SecProbe.io

CORRESP
 1
 filename1.htm

 Clinuvel Pharmaceuticals Limited

 July 15, 2026

 Via EDGAR

 Division of Corporation Finance

 Office of Life Sciences

 U.S. Securities and Exchange Commission

 100 F Street, NE

 Washington, D.C., 20549

 Attention:
 Vanessa Robertson

 Bonnie Baynes
 Joe McCann
 Lauren Sprague Hamill

 Re:
 Clinuvel Pharmaceuticals Limited

 Registration Statement on Form 20-F

 File No. 001-43353

 Ladies and Gentlemen:

 Pursuant to Rule 12d1-2 promulgated under the Securities
Exchange Act of 1934, as amended, Clinuvel Pharmaceuticals Limited (the "Registrant") hereby requests that the U.S. Securities
and Exchange Commission (the "Commission") take appropriate action to cause the Registration Statement on Form 20-F (File
No. 001-43353) to become effective at 4:00 p.m. Eastern time on July 17, 2024, or as soon thereafter as practicable, or at such later
time as the Registrant or its counsel may orally request by telephone call to the staff of the Commission.

 Very truly yours,

 Clinuvel Pharmaceuticals Limited

 By:
 /s/ Philippe Wolgen

 Name:
 Philippe Wolgen

 Title:
 Managing Director and Chief Executive Officer

CORRESP
 1
 filename1.htm

 Clinuvel
Pharmaceuticals Limited

 July
9, 2026

 Via
EDGAR

 Division
of Corporation Finance

 Office
of Life Sciences

 U.S.
Securities and Exchange Commission

 100
F Street, NE

 Washington,
D.C., 20549

 Attention:

 Vanessa
 Robertson

 Bonnie
 Baynes
 Joe
 McCann
 Lauren
 Sprague Hamill

 Re:
 Clinuvel
 Pharmaceuticals Limited

 Registration
 Statement on Form 20-F

 File
 No. 001-43353
 Withdrawal
 of Acceleration Request

 Ladies
and Gentlemen:

 Reference
is made to our letter, filed as correspondence with the U.S. Securities and Exchange Commission via EDGAR on July 6, 2026, in which we
requested the acceleration of the effective date of the above-captioned Registration Statement for July 8, 2026, at 4:00 p.m. Eastern
Time, or as soon as practicable thereafter, in accordance with Rule 12d1-2 promulgated under the Securities Exchange Act of 1934, as
amended. Clinuvel Pharmaceuticals Limited is no longer requesting that such Registration Statement be declared effective at such date
and time, and we hereby formally withdraw our request for acceleration of the effective date of the above-captioned Registration Statement.

 Very truly yours,

 Clinuvel Pharmaceuticals Limited

 By:
 /s/
 Philippe Wolgen

 Name:
 Philippe
 Wolgen

 Title:
 Managing
 Director and Chief Executive Officer

CORRESP
 1
 filename1.htm

 Clinuvel
Pharmaceuticals Limited

 July
6, 2026

 Via
EDGAR

 Division
of Corporation Finance

 Office
of Life Sciences

 U.S.
Securities and Exchange Commission

 100
F Street, NE

 Washington,
D.C., 20549

 Attention:

 Vanessa
 Robertson

 Bonnie
 Baynes
 Joe
 McCann
 Lauren
 Sprague Hamill

 Re:
 Clinuvel
 Pharmaceuticals Limited

 Registration
 Statement on Form 20-F

 File
 No. 001-43353

 Ladies
and Gentlemen:

 Pursuant
to Rule 12d1-2 promulgated under the Securities Exchange Act of 1934, as amended, Clinuvel Pharmaceuticals Limited (the "Registrant")
hereby requests that the U.S. Securities and Exchange Commission (the "Commission") take appropriate action to cause the
Registration Statement on Form 20-F (File No. 001-43353) to become effective at 4:00 p.m. Eastern time on July 8, 2024, or as soon thereafter
as practicable, or at such later time as the Registrant or its counsel may orally request by telephone call to the staff of the Commission.

