Hansa Biopharma AB · OMXSTO:HNSA
Hansa Biopharma AB — Investor Presentation (July 2024)
36 slides from Hansa Biopharma AB's investor presentation, July 2024
Slide 1: Corporate Presentation
Corporate Presentation July 2024
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: Table of Contents
Table of Contents Company Overview slides 4 – 11 strategy, science, pipeline Therapy Areas slides 13 - 26 autoimmune, gene therapy, transplantation Executive Summary slide 28 Additional Resources slides 30 - 36 ESG, patents, ownership, leadership, references © 2024 Hansa Biopharma AB
Slide 4: Hansa Biopharma – a commercial stage biotech delivering new medicines for rare immunological diseases
Hansa Biopharma – a commercial stage biotech delivering new medicines for rare immunological diseases SCIENTIFIC INNOVATION COMMERCIAL STAGE LONG-TERM POTENTIAL • Proprietary • First and only treatment • Backed by leading specialist immunomodulating approved for desensitization investors - financing
Slide 5: Roadmap to Leadership in Rare Immunological Diseases
Roadmap to Leadership in Rare Immunological Diseases ADVANCE DELIVER BUILD the science commercial growth the organization Ø Broaden imlifidase label beyond Ø Successfully launch IDEFIRIX Ø Build a focused, agile and kidney transplantation (imlifidase) in Europe empowered global organization Ø Develo
Slide 6: Imlifidase is an innovative, first in class molecule with a proven approach to inactivate IgG
Imlifidase is an innovative, first in class molecule with a proven approach to inactivate IgG Originates from a bacteria IgG antibody-cleaving enzyme Inactivates IgG in 2-6 hours Streptococcus pyogenes known from Interacts with Fc-part of IgG with Rapid onset of action that inactivates causing a str
Slide 7: IgG cleaving enzymes uniquely positioned through rapid onset of effect and therapeutic reach
IgG cleaving enzymes uniquely positioned through rapid onset of effect and therapeutic reach Comparison of established therapies to significantly reduce IgG levels within a few weeks IgG cleaving enzymes provide unmatched IgG cleaving enzymes cleave antibodies speed of antibody decrease across all d
Slide 8: HNSA-5487 is a next gen enzyme with long and short interval redosing potential
HNSA-5487 is a next gen enzyme with long and short interval redosing potential Lower immunogenicity Long interval redosing Short interval redosing could apply to diseases where keeps IgG at a low level, potentially create a longer IgG-low period prolonged or intermittent IgG free leading to greater
Slide 9: Hansa’s proprietary technology platform with two unique molecules and broad potential indications
Hansa’s proprietary technology platform with two unique molecules and broad potential indications LUNG HNSA-5487: Next gen antibody cleaving enzyme with redosing potential LUNG AMR HEART Guillain- HEART Barré AMR Ph 2 trial KIDNEY KIDNEY ANCA Anti-GBM Approved in AMR vasculitis EU Ph 3 trial Ph 2 tr
Slide 10: Key milestones over the next 18-24 months
Key milestones over the next 18-24 months 2024 2025 AUTOIMMUNE AUTOIMMUNE GBS Phase 2: comparative efficacy analysis read-out Anti-GBM Phase 3: full enrolment ANCA: full enrolment GENE THERAPY Crigler-Najjar Phase 1: trial initiation (Genethon) GENE THERAPY DMD Phase 1B: high level data read-out (Sa
Slide 11: Broad clinical pipeline in autoimmune, gene therapy and transplantation
Broad clinical pipeline in autoimmune, gene therapy and transplantation Research/ Marketing Project Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Partner Next Anticipated Milestone EU: Additional agreements around EU: Kidney transplantation in highly sensitized reimbursement
Slide 12: Table of Contents
