Corporate Presentation

January 2016

1

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

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

CTO: Wilfried Dalemans, PhD

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

Biologicals and Transgène

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

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

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

3

Investment Highlights

Positive Phase III

And Advanced EU

Regulatory

Strategy:

Cx601

• Complex perianal fistulas in Crohn’s disease 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)

• Results met primary endpoint

• Statistically superior to placebo in achieving combined remission at week 24 (p<0.025)

• Filing for MAA expected in 1Q16 and launch expected 2H17

• Fully-owned asset

• Consistent and robust manufacturing process

• Management team has valuable experience in regulatory approval / commercialization process; first

ever ATMP1 approved by EMA

• 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

• Phase III to start 1Q17

• Fully-owned asset

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

Clear US

Regulatory and

Clinical Strategy:

Cx601

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

myocardial infraction

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

• Interim data expected 2H16

• Final one year follow up data expected 1H17

• Cx611: Intravenously-administered allogeneic stem cell product for severe sepsis (Phase I study

completed)

• Severe sepsis Phase ll trial design has been finalized; expected to enroll first patient in 1Q16

Valuable Pipeline

Opportunities:

AlloCSC-01 and

Cx611

1 Advanced Therapy Medicinal Product 4

Multiple Product Candidates

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

Orphan Drug granted by EMA

Partnered2

SPA agreed to by FDA

1 Covered by 27 patent families 2 Distributed through Swedish Orphan Biovitrum (‘Sobi’) and the Finnish Red Cross Blood Service

5

Cx601: Positive Phase lll Data

Local injection of eASCs for the treatment of

complex perianal fistulas in Crohn’s disease patients

6

Mechanism of Action: Adipose-Derived Stem Cells

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

Inhibition of pro-inflammatory cytokines

* p<0.05 relative to supernatant from activated PBMCs

Source: De la Rosa et al. Tissue Engineering 2009

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 activated PBMCs without ASCs

Source: Tigenix data

Inhibition of Immune Cell Proliferation

7 Source: De la Rosa et al. Tissue Engineering 2009

Manufacturing Consistent and Robust Process

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

• Quality control parameters defined:

• Identity

• Purity

• Potency

• Approximately 2,400 finished products of Cx601

Liposuction

Cell isolation and expansion

Frozen Drug Substance (FDS)

Finished Product

Master cell bank (cryo)

8

Perianal Fistulas A Common Severe Complication of Crohn’s Disease

• Fistulas: sores or ulcers that tunnel

through the affected area into

surrounding tissues

• Around 11% of adult Crohn’s

disease patients are affected by

perianal fistulas

• 70% – 80% of these are complex

• Affect anal sphincters

• Present multiple tracts

• Are recurrent

• Are often associated with perianal

abscess

Almost 120,000 adult Crohn’s disease patients suffer from complex perianal fistulas in Europe and the US alone => compromised QoL, pain, depression

and risk of anal epithelial carcinoma

Fistula

9

Perianal Fistulas: Treatment Options and Shortfalls

10

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

Efficacy Safety

Antibiotics • Safety concerns with prolonged use

• Poor quality of evidence on fistulas

remission

• High rate of fistula relapse on drug cessation: 72% 1

Infliximab (Remicade®)

• Low remission rate of perianal fistulas:

23% after 54 weeks of treatment 4

• High rate of relapse: 54% after 54 weeks

of treatment 4, and 66% one year after

drug cessation 5

• Safety remains a concern with long term use of biologics

Adalimumab (Humira®)

• Low remission rate: 33% after 56 weeks of treatment 6

• Safety remains a concern with long term use of biologics

Immunosuppressants

• Poor quality of evidence on fistulas

remission

• High rate of fistula relapse on drug

cessation : 67-71% 2,3

• High risk of infectious complications

Surgery • Risk of complications (eg. incontinence,

abscesses formation, non-healing wounds 7,9)

• Risk of recurrence remains (up to ~50-70%, depending on the type of surgery) 7,8 unless radical, mutilating surgery is performed

• Mode of administration

1. Fistula curettage and closure of

internal opening (sutured)

