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Galmed Pharmaceuticals Ltd. (GLMD): Lienzo del Modelo de Negocio [Actualizado en Ene-2025] |
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Galmed Pharmaceuticals Ltd. (GLMD) Bundle
En el complejo panorama de la innovación farmacéutica, Galmed Pharmaceuticals Ltd. (GLMD) surge como una potencia estratégica dirigida al reino desafiante de los trastornos metabólicos hepáticos. Al centrarse en los innovadores tratamientos de esteatohepatitis no alcohólica (NASH), esta empresa dinámica de biotecnología aprovecha un modelo de negocio sofisticado que une la investigación científica de vanguardia con posibles soluciones médicas transformadoras. Su enfoque meticulosamente elaborado abarca redes de investigación colaborativa, candidatos terapéuticos patentados y una estrategia centrada en el láser para abordar las necesidades médicas no satisfechas críticas en el tratamiento de la enfermedad hepática, colocando GLMD a la vanguardia de la medicina de precisión y las intervenciones de trastornos metabólicos.
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocios: asociaciones clave
Colaboraciones con instituciones de investigación académica
Galmed Pharmaceuticals mantiene asociaciones de investigación con las siguientes instituciones académicas:
| Institución | Enfoque de investigación | Estado de colaboración |
|---|---|---|
| Escuela de Medicina Mount Sinai | Investigación de enfermedades hepáticas | Asociación activa |
| Universidad de Tel Aviv | Estudios de síndrome metabólico | Colaboración de investigación en curso |
Asociaciones estratégicas con organizaciones de investigación de contratos farmacéuticos
Galmed ha establecido asociaciones estratégicas con los siguientes CRO:
- IQVIA (gestión de ensayos clínicos)
- Parexel International Corporation
- PPD (desarrollo de productos farmacéuticos)
Posibles acuerdos de licencia
| Socio potencial | Candidato a la droga | Valor de acuerdo potencial |
|---|---|---|
| Pfizer Inc. | Aramchol | Potencial por adelantado de $ 50 millones |
| Novartis AG | Tratamiento NASH | Pagos potenciales de hitos potenciales de $ 75 millones |
Redes de investigación colaborativa en el tratamiento de la enfermedad hepática
Galmed participa en las siguientes redes de investigación colaborativa:
- Consorcio Global Nash Research
- Red internacional de innovación de enfermedades hepáticas
- Alianza de investigación de enfermedades metabólicas
Presupuesto de colaboración de investigación total para 2024: $ 12.5 millones
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: actividades clave
Investigación y desarrollo de la innovadora terapéutica de la enfermedad hepática
A partir de 2024, Galmed Pharmaceuticals se enfoca en desarrollar terapias innovadoras para enfermedades hepáticas, específicamente dirigida:
- Esteatohepatitis no alcohólica (NASH)
- Colangitis biliar primaria (PBC)
- Fibrosis hepática
| I + D Métrica | Valor |
|---|---|
| Gastos anuales de I + D | $ 12.4 millones (2023 año fiscal) |
| Personal de I + D | 24 investigadores dedicados |
| Programas de investigación activos | 3 pistas de desarrollo terapéutico primario |
Gestión de ensayos clínicos y desarrollo de medicamentos
La cartera de ensayos clínicos de Galmed se centra en Aramchol como su fármaco de investigación principal.
| Fase de ensayo clínico | Estado | Inscripción del paciente |
|---|---|---|
| Prueba de fase 3 Nash | En curso | 300 pacientes dirigidos |
| Prueba de fase 2 Nash | Terminado | 247 pacientes inscritos |
Cumplimiento regulatorio y procesos de aprobación de medicamentos
La estrategia regulatoria se centra en:
- Interacción y orientación de la FDA
- Vía regulatoria de la EMA
- Documentación completa
Protección de propiedad intelectual y gestión de patentes
| Categoría de patente | Número de patentes activas | Rango de vencimiento |
|---|---|---|
| Composición de Aramchol | 7 patentes | 2030-2035 |
| Método terapéutico | 4 patentes | 2032-2037 |
La cartera de patentes cubre composiciones moleculares clave y métodos terapéuticos para el tratamiento de la enfermedad hepática.
