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World-leading Expertise in Gene and Cell Therapy Annual General Meeting 7 May 2015

World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

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Page 1: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

World-leading Expertise in Gene and Cell Therapy

Annual General Meeting7 May 2015

Page 2: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

2

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

2

Forward-looking statements

This presentation does not constitute an offer to sell or a solicitation of offers to buy Ordinary Shares (the “Securities”).

Although reasonable care has been taken to ensure that the facts stated in this presentation are accurate and that the

opinions expressed are fair and reasonable, the contents of this presentation have not been formally verified by Oxford

BioMedica plc (the “Company”) or any other person. Accordingly, no representation or warranty, expressed or implied, is

made as to the fairness, accuracy, completeness or correctness of the information and opinions contained in this presentation,

and no reliance should be placed on such information or opinions. Further, the information in this presentation is not complete

and may be changed. Neither the Company nor any of its respective members, directors, officers or employees nor any other

person accepts any liability whatsoever for any loss howsoever arising from any use of such information or opinions or

otherwise arising in connection with this presentation.

This presentation may contain forward-looking statements that reflect the Company's current expectations regarding future

events, its liquidity and results of operations and its future working capital requirements. Forward-looking statements involve

risks and uncertainties. Actual events could differ materially from those projected herein and depend on a number of factors,

including the success of the Company's development strategies, the successful and timely completion of clinical studies,

securing satisfactory licensing agreements for products, the ability of the Company to obtain additional financing for its

operations and the market conditions affecting the availability and terms of such financing.

Page 3: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

3

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

3

Overview

• Oxford BioMedica is a world-leading gene & cell therapy business

• Proprietary technologies

• Gene delivery platform based on lentiviral vector IP

• 5T4 antigen/antibody in immunotherapy

• Pipeline of clinical and early product development candidates

• OXB Solutions business generating revenues

• Unique IP and technical capabilities validated by

• Lentiviral vector IP – Novartis (CAR-T programmes), GSK

• Product licences – Sanofi (StarGen™/UshStat®)

• Process development – Novartis, ImmuneDesign

• Well-financed and potential to generate cash by 2017

Page 4: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

4

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

4

2014/2015 key achievements

Proprietary pipeline advanced with four clinical programmes in development and

two other products being prepared for Phase I/II RetinoStat® recruitment completed in Phase I trial which will report in 2015

New CART-5T4 programme initiated in-house, combining both OXB’s LentiVector® and 5T4

technology platforms

£2.2 million grant received from Innovate UK to fund a Phase I/II clinical trial of OXB-102 in

Parkinson’s disease commencing early 2016

Sanofi granted global rights to StarGen™ and UshStat® across all ocular indications

IP, technology and manufacturing capability validated by major new licensing

and manufacturing contract with Novartis Agreement worth up to $90 million over the next three years including licensing royalties when

CTL019 is commercialised

Revenue increased through licensing, up front partner payments, manufacturing

and R&D collaborations

Cash position strengthened through £20m equity fundraise (June 2014) and

$50m loan facility (May 2015)

Page 5: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

5

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

5

Oxford BioMedica’s business model

Research & Development

Proprietary gene and cell therapy

pipeline

+

RevenuesGovernment

fundingLicence fees Milestones RoyaltiesManufacturing and

process development

OXB Solutions

Contracts for lentiviral vector

manufacture and process

development

IP Ownership

Key IP makes OXB an essential partner

for companies wanting to

commercialise lentiviral vector based products

+

Page 6: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

© Oxford BioMedica 2015, all rights reserved 6

Product Update

© Oxford BioMedica 2015, all rights reserved

Page 7: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

7

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

7

Portfolio of pipeline assets (excluding those already out-licensed)

Product Indication Stage Next inflectionEst.

date

Lentiviral vector TECHNOLOGY

OPHTHALMOLOGY RetinoStat® Wet AMD Phase I follow up

stage (primary end

point met)

Phase I CSR 2015

EncorStat® Corneal graft rejection Phase I/II preparation FPI Phase I/II 2016

Glaucoma-GT Chronic glaucoma Pre-clinical End pre-clinical 2016

CNS

ProSavin®

OXB-102 Parkinson’s disease

Phase I/II complete

Phase I/II

preparationFPI Phase I/II 2016

MoNuDin® Motor neuron disease Research End pre-clinical 2015/16

NEW IDEASInvestigating several therapy areas where Lenti based vectors have

an advantage over AAV due to payload capacity

TBD TBD

Exploring possibilities to enter cell therapy field in our own right – e.g.

CAR-T 5T4

5T4 TECHNOLOGY

ONCOLOGY TroVax® Cancer (multiple) Phase II ongoing End Phase II 2015/16

CAR-T 5T4 Cancer (multiple) Pre-clinical End pre-clinical 2016

Page 8: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

8

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

8

Product news

• Retinostat

• Phase I results

• Safe and well-tolerated

• Signs of clinical benefit – visual acuity stabilisation and reduction in

vascular leakage

• Next steps

• In-depth discussion with Principal Investigators and Key Opinion

Leaders

• Determine optimal indication(s) and pathway for future development

• ProSavin

• 3 year follow up data

• Indicates that the improvement in motor function seen at 6 and 12

months has been sustained in majority of patients for up to 3 years

Page 9: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

9

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

9

Product news

• OXB-102 and Encorstat

• Phase I/II studies expected to start in H1 2016

• Both partially funded by Innovate UK grants

• TroVax

• Three investigator-led open label Phase II studies in progress

• Mesothelioma, colorectal cancer, ovarian cancer

• Results expected from at least one study in 2015

• CAR-T 5T4

• A gene modified autologous T cell engineered with lentiviral vector

to express an antibody against 5T4; delivered by IV infusion

• Acts by re-directing a patient’s T cells to recognise the 5T4 tumour

antigen and kill the cell expressing it

• Pre-clinical results due 2016

Page 10: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

© Oxford BioMedica 2015, all rights reserved 10

Novartis contract

Page 11: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

11

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

11

Novartis contract (October 2014)

