Gain Therapeutics Reports Financial Results for the Fourth Quarter and Year End 2024 and Provides Corporate Update
Gain Therapeutics (NASDAQ: GANX) has reported its Q4 and full-year 2024 financial results, highlighting significant progress in the development of GT-02287 for Parkinson's disease treatment. The company has initiated dosing in its Phase 1b trial, with first analysis expected in Q2 2025.
Financial highlights for 2024 include:
- Net loss decreased to $20.4 million ($0.89 per share) from $22.3 million in 2023
- R&D expenses decreased to $10.8 million from $11.5 million in 2023
- G&A expenses reduced to $9.6 million from $10.8 million in 2023
- Cash position at $10.4 million as of December 31, 2024
Recent developments include new clinical data showing >50% increase in GCase activity among GT-02287 recipients, favorable safety profiles, and the appointment of Gene Mack as President and CEO. The company plans to submit an IND to FDA by year-end 2025.
Gain Therapeutics (NASDAQ: GANX) ha riportato i risultati finanziari del quarto trimestre e dell'intero anno 2024, evidenziando progressi significativi nello sviluppo di GT-02287 per il trattamento del morbo di Parkinson. L'azienda ha avviato la somministrazione nel suo studio clinico di Fase 1b, con la prima analisi prevista per il secondo trimestre del 2025.
I principali risultati finanziari per il 2024 includono:
- La perdita netta è diminuita a 20,4 milioni di dollari (0,89 dollari per azione) rispetto ai 22,3 milioni di dollari del 2023
- Le spese per R&S sono diminuite a 10,8 milioni di dollari rispetto agli 11,5 milioni di dollari del 2023
- Le spese generali e amministrative sono state ridotte a 9,6 milioni di dollari rispetto ai 10,8 milioni di dollari del 2023
- Posizione di cassa a 10,4 milioni di dollari al 31 dicembre 2024
Sviluppi recenti includono nuovi dati clinici che mostrano un aumento di oltre il 50% dell'attività di GCase tra i destinatari di GT-02287, profili di sicurezza favorevoli e la nomina di Gene Mack come Presidente e CEO. L'azienda prevede di presentare una richiesta IND alla FDA entro la fine del 2025.
Gain Therapeutics (NASDAQ: GANX) ha reportado sus resultados financieros del cuarto trimestre y del año completo 2024, destacando avances significativos en el desarrollo de GT-02287 para el tratamiento de la enfermedad de Parkinson. La compañía ha iniciado la dosificación en su ensayo clínico de Fase 1b, con el primer análisis esperado para el segundo trimestre de 2025.
Los aspectos financieros destacados para 2024 incluyen:
- La pérdida neta disminuyó a 20,4 millones de dólares (0,89 dólares por acción) desde 22,3 millones de dólares en 2023
- Los gastos de I+D disminuyeron a 10,8 millones de dólares desde 11,5 millones de dólares en 2023
- Los gastos generales y administrativos se redujeron a 9,6 millones de dólares desde 10,8 millones de dólares en 2023
- Posición de efectivo de 10,4 millones de dólares al 31 de diciembre de 2024
Los desarrollos recientes incluyen nuevos datos clínicos que muestran un aumento de más del 50% en la actividad de GCase entre los receptores de GT-02287, perfiles de seguridad favorables y el nombramiento de Gene Mack como Presidente y CEO. La compañía planea presentar una solicitud IND a la FDA para finales de 2025.
Gain Therapeutics (NASDAQ: GANX)는 2024년 4분기 및 연간 재무 결과를 보고하며 파킨슨병 치료를 위한 GT-02287 개발에서 중요한 진전을 강조했습니다. 회사는 1b 단계 시험에서 투약을 시작했으며, 첫 번째 분석은 2025년 2분기에 예상됩니다.
2024년 재무 하이라이트는 다음과 같습니다:
- 순손실이 2023년 2,230만 달러에서 2,040만 달러(주당 0.89달러)로 감소했습니다.
