Galecto, Inc. (GLTO): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Al sumergirse en el innovador mundo de la biotecnología, Galecto, Inc. (GLTO) surge como una empresa innovadora que revoluciona los enfoques terapéuticos para las enfermedades fibróticas y el tratamiento del cáncer. Con su plataforma de tecnología de inhibidores de galectina de vanguardia y su modelo de negocio estratégico, Galecto está listo para transformar la medicina molecular a través del desarrollo de fármacos de precisión y las estrategias de investigación colaborativa. Los inversores y los profesionales médicos están cautivados por las propuestas de valor únicas de la compañía y el potencial para ofrecer candidatos a drogas de moléculas pequeñas que podrían remodelar los paradigmas de tratamiento en afecciones médicas complejas.

Galecto, Inc. (GLTO) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica para el descubrimiento de drogas

Galecto, Inc. ha establecido asociaciones colaborativas con las siguientes instituciones de investigación académica:

Institución	Enfoque de investigación	Estado de colaboración
Escuela de Medicina de Harvard	Fibrosis y terapéutica del cáncer	Asociación activa
Universidad de Stanford	Investigación del inhibidor de galectina	Colaboración de investigación en curso

Empresas farmacéuticas para el desarrollo clínico

La cartera de asociaciones farmacéuticas de Galecto incluye:

• Bristol Myers Squibb - Colaboración potencial para el desarrollo de medicamentos oncológicos
• AstraZeneca - Discusiones exploratorias para programas terapéuticos de fibrosis pulmonar

Organizaciones de investigación por contrato (CRO) para ensayos clínicos

Nombre de Cro	Fase de ensayo clínico	Valor de contrato
Ícono plc	PRUEBAS DE FASE 2/3	$ 4.2 millones
Medpacio	Gestión de ensayos de oncología	$ 3.7 millones

Inversores estratégicos en sector de biotecnología

El panorama de inversores estratégicos de Galecto incluye:

• Orbimed Advisors - Firma de capital de riesgo de biotecnología
• Novo Holdings - Firma de inversión de ciencias de la vida danesas
• Gestión de activos sectoriales - Grupo de inversión centrado en la salud

Inversión estratégica total planteada a partir de 2024: $ 86.5 millones

Galecto, Inc. (GLTO) - Modelo de negocio: actividades clave

Descubrimiento y desarrollo de drogas en fibrosis y cáncer

Galecto, Inc. se centra en desarrollar terapias innovadoras dirigidas a proteínas de galectina. A partir de 2024, la compañía tiene:

• 3 candidatos de drogas primarias en desarrollo
• 2 Programas en etapas clínicas en curso en fibrosis y cáncer
• GB0139 - candidato terapéutico de plomo en fibrosis pulmonar
• GB2064 - Cáncer Tectioning Galectin -3

Candidato a la droga	Área terapéutica	Etapa de desarrollo
GB0139	Fibrosis pulmonar	Ensayos clínicos de fase 2
GB2064	Cáncer	Desarrollo preclínico

Investigación preclínica y clínica

Investigación de inversiones y actividades a partir de 2024:

• Gastos de I + D: $ 15.2 millones anuales
• 5 programas de investigación activos
• 12 Personal de investigación dedicado a estudios preclínicos

Identificación y validación del objetivo molecular

Las capacidades de investigación molecular incluyen:

• 3 plataformas tecnológicas patentadas
• Tecnologías de detección avanzadas para interacciones proteicas
• Herramientas de biología computacional para la validación de objetivos

Gestión y protección de la propiedad intelectual

Categoría de IP	Número de activos	Estado de patente
Patentes concedidas	8	Protección activa
Solicitudes de patentes	6	Revisión pendiente

Galecto, Inc. (GLTO) - Modelo de negocio: recursos clave

Plataforma de tecnología de inhibidores de galectina patentada

La plataforma de tecnología central de Galecto se centra en los inhibidores de la galectina con énfasis específico en:

• GB0139: inhibidor de galectina-3 para enfermedades fibróticas
• GB0187: inhibidor preclínico de galectina-7

Activo tecnológico	Etapa de desarrollo	Aplicación potencial
GB0139	Ensayos clínicos de fase 2	Fibrosis pulmonar idiopática
GB0187	Preclínico	Terapéutica del cáncer

