CLINUVEL’s achievements in the financial year ending 30 June 2025 spanned key areas of the business:
Towards Long-Term Value
Growth in revenues
Controlled expenses to support expansion
Ninth consecutive annual profit
Eighth consecutive dividend
Further increase in cash reserves
Board renewal and expansion with three new Non-Executive Directors appointed
Strategic programs prioritised
Clinical team restructured to deliver on larger, more complex global programs
Growing Distribution of SCENESSE®
Global growth in EPP patients, treatment centres and frequency of dosage
North American Specialty Centers increased to 104
Adolescent study CUV052 completed to support SCENESSE® label extension filing
Submission to European Medicines Agency (EMA) to align the label of SCENESSE® with the U.S.A.
Filing and validation of New Drug Submission to Health Canada
Distribution agreement in Argentina with Diligens Salud SA
SCENESSE® successfully administered to 9-year-old paediatric EPP patient
Steady progress SCENESSE® access in EPP
Increased patients, treatment centres and frequency of dosage
Partnership commenced with Valentech Pharma in Latin America
Adolescent study CUV052 expanded and underway
Developing Melanocortins
Completed recruitment Phase III vitiligo study, CUV105
Results in Phase II pilot monotherapy vitiligo study, CUV104
Results in Phase II stroke study, CUV803
Ongoing formulation and manufacturing development work on the PhotoCosmetic M-lines, “Preserve” and “Bronze”
Engaging Relevant Global Communities
Prominent presence at American Academy of Dermatology Meeting, Orlando, Florida
Sponsored International Congress of Porphyrias & Porphyrins (ICPP), results presented for Phase II variegate porphyria study, CUV040
Long-term safety, effectiveness data on SCENESSE® in EPP presented to European Academy of Dermatology and Venereology Spring Symposium
Data from German cohort of EPP patients treated with SCENESSE® in European post-authorisation safety study published in Photodermatology, Photoimmunology and Photomedicine journal
Results of study CUV151 presented at British Association of Dermatologists 104th Annual Meeting
Heightened social media activity
High profile media engagements – Financial Times, Vogue, Wired
Active Investor Relations – regular roadshows, briefings, and conference presentations