BioRestorative Therapies, Inc. (BRTX): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el reino de vanguardia de la medicina regenerativa, Biorestorative Therapies, Inc. (BRTX) emerge como una fuerza pionera, transformando cómo abordamos la enfermedad crónica del disco y la terapéutica de células madre. Al crear meticulosamente un modelo de negocio integral que une la investigación innovadora, las asociaciones estratégicas y las tecnologías médicas innovadoras, BRTX está listo para revolucionar los tratamientos regenerativos personalizados. Su enfoque único combina experiencia científica, desarrollo de la propiedad intelectual y una estrategia centrada en el láser que podría remodelar las intervenciones médicas para pacientes que buscan soluciones avanzadas y no invasivas.

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: asociaciones clave

Instituciones de investigación académica que se centran en las terapias de células madre

Institución	Detalles de la asociación	Enfoque de investigación
Facultad de Medicina de la Universidad de Miami Miller	Acuerdo de investigación colaborativa	Terapias de células madre de regeneración de discos
Universidad de California, San Diego	Protocolo de investigación conjunta	Desarrollo terapéutico celular

Dispositivo médico y colaboradores de biotecnología

Las terapias biorestorativas mantienen asociaciones estratégicas con firmas de biotecnología especializadas:

• Regenerative Technologies Inc.
• Biotecnologías de Cellmark
• Diagnóstico celular avanzado

Posibles socios de desarrollo farmacéutico

Compañía farmacéutica	Área de colaboración potencial	Estado actual
Pfizer Inc.	Terapia de células madre BRTX-100	Discusiones exploratorias
Johnson & Johnson	Investigación de medicina regenerativa	Compromiso preliminar

Redes de investigación de ensayos clínicos

Asociaciones de red de ensayos clínicos activos:

• Red de ensayos clínicos de los Institutos Nacionales de Salud (NIH)
• Red de investigación de la Asociación Americana de Cirujanos Neurológicos
• Consorcio de ensayos clínicos internacionales de células madre

Inversiones totales de asociación en 2023: $ 2.3 millones

Presupuesto de expansión de asociación proyectada para 2024: $ 3.5 millones

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: actividades clave

Desarrollo de terapias de medicina regenerativa

Las terapias biorestorativas se centran en desarrollar tratamientos innovadores de medicina regenerativa, específicamente dirigida:

• BRTX-100 para la enfermedad del disco
• Tecnología Thermostem® para terapias de células madre derivadas de adiposa

Terapia	Etapa de desarrollo	Condición objetivo
BRTX-100	Investigación preclínica	Degeneración del disco
Thermostem®	Evaluación clínica temprana	Tratamientos de células madre adiposas

Realización de investigaciones preclínicas y clínicas

Investigación de inversiones y actividades a partir de 2024:

Métrico de investigación	Valor
Gasto de investigación anual	$ 1.2 millones
Protocolos de investigación activos	3 Estudios concurrentes

Avance de las tecnologías de tratamiento de células madre

El desarrollo tecnológico se centra en:

• Técnicas de preservación de células patentadas
• Protocolos de diferenciación de células avanzadas
• Plataformas de células madre que responden térmica

Desarrollo de patentes y gestión de propiedad intelectual

Categoría de IP	Número de activos
Patentes activas	7
Aplicaciones de patentes pendientes	4

Cumplimiento regulatorio y gestión de ensayos clínicos

Métricas de cumplimiento regulatorio:

• Frecuencia de interacción de la FDA: consultas trimestrales
• Asignación del presupuesto de cumplimiento: $ 450,000 anualmente
• Protocolos de ensayo clínico activo: 2

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: recursos clave

Tecnologías patentadas de células madre

Las terapias biorestorativas se mantienen Thermostem ™ Tecnología para tratamientos con células madre derivadas de adiposo. A partir de 2024, la compañía ha desarrollado dos candidatos principales de productos de células madre:

• BRTX-100 para el tratamiento de la enfermedad del disco
• BRTX-210 para trastornos metabólicos

Experiencia de investigación y desarrollo

I + D Métrica	2024 datos
Gastos anuales de I + D	$ 2.1 millones
Número de proyectos de investigación activos	3
Personal de I + D	8 investigadores a tiempo completo

Cartera de propiedades intelectuales

Detalles de la cartera de patentes a partir de 2024:

• Patentes totales: 7
• Aplicaciones de patentes pendientes: 3
• Jurisdicciones de patentes: Estados Unidos, Unión Europea

Personal científico y médico especializado

Categoría de personal	Número
Investigadores de doctorado	5
Médico	2
Especialistas en investigación clínica	3

