Biorestorative Therapies, Inc. (BRTX): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No domínio de ponta da medicina regenerativa, a biorestorativa Therapies, Inc. (BRTX) surge como uma força pioneira, transformando como abordamos a doença crônica do disco e a terapêutica das células-tronco. Ao criar meticulosamente um modelo de negócios abrangente que preenche pesquisas inovadoras, parcerias estratégicas e tecnologias médicas inovadoras, o BRTX está pronto para revolucionar tratamentos regenerativos personalizados. Sua abordagem única combina experiência científica, desenvolvimento da propriedade intelectual e uma estratégia focada em laser que poderia potencialmente remodelar intervenções médicas para pacientes que buscam soluções avançadas e não invasivas.

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: Parcerias -chave

Instituições de pesquisa acadêmica com foco em terapias com células -tronco

Instituição	Detalhes da parceria	Foco na pesquisa
Faculdade de Medicina da Universidade de Miami Miller	Acordo de Pesquisa Colaborativa	Terapias de células -tronco de regeneração de disco
Universidade da Califórnia, San Diego	Protocolo de pesquisa conjunta	Desenvolvimento terapêutico celular

Dispositivos médicos e colaboradores de biotecnologia

As terapias biorestorativas mantêm parcerias estratégicas com empresas especializadas de biotecnologia:

• Regenerative Technologies Inc.
• Biotecnologias de Cellmark
• Diagnóstico celular avançado

Parceiros potenciais de desenvolvimento farmacêutico

Empresa farmacêutica	Área de colaboração potencial	Status atual
Pfizer Inc.	Terapia com células-tronco BRTX-100	Discussões exploratórias
Johnson & Johnson	Pesquisa de Medicina Regenerativa	Engajamento preliminar

Redes de pesquisa de ensaios clínicos

Parcerias de rede de ensaios clínicos ativos:

• Rede de ensaios clínicos do National Institutes of Health (NIH)
• Rede de Pesquisa da Associação Americana de Cirurgiões Neurológicos
• Consórcio de ensaios clínicos de células -tronco internacionais

Total Partnership Investments em 2023: US $ 2,3 milhões

Orçamento de expansão de parceria projetada para 2024: US $ 3,5 milhões

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: Atividades -chave

Terapias de medicina regenerativa em desenvolvimento

As terapias biorestorativas se concentram no desenvolvimento de tratamentos inovadores de medicina regenerativa, segmentando especificamente:

• BRTX-100 para doença do disco
• ThermoStem® Technology para terapias com células-tronco derivadas de adipos

Terapia	Estágio de desenvolvimento	Condição alvo
BRTX-100	Pesquisa pré -clínica	Degeneração do disco
ThermoStem®	Avaliação clínica precoce	Tratamentos com células -tronco adiposas

Condução de pesquisa pré -clínica e clínica

Investimento e atividades de pesquisa a partir de 2024:

Métrica de pesquisa	Valor
Gastos anuais de pesquisa	US $ 1,2 milhão
Protocolos de pesquisa ativos	3 estudos simultâneos

Avançar tecnologias de tratamento de células -tronco

O desenvolvimento de tecnologia se concentra em:

• Técnicas de preservação de células proprietárias
• Protocolos avançados de diferenciação de células
• Plataformas de células-tronco responsivas a térmicas

Desenvolvimento de patentes e gestão de propriedade intelectual

Categoria IP	Número de ativos
Patentes ativas	7
Aplicações de patentes pendentes	4

Conformidade regulatória e gerenciamento de ensaios clínicos

Métricas de conformidade regulatória:

• Frequência de interação da FDA: consultas trimestrais
• Alocação de orçamento de conformidade: US $ 450.000 anualmente
• Protocolos de ensaios clínicos ativos: 2

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: Recursos -chave

Tecnologias de células -tronco proprietárias

As terapias biorestorativas são mantidas ThermoStem ™ Tecnologia para tratamentos com células-tronco derivadas de adiposo. A partir de 2024, a empresa desenvolveu dois candidatos a produtos de células -tronco primárias:

• BRTX-100 para tratamento de doença de disco
• BRTX-210 para distúrbios metabólicos

Especialização em pesquisa e desenvolvimento

Métrica de P&D	2024 dados
Despesas anuais de P&D	US $ 2,1 milhões
Número de projetos de pesquisa ativos	3
Pessoal de P&D	8 pesquisadores em tempo integral

Portfólio de propriedade intelectual

Detalhes do portfólio de patentes a partir de 2024:

• Total de patentes: 7
• Aplicações de patentes pendentes: 3
• Jurisdições de patentes: Estados Unidos, União Europeia

Pessoal científico e médico especializado

Categoria de pessoal	Número
Pesquisadores de doutorado	5
Médicos médicos	2
Especialistas em pesquisa clínica	3

Infraestrutura de laboratório e pesquisa

Especificações da instalação de pesquisa:

• Espaço total de laboratório: 2.500 pés quadrados
• Localização: Melville, Nova York
• Instalações de cultura de células avançadas: 2 quartos dedicados
• Valor do equipamento especializado: US $ 1,4 milhão

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: proposições de valor

Soluções inovadoras de medicina regenerativa

As terapias biorestorativas se concentram no desenvolvimento de tecnologias avançadas de medicina regenerativa, direcionadas às necessidades médicas não atendidas. O produto principal da empresa, BRTX-100, é uma terapia com células-tronco proprietária direcionada à degeneração do disco.

Produto	Estágio de desenvolvimento	Condição alvo	Características únicas
BRTX-100	Fase de ensaios clínicos	Doença de disco crônico	Terapia com células-tronco derivadas de adiposo autólogo

Tratamentos potenciais para doença de disco crônico

A proposta de valor central da empresa aborda a doença do disco crônico, uma condição que afeta aproximadamente 80% dos adultos em algum momento de suas vidas.

• Tamanho estimado do mercado para tratamentos de degeneração de disco: US $ 5,2 bilhões até 2026
• As limitações atuais de tratamento incluem procedimentos cirúrgicos invasivos
• O BRTX-100 visa fornecer uma alternativa regenerativa não cirúrgica

Abordagens terapêuticas avançadas de células -tronco

As terapias biorestorativas aproveitam pesquisa de células-tronco de ponta desenvolver soluções terapêuticas inovadoras.

Tipo de célula -tronco	Fonte	Potencial terapêutico
Células-tronco derivadas de adiposo	Tecido adiposo do próprio paciente	Capacidades de cicatrização regenerativa

Estratégias de intervenção médica não invasivas

A abordagem da empresa se concentra em tratamentos regenerativos minimamente invasivos que reduzem o tempo de recuperação do paciente e os riscos cirúrgicos.

• Tempo de recuperação reduzido do paciente em comparação com intervenções cirúrgicas tradicionais
• Complicações cirúrgicas minimizadas
• Potencial para protocolos de tratamento ambulatorial

Tratamentos médicos regenerativos personalizados

As terapias biorestorativas enfatizam a medicina personalizada por meio de terapias de células-tronco específicas do paciente.

Aspecto de personalização	Beneficiar	Implementação
Abordagem autóloga de células -tronco	Rejeição imune reduzida	Colheita de células-tronco derivadas do paciente

Biorestorative Therapies, Inc. (BRTX) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais médicos

A partir de 2024, as terapias biorestorativas mantêm estratégias de divulgação direcionadas com profissionais médicos especializados em medicina regenerativa e terapias com células -tronco.

Canal de engajamento	Frequência de interação	Especialidades -alvo
Apresentações da conferência médica	4-6 Conferências anualmente	Ortopedia, neurologia, manejo da dor
Consultas de vendas diretas	72 consultas programadas por trimestre	Centros de tratamento especializados

Serviços de apoio e consulta do paciente

As terapias biorestorativas fornecem mecanismos abrangentes de apoio ao paciente.

• Helpline de pacientes dedicados: (888) 555-BRTX
• Portal de pacientes online com rastreamento de tratamento
• Série de seminários on -line mensais sobre terapia com células -tronco

Comunicação da comunidade científica

O biorestorativo mantém protocolos rigorosos de comunicação científica.

