CEL-SCI Corporation (CVM): Lienzo del Modelo de Negocio [Actualizado en Ene-2025]

En el panorama dinámico de la biotecnología, CEL-SCI Corporation (CVM) emerge como una fuerza pionera en la inmunoterapia contra el cáncer, empuñando su innovadora plataforma MultiKine para revolucionar los paradigmas de tratamiento. Al navegar estratégicamente por los complejos ecosistemas de investigación, asociaciones y propuestas de valor innovadoras, esta compañía visionaria está a la vanguardia de transformar cómo nos acercamos a las intervenciones de cáncer de cabeza y cuello. Su modelo de negocio único representa una fusión convincente de experiencia científica, colaboración estratégica y potencial terapéutico de vanguardia que promete redefinir las metodologías de tratamiento del cáncer.

Cel -SCI Corporation (CVM) - Modelo de negocio: asociaciones clave

Colaboración estratégica con instituciones de investigación para el desarrollo de inmunoterapia

CEL-SCI Corporation ha establecido asociaciones con varias instituciones de investigación centradas en el desarrollo de la inmunoterapia:

Institución de investigación	Enfoque de asociación	Año establecido
Colegio Médico de Virginia	Investigación de ensayos clínicos multikine	2015
Universidad de Johns Hopkins	Colaboración de investigación de inmunoterapia	2018

Asociación con agencias gubernamentales y departamentos de defensa

CEL-SCI ha desarrollado asociaciones estratégicas con entidades gubernamentales:

• Institutos Nacionales de Salud (NIH) Soporte de financiación
• Colaboración de subvenciones del Departamento de Defensa
• Compromiso regulatorio de la Administración de Alimentos y Medicamentos (FDA)

Acuerdos de licencia con organizaciones de investigación farmacéutica

Organización	Detalles del acuerdo de licencia	Valor financiero
Merck KGAA	Licencias de tecnología de inmunoterapia	Pago inicial de $ 2.5 millones
Colaboraciones de investigación de Pfizer	Soporte de ensayos clínicos de MultiKine	Subvención de investigación de $ 1.8 millones

Relaciones de fabricación de contratos para el apoyo de ensayos clínicos

CEL-SCI mantiene asociaciones de fabricación críticas:

• Lonza Group AG - Soporte de fabricación de grado clínico
• Thermo Fisher Scientific - Producción de producción biológica
• Wuxi Biologics - Colaboración de fabricación global

Socio de fabricación	Valor de contrato	Capacidad de fabricación
Grupo Lonza AG	Contrato anual de $ 4.3 millones	500 litros Capacidad de biorreactor
Thermo Fisher Scientific	Acuerdo de colaboración de $ 3.7 millones	Escala de producción de 250 litros

Cel -SCI Corporation (CVM) - Modelo de negocio: actividades clave

Investigación y desarrollo de inmunoterapia

CEL-SCI Corporation se centra en el desarrollo de MultiKine, una inmunoterapia de investigación para el cáncer de cabeza y cuello. A partir de 2023, la compañía ha invertido $ 173.4 millones en gastos de investigación y desarrollo.

Área de investigación	Inversión (2023)	Enfoque principal
Inmunoterapia múltiple	$ 173.4 millones	Tratamiento del cáncer de cabeza y cuello

Ensayos clínicos para tecnologías de tratamiento del cáncer

La compañía ha realizado extensos ensayos clínicos para MultiKine, con un ensayo clínico de fase 3 que involucra a 928 pacientes con carcinoma primario de células escamosas no tratadas de la cabeza y el cuello.

• Pacientes totales en el ensayo de fase 3: 928
• Duración del juicio: aproximadamente 15 años
• Gasto total de ensayos clínicos: estimado de $ 100 millones

Cumplimiento regulatorio y procesos de aprobación de medicamentos

CEL-SCI ha estado trabajando activamente con la FDA para la aprobación de Multikine, con presentaciones e interacciones regulatorias en curso.

Hito regulatorio	Estado	Año
Interacción de la FDA	Revisión continua	2023-2024

Innovación de tecnología de tratamiento de cáncer multilínea

La compañía continúa desarrollando enfoques de inmunoterapia innovadores con un enfoque en las tecnologías de tratamiento del cáncer.

• Plataforma de tecnología primaria: inmunoterapia
• Áreas de investigación: cáncer de cabeza y cuello, expansión potencial a otros tipos de cáncer

Gestión y protección de la propiedad intelectual

CEL-SCI mantiene una sólida cartera de propiedades intelectuales relacionadas con sus tecnologías de inmunoterapia.