 Very
 truly yours,

 Clinuvel
 Pharmaceuticals Limited

 By:
 /s/
 Philippe Wolgen

 Name:

 Philippe
 Wolgen

 Title:

 Managing
 Director and Chief Executive Officer

CORRESP
 1
 filename1.htm

 Clinuvel
Pharmaceuticals Limited

 June
15, 2026

 Via
EDGAR

 Division
of Corporation Finance

 Office
of Life Sciences

 U.S.
Securities and Exchange Commission

 100
F Street, NE

 Washington,
D.C., 20549

 Attention:

 Vanessa
 Robertson

 Bonnie
 Baynes
 Joe
 McCann
 Lauren
 Sprague Hamill

 Re:
 Clinuvel
 Pharmaceuticals Limited

 Amendment
 No. 3 to Draft Registration Statement on Form 20-F

 Submitted
 April 17, 2026

 CIK
 No. 0001290877

 To
Whom It May Concern:

 This
letter is in response to the letter dated April 23, 2026 from the staff (the "Staff") of the U.S. Securities and Exchange
Commission (the "Commission") addressed to Clinuvel Pharmaceuticals Limited (the "Company," "we,"
and "our"). For ease of reference, we have recited the Staff's comment in this response and numbered it accordingly.
We are including the requested updates in the public filing of the Registration Statement noted above(the "Registration Statement").

 Amendment
No. 3 to Draft Registration Statement on Form 20-F

 Interim
Consolidated Financial Statements for the six months ended December 31, 2025 and 2024 (Unaudited and Presented on an IFRS basis), page
F-24

 1.
 As
 your June 30, 2025 annual audited financial statements are prepared in accordance with U.S. GAAP, all interim unaudited financial
 statements required in the registration statement must also be prepared under U.S. GAAP as required by Item 8.A.5 of Form 20-F. Note
 that while foreign private issuers are allowed to initially include more current published information, that published data accommodation
 does not waive the underlying requirement for consistent accounting standards in a registration statement. Please revise to disclose
 the following:

 ●
 Revise
 to replace your current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared
 under U.S. GAAP that were due on April 1, 2026.

 ●

 Please
 revise other areas of the document impacted by this change, including your capitalization table and Item 5. Operating and financial
 review and prospects.

 Response :
In response to the Staff's comments, we have revised our disclosures beginning on page F-24 of the Registration Statement to replace
our current December 31, 2025 interim unaudited financial statement prepared under IFRS with financial statements prepared under U.S.
GAAP and also revised other areas of the Registration Statement impacted by the change, including our capitalization table and Item 5.
Operating and financial review and prospects.

 We
appreciate the assistance the Staff has provided with its comments. If you have any questions, please do not hesitate to call our counsel,
Louis Taubman, Esq., of Hunter Taubman Fischer & Li LLC, at (917) 512-0827.

 Very
truly yours,

 /s/
 Philippe Wolgen

 Name:

 Philippe
 Wolgen

 Title:

 Managing
 Director and Chief Executive Officer

 cc:
 Louis
 Taubman, Esq.

 Hunter
 Taubman Fischer & Li LLC

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 April 23, 2026

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

 Re: Clinuvel Pharmaceuticals Limited
 Amendment No. 3 to Draft Registrant Statement on Form 20-F
 Submitted April 17, 2026
 CIK No. 0001290877
Dear Phillipe Wolgen:

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

 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
April 7, 2026 letter.

Amendment No. 3 to Draft Registrant Statement on Form 20-F
Interim Consolidated Financial Statements for the six months ended December 31,
2025 and
2024 (Unaudited and Presented on an IFRS basis), page F-24

1. As your June 30, 2025 annual audited financial statements are prepared
in accordance
 with U.S. GAAP, all interim unaudited financial statements required in
the registration
 statement must also be prepared under U.S. GAAP as required by Item
8.A.5 of Form
 20-F. Note that while foreign private issuers are allowed to initially
include more current
 published information, that published data accommodation does not waive
the underlying
 requirement for consistent accounting standards in a registration
statement. Please revise
 to disclose the following:
 April 23, 2026
Page 2

 Revise to replace your current December 31, 2025 interim
unaudited financial
 statement prepared under IFRS with financial statements prepared
under U.S. GAAP
 that were due on April 1, 2026.
 Please revise other areas of the document impacted by this
change, including your
 capitalization table and Item 5. Operating and financial review and
prospects.

