UNITED
STATES
SECURITIES
AND EXCHANGE COMMISSION
Washington,
D.C. 20549
FORM
6-K
REPORT
OF FOREIGN PRIVATE ISSUER
PURSUANT
TO RULE 13a-16 OR 15d-16
UNDER
THE SECURITIES EXCHANGE ACT OF 1934
For
the month of August 2026
Commission
File Number: 001-43353
CLINUVEL
PHARMACEUTICALS LIMITED
Level
22, 535 Bourke Street
Melbourne,
VIC 3000
Australia
(Address
of principal executive office)
Indicate
by check mark whether the registrant files or will file annual reports under cover of Form 20-F or Form 40-F:
Form
20-F ☒ Form 40-F ☐
INFORMATION
CONTAINED IN THIS FORM 6-K REPORT
On
August 20, 2026, Clinuvel Pharmaceuticals Limited filed with the Australian Securities Exchange an announcement captioned “CLINUVEL
Annual Results – Investor Webinar”, a copy of which announcement is attached to this Form 6-K as Exhibit 99.1.
Exhibits
| Exhibit
No. |
|
Description |
| |
|
|
| 99.1 |
|
Press release dated August 20, 2026 |
SIGNATURES
Pursuant
to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by
the undersigned, thereunto duly authorized.
| |
CLINUVEL
PHARMACEUTICALS LIMITED |
| |
|
|
| Date:
August 20, 2026 |
By: |
/s/
Philippe Wolgen |
| |
Name:
|
Philippe
Wolgen |
| |
Title: |
Managing
Director and Chief Executive Officer |
Exhibit
99.1

CLINUVEL
Annual Results – Investor Webinar
Melbourne
/ New York – 20 August 2026 – CLINUVEL PHARMACEUTICALS LTD (ASX: CUV | Nasdaq: CUVL) will announce its results for the
financial year ending 30 June 2026 on 27 August 2026. An investor and analyst webinar will be held at 18:00 AEST on 27 August 2026 to
review the results. Participants can register using the link below:
INVESTOR
WEBINAR
27
August 2026
18:00-18:30 AEST (10:00-10:30 CET)
To
participate, please register using this link:
CLINUVEL
Investor Webinar
https://us06web.zoom.us/webinar/register/WN_PtGSnsu0TCeQOSToxLrW_A
Questions
may be tabled as you register, and during the webinar.
–
End –
ASX Announcement | P A G E 1 O F 2 |
About
CLINUVEL PHARMACEUTICALS LIMITED
CLINUVEL
is a global biopharmaceutical company focused on developing and delivering innovative therapies for patients with genetic, metabolic,
and dermatological disorders. The Company’s portfolio is centred around melanocortin peptides, with programs advancing in photomedicine
and vitiligo. CLINUVEL is listed on the Australian Securities Exchange (ASX: CUV) and the Nasdaq Stock Market (Nasdaq: CUVL).
CLINUVEL’s
lead therapy, SCENESSE® (afamelanotide 16mg), is approved for commercial distribution in Europe, the USA, Canada, Israel, and Australia
as the world’s first systemic photoprotective drug for the prevention of phototoxicity (anaphylactoid reactions and burns) in adult
patients with erythropoietic protoporphyria (EPP). For further information, visit www.clinuvel.com.
Authorised
for ASX release by the Board of Directors 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. All statements
other than statements of historical or current facts made in this document are forward-looking. We identify forward-looking statements
in this document by using words or phrases such as “anticipate,” “believe,” “consider,” “continue,”
“could,” “estimate,” “expect,” “foresee,” “intend,” “likely,”
“may,” “objective,” “potential,” “plan,” “predict,” “project,”
“seek,” “should,” “will” and similar words or phrases and their negatives. Forward-looking statements
reflect our current expectations and are inherently uncertain. Actual outcomes or results could differ materially for a variety of reasons.
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 but are not limited to risks relating to: our ability to develop and commercialise pharmaceutical products;
pandemics, epidemics, public health emergencies, geopolitical conflicts, trade restrictions, natural disasters and other disruptions
affecting global supply chains, including our ability to develop, manufacture, market and sell biopharmaceutical and PhotoCosmetic products;
competition for our products, especially SCENESSE® (afamelanotide 16mg), CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or
products developed and characterised by us as PhotoCosmetics; 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, the UK, Israel, China, Japan, and/or LATAM regions
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®, CYACÊLLE, PRÉNUMBRA®, NEURACTHEL® or products developed as PhotoCosmetics
which may lead to the Company being unable to launch, supply or serve its commercial markets, special access programs and/or clinical
trial programs; any failures to comply with any government payment system (i.e. Medicare, Medicaid, and U.S. Department of Veteran’s
Affairs) reporting and payment obligations; uncertainties surrounding the legislative and regulatory pathways for the registration and
approval of biotechnology, cosmetic 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, cosmetic industry and related industries; potential changes to tax liabilities or
legislation; environmental risks including the risk factors described in the Company’s Annual Report on Form 20-F and other filings
with the U.S. Securities and Exchange Commission, together with the Company’s announcements lodged with the Australian Securities
Exchange. Forward-looking statements speak only as of the date on which they are made, and the Company undertakes no obligation except
as required by applicable law, the rules of the Australian Securities Exchange, the U.S. Securities and Exchange Commission, Nasdaq,
or other applicable regulatory requirements, 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.
Contact:
Tel: +61 3 9660 4900
Fax: +61 3 9660 4909
Email: mail@clinuvel.com
Australia
(Head Office), Level 22, 535 Bourke Street, Melbourne, Victoria, 3000, Australia

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