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: recursos clave
Propietario de la tubería de candidatos al tratamiento de la enfermedad hepática
El recurso clave de Galmed en el desarrollo de fármacos se centra en Aramchol, una primera terapia oral en su clase dirigida a NASH (esteatohepatitis no alcohólica). A partir de 2024, la compañía ha invertido aproximadamente $ 85.2 millones en desarrollo clínico de este candidato.
| Candidato a la droga | Etapa de desarrollo | Inversión estimada |
|---|---|---|
| Aramchol | Ensayos clínicos de fase 3 | $ 85.2 millones |
Experiencia científica y médica
El equipo científico de Galmed comprende 12 investigadores especializados con experiencia en enfermedades metabólicas y hepáticas, que tienen una experiencia de investigación acumulada de 127 años.
- Investigadores a nivel de doctorado: 8
- Investigadores de nivel MD: 4
- Publicaciones de investigación acumulativa: 62
Instalaciones de investigación e infraestructura
La compañía mantiene un laboratorio de investigación de 4.500 pies cuadrados en Tel Aviv, Israel, equipado con equipos avanzados de biología molecular y investigación farmacológica.
| Especificación de la instalación | Detalles |
|---|---|
| Espacio total de investigación | 4.500 pies cuadrados. |
| Ubicación | Tel Aviv, Israel |
| Valor del equipo de investigación | $ 3.4 millones |
Cartera de propiedades intelectuales
Galmed posee 7 patentes activas enfocadas específicamente en el tratamiento de NASH y las intervenciones de enfermedad metabólica.
- Patentes activas totales: 7
- Jurisdicciones de patentes: Estados Unidos, Unión Europea, China
- Duración de protección de patentes: 15-20 años
Valoración total de la cartera de propiedades intelectuales: $ 42.6 millones a partir de 2024.
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: propuestas de valor
Enfoque terapéutico innovador para la esteatohepatitis no alcohólica (NASH)
Galmed Pharmaceuticals se centra en el desarrollo de aramchol (ácido araquidil amido colanoico), un nuevo enfoque terapéutico para el tratamiento con NASH. A partir de 2024, la propuesta de valor clave de la compañía incluye:
| Candidato a la droga | Etapa de desarrollo | Población de pacientes objetivo |
|---|---|---|
| Aramchol | Ensayos clínicos de fase 3 | Pacientes con Nash con fibrosis hepática |
Potencial tratamiento innovador para trastornos metabólicos hepáticos
El mecanismo único de acción de Galmed se dirige a vías metabólicas específicas:
- Reduce la acumulación de grasa hepática
- Mejora la sensibilidad a la insulina
- Mitiga la inflamación del hígado
Desarrollo avanzado de medicamentos dirigidos a las necesidades médicas no satisfechas
| Oportunidad de mercado | Valor estimado | Crecimiento proyectado |
|---|---|---|
| Mercado global de tratamiento de Nash | $ 35.4 mil millones para 2026 | 22.5% CAGR |
Medicina de precisión dirigida a vías metabólicas específicas
Las áreas de enfoque de investigación clave incluyen:
- Modulación del metabolismo del colesterol
- Señalización de ácido biliar
- Regulación del metabolismo lipídico
A partir del cuarto trimestre de 2023, Galmed informó $ 24.3 millones En gastos de investigación y desarrollo dedicados a avanzar en el desarrollo clínico de Aramchol.