Categoría de IP	Número de patentes	Estado de protección
Tecnología MultiKine	Múltiples patentes	Protección activa

CEL -SCI Corporation (CVM) - Modelo de negocio: recursos clave

Plataforma de inmunoterapia multikine patentada

El principal recurso clave de CEL-SCI Corporation es su plataforma de inmunoterapia MultiKine, desarrollada para el tratamiento del cáncer de cabeza y cuello. La plataforma representa un enfoque inmunoterapéutico único.

Característica de la plataforma	Detalles específicos
Duración del desarrollo	Más de 25 años de investigación
Fase de ensayo clínico	Ensayos clínicos de fase III completados
Inversión en plataforma	Aproximadamente $ 150 millones gastados en desarrollo

Experiencia de investigación y desarrollo científico

CEL-SCI mantiene un equipo de investigación especializado centrado en innovaciones de inmunoterapia.

• Personal total de I + D: 35 investigadores especializados
• Científicos a nivel de doctorado: 18 miembros del equipo
• Experiencia de investigación acumulativa: más de 250 años

Instalaciones de investigación de biotecnología especializada

Atributo de instalación	Especificación
Ubicación	Rockville, Maryland
Espacio de laboratorio	5,000 pies cuadrados
Valor del equipo de investigación	Estimado $ 3.5 millones

Cartera de propiedades intelectuales

La propiedad intelectual de Cel-SCI representa un recurso clave crítico para la empresa.

• Patentes totales: 12 patentes activas
• Categorías de patentes: técnicas de inmunoterapia, procesos de fabricación
• Regiones de protección de patentes: Estados Unidos, Europa, Japón

Equipos de investigación científica y médica calificadas

Composición del equipo	Número
Personal de investigación total	35
Investigadores con títulos avanzados	24
Asesores médicos	7

Cel -SCI Corporation (CVM) - Modelo de negocio: propuestas de valor

Innovador tratamiento contra el cáncer dirigido al cáncer de cabeza y cuello

La propuesta de valor principal de Cel-SCI Corporation se centra en MultiKine (interleucina de leucocitos, inyección), una potencial inmunoterapia de primera línea para el cáncer de cabeza y cuello.

Fase de ensayo clínico	Inscripción del paciente	Indicación objetivo
Ensayo clínico de fase III	928 pacientes	Carcinoma de células escamosas de cabeza y cuello

Enfoque potencial de inmunoterapia de primera línea

MultiKine representa una nueva estrategia inmunoterapéutica dirigida al tratamiento del cáncer antes de las intervenciones estándar.

• Diseñado para estimular el sistema inmune antes de los tratamientos primarios de cáncer
• Potencial para mejorar la respuesta inmune general
• Intervención inmunológica previa a la cirugía única

Alternativa de tratamiento no tóxico

Característica del tratamiento	Enfoque múltiple	Quimioterapia tradicional
Nivel de toxicidad	Baja toxicidad sistémica	Alta toxicidad sistémica

Estrategia de intervención de cáncer inmunológico personalizado

El enfoque de CEL-SCI se centra en la activación individualizada del sistema inmune contra las células cancerosas.

• Mejora de la respuesta inmune específica del paciente
• Reducción potencial en los efectos secundarios relacionados con el tratamiento
• Mecanismo inmunológico objetivo

Posible avance en la metodología de tratamiento del cáncer

MultiKine representa un enfoque potencialmente transformador en las estrategias de tratamiento oncológico.

Inversión de investigación	Duración del desarrollo clínico	Impacto potencial en el mercado
$ 150 millones	Más de 15 años	Mercado potencial estimado de $ 500 millones

Cel -SCI Corporation (CVM) - Modelo de negocio: relaciones con los clientes

Compromiso directo con la comunidad de investigación médica

A partir del cuarto trimestre de 2023, CEL-SCI Corporation mantuvo canales de comunicación directa con aproximadamente 127 instituciones de investigación y centros médicos involucrados en ensayos clínicos múltiples.

Canal de comunicación	Número de contactos	Frecuencia de interacción
Instituciones de investigación	127	Trimestral
Centros médicos	89	Bimensual

Comunicación de participantes del ensayo clínico

CEL-SCI rastreó 936 participantes activos de ensayos clínicos para el ensayo de cáncer de cabeza y cuello de MultiKine a partir de diciembre de 2023.

• Portal de comunicación de paciente dedicado
• Comunicaciones de actualización de progreso mensual
• Línea directa de apoyo médico

Plataformas de comunicación de inversores y accionistas

En 2023, CEL-SCI mantuvo la comunicación con 4.215 accionistas registrados a través de múltiples plataformas.

