Calzada Ltd. ASX:CZD Investor Overview September 2011

Transcription

1 Calzada Ltd ASX:CZD Investor Overview September 2011

2 Disclaimer This presentation is provided for general information purposes only. It is not intended to be relied upon as advice and does not take into account the investment objectives, financial situation or needs of any particular investor. Whilst Calzada Limited has taken all reasonable measures to ensure that the material contained in this newsletter is correct, Calzada Limited does not give any warranty or representation as to the accuracy, reliability or completeness of the information. To the extent permitted by law, neither Calzada Limited nor any of its related bodies corporate or their respective officers or employees will be liable in any way for any loss, damage, cost or expenses suffered or incurred by any person relying on the information contained in this presentation or in connection with the provision of contents of this presentation.

3 Calzada Ltd Top Shareholders 1. Entrust Investment Fund (Related party of Chairman) 17.2% 2. Fleming SG Capital Special Opportunities 8.4% 3. Senior Management 7.5% 4. Joint Venture Partners 1.5% Calzada 3 Senior Management 75% Stewart Washer ASX Code : CZD Share Price: 5.7 cents Market Cap: $20m Cash: $6.8m (August 2011) Cash Burn: < $3m pa PolyNovo Laurent Fossaert Metabolic David Kenley Owns NovoSorb, a suite of biodegradable polymers used in medical devices and as a tissue scaffold Owns AOD9604, a peptide proven safe in human trials with activity in fat reduction and bone health

4 SIX SHOTS AT GOAL PolyNovo (NovoSorb TM ) 1. Full thickness burn treatment (NovoSorb BTM) 2. Collaboration with a US major medical device company 3. Smith & Nephew bone repair license Metabolic (AOD9604) 4. Phosphagenics cellulite cream royalties (BodyShaper) 5. Nutraceutical for fat reduction 6. Bone repair applications EACH ONE OF THESE HAS THE POTENTIAL TO BE A COMPANY MAKER

5 Key Milestones Next 6 Months PolyNovo ISO10993 safety studies for NovoSorb Human trial starts for NovoSorb BTM Finalisation of collaboration with US major Advance license negotiations with US major from this collaboration Progress Smith & Nephew bone repair projects Metabolic Royalties from Phosphagenics BodyShaper cellulite cream Advance AOD9604 as Nutraceutical in the USA Investigate new indications for AOD9604 including bone repair

6

7 NovoSorb NovoSorb is a biodegradable polymer technology for medical products aimed at reconstructive surgery and tissue repair Our lead projects are: NovoSorb BTM - developing a step change treatment for full thickness burns Targeting NovoSorb for fracture fixation and bone void filler applications via our license agreement with global medical device company Smith & Nephew Collaboration with a major global medical device company in a new field

8 NovoSorb Advantages Wound Minimal acidic breakdown NovoSorb Collagen PolyLactide Can tailor mechanical properties Possible Flexible degradation time Easy to use Scalable manufacture Fully synthetic Enables drug elution Possible Affordable

9 NovoSorb BTM Treatment of Full Thickness Burns NovoSorb BTM is being developed within NovoSkin, our JV with leading burns surgeon Associate Professor John Greenwood who owns 20% of NovoSkin (PolyNovo 80%) NovoSorb BTM provides a scaffold to regrow dermal tissue that provides an ideal foundation for skin graft Rationale for use of BTM; Stabilise wound whilst awaiting skin graft Achieve better outcome after healing (supple and elastic skin)

10 NovoSorb BTM Project Status Completed preclinical studies (20 pigs) with results exceeding expectations Safety studies (ISO 10993) due for completion in Q Ethics approval for human trial received Pilot human trial expected to start Q A/Prof John Greenwood awarded the inaugural American Burn Association Burke Yannis prize for his work on NovoSkin's burn treatment product Product Advantages Preclinical studies showed rapid tissue integration, under 10 days compared to current industry norm of 21 days Ability to apply split skin graft immediately on BTM, creating multiple product opportunities Reduction in wound contraction superior to best in class product (Integra) Zero loss of implants from infection or mechanical failure (common in current treatments) Easy to manufacture and cost competitive Easy to use, should result in better uptake by Surgeons

