Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 84

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 5
Chunk 84
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, 2023 and 2022” in our Annual Report on Form 20-F for the year ended December 31, 2023.
 
Funding Requirements
 
We expect our expenses to continue to increase substantially in connection with our ongoing research and development activities, particularly as we advance the technical development work, nonclinical studies and clinical trials of our product candidates and the medical devices required to deliver such product candidates. In addition, if we obtain regulatory approval for any of our product candidates, we expect to incur significant commercialization expenses related to sales, marketing, manufacturing and distribution. Furthermore, we have incurred and expect to continue to incur additional costs associated with operating as a public company. We anticipate that our expenses will increase substantially if and as we:

•   continue to develop and conduct clinical trials, including in expanded geographies such as the United States, for our GH001 and GH002 product candidates for our initial indications and any additional indications;
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•   continue both the technical development and expansion of our external manufacturing capabilities for our current product candidates GH001 and GH002 and of the medical devices required to deliver these product candidates, such as
                                                                                             our proprietary aerosol delivery device for GH001;                                                                                         
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•   initiate and continue research and development, including technical, nonclinical, clinical, and discovery efforts for any future product candidates;
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•   seek to identify additional product candidates;
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•   seek regulatory approvals for our product candidates GH001 and GH002 including the medical devices required to deliver these product candidates, such as our proprietary aerosol delivery device for GH001, or any other product
                                                                                      candidates that successfully complete clinical development;                                                                                   
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•   progress any nonclinical programs and any other work that may be required to lift the clinical hold n the study we proposed in our IND for GH001;
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•   add operational, financial and management information systems and personnel, including personnel to support our product candidate and device development and help us comply with our obligations as a public company;
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•   hire and retain additional personnel, such as clinical, quality control, scientific, commercial, sales, marketing and administrative personnel;
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•   continue to prepare, file, prosecute, maintain, protect and enforce our intellectual property rights and claims;
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•   establish sales, marketing, distribution, manufacturing, supply chain and other commercial infrastructure in the future to commercialize various products for which we may obtain regulatory approval;
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