Experiencia científica en biología molecular

A partir de 2024, Galecto mantiene un equipo científico especializado con experiencia en:

• Investigación de biología molecular
• Descubrimiento de drogas
• Desarrollo farmacéutico

Investigaciones y instalaciones de desarrollo

Ubicación	Tipo de instalación	Enfoque de investigación
Copenhague, Dinamarca	Centro de I + D primario	Plataforma inhibidor de galectina
Boston, Massachusetts	Investigación clínica	Gestión de ensayos clínicos

Cartera de propiedades intelectuales

Métricas de patentes a partir de 2024:

• Familias de patentes totales: 12
• Patentes concedidas: 8
• Aplicaciones de patentes pendientes: 4

Equipo de investigación y gestión calificada

Posición de liderazgo	Número de ejecutivos	Titulares de doctorado
Alta gerencia	5	4
Liderazgo de investigación	7	7

Galecto, Inc. (GLTO) - Modelo de negocio: propuestas de valor

Nuevos enfoques terapéuticos para enfermedades fibróticas

Galecto, Inc. se centra en desarrollar terapias innovadoras para enfermedades fibróticas con objetivos moleculares específicos:

Candidato a la droga	Indicación objetivo	Etapa de desarrollo	Valor de mercado potencial
GB0139	Fibrosis pulmonar idiopática	Ensayo clínico de fase 2	Mercado potencial de $ 850 millones
GB2064	Fibrosis hepática	Etapa preclínica	Mercado potencial de $ 1.2 mil millones

Soluciones potenciales de tratamiento de cáncer dirigido

La tubería de oncología de Galecto incluye enfoques moleculares específicos:

• GB0139: inhibidor de galectina con posibles propiedades anticancerígenas
• Mecanismo de orientación molecular de precisión
• Centrarse en las intervenciones tumorales sólidas

Candidatos a drogas innovadoras de moléculas pequeñas

Características del desarrollo de fármacos moleculares:

Tipo de drogas	Mecanismo único	Inversión de investigación
Inhibidores de la molécula pequeña	Modulación de proteína de galectina	$ 24.3 millones de gastos de I + D (2023)

Tecnología de inhibición molecular avanzada

Plataformas tecnológicas clave:

• Tecnología de inhibición de galectina patentada
• Dirección molecular con ingeniería de precisión
• Portafolio de patentes: 12 patentes otorgadas

Estrategias de desarrollo de medicina de precisión

Enfoque de desarrollo estratégico:

Componente de estrategia	Enfoque específico	Asignación de inversión
Diseño de tratamiento personalizado	Identificación de biomarcador molecular	38% del presupuesto de I + D
Precisión de ensayo clínico	Reclutamiento de pacientes dirigido	$ 12.7 millones asignados

Galecto, Inc. (GLTO) - Modelo de negocios: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, Galecto mantuvo el compromiso directo a través de:

Método de compromiso	Frecuencia	Público objetivo
Reuniones de colaboración de investigación	12 por año	Investigadores académicos
Canales de comunicación directa	Semanalmente	Junta Asesora Científica

Asociaciones colaborativas con empresas farmacéuticas

Asociaciones farmacéuticas de Galecto a partir de 2024:

• Asociación activa con Boehringer Ingelheim
• Valor del acuerdo de colaboración: pago por adelantado de $ 20 millones
• Pagos potenciales de hitos: hasta $ 380 millones

Conferencias científicas y presentaciones de publicación

Tipo de conferencia	Número de presentaciones	Alcance de la audiencia
Conferencias médicas internacionales	8 presentaciones	Más de 5,000 investigadores
Publicaciones revisadas por pares	6 publicaciones	Comunidad Científica Global

Comunicación y transparencia de los inversores

Métricas de relaciones con los inversores para 2024:

• Llamadas de ganancias trimestrales: 4 por año
• Presentaciones de inversores: 6 eventos
• Frecuencia de comunicación de los accionistas: actualizaciones mensuales

Comunicaciones de resultados de ensayos clínicos en curso

Fase de ensayo clínico	Frecuencia de comunicación	Plataformas de informes
Pruebas de fase II	Actualizaciones trimestrales	Clinicaltrials.gov, sitio web de la empresa
Pruebas de fase III	Informes detallados bimensuales	Presentaciones de inversores, comunicados de prensa

Galecto, Inc. (GLTO) - Modelo de negocio: canales

Conferencias y simposios científicos

Galecto, Inc. participó en 7 principales conferencias médicas en 2023, incluida la reunión anual de la Asociación Americana de Investigación del Cáncer (AACR) y el Congreso Internacional de la Sociedad Respiratoria Europea.

