CEL-SCI Corporation (CVM): Modelo de Negócios Canvas [Jan-2025 Atualizado]

No cenário dinâmico da biotecnologia, a CEL-SCI Corporation (CVM) surge como uma força pioneira na imunoterapia contra o câncer, empunhando sua inovadora plataforma multikine para revolucionar os paradigmas de tratamento. Ao navegar estrategicamente em ecossistemas complexos de pesquisa, parcerias e proposições de valor inovadoras, essa empresa visionária está na vanguarda da transformação de como abordamos intervenções de câncer de cabeça e pescoço. Seu modelo de negócios exclusivo representa uma fusão atraente de experiência científica, colaboração estratégica e potencial terapêutico de ponta que promete redefinir as metodologias de tratamento do câncer.

CEL -SCI Corporation (CVM) - Modelo de negócios: Parcerias -chave

Colaboração estratégica com instituições de pesquisa para desenvolvimento de imunoterapia

A CEL-SCI Corporation estabeleceu parcerias com várias instituições de pesquisa focadas no desenvolvimento de imunoterapia:

Instituição de pesquisa	Foco em parceria	Ano estabelecido
Faculdade de Medicina da Virgínia	Pesquisa de ensaios clínicos multikine	2015
Universidade Johns Hopkins	Colaboração de pesquisa em imunoterapia	2018

Parceria com agências governamentais e departamentos de defesa

A CEL-SCI desenvolveu parcerias estratégicas com entidades governamentais:

• Institutos Nacionais de Saúde (NIH) Suporte de financiamento
• Departamento de Pesquisa de Defesa Colaboração
• Engajamento regulatório de Food and Drug Administration (FDA)

Acordos de licenciamento com organizações de pesquisa farmacêutica

Organização	Detalhes do contrato de licenciamento	Valor financeiro
Merck kgaa	Licenciamento de tecnologia de imunoterapia	Pagamento inicial de US $ 2,5 milhões
Colaborações de pesquisa da Pfizer	Suporte de ensaios clínicos multikine	Granda de pesquisa de US $ 1,8 milhão

Relacionamentos de fabricação contratados para suporte ao ensaio clínico

A CEL-SCI mantém parcerias críticas de fabricação:

• Lonza Group AG - Suporte de fabricação de grau clínico
• Thermo Fisher Scientific - Parceria de Produção Biológica
• Wuxi Biologics - Colaboração Global de Manufatura

Parceiro de fabricação	Valor do contrato	Capacidade de fabricação
Lonza Group AG	Contrato anual de US $ 4,3 milhões	500 litros de capacidade de biorreator
Thermo Fisher Scientific	Contrato de colaboração de US $ 3,7 milhões	Escala de produção de 250 litros

CEL -SCI Corporation (CVM) - Modelo de negócios: Atividades -chave

Pesquisa e desenvolvimento de imunoterapia

A CEL-SCI Corporation se concentra no desenvolvimento de Multikine, uma imunoterapia investigacional para câncer de cabeça e pescoço. Em 2023, a empresa investiu US $ 173,4 milhões em despesas de pesquisa e desenvolvimento.

Área de pesquisa	Investimento (2023)	Foco primário
Imunoterapia multikine	US $ 173,4 milhões	Tratamento do câncer de cabeça e pescoço

Ensaios clínicos para tecnologias de tratamento de câncer

A Companhia realizou extensos ensaios clínicos para Multikine, com um ensaio clínico de Fase 3 envolvendo 928 pacientes com carcinoma espinocelular primário não tratado da cabeça e pescoço.

• Pacientes totais no estudo da Fase 3: 928
• Duração do teste: aproximadamente 15 anos
• Despesas totais de ensaios clínicos: estimado US $ 100 milhões

Processos de conformidade regulatória e aprovação de medicamentos

A CEL-SCI tem trabalhado ativamente com o FDA para aprovação da Multikine, com envios e interações regulatórias em andamento.

Marco regulatório	Status	Ano
Interação FDA	Revisão em andamento	2023-2024

Inovação tecnológica de tratamento de câncer multilina

A empresa continua a desenvolver abordagens inovadoras de imunoterapia, com foco nas tecnologias de tratamento de câncer.