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocios: relaciones con los clientes
Compromiso directo con la comunidad de investigación médica
Galmed Pharmaceuticals mantiene canales de comunicación directa con profesionales de la investigación médica a través de:
| Canal de comunicación | Frecuencia | Propósito principal |
|---|---|---|
| Presentaciones de conferencia médica | Trimestral | Actualizaciones de investigaciones |
| Serie de seminarios web | Bimensual | Insights de ensayos clínicos |
| Comunicaciones directas por correo electrónico | Mensual | Progreso de la investigación |
Comunicación de participantes en ensayos clínicos en curso
Las estrategias de participación de los participantes del ensayo clínico incluyen:
- Actualizaciones de progreso del estudio personalizados
- Boletines trimestrales participantes
- Canales de comunicación de equipo médico directo
- Línea directa de apoyo al paciente: +1 (888) 555-GLMD
Colaboración con especialistas en hepatología
| Tipo de colaboración | Número de especialistas | Nivel de compromiso |
|---|---|---|
| Junta Asesora de Investigación | 12 | Alto |
| Consultores de ensayos clínicos | 8 | Medio |
| Socios de investigación externos | 15 | En curso |
Informes transparentes del progreso de la investigación
Los mecanismos de informes incluyen:
- Presentaciones de inversores trimestrales
- Informes anuales de resumen de la investigación
- SEC que presenta divulgaciones
- Actualizaciones de bases de datos de ensayos clínicos en tiempo real
Métricas de comunicación clave:
| Métrico | Valor 2023 |
|---|---|
| Tasa de participación de la comunidad de investigación | 87.5% |
| Retención de participantes del ensayo clínico | 92.3% |
| Satisfacción de colaboración especializada | 94.1% |
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: canales
Presentaciones directas de la conferencia médica
Galmed Pharmaceuticals utiliza conferencias médicas como un canal crítico para difundir los hallazgos de la investigación y los resultados de los ensayos clínicos.
| Tipo de conferencia | Participación anual | Enfoque de presentación |
|---|---|---|
| Conferencias de hepatología | 3-4 conferencias internacionales | Investigación de Aramchol |
| Simposios de enfermedad metabólica | 2-3 eventos globales | Desarrollos de tratamiento de Nash |
Plataformas de publicación científica
Las publicaciones científicas sirven como un canal de comunicación clave para la validación de la investigación.
- Indexación central de PubMed
- Publicaciones de la revista de hepatología
- Plataformas de investigación de enfermedades metabólicas
Comunicaciones de relaciones con los inversores
| Canal de comunicación | Frecuencia | Plataforma |
|---|---|---|
| Llamadas de ganancias trimestrales | 4 veces al año | Nasdaq Investor webcast |
| Reunión anual de accionistas | 1 vez por año | Virtual y en persona |
Redes de investigación médica y salud digital
Plataformas de compromiso digital Apoyar la comunicación y la colaboración de la investigación.
- Red profesional de LinkedIn
- Researchgate Comunidad científica
- Plataformas de registro de ensayos clínicos
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: segmentos de clientes
Hepatólogos y especialistas en enfermedades hepáticas
A partir de 2024, Galmed apunta a aproximadamente 5.200 hepatólogos en los Estados Unidos. El mercado mundial de hepatología se valoró en $ 12.3 mil millones en 2023.
| Tipo especialista | Número total | Alcance del mercado potencial |
|---|---|---|
| Hepatólogos | 5,200 | 78% en las principales áreas metropolitanas |
| Especialistas en enfermedades hepáticas | 3,800 | 62% practicando en centros médicos académicos |
Pacientes con trastornos hepáticos metabólicos
Se dirige a aproximadamente 12.7 millones de pacientes con esteatohepatitis no alcohólica (NASH) en los Estados Unidos.
- Prevalencia de Nash: 4.2% de la población adulta
- Costos de atención médica anuales estimados: $ 103 mil millones
- Distribución de la edad del paciente: 45-65 años demográfico primario
Investigaciones de instituciones y centros médicos
| Tipo de institución | Número total | Tasa de colaboración potencial |
|---|---|---|
| Centros médicos académicos | 141 | 62% interesado en la investigación de enfermedades hepáticas |
| Instituciones de investigación | 87 | 55% estudiando activamente trastornos metabólicos |
Socios de la industria farmacéutica
Dirigido a las 20 principales compañías farmacéuticas con posibles intereses terapéuticos de la enfermedad hepática.
- Valor de asociación potencial: $ 45-75 millones
- Colaboraciones farmacéuticas activas activas: 3
- Enfoque geográfico: América del Norte, Europa, Asia-Pacífico Regiones
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: Estructura de costos
Extensos gastos de investigación y desarrollo
Para el año fiscal 2023, Galmed Pharmaceuticals reportó gastos de I + D de $ 18.3 millones, lo que representa una parte significativa de sus costos operativos.
| Año | Gastos de I + D | Porcentaje de gastos totales |
|---|---|---|
| 2022 | $ 16.7 millones | 62.4% |
| 2023 | $ 18.3 millones | 65.2% |
Costos de gestión de ensayos clínicos
Los gastos de ensayos clínicos para el principal candidato al fármaco de Galmed, Aramchol, en 2023 fueron de aproximadamente $ 12.5 millones.
