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Gain Therapeutics Appoints Gene Mack as Chief Executive Officer and Director

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Gain Therapeutics (NASDAQ: GANX) has appointed Gene Mack as permanent President and Chief Executive Officer, effective January 6, 2025. Mack, who has served as CFO since April 2024 and interim CEO since June 2024, has also joined the Company's Board of Directors. Additionally, Gianluca Fuggetta has been promoted to Senior Vice President, Finance and Principal Financial Officer.

Mack brings over 25 years of life sciences experience spanning clinical research, financing, capital markets, investing, corporate strategy, and business development. His appointment comes as the company advances its lead candidate, GT-02287, through an ongoing Phase 1b trial in Parkinson's Disease during the first half of 2025, with potential Phase 2 activities planned for the second half of 2025.

Prior to joining Gain, Mack served as CFO at Imcyse SA (2021-2023) and OncoC4, following various CFO roles at development and commercial-stage biopharmaceutical companies. He also has experience as a senior publishing analyst covering biotechnology at investment banks including Gruntal & Co, Lazard, Mizuho, and HSBC.

Gain Therapeutics (NASDAQ: GANX) ha nominato Gene Mack come Presidente e Amministratore Delegato permanente, con effetto dal 6 gennaio 2025. Mack, che ha ricoperto il ruolo di CFO da aprile 2024 e CEO ad interim da giugno 2024, è anche entrato a far parte del Consiglio di Amministrazione della Società. Inoltre, Gianluca Fuggetta è stato promosso a Vicepresidente Senior, Finanza e Direttore Finanziario Principale.

Mack porta oltre 25 anni di esperienza nelle scienze della vita, coprendo settori come la ricerca clinica, il finanziamento, i mercati dei capitali, gli investimenti, la strategia aziendale e lo sviluppo commerciale. La sua nomina arriva mentre l'azienda avanza con il suo candidato principale, GT-02287, attraverso un trial di fase 1b in corso per il Parkinson nella prima metà del 2025, con potenziali attività di fase 2 pianificate per la seconda metà del 2025.

Prima di unirsi a Gain, Mack ha ricoperto il ruolo di CFO presso Imcyse SA (2021-2023) e OncoC4, dopo vari ruoli di CFO in aziende biofarmaceutiche in fase di sviluppo e commerciali. Ha anche esperienza come analista senior nel settore delle pubblicazioni, coprendo il settore biotecnologico in banche d'investimento tra cui Gruntal & Co, Lazard, Mizuho e HSBC.

Gain Therapeutics (NASDAQ: GANX) ha nombrado a Gene Mack como Presidente y Director Ejecutivo permanente, con efecto desde el 6 de enero de 2025. Mack, que ha sido CFO desde abril de 2024 y CEO interino desde junio de 2024, también se ha unido a la Junta Directiva de la Compañía. Además, Gianluca Fuggetta ha sido ascendido a Vicepresidente Senior, Finanzas y Director Financiero Principal.

Mack aporta más de 25 años de experiencia en ciencias de la vida que abarca investigación clínica, financiación, mercados de capitales, inversiones, estrategia corporativa y desarrollo de negocios. Su nombramiento se produce a medida que la empresa avanza con su candidato principal, GT-02287, a través de un ensayo de fase 1b en curso en la enfermedad de Parkinson durante la primera mitad de 2025, con actividades de fase 2 potenciales planeadas para la segunda mitad de 2025.

Antes de unirse a Gain, Mack fue CFO en Imcyse SA (2021-2023) y OncoC4, tras diversos roles de CFO en empresas biofarmacéuticas en desarrollo y comerciales. También tiene experiencia como analista senior de publicaciones cubriendo biotecnología en bancos de inversión, incluyendo Gruntal & Co, Lazard, Mizuho y HSBC.

게인 테라퓨틱스 (NASDAQ: GANX)는 2025년 1월 6일부터 유효한 정식 회장 겸 최고 경영자(CEO)로 진 맥을 임명했습니다. 맥은 2024년 4월부터 CFO로 재직해 왔으며, 2024년 6월부터는 임시 CEO 역할을 맡아 왔으며, 회사 이사회에도 합류했습니다. 또한, 지안루카 푸게타가 수석 부사장, 재무 및 주요 재무 책임자(PRINCIPAL FINANCIAL OFFICER)로 승진했습니다.