- R&D 비용이 2023년 1,150만 달러에서 1,080만 달러로 감소했습니다.
- 일반 및 관리 비용이 2023년 1,080만 달러에서 960만 달러로 줄었습니다.
- 2024년 12월 31일 기준 현금 보유액은 1,040만 달러입니다.
최근 개발 사항으로는 GT-02287 수혜자들 사이에서 GCase 활성도가 50% 이상 증가한 새로운 임상 데이터, 유리한 안전성 프로필, 그리고 Gene Mack을 사장 겸 CEO로 임명한 것입니다. 회사는 2025년 말까지 FDA에 IND를 제출할 계획입니다.
Gain Therapeutics (NASDAQ: GANX) a publié ses résultats financiers du quatrième trimestre et de l'année 2024, mettant en avant des progrès significatifs dans le développement de GT-02287 pour le traitement de la maladie de Parkinson. La société a commencé l'administration dans son essai de phase 1b, avec la première analyse prévue pour le deuxième trimestre 2025.
Les points financiers clés pour 2024 incluent :
- La perte nette a diminué à 20,4 millions de dollars (0,89 dollar par action) contre 22,3 millions de dollars en 2023
- Les dépenses de R&D ont diminué à 10,8 millions de dollars contre 11,5 millions de dollars en 2023
- Les dépenses générales et administratives ont été réduites à 9,6 millions de dollars contre 10,8 millions de dollars en 2023
- Position de trésorerie de 10,4 millions de dollars au 31 décembre 2024
Les développements récents incluent de nouvelles données cliniques montrant une augmentation de plus de 50 % de l'activité de GCase chez les récipiendaires de GT-02287, des profils de sécurité favorables et la nomination de Gene Mack en tant que Président et CEO. L'entreprise prévoit de soumettre une demande IND à la FDA d'ici la fin de 2025.
Gain Therapeutics (NASDAQ: GANX) hat seine finanziellen Ergebnisse für das vierte Quartal und das gesamte Jahr 2024 veröffentlicht und dabei bedeutende Fortschritte bei der Entwicklung von GT-02287 zur Behandlung der Parkinson-Krankheit hervorgehoben. Das Unternehmen hat die Dosisgabe in seiner Phase 1b-Studie gestartet, mit der ersten Analyse, die für das zweite Quartal 2025 erwartet wird.
Die finanziellen Highlights für 2024 umfassen:
- Der Nettoverlust verringerte sich auf 20,4 Millionen Dollar (0,89 Dollar pro Aktie) von 22,3 Millionen Dollar im Jahr 2023
- F&E-Ausgaben sanken auf 10,8 Millionen Dollar von 11,5 Millionen Dollar im Jahr 2023
- Allgemeine und Verwaltungskosten wurden auf 9,6 Millionen Dollar von 10,8 Millionen Dollar im Jahr 2023 gesenkt
- Die Liquiditätsposition betrug zum 31. Dezember 2024 10,4 Millionen Dollar
Zu den aktuellen Entwicklungen gehören neue klinische Daten, die einen Anstieg der GCase-Aktivität um mehr als 50 % bei den Empfängern von GT-02287 zeigen, günstige Sicherheitsprofile und die Ernennung von Gene Mack zum Präsidenten und CEO. Das Unternehmen plant, bis Ende 2025 einen IND bei der FDA einzureichen.