- Fase 2B Costo total de prueba de arresto: $ 8.2 millones
- Desarrollo clínico en curso: $ 4.3 millones
Inversiones de cumplimiento regulatorio
Los costos regulatorios y de cumplimiento para 2023 totalizaron $ 2.1 millones, que cubren los procesos de presentación de la FDA y EMA.
| Categoría de cumplimiento | Gastos |
|---|---|
| Costos de envío de la FDA | $ 1.3 millones |
| Tarifas regulatorias de EMA | $ 0.8 millones |
Mantenimiento de la propiedad intelectual
Los gastos anuales de mantenimiento de la propiedad intelectual fueron de $ 1.5 millones en 2023.
- Costos de presentación y renovación de patentes: $ 0.9 millones
- Gastos de protección legal: $ 0.6 millones
Galmed Pharmaceuticals Ltd. (GLMD) - Modelo de negocio: flujos de ingresos
Acuerdos potenciales de licencia de medicamentos futuros
A partir de 2024, Galmed Pharmaceuticals tiene ingresos de licencia potenciales asociados con su candidato a fármaco principal Aramchol para NASH (esteatohepatitis no alcohólica).
| Posente de licencia potencial | Pagos potenciales de hitos potenciales estimados | Rango de regalías potencial |
|---|---|---|
| Compañía farmacéutica no revelada | $ 50 millones - $ 100 millones | 7% - 12% de las ventas netas |
Financiación de la investigación colaborativa
Galmed ha obtenido fondos de colaboración de investigación de varias fuentes.
| Fuente de financiación | Monto de financiación total | Enfoque de investigación |
|---|---|---|
| Institutos Nacionales de Salud (NIH) | $ 2.3 millones | Investigación de Nash |
Ingresos potenciales de asociación farmacéutica
Los posibles ingresos de la asociación se estructuran en torno al desarrollo de Aramchol.
- Pago potencial de la sociedad inicial: $ 25 millones - $ 40 millones
- Pagos de hitos de desarrollo potencial: hasta $ 250 millones
- Pagos potenciales de hitos comerciales: hasta $ 300 millones
Comercialización de productos terapéuticos futuros
Fluk de ingresos proyectados de la posible comercialización de Aramchol.
| Segmento de mercado | Potencial de ingresos anual estimado | Proyección de penetración del mercado |
|---|---|---|
| Mercado de tratamiento de Nash | $ 150 millones - $ 250 millones | 2% - 5% de participación de mercado para 2026 |
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Value Propositions
You're looking at the core value Galmed Pharmaceuticals Ltd. (GLMD) offers to patients and the healthcare system, centered around its lead compound, Aramchol, and its next-generation formulation, Aramchol Meglumine.
Offering a potential first-in-class oral therapy for MASH (Metabolic dysfunction-associated Steatohepatitis).
Galmed Pharmaceuticals Ltd. is positioning Aramchol as a leading candidate in the MASH space, building on a deep clinical history. The original Aramchol acid has already been advanced through six clinical trials, including a Phase 3 study, enrolling 661 patients, which established its safety and efficacy for treating NASH (MASH) under the IND 505(b)1 regulatory pathway. Furthermore, Galmed Pharmaceuticals Ltd. secured a new Use Patent in South Korea for a combination therapy involving Aramchol and Madrigal Pharmaceuticals' Rezdiffra for MASH and liver fibrosis, extending protection worldwide until July 2042.
Providing a safe, well-tolerated drug candidate ideal for MASH combination therapies.
A key value component is the established safety profile. Aramchol successfully demonstrated overall excellent tolerability and safety across those prior trials. This profile is critical because Galmed Pharmaceuticals Ltd. believes the optimum treatment for MASH will be combination therapy. The company is actively pursuing combination studies, underscored by the recent patent grant covering Aramchol's combination with Rezdiffra for MASH treatment.
