ORTHOCELL LIMITED — Investor Presentation 2021

Oct 27, 2021

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Orthocell Presenting at Canaccord Genuity South-West Connect ASX Showcase

Perth, Australia, 28 October 2021: Regenerative medicine company Orthocell Limited (ASX:OCC, “Orthocell” or the “Company”) is pleased to announce its participation in the Canaccord Genuity South-West Connect ASX Showcase, being held on 27 and 28 October 2021 at Abbey Beach Resort, Busselton.

Orthocell MD, Paul Anderson, will be presenting an updated investor presentation at the conference at 10.15am on Thursday 28th October , to share the latest news and developments for the Company’s OrthoATI™ and CelGro™ platform technologies. A copy of the presentation being made is attached to this announcement.

Orthocell Managing Director, Paul Anderson, said: “We look forward to showcasing the promising and maturing investment opportunities within Orthocell’s regenerative medicine product portfolio. Attendance is free, so I encourage you to either register for or live stream the event for details of the latest developments and the significant upcoming catalysts.”

Interested investors are invited to attend or live stream the event for free:

• Investors in Western Australia are invited to attend event in-person and may register here: https://www.southwestconnect.com.au

• The event is also being livestreamed live via Zoom. Connection details here: https://www.southwestconnect.com.au/livestreamswconnect

• Latest investor presentation is available on the Company’s website here.

Release authorised by Orthocell Ltd Managing Director, Paul Anderson.

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For more information, please contact:

General & Investor enquiries

Paul Anderson Orthocell Limited Managing Director

P: +61 8 9360 2888 E: paulanderson@orthocell.com.au

Media enquiries

Haley Chartres H^CK Director

P: +61 423 139 163

E: haley@hck.digital

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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au

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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 soft tissue injuries. Orthocell’s portfolio of products include CelGro®, a collagen medical device which facilitates tissue repair and healing in a variety of dental, nerve and orthopaedic, reconstructive applications. Orthocell recently received FDA 510(k) approval for Striate+, the first application of the CelGro® platform for dental GBR applications. Striate+ is also approved in Australia (ARTG) and Europe (CE Mark) for the same. The Company’s other major products are the cell therapies Autologous Tenocyte Implantation (Ortho-ATI®) and Autologous Chondrocyte Implantation (Ortho-ACI®), which aim to regenerate damaged tendon and cartilage tissue respectively. Orthocell is moving forward with Ortho-ATI® clinical studies designed to assist in the US (FDA) approval process and has completed its pre-IND meetings with the FDA.

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

Forward Looking Statement

Any statements in this press release about future expectations, plans and prospects for the Company, the Company’s strategy, future operations, and other statements containing the words “anticipate,” “believe,” “estimate, ”expect,” “intend,” “may,” “plan,” “predict,” “project,” “target, ”potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the Company’s ability to successfully develop its product candidates and timely complete its planned clinical programs and the Company’s ability to obtain marketing approvals for is product candidates. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date hereof. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forwardlooking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date hereof.

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Ph: +61 8 9360 2888 Fax: +61 8 9360 2899 www.orthocell.com.au

Investor Presentation Canaccord Genuity South-West Connect ASX Showcase October 2021

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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 forwardlooking 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.

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Key Investment Highlights

Orthocell is a regenerative medicine company delivering breakthrough products for the treatment of serious musculoskeletal disorders.

Well-funded with $14.6m cash as at September 30, 2021

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About Orthocell Ltd

Orthocell is a regenerative medicine company delivering breakthrough products that restore mobility and function.

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CelGro [®]
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Collagen medical device

Ortho-ATI[™]

Cell therapy for tendon regeneration

• Designed to augment surgical repair of soft tissue

• Represents a breakthrough in soft tissue reconstruction

• Multiple applications in nerve, tendon, and bone repair

• Demonstrated superior clinical performance when compared to the current market leading product

• Initial US, EU and AUS approval achieved

• First injectable clinical stage cellular therapy for treatment of chronic tendon injuries

• Multiple tendon sites including shoulder, elbow, hip, hamstring and Achilles

• Addressing a significant unmet clinical need for a safe, effective and non-surgical solution

• Ortho-ATI v Corticosteroid (RCT) study results on track for Q4 CY2021

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Significant market opportunity

At the forefront of a large and growing market opportunity in regenerative medicine in the musculoskeletal space.

CelGro[®]

Total addressable market Ortho-ATI[®]

>US$10bn

>US$7.7bn

Driven by rising rate of musculoskeletal disorders and demand for efficient and costeffective treatments.

