• Expertise in peptides and melanocortins
• Integrated 'in-house' business model
• Commercialised SCENESSE® for EPP
• 9½ years of revenue growth, profitability, and self-financed expansion

Clinuvel Pharmaceuticals Ltd reported its H1 FY2026 results, maintaining underlying profit despite a 26% decline in net profit after tax. The company highlighted its expertise in peptides and melanocortins, integrated 'in-house' business model, commercialisation of SCENESSE® for EPP, and 9½ years of revenue growth, profitability, and self-financed expansion. Key activities and outcomes in H1 FY2026 included the ongoing Phase III vitiligo study with positive case reports, validation of the NEURACTHL® instant manufacturing process, and the company's application to the SEC to uplist its ADRs to Level II on Nasdaq. The company's balance sheet remains strong, with cash reserves of A$233 million as of 31 December 2025, covering over 3 years of operating expenses and enabling continued pipeline development and value-adding asset acquisition. Clinuvel's pipeline includes SCENESSE® for variegate porphyria, adolescent EPP, and adult vitiligo, as well as the NEURACTHL® platform for infantile spasms, multiple sclerosis, and central nervous system disorders, and the VLRX-L controlled-release peptide platform. The company outlined a clear roadmap for 2026 and 2027, including regulatory milestones, clinical trial readouts, and commercial updates.

Clinuvel expects to maintain its commercial sales and special access scheme revenues, with a 3% increase in commercial sales to A$33.4 million and a 15% increase in special access scheme revenues to A$3.5 million in H1 FY2026. The company also anticipates a 14% increase in interest income to A$5.3 million.

Clinuvel is focused on advancing its pipeline, including the ongoing Phase III vitiligo study, the NEURACTHL® platform, and the VLRX-L controlled-release peptide platform. The company is also preparing for the commercial launch of its products, with a focus on establishing distribution systems and securing market access and reimbursement. Clinuvel's experienced management team is well-positioned to execute on these objectives and drive the company's continued growth and diversification.