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ORTHOCELL LIMITED — Investor Presentation 2017
Nov 20, 2017
65477_rns_2017-11-20_893e52bd-2ba4-4dbf-82b5-47fae5a6c8cb.pdf
Investor Presentation
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Company Update Presentation
Perth, Australia 21 November 2017: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to release an updated company presentation. The presentation outlines Orthocell’s compelling investment highlights and development and commercialisation strategy and follows the recent receipt of European regulatory approval (CE Mark) for CelGro® for a range of dental bone and soft tissue regeneration procedures.
Investment Highlights:
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Significant upside potential driven by Orthocell’s product portfolio and underpinned by recent transactions in the sector
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Orthocell’s key products address markets worth more than US$10 billion p.a.
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Recently received marketing authorisation of CelGro® collagen scaffold medical device in the European Union (CE Mark) for dental bone and soft tissue reconstructive applications
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CelGro® regulatory approval acts to validate the entire technology platform and can be leveraged for additional indications
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Collaboration with Johnson & Johnson to advance world leading cell therapy for tendon repair
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Substantial clinical data and strong partner interest from large pharmaceutical companies provides derisked investment proposition
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TGA licensed and GMP certified manufacturing capabilities underpin competitive advantage and can be scaled to market demand
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Experienced founders and management team with successful track record developing, commercialising and monetising cell therapy products
Board and Management Commentary:
“We are pleased with the significant progress we have made this year. Orthocell has achieved a number of key milestones and we are now rapidly approaching exciting value inflection points. This includes signing research collaboration agreement with DePuy Synthes Products, part of the Johnson & Johnson Medical Devices Companies for Ortho-ATI®, our stem cell approach for the regeneration of damaged tendon and ligaments. To compliment this, Orthocell’s CelGro® received marketing authorisation (CE Mark) in the EU. The CE Mark allows us to accelerate the commercial rollout of CelGro® in the lucrative dental bone and soft tissue regeneration market and positions Orthocell at the forefront of a large and growing market opportunity. Orthocell is in the midst of an exciting stage of growth and are well positioned to accelerate commercialisation of its regenerative medicine technologies.” said Managing Director of Orthocell, Paul Anderson
Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au
For more information, please contact:
General enquiries
Investor and Media enquiries
Paul Anderson Orthocell, Managing Director
Ben Walsh WE Buchan
P: +61 8 9360 2888 E: [email protected]
P: + 61 411 520 012
About Orthocell Limited
Orthocell is a regenerative medicine company focused on regenerating mobility for patients by developing products for the repair of a variety of tendon, cartilage and soft tissue injuries. Orthocell’s portfolio of products include TGA-licensed cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue. The Company’s other major product is Celgro®, a collagen medical device which facilitates tissue repair and healing in a variety of orthopaedic, reconstructive and surgical applications and is being readied for first regulatory approvals.
For more information on Orthocell, please visit www.orthocell.com.au or follow us on Twitter @Orthocellltd and Linkedin www.linkedin.com/company/orthocell-ltd
Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au
Paul Anderson Managing Director
Investment hi hli hts g g
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Significant upside potential driven by Orthocell’s product portfolio and underpinned by recent transactions in the sector
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Orthocell’s key products address markets worth more than US$10 billion p.a.
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Recently received marketing authorisation of CelGro® collagen scaffold medical device in the European Union (CE Mark) for dental bone and soft tissue reconstructive applications
-
CelGro® regulatory approval acts to validate the entire technology platform and can be leveraged for additional indications
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Collaboration with Johnson & Johnson to advance world leading cell therapy for tendon repair
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Substantial clinical data and strong partner interest from large pharmaceutical companies provides de-risked investment proposition
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TGA[1] licensed and GMP[1] certified manufacturing capabilities underpin competitive advantage and can be scaled to market demand
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Experienced founders and management team with successful track record developing, commercialising and monetising cell therapy products
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TGA: Therapeutic Goods Administration; GMP: Good Manufacturing Practices
Cor orate overview p
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A diversified health care exposure, delivering breakthrough products in regenerative medicine, with treatments along the soft tissue therapy continuum spectrum
Share price performance
Share Price (A$)
Volume (k)
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0.60 3,000
0.50 2,500
0.40 2,000
0.30 1,500
0.20 1,000
0.10 500
- -
Nov-16 Jan-17 Mar-17 May-17 Jul-17 Sep-17 Nov-17
Volume traded (RHS) OCC (LHS)
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Trading information
| Trading information | |
|---|---|
| Share price (17-Nov-17) Shares on issue1 |
A$0.385 101.5m |
| Market capitalisation A$39.1m |
|
| Cash (as at 30-Sep-17) Debt (as at 30-Sep-17) |
A$5.3m2 - |
| Enterprise value A$33.7m |
Top shareholders (as at Aug-17)
| Top shareholders (as at Aug-17) | |
|---|---|
| Stone Ridge Ventures_– Associated with non-executive director_ | 10.0% |
| Ming Hao Zheng_– CSO and founder_ | 6.9% |
| Paul Anderson_– Managing director_ | 6.9% |
| Qi Xiao Zhou_– Non-executive director_ | 5.9% |
| Australian Super_– Superannuation and pension fund_ | 5.6% |
| Jia Xun Xu –Former director | 5.1% |
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Excludes 12.1m unquoted warrants with exercise price $0.58, expiry 19-Nov-2020 and 8.8m unquoted options with exercise prices ranging from $0.50-$0.65 and expiry dates between Nov-2017 and Jun-2020
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Cash figure based on A$3.0m held at 30-Sep-17 and A$2.3m R&D tax incentive cash refund received in Oct-17
Historical develo ment timeline p
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Orthocell is currently at a major inflection point as it accelerates the commercialisation of its key products that have more than 10 years of clinical development and product validation
Pre 2015
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Acquisition of key intellectual property
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Construction and accreditation of GMP laboratory facility
