Every 8-K that Gain Therapeutics, Inc. (GANX) has filed with the SEC in the last 24 months is listed below, newest first, and each one links through to the document itself with the summary and the scores our analysis gives it.
A 8-K covers material events a company has to report between its quarterly reports, so if you follow GANX and want that one kind of document rather than the whole filing history, this is the page to keep. The company's other filings, of every form, are on the full GANX filings page.
Gain Therapeutics, Inc. (GANX) announced a poster presenting long-term open-label extension data from its Phase 1b rexaceract study in Parkinson’s disease at the International Congress of Parkinson’s Disease and Movement Disorders, scheduled for October 4–8, 2026. As of August 31, 2026, 12 of 13 evaluable patients had completed 12 months of dosing. The company reported stable MDS-UPDRS motor scores over 12 months in 12 evaluable participants, with no clinically meaningful progression on Parts II and III. Among participants with high baseline cerebrospinal-fluid GluSph, the company reported a large decrease toward levels observed in healthy individuals after 90 days.
Gain described the long-term safety and tolerability data as preliminary, reported no new safety signals, and said treatment-emergent adverse events occurred at a lower incidence during the nine-month extension than during the initial three-month period. The company expects to submit a new Phase 2 protocol to the FDA in the coming weeks and initiate the trial in the first quarter of 2027.
Gain Therapeutics, Inc. said Gianluca Fuggetta, Senior Vice President of Finance and the company’s principal financial officer and principal accounting officer, notified the company on September 22, 2026, of his intention to resign effective September 30, 2026, to pursue other opportunities.
On September 24, 2026, the board appointed current President and Chief Executive Officer Gene Mack as interim Chief Financial Officer, effective October 1, 2026. Mack will continue as President and CEO and assume the principal financial officer and principal accounting officer duties until his successor is appointed or his earlier resignation or removal, and until a permanent replacement is named. The company is conducting an ongoing search for a permanent replacement. Mack’s compensatory and other material employment terms will remain unchanged.
Gain Therapeutics reported second quarter 2026 results and provided an update on its Parkinson’s disease program. The company highlighted FDA authorization of its IND for rexaceract, supporting advancement into planned Phase 2 development, and ongoing enrollment and follow-up in a Phase 1b trial, including a nine‑month extension with data expected in October 2026.
For the quarter ended June 30, 2026, research and development expenses were $2.1 million, down from $2.8 million a year earlier, mainly due to lower costs for rexaceract and pipeline optimization, partially offset by the expiration of Swiss grant funding and foreign exchange effects. General and administrative expenses were $2.5 million, up from $2.3 million, driven by higher professional fees, personnel costs and currency impacts. Net loss was $4.7 million, or $0.11 per share, compared with $5.8 million, or $0.19 per share, in the prior‑year quarter.
As of June 30, 2026, cash and cash equivalents were $13.1 million, down from $20.8 million as of December 31, 2025. Total assets were $15.4 million and stockholders’ equity was $11.3 million. Gain continues to position rexaceract, a brain‑penetrant allosteric modulator of beta‑glucocerebrosidase, as a potential disease‑modifying therapy for Parkinson’s disease and other indications.
Gain Therapeutics, Inc. reported, in a press release and shareholder letter, that its current cash and cash equivalents are anticipated to fund operations into the second quarter of 2027, based on current operating plans. This expected runway is tied to planned development activities.
The company highlighted plans to complete a Phase 1b open-label extension in October 2026 and to initiate a Phase 2 clinical study during the third quarter of 2026. Management described these as forward-looking statements and cautioned that actual results may differ materially.
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 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 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.
Gain Therapeutics reported new exploratory data from its Phase 1b study of GT-02287 in people with Parkinson’s disease. All participants who started with elevated levels of glucosylsphingosine (GluSph) in cerebrospinal fluid showed large decreases back toward levels seen in healthy individuals after 90 days of treatment, meeting a prespecified exploratory endpoint.
The Phase 1b trial enrolled 21 participants, with 19 completing the 90-day dosing period and 15 (79%) choosing to enter a nine‑month extension expected to conclude in September 2026. GT-02287 has been generally well-tolerated over 90 days at plasma exposures within the projected therapeutic range, and the data monitoring committee recommended the study continue with no changes.
