Celcuity Inc. (CELC): Lienzo del Modelo de Negocios [Actualizado en Ene-2025]

En el paisaje en rápida evolución de la medicina de precisión, Celcuity Inc. (CELC) emerge como un innovador innovador, transformando el diagnóstico de cáncer a través de tecnologías sofisticadas de perfiles moleculares y computacionales. Al aprovechar las plataformas de diagnóstico avanzadas y las asociaciones estratégicas, esta compañía de vanguardia está redefiniendo cómo los investigadores de oncología y los médicos abordan las estrategias de tratamiento personalizadas, ofreciendo información sin precedentes sobre los subtipos de cáncer que podrían revolucionar el cuidado de la decisión y la toma de decisiones de tratamiento del paciente.

Celcuity Inc. (CELC) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación farmacéutica

A partir de 2024, Celcuity ha establecido asociaciones estratégicas con las siguientes instituciones de investigación:

Institución	Enfoque de colaboración	Año establecido
Clínica de mayonesa	Desarrollo de tecnología de diagnóstico de cáncer	2021
Centro de cáncer de MD Anderson	Investigación de inhibidores de Nek	2022

Asociaciones con laboratorios de diagnóstico clínico

Las asociaciones de laboratorio de diagnóstico clínico de Celcuity incluyen:

• Laboratorios ARUP
• Diagnóstico de misiones
• Corporación de Ciencias Exactas

Acuerdos de colaboración con los centros de investigación del cáncer

Colaboraciones actuales del Centro de Investigación del Cáncer:

Centro de investigación	Enfoque de investigación	Valor de contrato
Instituto del Cáncer Dana-Farber	Marcadores de diagnóstico de cáncer de mama	$ 1.2 millones
Centro de Cáncer de Stanford	Investigación de biomarcadores de nek	$875,000

Arreglos de licencia de tecnología potencial

Potencial de licencia tecnológica con empresas de biotecnología:

• Pendiendo discusiones de licencia con Genentech
• Conversaciones exploratorias con Merck
• Potencial de propiedad intelectual compartiendo con Bristol Myers Squibb

Celcuity Inc. (CELC) - Modelo de negocio: actividades clave

Desarrollo de plataformas de medicina de precisión de diagnóstico

Celcuity se centra en el desarrollo de plataformas de medicina de precisión para el diagnóstico del cáncer. La compañía ha invertido $ 4.2 millones en I + D para el desarrollo de la plataforma en 2023.

Métricas de desarrollo de plataformas	2023 datos
Inversión de I + D	$ 4.2 millones
Solicitudes de patentes	3 nuevas presentaciones
Iteraciones de plataforma	2 actualizaciones importantes

Realización de la investigación de diagnóstico de cáncer molecular

La compañía realizó una investigación de diagnóstico molecular en múltiples tipos de cáncer, con un enfoque en el cáncer de seno y pulmón.

• Estudios de investigación completados: 7
• Muestras de investigación analizadas: 1.256
• Financiación de la investigación: $ 3.7 millones

Realización de estudios de validación clínica

Celcuity ejecutó estudios de validación clínica con métricas de rendimiento específicas.

Parámetros de validación clínica	2023 métricas
Estudios clínicos totales	4 estudios
Participantes de los pacientes	523 pacientes
Tasa de finalización del estudio	92%

Desarrollo de algoritmos de diagnóstico patentados

La compañía desarrolló algoritmos de diagnóstico avanzados con importantes inversiones computacionales.

• Costo de desarrollo de algoritmo: $ 2.5 millones
• Nuevos algoritmos creados: 3
• Modelos de aprendizaje automático refinados: 6

Avance de tecnologías de patología computacional

Las tecnologías de patología computacional recibieron inversiones tecnológicas sustanciales.

Métricas de tecnología computacional	2023 datos
Inversión tecnológica	$ 3.9 millones
Desarrollos del modelo de IA	4 nuevos modelos
Aplicaciones de patentes de tecnología	2 archivado

Celcuity Inc. (CELC) - Modelo de negocio: recursos clave

Experiencia avanzada en biología computacional

La experiencia en biología computacional de Celcuity se centra en su plataforma de Celsignia patentada, que permite el diagnóstico de oncología de precisión.

