Title: An emerging biotechnology company with a focus on:
1An emerging biotechnology company with a focus on
- drug development to reduce the incidence of skin
cancer and - the manufacture and distribution of dermatology
products.
December 2002EpiTan LimitedMelbourne, Australia
2Contents
- Page
- Market data 3
- The business 4
- Trial results 5
- Planned trials 9
- Current project plan 10
- Market size 11
- Other initiatives 12
- Upside 13
- Executional ability 15
- Fundraising 16
- Current financial position 17
- Summary 18
- Appendix I - Comparable companies 19
2
3Market data
- ASX Ticker EPT
- Listed February 2001
- Current price 0.13
- Current capital structure Issued Escrow Trading
- (Feb. 03)
- Shares (m) 86.4 38.0 48.4
- Options (m)
- Ordinary (ex price 30 cents) (m) 60.2 23.1 37.1
- Incentive scheme (m) 6.1
- Ordinary options expire 30 June 2003
- Shareholding
- 1340 shareholders
- 40 held by 2 largest shareholders (escrowed)
- Market capitalisation (at 0.13) 11.2 million
- 12 Month High/Low 0.32 / 0.05
3
4The business
- Exclusive worldwide development and
commercialisation rights to Melanotan. - Melanotan has the potential to reduce skin damage
(caused by the sun) by stimulating the bodys own
protective tanning mechanism. - Skin damage often leads to skin cancer, the most
common of all cancers. - Inverse relationship between the incidence of
skin cancer and pigmentation of the skin is well
documented. - EpiTan holds patents covering the structure and
method of application of Melanotan in the major
jurisdictions. - Ongoing research and development, particularly in
drug delivery, will lead to further intellectual
property protection.
4
5Trial results
- Physicians Investigational New Drug (IND) Trials
(FDA approved) on 100 human volunteers conducted
in Arizona (USA) in the 1990s. - IND Trials demonstrated safety and showed a small
dose of Melanotan given daily over 10 days
produces a 4-6 week tan. - Phase I/II clinical trial successfully completed
at Royal Adelaide Hospital in March 2002. - Phase I/II trial showed Melanotan caused a
statistically significant increase in skin
melanin density. - Minor side effects, including mild nausea,
injection site irritation and transient facial
flushing, related to the mode of administration
and drug formulation, which are now able to be
resolved by the Company.
5
6Preclinical animal trials
No Melanotan
Following Melanotan treatment
No Melanotan
Light-coloured hair regrowth upon cessation of
treatment
6
7Arizona IND studies
Three weeks of Melanotan treatment
No Melanotan
7
8Phase I/II clinical trial results Melanin Density
Baseline Corrected MelaninDensity Values on day
9 and 30
8
9Clinical trial schedule
- Phase IIb clinical trial commenced in November
2002 (80 subjects). - One objective to measure the effect of Melanotan
on reducing the incidence of sunburn cells after
controlled UV exposure. - Clinical trials of a sustained release
formulation of Melanotan anticipated to commence
in early 2003. - Sustained release formulation
- being developed in collaboration with the
Southern Research Institute (Alabama, USA) - will reduce levels of drug required (a single
dose will provide protection of up to 6 months)
and - will eliminate side effects noted in Phase I/II
clinical trials.
9
10Current Melanotan project plan
10
11Market size
- No other comparable drug known to be in clinical
trials. - Global dermatology market well over US1.5
billion per annum. - Cosmetic market (fake tanning stains / dyes and
solariums) estimated at gtUS5 billion per annum
worldwide. - A500 million per annum in skin cancer treatment
costs in Australia and rising. - Other potential therapeutic indications for
Melanotan - - Vitiligo - Polymorphous Light Eruptions
- - Albinism - Porphyria
- - Xeroderma Pigmentosa
11
12Other initiatives
- Expansion into new leading-edge dermatology
products to generate revenues in the short-term. - Appointment of a US-based consultant to source
new products for distribution in the Australasian
region. - Appointment of Mr Stan McLiesh (former General
Manager - Pharmaceuticals for CSL Limited) to the
Board. - Mr McLiesh brokered numerous in-licensing
agreements with international companies, enabling
CSL to expand into new markets.
12
13Upside
- Share price appreciation to come from
- Phase IIb trial development
- Currently only 13 ASX-listed companies with drugs
in Phase II clinical trials - Of these, EpiTan has one of the lowest market
capitalisations (refer Appendix I) - Phase IIb trials commenced in November and
- EpiTans trials conducted at a fraction of the
cost of other clinical trials because Melanotan
is a preventative drug rather than a therapeutic. - Revenue streams now being developed
- Company is currently investigating several
in-licensing opportunities for dermatology
products for distribution in Australia and New
Zealand.
13
14Upside continued
- Partnering
- Following successful completion of Phase I/II
trials, approaches to consider - partnering have come from Big Pharma. A
partnering deal could result in - recoupment of certain project expenditure
- substantial project funding
- shortening of time to market
- additional technical support
- global product distribution capability and
- increased credibility / profile.
14
15Executional ability
- Board of Directors
- Dr. Wayne Millen BSc(Hons) PhD FRACI C.CHEM AFAIM
CHAIRMAN and CEO - Dr. Helmer Agersborg BS PhD DEPUTY CHAIRMAN
- Dr. Terry Winters BSc PhD NON-EXECUTIVE DIRECTOR
- Clinical Assoc. Prof. Alan Cooper OAM, BSc MBBS
FACD Dip.Amer.Brd.Derm NON-EXECUTIVE DIRECTOR - Mr Stanley McLiesh BEd NON-EXECUTIVE DIRECTOR
- Management and consultants
- Dr. Stuart Humphrey BSc PhD MANAGERCLINICAL
DEVELOPMENT - Mr. Michael Kleinig BAppSc MANAGER-PHARMACEUTICAL
DEVELOPMENT - Professor Robert Dorr BS MS PhD RPh TECHNICAL
CONSULTANT Professor of Pharmacology and
Director of the Pharmacology Research Program at
the Arizona Cancer Center, USA - Professor Terry Dwyer AM MB BS MPH MD TECHNICAL
CONSULTANT Director of the Menzies Centre for
Population Health Research - Mr Thomas Laughlin BA MBA IN-LICENSING
CONSULTANT
15
16Fundraising
- Shareholder approval has been obtained to issue
up to 20 million new ordinary shares via a
placement. - Pricing to be determined (no less than 80 of
average market price). - Funds raised to be applied to
- accelerate development of Melanotan
- dermatology products operation and
- working capital.
16
17Current financial position
- Cash at bank - 1 July 2002 - 4.4 million.
- Cash budget - FY03
- million
- Cash at 1 July 2002 4.41
- Projected income (interest, GST refund) to 30
June 2003 0.50 - Total 4.91
- Preclinical clinical studies (1.8)
- Drug formulation and development (1.4)
- Suppliers, employees, corporate (1.4)
- Net surplus 30 June 2003 0.3
- The above does not allow for any revenues
generated from the in-licensing and distribution
of dermatology products.
17
18Summary
- Innovative technology.
- Granted world patents, licence and trademarks.
- Phase I/II clinical trial successfully completed
in March 2002. - Phase IIb clinical trial commenced in November
2002. - Major international market
US6.5 billion per annum. - Potential partnering with Big Pharma.
- In-licensed product opportunities being
developed. - World-class board and management team.
- Strong financial position as at 1 July 2002.
18
19Appendix I - Comparable companies
Includes market capitalisation of restricted
shares
19