Greenwich Lifesciences, Inc. (GLSI): Modelo de negócios Canvas [Jan-2025 Atualizado]

Na paisagem em rápida evolução da pesquisa do câncer, a Greenwich Lifesciences, Inc. (GLSI) surge como um farol de esperança, pioneiro em uma abordagem inovadora do tratamento do câncer de mama positivo por HER2. Sua plataforma inovadora de imunoterapia representa uma potencial mudança de paradigma em intervenções oncológicas, promissor estratégias terapêuticas personalizadas que podem revolucionar como entendemos e combatemos essa doença desafiadora. Ao elaborar meticulosamente um modelo de negócios abrangente que entrelaça a pesquisa científica de ponta, parcerias estratégicas e tecnologia médica transformadora, a GLSI fica na vanguarda de um potencial avanço médico que pode mudar inúmeras vidas.

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: Parcerias -chave

Potenciais colaborações de pesquisa com centros médicos acadêmicos

Centro Médico Acadêmico	Status de colaboração	Foco na pesquisa
MD Anderson Cancer Center	Discussões em andamento	Imunoterapia com alvo HER2/NEU
Memorial Sloan Kettering	Fase Exploratória Preliminar	Pesquisa de imunoterapia com câncer de mama

Parcerias estratégicas com instituições de pesquisa oncológica

Cenário de parceria atual:

• Estrutura de colaboração do National Cancer Institute (NCI)
• Rede de Pesquisa da Associação Americana de Pesquisa do Câncer (AACR)
• Plataformas de coordenação de ensaios clínicos em andamento

Possíveis alianças de desenvolvimento farmacêutico

Parceiro em potencial	Estágio de desenvolvimento	Investimento potencial
Pfizer oncologia	Estágio de discussão inicial	US $ 2,5 milhões em potencial investimento colaborativo
Merck terapêutica experimental	Avaliação preliminar	US $ 1,8 milhão em potencial financiamento de pesquisa

Relações colaborativas com redes de ensaios clínicos

Engajamentos de rede de ensaios clínicos ativos:

• Rede de pesquisa de câncer Swog
• Grupo de Pesquisa sobre Câncer Ecog-Acrina
• Plataforma de ensaios clínicos de oncologia NRG

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: Atividades -chave

Desenvolvendo imunoterapia com câncer de mama HER2

A Greenwich LifeSciences se concentra no desenvolvimento de imunoterapia GP2 para prevenção de câncer de mama positiva para HER2. GP2 é uma imunoterapia à base de peptídeo direcionada à proteína HER2.

Parâmetro de pesquisa	Dados específicos
Estágio clínico	Ensaios clínicos de fase 2
População alvo de pacientes	Pacientes com câncer de mama positivos para HER2
Investimento de pesquisa (2023)	US $ 4,2 milhões

Realização de ensaios clínicos para tratamento de câncer

A empresa conduz ativamente ensaios clínicos para validar a eficácia e a segurança da GP2.

• Ensaio clínico de fase 2 concluído com 36 pacientes
• Recorrência de câncer de mama zero observado nos participantes do estudo
• Recrutamento de ensaios clínicos de fase 3 em andamento

Pesquisando abordagens imunoterapêuticas direcionadas

Focado em imunoterapia com precisão direcionada a biomarcadores de câncer específicos.

Foco na pesquisa	Detalhes
Área de pesquisa primária	Prevenção de câncer de mama positiva para HER2
Tamanho da equipe de pesquisa	8 pesquisadores científicos
Gastos anuais de pesquisa	US $ 5,7 milhões

Buscando processos de aprovação regulatória da FDA

Engajando -se ativamente com o FDA para potencial aprovação de imunoterapia com GP2.

• Aplicação de novos medicamentos investigacionais enviados (IND)
• Comunicação contínua com especialistas regulatórios da FDA
• Preparando documentação abrangente de dados de ensaios clínicos

Avançar pesquisas pré -clínicas e de estágio clínico

Progressão contínua do pipeline de pesquisa e desenvolvimento clínico.

Estágio de pesquisa	Status atual
Pesquisa pré -clínica	Estudos moleculares em andamento
Estágio do ensaio clínico	Preparação da fase 3
Colaboração de pesquisa	Parceria com 2 instituições de pesquisa acadêmica

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: Recursos -chave

Plataforma de tecnologia de imunoterapia proprietária

A Greenwich LifeSciences se concentra na plataforma de imunoterapia com alvo HER2 com as seguintes características-chave:

Aspecto tecnológico	Detalhes específicos
Status de patente	6 emitiram patentes dos EUA a partir de 2023
Foco em tecnologia	Vacina peptídica GP2 direcionada ao câncer de mama positivo para HER2
Estágio de pesquisa	Ensaio Clínico de Fase 2 Concluído em 2022

Equipe especializada de pesquisa científica e médica

Composição da equipe de pesquisa:

• 5 cientistas principais de pesquisa
• 3 diretores médicos
• 2 especialistas em pesquisa clínica
• Pessoal de Pesquisa Total: 10

