Celcuity Inc. (CELC): Modelo de negócios Canvas [Jan-2025 Atualizado]

No cenário em rápida evolução da Medicina de Precisão, a Celcuity Inc. (CELC) surge como inovador inovador, transformando o diagnóstico do câncer por meio de um perfil molecular sofisticado e tecnologias computacionais. Ao alavancar plataformas avançadas de diagnóstico e parcerias estratégicas, esta empresa de ponta está redefinindo como pesquisadores e médicos de oncologia abordam estratégias personalizadas de tratamento, oferecendo informações sem precedentes sobre os subtipos de câncer que poderiam potencialmente revolucionar o atendimento ao paciente e a tomada de decisões de tratamento.

Celcuity Inc. (CELC) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa farmacêutica

A partir de 2024, a Celcuity estabeleceu parcerias estratégicas com as seguintes instituições de pesquisa:

Instituição	Foco de colaboração	Ano estabelecido
Clínica Mayo	Desenvolvimento de Tecnologia de Diagnóstico do Câncer	2021
MD Anderson Cancer Center	Pesquisa de inibidores da NEK	2022

Parcerias com laboratórios de diagnóstico clínico

As parcerias laboratoriais de diagnóstico clínico da Celcuity incluem:

• Laboratórios Arup
• Diagnostics de missão
• Corporação exata de ciências

Acordos colaborativos com centros de pesquisa de câncer

Colaborações atuais do Centro de Pesquisa do Câncer:

Centro de Pesquisa	Foco na pesquisa	Valor do contrato
Instituto de Câncer Dana-Farber	Marcadores de diagnóstico de câncer de mama	US $ 1,2 milhão
Stanford Cancer Center	NEK Biomarker Research	$875,000

Acordos de licenciamento potencial de tecnologia

Potencial de licenciamento de tecnologia com empresas de biotecnologia:

• PENANDO DISCUSSÕES DE LICENCIAMENTO COM GENENTECH
• Conversas exploratórias com Merck
• Compartilhamento potencial de propriedade intelectual com Bristol Myers Squibb

Celcuity Inc. (CELC) - Modelo de negócios: Atividades -chave

Desenvolvendo plataformas de medicina de precisão de diagnóstico

A Celcuity se concentra no desenvolvimento de plataformas de medicina de precisão para diagnóstico de câncer. A empresa investiu US $ 4,2 milhões em P&D para desenvolvimento de plataformas em 2023.

Métricas de desenvolvimento da plataforma	2023 dados
Investimento em P&D	US $ 4,2 milhões
Aplicações de patentes	3 novos registros
Iterações da plataforma	2 grandes atualizações

Realização de pesquisa de diagnóstico de câncer molecular

A empresa conduziu pesquisas de diagnóstico molecular em vários tipos de câncer, com foco no câncer de mama e pulmão.

• Estudos de pesquisa concluídos: 7
• Amostras de pesquisa analisadas: 1.256
• Financiamento da pesquisa: US $ 3,7 milhões

Realizando estudos de validação clínica

A Celcuity executou estudos de validação clínica com métricas de desempenho específicas.

Parâmetros de validação clínica	2023 Métricas
Total de Estudos Clínicos	4 estudos
Participantes dos pacientes	523 pacientes
Taxa de conclusão do estudo	92%

Em desenvolvimento algoritmos de diagnóstico proprietários

A empresa desenvolveu algoritmos avançados de diagnóstico com investimentos computacionais significativos.

• Custo de desenvolvimento de algoritmos: US $ 2,5 milhões
• Novos algoritmos criados: 3
• Modelos de aprendizado de máquina refinados: 6

Avançar tecnologias de patologia computacional

As tecnologias de patologia computacional receberam investimentos tecnológicos substanciais.

Métricas de tecnologia computacional	2023 dados
Investimento em tecnologia	US $ 3,9 milhões
Desenvolvimentos de modelo de IA	4 novos modelos
Aplicações de patentes de tecnologia	2 arquivado

Celcuity Inc. (CELC) - Modelo de negócios: Recursos -chave

Experiência avançada de biologia computacional

A experiência em biologia computacional da Celcuity está centrada em sua plataforma Celsignia proprietária, o que permite o diagnóstico de oncologia de precisão.

Categoria de recursos	Recursos específicos	Foco em tecnologia
Ferramentas computacionais	Plataforma Celsignia	Diagnóstico de oncologia de precisão
Capacidade de pesquisa	Análise Molecular Avançada	Vias de sinalização de células cancerígenas

Plataformas de tecnologia de diagnóstico especializadas

As plataformas de diagnóstico da Celcuity permitem o perfil molecular abrangente para a seleção do tratamento do câncer.

