CEL SCI CORP
For the period ended Dec 31, 2025. Filed Feb 17, 2026.
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A company's report for each of its first three quarters. The financial statements are not audited. It shows how the business has moved since the last annual report, and what management says changed.
Dec 31, 2025 · Filed Feb 17, 2026
CVM$1.45+5.8%Stored close · as of Nov 6, 2026
What changed in Management’s Discussion and Analysis?
Read the current filingPrevious report: 10-Q
Period ended 2025-06-30; filed 2025-08-14.
0001654954-25-009568
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-12-31; filed 2026-02-17.
0001654954-26-001319
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsThe baseline is this issuer’s latest earlier reporting period of the same form that was filed before the current report. A previous 10-Q is a different quarter, not a year-over-year comparison. Amendments are excluded.
Compared 67 previous paragraphs and 67 current paragraphs.
41 unchanged; 20 reworded; 5 added; 6 removed; 0 previous and 1 current paragraphs rearranged.
Tables are not compared: 9 previous and 10 current tables excluded. Dates, whitespace, punctuation and numbering changes are ignored; changes to financial figures remain significant.
A changed paragraph is not evidence that risk increased or decreased. An unchanged paragraph does not establish that risk stayed the same.
Added paragraphs (5)
Current report
These Quality of Life (QoL) improvements were self-reported by study participants and were sustained throughout the 3-years follow-up post SOC administration in which data on quality of life was systematically measured by EORTC validated QoL instruments specifically designed to measure QoL in Head and Neck Cancer patients.
Current report
Primarily as a result of CEL-SCI’s losses incurred to date, its expected continued future losses, and limited cash balances, CEL-SCI has included a disclosure in its financial statements expressing substantial doubt about its ability to continue as a going concern.
Current report
During the three months ended December 31, 2025, the research and development expenses decreased by approximately $0.8 million, or 17%, compared to the three months ended December 31, 2024. This decrease is primarily due to a $0.4 million decrease in clinical studies costs as a result of preparing the confirmatory study for enrollment in the prior period, $0.3 million decrease in costs incurred for supplies and materials used and a decrease of $0.1 million of employee stock compensation expense compared to the prior period.
Current report
CEL-SCI’s Phase III clinical trial began in December 2010 after the completion and validation of CEL-SCI’s dedicated manufacturing facility. The Phase III clinical trial was fully enrolled in September 2016, reached its primary endpoint in April 2020 and achieved database lock in December 2020. The data was unblinded in June 2021, the primary endpoint results were announced in June 2021, additional data was presented at ASCO 2022, ESMO 2022, ECHNO 2023, ESTRO 2023, ESMO 2023, IDDST 2024 and ESMO 2024. Data was then published in a comprehensive article in POR 2025. As part of CEL-SCI’s global regulatory approval strategy, CEL-SCI concurrently plans to conduct a Phase 3 confirmatory registration study to support a filing for marketing authorization in the United States and pursue filings for marketing authorization in Canada, United Kingdom and Europe. In August 2025, a Multikine Breakthrough Medicine Designation application was filed with the Saudi Food and Drug Authority (SFDA) in the Kingdom of Saudi Arabia by one of the Kingdom’s premier pharmaceutical and healthcare companies.
Current report
During the three months ended December 31, 2025, general and administrative expenses decreased by approximately $0.8 million, or 31%, compared to the three months ended December 31, 2024. This decrease is primarily due to a $0.1 million decrease in employee stock compensation, $0.6 million decrease in costs related to public relations, and $0.1 million decrease in accounting and legal fees for various registration statements in the prior period.
Removed paragraphs (6)
Previous report
Since inception, the Company has financed its operations through the issuance of equity securities, convertible notes, loans and certain research grants. The Company will likely continue to generate net operating losses as it continues the development of Multikine and brings other drug candidates into clinical trials. Until such time as the Company becomes profitable, any or all of these financing vehicles or others may be utilized to assist the Company’s capital requirements.
