GANX

BETHESDA, Md., Aug. 11, 2026 (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, 2026, and provided a corporate update. “The second quarter marked an important period of execution for Gain, highlighted by FDA authorization of our IND for rexaceract, which positions us to advance into Phase 2 clinical development,” said Gene Mack, President and CEO of Gain Therapeutics. “The encouraging biomarker and clinical data generated to date continue to support the potential disease-modifying properties of rexaceract, and we were pleased to further share these findings with the scientific community at the 3rd International GBA1 Meeting. We believe these data further strengthen the therapeutic rationale for rexaceract across both idiopathic and GBA1 Parkinson’s disease.” Mr. Mack continued, “We remain focused on completing the ongoing nine-month extension of our Phase 1b study, with final data expected to be presented at the International Congress of Parkinson’s Disease and Movement Disorders in Korea in October 2026, while advancing preparations for our Phase 2 clinical program. As of June 30, 2026, 14 of the 16 participants that elected to enroll in the Phase 1b nine-month extension had completed Day 270 with seven of those crossing the Day 360 mark. To date, MDS-UPDRS scores continue to demonstrate that patients with high baseline CSF GluSph experience an early and durable response to rexaceract that persists through Day 270 and Day 360, while the overall patient group continues to benefit from non-progression of their Parkinson’s symptoms through Day 360. We continue to believe rexaceract has the potential to shift the treatment paradigm beyond symptom management by addressing the underlying biology of Parkinson’s disease, and we look forward to achieving additional clinical and regulatory milestones throughout the remainder of the year.” Second Quarter 2026 and Recent Corporate and Pipeline Highlights Pipeline Updates Rexaceract Presented additional data from the Phase 1b clinical study of rexaceract (GT-02287) that supported its disease-modifying potential via demonstrating the restoration of glucocerebrosidase (GCase) biology at the 3rd International GBA1 Meeting 2026 in May 2026 in Phoenix, AZ. Rexaceract accepted as the International Nonproprietary Name (INN) for GT-02287, establishing the compound's official generic name as it continues to advance through clinical development. GT-04686 GT-04686 is moving towards IND-enabling studies and ultimately, clinical development. Corporate Updates Regulatory The U.S. Food and Drug Administration (FDA) completed its review of an Investigational New Drug (IND) application for rexaceract. Management Changes Promotion of Dr. Joanne Taylor to Chief Scientific Officer, reinforcing the Company's scientific leadership and advancing its research and development strategy. Promotion of Terenzio Ignoni to Chief Operating Officer, strengthening the Company's executive leadership and operational execution. Upcoming Anticipated Milestones Phase 2 clinical trial of rexaceract in people with Parkinson’s disease expected to begin in Q3 2026. Final results from Phase 1b clinical study of rexaceract expected in Q4 2026. GT-04686 initial target indication expected in Q4 2026. Q2 2026 Financial Results Research and development (R&D) expenses decreased by $0.6 million to $2.1 million for the three months ended June 30, 2026, compared to $2.8 million for the three months ended June 30, 2025. The decrease in research and development expenses was primarily related to lower costs associated with our lead program compound GT-02287 (rexaceract) for the treatment of Parkinson’s Disease and optimization of the pipeline, together with lower research and development personnel expenses, partially offset by the expiration of the grant awarded by Innosuisse under the Swiss Accelerator program in April 2026 and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. General and administrative (G&A) expenses increased by $0.2 million to $2.5 million for the three months ended June 30, 2026, compared to $2.3 million for the three months ended June 30, 2025. The increase in general and administrative expenses for the period was primarily attributable to higher professional fees, higher personnel costs, and unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S. dollar. Net loss for the three months ended June 30, 2026, was $0.11 per share, basic and diluted, compared to $0.19 per share, basic and diluted, for the three months ended June 30, 2025. Cash and cash equivalents were $13.1 million as of June 30, 2026, compared to $20.8 million as of December 31, 2025. About Rexaceract Gain Therapeutics’ lead drug candidate rexaceract, formerly known as GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is a beta-glucocerebrosidase (GCase) positive allosteric modulator, antiparkinsonian, that restores the function of the lysosomal enzyme GCase which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors, by stabilizing and chaperoning it to the lysosomes and mitochondria. In preclinical models of PD, rexaceract restored GCase enzymatic function, reduced endoplasmic reticulum stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, rexaceract was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of rexaceract, suggest that rexaceract may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of rexaceract in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with an increase in GCase activity among those receiving rexaceract at clinically relevant doses. Rexaceract is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across seven sites in Australia, is to evaluate the safety and tolerability of rexaceract after three months of dosing in people with Parkinson’s disease. The Phase 1b study extension allows participants to continue to be treated with rexaceract for up to a total of 12 months. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc.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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking StatementsThis release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates; expectations regarding the timing of patient enrollment and the completion and timing of results from a Phase 1b clinical study for rexaceract, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies; the timing of the commencement of the Phase 2 clinical study for rexaceract; the ability for the Company to enroll patients in its planned Phase 2 clinical study for rexaceract; the Company’s ability to replicate positive results from earlier preclinical studies or clinical trials in current or future clinical trials; the Company’s business development activities, strategic collaborations, licensing opportunities and financing activities; the advancement, prioritization and timing of the Company’s pipeline programs, including GT-04686; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2025 and other filings made with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors:Gain Therapeutics, Inc. Apaar Jammu Director, Investor Relations and Public [email protected] LifeSci Advisors LLCChuck PadalaManaging [email protected] Media:Russo Partners LLC Nic Johnson and Elio [email protected]@russopartnersllc.com(760) 846-9256

