UR9 Clinuvel Pharmaceuticals Ltd

CLINUVEL has expanded its pharmaceutical development portfolio with NEURACTHEL®, novel formulations of the melanocortin adrenocorticotropic hormone (ACTH). The Company has secured supply of ACTH with one of its strategic partners to meet existing global demand, and will be evaluating the potential of NEURACTHEL® for patients with neurological, endocrinological, and degenerative disorders, who lack alternative therapy.

ACTH is from the same family of bioactive hormones – melanocortins – as afamelanotide, the first pharmaceutical product CLINUVEL has successfully commercialised as SCENESSE®.1 Various formulations of ACTH are approved globally for patient use, with 2020 sales of the drug estimated at US$1.29 billion and expected to grow to around US$1.91 billion by 2031.2

“ACTH is a well recognised, licensed treatment for a number of neurological and endocrinological diseases, yet global supply and availability of the product have recently been disrupted and its full clinical potential remains unrealised,” CLINUVEL’s VP of Scientific Affairs, Dr Tim Zhao said.

“Our research and commercial expertise in melanocortin drugs and peptide drug delivery platforms means we are well placed to ensure the successful, safe and efficient development and commercialisation of ACTH formulations as NEURACTHEL®. We also know there are many more underserved patient groups who would benefit from NEURACTHEL® treatment, and we will be addressing these unmet medical needs. The Company now has multiple products in development for patients and other populations,” Dr Zhao said.

Melanocortins are hormones which act on cells throughout the body and can play a role in regulating the central nervous system, energy balance, appetite, photoprotection and DNA repair, as well sexual function. The naturally occurring human hormone ACTH is essential for the production of cortisol, enabling the combat of stress and regulation of immune responses, maintenance of blood pressure, moderation of blood sugar, and regulation of metabolism

“Over the last two decades CLINUVEL has established itself as the world experts in melanocortin drug development and commercialisation,” CLINUVEL’s Director of Global Operations, Mr Lachlan Hay said. “Our understanding of the technology and potential of these products allow us to unlock value for patients who lack alternatives.”

CLINUVEL’s teams have proven expertise in melanocortin development with an initial focus on SCENESSE®, the world’s first systemic photoprotective drug, formulated as a controlled-release injectable implant in light and UV-provoked diseases. The Company is currently evaluating the potential of afamelanotide and other melanocortin drugs as therapeutic agents for patients with acute and life-threatening genetic, metabolic, neurological, vascular, endocrinological, and degenerative disorders.

“We can now methodically pursue our NEURACTHEL® programs, having secured supply of ACTH to a current Good Manufacturing Practices, or cGMP, standard – the standard demanded by global regulatory authorities. CLINUVEL’s formulation teams at the VALLAURIX Research, Development and Innovation Centre in Singapore have advanced a number of innovative instant- and controlled-release formulations which are being used as platforms for melanocortin therapies, including ACTH,” Dr Zhao said.

1 SCENESSE® is approved in Europe, the USA and Australia for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP).2 Adrenocorticotropic hormone (ACTH) market – global industry analysis, size, share, trends, and forecast, 2017-2031 by Transparency Market Research (TMR), 2021.

Media Enquiries Monsoon Communications Mr Rudi Michelson, 61 411 402 737, rudim@monsoon.com.au

About CLINUVEL PHARMACEUTICALS LIMITED CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global and diversified biopharmaceutical company focused on developing and commercialising treatments for patients with genetic, metabolic, systemic, and life-threatening, acute disorders, as well as healthcare solutions for the general population. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL’s research and development has led to innovative treatments for patient populations with a clinical need for systemic photoprotection, DNA repair and acute or life-threatening conditions. These patient groups range in size from 5,000 to 45 million worldwide. CLINUVEL’s lead compound, SCENESSE® (afamelanotide 16mg), was approved by the European Commission in 2014, the US Food and Drug Administration in 2019 and the Australian Therapeutic Goods Administration in 2020 as the world’s first systemic photoprotective dug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult patients with erythropoietic protoporphyria (EPP). More information on EPP can be found at http://www.epp.care. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore and the USA. For more information, please go to http://www.clinuvel.com.

SCENESSE® , PRÉNUMBRA® , and NEURACTHEL® are registered trademarks 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. Please see www.clinuvel.com for further details

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