corporate presentation tigenix - september 2014

Corporate Presentation

September 2014

2

Forward Looking Statement

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.

Management Team with Proven Track Record of Success

3

Managing Director and CEO: Eduardo Bravo, MBA

• More than 20 years experience in the pharma and biotech industries at Sanofi-Aventis, Recordati, Cephalon and SmithKline Beecham

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

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

VP Regulatory Affairs & Corporate Quality : María Pascual, PhD

• More than 10 years experience in cell therapy companies; specialised in regulatory affairs for advanced therapies; external adviser to EMA

CTO: Wilfried Dalemans, PhD

CMO: Marie Paule Richard, MD

• More than 25 years experience in the global biopharmaceutical industry at Aicuris, Crucell and Sanofi Pasteur

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

Investment Highlights

Pivotal Phase III Orphan Asset:

Cx601

• Perianal fistulas in Crohn’s patients in the US & EU represents a multi-billion dollar market opportunity

• Pivotal Phase III allogeneic stem cell asset (local administration of a single dose) with data expected in 3Q2015

• Phase II: 56% of patients achieved remission

• Positive Type B meeting held with the FDA

– Agreement on key parameters of future US Phase III trial

– Use of data from pivotal Phase III trial in EU to support a BLA

– Application for SPA to be filed Q4 2014

Clear US Approval Strategy:

Cx601

• Intravenously-administered allogeneic stem cell product for rheumatoid arthritis (Phase IIb) and severe sepsis (Phase Ib)

• Positive phase IIa data in refractory RA

Valuable Pipeline Opportunity:

Cx611

Proprietary Technology Platform

• Expanded adipose-derived stem cells (eASCs)

• Acts by controlling inflammation

• Well defined and fully characterized products

• Consistent and robust manufacturing process

• Up to 360 billion cells can be obtained from one donor

– 2,400 doses of Cx601 and 4,000 doses of Cx611

Established Uniform Manufacturing

Commercialized Product:

ChondroCelect

• First ever ATMP1 approved by EMA; valuable experience in regulatory approval / commercialization process

• Indicated for the repair of cartilage defects in the knee

• Established national reimbursement and partnered with Swedish Orphan Biovitrium

41 Advanced Therapy Medicinal Product

Multiple Product Candidates in Clinical Development

5

Preclinical Phase I Phase II Phase III Market

Cx601 (local)

Allogeneic Adipose Derived Stem Cells

Complex Perianal Fistulas in Crohn’s Patients

Cx611 (intravenous)


Rheumatoid Arthritis

Severe Sepsis

Cx621 (intralymphatic)


Autoimmune Disorders

ChondroCelectCharacterized Autologous Chondrocytes

Cartilage Lesions (knee)

Orphan Drug (EU)

IndicationProduct1

1 Covered by 24 patent families2 Distributed through Swedish Orphan Biovitrum and the Finnish Red Cross Blood Systems

Partnered2

Orphan Drug Filed (US)

Cell Type

Cx601 and Cx611 are our two key products in clinical development

6

Clear US Strategy Defined for Product Candidate

• Positive Type B meeting held with FDA in December 2013• Adequacy of the existing non-clinical package to support an IND1 filing for a

US-based pivotal Phase III trial

• Acceptability of using data from the ongoing ADMIRE-CD2 Phase III study in Europe to support a biologic license application (BLA)

• Agreement on key parameters of future US pivotal Phase III trial

• Development plan for the US being implemented• Selection of contract manufacturing organization for technology transfer

(3Q 2014)

• Application for special protocol assessment (submission 4Q 2014)

• IND1 to be filed as soon as technology transfer finalized

• Partnering discussions initiated

1 Investigational New Drug2 Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn’s Disease

MSCs1 Interact Closely with the Immune System

7

From: Singer and Caplan, 2011

PBMCs

Activated PBMCs

PBMCs+ASCs

activated PBMCs+ASCs

ASCs

0 5 10 15 20

IFN- (ng/ml)0 1 2 3 4 5

TNF- (ng/ml)

* *

* p<0.05 relative to supernatant from activated PBMCs Source: De la Rosa et al. Tissue Engineering 2009

1 MSCs: Mesenchymal Stem Cells

The ability to interact with many players in the immune system qualify MSCs (including