BETHESDA, Md., May 11, 2026 (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 March 31, 2026, and provided a corporate update. “The first quarter of 2026 marked another exciting quarter for Gain, as we continued to build on the important advancements achieved in 2025 related to both the scientific understanding and clinical development of our lead candidate GT-02287, in development for the treatment of Parkinson’s disease with or without a GBA1 mutation. This is underscored by the promising biomarker and early clinical evidence from our ongoing Phase 1b study supporting the potential disease modifying properties of GT-02287 that we presented at AD/PD™ 2026 in Copenhagen this past March,” said Gene Mack, President and CEO of Gain Therapeutics. Mr. Mack added, “The analysis of biomarkers and clinical evidence of efficacy is ongoing throughout the nine-month extension of the Phase 1b study, which is expected to complete in October 2026. MDS-UPDRS scores have remained durable to date, and we look forward to sharing more details at the upcoming 3rd International GBA1 Meeting later this month in Phoenix, Arizona. We believe the totality of the data supports the potential of GT-02287 to treat both idiopathic and GBA1 Parkinson’s disease, and we remain focused on helping to shift the treatment paradigm from managing symptoms of Parkinson’s disease towards disease modification and addressing the underlying biology causing those symptoms. We expect to receive FDA clearance of our IND during Q2 2026 and remain on track to begin our Phase 2 study in Q3 2026.” First Quarter 2026 and Recent Corporate and Pipeline Highlights Pipeline Updates GT-02287 Presented additional data from the Phase 1b clinical study of GT-02287 demonstrating central target engagement, beneficial effects on downstream pathway abnormalities, and clinical improvement in participants, that supported the disease-modifying potential of GT-02287 at AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders in March 2026 in Copenhagen, Denmark. As of March 2026, 14 of 16 participants enrolled in Phase 1b nine-month extension had completed five months of dosing (Day 150). MDS-UPDRS scores remained stable over 150 days of dosing. In participants with elevated baseline levels of glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), GluSph decreased by an average of 81% after 90 days of treatment with GT-02287. In participants with elevated baseline levels of GluSph in CSF, levels of DOPA decarboxylase (DDC) decreased following 90 days of treatment with GT-02287. GT-04686 Also, at AD/PD™ 2026, presented new series of novel glucocerebrosidase (GCase) allosteric modulators, represented by the advanced lead GT-04686, identified using the Company’s proprietary Magellan™ drug discovery platform. Novel chemical series, led by GT-04686, demonstrated activity in both in vitro and in vivo models, including increase in GCase activity and lipid substrate depletion in patient fibroblasts harboring both mutated and wildtype GBA1, as well as restoration of motor and non-motor function in an animal model of Parkinson’s disease. GT-04686 is ready for IND-enabling studies for the treatment of Parkinson’s disease and other neurological disorders. Corporate Updates Hosted a KOL event in January highlighting biomarker evidence supporting disease-modifying potential of GT-02287 and current thinking on GCase substrates and biomarkers in PD. A replay of the event can be found here. Completed enrollment in the Phase 1b nine-month extension for GT-02287 in people with PD. All 16 participants have been enrolled as of January 2026. Continued Investigational New Drug (IND) engagement with the U.S. Food and Drug Administration (FDA) in preparation for GT-02287 Phase 2 clinical development in the United States. Publication of in vitro research on new small molecule allosteric modulators of β-galactosidase, identified using the Company’s Magellan™ drug discovery platform, targeting GM1 gangliosidosis and Morquio B, in the International Journal of Molecular Sciences, one of the Multidisciplinary Digital Publishing Institute’s (MDPI) flagship publications. Upcoming Anticipated Milestones FDA clearance of our IND submission, expected in Q2 2026, facilitating Phase 2 clinical development of GT-02287 to include clinical sites in the United States. Phase 2 clinical trial of GT-02287 in people with Parkinson’s disease expected to begin in Q3 2026. Results from Phase 1b clinical study of GT-02287 expected in Q4 2026. Q1 2026 Financial Results Research and development (R&D) expenses increased by $0.5 million to $2.8 million for the three months ended March 31, 2026, as compared to $2.3 million for the three months ended March 31, 2025. The increases in research and development expenses were primarily related to costs associated with the Company’s lead program compound GT-02287 for the treatment of Parkinson’s disease, unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar, and higher research and development personnel costs. General and administrative (G&A) expenses increased by $0.5 million to $2.6 million for the three months ended March 31, 2026, as compared to $2.1 million for the three months ended March 31, 2025. The increases in general and administrative expenses for the period were primarily attributable to higher professional fees, higher personnel costs, and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. Net loss for the three months ended March 31, 2026, was $0.13 per share, basic and diluted, compared to $0.16 per share, basic and diluted, for the three months ended March 31, 2025. Cash, cash equivalents and marketable securities were $16.5 million as of March 31, 2026, compared to $20.8 million as of December 31, 2025. About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling data in these models, demonstrating a disease-modifying effect of GT-02287, suggest that the drug candidate may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with an increase in GCase activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across seven sites in Australia, is to evaluate the safety and tolerability of GT-02287 after three months of dosing in people with Parkinson’s disease. The recently commenced Phase 1b study extension allows participants to continue to be treated with GT-02287 for up to a total of 12 months. Initial results from the Phase 1b clinical trial in people with Parkinson’s disease demonstrated central nervous system target engagement, a reduction to baseline levels in the prespecified endpoint glucosylsphingosine (GluSph), and improvement or stabilization in MDS-UPDRS scores. Additionally, participants with elevated levels of CSF GluSph also exhibited elevated levels of DOPA decarboxylase (DDC), which decreased following treatment with GT-02287. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking Statements This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287 and GT-04686; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287, including any extension studies; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies and the timing of any responses from the FDA or other regulatory bodies and agencies; the timing of the commencement of any Phase 2 clinical studies for GT-02287; and the potential therapeutic and clinical benefits of the Company’s product candidates, including GT-02287 and GT-04686. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2025, and other filings made with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors: Gain Therapeutics, Inc. Apaar Jammu Director, Investor Relations and Public Relations [email protected] LifeSci Advisors LLC Chuck Padala Managing Director [email protected] Media: Russo Partners LLC Nic Johnson and Elio Ambrosio [email protected] [email protected] (760) 846-9256

BETHESDA, Md., March 26, 2026 (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 fourth quarter and year ended December 31, 2025, and provided a corporate update. “We are encouraged by the progress made in 2025, as we made important advancements related to both the scientific understanding and clinical development of our lead candidate GT-02287, in development for the treatment of Parkinson’s disease with or without a GBA1 mutation. The promising impact GT-02287 has on the causative biology of Parkinson’s disease has been further elucidated from the analysis of functional and biomarker changes from the Phase 1b study,” commented Gene Mack, President and CEO of Gain Therapeutics. Mr. Mack continued, “We will continue to follow patients in the Phase 1b nine-month extension study that is expected to complete in September 2026 and look forward to presenting longer-term follow up at additional scientific conferences throughout the balance of the year. To date, MDS-UPDRS scores remained stable and durable across the overall study population after 150 days of treatment with GT-02287 and are becoming more encouraging with the passage of time. We believe the totality of the data continues to support the potential of GT-02287 in both idiopathic and GBA1 Parkinson’s disease and we hope to one day shift the treatment paradigm away from symptomatic relief and to disease modification.” Fourth Quarter 2025 and Recent Corporate and Pipeline Highlights Pipeline Updates Presented initial data from the Phase 1b clinical study of GT-02287 demonstrating the disease-modifying potential of GT-02287 in people with Parkinson’s disease (PD) at the International Congress of Parkinson’s Disease and Movement Disorders® in October 2025 in Honolulu, HI. Presented preclinical data demonstrating evidence that GT-02287 beneficially impacts mitochondrial health in addition to lysosomal health and endoplasmic reticulum stress at Neuroscience 2025 in November 2025 in San Diego, CA. Presented additional data from the Phase 1b clinical study of GT-02287 demonstrating central target engagement, beneficial effects on downstream pathway abnormalities, and clinical improvement in participants, that supported the disease-modifying potential of GT-02287 at AD/PD™ 2026 International Conference on Alzheimer’s and Parkinson’s Disease and Related Neurological Disorders in March 2026 in Copenhagen, Denmark. As of March 2026, 14 of 16 participants enrolled in Phase 1b nine-month extension had completed 5 months of dosing (Day 150). MDS-UPDRS scores remained stable over 150 days of dosing. In participants with elevated baseline levels of glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), GluSph decreased by an average of 81% after 90 days of treatment with GT-02287. In participants with elevated baseline levels of GluSph in CSF, levels of DOPA decarboxylase (DDC) decreased following 90 days of treatment with GT-02287. Also at AD/PD™ 2026, presented new series of novel glucocerebrosidase (GCase) allosteric modulators, represented by the advanced lead GT-04686, identified by the Company’s proprietary Magellan™ drug discovery platform. Novel chemical series, led by GT-04686, demonstrated activity in both in vitro and in vivo models, including increase in GCase activity and lipid substrate depletion in patient fibroblasts harboring both mutated and wildtype GBA1, as well as restoration of motor and non-motor function in an animal model of Parkinson’s disease. GT-04686 is ready for IND-enabling studies for the treatment of Parkinson’s disease and other neurological disorders. Corporate Updates Publication of Phase 1 clinical study data detailing GCase target engagement and therapeutic plasma and cerebrospinal fluid levels after GT-02287 administration in healthy volunteers in Movement Disorders, an official journal of the International Parkinson and Movement Disorder Society. Hosted a KOL event highlighting current thinking on Parkinson’s disease clinical outcome scales and biomarkers as well as the Company’s initial Phase 1b data. A replay of the event can be found here. Hosted a KOL event highlighting biomarker evidence supporting disease-modifying potential of GT-02287 and current thinking on GCase substrates and biomarkers in PD. A replay of the event can be found here. Completed enrollment in the Phase 1b nine-month extension for GT-02287 in people with PD. 16 participants have been enrolled as of January 2026. Continued Investigational New Drug (IND) engagement with the U.S. Food and Drug Administration (FDA) in preparation for GT-02287 Phase 2 clinical development in the United States. Upcoming Anticipated Milestones Clearance of IND submission to FDA, expected in 2Q26, facilitating Phase 2 clinical development of GT-02287 to include clinical sites in the United States. Phase 2 clinical trial of GT-02287 in people with PD expected to begin in 3Q26. Results from Phase 1b clinical study of GT-02287 expected in 4Q26. Year-End 2025 Financial Results Research and development (R&D) expenses decreased by $0.6 million to $10.2 million for the year