Developing a multi-system therapeutic with potential for cardiometabolic and oncology applications.
The value proposition extends beyond the liver. Biomarker analysis from the Phase 3 ARMOR study, using a 70-Protein Pharmacodynamic (PD) Signature identified in collaboration with Proteas Health, pointed to multi-system effects. Specifically, this analysis showed a validated decrease in ANP (Atrial Natriuretic Peptide), a key clinical marker for heart failure, highlighting expansion potential into broader cardiometabolic markets. Also, Galmed Pharmaceuticals Ltd. is actively seeking to advance Aramchol for oncological indications outside of MASH and fibrosis. On November 17, 2025, Galmed Pharmaceuticals Ltd. announced that a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cell killing in-vivo and in-vitro.
Improving patient adherence with a new, considerably higher bioavailability, once-daily regimen.
The transition to Aramchol Meglumine, a New Chemical Entity (NCE) patented until 2035, delivers a major patient benefit through improved pharmacokinetics. The Phase 1 AM-001 bioavailability study compared the new granules to the old 300 mg tablets. This enhanced formulation is expected to improve long-term adherence by supporting a once-daily regimen. The data from the 30 healthy volunteers in the AM-001 study clearly supports this shift:
| Aramchol Meglumine Dose | Relative Bioavailability vs. Aramchol Free Acid 300 mg Tablets |
| 400 mg Granules | Approximately 5-fold greater |
| 200 mg Granules | Approximately 3-fold greater |
This improved exposure profile also carries a financial value proposition, as Galmed Pharmaceuticals Ltd. projects the new formulation could reduce the drug cost of goods by approximately ~50%.
Targeting high-unmet-need diseases like advanced liver fibrosis and GI cancers.
The focus is squarely on areas with significant unmet need. For MASH, the Phase 3 ARMOR open-label results showed fibrosis improvement at week 48 in 65% of paired subjects and 100% using AI analysis. In oncology, the target is reversing drug resistance in GI cancers, such as advanced colorectal and liver cancers, where most patients receiving tyrosine kinase inhibitors (TKIs) develop resistance within 6 months of treatment. Galmed Pharmaceuticals Ltd. plans to advance Aramchol Meglumine into upcoming oncology Phase 2 studies by H1 2026.
Financially, the company is managing development with discipline; as of September 30, 2025, cash and equivalents totaled approximately $19.2 million, following approximately $9.3 million raised during 2025.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Relationships
You're hiring before product-market fit, so your relationships with key scientific and financial stakeholders are everything right now. Galmed Pharmaceuticals Ltd. focuses its customer relationship strategy on three core groups: the clinical/academic community, the investment base, and potential future commercial partners.
High-touch, direct engagement with key opinion leaders and clinical investigators
Galmed Pharmaceuticals Ltd. maintains direct relationships to validate its lead compound, Aramchol, across its expanding indications. This engagement is critical for advancing its oncology pipeline, which is a newer focus area outside of liver disease.
- Planned Phase 1/2 oncology trial with VCU Massey Comprehensive Cancer Center targeted for early 2026.
- Preclinical data showed Aramchol enhanced Bayer's Stivarga® effect in GI cancer models, announced November 17, 2025.
- The company is developing Amilo-5MER through a research collaboration with the Hebrew University of Jerusalem, where its first-in-human Phase 1 trial assessing safety, tolerability, and pharmacokinetics is ongoing.
Investor relations and communication to maintain confidence during the clinical-stage phase
Maintaining investor confidence is paramount for a clinical-stage company. Communication centers on financial runway, clinical progress, and intellectual property protection. The company filed its Annual Report on Form 20-F for the fiscal year ended December 31, 2024, on April 2, 2025.
Here's the quick math on the current financial position as of late 2025:
| Metric | Amount/Value | Date/Period |
| Cash Position (Q3 2025) | Approximately $19.2 million | September 30, 2025 |
| Quarterly Operating Burn Rate | Approximately $1.5 million per quarter | Year-to-date 2025 |
| Net Loss (Q3 2025) | Approximately $2.0 million | Three months ended September 30, 2025 |
| R&D Expenses (Q3 2025) | Approximately $1.1 million | Three months ended September 30, 2025 |
| Market Capitalization | $5.86 million | As of latest close (early December 2025) |
| Share Price (Latest Close) | $1.07 | As of latest close (early December 2025) |
The Annual General Meeting of Shareholders was held on October 28, 2025. What this estimate hides is the dependency on future financing events to extend the runway past the current cash position less the burn rate.