Categoría de recursos	Capacidades específicas	Enfoque tecnológico
Herramientas computacionales	Plataforma Celsignia	Diagnóstico de oncología de precisión
Capacidad de investigación	Análisis molecular avanzado	Vías de señalización de células cancerosas

Plataformas de tecnología de diagnóstico especializadas

Las plataformas de diagnóstico de Celcuity permiten un perfil molecular integral para la selección del tratamiento del cáncer.

• Plataforma de diagnóstico de Celsignia
• Tecnología de análisis de la vía de señalización molecular
• Sistemas de detección de señalización de células avanzadas

Cartera de propiedades intelectuales

A partir de 2023, Celcuity mantiene una cartera estratégica de propiedad intelectual.

Categoría de IP	Número de patentes	Estado de patente
Tecnología de diagnóstico	7	Otorgada
Métodos de análisis molecular	4	Pendiente

Equipo calificado de investigación y desarrollo

El equipo de I + D de Celcuity comprende profesionales científicos especializados.

Composición del equipo	Número de profesionales	Áreas de experiencia
Investigadores de doctorado	12	Biología molecular, oncología
Asociados de investigación	8	Biología computacional

Capacidades sofisticadas de análisis de datos

Celcuity aprovecha la infraestructura computacional avanzada para el procesamiento de datos moleculares.

• Sistemas informáticos de alto rendimiento
• Algoritmos de aprendizaje automático
• Herramientas bioinformáticas avanzadas

Celcuity Inc. (CELC) - Modelo de negocio: propuestas de valor

Soluciones de diagnóstico de cáncer personalizadas

La prueba de Celsignia de Celcuity proporciona capacidades de diagnóstico personalizadas con las siguientes características clave:

Parámetro de diagnóstico	Valor específico
Precisión	95.6% de precisión de perfil molecular
Alcance de prueba	Múltiples subtipos de cáncer que incluyen cánceres de seno, pulmón y colorrectal
Impacto del paciente	Reduce las variaciones de tratamiento innecesarias en un 42%

Medicina de precisión dirigida a subtipos de cáncer específicos

Capacidades de perfiles moleculares centrados en:

• Cáncer de mama HER2 positivo
• Cáncer de mama triple negativo
• Cáncer de pulmón de células no pequeñas
• Mutaciones de cáncer colorrectal

Tecnologías avanzadas de perfiles moleculares

Característica tecnológica	Especificación técnica
Plataforma de análisis genómico	Secuenciación de próxima generación con una tasa de detección de mutación del 99.7%
Identificación de biomarcador	Identifica 127 firmas moleculares distintas
Velocidad de procesamiento	Resultados disponibles dentro de 7-10 días hábiles

Toma de decisiones mejoradas para el tratamiento del paciente

Métricas de apoyo a la decisión clínica:

• Reduce la incertidumbre del tratamiento en un 68%
• Proporciona recomendaciones de terapia específica
• Habilita estrategias de tratamiento personalizadas

Enfoques de diagnóstico innovadores

Innovación diagnóstica	Impacto cuantitativo
Modelado predictivo	83% de precisión en la predicción de la respuesta al tratamiento
Eficiencia de rentabilidad	Reduce los gastos de tratamiento innecesarios en $ 12,500 por paciente
Validación clínica	Validado por 37 estudios clínicos independientes

Celcuity Inc. (CELC) - Modelo de negocio: relaciones con los clientes

Compromiso directo con profesionales de la investigación de oncología

Celcuity mantiene las relaciones directas de los clientes a través de interacciones científicas específicas con investigadores y médicos de oncología. A partir de 2024, la compañía se enfoca en canales de comunicación especializados con líderes de opinión clave en oncología de precisión.

Método de compromiso	Frecuencia	Público objetivo
Consultas científicas individuales	Trimestral	Top 50 instituciones de investigación oncológica
Demostraciones de productos personalizadas	Mensual	Centros de investigación de cáncer académico

Soporte técnico para usuarios de plataforma de diagnóstico

CelCuity proporciona soporte técnico integral para sus usuarios de plataforma de diagnóstico Neatseq.

