What CEL-SCI does

CEL-SCI Corporation (NYSE American: CVM) is a Vienna, Virginia-based clinical-stage biotechnology company founded in 1983 that develops immunotherapy products for cancer, autoimmune, and infectious diseases. The company's lead asset is Multikine (Leukocyte Interleukin, Injection), a patented defined mixture of 14 naturally occurring pro-inflammatory human cytokines (interleukins, interferons, chemokines, and colony-stimulating factors) administered as neoadjuvant therapy before standard-of-care surgery, radiation, or chemotherapy in newly diagnosed advanced primary head and neck cancer. Multikine received FDA Orphan Drug designation and was studied in a 928-patient global Phase III trial — the largest ever in head and neck cancer — across approximately 100 centers in North America, Europe, and Asia, which reported statistically significant 5-year overall survival benefit (62.7% vs 48.6% control; 14.1% absolute advantage) in the surgery-plus-radiotherapy arm. A secondary platform, LEAPS (Ligand Epitope Antigen Presentation System), is a patented T-cell modulation peptide technology with development candidates for rheumatoid arthritis (CEL-2000, CEL-4000) and pandemic influenza.

CEL-SCI operates a 73,000 square foot purpose-built cGMP manufacturing facility outside Baltimore, Maryland with True Cold Fill capability, intended to support commercial supply of Multikine pending FDA approval. The company is pre-revenue with no commercialized products and has historically funded operations through repeated small-cap public equity offerings (over $75 million raised since 2021, primarily via ThinkEquity as placement agent), supplemented by a Phase II SBIR grant from NIH for LEAPS development. Q1 FY2026 (ending December 31, 2025) net loss was $5.5 million, improved from $7.1 million in the prior-year period, with R&D expenses of $3.7 million. The company's regulatory strategy includes preparing a BLA/NDA submission for Multikine to the FDA following a planned 212-patient confirmatory Registration Study targeted to commence enrollment in summer 2026, plus a Breakthrough Medicine Designation application to the Saudi FDA via a June 2026 strategic agreement with Saudi AmaroX.

The company is led by long-tenured CEO Geert R. Kersten (since 1987/CEO since 1995), CSO Dr. Eyal Talor (since 1993, inventor on ten issued patents), Acting CMO Dr. Giovanni Selvaggi (since May 2024), and CFO/COO Patricia B. Prichep (with the company since 1992, promoted November 2024). Customer concentration is not yet a relevant risk because CEL-SCI has no paying customers; however, the Phase III trial database and physician relationships at ~100 oncology centers represent the foundational commercial channel for potential launch. The company holds an FDA Orphan Drug designation granting 7-year marketing exclusivity upon approval and has secured regulatory clearance from 24 agencies globally for its Phase III program.

Name

CEL-SCI

Legal name

CEL-SCI Corporation

Website

https://cel-sci.com

Company type

Public

Founded year

1983

Operating status

Operating

Headcount range

11–50 employees

Short description

CEL-SCI Corporation is a Vienna, VA-based clinical-stage biotechnology company developing Multikine, an investigational neoadjuvant immunotherapy for newly diagnosed advanced head and neck cancer, along with the LEAPS T-cell modulation peptide platform for autoimmune and infectious diseases. The company is pre-revenue and preparing for FDA BLA submission following a planned confirmatory Phase III study.

Ownership category

akta.pro rank

Product category

Cancer Immunotherapy Pharmaceuticals

NAICS

Biological Product (except Diagnostic) Manufacturing (325414), Research and Development in Biotechnology (except Nanobiotechnology) (541714)

SIC

Biological Products, (No Disgnostic Substances) (2836), Pharmaceutical Preparations (2834)

akta.pro primary industry

Therapeutic Vaccines (cancer, chronic infection immunotherapy) (HLAAAEAB)

akta.pro secondary industries

Cytokines, Interferons & Immunomodulatory Proteins (HLAAAAAC), Therapeutic Vaccines (e.g., Cancer/Chronic Infection) (HLAIAEAG)

Keywords

• Cancer immunotherapy
• Head and neck cancer
• Cytokine therapy
• Neoadjuvant immunotherapy
• Biologic drug development

Headquarters

HQ city

Vienna

HQ country

United States

HQ region

North America

Offices5 records

Markets served

GTM type

B2B

Offering type

Hardware or Manufacturing

Cost components

Technology or R&D, Personnel, Operations, Marketing or Sales, Infrastructure

Revenue model

1. Pharmaceutical Product Revenue (Future): CEL-SCI is a pre-revenue clinical-stage biotechnology company. The company has not commercialized any products. If Multikine receives FDA approval, the company plans to commercialize the drug directly or through partnerships. Revenue would come from pharmaceutical product sales for head and neck cancer treatment.

