{"url_path":"/sec/ganx/8-k/2026-06-29/item-8-01","section_key":"item-8-01","section_title":"Item 8.01 Other Events.**","topic":"sec","document":{"doc_type":"8-K","doc_date":"2026-06-29","source_url":"https://www.sec.gov/Archives/edgar/data/1819411/0001104659-26-078848-index.html","accession_number":"0001104659-26-078848","cik":"0001819411","ticker":"GANX","issuer_name":"Gain Therapeutics, Inc.","edgar_url":"https://www.sec.gov/Archives/edgar/data/1819411/0001104659-26-078848-index.html","primary_entity_key":"0001819411","primary_entity_name":"Gain Therapeutics, Inc."},"word_count":545,"has_tables":true,"body_markdown":"** **\n\n \n\n \n\n \n\n \n\n**Item 8.01. Other Events.**\n\n \n\nOn June 29, 2026, Gain Therapeutics, Inc. (the\n“Company”) announced that the U.S. Food and Drug Administration (“FDA”) has authorized the Company’s Investigational\nNew Drug application for GT-02287. FDA’s decision will allow initiation of the Company’s Phase 2 clinical development of GT-02287\nin Parkinson’s disease with or without a GBA1 mutation in the U.S. Both the Phase 1a and Phase 1b studies of GT-02287 were conducted\nin Australia. The sites in Australia are expected to also participate in the Phase 2 study along with new sites in the U.S. and select\nEuropean centers. The initiation of the Phase 2 study of GT-02287 is anticipated to occur during the third quarter of 2026.\n\n \n\nThe planned Phase 2a study of oral GT-02287\nin treated and untreated participants with early Parkinson’s disease is expected to enroll participants across sites in the\nUnited States, Australia, and Europe. The Company expects initiation of the Phase 2a in the third quarter of 2026.\n\n \n\n*Cautionary Note Regarding Forward-Looking Statements*\n\n* *\n\nThis Current Report on Form 8-K contains “forward-looking\nstatements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements\nare typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,”\n“will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s\ncurrent knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the\nexpectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that\nthose goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking\nstatements. Such forward-looking statements include, but are not limited to, statements regarding: the development of the Company’s\ncurrent or future product candidates; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287,\nincluding any extension studies; the timing of the commencement of the Phase 2 clinical study for GT-02287; the ability for the Company\nto enroll patients in its planned Phase 2 clinical study for GT-02287; the Company’s ability to replicate positive results from\nearlier preclinical studies or clinical trials in current or future clinical trials; and the potential therapeutic and clinical benefits\nof the Company’s product candidates, including. For a further description of the risks and uncertainties that could cause actual\nresults to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business\nin general, please refer to the Company’s Form 10-K for the year ended December 31, 2025, and other filings made with the SEC. All\nforward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance\non any forward-looking statements, which speak only as of the date of this release. The Company has no obligation, and expressly disclaims\nany obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events\nor otherwise.\n\n \n\n \n\n \n\n \n\n**Signature**\n\n \n\nPursuant to the requirements\nof the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto\nduly authorized.\n\n \n\n \n**GAIN THERAPEUTICS, INC.**\n\n \n \n\nDated: June 29, 2026\nBy:\n/s/ Gene Mack\n\n \n \nGene Mack\n\n \n \nChief Executive Officer"}