ended December 31, 2025, as compared to $10.8 million for the year ended December 31, 2024. The decrease in research and development expenses was primarily related to optimization of our pipeline costs. The decrease was partially offset by unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S. dollar. General and administrative (G&A) expenses decreased by $1.1 million to $8.5 million for the year ended December 31, 2025, from $9.6 million for the year ended December 31, 2024. The decrease in general and administrative expenses was primarily attributable to lower stock-based compensation and lower legal fees. The decrease was partially offset by higher personnel costs and unfavorable foreign exchange currency translation as the Swiss franc strengthened against the U.S. dollar. Net loss for the year ended December 31, 2025, was $20.2 million, or $0.61 per share, basic and diluted, compared to $20.4 million, or $0.89 per share, basic and diluted, for the year ended December 31, 2024. Cash, cash equivalent and marketable securities were $20.8 million as of December 31, 2025, compared to $10.4 million as of December 31, 2024. About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling data in these models, demonstrating a disease-modifying effect of GT-02287, suggest that the drug candidate may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with an increase in GCase activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across seven sites in Australia, is to evaluate the safety and tolerability of GT-02287 after three months of dosing in people with Parkinson’s disease. The recently commenced Phase 1b study extension allows participants to continue to be treated with GT-02287 for up to a total of 12 months. Initial results from the Phase 1b clinical trial in people with Parkinson’s disease demonstrated central nervous system target engagement, a reduction to baseline levels in the prespecified endpoint glucosylsphingosine (GluSph), and improvement or stabilization in MDS-UPDRS scores. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking Statements This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Such forward-looking statements include, but are not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287 and GT-04686; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287, including any extension studies; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies and the timing of any responses from the FDA or other regulatory bodies and agencies; the timing of the commencement of any Phase 2 clinical studies for GT-02287; and the potential therapeutic and clinical benefits of the Company’s product candidates, including GT-02287 and GT-04686. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2025, and other filings made with the SEC. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors: Gain Therapeutics, Inc. Apaar Jammu Director, Investor Relations and Public Relations [email protected] LifeSci Advisors LLC Chuck Padala Managing Director [email protected] Media: Russo Partners LLC Nic Johnson and Elio Ambrosio [email protected] [email protected] (760) 846-9256

Results showed CNS target engagement with reduction in GCase substrate glucosylsphingosine (GluSph) in cerebrospinal fluid (CSF), a prespecified endpoint The reduction in GluSph in CSF, a first-ever observation following the administration of a GCase modulator to PD patients, suggests increased GCase activity in the brain, which is expected to impact the progression of Parkinson’s disease (PD) KOL event planned for early January to discuss the results; registration information herein BETHESDA, Md., Dec. 18, 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 provided evidence, for the first time in Parkinson’s Disease (PD), of a reduction in glucocerebrosidase (GCase) substrate in cerebrospinal fluid (CSF). Decreased GluSph in CSF is an indication of increased GCase activity in the brain All individuals with elevated levels of glucosylsphingosine (GluSph) in the CSF displayed large decreases back towards levels observed in healthy individuals after 90 days of treatment with GT-02287. Importantly, the change observed in GluSph in CSF was a prespecified exploratory endpoint of this Phase 1b study. Elevated GluSph, a hallmark of GCase dysfunction, has been shown to increase the aggregation of alpha synuclein and to impair mitochondrial function and other intracellular processes in neurons. Gene Mack, president and CEO of Gain Therapeutics, commented on the results, stating, “We are excited by the unfolding biomarker evidence of GT-02287 activity and central nervous system target engagement. To our knowledge, GT-02287 is the first GCase modulator to demonstrate a reduction of GluSph in CSF in people with PD, providing downstream evidence of GCase enhancement in the brain. Further, we believe that reduction in brain GluSph levels will have a direct impact on neuronal health and translate to clinically observable improvements.” Mr. Mack continued, “With a capital position sufficient to fund operations through the end of the Phase 1b extension and year-end 2026, we look forward to presenting longer follow-up from the study at the AD/PD™ conference in March 2026, observing the effect of GT-02287 treatment on MDS-UPDRS scores in the participants who continued in the nine-month extension, and determining the durability of some of the anecdotal signs of early functional improvement.” GT-02287 Phase 1b Study Part 1 (90 days of dosing) of the ongoing Phase 1b study has concluded. The Phase 1b study enrolled 21 participants; 19 completed the 90-day dosing period, and 15 (79%) chose to continue in the nine-month extension (Part 2) portion of the study that is anticipated to conclude in September 2026. Consistent with the initial Phase 1b data presented at the International Congress of Parkinson’s Disease and Movement Disorders in October 2025, GT-02287 continues to be generally well-tolerated over 90 days of dosing at plasma exposures within the projected therapeutic range. The data monitoring committee (DMC) has recommended that the Phase 1b study continue with no changes. Upcoming Virtual KOL Event on GT-02287 Gain Therapeutics will host a webinar “Understanding GCase Substrates in Parkinson’s Disease: Perspectives on Biomarkers and Disease Modification, Contextualizing emerging biomarker data from the Phase 1b clinical study of GT-02287”, featuring key opinion leaders Roy Alcalay, M.D., M.Sc., and Peter Lansbury, Ph.D., on Tuesday, January 6, 2026 at 10:00 a.m. ET to discuss the results announced today and host a question-and-answer session. Additional details about the event will be issued closer to the event in a separate press release. To register, please click here. About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with an increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across seven sites in Australia, is to evaluate the safety and tolerability of GT-02287 after three months of dosing in people with Parkinson’s disease. The recently commenced Phase 1b study extension allows participants to continue to be treated with GT-02287 for up to a total of 12 months. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking Statements This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287, including any extension studies; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors: Gain Therapeutics, Inc. Apaar Jammu Manager, Investor Relations and Public Relations [email protected] LifeSci Advisors LLC Chuck Padala Managing Director [email protected] Media: Russo Partners LLC Nic Johnson and Elio Ambrosio [email protected] [email protected] (760) 846-9256