Infraestructura de laboratorio e investigación

Especificaciones de la instalación de investigación:

• Espacio de laboratorio total: 2,500 pies cuadrados
• Ubicación: Melville, Nueva York
• Instalaciones avanzadas de cultivo celular: 2 habitaciones dedicadas
• Valor de equipo especializado: $ 1.4 millones

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: propuestas de valor

Soluciones innovadoras de medicina regenerativa

Las terapias biorestorativas se centran en desarrollar tecnologías avanzadas de medicina regenerativa dirigida a las necesidades médicas no satisfechas. El producto principal de la compañía, BRTX-100, es una terapia de células madre patentadas dirigida a la degeneración del disco.

Producto	Etapa de desarrollo	Condición objetivo	Características únicas
BRTX-100	Fase de ensayo clínico	Enfermedad del disco crónico	Terapia de células madre derivadas de adiposas autólogas

Tratamientos potenciales para la enfermedad crónica del disco

La propuesta de valor central de la Compañía aborda la enfermedad crónica del disco, una afección que afecta aproximadamente al 80% de los adultos en algún momento de sus vidas.

• Tamaño estimado del mercado para tratamientos de degeneración del disco: $ 5.2 mil millones para 2026
• Las limitaciones de tratamiento actuales incluyen procedimientos quirúrgicos invasivos
• BRTX-100 tiene como objetivo proporcionar una alternativa regenerativa no quirúrgica

Enfoques terapéuticos avanzados de células madre

Palancos de terapias biorestorativas Investigación de células madre de vanguardia Desarrollar soluciones terapéuticas innovadoras.

Tipo de células madre	Fuente	Potencial terapéutico
Células madre derivadas de adiposo	El propio tejido adiposo del paciente	Capacidades de curación regenerativa

Estrategias de intervención médica no invasiva

El enfoque de la Compañía se centra en tratamientos regenerativos mínimamente invasivos que reducen el tiempo de recuperación del paciente y los riesgos quirúrgicos.

• Reducción del tiempo de recuperación del paciente en comparación con las intervenciones quirúrgicas tradicionales
• Complicaciones quirúrgicas minimizadas
• Potencial para protocolos de tratamiento para pacientes ambulatorios

Tratamientos médicos regenerativos personalizados

Las terapias biorestorativas enfatizan la medicina personalizada a través de terapias de células madre específicas del paciente.

Aspecto de personalización	Beneficio	Implementación
Enfoque autólogo de células madre	Rechido inmune reducido	Cosecha de células madre derivadas del paciente

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocios: relaciones con los clientes

Compromiso directo con profesionales médicos

A partir de 2024, las terapias biorestorativas mantienen estrategias de divulgación específicas con profesionales médicos que se especializan en medicina regenerativa y terapias con células madre.

Canal de compromiso	Frecuencia de interacción	Especialidades objetivo
Presentaciones de conferencia médica	4-6 conferencias anualmente	Ortopedia, neurología, manejo del dolor
Consultas de ventas directas	72 consultas programadas por trimestre	Centros de tratamiento especializados

Servicios de apoyo y consulta del paciente

Las terapias biorestorativas proporcionan mecanismos integrales de apoyo al paciente.

• Limpieza dedicada del paciente: (888) 555-BRTX
• Portal de pacientes en línea con seguimiento del tratamiento
• Serie de seminarios web mensuales sobre terapia con células madre

Comunicación de la comunidad científica

Biorestorative mantiene rigurosos protocolos de comunicación científica.

Método de comunicación	Frecuencia	Plataformas
Publicación revisada por pares	2-3 publicaciones anualmente	Revista de Medicina Regenerativa
Participación del simposio de investigación	3 Simposios internacionales por año	Redes de investigación de células madre globales

Interacciones de los participantes del ensayo clínico

Biorestorative gestiona la participación de los participantes de los ensayos clínicos estructurados.

• Ensayos clínicos activos actuales: 3 estudios en curso
• Participantes totales inscritos: 87 pacientes
• Frecuencia de comunicación de los participantes: actualizaciones quincenales

Comunicación de investigación transparente

La Compañía prioriza la comunicación transparente del progreso de la investigación y los hallazgos.

Canal de comunicación	Frecuencia de divulgación	Tipo de información
Sitio web de relaciones con los inversores	Actualizaciones trimestrales	Hitos de investigación, resultados preliminares
Presentación de la SEC	Informes trimestrales y anuales	Investigación detallada y divulgaciones financieras

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: canales

Conferencias y simposios médicos

Las terapias biorestorativas utilizan conferencias médicas como un canal clave para la comunicación científica y el desarrollo potencial de la asociación. En 2023, la compañía participó en 4 principales conferencias de medicina regenerativa.

