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Calzada Ltd ASX:CZD Investor Overview June 2013 1 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

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Calzada Ltd

ASX:CZD Investor Overview

June 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 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. 2

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Calzada Limited

  • ASX:CZD
  • Share price: 8 cents
  • Market Capitalisation: $28m
  • Current Cash: $2.9m (+ approx $750k R&D refund from ATO expected Q3 2013)
  • Cash Burn: approximately $2.5m per annum (net of R & D refund)
  • Major Shareholders:
  • Merchant Funds Management: 19.6%
  • Senior Management: 9%
  • Monash University & Prof Ng: 4%
  • Two 100% owned subsidiaries:
  • PolyNovo Biomaterials Pty Ltd:

Owns NovoSorb™, a suite of biodegradable polymers used in medical devices and as tissue repair scaffolds

  • Metabolic Pharmaceuticals Pty Ltd:

Owns AOD9604, a peptide proven safe in human trials with activity in fat reduction, bone health, cartilage and muscle applications

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PolyNovo Mission

“PolyNovo will develop a portfolio of medical devices, based on its NovoSorb™ technology, focussed on delivering superior clinical outcomes for patients and economic benefits to healthcare providers.”

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PolyNovo

  • 1. Products and technology
  • 2. Development
  • 3. Commercialisation strategy

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NovoSorb™

  • NovoSorb™ can be used as a wound scaffold for multiple tissue

repair applications and dissolves when the repair is complete

  • First applications in burns and wound management, developed by

NovoSkin (80% owned PolyNovo) in partnership with Dr John Greenwood, AM (Director, Adult Burns Unit, Royal Adelaide Hospital)

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NovoSorb™

  • The NovoSorb™ family of polymers is the result of
  • ver ten years of development including :
  • Four years of fundamental research conducted by world leading

biomaterial expert Dr Thilak Gunatillake at the Commonwealth Scientific and Industrial Research Organisation (CSIRO)

  • Seven years of applied research and development conducted by

NovoSkin to develop the wound management products

  • $18 million invested to date in developing NovoSorb™

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NovoSorb™

  • Key advantages:
  • Excellent biocompatibility (material and degradation products)
  • Cost effective
  • Easy to process
  • Excellent scalability
  • Sterilisation by Gamma irradiation
  • Long shelf life at room temperature

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NovoSorb™ Safety

  • Completed ISO 10993 testing to GLP standard
  • Sensitisation, Pyrogen, Irritation, Sub-cutaneous Implantation, Sub-chronic

Systemic Toxicity (90 days), Systemic Toxicity (180 days), Genotoxicity (Ames, Mouse Lymphoma), Cytotoxicity

  • Completed multiple large animal studies (30 pigs)
  • Successfully completed 1 human clinical trial Topical Negative Pressure (TNP)

wound dressings

  • 20 patients (controlled, randomised)
  • Full thickness wound clinical trial underway
  • 10 patients, Free Flap (full thickness wounds) donor site reconstruction
  • 8 patients already recruited and treated

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PolyNovo developments

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Revenues NovoSorb™ Topical Negative Pressure (TNP) Dressing

Diabetic,Pressure & Other Ulcers, Abdominal Surgical Wounds

Surgical wounds(BTM)

Surgical Wounds, Ulcers, Deep Dermal Burns,Other Wounds

Full thickness Burns (BTM)

Third Degree Burns

Urogynecology (Based on BTM)

Pelvic floor repair

Hernia Mesh (Based on BTM) Smith and Nephew Partnership Milestone achieved Target date Started Target date Not yet started R&D Pre-clinical CE mark Partnering PMA Clinical 510(k) Undisclosed

Q4 2013 Q4 2013 Q4 2014 Q3 2013 Q4 2013 TBD TBD Q2 2014 Q4 2015 Q1 2016 Q4 2014 Q2 2015 TBD Q2 2014 Q4 2015

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Biodegradable Temporising Matrix (BTM)

  • BTM is a NovoSorb™ foam coated with a non-biodegradable membrane

used as a scaffold for dermal repair in full thickness wounds

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BTM

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  • BTM advantages over current products:
  • Reduced risk of infection/ loss of device
  • Improved tissue growth and revascularisation
  • Mechanically robust
  • Cost effective manufacturing
  • Long term room temperature storage
  • Gamma sterilised.