Go-to-market motion1 record

Distribution channels2 records

Marketing channels6 records

Core offering

CEL-SCI is developing Multikine (Leukocyte Interleukin, Injection), an investigational combination immunotherapy consisting of a defined mixture of 14 pro-inflammatory human cytokines, intended as neoadjuvant therapy administered prior to surgery, radiation, and chemotherapy for newly diagnosed advanced primary head and neck cancer. The company also operates the LEAPS (Ligand Epitope Antigen Presentation System) platform, a patented T-cell modulation technology for designing peptide immunogens targeting rheumatoid arthritis (CEL-2000, CEL-4000) and infectious diseases including influenza.

Product overview

CEL-SCI is a late-stage cancer immunotherapy company with two main technology platforms. The core product is Multikine (Leukocyte Interleukin, Injection), an investigational combination immunotherapy consisting of 14 pro-inflammatory cytokines being developed for neoadjuvant treatment of advanced primary head and neck cancer. Multikine is administered prior to surgery, radiation, and chemotherapy to boost the immune system while it is still intact. The second platform is LEAPS (Ligand Epitope Antigen Presentation System), a T-cell modulation technology that enables design of peptide immunogens for autoimmune diseases (rheumatoid arthritis candidates CEL-2000, CEL-4000) and infectious diseases (influenza).

Differentiator

Problem solved

Functional benefit

Brands

• Multikine: Leukocyte Interleukin, Injection - CEL-SCI's lead investigational immunotherapy for head and neck cancer
• LEAPS

Products and services

• Multikine (Leukocyte Interleukin, Injection) Investigational combination immunotherapy defined mixture of 14 pro-inflammatory human cytokines administered as neoadjuvant therapy prior to surgery, radiation, and chemotherapy for newly diagnosed advanced primary head and neck cancer. Phase III demonstrated 14.1% absolute 5-year overall survival benefit (62.7% vs 48.6% control) in surgery plus radiotherapy arm with no added safety toxicity.
• LEAPS (Ligand Epitope Antigen Presentation System) Platform Patented T-cell modulation peptide epitope delivery platform technology that enables design and synthesis of proprietary peptide immunogens combining T-cell binding ligands with disease-associated peptide antigens. Supports drug candidates for autoimmune diseases and infectious diseases.
• CEL-4000 (LEAPS Rheumatoid Arthritis Vaccine Candidate) LEAPS-based drug candidate for rheumatoid arthritis where Th1 signature cytokine (IFN-γ) is dominant. Being developed as a therapeutic vaccine with potential for disease-specific therapy that acts earlier in the disease process than current treatments.
• CEL-2000 (LEAPS Rheumatoid Arthritis Vaccine Candidate) LEAPS-based drug candidate for rheumatoid arthritis with Th17 signature cytokine TNF-α. Being developed as a therapeutic vaccine demonstrating effectiveness with fewer administrations than current anti-rheumatoid arthritis treatments.
• LEAPS H1N1 / J-LEAPS Influenza Treatment Peptide treatment candidate for H1N1 (swine flu) and pandemic influenza. Designed to focus on conserved, non-changing epitopes of Type A Influenza viruses including H1N1, H5N1, and H3N1 strains to minimize viral escape from immune recognition.

Quantifiable outcome

• 14.1% absolute 5-year survival advantage for Multikine-treated patients vs control (62.7% vs 48.6%) in surgery + radiotherapy arm; p-value 0.0236 exceeding protocol requirement of <0.05; Hazard Ratio 0.68 exceeding protocol requirement of 0.721
• +3 more outcomes

Named customers1 record

Segments3 records

Ideal customer profiles2 records

Technology focussed Yes

API detail

Has API

No

API docs

API detail

Core technology

AI maturity

App detail

Feature3 records

Partnerships

Three partnerships are on record, tiered core and minor.

