People

Under Dr Wolgen’s leadership, a long-term strategy for CLINUVEL was devised. The lead product SCENESSE® (afamelanotide 16mg) was reformulated, its medical application identified, European marketing authorisation was obtained in 2014 and systems were established to self-distribute the prescriptive product in the European Economic Area from June 2016. Dr Wolgen oversaw the submission of the scientific dossier to the US Food & Drug Administration (FDA) under a New Drug Application, which was approved in October 2019. First treatment of US patients commenced in April 2020 through a controlled distribution system set up by the Company. SCENESSE® is the world’s first systemic photoprotective drug to have completed a clinical trial program and obtain marketing authorisation in two major markets. Dr Wolgen has been instrumental in the Company’s corporate turnaround, rebuilding a share register of long-term professional and institutional investors. He led CLINUVEL to attract more than AU$110 million in investments, and his international contacts and network contribute to the strategic support CLINUVEL enjoys globally. Under his tenure a business model was adopted to develop and launch SCENESSE®, guiding the Group through a complex pharmaceutical product development program. His overall business execution and exact financial management is viewed as exemplary within the life sciences industry and the funding strategy he led is considered different and unique within the sector. He is currently leading the Group’s expansion, both based on organic and inorganic strategies. His focus has been to establish a professional management team executing corporate objectives of establishing a sustainable, and profitable group diversified from its core pharmaceutical base, to cosmetics and other services within an integrated model.

Dr Wolgen’s long track record speaks to a strongly focussed, competitive and conscientious professional who is known to persevere in meeting challenging business objectives. He holds an MBA from Columbia University, NY. Trained as a craniofacial surgeon, Dr Wolgen obtained his MD from the University of Utrecht, the Netherlands.

Dr Agersborg is a Clinical Endocrinologist with diverse and extensive practice experience in Pennsylvania and New Jersey, USA. She is Board Certified in both Internal Medicine and Endocrinology, Diabetes & Metabolism and holds specific expertise on the class of melanocortins. Her career has included inpatient, outpatient, and hospitalist positions across a number of prominent medical institutions.

She is an Associate Professor of Medicine, teaching medical students and residents in endocrinology. Dr Agersborg had an extensive career in managing commercial sales & distribution at Wyeth Pharmaceuticals (formerly Ayerst Laboratories). Dr Agersborg has played an integral role in setting the CLINUVEL Group’s US regulatory and commercial strategy, resulting in the US FDA’s approval of SCENESSE® in October 2019 and the subsequent market launch in 2020.

Mrs Smith manages an established consultancy business, providing advisory services to a range of healthcare organisations, investors and boards of directors. She has led a distinguished career, serving for 14 years as Chief Executive Officer of The Princess Grace Hospital, London, and 11 years as the Chief Executive Officer of The Portland Hospital for Women and Children, London. Mrs Smith’s specific expertise is in the implementation of operational strategies within complex and acute care environments, and in the interaction with healthcare authorities and UK regulators. Her most recent role was as the Chief Executive Officer of the Independent Doctors Federation, a membership organisation representing practising physicians within the UK independent healthcare sector.

Her past experience Is now successfully translating into a diverse portfolio with non-executive director appointments. She is currently Board Chair of The Evewell Group Ltd which operates fully integrated medical centres of excellence dedicated to caring for, and protecting, all aspects of fertility and gynaecological health. Mrs Smith is also a Director of HCA Hope Fund UK, a charity providing financial aid and resources to its healthcare worker members to help them start rebuilding after an extended illness, injury, environmental disasters, or other extraordinary situations. In the face of the ever-changing healthcare market Mrs Smith fosters first class relationships with a wide range of healthcare stakeholders to provide care of excellence to patients. CLINUVEL Pharmaceuticals Ltd 2023 ANNUAL REPORT 48

Prof Rosenfeld is an internationally recognised neurosurgeon with extensive experience in senior healthcare and medical research executive roles and a distinguished and decorated career in the Australian Army. He is a retired Major General and a former Surgeon General, Australian Defence Force-Reserves. He has served on eight deployments to Rwanda, Iraq, Solomon Islands, Bougainville and East Timor. He was the Founding Director of Monash University Institute of Medical Engineering (MIME)-Melbourne. He is developing a bionic vision device to restore vision in people without eyesight, and he is also a leader in brain injury research. Prof Rosenfeld was Director of Neurosurgery at the Alfred Hospital for fifteen years, concurrently holding Professor and Head of the Department of Surgery at Monash University for nine years. Prof Rosenfeld is active in many community organisations and champions various charitable causes.

