Orthocell Ltd · ASX:OCC
Orthocell — Investor Presentation (October 2020)
54 slides from Orthocell's investor presentation, October 2020
Slide 1: Investor Presentation
Investor PFesentatia opteber 0 =
Slide 2: Well-funded with $20.4m cash as at June 30 2020
Well-funded with $20.4m cash as at June 30 2020 2
Slide 3: About Orthocell Ltd
About Orthocell Ltd Orthocell is a regenerative medicine company delivering breakthrough products that restore mobility and function. * Designed to augment surgical repair of soft tissue. * Injectable clinical stage cellular therapy for treatment * Represents a breakthrough in soft tissue reconstruc
Slide 4: Significant market opportunity
Significant market opportunity At the forefront of a large and growing market opportunity in regenerative medicine in the musculoskeletal space. CelGro®--------) Ortho-AT|/® ------- Total addressable market Driven by rising rate of musculoskeletal disorders and demand for efficient and cost-effectiv
Slide 5: CelGro®
CelGro® A unique collagen medical device that augments tissue repair and regeneration
Slide 6: SMRT® manufacturing process
SMRT® manufacturing process Flexible and easy to handle even Preservation of natural collagen removes all foreign tissue when wet. Does not collapse when structure promotes the rapid repair components and is completely placed over the defect and stays in of soft tissue and regeneration absorbed by t
Slide 7: CelGro®: strategic focus
CelGro®: strategic focus Orthocell is focused on the development and commercialisation of the nerve, tendon and bone applications. CelGro® has significant global commercial potential in its existing addressable markets as well as much wider applications in general surgical and soft tissue reconstruc
Slide 8: Strategic status
Strategic status Advanced product portfolio with near term milestones and emerging pipeline : NERVE : : Regulatory Phase : : Application : inical/Development Phase : Design Trial Implement Trial | Application : Upcoming Catalysts aus : : > Q1CY21: Multi centre mkg study kick off > Q4 CY21: AU TGA ap
Slide 9: Revolutionising nerve repair
“y ) a h i). 4 : « \ ~ ' \ ¢ ad = e 5, We We egeneration Revolutionising nerve repair
Slide 10: The peripheral nervous system
The peripheral nervous system The peripheral nervous system transmits signals from the brain to the rest of the body [including arms, hands, feet, legs and face) directing bodily function including muscle movement. Common and debilitating * Nerve injury an occur from a variety of accidents such as m
Slide 11: Reference: Weber et al. nerve conduits study
1. Weber, et al. A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans. PlastReconstrSurg. 2000; 106(5): 1036-1045. 11
Slide 12: CelGro®: nerve transfer surgery
CelGro®: nerve transfer surgery CelGro® is a versatile medical device that can be used to repair, protect and cap nerve injuries to return function to impaired or paralysed muscles. 1 : ae 2 Transferring Placing a stay superficial radial suture to oppose to ulnar nerve nerve ends 3 4 Wrapping CelGro
Slide 13: CelGro® Nerve trial participant, Adrian Walsh
- CelGro® Nerve trial participant, Adrian Walsh
Slide 14: Meet Adrian Walsh
Meet Adrian Walsh, a 43-year-old father of three who was diagnosed with quadriplegia after he broke his neck in a mountain bike accident in June 2017. Patient video link here
Slide 15: CelGro® is proven to be a faster and superior device for nerve repair
• • • CelGro® is proven to be a faster and superior device for nerve repair. Nerve repair using CelGro® resulted in improvements in muscle power at 12 months that were comparable to typical results expected at 24 months with other methods. 15
Slide 16: Recovery of Muscle Power in Patients with Quadriplegia
Figure 1 – Recovery of Muscle Power in Patients with Quadriplegia (11 nerve repairs) • Grade 3 and 4 – voluntary movement with improved strength and range of motion. Maximum level of recovery expected. Grade 2 – voluntary • movement restored, limited strength and range of movement. Grade 0 or 1 – no
Slide 17: CelGro®: nerve repair market opportunity
CelGro®: nerve repair market opportunity CelGro®’s addressable market in peripheral nerve repair is estimated to be worth more than >US$7.5 billion per year. $948M Global potential annual procedural estimates': > CONNECT: severed nerve repair, >2,000,000 procedures/year > PROTECT: carpal and cubital
Slide 18: Pathway to US market
