Corporate Presentation

July 2016

Forward Looking Statements

This document does not constitute or form part of any offer or invitation to sell or issue, or any solicitation

of any offer to purchase or subscribe for, any shares in the Company, nor shall any part of it nor the fact of

its distribution form part of or be relied on in connection with any contract or investment decision relating

thereto, nor does it constitute a recommendation regarding the securities of the Company.

This document may contain forward-looking statements and estimates made by the Company, including

with respect to the anticipated future performance of TiGenix and the market in which it operates. They

include all matters that are not historical facts. Such statements, forecasts and estimates are based on

various assumptions and assessments of known and unknown risks, uncertainties and other factors,

which were deemed reasonable when made but may or may not prove to be correct. Actual events are

difficult to predict and may depend upon factors that are beyond the Company's control. Therefore, actual

results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out

to be materially different from any future results, performance or achievements expressed or implied by

such statements, forecasts and estimates. Forward-looking statements, forecasts and estimates only

speak as of the date of this document and no representations are made as to the accuracy or fairness of

such forward-looking statements, forecasts and estimates. TiGenix disclaims any obligation to update any

such forward-looking statement, forecast or estimates to reflect any change in the Company’s

expectations with regard thereto, or any change in events, conditions or circumstances on which any such

statement, forecast or estimate is based.

2

Management Team With Proven Track Record of Success

Managing Director and CEO: Eduardo Bravo, MBA

• More than 25 years experience in the pharma and biotech industries at Sanofi-Aventis, Recordati,

Cephalon and SmithKline Beecham. With company since: July 2005

CFO: Claudia D’Augusta, PhD

• More than 15 years experience in equity and debt financing at Aquanima (Santander Group), Apax

Corporate Finance and Deloitte Corporate Finance. With company since: April 2004

CTO: Wilfried Dalemans, PhD

• More than 25 years experience in the pharma and biotech industries; previous engagements at GSK

Biologicals and Transgène. With company since: April 2007

CMO: Marie Paule Richard, MD

• More than 25 years experience in the global pharma and biotech industries at Bristol-Myers Squibb,

Sanofi Aventis, GSK, Sanofi Pasteur, Crucell and AiCuris. With company since: September 2014

VP Regulatory Affairs & Corporate Quality: María Pascual, PhD

• More than 10 years experience in cell therapy companies; specialized in regulatory affairs for

advanced therapies; external adviser to EMA. With company since: July 2003

VP Medical Affairs & New Product Commercialisation: Mary Carmen Diez, MD

• More than 20 years experience in the biopharmaceutical industry at Meda Pharma, Asta Médica,

Pfizer and Dupont Pharma. With company since: September 2014

3

Key Facts About TiGenix

Headquarters / Operations Leuven, Belgium / Madrid, Spain

Employees Approximately 75 employees

Stock Exchange Euronext Brussels. Ticker: TIG

Market Capitalization Approx. USD 190M June 27, 2016

Reference Shareholders ~20% held by Grifols and BNP Paribas

Liquidity ~80% free-float, of which ~30% held by institutional investors

Analyst Coverage 5 analysts covering the stock

Cash and Cash Equiv. USD 19.78M at December 31st, 2015

Last Capital Increase USD 26.1M raised from US and EU investors in March 2016

4

Note: Numbers reflect EUR/USD = 1.10 as of 06/27/16

Compelling Investment Case

Cx601: Global

Agreement Ex-US

with Takeda

• Complex perianal fistulas in Crohn’s disease patients in United States & EU is a multi-billion

dollar opportunity

• Pivotal Phase III (local administration of a single dose of allogeneic adipose derived stem cells)

• Primary endpoint met. Cx601 statistically superior to placebo in achieving combined remission

at week 24 (p=0.024)

• Long term efficacy sustained at week 52 on same endpoint (p=0.019)

• MAA submitted to EMA in 1Q16. Launch expected 2H17

• GMP process approved for commercial manufacturing by Spanish Agency in 1Q16.Takeda will

co-invest in the expansion of the Madrid facility to secure supply for the initial few years

• Up to €380M agreement with Takeda for the exclusive ex-US rights to Cx601 for the treatment of

complex perianal fistulas in Crohn’s disease patients

• Use of data from positive pivotal Phase III trial in EU to support a BLA in the US

• FDA’s agreement on SPA obtained for pivotal phase III trial in the US

• Same primary endpoint as positive EU Phase III trial

• US Phase III to start 1H17

• Fully-owned asset; granted patent valid until 2030

• Lonza selected as contract manufacturing organization for Cx601 in the US

Cx601: Clear

pathway to US

market

• AlloCSC-01: intra-coronary administered allogeneic cardiac stem cells, being developed for acute

myocardial infarction

• Randomized, double blind, placebo controlled Phase II trial ongoing

• Interim 6 months data confirmed safety. Final one-year follow up data expected 1H17

• Cx611: Intravenously-administered allogeneic adipose derived stem cell product for severe sepsis

• Phase I study completed

• Severe sepsis Phase I/ll trial design has been finalized; expected to enroll first patient in 2H16

Valuable Pipeline

Opportunities:

AlloCSC-01 and

Cx611

1 Advanced Therapy Medicinal Product 5

Multiple Product Candidates with Significant Upcoming Milestones

Product1 Indication Preclinical Phase I Phase II Phase III Market

Allogeneic Adipose-Derived Stem Cells

Cx601

(local)

