1. - Conference Dates: September 20th-23rd -

    BETHESDA, Md., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit and invites investors to participate via webcast and in one-on-one meetings. Please see additional details below:

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date:Wednesday, September 22nd
    Time: 1:15 to 1:55 p.m. ET
    Presenter: Eric Richman, Chief

    - Conference Dates: September 20th-23rd -

    BETHESDA, Md., Sept. 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present at the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit and invites investors to participate via webcast and in one-on-one meetings. Please see additional details below:

    Oppenheimer Fall Healthcare Life Sciences & MedTech Summit
    Date:Wednesday, September 22nd
    Time: 1:15 to 1:55 p.m. ET
    Presenter: Eric Richman, Chief Executive Officer
    Webcast: Registration Link – Click Here
     * a replay will be available following the presentation for 90 days

    Please contact your representative at Oppenheimer & Co. to schedule a virtual one-on-one meeting with Gain Therapeutics during the respective conference.

    For more information about the Oppenheimer Fall Healthcare Life Sciences & MedTech Summit, please refer to the conference website.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is positioned at the confluence of technology and healthcare and focused on redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.



    For more information, please visit https://www.gaintherapeutics.com

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates, and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate and manage its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com



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  2. BETHESDA, Md., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Manolo Bellotto, Ph.D., General Manager and President at Gain, will present an overview on the Company's proprietary Structurally Targeted Allosteric Regulators (STARs) for GM1 Gangliosidosis and Morquio B Disease.

    GM1 Virtual Community Conference

    Date:Tuesday, September 14th
    Time:2:00pm PT/5:00pm ET
    Presenter:Manolo Bellotto, Ph.D., General Manager and President

    To register to attend the conference visit https://registration.socio.events/e/gm1

    BETHESDA, Md., Sept. 09, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Manolo Bellotto, Ph.D., General Manager and President at Gain, will present an overview on the Company's proprietary Structurally Targeted Allosteric Regulators (STARs) for GM1 Gangliosidosis and Morquio B Disease.

    GM1 Virtual Community Conference

    Date:Tuesday, September 14th
    Time:2:00pm PT/5:00pm ET
    Presenter:Manolo Bellotto, Ph.D., General Manager and President

    To register to attend the conference visit https://registration.socio.events/e/gm1

    Morquio B, also known as Mucopolysaccharidosis type IV (MPS IV), is a progressive disease mostly impacting the skeleton, caused by mutations in GLB1, the gene that encodes the beta-galactosidase (GLB) enzyme. GM1 Gangliosidosis is a hereditary, progressive disease mostly impacting neurons in the brain and spinal cord, caused by mutations in GLB1. In both diseases, these mutations result in the misfolding and subsequent dysfunction of GLB, which leads to toxic substrate accumulation in organs and tissues. Gain is developing allosteric regulators that are designed to decrease toxic substrate accumulation in organs and tissues of patients with Morquio B and GM1 Gangliosidosis in order to potentially provide the first treatment approach for the disease's neurological symptoms.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is positioned at the confluence of technology and healthcare and focused on redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.

    For more information, please visit https://www.gaintherapeutics.com

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates, and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate and manage its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com



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  3. GT-02287and GT-02329 compounds display positive effects on GCase activity and related parameters
    --- 
    Study results demonstrate an increase in GCase protein levels with transport to the lysosomes and decrease of glucosylceramide and α-synuclein-p129 levels 
    --- 
    Comprehensive study results to be presented at Michael J. Fox Foundation's upcoming Innovating from Drug Discovery to the Clinic: Novel Approaches to PD Therapeutic Development webinar 
    --- 
    IND-initiating study planned for Q4'21

    BETHESDA, Md., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal…

    GT-02287and GT-02329 compounds display positive effects on GCase activity and related parameters

    --- 

    Study results demonstrate an increase in GCase protein levels with transport to the lysosomes and decrease of glucosylceramide and α-synuclein-p129 levels 

    --- 

    Comprehensive study results to be presented at Michael J. Fox Foundation's upcoming Innovating from Drug Discovery to the Clinic: Novel Approaches to PD Therapeutic Development webinar 

    --- 

    IND-initiating study planned for Q4'21

    BETHESDA, Md., Sept. 08, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced topline data from the Company's study, conducted at the University of Maryland School of Medicine (UMSOM). The study, evaluating two lead Structurally Targeted Allosteric Regulators (STARs) compounds – GT-02287 and GT-02329 – for the treatment of Gaucher and GBA1 Parkinson's Disease, demonstrated positive effects on all tested phenotypes.

    Ricardo Feldman, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, stated, "Our laboratory is using human induced pluripotent stem cells (iPSC) derived from patients with GD and GBA-associated Parkinson's disease to test the efficacy of the two lead STAR chaperones developed by Gain Therapeutics. Our studies in iPSC-derived cortical and dopaminergic neurons from neuronopathic Gaucher Disease patients show that these compounds increase the levels of GCase protein, its transport to the lysosome, and its enzymatic activity. In dopaminergic neurons, the two lead STAR chaperones also decrease the levels of α-synuclein-p129, demonstrating their potential to treat GBA1-associated Parkinson's Disease."

    "These data are extremely exciting, as it further demonstrates the potential of GT-02287 and GT-02329 and expands the body of evidence supporting our Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) drug discovery platform," said Eric Richman, Chief Executive Officer of Gain. "We plan to fully evaluate the results of this study and present a complete data set on the upcoming

    Michael J. Fox Foundation's Innovating from Drug Discovery to the Clinic: Novel Approaches to PD Therapeutic Development webinar. In addition, we anticipate initiating IND-enabling studies for Gaucher / Parkinson's Disease in the fourth quarter of this year."

    Gain identified the two lead STAR candidates (GT-02287 and GT-02329) through its proprietary SEE-Tx™ platform. The compounds were characterized in assays to potentially help Parkinson's patients with GBA1 gene mutations as well as patients whose glucocerebrosidase (GCase) protein is misfolded due to ageing cellular processes. This previous work was supported through grants from The Michael J. Fox Foundation (MJFF) and the Silverstein Foundation for Parkinson's with GBA.

    Mutations in GBA1, the gene encoding the lysosomal enzyme GCase, are among the most commonly known genetic risk factors for the development of Parkinson's Disease and related synucleinopathies. GBA1 mutations are causative for the rare autosomal storage disorder Gaucher Disease and may lead to degradation of the protein, disruptions in lysosomal targeting and diminished performance of the enzyme in the lysosome. Patients with Gaucher Disease including heterozygous carriers are at increased risk of developing Parkinson's Disease and Dementia with Lewy Bodies.

    The study conducted in collaboration with Ricardo A. Feldman, Ph.D., Associate Professor of Microbiology and Immunology at UMSOM and lead investigator, is using human induced pluripotent stem cells (iPSC) for Gaucher and Parkinson's Disease modeling and drug discovery. Gain's candidate molecules GT-02287 and GT-02329 have been initially assessed in this unique "disease-in-a-dish" iPSC model derived from Gaucher type 2 and 3 patient cells.

    Topline data from collaboration with University of Maryland School of Medicine on GBA-associated Parkinson's Disease in iPSC model. The two STAR compounds achieved the following results:

    • Displayed positive effects on key biological read-outs such as GCase activity, GCase protein levels, GCase transport to the lysosomes, glucosylceramide and depletion of P-alpha-synuclein: all parameters that are related to disease onset and progression
    • Increased GCase enzyme activity
    • Increased GCase protein levels and transport to the lysosome in cortical neurons
    • Decreased GluCer accumulation in cortical neurons
    • Increased GCase protein levels and transport to the lysosome in dopaminergic neurons
    • Decreased α-synuclein-p129 levels in dopaminergic neurons

    "We appreciate the close collaboration with Dr. Feldman and the University of Maryland School of Medicine in this important area of research," said Manolo Bellotto, Ph.D., General Manager at Gain. "The topline data demonstrates that our STARs compounds open a new potential approach for direct treatment of GBA1 Parkinson's Disease by guiding misfolded forms of the GCase enzyme to their proper shape and restoring enzymatic activity. This is an exciting validation of our platform technology and a promising potential therapeutic opportunity for patients suffering from these debilitating diseases."

    The combined data from Gain Therapeutics and Dr. Feldman's laboratory suggest that STARs bind to novel allosteric binding sites identified using Gain's proprietary SEE-Tx™ drug discovery platform, stabilize, and restore enzymatic activity to misfolded GCase. In these studies, the restoration of GCase activity resulted in the depletion of the toxic phosphorylated and aggregated forms of α-synuclein and a reversal of the neurodegenerative process resulting in improved locomotor activity in Parkinson's Disease model in rats. Given that STARs are small molecule therapies, they have significant advantages over the current standard of care for disorders associated with protein misfolding, including most enzyme replacement therapies and gene therapies. They can be administered as a simple oral pill and can reach organs and tissues not typically accessible through current therapeutic options, including the brain, bone and cartilage. As well, the Company believes that STARs are relatively easy and cost-effective to manufacture.

