Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 59

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 59
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 lose clinical trial sites. The importer for the  
 clinical trials must also obtain a Schedule I importer registration and an import permit for each import.                                                                                                                                    |

| • | Post-Approval Importation. If GH001 or GH002 is approved and classified as a Schedule II, III or IV substance, an importer can import it for commercial purposes if it obtains an importer                                                       
 registration and applies for and receives an import permit (Schedule II) or files an import declaration (Schedule III or IV) for each import shipment. The DEA provides annual assessments/estimates to the UN International Narcotics Control   
 Board, which guides the DEA in the amounts of controlled substances that the DEA authorizes to be imported. The failure to identify an importer or obtain the necessary import authority, including specific quantities, could affect the        
 availability of GH001 or GH002 and have a material adverse effect on our business, results of operations and financial condition. In addition, an application for a Schedule II importer registration must be published in the Federal Register, 
 and there is a notice and comment period to receive public comments. It is always possible that adverse comments may delay the grant of an importer registration. If GH001 or GH002 is approved and classified as a Schedule II controlled       
 substance, federal law may prohibit the import of the substance for commercial purposes. If GH001 or GH002 is listed as a Schedule II substance, we will not be allowed to import the drug for commercial purposes unless the DEA determines     
 that domestic supplies are inadequate or there is inadequate domestic competition among domestic manufacturers for the substance as defined by the DEA. Moreover, the DEA has not registered any companies to import Schedule I controlled       
 substances, including mebufotenin, for commercial purposes, only for scientific and research needs. Therefore, if neither GH001 or GH002, nor its drug substance could be imported, GH001 and GH002 would have to be wholly manufactured in the  
 United States, and we would need to secure a manufacturer that would be required to obtain and maintain a separate DEA registration for that activity.                                                                                           |

30 Table of Contents

| • | Manufacture in the United States. If, because of a Schedule II (and possibly Schedule III) classification or voluntarily, we were to conduct manufacturing or repackaging/relabeling in the United                                               
 States for commercial purposes, mebufotenin will be subject to an annual aggregate production quote established by the DEA and our contract manufacturers would be subject to the DEA’s annual and semi-annual manufacturing and procurement     
 quota requirements. Additionally,