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Paul Anderson Managing Director
Investor PresentationCorporate UpdateDecember 2016
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Disclaimer
This presentation prepared by Orthocell 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 writtenpermission 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.
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Cell therapies:
• Ortho-ATI® - world’s leading stem cell therapy to regenerate tendons
• Ortho-ACI® - 3rd generation arthroscopic cartilage repair
• Actively engaging strategic partners in US and Japan
CelGro® regenerative medicine collagen device:
• Highest quality collagen scaffold to enhance soft tissue and bone regeneration
• Platform technology
• First EU approval imminent
Company Overview
Delivering breakthrough products in regenerative medicine
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Corporate Overview
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Key Facts
Shareholding StructureShareholders 3,050 Directors & Management ---- 30% 60% --------Top 20
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• Botanix Pharmaceuticals• Glycan Bioscience
Director Prof Lars Lidgren • UN Bone and Joint Chair• Biomet• Uni Lund
Director Qui Xiao Zhoa • Shenzhen LD• Technology Co Ltd
ASX OCC
Share Price AU$0.44 (@ 30 Nov 2016)
Ordinary Shares on issue
91.2 million
Market Cap AU$40 million
Options & Warrants outstanding
21.2 million
Cash at bank AU$4 million (@ 30 Sep 2016)
Experienced team to execute
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Global Need & Opportunity
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Ageing population and rising musculoskeletal disorders• Demand for safe, efficient, cost effective treatments• Global soft tissue repair market - US$7B in 2013 expected US$10B by 2020
Superior products with compelling clinical evidence• Ortho-ATI® Tendon Regeneration - 300 patients treated• Ortho-ACI® Cartilage Regeneration - 380 patients treated• CelGro® - Paradigm shift in soft tissue repair
Validated pathway to market and tech transfer ready • Optimised manufacturing facility in Australia approved for commercial production
Significant partner interest• Large pharma currently investing/partnering in cell therapies and scaffolds/devices• Recent M&A deals show strong interest for innovative treatments
Orthocell is deal ready and positioned for growth
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Product Pipeline
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Near term regulatory approvals
, CH
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Ortho-ATI®
Autologous Tenocyte Implantation Breakthrough regenerative medical therapy Multiple tendon applications TGA licence Published long term data
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Ortho-ATI®
1. Biopsy procedure 3. Ultrasound guided tenocyte implantation
Two stage minimally invasive, walk-in, walk-out process.
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4-5 week end to end process
2. Tenocyte cultivation
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Healing Fatigue Model
Ortho-ATI® addresses the degenerative phase of tendon injury
Tendinopathy
6-12 months >12 months
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Current traditional therapies do not adequately address the underlying pathology of tendinopathy (reduction of tenocytes) and thus have limited long-term efficacy.
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Total cost of surgery is up to four (4) times more than Ortho-ATI
Limitations of traditional therapies
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Prevalence
Tendinopathy is a very common and costly condition
Joint Condition Prevalence in AdultPopulation 1
Shoulder Rotator cuff tendonitis (supraspinatus) 5.3%
Elbow Tennis Elbow 1.2%
Hand De Quervain’s disease 0.9%
Lower limb Patellar tendonitis (jumper’s knee)Achilles tendonitis
2.7% 2
2.0% 3
1. Walker-Bone K, Palmer KT, Reading I, Coggon D, Cooper C. Prevalence and impact of musculoskeletal disorders of the upper limb in the general
population. Arthritis Rheum. 2004 Aug 15;51(4):642-51
2. Firstconsult.com
3. Hargrove, Richard (2005). Achilles Tendon Pathology. eMedicine Online
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Why tenocytes?
Tenocytes(Ortho-ATI)
Dermal Fibroblasts
Embryonicstem cells
Mesenchymal stem cells
Autologous ×
Homologous × × ×
Engraftment ? × ×
Efficacy ? ? ?
Durability ? ? ?