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Relevant ethics approvals received
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Granted TGA licence for manufacturing
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Patent granted for ATI manufacturing and OrthoATI®
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First royalties generated
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Listed on the ASX in Aug 2014
Key clinical milestones achieved
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2015
2016
2017
Mar: Approval received for CelGro® dental study
May: Approval for hip cartilage regeneration study using CelGro®
Jan: Signed research collaboration agreement with DePuy Synthes (J&J)
Apr: Long term study showing Ortho-ATI® effective for tennis elbow published in leading publication
Jun: Early successful results for CelGro® tendon study
Feb: Commenced US FDA application process for CelGro® and early successful results for CelGro® nerve regeneration
Jul: Cell factory for bone and cartilage regeneration validated in leading publication
Jul: Approval received for Ortho-ATI® (vs. Surgery study)
May: Ethics approval received for Depuy Synthes (J&J) Ortho-ATI® Tendon Study
Jul: Grant received for lab grown tendon project
Oct: Approval received for CelGro® nerve regeneration study
Oct: Workers compensation study proves Ortho-ATI® repairs tendon injuries
May: Ortho-ACI® included on the Australian Register of Therapeutic Goods
Nov: Early successful results for CelGro® dental study
Oct: Surgical Specialities appointed as exclusive distributor
Dec: Approval received for CelGro® tendon study
Nov: CelGro® receives marketing authorisation in the European Union (CE Mark)
Since listing, Orthocell has received numerous patents for key products (Ortho-ATI®, CelGro® and ‘Cell Factory’) across key geographic markets (US, Canada, Europe, Australia, NZ, Singapore, China, HK)
Clinical development, product and technology validation and manufacturing optimisation
Execution of commercialisation strategy
Founders stor y
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Founders have extensive commercial and scientific experience in regenerative medicine, having previously demonstrated success in developing, commercialising and exiting cell therapy products with Verigen Australia
Paul Anderson
Managing Director
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20+ years’ experience within the medical device and cellular therapy fields, with intimate knowledge of the regenerative medicine space
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15+ years’ experience in Board and CEO roles, including as the former Managing Director and Executive Director of Verigen Australia, prior to its sale to Genzyme for US$50m in 2005
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Responsible for the introduction of first-generation autologous chondrocyte implantation (ACI) treatments, establishing Verigen’s manufacturing capabilities and key business development
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Key expertise in the development of emerging medical technology business, including extensive experience in:
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Establishing GMP manufacturing facilities for cell therapies
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Commercial scaling activities for cell therapies and biological medical devices, including sales and marketing and business development activities
Professor Ming-Hao Zheng Chief Scientific Officer
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Pathologist and i nventor of the Orthocell’s technologies (Ortho-ATI® and CelGro®) bringing a strong track record of innovation with 15+ years of experience
- Current Director of Research in the Department of Orthopaedic Surgery, School of Surgery and Pathology, University of Western Australia
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Proven ability to transform research into clinical practice – research focused on finding novel approaches in the treatment for osteoporosis, osteoarthritis and tendon injuries using cutting edge cellular and molecular biology techniques
- Has published over 150 papers and holds seven patents in the field of Orthopaedics
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Former CSO of Verigen Australia and led the first TGA approval of the ACI therapy
- Pivotal in establishing Verigen Australia’s clinical GMP laboratory
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Regulatory pathways of key global markets, including USA, Europe and Asia
Regenerative medicine in the musculoskeletal space is one of the most compelling unmet market opportunities, and Orthocell is focused on developing first-in-class solutions for a variety of soft tissue injuries
Orthocell strate gy
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Comprehensive strategy in place across key products to optimise shareholder value
Product development and validation
Commercialisation
Optimised manufacturing
- Own and operate a manufacturing facility which underpins optimised processing
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Key opinion leaders
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Drive adoption of products in key target markets
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Ensure quality manufacturing processes and scalable infrastructure in place
Clinical development
Pathway to market
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Ensure products are fully validated • Domestic: licensing vs. sales force
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• Complete relevant studies for key products • International: develop partnerships vs. (and target applications) distribution model
Regulatory approvals
Applications
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Well defined process to attain regulatory • Initially focused on primary targeted approvals in key target markets applications
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• Australia used as a validation platform • Expansion to other relevant applications in the near to medium term
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• Maintain strong IP protection
Si nificant market o ortunit g pp y
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Orthocell is at the forefront of a large and growing market opportunity in regenerative medicine in the musculoskeletal space where the addressable market is estimated to be in excess of US$10 billion p.a.
Key focus markets
Other addressable markets[3]
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CelGro® Dental [1] Tendon (rotator cuff) [1] Nerve [1]
addressable >US$0.6bn >US$0.9bn >US$1.1bn
markets [2]
~1,500,000 procedures p.a. ~460,000 procedures p.a. ~700,000 procedures p.a.
Ortho-ATI® Tennis elbow [3] Rotator cuff [3] Other indications
addressable >US$4.3bn >US$2.4bn >US$1.0bn
markets
~1,000,000 procedures p.a. ~530,000 procedures p.a. Gluteal, Patellar, Hamstring & Achilles
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Orthocell is focused on addressable markets estimated to be >US$8bn with upside from further expansion into new markets, expansion of key products and development of other pipeline products
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US, Japanese, European and Australian markets
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Analysis of addressable markets excludes the following CelGro® pipeline products including articular cartilage repair, ACL ligament replacement & general surgery
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US, Japanese, European, Australian and New Zealand markets
Ke roducts and i eline overview y p p p
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Solutions for soft tissue injuries and age related loss of function for regeneration of bone, tendon, nerve and cartilage