    "These encouraging results show promise for this approach to correct dysfunction in the GBA1 pathway, a leading target for Parkinson's drug development," said Marco Baptista, PhD, MJFF Vice President of Research Programs. "We look forward to hearing more on next steps to advance these potential therapies further in testing and closer to patients whose greatest unmet need is a treatment to slow or stop disease progression."

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is positioned at the confluence of technology and healthcare and focused on redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.



    For more information, please visit https://www.gaintherapeutics.com

    About the University of Maryland School of Medicine

    Now in its third century, the University of Maryland School of Medicine was chartered in 1807 as the first public medical school in the United States. It continues today as one of the fastest growing, top-tier biomedical research enterprises in the world -- with 46 academic departments, centers, institutes, and programs, and a faculty of more than 3,000 physicians, scientists, and allied health professionals, including members of the National Academy of Medicine and the National Academy of Sciences, and a distinguished two-time winner of the Albert E. Lasker Award in Medical Research. With an operating budget of more than $1.2 billion, the School of Medicine works closely in partnership with the University of Maryland Medical Center and Medical System to provide research-intensive, academic and clinically based care for nearly 2 million patients each year. The School of Medicine has nearly $600 million in extramural funding, with most of its academic departments highly ranked among all medical schools in the nation in research funding. As one of the seven professional schools that make up the University of Maryland, Baltimore campus, the School of Medicine has a total population of nearly 9,000 faculty and staff, including 2,500 student trainees, residents, and fellows. The combined School of Medicine and Medical System ("University of Maryland Medicine") has an annual budget of over $6 billion and an economic impact of nearly $20 billion on the state and local community. The School of Medicine, which ranks as the 8th highest among public medical schools in research productivity (according to the Association of American Medical Colleges profile) is an innovator in translational medicine, with 606 active patents and 52 start-up companies. In the latest U.S. News & World Report ranking of the Best Medical Schools, published in 2021, the UM School of Medicine is ranked #9 among the 92 public medical schools in the U.S., and in the top 15 percent (#27) of all 192 public and private U.S. medical schools. The School of Medicine works locally, nationally, and globally, with research and treatment facilities in 36 countries around the world. Visit medschool.umaryland.edu. To learn more about Dr. Feldman's research visit https://www.medschool.umaryland.edu/profiles/Feldman-Ricardo/

    About The Michael J. Fox Foundation for Parkinson's Research

    As the world's largest nonprofit funder of Parkinson's research, The Michael J. Fox Foundation is dedicated to accelerating a cure for Parkinson's disease and improved therapies for those living with the condition today. The Foundation pursues its goals through an aggressively funded, highly targeted research program coupled with active global engagement of scientists, Parkinson's patients, business leaders, clinical trial participants, donors and volunteers. In addition to funding $1 billion in research to date, the Foundation has fundamentally altered the trajectory of progress toward a cure. Operating at the hub of worldwide Parkinson's research, the Foundation forges groundbreaking collaborations with industry leaders, academic scientists and government research funders; increases the flow of participants into Parkinson's disease clinical trials with its online tool, Fox Trial Finder; promotes Parkinson's awareness through high-profile advocacy, events and outreach; and coordinates the grassroots involvement of thousands of Team Fox members around the world. For more information, visit us on at https://www.michaeljfox.org.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates, and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate and manage its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com



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  4. BETHESDA, Md., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually from September 13th - 15th.

    An on-demand corporate presentation will be accessible to conference attendees starting on Monday, September 13th at 7:00 am ET for 90 days after the event.

    Eric Richman, Chief Executive Officer and Salvatore Calabrese, Chief Financial Officer, will be…

    BETHESDA, Md., Sept. 02, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites never before targeted in neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present at the H.C. Wainwright 23rd Annual Global Investment Conference being held virtually from September 13th - 15th.

    An on-demand corporate presentation will be accessible to conference attendees starting on Monday, September 13th at 7:00 am ET for 90 days after the event.

    Eric Richman, Chief Executive Officer and Salvatore Calabrese, Chief Financial Officer, will be scheduling virtual 1x1 meetings and encourage investors to schedule a time during the conference. If you are interested in arranging a one-on-one meeting, please contact your H.C. Wainwright representative.

    For more information about the 23rd Annual Global Investment Conference, please visit the H.C. Wainwright conference website https://hcwevents.com/annualconference/

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is positioned at the confluence of technology and healthcare and focused on redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.



    For more information, please visit https://www.gaintherapeutics.com/

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates, and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate and manage its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com



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  5. GANX)" src="https://www.getnews.info/wp-content/uploads/2021/08/1629652289.png" alt="Strong Cash Position of $43.2 Million Provides Runway into 2nd half of 2023 to Advance the Company’s Programs for Gain Therapeutics, Inc. (NASDAQ:GANX)" width="225" height="117" />
    • Two Patents on Modulator Compounds for Treatment of CNS Disorders.

    • Initial Public Offering Raised $46 Million in Gross Proceeds.

    • Agreement with Zentalis Pharmaceuticals for New Cancer Treatments. 

    • Four New Independent BOD Members to Strengthen Leadership Team.

    • Expects to Complete Proof of Concept Studies and Begin IND-enabling Trials in the Second Half of 2021. 


    Gain Therapeutics, Inc. (NASDAQ:
    GANX) is redefining drug discovery with its SEE-Tx™ target identification platform.

    GANX)" src="https://www.getnews.info/wp-content/uploads/2021/08/1629652289.png" alt="Strong Cash Position of $43.2 Million Provides Runway into 2nd half of 2023 to Advance the Company’s Programs for Gain Therapeutics, Inc. (NASDAQ:GANX)" width="225" height="117" />
    • Two Patents on Modulator Compounds for Treatment of CNS Disorders.

    • Initial Public Offering Raised $46 Million in Gross Proceeds.

    • Agreement with Zentalis Pharmaceuticals for New Cancer Treatments. 

    • Four New Independent BOD Members to Strengthen Leadership Team.

    • Expects to Complete Proof of Concept Studies and Begin IND-enabling Trials in the Second Half of 2021. 


    Gain Therapeutics, Inc. (NASDAQ:
    GANX) is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, GANX is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. 

    GANX was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. 

    •  Granted Two New PCT Patents Covering GBA and GLAC Modulator Compounds for Treatment of CNS Disorders 


    GANX
    a biotechnology company focused on identifying and optimizing allosteric binding sites that have never been targeted in neurodegenerative diseases and lysosomal storage disorders, today announced its financial results as of and for the second quarter of June 30, 2021, and highlighted recent corporate accomplishments.

    Eric Richman, Chief Executive Officer of Gain, added, “We are pleased with the progress in advancing our preclinical compounds to the clinic and announced important and compelling data related to our GBA Parkinson’s program. Our SEE-Tx supercomputing platform technology designed to identify novel allosteric binding sites on misfolded proteins continues to meet objectives within our internal pipeline and our external pharmaceutical partnerships. We continue to advance our pipeline towards achieving our mission in redefining drug discovery and developing novel therapies for devastating conditions with significant unmet medical need.”

    Business and Recent Developments

    • Expansion of Intellectual Property Portfolio. GAIN continues to expand its intellectual property portfolio and in June announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson’s Disease, Lewy body dementia and Alzheimer’s Disease.

    • Signed Multi-Target Drug Discovery Collaboration with Zentalis Pharmaceuticals in April to discover new product candidates for the treatment of cancer. The Company will utilize its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. The intended deliverables are newly discovered targets or target protein interactions that can then be drugged for therapeutic benefit to intervene on protein misfolding.

    • Presented at the 26th International Association of Parkinsonism & Related Disorders (IAPRD) World Congress in May. Awarded top 10 best abstract, the presentation highlighted both in vitro & in vivo pre-clinical data demonstrating the potential of STAR compounds for the treatment of GBA1 Parkinson’s Disease. Through partnerships with the Michael J. Fox Foundation and the Silverstein Foundation for Parkinson’s with GBA, GAIN identified two STAR lead candidates (GT-02287 and GT-02329) that can potentially help Parkinson’s patients with GBA1 gene mutations as well as patients whose GCase protein is misfolded due to ageing cellular processes.

    • Expansion of the leadership team. In June, Terenzio Ignoni Pharm.D., joined the leadership team as SVP Quality and CMC overseeing all manufacturing operations, global CMC regulatory developments, and quality. Dr. Ignoni joins the Company with more than 20 years of experience in the biopharma industry, holding senior positions in multinational pharmaceutical companies including Jazz Pharmaceuticals, Gentium, Vicuron, and Zambon Group.