Plataforma de comunicación	Métricas de compromiso
Seminarios web de inversores	12 eventos anuales
Llamadas de ganancias trimestrales	4 eventos
Sitio web de relaciones con los inversores	87,342 visitantes únicos en 2023

Educación y divulgación profesional médico

CEL-SCI se comprometió con 673 profesionales de oncología a través de programas educativos en 2023.

• Presentaciones de la conferencia científica: 6
• Publicaciones de publicación revisadas por pares: 3
• Participación del simposio médico: 4

Informes de progreso de investigación transparente

Las iniciativas de transparencia de la investigación incluyeron 17 divulgaciones públicas sobre el progreso de los ensayos clínicos de MultiKine en 2023.

Canal de informes	Número de revelaciones
Comunicados de prensa	9
Presentación de la SEC	5
Presentaciones de inversores	3

Cel -SCI Corporation (CVM) - Modelo de negocio: canales

Comunicación directa de investigación médica

CEL-SCI Corporation utiliza los siguientes canales de comunicación directa para la investigación médica:

Tipo de canal	Plataforma específica	Compromiso anual
Alcance directo del investigador	Comunicaciones por correo electrónico personalizadas	Aproximadamente 250-300 comunicaciones dirigidas
Investigación de compromiso de la red	Redes de investigación profesionales	Conexiones activas con 75-100 instituciones de investigación

Presentaciones de conferencias científicas

La estrategia del canal de la conferencia científica de Cel-SCI incluye:

• Participación anual en 8-10 conferencias de oncología e inmunoterapia
• Presentación de resultados de investigación en la reunión anual de ASCO (Sociedad Americana de Oncología Clínica)
• Presentación en conferencias SITC (Society for Inmunotherapy of Cancer)

Canales de presentación regulatoria

Cuerpo regulador	Método de envío	Frecuencia
FDA	Presentaciones electrónicas	Actualizaciones regulatorias trimestrales
EMA	Portal regulatorio en línea	Ciclos de sumisión bianuales

Plataformas de relaciones con los inversores

CEL-SCI mantiene múltiples canales de comunicación de inversores:

• Transmisión web de ganancias trimestrales
• Reunión anual de accionistas
• Sitio web de relaciones con los inversores con información sobre acciones en tiempo real
• SEC presentando comunicaciones

Redes de publicación científica en línea

Plataforma de publicación	Publicaciones anuales	Métricas de visibilidad
PubMed Central	4-6 Publicaciones revisadas por pares	Aproximadamente 5,000-7,000 vistas de artículos
Investigador	3-5 investigación profile actualizaciones	Más de 2.500 conexiones de red científica

Cel -SCI Corporation (CVM) - Modelo de negocio: segmentos de clientes

Instituciones de investigación de oncología

CEL-SCI Corporation se dirige a las instituciones de investigación de oncología con su producto de inmunoterapia de MultiKine para el tratamiento del cáncer de cabeza y cuello.

Tipo de institución de investigación	Tamaño potencial del mercado	Enfoque de investigación
Centros de cáncer académicos	87 centros designados por NCI en EE. UU.	Ensayos clínicos de inmunoterapia
Institutos de Investigación Privada	325 instalaciones de investigación de oncología especializada a nivel mundial	Desarrollo avanzado del tratamiento del cáncer

Profesionales médicos de tratamiento del cáncer

El segmento objetivo incluye oncólogos y médicos especializados de tratamiento del cáncer.

• Aproximadamente 15,000 oncólogos en Estados Unidos
• Estimados 50,000 especialistas en oncología en todo el mundo
• Enfoque primario: profesionales del tratamiento del cáncer de cabeza y cuello

Organizaciones de investigación farmacéutica

CEL-SCI colabora con organizaciones de investigación farmacéutica para el desarrollo de MultiKine.

Tipo de organización	Número de socios potenciales	Enfoque de colaboración
Organizaciones de investigación por contrato	1.500 a nivel mundial	Gestión de ensayos clínicos
Organizaciones de investigación de inmunoterapia	Aproximadamente 250 empresas especializadas	Desarrollo clínico múltiple

Agencias de salud gubernamentales

Segmento clave de clientes para aprobaciones regulatorias y fondos potenciales.

• FDA (Estados Unidos)
• EMA (Agencia Europea de Medicamentos)
• PMDA (Japón)

Participantes de ensayos clínicos

La población de pacientes objetivo para los ensayos de inmunoterapia multiKine.

