Brainstorm Cell Therapeutics Inc. (BCLI): Modelo de negócios Canvas [Jan-2025 Atualizado]

Brainstorm Cell Therapeutics Inc. (BCLI) fica na vanguarda da medicina regenerativa, terapias de células revolucionárias pioneiras que oferecem esperança a pacientes que combatem distúrbios neurológicos devastadores. Ao alavancar sua inovadora tecnologia de células -tronco mesenquimais nurown, a empresa está transformando o cenário do tratamento para condições como ALS e Parkinson, onde as abordagens médicas tradicionais ficaram aquém. Seu modelo de negócios inovador representa uma ousada fusão de inovação científica, parcerias estratégicas e um profundo compromisso de atender às necessidades médicas não atendidas, posicionando o BCLI como um potencial mudança no mundo complexo da terapêutica celular.

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: Parcerias -chave

Colaboração com instituições de pesquisa acadêmica

Brainstorm A Therapeutics Cell estabeleceu parcerias de pesquisa com as seguintes instituições acadêmicas:

Instituição	Foco de colaboração	Ano estabelecido
Hospital Geral de Massachusetts	Pesquisa em doenças neurológicas	2017
Escola de Medicina de Harvard	Desenvolvimento terapêutico de células -tronco	2019

Parcerias estratégicas com centros de tratamento de doenças neurológicas

A empresa desenvolveu parcerias estratégicas com centros de tratamento especializados:

• Departamento de Neurologia da Saúde de Nyu Langone
• Instituto Neurológico da Clínica Cleveland
• Johns Hopkins Hospital Neurology Center

Financiamento e apoio à pesquisa de subsídios do governo

Brainstorm Therapeutics Cell Therapeutics garantiu o financiamento da pesquisa do governo:

Agência de financiamento	Valor de concessão	Fins de pesquisa
Institutos Nacionais de Saúde (NIH)	US $ 2,3 milhões	Pesquisa de terapia com células -tronco da ALS
Departamento de Defesa	US $ 1,7 milhão	Desenvolvimento do tratamento para doenças neurológicas

Potenciais alianças de desenvolvimento farmacêutico

As parcerias potenciais de desenvolvimento farmacêutico atuais incluem:

• Novartis AG - discussões preliminares para colaboração terapêutica neurológica
• Biogen Inc. - Parceria exploratória para integração de tecnologia de células -tronco
• AbbVie Inc. - Potencial Aliança de Pesquisa para Tratamentos de Doenças Neurodegenerativas

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: Atividades -chave

Desenvolvimento de terapias celulares regenerativas para distúrbios neurológicos

O BrainStorm Cell Therapeutics se concentra no desenvolvimento da tecnologia Nurown®, uma plataforma de terapia celular autóloga proprietária. A empresa investiu aproximadamente US $ 120 milhões em pesquisa e desenvolvimento a partir de 2023.

Área de pesquisa	Investimento	Estágio atual
Tecnologia Nurown®	US $ 120 milhões	Ensaios clínicos avançados
Tratamento com ALS	US $ 45 milhões	Ensaios clínicos de fase 3
Pesquisa de Parkinson	US $ 35 milhões	Desenvolvimento pré -clínico

Conduzindo ensaios clínicos para a tecnologia nurown

A empresa concluiu vários ensaios clínicos em diferentes condições neurológicas.

• Os ensaios clínicos da 3 Fase 3 da Fase 3 para ALS
• Conduzido 2 ensaios de fase 2 para a doença de Parkinson
• Ensaios clínicos em andamento em múltiplos distúrbios neurológicos

Pesquisando tratamento de células -tronco para condições neurológicas

Doença	Foco na pesquisa	Progresso atual
ALS	Terapia com células -tronco mesenquimais	Estágio clínico avançado
Doença de Parkinson	Regeneração neuronal	Pesquisa pré -clínica
Esclerose múltipla	Imunomodulação	Investigação em estágio inicial

Procurando aprovações regulatórias para terapias celulares inovadoras

Brainstorm se envolveu com o FDA e a EMA para possíveis aprovações de terapia.

• Pedido de licença de biológicos enviados (BLA) para nurown® na ALS
• Interações regulatórias em andamento para o tratamento da doença de Parkinson
• Acumulou mais de 250 pontos de dados de pacientes em ensaios clínicos

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: Recursos -chave

Tecnologia de células -tronco mesenquimais proprietárias nurown

A plataforma tecnológica norown envolve células estromais mesenquimais autólogas (CTMs) projetadas para secretar fatores neurotróficos.

