Hansa Biopharma AB · OMXSTO:HNSA
Hansa Biopharma AB — ABG Life Science Conference 2022
19 slides from Hansa Biopharma AB's conference presentation, May 18, 2022
Slide 1: Investor Presentation
Investor Presentation ABG Life Science Conference, Stockholm May 18, 2022 Søren Tulstrup President & CEO
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 Biopharma today
Hansa Biopharma today Successful track record... A validated Idefirix® is our first Broad pipeline in Strong momentum... technology approved drug in transplantation and Europe* autoimmunity Promising future... VALIDATION ACROSS KIDNEY TRANSPLANTS PROGRAMS IN CLINICAL THREE AREAS DEVELOPMENT Approval
Slide 4: Many milestones achieved during the last 18 months
Many milestones achieved during the last 18 months First patient enrolled in Pricing and Marketing the U.S. pivotal reimbursement authorization in randomized controlled achieved for Israel for Idefirix® study ”ConfIdeS” in Idefirix® in Germany (imlifidase) Healthcare Technology highly sensitized kid
Slide 5: Imlifidase
Imlifidase A novel approach to eliminate pathogenic IgG Origins from a bacteria A unique IgG antibody-cleaving enzyme Inactivates IgG in 2-6 hours Streptococcus pyogenes • Species of Gram-positive, • Interacts with Fc-part of IgG with extremely high specificity • Rapid onset of action that inactivat
Slide 6: Potential indication universe
Gene therapy pre-treatment Potential indication universe (partnership opportunity) Transplantation and post transplantation (Own commercial infrastructure in EU/US) … … … Limb- Transplantation and Pompe post transplantation Girdle … Lung Heart disease (LGMD) Other areas Lung Duchenne First generatio
Slide 7: Our Business model
Our Business model Leveraging our technology platform to develop new therapies targeting rare diseases with unmet medical need across a range of indications Growth engine Value chain Commercialization Leveraging our We are controlling Build-up of Indications Multiple proprietary antibody the full va
Slide 8: Idefirix (imlifidase) has received conditional approval in the European Union
Idefirix® (imlifidase) has received conditional approval in the European Union Low Higher complexity complexity transplants transplants ~70% of patients1,2 15-20% of patients1,2 10-15% of patients1,2 Non or less sensitized Moderately sensitized Highly sensitized (cPRA < 20%) (20% < cPRA < 80%) (cPRA
Slide 9: The kidney transplantation landscape in Europe and the U.S.
The kidney transplantation landscape in Europe and the U.S. Up to 15% of patients waiting for a new kidney are highly sensitized ~50,000 transplants done annually in the U.S. and Europe Breakdown of the kidney transplant U.S. annual transplantations 5Y avg 22 083 Total YoY waitlist in U.S. and EU 20
Slide 10: Commercial sales uptake
Our center focused and sequenced launch process will help build the foundation for Idefirix® to become a new Standard of Care in transplantation Idefirix® is the first and only approved treatment in Europe for desensitization treatment of highly sensitized kidney transplant patients. The long-term m
Slide 11: Full commercial access secured in Germany; Market access granted in France
Full commercial access secured in Germany; Market access granted in France through a reimbursed Early Access Program Market access procedures ongoing in 11 countries incl. Spain, Italy and the U.K. During 2021 market access was secured in Sweden and Netherlands as well as on an individual hospital b
Slide 12: U.S. ConfIdeS study: First patient enrolled Dec'21; BLA submission expected H1 2024
U.S. ConfIdeS study: First patient enrolled Dec’21; BLA submission expected H1 2024 U.S. trial design 64 highly sensitized kidney patients with the highest unmet medical need Timeline • Patients with a cPRA score of ≥99.9% will be enrolled 1:1 Randomization First patient 12m follow-up on • When a do
Slide 13: Broad clinical pipeline in transplantation and auto-immune diseases
Broad clinical pipeline in transplantation and auto-immune diseases Candidate/ Research/ Marketing Program Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Next Anticipated Milestone EU: Additional agreements EU: Kidney transplantation in highly sensitized patients 1,2 *) around
Slide 14: Our unique antibody cleaving enzyme technology may have relevance across a range of indications
Our unique antibody cleaving enzyme technology may have relevance across a range of indications Targeting rare IgG mediated diseases Expanding our commercial franchises Regulatory approval (conditional) Clinical development Partnership (preclinical development) Preclinical development Anti-GBM paves
Slide 15: Results from Phase 2 study of imlifidase in anti-GBM disease published in JASN
Results from Phase 2 study of imlifidase in anti-GBM disease published in Journal of American Society of Nephrology (JASN)1 U.S. FDA has accepted Hansa’s Investigational New Drug (IND) application to proceed with a Phase 3 study of imlifidase in 50 patients across U.S. and EU with the first patient
Slide 16: Enrollment in Phase 2 program in Antibody Mediated Rejection close to completion
Enrollment in Phase 2 program in Antibody Mediated Rejection (AMR) post kidney transplantation close to completion Long term graft survival is challenged by AMR episodes post transplantation Indication Phase 2 Study Path forward • Acute antibody mediated rejection episodes post • 29 out of a target
Slide 17: Upcoming milestones
Upcoming milestones Milestones subject to potential COVID-19 impact Long-term follow- Anti-GBM Kidney transplantation GBS up data 5-years Kidney Initiation of U.S. complete Phase 2 complete out in kidney transplantation Phase 3 study enrollment enrollment transplantation U.S. BLA submission (2022) (
Slide 18: Hansa Biopharma
MZ HANSAT BIOPHARMA
Slide 19: Corporate Contacts
Corporate Contacts Visit our web site Investor Relations and www.hansabiopharma.com Corporate Communications Calendar and events May 18, 2022 ABG ABGSC Life Science Summit 2022, Stockholm Klaus Sindahl June 2, 2022 Redeye Growth Day Head of Investor Relations June 16, 2022 CITI’s European Healthcare