Brainstorm Cell Therapeutics Inc. (BCLI): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

Brainstorm Cell Therapeutics Inc. (BCLI) se encuentra a la vanguardia de la medicina regenerativa, pionero en terapias de células revolucionarias que ofrecen esperanza a los pacientes que luchan contra los trastornos neurológicos devastadores. Al aprovechar su innovadora tecnología de células madre mesenquimales de Nurown, la compañía está transformando el panorama del tratamiento para afecciones como ALS y Parkinson, donde los enfoques médicos tradicionales se han quedado corto. Su modelo de negocio innovador representa una audaz fusión de innovación científica, asociaciones estratégicas y un profundo compromiso de abordar las necesidades médicas no satisfechas, posicionando a BCLI como un posible cambio de juego en el complejo mundo de la terapéutica celular.

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocios: asociaciones clave

Colaboración con instituciones de investigación académica

Brainstorm Therapeutics ha establecido asociaciones de investigación con las siguientes instituciones académicas:

Institución	Enfoque de colaboración	Año establecido
Hospital General de Massachusetts	Investigación de enfermedades neurológicas	2017
Escuela de Medicina de Harvard	Desarrollo terapéutico de células madre	2019

Asociaciones estratégicas con centros de tratamiento de enfermedades neurológicas

La compañía ha desarrollado asociaciones estratégicas con centros de tratamiento especializados:

• Departamento de Neurología de la Salud de NYU Langone
• Instituto Neurológico de Cleveland Clinic
• Centro de Neurología del Hospital Johns Hopkins

Financiación y apoyo de investigación de subvenciones gubernamentales

Brainstorm Therapeutics ha obtenido la financiación de la investigación del gobierno:

Agencia de financiación	Monto de subvención	Propósito de investigación
Institutos Nacionales de Salud (NIH)	$ 2.3 millones	Investigación de terapia con células madre de ALS
Ministerio de defensa	$ 1.7 millones	Desarrollo del tratamiento de enfermedades neurológicas

Alianzas potenciales de desarrollo farmacéutico

Las asociaciones de desarrollo farmacéutico potencial actual incluyen:

• Novartis AG - Discusiones preliminares para la colaboración terapéutica neurológica
• Biogen Inc. - Asociación exploratoria para la integración de tecnología de células madre
• Abbvie Inc. - Alianza de investigación potencial para los tratamientos de enfermedades neurodegenerativas

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: actividades clave

Desarrollo de terapias celulares regenerativas para trastornos neurológicos

Brainstorm Therapeutics se centra en el desarrollo de la tecnología Nurown®, una plataforma de terapia de células autólogas patentadas. La compañía ha invertido aproximadamente $ 120 millones en investigación y desarrollo a partir de 2023.

Área de investigación	Inversión	Etapa actual
Tecnología Nurown®	$ 120 millones	Ensayos clínicos avanzados
Tratamiento de ALS	$ 45 millones	Ensayos clínicos de fase 3
Investigación de Parkinson	$ 35 millones	Desarrollo preclínico

Realización de ensayos clínicos para la tecnología Nurown

La compañía ha completado múltiples ensayos clínicos en diferentes condiciones neurológicas.

• Ensayos clínicos de 3 fase 3 completados para ELA
• Realizó 2 ensayos de fase 2 para la enfermedad de Parkinson
• Ensayos clínicos en curso en múltiples trastornos neurológicos

Investigación del tratamiento con células madre para afecciones neurológicas

Condición	Enfoque de investigación	Progreso actual
Algancios	Terapia de células madre mesenquimales	Etapa clínica avanzada
Enfermedad de Parkinson	Regeneración neuronal	Investigación preclínica
Esclerosis múltiple	Inmunomodulación	Investigación en etapa inicial

Persiguiendo aprobaciones regulatorias para terapias celulares innovadoras

Brainstorm se ha comprometido con la FDA y la EMA para las posibles aprobaciones de terapia.