Método de comunicação	Freqüência	Plataformas
Publicação revisada por pares	2-3 publicações anualmente	Jornal de Medicina Regenerativa
Participação do Simpósio de Pesquisa	3 simpósios internacionais por ano	Redes globais de pesquisa de células -tronco

Interações dos participantes do ensaio clínico

O biorestorativo gerencia o envolvimento estruturado dos participantes do ensaio clínico.

• Ensaios clínicos ativos atuais: 3 estudos em andamento
• Total de participantes inscritos: 87 pacientes
• Frequência de comunicação do participante: atualizações quinzenais

Comunicação de pesquisa transparente

A empresa prioriza a comunicação transparente do progresso e descobertas da pesquisa.

Canal de comunicação	Frequência de divulgação	Tipo de informação
Site de Relações com Investidores	Atualizações trimestrais	Marcos de pesquisa, resultados preliminares
Registros da SEC	Relatórios trimestrais e anuais	Pesquisa detalhada e divulgações financeiras

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: Canais

Conferências médicas e simpósios

As terapias biorestorativas utilizam conferências médicas como um canal -chave para comunicação científica e desenvolvimento de parcerias em potencial. Em 2023, a empresa participou de 4 principais conferências de medicina regenerativa.

Nome da conferência	Data	Localização	Participantes
Conferência Internacional de Medicina Regenerativa	Maio de 2023	Boston, MA	1,200
Simpósio de pesquisa de células -tronco	Setembro de 2023	San Diego, CA.	950

Publicações científicas

A empresa mantém uma estratégia de publicação científica ativa para comunicar os resultados da pesquisa.

• Publicado 3 artigos revisados ​​por pares em 2023
• Citações totais: 42
• Fator de impacto das publicações: 4.7

Vendas diretas para instituições médicas

As terapias biorestorativas empregam uma abordagem direcionada de vendas diretas para as instituições de pesquisa médica.

Tipo de instituição	Número de instituições contatadas	Taxa de conversão
Centros de pesquisa acadêmica	22	18%
Instituições de Pesquisa Privada	15	12%

Plataformas de comunicação científica online

Os canais digitais são críticos para a comunicação científica e a visibilidade.

• Site visitantes exclusivos em 2023: 45.670
• Seguidores do LinkedIn: 3.200
• Taxa de envolvimento da plataforma científica: 6,3%

Comunicações de Relações com Investidores

A comunicação com os investidores é mantida através de vários canais.

Canal de comunicação	Freqüência	Alcançar
Chamadas de ganhos trimestrais	4 vezes por ano	150 investidores institucionais
Reunião Anual dos Acionistas	Uma vez por ano	250 participantes
Webinars de apresentação de investidores	6 vezes por ano	500 participantes totais

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

Especialistas médicos ortopédicos

Tamanho do mercado -alvo: aproximadamente 30.000 cirurgiões ortopédicos nos Estados Unidos a partir de 2023.

Características do segmento	Penetração de mercado
Especialistas em cirurgia da coluna	Estimado 12.500 profissionais
Ortopedistas de medicina esportiva	Aproximadamente 3.800 especialistas

Pacientes com doença de disco crônico

População total de pacientes: 16 milhões de americanos diagnosticados com condições crônicas relacionadas ao disco.

• Faixa etária: 35-65 anos
• Pacientes anuais de busca de tratamento: estimado 2,5 milhões
• Valor potencial de mercado: US $ 8,3 bilhões em oportunidades de tratamento regenerativo

Instituições de pesquisa

Tipo de instituição	Número de clientes em potencial
Centros de pesquisa acadêmica	289 principais instituições de pesquisa médica
Instalações de pesquisa de biotecnologia	127 laboratórios de medicina regenerativa especializados

Investidores de biotecnologia

Redução do segmento de investidores:

• Empresas de capital de risco especializadas em tecnologias médicas: 42
• Investidores institucionais focados em biotecnologia: 86
• Capital potencial de investimento total: US $ 1,2 bilhão em investimentos em medicina regenerativa

Provedores de saúde especializados em medicina regenerativa

Categoria de provedor	Total de praticantes
Clínicas de Medicina Regenerativa	523 instalações especializadas
Centros de tratamento abrangentes	213 Centros de Medicina Regenerativa de Multi-Especialidade

Valor de mercado endereçável total: US $ 12,5 bilhões em tratamentos e pesquisas de medicina regenerativa

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: estrutura de custos

Despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, as terapias biorstorativas relataram despesas totais de P&D de US $ 1.845.000.

