Significant advances in the treatment of skin cancer

1
Significant advances in the treatment of skin
cancer

• November 2006
• PEP.ASX
• www.peplin.com

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Peplin highlights..

• Two late stage dermatology products
• New class of small molecules
• Unique mechanism of action
• Highly attractive product profile
• Significant unmet medical need
• A significant advance for actinic keratosis and
  skin cancer
• gt200 patients, phase II stage of development
• Discrete, accessible prescriber population
• Broad, long-life patent portfolio
• Well capitalized to deliver phase IIb results
• Blue chip international investors
• Public company listed on the Australian Stock
  Exchange

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Product pipeline
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Significant unmet dermatology market
Supplant topicals, add to procedures

• Actinic keratosis
• US1.2 billion in 2004
• 8.2 million office visits in 2002 (1)
• Cryotherapy, emerging high growth topical market
• Non-melanoma skin cancer
• US1.4 billion in 2004
• 1.6 million office visits in 2002 (1)
• Surgery
• Unmet medical need
• Surgery
• Pain and discomfort
• Poor cosmetic profile
• Topical products
• Long course of therapy
• Significant side effects
• Poor compliance

1 The Burden of Skin Diseases, The Lewin Group
2005
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AK Topical
A new product for a large and unsatisfied market
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Actinic keratosis

• Pre-cancerous lesions
• Caused by photo-damage
• Can become skin cancer
• Highly prevalent, chronic condition
• Affects 50 of Caucasians gt40 yrs
• 58 million North Americans
• 8.2 million treatments annually (1)
• 78 of cases have multiple lesions
• Surgical and medical treatments

1. Source Lewin Group, The Burden of Skin
Diseases 2005
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In-office procedures
1. Source International Journal of Dermatology
2004, 43, 687-692
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Medical treatments
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AK Topical attractive profile

• Take-home, patient applied
• Field therapy for AK and surrounding photodamaged
  skin
• Short 2-3 day treatment
• Better compliance
• Well tolerated, transient local skin responses
• Attractive cosmetic outcome
• Competitive efficacy
• Phase II data

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Rapidly growing topical market
US market only, US000
Source IMS, Peplin, extrapolated from Q2 2006
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AK Topical Strong clinical data
Competitive efficacy, short therapy

• IND filed June 2004
• Three AK trials (2005-2006)
• Single dose phase I
• Two dose phase IIa
• Two dose field therapy
• Significant safety database
• gt100 patients treated
• Local skin responses mild to moderate and
  transient
• Comparable efficacy to marketed products

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Key AK clinical trial
Statistically significant clearance metrics

• PEP005-001 (actinic keratosis)
• Multi-center, vehicle controlled, blinded,
  parallel group
• 60 patients, 5 discrete lesions per patient, 3
  active arms
• Two applications of drug on two days
• Results
• Safe and well tolerated
• Majority of local skin responses mild to moderate
• Statistically significant clearance of lesions

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Next steps AK Topical

• US phase IIb (PEP005-006) underway
• 20 center, 200 subjects, vehicle controlled,
  double blind
• Take-home, patient applied on 2 or 3 days
• To a 5x5 cm2 area of skin with 4-8 AK lesions
• Complete mid 2007
• Phase III planned H2 2007

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BCC Topical
A new paradigm in the treatment of skin cancer
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Non-melanoma skin cancer

• Most prevalent cancer worldwide
• Basal cell carcinoma (BCC) 80
• Squamous cell carcinoma (SCC) 16
• 1.2 million cases in US in 2004 (1)
• Incidence 6-7 increase annually
• Gold standard is surgical excision

1. Source Lewin Group The Burden of Skin
Diseases 2005
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BCC Topical attractive product profile

• Physician applied
• 1 or 2 in-office treatments
• Higher concentration than AK treatment
• Reimbursed therapy
• Better cosmesis than surgery
• reduced pain, scarring, infections
• no sutures

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sBCC clinical trials
Statistically significant 70 clearance

• PEP005-003 sBCC
• Multi-center, vehicle controlled, blinded,
  parallel group
• 60 patients, 3 active arms, two applications on
  two days
• Results
• Safe and well tolerated
• Majority of local skin responses mild to moderate
• Dose dependent response to drug
• Statistically significant, histology confirmed
  clearance of sBCC

