Clinuvel Pharmaceuticals Ltd (CUVL, CLVLF) – SEC staff 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 →