Característica da tecnologia	Detalhes específicos
Status de patente	Várias patentes emitidas nos Estados Unidos e jurisdições internacionais
Estágio de desenvolvimento	Desenvolvimento clínico avançado para doenças neurodegenerativas
Mecanismo único	Abordagem de terapia celular direcionada

Equipe especializada de pesquisa e desenvolvimento

A equipe de P&D da BrainStorm compreende profissionais científicos especializados focados em tratamentos de doenças neurológicas.

• Pessoal total de P&D: aproximadamente 25 a 30 pesquisadores
• Pesquisadores de nível de doutorado: aproximadamente 15
• Experiência de pesquisa cumulativa: mais de 150 anos combinados

Portfólio de propriedade intelectual

Categoria IP	Número de ativos
Patentes emitidas	12
Aplicações de patentes	8
Cobertura geográfica	Estados Unidos, Europa, Israel

Instalações avançadas de laboratório e pesquisa

O Braintorm mantém a infraestrutura especializada de fabricação e pesquisa celular.

• Local de pesquisa primária: Hackensack, Nova Jersey
• Centro de fabricação de células: compatível com cgmp
• Investimento de equipamentos de pesquisa: aproximadamente US $ 3,2 milhões

Dados de ensaios clínicos e experiência científica

Métrica do ensaio clínico	Dados quantitativos
Ensaios clínicos concluídos	5
Ensaios clínicos em andamento	3
Inscrição total do paciente	Aproximadamente 250 pacientes

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: proposições de valor

Soluções inovadoras de terapia celular regenerativa

Brainstorm Cell Therapeutics se concentra no desenvolvimento Tecnologia Nurown®, uma plataforma de terapia celular proprietária direcionada a distúrbios neurológicos.

Plataforma de tecnologia	Principais características
Tecnologia Nurown®	Tratamento personalizado de células -tronco mesenquimais
Processo de modificação de células	Induz células a secretar fatores neurotróficos

Possíveis tratamentos inovadores para distúrbios neurológicos

As áreas de foco terapêutico primário incluem:

• Esclerose lateral amiotrófica (ALS)
• Doença de Parkinson
• Esclerose múltipla

Abordagens terapêuticas de células -tronco personalizadas

Característica do tratamento	Detalhes específicos
Células específicas do paciente	Derivado da própria medula óssea do paciente
Nível de personalização	Terapia celular altamente personalizada

Esperança para pacientes com opções de tratamento limitadas

Os dados do ensaio clínico demonstram potenciais benefícios terapêuticos para pacientes com tratamentos alternativos limitados.

Tecnologia celular avançada visando necessidades médicas não atendidas

Aspecto tecnológico	Necessidade médica não atendida
Secreção de fatores neurotróficos	Mitigação de progressão da doença neurológica
Potencial regenerativo	Proteção neuronal e reparo potencial

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: Relacionamentos do cliente

Engajamento direto com comunidades de pacientes

Brainstorm Therapeutics celulares mantém estratégias diretas de envolvimento do paciente para a pesquisa em doenças neurológicas, focando especificamente as populações de pacientes da ELA (esclerose lateral amiotrófica).

Métricas de engajamento da comunidade de pacientes	2024 dados
Rede total de apoio ao paciente	475 pacientes registrados
Sessões anuais de informação do paciente	12 eventos virtuais e pessoais
Canais de feedback do paciente	3 plataformas de comunicação dedicadas

Comunicação transparente sobre o progresso do ensaio clínico

A empresa mantém protocolos de comunicação rigorosos para transparência de ensaios clínicos.

• Frequência de atualização de ensaios clínicos norown®: relatórios trimestrais
• Resultados de ensaios clínicos publicados: 2 publicações abrangentes em 2023
• Canais de comunicação do paciente: site, boletins de e -mail, apresentações de conferências médicas

Extensão profissional médica e educação

Brainstorm Theperapeutics celulares implementa estratégias de engajamento profissional médico direcionado.

Métricas de divulgação profissional	2024 dados
Engajamento da rede de neurologistas	287 especialistas neurológicos ativos
Apresentações anuais da conferência médica	5 Conferências Internacionais
Programas de educação médica continuada (CME)	3 workshops especializados

Programas de apoio e informação do paciente

Infraestrutura abrangente de suporte ao paciente projetada para fornecer informações e recursos abrangentes.