맥은 임상 연구, 자금 조달, 자본 시장, 투자, 기업 전략 및 사업 개발을 아우르는 생명 과학 분야에서 25년 이상의 경력을 보유하고 있습니다. 그의 임명은 회사가 2025년 상반기 동안 파킨슨병에 대한 진행 중인 1b상 임상시험을 통해 주요 후보군인 GT-02287를 진행하는 것과 관련하여 이루어졌으며, 2025년 하반기에는 2상 활동이 계획되어 있습니다.

게인에 합류하기 전에, 맥은 임시 CFO로 재직하였으며, 2021-2023년동안은 Imcyse SA 및 OncoC4에서 CFO로 근무하였고, 개발 및 상업 단계의 생명공학 회사에서 여러 CFO 역할을 수행했습니다. 그는 또한 그룬탈 & Co, 라자르, 미즈호 및 HSBC와 같은 투자은행에서 생명공학 분야를 다루는 선임 출판 분석가로서 경험을 가지고 있습니다.

Gain Therapeutics (NASDAQ: GANX) a nommé Gene Mack en tant que Président et Directeur Général permanent, prenant effet le 6 janvier 2025. Mack, qui a été CFO depuis avril 2024 et PDG par intérim depuis juin 2024, a également rejoint le Conseil d'Administration de la Société. De plus, Gianluca Fuggetta a été promu Vice-Président Senior, Finances et Directeur Financier Principal.

Mack apporte plus de 25 ans d'expérience dans les sciences de la vie, couvrant la recherche clinique, le financement, les marchés des capitaux, les investissements, la stratégie d'entreprise et le développement commercial. Sa nomination intervient alors que l'entreprise avance avec son candidat principal, GT-02287, à travers un essai de phase 1b en cours pour la maladie de Parkinson pendant la première moitié de 2025, avec des activités de phase 2 potentielles prévues pour la seconde moitié de 2025.

Avant de rejoindre Gain, Mack a été CFO chez Imcyse SA (2021-2023) et OncoC4, après divers rôles de CFO dans des entreprises biopharmaceutiques en phase de développement et commerciale. Il a également de l'expérience en tant qu'analyste senior en publication couvrant la biotechnologie dans des banques d'investissement, y compris Gruntal & Co, Lazard, Mizuho et HSBC.

Gain Therapeutics (NASDAQ: GANX) hat Gene Mack zum festen Präsidenten und CEO ernannt, mit Wirkung zum 6. Januar 2025. Mack, der seit April 2024 CFO und seit Juni 2024 Interims-CEO ist, hat ebenfalls im Vorstand des Unternehmens Platz genommen. Zudem wurde Gianluca Fuggetta zum Senior Vice President für Finanzen und Hauptfinanzbeauftragten befördert.

Mack bringt über 25 Jahre Erfahrung in den Lebenswissenschaften mit, die klinische Forschung, Finanzierung, Kapitalmärkte, Investitionen, Unternehmensstrategie und Geschäftsentwicklung umfasst. Seine Ernennung erfolgt, während das Unternehmen seinen Hauptkandidaten, GT-02287, in einer laufenden Phase-1b-Studie zur Parkinson-Krankheit in der ersten Hälfte des Jahres 2025 vorantreibt, mit möglichen Phase-2-Aktivitäten, die für die zweite Hälfte des Jahres 2025 geplant sind.

Bevor er zu Gain wechselte, war Mack CFO bei Imcyse SA (2021-2023) und OncoC4, nachdem er verschiedene CFO-Positionen in biopharmazeutischen Entwicklungs- und Handelsunternehmen innehatte. Er hat auch Erfahrung als leitender Analyst für Veröffentlichungen im Bereich Biotechnologie bei Investmentbanken wie Gruntal & Co, Lazard, Mizuho und HSBC.

Positive
  • Appointment ensures leadership continuity during important clinical development phase of GT-02287
  • New CEO brings extensive experience in finance, capital markets, and biotechnology sector
  • Clear clinical development timeline with Phase 1b trial ongoing and Phase 2 planned for H2 2025
Negative
  • None.

Gene Mack Has Served As CFO Since April 2024 And Interim CEO Since June 2024

Gianluca Fuggetta Will Assume The Role Of Senior Vice President, Finance

BETHESDA, Md., Jan. 07, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today announced that Gene Mack, who has served as the Company’s Chief Financial Officer since April 2024 and interim Chief Executive Officer since June 2024, has been appointed President and Chief Executive Officer, effective January 6, 2025. Mr. Mack has also been appointed as a member of the Company’s Board of Directors, effective January 6, 2025. Additionally, Gianluca Fuggetta, the Company’s current Finance Vice President, has been appointed Senior Vice President, Finance and the Company’s Principal Financial Officer.

