Company presentation

September 6, 2018

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Forward-looking statements

This presentation may contain certain forward-looking statements and forecasts based on uncertainty, since they relate to events and

depend on circumstances that will occur in the future and which, by their nature, will have an impact on Hansa Medical’s business,

financial condition and results of operations. The terms “anticipates”, “assumes”, “believes”, “can”, “could”, “estimates”, “expects”,

“forecasts”, “intends”, “may”, “might”, “plans”, “should”, “projects”, “will”, “would” or, in each case, their negative, or other variations or

comparable terminology are used to identify forward-looking statement. There are a number of factors that could cause actual results

and developments to differ materially from those expressed or implied in a forward-looking statement or affect the extent to which a

particular projection is realized. Factors that could cause these differences include, but are not limited to, implementation of Hansa

Medical’s strategy and its ability to further grow, risks associated with the development and/or approval of Hansa Medical’s products

candidates, ongoing clinical trials and expected trial results, the ability to commercialize imlifidase (IdeS), technology changes and new

products in Hansa Medical’s potential market and industry, the ability to develop new products and enhance existing products, the

impact of competition, changes in general economy and industry conditions and legislative, regulatory and political factors.

No assurance can be given that such expectations will prove to have been correct. Hansa Medical disclaims any obligation to update or

revise any forward-looking statements, whether as a result of new information, future events or otherwise.

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About Hansa

› Biopharmaceutical company founded in 2007 based in Lund, Sweden

› Listed on Nasdaq Stockholm (ticker: HMED)

› Developing novel immunomodulatory enzymes for transplantation rejection and acute

autoimmune diseases

› Lead candidate imlifidase (IdeS)

› Clinical results published in e.g The New England Journal of Medicine (2017) and

American Journal of Transplantation (2018)

› Follow on programs NiceR/EnzE with significant potential in relapsing autoimmune

diseases and oncology

› Leading collaborations:

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Pipeline with blockbuster potential

4

Candidate /

Method / Project 1 Indication

Research/

Preclinical Phase 1 2 Phase 1/2 Phase 2 Pivotal Registration

THERAPEUTICS

Imlifidase (IdeS) Kidney transplantation in highly sensitized patients 3

Anti-GBM antibody disease

Antibody mediated kidney transplant rejection (AMR) 

Guillain-Barré syndrome

NiceRRecurring treatment in autoimmune disease,

transplantation and oncology

EnzE Cancer immunotherapy

DIAGNOSTICS

HBP-assay (IVD) 4 Prediction of severe sepsis

Planned Ongoing Completed

1) The EndoS project has been deprioritized and is put on hold.

2) Present and future imlifidase Phase 2 studies to be based on the same Phase 1 study. Results from the Phase 1 study have been published, Winstedt el al. (2015) PLOS ONE 10(7).

3) Two separate Phase 2 studies with imlifidase in highly sensitized patients are currently ongoing.

4) Out-licensed to Axis-Shield Diagnostics Ltd.

Imlifidase(IdeS)

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IgG Fc

F(ab’)2

imlifidas

e

Imlifidase: A unique, novel mechanism

› IgG-degrading enzyme of

Streptococcus pyogenes

› Effectively cleaves IgG1

› A novel approach to rapidly

eliminate pathogenic IgG

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1) Winstedt et al. (2015) PLoS ONE 10(7): e0132011

Imlifidase effectively and rapidly degrades IgG

› Very effective inactivation of IgG in

patients1

› Rapid onset

› An antibody-free window for

approximately a week

1: Lorant et al. Am J Transplant. 2018;1–11

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ADA toBiologics

ADA toGene Therapy

Anti-Drug Antibodies

MGrelapse

MSrelapse

AcuteITP Myasthenic

crisis

Dilatedcardiom.