    • Strong cash position to advance the Company’s programs. As of June 30, 2021, the Company’s cash position was $43.16 million, compared to $7.49 million as of December 31, 2020.


    Upcoming 2021 & 2022 Milestones

    • New Data Release – Top line data from collaboration with University of Maryland School of Medicine on GBA-associated Parkinson’s Disease in IPSC model.

    • Industry Conference – Full data from collaboration with University of Maryland School of Medicine on GBA-associated Parkinson’s Disease.

    • Initiate IND-enabling studies 2021 – Gaucher’s / Parkinson’s Disease.


    Activity of GBA and GALC Enzymes Play Key Roles in the Neurodegenerative Diseases and Lysosomal Storage Diseases

    On June 10thGANX announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson’s Disease, Lewy body dementia, and Alzheimer’s.

    The GANX patent PCT/IB2020/061158 covers compounds and therapeutic uses of conditions associated with the alteration of Beta-glucocerebrosidase (GBA). These conditions include Gaucher Disease, Parkinson’s Disease, and other Lewy body disorders including Alzheimer’s Disease and amyotrophic lateral sclerosis (ALS).

    The GANX patent PCT/IB2020/0611156 covers compounds and therapeutic uses of conditions associated with the alteration of galactosylceramidase (GALC). These conditions include lysosomal storage diseases and other demyelinating diseases, such as Krabbe Disease, Lewy body dementia, Multiple Sclerosis, and peripheral neuropathy.

    For more information on Gain Therapeutics, Inc. (NASDAQ: GANX) visit https://www.gaintherapeutics.com/

    DISCLAIMER:

    CAP/FrontPageStocks/CorporateAds.com (CA) is a third-party publisher and news dissemination service provider. CAP/FPS/CA is NOT affiliated in any manner with any company mentioned herein. CAP/FPS/CA is a news dissemination solutions provider and is NOT a registered broker/dealer/analyst/adviser, holds no investment licenses, and may NOT sell, offer to sell or offer to buy any security. CAP/FPS/CA’s market updates, news alerts, and corporate profiles are NOT a solicitation or recommendation to buy, sell or hold securities. The material in this release is intended to be strictly informational and is NEVER to be construed or interpreted as research material. All readers are strongly urged to perform research and due diligence on their own and consult a licensed financial professional before considering any level of investing in stocks. All material included herein is republished content and details which were previously disseminated by the companies mentioned in this release or opinion of the writer. CAP/FPS/ CA is not liable for any investment decisions by its readers or subscribers. Investors are cautioned that they may lose all or a portion of their investment when investing in stocks. CAP/FPS/CA has been compensated $500 by a third party for dissemination of this article.

    Disclaimer/Safe Harbor:

    These news releases and postings may contain forward-looking statements within the meaning of the Securities Litigation Reform Act. The statements reflect the Company’s current views with respect to future events that involve risks and uncertainties. Among others, these risks include the expectation that any of the companies mentioned herein will achieve significant sales, the failure to meet schedule or performance requirements of the companies’ contracts, the companies’ liquidity position, the companies’ ability to obtain new contracts, the emergence of competitors with greater financial resources and the impact of competitive pricing. In the light of these uncertainties, the forward-looking events referred to in this release might not occur.

    Media Contact
    Company Name: GAIN THERAPEUTICS, INC
    Contact Person: CEO: Eric I. Richman
    Email: Send Email
    Phone: (301) 500-1556
    Address:4800 Hampden Lane Suite 200
    City: Bethesda
    State: MD 37219
    Country: United States
    Website: https://www.gaintherapeutics.com/

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  6. Announced Multi-Target Drug Discovery Collaboration with Zentalis Pharmaceuticals in Oncology
    ---
    Granted Two Patents for Compounds that Stabilize G-Case for Gaucher's Disease and other Synucleinopathies including Parkinson's Disease, Lewy Body Dementia and Alzheimer's Disease
    ---
    $43.2 Million in Cash as of June 30, 2021, Provides Runway into Second half of 2023 and a Strong Cash Position to Advance the Company's Programs

    BETHESDA, Md., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites that have never been targeted in neurodegenerative diseases and lysosomal storage disorders, today announced its financial…

    Announced Multi-Target Drug Discovery Collaboration with Zentalis Pharmaceuticals in Oncology

    ---

    Granted Two Patents for Compounds that Stabilize G-Case for Gaucher's Disease and other Synucleinopathies including Parkinson's Disease, Lewy Body Dementia and Alzheimer's Disease

    ---

    $43.2 Million in Cash as of June 30, 2021, Provides Runway into Second half of 2023 and a Strong Cash Position to Advance the Company's Programs

    BETHESDA, Md., Aug. 11, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on identifying and optimizing allosteric binding sites that have never been targeted in neurodegenerative diseases and lysosomal storage disorders, today announced its financial results as of and for the second quarter June 30, 2021 and highlighted recent corporate accomplishments.

    Eric Richman, Chief Executive Officer of Gain, added, "We are pleased with the progress in advancing our preclinical compounds to the clinic and announced important and compelling data related to our GBA Parkinson's program. Our SEE-Tx supercomputing platform technology designed to identify novel allosteric binding sites on misfolded proteins continues to meet objectives within our internal pipeline and our external pharmaceutical partnerships. We continue to advance our pipeline towards achieving our mission in redefining drug discovery and developing novel therapies for devastating conditions with significant unmet medical need."

    Business and Recent Developments

    • Expansion of Intellectual Property Portfolio. GAIN continues to expand its intellectual property portfolio and in June announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson's Disease, Lewy body dementia and Alzheimer's Disease.

    • Signed Multi-Target Drug Discovery Collaboration with Zentalis Pharmaceuticals in April to discover new product candidates for the treatment of cancer. The Company will utilize its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. The intended deliverables are newly discovered targets or target protein interactions that can then be drugged for therapeutic benefit to intervene on protein misfolding.
    • Presented at the 26th International Association of Parkinsonism & Related Disorders (IAPRD) World Congress in May. Awarded top 10 best abstract, the presentation highlighted both in vitro & in vivo pre-clinical data demonstrating the potential of STAR compounds for the treatment of GBA1 Parkinson's Disease. Through partnerships with the Michael J. Fox Foundation and the Silverstein Foundation for Parkinson's with GBA, GAIN identified two STAR lead candidates (GT-02287 and GT-02329) that can potentially help Parkinson's patients with GBA1 gene mutations as well as patients whose GCase protein is misfolded due to ageing cellular processes.
    • Expansion of the leadership team. In June, Terenzio Ignoni Pharm.D., joined the leadership team as SVP Quality and CMC overseeing all manufacturing operations, global CMC regulatory developments, and quality. Dr. Ignoni joins the Company with more than 20 years of experience in the biopharma industry, holding senior positions in multinational pharmaceutical companies including Jazz Pharmaceuticals, Gentium, Vicuron and Zambon Group.

    • Strong cash position to advance the Company's programs. As of June 30, 2021, the Company's cash position was $43.16 million, compared to $7.49 million as of December 31, 2020.

    Upcoming 2021 & 2022 Milestones

    • New Data Release – Top line data from collaboration with University of Maryland School of Medicine on GBA-associated Parkinson's Disease in IPSC model.
    • Industry Conference - Full data from collaboration with University of Maryland School of Medicine on GBA-associated Parkinson's Disease.
    • Initiate IND-enabling studies 2021 - Gaucher's / Parkinson's Disease.

    Financial Results

    For the second quarter ended June 30, 2021, as compared to the second quarter ended June 30, 2020:

    • Revenues were $89 thousand compared to $7 thousand
    • Research and development expenses were $1,794 thousand compared to $439 thousand
    • General and administrative expenses were $1,810 thousand compared to $100 thousand
    • Total operating expenses increased to $3,604 thousand, which include the impact of non-cash stock-based compensation and warrants for $536 thousand, compared to $539 thousand
    • Net loss was $3,557 thousand compared to $543 thousand
    • GAAP basic and diluted net loss per share was $0.30, compared to basic and diluted net loss per share of $0.27

    Revenues were $89 thousand for the three-month period ended June 30, 2021 compared to $7 thousand for the same period of 2020. The increase was primarily attributable to program initiation fees and development services on the first target development program identified under the collaboration agreement with Zentalis Pharmaceuticals.

    Research and development expenses of $1,794 thousand for the three-month period ended June 30, 2021 compared to $439 thousand for the same period of 2020, an increase of $1,355 thousand. The increase in research and development expenses was primarily driven by increased program development activities related to the advancement of the Company's pre-clinical pipeline, as well as increased personnel-related costs resulting from an increase in employee headcount, which includes the impact of non-cash stock-based compensation.

