Hansa Biopharma Ab · OMXSTO:HNSA
Hansa Biopharma Ab — Q3 2022 Earnings Presentation
102 slides from Hansa Biopharma Ab's earnings presentation, Oct 20, 2022
Slide 1: Investor Road Show Presentation Q3 2022
Investor Road Show Presentation Q3 2022 Lund, October 20, 2022
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 1. Q3 2022 Business Update……………….. ......4 2. Company overview……………………….. ….15 3. Imlifidase in kidney transplantations….…..….33 4. Completed and ongoing studies………….….41 5. Our enzyme technology………….………. ….55 6. Clinical development programs………..... ….66 7. Pre-clinical programs……
Slide 4: Business update Q3'2022
Business update Q3’2022 4
Slide 5: Highlights for the third quarter of 2022
Positive reimbursement decisions received in Poland and Scotland; $70 million raised in non-dilutive financing; ESOT guidelines published in Transplant International Highlights for the third quarter of 2022 ü Launch activities and market access efforts in EU progressing as planned - Total Q3 revenue
Slide 6: Positive reimbursement decisions in Poland and Scotland for Idefirix
Positive reimbursement decisions received in Poland and Scotland for Idefirix® in highly sensitized kidney transplant patients Market access has now been secured in nine European countries and procedures are ongoing in eight countries including Spain, Italy and Belgium Health Technology Assessments
Slide 7: ESOT guidelines for desensitization published in Transplant International
The European Society for Organ Transplantation’s (ESOT) guidelines for desensitization treatment of highly sensitized patients published in Transplant International in August 2022 Guidelines represent first international consensus on a Transplant International management pathway for highly sensitize
Slide 8: Continuous progress in our ongoing clinical programs
Continuous progress in our ongoing clinical programs Enrollment status Enrollment status Oct 19, 2022 Oct 19, 2022 Antibody Mediated Rejection Phase 2 study Anti-GBM Phase 3 study • 30/30 patients enrolled in the AMR phase 2 study • FDA has accepted Hansa’s Investigational New Drug • Enrollment comp
Slide 9: Broad clinical pipeline in transplantation and auto-immune diseases
Broad clinical pipeline in transplantation and auto-immune diseases Potentially Candidate/ Research/ Pivotal/ Marketing Project Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Next Anticipated Milestone EU: Additional agreements around EU: Kidney transplantation in highly sensi
Slide 10: Total revenue SEK 67m in the third quarter
Total Revenue amounted to SEK 67m in the third quarter including SEK 23m in product sales Revenue (Q/Q) Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 67,1 22.7 Product sales 30,3 SEKm 26,4 43.7 Revenue recognition from 15,4 24.2 AskBio and Sarepta 19.5 4,9 9.0 4.4 5.3 5.2 6.2 0.7 Axis-Shield 0.6 1.1 0.8 0.8 Revenue
Slide 11: Continued investments in commercialization and our pipeline
Continued investments in commercialization and our pipeline SG&A expenses (Q/Q) R&D expenses (Q/Q) Net loss (Q/Q) Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 -83 -103 -80 -90 -83 -61 SEKm SEKm SEKm -68 -71 -138 -148 -154 -163 -170 -93 -91 SG&A expenses (
Slide 12: Cash runway extended through 2024
With recent financing transaction secured Hansa’s cash runway has extended through 2024 Operating cash flow (Q/Q) Cash & short-term investments (Q/Q) Number of employees (Q/Q) Q3'21 Q4'21 Q1'22 Q2'22 Q3'22 Employees 1,215 -116 SEKm -132 -131 -129 -136 SEKm 1,007 889 754 616 145 145 141 Operating cas
Slide 13: Upcoming milestones
Upcoming milestones Milestones subject to potential COVID-19 impact Kidney U.S. Kidney transplantation U.S. transplantation GBS Phase 2 AMR Phase 2 complete complete first data read first data read out enrollment randomization out (H2 2022) (H2 2022) (H1 2023) (2023) 2022 2023 2024 Anti-GBM NiceR co
Slide 14: Company overview
Company overview 14
Slide 15: 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 EUROPE KIDNEY THREE AREAS TRANSPLANTS PROGRAMS IN CLINICAL DEVELOPMENT A
Slide 16: We are building a global leader in rare diseases
We are building a global leader in rare diseases Today Tomorrow We are launching our first commercially We envision a world where approved product for enablement of patients with rare immunologic kidney transplantation in Europe* diseases can lead long and healthy lives 16 * European Economic Area i
