Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 9

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 9
---
 approval. To our knowledge, no such 
 therapies have been approved in the United States or the EU for commercialization;                                                                                                                                                       |

| • | Developing our proprietary aerosol delivery device for GH001 is a costly and uncertain process, and any failure of, or delay in, the development or manufacturing of the device may have a material adverse effect on our business and 
 results of operations;                                                                                                                                                                                                                 |

| • | Clinical development involves a lengthy, complex and expensive process, with an uncertain outcome. The outcome of nonclinical testing and early clinical trials may not be predictive of the success of later clinical trials, and the       
 results of our currently completed clinical trials, which to date have only been conducted in Europe, and of our ongoing and future clinical trials, may not satisfy the requirements of the FDA, EMA or other comparable foreign regulatory 
 authorities;                                                                                                                                                                                                                                 |

| • | Our product candidates or use of our product candidates through participation in our clinical trials, may cause undesirable side effects or have other properties that could delay or prevent their regulatory approval, limit their 
 commercial potential or result in significant negative consequences;                                                                                                                                                                 |

| • | GH001 and GH002, and any other product candidates we may develop, are subject to controlled substance laws and regulations in the territories where the product will be marketed, such as the United States, the EU, the United Kingdom, or     
 UK, and the rest of Europe, as well as the United Nations, or UN, international drug control treaties, and failure to comply with these laws and regulations, or the cost of compliance with these laws and regulations, may adversely affect   
 the results of our business operations, both during clinical development and post-approval, and our financial condition. In addition, during the review process of GH001 and GH002, and prior to approval, the FDA, EMA and/or other comparable 
 foreign regulatory authorities may require additional data, including with respect to whether GH001 or GH002 have abuse or misuse potential. This may delay approval and any potential rescheduling process;                                    |

| • | Mebufotenin is currently classified as a Schedule I drug in the United States and any product containing this substance, such as GH001 and GH002, must be rescheduled to be marketed. There can be no assurance that the Drug Enforcement        
 Administration, or DEA, will make a favorable scheduling decision. Even assuming categorization as a Schedule II or lower controlled substance (i.e., Schedule III, IV or V) at the federal level, such substances would also require scheduling