Risk Factors

Staff comment: You indicate that a reduction in U.S. government demand could materially harm your business, operating results, financial condition or cash flows. To provide greater context to investors about the significance of this customer to your business, please revise to quantify revenues from the U.S. government for the periods presented. As a related matter, please disclose the amount of revenue attributed to U.S. public sector markets for each period presented as part of your Management's Discussion and Analysis on page 40. We note that you provided this information in Exhibit 99.1 to your Form 8-Ks filed on May 29, 2025 and February 26, 2026. letter →

Staff comment: We note your disaggregation of revenue disclosure provided on page F-9 as well as the information provided in your February 20, 2024 response letter, specifically your response to comment four. You state that you disaggregate your revenue based on type of good or service (e.g., manufacturing and license fees) and regulatory pathway (e.g., ANDA vs NDA). Please address the following: • Given that you have paused further development of NDAs and do not appear to have engaged in business activities in this segment since 2021, explain to us how disaggregation by regulatory pathway provides a meaningful level of disaggregation of your revenues. • In your February 20, 2024 response to prior comment… 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: 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: 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: 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: 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: In your response to prior comment 2 you provide proposed revised disclosure of the referenced risk factor and Item disclosures. Please confirm that you intend to provide similar disclosure in the Item 3 disclosures regarding The Holding Foreign Companies Accountable Act. letter →

Staff comment: We note you disclose that you qualify as an emerging growth company (“EGC”) and have elected not to opt out of the extended transition period for complying with new or revised accounting standards. Please be advised that the EGC accounting deferral election is not applicable to IFRS filers and revise your disclosures accordingly in future filings. The Company respectfully acknowledges the Staff’s comment. The Company, as an EGC, prepares its financial statements in accordance with International Financial Reporting Standards (“ IFRS ”) as issued by the International Accounting Standards Board and, as an IFRS filer, is not eligible to elect the extended transition period for complying with… letter →

Staff comment: Please revise to provide additional disclosure regarding SOL and your staking plans. For example purposes only: • Disclose your policies and procedures regarding your plans to stake Solana, including how much of your SOL you intend to stake. • Revise to provide greater detail explaining how agreements with staking providers will operate. • If material, add a risk factor addressing any liquidity risks related to your staking plans. • Identify the custodians that hold and will hold your digital assets and disclose the material terms of the custody arrangements, including the amount and limitations of any insurance coverage. letter →

Staff comment: In future filings, please disclose the location of your auditor’s headquarters. Similarly revise the related risk factor regarding the HFCAA on page 38. letter →