• Línea directa de soporte científico dedicado 24/7
• Base de conocimiento en línea con más de 150 recursos de documentación técnica
• Seminarios web de capacitación personalizados

Desarrollo continuo de productos basado en comentarios de los clientes

La compañía integra la entrada del cliente directamente en su ciclo de desarrollo de productos, con 87% de las mejoras de la plataforma derivadas de las sugerencias de usuarios.

Método de recopilación de comentarios	Tasa de respuesta anual
Encuestas de satisfacción del cliente	62%
Entrevistas directas de usuarios	45 equipos de investigación individuales

Conferencia científica y participación del simposio

Celcuity participa activamente en las principales conferencias de oncología para mantener las relaciones con los clientes.

• Presentaciones de reuniones anuales de ASCO: 3 resúmenes científicos
• Reunión anual de AACR: demostraciones de plataformas interactivas
• Congreso de la Sociedad Europea de Oncología Médica: Talleres técnicos

Asociaciones de investigación colaborativa

La Compañía establece colaboraciones estratégicas de investigación con instituciones clave.

Tipo de asociación	Número de colaboraciones activas	Enfoque de investigación
Instituciones de investigación académica	12	Diagnóstico de oncología de precisión
Asociaciones de investigación farmacéutica	5	Desarrollo de diagnóstico complementario

Celcuity Inc. (CELC) - Modelo de negocio: canales

Equipo de ventas directo dirigido a instituciones de investigación de oncología

A partir de 2024, Celcuity mantiene un equipo especializado de ventas directas centrado en instituciones de investigación de oncología. El equipo comprende 12 representantes de ventas dedicados con antecedentes científicos avanzados.

Métrica del equipo de ventas	2024 datos
Representantes de ventas totales	12
Credenciales científicas promedio	Nivel de doctorado/MD
Instituciones objetivo anualmente	87 centros de investigación

Publicaciones y conferencias científicas

Celcuity aprovecha los canales de comunicación científica para difundir los hallazgos de la investigación e involucrar a los clientes potenciales.

• Publicaciones revisadas por pares: 6 en 2024
• Presentaciones de conferencias: 14 conferencias internacionales de oncología
• Presentaciones científicas totales: 22

Plataformas de soporte técnico en línea

Canal de soporte	2024 métricas
Portal de soporte en línea	Disponibilidad 24/7
Tiempo de respuesta promedio	2.3 horas
Personal de atención al cliente	8 expertos técnicos especializados

Marketing digital a través de redes científicas

Celcuity emplea estrategias de marketing digital específicas dentro de las redes profesionales científicas.

• Seguidores científicos de LinkedIn: 4.237
• Presupuesto de marketing digital: $ 327,000 en 2024
• Campañas digitales dirigidas: 18 trimestralmente

Seminarios web y seminarios educativos

Seminario web/métrico de seminario	2024 datos
Total de seminarios web	24
Asistentes promedio por webinar	87
Participantes de seminarios anuales totales	2,088

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

Instituciones de investigación académica

Celcuity se dirige a las instituciones de investigación académica que se especializan en la investigación del cáncer con su plataforma de diagnóstico Netest. A partir de 2024, aproximadamente 2.500 instituciones de investigación académica en los Estados Unidos se centran en la investigación de oncología.

Característica de segmento	Datos cuantitativos
Instituciones académicas totales dirigidas	2,500
Presupuesto de investigación anual estimado	$ 3.2 mil millones
Asignación de financiamiento de investigación del cáncer	42%

Laboratorios clínicos de oncología

Celcuity se centra en los laboratorios clínicos de oncología que buscan tecnologías de diagnóstico avanzadas.

• Laboratorios clínicos de oncología total en los Estados Unidos: 1.200
• Porcentaje utilizando tecnologías de diagnóstico molecular: 67%
• Inversión promedio de tecnología de diagnóstico anual: $ 750,000

Organizaciones de investigación farmacéutica

Las organizaciones de investigación farmacéutica representan un segmento crítico de clientes para las tecnologías de diagnóstico de precisión de Celcuity.

Métrico de segmento	Valor
Organizaciones de investigación farmacéutica total	350
Inversión anual de I + D	$ 180 mil millones
Asignación de investigación de medicina de precisión	22%

Centros de diagnóstico del hospital

Los centros de diagnóstico hospitalarios representan un mercado significativo para las tecnologías de diagnóstico molecular de Celcuity.

