EMA approves year-round SCENESSE® treatment

C O M P A N Y A N N O U N C E M E N T Melbourne, Australia, 23 September 2025 ASX: CUV | Börse Frankfurt: UR9 | ADR Level I: CLVLY ASX Announcement P A G E 1 O F 3 EMA approves year -round SCENESSE® treatment CHMP removes recommended maximum dose, issues positive opinion on benefit-risk of year-round treatment Executive summary • European label allows one implant every two months, removing recommended maximum dose and harmonising label with US FDA • Over 15 years of clinical trial data and Real World Evidence reviewed • CHMP determine no change in positive benefit-risk profile from uninterrupted dosing The European Medicines Agency (EMA) has agreed to amend the label for CLINUVEL’s photoprotective drug SCENESSE® (afamelanotide), enabling adult erythropoietic protoporphyria (EPP) patients to receive treatment every two months. The label removes a recommended maximum annual dose of four implants per year and harmonises treatment posology in Europe with the USA, where many patients receive year -round therapy. CHMP evaluate clinical trial data, Real World Evidence The EMA’s Committee for Medicinal Products for Human Use (CHMP) issued a positive opinion on the benefit - risk profile of year-round SCENESSE® treatment following extensive engagement with CLINUVEL’s team. The Committee evaluated data from two Phase III studies (CUV039 and CUV029) and Real World Evidence captured from over 15 years of SCENESSE® use under compassionate, special access and commercial programs. The data package included a review of the safety and effectiven ess profile of SCENESSE® in the European patients who have received four or more implants in any one calendar year. Recognising the clinical need for EPP patients to receive year-round treatment, the CHMP concluded that there were no significant safety concerns with the ongoing administration of SCENESSE® every two months. This variation can now be implemented immediately. CLINUVEL has committed to maintaining its obligations under a strict risk management plan for SCENESSE® in Europe, including continuing to collect safety and effectiveness outcomes data in EPP patients through the European EPP Disease Registry. The Registry comprises the largest database of EPP patients globally with nearly a decade of health, safety and treatment data available for analyses. Commentary “A decade after EMA’s approval of SCENESSE® we have generated a much deeper, richer pool of data helping to define the drug’s benefit-risk profile, with a dossier that supports year-round patient dosing,” CLINUVEL’s Chief Scientific Officer, Dr Dennis Wright said. “We have received ongoing requests from EPP expert physicians to facilitate year-round treatment in Europe and we are pleased that the CHMP’s positive opinion will enable EPP patients to receive year-round treatment for this very debilitating condition. There was a strong logic to removing the maximum dose restriction in Europe, which has now been validated by the CHMP. It also harmonises the label with the USA. ASX Announcement P A G E 2 O F 3 “Since we are administering SCENESSE® in vitiligo at higher frequency of one dose every three weeks, it is obvious that both programs – EPP and vitiligo – assist us in compiling our next regulatory dossier with robust safety data,” Dr Wright said. EPP – debilitating phototoxicity Due to an inherited genetic defect, EPP patients accumulate and store excessive phototoxic compounds (known as protoporphyrins) in their bodies, including in the liver and skin. When exposed to visible light, including sunlight, protoporphyrins produce free radicals which damage and destroy surrounding tissue. From infancy, EPP patients experience bullous cutaneous phototoxic reactions, described as akin to lava flowing underneath the skin, which render them unable to function for days or weeks. Repeated reactions result in scarring and thickening of the skin, especially on the back of the hands, nose and forehead. Most patients are forced to adapt their lives from an early age to avoid light exposure, resulting in severe psychosocial impacts. SCENESSE® is the only approved therapy for EPP. The drug has been shown to reduce phototoxic reactions in adult EPP patients, enabling them to lead more normal lives. To date, over 1 8,500 doses of SCENESSE® have been administered to EPP patients worldwide. – END – About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL (ASX: CUV; ADR LEVEL I: CLVLY; Börse Frankfurt: UR9) is a global specialty pharmaceutical group focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life -threatening, acute disorders, as well as healthcare solutions for specialised populations. As pioneers in photomedicine and the family of melanocortin peptides, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprot ection, assisted DNA repair, repigmentation and acute or life-threatening conditions who lack alternatives. CLINUVEL’s lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Israel, and Australia as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). Headquartered in Melbourne, Australia, CLINUVEL has operations in Eu rope, Singapore, and the USA. For more information, please go to https://www.clinuvel.com. 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 Forward-Looking Statements This release contains forward -looking statements, which reflect the current beliefs and expectations of CLINUVEL’s management. All statements other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,” “could,” “estimate,” “expect,” “foresee,” “intend,” “likely,” “may,” “objective,” “potential,” “plan,” “predict,” “project,” “seek,” “should,” “will” and similar words or phrases and their negatives. Forward -looking statements reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons. Statements may involve a number of known and unknown risks that could cause our future results, performance, or achievements to differ significantly from those expressed or implied by such forward - looking statements. Important factors that could cause or contribute to such differences include risks relating to: our abili ty to develop and commercialise pharmaceutical products; the COVID-19 pandemic and/or other world, regional or national events affecting the supply chain for a protracted period of time, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products; compe tition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed and characterised by us as PhotoCosmetics; our ability to achieve expected safety and effic acy results in a timely manner through ou r innovative R&D efforts; the effectiveness of our patents and other protections for innovative products, particularly in view of national and regional variations in patent laws; our potential exposure to product liabilit y claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, the UK, Israel, China, Japan, and/or LATAM regions of our agreements with third parties and suppliers; our exposure to currency fluctuations and restrictions as well as credit risks; the effects of reforms in healthcare regulation and pharmaceutical pricing and reimbursement; that the Company may inc ur unexpected delays in the outsourced manufacturing of SCENESSE®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways fo r the registration and approval of biotechnology, cosmetic and consumer based products; decisions by regulatory authorit ies regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel an d managerial ASX Announcement P A G E 3 O F 3 talent; the impact of broader change within the pharmaceutical industry, cosmetic industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2025 Annual Report. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation, outside of those required under applicable laws or relevant listing rules of the Australian Securities Exchange, to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise. More information on preliminary and uncertain forecasts and estim ates is available on request, whereby it is stated that past performance is not an indicator of future performance. Contact: Tel: +61 3 9660 4900 Fax: +61 3 9660 4909 Email: [email protected] Australia (Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

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