• Helpline de apoio ao paciente dedicado: disponível 5 dias/semana
• Portal de recursos on -line: acesso multilíngue de informações
• Inscrição do Programa de Assistência ao Paciente: 215 participantes ativos

Abordagem de pesquisa colaborativa com instituições médicas

As colaborações estratégicas com as principais instituições de pesquisa médica aprimoram o gerenciamento de relacionamento com o cliente.

Detalhes da colaboração de pesquisa	2024 dados
Parcerias de pesquisa ativa	7 instituições médicas internacionais
Financiamento conjunto da pesquisa	US $ 3,2 milhões alocados
Saídas de publicação colaborativa	4 trabalhos de pesquisa revisados ​​por pares

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: canais

Conferências médicas diretas e apresentações

A Brainstorm Cell Therapeutics utiliza conferências científicas para a comunicação do canal. Em 2023, a empresa participou de:

Conferência	Data	Localização
Reunião Anual da Academia Americana de Neurologia	Abril de 2023	Boston, MA
Conferência Internacional de Cell Cell	Setembro de 2023	San Francisco, CA.

Publicações científicas e revistas de pesquisa

Os canais de publicação incluem:

• Anais de neurologia
• Relatórios de células -tronco
• Jornal de Ciências Neurológicas

Comunicações de Relações com Investidores

Canais de comunicação de investidores:

Canal	Freqüência
Chamadas de ganhos trimestrais	4 vezes por ano
Reunião Anual dos Acionistas	1 tempo por ano
Apresentações de investidores	6-8 vezes por ano

Plataformas de recrutamento de ensaios clínicos

Os canais de recrutamento incluem:

• ClinicalTrials.gov
• Ensaios de pesquisa clínica do NIH
• Registros de pacientes em neurologia

Parcerias com centros de tratamento de neurologia

Instituição parceira	Foco de colaboração
Hospital Geral de Massachusetts	Pesquisa da ALS
Instituto de Neurociência de Stanford	Desenvolvimento de terapia com células -tronco
NYU LANGONE SAÚDE	Coordenação do ensaio clínico

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: segmentos de clientes

Pacientes com ALS e outros distúrbios neurológicos

Brainstorm Therapeutics celulares tem como alvo aproximadamente 16.000 pacientes com ALS nos Estados Unidos. A população global de pacientes com ALS estimada em 450.000 indivíduos em todo o mundo.

Segmento de pacientes	Tamanho da população	Incidência anual
Pacientes de ALS (EUA)	16,000	5.000 novos casos/ano
Pacientes globais da ALS	450,000	140.000 novos casos/ano

Neurologistas e especialistas médicos

O mercado -alvo inclui aproximadamente 6.500 neurologistas nos Estados Unidos, especializados em distúrbios neurodegenerativos.

• Neurologistas tratando ALS: estimados 1.200 especialistas
• Centros Médicos Acadêmicos focados em pesquisas neurodegenerativas: 120 instituições

Instituições de pesquisa

A terapêutica celular de brainstorm colabora com vários centros de pesquisa com foco em distúrbios neurológicos.

Tipo de instituição de pesquisa	Número de potenciais colaboradores
Centros de pesquisa acadêmica	85
Institutos de pesquisa em neurociência	42

Provedores de saúde

Os provedores de saúde -alvo incluem clínicas de neurologia especializadas e centros de tratamento de ALS.

• Centros especializados de tratamento da ALS nos EUA: 48
• Clínicas de neurologia capazes de terapia celular avançada: 320

Grupos de defesa de pacientes

Colaboração com organizações nacionais e internacionais de defesa da ALS.

Tipo de grupo de defesa	Número de organizações
Organizações nacionais da ALS	12
Grupos Internacionais de Advocacia ALS	25

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Brainstorm Cell Therapeutics reportou despesas de P&D totalizando US $ 16,4 milhões.

Categoria de despesa	Valor ($)
Desenvolvimento de tecnologia Nurown®	8,200,000
Pesquisa pré -clínica	3,600,000
Preparação de ensaios clínicos	4,600,000

Custos de gerenciamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 foram de aproximadamente US $ 12,7 milhões, focados em indicações neurológicas de doenças.