Prof Rosenfeld has been an active volunteer for the Australian-Aid funded Pacific Islands Project which transfers clinical skills and knowledge to healthcare professionals in Papua New Guinea, Fiji and the Solomon Islands. In 2018, Prof Rosenfeld was awarded the Companion of the Order of Australia, which is Australia’s highest civilian honour, the Meritorious Service Medal of the United States of America in 2017 and Officer in the Order of the British Empire in 2013. Prof Rosenfeld became an Emeritus Professor at Monash University in January 2021.

Mr Pringle has extensive experience in corporate finance, audit and assurance, governance and strategy, including over 25 years’ experience as a Partner at Pitcher Partners. His roles with Pitcher Partners included leading the corporate finance practice group, senior audit partner and leading the corporate governance and board advisory practice area. He is a director of Navalo Financial Services Group Limited, Hypersonix Launch Systems Limited, and the not-for-profit Anglicare Victoria.

Mr van Dievoet has significant experience in investment banking, specialising in M&A. In this capacity he has worked for leading financial institutions, including the Merchant bank of IndoSuez in Belgium, ABN-AMRO, Bank BNP Group, and as executive-director for MeesPierson. Over the years he has provided strategic support on corporate growth, structuring and buy-build approaches, and assisted companies listing on the Brussels and Amsterdam Stock Exchanges (EuroNext).

Dr Pearl Grimes is a globally recognised dermatologist and a leading international authority on vitiligo and pigmentation disorders. She is the Founder and Director of the Vitiligo and Pigmentation Institute of Southern California where she treats patients from all over the world.

Grimes Institute for Medical and Aesthetic Dermatology, where she expertly treats a wide range of dermatologic health and aesthetic concerns in patients of all ethnicities and skin types. Dr Grimes also serves as a Clinical Professor of Dermatology at the David Geffen School of Medicine at UCLA and Chief Dermatologist for Versicolor Technologies.

Mr Peter Vaughan joined CLINUVEL in April 2024 and assumed the Chief Financial Officer role on 01 July 2024. Mr Vaughan has over 20 years of experience in listed and unlisted companies in Australia, the USA, Europe, and Asia. Most recently with Toys “R” Us ANZ (ASX:TOY), he has previously held CFO and Company Secretary roles at Titomic (ASX:TTT), Immuron (ASX:IMC), Amaero (ASX:A3D) and Respiri (ASX:RSH), among others.

He has led M&A and licensing deals within life sciences, as well as the dual listing of two Australian companies on the Nasdaq (Immuron and Prima Biomed). A Chartered Accountant, Mr Vaughan holds a BBus (Accounting) from the Swinburne University of Technology and a Senior Executive MBA from Melbourne Business School.

Dr Wright is a seasoned professional with a rich background in the pharmaceutical and healthcare industry spanning over 40 years. He completed a pharmacy degree at Sydney University and undertook pharmacy accreditation at St George Hospital in Sydney. Unsatisfied with roles in hospital or retail pharmacies, he returned to Sydney University to complete a Masters in Science followed by a Doctor of Philosophy. He also completed a post-graduate certificate in health economics at Monash University. Dr Wright entered the pharmaceutical industry as a development chemist at Pfizer. He then moved to Melbourne to join CSL, followed by Nicholas Kiwi, before returning to CSL and then to Faulding/Mayne Pharma. During his time in Melbourne, Dr Wright worked in a variety of roles including regulatory affairs, clinical research, pharmacovigilance, business development and marketing.

In March 2005, Dr Wright assumed the role of Regulatory Affairs Manager in EpiTan, and from there, witnessed the transformation of EpiTan into CLINUVEL. While at CLINUVEL, he transitioned through a number of roles to Chief Scientific Officer, and was deeply involved in the clinical development of SCENESSE® and the successful regulatory process. Dr Wright’s desire to see erythropoietic protoporphyria (EPP) patients receive treatment was a major driving force in his role and contributed to his relocation to Switzerland to be at the centre of the development program and the regulatory dossier preparation. He has now returned to CLINUVEL’s Melbourne office.

