CEL SCI CORP
For the period ended Jun 30, 2025. Filed Aug 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.
Jun 30, 2025 · Filed Aug 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 2025-03-31; filed 2025-05-14.
0001654954-25-005606
Item 2. Management's Discussion and Analysis of Financial Condition and Results of OperationsCurrent 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 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 65 previous paragraphs and 67 current paragraphs.
51 unchanged; 13 reworded; 3 added; 1 removed; 0 previous and 0 current paragraphs rearranged.
Tables are not compared: 9 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 (3)
Current report
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 report
In contrast to the results of the KEYNOTE-689, CEL-SCI’s Phase 3 study showed that Multikine treated patients whose tumors expressed low (Tumor Proportion Score [TPS <10]) to zero PD-L1, had their risk of death reduced by 66% (hazard ratio 0.34, 95% CI [0.18, 0.65], p=0.0012) and extended the 5-year overall survival to 73% compared to 45% in the standard of care, log rank p=0.0015. About 70% of the patients in CEL-SCI’s Phase 3 study had low to zero levels of PD-L1.
Current 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.
Removed paragraphs (1)
Previous 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.
Reworded paragraphs (13)
Previous wording
Targeting low PD-L1 also differentiates Multikine from other immunotherapies. For example, checkpoint inhibitors like Keytruda and Opdivo appear to best serve patients having high PD-L1, because these drugs work by blocking PD1/PD-L1 receptors interaction; when this interaction (PD1/PD-L1) happens it leads to inactivation/death of the immune cells attacking the tumor. These checkpoint inhibitors appear to act best when tumors express high levels of PD-L1 receptors (usually TPS >20 to TPS >50). While none of these drugs are currently approved as a first-line treatment before surgery, even if such approvals were to come in the future, CEL-SCI believes the large majority of patients having low PD-L1 would still be expected to need Multikine.
Current wording
Targeting low PD-L1 also differentiates Multikine from other immunotherapies. For example, checkpoint inhibitors like Keytruda and Opdivo appear to best serve patients having high PD-L1, because these drugs work by blocking PD1/PD-L1 receptors interaction; when this interaction (PD1/PD-L1) happens it leads to inactivation/death of the immune cells attacking the tumor. These checkpoint inhibitors appear to act best when tumors express high levels of PD-L1 receptors (usually TPS >20 to TPS >50).
Previous 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) and the 2023 American Head and Neck Society (AHNS). These publications can be accessed at http://www.cel-sci.com.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous 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.
Current 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.
Previous wording
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 wording
Research and development expenses consist primarily of costs incurred for our research activities, including the development of our products, and include:
Previous wording
The following table summarizes our research and development expenses for the six months ended March 31, 2025 and 2024:
Current wording
The following table summarizes our research and development expenses for the nine months ended June 30, 2025 and 2024:
Previous 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.
Current wording
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 wording
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 wording
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 wording
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 wording
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 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.
Current 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.