AusBiotech 2013 Brokers meet Biotech CALZADA LIMITED ASX:CZD - - PowerPoint PPT Presentation

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AusBiotech 2013 Brokers meet Biotech CALZADA LIMITED ASX:CZD - - PowerPoint PPT Presentation

AusBiotech 2013 Brokers meet Biotech CALZADA LIMITED ASX:CZD September 2013 Disclaimer Disclaimer This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No party other than


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AusBiotech 2013

“Brokers meet Biotech”

CALZADA LIMITED

ASX:CZD September 2013

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Disclaimer

Disclaimer

This presentation has been prepared by Calzada Limited and is provided for general information purposes only. No party other than Calzada has authorised or caused the issue of this document, or takes responsibility for, or makes any statements, representations or undertakings in this presentation. This presentation is not intended to be relied upon as advice to investors or potential investors and does not take into account the investment

  • bjectives, financial situation or needs of any particular investor. Calzada Limited makes no warranty or representation (express or implied) as

to the accuracy, reliability or completeness of the information contained in this presentation. Specifically, several matters referred to in the presentation remain under investigation and are subject to change or even elimination, depending on further research and investigation. Further, any opinions (including any forward looking statements) expressed in this presentation are subject to change without notice. Calzada and its directors, officers, employees, advisers and agents shall have no liability (including liability to any person by reason of negligence or negligent misstatement) for any statements, opinions, information or matters (express or implied) arising out of, or contained in or derived from, or for any

  • missions from this presentation, except liability under statute that cannot be excluded.

This presentation, including the information contained in this disclaimer, does not form part of any offer, invitation or recommendation in respect

  • f shares, or an offer, invitation or recommendation to sell, or a solicitation of any offer to buy, shares in the United States, or in any other

jurisdiction in which, or to any person to whom, such an offer would be illegal.

Forward-looking statements

This presentation may include forward-looking statements. Forward-looking statements are only predictions and are subject to known and unknown risks, uncertainties and assumptions, many of which are outside the control of Calzada. Actual values, results or events may be materially different to those expressed or implied in this presentation depending on a range of factors. Given these uncertainties, recipients are cautioned not to place reliance on forward-looking statements. No representation or warranty (express or implied) is made by Calzada or any of its directors, officers, employees, advisers or agents that any forecasts, projections, intentions, expectations or plans set out in this presentation will be achieved.

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Calzada Limited

Directors

David Franklyn Chairman Bruce Rathie Non Exec. David McQuillan Non Exec.

Calzada LTD

ASX Code CZD Share Price 7.3 cents Issued Shares 406m Market Cap. $30 million Cash on Hand* $6.2 million

Major Shareholders

Merchant Funds 16% Management 8% Monash / Frank Ng 4%

*Includes estimated R&D tax concession

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PolyNovo’s biodegradable polymer technology, NovoSorbTM, has applications as a tissue scaffold and for use in reconstructive surgery.

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The NovoSorb™ Technology

Foam Polymers Other Polymers

Facial Augment.

NovoSorbTM

TNP Dermal Pelvic Hernia Ortho- Cardio- Bone Void Drug Wound Replace- Floor Repair paedic vascular Fillers eluting Dressings ment Repair implants Stents coatings

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The NovoSorb™ Foam

  • PolyNovo’

s lead products are based around the NovoSorbTM biodegradable foam which has applications as a tissue scaffold in:

  • Burn and wound repair (BTM)
  • Wound dressings (TNP)
  • Hernia repair
  • Facial augmentation
  • Pelvic Floor repair
  • Etc.
  • Key attributes of the NovoSorbTM BTM foam

as a tissue scaffold:

  • Integrates into the wound bed
  • Resists contraction
  • Repairs the dermal layer of skin without scarring
  • Resists infection
  • Inhibits water loss
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How does it work ?

BTM in third degree burn Tissue integration at day 3 BTM fully integrated at day 10 Ready for skin grafting Skin graft on integrated BTM

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Repair of a surgical wound – NovoSorbTM BTM

Day 0 (33.5cm2) Day 0 post BTM Implantation Day 5 (31.7cm2) Day 14 (35.6cm2) Day 21 Post delamination Day 21 Post grafting Three months post grafting Six weeks post grafting (23.1cm2) Six months post grafting

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Repairing Surgical Wounds – with and without BTM

Skin graft directly over wound – current treatment Wound treated with NovoSorb™ BTM foam

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Commercial Progress

Human Trials Regulatory US Commercialisation Market Size TNP foam Completed 510(k) submitted Discussions underway ~$400M Surgical wounds Completed 510(k) submission by Q1 2014 Preliminary discussions Burns Further required PMA Preliminary discussions ~$100M+ Hernia Partner Responsibility 510(k) Feasibility Agreement with US based group ~$1000M Facial Augmentation Partner Responsibility 510(k) Joint venture ~$1000M

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What is AOD9604?

Growth Hormone activates both the IGF-1 (crossed out) and direct cellular

  • pathways. AOD9604 does not act on the IGF-1 pathway which causes

significant insulin resistance and other negative side-effects.

2nd hormone - IGF1 (made in the liver)

Fat

AOD9604

Growth hormone fragment

(only 8% of the GH molecule)

Bone

Muscle and Organ growth Bone length Protein synthesis

Burns fat, Inhibits storage IGF-1 and pro-diabetic effects removed

Cartilage & Muscle

Promotes repair IGF-1 pathway Direct cellular pathway

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Commercialising AOD9604

  • Compounding Chemist licensing

AOD is legally available in Australia if prescribed by a Doctor and prepared by a compounding pharmacy Metabolic investigating opportunity to license compounding chemists Potential to deliver short term cash flow

  • Investigating Osteoarthritis opportunity

Draft trial protocol being prepared

  • GRAS approval opens the door for OTC products and licensing
  • pportunities in the USA

Requirement for further publications