2. Half of Cx601 dose (2 vials) is injected

in the tissue around the internal

opening, making several small blebs

3. The other half (2 vials) is injected along

the walls of the fistula tracts, also

making several small blebs

• Product description

o Expanded adipose-derived stem cells

(eASCs) for the treatment of complex

perianal fistulas in Crohn’s disease

o 4 vials containing 30 million cells in 6 mL

suspension each (total dose 120 million

cells)

Injection sites: Injection sites:

a. Fistula internal opening b. Fistula tract

11

Cx601: Product Description and Mode of Administration

Cx601 Phase III ADMIRE-CD1 Trial Robust Phase III Study Designed to Qualify as a Single Pivotal Study

TRIAL SUMMARY

Condition Complex perianal fistulas in Crohn’s disease patients

Study design • Randomized, double-blind, placebo-controlled trial • All tracts treated. Single procedure2

Status 24 weeks primary analysis finalized. Follow up ongoing

Enrollment 289 patients recruited

Number of sites 47 active sites in 8 countries

Primary endpoint Combined Remission3 at week 24 with α<0.025

Secondary endpoints

at Weeks 24 and 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 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 12

Patients Selection: Key Eligibility Criteria

• 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

13

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

Design: Double-Blind, Placebo-Controlled

14

W104

Screened

n= 289

Screening Failures

n= 77

Randomized

n= 212

Cx601

n= 107

Not Treated

n= 4

Treated

n= 103

Treated & post baseline assessment

n= 103

Placebo

n= 105

Treated

n= 102

Treated & post baseline assessment

n= 101

Not Treated

n= 3

Safety set

n= 205

15

ITT1 set

n= 212

mITT2 set

n= 204

1 ITT: Intention To Treat i.e. patients randomized 2 mITT: modified ITT i.e. patients randomized and treated, and with at least one post-baseline efficacy value

Largest Study in Complex Perianal Fistulas

Demographics, PDAI and Fistula Topography

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)

PDAI1 (ITT)

Mean (SD) 6.5 6.7

Topography of Internal &

External Openings (%) (Safety set)

Cx601

n= 103

Placebo

n= 102

One-tract fistula 53.4 68.3

Multiple-tract fistula 46.6 31.6

• Similar demographics and PDAI score between arms

• Higher proportion of multiple-tract fistulas in Cx601 group

1 Perianal Disease Activity Index 16

(ITT1 Population n= 212)

49.5%

34.3%

0

10

20

30

40

50

60

Cx601 Placebo

p < 0.025

51.5 %

35.6 %

0

10

20

30

40

50

60

Cx601 Placebo

p < 0.025

(mITT2 Population n= 204)

Cx601: A Major Breakthrough Primary Endpoint Met

• Cx601 significantly superior to placebo in achieving Combined Remission

• Patients receiving Cx601 have a 44% greater probability of achieving Combined

Remission than placebo patients

• Efficacy results consistent across all statistical populations

% %

1 ITT: Intention To Treat i.e. patients randomized 2 mITT: modified ITT i.e. patients randomized and treated, and with at least one post-baseline efficacy value

17

Overview of TEAEs up to W24

(Safety Population n=205)

TE(S)AE: Treatment-Emergent (Serious) Adverse Events

• 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.

18

Number of Patients with (%) Cx601

n= 103

Placebo

n=102

TEAEs 68 (66.0) 66 (64.7)

Related TEAEs 18 (17.5) 30 (29.4)

Withdrawn due to a TEAEs 5 (4.9) 6 (5.9)

TESAEs 18 (17.5) 14 (13.7)

Related TESAEs 5 (4.9) 7 (6.9)

Withdrawn due to TESAEs 4 (3.9) 4 (3.9)

The safety profile of Cx601 is favorable

Cx601: A Regulatory De-Risked and Fully-Owned Asset Preparing for European Approval in 2H17

• Clear and fast pathway to the market built on a solid regulatory strategy

• Team with previous experience in obtaining MA1 of cell therapy product

• 5 Scientific Advice Meetings held with EMA2 (2 pre-clinical, 2 CMC3, 1 clinical)

