Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 42

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 42
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 as to the potential advantages and risks of the product candidate being studied in relation to other available therapies, including any new drugs that may be approved 
 for the indications that we are investigating;                                                                                                                                                                                             |

| • | reluctance of physicians to encourage patient participation in clinical trials; |

| • | our ability to obtain and maintain patient consents; and |

| • | the risk that patients enrolled in clinical trials will drop out of the trials before completion. |

In addition, our clinical trials will compete with other clinical trials for product candidates that are in the same therapeutic areas as our product candidates, including product candidates studying N-methyl-D-aspartate antagonists, neurosteroids, and mebufotenin and other serotonergic psychedelics such as psilocybin and N,N-dimethyltryptamine. This competition will reduce the number and types of patients available to us, because some patients who might have opted to enroll in our trials may instead opt to enroll in a trial being conducted by one of our competitors. Since the number of qualified clinical investigators is limited, we expect to conduct some of our clinical trials at the same clinical trial sites that some of our competitors use, which will reduce the number of patients who are available for our clinical trials in such clinical trial site, or which may lead to a bias in recruitment between the competing trials, potentially affecting the outcome of those trials. Our inability to enroll a sufficient number of patients for our clinical trials would result in significant delays or might require us to abandon one or more clinical trials altogether. Delays in patient enrollment may result in increased costs, affect the timing or outcome of the planned clinical trials, product candidate development and approval process and jeopardize our ability to seek and obtain the regulatory approval required to commence product sales and generate revenue, which could prevent completion of these trials, adversely affect our ability to advance the development of our product candidates, cause the value of our company to decline and limit our ability to obtain additional financing if needed. We are also required to register certain clinical trials and post the results of certain completed clinical trials on a government-sponsored database, such as www.ClinicalTrials.gov in the United States and a similar system in the EU, within certain timeframes. Failure to do so can result in fines, adverse publicity and civil and criminal sanctions. The markets for GH001, GH002 and any other product candidates that we are developing or we may develop, for TRD or for any additional indications, may be smaller than we expect. Our estimates of the potential market