Complex Perianal

Fistulas in Crohn’s

Disease

Cx611

(intravenous) Severe Sepsis

Allogeneic Cardiac Stem Cells

AlloCSC-01

(intracoronary) Acute Myocardial

Infarction

Characterized Autologous Chondrocytes

ChondroCelect Knee Cartilage Lesions

Ex-US rights licensed to Takeda

Withdrawal of MA requested at European Commission2

SPA agreed to by FDA

1 Covered by 29 patent families

2 Implementation of withdrawal of Marketing Authorization (pending EC confirmation) and termination of all CC related agreements anticipated by December 31, 2016

6

Launch EU 2H17

Pivotal US starts 1H17

Ph I/II starts 2H16

Final results 1H17

Cx601 Local injection of expanded Adipose-derived Stem Cells

(“eASCs) for the treatment of complex perianal fistulas in Crohn’s disease patients

7

Cx601 Inhibits Pro-inflammatory Cytokines Mechanism of Action (“MoA”) is IDO1-Mediated

8

1 IDO: Indoleamine 2,3-dioxygenase 2 PBMC: Peripheral Blood Mononuclear Cells

Source: De la Rosa et al. Tissue Engineering 2009

Inhibition of Immune Cell Proliferation

* p<0.05 relative to activated PBMCs without ASCs

Source: Tigenix data IDO Mediated

Inhibits pro-inflammation

Activated PBMC + Cx601

Inhibition of pro-inflammatory cytokines

* p<0.05 relative to supernatant from activated PBMCs

PBMCs

Activated PBMCs

PBMCs+Cx601

Actiivated PBMCs+Cx601

Cx601

0 5 10 15 20

IFN- (ng/ml)

0 1 2 3 4 5

TNF- (ng/ml)

* *

• Cx601 has the ability to balance an inflammatory

milieu, through the reduction of PBMC2 mediated

secretion of pro-inflammatory cytokines among

other immunological processes

Key Characteristics of Cx601

• IDO is key to the immunomodulatory properties of

Cx601, as shown here by its effect on PBMC

proliferation

9

GMP Facility in Madrid Approved for Commercial Manufacturing Takeda1 Will Endeavor to Take Over Manufacturing ex-US

1 Liposuction

2,400 Finished Products (Cx601)

Consistent and Robust Process

• Production facility in Madrid approved for

commercial manufacturing

• Current capacity is about 400 patient lots of

finished product per year

• TiGenix will initially supply Cx601 to Takeda

at cost for the EEA2 and Switzerland (CH)

• Takeda will co-fund the expansion of the

Madrid facility to secure supply for the initial

few years

• Takeda will endeavor to take over

manufacturing asap to leverage on a global

supply network

• Outside of the EEA and CH, Takeda is

responsible for manufacturing from July

2016

• Takeda will be fully responsible for

distribution and logistics in the whole

Territory

Manufacturing Capabilities

1 In July 2016 TiGenix and Takeda entered into an exclusive Ex-US Licensing Agreement for Cx601 2 EEA stands for European Economic Area, it includes all 28 states currently part of the European Economic

Area as well as the three states Iceland, Lichtenstein and Norway

A Common and Severe Complication of Crohn’s Disease Complex Perianal Fistulas Affect 1 in 12 Adult Crohn’s Disease Patients

• Complex fistulas are sores or

ulcers that tunnel through the

affected area into surrounding

tissues, and that:

• Affect anal sphincters

• Present multiple tracts

• Are recurrent

• Are often associated with

perianal abscess

• Complex fistulas cause

compromised Quality of Life

(QoL), pain, depression and risk

of anal epithelial carcinoma

120,000 adult patients in Europe and the US alone

10

Fistula

Fistula

Treatments Lack Long Term Efficacy and Present Safety Issues

11

• Optimal management remains challenging

• Little progress due to limited trials and poorly validated endpoints

• Clear gap for a clinically validated treatment with long term efficacy

1 L.J. Brandt et al. Metronidazole Therapy for Perineal Crohn’s Disease: a Follow-Up Study, 83 GASTROENTEROLOGY 383-7 (1982) 2 E.S. Goldstein et al., 6 - Mercaptopurine Is Effective in Crohn’s Disease Without Concomitant Steroids, 10 INFLAMM BOWEL DIS 79-84 (2004) 3 B.I. Korelitz et al., Favorable Effect of 6-Mercaptopurine on Fistulae of Crohn’s Disease, 30 DIGEST DIS SCI 58-64 (1985) 4 B.E. Sands et al., Infliximab Maintenance Therapy for Fistulizing Crohn’s Disease, 350 N ENGL J MED 876-85 (2004) 5 E. Domenech et al., Clinical Evolution of Luminal and Perianal Crohn’s Disease after Inducing Remission with Infliximab, 22 ALIMENT PHARMACOL THER 1107-13 (2005) 6 J.F. Colombel et al., Adalimumab for Maintenance of Clinical Response and Remission in Patients with Crohn’s Disease: The CHARM Trial, 132 GASTROENTEROLOGY

52-65 (2007) 7 C.B. Geltzeiler et al., Recent Developments in the Surgical Management of Perianal Fistula for Crohn’s Disease, 27 ANN GASTROENTEROL 1-11 (2014) 8 T. Sonoda et al., Outcomes of Primary Repair of Anorectal and Rectovaginal Fistulas Using the Endorectal Advancement Flap, 45 DIS COLON RECTUM 1622-28 (2002) 9 A. Soltani and A. Kaiser, Endorectal Advancement Flap for Crypto Glandular or Crohn’s Fistula-in-Ano, 53 DIS COLON RECTUM 486-495 (2010)

