Investor Presentation Corporate Update December 2016

Transcription

1 Investor Presentation Corporate Update December 2016 Paul Anderson Managing Director

2 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 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. 2

3 Company Overview Delivering breakthrough products in regenerative medicine Cell therapies: Ortho-ATI - world s leading stem cell therapy to regenerate tendons Ortho-ACI - 3 rd 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 3

4 Corporate Overview Experienced team to execute CEO Paul Anderson Verigen Genzyme Biomet CSO Executive Chairman Prof Ming Hao Zheng Verigen Genzyme UWA 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 Key Facts ASX OCC Share Price AU$ Nov 2016) Ordinary Shares on issue Market Cap Options & Warrants outstanding 91.2 million AU$40 million 21.2 million Cash at bank AU$4 million 30 Sep 2016) Shareholding Structure Shareholders 3,050 Directors & Management % 60% Top 20 4

5 Global Need & Opportunity 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 products with compelling clinical evidence Ortho-ATI Tendon Regeneration patients treated Ortho-ACI Cartilage Regeneration 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 5

6 Product Pipeline Near term regulatory approvals, CH 6

7 Ortho-ATI Autologous Tenocyte Implantation Breakthrough regenerative medical therapy Multiple tendon applications TGA licence Published long term data 7

8 Ortho-ATI 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

9 Healing Fatigue Model Ortho-ATI addresses the degenerative phase of tendon injury Tendinopathy 6-12 months >12 months 9

10 Limitations of traditional therapies Current traditional therapies do not adequately address the underlying pathology of tendinopathy (reduction of tenocytes) and thus have limited longterm efficacy. Total cost of surgery is up to four (4) times more than Ortho-ATI 10

11 Prevalence 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) 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 Aug 15;51(4): Firstconsult.com 3. Hargrove, Richard (2005). Achilles Tendon Pathology. emedicine Online 11

12 Why tenocytes? Clinical trial data concludes Tenocytes are fit for purpose Tenocytes (Ortho-ATI) Dermal Fibroblasts Embryonic stem cells Mesenchymal stem cells Autologous Homologous Engraftment? Efficacy??? Durability??? Commercially Available 12

13 Clinical data supports efficacy 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 For personal use onlyand durability 13

14 New Ortho-ATI clinical trial underway 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 Targeted enrollment completion Q

15 Multiple trials completed 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. 15

16 Further publications pending 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. 16

17 Ortho-ATI Orthocell is tech transfer ready AUS and US addressable markets Tennis elbow market >$850M Rotator cuff market >$900M How stem cells gave violinist her life back 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 17

18 Ortho-ACI Autologous Chondrocyte Implantation Gold standard cartilage repair Multiple applications 18

19 Ortho-ACI Arthroscopic 3 rd 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 2cm 2) 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) license MI LI Orthocell is the only accredited manufacturer and supplier of ACI in SE Asia Highly customised, lesion-focused treatment therapy Significantly more cost effective treatment 19

20 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 weightbearing joints like the knee, ankle and hip. There are approximately 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 20

21 Treatment process 1. Biopsy procedure 2. Scaffold seeded in theatre 3. Arthroscopic Implant 4. Implant completed 21

22 Ortho-ACI versus 1 st generation techniques Orthocell is a 3 rd generation, minimally invasive, cost effective technique delivering superior outcomes for the regeneration of articular cartilage. Evaluation Criteria 1 st Generation ACI 3 rd 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 22

23 CelGro A true regenerative medicine scaffold Highest quality available Multiple applications 23

24 CelGro Regenerative medicine scaffold 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 24

25 CelGro CelGro is a platform technology with significant competitive advantages Superior soft tissue and bone repair qualities Highest quality raw material globally available CelGro Regenerative medicine scaffold Proven compatibility, pure collagen and acellular Guided tissue repair / optimal tissue integration and remodelling High tensile strength Versatile platform Bone Tendon Nerve Cartilage Pipeline Ligament replacement ACL General Surgery, Urogynaelogical 25

26 CelGro Competitors limitations include: not fit for purpose, poor integration and limited application 26

27 How CelGro works 1. Smooth layer Densely packed collagen Passage of fluids 2. Rough layer Loosely arranged collagen Applied to tissue defect 3. Tissue remodelling Integration of cells Guiding high quality tissue regeneration 27

28 CelGro 1. Bones loss 2. Bone void filler 3. Apply CelGro 4. Suture gum tissue 28

29 CelGro 29

30 CelGro 1. Rotator cuff injury 2. Stabilisation 3. CelGro fixation 4. Completed surgical repair 30

31 CelGro 31

32 CelGro Pathway to market 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 follow 32

33 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 These pipeline products and concepts are early stage opportunities that require further research and development prior commercialisation 33

34 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 34

35 Investment Highlights Superior products Significant de-risked opportunity Clear pathway to large markets Strong partner interest Expertise to partner and execute 35

36 Advancing tissue repair and regeneration Paul Anderson Managing Director