Slide 17: Our mission
Our mission We leverage our unique enzyme technology platform to develop innovative, lifesaving and life altering immunomodulating therapies, bring these to the patients with rare diseases who need them, and generate value to society at large. Deliver value to society Transplantation is a cost-effec
Slide 18: Hansa Biopharma's history
Hansa Biopharma’s history The EU Commission grants conditional approval for Idefirix® in 2. Clinical highly sensitized kidney transplant development patients in Europe After the first-in-man study in 2013, Hansa has Market access IPO secured in nine October 2007 completed four Ph. II studies since 2
Slide 19: Many milestones achieved during the last months
Many milestones achieved during the last 15 months Pricing and Marketing ESOT guidelines published in reimbursement authorization in Transplant International achieved for Israel for Idefirix® First patient enrolled in Idefirix® in Germany (imlifidase) the U.S. pivotal First national market access ra
Slide 20: Imlifidase: a novel approach to eliminate pathogenic IgG
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 21: 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 22: Potential indication universe
Gene therapy pre-treatment Potential indication universe (partnership opportunities) 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 generat
Slide 23: Our strategic priorities
Our strategic priorities Our mission is to become a global leader in rare diseases 1 2 3 4 5 Successfully Advance our Develop imlifidase Develop our next Successfully commercialize ongoing clinical as pre-treatment to generation IgG- develop and market Idefirix® in kidney programs in AMR gene therap
Slide 24: Becoming a fully integrated commercial stage biopharmaceutical company
Becoming a fully integrated commercial stage biopharmaceutical company while expanding our technology and global footprint We are here! Pre-clinical Early-stage clinic Late-stage clinic Commercial stage 1 2 3 Creating a scientific platform Preparing the company for Building and capturing value in ne
Slide 25: Our culture is driven by people passionate about making changes
Our culture is driven by people passionate about making changes Purpose Diverse and Skilled and Motivated driven culture international experienced team workforce For second consecutive year Hansa is certified as a Helping patients with rare diseases serves ~45% >50% “Great Place to Work” Internation
Slide 26: Experienced Board and Executive Committee
Experienced Board and Executive Committee Extensive experience from the global healthcare industry Executive Committee Board of Directors Sören Tulstrup Christian Kjellman Peter Nicklin Hilary Malone President & CEO (2018) SVP & CSO/COO (2008) Chairman (2022) Board Member (2021) +30 years in the Hea
Slide 27: Hansa Biopharma's Governance Structure
Hansa Biopharma’s Governance Structure External Nomination General Meeting auditors Committee Board of Directors Audit Remuneration Scientific U.S. Committee Committee Committee Committee Risk Executive management Electing / Appointing Committee Reporting / Informing Compliance 27
Slide 28: Strong technology protection
Strong technology protection through patents and orphan drug designations Patent coverage out to 2035 in key markets Orphan drug designation • Our lead product, imlifidase, is protected by six patent families • Orphan drug designation is granted to drugs intended for rare diseases including both gra
Slide 29: Hansa Biopharma is financed through 2024
Hansa Biopharma is financed through 2024 $70 million non-dilutive financing transaction announced in July 2022 to support the continued development of Hansa’s antibody-cleaving enzyme technology platform 1,600 1,476 1,378 1,400 Raised Financing SEK 1.1bn 1,255 SEK ~750m 1,215 Capital Raised Cash pos
Slide 30: Mid-term financial priorities
Mid-term financial priorities Our key financial priorities over the coming years will be focused on ensuring a successful European launch of Idefirix®, while targeting mid-term product profitability Hansa is fully financed through 2024 and we expect to use our current cash position to: Fund the laun
Slide 31: An exciting journey ahead
