CEL SCI CORP
For the period ended Mar 31, 2025. Filed May 14, 2025.
View on SEC.govAbout this filing
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.
Mar 31, 2025 · Filed May 14, 2025
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 2024-12-31; filed 2025-02-14.
0001654954-25-001578
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent report: 10-Q
Period ended 2025-03-31; filed 2025-05-14.
0001654954-25-005606
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 58 previous paragraphs and 65 current paragraphs.
49 unchanged; 8 reworded; 8 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 7 previous and 9 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 (8)
Current report
Research and development expenses consist primarily of costs incurred for our research activities, including our discovery efforts and the development of our products, and include:
Current report
The following table summarizes our research and development expenses for the six months ended March 31, 2025 and 2024:
Current report
During the three months ended March 31, 2025, research and development expenses decreased by approximately $0.6 million, or 13%, compared to the three months ended March 31, 2024. The major components of the decrease in research and development expenses over the prior period include an approximate $0.5 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 $0.1 million in other research and development costs.
Current report
General and Administrative Expenses
Current report
During the six months ended March 31, 2025, general and administrative expenses increased by approximately $0.3 million, or 6%, compared to the six months ended March 31, 2024. The major components of the increase in general and administrative expenses over the prior period include an approximate $0.7 million in public relation costs and $0.2 million in accounting fees due to out of scope work, offset by a decrease of $0.4 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 $0.2 million in other general and administrative expenses.
Current report
During the three months ended March 31, 2025 and 2024, there was no change in general and administrative expenses as it remained constant at approximately $2.4 million. The major components of general and administrative expenses include an approximate $0.4 million increase over the prior period in public relation costs primarily due to an increase in public relation efforts to attract more investors for the Company’s financings, offset by a decrease of $0.3 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 a decrease of $0.1 million in other general and administrative expenses.
Current report
Interest Expense, Net
Current report
Research and Development Expenses
Removed paragraphs (1)
Previous report
During the three months ended December 31, 2024, general and administrative expenses increased by approximately $0.3 million, or 15%, compared to the three months ended December 31, 2023. This increase is primarily due to a $0.2 million increase in non-employee stock compensation and $0.2 million increase in other costs related to public relations, offset by a decrease of approximately $0.1 million of employee stock compensation expense.
Reworded paragraphs (8)
Previous wording
It was not enough for us to show that Multikine likely leads to PSRs and PSDs as compared to a control group, CEL-SCI also had to test if PSRs and PSDs lead to improved survival. CEL-SCI’s Phase III trial demonstrated that PSR patients were 72% likely to be alive after five years, whereas control patients were only about 49% likely to be alive after five years. Patients with PSD saw similar improvement in CEL-SCI’s Phase III trial. Their five-year chance of survival was approximately 68%. Therefore, CEL-SCI believes that the Phase III trial demonstrated that those patients who had PSR or PSD resulting from Multikine lived longer than those who were not treated with Multikine. It is important to note that these results are from the entire Phase III study population, not from a subgroup. The likelihood of living at least five years is shown in the graphic below for patients with PSR (blue), patients with PSD (orange) and control patients who did not receive Multikine (gray).
Current wording
It was not enough for CEL-SCI to show that Multikine likely leads to PSRs and PSDs as compared to a control group, CEL-SCI also had to test if PSRs and PSDs lead to improved survival. CEL-SCI’s Phase III trial demonstrated that PSR patients were 72% likely to be alive after five years, whereas control patients were only about 49% likely to be alive after five years. Patients with PSD saw similar improvement in CEL-SCI’s Phase III trial. Their five-year chance of survival was approximately 68%. Therefore, CEL-SCI believes that the Phase III trial demonstrated that those patients who had PSR or PSD resulting from Multikine lived longer than those who were not treated with Multikine. It is important to note that these results are from the entire Phase III study population, not from a subgroup. The likelihood of living at least five years is shown in the graphic below for patients with PSR (blue), patients with PSD (orange) and control patients who did not receive Multikine (gray).