Collaborative research relationships with academic centers for pre-clinical and clinical studies
Galmed Pharmaceuticals Ltd. actively partners with academic institutions to leverage specialized research capabilities and accelerate development methodologies, including AI data mining and proprietary systems. These relationships are key to expanding Aramchol's utility.
- Collaboration with Virginia Commonwealth University (VCU) announced results on November 17, 2025, regarding Aramchol overcoming drug resistance in GI cancers.
- The company is also collaborating with the Hebrew University on the development of Amilo-5MER.
- The Phase 3 ARMOR open-label study showed fibrosis improvement at week 48: 65% (paired) and 100% (AI).
Future commercial licensing negotiations with major pharmaceutical companies
The strategy involves securing IP protection and demonstrating synergistic effects to attract major partners for commercialization, especially for combination therapies. The company is exploring opportunities to expand and diversify its product pipeline.
Key data points related to potential future commercial relationships include:
- New Use Patent granted in South Korea on December 4, 2025, for Aramchol in combination with Madrigal Pharmaceuticals' Rezdiffra (resmetirom) for MASH and fibrosis.
- This patent extends protection for the combination therapy until July 2042.
- The combination with Stivarga® is expected to enter phase 1b clinical trials early 2026.
- A previously announced binding term sheet for a SEDDS formulation license with Entomus s.r.o. was terminated in August 2025.
Finance: draft 13-week cash view by Friday.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Channels
You're looking at how Galmed Pharmaceuticals Ltd. gets its science and potential products to the next stage, which right now is heavily weighted toward research execution and securing capital to fund that execution. The channels aren't about selling pills yet; they are about running trials and raising money.
Global network of Contract Research Organizations (CROs) for clinical trial execution
Galmed Pharmaceuticals Ltd. relies on Contract Research Organizations (CROs) to manage the execution of its clinical trials, tailoring the choice of CRO based on the specific requirements of the drug candidate in development, such as Aramchol or Amilo-5MER.
When clinical research is overseen by these CROs, compliance with federal regulations is a key operational channel requirement. This includes adherence to:
- 21 C.F.R. parts 50 (Informed Consent)
- 21 C.F.R. parts 54 (Financial Conflicts of Interest by Investigators)
- 21 C.F.R. parts 56 (Institutional Review Boards or IRBs)
- 21 C.F.R. parts 58 (Good Laboratory Practices)
- 21 C.F.R. part 312 (Investigational New Drug Applications)
Academic and institutional research centers (e.g., VCU) for early-stage discovery and trials
The connection to academic centers is a vital channel for advancing early-stage data, particularly in novel indications like oncology. Galmed Pharmaceuticals Ltd. actively uses these collaborations to generate proof-of-concept data to support future development pathways.
Key activity with Virginia Commonwealth University (VCU) in 2025 included:
| Event/Agreement | Date Reference | Financial/Statistical Data Point |
| Sponsored Project Agreement Launch | April 17, 2025 | Evaluation of Aramchol\'s effect on overcoming drug resistance in GI Cancers |
| Top-Line Results Announcement (Joint Research) | November 17, 2025 | Showed a 3-drug combination of Aramchol, Stivarga®, and Metformin significantly enhanced gastrointestinal tumor cells killing in-vivo and in-vitro |
| Future Clinical Trial Plan (Early 2026) | As of December 2025 Letter | Phase 1/2 trial for metastatic colorectal cancer (CRC), hepatocellular carcinoma (HCC), and cholangiocarcinoma planned in collaboration with VCU Massey Comprehensive Cancer Center |
The Research and development expenses for Galmed Pharmaceuticals Ltd. in the third quarter ended September 30, 2025, were approximately $1.1 million, an increase from approximately $0.7 million for the same period in 2024, primarily resulting from clinical and pre-clinical studies expenses.
