Company: GHRS
Filing Date: 2025-02-27
Form Type: 20-F
Source: 0001140361-25-006175
Chunk: 77

Company: GH Research PLC
Filing Date: 2025-02-27
Form: 20-F
Item: Item 5
Chunk 77
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; and (iv) build our third-party or in-house process development, analytical, manufacturing and related capabilities, increase personnel costs and prepare for regulatory filings related to our potential or future product candidates. We also expect to incur additional IP-related expenses as we file further patent applications and prosecute our intellectual property to protect innovations arising from our research and development activities.
 
The successful development and commercialization of GH001 and GH002 and any potential future product candidate is highly uncertain. This is due to the numerous risks and uncertainties associated with development and commercialization, including the following:
 

•   successful enrollment in and completion of clinical trials;
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•   successful completion of nonclinical studies;
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•   sufficiency of our financial and other resources to complete the necessary technical development work, nonclinical studies and clinical trials;
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•   receiving regulatory approvals or clearance for conducting our planned clinical trials or future clinical trials, including in regards to the clinical hold on the study we proposed in our IND for GH001;
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•   receiving positive data from our clinical trials that support an acceptable risk-benefit profile of GH001 and GH002 and any future product candidates in the intended populations;
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•   receipt and maintenance of regulatory and marketing approvals from applicable regulatory authorities;
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•   establishing and scaling up, through third-party manufacturers, manufacturing capabilities of clinical supply for our clinical trials and commercial manufacturing, if any product candidates are approved;
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•   entry into collaborations to further the development of GH001 and GH002 and any future product candidates, including any required medical devices;
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•   obtaining and maintaining patent and trade secret protection or regulatory exclusivity for GH001 and GH002 and any future product candidates;
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•   successfully launching commercial sales of GH001 and GH002 and any future product candidates, if approved;
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•   acceptance of our current and future product candidates’ benefits and uses, if approved, by patients, the medical community and third-party payors; and
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•   maintaining a continued acceptable safety profile of GH001 and GH002 and our future product candidates following approval.
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A change in the outcome of any of these variables with respect to the development of our product candidates in nonclinical and clinical development could mean a significant change in the costs and timing associated with their development. For example, if we are required by the FDA, or other comparable foreign regulatory authorities, to perform clinical trials in addition to those that we currently expect