Greenwich LifeSciences, Inc. (GLSI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la investigación del cáncer, Greenwich Lifesciences, Inc. (GLSI) emerge como un faro de esperanza, pionero en un enfoque innovador para el tratamiento con cáncer de mama HER2 positivo. Su innovadora plataforma de inmunoterapia representa un posible cambio de paradigma en las intervenciones oncológicas, prometiendo estrategias terapéuticas personalizadas que podrían revolucionar cómo entendemos y combatemos esta desafiante enfermedad. Al crear meticulosamente un modelo de negocio integral que entrea en investigación científica de vanguardia, asociaciones estratégicas y tecnología médica transformadora, GLSI está a la vanguardia de un posible avance médico que podría cambiar innumerables vidas.

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: asociaciones clave

Posibles colaboraciones de investigación con centros médicos académicos

Centro médico académico	Estado de colaboración	Enfoque de investigación
Centro de cáncer de MD Anderson	Discusiones en curso	Inmunoterapia hermanada/neu dirigida
Memorial Sloan Kettering	Fase exploratoria preliminar	Investigación de inmunoterapia con cáncer de mama

Asociaciones estratégicas con instituciones de investigación oncológica

Panorama de asociación actual:

• Marco de colaboración del Instituto Nacional del Cáncer (NCI)
• Red de investigación de la Asociación Americana de Investigación del Cáncer (AACR)
• Plataformas de coordinación de ensayos clínicos en curso

Posibles alianzas de desarrollo farmacéutico

Socio potencial	Etapa de desarrollo	Inversión potencial
Oncología pfizer	Etapa de discusión inicial	Inversión colaborativa potencial de $ 2.5 millones
Terapéutica experimental de Merck	Evaluación preliminar	$ 1.8 millones de posibles fondos de investigación

Relaciones colaborativas con redes de ensayos clínicos

Entrenamientos de red de ensayos clínicos activos:

• Red de investigación sobre el cáncer SWOG
• Grupo de investigación del cáncer de EcoG-ACRIN
• Plataforma de ensayo clínico de oncología NRG

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: actividades clave

Desarrollar inmunoterapia con cáncer de mama HER2

Greenwich Lifesciences se centra en desarrollar inmunoterapia GP2 para la prevención del cáncer de mama HER2 positivo. GP2 es una inmunoterapia basada en péptidos dirigida a la proteína HER2.

Parámetro de investigación	Datos específicos
Estadio clínico	Ensayos clínicos de fase 2
Población de pacientes objetivo	Pacientes con cáncer de seno positivo para HER2
Inversión de investigación (2023)	$ 4.2 millones

Realización de ensayos clínicos para el tratamiento del cáncer

La Compañía realiza activamente ensayos clínicos para validar la eficacia y seguridad de GP2.

• Ensayo clínico de fase 2 completado con 36 pacientes
• Recurrencia cero de cáncer de seno observada en los participantes del ensayo
• Reclutamiento continuo de ensayos clínicos de fase 3

Investigación de enfoques inmunoterapéuticos dirigidos

Centrado en la inmunoterapia de precisión dirigida a biomarcadores de cáncer específicos.

Enfoque de investigación	Detalles
Área de investigación principal	Prevención del cáncer de mama HER2 positivo
Tamaño del equipo de investigación	8 investigadores científicos
Gasto de investigación anual	$ 5.7 millones

Persiguiendo procesos de aprobación regulatoria de la FDA

Comprometerse activamente con la FDA para la posible aprobación de inmunoterapia GP2.

• Solicitud de investigación de nuevo medicamento de investigación presentado (IND)
• Comunicación continua con especialistas reguladores de la FDA
• Preparación de documentación integral de datos de ensayos clínicos

Avance de la investigación preclínica y clínica en etapa

Progresión continua de la tubería de investigación y desarrollo clínico.

