VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2022, as well as key clinical and corporate developments.
Clinical and Corporate Developments include:
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The American Society of Clinical Oncology (ASCO) published two abstracts related to CEL-SCI’s pivotal randomized controlled Phase 3 Multikine® (Leukocyte Interleukin, Injection)* head and neck cancer clinical trial for presentation at the 2022 ASCO Annual Meeting to be held June 3-7, 2022 in Chicago, Illinois. The abstract titles are:
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“Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only.” - https://meetings.asco.org/abstracts-presentations/207202
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“Leukocyte interleukin injection (LI) immunotherapy extends overall survival (OS) in treatment-naive low-risk (LR) locally advanced primary squamous cell carcinoma of the head and neck: The IT-MATTERS study.” - https://meetings.asco.org/abstracts-presentations/207201
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“Novel algorithm for assigning risk/disease-directed treatment (DDT) choice in locally advanced primary squamous cell carcinoma of the head and neck (SCCHN): Using pretreatment data only.” - https://meetings.asco.org/abstracts-presentations/207202
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Multikine is given for three weeks after cancer diagnosis, but before surgery and other treatments. In the peer-reviewed abstract presented at ASCO, a clear survival advantage for patients treated with Multikine prior to surgery in the surgery-plus-radiation arm of the IT-MATTERS study was described. The survival advantage was driven by objective data derived from patients in the intent-to-treat (ITT) population who had a significant number of early complete and partial tumor responses which occurred prior to surgery. Five patients in the study had their tumors completely disappear (confirmed by pathology) before surgery. In the ITT population as a whole, 8.5% of all Multikine-treated patients had a tumor response before surgery, but not a single tumor response before surgery was seen in the ITT control group before surgery, statistically a highly significant finding (p-value of less than 0.00000000001). This indicates that the likelihood of seeing these results by chance is less than 1 in ten billion. These results confirm findings from the Phase 1 and 2 studies with Multikine and provide direct evidence of Multikine’s anticancer activity.
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Additional results from the Phase 3 study of Multikine in advanced primary head and neck cancer have been submitted to the U.S. government clinical trial website www.clinicaltrials.gov. That data is expected to be released to the public in the near future.
- CEL-SCI’s dedicated current Good Manufacturing Practice (cGMP) facility in which it manufactures Multikine is now undergoing validation following the completion of its commercial scale build out during the first quarter of 2022. The construction was designed to ensure the facility will be compliant with all U.S. Food and Drug Administration’s (FDA) GMP and European regulations.
“Advanced primary squamous cell carcinoma (cancer) of the head and neck is a horrible disease for which FDA has not approved a new treatment in many decades. Many leading drugs have failed in studies for the treatment of advanced primary head and neck cancer. Our Phase 3 study shows an almost 4-year median survival benefit for the patients who received Multikine treatment before surgery and radiation. We believe that this represents a meaningful clinical impact for those patients for whom no treatment has imparted a significant survival benefit in decades. We are looking forward to additional peer-reviewed publications of this data,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $27.1 million for the nine months ended June 30, 2022 versus an operating loss of $27.7 million for the nine months ended June 30, 2021. Net cash used during the nine months ended June 30, 2022 was $13.3 million. This represents a decrease of $0.7 million compared to the nine months ended June 30, 2021. CEL-SCI reported an operating loss of $8.7 million for the three months ended June 30, 2022 versus an operating loss of $10.5 million for the three months ended June 30, 2021.
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. Therefore, in the Phase 3 study CEL-SCI treated patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with the investigational product Multikine* first, BEFORE they received surgery and radiotherapy or surgery plus concurrent radiochemotherapy (the current standard of care for these patients). This approach is unique. Most other cancer immunotherapies are administered only after conventional therapies have been tried and/or failed. 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. CEL-SCI believes that this Phase 3 study is the largest Phase 3 study in the world for the treatment of advanced primary head and neck cancer.
Multikine is designed to help the immune system “see” 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. The Phase 3 study was started in early 2011 and was fully enrolled with 928 patients in September 2016. To prove an overall survival benefit, the study required CEL-SCI to wait until at least 298 (deaths) events had occurred among the two main comparator groups. The study results announced showed almost 4-year survival benefit for those patients who received Multikine treatment regimen plus surgery and radiation. When chemotherapy was added to radiotherapy following surgery the survival benefit was negated.
The Company’s LEAPS technology is being developed for rheumatoid arthritis. 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, 2021. 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, and 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 CONDENSED STATEMENTS OF OPERATIONS NINE MONTHS ENDED JUNE 30, 2022 AND 2021 (UNAUDITED) |
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|
2022 |
|
|
|
2021 |
|
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Operating expenses: |
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Research and development |
$ |
18,893,857 |
|
$ |
17,818,373 |
|
||
General and administrative |
|
8,220,768 |
|
|
9,902,120 |
|
||
Total operating expenses |
|
27,114,625 |
|
|
27,720,493 |
|
||
|
|
|||||||
Operating loss |
|
(27,114,625 |
) |
|
(27,720,493 |
) |
||
Gain (loss) on derivative instruments |
|
366,791 |
|
|
(991,562 |
) |
||
Other non-operating (loss) gain |
|
(30,793 |
) |
|
1,428,260 |
|
||
Interest expense, net |
|
(1,460,055 |
) |
|
(872,457 |
) |
||
|
|
|||||||
Net loss |
|
(28,238,682 |
) |
|
(28,156,252 |
) |
||
Modification of warrants |
|
(294,409 |
) |
|
(350,861 |
) |
||
|
|
|||||||
Net loss available to common shareholders |
$ |
(28,533,091 |
) |
$ |
(28,507,113 |
) |
||
Net loss per common share - basic |
$ |
(0.66 |
) |
$ |
(0.71 |
) |
||
Weighted average common shares outstanding - basic |
|
43,124,972 |
|
|
39,907,624 |
|
||
|
||||||||
Net loss per common share - diluted |
$ |
(0.66 |
) |
$ |
(0.74 |
) |
||
Weighted average common shares outstanding - diluted |
|
43,124,972 |
|
|
40,158,321 |
|
||
CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2022 AND 2021 (UNAUDITED) |
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|
2022 |
|
|
2021 |
|
|||
Operating Expenses: |
||||||||
Research and development |
$ |
6,286,873 |
|
$ |
7,182,099 |
|
||
General and administrative |
|
2,432,518 |
|
|
3,274,480 |
|
||
Total operating expenses |
|
8,719,391 |
|
|
10,456,579 |
|
||
|
|
|||||||
Operating loss |
|
(8,719,391 |
) |
|
(10,456,579 |
) |
||
Gain on derivative instruments |
|
- |
|
|
1,116,619 |
|
||
Other non-operating gains |
|
- |
|
|
753,024 |
|
||
Interest expense, net |
|
(913,193 |
) |
|
(351,332 |
) |
||
|
|
|||||||
Net loss |
|
(9,632,584 |
) |
|
(8,938,268 |
) |
||
Modification of warrants |
|
(294,409 |
) |
|
(265,082 |
) |
||
|
|
|||||||
Net loss available to common shareholders |
$ |
(9,926,993 |
) |
$ |
(9,203,350 |
) |
||
Net loss per common share - basic |
$ |
(0.23 |
) |
$ |
(0.22 |
) |
||
Weighted average common shares outstanding - basic |
|
43,174,775 |
|
|
41,020,485 |
|
||
|
||||||||
Net loss per common share - diluted |
$ |
(0.23 |
) |
$ |
(0.25 |
) |
||
Weighted average common shares outstanding - diluted |
|
43,174,775 |
|
|
41,231,082 |
|
||
