Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Canaccord NDRS (April 2022)
46 slides from Hansa Biopharma Ab's conference presentation, Apr 4, 2022
Slide 1: Investor Presentation Canaccord NDRS
Investor Presentation Canaccord NDRS April 4, 2022 Søren Tulstrup President & CEO …at Hansa Biopharma we envision a world where all patients with rare immunologic diseases can lead long and healthy lives...
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: Introduction to Hansa Biopharma
Introduction to Hansa Biopharma
Slide 4: 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 THREE AREAS EUROPE KIDNEY PROGRAMS IN CLINICAL TRANSPLANTS DEVELOPMENT A
Slide 5: Many milestones achieved during the last 15 months
Many milestones achieved during the last 15 months First patient enrolled in the U.S. pivotal randomized controlled study ”ConfIdeS” in Healthcare Technology highly sensitized kidney Pricing and Pricing and Assessment published by transplant patients reimbursement reimbursement for Swedish “TLV”, wi
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: 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 9: Upcoming milestones
Upcoming milestones Milestones subject to potential COVID-19 impact Kidney Long-term follow- AMR Anti-GBM transplantation GBS Phase 2 up data 5-years Kidney Phase 2 complete Initiation of U.S. complete first data read out* out in kidney transplantation enrollment Phase 3 study enrollment (Timeline g
Slide 10: Our strategic priorities
Our strategic priorities Building tomorrow’s Hansa Biopharma 10 *Idefirix approved in EEA under conditional approval for kidney transplantation
Slide 11: Our technology platform
Our technology platform MZ HANSAT BIOPHARMA
Slide 12: 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 13: 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 14: New preclinical collaboration with argenx BV
New preclinical collaboration with argenx BV Collaboration to evaluate the potential combination of companies’ IgG-modulating approaches • A combination of Hansa’s IgG antibody-cleaving enzyme, and efgartigimod, argenx’s FcRn antagonist could potentially be used in both the acute and chronic setting
Slide 15: NiceR for repeat dosing
“NiceR” for repeat dosing a new set of enzymes for repeat dosing for potential inactivation of flares in relapsing diseases NiceR - Novel Immunoglobulin Cleaving Enzymes NiceR can potentially inactivate flares for Repeat dosing with lower immunogenicity Illustrative flare 1 flare 2 flare 3 flare (n)
Slide 16: Imlifidase in kidney transplantation
Imlifidase in kidney transplantation
Slide 17: 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 18: 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 European transplantation rates were negatively affected by COVID-19 Breakdown of the kidney transplant U.S. annual transplantations 5Y avg 22 083 Total YoY waitlist in U.S
Slide 19: 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 20: Pricing and reimbursement obtained in Germany, France, Sweden, Netherlands, Finland and Greece
Pricing and reimbursement obtained in Germany, France (early access), Sweden, Netherlands as well as Finland and Greece on a hospital basis Market access processes ongoing in 10 countries EU4+UK represent ~15,000 annual kidney transplants1 Health Technology Assessments 3,649 (HTA) dossiers submitted
Slide 21: 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 • First patients enrolled at Columbia University, NYC First
Slide 22: 3-year follow up demonstrate graft survival of 84% after imlifidase treatment and transplantation
3-year follow up demonstrate graft survival of 84% after imlifidase treatment and transplantation Data accepted for publication in the American Journal of Transplantation1 Link AJT article 30 patients participating in follow-up study at year three AMR frequency in line with other desensitization pro
Slide 23: Additional imlifidase indications
Additional imlifidase indications
Slide 24: Hansa's antibody cleaving enzyme technology
Hansa’s antibody cleaving Clinical programs enzyme technology Potential autoimmune indications may have relevance in several autoimmune diseases *Total disease populations in EU & US, where IgG plays an important role in the pathogenesis based on prevalence and population data Rapidly progressive Ne
Slide 25: Positive high-level data from Phase 2 study in anti-GBM antibody disease
Positive high-level data from Phase 2 study in anti-GBM antibody disease marks an important milestone for Hansa’s expansion of imlifidase outside transplantation with 2/3 of patients achieved dialysis independence six months after treatment High-level data read out 5 5 5 • Study concludes that imlif
Slide 26: Exploring potential use of imlifidase in allogeneic HSCT
Exploring potential use of imlifidase in allogeneic hematopoietic stem cell transplantation (HSCT) Desensitization treatment of patients with high levels of donor specific antibodies (DSA) prior to allogeneic HSCT transplant is a challenge; Imlifidase may have the potential to inactivate DSAs prior
Slide 27: Gene Therapy
Gene Therapy Christian Kjellman CSO/COO
Slide 28: Neutralizing antibodies are immunological barriers in gene therapy
Neutralizing antibodies (Nabs) are immunological barriers in gene therapy; imlifidase may potentially eliminate Nabs Between approximately 5% and 70%1,2 of patients considered for gene therapy treatment carry neutralizing anti-AAV antibodies forming a barrier for treatment eligibility 1 Antibodies p
Slide 29: Systemic gene therapy is an emerging opportunity
Systemic gene therapy is Preclinical programs with Sarepta and AskBio an emerging opportunity with a focus on the potential to correct issues Potential gene therapy indications causing genes in rare monogenic diseases Rare monogenic diseases From hundreds of patients to thousands of patients Duchenn
Slide 30: Imlifidase highlighted in Nature Medicine
75 LETTERS 4 Anti-AAV8 Ig Day –1 Day –1 Day 0 Day 28 50 NATURE MEDICINE + 30 min 2 37 Imlifidase (IdeS) was highlighted a AAV-LK03-GAA 25 AAV-LK03-hFVIII IdeS Fc 0 eS (2 × 1012 vg kg–1) 20–1) (2 × 1012 vg kg–1) -C S in Nature Medicine1 (1 mg kg Animals were killed PB eS Id Id 5 min 24 h Day 0 Day 21
Slide 31: Global and exclusive agreement with Sarepta Therapeutics
Global and exclusive agreement with Sarepta Therapeutics to develop and promote imlifidase as pre-treatment ahead of gene therapy in select indications Indication exclusivity: Hansa’s key resources Sarepta’s key resources + • Duchenne Muscular • Imlifidase validated with positive clinical • World le
Slide 32: Collaboration with AskBio to evaluate imlifidase in gene therapy targeting Pompe disease
Collaboration with AskBio to evaluate imlifidase in gene therapy targeting Pompe disease Feasibility program to evaluate imlifidase as pre-treatment ahead of gene therapy in Pompe disease for patients with pre-existing neutralizing antibodies (NAbs) to adeno-associated virus (AAV) Fully owned subsid
Slide 33: Our mid-term financial priorities
Our mid-term financial priorities Fund a broad exploitation of our technology platform while securing a successful European launch …with current cash position and projected burn-rate, Hansa is financed into 2023 Fund commercial expansion across Europe, targeting mid-term product profitability SEK ~8
Slide 34: An exciting journey ahead!