ASCs) as a potent anti-inflammatory agent

ACTIVATED PBMCs

ACTIVATED PBMCs +

ASCs

0

5

10

15

20

% O

F C

D4

+C

D2

5+

++

ON

T

OT

AL

CD

4

*

* p<0.05 relative to activated PBMCs without ASCs

Source: Tigenix data

eASCs as a Preferred Source of MSCs

8

Source and expansion

• Easily accessible

• Considerably higher yield than bone marrow

• Cell stability during expansion

Pharmacological profile

• Low immunogenicity, no tissue matching needed

• Enables allogeneic use

• Demonstrated anti-inflammatory capabilities

Validated eASC Platform

9

Quality• Consistent and robust manufacturing process• Quality control parameters defined: Identity, Purity, Potency

Safety

• No signs of toxicity, tumorigenicity, nor ectopic tissue growth in preclinical safety studies

• Clinical safety data obtained

Efficacy

• Demonstrated control of inflammation in 5 different preclinical models, including different routes of administration

• Clinical efficacy demonstrated

Reproducibility

• No tissue type matching needed, tissue dissociation and isolation of cells according to defined protocol, and expansion through a standardized cell culture process without pooling of cells

Cx601

Local injection of eASCs for the treatment of complex perianal fistulas in Crohn’s patients

10

11

Perianal Fistulas

• Fistulas: sores or ulcers that tunnel through the affected area into surrounding tissues

• 12% of Crohn’s patients are affected by perianal fistulas1

• 80% of these are complex

• Affect anal sphincters

• Present multiple tracts

• Are recurrent

• Are often associated with perianal abscess

> 100,000 Crohn’s patients suffer from complex perianal fistulas every year in Europe and the US alone => compromised QoL, pain, depression, risk of anal epithelial carcinoma

Large intestine

Fistula

1 Source: >60 publications (including Schwartz 2002, Lapidus 2006), the European Federation of Crohn’s and Colitis Associations, US Department of Health and Human Services, Centers for Disease Control and Prevention, National Center for Health Statistics

A Common Severe Complication of Crohn’s Disease

Perianal Fistulas: Treatment Options and Shortfalls

12

1 50% recurrence within 4 months of cessation of treatment (Bnernstein LH et al. (1980). Gastroenterology 79: 357–365) 2 Pearson DC et al. (1995) Azathioprine and 6-mercaptopurine in Crohn disease. A meta-analysis. Ann Intern Med 123: 1323 ACCENT II clinical trial 4 54% for infliximab after 1 year (Sands BE et al. (2004). N Engl J Med 350: 876–885 5 CHARM clinical trial6 Schouten at al, Mizrahi et al, Sonoda et al, van der Hagen et al7 A. Soltani, A. Kaiser, Diseases of the Colon & Rectum vol.53:4 (2010)

Treatment Options Efficacy Safety

Antibiotics • Safety concerns with prolonged use• No long term healing data1

Infliximab(Remicade)

• Remission 23%3

• 20% need dose increase2

• High rate of relapse4

• Safety remains a concern with long term use of biologics

Adalimumab(Humira)

• Remission 33%5 • 20% need dose increase2

• High rate of relapse4

• Safety remains a concern with long term use of biologics

Immunossuppressants• Low healing rates• Relapse on drug cessation2

• High risk of infectious complications

Surgery • High risk of anal incontinence7• High proportion of recurrence6

0 250,000,000 500,000,000 750,000,000 1,000,000,000 1,250,000,000 1,500,000,000

16%12% 14%

60% 100%80%

70% 90%80%

20% 50%35%

$21k $48k

% CD patients with fistula2 (approximately 121,100 patients)

% Complex fistula – all fistula3 (approximately 97,000 patients)

% Patients failing biologic4 (approximately 77,500 patients)

% Market share (approximately 27,100 patients)

Average selling price $34k

1 TiGenix epidemiology report based on multiple publications 2 Schwartz et al, 2002, Vavricka et al., 2010, Pittet et al., 2010, KOL Interviews 3 Pittet et al., 2010, KOL Interviews4 Sands et al., 2004, Lichtiger et al., 2010, KOL Interviews

Market Potential: Perianal Fistula in Crohn’s Disease

Estimated peak year sales

•Assumptions:• Population EU28 + US: 824 million

• Prevalence of Crohn’s disease: 0.105% (865,200 patients)1

Note: Patient numbers refer to mid-point of the range given

13

Launch EU: 2017Launch US: 2020

2003 2004200

52006 2007 2008 2009 2010 2011 2012 2013 2014

Cx601: Developing a New Treatment Paradigm>10 years of experience, consistent efficacy and safety