Pemph.relapse

CIDP

Graves disease

NMOrelapse

NMDARE

LEMS

CAPS

ANCA (GPA)

SLEflares

Lupusnephritis

Anti-GBM

GBS

IgG-related autoimmune diseases

EnzE

BoneMarrow Oncology

ABOi

KidneyHLA

LiverHLA

LungHLA

HeartHLA

Transplantation

Pre-transplant treatment

KidneyAMR

LungAMR

HeartAMR

LiverAMR

Acute AMR

Planned studies Ongoing studies Number of patients

Imlifidase potential indication universe

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The addressable patient population for prioritized indications is ~36 000 in the seven major markets*

1) Organ Procurement and Transplantation Network (OPTN); EDQM Council of Europe

2) Jordan et al. British Medical Bulletin, 2015, 114:113-125

3) http://www.irodat.org

4) Internal report

5) Kluth et al. J Am Soc Nephrol. 1999 Nov;10(11):2446-53

6) Bloodcell transplant HRSA 2014, Center for International Blood and Marrow Transplant Research® (CIBMTR) as of January 20, 2016, Gratwohl-2010, Passweg-2016, Zachary-2014

7) Chih et al. The Journal of Heart and Lung Transplantation, Vol 35, No 8, August 2016

8) McGrogan et al. Neuroepidemiology 2009;32(2):150-63

* US, Germany, UK, France, Spain, Italy, and Japan

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0

10,000

20,000

30,000

40,000

Kidney transplant,AMR and ABOi

(1, 2, 3, 4)

Heart and lungtransplant (5)

Bone marrowtransplant (6)

Anti-GBM (7) GBS (8) Total

# of patients

Kidney transplantation in human leukocyte antigen (HLA) sensitized patients

HLA Sensitivity

› anti-HLA antibodies to potential

donors

› anti-HLA antibodies due to

pregnancy, earlier transplant or blood

transfusion

Prevalence

› 30% of patients on transplant waitlists

are sensitized1,2

1) Jordan et al. British Medical Bulletin, 2015, 114:113–125

2) Orandi et al. N Engl J Med 2016;374:940-50

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HLA-sensitized patients

by PRA1,2

PRA

20<80%

4.76

PRA 1-19%PRA<1%

2.89 3.09

?

Median years on kidney transplant waitlist (US)

1) US OPTN /SRTR 2012, 2011 Annual Data.

2) Primary research

The importance of desensitization

1) Orandi et al. N Engl J Med 2016;374:940-50, 2) www.usrds.org. 3) Shehata et al., Transfus Med Rev. 2010;24 Suppl 1: S7–S27

$178,254

$423,195

Kidney transplantation2,3

5 years of immunosuppression3

5 y

ears

of dia

lysis

3

Increased survival rate1 Lowered cost

77%

44%

0%

20%

40%

60%

80%

100%

Dialysis Transplantation

8-year survival rate

for sensitized patients

› Long-term dialysis

results in

cardiovascular

complications

Avoiding complications!

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Imlifidase development in transplantation according to plan

1) Winstedt et al. (2015) PLoS ONE 10(7): e0132011, 2) Lorant et al. Am J Transplant. 2018;1–11, 3) Jordan et al. N Engl J Med 2017;377:442-53

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Study Subjects Status Publication

Phase 1 (Sweden) 29 healthy subjects • Completed 2014 PLOS ONE (2015)1

Phase 2 (Sweden) 8 sensitized patients • Completed 2015

American Journal of

Transplantation

(2018)2

Phase 2 (Sweden) 10 sensitized patients • Completed 2016The New England

Journal of Medicine

(2017)3Phase 2 (US)17 highly sensitized

patients •Fully enrolled. Finalization by

end of Q3 2018

Highdes Phase 2 (US, France, Sweden)

18 highly sensitized

patients •Fully enrolled. Finalization by

end of Q3 2018

Observational

follow-up study (US, France, Sweden)

Up to 46 previously

treated and transplanted

patients•

Enrolling. Transplanted

patients to be followed up to

five years

Data published in The New England Journal of Medicine1

demonstrate potential of imlifidase in transplantation

› All HLA-antibodies eliminated

› 24/25 patients had normalized kidney function six months post transplantation

› One graft loss occurred (non-HLA IgM & IgA)

› Five biopsy confirmed episodes of antibody-mediated rejection (AMR)

› All AMRs responded well to treatment

› Imlifidase is generally well tolerated and effective

1) Jordan et al. N Engl J Med 2017;377:442-53

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Normalized kidney function 6 months post transplant in the 24 patients

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1) Jordan et al. N Engl J Med 2017;377:442-53

US investigator-initiated Phase 2 study – imlifidase in highly sensitized patients

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› 17 highly sensitized patients treated and transplanted with imlifidase by

July 2017 at Cedars-Sinai Medical Center, Los Angeles

› Imlifidase enabled kidney transplantation for all 17 patients

› All patients exhibited extensive sensitization with a median cPRA of 95%

› Long-term follow up results presented at ATC 2018 demonstrate:

· Good renal function at a mean 19 months post kidney transplantation

· Minimal evidence of antibody mediated rejection (AMR)

The Highdes Phase 2 study – imlifidase in highly sensitized patients

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› 18 highly sensitized patients treated and subsequently transplanted in the

US, France and Sweden

› The primary objective of the study achieved for all 18 patients:

Pre-treatment with imlifidase enables kidney transplantation in highly

sensitized patients

› All patients to be followed for six months, primarily to collect data on safety,

kidney function and frequency of rejection episodes

› Results expected late Q3 2018

Potential path to approval of imlifidase in kidney transplantation

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2018 2019 2020

6 month follow-up data from

35 patients

late Q3 2018

Filing BLA/MAA late 2018

or early 2019Potential launch 2020

Potential approval

during 2019

Clinical studies inadditional indications

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Additional imlifidase Phase 2 studies ongoing and planned

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Indication Description Number of patients Status

Anti-GBM

disease

Ultra rare kidney

disease Approx. 15

Ongoing. 7/15 patients

treated as of June 30,

2018

AMR

Antibody mediated

rejection post

transplantation

Approx. 15-25Anticipated start H2

2018

Guillain-Barré

syndrome

IgG attack on

peripheral nervesApprox. 30

Anticipated start H2

2018

Additional drug candidates in development

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Follow on programs with significant potential (pre-clinical)

NiceR - Novel IgG Cleaving Enzymes

for Repeat dosing

› Novel IgG cleaving enzymes

› Lowered immunogenicity

› Potentially enable repeat dosing

› Broadens the indication space

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EnzE – Enzyme based antibody

Enhancement

› Pre-treatment with imlifidase (IdeS)

potentiates antibody based cancer

therapy in models1

1) Järnum et al. Mol Cancer Ther 2017;16:1887-1897

Corporate

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Corporate & Financials

› Listed on Nasdaq Stockholm (ticker: HMED)

· Market cap: SEK 8.9 B / USD 976 M (Aug 31, 2018)

· Cash position: SEK 534 M / USD 58 M (June 30, 2018)

· Net loss H1 2018: SEK -105 M / USD -11.4 M

› Q4 2017 Offering: 65M USD placed with top international funds

› Runway through 2019

› Approx. 40 employees in Lund, Sweden and the US

Q&A

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Appendix

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Our long term vision for imlifidase and follow on drug candidates

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Current focus:

Prioritized indications

1st

Ph. II

Highdes

GBS

2nd

Ph. II

3rd

Ph. IIAMR

Anti-GBM

ABOi

EnzE

Lung

Heart

Planned studies

Transplantation

Acute IgG-related

autoimmune diseases

Cancer

Relapsing IgG-related

autoimmune diseases

(Next generation)

NiceRimlifidase

BMT

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Imlifidase and NiceR - Long term opportunities

Near term focus

› Finalization of the two ongoing imlifidase Phase 2 studies in highly sensitized

patients

· Six month follow-up data read-out

· 35 patients treated with imlifidase and transplanted in the two studies

· End of Q3 2018

› End-of Phase 2 meetings with FDA and EMA

› Aim: Imlifidase BLA/MAA filing in transplantation in late 2018

or early 2019 with potential launch in 2020

› Initiate Phase 2 in Antibody Mediated Rejection (AMR) and Guillain-Barré

syndrome (GBS)

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Management Team

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Soren Tulstrup, President and CEO (2018)Former CEO of Vifor Pharma AG and Santaris Pharma A/S. Soren has also served as Senior Vice President, Global Franchise Head, MPS at Shire Pharmaceuticals in several senior commercial roles within Merck & Co., Inc. and Sandoz Pharma AG (Novartis). He holds a Master of Science, Economics and Business Administration from Copenhagen Business School.

Dr. Christian Kjellman, SVP Research and DevelopmentJoined Hansa Medical in 2008 after serving at BioInvent AB and Cartela AB. Assistant Professor in Molecular Genetics at Lund University. Christian holds an M.Sc. in Chemical Biology and a Ph.D. in Tumour Immunology from Lund University.

Henk Doude van Troostwijk, VP Commercial OperationsHenk joined Hansa Medical in May 2016. He has extensive management experience in sales and marketing in the areas of transplantation and orphan drugs from Raptor Pharmaceuticals and Genzyme Europe BV. Henk holds an MBA from Henley Management College, UK.