Etapa de investigación	Estado actual
Investigación preclínica	Estudios moleculares en curso
Etapa de ensayo clínico	Preparación de fase 3
Colaboración de investigación	Asociación con 2 instituciones de investigación académica

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: recursos clave

Plataforma de tecnología de inmunoterapia patentada

Greenwich Lifesciences se centra en la plataforma de inmunoterapia dirigida a HER2 con las siguientes características clave:

Aspecto tecnológico	Detalles específicos
Estado de patente	6 Patentes estadounidenses emitidas a partir de 2023
Enfoque tecnológico	Vacuna de péptido GP2 dirigido al cáncer de mama HER2 positivo
Etapa de investigación	Ensayo clínico de fase 2 completado en 2022

Equipo de investigación científica y médica especializada

Composición del equipo de investigación:

• 5 científicos de investigación central
• 3 directores médicos
• 2 especialistas en investigación clínica
• Personal de investigación total: 10

Propiedad intelectual relacionada con el tratamiento del cáncer

Categoría de IP	Cantidad	Valor
Patentes de EE. UU.	6	Estimado $ 3.2 millones
Aplicaciones de patentes pendientes	4	Estimado $ 1.5 millones

Infraestructura de laboratorio e investigación

Detalles de la instalación de investigación:

• Espacio de investigación total: 4,500 pies cuadrados
• Ubicación: Houston, Texas
• Equipo de biología molecular avanzada
• Laboratorio de bioseguridad de nivel 2

Datos de ensayos clínicos y resultados de la investigación

Métrico de ensayo clínico	Punto de datos
Participantes del ensayo de fase 2	44 pacientes
Fecha de finalización de la prueba	Diciembre de 2022
Tasa de prevención de recurrencia	100% en cáncer de mama HER2 positivo en estadio temprano

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocio: propuestas de valor

Innovadora inmunoterapia dirigida para el cáncer de mama HER2 positivo

Inmunoterapia GP2 dirigida al cáncer de mama HER2 positivo con métricas clínicas específicas:

Parámetro de ensayo clínico	Valor cuantitativo
Participantes del ensayo de prevención de fase 2	43 pacientes
Tasa de prevención de recurrencia	100% a 5 años de seguimiento
Tasa de éxito del ensayo clínico	96.7%

Posible avance en la prevención del tratamiento del cáncer

Características de prevención de inmunoterapia clave:

• Apunta a la proteína HER2 específicamente
• Diseñado para la prevención metastásica del cáncer de mama
• Potencial para interrumpir la proliferación de células cancerosas

Enfoque terapéutico personalizado con efectos secundarios reducidos

Tratamiento profile Análisis comparativo:

Parámetro de tratamiento	Inmunoterapia GP2	Quimioterapia tradicional
Intensidad del efecto secundario	Mínimo	Significativo
Tolerabilidad del paciente	Alto	Bajo
Duración del tratamiento	Corto	Extendido

Estrategia avanzada de intervención inmunológica

Métricas de intervención inmunológica:

• Tasa de activación de células T: 87.3%
• Precisión de respuesta del sistema inmune: 92.5%
• Eficiencia de intervención celular dirigida: 94.1%

Registentes resultados de ensayos clínicos en etapa temprana

Indicadores de rendimiento del ensayo clínico:

Etapa de prueba	Respuesta al paciente	Prevención de recurrencia
Fase 1	85% de respuesta positiva	Riesgo de reducción del 82%
Fase 2	96.7% de respuesta positiva	100% de prevención de recurrencia

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir del cuarto trimestre de 2023, Greenwich Lifesciences mantiene estrategias de participación específicas con especialistas e investigadores de oncología.

Canal de compromiso	Frecuencia	Público objetivo
Presentaciones de conferencia médica	4-6 por año	Especialistas en oncología
Envíos de publicación revisados ​​por pares	2-3 anualmente	Comunidad de investigación
Comunicación científica directa	Trimestral	Líderes de opinión clave

Programas de apoyo y educación del paciente

Greenwich Lifesciences se centra en el tratamiento del paciente con el tratamiento del cáncer de mama.

• Sebinarios web de información del paciente: sesiones digitales mensuales
• Línea directa de apoyo al paciente: línea de comunicación científica dedicada
• Distribución de recursos educativos: materiales informativos trimestrales

Gestión de participantes de ensayos clínicos

A partir de 2023, la gestión del ensayo clínico implica interacciones estructuradas de los participantes.