14

I

Phase II

5 patients 1 center

50 patients 3 centers


Phase III (FATT 1)3

Cx601 (allogeneic)

Phase II

Phase II, IIS6

(ALOREVA)7

Phase III(ADMIRE-CD)8

Cx401 (autologous)



10 patients 1 center

Phase I

Note: Patient data refers to number of patients recruited

Crohn’s and non-Crohn’s perianal fistulas: 75% efficacy; open1

Crohn’s and non-Crohn’s perianal fistulas: 71% efficacy; p<0,0012

Non-Crohn’s perianal fistulas: 41% efficacy; p (n.s.)4

Crohn’s perianal fistulas: 56% efficacy; open5

Rectovaginal fistulas: 57% efficacy; open

1 García –Olmo, et al., 2005. Diseases of the Colon & Rectum 2 García –Olmo, et al., 2009. Diseases of the Colon & Rectum3 Fistula Advanced Therapy Trial 4 Herreros, et al., 2012. Diseases of the Colon & Rectum 5 de la Portilla, F. et al., 2012. Int. Journal of Colorectal Disease 6 Investigator Initiated Study7 Allogeneic adipose stem cells in rectovaginal fistulas8 Adipose Derived Mesenchymal Stem Cells for Induction of Remission in Perianal Fistulizing Crohn’s Disease

Cx601: Phase II

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Proof of concept for an allogeneic therapyTRIAL SUMMARY

Start June 2009

Completion September 2010

Conditions Complex perianal fistula in Crohn’s patients

Study design

• Single arm• Non-controlled• Safety/Efficacy study• One fistula/tract treated • Maximum of 2 doses1

Enrollment 34 patients recruited; 24 treated

# of centers 6 sites

Primary endpoint

Incidence of treatment emergent adverse-events

Secondary endpoints

• Closure of external openings (clinically and MRI)

• Reduce number of draining fistulas

Efficacy 56%

PATIENT SELECTION

• Older than 18 years: both genders • Complex perianal fistula fulfilling

some of the following conditions:• Associated fecal incontinence• Risk factors of anal incontinence• At least 1 previous treatment for a

fistulous disorder• Crohn’s disease (CDAI≤200)• Less than 3 fistulous tracts

• Wash out of anti-TNF of at least 8 weeks prior to inclusion

• No concomitant administration of anti-TNF allowed during the duration of the trial

• Efficacy confirmed by second gastroenterologist not involved in the direct care of the patient

1 First dose of 20M cells; Second dose of 40M cells injected if fistula has not closed after 12 weeks

Cx601: Phase II Results

16

Safety of allogeneic cells confirmed

• Repeated treatment with allogeneic eASCs well tolerated

• Favorable side effect profile•

Overview of adverse events. Full analysis set (n=24)

• Patients with at least one TEAE1 during the study: 13 (54.2%)

• Patients with at least one TEAE possibly related to eASCs during the study 5 (20.8%)

• Serious adverse events reported leading to withdrawal 22 (8.3%) (Events considered to be possibly related to the study treatment; no clinically relevant abnormalities found during physical examination or in vital signs)

1 Treatment Emergent Adverse Event2 Local abscess and pyrexia

Cx601: Phase II Results

17

Allogeneic eASCs confirmed efficacy of autologous cells

Closure of external openings of treated perianal fistula tracts

After 12 weeks (N=21) After 24 weeks (N=16)0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

38.1%

56.3%

Reduction in number of draining fistulas

Nº fistulas: 12

• Significant efficacy in closure of treated fistula tracts

• Reduction of drainage in treated fistulas that have not achieved complete closure

• Positive effect on adjacent fistula tracts that have not directly been treated

N= Patients with available information. Missing data not included in percentage calculations

(only 1 dose received) (week 26 if 2 doses received) (only 1 dose received)

After 12 weeks (N=21) After 24 weeks (N=16)0%

10%

20%

30%

40%

50%

60%

70%

80%

90%

100%

50.0%

61.5%

10.0% 7.7%

After 12 weeks (N=20) After 24 weeks (N=13)

(week 26 if 2 doses received)

Cx601: Investigator-Initiated Study ALOREVA

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Therapeutic effect of eASCs also confirmed in extremely tough condition