 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 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>

<DOCUMENT>
<TYPE>TEXT-EXTRACT
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<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>

<DOCUMENT>
<TYPE>TEXT-EXTRACT
<SEQUENCE>2
<FILENAME>filename2.txt
<TEXT>
 March 19, 2026

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

 Re: Clinuvel Pharmaceuticals Limited
 Amendment No. 1 to Draft Registrant Statement on Form 20-F
 Submitted March 4, 2026
 CIK No. 0001290877
Dear Phillipe Wolgen:

 We have reviewed your filing and have the following comments.

 Please respond to this letter within ten business days by providing the
requested
information or advise us as soon as possible when you will respond. If you do
not believe a
comment applies to your facts and circumstances, please tell us why in your
response.

 After reviewing your response to this letter, we may have additional
comments.

Amendment No. 1 to Draft Registrant Statement on Form 20-F
Item 3. Key Information
B. Capitalization and Indebtedness, page 4

1. We acknowledge your response to prior comment four. Please revise to
address the
 following:
 Revise the total capitalization amount in the table to reconcile to
the balance sheet
 rather than using market capitalization;
 Include a double line underneath the cash and cash equivalents and
short-term
 investments numbers to distinguish them from the capitalization line
items; and
 Explain what the 'All other assets' line item represents and why it
is included in the
 table.
Item 4. Information on the Company, page 22

2. We note that your January 12, 2026 press release announced a significant
expansion of
 your VALLAURIX Research, Development and Innovation (RD&I) Centre in
 March 19, 2026
Page 2

 Singapore. With reference to Items 4.D. and 10.C. of Form 20-F, please
revise to discuss
 this project and its impact or advise.
Item 4.B. Business Overview, page 24
Grow the Research and Development Capacities and Broaden Therapeutic Portfolio,
page 27

3. We note your response to prior comment 8, as well as the inclusion of
the pipeline table
 appearing on page 28. In this regard:
 We note that the row reflecting SCENESSE in adolescent EPP indicates
that the next
 anticipated program milestone is a "filing in H2 2026." Please revise
to clarify the
 relevant regulator or jurisdiction as appropriate.
 Revise the row reflecting SCENESSE in adolescent and adult vitiligo
to (1) clarify in
 a footnote or otherwise, that the ongoing Phase 3 CUV105 trial is
evaluating
 SCENESSE with adjunctive phototherapy and not as a monotherapy and
(2)
 to include the year in which you expect topline results from the
CUV105 trial.
 We note your disclosure on page 27 that you recently announced that
you are
 developing liquid injectable controlled-release doses for
melanocortin delivery, and
 that VLRX-L, the first of these platforms, entered a preclinical
study in early 2026;
 however it is not clear whether you have selected a targeted
indication for this
 program at this time. As it appears this program may be too
preliminary to be
 emphasized in the pipeline table at this time, please provide us with
your analysis
 supporting your determination to include it. If this program is
currently material,
 please revise the table to identify the targeted indication and/or
revise your
 disclosure as appropriate.
 Please remove the row reflecting "Other platforms TBA," as any such
platforms do
 not appear to be currently material enough to your business to
justify highlighting
 in the pipeline table.
 Please limit the pipeline table to depict only your material
pharmaceutical programs,
 and remove the row reflecting your PhotoCosmetics program. In this
regard, we note
 that the development of cosmetics is not subject to the same clinical
development
 and regulatory review process reflected by the table, and therefore,
the narrative
 disclosure is a more appropriate place to discuss the PhotoCosmetics
program.
4. We acknowledge your response to prior comment 11, which we reissue with
respect to
 the bullet points below. In this regard, we note that your pipeline
table should be a visual
 reflection of the narrative discussion in the prospectus, which
discussion should provide
 proper context and thoroughly address all completed, ongoing, and
planned preclinical
 and clinical trials of your material product candidates.
 The pipeline table, and your narrative disclosure on page 28
regarding the
 expected marketing submission for NEURACTHEL in the EU, suggests
that all
 clinical trials of NEURACTHEL for IS and MS are complete. However,
it does not
 appear that the design of these clinical trials, or the results
observed, are discussed.
 On page 28, you reference a prior CUV102 trial of SCENESSE in
adolescent and
 adult vitiligo; however, the trial phase, trial design, and results
observed do not
 appear to be discussed.
 Please revise or otherwise advise.
 March 19, 2026
Page 3