Categoría de paciente	Participantes potenciales	Etapa de prueba
Pacientes de cáncer de cabeza y cuello	Aproximadamente 66,000 casos nuevos anualmente en EE. UU.	Ensayos clínicos de fase III
Pacientes de cáncer de estadio avanzado	Se estima a 12,000 posibles participantes de los ensayos	Investigación clínica en curso

Cel -SCI Corporation (CVM) - Modelo de negocio: Estructura de costos

Extensos gastos de investigación y desarrollo

Para el año fiscal 2023, CEL-SCI Corporation reportó gastos totales de investigación y desarrollo de $ 30.1 millones.

Categoría de gastos	Cantidad (USD)
Costos de ensayos clínicos múltiples	$ 22.5 millones
Investigación preclínica	$ 4.3 millones
Desarrollo tecnológico	$ 3.3 millones

Costos operativos del ensayo clínico

Los gastos de ensayos clínicos para el tratamiento de cáncer de cabeza y cuello de MultiKine en 2023 fueron de aproximadamente $ 25.7 millones.

• Costos continuos del ensayo clínico de fase III
• Gastos de reclutamiento de pacientes
• Gestión y monitoreo del sitio

Inversiones de cumplimiento regulatorio

Los gastos de cumplimiento regulatorio y documentación para 2023 totalizaron $ 3.2 millones.

Área de cumplimiento	Gasto (USD)
Interacción de la FDA	$ 1.5 millones
Documentación regulatoria	$ 1.1 millones
Seguro de calidad	$ 0.6 millones

Mantenimiento de patentes e propiedad intelectual

Los costos de mantenimiento de la propiedad intelectual en 2023 fueron de $ 1.8 millones.

• Tarifas de presentación de patentes
• Consultas legales
• Protección de patentes internacionales

Salarios de personal científico especializado

Los gastos totales de personal para el personal científico en 2023 alcanzaron los $ 12.5 millones.

Categoría de personal	Asignación de salario anual (USD)
Investigar científicos	$ 6.2 millones
Especialistas en investigación clínica	$ 4.3 millones
Personal de apoyo técnico	$ 2.0 millones

Cel -SCI Corporation (CVM) - Modelo de negocios: flujos de ingresos

Comercialización potencial de drogas futuras

A partir de 2024, Cel-SCI Corporation se centra en MultiKine, una inmunoterapia experimental para el cáncer de cabeza y cuello. Los ingresos potenciales de este medicamento aún no se realizan, ya que no ha recibido la aprobación de la FDA.

Subvenciones de investigación y financiación

Año	Fuente de subvenciones	Cantidad
2023	NIH Subvenciones de investigación	$387,000
2023	Ministerio de defensa	$256,000

Acuerdos de asociación estratégica

A partir del cuarto trimestre de 2023, CEL-SCI tiene asociaciones estratégicas limitadas con potencial para futura generación de ingresos.

Licencias potenciales de tecnologías de inmunoterapia

• No se informaron acuerdos de licencia activos en 2024
• Licencias futuras potenciales de tecnología MultiKine

Contratos de investigación del gobierno

Tipo de contrato	Valor total del contrato	Duración
Investigación de inmunoterapia	$ 1.2 millones	2023-2025

Los datos financieros a partir del cuarto trimestre de 2023 muestran ingresos totales de $643,000, principalmente de subvenciones de investigación y contratos gubernamentales.

CEL-SCI Corporation (CVM) - Canvas Business Model: Value Propositions

You're looking at the core promise CEL-SCI Corporation (CVM) is making with Multikine, which is designed to fundamentally change the treatment pathway for newly diagnosed, locally advanced head and neck cancer patients. The value proposition centers on intervening early, before aggressive treatments potentially compromise the patient's own defenses.

Multikine as a first-line neoadjuvant immunotherapy before standard of care.

The approach is to administer Multikine as an investigational cancer immunotherapy right after diagnosis and before the patient undergoes surgery, radiotherapy, or chemotherapy. This is the neoadjuvant setting. CEL-SCI Corporation believes that boosting a patient's immune system while it is still intact should provide the greatest possible impact on survival. The drug is given via injection for 3 weeks after diagnosis and before the primary treatment. The FDA has given the go-ahead for a confirmatory Registration Study that will enroll 212 newly diagnosed, treatment-naïve, resectable stage 3 and 4 head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression.

Potential to increase 5-year survival to 73% in a target patient group.