Treatment options

• High relapse on cessation1

• Safety concern with prolonged use

Benefit Shortfall

Antibiotics

Anti-TNFs Infliximab- Remicade®

Adalimumab - Humira®

Immunosuppressants

Surgery

• Improve symptoms and short term healing

• High relapse on cessation2,3

• Risk of infectious complications

• Moderate benefit reported

• Limited clinical trial data

• Low remission4,6 and high relapse4,5

• Safety concern with long term use and systemic immunosuppression

• Moderate benefit in clinical trials

• Conservative surgery risks recurrence

• Risk of complications (incontinence, non healing wounds, abscesses)8,9

• Eliminating risk of recurrence is possible with radical, mutilating surgery7,8

Product description

Four (4) vials of 6ml suspension, each with

30 million cells (total dose 120 million cells)

12

Cx601: A Completely Different Approach; A Single Dosage Suspension of Expanded Adipose-derived Stem Cells (“eASC)

Injection sites: Injection sites:

a. Fistula internal opening b. Fistula tract

Mode of Administration

• Fistula curettage and closure of internal

opening (sutured)

• Half of Cx601 dose (2 vials) injected into

tissue around internal opening (small blebs)

• Other 2 vials injected along the walls of the

fistula tracts (several small blebs)

Trial Summary

Study design

• Randomized, double-blind, placebo-controlled trial

• All tracts treated. Single procedure2

Number of

sites 47 active sites in 8 countries

Enrollment 289 patients recruited

Primary

endpoint

Combined Remission3 at week 24

with α<0.025 for all existing

fistulas

Secondary

endpoints at

Weeks 24

and 52

• Combined Remission at week 52 • Clinical Remission4 • Response5 • Time to Clinical Remission / to

Response • PDAI6 and other scores • Safety and tolerability

1 Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulising Crohn’s Disease 2 120 million cells 3 Closure of all treated external openings draining at baseline despite gentle finger compression, and absence of collections > 2cm by MRI (Magnetic Resonance Imaging) 4 Closure of all treated external openings draining at baseline despite gentle finger compression 5 Closure of at least 50% of all treated external openings draining at baseline despite gentle finger compression 6 Perianal Disease Activity Index 13

• Men and women aged 18 years or older

• Non active or mildly active luminal Crohn’s

disease (CDAI ≤ 220) diagnosed for ≥ 6

months

• Patients with complex perianal fistulas with

≤ 2 internal openings and ≤ 3 external

openings

• Fistula draining ≥ 6 weeks prior to inclusion

• Patients with inadequate response to at

least one of the following: antibiotics,

immunosuppressants or anti-TNFs

• Medical standard of care was allowed to

continue without modification of treatment

dose or regimen

Patients selected to ensure clear cut-off results

Phase III ADMIRE-CD1 Trial Double-Blind, Placebo-Controlled, Designed to Qualify as a Single Pivotal Study

Treatment

W24

Primary Endpoint

W52

Preparation Screening

D0

Follow-Up

W6 W12 W18 W36 W-3 W-5

Baseline

MRI

W52

MRI

W24

MRI

MRI: Magnetic Resonance Imaging

week

Randomization Clinical Assessment

Clinical and MRI Combined Primary Endpoint at Week 24 Long Term Follow-Up for Persistence (Week 52) and Safety (up to Week 104)

14

W104

15

1 ITT: Intention To Treat i.e. patients randomized 2 Safety Set: patients randomized and treated 3 Surgical procedures for other reasons than fistulas; Fistulas not healing/worsening of fistula symptoms; No tract found or additional blind tract found by the surgeon

during preparation visit; Impossibility to administer 12 ml into the tract or to identify the primary opening; Fistula closed, etc

Cx601 Phase III Patient Populations Largest Ever Study in Complex Perianal Fistulas

• 1 Reoccurrence of

Crohn’s Disease

• 1 Deep Vein

Thrombosis

• 1 Informed Consent

Withdrawn

• 1 Missing Data

Screened n=289

Screening Failures

n=77

Randomized n=212

Cx601 n=107

Placebo n=105

Not Treated

n=4

Treated n=103

Treated n=102

Not treated

n=3

ITT 1 set n=212

Safety Set 2 n=205

• 1 Informed Consent

Withdrawn

• 1 No Longer Met

Inclusion Criteria

• 1 Did Not Have Post-

baseline Efficiency

Evaluation

• 43 Wrong Inclusion /

Exclusion criteria

• 20 Other3

• 12 Informed Consent

Withdrawn

• 2 (Serious) Adverse

Events

Demographics (ITT) Cx601

n= 107

Placebo

n= 105

Age (years) mean (SD) 39.0 (13.1) 37.6 (13.1)

Men (%) 60 (56.1) 56 (53.3)

Caucasian (%) 100 (93.5) 96 (91.4)

Weight (kg) mean (SD) 73.9 (15.0) 71.3 (14.9)

PDAI (ITT)

Mean (SD) 68 (2.5) 6.6 (2.9)

Topography of Internal &

External Openings (%) (ITT) 2

One-tract fistula 51.4 67.7

Multiple-tract fistula* 44.8 29.6

Good Balance Among Groups Except for Topography of Fistulas Cx601 Group Contained More Difficult to Treat Patients

• Similar demographics and PDAI1 score between arms

• Higher proportion of multiple-tract fistulas in Cx601 group

16

* Primary endpoint measured combined remission on all tracts 1 Perianal Disease Activity Index 2 Fistula topography not available in seven (7) patients

