CEL-SCI Corporation Reports First Quarter Fiscal 2021 Financial Results
CEL-SCI Corporation (NYSE American: CVM) reported its financial results for the quarter ending December 31, 2020, highlighting key clinical developments.
Notably, the Phase 3 head and neck cancer study for Multikine is in statistical analysis, following data lock completion. The company also expanded its cGMP facility to double production capacity. Financially, CEL-SCI recorded a net loss of approximately $7.9 million, compared to $5.5 million for the same quarter in 2019. Cash reserves stood at approximately $21.9 million as of December 31, 2020, bolstered by a public offering that raised about $13.6 million.
- Completion of data lock for Phase 3 trial of Multikine, entering statistical analysis phase.
- Facility expansion expected to double production capacity for Multikine.
- Achieved a 40% survival rate in animal studies for LEAPS COV-19, significant for COVID-19 treatment.
- Net loss increased to approximately $7.9 million from $5.5 million year-over-year.
- Total operating expenses rose to $8.7 million from $6.9 million, reflecting increased R&D and administrative costs.
CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2020, as well as key clinical and corporate developments.
Clinical and Corporate Developments include:
- In December 2020, CEL-SCI updated the status of its pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Injection). Data lock has been completed, and the study entered its final stage of statistical analysis. CEL-SCI remains blinded to the study data and is not involved in this process which is conducted by independent contractors. The statistical analysis plan follows the protocol stated objectives and is designed to meet FDA requirements to define the clinical benefits that Multikine might provide for patients newly diagnosed with advanced primary (not yet treated) squamous cell carcinoma of the head and neck. The analysis looks at multiple parameters to gain the most information on the possible benefits of using Multikine immunotherapy as a first line treatment before standard of care for these patients.
- CEL-SCI continued expanding and upgrading its dedicated cGMP facility in which it manufactures Multikine. The construction, which began in 2020, is expected to be completed in the coming months and will double the facility’s capacity to accommodate two shifts for increased production of Multikine.
-
In December 2020, CEL-SCI announced that its LEAPS COV-19 peptides, delivered as a therapeutic treatment following SARS-CoV-2 virus challenge, achieved a
40% survival rate in human ACE2 transgenic mouse model as compared to0% survival in the two control groups. These studies were conducted at the University of Georgia Center for Vaccines and Immunology. As COVID-19 mutations increase, LEAPS COV-19’s mechanism of action which targets the non-mutating part of the SARS-CoV-2 virus is becoming more important.
-
In December 2020, CEL-SCI sold 1,000,000 shares of common stock at a public offering price of
$14.65 per share and received aggregate proceeds of approximately$13.6 million . On December 31, 2020, CEL-SCI’s cash position was approximately$21.9 million . After December 31, 2020, CEL-SCI has received approximately$3.9 million through the exercise of warrants and stock options.
“As the data analysis for our Phase 3 trial is being conducted, we are focused on expanding manufacturing of Multikine so that we will be ready to produce significant commercial quantities for this unmet medical need. We believe that Multikine may add substantial clinical benefit and help these patients.” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net loss of approximately
During the three months ended December 31, 2020, CEL-SCI incurred approximately
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, are treated with the investigational product Multikine first, BEFORE they received surgery, radiation and/or 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), has received Orphan Drug designation from the FDA for the 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 head and neck cancer. Per the study’s protocol, newly diagnosed patients with advanced primary squamous cell carcinoma of the head and neck were treated with the Multikine treatment regimen right after diagnosis and prior to receiving the Standard of Care (SOC), which involves surgery, radiation or concurrent radiochemotherapy. 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 better be able to mount an attack on the tumor. The aim of treatment with Multikine is to boost the body’s immune system prior to SOC to attack the cancer. The Phase 3 study is fully enrolled with 928 patients and the last patient was treated in September 2016. To prove an overall survival benefit, the study requires CEL-SCI to wait until 298 (death) events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the statistical analysis phase.
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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED DECEMBER 31, 2020 AND 2019 (UNAUDITED) |
|||||||
2020 |
2019 |
||||||
Grant income |
$ |
- |
|
$ |
35,506 |
|
|
Operating Expenses: |
|||||||
Research and development |
|
5,414,760 |
|
|
4,252,813 |
|
|
General and administrative |
|
3,316,156 |
|
|
2,638,896 |
|
|
Total operating expenses |
|
8,730,916 |
|
|
6,891,709 |
|
|
|
|
||||||
Operating loss |
|
(8,730,916 |
) |
|
(6,856,203 |
) |
|
Other income |
|
- |
|
|
18,448 |
|
|
Gain on derivative instruments |
|
932,836 |
|
|
766,509 |
|
|
Other non-operating gains |
|
121,606 |
|
|
790,669 |
|
|
Interest expense, net |
|
(260,390 |
) |
|
(250,783 |
) |
|
|
|
||||||
Net loss |
|
(7,936,864 |
) |
|
(5,531,360 |
) |
|
Modification of warrants |
|
(85,779 |
) |
|
- |
|
|
|
|
||||||
Net loss available to common shareholders |
$ |
(8,022,643 |
) |
$ |
(5,531,360 |
) |
|
Net loss per common share |
|||||||
BASIC |
$ |
(0.21 |
) |
$ |
(0.16 |
) |
|
DILUTED |
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FAQ
What were CEL-SCI's net loss figures for the quarter ended December 31, 2020?
CEL-SCI reported a net loss of approximately $7.9 million for the quarter ended December 31, 2020.
What are the key developments reported by CEL-SCI on December 31, 2020?
CEL-SCI reported progress on its Phase 3 trial for Multikine and expansion of its manufacturing facility.
How much cash did CEL-SCI have as of December 31, 2020?
CEL-SCI's cash position was approximately $21.9 million as of December 31, 2020.
What was the outcome of CEL-SCI's public offering in December 2020?
CEL-SCI raised about $13.6 million by selling 1,000,000 shares at a price of $14.65 per share.
Cel-Sci Corporation
NYSE:CVMCVM RankingsCVM Latest NewsCVM Stock Data
38.28M
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Biotechnology
Biological Products, (no Disgnostic Substances)
United States of America
VIENNA
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