11 NovoSorb BTM Market potential The market for full thickness burn devices is currently a $200 million per annum market, but market size has been constrained by cost and high failure rate of market leading products As a bioengineered scaffold BTM has broader opportunities in other tissue repair applications and cosmetic surgery Key Milestones First in man is a significant event for the NovoSorb platform technology Success in this trial will provide strong evidence that the NovoSorb platform and BTM have substantial commercial value

12 NovoSorb Advantages Bone Biodegradable Bioresorbable NovoSorb PMMA Ceramic Can tailor mechanical properties In situ drilling Low exotherm Cost effective manufacture Injectable Possible Enables drug elution

13 Smith & Nephew License Three development programs 1. Fracture Fixation for the repair of bone fractures 2. Bone Void Fillers to provide a scaffold for new bone growth 3. A US Department of Defense project to develop a NovoSorb TM fracture putty to repair load bearing fractures caused by war injuries. Project Status We have developed formulations that are currently being tested in trials Early stage in-vivo studies commenced for two applications Product Advantages NovoSorb offering flexible product characteristics Potential to deliver a step change in the fracture fixation field Tissue scaffold characteristics are highly attractive as a next generation bone void filler Market potential The fracture repair market is mainly serviced by non-biodegradable devices Market size for three areas of investigation is in excess of US$1 billion +

14 US Company Collaboration The Collaboration We have a 12 month collaboration (ending December 2011) in place with a leader in the field They are testing NovoSorb as a significant improvement to their existing product They have committed to pay US$400,000 in milestone based payments during this period including an option to negotiate an exclusive license Project Status Group has been conducting a broad range of tests on NovoSorb. Feedback has been positive US$300,000 in milestone payments have been received so far Following conclusion of testing, the Medical Device company may negotiate a license to the field

15 US Company Collaboration Product Advantages This major medical device company chose NovoSorb after evaluating a multitude of biodegradable polymers Biodegradability, product flexibility, cost all provide advantages Market potential The company is the dominant player in a sizeable market (US$600 million +) Successful entry into this market would open up other market opportunities Key Milestones Negotiate a license in this specific field assuming positive results on the current trials

16

17 BodyShaper Cellulite Cream AOD9604 has been licensed to Phosphagenics Ltd (ASX:POH) for use in cellulite cream (BodyShaper ) and future cosmetics Positive results in clinical studies demonstrated cellulite reduction Launched in Australia in May 2011 through Myer and Priceline with strong interest US launch expected later this year Receiving royalties on sales and sublicenses

18

19 Fat Reducing Nutraceutical AOD9604 for fat reduction as an over the counter (OTC) product Investigating non-drug regulatory path to market As a nutraceutical in the US using regulatory advisors Faster and cheaper than drug development path Potentially valuable nutraceutical as pill or food additive for fat reduction Nutraceutical market for fat reduction is large and growing Next Steps Develop clear regulatory path in US with our advisors Test manufacturing scale up for the OTC market Assemble data pack for potential partners including regulatory, safety and efficacy Approach potential partners and negotiate license for OTC/nutraceutical AOD9604

20 Bone Repair AOD9604 has demonstrated bone anabolic and anti-resorptive activity in animal models Human stem cell assays demonstrating bone mineralisation This combined with the clinical safety data around AOD9604 could be of interest to partners for bone disease We are assembling a comprehensive data package for interested parties to review We would look to negotiate a license around the bone applications of AOD9604

21 Overview Positioned well in the fast growing tissue engineering field with NovoSorb as a tissue scaffold Yielding value from AOD9604 royalties from BodyShaper cellulite cream sales and potentially as a nutraceutical for fat loss in the US Upcoming milestones expected over the next 6 months include; Results from ISO safety studies on NovoSorb BTM Pilot human clinical trial for NovoSorb BTM begins for treating full thickness wounds Finalisation of collaboration with major US medical device company and pursue license Nutraceutical path mapped for AOD9604 in US Royalties from BodyShaper cellulite cream (containing AOD9604) Pursue license for bone repair applications of AOD9604