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 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 objectives, 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 omissions 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 of 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.
Calzada Limited Calzada LTD Directors ASX Code David Franklyn CZD Chairman Share Price Bruce Rathie 7.3 cents Non Exec. Issued Shares David McQuillan 406m Non Exec. Market Cap. $30 million Major Shareholders Cash on Hand* $6.2 million Merchant Funds 16% Management 8% Monash / Frank Ng 4% *Includes estimated R&D tax concession
PolyNovo ’ s biodegradable polymer technology, NovoSorb TM , has applications as a tissue scaffold and for use in reconstructive surgery.
The NovoSorb ™ Technology NovoSorb TM Foam Polymers Other Polymers TNP Dermal Pelvic Hernia Ortho- Cardio- Bone Void Drug Wound Replace- Floor Repair paedic vascular Fillers eluting Dressings ment Repair implants Stents coatings Facial Augment.
The NovoSorb ™ Foam • PolyNovo ’ s lead products are based around the NovoSorb TM 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 NovoSorb TM 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
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
Repair of a surgical wound – NovoSorb TM BTM Day 0 post Day 0 (33.5cm 2 ) Day 5 (31.7cm 2 ) BTM Implantation Day 21 Day 21 Day 14 (35.6cm 2 ) Post delamination Post grafting Six weeks post Three months Six months grafting (23.1cm 2 ) post grafting post grafting
Repairing Surgical Wounds – with and without BTM Wound treated with Skin graft directly over NovoSorb ™ BTM foam wound – current treatment
Commercial Progress Human Regulatory Commercialisation Market Trials US Size TNP foam Completed 510(k) Discussions ~$400M submitted underway Surgical Completed 510(k) Preliminary wounds submission discussions by Q1 2014 Burns Further PMA Preliminary ~$100M+ required discussions Hernia Partner 510(k) Feasibility ~$1000M Responsibility Agreement with US based group Facial Partner 510(k) Joint venture ~$1000M Augmentation Responsibility
What is AOD9604? Burns fat, AOD9604 Inhibits storage Growth hormone fragment (only 8% of the GH molecule) Fat Direct cellular pathway IGF-1 pathway IGF-1 and pro-diabetic Promotes repair effects removed Cartilage 2 nd hormone - IGF1 Bone & Muscle (made in the liver) Muscle and Protein Bone Organ synthesis length growth 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.
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 opportunities in the USA � Requirement for further publications
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