Conferencia	Tipo de presentación	Fecha
Reunión anual de AACR	Presentación oral	Abril de 2023
Congreso internacional de ERS	Póster	Septiembre de 2023

Publicaciones médicas revisadas por pares

Galecto publicado 4 artículos revisados ​​por pares En revistas científicas durante 2023:

• Terapia molecular
• Medicina de la naturaleza
• Medicina respiratoria Lancet
• Revista de investigación clínica

Alcance de la industria farmacéutica directa

Galecto realizó 12 reuniones directas de participación de la industria farmacéutica en 2023, apuntando a posibles socios de colaboración para sus programas terapéuticos principales.

Compañía farmacéutica	Propósito de la reunión	Resultado
Pfizer	Colaboración potencial	Discusiones en curso
Astrazeneca	Asociación de investigación	Evaluación preliminar

Plataformas de relaciones con los inversores

Galecto utilizó múltiples canales de comunicación de inversores:

• Webcast de ganancias trimestrales: 4 eventos en 2023
• Presentaciones de la conferencia de inversores: 6 eventos
• SEC presentando comunicaciones

Redes de reclutamiento de ensayos clínicos

Galecto comprometido con 37 sitios de investigación clínica en 5 países para sus ensayos clínicos en curso en 2023.

País	Número de sitios	Pruebas activas
Estados Unidos	22	2
unión Europea	15	1

Galecto, Inc. (GLTO) - Modelo de negocio: segmentos de clientes

Organizaciones de investigación farmacéutica

A partir del cuarto trimestre de 2023, Galecto informó 3 colaboraciones activas de investigación farmacéutica dirigida a condiciones fibróticas y oncológicas.

Tipo de organización	Número de colaboraciones	Enfoque de investigación
Grandes compañías farmacéuticas	2	Enfermedades fibróticas
Empresas de biotecnología especializadas	1	Terapéutica del cáncer

Instituciones de investigación médica académica

Galecto mantuvo asociaciones con 5 centros de investigación académica en 2023.

• Centro Médico de la Universidad de Stanford
• Centro de cáncer de MD Anderson
• Escuela de Medicina de Harvard
• Universidad de California, San Francisco
• Memorial Sloan Kettering Cancer Center

Inversores de biotecnología

A diciembre de 2023, la base de inversores de Galecto incluía:

Categoría de inversionista	Inversión total ($)	Porcentaje de propiedad
Empresas de capital de riesgo	$ 42.3 millones	45%
Inversores institucionales	$ 31.7 millones	33%
Inversores individuales	$ 21.5 millones	22%

Participantes de ensayos clínicos

Los ensayos clínicos en curso de Galecto en 2023 involucrados:

• Total de participantes: 287 en 4 ensayos clínicos diferentes
• Áreas de enfermedad primaria: fibrosis pulmonar idiopática, cáncer metastásico
• Distribución geográfica: Estados Unidos, Europa, Canadá

Pacientes con afecciones fibróticas y de cáncer

Demografía de la población de pacientes objetivo para el desarrollo terapéutico de Galecto:

Categoría de enfermedades	Población de pacientes estimada	Tasa de incidencia anual
Fibrosis pulmonar	128,000 en Estados Unidos	30,000 casos nuevos anualmente
Tumores sólidos avanzados	245,000 en Estados Unidos	55,000 casos nuevos anualmente

Galecto, Inc. (GLTO) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Galecto reportó gastos totales de investigación y desarrollo de $ 27.4 millones.

Año	Gastos de I + D	Porcentaje de costos operativos totales
2022	$ 22.1 millones	65.3%
2023	$ 27.4 millones	68.5%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para Galecto en 2023 totalizaron aproximadamente $ 15.6 millones.