5. Please revise page 28 to disclose the jurisdiction(s) where you plan to
apply for
 regulatory approval for SCENESSE in adolescent and adult vitiligo and in
variegate
 porphyria, and, as appropriate, in which order.
SCENESSE, page 28

6. We note your statement that "[c]urrently, the largest market opportunity
is seen in
 vitiligo..." To provide insight into the size of the market opportunity,
please revise to
 discuss the estimated size of the vitiligo patient population in
adolescents and adults
 worldwide and/or in markets that are material to your business
prospects. Similarly, with
 respect to your late-stage NERUACTHEL program, provide the estimated
size of the
 patient population with infantile spasms and acute exacerbations of MS,
which you state
 you believe would benefit from NEURACTHEL treatment.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Research and Development, page 46

7. We acknowledge your response to prior comment 24 and partially reissue
our comment.
 Please revise to disclose the following:
 Whether you track your research and development costs by program
area; and
 As 'Other costs' is over 40% of 2025 research and development
expense, please
 revise to quantify and disclose its components and whether this
material trend is
 expected in future periods.
Table of Contents, page F-1

8. Please revise the table of contents to your Item 18 financial statements
to address the
 following:
 Revise to disclose the December 31, 2025 interim financial
statements and notes
 thereto; and
 Please distinguish that your interim financial statements are
unaudited and presented
 on an IFRS basis, as opposed to your annual financial statements
that are audited and
 presented on a U.S. GAAP basis.
Notes to the Consolidated Financial Statements
Note 2. Summary of Significant Accounting Policies
Revenue, page F-8

9. We acknowledge your response to prior comment 23 and partially reissue
our comment.
 Please revise your footnotes or MD&A to disclose the amounts for each
significant
 category of sales rebate and other variable consideration adjustment
reflected in the
 periods presented.
10. We note your disclosure on page 35 that changes in pricing of SCENESSE,
from
 which you have consistently generated over 90% of your product sales,
may have a
 severe impact on your operations, that you do not offer rebates or
discounts on
 SCENESSE beyond statutory requirements and that you aim for uniform
pricing per
 jurisdiction. As it appears that uniform pricing may coexist with
expected rebates and
 other variable consideration with EEA and U.S. national or private
insurers, whether
 March 19, 2026
Page 4

 stated or implicit, tell us how you considered whether any non-uniform
elements exist,
 and if so, whether they are variable consideration that should be
estimated and
 constrained in determining your transaction price under ASC 606. Please
provide us the
 accounting guidance that supports your determination.
Interim Condensed Financial Statements, page F-24

11. Please revise your December 31, 2025 interim financial statements to
include a header
 for each of the statements and notes that prominently include "IFRS" and
 "Unaudited" for immediate visibility to distinguish them from the U.S.
GAAP annual
 statements.
Notes to the Condensed Financial Statements, page F-28

12. Please revise the basis of presentation footnote to include that these
statements are
 prepared according to IFRS as issued by the IASB to qualify for the
reconciliation
 exemption under Instruction 4 of Item 8.A.5 of Form 20-F.
 We remind you that the company and its management are responsible for
the accuracy
and adequacy of their disclosures, notwithstanding any review, comments, action
or absence of
action by the staff.

 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 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>

<DOCUMENT>
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<FILENAME>filename2.txt
<TEXT>
 January 30, 2026

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

 Re: Clinuvel Pharmaceuticals Limited
 Draft Registration Statement on Form 20-F
 Submitted December 18, 2025
 CIK No. 0001290877
Dear Phillipe Wolgen:

 We have reviewed your 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.