    General and administrative expenses were $1,810 thousand for the three-month period ended June 30, 2021 compared to $100 thousand for the same period of 2020, an increase of $1,710 thousand. This increase was primarily due to an increase in personnel-related costs resulting from an increase in employee headcount, which includes the impact of non-cash stock-based compensation, warrants, increase in expenses for legal fees relating to patent and corporate matters, professional fees for accounting and investor relations as we continue to expand our business and build management infrastructure.

    As a result of the above, net loss was $3,557 thousand, or ($.30) per share basic and diluted, for the three-month period ended June 30, 2021, compared to $543 thousand or ($.27) per share basic and diluted, for the same period of 2020. The increase in net loss was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    Cash and cash equivalents were $43.16 million as of June 30, 2021 compared to $7.49 million at December 31, 2020. The increase was primarily the result of the completion of the Company's initial public offering, from which the Company received aggregate net proceeds of $42.6 million offset by net cash used in operating, investing and payment of deferred offering cost for $6.93 thousand.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is positioned at the confluence of technology and healthcare and focused on redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.



    For more information, please visit https://www.gaintherapeutics.com

    Cautionary Note Regarding Forward-Looking Statements 

    This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the Securities and Exchange Commission on May 5 2021, as well as other documents that may be filed by the Company from time to time.

    New risks and uncertainties arise over time, and it is not possible for us to predict all such factors or how they may affect us. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We are under no duty to update any of these forward-looking statements after the date of this earnings release to conform these statements to actual results or revised expectations. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this earnings release.



    Gain Therapeutics, Inc.
    CONSOLIDATED BALANCE SHEETS (unaudited)
           
       June 30,   December 31, 
      2021 2020
    Assets      
    Current assets:      
    Cash and cash equivalents $43,162,583  $7,492,910 
    Restricted cash  10,969   11,371 
    Accounts receivable  353,166   8,548 
    Prepaid expenses and other current assets  808,456   257,011 
    Deferred offering costs $-  $1,217,988 
    Total current assets $44,335,174  $ 8,987,828 
           
    Non-current assets:      
    Property and equipment, net  75,063   29,633 
    Internal-use software  19,357   - 
    Operating lease - right of use assets  812,410   523,080 
    Restricted cash  31,100   - 
    Long-term deposits and other non-current assets  79,924   63,817 
    Total non-current assets $1,017,854  $616,530 
    Total Assets $45,353,028  $ 9,604,358 
           
    Current liabilities:      
    Accounts payable  978,393   961,516 
    Operating lease liability - current  181,306   122,756 
    Other current liabilities  848,343   767,380 
    Tax provision  6,837   1,070 
    Deferred income  370,518   239,483 
    Loans - short term $65,474  $22,626 
    Total current liabilities $2,450,871  $ 2,114,831 
           
    Non-current liabilities:      
    Defined benefit pension plan  235,690   171,558 
    Operating lease liability - non-current  630,902   400,324 
    Loans - long term $646,661  $715,656 
    Total non-current liabilities $1,513,253  $ 1,287,538 
           
    Stockholders' equity      
    Series A Preferred Stock, $0.0001 par value: nil and 1,185,879 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  -   118 
    Series B Preferred Stock, $0.0001 par value: nil and 2,965,600 shares issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  -   297 
    Common Stock, $0.0001 par value: 11,876,460 and 7,694,642 issued and outstanding as of June 30, 2021 and December 31, 2020, respectively  1,188   354 
    Additional paid-in capital  54,593,827   13,388,771 
    Accumulated other comprehensive loss  (164,118)  (152,698)
    Accumulated deficit  (7,034,853)  (3,457,171)
    Loss of the period  (6,007,140)  (3,577,682)
    Total Stockholders' equity $41,388,904  $ 6,201,989 
    Total Liabilities and Stockholders' equity $45,353,028   $ 9,604,358 





    Gain Therapeutics, Inc
    CONSOLIDATED STATEMENTS OF OPERATIONS
    (unaudited)
                 
      Three Months Ended June 30,  Six Months Ended June 30, 
       2021 2020  2021  2020
    Revenues:            
    Collaboration revenues  81,617   -   81,617   - 
    Other income  7,556   6,773   12,824   13,047 
    Total revenues $89,173  $6,773  $94,441  $13,047 
                 
    Operating expenses:            
    Research and development  (1,793,508)  (438,868)  (3,215,018)  (856,127)
    General and administrative  (1,810,228)  (99,970)  (2,860,903)  (201,644)
    Total operating expenses  (3,603,736)  (538,838)  (6,075,921)  (1,057,771)
                 
    Loss from operations $(3,514,563) $(532,465) $(5,981,480) $(1,044,724)
                 
    Other income (expense):            
    Interest income/(expenses), net  5.901   (1,517)  7,310   (3,265)
    Foreign exchange loss, net  (44,371)  (4,857)  (25,832)  (73,771)
    Loss before income tax $(3,553,033) $(538,839) $(6,000,002) $(1,121,760)
                 
    Income tax  (3,660)  (4,523)  (7,138)  (5,870)
                 
    Net Loss $(3,556,693) $(543,362) $(6,007,140) $(1,127,630)
                 
    Net loss per shares:            
    Net loss per share attributable to common stockholders - basic and diluted $(0.30) $(0.27) $(0.71) $(0.57)
    Weighted average common shares - basic and diluted  11,876,460   1,981,765   8,431,410   1,981,765 
                     

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com



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  7. BETHESDA, Md., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing novel allosteric binding sites on proteins responsible for neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the BTIG Virtual Biotechnology Conference being held on August 9 – 10.

    BTIG Virtual Biotechnology Conference
    Date: Monday, August 9TH
    Time:11:30 to 11:55 a.m. ET
    Presenter:Eric Richman, Chief Executive Officer

    Please contact your BTIG representative to listen to the live event and schedule a virtual one-on-one meeting with Gain's…

    BETHESDA, Md., Aug. 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing novel allosteric binding sites on proteins responsible for neurodegenerative diseases and lysosomal storage disorders, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the BTIG Virtual Biotechnology Conference being held on August 9 – 10.

    BTIG Virtual Biotechnology Conference
    Date: Monday, August 9TH
    Time:11:30 to 11:55 a.m. ET
    Presenter:Eric Richman, Chief Executive Officer

    Please contact your BTIG representative to listen to the live event and schedule a virtual one-on-one meeting with Gain's management team during the conference.

    About BTIG Virtual Biotechnology Conference

    The annual August conference will be held virtually. BTIG expects to host more than 120 corporate management teams throughout the two-day, private event which includes thematic panels featuring key opinion leaders, fireside chats, and one-on-one meetings.

    For further information, please visit: www.BTIG.com

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements due to a number of factors, including but not limited to, risks detailed in the Company's Quarterly Report on Form 10-Q for the quarter ended March 31, 2021, as filed with the Securities and Exchange Commission on May 5 2021, as well as other documents that may be filed by the Company from time to time.

    New risks and uncertainties arise over time, and it is not possible for us to predict all such factors or how they may affect us. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. We are under no duty to update any of these forward-looking statements after the date of this earnings release to conform these statements to actual results or revised expectations. You should, therefore, not rely on these forward-looking statements as representing our views as of any date subsequent to the date of this earnings release.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com 



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  8. BETHESDA, Md., June 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson's Disease, Lewy body dementia and Alzheimer's.

    "This is a pivotal milestone for Gain Therapeutics as these two patents highlight the association between the approach to treating rare diseases, such…

    BETHESDA, Md., June 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced the publication of two PCT patents. PCT/IB2020/061158 and PCT/IB2020/0611156 are directed at compounds targeting misfolded beta-​glucocerebrosidase (GBA) and galactosylceramidase (GALC) respectively, addressing central nervous system (CNS) and demyelinating disorders such as Parkinson's Disease, Lewy body dementia and Alzheimer's.

    "This is a pivotal milestone for Gain Therapeutics as these two patents highlight the association between the approach to treating rare diseases, such as Gaucher Disease and Krabbe Disease, and the approach to treating more widely prevalent and growing disease states like Parkinson's Disease and Multiple Sclerosis," said Eric Richman, Chief Executive Officer of Gain. "The two issued patents reflect our focus and commitment to developing first in class therapies for these CNS and lysosomal storage diseases, and we are excited to strengthen our intellectual property and advance our potential to treat patients with these devastating diseases."

    PCT/IB2020/061158 covers compounds and therapeutic uses of conditions associated with the alteration of Beta-glucocerebrosidase (GBA). These conditions include Gaucher Disease, Parkinson's Disease, and other Lewy body disorders including Alzheimer's Disease and amyotrophic lateral sclerosis (ALS).