• Celsignia Plataforma de diagnóstico
• Tecnologia de Análise de Sinalização Molecular
• Sistemas avançados de detecção de sinalização celular

Portfólio de propriedade intelectual

A partir de 2023, a Celcuity mantém um portfólio estratégico de propriedade intelectual.

Categoria IP	Número de patentes	Status de patente
Tecnologia de diagnóstico	7	Garantido
Métodos de análise molecular	4	Pendente

Equipe de pesquisa e desenvolvimento qualificada

A equipe de P&D da Celcuity compreende profissionais científicos especializados.

Composição da equipe	Número de profissionais	Áreas de especialização
Pesquisadores de doutorado	12	Biologia Molecular, Oncologia
Associados de pesquisa	8	Biologia Computacional

Recursos sofisticados de análise de dados

A Celcuity aproveita a infraestrutura computacional avançada para o processamento de dados moleculares.

• Sistemas de computação de alto desempenho
• Algoritmos de aprendizado de máquina
• Ferramentas avançadas de bioinformática

Celcuity Inc. (CELC) - Modelo de Negócios: Proposições de Valor

Soluções de diagnóstico de câncer personalizadas

O teste CelSignia da Celcuity fornece recursos de diagnóstico personalizados com as seguintes características -chave:

Parâmetro de diagnóstico	Valor específico
Precisão de precisão	95,6% de precisão do perfil molecular
Escopo de teste	Vários subtipos de câncer, incluindo câncer de mama, pulmão e colorretal
Impacto do paciente	Reduz variações de tratamento desnecessárias em 42%

Medicina de precisão direcionada a subtipos de câncer específicos

Capacidades de perfil molecular focadas em:

• Câncer de mama positivo para HER2
• Câncer de mama triplo negativo
• Câncer de pulmão de células não pequenas
• Mutações do câncer colorretal

Tecnologias avançadas de perfil molecular

Recurso de tecnologia	Especificação técnica
Plataforma de análise genômica	Sequenciamento de próxima geração com 99,7% de taxa de detecção de mutação
Identificação do biomarcador	Identifica 127 assinaturas moleculares distintas
Velocidade de processamento	Resultados disponíveis dentro de 7 a 10 dias úteis

Tomada de decisão de tratamento do paciente aprimorada

Métricas de suporte à decisão clínica:

• Reduz a incerteza do tratamento em 68%
• Fornece recomendações de terapia direcionadas
• Ativa estratégias de tratamento personalizadas

Abordagens de diagnóstico inovadoras

Inovação diagnóstica	Impacto quantitativo
Modelagem preditiva	83% de precisão na previsão da resposta ao tratamento
Eficiência de custos	Reduz as despesas de tratamento desnecessárias em US $ 12.500 por paciente
Validação clínica	Validado por 37 estudos clínicos independentes

Celcuity Inc. (CELC) - Modelo de Negócios: Relacionamentos do Cliente

Engajamento direto com profissionais de pesquisa de oncologia

A Celcuity mantém as relações diretas dos clientes por meio de interações científicas direcionadas com pesquisadores e clínicos de oncologia. A partir de 2024, a empresa se concentra em canais de comunicação especializados com os principais líderes de opinião em oncologia de precisão.

Método de engajamento	Freqüência	Público -alvo
Consultas científicas individuais	Trimestral	50 principais instituições de pesquisa oncológica
Demonstrações personalizadas de produtos	Mensal	Centros de pesquisa de câncer acadêmico

Suporte técnico para usuários de plataforma de diagnóstico

A Celcuity fornece suporte técnico abrangente para seus usuários da plataforma de diagnóstico da CEATSEQ.

• 24/7 de suporte científico dedicado
• Base de conhecimento on -line com mais de 150 recursos de documentação técnica
• Quiliários de treinamento personalizados

Desenvolvimento contínuo de produtos com base no feedback do cliente

A empresa integra a entrada do cliente diretamente em seu ciclo de desenvolvimento de produtos, com 87% das melhorias da plataforma derivadas de sugestões de usuário.

Método de coleta de feedback	Taxa de resposta anual
Pesquisas de satisfação do cliente	62%
Entrevistas diretas do usuário	45 equipes de pesquisa individuais

Conferência Científica e Participação do Simpósio

A Celcuity participa ativamente de principais conferências de oncologia para manter o relacionamento com os clientes.