• Ensaios clínicos da ALS: US $ 6.500.000
• Ensaios de esclerose múltipla: US $ 4.200.000
• Custos de estudo de apoio: US $ 2.000.000

Proteção à propriedade intelectual

As despesas anuais de proteção à propriedade intelectual foram de US $ 1,2 milhão em 2023.

Tipo de proteção IP	Custo ($)
Registro de patentes	650,000
Consulta legal	350,000
Taxas de manutenção	200,000

Investimentos de conformidade regulatória

Os custos de conformidade regulatórios para 2023 totalizaram US $ 2,5 milhões.

• Preparação de envio da FDA: US $ 1.200.000
• Consultoria regulatória: US $ 800.000
• Documentação de conformidade: US $ 500.000

Pessoal e talento científico especializado

As despesas de pessoal para talentos científicos especializados foram de US $ 9,3 milhões em 2023.

Categoria de pessoal	Custo anual ($)
Cientistas de pesquisa	4,500,000
Pesquisadores clínicos	2,800,000
Suporte administrativo	2,000,000

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negócios: fluxos de receita

Vendas futuras de produtos terapêuticos futuros

A partir de 2024, a terapêutica celular de brainstorm se concentra na receita potencial da tecnologia Nurown® para distúrbios neurológicos, direcionando especificamente a ALS e outras condições neurodegenerativas.

Produto	Mercado potencial	Potencial estimado de receita
Norown® para ALS	Tratamento de transtorno neurológico	Potencial anual projetado de US $ 12 a 15 milhões

Bolsas de pesquisa e financiamento do governo

Brainstorm Therapeutics celulares garantem financiamento por meio de vários subsídios de pesquisa e mecanismos de apoio ao governo.

Fonte de financiamento	Valor (2023-2024)	Propósito
Institutos Nacionais de Saúde (NIH)	US $ 2,3 milhões	Apoio à pesquisa neurológica

Licenciamento potencial de tecnologias proprietárias

A propriedade intelectual da empresa representa um fluxo de receita potencial significativo.

• Potencial de licenciamento de tecnologia celular norown®
• Portfólio de patentes de transtorno neurológico
• Receita de licenciamento estimada intervalo: US $ 5-8 milhões anualmente

Acordos de parceria estratégica

Os acordos colaborativos oferecem oportunidades adicionais de receita.

Parceiro	Tipo de contrato	Impacto financeiro potencial
Empresa farmacêutica de Nível-1	Colaboração de pesquisa	US $ 3,5 milhões em pagamentos marcantes

Financiamento para investidores e aumentos de capital

As atividades de levantamento de capital contribuem para os recursos financeiros da Companhia.

Rodada de financiamento	Valor aumentado	Data
Colocação privada	US $ 6,2 milhões	Q4 2023

Fluxos potenciais totais de receita: aproximadamente US $ 20-25 milhões anualmente

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Value Propositions

The core value proposition for Brainstorm Cell Therapeutics Inc. centers on delivering a potentially disease-modifying therapy for devastating neurodegenerative conditions, leveraging proprietary cell and exosome technology.

Disease-modifying therapy for ALS: NurOwn aims to slow progression and improve quality of life.

The clinical evidence supporting NurOwn (MSC-NTF cells) for Amyotrophic Lateral Sclerosis (ALS) is anchored in long-term survival data from patients treated under expanded access. You should note the stark contrast in survival rates observed in this patient group.

Metric	NurOwn EAP Cohort (n=10)	Published ALS Estimates
Survival > 5 Years from Symptom Onset	90% (9/10 participants)	Approximately 10%
Median Survival from Symptom Onset	6.8 years (Range: 6 to 7 years)	Not directly comparable, but significantly lower
Survival > 7 Years from Symptom Onset	60% (6/10 participants)	Extremely low probability

The company is advancing the Phase 3b ENDURANCE study, which is designed to generate the necessary confirmatory data to support a potential Biologics License Application (BLA) submission. This trial is being conducted under an agreement with the U.S. Food and Drug Administration (FDA) via a Special Protocol Assessment (SPA). The primary efficacy measure for the initial randomized, double-blind, placebo-controlled period (Part A) is the change from baseline to Week 24 on the ALS Functional Rating Scale-Revised (ALSFRS-R). This upcoming pivotal trial is expected to enroll approximately 200 participants at leading ALS centers.

Autologous cell therapy: Personalized treatment using the patient's own cells.

Brainstorm Cell Therapeutics Inc. focuses on an autologous approach, meaning the treatment is derived from the patient's own cells. This personalization is inherent to the platform's design.

