Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Bioshares Biotech Summit 2025
23 slides from Clinuvel Pharmaceuticals's conference presentation, Aug 7, 2025
Slide 1: Meeting the challenges of vitiligo
Meeting the challenges of vitiligo Bioshares Biotech Summit, Hobart Australia Lachlan Hay, COO, Acting CEO 7 August 2025 ASX: CUV | Börse Frankfurt: UR9 | ADR Level 1: CLVLY
Slide 2: Forward-looking statement
Forward-looking statement CLINUVEL GROUP This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to diff
Slide 3: Commercial stage biopharmaceutical
Commercial stage biopharmaceutical • SCENESSE® (afamelanotide) EMA, FDA, TGA approved for rare metabolic disorder EPP • Profitable, 8 years’ consecutive annual revenues growth (CAGR 38%) • A$198m in cash/equivalents (31 Dec) • Self-financing expansion strategy: new indications, new products (℞ & Pho
Slide 4: Addressing unmet need in vitiligo
Addressing unmet need in vitiligo
Slide 5: Vitiligo
Vitiligo • Autoimmune disorder destroys pigment producing cells (melanocytes) • ~1% of global population affected • No approved ℞ for: • systemic use • extensive depigmentation • active disease “They think it’s cosmetic, but it’s more for me. I am a lifelong colored person. I feel like I lost my ide
Slide 6: Impact of vitiligo: is it relevant?
Impact of vitiligo: is it relevant? Psychological impact Low-Moderate Moderate-Highest Localisation Limbs Face, Head and Neck Trunk Trunk (including genitalia) Hands and Feet Hands and feet Skin Type Fitzpatrick I – White Fitzpatrick III – Average Fitzpatrick II – Fair Fitzpatrick IV – Light Brown F
Slide 7: NB-UVB – follicular repigmentation
NB-UVB – follicular repigmentation NB-UVB differentiating Hair follicle follicular stem cells Epidermis Melanoblasts migrating, become fully functioning melanocytes Afamelanotide acting as agonist to MC1R expressed Dermal NB-UVB [308-313nm] sheath Bulge/Niche Dermis Day 0 Baseline Bulb Day 98 After
Slide 8: CLINUVEL's Global Vitiligo Program
CLINUVEL’s Global Vitiligo Program Clinical program Milestones De-risking the program CUV102 +NB-UVB n = 56 (Ph II) Phase II complete CUV102 results published in Clinical & regulatory acceptance: CUV103 +NB-UVB n = 21 (Ph II) JAMA Dermatology hormone analogue for severe disorders Positive safety pro
Slide 9: CUV102 Phase II study results
CUV102 Phase II study results Day 0 – Baseline Day 35 – 15 treatments/1 implant Day 66 – 29 treatments/2 implants Day 171 – 62 treatments/4 implants Day 0 Day 111 Day 179 Baseline 27 treatments/3 implants 40 treatments/4 implants Images have been amended/cropped and pixelated to protect the patient’
Slide 10: CUV105 Phase III study – first clinical observations
CUV105 Phase III study – first clinical observations CASE REPORT 1 CASE REPORT 3 Female, 55 years old, Skin Type IV PHYSICIAN’S REPORT Male, 56 years old, Skin Type IV PHYSICIAN’S REPORT Diagnosed with vitiligo in 2006, slowly 80–90% repigmentation seen after Diagnosed with vitiligo First repigmenta
Slide 11: Evolving vitiligo landscape
Evolving vitiligo landscape
Slide 12: Future treatment of vitiligo
Future treatment of vitiligo REDUCE REDUCE IMMUNE INCREASE MELANIN TRIGGERS ATTACK OF SKIN PRODUCTION Corticosteroids Phototherapy Anti-oxidants Tacrolimus Afamelanotide Avoid trauma Pimecrolimus Skin grafts JAK inhibitors Cellular grafts Phototherapy Adapted from AAD 2023
Slide 13: A new vitiligo treatment algorithm
A new vitiligo treatment algorithm NB-UVB Topical Topical JAK Oral JAK SCENESSE® Segmental 10% LOCALISED SYSTEMIC Generalised 90% ✓ ✓ ✓ ✓ ✓ ✓ Localisation ✓ ✓ ✓ Skin Type Fitzpatrick IV – Light Brown ✓ Fitzpatrick V – Brown ✓ Fitzpatrick VI – Black ✓ ✓ Extent ✓ ✓ >10% <50% Face, Head and Neck ✓ Trun
Slide 14: Treatment landscape
Treatment landscape1 COMPANY TREATMENT PHASE II PHASE III APPROVED JAK inhibitors = immune suppression Incyte Ruxolitinib (topical JAK 1/2) Povorcitinib (oral JAK 1) Pfizer Ritlecitinib (oral JAK 3) Abbvie Upadacitinib (oral JAK 1) Eli Lilly Baricitinib (oral JAK 1/2) + NB-UVB Merck MK-6194 (oral JA
Slide 15: Treatment landscape
Treatment landscape1 COMPANY TREATMENT PHASE II PHASE III APPROVED JAK inhibitors = immune suppression Incyte Ruxolitinib (topical JAK 1/2) Povorcitinib (oral JAK 1) Pfizer Ritlecitinib (oral JAK 3) Abbvie Upadacitinib (oral JAK 1) Topical JAK inhibitor (1.5% cream)1 Eli Lilly Baricitinib (oral JAK
Slide 16: Vitiligo
Vitiligo Addressable Market USA – afamelanotide for FST IV-V-VI INCIDENCE FST IV-V-VI ELIGIBLE FOR Tx SEEKING Tx PENETRATION 7–8 doses pp for >90% repigmentation No. 3,295,000 823,750 329,500 65,900 5,931 Revenues, yr 1–2 40% US$490–570m 9% yr 1–2 0.5% BSA 20% 0.2% H&N 25% 1% of population *Abbrevia
Slide 17: SCENESSE in the USA from EPP to vitiligo
SCENESSE ® in the USA from EPP to vitiligo
Slide 18: US Commercial Infrastructure
US Commercial Infrastructure Direct Distribution 2019–2025 In-house commercial team Logistics Medical centers Director, Nth American Operations DC – cold storage orders Financial specialists labelling / packaging pharmacy storage VA-Medicare-Medicaid QA Rx filled Patient liaison product release dire
Slide 19: US Commercial Infrastructure
US Commercial Infrastructure North America – Current Clinics and Targets • 87% of target achieved • 84% of CUV team established • Treatment codes in place OBJECTIVE CLINUVEL to be dominant in North American vitiligo market
Slide 20: Building CLINUVEL's US presence
Building CLINUVEL’s US presence Community & patient Social & traditional Patient databases HCP engagement assoc. engagement media – paid & earned & relationships
Slide 21: AAD 2025 Annual Meeting, Orlando FL
AAD 2025 Annual Meeting, Orlando FL Introducing CLINUVEL at the world’s largest dermatology conference • 4,800 sqft Pavilion of Photomedicine • 1,400 guests over 3 days • >193,000 organic social views across CLINUVEL channels • Short-listed for 2025 C&IT Awards – Pharma & Healthcare Event of the Yea
Slide 22: Catalysts and calendar
Catalysts and calendar 2025-2026 Commercial growth SCENESSE® Financial year end results FY25 4th week August EMA decision dosage expansion adults Q4 2025 EMA re-file adolescents SCENESSE® Q4 2025 Health Canada decision marketing authorisation: SCENESSE® in EPP Q4 2025 Distribution expansion to 120 S
Slide 23: Thank you for your interest
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 Level 22, 535 Bourke Street, Melbourne – Victor
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