    PCT/IB2020/0611156 covers compounds and therapeutic uses of conditions associated with the alteration of galactosylceramidase (GALC). These conditions include lysosomal storage diseases and other demyelinating diseases, such as Krabbe Disease, Lewy body dementia, Multiple Sclerosis, and peripheral neuropathy.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Media Contact:

    Joleen Schultz

    Joleen Schultz & Associates

    +1 760-271-8150

    joleen@joleenschultzassociates.com

     



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  9. BETHESDA, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the Jefferies Virtual Healthcare Conference being held on June 1 – 4.

    Jefferies Virtual Healthcare Conference
    Date:Tuesday, June 1ST
    Time:3:00 to 3:25 p.m. ET
    Presenter:Eric Richman, Chief Executive Officer
    Webcast:https://wsw.com/webcast/jeff174/ganx/1851714 or
     at the Company's News & Events section of their website (click here)

    replay of the session will be on the Gain Therapeutics…

    BETHESDA, Md., May 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the Jefferies Virtual Healthcare Conference being held on June 1 – 4.

    Jefferies Virtual Healthcare Conference

    Date:Tuesday, June 1ST
    Time:3:00 to 3:25 p.m. ET
    Presenter:Eric Richman, Chief Executive Officer
    Webcast:https://wsw.com/webcast/jeff174/ganx/1851714 or
     at the Company's News & Events section of their website (click here)

    replay of the session will be on the Gain Therapeutics website for approximately 30-days following the conference.

    Please contact your Jefferies representative to schedule virtual one-on-one meetings with Gain's management team during the conference.

    About Jefferies Virtual Healthcare Conference

    The annual June conference will be held virtually with video fireside chats, presentations, keynotes, panels and 1x1/small group meetings via Zoom. This virtual gathering of over 400 public & private healthcare companies and 3,000 leading executives, institutional investors, private equity investors & VCs will address near- and long-term investment opportunities and discuss the current trends driving healthcare in the U.S. and internationally.

    For further information, please visit: www.Jefferies.com

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com



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  10. BETHESDA, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and at the Oppenheimer Rare & Orphan Disease Summit, both taking place in May.

    2021 RBC Capital Markets Global Healthcare Virtual Conference

    Date: Wednesday, May 19TH
    Time: 9:10 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    Oppenheimer Rare & Orphan Disease Summit

    Date: Friday, May 21ST
    Time:

    BETHESDA, Md., May 17, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the 2021 RBC Capital Markets Global Healthcare Virtual Conference and at the Oppenheimer Rare & Orphan Disease Summit, both taking place in May.

    2021 RBC Capital Markets Global Healthcare Virtual Conference

    Date: Wednesday, May 19TH
    Time: 9:10 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    Oppenheimer Rare & Orphan Disease Summit

    Date: Friday, May 21ST
    Time: 8:15 a.m. ET
    Location: Webcast Linkor at the company's website (click here)

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com



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  11. Completed successful initial public offering and raised $46 million in gross proceeds
    ---
    Appointed four new independent board of directors to strengthen leadership team
    ---
    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer
    ---
    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™
    ---
    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never…

    Completed successful initial public offering and raised $46 million in gross proceeds

    ---

    Appointed four new independent board of directors to strengthen leadership team

    ---

    Signed a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer

    ---

    Presented positive pre-clinical lysosomal storage target data at annual WorldSymposium™

    ---

    Expect to complete proof of concept animal studies and begin IND-enabling trials in the second half of 2021

    BETHESDA, Md., May 10, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain", or the "Company"), a biotechnology company focused on redefining drug discovery by identifying allosteric sites that have never been targeted previously and discovering molecules that can bind stabilize and restore functional activity to misfolded enzymes, today announced its financial results as of and for the first quarter ended March 31, 2021 and provided a corporate update.

    "We were thrilled to complete our IPO in March on the Nasdaq Global Market Exchange," stated Sal Calabrese, Chief Financial Officer of Gain. "The Company now has sufficient financial resources to fund its research and development programs for the foreseeable future. The recent addition of four deeply talented and experienced independent board members provides us with a seasoned leadership team that can help advance the Company towards a clinical stage biopharmaceutical organization."

    Eric Richman, Chief Executive Officer of Gain, added, "We look forward to a very active 2021 and plan to meet several important milestones that will help us advance our SEE-Tx supercomputing platform technology to identify novel allosteric binding sites on misfolded proteins. Our lead pipeline candidates in lysosomal storage and CNS diseases are currently completing animal proof-of-concept studies, and we anticipate moving these into IND-enabling trials towards the end of 2021. We are confident that our Company is on the right path to achieve our mission in redefining drug discovery and develop novel therapies for devastating conditions with significant unmet medical need."

    Business and Recent Developments

    • Multi-target collaboration agreement. In April 2021, the Company announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology.

       
    • Presentation of data at the International Association of Parkinsonism and Related Disorders 2021 World Congress. In April 2021, the Company announced the presentation of a poster at the International Association of Parkinsonism and Related Disorders (IAPRD) 2021 World Congress being held virtually May 1-4, 2021. The poster highlights data demonstrating the potential of the Company's structurally targeted allosteric regulators (STARs) to restore relevant biological function in vitro and improve motor deficits in an in vivo model of Parkinson's disease.

       
    • Completed Successful IPO. In March 2021, the Company completed an oversubscribed initial public offering (IPO) of 4,181,818 shares of common stock at a public offering price of $11.00 per share, including the full exercise by the underwriters of their overallotment option to purchase 545,454 additional shares of common stock. Gain Therapeutics, Inc received gross proceeds of approximately $46 million in the offering. This financing strengthened the Company's balance sheet it with significant funding to advance its therapeutics programs and pipeline expansion.



    • Presented pre-clinical data at the 17th Annual WorldSymposium. In February 2021, the Company presented positive pre-clinical data supportive of in vitro engagement for Gaucher disease, GM1 gangliosidosis, and Morquio B programs at the 17th Annual WorldSymposium™.

       
    • Appointed new members to the board of directors with deep financial, clinical development and regulatory experience. In February 2021, the Company strengthened the leadership team with the appointment of four industry leaders to the Company's Board of Directors. Dov Goldstein, M.D., Gwen Melincoff, Claude Nicaise, M.D., and Hans Peter Hasler.

    Financial Results

    For the first quarter ended March 31, 2021, compared to same period of 2020:

    • Research and development expenses were $1,422 thousand compared to $417 thousand.
    • General and administrative expenses were $1,051 thousand compared to $102 thousand.
    • Total operating expenses increased to $2,472 thousand compared to $519 thousand.
    • Net loss was $2,450 thousand compared to $584 thousand.
    • Basic and diluted net loss per share was $0.50, compared to basic and diluted net loss per share of $0.29.

    Cash and cash equivalents were $46.59 million as of March 31, 2021 compared to $7.49 million at December 31, 2020. The increase was primarily the result of the completion of the Company's initial public offering, from which the Company received aggregate net proceeds of $42.6 million.

    Gain Therapeutics, Inc. was incorporated under the laws of the state of Delaware (U.S.) on June 26, 2020. On July 20, 2020, the Company consummated a Corporate Reorganization pursuant to which all of the issued and outstanding common and preferred stock of GT Gain Therapeutics SA, a Swiss company formed in 2017, were exchanged for common stock or preferred stock, as applicable, of Gain Therapeutics, Inc. For periods and at dates prior to the Corporate Reorganization, the consolidated financial statements were prepared based on the historical financial statements of GT Gain Therapeutics SA.

    Operating Results

    The Company incurred research and development expenses of $1,422 thousand for the three-month period ended March 31, 2021 compared to $417 thousand for the same period of 2020, an increase of $1,005 thousand. The increase in research and development expenses was primarily attributable to increases in outside services as we continue to expand our research and development activities, including external collaborations, chemical synthesis, toxicology studies, in vitro ADME and model studies, and in vivo. pharmacology and pharmacokinetic studies, as well as increases in payroll, payroll-related expenses and stock-based compensation.

    General and administrative expenses were $1,051 thousand for the three-month period ended March 31, 2021 compared to $102 thousand for the same period of 2020, an increase of $949 thousand. The increase is primarily due to increases in personnel-related costs, including stock based compensation, as a result of senior management hires, increase in expenses for legal fees relating to patent and corporate matters, professional fees for accounting, professional services and investor relations as we continue to expand our business and build management infrastructure.