Earlier Phase 1 data in healthy volunteers showed favorable safety, central nervous system exposure in the projected therapeutic range, and increased glucocerebrosidase (GCase) activity at clinically relevant doses. Gain Therapeutics stated it has sufficient capital to fund operations through completion of the Phase 1b extension and through year-end 2026.
Gain Therapeutics, Inc. filed a current report to furnish a press release announcing its financial results for the third quarter ended September 30, 2025, along with a business update. The press release, dated November 12, 2025, is included as Exhibit 99.1. The company states that this information is being furnished under the rules governing current reports and is not considered filed for liability purposes or automatically incorporated into other securities law filings unless specifically referenced.
Gain Therapeutics (GANX) furnished a virtual KOL event presentation under Item 7.01 Regulation FD. On October 14, 2025, the company hosted “Biomarkers, Clinical Endpoints, and the Path to Disease Modification: Contextualizing the emerging data from GT-02287,” featuring Karl Kieburtz, M.D., M.P.H. (University of Rochester) and Kenneth Marek, M.D. (Institute for Neurodegenerative Disorders).
The slide deck from the event was furnished as Exhibit 99.1. The information provided under Item 7.01, including Exhibit 99.1, is being furnished to the SEC and is not deemed filed or subject to Section 18 liability, nor incorporated by reference unless specifically referenced.
Gain Therapeutics, Inc. reported a change in its Board of Directors. On October 6, 2025, director Eric Richman resigned from the Board effective immediately. The company states that his resignation was not due to any disagreement with Gain Therapeutics regarding its operations, policies, or practices. On October 7, 2025, in connection with his departure, the company reduced the size of the Board from eight to seven members, reflecting the vacancy without appointing a replacement.
Gain Therapeutics reported preliminary results from its ongoing Phase 1b study of GT-02287 in people with Parkinson’s disease, with or without a GBA1 mutation. After 90 days of dosing, GT-02287 has been safe and generally well tolerated, with no treatment-emergent serious adverse events. Some participants showed transient increases in alkaline phosphatase and other liver enzymes, which returned to normal even while treatment continued.
The 21 participants include treatment-naïve patients, individuals on deep brain stimulation, and most on levodopa and other Parkinson’s drugs. Several participants experienced improvements in their MDS-UPDRS Part II and III scores by Day 90, while mean Part I scores were unchanged. The company notes that the mean improvement in Parts II and III by Day 90, not seen by Day 30, suggests a potential disease-slowing effect consistent with preclinical models and the proposed mechanism of GT-02287. Plasma pharmacokinetics were consistent across sampled participants and within the projected therapeutic range.
A data monitoring committee has twice recommended continuing the study, and Australian health authorities have approved an extension allowing patients to be treated for up to 12 months.
Gain Therapeutics, Inc. furnished a press release announcing its financial results for the quarter ended June 30, 2025 and provided a business update; that press release is included as Exhibit 99.1 to this Current Report. The filing also references an Interactive Data File as Exhibit 104.
The registrant indicates it is an emerging growth company and its common stock trades under GANX on The NASDAQ Stock Market. The company states the press release and related information are furnished and therefore are not deemed filed for purposes of Section 18 of the Exchange Act and are not incorporated by reference into other filings except by specific reference. This 8-K does not include the financial statements or numeric results within its text.
Gain Therapeutics (GANX) held its Annual Meeting on June 24, 2025, where stockholders approved several key proposals. Most significantly, shareholders approved doubling the company's authorized common stock from 50 million to 100 million shares, with 16.3M votes in favor versus 2.2M against.
The meeting also resulted in the following outcomes:
- All eight director nominees were successfully elected to one-year terms, with Gene Mack, Dov Goldstein, and Gwen Melincoff receiving the highest approval rates
- Ernst & Young AG's appointment as independent auditor was ratified with strong support (18M votes in favor)
- A contingency measure for meeting adjournment was approved with 17.9M supporting votes
The company, an emerging growth company listed on Nasdaq, filed the Certificate of Amendment with Delaware's Secretary of State to formally implement the authorized share increase. This expansion of authorized shares could provide additional flexibility for future capital raising or strategic transactions.