An exciting journey ahead! Our future Hansa Biopharma is a recognized global leader in rare diseases across multiple broad therapeutic areas with several market leading products and Key milestones to be achieved a highly valuable pipeline of late • Expand Idefirix® label in transplantation and in ot
Slide 32: Imlifidase in kidney transplantation
Imlifidase in kidney transplantation 32
Slide 33: Idefirix 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 34: 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 23 210 Total YoY waitlist in U.S. and EU 20
Slide 35: Positive reimbursement decisions in Poland and Scotland for Idefirix
Positive reimbursement decisions received in Poland and Scotland for Idefirix® in highly sensitized kidney transplant patients Market access has now been secured in nine European countries and procedures are ongoing in eight countries including Spain, Italy and Belgium Health Technology Assessments
Slide 36: 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 37: Approximately 10-15% of waitlist patients are highly sensitized
Approximately 10-15% of patients on wait list are highly sensitized Highly sensitized patients are difficult to match with an available kidney US Kidney Waitlist Patients by cPRA Causes of sensitization include 60% 12% 17% 5% 6% 55 000 % of Kidney Waitlist Patients # of Kidney Waitlist Patients Preg
Slide 38: Transplantation leads to better outcomes
Transplantation leads to better outcomes Saves lives, reduce costs and increase quality of life, incl. gains for the society Several complications and risks with dialysis Better outcomes for transplantation patients • Undergoing dialysis treatment is associated with many complications and side effec
Slide 39: First HTA report (TLV) published in Sweden
First HTA report (TLV) published in Sweden favourable to the use Idefirix® in highly sensitized patients incompatible to a deceased donor Two cost-effectiveness scenarios presented – both within the accepted threshold for costs related to new drugs One scenario even concluding Idefirix treatment wou
Slide 40: First patient experiences with Idefirix post approval
First patient experiences with Idefirix (imlifidase) in highly sensitized kidney transplant patients post approval published 29-year-old woman transplanted with Idefirix at 54-year-old man successfully transplanted at Vall Erasmus Medical Center, Rotterdam d’Hebron, Barcelona after being on dialysis
Slide 41: Completed and ongoing studies in kidney transplantation
Completed and ongoing studies in kidney transplantation 41
Slide 42: Imlifidase enabled transplantation in 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 43: 3-year follow up shows graft survival of 84%
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 44: U.S. ConfIdeS study: enrollment and BLA timeline
U.S. ConfIdeS study: Completion of enrollment expected H2 2022; BLA submission expected 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, N
Slide 45: U.S. kidney transplantation landscape
U.S. kidney transplantation landscape Our ConfIdeS study is currently enrolling patients across ten leading transplantation centers across seven states covering ~10% of annual kidney transplants in the U.S.; Aim to have up to 15 centers recruiting patients 463 >23,0001 annual kidney transplantations
Slide 46: First patient treated in post-authorization efficacy study
First patient treated in post-authorization efficacy study (PAES) of Idefirix® (imlifidase) in highly sensitized kidney transplant patients The study will provide further important insights regarding Idefirix® desensitization treatment of highly sensitized kidney transplant patients An open-label Ph
Slide 47: Study to assess imlifidase in combination
Study to assess imlifidase in combination to optimize patient outcome in highly sensitized patients with donor specific antibodies (DSA) rebound and antibody mediated kidney transplant rejection Trial design (ClinicalTrials.gov ID: NCT05049850) The study is designed to assess if imlifidase in combin
Slide 48: The 01 study results
Study 01 The 01 study results Data showed complete removal of Phase 1 IgG and a good tolerability profile Efficacy ü Rapid degradation of IgG in serum in subjects dosed with 0.12 and 0.24 mg/kg imlifidase. CLINICALTRIALS.GOV ID Imlifidase had full effect within 6 hours. The entire IgG pool was conve
Slide 49: The 02 study results