1. Addressable markets include US, Japanese, European and Australian markets, Ortho-ATI™addressable market includes the following indications: tennis elbow, rotator cuff, gluteal, patellar, hamstring and Achilles. CelGro® addressable market includes the following indications: dental, rotator cuff and nerve

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US Strategic Focus

Advanced product portfolio with near term milestones and emerging pipeline

1 2

1. Approved in the US, AUS and EU

2. Application submitted for AUS approval

Valuation upside

Valuation comparison to other medical device and life science companies

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$1,200m
Significant upside potential for OCC
$570m
$105m
Market Capitalisation $105m $570m $1,200m
Company
Device Autologous Injection and medical device Autologous cell harvesting device Synthetic scaffold device
Indication Bone, tendon and nerve Acute thermal burn wounds Dermal wound repair
Stage US Approved 2021 US Approved 2018 US Approved 2015
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Significant upside potential for OCC

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Ortho-ATI[™]

Advanced cellular therapy to directly address the root cause of degenerate tendon injury

Chronic tendon injury: significant unmet clinical need

Chronic tendon injury is a common and painful disorder affecting millions of people every year with no effective, non-surgical treatments currently available

Significant unmet clinical need

Multiple tendon injury sites

• Millions of people suffer from chronic tendon injury every year

• Traditional repair outcomes suboptimal i.e. PRP, corticosteroids and surgery

• Chronic tendon injury significantly reduces the ability of patients to work, exercise, and perform routine daily activities

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

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Ortho-ATI[™] : a global clinical first

Injectable cell therapy that returns patients to the workplace, recreational activities and elite sport pain-free, with minimal down-time.

Ortho-ATI[™] is a novel treatment

Two stage, minimally invasive procedure

• ✓ Breakthrough in regenerative medicine directly addressing the root cause of injury

• ✓ Replenishes degenerative tissue with healthy mature tendon cells, accelerating regeneration of tendon tissue

• ✓ Extensive clinical validation - over 700 patients treated with Ortho-ATI™ to date

• ✓ Optimised manufacturing capabilities : GMP-certified and TGA-licensed facility[1] and PPI[2] release criteria in place

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Healthy tendon cells
1. Biopsy removed via
procedure
minimally invasive
procedure
4-5 week
end-to-end
Tenocyte (cell) Healthy cells grown at process
Orthocell’s laboratory
cultivation
Ultrasound-guided
2. Tenocyte (cell)
implantation of
implantation
healthy cells
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1. GMP: good manufacturing practices; TGA: Therapeutic Goods Administration 2. PPI: purity, potency and identity

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Ortho-ATI[™] : compelling clinical evidence

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References for the above data, as at June 20 2020 : 1. Ortho-ATI workers compensation study; 2. Ortho-ATI clinical studies; 3. Annual Quality Survey.

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Ortho-ATI[™] : reducing pain

Ortho-ATI[™] treatment provides a meaningful and lasting reduction in pain

Clinical studies of Ortho-ATI[™]

Clinical Study Results

• Reduction in pain - Patients in clinical studies of Ortho-ATI[™] for lateral epicondylitis (ATI-001) and gluteal tendinopathy (ATI-002) experienced a significant reduction in pain within 6 months of Ortho-ATI[™] treatment

• Sustainable outcome - The improvements in pain were maintained in all studies, for up to 4.5 years post-treatment in the case of ATI-001, and two years post-treatment in ATI002

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10
8
ATI-001
6
ATI-002
4
2
0
0 10 20 30 40 50 60
Months (post-treatment)
Pain Score
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Pre-and post-treatment VAS pain score in clinical studies of Ortho-ATI for lateral epicondylitis (ATI-001), gluteal tendinopathy (ATI-002).

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Returning to function

Ortho-ATI[™] treatment improves strength and function

Clinical studies of Ortho-ATI[™]

Clinical study results

• Long term increases in strength - Average grip strength for patients in clinical study of Ortho-ATI[™] for lateral epicondylitis (ATI-001) was 19.85kg at baseline, improving to 37.38kg at one year and 46.60kg at final follow-up.

• Sustainable increases in function – Average Oxford Hip Score for patients in clinical study of Ortho-ATI[™] for gluteal tendinopathy (ATI-002) improved from 24.0 points at baseline to 38.8 points at 12 months and 39.4 at 24 months post-treatment.

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Pre-and post-treatment disability and function scores in clinical studies of Ortho-ATI for lateral epicondylitis (ATI-001), gluteal tendinopathy (ATI-002).

