Polynovo Limited · ASX:PNV
Polynovo — Calzada — Shareholder Meeting (November 2013)
17 slides from Polynovo's shareholder meeting presentation, November 2013
Slide 1: AGM Presentation 2013
For personal use only AGM Presentation 2013 CALZADA LIMITED ASX:CZD November 2013
Slide 2: Disclaimer
Disclaimer For personal use only 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, representat
Slide 3: Calzada LTD Directors
Calzada Limited For personal use only Calzada LTD Directors ASX Code CZD David Franklyn Chairman Share Price 7.3 cents Bruce Rathie Non Exec. Issued Shares 416m David McQuillan Non Exec. Market Cap. $30 million Cash on Hand* $6.2 million Major Shareholders Merchant Funds 16% Management 8% Monash / F
Slide 4: PolyNovo biomaterials
PolyNovo 9 biomaterials
Slide 5: 2013 Key Achievements
2013 Key Achievements For personal use only • NovoSorbTM Topical Negative Pressure (TNP) wound dressing (NovoPoreTM) successfully completed 20 patient clinical trial • Submitted 510(k) for US marketing of NovoPoreTM wound dressing • Biodegradable Temporising Matrix (BTM) polymer burn and wound scaff
Slide 6: The NovoSorb Technology
The NovoSorb™ Technology For personal use only NovoSorbTM Foam Polymers Other Polymers TNP Dermal Pelvic Hernia Orthopaedic Cardio- Bone Void Drug Wound Replacement Floor Repair implants vascular Fillers eluting Dressings Repair Stents coatings Facial Augment.
Slide 7: New patents/strengthening IP protection
New patents/strengthening IP protection For personal use only Title Country Application/ Registration No. Biocompatible and biodegradable (di)isocyanate USA 8,529,880 and polyols Biocompatible and biodegradable (di)isocyanate USA 8,343,472 and polyols Biocompatible polymer compositions USA 8,445,581
Slide 8: Current Regulatory Activities
Current Regulatory Activities For personal use only Europe • Contract Notified Body (TUV SUD, Munich) to achieve marketing authorisation in Europe for medical devices using NovoSorbTM • Contract Clinical Research Organisation (MedPass, Paris) To obtain ethics approval for a burns clinical trial
Slide 9: Leveraging the Technology
Leveraging the Technology For personal use only What we have • NovoSorbTM BTM the world’s first entirely synthetic dermal replacement matrix Advantages over existing animal collagen based products • NovoPoreTM TNP dressing First regulatory submission for a NovoSorbTM product • Safe and adaptable
Slide 10: Goals for the next months
Goals for the next 12 months For personal use only • Obtain regulatory approvals for TNP and BTM • BTM burns trial in Australia commencing recruitment by year end (2013) • European key opinion leader to conduct BTM burns trial in Europe H1 2014 • Continue to build IP position • Leverage data/approva
Slide 11: metabolic
metabolic Ajuo sn jeuosied JO3
Slide 12: 2013 Key Achievements
2013 Key Achievements For personal use only • Key patent filed - Use of AOD9604 to treat conditions related to muscle & cartilage and a range of other indications • Released positive rabbit model data showing efficacy in treating Osteoarthritis with AOD9604 • Progressed achieving unconditional GRAS
Slide 13: AOD9604 Background
AOD9604 Background For personal use only 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 2nd hormone - IGF1 Bone & Muscle (made in the liver) Muscle and
Slide 14: AOD9604 in Osteoarthritis in vivo
AOD9604 in Osteoarthritis in vivo For personal use only • Rabbit collagenase model of knee osteoarthritis (Kim et al 2010) • Positive results released on 5 February 2013 AOD given as a single intra-articular injection had similar efficacy to Hyaluronic acid (HA) on cartilage repair and recovery fr
Slide 15: Case for AOD9604 in Osteoarthritis
Case for AOD9604 in Osteoarthritis For personal use only • Benign safety and tolerability profile based on animal studies and previous trials in 925 human subjects • Novel mechanism of action protected by patent, filed Dec 2012 • Bone, cartilage and muscle repair with positive effects on mesenchymal
Slide 16: Licensing to Compounding Pharmacies
Licensing to Compounding Pharmacies For personal use only • Anecdotal evidence indicates that AOD9604 is being prescribed to reduce body fat and for muscle & cartilage repair • Registered doctors can legally prescribe AOD9604 • Prescriptions can be legally made up by compounding pharmacies under Ite
Slide 17: Immediate Future Goals
Immediate Future Goals For personal use only • License AOD9604 to compounding pharmacies Progress discussions with potential licensees • Explore human and veterinary medicine partnering opportunities Potential human applications for the treatment of bone, muscle & cartilage disorders Veterinar