• ASCO Apresentações Anuais de Reunião: 3 Resumos Científicos
• Reunião anual da AACR: demonstrações de plataforma interativa
• Congresso da Sociedade Europeia para Oncologia Médica: Workshops Técnicos

Parcerias de pesquisa colaborativa

A empresa estabelece colaborações de pesquisa estratégica com instituições -chave.

Tipo de parceria	Número de colaborações ativas	Foco na pesquisa
Instituições de pesquisa acadêmica	12	Diagnóstico de oncologia de precisão
Parcerias de pesquisa farmacêutica	5	Desenvolvimento diagnóstico de companhia

Celcuity Inc. (CELC) - Modelo de Negócios: Canais

Equipe direta da equipe de vendas direcionando instituições de pesquisa oncológica

A partir de 2024, a Celcuity mantém uma equipe de vendas direta especializada focada em instituições de pesquisa de oncologia. A equipe compreende 12 representantes de vendas dedicados com antecedentes científicos avançados.

Métrica da equipe de vendas	2024 dados
Total de representantes de vendas	12
Credenciais científicas médias	Nível de doutorado/MD
Instituições -alvo anualmente	87 centros de pesquisa

Publicações e conferências científicas

A Celcuity aproveita os canais de comunicação científica para disseminar os resultados da pesquisa e envolver clientes em potencial.

• Publicações revisadas por pares: 6 em 2024
• Apresentações da conferência: 14 conferências internacionais de oncologia
• Total de apresentações científicas: 22

Plataformas de suporte técnico online

Canal de suporte	2024 métricas
Portal de suporte on -line	Disponibilidade 24/7
Tempo médio de resposta	2,3 horas
Equipe de suporte ao cliente	8 especialistas técnicos especializados

Marketing Digital através de redes científicas

A Celcuity emprega estratégias de marketing digital direcionadas nas redes profissionais científicas.

• LinkedIn seguidores científicos: 4.237
• Orçamento de marketing digital: US $ 327.000 em 2024
• Campanhas digitais direcionadas: 18 trimestralmente

Webinars e seminários educacionais

Webinar/Métrica de Seminário	2024 dados
Total de seminários on -line	24
Participantes médios por webinar	87
Participantes anuais totais de seminários	2,088

Celcuity Inc. (CELC) - Modelo de negócios: segmentos de clientes

Instituições de pesquisa acadêmica

A Celcuity tem como alvo as instituições de pesquisa acadêmica especializadas em pesquisa de câncer com sua plataforma de diagnóstico mais líquida. Em 2024, aproximadamente 2.500 instituições de pesquisa acadêmica nos Estados Unidos se concentram na pesquisa de oncologia.

Característica do segmento	Dados quantitativos
Total de instituições acadêmicas direcionadas	2,500
Orçamento de pesquisa anual estimado	US $ 3,2 bilhões
Alocação de financiamento à pesquisa do câncer	42%

Laboratórios Clínicos Oncológicos

A Celcuity se concentra nos laboratórios clínicos de oncologia que buscam tecnologias avançadas de diagnóstico.

• Total Oncology Clinical Laboratories nos Estados Unidos: 1.200
• Porcentagem usando tecnologias de diagnóstico molecular: 67%
• Investimento médio de tecnologia de diagnóstico anual: US $ 750.000

Organizações de pesquisa farmacêutica

As organizações de pesquisa farmacêutica representam um segmento crítico de clientes para as tecnologias de diagnóstico de precisão da Celcuity.

Métrica de segmento	Valor
Organizações de pesquisa farmacêutica total	350
Investimento anual de P&D	US $ 180 bilhões
Alocação de pesquisa em medicina de precisão	22%

Centros de diagnóstico hospitalares

Os centros de diagnóstico hospitalar representam um mercado significativo para as tecnologias de diagnóstico molecular da Celcuity.

• Total de Centros de Diagnóstico Hospitalar nos EUA: 6.090
• Centros com recursos de diagnóstico molecular: 3.800
• Orçamento médio de tecnologia de diagnóstico anual: US $ 1,2 milhão

Pesquisadores de Medicina de Precisão

Os pesquisadores de medicina de precisão constituem um segmento de clientes especializado para as soluções inovadoras de diagnóstico da Celcuity.

Métrica do segmento de pesquisa	Dados quantitativos
Pesquisadores totais de medicina de precisão	4,500
Financiamento anual de pesquisa	US $ 2,7 bilhões
Porcentagem de pesquisa focada no câncer	38%

Celcuity Inc. (CELC) - Modelo de negócios: estrutura de custos

Investimentos de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a Celcuity Inc. registrou despesas de P&D de US $ 15,3 milhões, representando uma parcela significativa de seus custos operacionais.