75.0%

55.9%

0

20

40

60

80

Cx601 Placebo

Primary endpoint met at week 24 Benefit Sustained at Week 52

1 ITT: Intention To Treat i.e. patients randomized. Efficacy results are consistent across all statistical populations 17

54.2%

37.1%

0

20

40

60

Sustained Remission at W52

49.5%

34.3%

0

20

40

60

% Combined Remission at W24

(ITT1 Population n= 212)

p = 0.024

• 75.0% of Cx601 treated patients who achieved combined

remission at week 24 remained in combined remission at

week 52 compared to only 55.9% in the placebo arm

• Primary endpoint met: Combined remission at W24 was

44.3% higher in treated patients versus placebo (p=0.024)

• Benefit maintained at W52: Combined remission was 46%

higher in treated group versus placebo (p=0.012)

p = 0.012

Combined Remission at W52

(ITT1 Population n= 212)

Faster Time to Remission Cx601 Achieves Remission Twice as Fast as Placebo

1 ITT: Intention To Treat i.e. patients randomized

• Cx601-treated patients achieved Clinical Remission after 6.7 weeks 50% sooner that

placebo-treated patients

• The placebo-treated patients achieved Clinical Remission after 14.6 weeks (HR 1.75, 95%

CI (1.27-2.44))

18

ITT Population1 n=212

Safety Profile Maintained Over the Long Term Product is Free From Serious Side Effects of Biologic Treatments

19

Number of Patients with (%) Cx601

n= 103

Placebo

n=102

W24 W52 W24 W52

*TEAEs 68 (66.0) 79 (76.7) 66 (64.7) 74 (72.5)

Related TEAEs 18 (17.5) 21 (20.4) 301 (29.4) 271 (26.5)

Withdrawn due to a TEAEs 5 (4.9) 9 (8.7) 6 (5.9) 9 (8.8)

**TESAEs 18 (17.5) 25 (24.3) 14 (13.7) 21 (20.6)

Related TESAEs 5 (4.9) 7 (6.8) 7 (6.9) 7 (6.9)

Withdrawn due to TESAEs 4 (3.9) 6 (5.8) 4 (3.9) 7 (6.9)

Note: If a patient has multiple events of the same severity, relationship or outcome, then they are counted only once in that severity, relationship or outcome. However, patients can be counted more than once overall.

Overview of TEAEs up to Week 24 & Week 52 (Safety population n= 205)

*Most common TEAEs: Anal Abscess; Proctalgia; Nasopharyngitis; Diarrhoea; Abdominal pain; Pyrexia

**TE(S)AE: Treatment-Emergent (Serious) Adverse Events 1 Figures are cumulative; however prior AEs reevaluated at W52 as non-related are not adjusted retroactively.

Oral presentation in Plenary Session by

Dr. Panés (March 17, 2016)

Satellite Symposium chaired by

Dr. Van Assche (March 18, 2016)

Cx601: Communication of ADMIRE-CD Results ECCO1 2016 (Amsterdam, 16-19th March 2016)

20 1European Crohn’s and Colitis Organization

Cx601: Communication of ADMIRE-CD Results ECCO 2016 (Amsterdam, 16-19th March 2016)

21

Cx601’s Approach to the US Market Leveraging EU Data With Approved Phase III Protocol

Preparing for US BLA1 Filing with clear pathway to US Market

Solid regulatory and clinical development strategy

• Type B meeting with FDA2 confirmed:

• Adequacy of existing non-clinical package to support an IND3 filing

• Acceptability of using data from the ADMIRE-CD trial to support BLA

• SPA4 for US Phase III protocol agreed with FDA:

• Primary end-point identical to ADMIRE-CD trial

• p-value < 0.05 (vs. p-value <0.025 in ADMIRE-CD trial)

US Phase III trial scheduled to start by 1H17

Lonza selected as contract manufacturing organization for Cx601 in the US,

technology transfer ongoing

1 BLA: Biological License Application 2 FDA: Food and Drug Administration 3 IND: Investigational New Drug 4 SPA: Special Protocol Assessment

22

25% 75%15,18

Simple fistulas

# of cases = 39,404 Complex fistulas

# of cases = 118,211

Perianal fistulas = 157,615

Crohn’s Disease Patients *1-9 = 1.540.710

11% 10-17

93% 7,8

Adult Crohn’s Disease Patients = 1,432,860

Non-Perianal fistulas = 109,529 (41% of fistulas are not perianal 13,14)

Cx601: Estimated Potential Patient Population (EU & US) An Attractive Commercial Opportunity

66%19

Non-Controlled luminal CD

# of cases = 40,192

Refractory fistulas

# of cases = 70,217

90%19, 20

34%

10%

Non-refractory fistulas

# of cases = 7,802 (Further details on references provided in Appendix )

1 Stone MA et al. 2013 2 Hein R et al. 2014 3 Lucendo AJ et al. 2014 4 Dal Pont E et al. 2010 5 Cottone M et al. 2006 6 Herrinton LJ et al. 2007 7 Kappelman MD et al. 2007

8 Kappelman MD et al. 2013 9 Molodecky NA et al. 2012 10 SEESGCD.19

11 Gibson PR et al. 2007 12 Dranga M et al. 2015 13 Schwartz DA et al. 2002 14 Bell SJ et al. 2003

23

• A total of 267,144 CD patients experience fistulas

• 34-61% of CD patients with fistulas experience ≥ 2

fistulizing episodes13,14 or 90,829 - 162,958 patients

• 33% of CD patients with perianal fistulas experience

≥ 2 fistulizing episodes13 or 52,013 patients

Controlled luminal CD

# of cases = 78,019

* Estimated prevalence in US: 190/100,000

(average from US nationwide studies comprising study periods post year 2000) 6-9

Estimated average prevalence in EU: 180/100,000

(no nationwide studies available; average of regional studies conducted in EU5

comprising study periods post year 2000, weighed by country populations) 1-5, 9

15 Eglinton TW et al. 2012 16 Gray BK et al. 1965 17 Galandiuk S et al. 2005 18 Molendijk I et al. 2014 19 Sands BE et al. 2004 20 Domènech E et al. 2005

