Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Non-Deal Roadshow (July 2006)
40 slides from Clinuvel Pharmaceuticals's roadshow presentation, Jul 7, 2006
Slide 1: Clinuvel
Slide 2: Presenters
Ph ippe Wolgen, MBA MD Dr Terry Wi inters
Slide 3: Profile Summary Clinuvel
Profile Summary Clinuvel * Melbourne based drug development company * Potential block buster drug to induce melanin in skin * Phase 1 and 2 Australia trials showed: - Increased melanin concentration most significant in skin | and Il (Fitzpatrick) - Safe with no side effects ~...Dermal darkening (tan
Slide 4: Management Clinuvel Pharmaceuticals Ltd
Management Clinuvel Pharmaceuticals Ltd « Dr Philippe Wolgen ~ Chief Executive Officer * Dr Roger Aston ~ Executive Chairman ¢ Dr Hank Agersborg — Chief Scientific Officer — Chief Financial. Officer Mr Darren Keamy Head Regulatory.Affai
Slide 5: Intellectual property
Intellectual property ¢ Slow release IP is strong, active 2024 ~ Based on long-term human response to slow release delivery CUV1647 ~ Worldwide patents cover sustained blood concentration required irrespective of delivery form = Sole domain,owned by Clinuvel, free of royalties Increased barrier to e
Slide 6: History
History ¢ Work at U Arizona in 80’s developed analogues of MSH ¢ First use in humans in 1991 showed dermal darkening (tanning)
Slide 7: History
History e Epitan addressed the TGA on prevention of sun damage as indication. Developed controlled release formulation. « New team installed Nov 05 to reposition company Change strategy & na e to linuvel Pharmaceuti
Slide 8: Markets
Markets « Prevention of: ~ Skin cancer: 750,000 cases/year in USA ~ PLE : Prevalent in Caucasian (fair-skinned) population ~ 3rd orphan indication Larger cosmetic market
Slide 9: Technology
Technology « CUV1647 is a peptide analogue of a-MSH ¢« 100-1,000 x more potent & 50 x more stable in blood ° Delivery must be into bloodstream as systemic drug
Slide 10: Technology
Technology * Dermal Darkening (tan) develops over 4-5 days, lasts for up to 60 days photo protection UV protection Caused by| NATURAL Bynthesis-of- eu
Slide 11: Competition
Competition « No direct pharmaceutical or ‘drug’ competitors: * All competition is indirect: ~, Surgical excision of skin cancers. and-topical drugs to reduce Actinic Keratosis
Slide 12: Clinical trials to date
Clinical trials to date
Slide 13: Melanin density change by skin type
Melanin density change by skin type —-e- — Always burn, never tan (n=7) —*— Usually bum, tan less than average (with difficulty) (n=30) —-@--Sometimes mild burn, tan about average (n=8)
Slide 14: Interim results Phase II trial PLE
Interim results Phase II trial PLE 18th April 2006 (ASX announcement) a Polymorphous Light Eruption = severe skin disorder * Statistical significant difference (n=26) Active versus control (p<.01)
Slide 15: Mechanism of action CUV 1647
Mechanism of action CUV 1647 « 13-aminoacid linear peptide (analogue of human a-MSH) modified on A4 and A7 * .Agonistic for MC-1R/upregulation
Slide 16: Biological Building blocks
Biological Building blocks: 20 L-a-Amino Acids » Alanine « Arginine * lsoleucine « Asparagine * Leucine ° Aspartic Acid «. Gysteine « . Methionine * Phenylalanine + Glutamic acid y «Glutamine *~ Proline ean
Slide 17: Tyrosine
oO + NH3 Tyrosine O TYROSINE HYDROXYLASE | | | HO oO NH3" HO on DOPA (3,4 Dihydroxyphenylainine) “TYROSINE HYDROXYLASE
Slide 18: Consequences of Sun-induced UV-Damage
Consequences of Sun-induced UV-Damage (280-420 nm) » Karyometric changes to skin cells (DNA/p53) = nuclear signatures © 17p13, mutations in gene ps3 =.photo carcinogenesi
Slide 19: CUV 1647 implant
CUV 1647 implant A:
Slide 20: Polymorphous Light Eruption (PLE)
Polymorphous Light Eruption (PLE) * Sun-intolerance expressed as severe rashes / vesicles / papules / eryihema _ * - Socially debilitates patients Inability to go in the sun
Slide 21: Skin cancer
Skin cancer « US cases of skin cancer are equal to all other types combined Over 750,000 patienis/year ¢ Squamous and basal cell carcinoma caused by direct UV-radiation
Slide 22: Skin cancer