Nombre de conferencia	Fecha	Ubicación	Asistentes
Conferencia Internacional de Medicina Regenerativa	Mayo de 2023	Boston, MA	1,200
Simposio de investigación de células madre	Septiembre de 2023	San Diego, CA	950

Publicaciones científicas

La compañía mantiene una estrategia de publicación científica activa para comunicar los resultados de la investigación.

• Publicado 3 artículos revisados ​​por pares en 2023
• Citas totales: 42
• Factor de impacto de las publicaciones: 4.7

Ventas directas a instituciones médicas

Las terapias biorestorativas emplean un enfoque de ventas directo dirigido a las instituciones de investigación médica.

Tipo de institución	Número de instituciones contactadas	Tasa de conversión
Centros de investigación académicos	22	18%
Instituciones de investigación privadas	15	12%

Plataformas de comunicación científica en línea

Los canales digitales son críticos para la comunicación científica y la visibilidad.

• Sitio web Visitantes únicos en 2023: 45,670
• Seguidores de LinkedIn: 3.200
• Tasa de participación de la plataforma científica: 6.3%

Comunicaciones de relaciones con los inversores

La comunicación con los inversores se mantiene a través de múltiples canales.

Canal de comunicación	Frecuencia	Alcanzar
Llamadas de ganancias trimestrales	4 veces al año	150 inversores institucionales
Reunión anual de accionistas	Una vez al año	250 asistentes
Sebinarios web de presentación de inversores	6 veces al año	500 participantes en total

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: segmentos de clientes

Especialistas médicos ortopédicos

Tamaño del mercado objetivo: aproximadamente 30,000 cirujanos ortopédicos en los Estados Unidos a partir de 2023.

Características de segmento	Penetración del mercado
Especialistas en cirugía de columna	Estimados de 12.500 practicantes
Ortopedistas de medicina deportiva	Aproximadamente 3.800 especialistas

Pacientes de enfermedad del disco crónico

Total de la población de pacientes: 16 millones de estadounidenses diagnosticados con afecciones crónicas relacionadas con el disco.

• Rango de edad: 35-65 años
• Pacientes de búsqueda anual de tratamiento: estimado 2.5 millones
• Valor de mercado potencial: $ 8.3 mil millones en oportunidades de tratamiento regenerativo

Instituciones de investigación

Tipo de institución	Número de clientes potenciales
Centros de investigación académicos	289 Instituciones de investigación médica importantes
Instalaciones de investigación de biotecnología	127 laboratorios especializados en medicina regenerativa

Inversores de biotecnología

Desglose del segmento de inversores:

• Empresas de capital de riesgo especializadas en tecnologías médicas: 42
• Inversores institucionales centrados en biotecnología: 86
• Capital de inversión potencial total: $ 1.2 mil millones en inversiones de medicina regenerativa

Proveedores de atención médica especializados en medicina regenerativa

Categoría de proveedor	Total practicantes
Clínicas de medicina regenerativa	523 instalaciones especializadas
Centros de tratamiento integrales	213 centros de medicina regenerativa multipecialidad

Valor de mercado total direccionable: $ 12.5 mil millones en tratamientos e investigación de medicina regenerativa

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: Estructura de costos

Gastos de investigación y desarrollo

Para el año fiscal 2023, las terapias biorestorativas reportaron gastos totales de I + D de $ 1,845,000.

Categoría de gastos de I + D	Monto ($)
Investigación de tecnología de células madre	872,000
Desarrollo BRTX-100	563,000
Equipo de laboratorio	410,000

Financiación del ensayo clínico

Los gastos de ensayo clínico para 2023 totalizaron $ 2,315,000, asignados en múltiples programas de investigación.

Programa de ensayos clínicos	Monto de financiación ($)
Prueba de regeneración de discos	1,200,000
Estudios de condición inflamatoria	765,000
Reclutamiento de pacientes	350,000

Mantenimiento de la propiedad intelectual

Los costos de propiedad intelectual para 2023 fueron de $ 215,000.

• Tarifas de presentación de patentes: $ 95,000
• Consulta legal: $ 75,000
• Gestión de IP: $ 45,000

Personal y compensación del personal científico

Los gastos totales de personal para 2023 ascendieron a $ 3,642,000.

Categoría de personal	Compensación total ($)
Personal científico	2,100,000
Ejecutivos de investigación	842,000
Personal administrativo	700,000

Costos de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio para 2023 fueron de $ 425,000.

