Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF)

Staff comment: 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… letter →

Staff comment: 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 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… letter →

Staff comment: 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… letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: We note that your January 12, 2026 press release announced a significant expansion of your VALLAURIX Research, Development and Innovation (RD&I) Centre in 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. letter →

Staff comment: 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… letter →

Staff comment: 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… letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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 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… letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: Please provide us with the calculation of total capitalization. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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 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.). letter →

Staff comment: 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… letter →

Staff comment: 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. letter →

Staff comment: 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… letter →

Staff comment: 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. letter →

Staff comment: 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 CYACÊLLE 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… letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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 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. letter →

Staff comment: On pages 27 and 36, you state that Clinuvel "is developing" two melanocortin-based pharmaceutical products: PRÉNUMBRA® (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 PRÉNUMBRA® 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 PRÉNUMBRA® or otherwise advise. letter →

Staff comment: 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… letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →

Staff comment: 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. letter →