• Approved PIP4 with 20 patients to be started not before 2020

• Letter of intent submitted to the EMA and MAA filing planned for 1Q16

• Assuming industry-average clock stops, final approval expected in 2H17

1 MA: Marketing Authorization 2 EMA: European Medicines Agency

3 CMC: Chemistry Manufacturing and Controls 4 PIP: Pediatric Investigational Plan

5 AR: Assessment Report

6 LoQ: List of Questions

7 LoOI: List of Outstanding Issues

8 CHMP: Committee of Human Medicinal Products

19

Start of the

procedure AR5 LoQ6 Responses Joint AR LoOI7 Responses

D1 D80 D120 D121 D150 D180 D181

CHMP8

Opinion

D210 1st Clock

Stop

2nd Clock

Stop

Submission Comission

Decision

D277

Cx601: Capturing the Value of the Biggest Market Preparing for US BLA1 filing in 2019

• Clear and fast pathway to the market built on a 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 1Q17

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

1 BLA: Biological License Application 2 FDA: Food and Drug Administration 3 IND: Investigational New Drug 4 SPA: Special Protocol Assessment 20

21

TRIAL SUMMARY

Condition Complex perianal fistulas in Crohn’s disease patients

Study design • Randomized, double-blind, placebo-controlled trial • All draining tracts treated. Single injection2

Status In preparation

Enrollment 224 patients screened to allow for 168 randomized patients

Number of sites At least 50 – 60 active sites in the US

Primary endpoint Combined Remission3 at week 244 with α<0.05

Secondary endpoints

at Weeks 24 and 52

• Clinical Remission5 • Response6 • Time to Clinical Remission / to Response • PDAI7 and other scores • Safety and tolerability

Cx601: Phase III US Trial Trial Design Agreed to by FDA through SPA1 Procedure in August 2015

1 Special Protocol Assessment 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 4 The primary efficacy analysis, which has a week 24 endpoint, will be conducted at the time of the week 52 final analysis

5 Closure of all treated external openings draining at baseline despite gentle finger compression 6 Closure of at least 50% of all treated external openings draining at baseline despite gentle finger compression 7 Perianal Disease Activity Index

* Estimated average prevalence in EU: 180/100,000 1-4

Estimated prevalence in US: 190/100,000 3,6

Crohn’s disease: 1,540,710 * 1-6

Adults: 1,432,860 (93%) 5-6

Perianal fistulas: 157,615 (11%) 7-8

Complex: 118,211 (75%) 9-12

Controlled luminal CD: 78,019 (66%)13

Refractory fistulas: 70,217 (90%) 13-15

22

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

1 Stone MA et al. 2013 2 Hein R et al. 2014 3 Molodecky NA et al. 2012 4 Lucendo AJ et al. 2014 5 Kappelman MD et al. 2007 6 Kappelman MD et al. 2013 7 SEESGCD.1999 8 Gibson PR et al. 2007

9 Eglinton TW et al. 2012 10 Bell SJ et al. 2003 11 Lahat A et al. 2012 12 Molendijk I et al. 2014 13 Sands BE et al. 2004 14 Present DH et al. 1999 15 Domènech E et al. 2005

Cx601: A Fully-Owned Asset with Attractive Commercial Potential

• Global market addressable by a targeted commercial effort on reference prescribers

23

• Protection obtained through US patent until

2030

• More than 30,000 adult patients in the US

within target label

• Retain US rights to complete development up

to commercialization decision

Anticipated

Launch

2020

• Protection obtained through EU patent and

orphan designation until 2028

• More than 40,000 adult patients in Europe

within target label

• Finalizing commercial resource plan and

pricing and reimbursement strategy

• Considering partnerships in certain EU

countries

Anticipated

Launch

2H17

Conf

Cx611: Phase ll Ready

Intravenous injection of eASCs for the treatment of severe sepsis

24

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 $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 IIa trial has received the

support of the Horizon 2020 European

Commission Program and the endorsement

of key opinion leaders in Europe

25

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

eASCs Can Protect In Severe Sepsis

• 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

26

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

eASC Effect at the Cytokine and Cellular Level

27

Cx611: Phase I results and Next Steps

Phase IIa in Severe Sepsis Expected to Start 1Q16

• 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 RA

patients

• SEPCELL Phase Ib/IIa study in severe sepsis to start 1Q16

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

• 180 patients (90 per group) with sCABP1 requiring mechanical ventilation and/or