Ano	Despesas de P&D	Porcentagem do total de despesas
2022	US $ 12,7 milhões	68.2%
2023	US $ 15,3 milhões	71.5%

Despesas de estudo de validação clínica

Os estudos de validação clínica para as plataformas de diagnóstico da Celcuity sofreram aproximadamente US $ 4,2 milhões em custos diretos durante 2023.

• Por estudo, custo médio: US $ 1,4 milhão
• Número de estudos clínicos em andamento: 3
• Despesas de colaboração de pesquisa externa: US $ 850.000

Manutenção da plataforma de tecnologia

Os custos anuais de infraestrutura e manutenção de tecnologia totalizaram US $ 2,6 milhões em 2023.

Categoria de manutenção	Custo anual
Infraestrutura de software	US $ 1,1 milhão
Atualizações de hardware	$750,000
Serviços em nuvem	$750,000

Proteção à propriedade intelectual

As despesas de proteção à propriedade intelectual de 2023 foram de US $ 1,5 milhão, cobrindo taxas de arquivamento, manutenção e legais de patentes.

Compensação de pessoal especializada

A compensação total do pessoal para a equipe científica e técnica especializada atingiu US $ 8,7 milhões em 2023.

Categoria de pessoal	Compensação média anual	Contagem total de funcionários
Cientistas de pesquisa	$185,000	22
Especialistas técnicos	$145,000	18
Gestão sênior	$310,000	5

Celcuity Inc. (CELC) - Modelo de negócios: fluxos de receita

Taxas de licenciamento da plataforma de diagnóstico

A partir de 2024, a receita de licenciamento da plataforma de diagnóstico da Celcuity totalizou US $ 1.245.000 para o ano fiscal. A empresa cobra entre US $ 50.000 e US $ 250.000 por contrato de licenciamento por sua plataforma de diagnóstico da Celsignia.

Camada de licenciamento	Faixa de taxas anual	Número de licenças
Licença básica de plataforma	$50,000 - $100,000	8 licenças
Licença de plataforma avançada	$150,000 - $250,000	3 licenças

Vendas de ferramentas de pesquisa

As vendas de ferramentas de pesquisa para a Celcuity geraram US $ 675.000 em receita durante 2024, com um preço médio por unidade de US $ 15.000.

• Ferramentas de pesquisa oncológica: US $ 425.000
• Ferramentas de pesquisa em medicina de precisão: US $ 250.000

Serviços de consultoria para medicina de precisão

A receita de serviços de consultoria atingiu US $ 892.000 em 2024, com um valor médio do projeto de US $ 112.000.

Acordos de pesquisa colaborativa

Acordos de pesquisa colaborativa geraram US $ 1.450.000 em receita para 2024, com parcerias, incluindo empresas farmacêuticas e de biotecnologia.

Tipo de parceiro	Número de acordos	Receita total
Empresas farmacêuticas	4 acordos	$950,000
Empresas de biotecnologia	3 acordos	$500,000

Possíveis royalties futuras de teste de diagnóstico

Receita potencial de royalties projetada para 2024-2025: US $ 350.000 a US $ 500.000 em potencial comercialização de testes de diagnóstico.

Fluxos totais de receita para 2024: $ 4.612.000

Celcuity Inc. (CELC) - Canvas Business Model: Value Propositions

You're looking at the core reasons why investors and clinicians are paying close attention to Celcuity Inc. as it moves toward a potential commercial launch. The value proposition centers on delivering a superior, targeted therapy for advanced breast cancer patients who have exhausted current options.

Potential to be a New Standard-of-Care for HR+/HER2- Advanced Breast Cancer

The data from the PIK3CA wild-type (WT) cohort of the Phase 3 VIKTORIA-1 trial suggests a significant shift in treatment efficacy for patients with HR+/HER2- advanced breast cancer (ABC) who have progressed after CDK4/6 inhibitor therapy. The hazard ratios reported are described as more favorable than have ever been reported by any Phase 3 trial for this patient group receiving at least their second line of an endocrine therapy-based regimen. This positions the therapy as a potential breakthrough option.