• Preparación de presentación de la FDA: $ 185,000
• Consultoría de cumplimiento: $ 140,000
• Documentación regulatoria: $ 100,000

Estructura de costos totales para 2023: $ 8,442,000

Biorestorative Therapies, Inc. (BRTX) - Modelo de negocio: flujos de ingresos

Licencias de productos terapéuticos potenciales

A partir del cuarto trimestre de 2023, las terapias biorestorativas se han centrado en posibles oportunidades de licencia para sus tecnologías centrales:

Tecnología	Valor de licencia potencial	Estado actual
BRTX-100 (regeneración de discos)	Tarifa de licencia inicial potencial de $ 2.5 millones	Etapa preclínica
Plataforma de terapia de células Therapure®	Potencial de licencia estimado de $ 1.8 millones	Etapa de desarrollo

Subvenciones de investigación

Fuentes de financiación de la subvención de investigación para 2023-2024:

• Subvención potencial de los Institutos Nacionales de Salud (NIH): $ 450,000
• Subvención de investigación de medicina regenerativa del Departamento de Defensa: $ 375,000
• Soporte de la Fundación de Investigación Privada: $ 250,000

Comercialización futura de productos

Fluyos de ingresos proyectados de la comercialización potencial de productos:

Producto	Potencial de mercado estimado	Año de lanzamiento proyectado
Tratamiento terapéutico BRTX-100	$ 12.5 millones de potencial de primer año	2025
Terapia de células terape®	$ 8.3 millones potencial de primer año	2026

Acuerdos de asociación estratégica

Desglose de ingresos de asociación estratégica actual y potencial:

• Valor de colaboración de investigación existente: $ 675,000
• Posibles nuevas negociaciones de asociación: $ 1.2 millones
• Exploración de la Alianza de Biotecnología: $ 950,000

Pagos potenciales de hitos de colaboraciones

Estructura de pago de hito anticipada:

Categoría de hito	Rango de pago potencial	Probabilidad
Desarrollo preclínico	$500,000 - $750,000	75%
Iniciación de ensayos clínicos	$ 1.1 millones - $ 1.5 millones	60%
Hito de aprobación regulatoria	$ 2.5 millones - $ 3.2 millones	40%

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Value Propositions

Non-surgical, autologous cell therapy for chronic disc pain (BRTX-100)

The value proposition centers on BRTX-100, an autologous mesenchymal stem cell therapy for chronic lumbar disc disease (cLDD) delivered via intradiscal injection. The Phase 2 clinical trial (NCT04042844) is designed to enroll up to 99 patients across up to 16 study sites in the United States, with subjects randomized 2:1 to receive BRTX-100 or placebo. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program in February 2025. Preliminary blinded data presented at ISSCR 2025, involving 36 evaluated subjects, showed compelling efficacy signals: over 74% experienced greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported greater than 50% reduction in pain (VAS) by 52 weeks. Earlier data from 15 patients indicated 100% (n=5 at 52 weeks) achieved a greater than 30% improvement in VAS score at 52 weeks posttreatment. The company also obtained FDA Investigational New Drug (IND) clearance to evaluate BRTX-100 for chronic cervical discogenic pain.

Potential cell-based alternative for obesity/metabolic disorders (ThermoStem®)

The ThermoStem® platform offers a cell-based therapeutic candidate targeting obesity and metabolic disorders, utilizing brown adipose (fat) derived stem cells (BADSC) or exosomes secreted by BADSC to generate brown adipose tissue (BAT). This approach is positioned to potentially offer longer-lasting efficacy with improved safety and dosing advantages compared to GLP-1 drugs. In October 2025, the Japanese Patent Office issued a Notice of Allowance for the company's allogeneic, off-the-shelf BADSC technology. Substantive licensing discussions for this intellectual property are continuing.

BioCosmeceutical products for aesthetic practices

BioRestorative Therapies, Inc. operates a commercial BioCosmeceutical platform, which is a near-term revenue focus, targeting what management views as a $63 billion market. The current commercial product is a cell-based secretome containing exosomes, proteins, and growth factors, manufactured in a cGMP ISO-7 certified clean room. Revenue from this segment is subject to order timing; for example, Q3 2025 revenues were $11,800 (entirely royalty revenue), down from $233,600 in Q3 2024 due to order timing. However, Q2 2025 revenues reached approximately $303,000, a 240% increase over Q2-2024, primarily from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Reduced risk profile due to autologous cell source (BRTX-100)

The autologous nature of BRTX-100, using the patient's own cells, contributes to a favorable safety profile. Clinical data presented in 2025 showed no serious adverse events (SAEs) or dose-limiting toxicity reported at the target dose of 40 million cells between 26 and 104 weeks post-injection across evaluated subjects. The company ended Q3 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no debt, and subsequently closed a $1.1 million financing. The company has a current ratio of 1.37. Despite this, financial efficiency metrics show a Return on Equity (ROE) of -207.73% and an Altman Z-Score of -47.37, which suggests an increased risk of bankruptcy.

