgG Anti-Glomerular Basement Membrane Disease IgG plays a central role in anti-GBM binding to the An acute, rare, and very severe inflammatory disease in which IgG GBM and causing damage to the kidneys autoantibodies attack the glomerular base
Slide 20: Topline data from Phase 3 anti-GBM trial expected in Q4 2025
Topline data from Phase 3 anti-GBM trial expected in Q4 2025 Results from Phase 2 Study GOOD-IDES-02 Open Label Results Published in JASN (2022) Phase 3 Trial 10 out of 15 patients were dialysis independent after six months vs. the historical cohort, where • Fully enrolled 50 patients from 30+ only
Slide 21: Phase 2 Study demonstrated the role imlifidase may play in GBS
Phase 2 Study demonstrated the role imlifidase may play in halting the progression of GBS Guillain-Barré Syndrome Phase 2 Study Results A rare, acute, paralyzing, inflammatory disease of the peripheral nervous system caused by the immune ➢ Rapid overall improvement in functional system damaging nerv
Slide 22: Innovative next generation Compound HNSA-5487
Innovative next generation Compound HNSA-5487 © 2025, Hansa Biopharma AB
Slide 23: Non-human host derived; Phase 1 clinical data
Non-human host derived; Phase 1 clinical data Data demonstrated significantly lower immunogenicity for HNSA-5487 with rapid and robust IgG reduction – targeting FDA interaction in 1H 2026 for GBS Study Overview • Double blind, randomized, placebo-controlled trial in 36 healthy volunteers received a
Slide 24: Financials and Outlook
FINANCIALS AND OUTLOOK © 2025 Hansa Biopharma AB
Slide 25: Commercial traction & financial highlights
Commercial traction & financial highlights IDEFIRIX® sales grew by The product is available in ~20 Ended Q3 2025 with SEK 252m On 1st of October 2025 raised +25% YTD Q3 2025 to SEK European markets, with 117 cash, proforma SEK 888m USD 71 million through clinics equipped and ~70% ($93m) post capital
Slide 26: Validated, high value pipeline with transformative milestones ahead
Validated, high value pipeline with transformative milestones ahead Q4 2025 Q1 2026 Q2 2026 H1 2026 H2 2026 Q4 2026 onwards Potential US BLA approval/ acceptance ATC US launch Filing for EU / PDUFA ConfIdeS full full approval date data Read out presentation Genethon Ph2 PAES trial sBLA Anti gene the
Slide 27: 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 2026: EU PAES data read out Desensitization Kidney Transplantation Q4 2025: BLA submission to FDA based on Desensitization Kidney Transplantation ConfIdeS US Phase 3 da
Slide 28: Hansa Biopharma
IZ HAN SAP BIOPHARMA
Slide 29: NICE-01 first in human trial
NICE-01 first in human trial HNSA-5487 demonstrated rapid, robust reduction of IgG by 95% after a single dose As efficacious as imlifidase in IgG reduction Effective redosing at 6 and 12-months © 2025, Hansa Biopharma AB 29
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