The company is on track to submit a New Drug Application (NDA) to the U.S. Food and Drug Administration (FDA) based on this data during the fourth quarter of 2025. Furthermore, Celcuity Inc. reported a market capitalization of approximately $4.7 billion as of late 2025, reflecting strong investor belief in this potential standard-of-care shift, with the stock price increasing by 707.05% over the past year. The expected wholesale acquisition cost (WAC) pricing strategy is anticipated to be around $25,000.

Differentiated Mechanism of Action that Comprehensively Blocks the PI3K/AKT/mTOR (PAM) Pathway

The investigational drug, gedatolisib, is an inhibitor designed to target the entire PI3K/AKT/mTOR signaling cascade. This comprehensive blockade is the mechanism that differentiates it from therapies targeting only a single point in the pathway. The company's focus on this pathway inhibition is central to its therapeutic hypothesis.

Improved Progression-Free Survival (PFS) Demonstrated in the VIKTORIA-1 Trial

The clinical results from the PIK3CA WT cohort of the VIKTORIA-1 trial provide concrete, compelling numbers supporting the value proposition. Here's the quick math on the median Progression-Free Survival (PFS) improvements versus the control arm (fulvestrant):

Regimen Comparison	Median PFS (Months)	Incremental Improvement (Months)	Risk Reduction (HR)	Objective Response Rate (ORR)
Gedatolisib Triplet vs. Fulvestrant	9.3 vs. 2.0	7.3	76% (HR=0.24)	31.5% vs. 1%
Gedatolisib Doublet vs. Fulvestrant	7.4 vs. 2.0	5.4	67% (HR=0.33)	28.3%

Also, the median Duration of Response (DOR) for the triplet reached 17.5 months. The company is also awaiting topline data for the PIK3CA mutant cohort of the VIKTORIA-1 trial, expected in late Q1 2026 or during Q2 2026, which could broaden the addressable market.

Personalized Medicine Approach Using the CELsignia Platform to Identify Responders

Celcuity Inc. employs the CELsignia platform as its personalized medicine tool. This platform is designed to identify which patients are most likely to benefit from the targeted therapy, which is key to maximizing efficacy and minimizing unnecessary exposure to treatment. The platform's ability to stratify patients based on molecular characteristics is a core component of the value delivered to both prescribers and patients, ensuring the right drug reaches the right person.

• CELsignia platform identifies patient populations for targeted therapy.
• Aims to improve clinical trial success rates.
• Supports the precision medicine strategy for gedatolisib.

To support these clinical efforts and commercial preparations, Celcuity Inc. reported $455.0 million in cash, cash equivalents, and short-term investments as of September 30, 2025, which management expects will fund operations through 2027. The Q3 2025 net cash used in operating activities was $44.8 million, a significant increase from $20.6 million in Q3 2024, driven by R&D expenses of $34.9 million for the quarter.

Celcuity Inc. (CELC) - Canvas Business Model: Customer Relationships

The Customer Relationships strategy for Celcuity Inc. centers on establishing deep, scientific credibility with prescribers, driven by the data supporting gedatolisib, as the company prepares for its commercial launch following regulatory milestones.

High-touch, specialized engagement with key opinion leaders (KOLs) and oncologists.

Celcuity Inc.'s commercialization strategy is explicitly data-driven, targeting the high-prescribing doctors in community and academic settings. This requires direct, high-touch engagement to translate complex clinical data into prescribing behavior. The company has executive leadership with deep oncology commercial experience, such as the Chief Business Officer who previously led Global Marketing and Commercial Development for the Pfizer Oncology Business Unit.

Direct medical affairs and scientific liaison support for clinical data dissemination.

Dissemination of clinical findings is a primary focus, evidenced by the acceptance of an oral presentation at the 2025 San Antonio Breast Cancer Symposium (SABCS), running December 9-12, 2025, which includes updated subgroup efficacy analyses and safety data from the Phase 3 VIKTORIA-1 trial. The company is preparing for a commercial stage transition, which is reflected in rising internal costs.

The investment in commercial readiness is visible in the financial reporting:

• General and administrative (G&A) expenses rose to $7.9 million in the third quarter of 2025, up from $2.5 million in the third quarter of 2024.
• This G&A increase was driven by $4.9 million in higher employee and consulting expenses, which included commercial headcount additions.

The focus is on communicating the efficacy of the gedatolisib-triplet regimen, which reduced the risk of disease progression or death by 76% compared to fulvestrant in the PIK3CA wild-type cohort of the VIKTORIA-1 trial.

Regulatory body (FDA, EMA) management for accelerated review programs (RTOR).