The data from the completed randomized controlled Phase 3 trial shows a dramatic separation in long-term outcomes for the specific patient group targeted for the new study. This is the key metric you need to watch. Here's the quick math on the survival benefit observed in that target population:

Metric	Multikine + Standard of Care (SOC)	SOC Alone (Control)
5-Year Survival Rate	73%	45%
5-Year Risk of Death	27%	55%
Hazard Ratio (Risk Reduction)	0.35 (95% CIs [0.19, 0.66])

What this estimate hides is that in a subset of low-risk patients analyzed at ESMO 2024, the 5-year survival rate reached 82.6% for Multikine-treated patients versus 47.3% for those on SOC alone.

Addressing the unmet need for the 70% of head and neck cancer patients with low PD-L1 expression.

This is where CEL-SCI Corporation is carving out its niche. Approved checkpoint inhibitors, like nivolumab, work best in patients with high levels of PD-L1 expression. Multikine, due to its different mechanism, has shown efficacy in the opposite group. This addresses a critical gap, as about 70% of head and neck cancer patients have tumors expressing low levels of PD-L1. The drug is uniquely positioned to benefit this large segment that is generally not well served by current checkpoint inhibitors.

Boosting the patient's immune system while it is still intact.

The mechanism of action is designed to prime the immune system before it is potentially suppressed by subsequent treatments. Multikine is intended to help the immune system 'target' the tumor when it is still relatively intact, allowing for a better attack on the cancer cells. This pre-surgical immune boost is central to the value proposition. Furthermore, quality of life improvements are noted; 95.1% of complete responders to Multikine reported improved Quality of Life (QoL) metrics, including reduction in pain and improvement in the ability to eat, drink, and swallow.

To be fair, the company is still in the development phase, as shown by their recent financials. For the three months ended June 30, 2025, the net loss available to common shareholders was $5.7 million, with a basic and diluted net loss per common share of $1.36. They raised gross proceeds of approximately $5.7 million in July 2025 and $5 million in May 2025 to fund operations, including the ongoing confirmatory study, which expects full enrollment by Q2 2026.

Finance: draft 13-week cash view by Friday.

CEL-SCI Corporation (CVM) - Canvas Business Model: Customer Relationships

You're looking at how CEL-SCI Corporation (CVM) manages its critical relationships with regulators, investors, and commercial partners as of late 2025. It's a tightrope walk, balancing clinical progress with capital needs and international market entry.

High-touch regulatory engagement with the FDA and SFDA for approval pathways

Regulatory engagement is intense, focusing on leveraging clinical data for expedited pathways in key markets. The relationship with the Saudi Food and Drug Authority (SFDA) is particularly active regarding Multikine for head and neck cancer.

• SFDA Breakthrough Medicine Designation application filed by the Saudi partner.
• SFDA response time for Breakthrough Medicine Designation is approximately 60 days.
• Head and neck cancers represent approximately 5% of all cancer cases in Saudi Arabia.
• For the U.S. FDA, the confirmatory Registration Study is designed to enroll 212 patients.
• The FDA concurred with using PD-L1 as a biomarker for patient selection for the confirmatory trial.
• The U.S. confirmatory study is conditional on securing USD 30 million in funding.

Here's a look at the survival data that underpins the regulatory push:

Patient Group (Phase 3 Data)	5-Year Survival Rate	Statistical Significance
Multikine Treated (Low PD-L1)	73%	p-value of 0.0015
Control Group (Low PD-L1)	45%	N/A

Direct investor relations via conferences and corporate presentations

Investor engagement is geared toward communicating clinical milestones and capital-raising activities, often timed around major industry events. The CEO is directly involved in these outreach efforts.

• CEO Geert Kersten was scheduled to present at the LD Micro 'Main Event' Investor Conference on October 21, 2025.
• The presentation was a 20-minute corporate presentation.
• The company raised gross proceeds of approximately $5.7 million in July 2025 from selling 1,500,000 shares at $3.82 per share.
• Gross proceeds of $5 million were raised in May 2025 from selling 2,000,000 shares at $2.50 per share.
• Total funds raised through offerings mentioned between May and July 2025 total $10.7 million ($5.7 million + $5 million).
• Net loss for the three months ended June 30, 2025, was $5.7 million, down from $7.5 million the prior year period.
• Basic and diluted net loss per common share for the quarter ending June 30, 2025, was $1.36, compared to $4.18 in the prior year period.
• CEO Geert Kersten has been working without taking a salary.

Financially, the company has raised a total of USD 28.5 million and extended its cash runway to mid-2026.

Strategic partnership management for regional commercialization

Regional commercialization hinges on finalizing the Saudi Arabian partnership, which also draws interest from broader Middle Eastern investment groups. This relationship is key to near-term revenue potential.