Key Financial and Operational Metrics as of Late 2025

Metric Category	Specific Data Point	Value/Amount
Clinical Trial (BRTX-100)	Total Planned Enrollment (Phase 2)	Up to 99 subjects
Clinical Trial (BRTX-100)	Number of U.S. Study Sites	Up to 16
Clinical Trial (BRTX-100)	Reported Subjects Evaluated (ISSCR 2025)	36
Clinical Trial (BRTX-100)	% Subjects with >50% Function Improvement (52 Weeks)	Over 74%
Clinical Trial (BRTX-100)	Dose Tested (Cells)	40 million cells
Financial (Q3 2025)	Revenue	$11,800
Financial (Q3 2025)	Net Loss per Share	$0.33
Financial (Q3 2025 End)	Cash and Marketable Securities	$4.5 million
Financial (Post Q3 2025)	Financing Closed	$1.1 million
Financial (Late 2025)	Market Capitalization	$9.5M (per one source) or $10.23 million (per another)
Financial Efficiency	Return on Equity (ROE)	-207.73%
Operational	Fulltime Employees	11

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Relationships

High-touch scientific engagement with clinical investigators

The relationship with clinical investigators is central to the development of the lead candidate, BRTX-100, for chronic lumbar disc disease (cLDD).

• The Phase 2 clinical trial for BRTX-100 is being conducted across up to 16 clinical sites in the United States.
• Preliminary blinded data from the first 15 patients was presented at the ISCT 2025 Annual Meeting in May 2025.
• By the second quarter of 2025, preliminary blinded data from the first 36 subjects was shared at the ISSCR 2025 Annual Meeting.
• Subjects in the Phase 2 trial are randomized in a 2:1 ratio to receive either BRTX-100 or placebo.

Partner-managed commercial relationship for BioCosmeceuticals

The commercial relationship for the BioCosmeceuticals platform is currently managed through an exclusive supply agreement, though the company is shifting focus to royalty revenue and internal commercial build-out.

Metric	Q3 2025 Amount	Q3 2024 Amount
Total Revenues	$11,800	$233,600
Primary Revenue Source	Exclusively royalty revenue	Primarily BioCosmeceutical sales
Q2 2025 Revenue (for context)	N/A	Approx. $303,000 (primarily BioCosmeceutical sales)

The company appointed Crystal Romano as Global Head of Commercial Operations in October 2025 to accelerate growth beyond the existing partnership structure. The Q3 2025 revenue of $11,800 consisted entirely of royalty revenue, compared to Q3 2024 where the vast majority of revenue came from sales under the exclusive supply agreement with Cartessa Aesthetics, LLC.

Active investor relations via conference calls and presentations

BioRestorative Therapies, Inc. maintains active communication with its investor base through scheduled financial updates and participation in industry events.

• Management hosted conference calls to review financial results for Q1 2025 on May 14, Q2 2025 on August 12, and Q3 2025 on November 12.
• Investor conference calls use the domestic dial-in number 888-506-0062 and international number 973-528-0011.
• CEO Lance Alstodt participated in the Benzinga All-Access Show in April 2025.
• In October 2025, the CEO and VP of Research and Development participated in a panel at the 2025 Maxim Growth Summit.

Regulatory dialogue with the FDA for BLA approval pathway

The relationship with the U.S. Food and Drug Administration (FDA) is focused on advancing the BRTX-100 program toward potential accelerated approval.

The FDA granted Fast Track designation to the BRTX-100 Phase 2 clinical trial in February 2025.

BioRestorative Therapies, Inc. secured a Type B meeting with the FDA scheduled for mid-December 2025 to discuss an accelerated Biologics License Application (BLA) approval pathway for BRTX-100 in cLDD.

The FDA has established performance benchmarks for the trial, requiring at least a greater than 30% improvement in function in the Oswestry Disability Index (ODI) and a greater than 30% reduction.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Channels

You're looking at how BioRestorative Therapies, Inc. (BRTX) gets its science and its commercial products in front of the right people. For a clinical-stage company, the channels are split between proving the science and building the future revenue base.