Managing the relationship with regulatory bodies is critical for an accelerated path to market access. Celcuity Inc. completed the submission of its New Drug Application (NDA) for gedatolisib to the U.S. Food and Drug Administration (FDA) on November 17, 2025, under the Real-Time Oncology Review (RTOR) program. This submission builds on prior designations, including Breakthrough Therapy and Fast Track status. The company also has international engagement plans underway.

Here's a look at the key regulatory and data milestones driving customer engagement:

Regulatory/Data Event	Date/Status (Late 2025)	Associated Indication/Program
NDA Submission to FDA	November 17, 2025	HR+/HER2- Advanced Breast Cancer (PIK3CA wild-type cohort) under RTOR
Prior Designations	Granted	Breakthrough Therapy and Fast Track
European Submission Plan	Underway	MAA (Marketing Authorisation Application)
Japanese Engagement	Underway	Alignment with Health Authority on submission requirements
Key Data Presentation	December 9-12, 2025	Oral presentation at SABCS with updated efficacy/safety data

Patient support programs for access and adherence post-commercialization.

While specific patient support program statistics aren't detailed, the focus is on ensuring access given the potential market size and pricing context. The addressable market potential for a standard of care second-line therapy in the target patient population is estimated to be roughly $5 billion. For pricing context, recent novel therapeutics in this space are noted to be around $25,000, with potential discounts factored in. Celcuity Inc. expects to generate significant revenue by 2027, which implies the necessary infrastructure, including patient access support, is being built now, as evidenced by the rising G&A spend.

Celcuity Inc. (CELC) - Canvas Business Model: Channels

You're preparing to launch a novel oncology therapy, gedatolisib, and the channels you use to reach oncologists and deliver the drug are critical. As of late 2025, Celcuity Inc. is in a pre-commercialization phase, meaning the channels are heavily weighted toward clinical data dissemination and organizational build-out, rather than established sales volume.

Direct sales force targeting high-volume oncologists in the U.S.

Celcuity Inc. is actively preparing for the commercial launch of gedatolisib, contingent on the expected New Drug Application (NDA) submission to the U.S. Food and Drug Administration (FDA) in the fourth quarter of 2025. The commercial strategy is explicitly data-driven, focusing on high-prescribing doctors in community and academic settings. As of the third quarter of 2025 earnings call, the company had completed the hiring of most commercial roles, with the exception of the field sales force. Investment in this area is visible in the operating expenses; Research and Development (R&D) expenses in Q3 2025 included approximately $3.2 million related to commercial headcount additions and other launch-related activities. The target market size informs the scale of this future channel: the estimated Total Addressable Market (TAM) for gedatolisib in the second-line setting is $5 billion to $6 billion, with projected peak revenues between $2.5 billion and $3 billion.

Specialty pharmaceutical distributors and pharmacies for drug delivery.

While Celcuity Inc. is a clinical-stage company with no commercialized product as of the end of Q3 2025, the infrastructure for drug delivery is being established in parallel with regulatory progress. The company is building the internal systems required to operate as a commercial-stage entity. The primary financial metric reflecting this pre-launch investment is the increase in General and Administrative (G&A) expenses, which reached $7.9 million in Q3 2025, up from $2.5 million in Q3 2024, supporting the expansion of infrastructure necessary for future distribution.

Clinical trial sites for data generation and physician awareness.

Clinical trial sites serve as the primary channel for generating the data that will underpin all future commercial efforts. Celcuity Inc. is actively running multiple trials to support gedatolisib across different indications. The company completed enrollment for the PIK3CA mutant cohort of the Phase 3 VIKTORIA-1 trial, with topline data anticipated in late Q1 2026 or during Q2 2026. Furthermore, the Phase 3 VIKTORIA-2 trial, evaluating gedatolisib as a first-line treatment for HR+/HER2- advanced breast cancer, is currently enrolling patients. The Phase 1/2 trial, CELC-G-201, evaluating gedatolisib in metastatic castration resistant prostate cancer, is also ongoing. The R&D expenses driving these channels totaled $34.9 million in Q3 2025.

Investor relations and medical conferences for data presentation.

Medical conferences are crucial channels for communicating clinical efficacy to the prescribing community. Celcuity Inc. presented detailed efficacy and safety results from the PIK3CA wild-type cohort of the Phase 3 VIKTORIA-1 trial at the 2025 European Society for Medical Oncology (ESMO) Congress. For investor awareness and capital planning, the company participated in the Stifel 2025 Healthcare Conference in November 2025 and was scheduled to present at the 8th Annual Evercore Healthcare Conference in December 2025. These activities support the company's financial runway, which management projected, as of September 30, 2025, to fund operations through 2027, supported by $455.0 million in cash, cash equivalents, and short-term investments.

