Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (December 2016)
36 slides from Orthocell's investor presentation, Dec 2, 2016
Slide 1: Investor Presentation Corporate Update
For personal use only Investor Presentation Corporate Update December 2016 Paul Anderson Managing Director
Slide 2: Disclaimer
Disclaimer For personal use only 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
Slide 3: Company Overview
Company Overview For personal use only Delivering breakthrough products in regenerative medicine 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 C
Slide 4: Corporate Overview
Corporate Overview For personal use only Experienced team to execute CEO Paul Anderson • Verigen • Genzyme Key Facts • Biomet ASX OCC CSO Prof Ming Hao • Verigen Zheng • Genzyme Share Price AU$0.44 (@ 30 Nov 2016) • UWA Executive Dr Stewart Washer • Cynata Ordinary Shares on 91.2 million Chairman •
Slide 5: Global Need & Opportunity
Global Need & Opportunity For personal use only Orthocell is deal ready and positioned for growth 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 product
Slide 6: Product Pipeline
Product Pipeline For personal use only Near term regulatory approvals , CH 6
Slide 7: Ortho-ATI Autologous Tenocyte Implantation
For personal use only ® Ortho-ATI Autologous Tenocyte Implantation Breakthrough regenerative medical therapy Multiple tendon applications TGA licence Published long term data 7
Slide 8: Ortho-ATI
Ortho-ATI® For personal use only Two stage minimally invasive, walk-in, walk-out process. 1. Biopsy procedure 2. Tenocyte cultivation 3. Ultrasound guided tenocyte implantation 4-5 week end to end process 8
Slide 9: Healing Fatigue Model
Healing Fatigue Model For personal use only Ortho-ATI® addresses the degenerative phase of tendon injury Tendinopathy 6-12 months >12 months 9
Slide 10: Limitations of traditional therapies
Limitations of traditional therapies For personal use only Current traditional therapies do not adequately address the underlying pathology of tendinopathy (reduction of tenocytes) and thus have limited long- term efficacy. Total cost of surgery is up to four (4) times more than Ortho-ATI 10
Slide 11: Prevalence
Prevalence For personal use only Tendinopathy is a very common and costly condition Joint Condition Prevalence in Adult Population 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) 2.7% 2 Ach
Slide 12: Why tenocytes?
Why tenocytes? For personal use only Clinical trial data concludes Tenocytes are “fit for purpose” Tenocytes Dermal Embryonic Mesenchymal (Ortho-ATI) Fibroblasts stem cells stem cells Autologous × Homologous × × × Engraftment ? × × Efficacy ? ? ? Durability ? ? ? Commercially × × × A
Slide 13: Clinical data supports efficacy and durability
Clinical data supports efficacy and durability For personal use only 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-AT
Slide 14: New Ortho-ATI clinical trial underway
New Ortho-ATI® clinical trial underway For personal use only 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
Slide 15: Multiple trials completed
Multiple trials completed For personal use only 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 Glute
Slide 16: Further publications pending
Further publications pending For personal use only 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 improv
Slide 17: Ortho-ATI: Orthocell is tech transfer ready
Ortho-ATI® For personal use only Orthocell is tech transfer ready AUS and US addressable markets “How stem cells gave violinist her life back” • Tennis elbow market >$850M • Rotator cuff market >$900M Regulatory targets • US application (IND ) in preparation • AUS application (ARTG) in progress • JP
Slide 18: Ortho-ACI Autologous Chondrocyte Implantation
For personal use only Ortho-ACI ® Autologous Chondrocyte Implantation Gold standard cartilage repair Multiple applications 18
Slide 19: Ortho-ACI
Ortho-ACI® For personal use only Arthroscopic 3rd generation autologous chondrocyte implantation 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 Hi
Slide 20: Prevalence of Cartilage Injury
Prevalence of Cartilage Injury For personal use only • 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
Slide 21: Treatment process
Treatment process For personal use only 1. Biopsy procedure 2. Scaffold seeded in theatre 3. Arthroscopic Implant 4. Implant completed 21
Slide 22: Ortho-ACI versus 1st generation techniques
Ortho-ACI® versus 1st generation techniques For personal use only Orthocell is a 3rd generation, minimally invasive, cost effective technique delivering superior outcomes for the regeneration of articular cartilage. 1st Evaluation Generation 3rd Generation Ortho-ACI Criteria ACI × Requires a large s
Slide 23: CelGro: A true regenerative medicine scaffold
For personal use only CelGro ® A true regenerative medicine scaffold Highest quality available Multiple applications 23
Slide 24: CelGro Regenerative medicine scaffold
CelGro® Regenerative medicine scaffold For personal use only 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 m
Slide 25: CelGro platform technology with competitive advantages
CelGro® For personal use only CelGro® is a platform technology with significant competitive advantages Superior soft tissue and bone repair CelGro qualities Regenerative medicine scaffold Highest quality raw material globally available Proven compatibility, pure collagen and Bone Tendon Nerve Ca
Slide 26: CelGro competitor limitations
CelGro® For personal use only Competitors limitations include: not fit for purpose, poor integration and limited application 26
Slide 27: How CelGro works
How CelGro® works For personal use only 1. Smooth layer 2. Rough layer 3. Tissue remodelling Densely packed collagen Loosely arranged collagen Integration of cells Passage of fluids Applied to tissue defect Guiding high quality tissue regeneration 27
Slide 28: CelGro dental application
CelGro® For personal use only 1. Bones loss 2. Bone void filler 3. Apply CelGro 4. Suture gum tissue 28
Slide 29: CelGro
For personal use only CelGro® 29
Slide 30: CelGro rotator cuff repair
CelGro® For personal use only 1. Rotator cuff injury 2. Stabilisation 3. CelGro fixation 4. Completed surgical repair 30
Slide 31: CelGro
For personal use only CelGro® 31
Slide 32: CelGro Pathway to market
CelGro® Pathway to market For personal use only 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 juri
Slide 33: Next generation pipeline
Next generation pipeline For personal use only 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 f
Slide 34: Upcoming Milestones
Upcoming Milestones For personal use only 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 s
Slide 35: Investment Highlights
Investment Highlights For personal use only ➢ Superior products ➢ Significant de-risked opportunity ➢ Clear pathway to large markets ➢ Strong partner interest ➢ Expertise to partner and execute 35
Slide 36: Advancing tissue repair and regeneration
For personal use only Advancing tissue repair and regeneration Paul Anderson Managing Director