Table of Contents Company Overview slides 4 – 11 strategy, science, pipeline Therapy Areas slides 13 - 26 autoimmune, gene therapy, transplantation Executive Summary slide 28 Additional Resources slides ESG, patents, ownership, leadership © 2024 Hansa Biopharma AB
Slide 13: Autoimmune
Autoimmune
Slide 14: Autoimmune
autoimmune +100 diseases9 AUTOIMMUNE Rapidly progressive glomerulonephritis Neurological disorders Skin disorders Blood disorders In Phase 2 trials, imlifidase was shown to cleave autoantibodies and stop disease progression in monophasic conditions PROOF OF CONCEPT IN TWO INDICATIONS Anti-GBM diseas
Slide 15: Autoimmune: HNSA-5487 has the potential to quickly remove IgG
autoimmune +100 diseases9 Rapidly progressive AUTOIMMUNE glomerulonephritis Neurological disorders Skin disorders Blood disorders HNSA-5487 has the potential to quickly remove IgG Short interval 5487 redosing Long interval 5487 repeat dosing Hypothetical model Hypothetical model 1st dose HNSA-5487 H
Slide 16: Gene Therapy
Gene Therapy
Slide 17: Gene Therapy
AAVs 5-70% Pre-existing antibodies the delivery system patients considered for gene therapy excludes patients from of gene therapy26-29 have anti-AAV antibodies26 trials & treatment30 GENE THERAPY Eliminate antibodies as a pre- treatment to enable gene therapy Global partnerships with gene therapy c
Slide 18: Systemic gene therapy is an emerging opportunity
Systemic gene therapy is an emerging opportunity PREVALENCE ABOUT THE MARKET DM1 (100k) 100,000 Astellas, EditForce, ü ~ 7,000 known rare Locanabio monogenic diseases worldwide.31 ü Gene therapy market 60,000 poised to reach 52.4 Wilson (40k) Heamophilia A (40k) billion USD by 203332 Vivet, BioMarin
Slide 19: Global exclusive agreements with leading gene therapy companies in select indications
Global exclusive agreements with leading gene therapy companies in select indications CAPABILITIES & RESOURCES CAPABILITIES & RESOURCES CAPABILITIES & RESOURCES Ø Early innovator in gene therapy Ø A pioneer in the discovery and Ø World leader in gene therapy in development of gene therapies muscular
Slide 20: Imlifidase pre-treatment decreases pre-existing antibodies and enhances transduction in animal models
Imlifidase pre-treatment decreases pre-existing antibodies and enhances transduction and transgene expression in animal models EXPRESSION IN SKELETAL MUSCLE+ TRANSDUCTION Transduction† Expression in Skeletal Muscle‡ 1.5 ns vg/nucleus normalized to Cohort 1 * 1.0 eGFP expression (%Area) 50 (a.u.) 40
Slide 21: Transplantation
Transplantation
Slide 22: Transplantation
170k* DSAs SOC 10-15% Donor specific patients with DSAs – or highly patients waiting for based on organ antibodies that reject sensitized - unlikely to be a kidney compatibility transplant50 organ transplantation transplanted due to incompatibility51 **In the US and EU TRANSPLANTATION Long term data
Slide 23: Two key studies for imlifidase: 17-HMedIdeS-14 and ConfIdeS
Two key studies for imlifidase 17-HMedIdeS-14 ConfIdeS Long-term follow-up study US Ph 3 pivotal trial Extended pooled analysis from the 17- HMedIdeS-14 study Open-label, controlled, randomized trial evaluating 12-month kidney function in highly sensitized kidney transplant patients with positive cr
Slide 24: At a Glance: IDEFIRIX launch in Europe
At a Glance: IDEFIRIX launch in Europe Launch Progress Strategic Levers IDEFIRIX was launched in 2023 as the only desensitization strategy for highly sensitized kidney transplant patients: Market Access 15 7 25 9.3m 50 markets with Country issued centers with USD in product clinics IDEFIRIX reimburs
Slide 25: Solid commercial opportunity in kidney transplantation desensitization