Prevalence per 10,000 patients vs. prices for selected drugs

Cx601: Pricing Considerations Lower Prevalence Would Suggest Higher Price

24

€0

€50

€100

€150

€200

€250

€300

€350

€400

€450

€500

0 1 2 3 4 5 6 7 8 9 10

1 Ex-manufacturer prices per patient per year, including mandatory published discounts, obtained from CMS, L’Assurance Maladie, G-BA, Gazzetta

Ufficiale, Spanish MoH, British National Formulary. $1 = €0.90. Indications for select products: Kalydeco, G551D-mutation cystic fibrosis; Kuvan,

Phenylketonuria; Adempas, Chronic thromboembolic pulmonary hypertension; Revolade, Low blood platelet count in adults with chronic immune

thrombocytopenic purpura; Esbriet, idiopathic pulmonary fibrosis. Full list of references provided at back.

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Takeda exclusive Ex-US Licensing Agreement for Cx601

26

1 BioCentury, 30th May 2016

• Global pharmaceutical company, with a focus on GI, Oncology and CNS

• Market presence in over 70 countries and regions; with more than 30,000 employees

• Total sales in FY 2015 (as of March 2016) amounted to €15Bn.

• Major regions by sales are Japan (38%), the US (29%) and Europe (17%)

• In 2015, Takeda formed a GI drug discovery unit. The aim of this unit is to further develop

internal GI projects as well as execute deals which will complement Takeda’s GI franchise

• FY 2015 sales for Takeda’s GI franchise amounted to €720M. Takeda recently disclosed that

Entyvio is the company's No. 4 selling drug targeting sales >$2Bn by 2018

• Takeda is already among the top 10 companies by sales in GI space1

Takeda Pharmaceutical The Partner of Choice in the GI Space

Cx601 is the perfect fit with Takeda’s GI focus, with

clear synergies with Entyvio

27

Licensing Agreement with Takeda Summary of Key Terms

• Takeda acquires the exclusive ex-US rights to Cx601 for the treatment of complex

perianal fistulas in Crohn’s disease patients

• TiGenix retains 100% rights to the US market, estimated at 50% of Cx601 global

market and the rights to develop Cx601 in new GI indications

• Upfront payment of € 25 million and € 10 million of equity investment

• Regulatory and sales milestones payment for up to a potential total of € 355 million, of

which € 15 million at marketing approval of Cx601 in Europe expected in 2H17

• Following Marketing Authorization in the European Union, Takeda will become the

marketing authorization holder (MAH) and will be responsible for all commercialization

and regulatory activities

• Takeda will also be responsible for additional development activities of Cx601 for the

indication of complex perianal fistulas in Crohn’s disease and will eventually take over

manufacturing for Cx601 within the licensed territory

A deal for a potential total of € 380 million (excluding US)

the best partner to secure Cx601 commercial success

28

Cell Therapy Product Deals to Date The Largest “Product” Licensing Deal in Cell Therapy

Deal Indication/ Phase Territory Upfront Total deal Comments

TiGenix licenses Ex-US

rights of Cx601 to

Takeda (2016)

Complex Perianal

Fistulas in Crohn’s

disease patients; MAA

submitted to EMA

Worldwide

Ex-US

€25M

€10M in

equity

Up to

€380M

TiGenix maintains 100% rights

to US market, (≈50% market)

and full rights to develop Cx601

in other indications

Mesoblasts acquires

MSC business from

Osiris (2013)

Prochymal: Acute

GvHD in children

(approved in

Canada and NZ)

Worldwide $20M $100M > 50% potentially payable in

stock

Janssen options rights

to CAP-1002 from

Capricor (2014)

Large myocardial

infarction (in Ph. II)

Worldwide $12.5M Up to

$337.5M

Exclusive right to license CAP-

1002 at any time until 60 days

post 6-month follow-up data

from Phase II

Chugai licenses

Multistem from

Athersys (2015)

Ischemic stroke (in

Ph. II)

Japan $10M Up to

$205M

United Therapeutics

licenses PLX-PAD

from Pluristem (2011)

Pulmonary

hypertension

(in Ph. I)

Worldwide $7M $55M Agreement ended by UT

December 2015

29

• Cx601 addresses a severe and common unmet need in Crohn’s Disease

• Current treatment options lack long term efficacy and present safety concerns

• European Phase III clinical trial results show clear superiority in efficacy vs. standard of

care with just one single treatment

• Clinical effect is significantly quicker and efficacy persists at 52 weeks

• Product has good safety profile and is easy to administer

• Approval and launch in Europe expected 2H17

• US Pivotal Phase III trial agreed with FDA (SPA) to start 1H17

Cx601 a Major Breakthrough Clear Plan to Secure Even Further Upside

AlloCSC-01: Phase ll Data To Be Announced 1H 17

Intracoronary administration of allogeneic cardiac stem cells for the

treatment of acute ischaemic heart disease

30

AlloCSC-01: Preventing Chronic Heart Failure Myocardial Repair May Be The Only Feasible Alternative

• 1.9M Acute Myocardial Infarctions (US+EU)1 occur annually, mostly treated by PCI2 and stent

implantation

• Successful treatment of Acute Myocardial Infarctions (“AMI”) has increased short term survival

but contributed to a Chronic Heart Failure (CHF) epidemic (26M patients worldwide3)

• CHF post-AMI is a terminal disease with an annual mortality rate of ~5% after the first

episode, for which no curative treatment exists with the exception of heart transplantation

31

1 Datamonitor: Stakeholder Insight: Acute coronary syndromes, DMHC2347, 2007 2 PCI: Percutaneous Coronary Intervention 3 Ambrosy PA et al., J Am Coll Cardiol. 2014;63:1123-1133.

