Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Investor Presentation (March 2025)
32 slides from Hansa Biopharma Ab's investor presentation, Mar 11, 2025
Slide 1: Corporate Presentation
Corporate Presentation February 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 is a pioneer in first in class IgG-cleaving enzymes
Hansa is a pioneer in the development and commercialization of first in class IgG-cleaving enzymes Commercial stage, derisked Validated pipeline across Funded through key first-in-class asset three therapy areas milestones 1 TRANSPLANTATION Commercial stage IgG cleaving Paradigm shift for highly sen
Slide 4: Two novel molecules: imlifidase and HNSA-5487
Two novel molecules with potential for broad application in Autoimmune, Gene Therapy and Transplantation Two IgG- cleaving compounds IMLIFIDASE HNSA-5487 First generation, first-in-class, one-time dosing therapy Next generation molecule with redosing potential with proven efficacy and safety F(ab’)2
Slide 5: Significant addressable patient populations in areas of high unmet medical need
Significant addressable patient populations in areas of high unmet medical need AUTOIMMUNE GENE THERAPY TRANSPLANTATION GT market expected to reach $23.9B by 2028 Imlifidase: first and only approved treatment in IVIg market growth $40B by 2032 highly sensitized transplantation Europe and US Europe a
Slide 6: IgG-driven diseases are a significant burden on people, systems and society
IgG-driven diseases and conditions are a significant burden on people, systems and society Pathogenic IgG is a key element in Rapid reduction of IgG levels has several diseases and conditions the potential to benefit patients Depletion of IgG antibodies may halt disease Excessive or dysregulated imm
Slide 7: Hansa's IgG cleaving enzymes could be a transformative approach
Hansa’s IgG cleaving enzymes could be a transformative approach to treating IgG driven immune-mediated diseases Addressing 80+ autoimmune diseases, including GBS (150K cases/year Autoimmune Diseases WW), anti-GBM (1.6 people per million/year), and myasthenia gravis (83K people in the US). Democratiz
Slide 8: Broad clinical pipeline
Broad clinical pipeline Marketing Preclinical Phase 1 Phase 2 Phase 3 Marketed Partner Status Next anticipated milestone authorization Imlifidase EU: Kidney transplantation in highly sensitized Commercialization ongoing EU: Additional agreements around patients1,2 Post approval Clinical Phase reimbu
Slide 9: Multiple, value-creating pipeline catalysts in 2025
Multiple, value-creating pipeline catalysts in 2025 AUTOIMMUNE DISEASES GENE THERAPY TRANSPLANTATION IMLIFIDASE IMLIFIDASE IMLIFIDASE Guillain-Barré Syndrome (GBS) Gene Therapy Kidney Transplantation 15-HMedIdeS-09 Ph 2 Data publication. Ph 3 preparation Partnership Strategy ConfIdeS US Phase 3: Dat
Slide 10: Autoimmune Diseases
AUTOIMMUNE DISEASES Autoimmune diseases are conditions caused by the adaptive immune system mistakenly mounting an attack against the body’s own cells and tissues Acute indications can cause life-threatening organ failure and long-term damage. Chronic indications occur when damage develops over time
Slide 11: Guillain-Barré Syndrome 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 12: 15-HMedIdeS-09 Phase 2 study 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 13: Recovery of muscle strength seen as early as week 1
Recovery of muscle strength 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 10.7
Slide 14: Indirect treatment comparison shows benefit of imlifidase with IVIg
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 15: Imlifidase with IVIg delivered clinically meaningful benefit in severe GBS
Imlifidase in combination with IVIg delivered 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 pro
Slide 16: 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 17: Topline data from GOOD-IDES-02 Phase 3 anti-GBM trial expected 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 18: HNSA-5487 could address unmet need in neuro-autoimmune conditions including MG