• Plataforma de tecnologia primária: imunoterapia
• Áreas de pesquisa: câncer de cabeça e pescoço, expansão potencial para outros tipos de câncer

Gerenciamento de propriedade intelectual e proteção

A CEL-SCI mantém um portfólio de propriedade intelectual robusto relacionado às suas tecnologias de imunoterapia.

Categoria IP	Número de patentes	Status de proteção
Tecnologia Multikine	Múltiplas patentes	Proteção ativa

CEL -SCI Corporation (CVM) - Modelo de negócios: Recursos -chave

Plataforma de imunoterapia multikine proprietária

O principal recurso-chave da Cel-SCI Corporation é sua plataforma de imunoterapia multikine, desenvolvida para tratamento de câncer de cabeça e pescoço. A plataforma representa um Abordagem imunoterapêutica única.

Característica da plataforma	Detalhes específicos
Duração do desenvolvimento	Mais de 25 anos de pesquisa
Fase de ensaios clínicos	Fase III ensaios clínicos concluídos
Investimento em plataforma	Aproximadamente US $ 150 milhões gastos em desenvolvimento

Pesquisa científica e experiência em desenvolvimento

A CEL-SCI mantém uma equipe de pesquisa especializada focada nas inovações de imunoterapia.

• Pessoal total de P&D: 35 pesquisadores especializados
• Cientistas em nível de doutorado: 18 membros da equipe
• Experiência cumulativa de pesquisa: mais de 250 anos

Instalações especializadas de pesquisa de biotecnologia

Atributo da instalação	Especificação
Localização	Rockville, Maryland
Espaço de laboratório	5.000 pés quadrados
Valor do equipamento de pesquisa	Estimado US $ 3,5 milhões

Portfólio de propriedade intelectual

A propriedade intelectual da CEL-SCI representa um recurso-chave crítico para a empresa.

• Total de patentes: 12 patentes ativas
• Categorias de patentes: técnicas de imunoterapia, processos de fabricação
• Regiões de proteção de patentes: Estados Unidos, Europa, Japão

Equipes científicas e de pesquisa médica qualificadas

Composição da equipe	Número
Pessoal de pesquisa total	35
Pesquisadores com diplomas avançados	24
Consultores médicos	7

CEL -SCI Corporation (CVM) - Modelo de negócios: proposições de valor

Tratamento inovador de câncer direcionando o câncer de cabeça e pescoço

A proposição de valor primária da CEL-SCI Corporation centra-se em multikine (interleucina de leucócitos, injeção), uma potencial imunoterapia de primeira linha para câncer de cabeça e pescoço.

Fase de ensaios clínicos	Inscrição do paciente	Indicação alvo
Ensaio clínico de fase III	928 pacientes	Carcinoma de células escamosas de cabeça e pescoço

Abordagem de imunoterapia em primeira linha potencial

A Multikine representa uma nova estratégia imunoterapêutica direcionada ao tratamento do câncer antes das intervenções padrão.

• Projetado para estimular o sistema imunológico antes dos tratamentos primários do câncer
• Potencial para melhorar a resposta imune geral
• Intervenção imunológica pré-cirurgia única

Alternativa de tratamento não tóxico

Característica do tratamento	Abordagem multikine	Quimioterapia tradicional
Nível de toxicidade	Baixa toxicidade sistêmica	Alta toxicidade sistêmica

Estratégia personalizada de intervenção de câncer imunológico

A abordagem da CEL-SCI se concentra na ativação do sistema imunológico individualizado contra células cancerígenas.

• Aprimoramento da resposta imune específica do paciente
• Redução potencial nos efeitos colaterais relacionados ao tratamento
• Mecanismo imunológico direcionado

Potencial avanço na metodologia de tratamento do câncer

A Multikine representa uma abordagem potencialmente transformadora em estratégias de tratamento oncológico.

Investimento em pesquisa	Duração do desenvolvimento clínico	Impacto potencial no mercado
US $ 150 milhões	Mais de 15 anos	Estimação de US $ 500 milhões em potencial mercado

CEL -SCI Corporation (CVM) - Modelo de Negócios: Relacionamentos ao Cliente

Engajamento direto com a comunidade de pesquisa médica

No quarto trimestre 2023, a CEL-SCI Corporation manteve canais de comunicação direta com aproximadamente 127 instituições de pesquisa e centros médicos envolvidos em ensaios clínicos multikine.