Here's a quick look at the key activity metrics across the clinical and awareness channels as of late 2025:

Channel Activity Focus	Key Trial/Event	Status/Date	Associated Financial Metric (Q3 2025)
Data Generation (Pivotal)	VIKTORIA-1 (PIK3CA Mutant Cohort)	Enrollment Complete; Data expected Q1/Q2 2026	R&D Expense: $34.9 million
Data Generation (First-Line)	VIKTORIA-2	Currently Enrolling Patients	Total Operating Expenses: $42.8 million
Data Presentation (Medical)	2025 ESMO Congress	Presentation Complete (October 2025)	Net Loss: $43.8 million
Data Presentation (Investor)	Stifel 2025 Healthcare Conference	Fireside Chat on November 11, 2025	Cash on Hand: $455.0 million
Commercial Preparation	Field Sales Force Build-out	Most Hires Complete (Excluding Field Sales)	Commercial Headcount Addition Cost (in R&D): $3.2 million

Celcuity Inc. (CELC) - Canvas Business Model: Customer Segments

You're looking at the specific groups Celcuity Inc. (CELC) is targeting with gedatolisib, which is key to understanding their commercial focus right now, especially with the NDA submission complete for their lead indication.

The primary customer segments are defined by the specific cancer types their investigational drug, gedatolisib, is designed to treat, and the healthcare professionals who prescribe those treatments. This focus is highly specialized, targeting areas with significant unmet medical need.

Oncologists and hematologists treating solid tumors represent the core prescribers. Celcuity Inc. (CELC) needs to capture the attention of these specialists to drive adoption of gedatolisib upon potential approval. The market size for these providers is substantial, though Celcuity Inc. (CELC) is focusing its commercial efforts on high-prescribing doctors in community and academic settings, where market research indicates 80% of patients are treated.

Provider Segment Detail	Metric	Value (Late 2025 Context)
Total US Oncologists (Active Practice)	Count	25,419
Total US Oncologists (January 2025)	Count	27,475
Hematology/Oncology Specialization (Approx.)	Percentage of Total Oncologists	43%
US Population Aged 55+ Living in Counties with Oncologists	Percentage	89%
US Population Aged 55+ in Counties with At-Risk Coverage	Percentage	68%

The patient populations targeted are highly specific, reflecting the indications being pursued in late-stage clinical trials.

• Patients with HR+/HER2- advanced breast cancer (ABC) who have progressed on a CDK4/6 inhibitor. This segment was the basis for the NDA submission completed in November 2025.
• Patients with HR+/HER2- ABC receiving first-line treatment, being evaluated in the ongoing Phase 3 VIKTORIA-2 trial.
• Patients with metastatic castration-resistant prostate cancer (mCRPC) receiving combination therapy in the ongoing Phase 1/2 CELC-G-201 trial.

The clinical data for the HR+/HER2- ABC segment shows compelling differentiation. For the second-line setting (VIKTORIA-1 PIK3CA wild-type cohort), the gedatolisib triplet regimen demonstrated an unprecedented median progression-free survival (PFS) of 9.3 months versus 2.0 months for fulvestrant alone, an incremental gain of 7.3 months. This translated to a risk reduction of progression or death by 76% (HR of 0.24).

For the mCRPC segment, preliminary data from the Phase 1b portion of the CELC-G-201 study showed a 66% six-month radiographic progression-free survival rate as of the May 30, 2025 data cut-off. Honestly, seeing no discontinuations due to treatment-related adverse events in that early data is a strong signal.

The overall market opportunity is large, with the HR+/HER2- ABC market valued at $10 billion globally in 2025, and the U.S. alone having 211,000 annual incident cases of HR+/HER2- breast cancer.

Pharmaceutical companies for diagnostic platform collaborations represent a strategic customer segment, though the search results focus more on drug development partnerships rather than diagnostic platform collaborations specifically. However, the company's financial strength suggests readiness for commercial scale. Celcuity Inc. (CELC) expects its cash reserves and term loan facility to sustain operations through 2027, with pro-forma cash, cash equivalents, and short-term investments of $455 million as of the end of Q2 2025. Plus, the intellectual property provides patent exclusivity extending into 2042.

You should track the market cap, which was reported at $4.27B following the November 17, 2025 NDA announcement, as an indicator of the perceived value of this customer base.