    As a result of the above net loss was $2,450 thousand for the three-month period ended March 31, 2021, compared to $584 thousand for the same period of 2020. The increase in net loss was due to increased research and development expenses, as well as an increase in general and administrative expenses primarily related to investments in the Company's infrastructure as a publicly traded company.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Cautionary Note Regarding Forward-Looking Statements

    This press release contains "forward-looking statements." In some cases, you can identify these statements by forward-looking words such as "may," "might," "will," "should," "expect," "plan," "anticipate," "believe," "estimate," "predict," "potential" or "continue," the negative of these terms and other comparable terminology. These statements are not historical facts but instead represent the Company's belief regarding future results, many of which, by their nature, are inherently uncertain and outside the Company's control. It is possible that actual results, including with respect to any financial forecast or the possibility of any future regulatory approval or filing, may differ materially from those anticipated in these forward-looking statements. For a discussion of some of the risks and important factors that could affect future results, see the discussion in our prospectus filed with the Securities and Exchange Commission under the caption "Risk Factors."



    Gain Therapeutics, Inc.

    CONSOLIDATED BALANCE SHEETS (unaudited)

     March 31,

    2021
     December 31,

    2020
    Assets     
    Current assets:     
    Cash and cash equivalents$46,593,604  $7,492,910 
    Restricted cash 11,129   11,371 
    Accounts receivable 4,486   8,548 
    Prepaid expenses and other current assets 774,809   257,011 
    Deferred offering costs -   1,217,988 
    Total current assets$47,384,028  $8,987,828 
          
    Non-current assets:     
    Property and equipment, net 54,717   29,633 
    Operating lease - right of use assets 499,017   523,080 
    Restricted cash 31,554   - 
    Long-term deposits 12,008   12,152 
    Other non-current assets 59,740   51,665 
    Total non-current assets$657,036  $616,530 
    Total Assets$48,041,064  $9,604,358 
            
    Current liabilities:     
    Accounts payable 881,753   961,516 
    Operating lease liability - current 121,419   122,756 
    Other current liabilities 1,096,334   767,380 
    Tax provision 4,526   1,070 
    Deferred income 178,418   239,483 
    Loans - short term 44,287   22,626 
    Total current liabilities$2,326,737  $2,114,831 
          
    Non-current liabilities:     
    Defined benefit pension plan 194,465   171,558 
    Operating lease liability - non-current 377,598   400,324 
    Loans - long term 678,255   715,656 
    Total non-current liabilities$1,250,318  $1,287,538 
          
    Stockholders' equity     
    Series A Preferred Stock: $0.0001 par value, nil and 1,185,879 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   118 
    Series B Preferred Stock: $0.0001 par value, nil and 2,965,600 shares issued and outstanding as of March 31, 2021 and December 31, 2020, respectively -   297 
    Common Stock, $0.0001 par value: 11,876,460 and 7,694,642 issued and outstanding as of March 31, 2021 and December 31, 2020, respectively 1,188   354 
    Additional paid-in capital 54,104,982   13,388,771 
    Accumulated other comprehensive loss (156,861)  (152,698)
    Accumulated deficit (7,034,853)  (3,457,171)
    Loss of the period (2,450.447)  (3,577,682)
    Total Stockholders' equity$44,464,009  $6,201,989 
    Total Liabilities and Stockholders' equity$48,041,064  $9,604,358 



    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF OPERATIONS

    (unaudited)

     For Three Months Ended March 31,
      2021  2020
    Revenues:     
    Other income 5,269  6,673
    Total revenues $5,269 $6,673
          
    Operating expenses:     
    Research and development (1,421,509)  (417,259)
    General and administrative (1,050,675)  (101,674)
    Total operating expenses (2,472,184)  (518,933)
          
    Loss from operations$(2,466,915) $(512,260)
          
    Other income (expense):     
    Interest income/(expenses), net 1,408  (1,747)
    Foreign exchange gain/(loss), net 18,539  (68,914)
    Loss before income tax$(2,446,968) $(582,921)
          
    Income tax (3,479)  (1,347)
          
    Net Loss$(2,450,447) $(584,268)
          
    Net loss per shares:     
    Net loss per share attributable to common stockholders - basis and diluted$(0.50) $(0.29)
    Weighted average common shares - basic and diluted 4,868,915  1,981,765





    Gain Therapeutics, Inc

    CONSOLIDATED STATEMENTS OF CASH FLOWS

    (unaudited)

     For Three Months Ended March, 31
      2021  2020 
      USD  USD 
    Operating activities:      
    Net loss$(2,450,447) $(584,268) 
      -    
    Adjustments to reconcile net loss to net cash used in operating activities:    
    Depreciation 3,403  2,101 
    Stock based compensation 110,725  - 
    Changes in operating assets and liabilities:      
    Account receivables and other currents assets (513,738)  62,947 
    Other non current assets (8,075)    
    Account payables and other current liabilities 82,927  (184,920) 
    Tax payable 3,456  (2,355) 
    Pension liability 22,907  8,085 
    Deferred income (61,065)  (54,406) 
    Total changes in operating assets and liabilities (473,588)  (170,649) 
    Net cash used in operating activities$(2,809,907) $(752,816) 
           
    Cash flows from investing activities:      
    Purchase of computers and office equipment (28,488)  (4,897) 
    Net cash used in investing activities $(28,488) $(4,897) 
           
    Cash flow from financing activities:      
    Proceeds from long-term debts -  284,598 
    Proceeds from issuance of Series A Preferred Stock, net of issuance costs -  1,108,097 
    Proceeds from issuance of common shares upon completion of initial public offering, net of offering costs 42,629,998  - 
    Payments of deferred offering costs (639,693)    
    Net cash provided by financing activities$41,990,305 $1,392,695 
    Effect of exchange rate changes (19,904)  (3,573) 
    Net increase in cash, cash equivalents and restricted cash$39,132,006 $631,409 
    Cash, cash equivalents and restricted cash at beginning of period7,504,281  313,700 
    Cash, cash equivalents and restricted cash at end of period$46,636,287 $945,109 
           

    SOURCE: Gain Therapeutics, Inc.

    Investor & Media Contacts:

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com



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  12. Compounds reverse the neurodegenerative process observed in a Parkinson's disease in vivo model

    Compounds are novel allosteric regulators that bind, stabilize and restore activity of mutated GCase

    Compounds decrease both phosphorylated and aggregated α-synuclein levels in vitro and in vivo

    BETHESDA, Md., May 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by using super-computational methods to target allosteric binding sites and guide enzymes back to their proper shape, today announced new pre-clinical data from its GBA1 Parkinson's disease program. The findings were highlighted in a presentation at the XXVI International Association of Parkinsonism…

    Compounds reverse the neurodegenerative process observed in a Parkinson's disease in vivo model

    Compounds are novel allosteric regulators that bind, stabilize and restore activity of mutated GCase

    Compounds decrease both phosphorylated and aggregated α-synuclein levels in vitro and in vivo

    BETHESDA, Md., May 03, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by using super-computational methods to target allosteric binding sites and guide enzymes back to their proper shape, today announced new pre-clinical data from its GBA1 Parkinson's disease program. The findings were highlighted in a presentation at the XXVI International Association of Parkinsonism and Related Disorders (IAPRD) World Congress, a research conference dedicated to Parkinson's disease and other disorders affecting muscle tone and motor control, being held virtually May 1-4, 2021.

    "These data demonstrate that our Structurally Targeted Allosteric Regulators (STARs) compounds open a new potential approach for direct treatment of GBA1 Parkinson's disease by guiding misfolded forms of the GCase enzyme to their proper shape and restoring enzymatic activity," said Manolo Bellotto, Ph.D., General Manager and President at Gain. "STARs bind to novel allosteric binding sites identified using our proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) drug discovery platform, stabilize and restore enzymatic activity to misfolded GCase. The restoration of GCase activity results in the depletion of the toxic phosphorylated and aggregated forms of α-synuclein and a reversal of the neurodegenerative process resulting in improved locomotor activity in a Parkinson's disease model in rats. We will continue to further explore the potential of these compounds in Parkinson's disease and α-synucleopathies."

    Ricardo Feldman, Ph.D., Associate Professor of Microbiology and Immunology at the University of Maryland School of Medicine, stated, "Our laboratory is using human induced pluripotent stem cells (iPSC) derived from patients with GD and GBA-associated Parkinson's disease to test the efficacy of the two lead STAR chaperones developed by Gain Therapeutics. Our early studies in iPSC-derived neurons from neuronopathic GD patients show that both STAR compounds, GT-02287 and GT-02329 are very effective in meeting target goals. These include increasing the levels of GCase protein, its transport to the lysosome, and decreasing levels of pathogenic α-synuclein. As the work in our laboratory progresses, we look forward to working with Gain's team to further advance its GBA program."

