Clinuvel Pharmaceuticals : Presentation - H.C. Wainwright Bioconnect Conference 2022

CLINUVEL's Growth and Expansion

H.C. Wainwright Bioconnect Conference 2022

CLINUVEL'S GROWTH AND EXPANSION

Building a Specialty Pharmaceutical Group

		H.C. Wainwright Bioconnect Conference
		10-13 January 2022
		Presented by:
CLINUVEL Group
ASX:	CUV	Malcolm Bull
XETRA-DAX:	UR9
Level 1 ADR :	CLVLY
clinuvel.com		Head of Investor Relations
news.clinuvel.com

Thank you to the H.C. Wainwright team for the opportunity to tell our compelling investment story at the start of the new year, 2022. With focus and determination, CLINUVEL has evolved from a research and development focused company to a profitable group of companies with growing commercial operations and an active research and development pipeline. Our objective is to provide a range of pharmaceutical and healthcare solutions for patients and specific broader audiences with unmet needs, based on our leadership in the fields of photomedicine and melanocortins.

CLINUVEL's Growth and Expansion - H.C. Wainwright Bioconnect Conference 2022 www.clinuvel.com

CLINUVEL's Growth and ExpansionH.C. Wainwright Bioconnect Conference 2022

Legal Notice

This release contains forward-looking statements, which reflect the	reimbursement; that the Company may incur unexpected delays in the
current beliefs and intentions of CLINUVEL's management. Statements	outsourced manufacturing of SCENESSE®, PRÉNUMBRA® or
may involve a number of known and unknown risks that could cause our	NEURACTHEL® which may lead to it being unable to supply its
future results, performance, achievements or output to differ	commercial markets and/or clinical trial programs; any failures to
significantly from those expressed or implied by such forward-looking	comply with any government payment system (i.e. Medicare) reporting
statements. Important factors that could cause or contribute to such	and payment obligations; uncertainties surrounding the legislative and
differences include risks relating to: our ability to develop and	regulatory pathways for the registration and approval of biotechnology
commercialise pharmaceutical products; the COVID-19 pandemic and/or	and consumer based products; decisions by regulatory authorities
other world, regional or national events affecting the supply chain for a	regarding approval of our products as well as their decisions regarding
protracted period of time, including our ability to develop, manufacture,	label claims; our ability to retain or attract key personnel and managerial
market and sell biopharmaceutical products; competition for our	talent; the impact of broader change within the pharmaceutical industry
products, especially SCENESSE® (afamelanotide 16mg), PRÉNUMBRA®	and related industries; potential changes to tax liabilities or legislation;
or NEURACTHEL®; our ability to achieve expected safety and efficacy	environmental risks; risks originating from equity markets, and other
results in a timely manner through our innovative R&D efforts; the	factors that have been discussed in our 2021 Annual Report. Forward-
effectiveness of our patents, trademark and other protections for	looking statements speak only as of the date on which they are made,
innovative products, particularly in view of national and regional	and the Company undertakes no obligation, outside of those required
variations in patent laws; our potential exposure to product liability	under applicable laws or relevant listing rules of the Australian Securities
claims to the extent not covered by insurance; increased government	Exchange, to update or revise any forward-looking statement, whether as
scrutiny in either Australia, the U.S., Europe, Israel, China and Japan of	a result of new material information, future events or otherwise. More
our agreements with third parties and suppliers; our exposure to	information on preliminary and uncertain forecasts and estimates is
currency fluctuations and restrictions as well as credit risks; the effects	available on request, whereby it is stated that past performance is not an
of reforms in healthcare regulation and pharmaceutical pricing and	indicator of future performance.

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.

CLINUVEL's Growth and Expansion - H.C. Wainwright Bioconnect Conference 2022 www.clinuvel.com

Mission & Objectives

Establishing a specialty pharmaceutical group which is;

diversified,

vertically integrated, and

which serves unmet patient and healthcare needs.

We aim to provide a safe and accountable environment,

where our staff grow, thrive and build a career. In pursuing this mission, we provide long-term value for society and our shareholders.

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.

People are central to our company values and to our business, and we take a specific approach towards nurturing talent and encouraging our staff to develop their careers in a safe, accountable environment.

CLINUVEL's Growth and Expansion - H.C. Wainwright Bioconnect Conference 2022 www.clinuvel.com

CLINUVEL's Growth and Expansion

H.C. Wainwright Bioconnect Conference 2022

CLINUVEL Group

Functional divisions

		Communications,
Pharmaceuticals	Healthcare Solutions	Branding & Marketing	Manufacturing

Research, Development

& Innovation Centre

The 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).

CLINUVEL's initial phase from formation to late 2005 was to acquire the core technology, afamelanotide with a view to develop a tanning preparation. A new management team reset the strategy for the second phase of evolution from 2005 to 2020 to develop and commercialise a novel drug for an unmet medical need. SCENESSE® was developed and commercialised as the world's first systemic photoprotective for the genetic disorder erythropoietic protoporphyria (EPP). In 2021, we entered the third, current and most exciting phase of CLINUVEL's evolution to expand access to SCENESSE® in EPP and to translate our technology to new targeted indications and healthcare solutions for broader audiences.

To achieve this objective, 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-onformulations.

CLINUVEL's Growth and Expansion - H.C. Wainwright Bioconnect Conference 2022 www.clinuvel.com

CLINUVEL's Growth and Expansion

H.C. Wainwright Bioconnect Conference 2022

CLINUVEL Group

Proven technology

• SCENESSE® (afamelanotide 16mg)
• • Synthetic peptide, mimics naturally occurring α-MSH
  • First systemic photoprotective for erythropoietic protoporphyria (EPP)
• SCENESSE® positive safety profile maintained - >10,000 doses
• α-MSHpart of melanocortin family of peptides binding to melanocortin receptors
• Growing scientific recognition of role of melanocortins in key organs of the body

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, stimulates the production of eumelanin which provides 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 phototoxicity;
• 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 to address unmet medical and healthcare needs is the basis of CLINUVEL's strategy to translate the technology for broader audiences.

CLINUVEL's Growth and Expansion - H.C. Wainwright Bioconnect Conference 2022 www.clinuvel.com