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Results expected in Q4 2021

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More than a barrier membrane

Striate+™premium dental membrane

• Striate+ is a sterile, resorbable collagen membrane for use in dental bone and tissue regeneration procedures.

• Striate+ is designed to protect the bone defect space from ingrowth of gingival tissue, to provide a favourable environment for osteogenesis and to assure reliable formation of high-quality bone.

• Approved in the US, EU and AUS

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1. Preparation of repair site. Defect site is filled with voidfiller

2. Striate+ placed over defect and implant abutment installed

3. Wound closure

4. Crown placement 3-6 months later

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Striate+™: better results sooner

Patients treated using Striate+™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[1.]

1. 1. CG-002 Study of CelGro membrane in guided bone regeneration around exposed dental implants. ACTRN12615000027516. TGA trial number 2015/0171

Striate+™: world class KOL group

USA / AUS

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Justin Bonaventure Anthony Feck Louisiana Kentucky

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Sammy Noumbissi John Phillips Maryland Oklahoma

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Kathy Frazar Maria Lopez Howell David Little Marc Nevins Texas Texas Texas Massachusetts

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Pamela Ray Amanda Seay Lou Shuman Texas South Carolina Washington DC

Brent Allan Australia

UK / EU

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Nick Fahey Elaine Halley Céline Higton Reading Scotland London

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Giuseppe Luongo Sinead McEnhill Massimo Simion Rome Northern Ireland Milan

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Striate+™: path to partnering

Executing a strategy to engage high quality partners to manage the distribution and marketing of Striate+™- 10% market share equates to AU$35M revenue per annum[1]

Path to partnering Market development activities

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1. Orthocell‘s estimate based on 350,000 units sold @ competiive transfer prices per product size in target jurisdictions (US, EU and AU).

Remplir™ Revolutionising nerve repair

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Traditional repair outcomes are suboptimal

Using traditional repair methods for crushed/severed nerves can be ineffective and unpredictable in restoring function to affected limbs.

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Direct suture
Tension can result
in buckling and
misdirection of
regeneration
nerve fibres
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Rigid hollow
tube
Rigid tubes are
limited in use and
efficacy and can
result in a
34-57% failure
rate [1]
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Strong demand for a medical device that enables surgeons to perform complex surgical repairs efficiently with better results

1. Weber, et al. A randomized prospective study of polyglycolic acid conduits for digital nerve reconstruction in humans. PlastReconstrSurg. 2000; 106(5): 1036-1045.

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Remplir™: nerve transfer surgery

Remplir is a versatile medical device that can be used to repair, protect and cap nerve injuries to return function to impaired or paralysed muscles.

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1
Transferring
superficial radial
to ulnar nerve
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3
Wrapping Remplir
around nerve
ends
to create a
customised
conduit
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2
Placing a stay
suture to oppose
nerve ends
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4
Remplir guides
and supports
nerve repair
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Remplir™: compelling long term clinical results

Quadriplegic patients regained voluntary muscle movement within 12 months

Figure 1 – Recovery of Muscle Power in Patients with Quadriplegia

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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 voluntary movement.

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•
75.8% of all nerve repairs (25 of
33) in the clinical study resulted
in functional recovery (MRC
grade 3 or 4 [1] )
•
Quadriplegic patients regain
independence - brushing teeth,
drinking from a cup, and
transferring into and out of a
wheelchair without assistance
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Leading Australian orthopaedic nerve specialist and clinical trial lead, Dr Alex O’Beirne, said “We are now seeing a consistent return of arm and hand function following nerve transfer surgery with Remplir. The quadriplegic patient results are particularly promising, with improved results at 12 months post treatment compared to the literature. Remplir is increasing the success rate and efficiency of nerve transfer surgery .”

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Remplir™: nerve repair market opportunity

Remplir’s addressable market in peripheral nerve repair is estimated to be worth more than >US$7.5 billion per year.

Orthocell is focused on executing its regulatory program to gain approval in AUS and the US.

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$830M
$948M
$5,671M
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Clinical trial patient Adrian Walsh (far left) wheelchair rugby national champion – following treatment with Remplir

Addressable markets include US, Japanese, European and Australian markets . Referenced papers were used to derive specific assumptions in the procedure potential estimates. Papers used include both U.S. and OUS databases and studies.

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Conclusion

We are interested in working with

you. CEO and Managing Director, Paul Anderson

Orthocell Limited

P: +61 8 9360 2888

E: paul.anderson@orthocell.com.au

www.orthocell.com.au

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