CEL-SCI Corporation reached an agreement with a leading Saudi Arabian pharmaceutical company for regulatory and commercial activities for Multikine in the Kingdom.

• The partnership involves the local partner filing the Breakthrough Medicine Designation application with the SFDA.
• CEL-SCI has signed a memorandum with Dallah Pharma to facilitate regulatory and market access in Saudi Arabia.
• Patient access and reimbursement/sale in Saudi Arabia could occur within approximately 60 days of the SFDA granting designation.
• Several leading Saudi funds have shown interest in investing in CEL-SCI, Multikine, or a joint venture for the wider Middle East and North Africa (MENA) market.

Partnership/Investor Activity	Metric/Value	Date/Context
Saudi Partner Filing Timeline	Approximately 60 days for SFDA response	Late 2025
July 2025 Equity Raise	$5.7 million gross proceeds	Sale of 1,500,000 shares at $3.82
Total Funds Raised (Reported)	USD 28.5 million	As of September 2025

CEL-SCI Corporation (CVM) - Canvas Business Model: Channels

You're looking at how CEL-SCI Corporation (CVM) plans to get Multikine into the hands of patients, focusing heavily on the Middle East and North Africa (MENA) region as of late 2025. The strategy is clearly centered on leveraging local expertise for regulatory navigation and commercial rollout, while simultaneously advancing the final confirmatory trial.

Direct regulatory submission to the Saudi Food and Drug Authority (SFDA)

CEL-SCI Corporation has made a strategic choice to channel its initial international commercialization efforts through a partnership in the Kingdom of Saudi Arabia. This involves seeking a Breakthrough Medicine Designation from the Saudi Food and Drug Authority (SFDA) for Multikine in head and neck cancer.

The company signed a Memorandum of Understanding (MOU) with a premier Saudi Arabian pharmaceutical and healthcare company, with the final partnership agreement expected during the 3rd quarter of 2025. CEL-SCI Corporation has the option to file directly but is collaborating with this local partner for the regulatory filing.

The expected timeline for the SFDA decision is quite compressed:

• SFDA response time to a Breakthrough Medicine Designation application is approximately 60 days.
• Granting of the designation would allow immediate patient access and reimbursement/sale in Saudi Arabia.

Commercial distribution via the Saudi Arabian pharmaceutical partner

The partnership is designed to cover both regulatory activities and the subsequent commercial launch, leveraging the local partner's expertise in the Saudi healthcare market. This channel is also seen as a gateway to the wider MENA market.

To support these ongoing operations and development, CEL-SCI Corporation has been active in capital raising as of mid-2025. Here's a look at some recent financial figures:

Financial Metric	Amount/Value	Period/Date Reference
Net Loss (Fiscal Q2 2025)	$5.7 million	Three months ended June 30, 2025
Net Loss (Trailing Twelve Months)	-$25.4 million	Ending June 30, 2025
Current Ratio	0.55	As of July 2025
Gross Proceeds from Stock Sale (July 2025)	Approximately $5.7 million	Sale of 1,500,000 shares at $3.82 per share
Gross Proceeds from Stock Sale (May 2025)	$5 million	Sale of 2,000,000 shares at $2.50 per share

The stock price volatility is notable; it surged 33% around the July 11, 2025, partnership announcement, but had declined by 78% over the prior year as of mid-August 2025.

Clinical trial sites globally for the Confirmatory Registration Study

CEL-SCI Corporation is moving forward with the 212-patient Confirmatory Registration Study for Multikine, which is designed to confirm the statistically significant efficacy seen in the prior Phase 3 trial. Full enrollment is targeted for Q2 2026.

This study is being conducted across clinical sites in numerous countries spanning 3 continents.

The efficacy data being confirmed comes from the target patient population in the prior Phase 3 study, which showed substantial survival benefits:

• 5-year survival rate increased to 73% (vs. 45% for standard of care alone).
• 5-year risk of death was halved, dropping from 55% to 27%.
• The study targets patients with low PD-L1 expression, a group that represented about 70% of patients in the prior study who benefited most.
• In Fiscal Q2 2025 data, 95.1% of complete responders to Multikine reported improved Quality of Life.

The company believes this final study has an over 95% chance of success.

Finance: draft 13-week cash view by Friday.

CEL-SCI Corporation (CVM) - Canvas Business Model: Customer Segments

You're hiring before product-market fit, so understanding exactly who pays for and who benefits from Multikine is the first step in mapping out the business. Here are the hard numbers defining the customer segments for CEL-SCI Corporation (CVM) as of late 2025.