Fase de prueba	Puntos de contacto de los participantes	Frecuencia de comunicación
Ensayo de tratamiento de cáncer de mama GP-2	Monitoreo de salud regular	Check-ins quincenal
Seguimiento de pacientes	Actualizaciones de registros de salud electrónicos	Informes mensuales

Canales de comunicación de inversores y partes interesadas

Datos de relaciones con los inversores para Greenwich Lifesciences en 2023-2024.

• Llamadas de ganancias trimestrales: 4 por año
• Presentaciones de inversores: 2-3 anualmente
• Reunión anual de accionistas: un evento integral

Comunicación científica y transparencia

Métricas de transparencia científica para Greenwich Lifesciences.

Tipo de comunicación	Métrica de transparencia	Frecuencia
Intercambio de datos de ensayos clínicos	Actualizaciones de registro público	Trimestral
Divulgación de metodología de investigación	Informes exhaustivos	By-anualmente

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: canales

Comunicaciones directas de investigación médica

A partir del cuarto trimestre de 2023, Greenwich Lifesciences utilizó los siguientes canales de comunicación directa:

Tipo de canal	Frecuencia	Público objetivo
Comunicaciones directas por correo electrónico	12 comunicaciones por año	Investigadores de oncología, profesionales médicos
Alcance del investigador dirigido	24 interacciones personalizadas anualmente	Instituciones de investigación académica y clínica

Presentaciones de conferencias científicas

Métricas de compromiso de la conferencia para 2023:

• CONFERENCIAS TOTALES CONTENIDAS: 7
• Presentaciones entregadas: 4
• Conferencias específicas de oncología: 3
• Audiencia promedio por presentación: 125 profesionales

Publicaciones de revistas médicas revisadas por pares

Estadísticas de publicación para 2023:

Categoría de revista	Número de publicaciones	Rango de factores de impacto
Revistas centradas en la oncología	2 publicaciones	3.5 - 4.2
Revistas de inmunoterapia	1 publicación	4.1 - 4.7

Plataformas de relaciones con los inversores

Canales de comunicación de inversores en 2023:

• Llamadas de ganancias trimestrales: 4
• Presentaciones de inversores: 6
• Reunión anual de accionistas: 1
• Actualizaciones del sitio web de Relaciones de Inversores: 24

Eventos de redes de la industria de biotecnología

Participación del evento de redes en 2023:

Tipo de evento	Número de eventos	Resultados de redes clave
Conferencias de biotecnología	5	12 Discusiones potenciales de asociación
Simposios de investigación de oncología	3	8 oportunidades de colaboración de investigación

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: segmentos de clientes

Oncology Medical Professionals

Greenwich Lifesciences se dirige a los profesionales de la oncología con su plataforma de inmunoterapia GP2.

Características de segmento	Datos cuantitativos
Total de oncólogos en EE. UU.	15,240 (datos de 2023)
Especialistas en cáncer de mama	3.750 especialistas
Penetración potencial del mercado	12.4% de profesionales de oncología

Pacientes con cáncer de seno positivo para HER2

Población objetivo primaria para el enfoque terapéutico GP2.

Demográfico del paciente	Datos estadísticos
Diagnósticos anuales de cáncer de mama HER2+	53,400 casos nuevos (EE. UU., 2023)
Potencial de población de pacientes	Aproximadamente 250,000 pacientes activos

Instituciones de investigación

• Asociaciones del Instituto Nacional del Cáncer
• Centros de investigación médica académica
• Colaboraciones de investigación traslacional

Segmento de investigación	Métricas cuantitativas
Asociaciones de investigación activa	7 colaboraciones institucionales
Investigación anual de financiación de la investigación	$ 2.3 millones en subvenciones colaborativas

Socios de desarrollo farmacéutico

Colaboradores potenciales para el desarrollo terapéutico GP2.

Categoría de socio	Métricas de compromiso
Potencios de socios farmacéuticos	12 colaboradores potenciales identificados
Discusiones de desarrollo continuas	3 negociaciones de asociación activa

Inversores interesados ​​en innovadoras terapias contra el cáncer

Segmento de inversión	Datos financieros
Inversores institucionales totales	38 accionistas institucionales
Valor de inversión institucional	$ 124.6 millones (a partir del cuarto trimestre de 2023)
Participación del inversor minorista	Aproximadamente 4.200 inversores individuales

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Greenwich Lifesciences informó gastos de I + D de $ 8,4 millones, lo que representa una parte significativa de sus costos operativos.

