Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Investor Presentation (September 2025)
30 slides from Hansa Biopharma Ab's investor presentation, September 2025
Slide 1: Corporate Presentation
Corporate Presentation September 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: Hansa Leadership
Hansa Leadership Renée Aguiar-Lucander Evan Ballantyne Hitto Kaufmann, PhD Maria Törnsén CEO CFO SVP and Chief R&D Officer COO, President US © 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 FOCUS AREAS EU COMMERCIALIZATION KEY FACTS DESENSITIZATION IDEFIRIX (imlifidase) ➢ Publicly traded on OMX NASDAQ Sweden ➢ Enabling Transplantation significant ownership from global biotech First in class, paradigm shift f
Slide 5: imlifidase: Two novel molecules focused on Autoimmune Disease and Desensitization
Two novel molecules focused on Autoimmune Disease and Desensitization in Gene Therapy and Transplantation What is IgG Hansa’s IgG-cleaving Platform ➢ Immunoglobulin G (IgG): a protective antibody ➢ Autoimmune Disease: IgG becomes harmful and Imlifidase – first gen, first in class IgG cleaving enzyme
Slide 6: Significant addressable patient populations in areas of high unmet medical need
Significant addressable patient populations in areas of high unmet medical need DESENSITIZATION DESENSITIZATION GENE THERAPY AUTOIMMUNE TRANSPLANTATION GT market expected to reach $23.9B by 2028 Potential market opportunity well > $1bn IVIg market growth $40B by 2032 Europe and US Europe and US 12,0
Slide 7: Desensitization Transplantation
DESENSITIZATION Transplantation © 2025 Hansa Biopharma AB 7
Slide 8: Desensitization is key to transplanting highly sensitized kidney patients
Desensitization is key to transplanting highly sensitized kidney patients PREVALENCE ➢ ESRD affects 2.5M people CURRENT SITUATION worldwide ➢ 170K people are waiting for a ➢ Desensitization strategies have been predicated transplant (US & Europe) on compatibility and current approaches have limitati
Slide 9: Hansa's Phase 3 pivotal ConfIdeS trial data expected in 2H 2025
Hansa’s Phase 3 pivotal ConfIdeS trial data expected in 2H 2025 EU Conditional Approval Study Overview Submission based on data from four Phase Open-label, controlled, randomized trial evaluating 12-month kidney function in highly sensitized 2 studies including 46 adult patients at six kidney transp
Slide 10: PAES study completed enrolment; anticipate increased commercial utilization in key EU markets
PAES study completed enrolment; anticipate increased commercial utilization in key EU markets • Open label Phase 3 study ABOUT • 50 highly sensitized patients with positive crossmatch against an available deceased donor across PAES multiple countries and centers in Europe • Obligation to the EMA to
Slide 11: 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 survi
Slide 12: EU commercial opportunity in desensitization – kidney transplantation
EU commercial opportunity in desensitization – kidney transplantation Potential Market Opportunity IDEFIRIX Launch in Europe ➢ 72,000 patients on wait list in EU REIMBURSEMENT ➢ 5-30% of patients on wait list are highly sensitized* ➢ 30% anticipated peak penetration 18 markets across the EU *Access
Slide 13: Autoimmune Disease
AUTOIMMUNE DISEASE © 2025 Hansa Biopharma AB 13
Slide 14: 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 an acute, rare, and very severe inflammatory disease in which IgG IgG plays a central role in anti-GBM binding to the GBM and autoantibodies attack the glomerular basement membrane in the kidneys c
Slide 15: Topline data from GOOD-IDES-02 Phase 3 anti-GBM trial expected in 2H 2025
Topline data from GOOD-IDES-02 Phase 3 anti-GBM trial expected in 2H 2025 Results from Phase 2 Study GOOD-IDES-03 Open Label Results Published in JASN (2022) Phase 3 Trial • Fully enrolled 50 patients from 30+ centers in US, UK and EU • Primary Endpoints: eGFR at 6 Imlifidase granted months and need
Slide 16: Guillain-Barré Syndrome (GBS) is a rare, acute inflammatory disease driven by IgG
