CEL SCI CORP
CVM evidence brief
What we can confirm
- BioSniper Score:
- 6.8 / 10
- Market Cap:
- $26.2M
- Lead Asset:
- Multikine (Phase 3)
What it means
What to watch
Prepared research question
What matters most for CVM—catalysts, financial risk and supporting evidence?
Traceable citations · Unknowns marked
BioSniper AI · CVM
CEL-SCI Corporation is a late clinical-stage biotechnology company focused on developing Multikine, an investigational Phase 3 immunotherapy for head and neck cancer, and the LEAPS technology platform for various diseases.
Key risk: Regulatory approval uncertainty
BioSniper Score
Based on 4 of 6 signals
Market Cap
$26.2M
Cash Runway
—
Lead Asset
Multikine (Phase 3)
Next Catalyst
—
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for CEL SCI CORP.
CEL-SCI Corporation is a late clinical-stage biotechnology company focused on developing Multikine, an investigational Phase 3 immunotherapy for head and neck cancer, and the LEAPS technology platform for various diseases.
- CEL-SCI is a late clinical-stage biotechnology company focused on developing Multikine, an investigational Phase 3 immunotherapy for certain head and neck cancers, and the LEAPS technology platform [sec_mda · as of 2026-08-14].
- As of 2026-06-30, the company reported a net loss of -$5.7M and shareholders' equity of $11.0M [sec].
- Multikine has not been licensed or approved by the FDA or any other regulatory agency, and its safety or efficacy has not been established for any use [sec_mda · as of 2025-12-29].
- The company plans to conduct a Phase 3 confirmatory registration study to support a U.S. marketing authorization filing, and has filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority in August 2025 [sec_mda · as of 2026-08-14].
- The confirmatory registration study targets newly diagnosed locally advanced primary head and neck cancer patients with no lymph node involvement and low PD-L1 tumor expression [sec_mda · as of 2024-08-14].
What works
- Multikine targets a pre-surgical treatment indication in head and neck cancer where no drug is currently approved, potentially addressing an unmet medical need [sec_mda · as of 2024-08-14].
- The company has a defined regulatory pathway with a planned 212-patient confirmatory registration study and potential for early approval after full enrollment [sec_mda · as of 2024-08-14].
- CEL-SCI is pursuing global regulatory approvals, including a Breakthrough Medicine Designation application in Saudi Arabia, indicating a multi-jurisdictional strategy [sec_mda · as of 2026-08-14].
What to weigh
- Multikine has not received regulatory approval from the FDA or any other agency, and its safety and efficacy remain unestablished [sec_mda · as of 2025-12-29].
- The company has a history of net operating losses and relies on external financing through equity, convertible notes, and loans to fund operations [sec_mda · as of 2025-02-14].
- Clinical trials and regulatory approvals require significant costs and several years to complete, with the extent of programs dependent on available capital [sec_mda · as of 2026-08-14].
From the filings
Quoted directly from source documents.
Multikine is an investigational Phase 3 immunotherapy for head and neck cancers
“Multikine, an investigational Phase 3 immunotherapy under development for the potential treatment of certain head and neck cancers”
SEC MD&A · August 14, 2026
Multikine has not been approved by any regulatory agency
“Multikine has not been licensed or approved by the FDA or any other regulatory agency. Neither has its safety or efficacy been established for any use.”
SEC MD&A · December 29, 2025
CEL-SCI filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority in August 2025
“In August 2025, CEL-SCI filed a Breakthrough Medicine Designation application with the Saudi Food and Drug Authority (SFDA) for Multikine”
SEC MD&A · August 14, 2026
Risks & what to watch (3)›
Key risks
- Regulatory approval uncertainty — Multikine has not been approved by any regulatory agency; safety and efficacy not established [sec_mda · as of 2025-12-29]
- Capital dependence and losses
- Clinical trial and cost risks
What to watch
- Initiation and enrollment progress of the 212-patient confirmatory registration study for Multikine [sec_mda · as of 2024-08-14]
- Outcome of the Breakthrough Medicine Designation application with the Saudi Food and Drug Authority [sec_mda · as of 2026-08-14]
- Any updates on regulatory filings in the U.S., Canada, UK, and Europe [sec_mda · as of 2026-08-14]
- Changes in cash position and financing activities to support ongoing R&D [sec_mda · as of 2025-02-14]
Sources: SEC MD&A · Generated September 24, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 4 of 6 signals · derived from public data
Cash runway data unavailable
D/E 0.95
Lead: Phase 3
1 candidate
No upcoming catalysts tracked
2 buys · 0 sells (180d)
Pipeline
Financials
Short Interest
as of May 20, 2026- % of float
- 8.4%
- Days to cover
- 10.4
- Shares short
- 708,414
- Daily short volume
- -
Short percent of float and days-to-cover reflect reported short positioning. Daily short volume is the exchange-reported short share of a single day's trading volume and is noisier. See the most-shorted biotech ranking →
CVM short interestGovernance
Frequently asked questions
What is the AI investment thesis for CEL SCI CORP?
CEL-SCI Corporation is a late clinical-stage biotechnology company focused on developing Multikine, an investigational Phase 3 immunotherapy for head and neck cancer, and the LEAPS technology platform for various diseases.
What is CEL SCI CORP's lead drug candidate?
CEL SCI CORP's most advanced tracked candidate is Multikine (Phase 3) for Neoadjuvant therapy for treatment-naïve patients with resectable locally advanced primary squamous cell carcinoma of the head and neck (SCCHN).
Who is the CEO of CEL SCI CORP?
Mr. Geert R. Kersten Esq. is the chief executive officer of CEL SCI CORP (CVM).
Where is CEL SCI CORP headquartered?
CEL SCI CORP (CVM) is headquartered in Vienna, VA, United States.
What therapeutic areas does CEL SCI CORP focus on?
CEL SCI CORP develops therapies across Oncology.
The AI overview and BioSniper Score are neutral, data-derived signals built from public SEC filings, ClinicalTrials.gov and FDA records — not investment advice.