    Eric I. Richman, Chief Executive Officer, added, "There have been many promising treatments for Parkinson's disease that have not come to fruition. Through partnerships with the Michael J. Fox Foundation and the Silverstein Foundation for Parkinson with GBA, we identified two STAR lead candidates that have the potential to help Parkinson's patients with GBA1 gene mutations as well as patients whose GCase protein is misfolded due to aging cellular processes. Our preclinical data demonstrates that our STAR compounds successfully target protein misfolding rather than treating symptoms of the disease, and we are honored our abstract is recognized as one of the top 10 best abstracts at IAPRD this year."

    Key findings from the presentation are highlighted below. To access the presentation please visit the Publications section of the Gain website.

    Preclinical Development of Brain-Penetrant Structurally Targeted Allosteric Regulators (STARs) for the Treatment of GBA1 Parkinson's Disease and Related α-Synucleopathies

    The presented results highlight data from preclinical cell cultures and rodent models, including rotenone models of Parkinson's disease. STARs bound misfolded forms of GCase trapped in the endoplasmic reticulum (ER) and enhanced the processing from the ER to the lysosome. This improved lysosomal GCase activity restored normal lysosomal and autophagic activity and ultimately decreased α-synuclein levels.

    • Two lead STAR candidates (GT-02287 and GT-02329) were identified using Gain's proprietary SEE-Tx™ drug discovery platform
    • Both STAR compounds stabilized GCase and enhanced its enzymatic activity in human fibroblasts isolated from patients with GBA1-related Gaucher disease, which has a similar genetic profile to Parkinson's disease
    • Both STAR compounds were neuroprotective and lowered α-synuclein pathology in primary rat dopaminergic neurons
    • When delivered orally, GT-02329 successfully penetrated the blood brain barrier and enhanced GCase activity and protein levels in the striatum of wild-type mice
    • GT-02287 reduced α-synuclein accumulation in both cell culture and rat models of Parkinson's disease
    • GT-02287 improved locomotor activity in rats treated with rotenone, a model of Parkinson's disease that reproduces certain features of the human disease

    About SEE-Tx™

    SEE-Tx is the first technology platform exclusively designed to use the 3D structure of proteins to systematically identify allosteric binding sites never described previously and predict their druggability. Powered by supercomputers, its novel algorithm orchestrates molecular modeling at a speed and efficiency that has the potential to redefine drug discovery.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com 



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  13. BETHESDA, Md., April 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the B. Riley Securities' Virtual Neuroscience Conference being held on April 28 - 29.

    B. Riley Securities' Virtual Neuroscience Conference
    Date:     Wednesday, April 28th
    Time:    4:00 p.m. ET
    Location:      Webcast Link - or at the company's website (click here)

    About Gain Therapeutics, Inc.
    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification…

    BETHESDA, Md., April 27, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced that Eric Richman, Chief Executive Officer of Gain Therapeutics, will present a corporate overview at the B. Riley Securities' Virtual Neuroscience Conference being held on April 28 - 29.

    B. Riley Securities' Virtual Neuroscience Conference

    Date:     Wednesday, April 28th
    Time:    4:00 p.m. ET
    Location:      Webcast Link - or at the company's website (click here)

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    For more information, visit https://www.gaintherapeutics.com/

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com



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  14. BETHESDA, Md., April 22, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced a poster presentation at the International Association of Parkinsonism and Related Disorders (IAPRD) 2021 World Congress being held virtually May 1-4, 2021. The presentation will highlight data demonstrating the potential of the company's structurally targeted allosteric regulators (STARs) to restore relevant biological function in vitro and improve motor deficits in an in vivo model of Parkinson's disease.

    Presentation Details:

    Abstract Title: "Preclinical development of…

    BETHESDA, Md., April 22, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain"), a biotechnology company focused on redefining drug discovery by identifying and optimizing allosteric binding sites that have never before been targeted, today announced a poster presentation at the International Association of Parkinsonism and Related Disorders (IAPRD) 2021 World Congress being held virtually May 1-4, 2021. The presentation will highlight data demonstrating the potential of the company's structurally targeted allosteric regulators (STARs) to restore relevant biological function in vitro and improve motor deficits in an in vivo model of Parkinson's disease.

    Presentation Details:

    Abstract Title: "Preclinical development of brain-penetrant structurally targeted allosteric regulators for the treatment of GBA1 Parkinson's disease and related α-synucleinopathies"

    Presenter: Roberto Maj, Pharm.D., Head of Development, Gain Therapeutics

    Presentation Number: BA04

    Date/Time: The poster will be available starting Saturday, May 1, 2021, 14:30 CET/ 08:30 ET and will be accessible for the duration of the conference

    The presentation will be featured as one of the 10 Best Abstracts in 2021. Additional details can be found on the IAPRD 2021 World Conference website at https://www.iaprd-world-congress.com/. Presentation materials will be available on the Gain website following the conference.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Media Contact:

    Madeline Joanis

    LifeSci Communications

    +1 646-751-4366

    mjoanis@lifescicomms.com



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  15. Collaboration to use Gain's proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) computational platform technology to identify new and previously difficult-to-drug oncology targets

    BETHESDA, Md., April 20, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") today announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. SEE-Tx applies a proprietary computational algorithm and supercomputer processing to the published 3D structure of proteins to discover new binding sites…

    Collaboration to use Gain's proprietary Site-Directed Enzyme Enhancement Therapy (SEE-Tx™) computational platform technology to identify new and previously difficult-to-drug oncology targets

    BETHESDA, Md., April 20, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (NASDAQ:GANX) ("Gain") today announced a multi-target collaboration agreement with Zentalis Pharmaceuticals (NASDAQ:ZNTL) to discover new product candidates for the treatment of cancer. Gain will use its proprietary SEE-Tx computational platform technology to identify new sites on target proteins for potential use in oncology. SEE-Tx applies a proprietary computational algorithm and supercomputer processing to the published 3D structure of proteins to discover new binding sites with the ability to modulate protein function. The intended output is newly-discovered targets or target protein interactions that can then be drugged for therapeutic benefit to intervene on protein misfolding.

    "We are pleased to enter into a relationship with Zentalis, an oncology company at the forefront of developing differentiated treatments for patients," said Eric Richman, Chief Executive Officer at Gain. "Our unique algorithm, based on a patented method to analyze molecular dynamics and powered by supercomputers, is designed to enable discovery of novel targets in various therapeutic areas. Zentalis' team brings extensive industry experience and a proven track record in the discovery and clinical development of innovative cancer therapies, which will be beneficial as we work to further validate SEE-Tx for use in combating cancers and other devastating diseases. Together, we are looking forward to changing the way the industry thinks about drug discovery in oncology."

    Prof. Xavier Barril, Chief Scientific Officer of Gain, added, "Over the past several decades, the evidence linking protein misfolding and cancer has continued to grow, with chaperones that mediate protein folding being identified as critical modulators of proper cellular function. Of particular note, while most proteins have a half-life of one to two hours, many oncogenes have half-lives of just a few minutes, meaning that they are continually being synthesized, folded and degraded, offering significant opportunities for misfolding. We are excited to collaborate with Zentalis with its promising pipeline of oncology therapeutic candidates. Zentalis sees the potential of our SEE-Tx platform technology to address this challenge in cancer."

    Under the terms of the agreement, Gain will pursue binding site identification on target proteins that will be selected and agreed upon by both parties. Next, Gain will identify and determine the potential suitability of these sites as drug targets, as well as their prospective therapeutic use. Selected compounds will be tested in the lab by Zentalis against the target protein to confirm binding and action to identify and characterize novel compounds for development.

    About SEE-Tx™

    SEE-Tx is the first proprietary technology platform exclusively designed use the 3D structure of proteins to systematically identify allosteric binding sites never described previously and predict their druggability. Powered by supercomputers, its novel algorithm orchestrates molecular modeling at a speed and efficiency that has the potential to redefine drug discovery.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its SEE-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. Gain was established in 2017 with the support of its founders and institutional investors. It has been awarded funding support 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. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Forward-Looking Statements

    Any statements in this release that are not historical facts may be considered to be "forward-looking statements." Forward-looking statements are based on management's current expectations and are subject to risks and uncertainties which may cause results to differ materially and adversely from the statements contained herein. Such statements include, but are not limited to, statements regarding the market opportunity for Gain's product candidates; and the business strategies and development plans of Gain. Some of the potential risks and uncertainties that could cause actual results to differ from those expected include Gain's ability to: make commercially available its products and technologies in a timely manner or at all; enter into other strategic alliances, including arrangements for the development and distribution of its products; obtain intellectual property protection for its assets; accurately estimate its expenses and cash burn and raise additional funds when necessary. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Except as required by law, Gain does not undertake any obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events.

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 617-430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Cait Williamson, Ph.D.