Skin cancer « Australia, Arizona, Scotland and Scandinavia are “skin cancer capitals of the world” * Skin cancer occurs more frequently in fair skinned people and is rare in black people
Slide 23: Skin cancer precursor - Actinic Keratosis
Skin cancer precursor - Actinic Keratosis * Actinic/Solar Keratosis ~ lesions of the skin due to lifetime accumulated exposure to UV/sun — widely reported as carcinoma in situ (CIS) — 1:25 develops into full-blown skin cancer (SCC) -~. Seen in-normal population
Slide 24: Actinic Keratosis = Solar Keratosis
Actinic Keratosis = Solar Keratosis Accumulated exposure to sun Current treatment modalities by « Surgery « . Cryosurgery PDT(LASER). 5-FU
Slide 25: Normal Skin Skin Cancer
Normal Skin Skin Cancer (80C) 9 a Me ee Ore WS Br OL We ES Reversible irreversible AK is the precursor to skin cancer
Slide 26: eae
—_—, "y _ eae >) > em a wut exe ee ara fF ‘ Ca Normal Skin Skin Cancer . (scc) 290 A 6 we A ae A MEO OHO mS Oe Reversible irreversible
Slide 27: Markets for SkinCancer & SkinCare products
Markets for SkinCancer & SkinCare products « 7.9 million Americans saw physician for Actinic Keratosis (AIK) in 2004 at a cost of $US ‘billion
Slide 28: Summary of clinical results to date
Summary of clinical results to date * Initial trial with daily injection for 30 days gave modest darkening (tanning) with lignt nausea and flushing (yr ‘00) » First slow release implant gave. dramatic results at low dose, necessitating a much lower.dose a (yr 02) ~ Side effects disappeared
Slide 29: Clinical Program
Clinical Program Results PK trial (CUVO006) (06) Results PLE Phase Ilb Melbourne (to be announced) (06) Pilot trial in Phase {| Actinic Keratosis - reduction-in Tx patients (06) (06 Pilot trial in 3rd indication (to be announced)
Slide 30: Funding requirements CUV 1647
Funding requirements CUV 1647 AUD$ 2006 2007 2008 2009 Total interest (293,000) (395,000) (395,000) (395,000) | (1,478,000) Recv. Clin. 4,090,657 17,583,333 .| .9,766,667 4,390,000...) 35,830,657 Program ; Manufact. 3,267,126 3,024,487 -| 2,647,658 525,600 | 9,464,873 R&D
Slide 31: Business strategy
Business strategy « First approval in Australia, follow with US and EU * Co-market in USA with partner License in EU and other worldwide markets
Slide 32: Share price history
Share price history S420 During ‘08 During “04 Dudig 05 Benner oboe 283, 4,800,600, 1.40 $927,000 $2,499,000 $100,000 14,809,000 4,000,000 shatee ete oe alten shied 0 $300,000 4,204,002 Shes ded os $4,418,008 16,590,908 spas ated te $8,475,000 4,990,308 shine eset et).
Slide 33: Capital Structure
Capital Structure « Total Ordinary Shares -185.2m * Unlisted Options - 15.8 m (8.5%) ° ASX - CUV + ADR (level 1) ~CLVLY
Slide 34: Top shareholders
Fop 20 shareholders Ordinary fully paid shares 1. ANZ Nominees Limited 11. Chartport Financial 2. Westpac Custodian Nominees Services Pty Ltd Lid 12. Banque SCS Alliance Sa 3. Citicorp Nominees Pty Ltd 13. Mr Robert Thomas Dorr 4. Weighton Pty Ltd 14. Mac Eugene Hadley Family. 5. Loughran & Co 45. M
Slide 35: ACM Term Sheet Dec 2005
ACM Term Sheet Dec 2005 | Appt Wolgen, Agersborg ° 5 milestones il Phase Ill Aus lil IND filing in US IV AIM listing « Total A$10m V_ Corp partner “First payment/milestone A$im A$2m AS3m A$im A$3m
Slide 36: Finance & funding required
Finance & funding required * $5m Private Placement completed 1s! May 2006 * 7% ability for new placement (11m shares).
Slide 37: Investment proposal Clinuvel
Investment proposal Clinuvel ¢ Join ACM Term Sheet 9% @ 30 days VWAP - 5 milestones - 24 months - minimum A$1m tranches
Slide 38: Significant global interest
Significant global interest from clinicians, pharmaceutical companies, investors, public during the past 5 years 0,000 Web Hits: a / MIMI Jeti | Ne 1) a Te i iii: a a a — | a a A a : oN a. : i ee INN ie Appendix 1
Slide 39: Our ability to bring this drug to market
“Our ability to bring this drug to market does not hi 19¢ por Le fficac
Slide 40: Conclusions
Conclusions « CUV 1647 is potential blockbuster drug ~ Addressing vast markets * Past trials have shown natural darkening and no safely | issues 2006 exit Chirtvel
Clinuvel Pharmaceuticals — Non-Deal Roadshow (July 2006) on 6ix