NovoSorb Current Products (Integra) Vascularisation At 5 days Between 14 and 21 days Tissue growth By day 10 By day 21 Skin grafting Start at day 14 Start at day 21 Seal removal >28 days possible Max 28 days

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BTM Clinical Trial

  • Free flap full thickness wound donor site untreated
  • BTM implanted in donor site
  • Skin graft >10 weeks

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Patient 1

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Topical Negative Pressure Dressings

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Rationale

  • Issues with existing TNP dressings listed in the FDA Preliminary Public Health Notification: Serious

Complications Associated with Negative Pressure Wound Therapy Systems

  • Infection
  • Fragmentation
  • Dressing embedded in wound
  • Bleeding

The NovoSorb™ Solution:

Now:

  • Improved biocompatibility: less risk of infection from dressing fragments
  • Improved design: less fragmentation,
  • Biodegradable: will degrade safely if fragments are left behind
  • Less tissue ingrowth in dressing: Reduced bleeding

Potentially:

  • Reduce dressing change frequency
  • Increase patient pool

Reduce overall cost of treatment

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Topical Negative Pressure Dressings

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  • Key market data:

Cost*: Pressure ulcers cost $9.1-$11.6 billion per year in the US. Cost of individual patient care ranges from $20,900 to 151,700 per pressure ulcer. Medicare estimated in 2007 that each pressure ulcer added $43,180 in costs to a hospital stay. Deaths*: About 60,000 patients die as a direct result of a pressure ulcer each year.

*Source: Agency for Healthcare Research and Quality (US, AHRQ)

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NovoSorb™ Commercialisation Strategy

  • Leverage our NovoSorb™ technology platform
  • Establish commercial/strategic alliances to commercialise NovoSorb™ based medical

devices

  • Focus on developing medical devices to improve on existing devices and/or to resolve

unmet clinical needs

  • Topical Negative Pressure (TNP) dressing
  • Biodegradable Temporising Matrix (BTM)
  • Leverage BTM/TNP development and clinical data for new applications
  • Hernia Repair
  • Pelvic Floor Prolapse repair
  • Facial reconstruction (chin augmentation (genioplasty), cheek augmentation (malarplasty),nose augmentation (rhinoplasty))
  • Manufacture medical devices and/or device components
  • Commercialisation pathways
  • Establish distribution partnership with market leaders for high volume applications
  • Establish collaborative partnership leveraging marketing/technical capabilities
  • Investigate potential for direct hospital supply in small volume/niche markets

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NovoSorb™ next steps

  • 510K regulatory submission for TNP application Submission Q3 2013
  • Seeking a partner to distribute TNP dressing Market size >$400 m
  • In discussions with multiple potential partners
  • Investigate
  • BTM for surgical wounds
  • BTM for third degree burn Market size > $200 m
  • Awaiting BARDA contract response to determine commercialisation path
  • Hernia repair Market size >$1 b
  • In discussions with potential partner
  • Pelvic Floor Prolapse repair Market size >$1 b
  • In discussions with potential partner
  • Facial reconstruction
  • In discussions with potential JV partner

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20 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

AOD9604 Activity Pathways

Burns fat, Inhibits storage

IGF-1 and pro-diabetic effects removed Cartilage & Muscle

Promotes repair

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

IGF-1 pathway Direct cellular pathway

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AOD9604 Background & Strategy

Background

  • Positive in-vitro and in-vivo data in fat, bone, cartilage & muscle cells
  • Past clinical development proved AOD9604 is very safe with some evidence of weight loss in population

sub-sets observed - 700 humans and >1,000 animals treated

  • Has been used in Phosphagenics’ (ASX:POH) BodyShaper ant-cellulite cream
  • Existing “Black market” use may indicate that it is being used to reduce body fat and muscle repair

Commercialisation Strategy

  • Low cost strategy adopted to generate shareholder value. (Running costs approximately 10% of total CZD

costs)

  • Exploring licensing opportunities
  • Potential human applications for the treatment of bone, muscle & cartilage disorders
  • Determine the legal viability of licensing to compounding pharmacies
  • Veterinary applications – osteoarthritis, obesity and others
  • Over The Counter applications – AOD9604 could be added to foods, drinks & dietary supplements in USA.

Commercial options to be investigated. Has received conditional Generally Recognised As Safe (GRAS) status subject only to publication of existing safety data in peer scientific journal

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