    LifeSci Communications

    +1 646-751-4366

    cait@lifescicomms.com



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  16. HOUSTON, April 14, 2021 (GLOBE NEWSWIRE) -- Coya Therapeutics, Inc., (Coya™), a clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Tregs) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced that it has appointed Hideki Garren, M.D., Ph.D., Chief Medical Officer of Prothena and Dov Goldstein, M.D., Chief Financial Officer and Chief Business Officer of Indapta, to the Company's Board of Directors, effective immediately. Coya's Board is now composed of five members.

    "We are pleased to welcome these world-class leaders to our board; their expertise in research and development of neurological and autoimmune diseases, as well as in…

    HOUSTON, April 14, 2021 (GLOBE NEWSWIRE) -- Coya Therapeutics, Inc., (Coya™), a clinical-stage biotechnology company developing first-in-class approaches utilizing autologous regulatory T cells (Tregs) and Treg-derived exosome therapeutics for neurodegenerative and autoimmune diseases, today announced that it has appointed Hideki Garren, M.D., Ph.D., Chief Medical Officer of Prothena and Dov Goldstein, M.D., Chief Financial Officer and Chief Business Officer of Indapta, to the Company's Board of Directors, effective immediately. Coya's Board is now composed of five members.

    "We are pleased to welcome these world-class leaders to our board; their expertise in research and development of neurological and autoimmune diseases, as well as in global business development will be invaluable to Coya's future growth," said Howard Berman, Ph.D., Chief Executive Officer of Coya Therapeutics. "We look forward to working with Dr. Garren and Dr. Goldstein as we continue to advance novel therapeutics--delivering on our mission to improve outcomes and the standard of care for patients with amyotrophic lateral sclerosis and neurodegenerative diseases."

    Dr. Garren has 20 years of experience in the biopharmaceutical industry, spanning all aspects of novel drug development from discovery, to early-stage clinical trials, to late-stage clinical trials, to commercialization. He currently serves as the Chief Medical Officer for Prothena, a late-stage clinical company with expertise in protein dysregulation, focusing on rare peripheral amyloid and neurodegenerative diseases. From 2013 to 2020, he served as VP, Global Head of Neuroimmunology for F. Hoffmann-La Roche (Roche) & Genentech Inc., where he led the teams that conducted the Ocrevus® Phase III trials for multiple sclerosis and Enspryng™ Phase III trials for the rare disease neuromyelitis optica spectrum disorder. Previously, Dr. Garren served as Executive Director, Translational Medicine Expert in neuroscience for Novartis Pharma.

    In 2002, Dr. Garren co-founded Bayhill Therapeutics, centered on a novel therapeutic platform for treating autoimmune diseases that he co-discovered while at Stanford University, and served as Executive VP, Chief Scientific Officer and Chief Operating Officer. He served as adjunct clinical faculty in the Department of Neurology at Stanford University from 1997 to 2009. Dr. Garren earned his Bachelor of Science degree from the California Institute of Technology and his M.D. and Ph.D. from the University of California Los Angeles.

    Dr. Goldstein brings over 20 years of strategic financial and operational experience within the healthcare sector. He currently serves as the Chief Financial Officer and Chief Business Officer of Indapta Therapeutics, a biotechnology company focused on developing and commercializing a proprietary, off-the-shelf, allogeneic FcRy-deficient natural killer (G-NK) cell therapy to treat multiple types of cancer. Dr. Goldstein was previously Chief Executive Officer of RIGImmune. Prior to that he served as the Chief Financial Officer at Schrödinger, LLC from 2017 to 2018. Dr. Goldstein held various leadership roles at Aisling Capital, a private investment firm, from 2006 to 2017, serving as its Managing Partner from 2014 to 2017. Dr. Goldstein served as the Chief Financial Officer of Loxo Oncology, Inc. between 2014 and 2015. From 2000 to 2005, Dr. Goldstein served as Chief Financial Officer of Vicuron Pharmaceuticals, Inc., raising over $250 million in equity financings, facilitating company partnership transactions and participating in the M&A process when Vicuron was acquired by Pfizer, Inc. for $1.9 billion. Prior to joining Vicuron, he was Director of Venture Analysis at HealthCare Ventures.

    Dr. Goldstein currently serves on the board of Directors of NeuBase Therapeutics (NASDAQ:NBSE) and Gain Therapeutics (NASDAQ:GANX). He previously served as a director for ADMA Biologics, Loxo Oncology, Esperion Therapeutics, Duranta Therapeutics, Cempra and a number of private companies. He received a Bachelor of Science in biological sciences from Stanford University, an MBA from Columbia Business School and an M.D. from Yale School of Medicine.

    About Coya Therapeutics, Inc.

    Headquartered in Houston, TX, Coya Therapeutics™ is a clinical-stage biotechnology company developing first-in-class and best-in-class approaches utilizing adoptive regulatory T cells (Tregs) to target disease. The company's CTreg™ (Cryopreservation for Tregs) system is patent pending and the first in the industry to overcome prior limitations of Treg cell therapies, allowing for serial infusions from a single manufacturing round. Through our proprietary TAI™ (Tregs Against Inflammation™) and patent pending iscEXO™ (immunosuppressive cell Exosome) platforms, Coya is focused on the advancement of disease modifying approaches to address the significant unmet medical needs of patients with ALS, Frontotemporal Dementia, Parkinson's, Alzheimer's, and autoimmune diseases. For more information, please visit www.coyatherapeutics.com

    Investor Contact



    Daniel Ferry

    617-430-7576

    Daniel@lifesciadvisors.com
    Media Contact



    Joleen Schultz

    760-271-8150

    joleen@joleenschultzassociates.com
      


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  17. BETHESDA, Md., March 25, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. ("Gain") today announced the closing of its initial public offering of 3,636,364 shares of its common stock and full exercise of the underwriters' overallotment option to purchase 545,454 additional shares of common stock, at a public offering price of $11.00 per share. The gross proceeds to Gain from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Gain, were approximately $46 million.

    Gain's common stock is listed on the Nasdaq Global Market under the ticker symbol "GANX."

    BTIG, LLC and Oppenheimer & Co. Inc. served as book-running managers for the offering. National Securities Corporation also acted as…

    BETHESDA, Md., March 25, 2021 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. ("Gain") today announced the closing of its initial public offering of 3,636,364 shares of its common stock and full exercise of the underwriters' overallotment option to purchase 545,454 additional shares of common stock, at a public offering price of $11.00 per share. The gross proceeds to Gain from the offering, before deducting underwriting discounts and commissions and other offering expenses payable by Gain, were approximately $46 million.

    Gain's common stock is listed on the Nasdaq Global Market under the ticker symbol "GANX."

    BTIG, LLC and Oppenheimer & Co. Inc. served as book-running managers for the offering. National Securities Corporation also acted as co-manager for the offering.

    The offering was made only by means of a prospectus. Copies of the final prospectus may be obtained for free by visiting EDGAR on the Securities and Exchange Commission's (the "SEC") website at www.sec.gov. Alternatively, copies of the final prospectus may be obtained for free from the offices of BTIG, LLC, Attn: Equity Capital Markets, 65 East 55th Street, New York, New York 10022, by telephone at (212) 593-7555 or by email at ProspectusDelivery@btig.com; Oppenheimer & Co. Inc, by Oppenheimer & Co. Inc, Attn: Syndicate Prospectus Department, 85 Broad Street, 26th Floor, New York, New York 10004, by telephone at (212) 667-8055, or by email at EquityProspectus@opco.com; or National Securities Corporation, by National Securities Corporation, Attn: Adrian Adderley, 200 Vesey Street, 25th Floor, New York, New York 10281, by telephone at (561) 981-1074, or by email at prospectusrequest@nationalsecurities.com.

    The registration statement relating to this offering has been declared effective by the SEC on March 17, 2021. This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

    About Gain Therapeutics, Inc.

    Gain Therapeutics, Inc. is redefining drug discovery with its See-Tx™ target identification platform. By identifying and optimizing allosteric binding sites that have never before been targeted, Gain is unlocking new treatment options for difficult-to-treat disorders characterized by protein misfolding. In July 2020, Gain Therapeutics, Inc. completed a share exchange with Gain Therapeutics, SA, a Swiss corporation, whereby GT Gain Therapeutics SA became a wholly owned subsidiary of Gain Therapeutics, Inc.

    Gain Therapeutics Investor Contact:

    Daniel Ferry

    LifeSci Advisors

    +1 (617) 430-7576

    daniel@lifesciadvisors.com

    Gain Therapeutics Media Contact:

    Cait Williamson, Ph.D.

    LifeSci Communications

    +1 (646) 751-4366

    cait@lifescicomms.com

     



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