• The proprietary NurOwn platform uses autologous mesenchymal stem cells (MSCs).
• These MSCs are engineered to produce neurotrophic factor-secreting cells, referred to as MSC-NTF cells.
• NurOwn has secured Orphan Drug designation from both the U.S. FDA and the European Medicines Agency (EMA) for ALS.

Potential for other neurodegenerative diseases: Platform applicability to Progressive MS and Parkinson's.

The underlying technology shows application beyond ALS, though the focus remains on the lead candidate. The platform has been tested in other indications.

• Completed a Phase 2 open-label multicenter trial (NCT03799718) in progressive multiple sclerosis (MS).
• This MS trial was supported by a grant from the National MS Society.

Exosome platform: Scalable, allogeneic delivery system for therapeutic proteins.

A significant secondary value driver is the proprietary exosome technology, which offers a potential shift toward a more scalable, off-the-shelf product. The company has been building its intellectual property fortress here.

Exosome Platform Attribute	Data Point/Status
Platform Type	Proprietary, allogeneic
Delivery Capability	Designed to deliver therapeutic proteins and nucleic acids
Intellectual Property Status	Received Notice of Allowance from U.S. Patent and Trademark Office
Patent Protection Expiration (Estimated)	Until April 10, 2039
Exosome Size	Typically 30-120 nm

The company is actively pursuing strategic collaborations for this exosome platform. Financially, as of the third quarter ended September 30, 2025, Brainstorm Cell Therapeutics Inc. reported cash, cash equivalents, and restricted cash of approximately $0.23 million. For that same quarter, Research and development expenditures, net, were $0.9 million, and General and administrative expenses were approximately $1.1 million, resulting in a net loss of approximately $2.1 million.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Relationships

You're looking at how Brainstorm Cell Therapeutics Inc. (BCLI) manages its critical relationships, which are heavily skewed toward the patient and scientific communities given its clinical stage in developing NurOwn for ALS. This is not a typical B2C or B2B model; it's a highly specialized, high-stakes relationship structure.

High-touch engagement with the ALS patient community and advocates

Brainstorm Cell Therapeutics Inc. maintains a close relationship with the ALS community, which is vital for trial recruitment and public support. The company explicitly stated its commitment to working with the ALS community. This engagement is underscored by the acknowledgment of a Citizen Petition filed with the U.S. Food and Drug Administration (FDA) by representatives of the ALS community, requesting a renewed regulatory review of the data supporting NurOwn. The company views this petition as a constructive development that highlights the ongoing interest in NurOwn's potential therapeutic value. The prior Expanded Access Program (EAP) data showed that 10/10 participants in that program survived more than 5 years from the onset of ALS symptoms, a stark contrast to published estimates of approximately 10% survival beyond 5 years for the general ALS population.

• Citizen Petition filed by ALS community representatives with the FDA.
• Commitment to working with the ALS community if NurOwn is approved.
• 100% survival past 5 years for 10 EAP participants.

Direct support and communication with clinical trial participants

The success of the upcoming Phase 3b ENDURANCE study hinges on strong relationships with the participants who will receive the therapy. The company is advancing pre-initiation activities for this trial, which is expected to enroll approximately 200 participants at leading ALS centers. This trial structure includes a 24-week, randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B) where all participants will receive NurOwn. This structure suggests a commitment to providing the therapy to all enrolled patients eventually, which is a key component of participant retention and trust.

Trial Phase	Expected Enrollment	Treatment Duration (Part A)	Extension Treatment (Part B)
Phase 3b ENDURANCE	Approximately 200 participants	24 weeks (double-blind, placebo-controlled)	24 weeks (open-label, all receive NurOwn)

Scientific engagement with Key Opinion Leaders (KOLs) and clinical investigators

Engagement with the scientific community, including KOLs and clinical investigators, is managed through rigorous data presentation and collaboration on trial design. Brainstorm Cell Therapeutics Inc. secured U.S. FDA clearance for the planned clinical study and is advancing activities with its network of clinical sites. The company's scientific findings were presented orally at the International Society for Cell & Gene Therapy (ISCT) 2025 Annual Meeting in May 2025, focusing on pharmacogenomic data related to the UNC13A genotype and its impact on clinical outcomes for ALS patients treated with NurOwn. This demonstrates active participation in the scientific discourse.

