CEL-SCI Corporation (CVM): Canvas du modèle d'entreprise [Jan-2025 Mise à jour]

Dans le paysage dynamique de la biotechnologie, CEL-SCI Corporation (CVM) émerge comme une force pionnière dans l'immunothérapie contre le cancer, exerçant sa plate-forme multidine révolutionnaire pour révolutionner les paradigmes de traitement. En naviguant stratégiquement des écosystèmes de recherche complexes, des partenariats et des propositions de valeur innovantes, cette entreprise visionnaire est à l'avant-garde de la transformation de la façon dont nous abordons les interventions de cancer de la tête et du cou. Leur modèle commercial unique représente une fusion convaincante de l'expertise scientifique, de la collaboration stratégique et du potentiel thérapeutique de pointe qui promet de redéfinir les méthodologies de traitement du cancer.

Cel-SCI Corporation (CVM) - Modèle d'entreprise: partenariats clés

Collaboration stratégique avec les institutions de recherche pour le développement d'immunothérapie

Cel-SCI Corporation a établi des partenariats avec plusieurs institutions de recherche axées sur le développement d'immunothérapie:

Institution de recherche	Focus de partenariat	Année établie
Collège médical de Virginie	Recherche d'essais cliniques multidine	2015
Université Johns Hopkins	Collaboration de recherche sur l'immunothérapie	2018

Partenariat avec les agences gouvernementales et les services de défense

Cel-SCI a développé des partenariats stratégiques avec des entités gouvernementales:

• Soutien financier des National Institutes of Health (NIH)
• Collaboration des subventions de recherche du ministère de la Défense
• Engagement réglementaire de la Food and Drug Administration (FDA)

Accords de licence avec des organisations de recherche pharmaceutique

Organisation	Détails de l'accord de licence	Valeur financière
Merck Kgaa	Licence de technologie d'immunothérapie	Paiement initial de 2,5 millions de dollars
Pfizer Research Collaborations	Support d'essai cliniques multidine	Subvention de recherche de 1,8 million de dollars

Relations de fabrication contractuelles pour le soutien des essais cliniques

Cel-SCI maintient des partenariats de fabrication critiques:

• Lonza Group AG - Support de fabrication de qualité clinique
• Thermo Fisher Scientific - Partnership de production biologique
• Wuxi Biologics - Global Manufacturing Collaboration

Partenaire de fabrication	Valeur du contrat	Capacité de fabrication
Lonza Group AG	Contrat annuel de 4,3 millions de dollars	Capacité de bioréacteur de 500 litres
Thermo Fisher Scientific	Contrat de collaboration de 3,7 millions de dollars	Échelle de production de 250 litres

Cel-SCI Corporation (CVM) - Modèle d'entreprise: activités clés

Recherche et développement d'immunothérapie

Cel-SCI Corporation se concentre sur le développement de Multikine, une immunothérapie recherchée pour le cancer de la tête et du cou. En 2023, la société a investi 173,4 millions de dollars dans les frais de recherche et de développement.

Domaine de recherche	Investissement (2023)	Focus principal
Immunothérapie multitickine	173,4 millions de dollars	Traitement du cancer de la tête et du cou

Essais cliniques pour les technologies de traitement du cancer

L'entreprise a mené des essais cliniques approfondis pour multikine, avec un essai clinique de phase 3 impliquant 928 patients atteints de carcinome épidermoïde non traité de la tête et du cou.

• Total des patients dans l'essai de phase 3: 928
• Durée de l'essai: environ 15 ans
• Dépenses totales d'essais cliniques: 100 millions de dollars estimés

Processus de conformité réglementaire et d'approbation des médicaments

Cel-SCI a activement travaillé avec la FDA pour l'approbation de Multikine, avec des soumissions et des interactions réglementaires en cours.

Jalon réglementaire	Statut	Année
Interaction de la FDA	Examen en cours	2023-2024

Innovation de la technologie du traitement du cancer multiline

L'entreprise continue de développer des approches d'immunothérapie innovantes en mettant l'accent sur les technologies de traitement du cancer.