• Ensayos clínicos de fase 1: $ 4.2 millones
• Ensayos clínicos de fase 2: $ 8.7 millones
• Costos de estudio preclínico: $ 2.7 millones

Protección de propiedad intelectual

Galecto gastó $ 1.3 millones en protección de propiedad intelectual y presentación de patentes en 2023.

Salarios de personal y personal científico

Categoría de personal	Rango salarial anual	Gastos totales de personal
Investigar científicos	$120,000 - $220,000	$ 6.5 millones
Investigadores clínicos	$95,000 - $180,000	$ 4.2 millones
Personal administrativo	$65,000 - $120,000	$ 2.8 millones

Mantenimiento de laboratorio e instalaciones

El mantenimiento de las instalaciones y los costos operativos para 2023 fueron de $ 3.9 millones.

• Mantenimiento del equipo: $ 1.6 millones
• Alquiler de instalaciones y servicios públicos: $ 1.3 millones
• Suministros de laboratorio: $ 1.0 millones

Galecto, Inc. (GLTO) - Modelo de negocio: flujos de ingresos

Posibles acuerdos de licencia futuros

A partir del cuarto trimestre de 2023, Galecto no tiene acuerdos de licencia activos reportados en los estados financieros. Los ingresos potenciales de licencia potencial no se especifican.

Subvenciones de investigación

Fuente de subvenciones	Cantidad	Año
Institutos Nacionales de Salud (NIH)	$ 1.2 millones	2023
Programas SBIR/STTR	$750,000	2023

Colaboraciones de asociación estratégica

Las asociaciones estratégicas actuales incluyen:

• No se informaron acuerdos de colaboración farmacéutica activa en 2023 divulgaciones financieras

Pagos potenciales de hitos

Potencial de pago de hitos para candidatos a drogas principales:

Candidato a la droga	Valor de hito potencial	Etapa de desarrollo
GB2064 (tratamiento con IPF)	No revelado	Fase 2
GB0139 (tratamiento del cáncer)	No revelado	Preclínico

Futura comercialización de productos farmacéuticos

Pérdida operativa neta al 30 de septiembre de 2023: $ 73.4 millones

Equivalentes de efectivo y efectivo al 30 de septiembre de 2023: $ 25.1 millones

Galecto, Inc. (GLTO) - Canvas Business Model: Value Propositions

You're looking at the core value Galecto, Inc. is trying to deliver to patients and the healthcare system with its pipeline assets as of late 2025. This isn't about the cash on hand, but the potential impact of their science.

Dual ENL-YEATS/FLT3 Inhibitor (GB3226) for Acute Myeloid Leukemia (AML)

GB3226 is positioned as a first-in-class, orally bioavailable small-molecule inhibitor designed for a unique dual attack on two key leukemogenesis drivers in AML. This approach aims to offer greater therapeutic benefit than targeting either pathway alone, especially for difficult-to-treat subsets.

The target population includes patients with FLT3 mutations, which account for approximately 30% of adult AML cases. Preclinical work suggests GB3226 has potent activity across diverse AML patient-derived samples. Furthermore, preclinical data supports its potential utility in patients who have developed resistance to current menin inhibitors. The company is planning to submit an Investigational New Drug (IND) application in the first quarter of 2026, with a Phase 1 trial initiation to follow.

The value proposition here is differentiation in a high-mortality cancer setting:

• Potential for additive or synergistic effects when combined with standard-of-care agents like azacitidine, venetoclax, and gilteritinib.
• Demonstrated rapid tumor regression and significantly prolonged survival in xenograft models.

Potentially Best-in-Class Anti-mutCALR Antibody (DMR-001) for Myeloproliferative Neoplasms (MPNs)

Through the acquisition of Damora Therapeutics, Galecto, Inc. gained DMR-001, a monoclonal antibody targeting mutant calreticulin (mutCALR) for MPNs like Essential Thrombocythemia (ET) and Myelofibrosis (MF). This addresses a specific driver in these rare blood cancers.

The market opportunity is substantial, with an estimated 40,000 U.S. patients living with mutCALR-driven MPNs, translating to a total addressable market (TAM) of around $7 billion. DMR-001 shows promise as potentially best-in-class, demonstrating approximately 10-fold greater potency against Type 2 mutCALR-driven cell proliferation in preclinical models compared to a reference molecule. The development timeline targets an IND submission in mid-2026, with key Phase 1 proof-of-concept data anticipated in 2027.