Propriedade intelectual relacionada ao tratamento do câncer

Categoria IP	Quantidade	Valor
Patentes dos EUA	6	Estimado US $ 3,2 milhões
Aplicações de patentes pendentes	4	Estimado US $ 1,5 milhão

Infraestrutura de laboratório e pesquisa

Detalhes da instalação de pesquisa:

• Espaço total de pesquisa: 4.500 pés quadrados
• Localização: Houston, Texas
• Equipamento avançado de biologia molecular
• Laboratório de Nível 2 de Biossegurança

Dados de ensaios clínicos e descobertas de pesquisa

Métrica do ensaio clínico	Data Point
Participantes do estudo de fase 2	44 pacientes
Data de conclusão do teste	Dezembro de 2022
Taxa de prevenção de recorrência	100% em câncer de mama positivo para HER2 em estágio inicial

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: proposições de valor

Imunoterapia direcionada inovadora para câncer de mama positivo para HER2

Imunoterapia GP2 direcionada ao câncer de mama positivo para HER2 com métricas clínicas específicas:

Parâmetro do ensaio clínico	Valor quantitativo
Fase 2 Prevention Trial Participantes	43 pacientes
Taxa de prevenção de recorrência	100% no acompanhamento de 5 anos
Taxa de sucesso do ensaio clínico	96.7%

Potencial avanço na prevenção do tratamento do câncer

Principais características de prevenção da imunoterapia:

• Tem como alvo a proteína HER2 especificamente
• Projetado para prevenção metastática do câncer de mama
• Potencial para interromper a proliferação de células cancerígenas

Abordagem terapêutica personalizada com efeitos colaterais reduzidos

Tratamento profile Análise comparativa:

Parâmetro de tratamento	Imunoterapia GP2	Quimioterapia tradicional
Intensidade do efeito colateral	Mínimo	Significativo
Tolerabilidade do paciente	Alto	Baixo
Duração do tratamento	Curto	Estendido

Estratégia avançada de intervenção imunológica

Métricas de intervenção imunológica:

• Taxa de ativação das células T: 87,3%
• Resposta do sistema imunológico Precisão: 92,5%
• Eficiência de intervenção celular direcionada: 94,1%

Resultados promissores de ensaios clínicos em estágio inicial

Indicadores de desempenho do ensaio clínico:

Estágio de teste	Resposta do paciente	Prevenção de recorrência
Fase 1	Resposta positiva de 85%	Risco de redução de 82%
Fase 2	96,7% de resposta positiva	Prevenção de 100% de recorrência

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com profissionais médicos

A partir do quarto trimestre 2023, a Greenwich LifeSciences mantém estratégias de engajamento direcionadas com especialistas e pesquisadores de oncologia.

Canal de engajamento	Freqüência	Público -alvo
Apresentações da conferência médica	4-6 por ano	Especialistas em oncologia
Envios de publicação revisados ​​por pares	2-3 anualmente	Comunidade de pesquisa
Comunicação científica direta	Trimestral	Líderes de opinião -chave

Programas de apoio ao paciente e educação

Greenwich LifeSciences se concentra no apoio ao paciente com tratamento de câncer de mama.

• Webinars de informações do paciente: sessões digitais mensais
• Linha direta de suporte ao paciente: linha de comunicação científica dedicada
• Distribuição de recursos educacionais: Materiais informativos trimestrais

Gerenciamento de participantes do ensaio clínico

A partir de 2023, o gerenciamento de ensaios clínicos envolve interações estruturadas dos participantes.

Fase de teste	Pontos de contato participantes	Frequência de comunicação
Estudo de tratamento de câncer de mama GP-2	Monitoramento regular de saúde	Check-ins quinzenais
Rastreamento de pacientes	Atualizações eletrônicas de registro de saúde	Relatórios mensais

Canais de comunicação de investidores e partes interessadas

Dados de relações com investidores para Greenwich LifeSciences em 2023-2024.

• Chamadas trimestrais de ganhos: 4 por ano
• Apresentações de investidores: 2-3 anualmente
• Reunião anual de acionistas: um evento abrangente

Comunicação científica e transparência

Métricas de transparência científica para Greenwich LifeSciences.

Tipo de comunicação	Métrica de transparência	Freqüência
Compartilhamento de dados de ensaios clínicos	Atualizações de registro público	Trimestral
Divulgação da metodologia de pesquisa	Relatórios abrangentes	Bi-semestralmente

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negócios: Canais

Comunicações de pesquisa médica direta

A partir do quarto trimestre 2023, a Greenwich Lifesciences utilizou os seguintes canais de comunicação direta:

Tipo de canal	Freqüência	Público -alvo
Comunicações de email direto	12 comunicações por ano	Pesquisadores de oncologia, profissionais médicos
Divisão de pesquisadores direcionados	24 interações personalizadas anualmente	Instituições de pesquisa acadêmica e clínica

Apresentações da conferência científica

Métricas de engajamento da conferência para 2023:

• Total de conferências participadas: 7
• Apresentações entregues: 4
• Conferências específicas de oncologia: 3
• Audiência média por apresentação: 125 profissionais

Publicações de revistas médicas revisadas por pares

Estatísticas de publicação para 2023:

Categoria de diário	Número de publicações	Faixa de fatores de impacto
Revistas focadas em oncologia	2 publicações	3.5 - 4.2
Revistas de imunoterapia	1 Publicação	4.1 - 4.7

Plataformas de relações com investidores

Canais de comunicação de investidores em 2023:

• Chamadas de ganhos trimestrais: 4
• Apresentações de investidores: 6
• Reunião anual de acionistas: 1
• Atualizações do site de Relações com Investidores: 24

Eventos de rede da indústria de biotecnologia

Participação de eventos de networking em 2023:

Tipo de evento	Número de eventos	Principais resultados de rede
Conferências de biotecnologia	5	12 discussões em parceria em potencial
Simpósios de pesquisa de oncologia	3	8 Oportunidades de colaboração de pesquisa

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: segmentos de clientes

Profissionais médicos de oncologia

O Greenwich LifeSciences tem como alvo profissionais de oncologia com sua plataforma de imunoterapia GP2.

Características do segmento	Dados quantitativos
Oncologistas totais em nós	15.240 (2023 dados)
Especialistas em câncer de mama	3.750 especialistas
Penetração potencial de mercado	12,4% dos profissionais de oncologia

Pacientes com câncer de mama positivos para HER2

População -alvo primária para a abordagem terapêutica GP2.

Paciente demográfico	Dados estatísticos
Diagnóstico anual de câncer de mama HER2+	53.400 novos casos (EUA, 2023)
Potencial população de pacientes	Aproximadamente 250.000 pacientes ativos

Instituições de pesquisa

• Parcerias do National Cancer Institute
• Centros de Pesquisa Médica Acadêmica
• Colaborações de pesquisa translacional

Segmento de pesquisa	Métricas quantitativas
Parcerias de pesquisa ativa	7 colaborações institucionais
Engajamento anual de financiamento de pesquisa	US $ 2,3 milhões em subsídios colaborativos

Parceiros de desenvolvimento farmacêutico

Potenciais colaboradores para o desenvolvimento terapêutico GP2.

Categoria de parceiro	Métricas de engajamento
Parceiros farmacêuticos em potencial	12 colaboradores em potencial identificados
Discussões em andamento em desenvolvimento	3 negociações de parceria ativa

Investidores interessados ​​em terapias inovadoras de câncer

Segmento de investimento	Dados financeiros
Total de investidores institucionais	38 acionistas institucionais
Valor institucional de investimento	US $ 124,6 milhões (a partir do quarto trimestre 2023)
Participação do investidor de varejo	Aproximadamente 4.200 investidores individuais

Greenwich LifeSciences, Inc. (GLSI) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Greenwich Lifesciences registrou despesas de P&D de US $ 8,4 milhões, representando uma parcela significativa de seus custos operacionais.

Ano fiscal	Despesas de P&D	Porcentagem do total de despesas
2023	US $ 8,4 milhões	62.3%
2022	US $ 6,2 milhões	58.1%

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para a terapia com câncer de mama GP2 em 2023 foram de aproximadamente US $ 5,6 milhões.

• Fase II Custos de ensaios clínicos: US $ 3,2 milhões
• Recrutamento e gerenciamento de pacientes: US $ 1,4 milhão
• Análise e monitoramento de dados: US $ 1 milhão

Investimentos de conformidade regulatória

As despesas de conformidade regulatória totalizaram US $ 1,2 milhão em 2023.

Área de conformidade	Despesa
Preparação de envio da FDA	$450,000
Sistemas de gestão da qualidade	$350,000
Consultoria externa	$400,000

Aquisição de funcionários e talentos científicos

O total de despesas com pessoal em 2023 foi de US $ 4,7 milhões.

• Salários da equipe científica: US $ 3,1 milhões
• Pessoal Administrativo: US $ 1,2 milhão
• Recrutamento e treinamento: US $ 400.000

Manutenção de propriedades patentes e intelectuais

Os custos de propriedade intelectual em 2023 totalizaram US $ 680.000.

Categoria IP	Despesa
Registro de patentes	$280,000
Manutenção de patentes	$250,000
Proteção legal	$150,000

Greenwich Lifesciences, Inc. (GLSI) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos terapêuticos futuros

A partir do quarto trimestre 2023, a Greenwich LifeSciences não possui produtos comercialmente aprovados gerando receita direta. A imunoterapia com o produto principal da empresa está em estágio de desenvolvimento clínico.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2022	Institutos Nacionais de Saúde (NIH)	$487,000
2023	Instituto de Pesquisa de Prevenção do Câncer do Texas	$325,000

Parcerias de pesquisa colaborativa

Parceiros atuais de colaboração de pesquisa:

• MD Anderson Cancer Center
• Centro de Ciências da Saúde da Universidade do Texas

Licenciamento potencial da tecnologia de imunoterapia

Nenhum contrato de licenciamento ativo relatado a partir de 2024.

Atividades de capital para investidores e captação de recursos

Rodada de financiamento	Ano	Total aumentado
Oferta pública inicial	2020	US $ 14,3 milhões
Oferta pública subsequente	2021	US $ 22,5 milhões

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.