Clinuvel Pharmaceuticals : H.C. Wainwright Global Investment Conference Presentation

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On the road towards a

Diversified & Sustainable

Specialty Pharmaceutical

H.C. Wainwright Global Investment Conference

23-26 May 2022

Thank you to the H.C. Wainwright team for the opportunity.

In January this year, we presented virtually at the H.C. Wainwright Bioconnect Conference, it is pleasing to be present in Miami in person to present our story at this prestigious conference.

The CLINUVEL story is one of determination and perseverance to evolve from a research and development focused company to a profitable group with growing commercial operations. Our objective is to provide a range of pharmaceutical solutions aided and flanked by healthcare products for patients and specific broader audiences with unmet needs. We base our leadership in the field of melanocortins, with a subspecialty in photomedicine.

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Forward-looking

Statements

This release contains forward-looking statements, which reflect the current beliefs and expectations of CLINUVEL's management. 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 ability 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 products; competition for our products, especially SCENESSE® (afamelanotide 16mg), PRÉNUMBRA® or NEURACTHEL®; our ability to achieve expected safety and efficacy results in a timely manner through our 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 liability claims to the extent not covered by insurance; increased government scrutiny in either Australia, the U.S., Europe, Israel, China and Japan 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 incur unexpected delays in the outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or NEURACTHEL® which may lead to it being unable to supply its commercial markets and/or clinical trial programs; any failures to comply with any government payment system (i.e. Medicare) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and approval of biotechnology and consumer based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; our ability to retain or attract key personnel and managerial talent; the impact of broader change within the pharmaceutical industry and related industries; potential changes to tax liabilities or legislation; environmental risks; and other factors that have been discussed in our 2021 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 estimates is available on request, whereby it is stated that past performance is not an indicator of future performance.

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Your attention is drawn to our legal notice which highlights that there are many risks that can materialise and impact

the business or execution of CLINUVEL's plans, noting this presentation contains forward-looking statements.

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CLINUVEL is building a specialty pharmaceutical group, based on our expertise and unparalleled knowledge and

experience in the development and commercialisation of melanocortins - a family of bioactive hormones which act on human tissues.

Having commercialised our first melanocortin product - SCENESSE® - CLINUVEL is now establishing a diversified, vertically integrated group of companies which address unmet patient and healthcare needs.

The right talent is central to our company values and to our business, and we take a specific approach towards developing careers and encouraging our staff to seek further education in a safe, accountable environment.

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e CLINUVEL Group is a global enterprise, headquartered in Australia with operations in Europe, Singapore, and the USA. Formed in 1999 and listed on the Australian Securities Exchange in 2001, we also trade, since 2004, on the Xetra-Dax in Germany (as UR9), and the OTC securities market in the USA as a Level One American Depositary Receipt (CLVLY).

To achieve our objective to expand access to SCENESSE® in erythropoietic protoporphyria (EPP) and to translate our technology to new targeted indications and healthcare solutions for broader audiences, the Group is organised across four Divisions:

• The Pharmaceuticals Division - CLINUVEL's core business, focussed on developing and delivering drugs for patients with unmet medical need.
• The Healthcare Solutions Division - concentrated on non-prescription products derived from the knowhow and active ingredients used in the Pharmaceuticals Division.
• The Communications, Branding & Marketing Division - prepares communications to wider differentiated audiences, positioning the Group for broader engagement.
• The Manufacturing Division - focused on manufacturing novel formulations and products for CLINUVEL and

research, development and production for other companies and research groups in the biopharmaceutical sector. Underlying the divisional structure is the Research, Development & Innovation (RDI) Centre in Singapore, researching molecular science, biology, and follow-on formulations.

We are committed to develop the business with the expenditure of A$175m over 5 years to FY2025. We will achieve growth with profitability for future sustainability.

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The Group's lead technology is SCENESSE®, the only approved treatment for EPP, a poorly characterised, metabolic disorder causing lifelong light intolerance. Patients suffer acute phototoxic reactions after exposure to light. Without treatment, patients must avoid exposure to light and thus lead a life of social isolation.

The active ingredient of SCENESSE® is afamelanotide, a synthetic peptide which mimics the naturally occurring alpha-melanocyte stimulating hormone (α-MSH). The peptide acts as a strong anti-oxidativeagent, serves as a hormone combatting fluid formation following tissue damage and stimulates the production of eumelanin to provide protection from UV and visible light. SCENESSE®:

• was developed as a controlled-release subcutaneous injectable implant formulation, for administration in an outpatient setting;
• has been shown to reduce the incidence and severity of phototoxic reactions and increase the time EPP patients can expose to light without 3rd degree burns;
• is monitored in post-authorisation use in EPP patients by an extensive pharmacovigilance program; and
• has maintained a positive safety profile from over 10,000 doses administered.

α-MSH is part of a family of peptides known as melanocortins, all of which are cleaved from the precursor polypeptide proopiomelanocortin (POMC) and bind to specific melanocortin receptors throughout the body. There is growing recognition of their role in the function of key organs of the body.

The safety and potential of SCENESSE® and other melanocortins (such as ACTH, CUV9900) to address unmet medical and healthcare needs is the basis of CLINUVEL's strategy to translate the technology for broader audiences.