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Cell Therapies Pty Ltd Leading manufacturing and delivery of cell based therapeutics in Asia Pacific Tim Oldham PhD, CEO and Managing Director 4 December 2014

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Page 1: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Cell Therapies Pty LtdLeading manufacturing and delivery ofcell based therapeutics in Asia Pacific

Tim Oldham PhD, CEO and Managing Director4 December 2014

Page 2: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Cell Therapies Pty Ltd:investment thesis

High growth market: cell basedtherapeutics

Unique capabilities in pivotal stage of valuechain

Established regional leader

Substantial growth options – technically de-risked

Capital efficient capacity expansion

Multiple exit options

$25m growthcapital

required

$100+mrevenue

potential by2020

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Page 3: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Cell based therapeutics:transforming healthcare

Living human cells astherapeutics 50:50 autologous:allogeneic 20% CAGR

Regenerative medicine Muscle repair for urinary

incontinence

Immunotherapy/gene therapy 90% complete remission of

chemo refractory leukemia β-thalassemia transfusion

independence

Attracting significant investment >$3b capital raise/deals pa

including big pharma

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“I’ve told the team that resourcesare not an issue. Speed is the issue.”Novartis CEO Joseph Jimenez

Page 4: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

New, local distribution and deliverymodels needed

Can be manufactured at massivescale in 1-2 global facilities

On the shelf when prescriberneeds it

Prescriber initiates ‘needle-to-needle’ production process

Must be manufactured close topatient

This is CT’s uniqueexpertise

Drug/biologic Cell/tissue

Allogeneic Autologous

Startingmaterial Inert, stable, pure Living, complex, variable

Batch size Thousands to millionsof doses <1,000 doses 1 dose

Shelf-life 2-4 years Varies 24-48h

Storage/transport Room temp or 2-8 degC −196 degC (liquid nitrogen)

Scheduling oftreatment

Independent ofmanufacturing

Integrated with JITmanufacturing

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Page 5: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Established regional leadershipReal “needle-to-needle”

delivery since 2003

Unmatched experience,global reputation and

networks

World class clinical &research linkages

Unique locationadvantages, deep regional

experience

Quality, capital efficientassets

Existing sales and profit

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Page 6: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Class Product/ProjectPotentialpatients 2014 2015 2016 2017 2018 2019 2020

FIG-01 (Cartilage repair) 5.6mKSJ-01 (Cartilage repair) 0.3mGRO-01 (Muscle repair) 2.2mBMI-01 (Bone repair) 0.3mMIC-01/02 (Leukaemia) 8kDMY-01 (Hematologic disease) 5kEVE-01 (NSCLC)BEA-01 (mMelanoma)JET-01 (mRCC) 8kSmaller projectsIn-licensed developmentRegional contract manufacturingContractedTerm sheet/LoI or beyond

Musculo-skeletal

Haem-atology

Oncology

Clinical development Reg submission Commercial supply

In-licensed manufacturing and/or marketingCMO contract

Significant growth options: robustproduct pipeline in development

Moving up value chainClinical CMO

Commercial licensee

>$100m salespotential 2020

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Page 7: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Capital efficient capacityexpansion

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Cell Therapies: EastMelbourne, VIC

•5 clean rooms•Managed for Peter Mac•Moving to Parkville

Cell Therapies:Parkville, VIC

•10 clean rooms•Leased from Peter Mac @

VCCC•Tech transfer H1’16

Nextcell: Adelaide,SA (49% owned; one qualitysystem)•2 clean rooms•Serve CTM@CRC•Leased from UniSA•Commissioning H1’15

Cell Therapies:Malaysia

•2-10 clean rooms•Licensed /built at several

possible locations•T/sheet discussion with

strategic investor•Operating mid’16•BioNexus status application

AutologousProduction for theFuture: ASEAN•Feasibility study to meet

commercial autologouscapacity demand at lowercost, greater consistency

•Production from 2017/18•ASEAN hub

Strategic alliance:Japan

•Draft MoU•Joint business

development•Common quality system•Up to 50 clean room

capacity from 2016

Exis

ting

/com

mit

ted

Prop

osed

Page 8: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Today

Seed $5-10m

Expand $13-18m

Accelerate

• Initial MY facility build-out• Due diligence, business

planning, licensing 3 products

• Contract business covers basiccash burn

$25m expansion capital requirement8

• Additional products• Capacity expansion• Automation• Autologous Production

for Future

Revenue >$100m in 5-7 yearsMultiple exit options

• Project funding forthree product launches

Page 9: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Several exit/value realisation options in5-7 years or less

Trade sale tocompetitor

• Complimentsexisting footprint,enabling globalreach

• Indicativeprospects/examples:• NeoStem• PharmaCell

Trade sale tocustomer

• Gives full supplychain control forsuccessfullycommercialisedproduct

• Indicativeprospects/examples:• NeoStem

acquisition of PCT• Big (bio)pharma

customers

IPO

• Self-sustainingregionalinfrastructure leaderwith significantgrowth still to come

• Attractiveinvestmentproposition forinstitutions

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Page 10: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Our world-class teamExecutive Leadership

Dr Tim Oldham, CEO and Managing DirectorFormer President APAC, Hospira

Dr Dominic Wall, CSOInternationally recognised leader in regenerative medicine

Wendy Chung, OperationsExperienced cGMP facilities manager

Jeanette Ripper QA/RAFormer TGA cGMP expert/auditor

Sven Straub, CFOEx-Novartis, PZ Cussons

Andrew Moore, Business Advisor – SE AsiaBased in Malaysia, Former CEO Novartis Malaysia

Board

Ray WoodCo-founder, former CEO

Prof James AngusHonorary Professor, Univ ofMelbourne

Dennis O’KeeffeCFO, Peter Mac

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Advisors

Dr Miles PrinceDirector of CBCT

Dr Chris BehrenbruchExperienced life sciences entrepreneur

Page 11: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

Cell Therapies Pty Ltd:investment thesis

High growth market: cell basedtherapeutics

Unique capabilities in pivotal stage of valuechain

Established regional leader

Substantial growth options – technically de-risked

Capital efficient capacity expansion

Multiple exit options

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$25m growthcapital

required

$100+mrevenue

potential by2020

Page 12: Cell Therapies Pty Ltdcelltherapies.com.au/.../2014/12/AusBiotech-Investment-Brochure.pdf · 90% complete remission of ... Ex-Novartis, PZ Cussons Andrew Moore, ... Cell Therapies

www.celltherapies.com

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