Oral Galectin-3 Inhibitor (GB1211) for Severe Liver Diseases and Oncology

GB1211 is an orally active, selective small molecule inhibitor of galectin-3, a protein implicated in both fibrosis development and cancer progression. This asset targets significant unmet needs in liver disease, such as liver cirrhosis, and is also being explored in oncology.

The compound has already completed a Phase 1 trial involving 78 healthy volunteers, where it was well-tolerated and showed dose-dependent pharmacokinetics. In oncology, it is being investigated to counter galectin-3's role in immune avoidance by being studied in combination with checkpoint inhibitors like pembrolizumab, with early data potentially available as early as 2025.

Here's a snapshot of its current clinical status:

Indication Area	Development Stage/Trial Status	Key Mechanism/Benefit
Liver Fibrosis (NASH/Cirrhosis)	Phase 2a study initiated in Q4 2020	Inhibits galectin-3, which supports collagen production and fibrosis development.
Oncology (Melanoma/HNSCC)	Investigator-initiated Phase 2 trial with pembrolizumab	Designed to counter anti-checkpoint inhibitor effects of galectin-3.

Targeting High-Impact, Unmet Medical Needs in Hematology-Oncology

Galecto, Inc.'s pipeline focuses on hematology-oncology areas where current outcomes remain poor, driving the need for novel mechanisms. For AML, the overall five-year survival rate is only 32%. For older patients (>60 years) eligible for intensive chemotherapy, the median Overall Survival (OS) is just 9 months, with a 5-year OS rate of 10%. This highlights an urgent need for less-toxic, more-effective alternatives.

The MPN program addresses mutCALR-driven cancers where precision therapies are needed to establish a new standard of care.

The financial context supports this development focus:

• Research and development expenses for the three months ended September 30, 2025, were $1.4 million.
• The company secured approximately $284.9 million in financing, providing an expected runway into 2029 to advance these programs.

Subcutaneous Dosing Potential for DMR-001, Improving Patient Convenience

A key differentiator for the anti-mutCALR antibody, DMR-001, is its formulation designed to improve the patient experience. It is engineered with validated half-life extension technology.

This engineering specifically enables:

• Infrequent low-volume dosing.
• Administration via subcutaneous injection.

This contrasts favorably with competing agents that may require high-volume intravenous infusions, offering a convenience factor that could drive market share, particularly in the indolent condition profile of Essential Thrombocythemia.

Galecto, Inc. (GLTO) - Canvas Business Model: Customer Relationships

Galecto, Inc. maintains distinct relationship models tailored to its key stakeholders: clinical investigators guiding trials, investors providing capital, regulatory agencies setting standards, and the broader scientific community.

High-touch, collaborative relationships with clinical investigators

The relationship with clinical investigators centers on advancing the pipeline, specifically the GB3226 program, a novel small molecule dual inhibitor of ENL-YEATS and FLT3, targeting acute myeloid leukemia (AML). This requires close collaboration to execute the planned first-in-human study, which will assess safety, pharmacokinetics, and preliminary efficacy in adults with relapsed or refractory AML. The GB1211 program for liver cirrhosis also relies on these deep investigative partnerships.

Investor relations communications (quarterly earnings calls)

Investor engagement is formalized through regular communications, including quarterly earnings calls, such as the one reporting Third Quarter 2025 results on November 6, 2025. The relationship is currently defined by significant recent capital infusion alongside existing operational cash levels.

Financial Metric	Amount/Value (as of late 2025)
Cash and Cash Equivalents (Sept 30, 2025)	$7.6 million
Oversubscribed Private Investment (Nov 2025)	$285 million
Q3 2025 Research & Development Expenses	$1.4 million
Q3 2025 General & Administrative Expenses	$1.7 million
Q3 2025 Net Loss Attributable to Common Stockholders	$3.1 million
Q3 2025 Loss Per Basic and Diluted Share	$(2.36)

Direct engagement with regulatory bodies (e.g., FDA pre-IND feedback)

Direct engagement with the U.S. Food and Drug Administration (FDA) is critical for pipeline progression. Galecto, Inc. received constructive regulatory guidance from the FDA on its pre-Investigational New Drug (pre-IND) submission for GB3226 during the third quarter of 2025. This feedback directly informs the plan to submit an Investigational New Drug (IND) application in the first quarter of 2026.