Previous report
During the nine months ended June 30, 2025, research and development expenses decreased by approximately $1.5 million, or 11%, compared to the nine months ended June 30, 2024. The major components of the decrease in research and development expenses over the prior period include an approximate $1.9 million of employee stock compensation expense due to the options issued in the prior period having a higher fair value because of the Company’s stock price, and an approximate $0.3 million of other research and development expenses, offset by an increase of $0.5 million in costs incurred for supplies and materials related to the manufacturing of a clinical lot and an increase of $0.2 million in depreciation and amortization.
Previous report
During the three months ended June 30, 2025, research and development expenses decreased by approximately $1.0 million, or 21%, compared to the three months ended June 30, 2024. The major components of the decrease in research and development expenses over the prior period include an approximate $0.9 million of employee stock compensation expense due to the forfeiture of milestone options, and an approximate $0.1 million decrease in expenses related to the Phase 3 clinical study.
Previous report
During the nine months ended June 30, 2025, general and administrative expenses remained constant at $6.6 million compared to the nine months ended June 30, 2024. The major components of general and administrative expenses include an approximate $0.2 million decrease of employee stock compensation expense due to the options issued in the prior period having a higher fair value because of the Company’s stock price, an approximate $0.3 million decrease in depreciation and amortization, and an approximate decrease of $0.1 million in consulting expenses due to larger costs incurred in the prior period for the preparation of the confirmatory study, offset by an approximate $0.2 million increase in legal and accounting fees due to out of scope work and an approximate $0.4 million increase in public relations costs.
Previous report
During the three months ended June 30, 2025, general and administrative expenses decreased by approximately $0.2 million, or 11%, compared to the three months ended June 30, 2024. The major components of the decrease in general and administrative expenses include an approximate $0.4 million over the prior period in public relation expenses primarily due to increased public relations hirings in the prior year, offset by an approximate $0.2 million increase of employee stock compensation expense due to options forfeited by board members in the prior period.
Previous report
Research and Development Expenses
Reworded paragraphs (20)
Previous wording
CEL-SCI Corporation is a late clinical-stage biotechnology company dedicated to research and development directed at improving the treatment of cancer and other diseases by using the immune system, the body’s natural defense system. CEL-SCI is currently focused on the development of the following product candidates and technologies:
Current wording
CEL-SCI Corporation is a late clinical-stage biotechnology company dedicated to research and development directed at improving the treatment of cancer and other diseases by using the immune system, the body’s natural defense system. CEL-SCI is currently focused on the development of the following product candidates and technologies with emphasis on Multikine:
Previous wording
CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms. Therefore, no bias was found, which supports confidence in Multikine’s efficacy results.
Current wording
CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for a confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms. Therefore, no bias was found, which supports confidence in Multikine’s efficacy results.
Previous wording
PD-L1 is a protein receptor on the tumor surface that helps the tumor repel cells of the immune system. CEL-SCI believes that patients with tumors having low PD-L1 would be more likely to respond to Multikine because their tumors have lower defenses against the patient’s immune system. CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary SCCHN patients.
Current wording
PD-L1 is a protein receptor on the tumor surface that helps the tumor repel cells of the immune system. CEL-SCI believes that patients with tumors having low PD-L1 would be more likely to respond to Multikine because their tumors have lower defenses against the patient’s immune system. CEL-SCI estimates that patients with tumors having low PD-L1 represent about 70% of locally advanced primary patients with squamous cell carcinoma of the head and neck, or SCCHN (hereafter also referred to as advanced primary head and neck cancer).
Previous wording
Keytruda was approved by FDA in June 2025 as a perioperative (before and after surgery) treatment for resectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.
Current wording
Keytruda was approved by FDA in June 2025 as a perioperative (before and after surgery) treatment for respectable locally advanced head and neck cancer patients whose tumors express PD-L1 at a positive level. In Merck’s Phase 3 KEYNOTE-689 trial, Keytruda reduced the risk of recurrence and progression by 30%, compared with standard of care, in patients whose tumors expressed PD-L1 (CPS ≥1). The study did not show an improvement in overall survival. Patients with low to zero levels of PD-L1 did not benefit from Keytruda.