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. “We are encouraged by the progress made during the third quarter of 2025 and remain on track to report the analysis of both functional changes and biomarker activity during the fourth quarter of 2025. We are excited to better understand the impact GT-02287 has on the biology of Parkinson’s disease from this analysis and look forward to presenting what we learn. We presented early clinical findings last month at the 2025 MDS conference in Hawaii suggesting GT-02287 has a disease-slowing effect as evidenced by stabilization and improvement in Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) scores that appears after approximately 30 days of administration according to our data,” said Gene Mack, President and CEO of Gain. “We are further encouraged by the strong engagement we have seen in the Phase 1b study, with approximately 80% of participants having joined or confirmed their interest in the study extension phase. We look forward to generating additional feedback from this study extension that we can incorporate into our Phase 2 planning, which is already underway.” Important highlights during the quarter included completion of enrollment for the company’s Phase 1b study evaluating lead candidate GT-02287 in Parkinson’s disease with or without a GBA1 mutation. Of the 21 participants enrolled, which is a number that surpassed the original target of 15 participants, 16 have completed 90 days of dosing. The remaining 5 participants are expected to complete dosing in December 2025. Eligible participants that have completed 90 days of treatment with GT-02287 continue to transition into the Phase 1b study extension, which commenced September 2025. Recent data presented at the International Congress of Parkinson’s Disease and Movement Disorders® demonstrated improvement in MDS-UPDRS scores after 90 days of dosing in the first nine participants enrolled and suggest a disease-slowing effect consistent with the preclinical models in vivo and the proposed mechanism of action of GT-02287. Accordingly, Gain expects a full 90-day analysis, including functional changes scored according to MDS-UPDRS and biomarker data from cerebrospinal fluid and blood, from participants that were enrolled as of June 30, 2025, to be available in Q4 2025 as previously expected. Mr. Mack continued, “We are deeply grateful to the patients, investigators, and clinical sites for their continued commitment to advancing this important program. Participating in a Parkinson’s disease trial is never an easy undertaking but the interest we continue to see underscores the significant unmet need for a disease-modifying therapy. We hope to shift the treatment paradigm and deliver a life-changing treatment to those that need it, and we believe we are well-positioned to do so.” Third Quarter 2025 and Recent Corporate and Clinical Program Highlights Clinical Program Highlights Presented initial clinical data in October 2025 that supported the disease-modifying potential of GT-02287 in people with Parkinson’s disease at International Congress of Parkinson’s Disease and Movement Disorders® held in Honolulu, HI. GT-02287 was generally well tolerated, with no treatment-emergent serious adverse events observed. Several participants experienced an improvement in their UPDRS Part II and III scores after 90 days of dosing with GT-02287 while mean Part I scores remained unchanged. The mean improvement in Parts II and III by Day 90, which was not observed by Day 30, suggests that GT-02287 has a disease-slowing effect, consistent with preclinical models in vivo and the proposed mechanism of action. Plasma pharmacokinetics (PK) profile was consistent across all 14 participants sampled, was within the projected therapeutic range, and comparable to exposures observed in healthy volunteers in the Phase 1 study. Corporate Updates Received Australian approval to extend dosing by an additional nine months in the ongoing Phase 1b study, beyond the 90-day period originally allowed in the protocol. A review of interim safety data by the independent data monitoring committee resulted in no safety concerns identified and a recommendation to continue the Phase 1b study with no changes. Completed enrollment in the Phase 1b study for GT-02287 in people with Parkinson’s disease regardless of GBA1 status. 21 participants have been enrolled as of September 30, 2025, surpassing original target enrollment of 15 participants. Commenced Phase 1b study extension allowing participants to continue treatment with GT-02287 for a total of 12 months. Eligible participants continue to transition into the study extension to further assess long-term safety and tolerability, functional changes scored according to MDS-UPDRS, and biomarker levels. Hosted a KOL event highlighting current thinking on Parkinson’s disease clinical outcome scales and biomarkers as well as the Company’s initial Phase 1b data. A replay of the event can be found here. Completed an underwritten public offering that resulted in approximately $7.1 million of net proceeds. Upcoming Anticipated Milestones Analysis of functional changes scored according to MDS-UPDRS and biomarker levels in cerebrospinal fluid and blood samples from participants who completed 90 days of the Phase 1b study evaluating GT-02287 in people with Parkinson’s disease expected in the fourth quarter of 2025. IND submission to FDA, expected by year end 2025, facilitating expansion into Phase 2 clinical development of GT-02287 to include clinical sites in the United States. Results from Phase 1b study extension expected the second half of 2026. Q3 2025 Financial Results Research and Development (R&D) expenses increased by $0.2 million to $2.8 million for the three months ended