• Initial contract May 2013 – proved our capabilities

• Non-exclusive licence to OXB’s lentiviral vector platform IP in oncology

• Process development collaboration

• Arising IP owned by OXB

• NVS have exclusive licence to arising IP in CAR-T cell products

• Initial 3 year manufacturing contract for clinical supply for NVS CTL019 programme – potential to extend

• Financial terms include

• $4.3m equity investment

• IP licence

• $9.7m non-refundable upfronts

• Undisclosed royalties on CTL019 and other CAR-T products

• Manufacturing and process development

• Up to $76m over 3 years

Page 12: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

© Oxford BioMedica 2011, all rights reserved

Heading style for cover slide goes here

Sub heading style goes here

12© Oxford BioMedica 2015, all rights reserved

Capacity Expansion

Page 13: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

13

Acquisition of Windrush Court

• Windrush Court office and laboratory facilities

• Completed purchase (announced 13 October 2014; £3.2 million)

• Refurbishment underway

• Headquarters office building with fully fitted laboratories on secure site. 6,684 m2

(71,955 sq ft)

• Consolidates entire activities in Oxford, improving operational effectiveness, and will

also provide additional capacity to accommodate the planned growth in business

Medawar Centre Windrush Court

Page 14: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

14

Medawar CentreThe Oxford Science Park

28, 000 sq. ft (2,610 sq. m)

GLP/GMP/GCP Laboratories

GMP QC analytics/ release/stability testing

Clinical/non-clinical analysis

Analytical development

Product/Process development

Yarnton (GMP4) 18,300 sq. ft (1,700 sq. m)

API manufacturing facility

(under construction)

Windrush CourtCorporate Headquarters &

Laboratories

71,955 sq. ft (6,684 sq m)

(under reconfiguration)

Harrow House (GMP1/GMP2/GMP3)

Fill & Finish & Chancery Gate)32,000 sq.ft (2,980 sq.m)

API manufacturing facility

(under reconfiguration)

GMP QC microbiology laboratories

Raw material testing

GMP cold chain warehouse &

office space

GMP Warehouse Hub2,691 sq.ft (250 sq. m)

Material transfer/ temperature

controlled / monitored storage

OXB facilities

Page 15: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

15

Transport Way facilities

Page 16: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

16

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

16

Yarnton facility

Page 17: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

17

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

17

Future manufacturing capacity

17%

11%

25%

32%

15%

Floor space %

HH GMP1

HH GMP2

Yarnton GMP4

HH GMP3

HH F&F

Current facility

Under

construction

Under

construction

Construction

starts H2 2015

Construction

starts H2 2015

Clean room capacity• Current (GMP1) = 390 sq.m,

• Future state (4Q,2016) = 2,245 sq.m

Page 18: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

18

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

18

Financial position

• Cash at end 2014 – £14m

• $50m loan facility secured May 2015• $25m drawn down

• £3m AMSCI loan repaid and facility terminated

• Capital expenditure across 2015/2016 expected to be in the

region of £20m

• Manufacturing and process development revenues set to

grow in 2015, reducing underlying operational cash burn

Page 19: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

19

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

19

Upcoming potential value driving news flow

2015 Further IP licences/manufacturing/process development contracts

RetinoStat® decision regarding Phase II indication and development pathway

Identification of new product development candidates

TroVax® Phase II studies – initial results

2016 MoNuDin® pre-clinical results

FPI OXB-102 clinical programme

FPI EncorStat® clinical programme

StarGen™/UshStat® development milestones

Glaucoma-GT pre-clinical results

CAR-T 5T4 pre-clinical results

PLUS - updates from Novartis on CTL019 programme from time to time

Page 20: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

20

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

20

Summary

• Lentiviral vector IP recognised by Novartis, GSK

• Internal clinical programmes

• Three gene therapy product candidates in Phase I/II development

• Three investigator-led Phase II TroVax® studies

• Out-licensed clinical programmes

• Two ophthalmology in vivo Phase I/II products licensed to Sanofi

• Two out-licensed 5T4 antibody technology phase I studies

• Further potential product development opportunities being evaluated

• Including CAR-T 5T4

• Significant revenue potential from manufacturing and process development

Page 21: World-leading Expertise in Gene and Cell Therapy · 3 Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS) 1, n=3 1x Original Mean 27% Max

21

Cohort2 Dose Administration 3 months (UPDRS) 6 months (UPDRS) 1 year (UPDRS) 2 years (UPDRS)

1, n=3 1x Original Mean 27%Max. up to 30%

Mean 30%Max. up to 50%

Mean 29%Max. up to 44%

Mean 20%Max. up to 30%

2, n=3 2x Original Mean 28%Max. up to 53%

Mean 34%Max. up to 53%

Mean 29%Max. up to 56%

-

3, n=3 2x Enhanced Mean 26% - - -

21

Contact us

Oxford BioMedica plc

Windrush Court

Transport Way

Oxford

OX4 6LT

[email protected]

John Dawson, CEO

Tim Watts, CFO

Tel: +44 (0) 1865 783 000