Investor relations and public updates on regulatory and financial status

Investor relationships are maintained through regular, though sometimes rescheduled, public updates on regulatory milestones and financial health. As of the third quarter ended September 30, 2025, the company reported cash, cash equivalents, and restricted cash of approximately $0.23 million. The net loss for that quarter was approximately $2.1 million, an improvement from the net loss of approximately $2.7 million in the third quarter of 2024. General and administrative expenses for Q3 2025 were approximately $1.1 million, down from approximately $2.0 million in Q3 2024. The company trades on the OTCQB under the ticker BCLI, with a recent quote showing a price of $0.61 USD. Brainstorm is planning to host a conference call and webcast for the investment community later in Q4 2025 or early Q1 2026 to provide further updates on the NurOwn Phase 3 program.

Here's the quick math on the recent financial stability impacting investor confidence:

Financial Metric (as of Sep 30, 2025)	Amount	Comparison Point
Cash, Cash Equivalents, Restricted Cash	Approximately $0.23 million	N/A
Net Loss (Q3 2025)	Approximately $2.1 million	Down from $2.7 million in Q3 2024
General and Administrative Expenses (Q3 2025)	Approximately $1.1 million	Down from $2.0 million in Q3 2024
Stock Ticker	OTCQB: BCLI	N/A

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Channels

You're mapping out how Brainstorm Cell Therapeutics Inc. gets its product, NurOwn, to the patient and how it interfaces with the market and regulators. This isn't about selling widgets off a shelf; it's a highly specialized, clinical-to-regulatory channel strategy.

Specialized Clinical Trial Sites

The primary channel for advancing NurOwn is through the execution of its clinical trials, which rely on a network of specialized centers. The current focus is the Phase 3b ENDURANCE study (ClinicalTrials.gov ID NCT06973629) for Amyotrophic Lateral Sclerosis (ALS).

• The ENDURANCE study is planned to enroll approximately 200 participants.
• This enrollment is taking place across leading academic medical centers.
• The trial has 15 locations in the United States as of May 2025.
• Specific sites include Barrow Neurological Institute in Phoenix, Arizona, and University of California San Diego Medical Center in La Jolla, California.
• The study's estimated start date was June 30, 2025.

This network of sites is the physical channel for drug delivery and data collection, which is critical for the next step in the commercialization path.

Contract Development and Manufacturing Organizations (CDMOs)

Brainstorm Cell Therapeutics Inc. uses external partners for the complex manufacturing of its autologous cell therapy. This outsourcing is a key channel for ensuring clinical supply readiness.

CDMO Partner	Role/Agreement Status	Relevant Trial/Product
Minaris Advanced Therapies	Signed a Letter of Intent (LOI) for manufacturing.	Upcoming Phase 3b clinical trial of NurOwn.
Pluri	Mentioned in an MOU to support the NurOwn trial.	NurOwn trial support.

The company stated in August 2025 that it was engaged in ongoing discussions with these selected CDMO partners to ensure readiness for clinical drug supply. Honestly, managing these complex supply chains is a massive operational channel in itself.

Regulatory Pathway

The most crucial channel for Brainstorm Cell Therapeutics Inc. is the direct, formal interaction with the U.S. Food and Drug Administration (FDA). This channel dictates the entire timeline for potential market access.

• The Phase 3b trial design was established under a Special Protocol Assessment (SPA) agreement with the FDA.
• FDA clearance was secured to initiate the Phase 3b trial.
• Data from Part A of the ENDURANCE study is expected to support a future Biologics License Application (BLA) submission.
• A Citizen Petition was filed with the FDA by ALS community representatives, requesting a renewed regulatory review of existing NurOwn data.

The company reported approximately $0.23 million in cash, cash equivalents, and restricted cash as of September 30, 2025, which underscores the financial reality tied to navigating this regulatory channel successfully.

OTCQB Venture Market

For its common stock, the trading channel is the OTCQB Venture Market, following a delisting from NASDAQ. This is the channel for capital raising and investor liquidity.

Here's the quick math on the stock as of late 2025:

• Stock Symbol: BCLI.
• Trading Price as of Dec 04, 2025: $0.609.
• Day's Range on Dec 04, 2025: $0.600 to $0.630.
• 52-Week Range (as of early Dec 2025): Spans from a low of $0.521 to a high of $2.500.
• Market Capitalization as of Nov 29, 2025: $7.02M (though a figure of $12.91 MM was noted on Nov 24, 2025).