Myocardial repair is the only

feasible treatment to

address the post-acute

phase of the disease and

prevent the onset of CHF

AlloCSC-01: Efficacy Demonstrated in Pig Model

1 MRI: Magnetic Resonance Imaging 2 EDVi: End-Diastolic Volume Index 3 ESVi: End-Systolic Volume Index 4 EF: Ejection Fraction

• AlloCSC-01 prevents cardiac remodelling after infarction preserving heart function

• AlloCSC-01 reduces scar size promoting formation of new contractile tissue

• Significant dose effect observed

32

CARDIAC REMODELING CARDIAC FUNCTION

Efficacy Data from MRI1 Histological Analysis

CONTROL

AlloCSC-01 * *

*

* p-value < 0.05

2 3 4

CAREMI Phase I/II Trial Final Results Expected 1H17 Safety and Efficacy of Intracoronary Infusion of Allogeneic Cardiac Stem Cells in

Patients with Acute Myocardial Infarction (“AMI”)

TRIAL SUMMARY

Condition Acute Myocardial Infarction

Study design

AlloCSC-01 administered 5-7 days after PCI4

• Phase 1. Open label dose escalation in 6 patients

• Phase 2: Placebo controlled, 49 patients randomized 2:1 (35M cell dose in active arm)

Recruitment

• Phase 1: Completed

• Phase 2: Completed recruitment in 4Q15

# of centers 8 sites

Primary endpoint Mortality and MACE5 from any cause at

30 days

Secondary

endpoints (6 and

12 months)

Safety: Mortality and MACE

Efficacy: evolution of infarct size, biomechanical parameters by MRI

Clinical parameters: 6m walk test, NYHA6 scale

Completion 1H17 (Interim data announced June 16)

PATIENT SELECTION

Initial clinical pre-screening:

• Males, females ≥18 years and ≤80 years

• Patients who present a STEMI1

• Killip ≤ 2 on admission

• Successful revascularization by PCI (TIMI2 = 3)

within 12h after the onset of symptoms

• EF≤50% by echocardiography (day 2 after infarct

symptoms)

• EF≤45% by MRI on D3-5 post-STEMI

• Infarct size (1st MRI) >25% in LV3

• Bare-metal stents or second generation drug

eluting stent at PCI

• The infarct culprit coronary artery is adequate for

treatment administration and the procedure is

technically feasible

• The patient is stable and in adequate clinical

condition to undergo the procedure

1 STEMI: ST-Segment-Elevation Myocardial Infarction 2 TIMI: Thrombolysis In Myocardial Infarction 3 LV: Left Ventricle 4 PCI: Percutaneous Coronary Intervention 5 MACE: Major Adverse Cardiac Events 6 NYHA: New York Heart Association 33

• In the dose-escalation open-label phase, 6 patients were treated and 5 of them were followed up for 6 months

• Patients received a single injection of 11 million (M), 22M or 35M cells of AlloCSC-01 (n=2 each) by intracoronary infusion 5 to 7 days after Percutaneous Coronary Intervention (PCI)

• Data presented at the European Society of Cardiology meeting in London, showed that AlloCSC-01 has a good safety profile as no adverse events or Major Adverse Cardiac Events (MACE) were observed during the 6 month follow-up period

• Preliminary data from this treated group showed a reduction in infarct size, and a LVEF improvement on MRI, over the 6-month follow-up period (n=54; p<0.05 for both parameters)

* p-value < 0.1

** p-value < 0.05

34

CAREMI Phase I/II Trial Positive Preliminary Results from Phase I Presented at ESC

1 3 2

1 LVEF (%): Left Ventricular Ejection Fraction % change versus screening MRI 2 IS (mL): Infarct Size 3 IS (% of LV): Infarct Size as % of Left Ventricular mass 4 The patient lost to follow-up received the 11 million dose

• 51 patients were evaluated: 34 patients received AlloCSC-01 (35 M cells) and 17 patients received placebo

• Primary endpoint met: No mortality of any cause within one month was recorded for both placebo and AlloCSC-01 groups

• No major adverse cardiac event (MACE) was recorded within one month in either group

• Importantly for the long term safety evaluation, no mortality of any cause nor MACE was recorded in either group at six months

• Preliminary secondary efficacy data at six months was limited to infarct size evolution, defined as a percent of the left ventricular mass measured by magnetic resonance imaging. The mean absolute change in infarct size from baseline to six months was similar in both groups

• The final full set of safety and efficacy study results at twelve months will be reported in first half of 2017

35

CAREMI Phase I/II Trial Interim Results at 6 Months Confirm Safety Profile of AlloCSC-01

