Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 4

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 4
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 and resolution of such discussions related to the clinical hold on the GH001 investigational new drug application, or IND, research and development costs, cash runway, timing and likelihood of success, as well as plans and objectives of management for future operations are forward-looking statements. Many of the forward-looking statements contained in this Annual Report can be identified by the use of forward-looking words such as “anticipate,” “believe,” “could,” “expect,” “should,” “plan,” “intend,” “estimate,” “will” and “potential,” among others. Forward-looking statements appear in a number of places in this Annual Report and include, but are not limited to, statements regarding our intent, belief or current expectations. Forward-looking statements are based on our management’s beliefs and assumptions and on information currently available to our management. Such statements are subject to risks and uncertainties, and actual results may differ materially from those expressed or implied in the forward-looking statements due to various factors, including, but not limited to, those identified under “Item 3. Key Information—D. Risk Factors.” These risks and uncertainties include, among others, factors relating to: iii Table of Contents

| • | the commencement, timing, progress and results of our research and development programs, nonclinical studies and clinical trials, including the ongoing open label extension phase of our Phase 2b trial with GH001 in TRD; |

| • | the timing, progress and results of developing and conducting clinical trials for our GH001 and GH002 product candidates and the medical devices required to deliver these product candidates, such as our proprietary aerosol delivery 
 device for GH001, for our initial and any additional indications;                                                                                                                                                                       |

| • | our efforts to expand into other jurisdictions such as the United States and in the European Union, or EU; |

| • | our expectations related to the technical development and expansion of our external manufacturing capabilities for our GH001 and GH002 product candidates as well as the medical devices required to deliver these product candidates, such 
 as our proprietary aerosol delivery device for GH001;                                                                                                                                                                                       |

| • | our reliance on the success of our GH001 and GH002 product candidates; |

| • | the timing, scope or likelihood of regulatory filings and approvals by the FDA, the European Medicines Agency, or the EMA, or other comparable foreign regulatory authorities, for our GH001 and GH002 product candidates and our initial and 
 any additional indications;                                                                                                                                                                                                                   |

| • | our expectations related to the clinical hold imposed