Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 24

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 24
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| • | identifying, assessing, acquiring and/or developing new product candidates; |

| • | negotiating favorable terms in any collaboration, licensing or other arrangements into which we may enter; |

| • | successfully getting our product candidates rescheduled under the federal Comprehensive Drug Abuse Prevention and Control Act of 1970, also known as the Controlled Substances Act, or CSA, and comparable state laws by the DEA and other 
 applicable regulatory agencies inside and outside the United States;                                                                                                                                                                       |

10 Table of Contents

| • | launching and successfully commercializing product candidates and the medical devices required to deliver these product candidates for which we obtain regulatory approval, either by collaborating with a partner or, if launched 
 independently, by establishing a sales, marketing and distribution infrastructure;                                                                                                                                                 |

| • | obtaining and maintaining an adequate price for our product candidates and devices in the countries where our products are commercialized; |

| • | obtaining coverage and adequate reimbursement for our product candidates and medical devices from payors; |

| • | obtaining market acceptance of our product candidates as viable treatment options; |

| • | addressing any competing technological and market developments; |

| • | receiving milestone and other payments under any future collaboration arrangements; |

| • | maintaining, protecting, expanding and enforcing our portfolio of intellectual property rights, including patents, trade secrets and know-how; |

| • | attracting, hiring and retaining qualified personnel; and |

| • | complying with laws and regulations, including laws applicable to controlled substances, data privacy and pre-commercial activities. |

For example, our initial inhalation toxicity study in rats showed respiratory tract histology findings, contributing to the clinical hold on our GH001 IND, and leading the FDA to request an inhalation toxicology study in a non-rodent species and an additional inhalation toxicology study.Because of the numerous risks and uncertainties associated with drug and drug-device combination product development, we are unable to predict the timing or amount of our expenses, or when we will be able to generate any meaningful revenue or achieve or maintain profitability, if ever. GH001 and GH002 are investigational mebufotenin therapies based on a novel technology, which makes it difficult to predict the time and cost of development and of subsequently obtaining regulatory approval. To our knowledge, no such therapies have been approved in the United States nor the EU for commercialization. We have concentrated our research and development efforts on GH001 and GH002 for the treatment of psychiatric or neurological disorders and our future success depends on our successful development of these product candidates