Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 37

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 37
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 a marketing application to the FDA or other comparable foreign regulatory authorities for each product candidate and any relevant device required to deliver such product candidate, and, consequently, the ultimate approval and commercial marketing of any product candidates and medical devices. We may experience negative or inconclusive results, or regulators may be unwilling to accept nonclinical or clinical data obtained in foreign jurisdictions, which may result in our deciding, or our being required by regulators, to conduct additional clinical studies or trials or abandon some or all of our product development programs, which would have a material adverse effect on our business. Even if we obtain regulatory approval with respect to GH001 for TRD, we may not be able to complete clinical development or obtain regulatory approval for additional indications, such as bipolar II disorder and postpartum depression, or we may be required to conduct trials in addition to those that we plan to conduct, which could limit our ability to realize the maximum market potential of GH001 or increase the costs of developing GH001 for any additional indications. Given GH001’s proposed mechanisms of resetting human brain functional connectivity, or FC, and serotonergic agonism, we believe that it represents a compelling therapeutic option for multiple psychiatric and neurological disorders other than TRD. Through collaborations with academic institutions and CROs we have begun to explore and intend to continue to explore the benefits of GH001 in additional psychiatric or neurological indications, the first of which have been BDII and PPD. However, there can be no assurance that, even if we obtain approval for GH001 for our initial indication, TRD, we will obtain approval for any other indication, including for BDII or PPD. The ability to obtain approval for any of these additional indications will require additional clinical development. If we fail to obtain and maintain required approvals for these additional or broadened indications, or if regulatory approvals are delayed, we will not realize the maximum market potential of GH001. Additionally, the FDA, EMA or other comparable foreign regulatory authorities may require us to conduct clinical trials, beyond those that we plan to conduct, and/or other tests, before seeking regulatory approval. For example, based on our existing nonclinical and clinical data for GH001, we believe that we can proceed to Phase 2a clinical trials in additional indications without first completing Phase 1 clinical trials, as we did with our Phase 2a proof-of-concept trials of GH001 in BDII and PPD. However, there can be no assurance that the FDA, EMA or other comparable foreign regulatory authorities will agree with such assessment