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Share Name | Share Symbol | Market | Type |
---|---|---|---|
Cel Sci Corporation New | AMEX:CVM | AMEX | Common Stock |
Price Change | % Change | Share Price | High Price | Low Price | Open Price | Shares Traded | Last Trade | |
---|---|---|---|---|---|---|---|---|
0.0127 | 0.89% | 1.4327 | 1.47 | 1.43 | 1.44 | 4,005 | 14:40:53 |
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2021, as well as key clinical and corporate developments.
Clinical and Corporate Developments include:
CEL-SCI raised net proceeds of $53.6 million during the nine months ended June 30, 2021 through the sale of common stock and the exercise of warrants and options. As of June 30, 2021, CEL-SCI had $47.1 million in cash, cash equivalents and U.S. Treasury Bills.
“The results of this 10-year landmark study proved our novel concept of cancer treatment, 1) that the use of our investigational cancer immunotherapy Multikine before the usual first cancer treatments (as neoadjuvant treatment) should significantly increase survival and 2) that a cancer drug can have a very favorable safety profile. Our Phase 3 study results are the first sign of real progress in the treatment of advanced primary head and neck cancer in many decades. We estimate about 210,000 patients per year globally who could potentially benefit from this drug once approved. Our goal is to seek FDA approval based on the data from our recently concluded pivotal Phase 3 study,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported an operating loss of $27.7 million for the nine months ended June 30, 2021, versus an operating loss of $20.5 million for the nine months ended June 30, 2020. CEL-SCI reported an operating loss of $10.5 million for the quarter ended June 30, 2021, versus an operating loss of $7.0 million for the quarter ended June 30, 2020.
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 radiotherapy and chemotherapy (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 pivotal 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 arms of the study. This study milestone occurred in late April 2020 and database lock occurred in December 2020. The study results announced in June 2021 showed excellent 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 and as a potential treatment for COVID-19 infection. 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, 2020. 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, 2021 AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
530,106
Operating Expenses:
Research and development
17,818,373
12,680,430
General and administrative
9,902,120
8,389,821
Total operating expenses
27,720,493
21,070,251
Operating loss
(27,720,493
)
(20,540,145
)
Other income
(8,213
)
38,741
Loss on derivative instruments
(991,562
)
(3,565,347
)
Warrant inducement expense
-
(805,753
)
Other non-operating gains
1,436,473
774,245
Interest expense, net
(872,457
)
(777,898
)
Net loss
(28,156,252
)
(24,876,157
)
Modification of warrants
(350,861
)
(21,734
)
Net loss available to common shareholders
$
(28,507,113
)
$
(24,897,891
)
Net loss per common share - basic
$
(0.71
)
$
(0.69
)
Weighted average common shares outstanding - basic
39,907,624
36,230,092
Net loss per common share - diluted
$
(0.74
)
$
(0.69
)
Weighted average common shares outstanding - diluted
40,158,321
36,230,092
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF OPERATIONS
THREE MONTHS ENDED JUNE 30, 2021 AND 2020
(UNAUDITED)
2021
2020
Grant income
$
-
$
195,874
Operating Expenses:
Research and development
7,182,099
3,969,070
General and administrative
3,274,480
3,192,403
Total operating expenses
10,456,579
7,161,473
Operating loss
(10,456,579
)
(6,965,599
)
Other (expense) income
(8,213
)
1,845
Gain (loss) on derivative instruments
1,116,619
(1,282,829
)
Warrant inducement expense
-
(805,753
)
Other non-operating gains (losses)
761,237
(950,935
)
Interest expense, net
(351,332
)
(273,708
)
Net loss
(8,938,268
)
(10,276,979
)
Modification of warrants
(265,082
)
-
Net loss available to common shareholders
$
(9,203,350
)
$
(10,276,979
)
Net loss per common share - basic
$
(0.22
)
$
(0.27
)
Weighted average common shares outstanding - basic
41,020,485
37,453,539
Net loss per common share - diluted
$
(0.25
)
$
(0.27
)
Weighted average common shares outstanding - diluted
41,231,082
37,453,539
View source version on businesswire.com: https://www.businesswire.com/news/home/20210816005105/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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