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SEC Comment Letter for Clinuvel Pharmaceuticals (CUVL) — Apr 7, 2026

Clinuvel Pharmaceuticals Ltd
Date: April 7, 2026 · CIK: 0001290877 · Accession: 0000000000-26-003510

Regulatory Compliance Financial Reporting Business Model Clarity

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Summary

Reasoning

Date
April 7, 2026
Author
cc: Louis Taubman
Form
UPLOAD
Company
Clinuvel Pharmaceuticals Ltd

Letter

Re: Clinuvel Pharmaceuticals Limited Amendment No. 2 to Draft Registrant Statement on Form 20-F Submitted March 30, 2026 CIK No. 0001290877 Dear Phillipe Wolgen:

April 7, 2026

Phillipe Wolgen Chief Executive Officer Clinuvel Pharmaceuticals Limited Level 22, 535 Bourke Street Melbourne, VIC 3000 Australia

We have reviewed your amended draft registration statement and have the following comments.

Please respond to this letter by providing the requested information and either submitting an amended draft registration statement or publicly filing your registration statement and non- public draft submissions on EDGAR. If you do not believe a comment applies to your facts and circumstances or do not believe an amendment is appropriate, please tell us why in your response.

After reviewing the information you provide in response to this letter and your amended draft registration statement or filed registration statement, we may have additional comments. Unless we note otherwise, any references to prior comments are to comments in our March 19, 2026 letter.

Amendment No. 2 to Draft Registration Statement on Form 20-F Item 4. Information on the Company Grow the Research and Development..., page 27

1. We note your revisions in response to prior comment 3. Please address the following: We note that your disclosure on page 6 indicates that one or more submissions to EMA would be required prior to commercializing Scenesse for treatment of EPP in adolescents. Accordingly please revise the gray bar in the table so that it does not extend into the Commercial column. We note you are developing novel formulations of the melanocortin April 7, 2026 Page 2

adrenocorticotropic hormone ( ACTH ) as NEURACTHEL in multiple dosage forms. You disclose that the NEURACTHEL Instant candidate is a generic and that you have not conducted any clinical trials. Accordingly, please revise the graphic itself to reflect that you plan to seek approval for a generic product and remove the solid blue coloring from the Phase 1, 2 and 3 columns. Also revise the footnotes, as well as your discussion of NEURACTHEL on page 27, to identify the indication or indications that will be covered by your initial submission(s) to a European regulator or indicate that you have not yet made such a determination. Similarly, revise the graphic and footnotes thereto to disclose the indication(s) for which the NEURACTHEL modified release formulation is being studied, and revise your discussion on page 27 and throughout as appropriate to describe the ongoing preclinical program for this product candidate. With respect to your presentation of the VLRX-L controlled-release peptide platform, please revise the table to explain, if true, that (i) this platform involves liquid injections and (ii) that you have not chosen a specific peptide for clinical development. Research and Development, page 35

2. We note your revisions in response to prior comment 2, which we reissue in part. Please further revise your discussion related to your announced expansion of the VALLAURIX RD&I Centre to address the following: Discuss and quantify the support that you are to receive under the five-year investment plan. Disclose whether you are receiving grants, loans and/or other forms of support. Also, discuss your material obligations under the contract as well as the term and termination provisions. With reference to Items 4.D of Form 20-F, disclose an estimate of the amount of your planned expenditures for the expansion, including the amount of expenditures already paid. Clarify whether these expenditures are exclusive or inclusive of funding slated to be received from the Singaporean Economic Development Board. For guidance, refer to Item 4.D. of Form 20-F.

Item 5. Operating and Financial Review and Prospects A. Operating Results - Research and Development, page 46

3. We acknowledge your response to prior comment seven and partially reissue our comment. Please revise to include in your disclosures a statement regarding whether you track direct research and development costs by program area. Revise your disclosure to disaggregate 'Direct R&D clinical site and program costs' currently included in 'other costs' for each period presented. We do not believe potential competitive harm is a valid reason for omitting this material information. April 7, 2026 Page 3

Please contact Bonnie Baynes at 202-551-4924 or Vanessa Robertson at 202-551-3649 if you have questions regarding comments on the financial statements and related matters. Please contact Lauren Sprague Hamill at 303-844-1008 or Joe McCann at 202-551-6262 with any other questions.