TRIAL SUMMARY

Start September 2009

Completion December 2011

ConditionsRectovaginal fistulas (RV) in

Crohn’s patients

Study design

• Open label• Non-controlled• Safety and efficacy study

Enrollment 10 patients

# of centers 1 site

Primary endpoint

Closure of the external opening of the treated RV fistula

Secondary endpoints

• Quality of life (SF-36)• Number of adverse events • Clinically relevant variations in

laboratory test

Efficacy 57% (1 year)

PATIENT SELECTION and RESULTS PATIENT SELECTION and RESULTS

• Women of a childbearing age (>18)• Rectovaginal fistula• Patients with Crohn’s disease

diagnosed at least 12 months earlier with either one previous surgery for fistulous disease or a physical status which discourage liposuction

• 7 patients completed the study• 4 out of these showed complete

closure of the fistula• All 10 patients avoided the previously

indicated colostomy

Cx601: Phase III ADMIRE-CD Trial

19

Robust Phase III designed to qualify as a single pivotal study

TRIAL SUMMARY

Start July 2012

Completion Ongoing

ConditionComplex perianal fistula in Crohn’s

patients

Study design

• Randomized, double blind, placebo controlled trial

• All tracts treated. Fixed single dose1

Enrollment278 patients screened

208 patients randomized

# of centers 52 sites in 8 countries

Primary endpoint

Remission2 at week 24

Secondary endpoints

• Response3 • Time to remission / time to

response• PDAI score and QoL assessment

(IBDQ4)

PATIENT SELECTIONPATIENT SELECTION

• Older than 18 years: both genders • Patients with perianal fistulizing Crohn’s

disease refractory to antibiotics, immunosuppressants and/or anti-TNF

• Exclusion of naïve patients• Limit of patients refractory to antibiotics to

< 25% of total recruited patients• ≤ 2 internal openings (fistulas) and ≤ 3

external openings (tracts)• Non active luminal CD (CDAI5 ≤ 220)• CD diagnosed for ≥ 6 months; Fistula

draining < 6 weeks prior to inclusion• Concomitant treatments allowed without

modification of treatment dose or regimen

1 120 million cells2 Closure of all draining tracts at baseline despite gentle finger compression confirmed by MRI (no collections > 2cm) 3 Closure of 50% draining tracts at baseline despite gentle finger compression confirmed by MRI (no collections > 2cm) 4 Inflammatory Bowel Disease Questionnaire 5 Crohn's Disease Activity Index

Cx601: Phase III ADMIRE-CD Trial

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• Statistical plan:

• Evaluations at weeks 6, 12, 18 and 24 (after dosing)

• Final evaluation at week 52

• Blind clinical and MRI assessment

• Statistical pre-determination:

• α = 0.025

• β = 0.20

• Power: Designed for finding at least 25% difference among study groups

• Patient enrollment: More than 95% completed

• Follow-up: Initial follow up of six months completed with 1 year long-term follow-up study expected 3Q 2015 and 1Q 2016, respectively

Robust Phase III designed to qualify as a single pivotal study

Cx611

Intravenous injection of eASCs for the treatment of early rheumatoid arthritis

21

Rheumatoid Arthritis: A Huge Market Opportunity

22

• On a dollar basis, the market is dominated by biologic drugs (>80% of the market), and especially by antibodies which block tumor necrosis factor TNF1 (5 out of the 9 currently approved biologicals2)

• TNF inhibitors dominate the market with yearly average cost of ~$19k

• The overall RA market is expected to grow at a CAGR of slightly above 7% to approximately $23.4Bn in 2016

• Despite a wide variety of therapeutic options, a high level of unmet patient need exists

1 Wiki Analysis: Arthritis Drug market 2 Humira, Enbrel, Remicade, Simponi and Cimzia

• Induce and maintain low disease activity

• Target acute & inflammatory disease state

• Indication of activity evidenced in refractory patients in Phase IIa trial

Early Rheumatoid Arthritis

23

eASCs are Functional in RA Models

Source: TiGenix data on file

Days after treatment

Arthritic score after three i.v. doses of eASCs TNF - alpha

% c

ytok

ine-

secr

etin

g T

cel

ls

* p<0.001

IL - 10

% c

ytok

ine-

secr

etin

g T

cel

ls

Source: González-Rey et al. Ann. Rheum. Dis. 2009

Intravenous administration of eASCs does protect animals from rapid progress to arthritic joints (CIA model)

T cells from RA patients reduce their inflammatory profile upon contact with

eASCs (in vitro experiment)

