CEL SCI CORP
CVM evidence brief
What we can confirm
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 CORP (CVM) is a clinical-stage biotechnology company focused on developing its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), for the treatment of cancer, and a pre-clinical technology platform called LEAPS. The company has not yet received FDA approval for any product and faces significant capital requirements to complete clinical development.
Key risk: Regulatory approval uncertainty
BioSniper Score
Based on 5 of 6 signals
Financial data as of Jun 30, 2026.
Tracking 1 pipeline candidate for CEL SCI CORP.
CEL SCI CORP (CVM) is a clinical-stage biotechnology company focused on developing its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), for the treatment of cancer, and a pre-clinical technology platform called LEAPS. The company has not yet received FDA approval for any product and faces significant capital requirements to complete clinical development.
- Lead product candidate is Multikine, an investigational therapy that has not been licensed or approved by the FDA; its safety and efficacy have not been established for any use [sec_mda · as of 2025-12-29].
- CEL-SCI plans to initiate a 212-patient confirmatory registration study for Multikine as soon as sufficient capital is raised, with full enrollment expected about 15 months later [sec_mda · as of 2025-08-14].
- The company also owns a pre-clinical technology called LEAPS (Ligand Epitope Antigen Presentation System) [sec_mda · as of 2025-12-29].
- As of June 30, 2026, the company reported cash and equivalents of $6.5 million, shareholders' equity of $12.9 million, and total debt of $3.8 million [sec].
- CEL-SCI has incurred net losses and expects to continue generating net operating losses as it advances its product candidates; the company will need to raise additional funds to continue operations [sec_mda · as of 2025-08-14].
What works
- The FDA acknowledged a great unmet need in the target patient population for improved therapies, which CEL-SCI views as a factor that weighs in favor of approval for Multikine [sec_mda · as of 2024-05-15].
- The planned confirmatory study is much smaller (less than a quarter the size of the prior Phase 3 study) and focuses on patients who showed the greatest survival benefit with Multikine, potentially reducing development time and cost [sec_mda · as of 2024-05-15].
- CEL-SCI has a co-development agreement with Ergomed, a global CRO, which agreed to contribute up to $12 million towards the Phase 3 study in exchange for a single-digit percentage royalty, providing non-dilutive funding support [sec_mda · as of 2024-05-15].
What to weigh
- Multikine has not been approved by the FDA or any other regulatory agency, and its safety and efficacy have not been established for any use [sec_mda · as of 2025-12-29].
- The company has a history of net operating losses and will need to raise additional funds to complete clinical trials and bring any product to market; there is no assurance of successful fundraising [sec_mda · as of 2025-08-14].
- Clinical trials are costly and time-consuming, and any delays or terminations could harm the company's business, financial condition, and ability to generate revenue [sec · filed 2026-04-17].
- The company's ability to continue as a going concern is dependent on raising capital, and failure to do so could have severe material consequences [sec · filed 2026-04-17].
From the filings
Quoted directly from source documents.
Multikine is not yet approved by the FDA.
“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
The confirmatory study will be smaller and focused on the most responsive patients.
“The much smaller confirmatory study--less than a quarter the size of the prior study--will focus on the patients who saw the greatest survival benefit when treated with Multikine.”
SEC MD&A · May 15, 2024
The company needs to raise additional funds to continue operations.
“CEL-SCI will need to raise additional funds, either through debt or equity financings or a partnering arrangement, to bring Multikine to market.”
SEC MD&A · January 13, 2025
The FDA acknowledged unmet need in the target population.
“The FDA also acknowledged in the meeting that there is a great unmet need in the target population for improved therapies.”
SEC MD&A · May 15, 2024
Risks & what to watch (4)›
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 requirement risk — Company needs to raise additional funds to complete trials and operations; no assurance of success [sec_mda · as of 2025-08-14].
- Clinical trial delays — Delays or termination of trials could harm business, increase costs, and delay revenue generation [sec · filed 2026-04-17].
- Going concern risk — Inability to raise capital could lead to severe material consequences and impact ability to continue as a going concern [sec · filed 2026-04-17].
What to watch
- Initiation and enrollment progress of the 212-patient confirmatory registration study for Multikine [sec_mda · as of 2025-08-14].
- Ability to raise additional capital through debt, equity, or partnering arrangements [sec_mda · as of 2025-01-13].
- Any updates on FDA interactions or regulatory submissions for Multikine [sec_mda · as of 2024-05-15].
- Cash burn rate and financial runway given $6.5M cash as of June 30, 2026 [sec].
Sources: SEC filings · SEC MD&A · Generated August 25, 2026 · How we verify sources →
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Evidence & data
Score breakdownBased on 5 of 6 signals · derived from public data
5.1 months
D/E 0.95
Lead: Phase 3
1 candidate
No upcoming catalysts tracked
2 buys · 0 sells (180d)
Runway
Pipeline
Financials
Institutional Holdings
Source: SEC Form 13F · as of Mar 2026Institutional holders
36
Total value held
$2.8M
| Holder | Shares | Value |
|---|---|---|
| vanguard capital management llc | 487,290 | $1.6M |
| geode capital management, llc | 85,311 | $274K |
| vanguard fiduciary trust co | 49,036 | $157K |
| blackrock, inc. | 43,261 | $139K |
| bank of america corp /de/ | 40,997 | $132K |
| renaissance technologies llc | 35,890 | $115K |
| state street corp | 27,270 | $88K |
| xtx topco ltd | 22,556 | $72K |
| northern trust corp | 18,934 | $61K |
| commonwealth equity services, llc | 17,622 | $57K |
Showing top 10 of 36 institutional holders of CEL SCI CORP. Open the full 13F history after sign-in.
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 CORP (CVM) is a clinical-stage biotechnology company focused on developing its lead investigational therapy, Multikine (Leukocyte Interleukin, Injection), for the treatment of cancer, and a pre-clinical technology platform called LEAPS. The company has not yet received FDA approval for any product and faces significant capital requirements to complete clinical development.
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.