P0.02
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Next steps BCC Topical
Dose optimization

• PEP005-009
• Open label, dose escalation to establish MTDs
• Single dose and 2 dose application
• 25 subjects at MTD
• Establish 95 confidence interval around efficacy
  rate
• Initiate Q4 2006

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PEP005 (3-ingenyl angelate)

• Dual mode of action
• 1) Local primary necrosis1
• Mitochondrial breakdown
• 2) Recruitment of neutrophils
• Kill residual tumor cells preventing relapse of
  the tumor via ADCC
• gt70 relapse rate in(2) neutrophil depleted
  animals

• Cancer Research 64 2833-2899 April 15, 2004
• J. Immunology in press

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Manufacturing

• PEP005 from Euphorbia peplus
• Grown, harvested in lt16 weeks
• Dried, milled and crude extraction
• GMP purification to pure crystalline API
• Highly attractive COGS
• GMP licensed manufacturing facility
• Southport, Queensland
• Government grants
• Passed TGA regulatory inspection

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Discrete, accessible market
Modest resource requirements

• Accessible dermatologists targets
• 10,000 board certified US
• High prescribers 20 write 80 of Rx
• 50-60 person sales force
• Modest marketing budget
• Target key opinion leaders
• Components of product commercialization
• Proprietary US sales
• Potential to license non-core non-US rights
• Co-marketing opportunities in primary care

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Peplin outlook

• Focus advance lead product for skin cancer
• Progress dermatology focused pharmaceutical
  pipeline
• North American focus
• Enhance capability in later stage product
  development
• Key hires in regulatory, finance, medical
  commercial functions
• Fund growth and development

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Team with track-record
90 years relevant experience

• Michael Aldridge, Managing Director CEO
• Healthcare investment banking
• Bears Stearns Co (New York), Volpe Brown Whelan
  Co (San Francisco)
• Philip Moody, Chief Financial Officer
• Vice President, Finance and Operations, Chiron
  Corporation (California)
• 11 years with Chiron in senior finance and
  operational roles
• Peter Welburn, CSO
• Strategic marketing, SmithKline Beecham
• Research development, Janssen-Cilag
• Gary Patou, CMO
• Senior Vice President Director, Project and
  Portfolio Management, SB
• FDA-approved products Avandia, Paxil and
  Augmentin
• Cheri Jones, VP Regulatory Affairs
• Vice President Regulatory Affairs QLT USA, Inc.
  previously Valeant and Bristol Myers
• Three NDA approvals, including Aczone for acne
  vulgaris

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International board
Matched to strategic opportunity

• Non-executive directors
• Dr Cherrell Hirst, Chairman
• Gene Bauer MD, CEO, Neosil, Inc.
• Founder of Connetics, Dean Stanford Medical
  School
• Gary Pace, CEO Chairman, QRx Pharma Pty Ltd
• Founder and Board member Resmed, Inc.
• Jim Scopa, Partner MPM Capital
• Co-head healthcare Thomas Weisel, Deutsche Bank
  Alex Brown
• Michael Spooner, Executive Chairman, Mesoblast
  Ltd.
• CEO Ventracor, PricewaterhouseCoopers

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Successful international financing

• International placement
• A26 million
• A0.71 per share, 30 warrants, 4 years at A0.84
• MPM Capital, Deerfield, Orbis, AMP
• Two equal A13 million tranches
• First closed on June 26 2006
• Second closed November 1 2006
• Entitlement offer
• Pro-rata offer to Peplin shareholders
• A13 million
• A0.71 per share, 30 warrants, 4 years at A0.84
• Closed 3 July 2006

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Financial summary
Pro-forma MPM Capital led June capital raising,
market cap at offer price
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Financial summary
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News flow 2006/07

• Achievements
• Positive results of sBCC trial
• Major international capital raising
• Established North American presence
• Opened manufacturing facility
• Milestones
• Results AK phase IIb trial (US)
• Results BCC phase IIb trial (US/Aus)
• Initiate AK phase III

May 2006 June 2006 June 2006 July 2006
Mid 2007 H2 2007 H2 2007
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Significant advances in the treatment of skin
cancer

• November 2006
• PEP.ASX
• www.peplin.com