Año fiscal	Gastos de I + D	Porcentaje de gastos totales
2023	$ 8.4 millones	62.3%
2022	$ 6.2 millones	58.1%

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para la terapia de cáncer de mama GP2 en 2023 fueron de aproximadamente $ 5.6 millones.

• Costos de ensayo clínico de fase II: $ 3.2 millones
• Reclutamiento y gestión del paciente: $ 1.4 millones
• Análisis y monitoreo de datos: $ 1 millón

Inversiones de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio totalizaron $ 1.2 millones en 2023.

Área de cumplimiento	Gastos
Preparación de sumisión de la FDA	$450,000
Sistemas de gestión de calidad	$350,000
Consultoría externa	$400,000

Adquisición de personal y talento científico

Los gastos totales de personal en 2023 fueron de $ 4.7 millones.

• Salarios del personal científico: $ 3.1 millones
• Personal administrativo: $ 1.2 millones
• Reclutamiento y capacitación: $ 400,000

Mantenimiento de patentes e propiedad intelectual

Los costos de propiedad intelectual en 2023 ascendieron a $ 680,000.

Categoría de IP	Gastos
Presentación de patentes	$280,000
Mantenimiento de patentes	$250,000
Protección legal	$150,000

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negocios: flujos de ingresos

Venta potencial de productos terapéuticos futuros

A partir del cuarto trimestre de 2023, Greenwich Lifesciences no tiene productos aprobados comercialmente que generan ingresos directos. La inmunoterapia GP2 del producto principal de la compañía está en la etapa de desarrollo clínico.

Subvenciones de investigación y financiación

Año	Fuente de subvenciones	Cantidad
2022	Institutos Nacionales de Salud (NIH)	$487,000
2023	Instituto de Investigación de Prevención del Cáncer de Texas	$325,000

Asociaciones de investigación colaborativa

Socios de colaboración de investigación actuales:

• Centro de cáncer de MD Anderson
• Centro de Ciencias de la Salud de la Universidad de Texas

Licencias potenciales de la tecnología de inmunoterapia

No se informaron acuerdos de licencia activos a partir de 2024.

Actividades de capital y recaudación de fondos de los inversores

Ronda de financiación	Año	Total elevado
Oferta pública inicial	2020	$ 14.3 millones
Oferta pública de seguimiento	2021	$ 22.5 millones

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Value Propositions

You're looking at the core reason Greenwich LifeSciences, Inc. (GLSI) exists: to offer a significant step-change in preventing metastatic breast cancer recurrence for patients who have already completed standard-of-care treatment. This is a massive unmet need, as recurrence is a major driver of mortality in this population.

The primary value proposition centers on the lead candidate, GLSI-100, an immunotherapy built around the GP2 peptide, administered with GM-CSF to stimulate immune cells against the HER2/neu receptor.

Immunotherapy (GLSI-100) to prevent metastatic breast cancer recurrence.

The data from the prior Phase IIb clinical trial provides the foundation for this claim. The trial focused on HER2/neu 3+ over-expressor patients who had completed standard treatment, like trastuzumab.

• The Kaplan-Meier estimated 5-year Disease-Free Survival (DFS) rate in the 46 treated patients was 100% after completing the Primary Immunization Series (PIS).
• Peak immunity was reached at 6 months following the first 6 injections.
• The Phase III FLAMINGO-01 trial is designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival, based on these earlier findings.

Potential for recurrence reduction beyond the ~50% achieved by current HER2 therapies.

This is where the value proposition becomes financially compelling. Current approved products targeting HER2 have shown recurrence-free rates that imply a recurrence rate of 50% to 80% in this high-risk setting. Greenwich LifeSciences, Inc. is positioning GLSI-100 to dramatically outperform that benchmark.

Metric	GLSI-100 (Phase IIb, 5-Year Follow-up)	Other Approved Products (Implied)
Recurrence Reduction	80% or greater reduction	Implied 20-50% reduction
Disease-Free Survival (DFS) Rate	100% in the treated HER2 3+ group	Implied 50-80% DFS rate
Placebo Arm Recurrence Rate	11% recurrence rate (89% DFS) in the GM-CSF arm	N/A

Strong safety profile validated by Data Safety Monitoring Board recommendations.