Previous wording
The major regulatory bodies with whom we are working, U.S. FDA, Health Canada, European Medicine Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) all have conditional approval pathways designed for situations where the target population has not been fully tested prospectively and there is strong data supporting clinical benefit for patients. The reason is that regulators understand that in many cases patients should not have to wait for additional data before being offered the chance to benefit from a new drug, especially if the drug has been shown to be safe. Every situation is different and depends on the specific facts.
Current wording
The major regulatory bodies with whom we are working, U.S. FDA, Health Canada, European Medicines Agency (EMA) and the Medicines and Healthcare products Regulatory Agency (MHRA) in the United Kingdom (UK) all have conditional approval pathways designed for situations where the target population has not been fully tested prospectively and there is strong data supporting clinical benefit for patients. The reason is that regulators understand that in many cases patients should not have to wait for additional data before being offered the chance to benefit from a new drug, especially if the drug has been shown to be safe. Every situation is different and depends on the specific facts.
Previous 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 their finance lease obligations.
Current wording
During the six months ended March 31, 2025, the Company’s cash decreased by approximately $2.8 million. Significant components of this decrease included net proceeds from the December 2024 and March 2025 financings of $6.7 million offset by cash used to fund the Company’s regular operations of approximately $8.5 million and approximately $1.0 million in payments on their finance lease obligations.
Previous wording
During the three months ended December 31, 2023, the Company’s cash decreased by approximately $0.9 million. The significant component of this decrease included cash used to fund the Company’s regular operations of approximately $4.9 million, and approximately $0.4 million in payments on the Company’s finance lease obligations, offset by net proceeds from the November 2023 financing of approximately $4.5 million.
Current wording
During the six months ended March 31, 2024, the Company’s cash increased by approximately $1.2 million. The significant component of this increase included net proceeds from the November 2023 and February 2024 financing of $11.5 million offset by cash used to fund the Company’s regular operations of approximately $9.4 million and approximately $0.9 million in payments on their finance lease obligations.
Previous wording
During the three months ended December 31, 2024, 1,450,000 pre-funded warrants were exercised. No warrants were exercised during the three months ended December 31, 2023.
Current wording
During the six months ended March 31, 2025, 7,427,500 pre-funded warrants were exercised. No warrants were exercised during the six months ended March 31, 2024.
Previous wording
The Company incurred a net operating loss of approximately $6.9 million for the three months ended December 31, 2024. This net operating loss consists of significant non-cash expenses including approximately $1.1 million in share-based compensation to employees and non-employees, and approximately $1.0 million in depreciation and amortization expense.
Current wording
The Company incurred a net operating loss of approximately $13.3 million for the six months ended March 31, 2025. This net operating loss consists of significant non-cash expenses including approximately $1.9 million in share-based compensation to employees and non-employees, and approximately $2.0 million in depreciation and amortization expense. The Company incurred a net operating loss of approximately $13.6 million for the six months ended March 31, 2024. This net operating loss consists of significant non-cash expenses including approximately $3.2 million in share-based compensation to employees and non-employees, and approximately $2.0 million in depreciation and amortization expense.
Previous wording
During the three months ended December 31, 2024 and 2023, there was no change in the research and development expenses as it remained constant at approximately $4.4 million. The major components of research and development expenses include an approximate $0.2 million increase over the prior period in clinical studies costs as a result of preparing the confirmatory study for enrollment, costs incurred for supplies and materials used which increased by $0.2 million compared to the prior period and an increase over the prior period in other research and development expenses of $0.1 million, offset by a decrease of $0.5 million of employee stock compensation expense compared to the prior period.
Current wording
During the six months ended March 31, 2025, research and development expenses decreased by approximately $0.5 million, or 6%, compared to the six months ended March 31, 2024. The major components of the decrease in research and development expenses over the prior period include an approximate $1.0 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, offset by an increase of $0.1 million in clinical studies costs, $0.2 million in costs incurred for supplies and materials used as a result of preparing the confirmatory study for enrollment and $0.2 million in other research and development costs.
Previous wording
During the three months ended December 31, 2024 and 2023, 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 six months ended March 31, 2025 and 2024, net interest expense remained constant at approximately $0.4 million, which is primarily due to the interest paid on the Company’s lease liabilities. During the three months ended March 31, 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.