Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 10

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 10
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 determinations under state laws and regulations;                                                                                                                                                                                                 |

| • | The potential reclassification of mebufotenin by the DEA in the United States could create additional regulatory burdens on our operations and negatively affect our results of operations; |

| • | Our commercial success depends upon attaining significant market acceptance of our product candidates, if approved, among physicians, patients, third-party payors and other members of the medical community; |

| • | We currently have no marketing and sales organization and have no experience as a company in commercializing products, and we may have to invest significant resources to develop these capabilities. If we are unable to establish marketing 
 and sales capabilities or enter into agreements with third parties to market and sell our product candidates, if approved, we may not be able to generate product revenue;                                                                    |

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| • | Our business and commercialization strategy depends on our ability to identify, qualify, prepare, certify, and support third-party clinics or treatment centers offering any of our product candidates, if approved. If we are unable to do 
 so, our commercialization prospects would be limited and our business, financial condition, and results of operations would be harmed;                                                                                                      |

| • | We rely on patents, applications for patents and other intellectual property rights to protect our GH001 and GH002 product candidates, the prosecution, enforcement, defense and maintenance of which may be challenging and costly. Failure 
 to adequately prosecute, maintain, enforce or protect these rights could harm our ability to compete and impair our business;                                                                                                                |

| • | We rely on third parties to assist in conducting our nonclinical studies and clinical trials. If they do not perform satisfactorily, we may not be able to initiate new clinical trials, successfully complete clinical trials, obtain 
 regulatory approval or commercialize our product candidates, or such approval or commercialization may be delayed, and our business could be substantially harmed;                                                                     |

| • | The development and manufacture of our active pharmaceutical ingredients, product candidates and medical devices required to deliver such product candidates is complex, and we may encounter difficulties during further development or in      
 production. We currently rely completely on third parties to develop, formulate and manufacture our nonclinical study and clinical trial supplies. The development and commercialization of any of our active pharmaceutical ingredients,        
 product candidates and medical devices required to deliver such product candidates could be stopped, delayed or made less profitable if those third parties fail to provide us with sufficient quantities of such drug supplies or fail to do so 
 at acceptable quality levels, including in