• Solicitud de licencia de biología enviada (BLA) para Nurown® en ALS
• Interacciones regulatorias continuas para el tratamiento de la enfermedad de Parkinson
• Acumulado más de 250 puntos de datos del paciente en ensayos clínicos

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: recursos clave

Tecnología patentada de células madre mesenquimales de Nurown

La plataforma de tecnología Nurown implica células del estroma mesenquimatoso autólogo (MSC) que están diseñadas para secretar factores neurotróficos.

Tecnología característica	Detalles específicos
Estado de patente	Múltiples patentes emitidas en jurisdicciones internacionales e internacionales
Etapa de desarrollo	Desarrollo clínico avanzado para enfermedades neurodegenerativas
Mecanismo único	Enfoque de terapia celular dirigido

Equipo de investigación y desarrollo especializado

El equipo de I + D de Brainstorm comprende profesionales científicos especializados centrados en los tratamientos de enfermedades neurológicas.

• Personal total de I + D: aproximadamente 25-30 investigadores
• Investigadores a nivel de doctorado: aproximadamente 15
• Experiencia de investigación acumulativa: más de 150 años combinados

Cartera de propiedades intelectuales

Categoría de IP	Número de activos
Patentes emitidos	12
Solicitudes de patentes	8
Cobertura geográfica	Estados Unidos, Europa, Israel

Instalaciones avanzadas de laboratorio e investigación

Brainstorm mantiene la infraestructura de investigación e investigación celular especializada.

• Ubicación de la investigación principal: Hackensack, Nueva Jersey
• Instalación de fabricación de células: CGMP compatible con
• Inversión en equipos de investigación: aproximadamente $ 3.2 millones

Datos de ensayos clínicos y experiencia científica

Métrico de ensayo clínico	Datos cuantitativos
Ensayos clínicos completados	5
Ensayos clínicos en curso	3
Inscripción total del paciente	Aproximadamente 250 pacientes

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de terapia de células regenerativas

Brainstorma Therapeutics se centra en el desarrollo Tecnología Nurown®, una plataforma de terapia celular patentada dirigida a los trastornos neurológicos.

Plataforma tecnológica	Características clave
Tecnología Nurown®	Tratamiento personalizado de células madre mesenquimales
Proceso de modificación de células	Induce las células a secretar factores neurotróficos

Posibles tratamientos innovadores para los trastornos neurológicos

Las áreas de enfoque terapéutico primario incluyen:

• Esclerosis lateral amiotrófica (ELA)
• Enfermedad de Parkinson
• Esclerosis múltiple

Enfoques terapéuticos de células madre personalizadas

Característica del tratamiento	Detalles específicos
Células específicas del paciente	Derivado de la propia médula ósea del paciente
Nivel de personalización	Terapia celular altamente personalizada

Esperanza para pacientes con opciones de tratamiento limitadas

Los datos del ensayo clínico demuestran beneficios terapéuticos potenciales para pacientes con tratamientos alternativos limitados.

Tecnología celular avanzada dirigida a las necesidades médicas no satisfechas

Aspecto tecnológico	Necesidad médica insatisfecha
Secreción de factor neurotrófico	Mitigación de progresión de la enfermedad neurológica
Potencial regenerativo	Protección neuronal y reparación potencial

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocios: relaciones con los clientes

Compromiso directo con las comunidades de pacientes

Brainstorm Therapeutics mantiene estrategias directas de participación del paciente para la investigación de enfermedades neurológicas, enfocándose específicamente en las poblaciones de pacientes con ELA (esclerosis lateral amiotrófica).

Métricas de compromiso de la comunidad de pacientes	2024 datos
Red total de apoyo al paciente	475 pacientes registrados
Sesiones anuales de información del paciente	12 eventos virtuales y en persona
Canales de retroalimentación del paciente	3 plataformas de comunicación dedicadas

Comunicación transparente sobre el progreso del ensayo clínico

La compañía mantiene rigurosos protocolos de comunicación para la transparencia de los ensayos clínicos.

