Results of Operations and Financial Condition. On August 11, 2026, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2026, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Ac…

Other Events. On July 16, 2026, Gain Therapeutics, Inc. (the “Company”) issued a press release and shareholder letter in which it announced, among other things, that its current cash and cash equivalents are anticipated to fund the Company’s operations into the second quarter of 2027, based on current operating plans, including the completion of the Phase 1b open-label extension in October 2026 and initiation of a Phase 2 clinical study during the third quarter of 2026. Cautionary Note Regard…

Other Events. On June 29, 2026, Gain Therapeutics, Inc. (the “Company”) announced that the U.S. Food and Drug Administration (“FDA”) has authorized the Company’s Investigational New Drug application for GT-02287. FDA’s decision will allow initiation of the Company’s Phase 2 clinical development of GT-02287 in 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 in Australia. The sites in Australia are expected to als…

Results of Operations and Financial Condition. On May 11, 2026, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2026, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act o…

Results of Operations and Financial Condition. On March 26, 2026, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2025, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 19…

Other Events. On March 18, 2026, the Company issued a press release announcing the presentation of an oral presentation and poster at AD/PD ™ 2026 International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders, being held March 17-21, 2026 in Copenhagen, Denmark. The oral presentation outlined new clinical and biomarker data from the Phase 1b clinical study of GT-02287 further supporting disease-modifying potential in both idiopathic and GBA1 Parkinson’s di…

Other Events. On December 18, 2025, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing results in exploratory endpoint from its Phase 1b clinical study of GT-02287 in people with Parkinson’s Disease (“PD”). All individuals with elevated levels of glucosylsphingosine (“GluSph”) in the cerebrospinal fluid (“CSF”) displayed large decreases back towards levels observed in healthy individuals after 90 days of treatment with GT-02287. The change observed in GluSph in CSF was…

Other Events. On November 28, 2025, Gain Therapeutics, Inc. (the “Company”), filed a prospectus supplement (the “Prospectus Supplement”) with the U.S. Securities and Exchange Commission (the “SEC”) in connection with the Company’s “at the market offering” program for the offer and sale of up to $35,530,980.56 of the Company’s common stock, par value $0.0001 per share (the “Common Stock”), from time to time through Oppenheimer & Co. Inc. (“Oppenheimer”), as sales agent, pursuant to the Company…

Results of Operations and Financial Condition. On November 12, 2025, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2025, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Excha…

Director — Eric Richman: Eric Richman resigned from the Board of Directors.

Results of Operations and Financial Condition. On August 12, 2025, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2025, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Ac…

Entry into a Material Definitive Agreement. On July 16, 2025, Gain Therapeutics, Inc., a Delaware corporation (the “ Company ”), entered into an underwriting agreement (the “ Underwriting Agreement ”) with Newbridge Securities Corporation, as underwriter (the “ Underwriter ”), relating to the offering, issuance and sale of an aggregate of (i) 4,501,640 shares of the Company’s common stock, par value $0.0001 per share (“ Common Stock ”) and (ii) warrants to purchase 2,250,820 shares of Common…

The offer and sale of the Underwriter’s Warrants have not been registered under the Securities Act and are instead being offered pursuant to the exemption provided in Section 4(a)(2) under the Securities Act and/or Rule 506(b) promulgated thereunder.

Regulation FD Disclosure. On July 15, 2025, the Company issued a press release regarding the launch of the Offering (the “ Launch Press Release ”). On July 16, 2025, the Company issued a press release announcing that it had priced the Offering (the “ Pricing Press Release ”). Copies of the Launch Press Release and the Pricing Press Release are furnished hereto as Exhibit 99.1 and Exhibit 99.2, respectively. The information in this Current Report on Form 8-K under Item 7.01, including the info…

Results of Operations and Financial Condition. On May 14, 2025, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the first quarter ended March 31, 2025, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act o…

Results of Operations and Financial Condition. On March 27, 2025, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the year ended December 31, 2024, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 19…

Notice of Delisting or Failure to Satisfy a Continued Listing Rule or Standard; Transfer of Listing. On January 8, 2025, Gain Therapeutics Inc. (the “Company”) received a letter (the “MVLS Deficiency Notice”) from the listing qualifications department staff (the “Staff”) of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that that from November 14, 2024 to December 27, 2024, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $50 million required for con…

President and Chief Executive Officer — Gene Mack: Gene Mack was promoted from interim CEO and CFO to President and CEO.

Results of Operations and Financial Condition. On November 14, 2024, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the third quarter ended September 30, 2024, and a business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Excha…

Entry into a Material Definitive Agreement. On September 6, 2024, Gain Therapeutics, Inc. (the “ Company ”) entered into an Equity Distribution Agreement (the “ Distribution Agreement ”) with Oppenheimer & Co. Inc., serving as agent (“ Oppenheimer ”) with respect to an at-the-market offering program under which the Company may offer and sell, from time to time at its sole discretion, shares of its common stock, par value $0.0001 per share (the “ Common Stock ”), having an aggregate offering p…

Results of Operations and Financial Condition. On August 8, 2024, Gain Therapeutics, Inc. (the “Company”) issued a press release announcing its financial results for the second quarter ended June 30, 2024, and business update. A copy of the press release is being furnished as Exhibit 99.1 to this Current Report on Form 8-K. The information included or incorporated in this Item 2.02, including Exhibit 99.1, shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act o…

Notice of Delisting or Failure to Satisfy Continued Listing Rule or Standard; Transfer of Listing. On June 11, 2024, Gain Therapeutics, Inc. (the “Company”) received a letter (the “MVLS Deficiency Notice”) from the listing qualifications department staff (the “Staff”) of The Nasdaq Stock Market (“Nasdaq”) notifying the Company that that from May 8, 2024 to July 10, 2024, the Company’s Market Value of Listed Securities (“MVLS”) was below the minimum of $50 million required for continued listin…

Chief Executive Officer — Matthias Alder: Matthias Alder resigned as CEO to pursue other opportunities.

Entry into a Material Definitive Agreement. On June 13, 2024, Gain Therapeutics, Inc., a Delaware corporation (the “ Company ”), entered into an underwriting agreement (the “ Underwriting Agreement ”) with Titan Partners Group LLC, a division of American Capital Partners, LLC, as the underwriter (the “ Underwriter ”), relating to the offering, issuance and sale of an aggregate of (i) 7,116,547 shares of the Company’s common stock, par value $0.0001 per share (“ Common Stock ”), and (ii) pre-f…

Regulation FD Disclosure. On June 13, 2024, the Company issued two press releases regarding (i) the launch (the “ Launch Press Release ”) and (ii) the pricing of the Offering (the “ Pricing Press Release ”). Copies of the Launch Press Release and the Pricing Press Release are furnished hereto as Exhibit 99.1 and Exhibit 99.2, respectively. The information in this Current Report on Form 8-K under Item 7.01, including the information contained in Exhibits 99.1 and 99.2, is being furnished to th…