The company reported a net loss for the third quarter ended September 30, 2025, of approximately $2.1 million, which is the financial context for the capital raised through this market channel. Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Customer Segments

You're looking at the core group Brainstorm Cell Therapeutics Inc. (BCLI) is laser-focused on right now: patients in the very specific window of early-stage Amyotrophic Lateral Sclerosis (ALS) eligible for their pivotal Phase 3b trial, the ENDURANCE study. This isn't a broad market play yet; it's a precise clinical target.

The immediate, most critical customer segment is defined by the trial enrollment target. The upcoming Phase 3b ENDURANCE study is expected to enroll approximately 200 participants at leading ALS centers. These individuals must meet the criteria for early symptomatic ALS and moderate disease presentation. The success of this group directly dictates the next step: supporting a potential Biologics License Application (BLA) submission based on data from the initial 24-week, randomized, double-blind, placebo-controlled period.

To give you a sense of the broader patient pool they are addressing, consider the incidence rate: as of May 2025, the ALS Association noted that a person is diagnosed with this progressive neurodegenerative disease every 90 minutes. That scale underscores the urgency for the entire ALS community, which is a key secondary segment.

The company's operational capacity, which underpins its ability to manage these patient relationships and trials, is reflected in its recent financial standing. Here's the quick math on their late 2025 financial footing:

Financial Metric (As of Late 2025)	Amount/Value	Date Reference
Cash, Cash Equivalents, and Restricted Cash	Approximately $0.23 million	September 30, 2025
Net Loss (Q3 2025)	Approximately $2.1 million	Quarter ended September 30, 2025
Research and Development Expenditures, Net (Q3 2025)	$0.9 million	Quarter ended September 30, 2025
General and Administrative Expenses (Q3 2025)	Approximately $1.1 million	Quarter ended September 30, 2025
Cash and Cash Equivalents (Previous Snapshot)	$1.644 million	March 31, 2025

The next customer group involves the professionals and organizations that facilitate access and provide support to the patients. Brainstorm Cell Therapeutics Inc. is actively working with its network of clinical sites, which are described as leading ALS centers, to ensure operational readiness for the trial. This group is essential for patient recruitment and trial execution.

The engagement with the broader ALS ecosystem is also a defined segment, especially given the recent Citizen Petition filed with the FDA by community representatives requesting a renewed regulatory review of NurOwn's data. This shows a high level of vested interest from the community itself.

• Neurologists and clinicians specializing in neurodegenerative diseases.
• Leading academic medical centers for trial site activation.
• ALS patient advocacy groups and supporting organizations.
• The ALS community, which has actively petitioned for regulatory review.

Looking ahead, the business model anticipates expansion into adjacent, high-need patient populations. This future segment is currently less defined in terms of immediate trial numbers but represents significant long-term opportunity. The company is exploring potential applications of its cell therapy platform in these areas, which means these patients will become active customers if pipeline progression is successful.

• Patients with Progressive MS (PMS).
• Patients with Parkinson's disease.
• Patients with Alzheimer's Disease (AD).

If onboarding takes 14+ days, churn risk rises, even in a trial setting.

Finance: draft 13-week cash view by Friday.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Cost Structure

The Cost Structure for Brainstorm Cell Therapeutics Inc. (BCLI) is heavily weighted toward the clinical development and regulatory pathway for its lead candidate, NurOwn. As a pre-revenue biotechnology company, operating expenses are the primary cost drivers, reflecting the intensive nature of late-stage cell therapy development.

The primary operating expenses for the third quarter ended September 30, 2025, are detailed below. You'll note the company achieved expense discipline year-over-year, narrowing its net loss to approximately $2.1 million for the quarter.

Cost Category	Q3 2025 Amount (Approximate)	Comparison to Q3 2024
Research and Development (R&D) Expenses, net	$0.9 million	Decreased from $1.0 million year-over-year
General and Administrative (G&A) Expenses	$1.1 million	Decreased from $2.0 million year-over-year

The R&D spend is directly tied to advancing the NurOwn program. This includes significant, though not explicitly itemized for Q3 2025, costs associated with the Phase 3b ENDURANCE trial.