Karin Aschan, VP Regulatory AffairsKarin joined Hansa in 2016. She has long experience from working within

Regulatory Affairs, initially at AstraZeneca and later as Head of Regulatory

Affairs at Active Biotech and at ClinicalDataCare. Karin holds a M.Sc. in

Pharmacy from Uppsala University.

Eva-Maria Joed, VP, Chief Financial OfficerEva-Maria joined Hansa Medical in 2015. She has held positions both as Chief

Accountant and CFO at Kemira Kemi AB, Johns Manville AB within the

Berkshire Hathaway group and Procordia Food AB Eva-Maria holds an M. Sc.

in Business and Economics from Lund University.

Emanuel Björne, VP Business Development and Investor RelationsJoined Hansa Medical in 2007 - experience as start-up CEO at Hansa Medical, research analyst at Biolin Scientific and analytical chemist at Polypeptide Labs. Emanuel holds an M.Sc. in Engineering Physics (biophysics core) from Lund University and the University of California at Santa Barbara.

Dr. Lena Winstedt, VP Project ManagementBefore joining Hansa Medical in 2011, she served at BioInvent International

AB, Genmab A/S and H. Lundbeck AB. Lena holds an M.Sc. in Molecular

Biology from Lund University and the University of Glasgow and a Ph.D. in

Microbiology from Lund University.

Max Sakajja, VP Corporate StrategyMax joined Hansa Medical in 2017. He has broad corporate development

background and experience within corporate finance, strategy and business

development from Biovitrum, Sobi and Envirotainer. Max holds an M.Sc. in

Biotechnology from the Royal Institute of Technology.

Prof. Robert MontgomeryM.D., Ph.D., FACS, Director at NYU

Langone Transplant Institute, New York, NY,

USA

Prof. 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, California

Prof. Kathryn WoodPh.D. Fellow of the Academy of Medical

Sciences, Professor of Immunology in the

Nuffield Department of Surgical Sciences,

University of Oxford, England, runs the

Transplantation Research Immunology

Group

Prof. Christophe LegendreM.D., Ph.D. Professor at Paris Descartes

University and Head of the Adult Nephrology and

Transplantation unit at Necker Hospital in Paris.

USA Europe

Medical Advisory Board

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Strong patent protection – 11 separate patent families

Expected year of expiry for two important patent families

Note: 1) Includes additional term from PTA. 2) Assumes maximum 5 year SPC / PTE term is awarded in each territory

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2021 2023 2025 2027 2029 2031 2033 2035 2037

Imlifidase: Dose Regime

Imlifidase: Medical Use

Imlifidase: Dose Regime

Imlifidase: Medical Use

Imlifidase: Dose Regime

Imlifidase: Medical Use

Expiry Year

Normal patent term Supplementary protection / PTE

1

2

Anti-HLA antibodies Eliminated1

1) Jordan et al. N Engl J Med 2017;377:442-53

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IgG Eliminated in all 25 pts1

High medical need for kidney transplantationBuild up of patients in need of kidney transplantation in the US

Source: USRDS Annual Data Report 2016, US HHS Organ Procurement and Transplantation Network

Note: 5-year CAGRs (until 2016 for waiting list and transplantations; 2014 for rest). 1) ESRD=End stage renal disease

800,000

600,000

200,000

0

400,000

1,000,000

# patients

100,000

Patients on dialysis

700,000

Number of patients

being transplanted

19,000

Kidney waiting list

500,000

Patients with ESRD1

+4%/yr

+4%/yr

+4%/yr+3%/yr

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Imlifidase in anti-GBM antibody disease

› Rare acute kidney disease affecting 1/1,000,000 per year

› Continued enrollment in the investigator initiated Phase 2 study with imlifidase in anti-GBM.

› As of June 30, seven patients had been included in the study. Approximately 15 patients will be recruited in the investigator initiated study at up to 15 clinics in Europe.

› Limited follow-up data is currently available from five of these seven patients who have responded favorably. Imlifidase appears to be well tolerated in these patients so far.

› Patients enrolled in the study will be monitored for six months.

› The primary objective of this study is to evaluate the safety and tolerability of imlifidase as well as efficacy assessed by evaluating renal function at six months after imlifidase treatment.