Previous wording
In March 2025, CEL-SCI published a comprehensive presentation of results from the Phase 3 trial in the peer reviewed journal Pathology and Oncology Research (POR). The article is titled “Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study”. CEL-SCI also published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022 and 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society’s (EHNS’s) annual European Conference on Head and Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO) and the 2023 American Head and Neck Society (AHNS).These publications can be accessed at http://www.cel-sci.com.
Current wording
CEL-SCI published its data as abstracts and posters at the annual conferences for the 2022 American Society of Clinical Oncology (ASCO), 2022 and 2023 European Society for Medical Oncology (ESMO), the 2023 European Head and Neck Society’s (EHNS’s) annual European Conference on Head and Neck Oncology (ECHNO), the 2023 European Society for Therapeutic Radiology and Oncology (ESTRO), the 2023 American Head and Neck Society (AHNS), 2024 ESMO Congress and in the peer reviewed journal Pathology Oncology Research (POR) 2025.
Previous wording
A “pre-surgical response” is a significant change in disease before surgery. CEL-SCI saw two kinds of responses in the Phase III trial. First, there were “reductions” in the size of the tumor—a reduction of 30% or more qualified as a “pre-surgical reduction,” or “PSR” for short. Second, there were disease “downstages” (e.g., the disease improved from Stage IV to Stage III) pre-surgery. CEL-SCI calls this a “pre-surgical downstaging” or “PSD” for short. CEL-SCI’s 2022 ESMO cancer conference presentation reported on PSR, and CEL-SCI’s new 2023 ESMO presentation reported on PSD.
Current wording
A “pre-surgical response” is a significant change in disease before surgery. CEL-SCI saw two kinds of responses in the Phase III trial. First, there were “reductions” in the size of the tumor—a reduction of 30% or more qualified as a “pre-surgical reduction” or “PSR” for short. Second, there were disease “downstages” (e.g., the disease improved from Stage IV to Stage III) pre-surgery. CEL-SCI calls this a “pre-surgical downstaging” or “PSD” for short. CEL-SCI’s 2022 ESMO cancer conference presentation reported on PSR, and CEL-SCI’s new 2023 ESMO presentation reported on PSD and POR 2025.
Previous wording
CEL-SCI’s physician consultants have informed CEL-SCI that the early separation of these two survival curves (e.g., at 12 months) adds validation to the potential positive effects of Multikine.
Current wording
CEL-SCI’s physician consultants tell CEL-SCI that the early separation of these two survival curves (e.g., at 12 months) adds validation to the potential positive effects of Multikine.
Previous wording
CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms. Therefore, no bias was found, which supports confidence in Multikine’s efficacy results.
Current wording
CEL-SCI completed a bias analysis for the target population in the Phase III study in preparation for submission of data to regulatory agencies including the FDA for a confirmatory registration study. The detailed data on parameters including patient age, sex, race, tumor locations, and staging demonstrate balance between the treatment and control arms. Therefore, no bias was found, which supports confidence in Multikine’s efficacy results.
Previous wording
CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year. In May 2024, CEL-SCI announced that the FDA indicated CEL-SCI may move forward with a confirmatory registration study of Multikine in the target population.
Current wording
CEL-SCI applied to the FDA for a 212-patient randomized controlled confirmatory registration study focusing only on those patients in the target population, which accounts for approximately 100,000 patients worldwide per year. CEL-SCI is moving forward with a Phase 3 confirmatory registration study of Multikine in the target population.
Previous wording
Capital raised by the Company has been expended primarily for patent applications, research and development, administrative costs, the construction and upgrade of the Company’s manufacturing and laboratory facilities and clinical trials. The Company does not anticipate realizing significant revenues until entering into licensing arrangements for its technology and know-how or until it receives regulatory approval to sell its products (which could take several years). Thus, the Company has been dependent upon the proceeds from the sale of its securities to meet all of the Company’s liquidity and capital requirements and anticipates having to do so in the future.