September 30, 2025, as compared to $2.6 million for the three months ended September 30, 2024. The increase in R&D expenses was primarily related to costs associated with the ongoing Phase 1b clinical trial and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. The increase was partially offset by optimization of our pipeline costs and lower research and development personnel costs. General and Administrative (G&A) expenses increased by $0.1 million to $1.9 million for the three months ended September 30, 2025, as compared to $1.8 million for the three months ended September 30, 2024. The increase in G&A expenses for the period was primarily attributable to higher stock-based compensation, higher personnel costs, and unfavorable foreign exchange currency translation as the Swiss franc and Australian dollar strengthened against the U.S. dollar. The increases were partially offset by lower legal and professional fees related to general corporate matters. Net loss for the three months ended September 30, 2025, was $0.15 per share, basic and diluted, compared to $0.17 per share, basic and diluted, for the three months ended September 30, 2024. Cash and cash equivalents were $8.8 million as of September 30, 2025, compared to $10.4 million as of December 31, 2024. About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with an increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which enrolled participants across 7 sites in Australia, is to evaluate the safety and tolerability of GT-02287 after 3 months of dosing in people with Parkinson’s disease. Early observations of exploratory endpoints suggest that GT-02287 has disease-modifying effects consistent with the proposed mechanism of action and seen in preclinical models in vivo. The recently commenced Phase 1b study extension allows participants to continue to be treated with GT-02287 for up to a total of 12 months. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking Statements This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287, including any extension studies; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287, including any extension studies; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors: Gain Therapeutics, Inc. Apaar Jammu Manager, Investor Relations and Public Relations [email protected] LifeSci Advisors LLC Chuck Padala Managing Director [email protected] Media: Russo Partners LLC Nic Johnson and Elio Ambrosio [email protected] [email protected] (760) 846-9256

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. Important highlights during the quarter included earlier-than-anticipated completion of target enrollment for the company’s Phase 1b study evaluating lead candidate GT-02287 in Parkinson’s disease with or without a GBA1 mutation. As a result, Gain expects the analysis of participants’ functional changes scored according to the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and biomarker activity from cerebrospinal fluid at 90 days to be available during 4Q 2025. As of June 30, 2025, a total of 16 patients were enrolled in the Phase 1b study. However, enrollment has been kept open to any participants screened prior to July 31 who meet the criteria for the study. Total enrollment of the Phase 1b is not expected to exceed 20 participants. Additionally, the company recently submitted a request to extend the dosing duration of the Phase 1b study beyond the current 90 days allowable in the original protocol; an update on the status of that request is expected in the coming weeks. “Reaching target enrollment in the Phase 1b study of GT-02287 during 2Q 2025 was an exciting achievement for Gain and we look forward to reporting the analysis of both functional changes and biomarker activity during 4Q 2025, which will go a long way in planning the design of our Phase 2 clinical trial for GT-02287, an effort that has already begun in earnest,” said Gene Mack, President and CEO of Gain. “We are further encouraged by clinicians’ request to extend the screening window for participants by another month and their support to extend the dosing duration for participants in the study who wish to continue beyond the original 90-day dosing duration. We believe extending the dosing duration will also provide additional valuable feedback we can incorporate into our Phase 2 planning.” Mr. Mack continued, “We are thankful not only to the clinicians but to the patients who have continued to express their desire to join this study or carry on as part of a potential dosing extension. The interest we have seen throughout the entirety of this study underscores the significant unmet need for a disease-modifying therapy for Parkinson’s. We believe we are well-positioned to continue executing on our milestones, all with the goal of potentially shifting the treatment paradigm and delivering a life-changing treatment to those that need it.” Second Quarter 2025 and Recent Corporate and Clinical Program Highlights Clinical Program Highlights Presented preclinical data supporting the disease-modifying potential of GT-02287 in GBA1 and idiopathic PD models, including rescue of motor deficits, prevention of deficits in complex behaviors and rescue of biomarker changes that persisted even following withdrawal of GT-02287, at AD/PD 2025 in April 2025 in Vienna, Austria. Presented a poster highlighting the design of the Company’s Phase 1b study to evaluate GT-02287 in people with or without a GBA1 mutation at AD/PD 2025 in April 2025 in Vienna, Austria. Presented preclinical data demonstrating GT-02287’s broader neuroprotective effect on dopaminergic neurons treated with mitochondrial toxin MPP+, importantly suggesting an action on mitochondrial GCase in addition to its improvement of lysosomal GCase activity, at IAPRD 2025 in May 2025 in New York City, NY. Presented update on GT-02287 clinical program at the GBA1 Meeting 2025 in June 2025 in Montreal, Canada. Corporate Updates Completed target enrollment in the Phase 1b study for GT-02287 in people with Parkinson’s disease (PD) regardless of GBA1 status. 