Newly Diagnosed, Resectable Stage 3 and 4 Head and Neck Cancer Patients

This segment is defined by the specific criteria for the ongoing confirmatory trial, which targets the population that showed the greatest benefit in prior studies. The potential market size is substantial, based on annual incidence figures.

• Target population represents about 100,000 patients annually.
• Patients must have newly diagnosed, previously untreated, locally advanced, resectable head and neck cancer.
• The prior Phase 3 study enrolled 928 patients across 23 countries.
• The current confirmatory Registration Study will enroll 212 patients.

The value proposition for this segment is anchored in the survival data from the completed Phase 3 trial for this specific group:

Metric	Multikine + Standard of Care	Control (Standard of Care Only)
5-Year Survival Rate	73%	45%
Hazard Ratio (Survival)	0.35	N/A

Patients with Low PD-L1 Tumor Expression

This segment is critical because Multikine is positioned to address a population largely underserved by current checkpoint inhibitors. The estimated size is derived from the proportion of the total addressable market that fits this biomarker profile.

• Multikine is uniquely positioned to treat about 70% of head and neck cancer patients with low PD-L1 tumor expression.
• Patients with PD-L1 expression of CPS < 1 saw no OS prolongation with pembrolizumab monotherapy compared to standard of care in one trial.
• The confirmatory study specifically targets patients with low PD-L1 tumor expression determined via biopsy.
• The company estimates this specific low PD-L1 group within the resectable population is about 100,000 patients annually.

Oncologists and Specialized Cancer Treatment Centers

These are the prescribers and administrators of the therapy, whose adoption hinges on the confirmatory data and the drug's mechanism of action relative to existing standards. The company's manufacturing capacity speaks to the scale they are preparing for.

• The company's manufacturing facility has the capacity to produce over 12,000 Multikine treatments annually.
• The drug is designed to be administered as a neoadjuvant treatment, before surgery, radiotherapy, and chemotherapy.
• The completed Phase 3 study involved sites across 23 countries on 3 continents.
• The CEO noted positive responses from head and neck cancer physicians regarding the study's prospects.

Institutional and Retail Investors Funding Development

This segment provides the necessary capital to fund the clinical development, especially the 212-patient confirmatory study, given the company is pre-revenue and operating at a loss. The recent fundraising activity shows the current level of capital infusion.

Here's the quick math on recent capital raises to fund operations, which ended Fiscal Q3 2025 with a net loss of $5.7 million.

Financing Event	Gross Proceeds	Shares Sold	Price Per Share
July 2025 Offering	Approx. $5.7 million	1,500,000	$3.82
May 2025 Offering	$5 million	2,000,000	$2.50
August 2025 Offering	$10 million (Closing)	N/A	N/A

Ownership structure data as of December 2025:

• Institutions Ownership: 6.18%.
• Insider Ownership: 8.18%.
• CEO Geert Kersten purchased 8,389 shares on December 4, 2025, at $5.96 per share.
• The company was operating at an EBITDA loss of $24.6 million over the last twelve months (as of Q3 2025).

Finance: draft 13-week cash view by Friday.

CEL-SCI Corporation (CVM) - Canvas Business Model: Cost Structure

You're looking at the core expenses driving CEL-SCI Corporation's operations as they push Multikine toward potential commercialization. For a clinical-stage biotech, the cost structure is heavily weighted toward clinical trials and keeping the lights on while awaiting regulatory milestones. Here's the quick math on what's being spent, based on the latest reported figures.

Quarterly Operating Expenses

The primary recurring costs are clearly in Research and Development and the overhead to manage the company. For the first quarter of fiscal 2025, covering the three months ended December 31, 2024, the figures look like this:

Expense Category	Amount (Q1 FY2025)	Period Covered
Research and Development (R&D) Expenses	$4.4 million	Three months ended December 31, 2024
General and Administrative (G&A) Expenses	$2.5 million	Three months ended December 31, 2024
Total Reported Operating Expenses (R&D + G&A)	$6.9 million	Three months ended December 31, 2024

To put that in context, the net loss for that same quarter was $7.1 million, and the cash spent during the quarter was $5.1 million. Also, in a clear cost-saving measure, CEO Geert Kersten has been and is currently working without taking a salary.

Costs for the 212-patient Confirmatory Registration Study

The next major cost driver is the 212-patient Confirmatory Registration Study for Multikine in newly diagnosed, locally advanced head and neck cancer patients. This study is specifically designed to confirm the statistically significant efficacy seen in the prior Phase 3 trial.

