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Gain Therapeutics, Inc. filings document a clinical-stage biotechnology issuer with Nasdaq-listed common stock and emerging growth company status. Recent Form 8-K disclosures cover financial results, business updates, Regulation FD materials, scientific presentations, and clinical or biomarker updates related to GT-02287 and Parkinson’s disease.
The company’s proxy materials describe annual meeting matters, director elections, board composition, executive compensation, equity awards and auditor ratification. Other filings record governance changes, including board membership updates, and identify the company’s registered common stock, Delaware incorporation and reporting framework.
Gain Therapeutics, Inc. reported that the U.S. Food and Drug Administration has authorized its Investigational New Drug application for GT-02287. This authorization allows the company to begin Phase 2 clinical development of GT-02287 in Parkinson’s disease, with or without a GBA1 mutation, in the United States.
Phase 1a and Phase 1b studies were conducted in Australia, and those sites are expected to participate in Phase 2 together with new sites in the U.S. and selected European centers. The company anticipates initiating the Phase 2/2a study of oral GT-02287 in treated and untreated participants with early Parkinson’s disease during the third quarter of 2026.
Gain Therapeutics, Inc. reported the results of its annual stockholder meeting held on June 24, 2026. Stockholders elected seven directors — Gene Mack, Dov Goldstein, M.D., Hans Peter Hasler, Khalid Islam, Ph.D., Gwen Melincoff, Claude Nicaise, M.D., and Jeffrey Riley — each to serve a one-year term until their successors are elected and qualified. Support for these nominees ranged from 13.5 million to 14.5 million votes in favor, with broker non-votes of 11.67 million on each director proposal. Stockholders also ratified the appointment of Ernst & Young AG as the Company’s independent registered public accounting firm for the fiscal year ending December 31, 2026, with 25,865,468 votes for, 1,074,319 against, and 40,462 abstentions.
Gain Therapeutics reported interim results from Part 2, the nine‑month extension of its Phase 1b open‑label study of GT‑02287 in Parkinson’s disease. Sixteen of 19 patients from Part 1 chose to continue and all 16 have completed five months of dosing.
In patients with elevated baseline levels of the biomarker GluSph in cerebrospinal fluid, GluSph fell by an average of 81% after 90 days of treatment. At Day 150, these patients showed a 4.8‑point better combined MDS‑UPDRS Part II and III score than those with low baseline GluSph, and overall scores remained stable.
The study’s Data Monitoring Committee recommended continuation without changes, and patients reported perceived benefits such as improved smell, taste, balance, gait, and sleep. A planned Phase 2 trial is expected to add formal smell and gait assessments using UPSIT and Opal wearable sensors.
Gain Therapeutics reported a Q1 2026 net loss of $5.6 million, wider than the $4.5 million loss a year earlier, as research and development and general and administrative expenses both increased.
Cash and cash equivalents were $16.5 million as of March 31, 2026, down from $20.8 million at year-end, with operating activities using $4.7 million of cash in the quarter. The company concluded its current cash will not fund operations for 12 months after these statements are issued, raising substantial doubt about its ability to continue as a going concern absent additional financing.
Gain continues to advance lead candidate GT-02287 for Parkinson’s disease. Two clinical studies are complete, a Phase 1b trial is ongoing, and new 2026 data showed biomarker changes and clinical score improvements in certain participants. The company also raised modest capital via its at-the-market program and warrant exercises and is pursuing further financings, cost optimization, and strategic collaborations.
Gain Therapeutics reported first quarter 2026 results and updated progress on its lead Parkinson’s disease candidate GT-02287. The company highlighted promising biomarker and early clinical signals from an ongoing Phase 1b trial and expects to receive FDA clearance of an IND in Q2 2026 and begin a Phase 2 study in Q3 2026.
Research and development expenses were $2.8 million for the quarter ended March 31, 2026, up from $2.3 million a year earlier, mainly driven by GT-02287 program costs, personnel and foreign exchange impacts. General and administrative expenses rose to $2.6 million from $2.1 million.
Net loss was $5.6 million, or $0.13 per share, compared with a net loss of $4.5 million, or $0.16 per share, for the same period in 2025. Cash, cash equivalents and marketable securities totaled $16.5 million as of March 31, 2026, compared with $20.8 million as of December 31, 2025.
Gain Therapeutics, Inc. is asking stockholders to vote at its 2026 Annual Meeting on June 24, 2026 in New York. Investors will elect seven directors and ratify Ernst & Young AG as independent auditor for 2026. The record date is April 27, 2026, with 42,654,038 common shares entitled to vote.
The proxy details board independence, committee structure and director biographies, as well as 2025 executive pay. CEO Gene Mack earned total 2025 compensation of $1.47 million, while Principal Financial Officer Gianluca Fuggetta earned $345,074, combining salary, equity awards and performance-based bonuses.
Gain Therapeutics, Inc. reported that CEO and President Gene Mack received a grant of 200,000 employee stock options to buy common stock at an exercise price of $1.86 per share. All 200,000 options were newly awarded and represent his total option holdings reported after this grant.
The options expire on March 24, 2036. According to the vesting terms, 25% of the underlying shares vest on March 24, 2027, with the remaining shares vesting in 36 equal monthly installments thereafter, as long as he continues in service through each vesting date.
Gain Therapeutics, Inc. reported that officer Gianluca Fuggetta received a grant of employee stock options covering 50,000 shares of common stock. The options have an exercise price of $1.86 per share and expire on March 24, 2036.
These options were awarded as a compensation-related grant, not an open-market purchase. According to the vesting terms, 25% of the underlying shares vest on March 24, 2027, with the remaining shares vesting in 36 equal monthly installments thereafter, as long as he remains in continuous service. Following this grant, he holds 50,000 options directly.
Gain Therapeutics files its annual report describing a CNS-focused biotech developing small-molecule drugs that correct protein misfolding using its Magellan computational discovery platform. The lead candidate, GT-02287, targets GCase for Parkinson’s disease, Gaucher disease and other neurodegenerative conditions.
A 72-subject Phase 1 trial in healthy volunteers showed GT-02287 was generally well tolerated with linear pharmacokinetics, CNS exposure and 53% higher GCase activity at the highest 13.5 mg/kg dose. A 90-day Phase 1b trial in 21 Parkinson’s patients completed Part 1 with 19 completers and a 9‑month extension under way, with Phase 2 planned for the second half of 2026. Gain reports exclusive Magellan-related licenses from Minoryx, global composition-of-matter patents for GBA and GLB programs expected to run to 2037, and 42,241,947 common shares outstanding as of February 28, 2026.