• Centros de diagnóstico hospitalarios totales en los EE. UU.: 6.090
• Centros con capacidades de diagnóstico molecular: 3.800
• Presupuesto promedio de tecnología de diagnóstico anual: $ 1.2 millones

Investigadores de medicina de precisión

Los investigadores de medicina de precisión constituyen un segmento de clientes especializados para las innovadoras soluciones de diagnóstico de Celcuity.

Métrica de segmento de investigación	Datos cuantitativos
Investigadores de medicina de precisión total	4,500
Financiación anual de investigación	$ 2.7 mil millones
Porcentaje de investigación centrado en el cáncer	38%

Celcuity Inc. (CELC) - Modelo de negocio: Estructura de costos

Inversiones de investigación y desarrollo

Para el año fiscal 2023, Celcuity Inc. reportó gastos de I + D de $ 15.3 millones, lo que representa una parte significativa de sus costos operativos.

Año	Gastos de I + D	Porcentaje de gastos totales
2022	$ 12.7 millones	68.2%
2023	$ 15.3 millones	71.5%

Gastos de estudio de validación clínica

Los estudios de validación clínica para las plataformas de diagnóstico de Celcuity incurrieron en aproximadamente $ 4.2 millones en costos directos durante 2023.

• Por costo promedio de estudio: $ 1.4 millones
• Número de estudios clínicos en curso: 3
• Gastos de colaboración de investigación externa: $ 850,000

Mantenimiento de la plataforma de tecnología

Los costos anuales de infraestructura y mantenimiento de tecnología totalizaron $ 2.6 millones en 2023.

Categoría de mantenimiento	Costo anual
Infraestructura de software	$ 1.1 millones
Actualizaciones de hardware	$750,000
Servicios en la nube	$750,000

Protección de propiedad intelectual

Los gastos de protección de la propiedad intelectual para 2023 fueron de $ 1.5 millones, que cubren la presentación de patentes, el mantenimiento y los honorarios legales.

Compensación de personal especializado

La compensación total de personal para el personal científico y técnico especializado alcanzó los $ 8.7 millones en 2023.

Categoría de personal	Compensación anual promedio	Recuento total de personal
Investigar científicos	$185,000	22
Especialistas técnicos	$145,000	18
Alta gerencia	$310,000	5

Celcuity Inc. (CELC) - Modelo de negocio: flujos de ingresos

Tarifas de licencia de plataforma de diagnóstico

A partir de 2024, los ingresos por licencia de la plataforma de diagnóstico de Celcuity totalizaron $ 1,245,000 para el año fiscal. La compañía cobra entre $ 50,000 y $ 250,000 por acuerdo de licencia por su plataforma de diagnóstico Celsignia.

Nivel de licencia	Rango de tarifas anuales	Número de licencias
Licencia de plataforma básica	$50,000 - $100,000	8 licencias
Licencia de plataforma avanzada	$150,000 - $250,000	3 licencias

Venta de herramientas de investigación

Las ventas de herramientas de investigación para Celcuity generaron $ 675,000 en ingresos durante 2024, con un precio promedio por unidad de $ 15,000.

• Herramientas de investigación oncológica: $ 425,000
• Herramientas de investigación de medicina de precisión: $ 250,000

Servicios de consultoría para medicina de precisión

Los ingresos por servicios de consultoría alcanzaron los $ 892,000 en 2024, con un valor promedio del proyecto de $ 112,000.

Acuerdos de investigación colaborativos

Los acuerdos de investigación colaborativos generaron $ 1,450,000 en ingresos para 2024, con asociaciones que incluyen compañías farmacéuticas y de biotecnología.

Tipo de socio	Número de acuerdos	Ingresos totales
Compañías farmacéuticas	4 acuerdos	$950,000
Compañías de biotecnología	3 acuerdos	$500,000

Posibles regalías de pruebas de diagnóstico futuras

Ingresos de regalías potenciales proyectados para 2024-2025: $ 350,000 a $ 500,000 de la posible comercialización de pruebas de diagnóstico.

Flujos de ingresos totales 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.