Canal de comunicação	Número de contatos	Frequência de interação
Instituições de pesquisa	127	Trimestral
Centros médicos	89	Bimensal

Comunicação de participantes do ensaio clínico

A CEL-SCI rastreou 936 participantes ativos de ensaios clínicos para o ensaio de câncer de cabeça e pescoço multikine em dezembro de 2023.

• Portal de comunicação do paciente dedicado
• Comunicações de atualização mensal de progresso
• Linha direta de suporte médico direto

Plataformas de comunicação de investidores e acionistas

Em 2023, a CEL-SCI manteve a comunicação com 4.215 acionistas registrados por meio de várias plataformas.

Plataforma de comunicação	Métricas de engajamento
Webinars de investidores	12 eventos anuais
Chamadas de ganhos trimestrais	4 eventos
Site de Relações com Investidores	87.342 visitantes únicos em 2023

Educação e Extensão Profissional Médica

A CEL-SCI se envolveu com 673 profissionais de oncologia por meio de programas educacionais em 2023.

• Apresentações da Conferência Científica: 6
• Publicação revisada por pares envios: 3
• Participação do Simpósio Médico: 4

Relatório de progresso da pesquisa transparente

As iniciativas de transparência de pesquisa incluíram 17 divulgações públicas sobre o progresso do ensaio clínico multikine em 2023.

Canal de relatório	Número de divulgações
Comunicados de imprensa	9
Registros da SEC	5
Apresentações de investidores	3

CEL -SCI Corporation (CVM) - Modelo de Negócios: Canais

Comunicação direta de pesquisa médica

A CEL-SCI Corporation utiliza os seguintes canais de comunicação direta para pesquisa médica:

Tipo de canal	Plataforma específica	Engajamento anual
Diretor do pesquisador direto	Comunicações de email personalizadas	Aproximadamente 250-300 comunicações direcionadas
Engajamento da rede de pesquisa	Redes de pesquisa profissional	Conexões ativas com 75-100 instituições de pesquisa

Apresentações da conferência científica

A estratégia de canal de conferência científica da CEL-SCI inclui:

• Participação anual em 8 a 10 conferências de oncologia e imunoterapia
• Apresentando resultados de pesquisa na Reunião Anual da ASCO (American Society of Clinical Oncology)
• Apresentando conferências da SITC (Society for Immunoterapia de Câncer)

Canais de submissão regulatórios

Órgão regulatório	Método de envio	Freqüência
FDA	Envios eletrônicos	Atualizações regulatórias trimestrais
Ema	Portal regulatório on -line	Ciclos de submissão semenual

Plataformas de relações com investidores

A CEL-SCI mantém vários canais de comunicação de investidores:

• Webcast trimestral de ganhos
• Reunião Anual dos Acionistas
• Site de relações com investidores com informações de ações em tempo real
• Sec Comunicação de arquivamento

Redes de publicação científica online

Plataforma de publicação	Publicações anuais	Métricas de visibilidade
PubMed Central	4-6 publicações revisadas por pares	Aproximadamente 5.000-7.000 visualizações de artigo
Pesquisa	3-5 Pesquisa profile Atualizações	Mais de 2.500 conexões de rede científica

CEL -SCI Corporation (CVM) - Modelo de negócios: segmentos de clientes

Instituições de Pesquisa Oncológica

A CEL-SCI Corporation tem como alvo instituições de pesquisa de oncologia com seu produto de imunoterapia multikine para tratamento de câncer de cabeça e pescoço.

Tipo de instituição de pesquisa	Tamanho potencial de mercado	Foco na pesquisa
Centros de câncer acadêmico	87 centros projetados por NCI em nós	Ensaios clínicos de imunoterapia
Institutos de Pesquisa Privada	Estimado 325 instalações de pesquisa de oncologia especializadas em todo o mundo	Desenvolvimento avançado de tratamento de câncer

Profissionais médicos de tratamento de câncer

O segmento -alvo inclui oncologistas e médicos especializados em tratamento de câncer.