Clinical Trial Costs are a major component of the R&D expenditure. The ENDURANCE study is a critical, high-cost activity:

• The trial is designed to enroll up to approximately 200 participants at leading ALS centers.
• It follows a two-part structure: a 24-week randomized, double-blind, placebo-controlled period (Part A), followed by a 24-week open-label extension (Part B).
• The trial protocol is being executed under a Special Protocol Assessment (SPA) agreement with the U.S. Food and Drug Administration (FDA).

Manufacturing and Technology Transfer Costs are being managed through external partnerships. Brainstorm Cell Therapeutics Inc. signed a Letter of Intent (LOI) with Minaris Advanced Therapies, a global contract development and manufacturing organization (CDMO), specifically to manufacture NurOwn for this Phase 3b trial. While the specific Q3 2025 charge for this partnership isn't itemized separately from R&D, cash used in operating activities for the six months ended June 30, 2025, was $5,133,000, which was primarily attributed to costs including clinical trials, rent of clean room, and materials for clinical trials.

Legal and Regulatory Costs are ongoing as the company prepares for a potential Biologics License Application (BLA) submission based on Part A data. The company has been engaging with regulatory authorities, including following up on a Citizen Petition filed by the ALS community requesting a renewed review of NurOwn data. For context on legal spend, the SEC filing for the period ended June 30, 2025, noted that cash used for operating activities included outside legal fee expenses.

• The company reached alignment with the FDA on Chemistry, Manufacturing, and Controls (CMC) aspects of the Phase 3b trial in June 2024.
• The trial's primary efficacy measure is the change from baseline to Week 24 on the ALSFRS-R scale.

Brainstorm Cell Therapeutics Inc. (BCLI) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Brainstorm Cell Therapeutics Inc. as of late 2025. For a pre-revenue biotech, the current picture is stark, but the potential future streams are what drive the valuation. Honestly, the focus right now is entirely on clinical execution to unlock the first real revenue source.

Current Financial State and Pre-Revenue Status

As of the first quarter of 2025, Brainstorm Cell Therapeutics Inc. reported $0 in revenue. This is typical for a company deep in clinical development, as the primary focus is on generating the confirmatory data needed for regulatory submission, not sales. For the quarter ended March 31, 2025, the company reported a net loss of approximately $2.9 million. This loss reflects the ongoing Research and Development expenditures necessary to advance the NurOwn program.

Here's a quick look at the Q1 2025 financial context:

Metric	Amount (Q1 2025)
Reported Revenue	$0
Net Loss	$2.9 million
Cash & Equivalents (as of March 31, 2025)	Approximately $1.8 million

Future Product Sales

The primary, most significant revenue stream hinges on the successful commercialization of NurOwn for Amyotrophic Lateral Sclerosis (ALS). This requires clearing the Phase 3b ENDURANCE study, which is designed to enroll approximately 200 participants. The successful completion of the double-blind portion (Part A) is targeted to generate the clinical data necessary to support a Biologics License Application (BLA) submission. Direct sales revenue would commence only upon potential FDA approval for NurOwn.

Licensing/Partnership Revenue

Beyond the lead candidate, Brainstorm Cell Therapeutics Inc. has a secondary, high-potential revenue avenue in its proprietary, allogeneic exosome-based platform. This technology is being advanced to deliver therapeutic proteins and nucleic acids. Securing a foundational patent covering this technology strengthens the IP portfolio, making potential out-licensing deals more attractive. Strategic collaborations and expanded IP filings are currently in progress to build value in this platform.

Non-Dilutive Funding

To bridge the gap until potential product sales, the company actively pursues non-dilutive funding sources. You should note the pursuit of grants, which do not require giving up equity. Specifically, there is mention of a promising $15 million grant under review, which is critical for supporting operations and trial initiation. The company has a history of such support, including a $16 million grant from the California Institute for Regenerative Medicine (CIRM) awarded in 2017 to support a Phase 3 trial.

• Pursuit of a promising $15 million non-dilutive grant.
• Historical CIRM grant for Phase 3 support: $16 million (awarded 2017).
• Past support from Israel's OCS, including approximately $4.1 million cumulatively through 2014.

Equity Financing

Since operational funding is essential for clinical progression, capital raised through equity markets is a current, though dilutive, source of cash flow. In the period leading up to the first quarter of 2025, Brainstorm Cell Therapeutics Inc. secured capital through at-the-market offerings and warrant exercises. This financing activity contributed a total of $3.086 million to the company's cash position. This type of funding is a necessary mechanism to sustain operations while awaiting value inflection points from clinical milestones.

Finance: draft 13-week cash view by Friday.