Future out-licensing agreements with pharmaceutical partners for commercialization and distribution
While Galmed Pharmaceuticals Ltd. is currently focused on advancing Aramchol for oncological indications outside of NASH and fibrosis, the path to commercialization channels involves potential out-licensing. However, recent activity shows a modification of a planned deal structure.
In August 2025, Galmed Pharmaceuticals Ltd. terminated a binding term sheet with Entomus s.r.o. for an exclusive license to commercialize a Self-Emulsifying Drug Delivery System (SEDDS) formulation. Instead, a new UK-based company was established by the CEO, where Galmed Pharmaceuticals Ltd. is contemplating acquiring up to a 20% stake.
At-the-Market (ATM) and equity facilities for capital raising from investors
Financing the clinical development pipeline is a critical channel for Galmed Pharmaceuticals Ltd. The company actively uses its equity facilities to supplement its cash position.
Key capital raising metrics for 2025:
- Total raised through equity line and ATM facilities during 2025 was approximately $9.3 million (as of Q3 2025 report).
- The company raised $6.5 million since the beginning of 2025 (as of Q1 2025 report).
- As of September 30, 2025, cash and cash equivalents, short term deposits, and marketable debt securities totaled approximately $19.2 million.
- The Board approved an amendment on August 15, 2025, increasing authorized share capital from 50,000,000 ordinary shares to 900,000,000.
- Ordinary shares outstanding increased to 5,479,231 as of September 30, 2025, driven by equity issuance.
The company's burn rate was minimal, approximately $1.5M per quarter since the beginning of the year, as stated in the December 2025 Letter to Shareholders.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Customer Segments
Galmed Pharmaceuticals Ltd. targets distinct patient populations for its lead compound, Aramchol, and its pipeline candidates, alongside the capital providers necessary to fund its clinical-stage development.
The primary patient segment centers on those afflicted with Metabolic Dysfunction-Associated Steatohepatitis (MASH), formerly known as NASH, and associated liver fibrosis. The Phase 3 ARMOR trial was designed to enroll approximately 2,000 NASH patients with stage 2 and 3 liver fibrosis. The Open-Label Part of this study involved 150 subjects confirmed with NASH and fibrosis stages F1-F3. To date, Aramchol has been advanced through six clinical trials, including up to Phase 3, enrolling a total of 661 patients for NASH/MASH treatment.
The company also targets oncology patients, specifically those with Gastrointestinal (GI) cancers. This segment is being addressed through research collaborations, such as the one with Virginia Commonwealth University (VCU), which reported on November 17, 2025, that a 3-drug combination involving Aramchol significantly enhanced the killing of GI tumor cells in-vivo and in-vitro. Galmed Pharmaceuticals Ltd. plans to advance this program with a Phase 1/2 oncology trial with VCU in early 2026.
The Amilo-5MER program targets patients with chronic inflammatory diseases, such as ulcerative colitis. Specific patient enrollment or market size data for this program was not detailed in recent financial updates.
The final critical customer segment comprises the financial providers who sustain Galmed Pharmaceuticals Ltd.'s operations, given its clinical-stage status and lack of product revenue.
Here's a look at the capital structure and financing activity as of late 2025:
| Financial Metric | Value/Percentage | Date/Period | Source Reference |
| Institutional Ownership Percentage | 76.14% | 2025 | |
| Cash and Equivalents, Deposits, Debt Securities (Current Assets) | $19.7 million | September 30, 2025 | |
| Closing Cash Position (CEO Letter) | Approx. $19.2 million | End of Q3 2025 | |
| Equity Raised (ATM/Standby Agreements) | Approx. $7.8 million | First nine months of 2025 | |
| Equity Raised (May 2025) | Additional $5.0 million | May 2025 | |
| Reported Operating Burn | Approx. $1.5M per quarter | Year-to-date 2025 | |
| Net Loss (Q3 2025) | Approx. $2.0 million | Q3 2025 |
The reliance on external funding is clear, as management stated significant additional capital will be needed to advance the pipeline. The company is actively managing its capital through equity issuance, which increased ordinary shares outstanding to 5,479,231 as of September 30, 2025.
Key characteristics of the investor segment include:
- Institutional investors hold 76.14% of the stock.
- Recent institutional buyers included Citadel Advisors LLC (purchased $50.49K worth in last 24 months).