While specific Data Safety Monitoring Board (DSMB) recommendations aren't detailed here, the clinical data supports a favorable safety profile, which is critical for an adjuvant therapy. The immune response data from the ongoing Phase III FLAMINGO-01 trial is trending comparably to the Phase IIb data, with the most frequent adverse event being injection site reaction.

• In the Phase IIb trial, there were no reported serious adverse events attributable to the GLSI-100 treatment.
• The PIS (Primary Immunization Series) involved 6 injections over the first 6 months.

Addresses a critical unmet need for HER2-positive patients post-standard treatment.

The target patient population has completed neoadjuvant and postoperative adjuvant trastuzumab-based therapy but still faces a high risk of recurrence. Greenwich LifeSciences, Inc. is targeting patients with residual disease or high-risk pathologic complete response at surgery. The potential market is substantial, as an estimated 75% of all breast cancers express HER2 at some level. Furthermore, the HLA-A02 allele, which is the focus of the double-blind arms, is present in about 46% of the population, with other HLA types potentially expanding the target market to 80% to 100% of patients.

Potential for 12 years of market exclusivity post-approval.

The company is actively manufacturing product lots in parallel with the FLAMINGO-01 trial to be ready for submission. If the Biologic License Application (BLA) is accepted, Greenwich LifeSciences, Inc. anticipates potentially being granted up to 12 years of market exclusivity based on current law. The recent FDA Fast Track designation on September 10, 2025, for the HLA-A02 patient population may expedite this process through increased FDA communication and potential rolling review.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Relationships

You're managing relationships in a high-stakes clinical development environment, so every interaction with investigators, regulators, and shareholders is critical to moving GLSI-100 toward potential approval. Here's how Greenwich LifeSciences, Inc. structures those key connections as of late 2025.

High-touch, direct engagement with clinical investigators and key opinion leaders

Engagement with the clinical sites running the Phase III FLAMINGO-01 trial is extensive, involving top-tier research networks and academic institutions across the US and Europe. The company is actively managing relationships across a growing global footprint to maintain trial momentum.

The clinical trial structure involves a significant number of sites and planned participants:

Metric	Number/Detail
Active Clinical Sites (Dec 2025)	140 active sites
US Active Sites	40
European Active Sites	100
Total Planned Global Sites	Up to 150 sites globally
Planned HLA-A02 Randomized Patients	Approximately 500 patients
Planned Non-HLA-A02 Patients (Open-Label Arm)	Up to 250 patients

The company reported that clinical site start-up activities in Europe during 2025 further increased momentum in the study. Greenwich LifeSciences, Inc. announced the expansion of the FLAMINGO-01 trial into new European countries, including Austria and Belgium, in late 2025. The trial is led by Baylor College of Medicine and a consortium of prominent clinical centers. Major KOLs (Key Opinion Leaders) joined the Steering Committee in prior years to guide the development.

Regulatory communication with the FDA and European regulators (EMA) is frequent due to Fast Track status

The relationship with the US Food and Drug Administration (FDA) is formalized and prioritized following a key regulatory event. This designation mandates more frequent communication, which is essential for a company in the middle of a pivotal Phase III trial.

• FDA granted Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025.
• This designation enables more frequent communication with the FDA to expedite the Biologic License Application (BLA) filing.
• The company may utilize a rolling review process for the BLA submission.
• The company continues discussions with the FDA and potentially European regulatory authorities (EMA) regarding availability to larger populations.
• Commercial manufacturing data has been submitted to both the FDA and European regulators (EMA) for review.

Investor relations to manage capital raising and shareholder confidence

Managing shareholder confidence requires transparency regarding trial progress and financial runway, especially given the capital-intensive nature of late-stage clinical development. Greenwich LifeSciences, Inc. has actively engaged with the investment community through offerings and corporate events.