A pharmacist (PharmD) with a master’s degree in cancer biology, Dr Rodenburger worked with the CLINUVEL Group for over a decade in clinical development roles in Australia, the USA and Europe. During this time, she led the Company’s first vitiligo trials as well as being one of two clinical managers completing the EPP program resulting in the successful approval and commercialisation of SCENESSE® (afamelanotide) as the first systemic photoprotective therapy.

Dr Rodenburger rejoined CLINUVEL in 2024, having spent four years with Roche in senior clinical roles.

Based in the UK, Dr Rodenburger oversees CLINUVEL’s global clinical program, evaluating melanocortin-based drugs for a range of disorders of the skin and brain.

Mr Hay joined CLINUVEL in communications roles in Australia in 2007 before transitioning into broader operations and management positions in Switzerland, the UK and, most recently, Singapore. In his current role, Mr Hay supports global functions including commercial, compliance, clinical, new product development, business development, and communications. Having previously held the role of General Manager of CLINUVEL’s UK office, he is actively involved in the ongoing commercial roll-out of the Company’s first pharmaceutical product, with a focus on patient access.

Mr Hay has previously held marketing communications roles in the not-for-profit sector in Australia. He holds a BA (Media & Communications) from the University of Melbourne, Australia, and a MA (International Relations) from the Freie Universität Berlin, Germany.

Dr Linda Teng is an expert in the regulatory and clinical research for orphan indications, having spent two decades of her career focused on finding solutions for patients with rare disorders. Dr Teng was introduced to ultra-rare orphan indications at BioMarin, where she developed a deep-seated passion for rare diseases. This passion ignited a decade-long journey with CLINUVEL, during which her team successfully brought the world’s first-in-class treatment for erythropoietic protoporphyria (EPP).

Dr Teng received her pharmacy degree from National Taiwan University and her Doctor of Health Administrations at the Medical University of South Carolina. In her current role, Dr Teng oversees the clinical, regulatory, commercial, and distribution divisions of North America. Dr Teng is proud to be a part of the team that pursues the mission to bring hope to those most in need.

Mr Bull studied economics, completing Bachelors and Honours degrees at the University of Adelaide, and later, a Masters degree at Monash University in Melbourne. He initially worked as an Economist in Canberra, with a focus on research and policies of the Australian Government and the Economics Department of a major Australian Bank. Subsequently, he moved into the banking sector, working across credit, business development and strategy, and relationship management.

Mr Bull joined CLINUVEL in January 2019 to develop the investor relations function, learning quickly and contributing to the Company’s objectives on shareholder diversity and composition, independent analyst coverage, and communication of the CLINUVEL story as part of the Company’s broader communications programme. His role broadened in 2021 with promotion to the Executive Management team, taking on additional responsibilities for Australian Operations.

Ms Colucci holds a MA in Germanic Languages and a MA in International Relations from the Catholic University of Sacred Heart (Milan). Fluent in five languages, she started her career in the medical/pharmaceutical industry 25 years ago and, before joining CLINUVEL in 2011, worked as research project manager at a renowned Italian academic centre. In her current role, Ms Colucci oversees the commercial and distribution divisions of Europe and Middle East and global market access.

Ms Colucci has always been captivated by the unknown and unexplored that is why she eagerly embraces the opportunity to learn and grow offered by CLINUVEL. She particularly enjoys the challenges and diverse responsibilities that come with her role. The true fulfilment for her lies in the moments when she gets approached by patients with heartfelt gratitude, thanking the team for the positive impact made in their lives.

Dr Quadbeck-Diel has 30 years of experience in international pharmaceutical regulatory affairs, and quality assurance. In that time, she has worked in companies of different scales—from small start-ups to big pharma.

Dr Quadbeck-Diel joined CLINUVEL in 2012 as Regulatory Affairs Manager, and has subsequently built a team of professionals across Europe to handle filings, agency interactions and compliance, while ensuring a high standard of regulatory competency across the Group.

Dr Hamila is a pharmacist, responsible for ensuring the Company’s adherence to the GxP standards and overall patient safety. Having joined CLINUVEL in 2015, Dr Hamila has been instrumental in ensuring the Company’s quality management system and pharmacovigilance operations serve the needs of patients and meet global regulatory compliance.

Prior to joining CLINUVEL, Dr Hamila held quality assurance and Qualified Person roles with large and mid-sized pharma companies, as well as working as a dispensing pharmacist in France.