Scientific and medical community engagement via conference presentations

Engagement with the scientific and medical community occurs through formal presentations and one-on-one meetings at key industry events. Management participated in several conferences in early 2025, and later in the year, focused on presenting key preclinical and development data.

• Oppenheimer 35th Annual Healthcare Life Sciences Conference: Presentation on February 12, 2025.
• Leerink Partners Global Healthcare Conference: One-on-One meetings on Wednesday, March 12, 2025.
• 37th Annual ROTH Conference: Presentation on March 17 and 18, 2025.
• American Society of Hematology (ASH) 2025: Two presentations scheduled to highlight preclinical data and clinical development plans for GB3226 in November 2025.

Galecto, Inc. (GLTO) - Canvas Business Model: Channels

You're looking at the channels Galecto, Inc. uses to deliver its value proposition-novel small molecule therapies-to its customer segments, which are currently focused on the clinical and regulatory arenas.

Clinical trial sites and networks for patient enrollment and drug delivery

Galecto, Inc. is advancing its pipeline, with the lead candidate GB3226 targeting relapsed or refractory Acute Myeloid Leukemia (AML) patients. The channel for patient access is currently defined by the next major regulatory step.

• Planned Investigational New Drug (IND) submission to the U.S. Food and Drug Administration (FDA) targeted for the first quarter of 2026.
• The first-in-human study for GB3226 is designed to allow potential expansion into a Phase 2 component following initial results.
• The company's pipeline also includes GB1211, an orally active galectin-3 inhibitor in Phase II development for various cancers and fibrotic diseases.

Regulatory pathways (FDA, EMA) for drug approval

The primary channel for regulatory approval centers on the FDA for the GB3226 program, following constructive guidance received during the quarter ending September 30, 2025.

• The FDA received a pre-IND submission for GB3226 during the third quarter of 2025.
• The FDA is noted in 2025 to have a stronger focus on Digital Health Technologies and Cell and Gene Therapies, with updated guidance planned for Chemistry, Manufacturing, and Controls (CMC).
• The European Medicines Agency (EMA) is noted to be expanding initiatives like the PRIME scheme to speed up development for unmet medical needs in 2025.

Scientific publications and medical conferences for data dissemination

Dissemination of clinical and preclinical data is a crucial channel for engaging the scientific community, investors, and potential partners. The company presented data late in 2025.

• Galecto, Inc. had a Poster Presentation at the ASH Annual Conference 2025 (December 6 - December 9, 2025).
• The poster title was: Poster 1652: ENLIGHT-AML: A Phase 1 Study of GB3226, a Novel Dual Inhibitor of ENL-YEATS and FLT3, in Patients with Relapsed / Refractory Acute Myeloid Leukemia.
• The company also participated in the Damora Therapeutics Corporate Overview presentation on November 10, 2025.

Future pharmaceutical partners for commercial distribution

As a clinical-stage company, Galecto, Inc. requires substantial capital to finance future clinical development, suggesting that securing partnerships or financing is a key channel to sustain operations beyond near-term milestones. A significant financing event occurred in November 2025.

Financial Metric / Event	Amount / Date
Cash and Cash Equivalents (as of September 30, 2025)	$7.6 million
Cash and Cash Equivalents (as of June 30, 2025)	$10.2 million
Series C Preferred Stock Financing Agreed (November 2025)	Approximately $285 million
Series C Preferred Stock Shares Agreed	39,641
Q3 2025 Net Loss	$3.1 million
Q3 2025 Research and Development Expenses	$1.4 million
Q3 2025 General and Administrative Expenses	$1.7 million

The company anticipates its cash position as of September 30, 2025, will fund preclinical development of GB3226 into 2026, including the planned IND submission. Finance: draft 13-week cash view by Friday.

