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Current Report · Items 2.02, 9.01 · 8-K

Gain Therapeutics, Inc.

GANXNASDAQEQUITYCurrent

Results of Operations and Financial Condition

Item 2.02 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.…

Filed Nov 12, 2025Accepted Nov 12, 2025, 4:06 PM ESTCIK 1819411Accession 0001104659-25-110343
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Company context

Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, rexaceract is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. Rexaceract has further potential in Gaucher’s disease, dementia with Lewy bodies, and Alzheimer’s disease. Gain has multiple undisclosed preclinical assets targeting lysosomal storage disorders, metabolic diseases, and solid tumors.

Current securities

Recent company filings

  1. Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers; Compensatory ArrangementsSep 28, 2026
  2. 10-Q filingAug 11, 2026
  3. Results of Operations and Financial ConditionAug 11, 2026
  4. 4 filingJul 17, 2026
  5. 4 filingJul 17, 2026

Disclosure sections

Items 2.02, 9.01

Select an item to read the extracted section. The as-filed document remains the primary evidence.

Item 2.02Item 2.02 - Results of Operations
Item 2.02 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 Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall such information and exhibit be deemed incorporated by reference into any of the Company’s filing under the Securities Act of 1933, as amended, or the Exchange Act, except as shall be expressly set forth by specific reference in such a filing. Item 9.01. Financial Statements and Exhibits. (d) Exhibits The exhibits listed below are furnished as part of this Current Report on Form 8-K. Exhibit No. Description ───────────────────────────────────────────────────────────────────────────────────────────────── 99.1 Gain Therapeutics, Inc. Press Release dated November 12, 2025 104 Cover Page Interactive Data File (embedded within the Inline XBRL document).
Filed exhibits (1)
EX-99.1 (by filename) ganx-20251112xex99d1.htm

EX-99.1 2 ganx-20251112xex99d1.htm EX-99.1 Exhibit 99.1 Gain Therapeutics Reports Financial Results for Third Quarter 2025 and Provides Corporate Update Presented initial data from Phase 1b study suggesting GT-02287 has a disease-slowing effect consistent with the preclinical models in vivo and the proposed mechanism of action Completed enrollment of 21 participants in Phase 1b study evaluating GT-02287 in Parkinson’s Disease with or without GBA1 mutations during 3Q 2025 Received approval from the Australian health authorities to extend the duration of the Phase 1b study, allowing participants to continue treatment with GT-02287 for a total of 12 months; with a majority of subjects electing to participate in the study extension Analysis of functional changes and biomarker activity at 90 days expected to be available during 4Q 2025 BETHESDA, Md., November 12, 2025 -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reported financial results for the quarter ended September 30, 2025, and provided a corporate upda…

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