Soft tissue therapy continuum
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Ortho-ATI®
Regeneration of tendons
Two stage, minimally invasive, walkin & walk-out procedure
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CelGro®
Tissue and bone repair
Off the shelf collagen scaffold to support soft tissue and bone repair
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Cells and growth factors that regenerate Collagen scaffold to support regeneration
Legend: Legend:
Tendon Current
Pre-
Ortho-ATI®
Pipeline Pipeline
surgery
CelGro®
Growth factors
Bone
Ligament
replacement – ACL
Tendon
General surgery –
Ortho-ATI®
Surgery Hernia repair
Nerve
Urogynecology –
Prolapse repair
Lab grown tendon Cartilage
and MATT [1]
Post
Ortho-ATI [®]
surgery
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- MATT: a combination product of CelGro® seeded with cells
Ke roduct ortfolio y p p
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Diversified multi-product portfolio with exciting R&D development pipeline
| Diversified health care |
Products | Key focus | Applications | Stages of development | Stages of development | Stages of development | Upcoming Milestones |
Comments |
|---|---|---|---|---|---|---|---|---|
| Discovery | Pre-clinical | Clinical | ||||||
| CelGro® | Biological medical device for soft tissue reconstruction & repair |
Dental | 1Q CY2018 EU KOL1 engagement; EU distribution negotiations; establish CoE1, continue approval process (US, Aus, other) |
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| Pure collagen medical device |
||||||||
| Orthopaedic: rotator cuff tendon, nerve & cartilage |
1H CY2019 Leverage CE Mark dental approval for EU market entry Commence US approval process |
|||||||
| ACL ligament replacement | 1H CY2018 In development, further pre-clinical animal studies to commence in 1H CY2018 |
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| Ortho- ATI® |
Tendon regeneration | Tennis elbow, gluteal, patella, Achilles & rotator cuff |
1H CY2018 Completion of recruitment to J&J Ortho-ATI trial |
|||||
| Cell based therapies |
Ortho- ACI® |
Cartilage regeneration | Knee & ankle cartilage repair | 2H CY2018 Optimise value opportunity through strategic partnerships in targeted regions |
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| R&D pipeline |
“Off-the shelf” tissue repair therapies |
Growth factors | 1H CY2018 In development, further pre-clinical animal studies to commence in 1H CY2018 |
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| Allogenic tendon repair | Lab grown tendon | 1H CY2018 In development, further pre-clinical animal studies to commence in 1H CY2018 |
Proven and logical clinical development strategy, grounded on an evidence-based translational programme to deliver cost effective treatments that transform patients lives
- KOL: key opinion leader; CoE: centres of excellence
CelGro[®] - Product overview
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A superior medical device designed for soft tissue repair, expected to be approved in the near-term for marketing and distribution within the European Union for dental applications
What is CelGro[®]
CelGro[® ] - a versatile collagen-based scaffold
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CelGro® is a medical scaffold comprised entirely of natural collagen
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Medical scaffolds are analogous to construction scaffolds in that they provide integral support to the soft tissue whilst its undergoes repair
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Collagen medical scaffolds are widely used to augment the surgical repair of soft tissue and bone
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CelGro [®]
Regenerative medicine scaffold
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A key advantage of CelGro® over other scaffolds is that it integrates with the soft tissue under repair and also degrades at the same rate as the body heals
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Manufactured inhouse by Orthocell at a quality controlled (GMP) facility in Western Australia, using proprietary SMRT[TM] tissue engineering process[1]
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Recently received CE mark approval for dental application
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Submitted for regulatory approval (dental application)
Existing Applications
Pipeline
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Ligament
Bone Tendon Neurological Cartilage replacement
– e.g. ACL surgery
Provides a nerve
General surgical
Provide a barrier to Augments surgical conduit to Augment surgical – e.g. hernia repair
allow bone growth repair of the augment the
repair of articular
during dental rotator cuff tendon surgical repair of
cartilage
implant treatment in the shoulder peripheral nerve Urogynaelogical
injuries
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- US: FDA 510(k) – approval expected in 2H CY2018
CelGro[®] - Platform technology
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CelGro[®] is a platform technology that supports tissue growth and enables rapid repair, it has demonstrated clinical efficacy and has a clear path to market across multiple applications
Multiple applications
Bone
e.g. Dental surgery
Tendon e.g. Orthopaedic surgery
Neurological
e.g. Peripheral nerve repair
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1. Defect Site
Insufficient bone volume to anchor the dental implant
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1. Tendon Tear
Tendon detached from bone and retracted at tear site
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1. Peripheral Nerve Injury
Nerve severed and ends retracted into wound after traumatic injury to limb
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2. Bone Graft
Defect site filled with bone grafting material
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2. Preparation of Repair Site
Torn tendon trimmed and sutures anchored in healthy bone
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2. Preparation of Repair Site
Nerve ends located and brought to repair site without tension
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3. Apply CelGro®
Customised to size and placed over defect site to contain graft, ‘guiding’ bone regeneration
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3. Apply CelGro®
Customised to size and placed over repair site to promote tendon healing
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3. Microsurgical Repair with CelGro® CelGro® secured around nerve ends, forming a sealed conduit
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4. Implant Crown
Gum tissue stitched over CelGro® and Crown secured
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4. Reattachment
Tendon and CelGro® secured in place with sutures
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4. Nerve Healing
Conduit protects nerve ends and enhances regeneration
CelGro[®] - Ke advanta es y g
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CelGro® boasts superior tissue repair qualities and can be customised to accommodate the specific needs of tissue repair in multiple applications, making it the best in class bioderived scaffold on the market
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Orthocell’s proprietary SMRT[TM] manufacturing process method produces collagen scaffolds with numerous competitive advantages over existing tissue repair scaffolds, particularly in the areas of compatibility, tensile strength, promotion of quality tissue repair and versatility
| Key advantages | Dental | Dental | Dental | Tendon | Tendon | Nerve | Nerve | Comments | |||
