Calzada Ltd ASX:CZD. Presentation to Annual General Meeting 14 November 2012

Transcription

1 Calzada Ltd ASX:CZD Presentation to Annual General Meeting 14 November 2012

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. Specifically, we note that several of the items here are still under investigation and are subject to change or even elimination, depending on further research and investigation. 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.

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4 Key Achievements Low cost out-licensing strategy to generate value Metabolic s costs running at approx 10% of total CZD after tax costs Invented new applications for AOD9604 in muscle & cartilage Mt Sinai Hospital testing showed that AOD has the potential repair muscle and cartilage Contracted a Korean group to test AOD in a collagenase-induced osteoarthritis model in a rabbit. Results due early AOD may have application in a range of musculoskeletal disorders including joint disease New patent filed to protect this discovery May be possible to commence clinical development at phase 2 Potential human and veterinary applications Achieved GRAS status in the US, conditional on publication of existing safety data

5 Progress advancing AOD9604 Updated Manufacturing Plan and working closely with one company to be ready for market scale production Veterinary Applications Two large vet companies have shown some early stage interest in AOD Looking at conducting a trial in thoroughbreds for shin soreness and leg injuries Talked to other interested groups involved with Stem cells and obese dogs Human Pharmaceutical One large company completed due diligence on the osteoporosis application but declined to proceed One large device company has asked to look at the bone biologic data with the aim of enhancing bone formation Considering clinical trial opportunities in AU and overseas for weight management and joint disease US CDC - Lifetime risk of OA is 45% but for obese it is 66% and 50% for Diabetics

6 Progress advancing AOD9604 Human GRAS status Conditional on publication Two papers on existing safety data recently prepared Papers currently being submitted to journals Publication expected Q1/Q Publication will remove the condition on the GRAS enabling AOD to be added to foods, drinks & dietary supplements in the US market Exploring EU options including a novel food application

7 Summary Aim to rapidly confirm that AOD9604 has substantial potential commercial value Continue a low cost out-licensing strategy to generate shareholder wealth by exploring high potential opportunities for AOD9604 in: Human pharmaceuticals joint disease and if possible weight loss Veterinary applications - obesity and musculoskeletal disease; and GRAS foods, drinks & dietary supplements in the US Consider human clinical trial options to speed development and to significantly enhance value

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9 Negative Pressure Wound Therapy Dressing Background Around mid 2010, PolyNovo started to work on the development of a Negative Wound Pressure Therapy dressing, this product is designed to overcome the infection issue described in the FDA Preliminary Public Health Notification dated 23, November 2009 (updated in February 2011) The NPWT dressing market is estimated at $500 million per year and is increasing steadily year on year Goals Develop a product with a better biological safety profile Improve patient outcome and reduce infection risk Have a market ready product in 2013 Regulatory strategy Concentrate efforts on 510 k) application for the US market Predicate device includes Granufoam TM Lodge 510 k) application as soon as possible (clinical trial results not required) Obtain marketing authorisation in 2013 CE mark application during 2013 Prepare technical file (Class 2B device) Achieve ISO accreditation (scope to include medical device manufacturing)

10 Negative Pressure Wound Therapy Dressing Clinical trial Status 15 patients enrolled: 10 completed treatment, 2 withdrawn ( one in each group), 3 currently in treatment NovoSorb Vac dressings perform as expected Commercial strategy Publish clinical data to support commercial activities Select a partner for distribution or licencing agreement in 2013 Generate revenue through product manufacturing and royalties

11 Biodegradable Temporising Matrix BTM Background BTM project was given highest priority in the new strategic plan formulated in 2010, in order to achieve a First in Man event within 2 years. Following the award of a BioSA grant in July 2010, the device development and preclinical activities commenced The BTM is designed to provide a best in class alternative to existing dermal replacement devices for third degree burns The market size for dermal replacement device is currently estimated at $200 million Goals Develop a synthetic product to overcome the issues associated with collagen based products Improve patient outcome Reduce third degree burn treatment cost Achieve first in man use of the NovoSorb technology Have a market ready product in 2013/2014 Regulatory strategy CE mark application for the European Market Prepare Design Dossier (Class 3 device) Achieve ISO accreditation (scope to include medical device manufacturing) Evaluate clinical trial requirements after Free Flap trial completion

12 Biodegradable Temporising Matrix BTM US market Third degree burn treatment requires PMA IDE required to commence clinical trial Prepare first IDE (2012) for Feasibility Trial in 2013 Obtain PMA in 2014 Evaluate 510k) application for full thickness surgical wounds and deep dermal burns requiring skin graft Predicate device includes Integra TM If 510 k) is an option, have a product ready in 2013 Clinical trial Status 4 patients enrolled: 4 completed treatment NovoSorb TM BTMs perform as expected Further Clinical trials HREC application for Burn trial lodged (decision 15 November) Received positive feedback from KOLs to participate in pivotal trial including US, France, Japan Started dialogue with the FDA regarding US trial

13 Biodegradable Temporising Matrix BTM Commercial strategy Publish clinical data to support commercial activities Validate device manufacturing processes Continue dialogue with KOL s in Europe and US Small concentrated market reduces reliance on distributor for BTM, offering the possibility for NovoSkin to market product independently Finalise commercial strategy by H1 2012

14 Smith and Nephew license PolyNovo continues to work with Smith and Nephew to develop products in the Bone Void Filler and Fracture Fixation fields Supply of testing material for the DARPA project generated small revenue in 2012 (US$120,000) Device developments are driven by Smith and Nephew

15 PolyNovo Key Achievements Developed a NovoSorb TM scaffold with utility in multiple medical device applications Developed and optimised BTM for full thickness burns First in Man event with 2 clinical trials currently underway Established relationship with KOLs Demonstrated PolyNovo s ability to deliver on its strategy Cultured Composite Skin ( Artificial skin ) proof of concept achieved, demonstrating NovoSorb TM scaffold utility in Tissue Engineering applications