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

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 29
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 investigators to drop out of the trial, which may require that we add new clinical trial sites or investigators;                                              |

| • | due to the impact of a pandemic, epidemic, outbreak of an infectious disease or a similar event, we may experience some delays and interruptions to our technical development efforts, nonclinical studies, clinical trials and/or regulatory 
 approvals, we may experience delays or interruptions to our manufacturing supply chain, or we could suffer delays in reaching, or we may fail to reach, agreement on acceptable terms with third-party service providers on whom we rely;     |

13 Table of Contents

| • | greater-than-anticipated clinical trial costs, including as a result of delays or interruptions that could increase the overall costs to finish our clinical trials as our fixed costs are not substantially reduced during delays; |

| • | we may elect to, or regulators, IRBs, Data Safety Monitoring Boards, or DSMBs, or ethics committees may require that we or our investigators, suspend or terminate clinical research or trials for various reasons, including non-compliance 
 with regulatory requirements or a finding that the participants are being exposed to unacceptable health risks;                                                                                                                              |

| • | we may not have the financial resources available to begin and complete the planned trials, or the cost of clinical trials of any product candidates may be greater than we anticipate; |

| • | the supply or quality of our product candidates, medical devices required to deliver our product candidates, or other materials necessary to conduct clinical trials of our product candidates may be insufficient or inadequate to initiate 
 or complete a given clinical trial;                                                                                                                                                                                                          |

| • | inability to compete with other therapies; |

| • | poor efficacy of our product candidates during clinical trials; |

| • | failure to demonstrate an acceptable benefit/risk profile for our product candidates; |

| • | inability to provide sufficient design, testing, manufacturing and quality information for the medical devices required to deliver our product candidates, including information to support their use and compatibility with the drug 
 constituent of our product candidates;                                                                                                                                                                                                |

| • | unfavorable FDA, EMA or other comparable foreign regulatory authority inspection and review of clinical trial sites or manufacturing facilities; |

| • | if the DEA, or any state or other jurisdiction, delays rescheduling or fails to reschedule mebufotenin to Schedule II, III, IV or V, or delays classifying or fails to classify our product candidates to Schedule II, III, IV or V; |

| • | unfavorable product labeling associated with any product approvals and any requirements for a Risk Evaluation