Commercially Available
× × ×
Clinical trial data concludes Tenocytes are “fit for purpose”
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Ortho-ATI tennis elbow study (ATI-001):
• 17 patients that had failed all other treatments, with average 31 month symptoms
• 207.6% increase in Grip Strength• 4.5 year durability reported. American
Journal Sports Medicine
Ortho-ATI gluteal tendon study (ATI-002):
• 12 patients that had failed all other treatments, average duration of symptoms of 33 months
• Significant clinical improvement in pain and function scores at 24 months
• 2yr durability reported• Data submitted for publication
Clinical data supports efficacy and durability
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New Ortho-ATI® clinical trial underway
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Tennis elbow study versus surgery
• Phase 2 study by two of Australia’s leading elbow surgeons
• Comparing Ortho-ATI versus surgery, for treatment resistant tennis elbow
• Study designed to show that a single noninvasive treatment of Ortho-ATI is equivalent or superior to the more costly and invasive surgical intervention
• 50 patient study (50/50 randomisation) with 7 patients currently enrolled
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Multiple trials completed
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Orthocell has the largest longitudinal data set for cell therapy treatment of tendinopathy
Clinical studies completed for tennis elbow, gluteal tendinopathy, rotator cuff and patellar tendon concluded Ortho-ATI is safe, durable and cost effective
Gluteal Tendon Study completed involving twelve (12) patients with gluteal tendinopathy who had failed conservative treatments (including at least one corticosteroid injection) and with symptom duration > 6 months. The study confirmed that Ortho-ATI is safe, durable and cost effective with an average 148% increase in quality of life at 2 years post treatment and has been accepted for publication
Achilles Tendon Randomized Study completed involving 90 patients with mid-substance Achilles tendinopathy comparing Ortho-ATI versus a normal saline fluid injection. Positive safety and tolerability data was generated, despite a deviation from study treatment protocol by the investigators, that stipulated the use of an ultrasound guided injection to administer Ortho-ATI.
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Further publications pending
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Workers compensation patient retrospective study
• Orthocell announced the release of new positive results in Oct 2015, from a study of Ortho-ATI for tennis elbow in 25 workers compensation patients
• Data demonstrates Ortho-ATI significantly improved the clinical outcomes of patients with long-term tennis elbow degeneration, with reduced pain and increased functionality enabling patients to return to work
• A significant 88% of patients were able to return to work and more than 50% of these, returned at full capacity following ATI treatment
• Data generated from this study is being prepared for publication.F
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AUS and US addressable markets• Tennis elbow market >$850M• Rotator cuff market >$900M
Regulatory targets• US application (IND ) in preparation• AUS application (ARTG) in progress• JP application (PMDA) commencing
Strategic partnering• Discussions ongoing with US & EU potential
partners• Discussions in Japan underway to leverage
abridged approval process
Orthocell is tech transfer ready
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Ortho-ATI®
“How stem cells gave violinist her life back”
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Ortho-ACI®
Autologous Chondrocyte Implantation Gold standard cartilage repair Multiple applications
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Gold standard intervention for symptomatic defects of the articulating cartilage of the joints, predominately the knee and ankle (lesions greater than 2cm2)
Over 380 patients treated in AUS, HK and SG
Highest quality cells with superior outcomes delivered by optimised manufacturing and treatment process
Therapeutic Goods Administration (TGA) licenseMI-19052008-LI-002420-11 Orthocell is the only accredited manufacturer and supplier of ACI in SE Asia
Highly customised, lesion-focused treatment therapy
Significantly more cost effective treatment
Ortho-ACI®
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Arthroscopic 3rd generation autologous chondrocyte implantation
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Prevalence of Cartilage Injury
• Chondral and osteochondral injuries are commonly seen in today's clinical practice.
• Approximately 900,000 people per annum develop cartilage disease in the US alone.
• Articular cartilage lesions are most commonly seen during the fourth decade of life, with full thickness lesions common in young adults in their third decades, following acute traumatic injuries.
• Articular cartilage injuries often cause symptoms in weight-bearing joints like the knee, ankle and hip.
• There are approximately 70 000 arthroscopies per year in Australia and it is estimated that 60% of these are due to chondral defects (localised loss of cartilage).
• Full-thickness lesions are found in 5-10% in knees undergoing arthroscopy.
• 36% higher prevalence in high level athletes
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Treatment process
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1. Biopsy procedure 2. Scaffold seeded in theatre
3. Arthroscopic Implant 4. Implant completed
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Ortho-ACI® versus 1st generation techniques
Orthocell is a 3rd generation, minimally invasive, cost effective technique delivering superior outcomes for the regeneration of articular cartilage.