“On behalf of the Board of Directors, I am pleased to announce that Mr. Gene Mack has been promoted to lead Gain Therapeutics as Chief Executive Officer. Over the last nine months Gene has served as both our CFO and interim CEO and has demonstrated a leadership approach that supports strong alignment between the Company’s short-term and long-term objectives. Gene’s appointment as CEO will maintain continuity as GT-02287 advances through clinical development. Since joining Gain, Gene has proven himself to be a strategic and effective leader who is focused on achieving the Company’s goals for patients, shareholders, and other stakeholders. It is also my pleasure to welcome Gene to the Board of Directors and I look forward to his contributions in the future,” stated Dr. Islam, Chairman of the Board of Directors. “Following Gene’s appointment as CEO, I will no longer maintain an executive role in the Company but will continue in my function as Chairman of the Board of Directors,” concluded Dr. Islam.

Gene Mack, newly appointed CEO of Gain, added, “I am honored by the opportunity to lead the passionate team we have here at Gain – a team that I have grown very fond of after experiencing firsthand during 2024 how uniformly committed everyone is to our mission of developing truly disease-altering treatments that go beyond temporary symptom relief. I look forward to providing continuing support and contributing to the impressive work being done by my colleagues at Gain as we guide our lead candidate, GT-02287, through the currently ongoing Phase 1b trial in people with Parkinson’s Disease during the first half of 2025, while also preparing for potential Phase 2 activities during the second half of 2025.”

Gene has over 25 years of experience in the life sciences sector spanning clinical research, financing and capital markets, investing, corporate strategy and business development. Prior to joining Gain, Gene was CFO at privately held Imcyse SA between 2021 and 2023. Prior to Imcyse, Gene was CFO at OncoC4, a privately held biotechnology company that spun out of Merck & Co’s (MSD) acquisition of OncoImmune in 2020 where he had also been CFO. Before that, he has held the CFO role for several development- and commercial-stage biopharmaceutical companies. Prior to his operational experience, Gene covered the biotechnology and life sciences sector as a senior publishing analyst at various investment banks, including Gruntal & Co, Lazard, Mizuho, and HSBC. Gene received his BS in Biochemistry and MBA in Finance from Fordham University.

About GT-02287
Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric protein modulator that restores the function of the lysosomal protein enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker for neurodegeneration.

Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggests that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease.

Gain’s lead program in Parkinson’s disease has been awarded funding support from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency.

About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme.

Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.

Forward-Looking Statements
This release contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements are typically preceded by words such as “believes,” “expects,” “anticipates,” “intends,” “will,” “may,” “should,” or similar expressions. These forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct or that those goals will be achieved, and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties, including, but not limited to, statements regarding: the development of the Company’s current or future product candidates including GT-02287; expectations regarding the timing of results from a Phase 1b clinical study for GT-02287; expectations regarding the timing of patient enrollment for a Phase 1b clinical study for GT-02287; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2023 and Form 10-Q for the quarter ended September 30, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.

Investor Contacts:
Apaar Jammu and Chuck Padala
ajammu@gaintherapeutics.com
chuck@lifesciadvisors.com

Media Contacts:
Russo Partners
Nic Johnson and Elio Ambrosio
nic.johnson@russopartnersllc.com
elio.ambrosio@russopartnersllc.com
(760) 846-9256


FAQ

When will GANX's GT-02287 Phase 1b trial for Parkinson's Disease complete?

The Phase 1b trial of GT-02287 in people with Parkinson's Disease is expected to complete during the first half of 2025.

What is Gene Mack's background before joining GANX as CEO?

Gene Mack has over 25 years of life sciences experience, previously serving as CFO at Imcyse SA (2021-2023) and OncoC4, with additional CFO roles at various biopharmaceutical companies and analyst positions at major investment banks.

When did Gene Mack become interim CEO of GANX?

Gene Mack served as interim CEO of Gain Therapeutics since June 2024 before being appointed permanent CEO in January 2025.

What are GANX's clinical development plans for GT-02287 in 2025?

GANX plans to complete the Phase 1b trial for GT-02287 in Parkinson's Disease during H1 2025 and prepare for potential Phase 2 activities in H2 2025.

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