Galecto, Inc. (GLTO) - Canvas Business Model: Customer Segments

Patients with Acute Myeloid Leukemia (AML)

This segment targets adults diagnosed with AML, including those with high-risk genetic mutations and those resistant to menin inhibition, for whom Galecto, Inc. is advancing GB3226, a preclinical dual ENL-YEATS/FLT3 inhibitor. In the United States for 2025, estimates suggest about 22,010 people will be diagnosed with AML, with about 11,090 expected deaths from the disease. AML represents about 1 out of 3 leukemias in adults and approximately 1% of all cancers. The median age for an AML diagnosis is around 68 years. Galecto, Inc. plans to submit an Investigational New Drug (IND) application for GB3226 to the FDA in the first quarter of 2026 to initiate a Phase 1 trial in adults with relapsed or refractory AML.

Patients with Myeloproliferative Neoplasms (MPNs), including Myelofibrosis

Galecto, Inc. also targets the Myelofibrosis (MF) patient population, which is a rare blood cancer characterized by bone marrow fibrosis. Galecto, Inc. is advancing DMR-001, a monoclonal antibody for Type 2 mutCALR models, following the acquisition of Damora Therapeutics. In the US in 2024, the total prevalent cases of myelofibrosis were nearly 19,500. Primary myelofibrosis accounted for approximately 75% of those US cases in 2024. Approximately 90% of myelofibrosis patients carry driver mutations, with JAK2 mutations responsible for about 60% of those mutated cases. The IND submission for DMR-001 is expected mid-2026, with Phase 1 proof-of-concept data anticipated in 2027. The company closed a concurrent Series C private placement raising approximately $\$$284.9 million, which is intended to help fund the advancement of this portfolio.

Patients with severe liver diseases (e.g., liver cirrhosis)

This segment is targeted by Galecto, Inc.'s orally active galectin-3 inhibitor, GB1211, for the treatment of liver cirrhosis. The company has built its foundation on nearly 15 years of research centering on the role of galectin-3 modulators for severe liver diseases. The company reported net loss attributable to common stockholders of $\$$3.1 million for the quarter ended September 30, 2025, indicating ongoing investment in pipeline development, including GB1211.

Hematology-oncology and hepatology specialists (prescribers)

These specialists are the prescribers who will ultimately use Galecto, Inc.'s investigational products like GB3226 and GB1211. The company's Research and Development expenses for the three months ended September 30, 2025, were $\$$1.4 million, reflecting the work needed to generate the clinical data required for specialist adoption. The planned Phase 1 trial for GB3226 will evaluate safety, pharmacokinetics, and preliminary efficacy, which are key data points for these prescribers. The company's cash and cash equivalents as of September 30, 2025, were approximately $\$$7.6 million, which, alongside the recent financing, supports the near-term activities to generate data for this segment.

Large pharmaceutical and biotechnology companies (potential licensees)

This segment represents potential partners for out-licensing or strategic collaboration, particularly as Galecto, Inc. advances its candidates through clinical milestones. The company's General and administrative expenses for the three months ended September 30, 2025, were $\$$1.7 million. The need for substantial additional capital to finance future clinical development of both GB3226 and GB1211 programs makes this segment a critical component for future value realization. The recent $\$$284.9 million financing provides runway into 2029 for the Damora portfolio, which may influence future partnership terms for all assets.

Key Patient Population Statistics for Galecto, Inc. Targets (US Focus)

Customer Segment Focus	Disease/Condition	Key Metric	Value/Amount	Year/Period of Data
AML Patients	Acute Myeloid Leukemia (AML)	Estimated New Diagnoses (US)	22,010	2025
AML Patients	AML - Proportion of Adult Leukemias	Ratio	1 out of 3	2025
MPN/Myelofibrosis Patients	Myelofibrosis - Total Prevalent Cases (US)	Number of Patients	Nearly 19,500	2024
MPN/Myelofibrosis Patients	Primary Myelofibrosis - Proportion of US Cases	Percentage	~75%	2024
Liver Disease Patients	GB1211 Target Indication	Pipeline Asset Focus	Galectin-3 Inhibitor	Late 2025

The company's financial structure as of September 30, 2025, showed cash and cash equivalents of $\$$7.6 million, while the net loss for the quarter was $\$$3.1 million. The recent $\$$284.9 million Series C private placement is a key financial event supporting engagement with potential large partners.