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Status

› Drug substance (DS) / drug product (DP)

currently used for clinical trial is a frozen

10 mg/mL solution

› The DS and DP processes have been

developed and transferred to manufacturers

suitable for commercialization

› The DP will be a lyophilized product

Ongoing and planned

› First GMP batch for clinical trials and

commercial supply produced in late 2017

› Process characterization and validation for

commercial is scheduled to be completed

2018

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Imlifidase (IdeS) CMC overview

Guillain-Barré syndrome

1) McGrogan et al. Neuroepidemiology 2009;32(2):150-63. 2) 7MM=Seven major markets – US, Germany, UK, France,

Spain, Italy, and Japan

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› GBS is an autoimmune attack on the peripheral

nervous system, which rapidly and progressively

weakens extremities

· 40% lose strength and have pain; 3-7% mortality

› Can affect anyone, at any age

› Addressable population of ~ 11,0001 per year in 7MM2

Indication overview

› Current SOC is treatment with IVIG or PE

› Only parts of the patients fully recover from GBS,

thus a high unmet need for new treatments

Treatment options

Time from onset of weakness (weeks)

Infection

Par

alys

isN

o w

eakn

ess

-4 0 4 8 12

Time from onset of weakness (weeks)

Infection

Par

alys

isN

o w

eakn

ess

-4 0 4 8 12

PLEX/IVIg

Potential with imlifidase

Acute kidney AMR

Source: 1) Puttarajappa et al., Journal of Transplantation, 2012, Article ID 193724. 2) Jordan et al., British Medical Bulletin, 2015, 114:113-125. 3) http://www.irodat.org. Note: 4) Seven major

markets – US, Germany, UK, France, Spain, Italy, and Japan

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› Acute antibody mediated rejection after

transplantation is a significant challenge to long

term graft survival

› Occurring in ~10-15% of kidney transplants1

› Addressable population of ~ 3,2002,3 in 7MM4

Indication overview

› There are no approved drugs for treatment of AMR;

PE and steroids are primarily used today

› AMR patients not treated successfully risk graft

failure, dialysis and return to transplantation waitlist

Treatment options

› Imlifidase treatment of AMR is a quick and effective

method to inactivate donor specific antibodies and

we expect this to translate into a clinical benefit for

the patient

Imlifidase opportunity

ABOi kidney transplantation

Source: 1) Internal report. 2) Lipshutz, McGuire, Zhu et al., Arch Surg. 2011 Apr;146(4):453-8. Note: 3) Seven major markets – US, Germany, UK, France, Spain, Italy, and Japan

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› Desensitization protocols are used in ABO

incompatible transplant to lower antibodies to blood

group antigens

› ABOi transplantation increases the donor pool

› Addressable population of >2,6001 per year in 7MM3

Indication overview

› SoC: combinations of antibody removal by PE or IA,

rituximab and standard triple immunosuppression2

› Current protocols are often cumbersome, time

consuming and not suitable for deceased donor

transplantation

Treatment options

› Strong scientific rationale due to an significant role

of IgG

› Strong clinical rationale with high likelihood of

success

Imlifidase opportunity

Heart transplantation

Note: 1) Chih et al. The Journal of Heart and Lung Transplantation, Vol 35, No 8, August 2016. 2) Seven major markets – US, Germany, UK, France, Spain, Italy, and Japan

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› Presence of donor specific anti-HLA antibodies in

the patient means transplantation cannot be carried

out without antibody mediated rejection (AMR)

› Addressable population of ~ 6501 per year in 7MM2

Indication overview

› Deferral of transplantation or desensitization by PE

(experimental protocol – no approved methods)

› High unmet need as heart transplant has an overall

low long-term survival rate, while AMR rejection is

associated with higher morbidity and mortality

compared to other rejection types

Treatment options

› Imlifidase can enable heart transplantation by

removing donor specific antibodies - similar to

kidney transplantation

Imlifidase opportunity

Lung transplantation

Note: 1) Chih et al. The Journal of Heart and Lung Transplantation, Vol 35, No 8, August 2016. 2) Seven major markets – US, Germany, UK, France, Spain, Italy, and Japan

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› Presence of donor specific anti-HLA antibodies in

the patient means transplantation cannot be carried

out without antibody mediated rejection (AMR)

› Addressable population of ~ 5501 per year in 7MM2

Indication overview

› Deferral of transplantation or desensitization by PE

(experimental protocol – no approved methods)

› High mortality rates on waiting lists

Treatment options

› Imlifidase can enable lung transplantation by

removing donor specific antibodies - similar to

kidney transplantation

Imlifidase opportunity

www.hansamedical.com

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