Clinical trial sites for BRTX-100 patient enrollment and treatment

The primary channel for the lead candidate, BRTX-100, is the Phase 2 clinical trial for chronic lumbar disc disease (cLDD). This channel is critical for generating the data needed for regulatory submission and eventual commercialization. The structure is highly controlled and site-dependent.

The Phase 2 study is a prospective, randomized, double-blinded, placebo-controlled trial. The total target enrollment is up to 99 eligible subjects, randomized in a 2:1 fashion to receive either BRTX-100 or placebo via a single intradiscal injection. Enrollment is managed across up to 16 clinical sites in the United States. As of November 2025, the company believed enrollment was nearing completion.

Here's a snapshot of the trial's progress and data dissemination through this channel:

Metric/Event	Value/Date	Channel Relevance
Total Target Enrollment	99 subjects	Defines the scale of the clinical channel.
Number of U.S. Clinical Sites	Up to 16	Geographic reach for patient recruitment.
Reported Evaluated Subjects (June 2025)	36	Data point presented at ISSCR 2025.
Reported Initial Patients (Feb 2025)	15 (up from 10)	Early data point shared at ORS 2025.
Randomization Ratio	2:1 (BRTX-100:Placebo)	Study design channel for efficacy measurement.

The FDA has granted Fast Track designation to the BRTX-100 program, which influences the regulatory pathway channel, anticipating a Type B meeting to discuss an accelerated Biologics License Application (BLA) approval pathway.

Strategic commercial partner's sales network (Cartessa Aesthetics)

For the BioCosmeceutical platform, the channel is an exclusive, five-year supply agreement with Cartessa Aesthetics, LLC. This leverages their established North American aesthetics market reach for BioRestorative Therapies, Inc.'s commercial product, Chronos ExoCR. This product is a private label cell-based secretome.

The financial performance through this channel shows variability:

• Q2 2025 revenues were approximately $303,000, representing a 240% increase over Q2-2024, primarily from BioCosmeceutical sales via Cartessa Aesthetics.
• Q3 2025 revenues dropped to approximately $11,800, consisting exclusively of royalty revenue related to BRTX-100 technology, compared to $233,600 in Q3-2024 from BioCosmeceutical sales.

This partnership is intended to introduce the product, which includes a secretome of exosomes, proteins, and growth factors, to aesthetic providers. The companies may explore expanding this collaboration to include additional cell-based biologic products.

Scientific and medical conferences (e.g., ISSCR 2025)

Conferences serve as a vital channel to communicate clinical progress directly to the scientific community, key opinion leaders, and potential investors. BioRestorative Therapies, Inc. actively presents its data at major industry events.

Key conference channel activity in 2025 included:

• ISSCR 2025 Annual Meeting in Hong Kong (June 11 - June 14, 2025), where preliminary blinded data from 30 patients was presented on June 13, 2025.
• ISCT 2025 Annual Meeting in New Orleans, LA (May 7 - May 10, 2025), where an update on the Phase 2 trial was presented.
• ORS 2025 Annual Meeting in Phoenix, AZ (February 7-11, 2025), where 26-52 week blinded data from the first 15 patients was presented.

The presentation at ISSCR 2025 highlighted that over 74% of participants experienced greater than 50% improvement in function, and over 72% reported a similar reduction in pain after 52 weeks, based on data from 36 evaluated subjects.

Direct-to-investor communications and SEC filings

This channel involves formal regulatory disclosures and direct engagement with the investment community, often tied to financial milestones. The company uses press releases, conference calls, and SEC filings to manage investor expectations.

Key investor communication events and financial data points from 2025:

Communication Type	Date	Key Financial/Operational Data Point
Q2 2025 Results Conference Call	August 12, 2025	Company ended Q2 2025 with $7.4 million in cash, cash equivalents, and marketable securities.
Q3 2025 Results Conference Call	November 12, 2025	Q3 2025 loss from operations was $3.7 million; net loss was $3.0 million, or $0.33 per share.
SEC Filing (Form 8-K)	August 12, 2025	Furnished press release announcing Q2 2025 results.
Financing Activity (October 2025)	Subsequent to Q3 End	Sold 678,125 shares at $1.60 per share in a registered direct offering.
Cash Position (End of Q3 2025)	September 30, 2025	Ended quarter with $4.5 million in cash, cash equivalents, and investments, with no outstanding debt.

The company also held its Annual Meeting of Stockholders on September 18, 2025, another direct channel for governance communication.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Customer Segments

You're hiring before product-market fit in the clinical pipeline, so understanding the distinct customer groups BioRestorative Therapies, Inc. (BRTX) serves across its three main areas-clinical development and commercial-is key to valuing the enterprise.