• Frecuencia de actualización del ensayo clínico de Nurown®: informes trimestrales
• Resultados de ensayos clínicos publicados: 2 publicaciones integrales en 2023
• Canales de comunicación del paciente: sitio web, boletines por correo electrónico, presentaciones de la conferencia médica

Alcance y educación médica profesional

Brainstorme la terapéutica celular implementa estrategias de participación médica dirigidas.

Métricas de divulgación profesional	2024 datos
Compromiso de la red de neurólogos	287 especialistas neurológicos activos
Presentaciones anuales de la conferencia médica	5 conferencias internacionales
Programas de Educación Médica Continua (CME)	3 talleres especializados

Programas de apoyo e información del paciente

Infraestructura integral de apoyo al paciente diseñada para proporcionar información y recursos integrales.

• Línea de ayuda de apoyo al paciente dedicado: disponible 5 días/semana
• Portal de recursos en línea: acceso a información multilingüe
• Inscripción del programa de asistencia al paciente: 215 participantes activos

Enfoque de investigación colaborativa con instituciones médicas

Las colaboraciones estratégicas con las principales instituciones de investigación médica mejoran la gestión de la relación con el cliente.

Detalles de la colaboración de investigación	2024 datos
Asociaciones de investigación activa	7 instituciones médicas internacionales
Financiación de la investigación conjunta	$ 3.2 millones asignados
Publicaciones de colaboración	4 trabajos de investigación revisados ​​por pares

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: canales

Conferencias y presentaciones médicas directas

Brainstorm Cell Therapeutics utiliza conferencias científicas para la comunicación de canales. En 2023, la compañía participó en:

Conferencia	Fecha	Ubicación
Reunión anual de la Academia Americana de Neurología	Abril de 2023	Boston, MA
Conferencia internacional de células madre	Septiembre de 2023	San Francisco, CA

Publicaciones científicas y revistas de investigación

Los canales de publicación incluyen:

• Anales de neurología
• Informes de células madre
• Revista de Ciencias Neurológicas

Comunicaciones de relaciones con los inversores

Canales de comunicación de inversores:

Canal	Frecuencia
Llamadas de ganancias trimestrales	4 veces al año
Reunión anual de accionistas	1 vez por año
Presentaciones de inversores	6-8 veces al año

Plataformas de reclutamiento de ensayos clínicos

Los canales de reclutamiento incluyen:

• Clinicaltrials.gov
• Ensayos de investigación clínica de NIH
• Registros de pacientes neurología

Asociaciones con centros de tratamiento de neurología

Institución asociada	Enfoque de colaboración
Hospital General de Massachusetts	Investigación de ALS
Instituto de Neurociencia de Stanford	Desarrollo de terapia con células madre
Nyu Langone Health	Coordinación del ensayo clínico

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

Pacientes con ELA y otros trastornos neurológicos

Brainstorma la terapéutica celular se dirige a aproximadamente 16,000 pacientes con ELA en los Estados Unidos. La población mundial de pacientes con ELA estimada en 450,000 personas en todo el mundo.

Segmento de paciente	Tamaño de la población	Incidencia anual
Pacientes con ELA (EE. UU.)	16,000	5,000 casos nuevos/año
Pacientes globales de ELA	450,000	140,000 casos nuevos/año

Neurólogos y especialistas médicos

El mercado objetivo incluye aproximadamente 6.500 neurólogos en los Estados Unidos especializados en trastornos neurodegenerativos.

• Neurólogos tratando ELA: estimados de 1.200 especialistas
• Centros médicos académicos centrados en la investigación neurodegenerativa: 120 instituciones

Instituciones de investigación

Brainstorme la terapéutica celular colabora con múltiples centros de investigación centrados en los trastornos neurológicos.

Tipo de institución de investigación	Número de colaboradores potenciales
Centros de investigación académicos	85
Institutos de investigación de neurociencia	42

Proveedores de atención médica

Los proveedores de atención médica objetivo incluyen clínicas de neurología especializada y centros de tratamiento de ELA.