- Phase 1 trial showed >50% increase in GCase activity with favorable safety profile
- Net loss decreased by $1.9 million year-over-year
- R&D expenses reduced by $0.7 million to $10.8 million
- G&A expenses decreased by $1.2 million to $9.6 million
- Cash position declined from $16.8M to $10.4M year-over-year
- Continued net losses of $20.4 million in 2024
Insights
Gain Therapeutics' financial results reveal a company making tangible progress in operational efficiency while facing typical biotech cash management challenges. The firm reported a $20.4 million net loss for 2024 ($0.89 per share), narrowing from the previous year's $22.3 million loss ($1.71 per share). Both R&D and G&A expenses decreased year-over-year by
The concerning metric is Gain's cash position of
The timing is critical – Gain expects first analysis from their Phase 1b Parkinson's trial by Q2 2025, representing a potential value inflection point. Their strategy appears focused on generating compelling clinical data before pursuing additional funding, which could potentially improve financing terms. For a microcap biotech with only
Gain Therapeutics' clinical program for GT-02287 represents a mechanistically differentiated approach to Parkinson's disease treatment. The Phase 1 data presented at the Michael J. Fox Foundation conference revealed two critical findings: adequate CNS penetration (essential for neurological therapies) and robust target engagement with
The GCase enzyme is particularly significant in Parkinson's pathology, especially for patients with GBA1 mutations, which represent the most common genetic risk factor for the disease. By enhancing GCase activity, GT-02287 aims to address the underlying lysosomal dysfunction rather than merely treating symptoms - a potential disease-modifying approach rather than symptomatic relief.
The recently initiated Phase 1b trial represents the crucial transition from healthy volunteers to actual Parkinson's patients. The Q2 2025 readout will assess whether the biochemical target engagement translates to meaningful clinical signals. Importantly, their preclinical data now suggests broader impact beyond GCase, including mitochondrial health benefits, which could expand therapeutic potential beyond GBA1 mutation carriers to the broader Parkinson's population.
The formation of a specialized Clinical Advisory Board and engagement with FDA for potential US expansion demonstrates appropriate preparation for later-stage development. While still early in clinical development, Gain's systematic approach aligns with successful drug development practices in the neurodegenerative space.
First Analysis from Phase 1b Study of GT-02287 in Parkinson’s Disease Expected in Q2 2025
BETHESDA, Md., March 27, 2025 (GLOBE NEWSWIRE) -- Gain Therapeutics, Inc. (Nasdaq: GANX) (“Gain”, or the “Company”), a clinical-stage biotechnology company leading the discovery and development of the next generation of allosteric small molecule therapies, today reported financial results for the fourth quarter and year ended December 31, 2024, and provided a corporate update.
“2024 was a year of significant progress for Gain, as we made important advancements related to both the scientific understanding and clinical development of our lead candidate GT-02287, in development for the treatment of Parkinson’s disease with or without GBA1 mutation,” said Gene Mack, President and CEO of Gain. “Building upon this momentum in 2025, we have recently initiated dosing in our Phase 1b trial of GT-02287 and look forward to sharing results from a first analysis of the study anticipated for the end of the second quarter of 2025. We believe the observations from this analysis will mark a significant value inflection point for the GT-02287 program and importantly, inform the planning of our Phase 2 study during the second half of 2025. At the same time, we are working towards expanding GT-02287 clinical development to the U.S. and continue to have productive dialogue with the FDA. We look forward to providing continued updates on our progress as we aim to achieve these milestones throughout the year.”
Fourth Quarter 2024 and Recent Corporate Highlights
Pipeline Updates
- First participant dosed in the Phase 1b trial of GT-02287 in Parkinson’s disease. First analysis is anticipated at the end of the second quarter 2025.
- Presented new clinical data from a Phase 1 study of GT-02287 in healthy volunteers that demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement with a statistically significant >
50% increase in glucocerebrosidase (GCase) activity among those receiving GT-02287 at clinically relevant doses during the Michael J. Fox Foundation’s 16th Annual Parkinson’s Disease Therapeutics Conference in October 2024 in New York, NY. - Presented preclinical data elucidating a broader impact on the biology of Parkinson’s disease than was previously understood to be associated with GT-02287 stabilization and modulation of GCase, including important observations of its role in supporting mitochondrial health at the Society for Neuroscience 2024 conference in October 2024 in Chicago, IL.
