Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 133

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 133
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 similar event occurs in Ireland or worldwide our business may be adversely affected. Such an event could delay enrollment in our clinical trials due to prioritization of hospital resources toward the outbreak or other factors, and some patients may be unwilling to enroll in our trials or be unable to comply with clinical trial protocols if quarantines impede patient movement or interrupt healthcare services, which would delay our ability to conduct clinical trials or release clinical trial results and could delay our ability to obtain regulatory approval and commercialize our product candidates. Furthermore, such an outbreak could affect the operations of key governmental agencies, such as the FDA, EMA or other comparable foreign regulatory authorities, which could delay the development or approval process for any or all of our product candidates. The spread of a pandemic, epidemic, outbreak of an infectious disease or similar event may also result in the inability of our suppliers to deliver components or raw materials on a timely basis or at all. In addition, hospitals may reduce staffing and reduce or postpone certain treatments in response to an outbreak. Such events may result in a period of business disruption, and in reduced operations, or doctors and medical providers may be unwilling to participate in our clinical trials, any of which could materially affect our business, financial condition and results of operations. Finally, an ongoing outbreak of this nature may also cause the risks associated with our industry and business described herein and in our other public filings to become more significant. A significant pandemic, epidemic, outbreak of an infectious disease or similar event also could result in a widespread health crisis that could adversely affect the economies and financial markets worldwide, resulting in an economic downturn that could impact our business, financial condition and results of operations. Additionally, a significant number of components in our proprietary aerosol delivery device for GH001 are manufactured in China. As such, if the relationship between China and Taiwan materially deteriorates, or if a trade war or other series of events occur that disrupt our supply chain for these raw materials, such changes could to deteriorate, this could disrupt our supply chain, adversely affect our ability to conduct ongoing and future clinical trials of our product candidates, and/or adversely affect our ability to commercialize our products (subject to regulatory approval). For further information regarding risks to our supply chain from our international operations, see the risk factor titled “We depend on third-party suppliers for key raw materials used in our manufacturing processes, as well as for the vaporization device used to administer GH001, and we expect to depend on third-party suppliers for the devices required for administration of GH002, some of which are our