EvaluationCriteria
1st
GenerationACI
3rd Generation Ortho-ACI
Minimally invasive
× Requires a large surgical incision× Harvested periosteal flap sutured
over defect to assist in containing cells
Ortho-ACI is delivered arthroscopically Scaffold/cells combined
Control of cell density× Lack of control over cell quantity
delivered to patient
Ortho-ACI is customised per patient delivering a targeted cell quantity a superior outcome
Highest quality outcome× Use of periosteal flap can lead to
post operative complications Seeded collagen used in Ortho-ACI is
proven as safe and well tolerated
Cost effective× High current patient costs × Long operation time
Highly customised Optimised manufacturing Significantly more cost effective
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CelGro®
A true regenerative medicine scaffold Highest quality available Multiple applications
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CelGro®
Regenerative medicine scaffold
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CelGro® is manufactured by Orthocell to augment soft tissue and bone regeneration
A paradigm shift in soft tissue reconstruction
1. Regenerative medicine focus in design and development
2. Highest quality scaffold available that directly meets the requirements of soft tissue reconstruction
3. Versatile platform with applications in bone, tendon, nerve, MATT and others
4. Cell/scaffold combined product
5. Fit for purpose
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CelGro®
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CelGro® is a platform technology with significant competitive advantages
CelGroRegenerative medicine scaffold
Bone Tendon Nerve Cartilage
PipelineLigament replacement – ACL
General Surgery, Urogynaelogical
Superior soft tissue and bone repair qualities
Highest quality raw material globally available
Proven compatibility, pure collagen and acellular
Guided tissue repair / optimal tissue integration and remodelling
High tensile strength
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CelGro®
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Competitors limitations include: not fit for purpose, poor integration and limited application
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How CelGro® works
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1. Smooth layer
Densely packed collagenPassage of fluids
2. Rough layer
Loosely arranged collagenApplied to tissue defect
3. Tissue remodelling
Integration of cellsGuiding high quality tissue regeneration
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CelGro®
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1. Bones loss 2. Bone void filler
3. Apply CelGro 4. Suture gum tissue
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CelGro®
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CelGro®
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1. Rotator cuff injury 2. Stabilisation
3. CelGro fixation 4. Completed surgical repair
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CelGro®
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CelGro®
Pathway to market
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CelGro® first EU approval imminent for guided bone regeneration and soft tissue reconstruction
What does it mean? Authorised to market and distribute in the EU Validates the platform technology Foundation for regulatory applications in other jurisdictions US,
AUS and JP
Near term regulatory targets• EU approval for Dental with regulatory application to follow (US,
AUS & JP)• EU Tendon application with other jurisdictions to follow (US, AUS
& JP)
Strategic Partnering• EU discussion in progress• US and Japan to followF
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Next generation pipeline
Strong product pipeline:
CelGro®
• ACL ligament replacement• collagen powder for bone void fillers
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
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These pipeline products and concepts are early stage opportunities that require further research and development prior commercialisation
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Upcoming Milestones
1. Generating further clinical data• CelGro® - dental study completion and publication submission• CelGro® - interim trial results for tendon, cartilage and nerve studies• Ortho-ATI® v Surgery for tennis elbow interim results• Ortho-ATI® Gluteal Tendon study and Workers Compensation retrospective study
publication
2. Regulatory applications and approvals• CelGro® - EU approval for “Guided Bone Regeneration and Soft Tissue Reconstruction”• CelGro® - Regulatory applications/approvals for Dental, Tendon and Nerve in EU, US,
AUS and JP• Ortho-ATI® – Advance US tendon and ligament application (pre IND meeting)
3. Strategic partnering • CelGro® - EU partner/distributor deal for the Dental application • Ortho-ATI® - US/AUS partnering deal• Ortho-ATI® and Ortho ACI® – Japan partnering/licensing deal
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➢ Superior products
➢ Significant de-risked opportunity
➢ Clear pathway to large markets
➢ Strong partner interest
➢ Expertise to partner and execute
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Investment HighlightsF
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Paul Anderson Managing Director
Advancing tissue repair and regeneration
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