VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended March 31, 2024, as well as key recent clinical and corporate developments.
Clinical and Corporate Developments include:
-
In May 2024, CEL-SCI received the go-ahead from the U.S. Food and Drug Administration (FDA) for its confirmatory Registration Study of Multikine* in the treatment of head and neck cancer based on very strong safety and efficacy data from the completed Phase 3 study which enrolled 928 patients. The survival benefit for the target population treated with Multikine vs standard of care alone was so strong and clear that the confirmatory study only needs to enroll 212 people. The FDA agreed with the pre-surgical selection of patients most likely to benefit from Multikine—those with newly diagnosed advanced primary head and neck cancer with no lymph node involvement (determined via PET scan) and with low PD-L1 tumor expression (determined via biopsy).
According to statisticians, the Registration Study is highly likely to succeed because it aims to confirm prior findings and to show a 10% absolute survival benefit vs control at 5 years following treatment. In the Phase 3 study, Multikine demonstrated the following in the target population:
- 28% absolute survival benefit vs control at 5 years
- Risk of death cut in half compared to control at 5 years
- 73% survival for Multikine vs 45% in the control at 5 years
- No safety signals or toxicities vs standard of care
- More detailed results may be viewed here: LINK
- In February 2024, CEL-SCI’s cGMP state-of-the-art dedicated manufacturing facility commissioning was completed, a significant milestone toward a regulatory approval of Multikine.
- In January 2024, the European Medicines Agency’s Paediatric Committee granted CEL-SCI a product-specific waiver of strict requirements for commercialization of cancer drugs in the European Union. The waiver is a significant step forward for Multikine, as it removes a major hurdle on the path towards commercialization in Europe.
- CEL-4000, CEL-SCI’s LEAPS vaccine technology, was featured in an article titled "Current status of immunological therapies for rheumatoid arthritis with a focus on antigen-specific therapeutic vaccines" published in the peer reviewed journal Frontiers in Immunology. The article articulates how CEL-4000 may deliver a safe and effective therapy for rheumatoid arthritis by rebalancing inflammatory response, without weakening important immune defense mechanisms, risking infections or cancer, as current treatments may.
“We are eager to commence our FDA Registration Study to confirm the remarkable overall survival benefits Multikine delivered for patients in our target population. The FDA has acknowledged the great unmet need in this patient population. Through the wealth of data produced in our Phase 3 trial, we were able to identify the precise selection criteria for patients and the corresponding diagnostics to identify these patients prior to surgery. This achievement paved the way for us to get FDA agreement to conduct a study on what could become a pre-surgical standard of care in head and neck cancer,” stated CEL-SCI CEO, Geert Kersten. “We believe the Registration Study is de-risked, thereby building even more confidence in CEL-SCI and our prospects for Multikine in other solid-tumor cancers.”
Financial Results
Research and development expenses decreased by $2.5 million, or 22%, to approximately $9 million during the six months ended March 31, 2024, compared to $11.5 million for the six months ended March 31, 2023. General and administrative expenses in the six months ended March 31, 2024 were $4.6 million compared to $4.4 million in the six months ended March 31, 2023. During the six months ended March 31, 2024, net loss narrowed by $2.2 million or 14% to $14.0 million, approximately $5.3 million of which are non-cash expenses, from $16.4 million in the prior year period. CEL-SCI raised gross proceeds of approximately $7.75 million through a public offering of common stock during the second fiscal quarter.
About CEL-SCI Corporation
CEL-SCI believes that boosting a patient’s immune system while it is still intact should provide the greatest possible impact on survival. Multikine is designed to help the immune system "target" the tumor at a time when the immune system is still relatively intact and thereby thought to be better able to mount an attack on the tumor. In the completed Phase 3 study, CEL-SCI studied patients who were newly diagnosed with locally advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine administered first, before they received the standard of care, which involved surgery followed by either radiation or chemoradiation. The Phase 3 study enrolled 928 patients. Our approach is unique because most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed.
After analyzing data from the Phase 3 study, we have better defined the target population for Multikine, which is locally advanced primary head and neck cancer patients with no lymph node involvement and with low PD-L1 tumor expression. In the Phase 3 study, we observed statistically significant survival in this target population, showing that Multikine cut the risk of death in half at five years vs control.