Pathway to US market With the safety and efficacy of the CelGro® nerve repair product established, Orthocell is focused on executing its regulatory program to gain approval in the US. To support an evaluation of substantial equivalence to an approved nerve repair device, meeting the requirements of
Slide 19: Guiding superior bone regeneration
Guiding superior bone regeneration
Slide 20: CelGro® product sizes
15 x 20mm 20 x 30mm 30 x 40mm 40 x 50mm 20
Slide 21: CelGro®: better results sooner
CelGro®: better results sooner Patients treated using CelGro® successfully generated enough new bone to stabilise their implants and complete their treatment in approximately 4 months, compared to the 8 months required for standard dental implant treatment: Treatment Complete 8 months SURGERY 1 SURG
Slide 22: CelGro®: orthognathic surgery
CelGro®: orthognathic surgery “My experience in using CelGro® in dental implant procedures has given me the confidence to use it in Orthognathic procedures. Corrective jaw surgeries are life changing and technically demanding. Predictable and high-quality bone regeneration is of upmost importance to
Slide 23: Key opinion leaders
Nick Fahey Massimo Simion Brent Allan David Little Pamela Ray Sinead McEnhill UK Italy Australia USA USA UK Lance Knight Amanda Seay Guiseppe Luongo Elaine Halley Kathy Fraser Maria Lopez Howell UK USA Italy UK USA USA 23
Slide 24: CelGro®: dental path to partnering
CelGro®: dental path to partnering Executing a strategy to engage a global partner to manage the distribution and marketing of CelGro® for dental bone and soft tissue repair procedures. Path to partnering Market development activities * Publication in high impact journals * Increase SAS use in key a
Slide 25: CelGro®: GBR market opportunity
CelGro®: GBR market opportunity There has been very little innovation in the biologics membrane market resulting in a lack of product differentiation. Existing products have inferior functionality The CelGro® advantage: and handling characteristics: v Regenerative medicine collagen membrane manufact
Slide 26: CelGro® Tendon Regeneration
CelGro® Tendon Regeneration Revolutionising mobility
Slide 27: CelGro®: reducing surgical revisions
CelGro®: reducing surgical revisions CelGro®’s handling characteristics assist surgeons perform reconstructive procedures, while creating a unique healing environment to improve the quality of the regenerated tendon tissue. Better quality tissue strengthens the repair and reduces the risk of re-tear
Slide 28: CelGro®: tendon indications
CelGro®: tendon indications CelGro® is currently being used via SAS by KOL’s to augment tendon repair at multiple sites throughout the body. Tennis elbow Hand tendon repair surgical repair Ligament repair within the knee Achilles tendon Ankle tendon repair surgical repair 28
Slide 29: CelGro®: key benefits and upcoming milestones
CelGro®: key benefits and upcoming milestones “Rotator cuff repair can be a challenging area. An effective biological augment to surgical repair is increasingly desired by the orthopaedic community. CelGro® has been shown to improve tissue healing and assists in reducing the surgical revision rate o
Slide 30: Ortho-ATI®
Ortho-ATI® Advanced cellular therapy to directly address the root cause of degenerate tendon injury
Slide 31: Ortho-ATI® tendon indications
• Rotator cuff Quadriceps tendon Tennis elbow • Patellar tendon Flexor/Extensor ligament • Gluteal tendon (hip) Achilles tendon 31
Slide 32: Ortho-ATI®: a clinical first
Ortho-ATI®: a clinical first Injectable cell therapy that returns patients to the workplace, recreational activities and elite sport pain-free. Ortho-ATI® is a novel treatment Two stage, minimally invasive procedure v Breakthrough in regenerative medicine directly Healthy tendon cells addressing the
Slide 33: Ortho-ATI®: compelling clinical evidence
Ortho-ATI® : compelling clinical evidence Patients have experienced an average of two years chronic pain and three failed treatments. At this point, the only remaining treatment option is generally elective surgery. References for the above data, as at June 20 2020: 1. Ortho-ATI workers compensation
Slide 34: Pain Score
10 • 8 ATI-001 Pain Score • 6 ATI-002 4 2 • 0 • 0 10 20 30 40 50 60 • Months (post-treatment) 34
Slide 35: Annual Quality Study
Annual Quality Study 73% 81% 1 Ortho-ATI® Annual Quality Survey 35
Slide 36: Pre- and post-treatment disability and function scores
• • • • Pre-and post-treatment disability and function scores in clinical studies of for lateral epicondylitis (ATI-001), gluteal tendinopathy (ATI-002). 36
Slide 37: Return to sport