34 An exciting journey ahead! This is just the beginning! Clinical validation External validation Regulatory validation Validated manufacturing Strong IPR Exciting pipeline Strong team Key milestones to be achieved * Full commercial launch of Idefirix® in Europe and other markets* * Complete Phase 3
Slide 35: HANSAT
MZ HANSAT BIOPHARMA
Slide 36: Additional slides
Additional slides HANSAT BIOPHARMA
Slide 37: Revenue amounted to SEK 15m for Q4'21 and SEK 34m for FY'21
Revenue amounted to SEK 15m for Q4’21 and SEK 34m for FY’21 Revenue (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 15 Product sales 9 9 SEKm 4,9 Revenue 6 4,5 3,8 Recognition 2,4 4,4 5,3 Sarepta 2,6 3,6 1,2 0,5 0,9 0,6 1,1 Axis-Shield Revenue (FY/FY) 2019 2020 2021 34 Product sales 15,0 SEKm Revenue 15,7 Recog
Slide 38: Continued investments in our commercialization and pipeline
Continued investments in our commercialization and pipeline SG&A expenses (Q/Q) R&D expenses (Q/Q) Net loss (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 -63 -60 -81 -83 -47 -103 -50 -55 -106 -104 -61 SEKm SEKm SEKm -68 -133 -148 -163 SG&A expenses (
Slide 39: Operations financed into 2023
With current cash position and projected burn-rate, operations is financed into 2023 Operating cash flow (Q/Q) Cash & short-term investments (Q/Q) Shareholders’ equity (Q/Q) Q4'20 Q1'21 Q2'21 Q3'21 Q4'21 -39% -35% -97 -121 -113 -116 -132 SEKm SEKm SEKm 1 139 1 007 1 378 1 255 889 1 242 1 031 900 758
Slide 40: Imlifidase enabled kidney transplantation in 46 highly sensitized patients
Imlifidase enabled kidney transplantation in 46 highly sensitized patients during clinical trials Pooled analysis from four Phase 2 trials Study design of our four Phase 2 trials • Analysis included 46 patients Subjects 8 patients • 50% had a cPRA of 100% (Average 99%) Study 02 Design Single-center,
Slide 41: Our antibody cleaving enzymes in oncology (EnzE)
Our antibody cleaving enzymes may potentially improve the therapeutic effect of immunotherapy in oncology (EnzE) Proof of concept demonstrated in vivo for mice Mice with human IgG (~9mg/mL) • Enzyme based antibody enhancement through pre-treatment • The abundance of normal IgG in blood interferes wi
Slide 42: Antibody Mediated Rejection
Antibody Mediated Rejection Long term graft survival is challenged by AMR post transplantation There is no approved treatment for AMR • Active antibody mediated rejection after transplantation occurs in ~10% of kidney transplants1 annually4 and is a significant challenge to long term graft survival
Slide 43: Ongoing AMR Phase 2 study
Ongoing AMR Phase 2 study AMR Phase 2 New AMR Phase 2 study initiated to test imlifidase ability to reduce the amount of DSA in AMR patients post transplantation CLINICALTRIALS.GOV ID Potential of using imlifidase vs. PLEX in AMR NCT03897205 (2019) Illustrative SUBJECTS 30 patients targeted (20 pati
Slide 44: Guillain-Barré syndrome
Guillain-Barré syndrome GBS is an acute autoimmune attack on the peripheral nervous system GBS can affect anyone at any age • GBS is an acute autoimmune attack on the peripheral nervous system, which rapidly and progressively weakens extremities. • Only parts of the patients fully recover from GBS,
Slide 45: New Phase 2 study initiated in GBS
New Phase 2 study initiated in GBS to GBS evaluate safety, tolerability and efficacy of Phase 2 imlifidase in GBS patients CLINICALTRIALS.GOV ID NCT03943589 (2019) Today’s Standard of Care IVIg or PLEX Potential with imlifidase SUBJECTS Illustrative Illustrative 30 patients targeted Paralysis Paraly
Slide 46: Strong technology protection
Strong technology protection through patents and orphan drug designations Patent coverage out to 2035 in key markets Orphan drug designation • Hansa Biopharma’s portfolio consist of 11 separate patent families • Orphan drug designation is granted to drugs intended for rare incl. 7 patent families in