ORTHOCELL LIMITED — Investor Presentation 2016

Mar 14, 2016

==> picture [192 x 41] intentionally omitted <==

Paul Anderson Managing Director

Disclaimer

This presentation prepared by Orthocell Pty Ltd (" Company ") does not constitute, or form part of, an offer to sell or the solicitation of an offer to subscribe for or buy any securities, nor the solicitation of any vote or approval in any jurisdiction, nor shall there be any sale, issue or transfer of the securities referred to in this presentation in any jurisdiction in contravention of applicable law. Persons needing advice should consult their stockbroker, bank manager, solicitor, accountant or other independent financial advisor.

This document is confidential and has been made available in confidence. It may not be reproduced, disclosed to third parties or made public in any way or used for any purpose other than in connection with the proposed investment opportunity without the express written permission of the Company.

This presentation should not be relied upon as a representation of any matter that an advisor or potential investor should consider in evaluating the Company. The Company and its related bodies corporate or any of its directors, agents, officers or employees do not make any representation or warranty, express or implied, as to the accuracy or completeness of any information, statements or representations contained in this presentation, and they do not accept any liability whatsoever (including in negligence) for any information, representation or statement made in or omitted from this presentation.

This document contains certain forward looking statements which involve known and unknown risks, delays and uncertainties not under the Company’s control which may cause actual results, performance or achievements of the Company to be materially different from the results, performance or expectations implied by these forward looking statements. The Company makes no representation or warranty, express or implied, as to or endorsement of the accuracy or completeness of any information, statements or representations contained in this presentation with respect to the Company.

It is acknowledged that the Company will not undertake any obligation to release publicly any revisions or updates to these forward-looking statements to reflect events, circumstances or unanticipated events occurring after the date of this presentation except as required by law or by any appropriate regulatory authority.

MSK Demographic Status

Orthopaedic Wave > Cost Effectiveness > Investment Radar

==> picture [442 x 288] intentionally omitted <==

----- Start of picture text -----

MSK
Regenerative
Medicine
Growth
Factors
Cellular Collagen Growth
Therapies Scaffolds Factors
----- End of picture text -----

Company Overview

Orthocell Ltd is a regenerative medicine company developing cellular therapies, collagen scaffolds and growth factors for the treatment of human tendons, ligaments and soft tissue defects

• Founded in 2006, headquartered in Australia, ASX listed August 2014

==> picture [153 x 154] intentionally omitted <==

==> picture [154 x 154] intentionally omitted <==

• Unique cell therapy and regenerative medicine products

• Marketed in Australia, Singapore, Hong Kong, New Zealand , with US clinical program advancing

• Additional commercial stage products in cartilage and pipeline products in laboratory grown tendon and growth factors

Positioned for growth

OCC is deal ready and positioned for growth:

Clinically validated and Next product in late Global approvals and marketed treatments stage development expansion underway Key areas of investment in MSK regenerative medicine by Pharma and Large Cap Biotechs:

==> picture [599 x 205] intentionally omitted <==

----- Start of picture text -----

Percentage (%) Pharma and Large Cap Biotechs Investment in Regenerative Medicine X
69%
64%
56%
31% 31%
Cell therapies Use of stem cells for Combination products Endogenous stem cell Gene and Gene-modified
disease modelling, drug including tissue activation cell therapies
discovery and toxicology engineered
scaffolds/devices
----- End of picture text -----

x Research and Markets (2014): Global Cell Therapy – Technologies, Markets and Companies

6

Product overview

Cell Therapies

Product	Development Stage	Approval Status	Current Applications
World 1st Tendon Regeneration -Ortho-ATI™	Commercial	Marketed in Australia Clinical in US/EU	Tennis elbow, achilles, gluteal, patellar, rotator cuff
Ortho-ACI™	Commercial	Marketed in Australia	Knee and Ankle

Collagen Scaffolds

Product	Development Stage	Approval Status	Current Applications
Celgro™	Clinical	CE Mark planned 2016 510(k) 2016	Orthopedic, dental, ENT, general surgical & nerve repair
Pipeline
Product	Development Stage	Approval Status	Current Applications
Growth factors	Proof of Concept	Pre-clinical	Soft tissue repair (bone cartilage tendons)
Laboratory Tendon & Ligament replacement technology	Proof of Concept	Pre-clinical	Tendon and ligament replacement

7

==> picture [445 x 304] intentionally omitted <==

Ortho-ATI™– Autologous Tenocyte Implantation

Ortho-ATI™ is a stem cell therapy to regenerate tendons and ligaments:

• Autologous cell therapy to regenerate tendon tissue

==> picture [331 x 213] intentionally omitted <==

• enables healing of tendons, reduces pain and increases strength

• greatly improves the patient’s mobility and quality of life

• multiple tendon applications

Ortho-ATI™ is a two stage minimally invasive, walk-in, walk-out process:

Biopsy procedure and tenocyte cultivation U/S guided intratendinous cell implantation

• 4-5 week end to end process

• early systematic relief, followed by structural and functional improvements

Ortho-ATI™4.5 yr. clinical data

Ortho-ATI™ tennis elbow study:

• 20 patients that had failed all other treatments, with average 31 month symptoms on

• Patients improved significantly with 1 patient proceeding to surgery

• Data to 4.5 years recently published in American Journal Sports Medicine

==> picture [436 x 167] intentionally omitted <==

Ortho-ATI™ gluteal tendon study:

• 12 patients with gluteal tendinopathy – no remaining treatment options average duration of symptoms of 33 months

• Significant clinical improvement in pain and function scores at 24 months

• Data submitted for publication

==> picture [440 x 152] intentionally omitted <==

Positioning Ortho-ATI™

==> picture [28 x 27] intentionally omitted <==

==> picture [28 x 26] intentionally omitted <==

==> picture [28 x 27] intentionally omitted <==

Market leading world first tendon regeneration treatment

Over 300 patients treated to date. Demonstrated pathway to market

• Non operative procedure with high costbenefit outcomes

==> picture [351 x 136] intentionally omitted <==

==> picture [27 x 27] intentionally omitted <==

Directly addresses the underlying pathology of tendinopathy (disease modifying)

==> picture [27 x 27] intentionally omitted <==

Long term data demonstrating durability and effectiveness in recalcitrant patients:

• Tennis Elbow – structurally repaired tendon tissue, 203% improvement grip strength at (3-5 yrs)

• Gluteal Tendinopathy – clinical improvements at 3 months, maintained to 24 months

Ortho-ATI™ expansion plans

==> picture [215 x 214] intentionally omitted <==

Bringing Ortho-ATI™ to the world’s largest markets:

• IND being prepared for US Phase 2 tennis elbow study

• partnering discussions ongoing with US and EU potential partners

• discussions in Japan underway to leverage abridged approval process

Australian approval and marketing of Ortho-ATI™ de-risks global expansion:

• 300 patients treated in Australia and parts of Asia

• multiple tendons treated with no reported serious AE’s

• sales tools and market entry strategy honed in pilot market

Ortho-ACI™ - Autologous Chondrocyte Implantation

Ortho-ACI™ - Offers an effective treatment for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle.

Ortho-ACI™ - 2 stage procedure: Biopsy and chondrocyte cultivation followed by cell implantation via Celgro™ scaffold:

• Highly customised approach

• Low passage / high quality

• Greater cost effectiveness

Ortho-ACI™ growth strategy:

• Orthocell is the only accredited manufacturer and supplier of ACI/MACI type therapies in Australia, SE ASIA

• secure a strategic partner in Japan

• targeting international product registrations in Japan, then EU and USA

==> picture [183 x 184] intentionally omitted <==

13

==> picture [480 x 327] intentionally omitted <==

Collagen Scaffold Platform – CelGro™

==> picture [209 x 150] intentionally omitted <==

CelGro™ is a superior soft tissue regeneration technology:

Significantly differentiated:

• Structure - mechanical

• Use – bio-degradable

• Origin - bio compatable

Multiple applications with significant market potential:

==> picture [266 x 211] intentionally omitted <==

Clinical Trial Stage

• tendon augmentation and repair (300,000 RC Surgeries/year)

• dental / orthopaedic bone repair and regeneration (fastest growing market segment)

• ENT tympanic membrane (unmet need)

Proof of Concept Stage

• gynaecological and urological soft tissue repair

• general surgical soft tissue reconstruction

• nerve repair

CelGro™ path to market

Regulatory pathway

• CE Mark submission being finalised for submission targeting an approval in 2016

• FDA 510(k) submission planned for late 2016

• Other international markets to follow

Pursuing direct sales as well as licence opportunities:

• dental, orthopedic, ENT, gynaecology, general surgical

• • Bone Support AB partnership is first commercial collaboration and a strong external validation of the technology

• significant opportunities in orthopedic, ENT and general surgical applications

==> picture [209 x 151] intentionally omitted <==

==> picture [179 x 180] intentionally omitted <==

16

==> picture [457 x 312] intentionally omitted <==

Next generation pipeline

Strong product pipeline:

Celgro

• collagen powder for bone void fillers

• guided nerve regeneration

• braided ligament and ACL replacement

Lab Grown Tendons

• laboratory manufactured human tendon

• replacement tendons for hands and other applications

Growth Factors

• tissue specific growth factor ‘Cell Factory’

• off the shelf growth factors - bone, cartilage and tendon

==> picture [160 x 317] intentionally omitted <==

These pipeline products and concepts are early stage opportunities that require further research and development prior commercialisation

Corporate Overview

Corporate

Team

ASX OCC Share Price AU$0.40 Ordinary Shares on issue 91.5 million Market Cap AU $37 million US $ 29 million Options & Warrants outstanding 5,912,500 (ex @ $0.50) 3,520,000 (ex @ $0.62) 1,350,000 (ex @ $0.56) 12,122,237 (ex @ $0.58) Cash at bank AU$6 million (@ 19 Jan 2016)	CEO Paul Anderson • Verigen • Genzyme • Biomet CSO Prof Ming Hao Zheng • Verigen • Genzyme • UWA Executive Chairman Dr Stewart Washer • Cynata • Minomic Director Matt Callahan • iCeutica • Glycan Bio • Dimerix Director Prof Lars Lidgren • UN Bone and Joint Chair • Biomet • Uni Lund 18

Recent Recognition

==> picture [306 x 133] intentionally omitted <==

==> picture [320 x 201] intentionally omitted <==

For further information contact www.Orthocell.com.au

==> picture [192 x 41] intentionally omitted <==

Paul Anderson Managing Director