Company Announcement

ASX:

CUV

Nasdaq International Designation: CLVLY

XETRA-DAX:

UR9

JEFFERIES INITIATES RESEARCH COVERAGE OF CLINUVEL

Melbourne, Australia, 13 October 2020

CLINUVEL PHARMACEUTICALS LTD today informed its shareholders and interested investors that Jefferies Australia Pty Ltd has initiated independent analyst coverage on the Company.

Independent research analyst coverage

The Jefferies Financial Group Inc. (NYSE:JEF) is a leading international financial services company offering a range of investment banking, equities, fixed income, asset and wealth management products and services through subsidiaries worldwide. Healthcare is one of the firm's 12 focus areas, with Jefferies maintaining a dedicated global healthcare research team which issues analyst coverage on over 270 companies in the sector. The annual Jefferies Global Healthcare Conference is recognised as the largest life sciences investment event in Europe.

Jefferies is the fifth independent holder of an Australian Financial Services License (AFSL) to issue research reports on CLINUVEL, reflecting growing investor interest in the Company, particularly since it entered the S&P/ASX 200 Index.

Jefferies' Head of Healthcare Equity Research Australia, Dr David Stanton, has led the development of the coverage, engaging with CLINUVEL's management. Dr Stanton, a qualified Medical Specialist and holding a Master of Business Administration, has followed CLINUVEL's development program since 2007. Jefferies' coverage follows the commercialisation of CLINUVEL's lead drug SCENESSE® (afamelanotide 16mg)1 in the USA and the Company's recent announcement that it is seeking to confirm the ability of afamelanotide to repair ultraviolet-induced DNA damage.

Firm/Institution

Analyst

Date of Last Report

Bioshares

David Blake & Mark Pachacz

14 September 2020

Intelligent Investor

Graham Whitcomb

28 August 2020

Jefferies Australia

David Stanton

13 October 2020

Lonsec Research

Chad Troja

09 September 2020

Moelis Australia Securities

Sarah Mann

27 August 2020

Above: Independent AFSL firms providing analyst coverage of CLINUVEL. Further details are available at www.clinuvel.com. CLINUVEL does not republish analyst reports.

Commentary

"As CLINUVEL has progressed its global commercial and clinical programs we have seen increased interest in our growth story from a range of research analysts and institutional investors," CLINUVEL's Head of Investor Relations, Mr Malcolm Bull said. "We take a transparent approach in engaging with the financial community, and remain open to independent, licensed research firms to analyse our progress based on public information, and to publish analytical reports for their clients."

No guidance or endorsement

CLINUVEL does not provide financial guidance on its earnings and financial performance. The Company does not endorse, confirm or express a view as to the accuracy of the analyst reports and the forecasts contained within these. CLINUVEL does not induce, incentivise or remunerate analysts and journalists to publish and recommend the Company in their reports.

- End -

1 SCENESSE® (afamelanotide 16mg) is approved in the European Union as an orphan medicinal product for the prevention of phototoxicity in adult patients with erythropoietic protoporphyria (EPP). SCENESSE® is approved in the USA to increase "pain- free" light exposure in adult EPP patients with a history of phototoxicity. Information on the product can be found on CLINUVEL's website at www.clinuvel.com.

Authorised for ASX release by the Board of Directors of CLINUVEL PHARMACEUTICALS LTD

About CLINUVEL PHARMACEUTICALS LIMITED

CLINUVEL PHARMACEUTICALS LTD (ASX: CUV; NASDAQ INTERNATIONAL DESIGNATION ADR: CLVLY; XETRA-DAX: UR9) is a global biopharmaceutical company focused on developing and delivering treatments for patients with a range of severe genetic, skin, and systemic disorders. As pioneers in photomedicine and understanding the interaction of light and human biology, CLINUVEL's research and development initially has led to innovative treatments for patient populations with a clinical need for photoprotection and repigmentation. 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 and the US Food and Drug Administration in 2019 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. CLINUVEL is advancing its portfolio of melanocortins, among which is PRÉNUMBRA® for the treatment of several critical disorders. Headquartered in Melbourne, Australia, CLINUVEL has operations in Europe, Singapore, and the USA. For more information please go to http://www.clinuvel.com.

SCENESSE® and PRÉNUMBRA® 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, 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 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); our ability to achieve expected safety and efficacy results 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, 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® 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 based products; decisions by regulatory authorities regarding approval of our products as well as their decisions regarding label claims; any failure 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 2020 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 the forecasts and estimates is available on request. Past performance is not an indicator of future performance.

www.clinuvel.com

Level 11

T +61 3 9660 4900

535 Bourke Street

F +61 3 9660 4999

Melbourne, Victoria, Australia, 3000

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Clinuvel Pharmaceuticals Limited published this content on 13 October 2020 and is solely responsible for the information contained therein. Distributed by Public, unedited and unaltered, on 12 October 2020 23:09:04 UTC