Orthocell Ltd · ASX:OCC

Orthocell — Investor Presentation (September 2020)

55 slides from Orthocell's investor presentation, Sep 15, 2020

  1. Slide 1: Investor Presentation

    Investor Presentation For personal use only Perth, Australia; 15th September 2020: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to provide the attached investor presentation. The presentation provides a comprehensive update of Orthocell’s regener

  2. Slide 2: Forward Looking Statement

    statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various For personal use only important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs a

  3. Slide 3: Investor Presentation

    ‘ . . : ; . Investor Presentatia opteber 0 — = For persona

  4. Slide 4: Well-funded with $20.4m cash as at June 2020

    For personal use only Well-funded with $20.4m cash as at June 30 2020 2

  5. Slide 5: For personal use only

    For personal use only • • • • • • • • • 3

  6. Slide 6: 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-ATl|"*------- Total addressable market Driven by rising rate of musculoskeletal disorders and demand for efficient and cost-effectiv

  7. Slide 7: CelGro

    \W/ m|| @ SrSGhal- Use )) y) I I CelGro® A unique collagen medical device that augments tissue repair and regeneration

  8. Slide 8: CelGro features

    For personal use only 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 rege

  9. Slide 9: CelGro: strategic focus

    CelGro®: strategic focus Orthocell is focused on the development and commercialisation of the bone, nerve and tendon 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

  10. Slide 10: Strategic status

    Strategic status _ Advanced product portfolio with near term milestones and emerging pipeline 3 Target : Regulatory Phase + Application : Market ‘ Clinical/Development Phase : Design Trial | ImplementTrial | Application Upcoming Catalysts AUS SD | NERVE > Q1 CY21: Multi centre mkg sudy kick off > Q4

  11. Slide 11: Revolutionising nerve repair

    aie aL Revolutionising nerve repair

  12. Slide 12: Point of injury

    For personal use only Point Injury • • • • • 10

  13. Slide 13: Traditional repair outcomes are suboptimal

    Traditional repair outcomes are suboptimal Using traditional repair methods for crushed/severed nerves can be ineffective and unpredictable in restoring function to affected limbs. Direct Rigid hollow suture tube Tension can . Rigid tubes are result in limited in use buckling and and efficacy and mi

  14. Slide 14: 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

  15. Slide 15: CelGro Nerve trial participant, Adrian Walsh

    For personal use only - CelGro® Nerve trial participant, Adrian Walsh

  16. Slide 16: Meet Adrian Walsh

    2) 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.

  17. Slide 17: CelGro proven faster and superior for nerve repair

    For personal use only  •  •  • 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

  18. Slide 18: Recovery of Muscle Power in Patients with Quadriplegia

    For personal use only 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 movem

  19. Slide 19: For personal use only

    For personal use only $948M $830M $5,671M 17

  20. Slide 20: 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

  21. Slide 21: Guiding superior bone regeneration

    For personal use only Guiding superior bone regeneration

  22. Slide 22: 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

  23. Slide 23: 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

  24. Slide 24: For personal use only

    For personal use only 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

  25. Slide 25: 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

  26. Slide 26: For personal use only

    For personal use only         25

  27. Slide 27: CelGro Tendon Regeneration

    © jor MS © ™ CelGro® Tendon Regeneration Revolutionising mobility

  28. Slide 28: 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

  29. Slide 29: 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

  30. Slide 30: Regulatory milestones

    For personal use only Regulatory milestones • • Q4 CY20: AU TGA submission (estimate) • Q4 CY20: US FDA pre-submission meeting to • define study requirements • 29

  31. Slide 31: Ortho-ATI

    For personal Ortho-ATI™ Advanced cellular therapy to directly address the root cause of degenerate tendon injury

  32. Slide 32: No non-surgical treatments for chronic tendon injury

    For personal use only • Rotator cuff Quadriceps tendon Tennis elbow • Patellar tendon Flexor/Extensor ligament • Gluteal tendon (hip) Achilles tendon There are no ‘non-surgical’ treatments currently available to treat chronic tendon injury 31

  33. Slide 33: 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

  34. Slide 34: 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 compensatio

  35. Slide 35: Pain score results

    For personal use only 10 • 8 ATI-001 Pain Score • 6 ATI-002 4 2 • 0 • 0 10 20 30 40 50 60 • Months (post-treatment) 34

  36. Slide 36: Annual Quality Study

    For personal use only Annual Quality Study 73% 81% 35

  37. Slide 37: Disability and function scores

    For personal use only • • • • Pre-and post-treatment disability and function scores in clinical studies of for lateral epicondylitis (ATI-001), gluteal tendinopathy (ATI-002). 36

  38. Slide 38: Return to sport

    RETURN TO SPORT Elite athletes: > AFL players, Australian soccer p skiers returned to competition pa Ortho-ATI™ > 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

  39. Slide 39: 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 MRI

  40. Slide 40: 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 Total population Estimated Resistant patients To

  41. Slide 41: 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+ pati

  42. Slide 42: 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 CO) a . ™ ) Treatment of 1 33 of 50 I 1° CY21: Finish recruitment 5 Ortho-ATI"'v Surgery {| chronic lat

  43. Slide 43: For personal use only

    For personal use only

  44. Slide 44: Share price and milestones

    For personal use only 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 OCC.ASX 43

  45. Slide 45: 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 COMPANIES vom $1,40

  46. Slide 46: Upcoming catalysts

    Upcoming catalysts CelGro®: Dental Australian market authorisation estimate US market authorisation estimate CelGro®: Nerve and Tendon Clinical study data update [nerve] Australian market authorisation estimate (nerve) Commence FDA [US] regulatory study (nerve) ersonal use only Q, TGA [AUS] submissi

  47. Slide 47: Appendix contents

    For personal use only Corporate overview | Executive team| Global patent portfolio | Patient testimonials | Ortho-ACI™ and R&D Pipeline

  48. Slide 48: Corporate overview: share price

    For personal use only 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

  49. Slide 49: For personal use only

    For personal use only • • • • • • • • • • • • • • 48

  50. Slide 50: 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

  51. Slide 51: Ortho-ATI: patient testimonials

    Ortho-ATI™: patient testimonials “I'm 100% happy with the Ortho-AT|™ 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 at

  52. Slide 52: 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

  53. Slide 53: For personal use only

    For personal use only • • • • • • • • • • • • 52

  54. Slide 54: 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

  55. Slide 55: We are interested in working with you

    For personal use only We are interested in working with you. @

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