Study 02 The 02 study results Phase 2 Data showed that 1-2 doses of imlifidase at 0.25 mg/kg BW resulted in HLA antibody levels acceptable for transplantation1 CLINICALTRIALS.GOV ID NCT02224820 ü Imlifidase is well tolerated in patients with chronic kidney disease SUBJECTS ü Efficacy results strongl
Slide 50: The study proved safety and efficacy
The 03 study proved safety and efficacy Study 03 HLA antibodies at acceptable levels; enabling transplantation in all patients Phase 2 Analysis of IgG in patient serum Analysis of complement binding HLA CLINICALTRIALS.GOV ID before and after imlifidase treatment antibodies before and after imlifidas
Slide 51: The 04 study results
Study 04 The 04 study results Phase 2 Study proved safety and efficacy with Cedar Sinai’s standard protocol (rituximab and IVIg) CLINICALTRIALS.GOV ID Cedar’s desensitization protocol in NCT024226684 Graft function (eGFR) post six months combination with imlifidase SUBJECTS 17 Patients (US) DOSES/FO
Slide 52: The 06 study results
The 06 study results Study 06 Study showed proved safety and efficacy in making highly Phase 2 sensitized patients eligible for kidney transplantation Graft function (eGFR) post imlifidase DSA level pre-dose and post imlifidase CLINICALTRIALS.GOV ID NCT02790437 SUBJECTS 18 Patients (US+Sweden+France
Slide 53: Completed studies with imlifidase in transplantation
Completed studies with imlifidase in transplantation SUBJECTS/ STATUS/ STUDY STUDY DESIGN PRIMARY ENDPOINT SECONDARY ENDPOINTS COUNTRY PUBLICATION • Randomized placebo-controlled dose- • Efficacy in IgG cleavage, the Study 01 29 subjects Complete Phase 1 escalation study with 29 (20 active plus 9 •
Slide 54: Medical Advisory Board in kidney transplantation
Medical Advisory Board in kidney transplantation Professor Stanley Jordan (Chairman) M.D., Ph.D., Director of Kidney Transplantation and Transplant Immunology, Kidney and Pancreas Transplant Center and Director of Division of Pediatric and Adult Nephrology, Cedars-Sinai Medical Center, Los Angeles,
Slide 55: Our antibody cleaving enzyme technology
Our antibody cleaving enzyme technology 55
Slide 56: Broad clinical pipeline in transplantation and auto-immune diseases
Broad clinical pipeline in transplantation and auto-immune diseases Potentially Candidate/ Research/ Pivotal/ Marketing Project Indication Preclinical Phase 1 Phase 2 Phase 3 Authorization Marketed Next Anticipated Milestone EU: Additional agreements around EU: Kidney transplantation in highly sensi
Slide 57: Continuous progress in our ongoing clinical programs
Continuous progress in our ongoing clinical programs Enrollment status Enrollment status Oct 19, 2022 Oct 19, 2022 Antibody Mediated Rejection Phase 2 study Anti-GBM Phase 3 study • 30/30 patients enrolled in the AMR phase 2 study • FDA has accepted Hansa’s Investigational New Drug • Enrollment comp
Slide 58: Development of IgG-modulating technologies
Development of IgG-modulating technologies Mechanisms can be both complementary and competing Imlifidase – IgG-cleaving enzyme PLEX, plasmapheresis, B-cell depleting mAbs Deactivates IgG within 2-6 F(ab’)2 Lowering antibody levels hours through enzymatic immunoadsorption through B-cell elimination c
Slide 59: Imlifidase mode of action
Imlifidase mode of action Novel approach to effectively eliminate pathogenic IgG Proven mechanism of action Inactivation of IgG in human serum • Interacts with Fc-part of IgG with extremely high specificity • Rapid onset of action that takes down IgG below detectable • Cleaves IgG at the hinge regio
Slide 60: Antibody cleaving enzyme technology across a range of indications
Our unique antibody cleaving enzyme technology may have relevance across a range of indications Expanding our commercial franchises Targeting rare IgG mediated diseases Regulatory approval (conditional) Clinical development Partnership (preclinical development) Preclinical development Potential indi
Slide 61: The technology platform is the primary basis for our vision
The technology platform is the primary basis for achieving our vision Targeting rare IgG mediated diseases and conditions IgG levels after imlifidase treatment in in highly sensitized patients – First 30 days IgG Key opportunities: • Expanding into new indications • Reduce immune response to IgG-cle
Slide 62: Our IgG antibody-cleaving enzyme, imlifidase
Our IgG antibody-cleaving enzyme, imlifidase Origins from Streptococcus pyogenes Imlifidase consists of 311 amino acids • Cysteine protease derived from an Immunoglobulin G (IgG)- degrading enzyme of Streptococcus pyogenes • Contains only one cysteine - no disulfide bridges • Monomeric protein with
