Clinuvel Pharmaceuticals Limited · ASX:CUV
Clinuvel Pharmaceuticals — Investor Presentation (November 2023)
16 slides from Clinuvel Pharmaceuticals's investor presentation, Nov 10, 2023
Slide 1: Afamelanotide for vitiligo: CLINUVEL's Phase III program
For personal use only Afamelanotide for vitiligo CLINUVEL’s Phase III program: setting a new standard of care 9 November 2023 ASX CUV Börse Frankfurt UR9 Level 1 ADR CLVLY
Slide 2: Forward-looking statement
Forward-looking statement For personal use only This release contains forward-looking statements, which reflect the and reimbursement; that the Company may incur unexpected delays in the current beliefs and expectations of CLINUVEL’s management. Statements outsourced manufacturing of SCENESSE®, CYAC
Slide 3: Vitiligo
Vitiligo For personal use only Autoimmune disorder leads to loss of melanocytes Severe impact on patient quality of life, highest impact in skin of colour Lack of effective therapies, no pharmaceutical therapy >10% BSA “They think it’s cosmetic, but it’s more for me. I am a lifelong colored person.
Slide 4: NB-UVB – follicular repigmentation
NB-UVB – follicular repigmentation NB-UVB differentiates stem cells in the “niche” of the hair follicle to become melanoblasts. Melanoblasts differentiate and become fully functioning melanocytes, capable of producing melanin once For personal use only activated by alpha-melanocyte-stimulating-hormo
Slide 5: Future treatment of vitiligo
Presented at AAD 2023 - Vitiligo Future Treatment Future treatment of vitiligo For personal use only REDUCE REDUCE IMMUNE INCREASE MELANIN TRIGGERS ATTACK OF SKIN PRODUCTION Corticosteroids Phototherapy Anti-oxidants Tacrolimus Afamelanotide Avoid trauma Pimecrolimus Skin grafts JAK inhibitors Cellu
Slide 6: Vitiligo - active R&D landscape
Vitiligo - active R&D landscape Active and ongoing clinical development programs COMPANY TREATMENT PHASE II PHASE III APPROVED JAK inhibitors = immune suppression For personal use only Incyte Ruxolitinib (topical JAK 1/2) n=157 n=674 (2 trials) patients 12 years and n=30* (subset) older Povorcitinib
Slide 7: CUV102 study results
CUV102 study results Results: CUV102 (Phase IIa n=56) For personal use only Treatment (6 months) SCENESSE®+NB-UVB vs. NB-UVB Repigmentation VASI p=0.025 Median time to repigmentation (trunk) 41 days vs 59.5 days p=0.082 Fitzpatrick Skin Types IV-VI subset analyses (n=34) Repigmentation VASI p<0.001
Slide 8: CUV102 Phase II study results
CUV102 Phase II study results For personal use only Day 0 Baseline Day 35 15 treatments/1 implant Day 66 29 treatments/2 implants Day 0 Day 111 Day 176 Baseline After 27 NB-UVB treatments, After 40 NB-UVB treatments, 3 implants 4 implants Day 171 62 treatments/4 implants
Slide 9: Vitiligo – global Phase III study (CUV105)
Vitiligo – global Phase III study (CUV105) Pfizer pivotal Phase III CLINUVEL CUV105 Phase III Incyte Phase III program1 oral JAK inhibitor2 For personal use only N=200, adults and adolescents (≥12 years) highest Study population N=647, adults and adolescents (≥12 years) unmet need: darker skin (Fitz
Slide 10: Path to market - afamelanotide
Path to market - afamelanotide CUV102 Step 1 >15,200 doses afamelanotide administered2 For personal use only +NB-UVB n = 56 • Safety profile accepted CUV103 +NB-UVB n = 21 Step 2 NB-UVB combination • program planning resulted in savings US$75 – $145M CUV104 Step 3 2022 FDA – precedent for NB-UVB as
Slide 11: Pricing & reimbursement
Pricing & reimbursement Evolving landscape in dermatology Annual costs of successful moderate-severe psoriasis Annual costs for vitiligo therapies (US$)2 For personal use only biologic treatment ($US, Feldman et al, 2019) $40,000 $400,000 ≤10 BSA $30,000 $300,000 $20,000 $200,000 Median: $205,393 $1
Slide 12: North American vitiligo population
North American vitiligo population 2022 population: 333,287,557 (USA), 39,566,248 (Canada) Demographics (USA) For personal use only Children (0-11) 21.7% Adolescents (12-17) Estimated population Vitiligo prevalence 1% Fitzpatrick Skin Types IV-VI Adults ~22% 823,750 patients 78.3% (18+) White (inc m
Slide 13: Addressable market – North America
Addressable market – North America For personal use only Global market US$5.4B Incidence Eligible 0.5% BSA Seeking Tx Penetration 0.2% H/N Yr 1-2 Market US$490-570M 1% 25% 40% 20% 9% 3,295,000 823,750 329,500 65,900 5,931 Total vitiligo 7–8 doses afamelanotide > 90% population repigmentation 47,448
Slide 14: Conclusions
Conclusions For personal use only I. Vitiligo has a severe impact on patients’ quality of life II. Current treatment options limited, partially effective, clinically frustrating III. SCENESSE® offers a systemic “pigmentary booster” effect without suppressing the immune system IV. Phase III CUV105 st
Slide 15: References and further reading
References and further reading For personal use only Further details on the CUV105 study are available on CLINUVEL’s website, www.clinuvel.com. targeted therapeutics in Vitiligo. Journal of Cosmetic Dermatology, jocd.14770. https://doi.org/10.1111/jocd.14770 Bibeau, K., Ezzedine, K., Harris, J. E.,
Slide 16: Investor enquiries
For personal use only 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, 535 Bourke Street Melbourne
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