HNSA-5487 could address unmet need in neuro-autoimmune conditions including Myasthenia Gravis (MG) Most people with MG have IgG antibodies against the Myasthenia Gravis (MG) acetylcholine receptor A rare, chronic autoimmune neuromuscular disorder that is characterized by fluctuating weakness of the
Slide 19: NICE-01 first in human trial data for HNSA-5487
NICE-01 first in human trial data demonstrated clear redosing potential for HNSA-5487 with 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) infusi
Slide 20: HNSA-5487 reduced 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 20
Slide 21: HNSA-5487 uniquely positioned to treat acute and chronic conditions
HNSA-5487 is uniquely positioned to treat acute and chronic conditions due to its rapid IgG reduction HNSA-5487 provides unmatched speed in reducing IgG IgG cleaving enzymes cleave antibodies across all domains Intravascular Extravascular Cell bound IgG lowering IgG IgG IgG modalities Imlifidase HNS
Slide 22: Gene Therapy
GENE THERAPY Over 7,000 monogenic diseases and up to 1 in 3 people can’t benefit from gene therapy due to anti-AAV antibodies IMLIFIDASE • Three partnerships in place with leading gene therapy companies; • Phase 1 data read out with Sarepta expected in 2025 • Phase 2 trial with Genethon in Crigler N
Slide 23: Global exclusive agreements with leading gene therapy companies
Global exclusive agreements with leading gene therapy companies in select indications CAPABILITIES & RESOURCES CAPABILITIES & RESOURCES CAPABILITIES & RESOURCES ➢ World leader in gene therapy in muscular dystrophies ➢ A pioneer in the discovery and ➢ Early innovator in gene therapy development of ge
Slide 24: Imlifidase pre-treatment enhances transduction and transgene expression in animal models
Imlifidase pre-treatment decreases pre-existing antibodies and enhances transduction and transgene expression in animal models EXPRESSION IN SKELETAL MUSCLE + TRANSDUCTION Data from animal models *P<0.05. †Data are represented as mean ± SEM and analyzed by one-way ANOVA followed by post-hoc analysis
Slide 25: Transplantation
TRANSPLANTATION More than 170K on the kidney transplant wait list; 10-15% highly sensitized and face significantly longer wait times IMLIFIDASE • Conditionally approved (2020) and commercialized in EU as desensitization for kidney transplantation • Positive 5-year survival data shows durable graft a
Slide 26: Kidney transplantation is viewed as optimal treatment for ESRD
Kidney transplantation is viewed as optimal treatment for end stage renal disease (ESRD) End Stage Renal Disease (ESRD) Causes of Transplantation of highly sensitized patients has increased A serious condition that requires renal replacement therapy – either Sensitization since the introduction of t
Slide 27: Solid commercial opportunity in kidney transplantation desensitization
Solid commercial opportunity in kidney transplantation desensitization Significant Unmet Medical Need IDEFIRIX Launch in Europe ConfIdeS Phase 3 Inability to match or effectively Nearing Completion European launch has reached inflection desensitize patients remains a barrier point with increasing ad
Slide 28: US Phase 3 pivotal ConfIdeS trial data expected in 2H 2025
US Phase 3 pivotal ConfIdeS trial data expected in 2H 2025 STUDY OVERVIEW Open-label, controlled, randomized trial evaluating 12-month kidney function in highly sensitized kidney transplant patients with positive crossmatch against a deceased donor, comparing desensitization using imlifidase with st
Slide 29: 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 30: Poised to deliver therapies that will change the immune-mediated treatment landscape
Poised to deliver therapies that will change the immune-mediated treatment landscape 3 Therapeutic Well Capitalized Proprietary IgG- Highly Clinically Areas, Broad into 2026, cleaving Platform Validated Application Experienced Team © 2025, Hansa Biopharma AB 30
Slide 31: Financing and Leadership
FINANCING AND LEADERSHIP Leadership team Board of Directors Leadership team with significant Søren Tulstrup President & CEO Peter Nicklin Chairman experience in immune modulating therapies and global healthcare Anders Gersel Pedersen Director Evan Ballantyne Mats Blom Director NASDAQ STOCKHOLM TICKE
Slide 32: Thank you
Thank you IR@hansabiopharma.com