|---|---|---|---|---|---|---|---|---|---|---|---|
| Biogide® | BioMed Extend® |
GraftJacket® | Tissuemend® | AxoGuard® | Nueroflex® | ||||||
| Proven compatibility | | +/- | +/- +/- |
+/- +/- SMRTTMprocess removes all DNA and other tissue components, collagen scaffold isbiocompatible and naturally degradesafter implantation at the same rate as the body heals |
|||||||
| Strong mechanical properties |
+/- | | |
No cross-linking or artificial additives required to boost strength of intact collagen fibres.CelGro® is easy to use, ductile and very strong |
|||||||
| Quality of tissue repair (Native bilayer structure) |
| x | x x |
x x Preservation of the natural collagen structure from the source material promotes healing and regeneration.CelGro® integrates with the soft tissue under repairleaving no remnant material to scar or cause inflammation |
|||||||
| Versatile/customisable to multiple applications |
x | x | x x |
x x Easily customisable, withmultiple applicationsand the ability to be used on its own in surgical repair, or in combination with stem cells and other drugs |
Biogide® currently generates €50m p.a. in dental bone graft sales in the EU alone – CelGro® has been proven, through clinical studies, to produce superior bone regeneration
+/- No clinical data available to support characteristic required for optimal tissue repair
CelGro[®] - Pathwa to market y
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Having received CE Mark approval for dental bone repair, CelGro® can be marketed and sold within the European Union while continuing to expand into other orthopaedic applications
Indicative commercialisation pathway (calendar year basis)
- The CE Mark approval, for the initial application of CelGro® in dental bone applications, validates the entire technology platform
| 3Q17 | 4Q17 | 1Q18 | 2Q18 | 2H18 | |
|---|---|---|---|---|---|
| Completion of clinical study in dental bone procedures | |||||
| CE Mark approval (dental) | |||||
| Dental distribution negotiations (EU, UK and other) | |||||
| US and Australia market authorisation (dental) | |||||
| Completion of orthopaedic market entry studies | |||||
| Strategic partnership discussions for orthopaedic applications |
| 3Q17 | 4Q17 | 1Q18 | 2Q18 | 2H18 | |
|---|---|---|---|---|---|
| Completion of clinical study in dental bone procedures | |||||
| CE Mark approval (dental) | |||||
| Dental distribution negotiations (EU, UK and other) | |||||
| US and Australia market authorisation (dental) | |||||
| Completion of orthopaedic market entry studies | |||||
| Strategic partnership discussions for orthopaedic applications |
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Endorses the clinical performance of CelGro®, quality of Orthocell’s manufacturing standards, and provides a strong foundation for regulatory approval in USA, Australia and Japan
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Orthocell can now leverage the dental CE Mark to get CelGro®’s other orthopaedic applications to market, once clinical efficacy is established through comparative trials
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Key milestones
- Orthocell is actively engaging Brand Ambassadors and Key Opinion Leaders, who will be critical to drive mass market adoption
Scalable technology platform with multiple applications
| Multiple application | Stage of development | Upcoming milestones |
|---|---|---|
| Dental bone repair | Commercialisation | KOL engagement & Distribution negotiations: 1Q CY2018 |
| Cartilage applications | Clinical | Recruitment complete: 2Q CY2018 |
| Tendon (rotator cuff) | Clinical | Interim results: 1Q CY2018 Recruitment complete: 2H CY2018 |
| Nerve applications | Clinical | Recruitment complete: 2Q CY2018 |
| ACL ligament replacement | Pre-clinical | ACL replacement in animals: 2Q CY2018 |
-
Extensive validation already achieved to date:
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Testimonial: Dr Brent Allan (Oral & Maxillofacial surgeon) – “ I prefer to use CelGro® over existing scaffolds… It’s easy to handle and enables a high quality tissue repair ”
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Currently in discussions with a number of potential strategic commercial partners for product licensing and distribution in both Europe and other regions
Ortho-ATI[® ] - Product overview
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Ortho-ATI® is a world leading breakthrough in regenerative medicine – a novel, stem cell therapy developed to treat chronic degenerative tendon injuries (tendinopathy/tendonitis), it can be utilised in both surgical and non-surgical applications What is Ortho-ATI[®]
Multiple tendon applications (common injuries)
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Orthocell’s current focus
Rotator cuff Quadriceps tendon
Tennis elbow
Patellar tendon
Flexor/Extensor ligament
Achilles tendon
Gluteal tendon (hip)
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Enables the accelerated regeneration of injured tendons, by replenishing degenerative tissue with healthy mature tendon cells (known as tenocytes)
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Safe and minimally invasive procedure for patients who fail to respond to conservative treatments (e.g. physiotherapy, Platelet Rich Plasma injection (PRP) or corticosteroids)
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Extensive clinical validation with over 450 patient implants with Ortho-ATI[®] to date
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Published clinical data, up to 5 years post treatment, clearly demonstrating durability and efficacy as the leading tendon regeneration treatment
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Tennis elbow study : 207.6% increase in grip strength (data to 4.5 years post treatment recently published in American Journal Sports Medicine)
Two stage, minimally invasive, walk-in & walk-out procedure
1. Biopsy procedure 2. Tenocyte (cell) cultivation 3. Tenocyte (cell) implantation
- Gluteal tendon study: 148.1% increase in quality of life (data to 2 years post treatment; recently submitted for publication)
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Manufactured inhouse at Orthocell’s GMP-certified laboratory facility in Western Australia with TGA-approved quality systems
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Collaboration agreement established with DePuy Synthes Products, a subsidiary of the global pharmaceutical company Johnson & Johnson (NYSE:JNJ, market capitalisation: US$373.1bn) to jointly develop the novel regenerative tendon treatment
Healthy tendon cells removed Healthy cells grown at Ultrasound guided via minimally invasive procedure Orthocell’s laboratory implementation of healthy cells
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4-5 week end-to-end process
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- Ortho-ATI[®] Key advantages (vs. traditional therapies)
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Ortho-ATI[®] is the preferred therapy for degenerative tendon repair because it addresses the underlying pathology, is minimally invasive, cost effective with long term clinical data
Comparative advantages to traditional therapies
-
Traditional therapies only address the symptoms of tendinopathy (pain, immobility and stiffness), thus have limited long-term efficacy
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• PRP : associated with symptomatic relief, but has inconsistent outcomes and duration of effect is not long-lasting
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Corticosteroids: reduces pain but weakens tendon structure long term (especially if repeated)
