Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 54

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 54
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MA or other comparable foreign regulatory authorities, may not accept this device for clinical trials. In current and previous clinical trials, GH001 has been vaporized using a device we have purchased on the market from a third party. This device has been used in previous trials, conducted by other parties with other products or product candidates, in Europe and the United States. However, there can be no assurance that the FDA or other comparable foreign regulatory authorities will allow it to be used with GH001 in future trials. In addition, we may decide in future clinical trials to use a different device than the one we have used previously, and the FDA or other comparable foreign regulatory authorities could similarly object to the use of any such device with GH001. For example, in 2021, we initiated the development of a proprietary aerosol delivery device for GH001 for use in our pivotal clinical trial program and for commercial use. Based on this proprietary device’s development progress, in August 2023 we submitted an IND for GH001 in TRD to be delivered with such device, which was placed on clinical hold by the FDA, requesting, among other aspects, additional device design verification information before clinical trials with this device may be initiated. We are in the process of preparing this information but we would also need to carry out additional development work and conduct additional studies, including bridging studies, to bridge our prior device to any new device we may decide to use, prior to using the new device in future clinical trials. Any delays as a result of changing medical devices to deliver our product candidates would have a material adverse effect on our business. We do not have a commercial supply agreement with the third-party manufacturer of the device we currently use in clinical trials, nor have we established license agreements with any alternative provider of a device that would be suitable to generate a pharmaceutically acceptable aerosol from GH001. There can be no assurance that the development of our proprietary aerosol delivery device will lead to a device that is suitable for our purpose, either in terms of efficacy or safety. If the FDA, EMA or other comparable foreign regulatory authorities refuse to accept the use of our proprietary aerosol device for GH001 in our planned clinical trials and if we fail to develop, manufacture, license, or acquire an alternative device which would be suitable to generate a pharmaceutically acceptable aerosol from GH001, or if we fail to get sufficient supplies of the current third-party device or any alternative device, then initiation of additional clinical trials or marketing approval could be significantly delayed or prevented. Additional time