Draft Registration Statement on Form 20-F submitted December 18, 2025
Item 3.B. Capitalization and Indebtedness, page 4

1. Please revise your statement of capitalization and indebtedness as of a
date no earlier
 than 60 days prior to the date of the registration statement. Refer to
Item 3.B of Form 20-
 F.
Item 3.D. Risk Factors, page 4

2. Please describe the risks related to your quorum requirements and voting
on a show of
 hands. Additionally, expand the disclosure on pages 18 and 65 to
describe the distinction
 between poll voting and voting on a show of hands. Disclose whether
proxies are
 counted in show of hands voting. If there are any circumstances in which
proxies are not
 counted, please explain those circumstances and expand your risk factor
discussion to
 describe the circumstances under which proxies will not be counted.
 January 30, 2026
Page 2

3. Based on your patent disclosures beginning on page 39, it appears that
certain patents in
 various jurisdictions related to the method for treatment of
photodermatoses will expire
 in 2027. As appropriate, please provide risk factor disclosure
discussing the extent to
 which you face material risk stemming from the expiration of these
patents, or otherwise
 advise.
Item 3. Key Information
B. Capitalization and Indebtedness, page 4

4. Please provide us with the calculation of total capitalization.
We rely on one manufacturer to synthesize the API in SCENESSE ..., page 7

5. We note that you rely on a sole contract manufacturer in China,
"Manufacturer A," to
 manufacture the API in SCENESSE in Manufacturer A s factory in
China. We also
 note your statement on page 15 that you expect to continue relying
solely on
 Manufacturer A in the next five years. In this regard:
 Please revise here and throughout where appropriate to identify
Manufacturer A.
 To the extent applicable, revise your Risk Factors where appropriate
to discuss the
 potential impact of the BIOSECURE Act, as included in the FY 2026
National
 Defense Authorization Act and singed into law on December 18, 2025,
on your
 operations, or otherwise advise.
ADS holders may not be entitled to a jury trial with respect to claims arising
under the deposit
agreement..., page 17

6. We note your disclosure that the deposit agreement governing the ADSs
representing
 your Ordinary Shares provides that, to the fullest extent permitted by
applicable law,
 owners and holders of ADSs irrevocably waive the right to a jury trial
for any claim that
 they may have against you or the depositary arising from or relating to
your Ordinary
 Shares, the ADSs, or the deposit agreement, including any claim under
the U.S. federal
 securities laws. Please revise this risk factor to also highlight risks
to investors including
 the potential for increased costs to bring a claim and the possibility
of less favorable
 outcomes.

Item 4.B. Business Overview, page 24

7. We refer to page F-16, which indicates that nearly all of your revenues
derive from
 product sales in Ireland and the United States, and your disclosure on
page 28 that
 Scenesse for EPP patients accounted for approximately 90% of your sales
in FY2025.
 Accordingly, please revise the Overview section to discuss the
concentration of sales in
 these two jurisdictions. Also, revise your Marketing and Sales section
to discuss your
 operations, as well as the coverage, pricing and reimbursement for
Scenesse, in these two
 jurisdictions.
8. Please tell us your consideration of including a pipeline table
depicting all material
 pharmaceutical candidate programs, the specific indications and patient
populations
 being pursued, and the status of development for each product candidate,
including
 separate columns of equal width for preclinical development, Phase 1,
Phase 2 and Phase
 January 30, 2026
Page 3