Current wording
CEL-SCI has relied primarily upon capital generated from the public and private offerings of its common stock. In addition, CEL-SCI has utilized short-term loans to meet its capital requirements. Capital raised by CEL-SCI has been used to acquire an exclusive worldwide license to use, and later purchase, certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system and for clinical trials. Capital has also been used for patent applications, debt repayment, research and development, administrative costs, and for CEL-SCI’s laboratory and manufacturing facilities. CEL-SCI does not anticipate realizing significant revenues until it enters into licensing arrangements regarding its technology and know-how or until it receives regulatory approval to sell its products (which could take a number of years). As a result, CEL-SCI has been dependent primarily upon the proceeds from the sale of its securities to meet all of its liquidity and capital requirements and anticipates having to do so in the future.
Previous wording
The cost of the confirmatory registration study is estimated to be about $30 million. The Company will be required to raise additional capital or find additional long-term financing to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. Due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern.
Current wording
The cost of the confirmatory registration study is estimated to be about $30-$35 million. The Company will be required to raise additional capital or find additional long-term financing to continue with its research efforts. The ability to raise capital may be dependent upon market conditions that are outside the control of the Company. The ability of the Company to complete the necessary clinical trials and obtain FDA approval for the sale of products to be developed on a commercial basis is uncertain. Ultimately, the Company must complete the development of its products, obtain the appropriate regulatory approvals and obtain sufficient revenues to support its cost structure. However, there can be no assurance that the Company will be able to raise sufficient capital to support its operations. Due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern.
Previous wording
During the nine months ended June 30, 2025, all remaining 733,834 pre-funded warrants were exercised. No warrants were exercised during the nine months ended June 30, 2024.
Current wording
During the three months ended December 31, 2024, 48,333 pre-funded warrants were exercised. No warrants were exercised during the three months ended December 31, 2025.
Previous wording
During the nine months ended June 30, 2024, the Company’s cash decreased by approximately $3.8 million. The significant component of this decrease included cash used to fund the Company’s regular operations of approximately $14.0 million and approximately $1.3 million in payments on their finance lease obligations offset by net proceeds from the November 2023 and February 2024 financing of $11.6 million.
Current wording
During the three months ended December 31, 2025, the Company’s cash decreased by approximately $4.7 million. The significant components of this decrease included cash used to fund the Company’s regular operations of approximately $4.0 million, approximately $0.5 million in payments on the Company’s finance lease obligations, and approximately $0.2 million in stock issuance costs.
Previous wording
During the nine months ended June 30, 2025, the Company’s cash decreased by approximately $2.9 million. Significant components of this decrease included net proceeds from the December 2024, March 2025 and June 2025 financings of $11.0 million offset by cash used to fund the Company’s regular operations of approximately $12.5 million and approximately $1.5 million in payments on the Company’s finance lease obligations.
Current wording
During the three months ended December 31, 2024, the Company’s cash decreased by approximately $0.1 million. Significant components of this decrease included net proceeds from the December 2024 financing of $4.5 million offset by cash used to fund the Company’s regular operations of approximately $4.1 million and approximately $0.5 million in payments on the Company’s finance lease obligations.
Previous wording
The Company incurred a net operating loss of approximately $18.8 million for the nine months ended June 30, 2025. This net operating loss consists of significant non-cash expenses including approximately $2.1 million in share-based compensation to employees and non-employees, and approximately $2.9 million in depreciation and amortization expense. The Company incurred a net operating loss of approximately $20.2 million for the nine months ended June 30, 2024. This net operating loss consists of significant non-cash expenses including approximately $4.1 million in share-based compensation to employees and non-employees, and approximately $3.0 million in depreciation and amortization expense.
