Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 27

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 27
---
 of our product candidates are approved, we must ensure access to sufficient commercial manufacturing capacity for the product candidates and the medical devices required to deliver these product candidates and conduct significant marketing efforts in connection with any commercial launch, as well as obtaining pricing and reimbursement authorizations in individual European and other countries. These efforts will require substantial investment, and we may not have the financial resources to continue development of our product candidates or commercialization of any products. We may experience setbacks that could delay or prevent regulatory approval of our product candidates, including the medical devices to deliver our product candidates, such as our proprietary aerosol delivery device for GH001, or our ability to commercialize any products, including:

| • | delay or failure in establishing acceptable performance characteristics, quality manufacturing standards and manufacturing capabilities for our product candidates or for the medical devices required to deliver our product candidates; |

| • | negative or inconclusive results from our nonclinical studies or clinical trials or the clinical trials of others for product candidates similar to ours, leading to a decision or requirement to conduct additional nonclinical testing or 
 clinical trials or abandon a program;                                                                                                                                                                                                       |

| • | product or device-related side effects experienced by subjects in our clinical trials or by individuals using drugs or therapeutics similar to our product candidates; |

12 Table of Contents

| • | delays in submitting INDs (or IDEs, if applicable) in the United States or comparable foreign applications or delays or failure in obtaining the necessary approvals from regulators or institutional review boards, or IRBs, to commence a 
 clinical trial, including Schedule I research protocols required by the DEA, or a suspension or termination of a clinical trial once commenced;                                                                                             |

| • | if the FDA, EMA or other comparable foreign regulatory authorities do not find the earlier technical, nonclinical and clinical trial work sufficient, then we may need to conduct additional technical development work or nonclinical or        
 clinical trials beyond what we had previously planned. For example, our previously completed nonclinical data anddevice design verification information submitted with our GH001 IND was deemed by the FDA to                                    
 contain insufficient information to assess risks to human subjects, and the FDA therefore requestedadditional nonclinical toxicology studies and other work (including acceptable device design verification information) before the             
 FDA may lift the clinical hold and allow us to initiate clinical studies in the United States, such as the study we proposed in our IND for GH001. Any significant technical development, nonclinical or clinical trial delays could also        
 shorten any periods during which we may have the exclusive right to commercialize our