 3 clinical trials with arrows showing how far each program has
progressed. As
 applicable, consider a column indicating the next material milestone for
each program
 (e.g., submission of an IND or equivalent, timing of expected data from
ongoing trials,
 etc.).
9. We note your disclosure on page 28 that in addition to the current use
of SCENESSE
 for the treatment for adult EPP patients, you are (1) focused on
treating a wider group of
 EPP patients, most notably adolescent EPP patients, and (2) exploring
its use as a drug
 therapy in other indications such as vitiligo and variegate porphyria.
Additionally, we
 note that you are developing additional pharmaceutical products, such as
novel
 formulations of the melanocortin adrenocorticotropic hormone ( ACTH
) as
 NEURACTHEL in multiple dosage forms for patients with neurological,
 endocrinological, and degenerative disorders. With respect to each of
your development-
 stage programs, please:
 Revise your narrative disclosure to clearly disclose the development
status of each
 program/product candidate (i.e., preclinical or clinical-stage).
 With respect to each clinical-stage program/product candidate,
specifically state the
 applicable current clinical trial phase. For example only, revise
references
 throughout to your "advanced CUV105 clinical study" of SCENESSE for
the
 treatment of vitiglio to indicate the applicable clinical trial
phase.
10. With respect to each of your development-stage pharmaceutical product
candidates,
 please disclose the location(s) of completed, ongoing, and planned
clinical trials. As
 appropriate, disclose that clinical data generated in a jurisdiction
outside of the United
 States may not be accepted by the FDA or comparable foreign regulatory
authorities and
 if so, may result in the need to conduct additional trials.
Additionally, revise to include
 Risk Factor disclosure to this effect.
11. We note references here and elsewhere throughout to studies and clinical
trials of your
 product candidates, such as a recently completed pharmacokinetic study
in adolescent
 and adult EPP patients. We also note references on page 46 to "the
CUV104 Phase II
 pilot monotherapy vitiligo study and the CUV803 Phase II stroke study."
In your
 discussion of the preclinical and clinical development of your currently
material
 programs, please revise your disclosure to specify the following
information with respect
 to the preclinical studies and/or clinical trials that you have
conducted, are currently
 conducting, or plan to conduct:
 regulatory authorization(s) received or required to be received to
conduct the trial,
 and when such authorization(s) were received or will be sought;
 trial sponsor(s);
 dates of the trial and location;
 trial design;
 subject/patient information (e.g., number and age of
subjects/patients enrolled and
 treated and the criteria for participation in the study);
 duration of treatment and dosage information;
 primary and secondary endpoints, as well as any observed results as
they relate to
 those endpoints; and
 January 30, 2026
Page 4

 occurrence of serious adverse events, if applicable; and
 discussion of results, including whether statistical significance
was demonstrated and
 supporting p-values, as applicable.
12. You state on pages 24 and 28 that you are "developing and
commercializing novel
 formulations of the melanocortin adrenocorticotropic hormone ( ACTH
) as
 NEURACTHEL ..." Please remove or revise the present-tense reference to
 "commercializing," or otherwise advise. In this regard, we note that it
does not appear
 from your disclosure that you have received any regulatory approval for
 NEURACTHEL, which will seemingly be required prior to commercialization.
13. We note your disclosures on page 29 and 35 concerning your plans to
launch a number
 of non-pharmaceutical PhotoCosmetics products for the general population
based on
 melanocortin technology, including products to assist DNA repair and
melanocyte-
 stimulating hormone ( MSH )-response for assisting risk-free
bronzing "in the next few
 years." In this regard:
 Please revise where appropriate to describe the remaining material
steps, if any, that
 must be completed prior to fully launching your CYAC LLE products,
and when
 you plan for such steps to be completed, or otherwise advise.
 Briefly describe your various "PhotoCosmetic M-lines," including the
"Preserve"
 and "Bronze" product ranges referenced on page 46. Describe the
material steps you
 have taken to develop the products in each line, the material steps
that remain to be
 taken in order to commercially launch each line, and when you plan
such steps to be
 completed.
14. We note your disclosure on page 45 indicating that EPP is a rare
metabolic disorder. To
 provide insight into the size of the market opportunity, please revise
to discuss the
 estimated size of the EPP patient population worldwide and/or in markets
that are
 material to your business prospects.
Competitive Strengths, page 25

15. We note your references to Clinuvel's "rare and defensible advantage in
the orphan drug
 space" and to "orphan drug exclusivity" on page 25. In this regard,
please:
 Disclose whether SCENESSE received Orphan Drug designation for adult
patients
 with EDD, or otherwise advise. If so, disclose when such designation
was
 received, identify the regulator(s) that granted such designation,
and briefly describe
 the significance of having obtained Orphan Drug designation.
 Disclose the "certain regions" in which orphan drugs exclusivity
periods are still
 active, and state when such exclusivity will lapse. Make conforming
revisions to
 your Risk Factors, as appropriate.
Growth Strategy
Enhance the Distribution Network and Expand into New Geographic Markets, page
26