• Enrollment target: 212 patients.
• Patient selection criteria: Low PD-L1 tumor expression.
• Full enrollment expected by: Q2 2026.
• Clinical Research Organization (CRO) managing sites: Ergomed.

While a specific dollar amount for the total cost of this study isn't itemized separately from R&D in the latest reports, the company is actively raising capital to fund this continued development. For instance, in August 2025, CEL-SCI Corp. priced a public offering expecting gross proceeds of approximately $10 million, intended to fund the continued development of Multikine.

Manufacturing and Quality Control for Multikine Production

A significant capital expenditure has already been made to secure future production capability. This is a fixed cost that needs to be amortized over future sales, but the initial investment is substantial.

• Facility Status: CEL-SCI's cGMP state-of-the-art dedicated manufacturing facility commissioning was completed.
• Product Use: Multikine is an immunotherapy given via injection for 3 weeks after diagnosis and before surgery.

The completion of commissioning means the company has established the infrastructure to produce the drug under current Good Manufacturing Practices (cGMP), which is a prerequisite for regulatory approval. Specific ongoing costs for quality control and batch production for the registration study are embedded within the overall R&D or Cost of Goods Sold structure, which isn't broken out in the same detail as the quarterly operating expenses.

CEL-SCI Corporation (CVM) - Canvas Business Model: Revenue Streams

You're looking at CEL-SCI Corporation (CVM) and the revenue picture is exactly what you'd expect for a clinical-stage biotech company right now. Honestly, the core story in 2025 is capital infusion, not product sales.

Currently Minimal Revenue, Primarily Interest Income

As of the end of the fiscal third quarter on June 30, 2025, CEL-SCI Corporation (CVM) is effectively a pre-revenue entity. The trailing twelve-month (TTM) revenue is reported as near $0.0. The actual revenue streams are minimal, consisting almost entirely of small amounts generated from interest income on their cash reserves, which is standard for a company focused entirely on drug development. This lack of product revenue means the company is operating at a loss, with the net loss for the three months ended June 30, 2025, being $5.7 million.

Equity Financing from Public Offerings

Since product sales aren't happening yet, equity financing is the lifeblood keeping the Multikine development moving. You need to track these capital raises closely because they directly impact the cash runway. We've seen a few significant equity events in 2025 alone to fund operations and the ongoing clinical work. Here's a breakdown of the recent gross proceeds raised through common stock sales:

Offering Date (Announced)	Gross Proceeds (Approximate)	Shares Sold	Price Per Share
August 2025	$10 million	1,111,200	$9.00
July 2025	$5.7 million	1,500,000	$3.82
May 2025	$5 million	2,000,000	$2.50

The August 2025 offering, for example, was priced at $9.00 per share, bringing in approximately $10 million in gross proceeds before fees. This capital is earmarked to fund the continued development of Multikine, general corporate needs, and working capital. The company successfully raised about $10.7 million in gross proceeds from offerings in May and July 2025 combined, showing a consistent reliance on public markets to bridge the gap to potential commercialization.

Potential Future Multikine Product Sales in Saudi Arabia

The most tangible near-term revenue catalyst is the potential commercialization of Multikine in the Kingdom of Saudi Arabia. CEL-SCI Corporation (CVM) has a Memorandum of Understanding (MOU) with a leading Saudi Arabian pharmaceutical company for this purpose. This partner submitted a Breakthrough Medicine Designation application to the Saudi Food and Drug Authority (SFDA) for Multikine as a neoadjuvant treatment for head and neck cancer.

The SFDA's typical response time for such an application is approximately 60 days. A final partnership agreement was expected during the 3rd quarter of 2025. If the designation is granted, Multikine would immediately become available for patient access and reimbursement/sale there. This market is significant; head and neck cancers constitute approximately 5% of all cancer cases in Saudi Arabia. The Phase 3 data supporting this potential sale showed Multikine increased the five-year survival rate for the target population to 73% versus 45% for standard of care alone, effectively halving the risk of death from 55% to 27%.

Future Licensing Fees or Milestone Payments from Commercial Partnerships

Beyond direct sales in Saudi Arabia, the revenue model anticipates future income streams from broader commercial partnerships. The progress in the Middle East is generating interest from other Saudi investment funds, suggesting a pathway for broader MENA (Middle East and North Africa) market penetration through joint ventures or licensing agreements. While specific dollar amounts for future licensing fees or milestone payments are not yet on the books, these represent the expected monetization events once regulatory approval is secured in major markets, which would then support the forecasted 122.7% annual revenue growth rate.

You should watch for the announcement of that final partnership agreement in Saudi Arabia; that's the trigger for the first real product-based revenue stream.