Company: GHRS
Filing Date: 2025-07-29
Form Type: 20-F/A
Source: 0001140361-25-027850
Chunk: 61

Company: GH Research PLC
Filing Date: 2025-07-29
Form: 20-F/A
Chunk 61
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 of Drugs Regulations 2001, or reclassified under the UK’s Misuse of Drugs Act 1971 (under which it is a Class A controlled substance).                           |

The potential reclassification of mebufotenin by the DEA in the United States could create additional regulatory burdens on our operations and negatively affect our results of operations. If mebufotenin, rather than just a specific FDA-approved formulation, is rescheduled under the CSA as a Schedule II or lower controlled substance (i.e., Schedule III, IV or V), the ability to conduct research on mebufotenin would most likely be improved. However, rescheduling mebufotenin may materially alter enforcement policies across many federal and state agencies, primarily the FDA and DEA. The FDA is responsible for ensuring public health and safety through regulation of food, drugs, supplements, and cosmetics, among other products, through its enforcement authority pursuant to the Federal Food, Drug, and Cosmetic Act, or FDCA. The FDA’s responsibilities include regulating the ingredients as well as the marketing and labeling of drugs sold in interstate commerce. Because it is currently illegal under federal law to produce and sell mebufotenin, and because there are no federally recognized medical uses, the FDA has historically deferred enforcement related to mebufotenin to the DEA. If mebufotenin were to be rescheduled to a federally controlled, yet legal, substance, the FDA would likely play a more active regulatory role. The DEA would continue to be active in regulating manufacturing, distribution and dispensing of such substances. The potential for multi-agency enforcement post-rescheduling, including state agencies, e.g., Boards of Pharmacy, could threaten or have a materially adverse effect on our business. 31 Table of Contents GH001 and GH002 contain controlled substances, the use of which may generate public controversy. Adverse publicity or public perception regarding mebufotenin and psychedelics generally or our current or future product candidates using mebufotenin may negatively influence the success of these therapies. Therapies containing controlled substances may generate public controversy. Political and social pressures and adverse publicity could lead to delays in approval of, and increased expenses for, GH001, GH002 and any other product candidates we may develop. Opponents of these therapies may seek restrictions on marketing and withdrawal of any regulatory approvals. In addition, these opponents may seek to generate negative publicity in an effort to persuade the medical community to reject these therapies. For example, we may face media-communicated criticism directed at our clinical development program. Adverse publicity from