Sincerely,
Division of
Corporation Finance
Office of Life
Sciences
cc: Louis Taubman

Show Raw Text
<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 7, 2026

Phillipe Wolgen
Chief Executive Officer
Clinuvel Pharmaceuticals Limited
Level 22, 535 Bourke Street
Melbourne, VIC 3000
Australia

 Re: Clinuvel Pharmaceuticals Limited
 Amendment No. 2 to Draft Registrant Statement on Form 20-F
 Submitted March 30, 2026
 CIK No. 0001290877
Dear Phillipe Wolgen:

 We have reviewed your amended draft registration statement and have the
following
comments.

 Please respond to this letter by providing the requested information
and either submitting
an amended draft registration statement or publicly filing your registration
statement and non-
public draft submissions on EDGAR. If you do not believe a comment applies to
your facts and
circumstances or do not believe an amendment is appropriate, please tell us why
in your
response.

 After reviewing the information you provide in response to this letter
and your amended
draft registration statement or filed registration statement, we may have
additional
comments. Unless we note otherwise, any references to prior comments are to
comments in our
March 19, 2026 letter.

Amendment No. 2 to Draft Registration Statement on Form 20-F
Item 4. Information on the Company
Grow the Research and Development..., page 27

1. We note your revisions in response to prior comment 3. Please address
the following:
 We note that your disclosure on page 6 indicates that one or more
submissions to
 EMA would be required prior to commercializing Scenesse for treatment
of EPP in
 adolescents. Accordingly please revise the gray bar in the table so
that it does not
 extend into the Commercial column.
 We note you are developing novel formulations of the melanocortin
 April 7, 2026
Page 2

 adrenocorticotropic hormone ( ACTH ) as NEURACTHEL in
multiple dosage
 forms. You disclose that the NEURACTHEL Instant candidate is a
generic and that
 you have not conducted any clinical trials. Accordingly, please
revise the graphic
 itself to reflect that you plan to seek approval for a generic
product and remove the
 solid blue coloring from the Phase 1, 2 and 3 columns. Also revise
the footnotes, as
 well as your discussion of NEURACTHEL on page 27, to identify the
indication or
 indications that will be covered by your initial submission(s) to a
European regulator
 or indicate that you have not yet made such a determination.
Similarly, revise the
 graphic and footnotes thereto to disclose the indication(s) for
which the
 NEURACTHEL modified release formulation is being studied, and
revise your
 discussion on page 27 and throughout as appropriate to describe the
 ongoing
 preclinical program for this product candidate.
 With respect to your presentation of the VLRX-L
controlled-release peptide
 platform, please revise the table to explain, if true, that (i)
this platform involves
 liquid injections and (ii) that you have not chosen a specific
peptide for clinical
 development.
Research and Development, page 35

2. We note your revisions in response to prior comment 2, which we reissue
in part. Please
 further revise your discussion related to your announced expansion of
the VALLAURIX
 RD&I Centre to address the following:
 Discuss and quantify the support that you are to receive under the
five-year
 investment plan. Disclose whether you are receiving grants, loans
and/or other forms
 of support. Also, discuss your material obligations under the
contract as well as the
 term and termination provisions.
 With reference to Items 4.D of Form 20-F, disclose an estimate of
the amount of
 your planned expenditures for the expansion, including the amount of
expenditures
 already paid. Clarify whether these expenditures are exclusive or
inclusive of
 funding slated to be received from the Singaporean Economic
Development Board.
 For guidance, refer to Item 4.D. of Form 20-F.

Item 5. Operating and Financial Review and Prospects
A. Operating Results - Research and Development, page 46

3. We acknowledge your response to prior comment seven and partially
reissue our
 comment.
 Please revise to include in your disclosures a statement regarding
whether you track
 direct research and development costs by program area.
 Revise your disclosure to disaggregate 'Direct R&D clinical site and
program costs'
 currently included in 'other costs' for each period presented. We do
not believe
 potential competitive harm is a valid reason for omitting this
material information.
 April 7, 2026
Page 3

 Please contact Bonnie Baynes at 202-551-4924 or Vanessa Robertson at
202-551-3649 if
you have questions regarding comments on the financial statements and related
matters. Please
contact Lauren Sprague Hamill at 303-844-1008 or Joe McCann at 202-551-6262
with any other
questions.

 Sincerely,

 Division of
Corporation Finance
 Office of Life
Sciences
cc: Louis Taubman
</TEXT>
</DOCUMENT>