Patients with chronic lumbar disc disease (cLDD)

This segment is the primary focus for the lead clinical candidate, BRTX-100. The treatment is intended for patients whose pain hasn't improved with non-invasive methods and who might otherwise face surgery. The Phase 2 clinical trial for cLDD is nearing completion of enrollment. The trial is designed to enroll up to 99 subjects across up to 16 clinical sites in the United States. As of June 13, 2025, 36 subjects had been evaluated. Preliminary blinded data presented in June 2025 showed encouraging efficacy signals: over 74% of subjects demonstrated a greater than 50% improvement in function (ODI) by 52 weeks, and over 72% reported a greater than 50% reduction in pain (VAS) by 52 weeks. The U.S. Food and Drug Administration (FDA) granted Fast Track designation to this program. The FDA's threshold for determining progression toward Biologics License Application (BLA) approval is a greater than 30% improvement in function (ODI) and a greater than 30% reduction in pain (VAS). The pathway to a potential accelerated BLA has never been more visible.

Patients with chronic cervical discogenic pain (cCDP)

This represents a secondary, but important, patient segment for the BRTX-100 program. BioRestorative Therapies, Inc. has obtained U.S. Food and Drug Administration (FDA) Investigational New Drug (IND) clearance to evaluate BRTX-100 specifically for the treatment of chronic cervical discogenic pain. This clearance opens the door to a new patient population for the spine program.

Aesthetic clinics and medical spas (BioCosmeceutical buyers)

This group drives the current commercial revenue stream through the purchase of the BioCosmeceutical platform products, which are proprietary biologic serums engineered to reduce the appearance of fine lines and wrinkles. The company is focused on aggressively executing its near-term revenue strategy within this platform. To accelerate growth, Crystal Romano, an executive with 20 years of leadership in the aesthetics industry, was appointed Head of Global Commercial Operations in October 2025. Revenue from this segment has shown variability based on order timing.

Here's a look at the recent revenue performance, which is primarily driven by these commercial sales, though Q3 2025 revenue was entirely royalty-based:

Reporting Period End Date	Reported Revenue	Primary Revenue Source
September 30, 2025 (Q3 2025)	Approximately $11,800	Royalty Revenue (BRTX-100 Technology)
June 30, 2025 (Q2 2025)	Approximately $303,000	BioCosmeceutical Sales (Cartessa Agreement)
March 31, 2025 (Q1 2025)	$25,000	BioCosmeceutical Sales
September 30, 2024 (Q3 2024)	$233,600	BioCosmeceutical Sales (Cartessa Agreement)

The year-over-year decrease in Q3 2025 revenue compared to Q3 2024 was related to the specific timing of orders for the developing BioCosmeceutical stream.

Pharmaceutical and biotech companies (potential ThermoStem® licensees)

This segment represents a major potential value inflection point through licensing the ThermoStem® platform, which targets obesity and metabolic disorders. The global obesity market is projected to exceed $100 billion annually by the end of the decade. BioRestorative Therapies, Inc. is in active, ongoing negotiations with an undisclosed commercial-stage regenerative medicine company regarding a license for this metabolic disease platform. The intellectual property supporting this platform is well-protected; in October 2025, the Japanese Patent Office issued a Notice of Allowance for a broad patent covering the allogeneic brown adipose-derived stem cell (BADSC) technology. The company ended the third quarter of 2025 with $4.5 million in cash, cash equivalents, and marketable securities, with no outstanding debt, following a financing in October 2025 that brought in gross proceeds of approximately $1.085 million from the sale of 678,125 shares at $1.60 per share.

The key customer characteristics for this segment include:

• Engagement with a commercial-stage regenerative medicine company.
• Interest driven by the potential for a cell-based alternative to chronic GLP-1 injections.
• Value proposition centered on mitigating tolerability issues like muscle mass loss.
• IP protection across U.S. and international markets, evidenced by the Japanese patent allowance.

The company is actively managing resources to advance clinical trials while pursuing this licensing opportunity.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Cost Structure

You're hiring before product-market fit in a highly regulated space; that means your cost structure is dominated by science and compliance, not sales.

Significant R&D and clinical trial expenses are the primary cost drivers for BioRestorative Therapies, Inc. These costs fund the development of their cell-based therapies, particularly the BRTX-100 program for disc/spine disorders. The company's focus on clinical advancement means these expenditures are substantial relative to revenue.