* p<0.001

Phase IIa Trial

First randomized trial with eASCs in refractory RA patients

24

TRIAL SUMMARY

Start March 2011

Completion January 2013

ConditionPatients with RA refractory to at

least two biologics

Study design

• Dose escalation, single blind, placebo-controlled (Cx611+ DMARD1 vs. placebo + DMARD)

Enrollment 53 patients

# of centers 23 sites

Primary endpoint

Safety (tolerability and treatment- emergent adverse events)

Secondary endpoints

• Efficacy measured by: – ACR2 remission (ACR 20,

ACR50, ACR 70)– EULAR3 (DAS4 28, VSG5)– Imaging (RAMRIS)– Quality of life (SF-36)

PATIENT SELECTION

• Heterogeneous patient population: Median range of diagnoses 5 – 69 years

• Patients with severe grade of RA: Median DAS 28 score: 3.2 – 7.9

• Patients refractory to at least two biologics

• Mean nº of previous DMARDs: 3.38 => 74% of patients received 3 or more DMARDs

• Mean nº of previous biologics: 2.92 => 45% of patients received 3 or more biologics

• 66% of patients had received Enbrel• 64% of patients had received Humira• 51% of patients had received Infliximab

1 DMARD: Disease-modifying anti-rheumatic drugs2 American College of Rheumatology 3 European League Against Rheumatism 4 Disease Activity Score 5 Variable Surface Glycoprotein

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Safety profile Cx611+DMARD(N=46)

Placebo+DMARD (N=7)

Patients with any adverse events (AE) 38 (83%) 4 (57%)

Patients with any related AE 22 (48%) 1 (14%)

Patients with any grade 3-4 related AE 1 (2%) 1 (14%)

Patients with any AE leading to discontinuation 1 (2%) 0 (0%)

• Only one patient experienced a serious adverse event leading to discontinuation of the treatment1

• All other side effects were mild and transient: most common related adverse events in the Cx611+DMARD group: fever (15%), headache (9%), asthenia (6%)

1 Lacunar infarction, which is defined as a type of stroke in the brain's deep structures

Phase IIa Trial

Favorable safety profile of all three doses of Cx611

Phase IIa Results

Encouraging therapeutic activity

26

ACR20 ACR50 ACR70

M1 M2 M3 FV0

10

20

30

40 3326

20 20

29

14

0 0

M1 M2 M3 FV0

10

20

30

11 13 11 1114

0 0 0

1 2 3 40

5

10

15

20

4 4 42

0 0 0 0

% % %

M

ACR criteria

M6 (FV) M6 (FV) M M M6 (FV)

Results shown are response rates in percentageM1, M2, M3 and M6 (FV) refers to month 1, 2, 3 and 6 (Final Visit) respectively;

For all graphs: N=46 for Cx611+DMARD cohort and N=7 for placebo + DMARD cohort

M1 M2 M3 FV0

10

20

30

4037 35

39

24

43

29

0 0

EULAR response Good + Moderate

DAS 28 (CRP) <3.2 DAS 28 (CRP) <2.6(remission)

M1 M2 M3 FV05

10152025

1520 20

1315 15

0 0

M1 M2 M3 FV0

5

10

15

20

711 11

9

0 0 0 0

M6 (FV) M6 (FV)

% % %

M6 (FV)

Cx611 + DMARD

Placebo + DMARD

EULAR criteria

Cx611

Intravenous injection of eASCs for the treatment of severe sepsis

27

eASCs Can Protect in Severe Sepsis

28

LPS Model

• 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

CLP Model

ChondroCelect

Characterized autologous chondrocytes for the treatment of cartilage lesions in the knee

29

ChondroCelect

• Suspension of characterized autologous chondrocytes injected intra-articularly

• Indicated for the repair of single symptomatic cartilage defects of the femoral condyle of the knee (ICRS III or IV) in adults

• Market: Between 17,000 – 28,000 new patients per year in Europe

• Additional expansion opportunity ex-Europe and Middle East

• Currently on the market in BE, NL, ES, UK and Finland => 2013 gross sales of €4.3M

• Further market penetration to be achieved through distribution agreement with Swedish Orphan International (Sobi), effective as of 1st June 20141

• 20% royalty on ChondroCelect net sales (22% in year 1) and reimbursement of almost all ChondroCelect expenses => ChondroCelect becomes a cash-flow positive asset for TiGenix