16. Please revise your disclosure on page 27 to indicate when you received
approval to
 commercially distribute SCENESSE in Australia and explain whether you
plan to
 start distribution in Australia in the near term. To the extent that you
have had this
 regulatory approval for an extended period, revise to explain the
decision to initiate
 January 30, 2026
Page 5

 distribution now. With respect to Australia, Colombia and Argentina,
discuss the key
 steps, if any, that must be completed in each jurisdiction prior to
commercialization.
Grow the Research and Development Capacities and Broaden Therapeutic Portfolio,
page 27

17. On pages 27 and 36, you state that Clinuvel "is developing" two
melanocortin-based
 pharmaceutical products: PR NUMBRA (afamelanotide) and NEURACTHEL
 (adrenocorticotropic hormone - ACTH). However, this disclosure seems to
conflict with
 your statement on page 28 that in November 2024, you "decided to
temporarily suspend
 further clinical development of PR NUMBRA to focus on the development
of
 afamelanotide for vitiligo and porphyrias, as well as the development of
ACTH and
 PhotoCosmetic product lines." Please revise throughout wherever
appropriate to clarify
 the current development status of PR NUMBRA or otherwise advise.

18. We note your disclosure that in September 2022, Clinuvel submitted a
formal application
 to the EMA to expand the approved EPP indication for SCENESSE to
include
 adolescent patients aged 12-17 years, but that application was withdrawn
"due to the
 EMA s opinion on the benefit-risk profile for adolescents." In this
regard, please:
 Please revise to briefly disclose the nature of the EMA's "opinion"
and describe any
 material feedback the EMA provided after the initial application
was submitted.
 You state that you are preparing a new submission with additional
data, including
 from a recently completed pharmacokinetic study in adolescent and
adult EPP
 patients. Please revise to disclose when you plan to submit the new
application to the
 EMA.
 Tell us your consideration of including Risk Factor disclosure
concerning the risks
 associated with drug development in pediatric populations, and/or
 regulatory disclosure discussing how the pediatric drug approval
process differs
 from the approval process in adult populations.
19. You state on page 27 that "[f]urther platform products liquid
injectable controlled-
 release doses for melanocortin delivery developed in CLINUVEL s
RD&I Centre in
 Singapore, have recently been announced." Please revise to disclose the
development
 status of these announced platform product candidates (i.e., preclinical
or clinical), and
 describe your near- and longer-term development plans for such
candidates.
NEURACTHEL , page 28

20. Please revise to expand your statement that you are "preparing
regulatory submissions to
 the U.S. FDA and other regulatory agencies." Explain the type(s) of
submission to which
 you refer, and explain when you plan to make such submissions.
Manufacturing and Logistics, page 32

21. Please revise to discuss the availability of raw materials, including a
description of
 whether prices of principal raw materials are volatile. Refer to Item
4.B.4 of Form 20-F.
 January 30, 2026
Page 6
Intellectual Property
Patents, page 39

22. Please revise your intellectual property disclosure to disclose for each
material patent
 and/or patent application the specific products or technologies to which
such patents or
 patent applications relate. Also clearly describe on an individual basis
the type of patent
 protection granted for each product or technology (composition of
matter, use, or
 process) and whether the patents are owned or licensed. For instance, it
should be clear
 when patent protections covering Scenesse will expire in the US and
Europe.
Item 5. Operating and Financial Review and Prospects
A. Operating Results
Revenue, page 45

23. We note your disclosure on page F-8 that revenue is reduced for variable
consideration
 when control of the product transfers. Please revise to disclose the
types and amounts of
 variable consideration and the significant judgments and estimates
involved in its
 measurement.
Research and Development, page 46

24. Please tell us whether you track your research and development costs by
program area. If
 so, revise to provide disaggregate disclosure of your research and
development expenses
 by program for each period presented. If not, revise to state that fact
and disclose other
 quantitative and qualitative disclosure that provides transparency as to
the types of costs
 incurred (i.e. preclinical and clinical and by nature or type of
expense) which should
 reconcile to total research and development expense on the Statements of
Operations.
C. Research and Development, Patents and Licenses, page 50

25. Please revise your disclosure for each of your pipeline candidates to
discuss each
 program's current phase of development, any prior material preclinical
or clinical studies
 and results, and any regulatory submissions made to date.

 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