Guillain-Barré Syndrome (GBS) is a rare, acute inflammatory disease driven by IgG IgG is a key driver of inflammatory attacks on peripheral nerves and has Guillain-Barré Syndrome been clinically linked to the severity and progression of the disease. a rare, acute, paralyzing, inflammatory disease of
Slide 17: 15-HMedIdeS-09 Phase 2 Study demonstrated the role imlifidase may play in GBS
15-HMedIdeS-09 Phase 2 Study demonstrated the role imlifidase may play in halting the progression of GBS Study Overview • Open-label, single arm, multi-center study across the UK, France, and the Netherlands. Patients with severe GBS were included (GBS DS ≥ 3) • Evaluated safety, tolerability, and e
Slide 18: Indirect treatment comparison demonstrates benefit of imlifidase with IVIg in GBS
Indirect treatment comparison demonstrates the robust, consistent benefit of imlifidase in combination with IVIg in GBS 15-HMedIdeS-09 data Weighted Prognostic Variables compared to IGOS Time from weakness onset to treatment initiation and baseline values for: Age GBS DS Cranial Nerve Involvement MR
Slide 19: Phase 2 GBS study supports potential for imlifidase in additional Autoimmune Diseases
Phase 2 GBS study supports potential for imlifidase in additional Autoimmune Diseases Imlifidase Clinical Trials Potential Opportunities for in Autoimmune Imlifidase in Autoimmune Guillain- Barré CDIP Ph 2 trial ANCA Ph 3 IIT IMLIFIDASE trial Anti-GBM Lupus Ph 3 trial Nephritis © 2025 Hansa Biopharm
Slide 20: Desensitization Gene Therapy
DESENSITIZATION Gene Therapy © 2025 Hansa Biopharma AB 20
Slide 21: Desensitization holds the promise to provide access to gene therapies for rare disease patients
Desensitization holds the promise to provide access to gene therapies for rare disease patients with anti-AAV antibodies PREVALENCE Imlifidase pre-treatment decreases pre-existing antibodies ➢ Over 7,000 known rare monogenic and enhances transduction and transgene expression in animal models disease
Slide 22: Representative global exclusive agreements
Representative global exclusive agreements CAPABILITIES & RESOURCES CAPABILITIES & RESOURCES ➢ World leader in gene therapy in muscular dystrophies ➢ A pioneer in the discovery and development of gene therapies ➢ Pre-clinical and clinical plan ➢ Conducts pre-clinical and clinical trials (Phase 1/2)
Slide 23: HNSA-5487 Next Generation Molecule
HNSA-5487 Next Generation Molecule © 2025 Hansa Biopharma AB 23
Slide 24: NICE-01 first in human trial data demonstrated redosing potential for HNSA-5487
NICE-01 first in human trial data demonstrated redosing potential for HNSA-5487 with rapid and robust IgG reduction Study Overview • Double blind, randomized, placebo-controlled trial in 36 healthy volunteers received a single ascending doses of HNSA-5487 administered as a single intravenous (IV) in
Slide 25: HNSA-5487 demonstrated rapid, robust reduction of IgG by 95% after a single dose
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 25
Slide 26: HNSA-5487 is uniquely positioned to treat acute autoimmune diseases
HNSA-5487 is uniquely positioned to treat acute autoimmune diseases or periodic exacerbations due to its rapid IgG reduction HNSA-5487 provides unmatched speed in reducing IgG IgG cleaving enzymes cleave antibodies across all domains Extravascular Cell bound IgG lowering Intravascular IgG IgG IgG mo
Slide 27: Pipeline and Financing
Pipeline and Financing © 2025 Hansa Biopharma AB 27
Slide 28: 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 Ph 3 PAES data read out Desensitization Kidney Transplantation 2H 2025: ConfIdeS US Phase 3 data read out Desensitization Kidney Transplantation 2025: GNT-018-
Slide 29: Current financial snapshot
Current financial snapshot Nasdaq OMX Stockholm HNSA # of Shares Outstanding: 67.8 million Market Cap: 1.5556 BSEK (~$161.6 million) @ 23.72 SEK (~$2.47) per share Cash & Cash Equivalents: 250.2 MSEK (~$26.0 million) Debt and Restructuring Terms ➢ July 2022, the Company entered into a US $70.0 milli
Slide 30: Thank you
IZ HAN Sar BIOPHARMA Thank you
Hansa Biopharma — Investor Presentation (September 2025) on 6ix