30

First ever ATMP approved by EMA (2009)

First, and so far, only cell therapy product with national reimbursement

1 Sobi Territory: European Union (excl. Finland), Switzerland, Norway, Russia, Turkey and the MENA region, whereby certain countries within MENA will only become part of Sobi’s territory as of Nov. 12th, 2014

Manufacturing, Intellectual Property, and Milestones

31

eASC Manufacturing

32

Isolation of Stromal Vascular Fraction(SVF)

Cellular expansion

Freezing Cell Banks

Schematic manufacturing overview

Manufacturing Process Scheme

33

Uniform manufacturing scheme for all products

Liposuction

Cell isolation and expansion

Frozen Drug Substance (FDS)

Finished Product

Master cell bank (cryo)

• Up to 360 billion cells can be obtained from 1 donor

• Finished product units at current doses (clinical trials):

• 2,400 doses of Cx6011

• 4,000 doses of Cx6112

1 Based on ongoing Phase III trial (120M cells per patient)2 Assumes 1 million eASCs/ Kg, weight average 80Kgs

A Growing Patent Portfolio in Cell Therapy

• 24 patent families related to cell therapy products

• Pending & granted patents in over 20 jurisdictions including the US; expiry dates 2024 onwards

• Key patent for Cx601 (PCX007) granted in 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’ chondrocyte and stem cell 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 confirmed by external counsels • US: Morrison & Foerster• Europe: Carpmaels & Ransford

34

Key Milestones

35

2014 2015 2016 2017

Cx601 (local)

Europe

US

Cx611 (IV)

RA

Severe Sepsis

ChondroCelect

Product

3Q15 primary endpoint results (24 weeks)

1Q16 study results (1 year follow-up)

1H16 EMA filing

3Q14 CMO selection 1H16 tech transfer finalized

4Q14 SPA submission

Increase market penetration in existing countries

Expand geographic reach through new market entry

4Q14 Phase 3 enrollment completed

2H16 pivotal Phase 3 initiated

3Q15 Phase 2 enrollment initiated

YE16 Phase 2 enrollment completed

1H17 Phase 2 study results

1H17 EU launch

1Q15 Phase 1b initiated

3Q15 Phase 1b study results

3Q16 Phase 2 enrollment initiated

Key Facts about TiGenix

36

1 Exchange rate as of 14 July 2014 (oanda)

Headquarter Leuven, Belgium

Operations Madrid, Spain

Employees Approximately 50 employees

Stock Exchange Traded on NYSE Euronext Brussels (TIG)

Market Capitalization Approximately $130M

Reference Shareholders 30% held by Grifols, Roche, and Novartis

Liquidity ≈ 70% free-float of which 30% held by institutional investors

Analyst Coverage 6 analysts covering the stock, of which four are independent

Cash Balance $29M as of Q2 20141

Investment Highlights

Pivotal Phase III Orphan Asset:

Cx601

• Perianal fistulas in Crohn’s patients in the US & EU represents a multi-billion dollar market opportunity

• Pivotal Phase III allogeneic stem cell asset (local administration of a single dose) with data expected in 3Q2015

• Phase II: 56% of patients achieved remission

• Positive Type B meeting held with the FDA

– Agreement on key parameters of future US Phase III trial

– Use of data from pivotal Phase III trial in EU to support a BLA

– Application for SPA to be filed Q4 2014

Clear US Approval Strategy:

Cx601

• Intravenously-administered allogeneic stem cell product for rheumatoid arthritis (Phase IIb) and severe sepsis (Phase Ib)

• Positive phase IIa data in refractory RA

Valuable Pipeline Opportunity:

Cx611

Proprietary Technology Platform

• Expanded adipose-derived stem cells (eASCs)

• Acts by controlling inflammation

• Well defined and fully characterized products

• Consistent and robust manufacturing process

• Up to 360 billion cells can be obtained from one donor

– 2,400 doses of Cx601 and 4,000 doses of Cx611

Established Uniform Manufacturing

Commercialized Product:

ChondroCelect

• First ever ATMP1 approved by EMA; valuable experience in regulatory approval / commercialization process

• Indicated for the repair of cartilage defects in the knee

• Established national reimbursement and partnered with Swedish Orphan Biovitrium

371 Advanced Therapy Medicinal Product

Corporate Presentation

September 2014

38

corporate presentation tigenix - september 2014

Presentations & Public Speaking