Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 60

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 60
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 regardless of the scheduling of GH001 or GH002, the active ingredient in the final dosage form is currently a Schedule I controlled substance and would be subject to such quotas as this substance could      
 remain listed on Schedule I during the clinical trials. The annual and semi-annual quota allocated to us or our contract manufacturers for the active ingredient in GH001 or GH002 may not be sufficient to complete clinical trials or meet     
 commercial demand. Consequently, any delay or refusal by the DEA in establishing our, or our contract manufacturers’, procurement and/or production quota for controlled substances could delay or stop our clinical trials or product launches, 
 which would have a material adverse effect on our business, financial position and results of operations.                                                                                                                                        |

| • | Distribution in the United States and the UK. If GH001 or GH002 is scheduled as Schedule II, III, IV or V, we would also need to identify wholesale distributors with the appropriate DEA                                                        
 registrations and authority to distribute GH001, GH002 and any other product candidates. These distributors would need to maintain Schedule II, III, IV or V distribution registrations. This limitation in the ability to distribute GH001 or   
 GH002 more broadly may limit commercial uptake and could negatively impact our prospects. The failure to obtain, or delay in obtaining, or the loss of any of those registrations could result in increased costs to us. If GH001 or GH002 is    
 classified as a Schedule II drug, participants in our supply chain may have to maintain enhanced security including specially constructed vaults at manufacturing and distribution facilities. This additional security may also discourage some 
 pharmacies from carrying the product. In addition, GH001 and/or GH002 could be required to be administered at our trial sites or other certified healthcare settings, which could limit commercial uptake. Furthermore, state and federal        
 enforcement actions, regulatory requirements, and legislation intended to reduce prescription drug abuse, such as the tracking of prescribing and dispensing of controlled substances through a state prescription drug monitoring program, may  
 make physicians less willing to prescribe, and pharmacies to dispense, certain controlled substances, especially Schedule II products. Similarly, the Medicines and Healthcare products Regulatory Agency, or MHRA, considers that all Schedule  
 1 drugs under the UK’s Misuse of Drugs Regulations 2001 (which Schedule includes mebufotenin) have no therapeutic benefit, and can only be imported, exported, produced, supplied, possessed and the like under a license issued by the UK       
 government’s Home Office. Mebufotenin may never be rescheduled under the Misuse