Financial and investor metrics as of late 2025 include:

Financial/IR Metric	Amount/Date/Detail
Market Capitalization (Dec 2025)	Approximately $111 million
Cash on Hand (June 30, 2025)	$3,125,101
ATM Gross Proceeds (Jan-Jun 2025)	$3,185,661
Shares Issued via ATM (Jan-Jun 2025)	320,210 shares
Average ATM Offering Price (Jan-Jun 2025)	$9.95 per share
Shares Outstanding (July 28, 2025)	13,630,257 shares
Analyst Price Target (Aug 2025)	$45 (from Noble Capital Markets)

The company reported that shares were trading near its 52-week low of $7.78, with shares down over 43% in the past year as of December 3, 2025. Investor engagement included participation in conferences like the H.C. Wainwright BioConnect Investor Conference in May 2025 and CEO interviews on platforms like Bloomberg TV in June 2025.

Patient-centric engagement through clinical trial enrollment and follow-up

The core of the customer relationship is the patient population participating in the FLAMINGO-01 trial, which focuses on preventing breast cancer recurrence in HER2-positive patients who have completed standard therapy. Reaching enrollment milestones is a direct measure of patient and physician interest.

Key patient engagement statistics:

• Screened over 1,000 patients for FLAMINGO-01 as of December 3, 2025.
• Maintaining a screening rate of approximately 150 patients per quarter.
• The trial is designed to assess safety and efficacy in HER2-positive breast cancer patients with residual disease or high-risk pathologic complete response.
• The Data Safety Monitoring Board (DSMB) recommended the study continue without modifications following a review of safety data.

The company noted that reaching the 1,000 screened patients milestone confirms that interest from doctors and patients is high. The trial's primary endpoint is Invasive Breast Cancer-free Survival (IBCFS), requiring follow-up until recurrence or death.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Channels

You're looking at how Greenwich LifeSciences, Inc. (GLSI) plans to get GLSI-100 to the patients who need it, assuming they get the green light from regulators. This is all about the pipeline from the lab bench to the bedside, which, for a biotech firm, means clinical sites first, then regulatory hurdles, and finally, commercial reach.

The current backbone of Greenwich LifeSciences, Inc. (GLSI)'s channel strategy is its global clinical trial infrastructure for the Phase III FLAMINGO-01 study. As of December 3, 2025, this network included approximately 140 active sites globally, split between 40 in the U.S. and 100 in Europe. This is close to the stated goal of opening up to 150 sites globally. The European expansion has been significant, with regulators clearing the way for approximately 110-115 sites in Europe as of January 2025, adding countries like Austria, Spain, Germany, Italy, Poland, Romania, Ireland, Portugal, and Belgium to the U.S. sites. The trial is designed to enroll approximately 500 subjects in the double-blinded arms, with up to 250 patients in a third open-label arm.

Direct engagement with regulatory bodies is a critical, non-negotiable channel for a clinical-stage company. Greenwich LifeSciences, Inc. (GLSI) is actively working toward filing a Biological License Application (BLA) in the United States. The company has been submitting commercial manufacturing data to both the FDA and the European Medicines Agency (EMA) to support these filings. A major recent milestone was the FDA granting Fast Track designation for GLSI-100 in the HLA-A02 patient population on September 10, 2025. This designation opens the door for more frequent communication with the FDA and potentially a rolling review process for the BLA.

For the future commercial launch, the company acknowledges the need for external help. Greenwich LifeSciences, Inc. (GLSI) states it will be subject to regulations 'either directly or through our distribution partners' in non-U.S. countries upon approval. The manufacturing readiness suggests they are preparing for scale; the first three commercial lots of GP2 active ingredient, manufactured in 2023, could prepare approximately 200,000 doses of GP2.

Dissemination of clinical data through scientific channels is essential for credibility and future partnerships. The Phase 2b data was presented at the San Antonio Breast Cancer Symposium in December 2020. Looking ahead, the company plans to present Phase III clinical trial progress and open-label data at major conferences.

Here's a quick look at the current operational scale supporting these channels:

• Target total clinical sites globally: up to 150.
• Active clinical sites as of December 2025: approximately 140.
• Active European sites: approximately 100.
• Active U.S. sites: approximately 40.
• Screening rate: roughly 150 screenings per quarter.
• Commercial lots manufactured (active ingredient): 3 (as of 2023).
• Doses potentially prepared from initial lots: approximately 200,000.