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• Surgery : invasive, expensive, requires lengthy rehabilitation and increases economic burden on the healthcare system; patients cannot return to work / sport for months after treatment
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Rest, physiotherapy and injections: ineffective in the degenerative injury phase (more suited to acute injury)
| Tenocytes (Ortho-ATI®) |
PRP | Corticosteroids | Surgery | |
|---|---|---|---|---|
| Minimally invasive | | | | |
| Long term durability | | +/- | | +/- |
| Safe | | | +/- | +/- |
| Cost effective | | +/- | +/- | |
| Addresses underlying pathology |
| | | |
+/- No clinical data available to support characteristic required for optimal tissue repair
- Ortho-ATI[®] Key advantages (vs. stem cell technologies)
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Ortho-ATI[®] is the only clinically proven stem cell therapy that addresses the underlying pathology of tendon damage facilitating tendon regeneration
| • Stem cell therapiesaim to address the underlying cause of a disease/condition —Tenocytes (Ortho-ATI®) are the only clinically proven stem cell therapy that address the underlying cause of tendinopathy and repair the tendon • Ortho-ATI® is significantly ahead of the competition and cannot be easily replicated —Patent protected in major global jurisdictions, including USA, China, Singapore, Hong Kong and New Zealand —Optimised manufacturingprocesses —Extensive dataon purity, potency and identity of cell therapy Market positioning against alternative stem cell technologies |
Tenocytes (Ortho-ATI®) Dermal fibroblasts Embryonic stem cells MSC (umbilical cord)3 MSC (other3) |
|---|---|
| Homologous1 |
|
| Autologous2 |
|
| Proven efficacy ? ? ? ? |
|
| Proven durability ? ? ? ? |
|
| Commercially available |
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Homologous: the treatment of a recipient’s cells or tissues with cells that performs the same basic function or functions in the recipient as in the donor
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Autologous: undifferentiated treatment cells are obtained from the same injured individual into whom they are reimplanted as part of the treatment
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MSC: mesenchymal stem cells; ‘Other’ refers to MSC for blood, fat and bone marrow
- Ortho-ATI[®] Path to market
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Market leading product with a validated pathway and attracting the attention of large global partners
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Clinical validation – Over 450 patient implants with Ortho-ATI[®] –
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Optimise manufacturing capability GMP-certified/TGA licensed facility
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Treatment pathway validated Australian Key Opinion Leader network established and
-
already referring patients for treatment –
-
Establish a project partner Collaboration agreement with Johnson & Johnson (J&J)
Target prospective licensing partners and key opinion leaders Attain regulatory approval in key markets
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-
Collaboration agreement signed in January 2017
-
Co-funded study commenced in May 2017 , designed to support a US pivotal study
-
30 patient, randomised, controlled study comparing Ortho-ATI® to corticosteroid injection for the treatment of rotator cuff tendinopathy
-
Trial led by Professor Allan Wang, President of Australian Elbow and Shoulder Society
-
Ortho-ATI[® ] is a market leading therapy and would be highly complimentary to DePuy Synthes’ comprehensive portfolio of orthopedic and neuro products, as well as musculoskeletal, reconstructive and therapeutic services
Indicative commercialisation pathway (calendar year basis)
| 4Q17 | 1Q18 | 2Q18 | 2H18 | 1H19 | |
|---|---|---|---|---|---|
| Pre Investigation New Drug meeting with FDA | |||||
| Discussion on distribution / licensing agreements (AUS) | |||||
| J&J rotator cuff clinical trial recruitment | |||||
| Workers compensation study publication | |||||
| Ortho-ATI® vs. surgery trial recruitment | |||||
| J&J rotator cuff clinical trial interim results analysis | |||||
| Potential USA / Australian licensing agreement | |||||
| Key milestones |
Targeting key global markets
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- In advanced discussions with a potential Japanese distribution partner to leverage abridged approval process
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- In advanced discussions with potential US & EU distribution partners
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-
Australia has been used as the platform for clinical validation
-
Small internal sales team; leverage other distribution partnerships
Key milestones
Ortho-ATI[® ] - Develo ment athwa p p y
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Orthocell is currently focused on completing current clinical studies and continuing strategic discussions
Ortho-ATI[® ] development pathway
Development pathway overview
Stage Purpose Discovery / preclinical testing Discovery / Discovery of an unmet clinical need preclinical Completed preclinical testing testing
- Ortho-ATI® is substantially **de-risked** from an evidence and manufacturing based perspective – Australia used as a validation platform
- 6 key clinical studies completed and 5 years of post-treatment clinical data collected
-
Safety & tolerability
-
Efficacy – comparison to existing market interventions
-
Clinical trials Pre-IND meeting with the FDA to confirm approval trial clinical requirements
-
Approval trial – in-country trial for US regulatory approval
Regulatory Regulatory approval (FDA and/or CE mark) registration
-
Placebo controlled testing is not required due to significant ethical issues in conducting a placebo treatment on patients at the end of the treatment spectrum
-
Efficacy established through clinical trials followed by post market surveillance
-
Post the current clinical trial being undertaken with J&J, Orthocell (and/or J&J) will complete a market entry designed study
Monitoring Post market – monitoring of intervention effectiveness
The Orthocell and J&J collaboration significantly de-risks the development of Ortho-ATI[®]
Ortho-ACI[®] and R&D i eline p p
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Orthocell is undertaking a “capital light” approach to commercialising Ortho-ACI® and developing other pipeline products which represent exciting potential value upside within the regenerative medicine space
Orthocell’s foundation product
Significant market opportunity
Significant commercial appeal expected in “off the shelf” products
Ortho-ACI®
CelGro® pipeline
Growth factors
Lab grown tendons
Marketable cartilage repair and regeneration therapy
-
3rd generation product
-
>380 patient implants to date
-
Included on the Australian Register of Therapeutic Goods,
-
enabling the commencement of the process for reimbursement
-
Cost effective treatment with potential for multiple applications
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Ortho-ACI® procedure
----- End of picture text -----
Potential for innovative platform technology solutions
-
ACL ligament replacement: commence clinical study; positive results from initial animal study (recently completed)
-
Other potential applications: General surgery, Urogynaelogical, Collagen powder (for bone void fillers)
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ACL ligament replacement
----- End of picture text -----
Leverage existing knowledge towards human clinical trials
-
Cell factory-derived tissue specific growth factors to augment bone, cartilage and tendon repair
-
Part of successful international collaboration[2 ] – multiple animal studies completed and published