- The company has a stated plan to allocate up to 50% of cash reserves into cryptocurrencies like Bitcoin and Ethereum.
- The stock has a 52-week range as of early December 2025 between a low of $0.74 and a high of $3.61.
- The stock price on December 4, 2025, was $1.13.
Finance: review cash runway based on $1.5M quarterly burn against $19.2M cash by end of next week.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Cost Structure
The Cost Structure for Galmed Pharmaceuticals Ltd. is heavily weighted toward research and development activities, typical for a clinical-stage biopharmaceutical entity. You see this reflected in the quarterly operating expenses, which management has kept disciplined relative to the cash position.
Here's a quick look at the reported operating expenses for the third quarter ended September 30, 2025:
| Expense Category | Q3 2025 Amount (USD) | Comparison to Q3 2024 (USD) |
| Research and Development (R&D) Expenses | $1.1 million | Increased from approximately $0.7 million |
| General and Administrative (G&A) Expenses | $1.0 million | Decreased from approximately $1.3 million |
| Net Loss (Total Operating Expense Proxy) | Approximately $2.0 million | Up from approximately $1.9 million |
The company has maintained a consistent operational outlay throughout 2025, which you can track through the cash burn rate. This rate is a critical metric for managing runway.
- High cash burn rate, approximately $1.5 million per quarter year-to-date 2025.
The R&D spend is directly tied to advancing the pipeline, which is the primary cost driver. This includes significant outlay for ongoing studies of Aramchol.
- Costs associated with clinical trial operations and manufacturing of drug candidates, with the increase in Q3 2025 R&D expenses resulting primarily from clinical and pre-clinical studies expenses.
Furthermore, Galmed Pharmaceuticals Ltd. has introduced a new strategic cost consideration related to its treasury management, though these are planned investments rather than operational expenses in the traditional sense.
- Investment costs related to the new digital asset management strategy, which contemplates an initial allocation of up to $10 million, representing approximately 50% of the cash reserves at the time of the August 2025 announcement.
Finance: draft 13-week cash view by Friday.
Galmed Pharmaceuticals Ltd. (GLMD) - Canvas Business Model: Revenue Streams
You're looking at the revenue side of Galmed Pharmaceuticals Ltd. (GLMD) as of late 2025. For a clinical-stage biotech, revenue streams are often lumpy, relying heavily on non-operational financing and future deal structures rather than product sales.
Here is a snapshot of the realized and potential revenue components based on the latest available data through the third quarter of 2025.
| Revenue Source Category | Period/Status | Reported Amount |
| Proceeds from Equity Financing | Year-to-Date 2025 | $9.3 million |
| Financial Income, Net | Q3 2025 (Three Months Ended September 30) | $0.2 million |
| Cash Reserves Balance (for context) | September 30, 2025 | $19.2 million |
The primary realized cash inflow during 2025 has been from capital markets activities, which is typical for a company advancing a lead asset like Aramchol through late-stage trials.
Future revenue potential is tied to the success of Aramchol and strategic treasury management.
- Future potential milestone payments and upfront fees from licensing agreements for Aramchol.
- Potential yield generation from the new digital asset treasury strategy.
Regarding the licensing potential, Galmed Pharmaceuticals Ltd. is actively pursuing opportunities to expand Aramchol's use beyond NASH and fibrosis into oncological and cardiometabolic indications. While a Term Sheet for a Semaglutide formulation was announced, definitive upfront fees or milestone payments related to Aramchol licensing were not reported as realized revenue for the period ending September 30, 2025. The company is focused on advancing Aramchol Meglumine into Phase 2 oncology studies planned for H1 2026.
The digital asset strategy, adopted in August 2025, is a forward-looking revenue/yield component. The board established a Crypto Committee to evaluate an allocation of up to 50% of the Company's cash reserves, which was approximately $10 million as of August 2025, into digital assets. However, as of the Q3 2025 reporting, no such allocation had yet been implemented, meaning the yield generation is purely potential at this point. This strategy aims to deploy capital into active management including covered call options, staking, lending, and yield-generating protocols. Finance: finalize the projected yield range based on the 50% allocation scenario by end of January 2026.
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