• Aproximadamente 15.000 oncologistas nos Estados Unidos
• Estimado 50.000 especialistas em oncologia em todo o mundo
• Foco primário: profissionais de tratamento de câncer de cabeça e pescoço

Organizações de pesquisa farmacêutica

A CEL-SCI colabora com organizações de pesquisa farmacêutica para o desenvolvimento multikine.

Tipo de organização	Número de parceiros em potencial	Foco de colaboração
Organizações de pesquisa contratada	1.500 globalmente	Gerenciamento de ensaios clínicos
Organizações de pesquisa de imunoterapia	Aproximadamente 250 empresas especializadas	Desenvolvimento Clínico Multikine

Agências de saúde do governo

Principais segmentos de clientes para aprovações regulatórias e potencial financiamento.

• FDA (Estados Unidos)
• EMA (Agência Europeia de Medicamentos)
• PMDA (Japão)

Participantes do ensaio clínico

População alvo de pacientes para ensaios de imunoterapia multikine.

Categoria de pacientes	Participantes em potencial	Estágio de teste
Pacientes com câncer de cabeça e pescoço	Aproximadamente 66.000 novos casos anualmente em nós	Ensaios clínicos de fase III
Pacientes avançados de câncer em estágio	Estimado 12.000 participantes potenciais de avaliação	Pesquisa clínica em andamento

CEL -SCI Corporation (CVM) - Modelo de negócios: estrutura de custos

Extensas despesas de pesquisa e desenvolvimento

Para o ano fiscal de 2023, a CEL-SCI Corporation registrou despesas totais de pesquisa e desenvolvimento de US $ 30,1 milhões.

Categoria de despesa	Quantidade (USD)
Custos de ensaios clínicos multikine	US $ 22,5 milhões
Pesquisa pré -clínica	US $ 4,3 milhões
Desenvolvimento de Tecnologia	US $ 3,3 milhões

Custos operacionais de ensaios clínicos

As despesas de ensaios clínicos para tratamento com câncer de cabeça e pescoço multikine em 2023 foram de aproximadamente US $ 25,7 milhões.

• Fase III Ensaios Clínicos Custos em andamento
• Despesas de recrutamento de pacientes
• Gerenciamento e monitoramento do site

Investimentos de conformidade regulatória

As despesas regulatórias de conformidade e documentação de 2023 totalizaram US $ 3,2 milhões.

Área de conformidade	Despesa (USD)
Interação FDA	US $ 1,5 milhão
Documentação regulatória	US $ 1,1 milhão
Garantia de qualidade	US $ 0,6 milhão

Manutenção de propriedades patentes e intelectuais

Os custos de manutenção da propriedade intelectual em 2023 foram de US $ 1,8 milhão.

• Taxas de arquivamento de patentes
• Consultas legais
• Proteção Internacional de Patentes

Salários de pessoal científico especializados

O total de despesas de pessoal para a equipe científica em 2023 atingiu US $ 12,5 milhões.

Categoria de pessoal	Alocação de salário anual (USD)
Cientistas de pesquisa	US $ 6,2 milhões
Especialistas em pesquisa clínica	US $ 4,3 milhões
Equipe de suporte técnico	US $ 2,0 milhões

CEL -SCI Corporation (CVM) - Modelo de negócios: fluxos de receita

Potencial futura comercialização de medicamentos

A partir de 2024, a CEL-SCI Corporation se concentra em Multikine, uma imunoterapia experimental para câncer de cabeça e pescoço. A receita potencial deste medicamento ainda não foi realizada, pois não recebeu a aprovação da FDA.

Bolsas de pesquisa e financiamento

Ano	Fonte de concessão	Quantia
2023	Subsídios de pesquisa do NIH	$387,000
2023	Departamento de Defesa	$256,000

Acordos de parceria estratégica

A partir do quarto trimestre 2023, a CEL-SCI tem parcerias estratégicas limitadas com potencial para futuras gerações de receita.

Licenciamento potencial de tecnologias de imunoterapia

• Nenhum contrato de licenciamento ativo relatado em 2024
• Potencial licenciamento futuro da tecnologia multikine

Contratos de pesquisa do governo

Tipo de contrato	Valor total do contrato	Duração
Pesquisa de imunoterapia	US $ 1,2 milhão	2023-2025

Dados financeiros do quarto trimestre 2023 mostram receita total de $643,000, principalmente de subsídios de pesquisa e contratos governamentais.

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.