-
“Cell Factory” patents granted in key jurisdictions (USA and Europe)
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Lab grown tendon
Next generation product to complement Ortho-ATI®
-
Successfully manufactured human tendon in a laboratory
-
Ongoing collaboration with academic researchers[1 ] (received ARC linkage grant )
-
Significant unmet patient needs and multiple applications (i.e. hand, shoulder and hamstring)
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Growth factor samples
-
Successful collaboration with Griffith University; University of Western Australia; La Trobe University; and University of Auckland
-
Successful collaboration with Lund University (Sweden); University of Western Australia; Indian Institute of Technology Kanpur (India)
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Vericel case stud hi hli hts Orthocell’s valuable ortfolio y g g p
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Significant upside potential exists for Orthocell’s product portfolio which addresses a range of tendon, cartilage and soft tissue injuries
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-
Vericel is a US company that develops, manufactures, and markets two autologous cell therapies:
-
Epicel®: cultured epidermal autografts
-
MACI®: autologous chondrocytes on porcine collagen membrane
-
MACI® was the first FDA approved product to grow cells on scaffolds using healthy cartilage tissue from the patient’s own knee
| Orthocell Vericel Commentary |
Orthocell Vericel Commentary |
Orthocell Vericel Commentary |
|---|---|---|
| ACI stem-cell product (cartilage focus) |
| MACI® is Vericel’s commercialised ACI product for knee, Ortho-ACI® is the next generation of this technology |
| ATI stem-cell product (tendon focus) |
| x Orthocell’s Ortho-ATI® in clinical stage, collaboration discussions with Johnson & Johnsonexpected to commence 1H CY2019 |
| Platform technology (Collagen medical device for multiple uses) |
| x CelGro® has received EU regulatory approval and serves as aplatformfor developing future approaches to soft tissue repair |
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Upside
Vericel’s market capitalisation (US$m)
potential
200
Jun 2014June 2014 Mar 2015March 2015 December 2016Dec 2016
Aastrom (now Vericel) obtains commercial obtains rights Vericel MACI Phase follow up results from Vericel reports 3-year Positive MACI attains FDA approval; 70% MACI FDA approval;
150 rights to MACIto MACI III trial results Phase III SUMMIT share price increasestock up + 70%
extension study of MACI
100
50
Orthocell’s market capitalisation
-
Jan-14 May-14 Sep-14 Jan-15 May-15 Sep-15 Jan-16 May-16 Sep-16 Jan-17 May-17 Sep-17
----- End of picture text -----
Vericel’s market capitalisation (US$m)
-
Orthocell has a superior 3[rd] generation ACI product for cartilage repair
-
Orthocell also has the world’s first cell therapy for tendon repair – a much larger addressable market than cartilage
-
Orthocell also CelGro® which address unmet needs in multi-billion dollar markets
-
Significant upside potential exists considering Orthocell’s diversified multiproduct portfolio of cell therapies and regenerative medicine products
U side otential under inned b recent transactions p p p y
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Significant upside potential in Orthocell based on recent transactions executed in the regenerative medicine and medical scaffold sectors
| Deal date Deal type Licensee/ Acquirer Licensor/ Target Phase Transaction value1 Dec 16 Corporate Commercial May 12 Corporate Commercial Jan 14 Asset Commercial Oct 17 Corporate Commercial Mar 15 Corporate Commercial Jul 15 Corporate Phase II Apr 15 Strategic ownership stake / asset rights Multiple in Phase III Jan 17 Strategic ownership stake / asset option Phase I Dec 16 Licensing (Japanese market) Completed Phase I US$0.3bn US$0.3bn US$0.2bn US$0.3bn US$0.4bn Medical scaffold transactions Regenerative medicine transactions Japanese cell therapy licensing US$2.9bn US$45m US$51m US$17m |
Deal date Deal type Licensee/ Acquirer Licensor/ Target Phase Transaction value1 Dec 16 Corporate Commercial May 12 Corporate Commercial Jan 14 Asset Commercial Oct 17 Corporate Commercial Mar 15 Corporate Commercial Jul 15 Corporate Phase II Apr 15 Strategic ownership stake / asset rights Multiple in Phase III Jan 17 Strategic ownership stake / asset option Phase I Dec 16 Licensing (Japanese market) Completed Phase I US$0.3bn US$0.3bn US$0.2bn US$0.3bn US$0.4bn Medical scaffold transactions Regenerative medicine transactions Japanese cell therapy licensing US$2.9bn US$45m US$51m US$17m |
Deal date Deal type Licensee/ Acquirer Licensor/ Target Phase Transaction value1 Dec 16 Corporate Commercial May 12 Corporate Commercial Jan 14 Asset Commercial Oct 17 Corporate Commercial Mar 15 Corporate Commercial Jul 15 Corporate Phase II Apr 15 Strategic ownership stake / asset rights Multiple in Phase III Jan 17 Strategic ownership stake / asset option Phase I Dec 16 Licensing (Japanese market) Completed Phase I US$0.3bn US$0.3bn US$0.2bn US$0.3bn US$0.4bn Medical scaffold transactions Regenerative medicine transactions Japanese cell therapy licensing US$2.9bn US$45m US$51m US$17m |
Deal date Deal type Licensee/ Acquirer Licensor/ Target Phase Transaction value1 Dec 16 Corporate Commercial May 12 Corporate Commercial Jan 14 Asset Commercial Oct 17 Corporate Commercial Mar 15 Corporate Commercial Jul 15 Corporate Phase II Apr 15 Strategic ownership stake / asset rights Multiple in Phase III Jan 17 Strategic ownership stake / asset option Phase I Dec 16 Licensing (Japanese market) Completed Phase I US$0.3bn US$0.3bn US$0.2bn US$0.3bn US$0.4bn Medical scaffold transactions Regenerative medicine transactions Japanese cell therapy licensing US$2.9bn US$45m US$51m US$17m |
|---|---|---|---|
| Dec 16 Corporate Commercial |
|||
| US$2.9bn | |||
| US$0.3bn US$0.3bn US$0.2bn US$0.3bn US$0.4bn tr R t Ja US$45m US$51m S$17m |
|||
| May 12 Corporate Commercial |
|||
| Jan 14 Asset Commercial |
|||
| Oct 17 Corporate Commercial |
|||
| Mar 15 Corporate Commercial |
|||
| Jul 15 Corporate Phase II |
|||
| Apr 15 Strategic ownership stake / asset rights Multiple in Phase III |
|||
| Jan 17 Strategic ownership stake / asset option Phase I |
|||
| Dec 16 Licensing (Japanese market) Completed Phase I |
U |
Orthocell market capitalisation
- Transaction value is the estimated transaction value based on the combination of cash and/or script consideration, upfront payments and any milestone payments agreed upon
Rotation Medical case stud y
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The recent US$210m acquisition of Rotation Medical, by Smith & Nephew, demonstrates significant upside potential for Orthocell in the regenerative medicine space
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-
In October 2017, Smith & Nephew announced they would acquire Rotation Medical for up to US$210m
-
US$125m upfront, US$85m in instalments over 5 years (subject to financial milestones)
-
Smith & Nephew (LON:SN, Market Cap: £11.8bn) is a multinational medical equipment and technology company
-
Rotation Medical is a private medical scaffold company focused on rotator cuff repair
-
Its Rotator Cuff Repair System is a collagen-based bioinductive implant derived from bovine tendon
-
Implant has been shown to heal rotator cuff tendon by inducing the growth of new tendon-like tissue
-
Commercially available having earnt FDA 510(k) clearance in 2014 for sale in the US, with a filing being prepared for EU approval
-
Rotation
-
Orthocell Commentary Medical • Orthocell’s CelGro® is a biological medical scaffold to augment the
-
Tendon regenerative • surgical repair of damaged tendonsRotation Medical is focused on developing a medical scaffold for therapy rotator cuff tendon repair
