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 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.
Gain Therapeutics reported its fourth quarter and full-year 2025 results and provided a corporate update centered on its lead Parkinson’s disease candidate GT-02287. The company highlighted encouraging Phase 1b data, including central nervous system target engagement and stable or improved MDS-UPDRS scores after 150 days of treatment.
For the year ended December 31, 2025, research and development expenses were $10.2 million, down from $10.8 million in 2024, mainly from pipeline cost optimization. General and administrative expenses fell to $8.5 million from $9.6 million, primarily due to lower stock-based compensation and legal fees.
Net loss for 2025 was $20.2 million, or $0.61 per share, compared with a $20.4 million loss, or $0.89 per share, in 2024. Cash, cash equivalents and marketable securities increased to $20.8 million as of December 31, 2025, up from $10.4 million a year earlier, providing additional funding runway for ongoing clinical development.
Gain Therapeutics, Inc. reported new clinical and biomarker data from its Phase 1b study of GT-02287 in Parkinson’s disease, presented at the AD/PD 2026 conference. In Part 1, 19 participants completed dosing and 16 chose to enter a nine‑month extension, and an independent Data Monitoring Committee recommended the study continue unchanged.
In participants with elevated baseline glucosylsphingosine (GluSph) in cerebrospinal fluid, GluSph fell substantially after 90 days of GT-02287 and DOPA decarboxylase levels also declined. After 150 days, MDS‑UPDRS scores remained stable overall, with a 6.7‑point difference in combined Part II and III scores favoring those with high baseline GluSph. The company also highlighted a novel GCase modulator series led by GT‑04686 that is orally available, brain‑penetrant and ready for IND‑enabling studies in Parkinson’s and other neurological disorders.
Gain Therapeutics, Inc. filed a current report to state that it has posted an investor presentation on its website. On February 3, 2026, the company furnished a set of business overview slides as Exhibit 99.1. These slides are meant to describe the company’s business and are being provided to the SEC for informational purposes only.
The materials are expressly described as “furnished” rather than “filed,” meaning they are not subject to certain liability provisions of the Exchange Act and are not automatically incorporated into other securities law filings unless specifically referenced.