Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 16

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 16
---
 to obtain regulatory approval for GH001, GH002 or any other product candidates. We are a clinical-stage biopharmaceutical company with a limited operating history, focused on novel therapies which may be able to induce ultra-rapid and durable remissions in patients with depression and in other indications within our focus area of psychiatric and neurological disorders. We commenced operations in 2018, have no products approved for commercial sale, and have not generated any revenue from product sales. Drug development is a highly uncertain undertaking and involves a substantial degree of risk. The results of clinical trials with smaller sample sizes, shorter follow-up and no concurrent control group, such as our completed Phase 1 clinical trial of GH001 in 22 healthy volunteers (GH001-HV-101), our completed Phase 1/2 clinical trial of GH001 in 16 patients with Treatment-Resistant Depression, or TRD (GH001-TRD-102), both with seven days follow-up, our completed Phase 1 clinical trial of GH001 in 46 healthy volunteers (GH001-HV-103) with thirty days follow-up, our Phase 2a proof-of-concept clinical trials of GH001 for the treatment of patients with bipolar II disorder, or BDII, and a current depressive episode (GH001-BD-202) and for the treatment of patients with postpartum depression, or PPD (GH001-PPD-203), and our Phase 1 clinical trial of GH002 in 64 healthy volunteers (GH002-HV-105) can each be disproportionately influenced by various biases associated with the conduct of small, uncontrolled, short-term clinical trials, such as the potential failure of the smaller sample size to accurately depict the features of the broader patient population, and the potential failure of shorter studies to accurately depict long-term safety and efficacy results, which limits the ability to generalize the results, thus making the clinical trial results less reliable than clinical trials with a larger number of patients and longer follow-up. As a result, there may be less certainty that such product candidate would achieve a statistically significant effect in any future clinical trials. If we conduct any future clinical trials of GH001 or GH002, we may not achieve a statistically significant result or the same level of statistical significance, if any, that we might have anticipated based on the results observed in our initial clinical trials. To date, our completed clinical trials have been conducted only in Europe, and we have not initiated nor completed a pivotal clinical trial, obtained marketing approval for any product candidates, manufactured