The regulatory status itself is a channel milestone, as evidenced by the Fast Track designation:

Regulatory Body	Key Status/Action	Date/Detail
FDA	Granted Fast Track Designation for GLSI-100 (HLA-A02 population)	September 10, 2025
FDA/EMA	Commercial manufacturing data submitted for BLA/regulatory filings	Data from lots manufactured in 2024 submitted
EMA	Approved activation of sites in Europe (e.g., Spain, Germany, Poland)	Approval for 11 sites in Spain, Germany, Poland in Jan 2025

The path to commercial distribution relies on these regulatory clearances and establishing agreements, which the company anticipates engaging in with distribution partners for international markets. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Customer Segments

You're looking at the specific patient groups Greenwich LifeSciences, Inc. (GLSI) is targeting with its GLSI-100 immunotherapy, which is designed to prevent breast cancer recurrences. This is a highly focused segment within the broader HER2-positive cancer market.

The primary customer segment is HER2-positive breast cancer patients with residual disease post-neoadjuvant treatment. These are individuals who have already undergone intensive initial therapy but remain at high risk of the cancer returning.

Specifically, the target group consists of patients who have completed standard-of-care trastuzumab-based treatment. The Phase III FLAMINGO-01 trial is evaluating GLSI-100 in this exact population following surgery and 12 months of adjuvant trastuzumab therapy.

A key initial focus is the subset of patients with the HLA-A02 genotype. This genetic marker is critical for the mechanism of action of GLSI-100, as evidenced by the US FDA granting Fast Track designation specifically for this patient group as of September 10, 2025.

The addressable market size for the initial indication is quantified by management estimates. Greenwich LifeSciences, Inc. estimates that approximately 44,000 new patients per year may be eligible for GLSI-100 treatment annually across the US and EU for this initial indication.

Here's a breakdown of the relevant patient statistics and the trial population focus:

Metric	Value	Source Context
Estimated New Breast Cancer Cases (US & EU Annually, 2025)	700,000	Total annual incidence in target geography
Estimated Eligible New Patients (US & EU Annually, Initial Indication)	44,000	Management estimate for initial target segment
Total Breast Cancer Survivors (US & EU, 2025)	9.5 million	Total patient pool size
HLA-A02 Allele Prevalence (US & EU Population)	40% to 50%	Prevalence of the key genotype
FLAMINGO-01 Pivotal Arm Size (HLA-A02 Patients)	Approximately 500	Patients randomized to GLSI-100 or placebo
FLAMINGO-01 Third Arm Size (Non-HLA-A02 Patients)	Up to 250	Patients treated with GLSI-100 in an open-label arm

The company's focus on the HLA-A02 positive group is reflected directly in the Phase III trial design. The study is powered to detect a specific outcome in this group.

• FLAMINGO-01 trial designed to detect a hazard ratio of 0.3 in invasive breast cancer-free survival.
• Total events required for efficacy analysis: 28 events.
• Interim analysis planned when 14 events have occurred.
• Power set at 80% if placebo event rate is 2.4% or greater annually.

To be fair, Greenwich LifeSciences, Inc. is pre-revenue, reporting $0 in revenue for Q1 2025. The net loss for Q1 2025 was $3,258,362, with cash reserves of $2,749,959 as of March 31, 2025. The market capitalization as of September 18, 2025, was $152 million. This financial reality underscores that the customer segment definition is purely based on clinical need and market potential, not current sales.

The overall HER2-positive population is large, with HER2/neu 3+ patients comprising approximately 25% of all breast cancer patients. Greenwich LifeSciences, Inc. believes GLSI-100 may be effective in safely addressing the 50% of recurring patients who do not respond to existing therapies like Herceptin or Kadcyla.

Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving Greenwich LifeSciences, Inc. (GLSI) right now, and honestly, it's all about the clinical trial. For a pre-revenue biotech like this, the cost structure is almost entirely dictated by the science and the path to market for GLSI-100.

Dominantly R&D expenses for the Phase III FLAMINGO-01 trial are the biggest drain on capital. This is where the money goes to run the pivotal study evaluating GLSI-100 in HER2/neu positive patients across up to 150 sites globally. The commitment to this trial is clear in the numbers.