Slide 63: Imlifidase is a lyophilized product formulation
Imlifidase is a lyophilized product formulation Shelf life of 18 months at 2-8o Celsius storage Imlifidase will be infused in 15 minutes • The product for commercial supply will be a lyophilized (cold chain) powder concentrate (11 mg solution) for infusion currently with a claimed shelf life of 18 m
Slide 64: Supply Chain
Supply Chain Imlifidase in kidney transplantation Drug Development Drug substance Final product Distribution Clinics and hospitals Patients Manufacturer (API) (packaging and labelling) Logistics of bulk product - handling of drug substance product Drug product manufacturer (upscaling) 64
Slide 65: Manufacturing process
Manufacturing process Hansa has close collaborations with highly experienced European based third party CMOs Drug substance production process (API) Drug product production process (upscaling) Northway Biotech Baxter Fermentation/ Protein purification Protein purification cont. Filling Thawing of dr
Slide 66: Clinical development programs
Clinical development programs 66
Slide 67: Potential autoimmune indications
Hansa’s antibody cleaving Clinical programs Potential autoimmune indications enzyme technology (currently not pursued) 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 dat
Slide 68: Anti-GBM, a rare acute autoimmune disease
Anti-GBM, a rare acute autoimmune disease Positive read-out from phase 2 study with 2/3 of anti-GBM patients achieving dialysis independence six months after treatment Anti-GBM • Indication: Antibodies are directed against an antigen intrinsic to the glomerular basement membrane (GBM) causing acute
Slide 69: Imlifidase in Anti-GBM
Imlifidase in Anti-GBM Anti-GBM Phase 2 The idea is that imlifidase in anti-GBM patients may cleave IgG bound to the GBM within a few hours and prevent further renal damage CLINICALTRIALS.GOV ID Today only a fraction of the total IgG antibodies are removed with plasma exchange NCT03157037 (Since Mar
Slide 70: Phase 2 anti-GBM results 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 global Phase 3 study expected to commence in 2022 JASN recognises the potential in 10
Slide 71: Phase 2 study in Guillain-Barré syndrome
Phase 2 study to evaluate safety, tolerability and efficacy of imlifidase in patients with Guillain-Barré syndrome (GBS) Design of the GBS trial Main objective Status • To evaluate safety, tolerability, PK/PD, • 20/30 patients enrolled end of Q2 2022 • Open-label, single-arm trial in combination wit
Slide 72: 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 73: 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 74: Enrollment in AMR Phase 2 program completed
Enrollment in Phase 2 program in Antibody Mediated Rejection (AMR) post kidney transplantation completed Long term graft survival is challenged by AMR episodes post transplantation Indication Phase 2 Study Path forward • Acute antibody mediated rejection episodes post • 30 patients with active or ch
Slide 75: 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 5-7% of kidney transplants1 annually4 and is a significant challenge to long term graft survival
Slide 76: AMR Phase 2 study
AMR Phase 2 study AMR Phase 2 Aim of the study is test imlifidase ability to reduce the amount of donor specific antibodies in AMR patients post transplantation CLINICALTRIALS.GOV ID Potential of using imlifidase vs. PLEX in AMR NCT03897205 (2019) Illustrative SUBJECTS 30 patients targeted (20 patie
Slide 77: 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 78: Pre-clinical programs
Pre-clinical programs SZ HANSA BIOPHARMA
Slide 79: Preclinical collaboration with argenx BV
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 of
Slide 80: 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 81: 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 82: Gene Therapy
82 Gene Therapy 3% HANSA BIOPHARMA
Slide 83: Exploring opportunities in gene therapy
Exploring opportunities in gene therapy Exploring the opportunities in systemic administration of gene therapy for our unique antibody cleaving enzyme platform to potentially enable gene therapy treatment in NAb+ patients A Encouraging Significant Partnership revolutionary pre-clinical unmet need st
Slide 84: Tropism and target tissue
