Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 28

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 28
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 drug candidates and medical devices or allow our competitors to bring products to market before we do and impair our ability to successfully commercialize 
 our drug candidates and medical devices and may harm our business and results of operations;                                                                                                                                                     |

| • | conditions imposed by the FDA, EMA or other comparable foreign regulatory authorities regarding the scope or design of our clinical trials; |

| • | the FDA, EMA or other comparable foreign regulatory authorities may disagree with our clinical trial design, including with respect to dosing levels administered in our planned clinical trials, or the medical devices used to deliver our 
 product candidates in the clinical trials, which may delay or prevent us from initiating our clinical trials with our originally intended trial design and the originally planned medical devices;                                           |

| • | delays in contracting with clinical trial sites or enrolling subjects in clinical trials, the inability to identify clinical trial sites willing to host our clinical trials and the required scheduled drug DEA researcher registration and 
 Schedule I research protocol in the United States and similar licenses in other jurisdictions to be obtained and maintained by our clinical investigators;                                                                                   |

| • | delays or interruptions in the supply of materials necessary for the conduct of our clinical trials; |

| • | regulators, IRBs or ethics committees may not authorize us or our investigators to commence a clinical trial or conduct a clinical trial at a prospective trial site; |

| • | the FDA has in relation to our clinical hold required, and it or the EMA or other comparable foreign regulatory authorities may in the future require, us to submit additional data such as long-term toxicology studies, additional device 
 design verification information or additional data for our product candidates or the medical devices required to deliver our product candidates;                                                                                            |

| • | delays in reaching, or failure to reach, agreement on acceptable terms with prospective trial sites and prospective contract research organizations, or CROs, which can be subject to extensive negotiation and may vary significantly among 
 different CROs and trial sites;                                                                                                                                                                                                              |

| • | the number of subjects required for clinical trials of any product candidates may be larger than we anticipate, or subjects may drop out of these clinical trials or fail to return for post-treatment follow-up at a higher rate than we 
 anticipate;                                                                                                                                                                                                                               |

| • | our third-party contractors for nonclinical studies or clinical trials may fail to comply with regulatory requirements or meet their contractual obligations to us in a timely manner, or at all, or may deviate from the clinical trial 
 protocol or take actions that could cause clinical trial sites or clinical