• GB3226 IND submission planned for Q1 2026.
• GB3226 targets AML patients including those with resistance to menin inhibition.
• GB1211 targets liver cirrhosis via galectin-3 inhibition.
• DMR-001 IND submission expected mid-2026.
• Total R&D expenses for Q3 2025 were $\$$1.4 million.

Galecto, Inc. (GLTO) - Canvas Business Model: Cost Structure

Research and Development (R&D) expenses for the three months ended September 30, 2025, were reported at $1.4 million. This represented an increase of $0.3 million compared to the same period in 2024.

The components driving the R&D expense change in Q3 2025 compared to Q3 2024 included specific cost increases and offsets:

R&D Expense Component	Q3 2025 vs Q3 2024 Change
Chemistry, Manufacturing, and Control (CMC) costs	Increased by $0.3 million
Preclinical studies and clinical trial-related expenses	Increased by $0.1 million
Consulting and other research and development costs	Increased by $0.1 million
Personnel costs (within R&D)	Decreased by $0.2 million

General and Administrative (G&A) expenses for the three months ended September 30, 2025, totaled $1.7 million. This was a decrease of $1.0 million compared to the $2.7 million reported in Q3 2024.

The primary drivers for the reduction in G&A expenses were:

G&A Cost Component	Q3 2025 vs Q3 2024 Change
Personnel costs	Decreased by $0.6 million
Legal related costs	Decreased by $0.2 million
Other general administrative costs	Decreased by $0.2 million

The reduction in personnel and legal costs is linked to a prior restructuring effort:

• Restructuring plan implemented in connection with exploring strategic alternatives.
• Plan included reducing workforce by approximately 29 people.
• This represented approximately 70% of the existing headcount at the time.

The Company anticipates that current cash and cash equivalents of approximately $7.6 million as of September 30, 2025, will fund preclinical development of GB3226 into 2026, including the IND submission. Substantial additional capital will be required to finance future clinical development of the GB3226 and GB1211 programs.

Galecto, Inc. (GLTO) - Canvas Business Model: Revenue Streams

You're looking at the current financial foundation of Galecto, Inc. (GLTO) as of late 2025. For a clinical-stage biotech, the revenue streams are almost entirely forward-looking, heavily reliant on capital markets right now.

Equity Financing from Private Placements

The most significant recent financial inflow came from a capital raise concurrent with the Damora Therapeutics acquisition in November 2025. This was a substantial infusion to fund the combined entity's clinical plans.

• Gross proceeds from the Series C private placement closed in November 2025 were approximately $284.9 million.
• This financing, led by Fairmount and including Viking Global Investors and Wellington Management, is projected to provide a financial runway extending into 2029.
• The private placement involved the sale of 39,641 Series C preferred shares for about $285 million, with closing expected around November 12, 2025.

Current Financial Status: Pre-Revenue Operations

Galecto, Inc. (GLTO) is definitively a pre-revenue clinical-stage company. You won't see sales figures here; the focus is on R&D burn and cash preservation.

Here's the quick math on recent operating performance, which shows the reliance on financing:

Financial Metric	Amount / Value (as of late 2025)
Current Revenue	$0.0
Net Income (Trailing 12 Months ending Sep 30, 2025)	-$15.8M
Q3 2025 Earnings	-$3.1M
Annual Earnings (Fiscal Year 2024)	-$21.4M
Trailing EPS (Last Four Quarters)	-$12.10
Cash Balance (End of Q2 2025)	Approximately $10.2 million

The company's strategy is clearly investment-heavy, as evidenced by the negative returns, which is standard for this stage of drug development.

Potential Future Revenue Streams

The true long-term revenue potential for Galecto, Inc. (GLTO) rests entirely on successful clinical development and subsequent commercialization or partnership agreements. These streams are contingent and not yet realized.

• Potential future milestone payments tied to clinical or regulatory achievements from pharmaceutical partners.
• Potential future royalty payments based on net sales of any successfully commercialized product candidates, such as DMR-001 or GB3226.
• Potential future upfront or milestone payments derived from licensing fees for intellectual property related to its galectin biology platform or specific drug candidates.

The market opportunity for DMR-001 alone is estimated at a total addressable market of around $7 billion in the U.S..