Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 40

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 40
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 or clinical trials or deny approval of our product candidates for any or all targeted indications. Treatment-emergent side effects that are deemed to be drug-related could also affect subject recruitment or the ability of enrolled subjects to complete the trial or result in potential product liability claims. Undesirable side effects in one of our clinical trials for our product candidates in one indication could adversely affect enrollment in clinical trials, regulatory approval and commercialization of our product candidates in other indications. In addition, these side effects may not be appropriately recognized or managed by the treating medical staff. Any of these occurrences may harm our business, financial condition and prospects significantly. 19 Table of Contents Moreover, clinical trials of our product candidates are conducted in carefully defined sets of healthy volunteers and patients who have agreed to be enrolled in clinical trials. Consequently, it is possible that our clinical trials, or those of any future collaborator, may fail to identify undesirable side effects. Clinical trials by their nature utilize a sample of the potential patient population. With a limited number of patients, rare and severe side effects of our product candidates may only be uncovered with a significantly larger number of patients’ use of the product candidate. If our product candidates, including the medical devices to deliver such product candidates, such as our proprietary aerosol delivery device for GH001, receive marketing approval and we or others identify undesirable side effects caused by such product candidates (or any other similar products) after such approval, a number of potentially significant negative consequences could result, including:

| • | regulatory authorities may withdraw or limit their approval of such product candidates or medical devices; |

| • | regulatory authorities may require the addition of labeling statements, such as a “Boxed Warning” or contraindications; |

| • | we may be required to change the way such product candidates are distributed or administered, or change the labeling of the product candidates or medical devices; |

| • | the FDA may require a REMS to mitigate risks, which could include medication guides, physician communication plans or elements to assure safe use, such as restricted distribution methods, patient registries and other risk minimization 
 tools, and regulatory authorities in other jurisdictions may require comparable risk mitigation plans;                                                                                                                                     |

| • | we may be subject to regulatory investigations and government enforcement actions; |

| • | the FDA, EMA or a comparable foreign regulatory authority may require us to conduct additional technical development work or clinical trials or costly post-marketing testing and surveillance to establish and monitor the safety and 
 efficacy of the product;                                                                                                                                                                                                               |

| • |