Clinuvel Pharmaceuticals (ASX: CUV) is advancing its vitiligo treatment pipeline with the integration of its proprietary Vitiligo Visual Algorithm (VVA), an in-house AI tool for objective clinical image assessment, alongside ongoing efforts in EPP commercialisation.
The company showcased the VVA in **Denver **at AAD 2026, America’s largest dermatology conference.
The VVA is an in-house developed AI tool designed to objectively evaluate vitiligo clinical images by using standardised photographs to track treatment progress over time.
This tool is currently being used alongside the ongoing CUV105 vitiligo study, and Clinuvel plans to incorporate the VVA into the protocol for its upcoming CUV107 Phase III vitiligo program.
The company is actively seeking feedback from the dermatology community on the VVA at the AAD 2026 conference.
Melanocortin Therapies Highlighted
At AAD 2026, Clinuvel emphasised its melanocortin therapies focusing on vitiligo development with afamelanotide, and its commercial and clinical efforts for erythropoietic protoporphyria (EPP).
The company highlighted SCENESSE (afamelanotide) as the FDA-approved product for EPP, and also holds EMA approval for year-round EPP treatment in Europe.
Beyond SCENESSE, Clinuvel is progressing other melanocortin-related projects.
This includes the validation of the NEURACTHEL instant manufacturing process and the advancement of a controlled-release injectable peptide platform into preclinical programs.
The company plans its first European filing for NEURACTHEL® in mid-2026.
Financials and Strategy
Clinuvel reported revenues of A$36.9 million for the first half of financial year 2026, a 4% increase.
However, profit after tax for the period fell 26% to A$10.4 million.
This decline was attributed to a 22% increase in total expenses, which rose to A$26.0 million, supporting expanded operations, increased research and development, and personnel costs.
Despite increased expenditure, the company maintained a strong financial position, with zero debt and cash reserves of A$233.0 million as of 31 December 2025.
Strategically, Clinuvel is prioritising the vitiligo program, particularly the CUV107 study.
The company is also pursuing an application with the US Securities and Exchange Commission to uplift its American Depository Receipts to Nasdaq Level II, aiming to broaden its US investor base.
Pipeline and Development
The ongoing CUV105 Phase III vitiligo study continues to inform the design of the next-generation CUV107 Phase III program.
Topline results for CUV105 are anticipated in H2 2026, with complete results in 2027.
Preparation for the CUV107 Phase III study includes seeking Scientific Advice from the EMA in 2026 before recruitment commences.
Further pipeline advancements include accelerated research on new long-acting formulations and the progression of the VLRX-L controlled-release injectable peptide platform through preclinical studies, with topline preclinical results expected in H1 2026.
