Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 58

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 58
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 DEA to prevent drug loss and diversion. All these facilities must renew their registrations annually, 
 except dispensing facilities (e.g. pharmacies), which must renew every three years. The DEA conducts periodic inspections of certain registered establishments that handle controlled substances. Failure to obtain or maintain the necessary    
 registrations may result in delay of the importation, manufacturing or distribution of GH001 or GH002. Furthermore, importation of controlled substances is subject to additional permits or approvals, which must be obtained prior to each     
 importation. Failure to comply with the CSA and implementing regulations promulgated by the DEA, particularly non-compliance resulting in theft, loss or diversion, can result in regulatory action that would have a material adverse effect on 
 our business, financial condition and results of operations. The DEA and the U.S. Department of Justice may seek civil penalties, refuse to renew necessary registrations, or initiate proceedings to restrict, suspend or revoke those          
 registrations. In certain circumstances, violations could lead to criminal proceedings.                                                                                                                                                          |

| • | State-controlled substances laws. Individual U.S. states have also established controlled substance laws and regulations. Though state-controlled substances laws often mirror federal law, because                                              
 the states are separate jurisdictions, they will need to separately reschedule GH001 or GH002. While some states automatically schedule or reschedule a drug based on federal action, other states schedule drugs through rule making or a       
 legislative action. State scheduling may delay commercial sale of any product for which we obtain federal regulatory approval and adverse scheduling would have a material adverse effect on the commercial attractiveness of such product. We   
 or our partners must also obtain separate state registrations, permits or licenses in order to be able to obtain, handle, and distribute controlled substances for clinical trials or commercial sale, and failure to meet applicable regulatory 
 requirements could lead to enforcement and sanctions by the states in addition to those from the DEA or otherwise arising under federal law.                                                                                                     |

| • | Clinical trials. Because our GH001 and GH002 product candidates contain mebufotenin, to conduct clinical trials with GH001 and GH002 in the United States prior to approval, each of our research                                            
 sites must submit a research protocol to the DEA and obtain and maintain a DEA Schedule I researcher registration that will allow those sites to handle and dispense GH001 and GH002 and to obtain the product from our importer. If the DEA 
 delays or denies the grant of a researcher registration or approval of the research protocol to one or more research sites, the clinical trial could be significantly delayed, and we could