Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (March 2023)
20 slides from Clinuvel Pharmaceuticals's investor presentation, Mar 30, 2023
Slide 1: Nasdaq 29 March 2023
For personal use only Nasdaq 29 March 2023 ASX CUV Börse Frankfurt UR9 ADR CLVLY
Slide 2: Safe Harbor
Safe Harbor For personal use only This release contains forward-looking statements, which reflect the reimbursement; that the Company may incur unexpected delays in the current beliefs and expectations of CLINUVEL’s management. outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or Statements may invo
Slide 3: The Melanocortin Story 1933-2025
The Melanocortin Story 1933-2025 ACTH 1-24 / 1-39 Properties Environment NME-Branded For personal use only Libido FDA – SCENESSE® vitiligo 2025 Parvysmelanotide 2025 α-MSH / Conjugates Anorexic EMA – SCENESSE® XP 24/25 Melanogenesis ACTH – controlled-release 2024 2021 1st FDA workshop - Anti-oxidati
Slide 4: Chiaroscuro
Chiaroscuro For personal use only Carvaggio 1608: Fra Antonio Martelli - portrait Who sees light and who sees shadows?
Slide 5: CLINUVEL's Model – Phases
CLINUVEL’s Model – 2 Phases Risk Management For personal use only 1.Weighted Investment Thesis COM DEM PRE PAY REG CLI R&D Unmet Need RWE Willingness Evidence In-house Exec & Scale Fin PoP Period CAR* SCA** HDC EQ OPEX 2. Fiscal Discipline ‘05–’10 6m 16–32m 24 R&D A$110m – A$140m Phase 1 ‘11–’16 12m
Slide 6: Targeting Arterial Ischemic Stroke (AIS)
Targeting Arterial Ischemic Stroke (AIS) DISEASE BURDEN Pharmacology afamelanotide For personal use only Melanocortin receptors - ubiquitous cerebral location US stroke statistics: ‘The potential for melanocortins and their analogs to address CNS disorders has been widely researched’ • 795,000 patie
Slide 7: Arterial Ischemic Stroke
Arterial Ischemic Stroke Individual NIHSS scores – CUV801 Days 0–42 For personal use only Targeted product position A hormonal treatment to assist hypoxic brain. Study CUV801 (n=6): Proof of Concept – afamelanotide • open-label, up to 4 doses: days 0, 1, 7, 8; evaluation at day 42 • occlusion higher
Slide 8: DNA Repair: Xeroderma Pigmentosum (XP)
DNA Repair: Xeroderma Pigmentosum (XP) Afamelanotide – enhancing cellular signalling For personal use only Modulates proliferation Reduces DNA Damage Base Excision Repair (BER) Regulates Melanocyte Function and Survival Nucleotide Excision Repair (NER) Stalls the Cell Cycle Cell Survival 8
Slide 9: DNA Repair: Xeroderma Pigmentosum (XP)
DNA Repair: Xeroderma Pigmentosum (XP) For personal use only Clinical profile - XP TAM 1,000 EU/US/LATAM/MENA patients Gene defects: 3p25, 6p21 Highest rate of skin cancer(s) – shortened life expectancy DNA repair program CUV156: Phase IIa ongoing (XPC, n=6) CUV151: completed (n=9) - control • EP: s
Slide 10: Vitiligo Program
Vitiligo Program SCENESSE® in combination with NB-UVB For personal use only provided >80% repigmentation of head & neck in darker skin [CUV102] DAY 0 DAY 35 DAY 66 DAY 171 Baseline – At start of study After 1 implant – 15 NB-UVB After 2 implants – 29 NB-UVB After 4 implants – 62 NB-UVB Statistical s
Slide 11: Presented at AAD 2023 - Vitiligo Future Treatment
Presented at AAD 2023 - Vitiligo Future Treatment Global Vitiligo Foundation Afamelanotide For personal use only 1. non-immune suppressant 2. physiological response Future 3. activates eumelanin treatment of vitiligo 4. icw NB-UVB differentiates stem cells 5. stabilizes eumelanin 6. < 4 weeks to 1st
Slide 12: Addressable Vitiligo Market
Addressable Vitiligo Market Global market 2027 Afamelanotide – North America $4.5B** For personal use only 0.5% BSA Penetration Population Incidence Eligible 0.2% H/N Seeking Tx Yr 1-2 Market 253,720* $490-570M** 1% 25% 40% 40% 9% total est. vitiligo 3,295,000 823,750 329,500 65,900 5,931 population
Slide 13: CLINUVEL Strategy part I
CLINUVEL Strategy part I Targeted Translational Technology For personal use only PHARMACEUTICAL Rx = B2B DERMATOCOSMETICS = B2C EPP Rx POLYCHROMATIC SCREEN 2 Absolute light intolerance Photoprotection: 390-700nm UV–HEV: 320-650nm Reflective & refractive Systemic photoprotection Tinted / non-tinted E
Slide 14: CLINUVEL Strategy part II
CLINUVEL Strategy part II Targeted Translational Technology For personal use only PHARMACEUTICAL Rx = B2B DERMATOCOSMETICS = B2C XP Phase IIb DNA REPAIR 3 Highest incidence of photodamage Reduce ‘UV photoproducts’ Highest frequency of skin cancers Assist DNA-damage repair Increase time of skin repai
Slide 15: CLINUVEL Strategy part III
CLINUVEL Strategy part III Targeted Translational Technology For personal use only PHARMACEUTICAL Rx = B2B DERMATOCOSMETICS = B2C Vitiligo Phase II/III MELANOGENESIS 3 Progressive loss of pigment Active pigmentation Highest impact on dark skin Stabilize pigmentation Repigmentation with NB-UVB Self-t
Slide 16: CLINUVEL's Strategy
CLINUVEL’S STRATEGY IN 3 Targeted Technology Translation - Evidence-based For personal use only PHARMACEUTICAL Rx = B2B DERMATOCOSMETICS = B2C Absolute light intolerance UV–HEV: 320-650nm POLYCHROMATIC SCREEN I Systemic photoprotection Photoprotection: 390-700nm EPP 2 Reflective & refractive Rx Tint
Slide 17: CLINUVEL's Odyssey 2005 - 2025
CLINUVEL’s Odyssey 2005 - 2025 For personal use only Depigmentation DNA damage MELANOCORTINS Phototoxicity DATA Photoaging EXPERTISE Prevention EPP images courtesy of the patients and their families 17
Slide 18: Financial performance 2016 - 2023
CLINUVEL Financial performance 2016 - 2023 For personal use only Projections ‘21–’25 FYE A$175m US$116m After 30/60 months 41% of projected expense A$72m US$47m Cash reserves 31-12-’22 A$140m US$93m 18
Slide 19: Summary
Summary For personal use only Pharmaceuticals CATALYSTS 2022-2023 1 Xeroderma pigmentosum – assisted DNA repair (3 trials ongoing) XP/DNA repair read out Ph II ongoing 2 Vitiligo - afamelanotide monotherapy + combination therapy (1 trial ongoing, 1 in prep.) Start Ph II trial Vitiligo (CUV105) in pr
Slide 20: Thank you for your interest…
For personal use only Thank you for your interest… Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD Head of Investor Relations Mr Malcolm Bull, CLINUVEL PHARMACEUTICALS LTD Investor Enquiries https://www.clinuvel.com/investors/contact-us www.clinuvel.com Level 11,
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