-
• Orthocell’s CelGro® is easily customisable with multiple applications
-
Platform (i.e. bone, tendon, nerve and cartilage)
-
technology • Rotational Medical’s medical scaffold is only focused on a single application (i.e. rotator cuff tendon)
-
• Orthocell’s product portfolio includes CelGro®, Ortho-ATI® and Ortho-
-
Multiple ACI and multiple pipeline products
-
products • Rotation Medical only has one product in its portfolio • Orthocell’s CelGro® is approved in EU and Ortho-ACI® is approved in
-
Global regulatory • Australia Rotation Medical received FDA clearance for sales in the US and are approval preparing for EU approval
U comin catal sts p g y
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Significant operational milestones expected over the next year as Orthocell continues to develop its product portfolio
| 2017 | 2018 onwards | |
|---|---|---|
| CelGro® | • Dental study completion and publication submission • Explore strategic partnerships and distribution opportunities (i.e. EU partner/distributor for dental application) • Recognition of (dental) CE Mark in Hong Kong and Taiwan • Complete other (dental) regulatory applications (i.e. US and Australia) • Interim trial results for tendon, cartilage and nerve studies • Commence market entry studies (dental, tendon and nerve) for US and Australia • Progress regulatory applications for tendon and nerve in Europe, US and Australia • Explore strategic partnerships and distribution opportunities |
|
| Ortho-ATI® | • Advance US tendon and ligament regulatory process • Explore commercialisation and distribution opportunities (US and Japan) • Collaborative J&J rotator cuff study – interim results • Ortho-ATI® vs. surgery for tennis elbow – interim results • Publish worker compensation retrospective study • Explore commercialisation and distribution opportunities (US and Japan) • Progress key market regulatory approval submissions |
|
| Ortho-ACI® | • Explore commercialisation and distribution opportunities (US and Japan) • Explore commercialisation and distribution opportunities (US and Japan) |
Appendix Board of Directors, IP portfolio and further product slides
Board of Directors
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Dr Stewart James Washer
Chairman
-
20 years’ CEO and board experience in medical technology, biotech and agri-food companies
-
Executive Director of Zelda Therapeutics (ASX:ZLD) and Minomic International, Director of Cynata (ASX:CYP)
-
Previous Board positions include Chairman of Hatchtech Pty Ltd that was sold in 2015 for A$279m and was a Director of iCeutica that was sold to a US Pharma. He was also a Senator with Murdoch University and was a Director of AusBiotech Ltd
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Paul Anderson
Managing Director
-
20 years’ experience in medical device and cellular therapeutic fields, with intimate knowledge of regenerative medicine
-
Expertise in commercialising emerging R&D technologies and in the establishment of GMP manufacturing facilities
-
15 years’ experience in CEO and board roles, including as former MD of Verigen Australia, the developer of the 1[st] generation ACI treatment
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Matthew Callahan
Non-Executive Director
-
20 years’ legal, IP and investment management experience
-
Developed 3 FDA approved products
-
Founding CEO of iCeutica and Churchill Pharmaceuticals
-
Investment Director at 2 venture capital firms
-
Current Executive Director of Botanix Pharmaceuticals (ASX:BOT)
-
Co-founding director of Orthocell and led initial VC investment
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Professor Lars Lidgren
Board Member
-
Professor in Orthopaedics at the University Hospital of Lund
-
Leads a productive regenerative medicine research group at the University Hospital of Lund
-
Founded multiple biotechnology companies (Scandimed, Bone Support, AMeC and GWS)
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Mr Qi Xiao Zhou
Board Member
-
15 years’ experience in China as a senior business manager and executive
-
General Manager of Shenzhen Lightning Digital Technology
-
Experience within public markets of Hong Kong, China and Taiwan
-
Business management and development experience in Asia
Commercialisation Regenerative medicine IP management Regulatory and clinical Corporate Manufacturing
Corporate Regulatory and clinical IP and legal
Regenerative medicine Corporate Research & development Commercial
Executive Mana ement Team g
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Professor M.H. Zheng Chief Scientific Officer
-
Inventor of the Orthocell technology with a strong track record of innovation
-
Director of Research in the Department of Orthopaedic Surgery at the University of WA
-
Research focus on new treatment methods for osteoporosis, osteoarthritis and tendon injuries using cellular and molecular biology techniques
-
Ph.D., Doctor of Medicine and Fellow of the Royal College of Pathologists
Alexander McHenry Chief Operating Officer
-
Over 14 years of experience in corporate advisory and management consulting
-
Background in the implementation of corporate transaction and business transformation initiatives
-
Master of Business Administration from The University of Western Australia
-
Former senior manager of the strategy and operations division of Deloitte, Perth WA
Nicole Telford Chief Financial Officer
-
Chartered accountant with over 14 years’ commercial experience in financial controller and group accountant roles
-
Background of broad commercial experience in financial and management reporting, office administration and staff management
-
Achieved professional qualifications whilst employed with Arthur Andersen in the audit division
Gregor Maier Sales & Marketing Director
Dr Clair Lee Clinical Research Manager
Monique Cannon Quality Director
-
Over 14 years’ commercial experience in the pharmaceutical and surgical industries having previously worked in the UK, EU, Malaysia and South Africa
-
Oversaw successful launch of Ortho-ATI® and Ortho-AC® launch into Hong Kong, NZ and Singapore markets
-
Wealth of senior management experience following key management roles in Malaysia and South Africa
-
Clinical research professional with over 17 years of experience in pharmaceutical and medical device clinical trials
-
Specialist in translation of basic scientific research into clinical trial and regulatory application strategies
Ph.D. in Cell Biology from the University of WA
-
Former Program Manager and Faculty Member at Telethon Kids Institute, Perth WA
Background includes research in cellular development and differentiation, with significant experience in cell culture
- Previous role in the GMP-compliant manufacture of an autologous cell-based therapeutic product
Over 14years experience in coordination of qualification systems, quality system management, and significant regulatory experience (ISO, TGA, FDA)
IP ortfolio and strate p gy
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Orthocell has protected its suite of development products through various patents granted across major jurisdictions, with further applications awaiting grant
Overview
Patents granted in major global jurisdictions
-
Orthocell is focused on maintaining patent protection for its leading manufacturing technologies and treatment processes
-
Orthocell maintains an active program of patenting, with ownership of 27 granted patents across the Ortho-ATI®, Ortho-ACI® and CelGro® technologies, and related methods of treatment and manufacturing
-
Patents granted and applications also cover pipeline products such as the ‘Cell Factory’ technologies and ‘Sutureless Repair of Soft Tissue”
-