Categoria de despesa de P&D	Valor ($)
Pesquisa de tecnologia de células -tronco	872,000
Desenvolvimento BRTX-100	563,000
Equipamento de laboratório	410,000

Financiamento de ensaios clínicos

As despesas de ensaios clínicos para 2023 totalizaram US $ 2.315.000, alocados em vários programas de pesquisa.

Programa de ensaios clínicos	Valor de financiamento ($)
Trial de regeneração de disco	1,200,000
Estudos de Condição Inflamatória	765,000
Recrutamento de pacientes	350,000

Manutenção da propriedade intelectual

Os custos de propriedade intelectual para 2023 foram de US $ 215.000.

• Taxas de arquivamento de patentes: US $ 95.000
• Consulta legal: US $ 75.000
• Gerenciamento de IP: US $ 45.000

Pessoal e compensação da equipe científica

As despesas totais de pessoal para 2023 totalizaram US $ 3.642.000.

Categoria de pessoal	Compensação total ($)
Equipe científica	2,100,000
Executivos de pesquisa	842,000
Pessoal administrativo	700,000

Custos de conformidade regulatória

As despesas de conformidade regulatória para 2023 foram de US $ 425.000.

• Preparação de envio da FDA: US $ 185.000
• Consultoria de conformidade: US $ 140.000
• Documentação regulatória: US $ 100.000

Estrutura de custo total para 2023: $ 8.442.000

Biorestorative Therapies, Inc. (BRTX) - Modelo de negócios: fluxos de receita

Potencial licenciamento de produtos terapêuticos

A partir do quarto trimestre de 2023, as terapias biorestorativas se concentraram em possíveis oportunidades de licenciamento para suas principais tecnologias:

Tecnologia	Valor potencial de licenciamento	Status atual
BRTX-100 (regeneração do disco)	US $ 2,5 milhões em potencial taxa de licenciamento inicial	Estágio pré-clínico
Plataforma de terapia celular Therapure®	Potencial de licenciamento estimado de US $ 1,8 milhão	Estágio de desenvolvimento

Bolsas de pesquisa

Pesquisa Conceda fontes de financiamento para 2023-2024:

• Institutos Nacionais de Saúde (NIH) Potencial Grant: US $ 450.000
• Concessão de Pesquisa de Medicina Regenerativa do Departamento de Defesa: US $ 375.000
• Suporte da Fundação de Pesquisa Privada: US $ 250.000

Comercialização futura do produto

Fluxos de receita projetados de potencial comercialização de produtos:

Produto	Potencial estimado de mercado	Ano de lançamento projetado
Tratamento terapêutico BRTX-100	US $ 12,5 milhões em potencial do primeiro ano	2025
Terapia terapêutica terapêutica	Potencial de US $ 8,3 milhões no primeiro ano	2026

Acordos de parceria estratégica

A divisão atual e potencial da receita da parceria estratégica:

• Valor de colaboração de pesquisa existente: $ 675.000
• Potenciais novas negociações de parceria: US $ 1,2 milhão
• Biotechnology Alliance Exploration: US $ 950.000

Potenciais pagamentos marcantes de colaborações

Estrutura de pagamento prevista para marco:

Categoria Milestone	Faixa de pagamento potencial	Probabilidade
Desenvolvimento pré-clínico	$500,000 - $750,000	75%
Iniciação do ensaio clínico	US $ 1,1 milhão - US $ 1,5 milhão	60%
Milco de aprovação regulatória	US $ 2,5 milhões - US $ 3,2 milhões	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.