Current wording
The Company incurred a net operating loss of approximately $5.4 million for the three months ended December 31, 2025. This net operating loss consists of significant non-cash expenses including approximately $0.5 million in share-based compensation to employees and non-employees, and approximately $1.0 million in depreciation and amortization expense.
Previous wording
The following table summarizes our research and development expenses for the nine months ended June 30, 2025 and 2024:
Current wording
The following table summarizes our research and development expenses for the three months ended December 31, 2025 and 2024:
Previous wording
The Company’s research and development efforts involve Multikine and LEAPS. The table below shows the research and development expenses associated with each project.
Current wording
CEL-SCI’s research and development efforts involved Multikine and LEAPS. The table below shows the research and development expenses associated with each project during the reporting periods.
Previous wording
Clinical and other studies necessary to obtain regulatory approval of a new drug involve significant costs and require several years to complete. The extent of the Company’s clinical trials and research programs are primarily based upon the amount of capital available to the Company and the extent to which the Company has received regulatory approvals for clinical trials. The inability of the Company to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent the Company from completing the studies and research required to obtain regulatory approval for any products which the Company is developing. Without regulatory approval, the Company will be unable to sell any of its products. Since all of the Company’s projects are under development, the Company cannot predict when it will be able to generate any revenue from the sale of any of its products.
Current wording
Clinical and other studies necessary to obtain regulatory approval of a new drug involve significant costs and require several years to complete. The extent of the CEL-SCI’s clinical trials and research programs are primarily based upon the amount of capital available to CEL-SCI and the extent to which CEL-SCI has received regulatory approvals for clinical trials. The inability of CEL-SCI to conduct clinical trials or research, whether due to a lack of capital or regulatory approval, will prevent CEL-SCI from completing the studies and research required to obtain regulatory approval for any products which CEL-SCI is developing. Without regulatory approval, CEL-SCI will be unable to sell any of its products. Since all of CEL-SCI’s projects are under development, CEL-SCI cannot predict when it will be able to generate any revenue from the sale of any of its products.
Previous wording
During the nine months ended June 30, 2025, net interest expense decreased by approximately $0.1 million or 9% compared to the nine months ended June 30, 2024 which is primarily due to less interest paid on leases as higher principal balances have been paid over the last nine months. During the three months ended June 30, 2025 and 2024, net interest expense remained constant at approximately $0.2 million, which is primarily due to the interest paid on the Company’s lease liabilities.
Current wording
During the three months ended December 31, 2025, net interest expense decreased by approximately $0.1 million, or 47%, compared to the three months ended December 31, 2024. This decrease is primarily due to less interest paid on leases as higher principal balances have been paid over the last period and higher interest and dividend income received in the current period.
Previous wording
Share-based Compensation– Compensation cost for all share-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718,Compensation – Stock Compensation (“ASC 718”). The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires five input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free rate and the volatility. The share-based compensation cost is recognized using the straight-line method as expense over the requisite service or vesting period.
Current wording
Share-based Compensation– Compensation cost for all share-based awards is measured at fair value as of the grant date in accordance with the provisions of ASC 718,Compensation – Stock Compensation (“ASC 718”). The fair value of stock options is calculated using the Black-Scholes option pricing model. The Black-Scholes model requires six input variables: the strike price of an option, the current stock price, the time to expiration, the risk-free rate, the dividend yield and the volatility. The share-based compensation cost is recognized using the straight-line method as expense over the requisite service or vesting period.
Rearranged current paragraphs (1)
Current report — wording carried from elsewhere
In March 2025, CEL-SCI published a comprehensive presentation of results from the Phase 3 trial in the peer reviewed journal Pathology and Oncology Research (POR). The article is titled “Neoadjuvant Leukocyte Interleukin Injection Immunotherapy Improves Overall Survival in Low-risk Locally Advanced Head and Neck Squamous Cell Carcinoma -The IT-MATTERS Study” and included new data on quality of life, in addition to improved overall survival (OS) in the Multikine-treated low-risk with a 46.5 months median OS advantage over low-risk control (treated with standard of care only, SOC).