Cx611: Phase lI Ready

Intravenous injection of eASCs for the treatment of severe sepsis

36

1 The Lancet Infectious Diseases; Volume 12; issue 2; page 89; February 2012 2 Martin GS Expert Rev Anti Infect Ther. 2012 June ; 10(6): 701–706. 3 Torio et al. National inpatient hospital costs: the most expensive conditions by payer. AHRQ, Healthcare Cost Brief No. 160 August 2013. 4 Adapted from Lagu, T., et al. Critical Care Medicine, 40(3):754-761; 2012 5 Adapted from: Elixhauser et al. Septicemia in U.S. Hospitals 2009, AHRQ, Healthcare Cost Brief No. 122 October 2011

Severe Sepsis - A High Unmet Medical Need

• Sepsis is a life-threatening complication of

infection leading to systemic inflammation and

organ failure

• Between 15M to 19M sepsis cases occur

worldwide each year1

• Mortality reaches 50% for severe sepsis raising

to 80% in septic shock2

• In the US, sepsis generates USD 20 billion in

hospital-related costs and is the most

expensive condition billed to Medicare3

• Cx611’s novel mechanism of action may offer

an innovative alternative to the treatment of

severe sepsis

• Soon to start Phase II trial has received the

support of the Horizon 2020 European

Commission Program and the endorsement of

key opinion leaders in Europe

37

600

800

1000

1200

1400

1600

1800

2000 2002 2004 2006 2008 2010

Dis

ch

arg

es th

ou

san

ds

Trend in U.S. hospital stays with septicemia 2000−20095

8% CAGR

750.000

466.000

375.000

84.000

0

200.000

400.000

600.000

800.000

1.000.000

1.200.000

Sepsis Breast, Prostate Cancer & AIDS

Diagnosed cases and mortality of Sepsis vs. Breast Cancer, Prostate Cancer & AIDS4

Diagnosis Deaths

Cx611 Reduces Mortality in Animal Models of Sepsis

• This effect is due to a combination of reducing pro-inflammatory and increasing anti-

inflammatory mediators, production of anti-microbial effectors, and increased

phagocytosis

Source: Gonzalez-Rey, 2009 * p < 0.001

LPS1 Model CLP2 Model

38

1 LPS: lipopolysaccharide. LPS model is based on endotoxemia induced by high-dose of endotoxin 2 CLP: cecal ligation and puncture. This model mimics the clinical situation of patients with colonic leakage following surgical procedures or diffused peritonitis

CL

P m

od

el • ↓ of pro-inflammatory mediators

• of anti-inflammatory mediator

• ↓ of inflammatory cells

LP

S m

od

el

* p<0.001

Source: Gonzalez-Rey et al. Gut. 2009 Jul;58(7):929-39

Cx611 Has an Effect at Cytokine and Cellular Level

39

Cx611: Phase I/II in Severe Sepsis Expected to Start 2H16

CELLULA Phase I trial results

• 250k, 1M, 4M eASC/kg and placebo administered to 32 healthy volunteers (8 per group)

• Favorable safety and tolerability profile of Cx611, consistent with Phase I/IIa in refractory RA1

patients

SEPCELL Phase I/II study in severe sepsis to start 2H16

• Randomized, double blind, parallel groups, placebo controlled, multicenter study

• 180 patients (90 per group) with sCABP2 requiring mechanical ventilation and/or vasopressors,

admitted to the ICU. At least 50 centers in at least 4 countries

• 160M eASC or placebo on days 1 and 3 (320M in total) in addition to standard of care therapy.

90 days follow up

• Primary endpoint: Adverse event and potential immunological host responses against the

administered cells

• Secondary endpoint: Reduction in the duration of mechanical ventilation and/or vasopressors

needed and/or improved survival, and/or clinical cure of the CAPB, and other infection-related

endpoints

• Partially funded with EUR 5.4 million from the European Commission through its Horizon 2020

Program

40

1 Rheumatoid Arthritis 2 Severe community-acquired bacterial pneumonia

41

IP, Key Milestones and

Compelling Investment Case

Key Intellectual Property Patent Portfolio in Cell Therapy

• 29 patent families related to cell therapy products

• Pending & granted patents in over 20 jurisdictions including the US; expiry dates

2024 onwards for the products in development

• Patent covering eASC population and therapeutic uses granted in EU recently

• Key patent for Cx601 (PCX007) granted in US, AU, RU, MX, IL and NZ

• Patent protects use of ASCs in treatment of fistula

• Complementary protection possible through additional patents under review

• Portfolio covers key features of TiGenix’s stem cell and chondrocyte platforms

• Expanded cell compositions and preparations

• Use of expanded cells in treatment of broad range of indications

• Cell preparation methods & delivery systems

• FTO for indications in clinical development reviewed by external counsel

• US: Morrison & Foerster

• Europe: Carpmaels & Ransford

42

Product 2014 2015 2016 2017

Cx601

(local)

Europe

US

AlloCSC-01 (intracoronary)

acute

myocardial

infarction

Cx611

(IV)

severe

sepsis

ChondroCelect

Key Milestones

3Q15 Phase 3 primary endpoint met (24 weeks)

1Q16 study results (1 year follow-up)

1Q16 EMA filing

3Q14 CMO selection

2H16 tech transfer finalized

4Q14 SPA submission

4Q14 Phase 3 enrollment completed

1H17 start US Phase 3

Takeda Deal

3Q15 positive SPA

1Q14 manufacturing facility sold

2Q14 licensed to SOBI

2H16 Phase 2 interim analysis

1H17 Phase 2 study results

1Q15 Phase 2 enrollment initiated

4Q15 Phase 2 enrollment completed

1Q17 IND filing

4Q14 Phase 1 initiated

2Q15 Phase 1 study results

2H16 Phase 2 enrollment initiated

43

2H17 EMA approval

2H17 launch

Termination of agreement with SOBI

Withdrawal of MAA requested

Compelling Investment Case

Cx601: Global

Agreement Ex-US

with Takeda

• Complex perianal fistulas in Crohn’s disease patients in United States & EU is a multi-billion

dollar opportunity

• Pivotal Phase III (local administration of a single dose of allogeneic adipose derived stem cells)