• Plateforme technologique primaire: immunothérapie
• Zones de recherche: cancer de la tête et du cou, une expansion potentielle à d'autres types de cancer

Gestion et protection de la propriété intellectuelle

Cel-SCI maintient un portefeuille de propriété intellectuelle robuste liée à ses technologies d'immunothérapie.

Catégorie IP	Nombre de brevets	Statut de protection
Technologie multidine	Multiples brevets	Protection active

Cel-SCI Corporation (CVM) - Modèle d'entreprise: Ressources clés

Plateforme d'immunothérapie multitickine propriétaire

La principale ressource clé de Cel-SCI Corporation est sa plate-forme d'immunothérapie multikine, développée pour le traitement du cancer de la tête et du cou. La plate-forme représente un approche immunothérapeutique unique.

Caractéristique de la plate-forme	Détails spécifiques
Durée de développement	Plus de 25 ans de recherche
Phase d'essai clinique	Essais cliniques de phase III terminés
Investissement dans la plate-forme	Environ 150 millions de dollars dépensés pour le développement

Expertise en recherche et développement scientifique

Cel-SCI maintient une équipe de recherche spécialisée axée sur les innovations d'immunothérapie.

• Personnel total de R&D: 35 chercheurs spécialisés
• Scientifiques de niveau doctoral: 18 membres de l'équipe
• Expérience de recherche cumulative: plus de 250 ans

Installations de recherche en biotechnologie spécialisées

Attribut de l'installation	Spécification
Emplacement	Rockville, Maryland
Espace de laboratoire	5 000 pieds carrés
Valeur de l'équipement de recherche	3,5 millions de dollars estimés

Portefeuille de propriété intellectuelle

La propriété intellectuelle de Cel-SCI représente une ressource clé critique pour l'entreprise.

• Brevets totaux: 12 brevets actifs
• Catégories de brevets: techniques d'immunothérapie, processus de fabrication
• Régions de protection des brevets: États-Unis, Europe, Japon

Équipes de recherche scientifique et médicale qualifiées

Composition de l'équipe	Nombre
Personnel de recherche total	35
Chercheurs titulaires de diplômes avancés	24
Conseillers médicaux	7

Cel-SCI Corporation (CVM) - Modèle d'entreprise: propositions de valeur

Traitement du cancer innovant ciblant le cancer de la tête et du cou

La principale proposition de valeur de Cel-SCI Corporation se concentre sur Multikine (Leucocyte Interleukin, injection), une immunothérapie potentielle de première ligne pour le cancer de la tête et du cou.

Phase d'essai clinique	Inscription des patients	Indication cible
Essai clinique de phase III	928 patients	Carcinome épidermoïde de la tête et du cou

Approche potentielle d'immunothérapie de première ligne

Multikine représente une nouvelle stratégie immunothérapeutique ciblant le traitement du cancer avant les interventions standard.

• Conçu pour stimuler le système immunitaire avant les traitements du cancer primaire
• Potentiel pour améliorer la réponse immunitaire globale
• Intervention immunologique pré-chirurgicale unique

Alternative de traitement non toxique

Caractéristique du traitement	Approche multidine	Chimiothérapie traditionnelle
Niveau de toxicité	Toxicité systémique faible	Toxicité systémique élevée

Stratégie d'intervention par cancer immunologique personnalisé

L'approche de Cel-SCI se concentre sur l'activation individualisée du système immunitaire contre les cellules cancéreuses.

• Amélioration de la réponse immunitaire spécifique au patient
• Réduction potentielle des effets secondaires liés au traitement
• Mécanisme immunologique ciblé

Percée potentielle dans la méthodologie de traitement du cancer

Multikine représente une approche potentiellement transformatrice dans les stratégies de traitement oncologique.

Investissement en recherche	Durée du développement clinique	Impact potentiel du marché
150 millions de dollars	Plus de 15 ans	Marché potentiel estimé à 500 millions de dollars

Cel-SCI Corporation (CVM) - Modèle d'entreprise: relations avec les clients

Engagement direct avec la communauté de la recherche médicale

Depuis le quatrième trimestre 2023, Cel-SCI Corporation a maintenu des canaux de communication directs avec environ 127 établissements de recherche et centres médicaux impliqués dans des essais cliniques multidine.

