CEL-SCI

CEL-SCI

CVM
United States· Est.
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CVM · Stock Price

USD 1.60-5.90 (-78.67%)
Market Cap: $12.9M

Historical price data

Overview

CEL-SCI is a long-standing, publicly-traded biotech focused on developing Multikine, a first-in-class neoadjuvant immunotherapy for advanced primary head and neck cancer. The company's core strategy is predicated on administering immunotherapy when the patient's immune system is most intact, a paradigm validated by a large, global Phase 3 trial that demonstrated a significant 14.1% absolute overall survival benefit in a key treatment arm. Having completed this pivotal study, CEL-SCI's primary objective is to secure regulatory approval via a BLA/NDA submission, aiming to establish a new standard of care in a significant unmet medical need.

OncologyAutoimmune DiseasesInfectious Diseases

Technology Platform

Neoadjuvant, off-the-shelf cytokine immunotherapy (Multikine) and the LEAPS (Ligand Epitope Antigen Presentation System) platform for modulating immune responses in autoimmune and infectious diseases.

Pipeline

3
3 drugs in pipeline1 in Phase 3
DrugIndicationStageWatch
LI + Cyclophosphamide + Indomethacin + CisplatinSquamous Cell Carcinoma of the Oral CavityPhase 3
Leukocyte Interleukin, Injection 200IU + Leukocyte Interleuk...CondylomaPhase 1
Leukocyte Interleukin, InjectionPerianal WartsPhase 1

Opportunities

Approval of Multikine could establish a new front-line standard of care in head and neck cancer, addressing a global patient population of ~210,000 annually.
The neoadjuvant immunotherapy paradigm, if proven, could be expanded to other solid tumor types, creating significant pipeline expansion opportunities.

Risk Factors

The company faces high regulatory risk with its pending BLA/NDA submission, significant financial risk as a pre-revenue micro-cap, and commercialization risk due to lack of infrastructure.
Clinical benefit was limited to a specific treatment arm (no concurrent chemo), which may restrict the addressable patient population.

Competitive Landscape

Multikine's primary competition is the current standard of care (surgery + radiation/chemo), as no other neoadjuvant immunotherapy is approved for this setting. However, large pharma companies are actively investigating checkpoint inhibitors in neoadjuvant regimens across oncology, posing a future competitive threat.