Solid commercial opportunity in kidney transplantation desensitization Significant Unmet Medical Need Idefirix Launch in Europe Phase 3 Nearing Completion Inability to match or effectively desensitize Market size patients remains a barrier for transplantation Market size in highly sensitized patient
Slide 26: Opportunities for imlifidase in transplantation beyond kidney
Opportunities for imlifidase in transplantation beyond kidney Lung transplantation desensitization Heart transplantation desensitization 10-15% of lung transplant ~3,000 ~2,000 recipients have some degree of ~4,000 ~2,000 ~30% of patients awaiting heart annual lung pre-sensitization to allo-antigens
Slide 27: Table of Contents
Table of Contents Company Overview slides 4 – 11 strategy, science, pipeline Therapy Areas slides 13 - 26 autoimmune, gene therapy, transplantation Executive Summary slide 28 Additional Resources slides 30 - 36 ESG, patents, ownership, leadership, references © 2024 Hansa Biopharma AB
Slide 28: Hansa Biopharma has the potential to lead the way in rare immunological diseases
Hansa Biopharma has the potential to lead the way in rare immunological diseases Commercial stage, Validated Funded into 2026 first-in-class asset pipeline Commercial stage IgG Paradigm shift for kidney Publicly traded on cleaving enzyme with transplantation NASDAQ Stockholm long-term data 7 ongoing
Slide 29: Table of Contents
Table of Contents Company Overview slides 4 – 11 strategy, science, pipeline Therapy Areas slides 13 - 26 autoimmune, gene therapy, transplantation Executive Summary slide 28 Additional Resources slides 30 - 36 ESG, patents, ownership, leadership, references © 2024 Hansa Biopharma AB
Slide 30: Hansa Sustainability Priorities and Approach
Hansa Sustainability Priorities and Approach HEALTHY BUSINESS HEALTHY PLANET HEALTHY PEOPLE Be an ethical, transparent business with Embrace sustainable decision making and Address the unmet needs of people with the highest integrity and standards driving environmental stewardship by becoming a rare
Slide 31: Strong technology protection through patents and orphan drug designations
Strong technology protection through patents and orphan drug designations Imlifidase patent coverage out to 2035* in key HNSA-5487 patent coverage to at least 2041* markets § Our lead enzyme, imlifidase, is protected by six patent families § Our next-generation enzyme, HNSA-5487, is protected by cur
Slide 32: Ownership in Hansa Biopharma
Ownership in Hansa Biopharma Top 10 shareholders as per June 30, 2024* Classification of ownership as per January 31, 2024 Ownership by region Ownership by type Shareholder Name No. of Shares Ownership % Redmile Group, LLC 13,156,700 19.4% Institution s & funds 29% 30% 33% Braidwell, L.P. 8,247,600
Slide 33: Experienced Board and Executive Committee
Experienced Board and Executive Committee Extensive experience from the global healthcare industry Executive Committee Board of Directors Peter Nicklin Hilary Malone Søren Tulstrup Chairman (2022) President & CEO (2018) +30 years in the Healthcare sector Board Member (2021) +30 years in the Healthca
Slide 34: References
References 1. European Medicines Agency. Idefirix® summary of product characteristics. Available at: https://www.ema.europa.eu/en/documents/product-information/idefirix-epar-product-information_en.pdf 2. Kjellman C et al. Am J Transplantation 2021 Dec;21(12):3907-3918. 3. Trial NCT03611621 4. Winste
Slide 35: References
References 32. Biospace https://www.biospace.com/article/releases/gene-therapy-market-size-poised-to-surge-usd-52-40-billion-by-2033/#:~:text=The%20global%20gene%20therapy%20market,period%20(2024%2D2033). Accessed June 4, 2024. 33. Pharmaprojects| Informa, April 2022. https://www.asgct.org/global/do
Slide 36: Hansa Biopharma
MZ HAN Sar BIOPHARMA