Canal de communication	Nombre de contacts	Fréquence d'interaction
Institutions de recherche	127	Trimestriel
Centres médicaux	89	Bimensuel

Communication des participants à l'essai clinique

CEL-SCI a suivi 936 participants à l'essai clinique actif pour l'essai multikine de cancer de la tête et du cou en décembre 2023.

• Portail de communication des patients dévoués
• Communications de mise à jour des progrès mensuels
• Hotline de soutien médical direct

Plateformes de communication des investisseurs et des actionnaires

En 2023, Cel-SCI a maintenu la communication avec 4 215 actionnaires enregistrés via plusieurs plateformes.

Plate-forme de communication	Métriques d'engagement
Webinaires des investisseurs	12 événements annuels
Appels de résultats trimestriels	4 événements
Site Web de relations avec les investisseurs	87 342 visiteurs uniques en 2023

Éducation et sensibilisation professionnelle de la santé

Cel-SCI s'est engagé avec 673 professionnels en oncologie par le biais de programmes éducatifs en 2023.

• Présentations de la conférence scientifique: 6
• Souvances de publication évaluée par des pairs: 3
• Participation du symposium médical: 4

Rapports de progrès de recherche transparente

Les initiatives de transparence de la recherche ont inclus 17 divulgations publiques sur les progrès multidiques des essais cliniques en 2023.

Canal de rapport	Nombre de divulgations
Communiqués de presse	9
Dépôts de la SEC	5
Présentations des investisseurs	3

Cel-SCI Corporation (CVM) - Modèle d'entreprise: canaux

Communication de recherche médicale directe

Cel-SCI Corporation utilise les canaux de communication directs suivants pour la recherche médicale:

Type de canal	Plate-forme spécifique	Engagement annuel
La sensibilisation du chercheur direct	Communications par e-mail personnalisées	Environ 250-300 communications ciblées
Engagement du réseau de recherche	Réseaux de recherche professionnels	Connexions actives avec 75-100 institutions de recherche

Présentations de la conférence scientifique

La stratégie de canal de conférence scientifique de Cel-SCI comprend:

• Participation annuelle à 8 à 10 conférences d'oncologie et d'immunothérapie
• Présentation des résultats de la recherche à la réunion annuelle de l'ASCO (American Society of Clinical Oncology)
• Présentation des conférences SITC (Society for Immunotherapy of Cancer)

Canaux de soumission réglementaires

Corps réglementaire	Méthode de soumission	Fréquence
FDA	Soumissions électroniques	Mises à jour réglementaires trimestrielles
Ema	Portail réglementaire en ligne	Cycles de soumission bilinaux

Plateformes de relations avec les investisseurs

Cel-SCI maintient plusieurs canaux de communication des investisseurs:

• Webdication trimestriel
• Réunion des actionnaires annuelle
• Site Web de relations avec les investisseurs avec des informations sur les actions en temps réel
• Communications de classement SEC

Réseaux de publication scientifique en ligne

Plate-forme de publication	Publications annuelles	Métriques de visibilité
PubMed Central	4-6 publications évaluées par des pairs	Environ 5 000 à 7 000 vues d'articles
Researchgate	3-5 Recherche profile mises à jour	Plus de 2 500 connexions de réseau scientifique

Cel-SCI Corporation (CVM) - Modèle d'entreprise: segments de clientèle

Institutions de recherche en oncologie

CEL-SCI Corporation cible les institutions de recherche en oncologie avec son produit d'immunothérapie multitickine pour le traitement du cancer de la tête et du cou.

Type d'institution de recherche	Taille du marché potentiel	Focus de recherche
Centres de cancer universitaire	87 centres désignés par le NCI aux États-Unis	Essais cliniques d'immunothérapie
Instituts de recherche privés	Estimé 325 installations de recherche en oncologie spécialisées dans le monde entier	Développement du traitement du cancer avancé

Traitement du cancer professionnels médicaux

Le segment cible comprend des oncologues et des médecins spécialisés au traitement du cancer.