• Centros de tratamiento especializados de ELA en EE. UU.: 48
• Clínicas de neurología capaces de terapia celular avanzada: 320

Grupos de defensa del paciente

Colaboración con organizaciones de defensa nacionales e internacionales de ALS.

Tipo de grupo de defensa	Número de organizaciones
Organizaciones nacionales de ELA	12
Grupos internacionales de defensa de la ELA	25

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, Brainstorm Cell Therapeutics reportó gastos de I + D por un total de $ 16.4 millones.

Categoría de gastos	Monto ($)
Desarrollo de la tecnología de Nurown®	8,200,000
Investigación preclínica	3,600,000
Preparación de ensayos clínicos	4,600,000

Costos de gestión de ensayos clínicos

Los gastos de ensayo clínico para 2023 fueron de aproximadamente $ 12.7 millones, centrados en indicaciones de enfermedad neurológica.

• Ensayos clínicos de ALS: $ 6,500,000
• Ensayos de esclerosis múltiple: $ 4,200,000
• Costos de estudio de apoyo: $ 2,000,000

Protección de propiedad intelectual

Los gastos anuales de protección de la propiedad intelectual fueron de $ 1.2 millones en 2023.

Tipo de protección de IP	Costo ($)
Presentación de patentes	650,000
Consulta legal	350,000
Tarifas de mantenimiento	200,000

Inversiones de cumplimiento regulatorio

Los costos de cumplimiento regulatorio para 2023 totalizaron $ 2.5 millones.

• Preparación de presentación de la FDA: $ 1,200,000
• Consultoría regulatoria: $ 800,000
• Documentación de cumplimiento: $ 500,000

Personal y talento científico especializado

Los gastos de personal para talento científico especializado fueron de $ 9.3 millones en 2023.

Categoría de personal	Costo anual ($)
Investigar científicos	4,500,000
Investigadores clínicos	2,800,000
Apoyo administrativo	2,000,000

Brainstorm Cell Therapeutics Inc. (BCLI) - Modelo de negocio: flujos de ingresos

Venta potencial de productos terapéuticos futuros

A partir de 2024, la terapéutica celular de Brainstorm se centra en los ingresos potenciales de la tecnología NUROWN® para los trastornos neurológicos, específicamente dirigidos a la ELA y otras afecciones neurodegenerativas.

Producto	Mercado potencial	Potencial de ingresos estimado
Nurown® para ALS	Tratamiento de trastorno neurológico	$ 12-15 millones de potencial anual proyectado

Subvenciones de investigación y financiación del gobierno

Brainstorm Therapeutics de células obtiene fondos a través de diversas subvenciones de investigación y mecanismos de apoyo gubernamental.

Fuente de financiación	Cantidad (2023-2024)	Objetivo
Institutos Nacionales de Salud (NIH)	$ 2.3 millones	Apoyo de investigación neurológica

Licencias potenciales de tecnologías propietarias

La propiedad intelectual de la compañía representa un flujo de ingresos potencial significativo.

• Potencial de licencia de tecnología celular de Nurown®
• Portafolio de patentes de tratamiento de trastorno neurológico
• Rango de ingresos de licencia estimado: $ 5-8 millones anualmente

Acuerdos de asociación estratégica

Los acuerdos de colaboración brindan oportunidades de ingresos adicionales.

Pareja	Tipo de acuerdo	Impacto financiero potencial
Compañía farmacéutica de nivel 1	Colaboración de investigación	Pagos de hitos de $ 3.5 millones

Financiación de los inversores y aumentos de capital

Las actividades de aumento de capital contribuyen a los recursos financieros de la compañía.

Ronda de financiación	Cantidad recaudada	Fecha
Colocación privada	$ 6.2 millones	P4 2023

Flujos de ingresos potenciales totales: aproximadamente $ 20-25 millones anuales

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.