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Gain Therapeutics, Inc., a biotechnology company, engages in developing various therapies to treat diseases caused by protein misfolding. It focuses on rare genetic diseases and neurological disorders. The company uses its Site-Directed Enzyme Enhancement Therapy platform to discover allosteric sites on misfolded proteins and identify proprietary small molecules that bind these sites, restore protein folding, and treat disease. It is developing structurally targeted allosteric regulator candidates to treat various diseases, including Morquio B, GM1 gangliosidosis (GM1), neuronopathic Gaucher disease, GBA1 Parkinson's, Krabbe, and Mucopolysaccharidosis type 1 diseases. The company was founded in 2017 and is based in Bethesda, Maryland.

Gain Therapeutics, Inc.

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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., NOV. 12, 2025 (GLOBE NEWSWIRE) -- 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 UPDATE.

GAIN THERAPEUTICS REPORTS FINANCIAL RESULTS FOR THIRD QUARTER 2025 AND PROVIDES CORPORATE UPDATE

BETHESDA, MD., OCT. 30, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED A POSTER PRESENTATION AT THE SOCIETY FOR NEUROSCIENCE ANNUAL MEETING, NEUROSCIENCE 2025, BEING HELD NOVEMBER 15TH19TH IN SAN DIEGO, CA.

GAIN THERAPEUTICS TO PRESENT AT NEUROSCIENCE 2025

BETHESDA, MD., OCT. 16, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED IT WILL PARTICIPATE IN THE UPCOMING 2025 MAXIM GROWTH SUMMIT, TAKING PLACE FROM OCTOBER 22ND TO 23RD AT THE HARD ROCK HOTEL NYC.

GAIN THERAPEUTICS TO ATTEND THE 2025 MAXIM GROWTH SUMMIT

BETHESDA, MD., OCT. 09, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED THAT IT WILL HOST A VIRTUAL KEY OPINION LEADER (KOL) EVENT, BIOMARKERS, CLINICAL ENDPOINTS, AND THE PATH TODISEASE MODIFICATION : CONTEXTUALIZING THE EMERGING DATA FROM GT-02287 FEATURING KEY OPINION LEADERS (KOLS), KARL KIEBURTZ, M.D.

GAIN THERAPEUTICS TO HOST VIRTUAL KOL EVENT ON GT-02287 FOR PARKINSON'S DISEASE

IMPROVEMENT OBSERVED IN MDS-UPDRS SCORES IN FIRST 9 PARTICIPANTS ENROLLED; 90-DAY FOLLOW-UP CONTINUING IN REMAINING PARTICIPANTS

GAIN THERAPEUTICS PRESENTS INITIAL DATA FROM PHASE 1B CLINICAL STUDY OF GT-02287 IN PARKINSON'S PATIENTS AT INTERNATIONAL CONGRESS OF PARKINSON'S DISEASE AND MOVEMENT DISORDERS

BETHESDA, MD., SEPT. 23, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED THAT DR. RINALDO MONTALVO, DIRECTOR OF ARTIFICIAL INTELLIGENCE AT GAIN THERAPEUTICS, WILL DELIVER A TALK AT THE WORLD BI SPONSORED DRUG DISCOVERY INNOVATION PROGRAMME (DDIP) 2025, BEING HELD SEPTEMBER 25TH -26TH IN BARCELONA, SPAIN.

GAIN THERAPEUTICS TO PARTICIPATE AT DRUG DISCOVERY INNOVATION PROGRAMME 2025

EXTENSION OF THE PHASE 1B STUDY WILL ALLOW PARTICIPANTS TO CONTINUE DOSING WITH GT-02287 FOR AN ADDITIONAL NINE MONTHS AFTER COMPLETING THE FIRST 90-DAY DOSING SCHEDULE