• Saudi AmaroXcoreStrategic or Co-development Partner · 24 June 2026Strategic agreement signing ceremony held at Bio 2026 to advance U.S.-Saudi cooperation in cancer care. The partnership focuses on bringing Multikine therapy to Saudi Arabia and the Middle East market. CEL-SCI has submitted a Breakthrough Medicine Designation application to Saudi Food and Drug Authority (SFDA) for Multikine in head and neck cancer.
• Rush University Medical CenterminorStrategic or Co-development PartnerCollaborative research with Dr. Tibor Glant and Dr. Katalin Mikecz laboratories for LEAPS technology development in rheumatoid arthritis. Work conducted on CEL-4000 and CEL-2000 RA vaccine candidates.
• NIAID (National Institute of Allergy and Infectious Diseases)minorStrategic or Co-development PartnerCollaborated with NIAID scientists led by Dr. Kanta Subbarao on LEAPS H1N1 flu treatment research. NIAID scientists presented positive efficacy data in mice at Keystone Conference 2011.

Scale indicators18 records

Recent moves7 records

Expansion highlights5 records

Emerging players

• MacroGenics: Clinical-stage oncology company developing antibody-based immunotherapies including bispecifics. Comparable therapeutic modality (biologic immunotherapy) and similar clinical-stage status.
• Compugen: Clinical-stage cancer immunotherapy company using computational discovery to identify novel immune targets. Comparable as a small-cap IO developer with multiple pipeline assets.
• Cue Biopharma: Clinical-stage developer of IL-2-based immunotherapy for head and neck cancer and other indications. Highly comparable therapeutic area overlap with Multikine's lead indication.

Broad incumbents

• Bristol-Myers Squibb: Large pharmaceutical company with Opdivo (nivolumab) approved for head and neck cancer. Sets the competitive benchmark for immunotherapy in CEL-SCI's lead indication and represents a potential acquirer.
• Regeneron Pharmaceuticals: Large biotech with Libtayo (cemiplimab) approved in head and neck cancer and a broader oncology immunotherapy pipeline. Representative of large-cap strategic acquirers and direct competitive benchmark.
• Merck & Co. Large pharmaceutical company with Keytruda (pembrolizumab) approved for head and neck cancer. Dominant incumbent in the indication CEL-SCI targets and benchmark for IO pricing/penetration.

Direct peers

• Adaptimmune Therapeutics: Clinical-stage cell therapy company developing engineered TCR-T therapies for solid tumors. Comparable as a small-cap oncology immunotherapy developer targeting solid tumor indications.
• Innate Pharma: Clinical-stage immuno-oncology company developing antibody-based therapies that modulate the innate immune system for cancer treatment. Comparable to CEL-SCI as a small/mid-cap focused cancer immunotherapy developer.
• Iovance Biotherapeutics: Clinical-stage cell therapy company focused on tumor-infiltrating lymphocyte (TIL) therapy for solid tumors including head and neck cancer. Direct peer in late-stage cancer immunotherapy development with similar scale and pre-revenue profile.
• Nektar Therapeutics: Clinical-stage developer of cytokine-based immunotherapies (e.g., bempegaldesleukin). Closely comparable to CEL-SCI in leveraging cytokine mechanisms to drive anti-tumor immune responses, with similar small-cap clinical-stage profile.

Market position

Strengths5 records

Weaknesses5 records

Competitive moat4 records

Key risks7 records

Key highlights6 records

Customer concentration

• YouTubeyoutube.com/watch?v=dJ6TFc5joy4
• Xx.com/CelSciCorp
• LinkedInlinkedin.com/company/cel-sci

Revenue estimate

Valuation estimate

Number of profiles

Profiles9 records

Funding overview

Funding rounds19 records

Investors8 records

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M&A

Investments

M&A and investment is available on the Subscription and Enterprise plan.Contact sales →

Frequently asked questions about CEL-SCI