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

• 80M eASC or placebo on days 1 and 3 (160M 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 $5.9M from the European Commission through its Horizon 2020

Program

28 1 Severe community-acquired bacterial pneumonia

AlloCSC-01: Phase ll interim data in <12 months

Intracoronary administration of allogeneic cardiac stem cells for the

treatment of acute ischaemic heart disease

29

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 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

30

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. 4 Circulation. 2015 Jan 27;131(4):e29-322.

Myocardial repair is the only

feasible treatment to

address the post-acute

phase of the disease and

prevent the onset of CHF

CARDIAC REMODELING CARDIAC FUNCTION

AlloCSC-01: Efficacy Demonstrated in Pig Model

Efficacy Data from MRI1 Histological Analysis

CONTROL

AlloCSC-01

80

90

100

110

120

130

140

150

CONTROL

25M

50M

EDVi

30

40

50

60

70

80

90

100

CONTROL

25M

50M

ESVi

30

35

40

45

50

55

60

CONTROL

25M

50M

EF

* *

*

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

* p-value < 0.05

• 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

31

2 3 4

CAREMI Phase I/II Trial Finalizing Recruitment 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 2H16)

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 32

• 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 efficacy 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=5; p<0.05 for both parameters)

* p-value < 0.1

** p-value < 0.05

33

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

Key Milestones, IP, Facts and Investment Highlights

34

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)

2Q16 study results (1 year follow-up)

1Q16 EMA filing

3Q14 CMO selection

2H16 tech transfer finalized

4Q14 SPA submission

Increase market penetration in existing countries

Expand geographic reach through new market entries

4Q14 Phase 3 enrollment completed

1Q17 pivotal Phase 3 initiated

2H17 EMA approval

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

1Q16 Phase 2 enrollment initiated

2Q17 Phase 2

enrollment completed

YE17 Phase 2 study results

35

2H17 launch

Key Intellectual Property Patent Portfolio in Cell Therapy

• 27 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 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 reviewed by external counsels

• US: Morrison & Foerster

• Europe: Carpmaels & Ransford

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Key Facts About TiGenix

Headquarters / Operations Leuven, Belgium / Madrid, Spain

Employees Approximately 75 employees

Stock Exchange Euronext Brussels. Ticker: TIG

Market Capitalization Approx. $220M December 24, 2015

Reference Shareholders 22% held by Grifols and Novartis

Liquidity ~78% free-float, of which ~30% held by institutional investors

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

Cash and Cash Equiv. $25M at June 30, 2015

Last Capital Increase $9,6M raised from US and EU institutional investors in Nov. 15

37 Note: Numbers reflect EUR/USD = 1.1 as of 12/22/15

Investment Highlights

Positive Phase III

And Advanced EU

Regulatory

Strategy:

Cx601

• Complex perianal fistulas in Crohn’s disease 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)

• Results met primary endpoint

• Statistically superior to placebo in achieving combined remission at week 24 (p<0.025)

• Filing for MAA expected in 1Q16 and launch expected 2H17

• Fully-owned asset

• Consistent and robust manufacturing process

• Management team has valuable experience in regulatory approval / commercialization process; first

ever ATMP1 approved by EMA

• 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

• Phase III to start 1Q17

• Fully-owned asset

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

Clear US

Regulatory and

Clinical Strategy:

Cx601

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

myocardial infraction

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

• Interim data expected 2H16

• Final one year follow up data expected 1H17

• Cx611: Intravenously-administered allogeneic stem cell product for severe sepsis (Phase I study

completed)

• Severe sepsis Phase ll trial design has been finalized; expected to enroll first patient in 1Q16

Valuable Pipeline

Opportunities:

AlloCSC-01 and

Cx611

1 Advanced Therapy Medicinal Product 38

Corporate Presentation

January 2016

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