RETURN TO SPORT Elite athletes: > AFL players, Australian soccer p skiers returned to competition pa Ortho-ATl® > Olympic swimmer and elite gym \ tendinopathy returned to competi Improves : . Weekend warriors: strength Elderly male with (77 years old) w and tendinopathy able to resume gardé function
Slide 38: Tendon Structure
Tendon Structure MRI assessments in clinical studies of LE and RC tendinopathy demonstrated improvements in tendon structure, including in-fill of tendon tears and resolution of tendinopathy. Improvements in tendon structure were sustained at 4.5 years post-treatment (ATI-001). Before treatment 1 Ye
Slide 39: Ortho-ATI®: multiple, large addressable markets
Ortho-ATI® : multiple, large addressable markets Ortho-ATI® is at the forefront of a large and growing market opportunity where the addressable market is estimated to be >US$7.7bn p.a. Estimated addressable market in excess of US$7.7bn incorporates: ve Illustrative analysis: tennis elbow addressable
Slide 40: Ortho-ATI®: research collaboration
Ortho-ATI® : research collaboration Orthocell is focused on completing current clinical studies and preparing for US market entry Key factors in attracting Ortho-ATI® research collaboration * Significant clinical validation: published clinical data in American Journal of Sports Medicine and 500+ pat
Slide 41: Upcoming milestones
Upcoming milestones Orthocell is focused on completing current clinical studies and preparing for AUS and US market entry Randomised Clinical Study Indication Status Market Upcoming Milestones | Treatment of | 33 of 50 CY21: Finish recruitment (estimate) I 1° Ortho-ATI® v Surgery {| chronic lateral
Slide 42: Near-term milestones
Near-term milestones
Slide 43: Share price and volume with milestones
First EU sales 3.50 BARDA grant US military access and 14.0 revenue growth • 3.00 12.0 • 2.50 TGA approval 10.0 Share Price ($) Volume (m) 2.00 8.0 • 1.50 First US sales 6.0 • 1.00 4.0 0.50 2.0 - - Volume PNV.ASX 43
Slide 44: Valuation upside
Valuation upside Valuation comparison to other medical device and life science Significant upside potential for OCC $75m a Market Capitalisati $75m Col Autologous Injection and medical device $796m $796m Autologous cell harvesting device Acute thermal burn wounds US Approved 2018 COMPAaNlEs vom $1,4
Slide 45: Timelines are an estimate only
1. Timelines are an estimate only and may be subject to change due to matters not under the Company’s control such as COVID-19 mitigation measures. 45
Slide 46: Corporate overview | Executive team | Global patent portfolio | Patient testimonials | R&D Pipeline
Corporate overview | Executive team| Global patent portfolio | Patient testimonials | Ortho-ACI and R&D Pipeline
Slide 47: Share price and volume
0.70 14.0 0.60 12.0 0.50 10.0 Share Price ($) Volume (m) 0.40 8.0 0.30 6.0 0.20 4.0 0.10 2.0 - - Sep-19 Dec-19 Mar-20 Jun-20 Volume OCC.ASX 47
Slide 48: Executive team
Executive team Experienced board with prior success commercialising regenerative medicine a t Dr Stewart Washer Paul Anderson Chairman Managing Director * 20+ years’ CEO and board» 20+ years’ regenerative experience medicine experience * Commercialisation, * Former MD of Verigen capital markets and
Slide 49: IP: well protected and clinically validated
IP: well protected and clinically validated Orthocell has significant levels of clinical validation and has protected its suite of regenerative medicine products in 11 patent families comprising 108 separate patents/applications (78 Granted) across major jurisdictions, with further applications awai
Slide 50: Ortho-ATI®: patient testimonials
Ortho-ATI® : patient testimonials “I'm 100% happy with the Ortho-ATI® treatment, the “Il couldn't write, drive, play my violin, or even walk only thing that enabled me to get back to doing without pain. Ortho-ATI® gave me my life back.” normal daily activities without pain and return to ; swimming a
Slide 51: CelGro®: patient testimonials
CelGro®: patient testimonials es atk ea a ie “The tendon in my right shoulder was frayed at the ends and difficult to repair because !'d left it so long. I’m an active person and wanted long-lasting mobility, without going under the knife again and again. That's why CelGro® made sense for me. So muc
Slide 52: Ortho-ACI® and R&D pipeline
Ortho-ACI® and R&D pipeline 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 Next generation product to complement Ortho-ATI® Leverage existi
Slide 53: Disclaimer
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 tr
Slide 54: We are interested in working with you
We are interested in working with you. @