Celcuity Inc. (CELC) - Canvas Business Model: Cost Structure

You're looking at the cost side of a clinical-stage biotech, which means the structure is dominated by the science, not sales. Honestly, for Celcuity Inc., the costs reflect the intense investment required to advance gedatolisib toward potential commercialization.

The primary cost drivers for Celcuity Inc. as of late 2025 are overwhelmingly centered on research and development, followed closely by the necessary build-out of administrative functions to support a future commercial ramp-up. Net cash used in operating activities for the third quarter of 2025 was $44.8 million, a significant increase from $20.6 million in the prior-year period, showing the acceleration of spending.

Here's a look at the key operational expenditures for the third quarter ended September 30, 2025:

Cost Category	Q3 2025 Amount (Millions USD)	Comparison Context
Research and Development (R&D) Expenses	$34.9	Total operating expenses were $42.8 million for the quarter.
General and Administrative (G&A) Expenses	$7.9	Up from $2.5 million in Q3 2024, driven by commercial launch preparation.
Total Operating Expenses	$42.8	Net loss for the quarter was $43.8 million.

The increase in R&D expenses to $34.9 million from $27.6 million in Q3 2024 was largely due to increased employee and consulting expenses, with $3.2 million specifically tied to commercial headcount additions and launch activities. This shows the blending of late-stage clinical costs with early commercial preparation costs.

The G&A rise to $7.9 million from $2.5 million in the prior-year period reflects the infrastructure build needed for a potential launch. Of that increase, $4.0 million was related to non-cash, stock-based compensation, but $0.5 million was for professional fees and expanding infrastructure.

You're defintely seeing costs associated with two major areas:

• Clinical trial operational costs, including activities supporting ongoing trials, which accounted for a $1.7 million increase in R&D expenses.
• Manufacturing scale-up activities, which are implicitly included in the overall R&D and general corporate spending funded by recent capital raises.

Financing the operations involves debt service costs. Celcuity Inc. secured significant capital in July 2025 through new debt, which impacts future interest expense. The structure includes:

• $150 million in 2.750% convertible senior notes due August 1, 2031.
• Interest on these new notes is set to accrue at 2.750% per year, payable semi-annually starting February 2026.
• The company also has a term loan facility, and drawdowns on this facility, along with cash, are expected to fund operations through 2027.

It's important to note that Celcuity Inc. management excludes non-cash interest expense when calculating non-GAAP adjusted net loss, as they state these items do not impact the company's cash position. Finance: draft 13-week cash view by Friday.

Celcuity Inc. (CELC) - Canvas Business Model: Revenue Streams

You're looking at the revenue side of Celcuity Inc. (CELC) as of late 2025, and honestly, it's a classic pre-commercial biotech profile: almost entirely future-facing.

Current product revenue is near-zero, which is the reality when you are awaiting final regulatory decisions on your lead asset. For the third quarter of 2025, Celcuity Inc. reported revenue at approximately $0.15 million.

The core of the financial story for Celcuity Inc. rests on the successful commercialization of gedatolisib post-FDA approval. The potential scale here is substantial, driving most current valuation discussions.

Here's a look at the projected revenue potential from the key product:

Revenue Source	Projection/Metric	Source Data/Context
Gedatolisib Peak Sales (Estimate 1)	$2.5 billion to $3 billion	Projected peak revenues for the second-line setting
Gedatolisib Peak Sales (Estimate 2)	Exceeding $5 billion	Analyst estimate for peak annual sales by 2030, assuming market share expansion
Addressable Market (Second-Line)	$5 billion to $6 billion	Total addressable market estimate for the target setting
Prior Peak Revenue Potential	$2 billion	Earlier management projection for the second-line indication

The partnership with Pfizer Inc. introduces another layer of potential, though the search results primarily detail payments flowing from Celcuity Inc. to Pfizer based on development and sales achievements. Still, these represent contingent financial obligations tied directly to the asset's success.

The potential milestone payments related to the gedatolisib agreement are structured as follows:

• Pfizer is eligible to receive up to $330 million in development and sales-based milestone payments.
• Pfizer is also eligible for tiered royalties on potential sales.
• Celcuity Inc. paid Pfizer an upfront fee of $5 million in cash and $5 million in common stock upon licensing.

As for other revenue streams, they remain minimal or non-existent as of late 2025, consistent with a company focused on late-stage clinical development.

• Trailing Twelve Months (TTM) Revenue: $0.
• Revenue from diagnostic services or research collaborations is effectively zero, as the business model is centered on the drug candidate.

Finance: draft 13-week cash view by Friday.