Tropism and target tissue AAV subtypes targets different tissues AAV 4 & 8 Brain (local target) ~1x1012 vg AAV 1, 2 & 5 Eye (local target) ~1x1011 vg AAV 3, 7 & 8 AAV 6, 7, rh74 Liver (systemic) ~1x1014 vg Muscle (systemic) ~1x1015 vg Target tissues Dose of gene therapy (vg) 84
Slide 85: Neutralizing antibodies are a barrier to gene therapies
Neutralizing antibodies are a barrier that precludes gene therapies from working in a large group of patients. The prevalence of NAbs varies significantly across the different vectors AAV 1 CNS, Eye, Skeletal muscle Up to 70% AAV 2 CNS, Eye, Kidney Up to 60% AAV 8 Liver, CNS, Heart, Eye, Pancreas, S
Slide 86: Imlifidase may eliminate neutralizing antibodies
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 87: 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 88: 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 89: Collaboration with AskBio on 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 90: 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 (currently not pursued) causing genes in rare monogenic diseases AAVrh74, AAV9 etc Rare monogenic diseases NAbs: up to ~30%
Slide 91: Duchenne Muscular Dystrophy (DMD) SRP-9001
Duchenne Muscular Dystrophy (DMD) SRP-9001 About Duchenne Muscular Dystrophy (DMD)1 SRP-9001 micro-dystrophin gene therapy for treatment of DMD • Rare, fatal neuromuscular genetic disease • AAVrh74 vector with micro-dystrophin transgene Pre-treatment • Muscle weakness noticeable by age 3 to 5, • Bro
Slide 92: Limb-Girdle muscular dystrophy (LGMD) SRP-9003
Limb-Girdle muscular dystrophy (LGMD) SRP-9003 SRP-9003 β-sarcoglycan (SGCB) gene About limb-girdle muscular dystrophy therapy for treatment of LGMD2E • AAVrh74 vector with transgene β-sarcoglycan Limb-girdle muscular dystrophy is a group of diseases that cause weakness and wasting of • Open label s
Slide 93: Pompe Disease AAV2/8-LSPhGAA
Pompe Disease (PD) AAV2/8-LSPhGAA About Pompe Disease AskBio’s AAV2/8-LSPhGAA gene therapy • Defect in a gene making an enzyme called acid alpha- • AAV2 vector genome cross-packaged as AAV8 glucosidase (GAA), which is used to break down glycogen • Liver-specific promoter to express GAA enzyme • Accu
Slide 94: ESG Overview
ESG Overview 3% HAN PAS BIOPHARMA
Slide 95: Formalising our ESG approach
Formalising our ESG approach At Hansa, we have always strived to achieve sustainable business practices. We are now formalizing our approach to sustainability and ESG issues, starting with identifying our key material focus areas. ESG context Stakeholder dialogue Key material aspects Our ESG approac
Slide 96: Our key ESG material aspects
Our key ESG material aspects Environment Social Governance Climate & waste impacts of Unmet needs and Putting patients first Third-party risks Safety, efficacy and ethics production and logistics equity in health In the biopharma industry, We diligently select new To build a successful Hansa’s envir
Slide 97: UN Sustainable Development Goals
UN Sustainable Development Goals The Sustainable Development Goals (SDGs) were adopted by all UN Member States in 2015 as a universal call to action to end poverty, protect the planet and ensure that all people enjoy peace and prosperity by 2030. They have since become a gold standard for sustainabi
Slide 98: Capital Markets
Capital Markets 98 3% HAN PAS BIOPHARMA
Slide 99: Ownership in Hansa Biopharma
Ownership in Hansa Biopharma Top 10 ownership as per September 30, 2022 Classification of ownership as per Dec 31, 2021 Ownership by country Ownership by type Name No. of shares Ownership Redmile Group, LLC 5 252 057 11,8% 13% 4% Swe den Institution s & Fund s Fjärde AP-Fonden (AP 4) 2 207 397 5,0%
Slide 100: Company collected consensus
Company collected consensus Consensus is based on a collection of analyst estimates pre our Q3 2022 report (October 14, 2022) Patient uptake, EU Revenue, SEKm Price Target, SEK WACC FY’22e FY’23e FY’24e FY’22e FY’23e FY’24e Average 238 11,1% 28 59 107 106 205 358 Median 228 11,5% 28 59 103 115 197 3
Slide 101: Investor Relations
Investor Relations Contact Calendar and events Oct 20, 2022 Redeye After Work presentation, Gothenburg Klaus Sindahl Oct 21, 2022 Redeye Lunch presentation, Stockholm Head of Investor Relations Oct 26, 2022 Økonomisk Ugebrev Life Science Conference, Copenhagen Mobile: +46 (0) 709-298 269 Oct 27, 202
Slide 102: HANSAT
MZ HANSAT BIOPHARMA