- Presented a poster highlighting the use of the Company’s Magellan™ drug discovery platform to identify allosteric inhibitors targeting discoidin domain receptor 2 at the 36th EORTC-NCI-AACR Symposium in October 2024 in Barcelona, Spain.
Corporate Updates
- Gene Mack was appointed President and Chief Executive Officer effective January 6, 2025. Gianluca Fuggetta assumed the role of Senior Vice President Finance and Principal Financial Officer.
- Announced formation of Clinical Advisory Board composed of leading experts in Parkinson’s disease to support the advancement of GT-02287 through late-stage clinical development.
- Commenced pre-Investigational New Drug (IND) engagement with U.S. Food and Drug Administration (FDA) in preparation for expansion of GT-02287 Phase 2 clinical development to include the United States.
Upcoming Anticipated Milestones
- First analysis from Phase 1b trial evaluating GT-02287 in Parkinson’s disease patients expected at the end of Q2 2025.
- IND submission to FDA expected by year end 2025.
Year End 2024 Financial Results
Research and development (R&D) expenses decreased by
General and administrative (G&A) expenses decreased by
Net loss for the year ended December 31, 2024, was
attributable to decreases in R&D expenses of
Cash, cash equivalent and marketable securities were
About GT-02287
Gain Therapeutics’ lead drug candidate, GT-02287, is in clinical development for the treatment of Parkinson’s disease (PD) with or without a GBA1 mutation. The orally administered, brain-penetrant small molecule is an allosteric enzyme modulator that restores the function of the lysosomal enzyme glucocerebrosidase (GCase) which becomes misfolded and impaired due to mutations in the GBA1 gene, the most common genetic abnormality associated with PD, or other age-related stress factors. In preclinical models of PD, GT-02287 restored GCase enzymatic function, reduced aggregated α-synuclein, neuroinflammation and neuronal death, and improved motor function and cognitive performance. Additionally, GT-02287 significantly reduced plasma neurofilament light chain (NfL) levels, an emerging biomarker of neurodegeneration.
Compelling preclinical data in models of both GBA1-PD and idiopathic PD, demonstrating a disease-modifying effect after administration of GT-02287, suggest that GT-02287 may have the potential to slow or stop the progression of Parkinson’s disease.
Gain’s lead program in Parkinson’s disease has been awarded funding support early in its development from The Michael J. Fox Foundation for Parkinson’s Research (MJFF) and The Silverstein Foundation for Parkinson’s with GBA, as well as from the Eurostars-2 joint program with co-funding from the European Union Horizon 2020 research and Innosuisse – Swiss Innovation Agency.
About Gain Therapeutics, Inc.
Gain Therapeutics, Inc. is a clinical-stage biotechnology company leading the discovery and development of next generation allosteric therapies. Gain’s lead drug candidate, GT-02287 is currently being evaluated for the treatment of Parkinson’s disease with or without a GBA1 mutation. Results from a Phase 1 study of GT-02287 in healthy volunteers demonstrated favorable safety and tolerability, plasma exposure in the projected therapeutic range, CNS exposure, and target engagement and modulation of GCase enzyme.
Gain’s unique approach enables the discovery of novel, allosteric small molecule modulators that can restore or disrupt protein function. Deploying its highly advanced Magellan™ platform, Gain is accelerating drug discovery and unlocking novel disease-modifying treatments for untreatable or difficult-to-treat disorders including neurodegenerative diseases, rare genetic disorders and oncology.