• Primary endpoint met. Cx601 statistically superior to placebo in achieving combined remission

at week 24 (p=0.024)

• Long term efficacy sustained at week 52 on same endpoint (p=0.019)

• MAA submitted to EMA in 1Q16. Launch expected 2H17

• GMP process approved for commercial manufacturing by Spanish Agency in 1Q16.Takeda will

co-invest in the expantion of the Madrid facility to secure supply for the initial few years

• Up to €380M agreement with Takeda for the exclusive ex-US rights to Cx601 for the treatment of

complex perianal fistulas in Crohn’s disease patients

• Use of data from positive pivotal Phase III trial in EU to support a BLA in the US

• FDA’s agreement on SPA obtained for pivotal phase III trial in the US

• Same primary endpoint as positive EU Phase III trial

• US Phase III to start 1H17

• Fully-owned asset; granted patent valid until 2030

• Lonza selected as contract manufacturing organization for Cx601 in the US

Cx601: Clear

pathway to US

market

• AlloCSC-01: intra-coronary administered allogeneic cardiac stem cells, being developed for acute

myocardial infarction

• Randomized, double blind, placebo controlled Phase II trial ongoing

• Interim 6 months data confirmed safety. Final one-year follow up data expected 1H17

• Cx611: Intravenously-administered allogeneic adipose derived stem cell product for severe sepsis

• Phase I study completed

• Severe sepsis Phase I/ll trial design has been finalized; expected to enroll first patient in 2H16

Valuable Pipeline

Opportunities:

AlloCSC-01 and

Cx611

1 Advanced Therapy Medicinal Product 44

45

References

46

References

1. Stone MA et al. Prevalence and management of inflammatory bowel disease: A cross-sectional study from central England. European Journal of Gastroenterology

& Hepatology 2013; 15:1275-1280.

2. Hein R et al. Prevalence of inflammatory bowel disease: estimates for 2010 and trends in Germany from a large insurance-based regional cohort. Scandinavian

Journal of Gastroenterology 2014; 49:1325-1335.

3. Lucendo AJ et al. Epidemiology and temporal trends (2000-2012) of inflammatory bowel disease in adult patients in a central region of Spain. European Journal of

Gastroenterology & Hepatology 2014; 26:1399-1407.

4. Dal Pont E et al. Inflammatory bowel diseases (IBD) incidence and prevalence in a North East limited area of Italy. Digestive Liver Disease 2010; S180.

5. Cottone M et al. Incidence of Crohn’s disease and CARD 15 mutation in a small town in Sicily. European Journal of Epidemiology 2006; 21:887-892.

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pharmacy dispensings. Inflammatory Bowel Disease 2007; 13:451-661.

7. Kappelman MD et al. The prevalence and geographic distribution of Crohn’s disease and ulcerative colitis in the United States. Clinical Gastroenterology &

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8. Kappelman MD et al. Recent trends in the prevalence of Crohn’s disease and ulcerative colitis in a commercially insured US population. Digestive Diseases &

Sciences 2013; 58:519-525.

9. Molodecky NA et al. Increasing incidence and prevalence of inflammatory bowel diseases with time, based on systematic review. Gastroenterology 2012; 142:46-

54.

10. Spanish Epidemiological and Economic Study Group on Crohn’s disease. Epidemiological and clinical features of Spanish patients with Crohn’s disease. European

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11. Gibson PR et al. Relationship between disease severity, quality of life and health care resource use in a cross-section of Australian patients with Crohn’s disease.

Journal of Gastroenterology & Hepatology 2007; 22:1306-1312.

12. Dranga M et al. Are there any particularities in Crohn’s disease in North-Eastern Romania? Revista Medico-Chirurgicala a Societatii de Medici si Naturalisti din Iasi

2015; 119:334-339.

13. Schwartz DA et al. The natural history of fistulizing Crohn’s disease in Olmsted county, Minnesota. Gastroenterology 2002; 122:875-880.

14. Bell SJ et al. The clinical course of fistulating Crohn’s disease. Alimentary Pharmacology & Therapeutics 2003; 17:1145-1151.

15. Eglinton TW et al. The spectrum of perianal Crohn’s disease in a population-based cohort. Diseases of the Colon & Rectum 2012; 55: 773-777.

16. Gray BK et al. Crohn’s disease of the anal region. Gut 1965; 6:515-524.

17. Galandiuk S. Perianal Crohn’s disease. Predictors of need for permanent diversion. Annals of Surgery 2005; 241:796-802.

18. Molendijk I et al. Disappointing durable remission rates in complex Crohn’s disease fistula. Inflammatory Bowel Disease 2014; 20:2022-2028.

19. Sands BE et al. Infliximab maintenance therapy for fistulizing Crohn’s disease. The New England Journal of Medicine 2004; 350:876-85.

20. Domènech E et al. Clinical evolution of luminal and perianal Crohn’s disease after inducing remission with infliximab: how long should patients be treated?

Alimentary Pharmacology & Therapeutics 2005; 22:1107-1113.

21. Gammie T et al. Comprehensive Review of Legislations, Regulations and Policies in 35 Countries. PLoS One. 2015;10(10):e0140002, 2015.

Corporate Presentation

July 2016

47