16 participants have been enrolled as of June 30, 2025, with full enrollment not expected to exceed 20 participants. Analysis of functional changes and biomarker activity from the Phase 1b study is expected to be available during 4Q 2025. Completed an underwritten public offering that resulted in approximately $7.1 million of net proceeds, extending the current cash runway beyond the completion of the Phase 1b study. Upcoming Anticipated Milestones Analysis of functional changes measured by the Movement Disorder Society Unified Parkinson’s Disease Rating Scale (MDS-UPDRS) and biomarker activity in cerebrospinal fluid and blood samples from participants who completed 90 days of the Phase 1b study evaluating GT-02287 in people with Parkinson’s disease expected 4Q25. Approval from healthcare authorities in Australia to extend the dosing duration for participants in the Phase 1b beyond the 90 days specified under the current protocol. IND submission to FDA expected by year end 2025 facilitating expansion of Phase 2 clinical development for GT-02287 to include clinical sites in the United States. Q2 2025 Financial Results Research and Development (R&D) expenses decreased by $1.7 million to $2.8 million for the three months ended June 30, 2025, as compared to $4.4 million for the three months ended June 30, 2024. The decrease in research and development was primarily related to recognition of research grant income, the research and development tax incentive program tax credit, and optimization of our pipeline costs and R&D personnel. The decrease was partially offset by an increase in stock-based compensation. General and Administrative (G&A) expenses decreased by $1.4 million to $2.3 million for the three months ended June 30, 2025, as compared to $3.7 million for the three months ended June 30, 2024. The decrease in general and administrative expenses for the period was primarily attributable to a decrease in stock-based compensation. The decrease was partially offset by an increase in legal and professional fees relating to general corporate matters. Net loss for the three months ended June 30, 2025, was $0.19 per share, basic and diluted, compared to $0.42 per share, basic and diluted, for the three months ended June 30, 2024. Cash and cash equivalent were $6.7 million as of June 30, 2025, compared to $10.4 million as of December 31, 2024. About GT-02287 Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with a >50% increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which is currently enrolling participants across 7 sites in Australia, is to evaluate the safety and tolerability of GT-02287 after 3 months of dosing in people with Parkinson’s disease. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc. Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking Statements This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors: Gain Therapeutics, Inc. Apaar Jammu Manager, Investor Relations and Public Relations [email protected] LifeSci Advisors LLC Chuck Padala Managing Director [email protected] Media: Russo Partners LLC Nic Johnson and Elio Ambrosio [email protected] [email protected] (760) 846-9256

First Biomarker Analysis from Phase 1b Study of GT-02287 in Parkinson’s Disease Expected Mid-2025 BETHESDA, Md., May 14, 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 March 31, 2025, and provided a corporate update. “The first quarter of 2025 marked yet another exciting milestone for Gain with the first administration of GT-02287, our lead drug candidate in development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation, to participants with Parkinson’s disease in our ongoing Phase 1b study which began enrollment in early March,” said Gene Mack, President and CEO of Gain. “We are encouraged by enrollment of the study to date and expect to complete enrollment by the end of July 2025. In the meantime, we look forward to sharing results from a first biomarker analysis of the study in mid-2025. This readout is of significance as we believe that these observations will further elucidate the mechanism of GT-02287, which we believe goes beyond activation of lysosomal GCase to stabilize and chaperone the enzyme through various cellular compartments where it functions to promote neuroprotection. We look forward to incorporating what we learn from the Phase 1b into our Phase 2 planning for GT-02287 in 2H25. As we progress through the year, we will continue to engage with the FDA and anticipate IND submission by year end.” First Quarter 2025 and Recent Corporate and Clinical Program Highlights Corporate Updates Gene Mack was appointed President and Chief Executive Officer effective January 6, 2025. Prior to the appointment Gene served as Chief Financial Officer from April 2024. Since Mr. Mack’s appointment, Gianluca Fuggetta has assumed the role of Senior Vice President Finance and Principal Financial Officer. Announced formation of a Clinical Advisory Board composed of leading experts in Parkinson’s disease to support the advancement of GT-02287 through late-stage clinical development. including Parkinson’s Initiated enrollment of a Phase 1b study for GT-02287, which is now being administered for the first time to individuals with Parkinson’s disease (PD) regardless of GBA1 status. The open-label study will enroll 15-20 participants with PD either with or without a GBA1 mutation. A first biomarker analysis from the Phase 1b study is expected to be available mid-2025. Expect enrollment to continue through the summer with the initial participants from the study completing a 90-day dosing duration of GT-02287 during the fourth quarter of 2025. Upcoming Anticipated Milestones First biomarker analysis from the Phase 1b study evaluating GT-02287 in people with Parkinson’s disease expected mid-2025. Completion of Phase 1b study expected 4Q25. IND submission to FDA expected by year end 2025. Q1 2025 Financial Results Research and Development (R&D) expenses decreased by $0.2 million to $2.3 million for the three months ended March 31, 2025, as compared to $2.5 million for the three months ended March 31, 2024. The decrease in research and development expenses was primarily related to recognition of research grant income, a tax rebate in Australia, and optimization of pipeline cost. General and Administrative (G&A) expenses increased by $0.2 million to $2.1 million for the three months ended March 31, 2025, as compared to $1.9 million for the three months ended March 31, 2024. The increase in general and administrative expenses for the period was primarily attributable to an increase in legal and professional fees related to general corporate matters. Net loss for the three months ended March 31, 2025, was $0.16 per share, basic and diluted, compared to $0.22 per share, basic and diluted, for the three months ended March 31, 2024. Cash, cash equivalent and marketable securities were $9.1 million as of March 31, 2025, compared to $10.4 million as of December 31, 2024. About GT-02287Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced ER stress, lysosomal and mitochondrial pathology, aggregated α-synuclein, neuroinflammation and neuronal death, as well as plasma neurofilament light chain (NfL) levels, a biomarker of neurodegeneration. In rodent models of both GBA1-PD and idiopathic PD, GT-02287 was shown to rescue deficits in motor function and gait and prevent the development of deficits in complex behaviors such as nesting. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma and CNS exposures in the projected therapeutic range, and target engagement with a >50% increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses. GT-02287 is currently being evaluated in a Phase 1b clinical trial for the treatment of Parkinson’s disease with or without a GBA1 mutation. The primary endpoint of the trial, which is currently enrolling participants across 7 sites in Australia, is to evaluate the safety and tolerability of GT-02287 after 3 months of dosing in people with Parkinson’s disease. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc.Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation in a Phase 1b clinical trial. GT-02287 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. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking StatementsThis release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the completion and timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether because of new information, future events or otherwise. Investors:Gain Therapeutics, Inc. Apaar Jammu Manager, Investor Relations and Public [email protected] LifeSci Advisors LLCChuck PadalaManaging [email protected] Media:Russo Partners LLC Nic Johnson and Elio [email protected]@russopartnersllc.com(760) 846-9256

First Analysis from Phase 1b Study of GT-02287 in Parkinson’s Disease Expected in Q2 2025 BETHESDA, Md., March 27, 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 fourth quarter and year ended December 31, 2024, and provided a corporate update. “2024 was a year of significant progress for Gain, as we made important advancements related to both the scientific understanding and clinical development of our lead candidate GT-02287, in development for the treatment of Parkinson’s disease with or without GBA1 mutation,” said Gene Mack, President and CEO of Gain. “Building upon this momentum in 2025, we have recently initiated dosing in our Phase 1b trial of GT-02287 and look forward to sharing results from a first analysis of the study anticipated for the end of the second quarter of 2025. We believe the observations from this analysis will mark a significant value inflection point for the GT-02287 program and importantly, inform the planning of our Phase 2 study during the second half of 2025. At the same time, we are working towards expanding GT-02287 clinical development to the U.S. and continue to have productive dialogue with the FDA. We look forward to providing continued updates on our progress as we aim to achieve these milestones throughout the year.” Fourth Quarter 2024 and Recent Corporate Highlights Pipeline Updates First participant dosed in the Phase 1b trial of GT-02287 in Parkinson’s disease. First analysis is anticipated at the end of the second quarter 2025. Presented new clinical data from a Phase 1 study of GT-02287 in healthy volunteers that demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement with a statistically significant >50% increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses during the Michael J. Fox Foundation’s 16th Annual Parkinson’s Disease Therapeutics Conference in October 2024 in New York, NY. Presented preclinical data elucidating a broader impact on the biology of Parkinson’s disease than was previously understood to be associated with GT-02287 stabilization and modulation of GCase, including important observations of its role in supporting mitochondrial health at the Society for Neuroscience 2024 conference in October 2024 in Chicago, IL. Presented a poster highlighting the use of the Company’s Magellan™ drug discovery platform to identify allosteric inhibitors targeting discoidin domain receptor 2 at the 36th EORTC-NCI-AACR Symposium in October 2024 in Barcelona, Spain. Corporate Updates Gene Mack was appointed President and Chief Executive Officer effective January 6, 2025. Gianluca Fuggetta assumed the role of Senior Vice President Finance and Principal Financial Officer. Announced formation of Clinical Advisory Board composed of leading experts in Parkinson’s disease to support the advancement of GT-02287 through late-stage clinical development. Commenced pre-Investigational New Drug (IND) engagement with U.S. Food and Drug Administration (FDA) in preparation for expansion of GT-02287 Phase 2 clinical development to include the United States. Upcoming Anticipated Milestones First analysis from Phase 1b trial evaluating GT-02287 in Parkinson’s disease patients expected at the end of Q2 2025. IND submission to FDA expected by year end 2025. Year End 2024 Financial Results Research and development (R&D) expenses decreased by $0.7 million to $10.8 million for year ended December 31, 2024, as compared to $11.5 million for the year ended December 31, 2023. The decrease in research and development expenses was primarily related to higher recognition of research grant income principally comprised of a tax credit for eligible research and development expenses in Australia. These increases were partially offset by higher costs during 2024 associated with the Phase 1 clinical trial of the Company’s lead program compound GT-02287 for the treatment of Parkinson’s disease. General and administrative (G&A) expenses decreased by $1.2 million to $9.6 million for the year ended December 31, 2024, as compared to $10.8 million for the year ended December 31, 2023. The decrease in general and administrative expenses was primarily attributable to lower personnel and stock-based compensation costs. Net loss for the year ended December 31, 2024, was $20.4 million, or $0.89 per share, basic and diluted, compared to $22.3 million, or $1.71 per share, basic and diluted, for the year ended December 31, 2023. The decrease in net loss for 2024 compared to 2023 was primarilyattributable to decreases in R&D expenses of $0.7 million and G&A expenses of $1.2 million. Cash, cash equivalent and marketable securities were $10.4 million as of December 31, 2024, compared to $16.8 million as of December 31, 2023. About GT-02287Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker of neurodegeneration. Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease. Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency. About Gain Therapeutics, Inc.Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme. Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology. Forward-Looking StatementsThis release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise. Investor Contacts:Apaar Jammu and Chuck [email protected]@lifesciadvisors.com Media Contacts:Russo PartnersNic Johnson and Elio [email protected]@russopartnersllc.com(760) 846-9256