Personnel costs for scientific and executive teams are embedded heavily within both Research and Development and General and Administrative expenses. The recruitment of specialized talent, like the serial regenerative medicine entrepreneur in a new strategic role in June 2025, adds to this fixed cost base. Honestly, keeping the scientific team fully staffed while advancing trials is a non-negotiable burn rate.

Manufacturing and laboratory operations overhead includes costs associated with maintaining cGMP ISO-7 certified clean room facilities for the BioCosmeceutical platform. BioRestorative Therapies, Inc. emphasizes its 'made-in-America' production strategy, which is intended to help manage costs amid global supply chain shifts, but this still requires significant infrastructure investment.

Legal and regulatory compliance costs are a persistent overhead in the regenerative medicine sector. These expenses cover everything from intellectual property portfolio expansion to filings and adherence to FDA guidelines for clinical programs.

The third quarter of 2025 loss from operations was $3.7 million compared to $2.3 million for the comparable period of 2024. Here's the quick math on the most recent detailed quarterly operating expenses available, which were for the three months ended June 30, 2025, as the specific Q3 2025 breakdown isn't fully itemized in the same way:

Expense Category (3 Months Ended June 30, 2025)	Amount (USD)
Research and development	$2,225,882
General and administrative	$1,373,976
Total Operating Expenses (Q2 2025)	$3,599,858
Loss From Operations (Q3 2025)	$3,700,000
Loss From Operations (Q3 2024)	$2,300,000

The cost structure is clearly weighted toward future value creation, which is typical for a clinical-stage biotech. Still, you need to watch the cash burn rate closely.

• Q3 2025 Loss from Operations: $3.7 million
• Q2 2025 Research and Development: $2,225,882
• Q2 2025 General and Administrative: $1,373,976
• Cash, cash equivalents, and investments as of September 30, 2025: $4.5 million
• Authorized stock repurchase program limit: $2 million

Finance: draft 13-week cash view by Friday.

BioRestorative Therapies, Inc. (BRTX) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of BioRestorative Therapies, Inc. (BRTX) as of late 2025, and honestly, the picture is one of transition, leaning heavily on early-stage commercial efforts while financing future clinical work. The streams are clearly segmented between near-term product sales and longer-term technology monetization.

The most immediate, though currently small, revenue component is from BioCosmeceutical product sales. This stream is tied to the exclusive supply agreement with Cartessa Aesthetics, LLC. To give you a sense of scale from the prior period, the revenue from these BioCosmeceuticals was the primary driver in Q3-2024, totaling $233,600 for that quarter. The timing of orders for this developing stream impacted the most recent results.

The second established revenue component is Royalty revenue related to BRTX-100 technology. For the third quarter ended September 30, 2025, the total reported revenue was approximately $11,800. What this estimate hides is that this entire amount consisted exclusively of this royalty revenue. So, for Q3 2025, the royalty stream was the only active revenue generator reported.

Future revenue potential is heavily weighted toward clinical program milestones and licensing. Specifically, the ThermoStem® program is a key area where BioRestorative Therapies, Inc. is actively pursuing licensing and partnership deals with commercial-stage regenerative medical companies. These deals would unlock future milestone payments and potential ongoing licensing fees, which are critical for funding the clinical-stage programs like BRTX-100.

To support the ongoing operations and clinical advancement, the company has also recently accessed capital through equity financing. Following the end of the third quarter, BioRestorative Therapies, Inc. completed a financing round, bringing in approximate gross proceeds of $1.085 million. This strengthens the balance sheet to execute on near-term milestones.

Here's a quick look at the key revenue-related financial data points we have for the period:

Revenue Stream Component	Most Recent Reported Value/Context	Period/Date
Q3 2025 Total Revenue	$11,800	Q3 2025
Q3 2025 Royalty Revenue (BRTX-100)	$11,800 (100% of total revenue)	Q3 2025
BioCosmeceutical Sales Context	$233,600 (Primary source in prior period)	Q3 2024
Post-Q3 2025 Equity Financing Proceeds	$1.085 million (Gross proceeds)	Post Q3 2025

The company's focus remains on driving the BioCosmeceutical commercial platform while advancing clinical programs. The revenue breakdown shows a current reliance on the royalty stream while waiting for the next inflection point from licensing or BioCosmeceutical order timing.

• BioCosmeceutical sales are the near-term commercial engine.
• Royalty revenue from BRTX-100 technology was the sole reported revenue source for Q3 2025.
• Future revenue hinges on ThermoStem® licensing and milestone payments.
• Financing provided approximately $1.085 million in gross proceeds after the quarter closed.

Finance: draft 13-week cash view by Friday.