Multikine (Leukocyte Interleukin, Injection) received Orphan Drug designation from the FDA for neoadjuvant therapy in patients with squamous cell carcinoma (cancer) of the head and neck.
The Company has operations in Vienna, Virginia, and near/in Baltimore, Maryland.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, the words "intends," "believes," "anticipated," "plans" and "expects," and similar expressions, are intended to identify forward-looking statements. Such statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Such statements include, but are not limited to, statements about the terms, expected proceeds, use of proceeds and closing of the offering. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical studies, timely development of any potential products that can be shown to be safe and effective, receiving necessary regulatory approvals, difficulties in manufacturing any of the Company's potential products, inability to raise the necessary capital and the risk factors set forth from time to time in CEL-SCI's filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2023. The Company undertakes no obligation to publicly release the result of any revision to these forward-looking statements which may be made to reflect the events or circumstances after the date hereof or to reflect the occurrence of unanticipated events.
* Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy. This proprietary name is subject to FDA review in connection with the Company's future anticipated regulatory submission for approval. Multikine has not been licensed or approved for sale, barter or exchange by the FDA or any other regulatory agency. Similarly, its safety or efficacy has not been established for any use.
CEL-SCI CORPORATION |
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CONDENSED STATEMENTS OF OPERATIONS |
|||||||
SIX MONTHS ENDED MARCH 31, 2024 AND 2023 |
|||||||
(UNAUDITED) |
|||||||
2024 |
|
2023 |
|||||
Operating expenses: |
|||||||
Research and development |
$ |
8,981,044 |
|
$ |
11,476,034 |
|
|
General and administrative |
|
4,580,791 |
|
|
4,350,761 |
|
|
Total operating expenses |
|
13,561,835 |
|
|
15,826,795 |
|
|
|
|
||||||
Operating loss |
|
(13,561,835 |
) |
|
(15,826,795 |
) |
|
Interest expense, net |
|
(380,397 |
) |
|
(311,852 |
) |
|
Other expense |
|
(12,183 |
) |
|
|
(57,671 |
) |
|
|
||||||
Net loss |
|
(13,954,415 |
) |
|
(16,196,318 |
) |
|
Modification of warrants |
|
- |
|
|
(171,552 |
) |
|
|
|
||||||
Net loss available to common shareholders |
$ |
(13,954,415 |
) |
$ |
(16,367,870 |
) |
|
Net loss per common share – basic and diluted |
$ |
(0.28 |
) |
$ |
(0.38 |
) |
|
Weighted average common shares outstanding – basic and diluted |
|
50,228,860 |
|
|
43,513,571 |
|
|
|
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CEL-SCI CORPORATION |
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CONDENSED STATEMENTS OF OPERATIONS |
|||||||
THREE MONTHS ENDED MARCH 31, 2024 AND 2023 |
|||||||
(UNAUDITED) |
|||||||
2024 |
|
2023 |
|||||
Operating expenses: |
|||||||
Research and development |
$ |
4,628,535 |
|
$ |
6,083,488 |
|
|
General and administrative |
|
2,447,413 |
|
|
2,092,758 |
|
|
Total operating expenses |
|
7,075,948 |
|
|
8,176,246 |
|
|
|
|
||||||
Operating loss |
|
(7,075,948 |
) |
|
(8,176,246 |
) |
|
Interest expense, net |
|
(182,701 |
) |
|
(159,063 |
) |
|
Other income (expense) |
|
13,758 |
|
|
|
(7,500 |
) |
|
|
||||||
Net loss |
|
(7,244,891 |
) |
|
(8,342,809 |
) |
|
|
|
||||||
Net loss available to common shareholders |
$ |
(7,244,891 |
) |
$ |
(8,342,809 |
) |
|
Net loss per common share – basic and diluted |
$ |
(0.14 |
) |
$ |
(0.19 |
) |
|
Weighted average common shares outstanding – basic and diluted |
|
52,006,442 |
|
|
43,588,381 |
|
|
|
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