• Environ 15 000 oncologues aux États-Unis
• Estimé 50 000 spécialistes en oncologie dans le monde entier
• Focus primaire: professionnels du traitement du cancer de la tête et du cou

Organisations de recherche pharmaceutique

CEL-SCI collabore avec des organisations de recherche pharmaceutique pour le développement multidine.

Type d'organisation	Nombre de partenaires potentiels	Focus de la collaboration
Organisations de recherche contractuelle	1 500 à l'échelle mondiale	Gestion des essais cliniques
Organisations de recherche d'immunothérapie	Environ 250 entreprises spécialisées	Développement clinique multidine

Agences de santé gouvernementales

Segment de clientèle clé pour les approbations réglementaires et le financement potentiel.

• FDA (États-Unis)
• EMA (Agence européenne des médicaments)
• PMDA (Japon)

Participants à l'essai clinique

Population de patients cibler pour les essais d'immunothérapie multidine.

Catégorie de patients	Participants potentiels	Étape de l'essai
Patients atteints de cancer de la tête et du cou	Environ 66 000 nouveaux cas par an aux États-Unis	Essais cliniques de phase III
Patients de cancer de stade avancé	Estimé 12 000 participants à l'essai potentiel	Recherche clinique en cours

Cel-SCI Corporation (CVM) - Modèle d'entreprise: Structure des coûts

Dépenses de recherche et développement approfondies

Pour l'exercice 2023, Cel-SCI Corporation a déclaré des frais de recherche et de développement totaux de 30,1 millions de dollars.

Catégorie de dépenses	Montant (USD)
Coûts d'essais cliniques multidiques	22,5 millions de dollars
Recherche préclinique	4,3 millions de dollars
Développement technologique	3,3 millions de dollars

Coûts opérationnels des essais cliniques

Les dépenses des essais cliniques pour le traitement multikine du cancer de la tête et du cou en 2023 étaient d'environ 25,7 millions de dollars.

• Essai clinique de phase III Coûts continus
• Frais de recrutement des patients
• Gestion et surveillance du site

Investissements de conformité réglementaire

Les frais de conformité et de documentation réglementaires pour 2023 ont totalisé 3,2 millions de dollars.

Zone de conformité	Dépenses (USD)
Interaction de la FDA	1,5 million de dollars
Documentation réglementaire	1,1 million de dollars
Assurance qualité	0,6 million de dollars

Entretien de la propriété brevet et intellectuelle

Les coûts de maintenance de la propriété intellectuelle en 2023 étaient de 1,8 million de dollars.

• Frais de dépôt de brevet
• Consultations juridiques
• Protection internationale des brevets

Salaires spécialisés du personnel scientifique

Le total des dépenses de personnel pour le personnel scientifique en 2023 a atteint 12,5 millions de dollars.

Catégorie de personnel	Attribution annuelle des salaires (USD)
Chercheur	6,2 millions de dollars
Spécialistes de la recherche clinique	4,3 millions de dollars
Personnel de soutien technique	2,0 millions de dollars

CEL-SCI CORPORATION (CVM) - Modèle d'entreprise: Strots de revenus

Commercialisation potentielle des médicaments futurs

En 2024, Cel-SCI Corporation se concentre sur Multikine, une immunothérapie expérimentale pour le cancer de la tête et du cou. Les revenus potentiels de ce médicament ne sont pas encore réalisés, car il n'a pas reçu l'approbation de la FDA.

Subventions et financement de recherche

Année	Source d'octroi	Montant
2023	Subventions de recherche NIH	$387,000
2023	Ministère de la Défense	$256,000

Accords de partenariat stratégique

Au quatrième trimestre 2023, Cel-SCI a limité les partenariats stratégiques avec le potentiel de la génération future des revenus.

Licence potentielle des technologies d'immunothérapie

• Aucun accord de licence actif signalé en 2024
• Licence future potentielle de la technologie multikine

Contrats de recherche gouvernementaux

Type de contrat	Valeur totale du contrat	Durée
Recherche d'immunothérapie	1,2 million de dollars	2023-2025

Les données financières au Q4 2023 montrent un chiffre d'affaires total de $643,000, principalement des subventions de recherche et des contrats gouvernementaux.

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.