GAIN THERAPEUTICS BEGINS ITS GT-02287 PHASE 1B EXTENSION STUDY IN PEOPLE WITH PARKINSON'S DISEASE

ONGOING PHASE 1B TRIAL OF GT-02287 TO BE EXTENDED BY AN ADDITIONAL NINE MONTHS FOR PARTICIPANTS WHO ENROLLED IN THE ORIGINAL THREE-MONTH STUDY DESIGN THE INDEPENDENT DATA MONITORING COMMITTEE (DMC) MET RECENTLY AND RECOMMENDED TO CONTINUE THE STUDY WITH NO CHANGES TO STUDY DESIGN BETHESDA, MD., SEPT. 04, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED THE COMPANY HAS RECEIVED APPROVAL FROM THE BELLBERRY HUMAN RESEARCH ETHICS COMMITTEE AND ALFRED HOSPITAL ETHICS COMMITTEE TO EXTEND DOSING BY AN ADDITIONAL NINE MONTHS IN ITS ONGOING PHASE 1B CLINICAL STUDY OF GT-022887, BEYOND THE 90-DAY PERIOD CURRENTLY ALLOWED IN PROTOCOL.

GAIN THERAPEUTICS RECEIVES AUSTRALIAN APPROVAL OF PHASE 1B DOSING EXTENSION AND REPORTS POSITIVE INDEPENDENT DATA MONITORING COMMITTEE RECOMMENDATION

REACHED FULL ENROLMENT OF PHASE 1B STUDY EVALUATING GT-02287 IN PARKINSON'S DISEASE (PD) WITH OR WITHOUT GBA1 MUTATIONS DURING 2Q 2025, EARLIER THAN ANTICIPATED ANALYSIS OF FUNCTIONAL CHANGES AND BIOMARKER ACTIVITY AT 90 DAYS WILL BE AVAILABLE DURING 4Q 2025 IN JULY 2025 FOLLOWING THE CLOSE OF 2Q 2025, GAIN COMPLETED AN UNDERWRITTEN PUBLIC OFFERING THAT RESULTED IN APPROXIMATELY $7.1 MILLION OF NET PROCEEDS BETHESDA, MD., AUG. 12, 2025 (GLOBE NEWSWIRE) -- 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 JUNE 30, 2025, AND PROVIDED A CORPORATE UPDATE.

GAIN THERAPEUTICS REPORTS FINANCIAL RESULTS FOR SECOND QUARTER 2025 AND PROVIDES CORPORATE UPDATE

BETHESDA, MD., JULY 24, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED THAT THE COMPANY'S MANAGEMENT TEAM WILL PARTICIPATE IN A FIRESIDE CHAT AND ONE-ON-ONE MEETINGS AT BTIG'S ANNUAL VIRTUAL BIOTECHNOLOGY CONFERENCE, BEING HELD TUESDAY, JULY 29TH THROUGH WEDNESDAY, JULY 30TH.

GAIN THERAPEUTICS TO PRESENT AT BTIG ANNUAL VIRTUAL BIOTECHNOLOGY CONFERENCE

BETHESDA, MD., JULY 16, 2025 (GLOBE NEWSWIRE) -- 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 ANNOUNCED THE PRICING OF AN UNDERWRITTEN PUBLIC OFFERING OF 4,501,640 SHARES OF ITS COMMON STOCK AND WARRANTS TO PURCHASE UP TO AN AGGREGATE OF 2,250,820 SHARES OF ITS COMMON STOCK. THE PUBLIC OFFERING PRICE FOR EACH SET OF TWO SHARES OF COMMON STOCK AND ACCOMPANYING WARRANT TO PURCHASE ONE SHARE OF COMMON STOCK IS $3.11 PER SET OF SECURITIES, YIELDING AN EFFECTIVE PRICE OF $1.55 PER SHARE AND $0.01 PER WARRANT. THE WARRANTS ARE BEING SOLD AT THE RATE OF ONE WARRANT FOR EVERY TWO SHARES OF COMMON STOCK. THE WARRANTS WILL HAVE AN EXERCISE PRICE OF $1.65 PER SHARE, ARE EXERCISABLE IMMEDIATELY UPON ISSUANCE AND WILL EXPIRE FIVE YEARS FOLLOWING THE DATE OF ISSUANCE.

Gain Therapeutics, Inc.

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Gain Therapeutics, Inc.

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