Orthocell currently has 31 patent applications across 7 different patent families
-
Patent protection is targeted at major jurisdictions across Australia, Asia, Europe and North America, which represent key regions where Orthocell is targeting regulatory approval
Patents granted
CelGro[® ] - Clinical trials com leted & in ro ress p p g
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Orthocell’s clinical development strategy is designed to increase the probability of achieving regulatory approvals, with significant levels of clinical validation achieved, and optimised manufacturing capabilities in place
| Study ID | Description | No. of subjects | Treatment site | Duration (months) | Outcome Measures | Study status |
|---|---|---|---|---|---|---|
| CG-002 | Study of CelGro for dental guided bone regeneration around dental implants |
10 | Dental | 6 | • Bone regeneration |
Unpublished |
| CG-004 | Study of CelGro to augment surgical repair of rotator cuff tendinopathy and tear |
30 | Shoulder | 12 | • Improvement in pain and function of shoulder • Quality of life • Measurement of tendon healing by MRI |
Recruiting patients |
| CG-005 | Treatment of hip cartilage defects with microfracture and CelGro |
25 | Hip | 12 | • Improvement in pain and function of hip • Return to sporting activities • Quality of life |
Recruiting patients |
| CG-006 | Surgical repair of peripheral nerve injury with CelGro |
20 | Upper limb | 24 | • Improvement in pain and function of arm/hand • Recovery of nerve function (sensory and motor) • Quality of life |
Recruiting patients |
| CG-007 | Study of CelGro to augment arthroscopic repair of rotator cuff tendinopathy and tear |
30 | Shoulder | 12 | • Improvement in pain and function of shoulder • Quality of life • Measurement of tendon healing by MRI |
Awaiting ethical approval |
Ortho-ATI[® ] - Clinical studies com leted to date p
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Ortho-ATI[®] has been significantly de-risked from an evidence based perspective, with clinical efficacy having been demonstrated through numerous clinical trials
• NOTE: Patients involved in clinical trials had failed all other treatment alternatives (e.g. physiotherapy, at least 1 corticosteroid injection)
| Study ID | Description | Implant site |
Duration (months) |
Avg. symptom duration (months) |
Key outcomes | Publication status |
|---|---|---|---|---|---|---|
| ATI-001 | Pilot study of Ortho-ATI® in severe, chronic, resistant lateral epicondylitis_(tennis elbow)_ |
Lateral epicondyle (elbow) |
60 | 31 | • MRI studies showed tendon regeneration at 12 months, sustained to 4.5 years • +207% ingripstrengthpost treatment |
6 month data abstract 1 year data published 4.5 year data published |
| ATI-002 | Pilot study of Ortho-ATI® in gluteal tendinopathy_(hips)_ |
Gluteal tendon (hip) |
24 | 33 | • Significant clinical improvement in pain and function scores at 24 months • Nopersistent complications fromprocedure |
Published |
| ATI Case Study 1 |
Novel treatment for partial-thickness rotator cuff tear and tendinopathy in an elite athlete |
Rotator cuff (shoulder) |
10 | 12 | • Substantial improvement in pain and function • MRI studies showed complete resolution of tendon tear • Elite athlete was able to return to national-level competition after treatment |
Published |
| ATI Case Study 3 |
A novel treatment for recalcitrant patellar tendinopathy |
Patellar tendon (knee) |
9 | 10 | • Patient able to return to heavy manual labour job after treatment • MRI scans taken at 6 months after treatment showed resolution of tendinopathy |
Unpublished |
| ATI Case Study 2 |
Treatment resistant tendinopathy of the patellar tendon |
Patellar tendon (knee) |
5 | 24 | • Improvement in knee function and pain observed after 5 months • MRI studies at 5 months showed significant reduction in tendinopathyand size of tendon tear |
Unpublished |
| Retrospective Study |
Ortho-ATI® for the treatment of compensating occupationally related later epicondylitis: A Retrospective Case Study |
Lateral epicondyle (elbow) |
Various | 22 | • ↓ pain in the affected limb by ~90% at rest and ~54% with usage at time of assessment • 88% ofpatients were able to return to work |
Unpublished |
Ortho-ACI[®] - Product overview
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Gold standard Autologous Chondrocyte Implantation which offers a customised approach to treat articulating cartilage defects
-
Articular cartilage provides a smooth, lubricated surface for low friction movement of joints
-
Defects in cartilage occurs through injury or wear and tear and leads to increasing joint pain and impaired mobility
-
Unlike other tissues, cartilage fails to repair itself effectively
-
Ortho-ACI® leverages autologous and homologous cell therapy to regenerate cartilage
-
Market for cartilage repair is large and growing
-
Approximately 900,000 people develop cartilage disease each year in the US alone
-
60% of the 70,000 arthroscopies conducted in Australia are estimated to be due to localised loss of cartilage
-
Over 380 patient implants have been treated with Ortho-ACI® to date in Australia, Hong Kong and Singapore
-
Having already received Australian approval for manufacturing and marketing, a low capital approach will be used to commercialise Ortho-ACI® globally
Ortho-ACI® utilises a two-stage surgical process to treat symptomatic defects of articulating cartilage
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----- Start of picture text -----
Chrondrocytes are
1 2 After debridement and
isolated from healthy
cleaning of the cartilage
cartilage collected from
defect site, scaffold is
each patient via a biopsy,
placed cell-side down
cultured then loaded into
over the defect and
CelGro® scaffolds in
secured with fibrin glue
theatre
----- End of picture text -----
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----- Start of picture text -----
Rehabilitation occurs over 12 weeks, with patients able to
return to sport after 6-12 months (patient dependent)
----- End of picture text -----
Ortho-ACI[®] - Market ositionin p g
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Ortho-ACI® has significant competitive advantages to 1[st] generation ACI techniques and other technologies for the repair and regeneration of articular cartilage
| Evaluation Criteria |
1st Generation ACI | 3rd Generation Ortho-ACI® |
Evaluation Criteria |
Microfracture | 3rd Generation Ortho-ACI® |
|
|---|---|---|---|---|---|---|
| Requires a large surgical | ||||||
| Invasiveness of procedure |
incision Periosteal flap harvested and sutured over defect to |
Delivered arthroscopically through a small incision Scaffold and cells combined |
Maintenance of subchondral bone integrity |
Drills into bone to facilitate marrow stimulation which may lead to complications |
Maintains integrity of bone to deliver superior outcomes |
|
| contain cells | ||||||
| Control of cell density |
Lack of control over cell quantity delivered to patient |
Customised per patient delivering a targeted cell quantity |
Infill generated | Generates fibrocartilage infill | Generates high quality hyaline cartilage |
|
| Quality of outcome |
Use of periosteal flap can lead to post operative complications |
Seeded collagen is proven as safe and well tolerated |
Suitability for lesions >2cm2 |
Not recommended for lesions >2cm2 |
Gold standard for lesions >2cm2 |
|
| Cost effectiveness |
Long operation time and high current patient costs |
Reduces product wastage and cultivation time, minimising costs |
Durability of repair |
Less durability of repair | Longer durability of repair |
Disclaimer
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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 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.