Forward-Looking 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; the timing of any submissions to the FDA or other regulatory bodies and agencies; and the potential therapeutic and clinical benefits of the Company’s product candidates. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the Company’s business in general, please refer to the Company’s Form 10-K for the year ended December 31, 2024. All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Investor Contacts:
Apaar Jammu and Chuck 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
Gain Therapeutics, Inc Consolidated Statements of Operations | ||||||||
Year Ended December 31, | ||||||||
2024 | 2023 | |||||||
Revenues: | ||||||||
Collaboration revenues | $ | — | $ | 55,180 | ||||
Other income | — | — | ||||||
Total revenues | — | 55,180 | ||||||
Operating expenses: | ||||||||
Research and development | (10,791,058 | ) | (11,520,613 | ) | ||||
General and administrative | (9,559,534 | ) | (10,787,700 | ) | ||||
Total operating expenses | (20,350,592 | ) | (22,308,313 | ) | ||||
Loss from operations | (20,350,592 | ) | (22,253,133 | ) | ||||
Other income (expense): | ||||||||
Interest income, net | 357,096 | 494,234 | ||||||
Foreign exchange gain (loss), net | 119,120 | (429,346 | ) | |||||
Loss before income tax | (19,874,376 | ) | (22,188,245 | ) | ||||
Income tax | (536,815 | ) | (79,275 | ) | ||||
Net loss | $ | (20,411,191 | ) | $ | (22,267,520 | ) | ||
Net loss per shares: | ||||||||
Net loss per share attributable to common stockholders - basic and diluted | $ | (0.89 | ) | $ | (1.71 | ) | ||
Weighted average common stock - basic and diluted | 22,881,415 | 13,011,361 |
Gain Therapeutics, Inc Consolidated Balance Sheets | |||||||||
December 31, | December 31, | ||||||||
2024 | 2023 | ||||||||
Assets | |||||||||
Current assets: | |||||||||
Cash and cash equivalents | $ | 10,385,863 | $ | 11,794,949 | |||||
Marketable securities - current | — | 4,999,704 | |||||||
Tax credits | 271,079 | 242,577 | |||||||
Prepaid expenses and other current assets | 945,536 | 741,638 | |||||||
Total current assets | 11,602,478 | 17,778,868 | |||||||
Noncurrent assets: | |||||||||
Property and equipment, net | 103,619 | 125,962 | |||||||
Internal-use software | 134,268 | 193,375 | |||||||
Operating lease - right-of-use assets | 219,715 | 459,215 | |||||||
Restricted cash | 31,695 | 34,021 | |||||||
Long-term deposits and other noncurrent assets | 32,109 | 17,890 | |||||||
Total noncurrent assets | 521,406 | 830,463 | |||||||
Total assets | $ | 12,123,884 | $ | 18,609,331 | |||||
Liabilities and stockholder's equity | |||||||||
Current liabilities: | |||||||||
Accounts payable | $ | 946,259 | $ | 1,318,965 | |||||
Operating lease liability - current | 160,913 | 229,693 | |||||||
Other current liabilities | 2,441,761 | 2,160,366 | |||||||
Deferred grant income - current | 252,211 | 1,122,138 | |||||||
Loans - current | 110,177 | 118,797 | |||||||
Total current liabilities | 3,911,321 | 4,949,959 | |||||||
Noncurrent liabilities: | |||||||||
Defined benefit pension plan | 443,623 | 307,454 | |||||||
Operating lease liability - noncurrent | 53,598 | 229,855 | |||||||
Deferred grant income - noncurrent | 47,441 | 94,786 | |||||||
Loans - noncurrent | 328,327 | 449,053 | |||||||
Total noncurrent liabilities | 872,989 | 1,081,148 | |||||||
Total liabilities | $ | 4,784,310 | $ | 6,031,107 | |||||
Stockholders’ equity | |||||||||
Preferred stock, | $ | — | $ | — | |||||
Common stock, | 2,713 | 1,621 | |||||||
Additional paid-in capital | 88,779,318 | 73,113,079 | |||||||
Accumulated other comprehensive (loss) income | (247,549 | ) | 247,241 | ||||||
Accumulated deficit | (60,783,717 | ) | (38,516,197 | ) | |||||
Loss of the period | (20,411,191 | ) | (22,267,520 | ) | |||||
Total stockholders’ equity | 7,339,574 | 12,578,224 | |||||||
Total liabilities and stockholders’ equity | $ | 12,123,884 | $ | 18,609,331 |