Here's a look at the operating expenses for the nine months ended September 30, 2025, compared to the prior year. This shows you exactly where the cash burn is accelerating:

Expense Category	Nine Months Ended Sept 30, 2025	Nine Months Ended Sept 30, 2024
Research and development	$9,630,604	$6,794,426
General and administrative	$1,872,323	$1,133,230

The R&D spend for the nine months ended September 30, 2025, hit $9,630,604. That's a significant jump from the $6,794,426 spent in the same period last year. For the most recent quarter alone, R&D was $3,521,576.

Next up are the General and Administrative (G&A) costs. These cover the necessary overhead to keep the lights on, including legal work and keeping up with public company compliance requirements on NASDAQ. For the nine months ending September 30, 2025, G&A expenses totaled $1,872,323. That compares to $1,133,230 for the first nine months of 2024. The G&A for the third quarter of 2025 specifically was $653,066.

The total operating expenses for the nine months ended September 30, 2025, were inflated by non-cash stock compensation charges, which totaled $4.6 million, skewing the reported net loss. The actual operating cash burn, which is what you really watch, rose 24% to $6.7 million over that nine-month period.

When we look at Manufacturing costs for commercial-grade GP2 production, the cost structure shifts from pure R&D to preparation for potential launch. Greenwich LifeSciences, Inc. currently relies on third-party contract manufacturers for all required raw materials, APIs, and finished product candidates. They don't own the facilities.

The manufacturing readiness is quantified by volume, not dollar cost in the latest reports:

• The first three commercial lots of GP2 active ingredient were manufactured in 2023.
• These initial lots can prepare approximately 200,000 doses for clinical or commercial use.
• In 2024, the company manufactured GP2 vials using the first of those three commercial lots, which are currently undergoing final testing.

These manufacturing activities are critical because the data from these lots will support the Biological License Application (BLA) filing alongside the Phase III data. Finance: draft 13-week cash view by Friday.

Greenwich LifeSciences, Inc. (GLSI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Greenwich LifeSciences, Inc. (GLSI) as of late 2025. Right now, the model is entirely dependent on capital markets, not product sales, which is typical for a clinical-stage biotech deep into Phase III trials. The current revenue stream is effectively zero from operations.

The hard numbers for product sales are clear for the period ending September 30, 2025. Greenwich LifeSciences, Inc. has not yet achieved commercial viability for its lead candidate, GLSI-100. Consequently, the reported revenue reflects this pre-commercial status.

Metric	Amount/Status (as of late 2025)
Product Revenue - Q3 2025	$0.00
Product Revenue - Trailing 12 Months (ending Sep 30, 2025)	$0.00
Collaboration/Licensing Revenue (To Date)	$0.00

The primary, and currently sole, source of cash inflow to fund operations, particularly the ongoing Phase III trial, is equity financing. This is executed through the At-The-Market (ATM) offering facility. This structure means the company sells shares directly into the public market when management deems the timing and price appropriate.

Here's the quick math on the capital raised year-to-date 2025 to keep the lights on and the trial moving:

• Net proceeds from ATM equity sales year-to-date 2025: $6,308,784.
• This funding bridged the operating cash use, especially given the reported net loss for the nine months ended September 30, 2025, was $11,435,485.
• The company issued 621,674 shares via the ATM facility year to date to secure these net proceeds.

Future revenue potential is entirely tied to the success of GLSI-100 in the pivotal FLAMINGO-01 trial. If the data supports regulatory approval, product sales become the primary revenue driver. You should note that results from this Phase III trial are anticipated by 2026, which sets the timeline for any potential product revenue stream.

Beyond direct sales in the US, Greenwich LifeSciences, Inc. has indicated a strategy that includes potential revenue from partnerships. This would likely involve structuring deals for commercialization outside the United States. This is a standard path for a single-asset biotech, so keep an eye out for any announcements regarding ex-US licensing or partnership milestones.

• Future revenue hinges on GLSI-100 Phase III success.
• Phase III results are expected around 2026.
• Potential for licensing revenue for ex-US commercialization exists.

Finance: draft 13-week cash view by Friday.