VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2020 and provided an update on clinical developments:
- CEL-SCI reached the targeted threshold of 298 events (deaths) required to conduct the data evaluation for its global pivotal Phase 3 head and neck cancer study of Multikine* (Leukocyte Interleukin, Inj.) immunotherapy. The study is currently in the database lock and analysis phase. CEL-SCI will be advised of the results when the analysis is finalized, and the study results will be announced to the public and investors at that time.
- CEL-SCI initiated the development of an immunotherapy with the potential to treat the COVID-19 coronavirus using its patented LEAPS peptide technology. The initial animal experiments showed that after only one injection, LEAPS COVID-19 conjugates induced antibody responses faster and in much higher titers than expected against a non-mutating region of the virus that causes COVID-19. These animal experiments provide the basis for moving forward into animal challenge studies with live virus SARS-CoV-2, the causative agent of COVID-19, at the University of Georgia Vaccine Center.
- CEL-SCI signed a collaboration agreement with the University of Georgia’s Center for Vaccines and Immunology to develop the LEAPS COVID-19 immunotherapy. Initial studies with COVID-19 aim to replicate prior successful preclinical experiments of LEAPS against the H1N1pandemic flu virus in mice conducted at and in collaboration with the National Institutes for Allergies and Infectious Diseases (NIAID). These studies demonstrated improvement in both morbidity and mortality of H1N1 infected animals treated with the LEAPS-H1N1 construct as compared to controls. CEL-SCI believes its COVID-19 approach is unique for two reasons: 1) LEAPS focuses on a non-changing part of the virus; and 2) LEAPS has both anti-viral and anti-inflammatory attributes. The goal is to develop a more successful treatment for infected patients.
- CEL-SCI raised approximately $27.0 million in gross proceeds during the nine months ended June 30, 2020 through the sale of common stock through public offerings and the exercise of warrants.
“Our goal is to create the first non-toxic cancer drug that is effective in increasing survival. This is the first cancer drug in decades that would be used to improve the success rate of the current first ‘intent to cure’ head and neck cancer standard of care treatment. Now that the long Phase 3 study is finished, the organizations who run the study are responsible for cleaning up/collecting all final data and analyzing it. This is a very big job since the study ran for 9.5 years in 100 hospitals in 24 countries. Once we know the final study results, we will share them with our shareholders. We believe that our Multikine will help these patients,” stated CEL-SCI CEO, Geert Kersten.
During the nine months ended June 30, 2020, the Company’s cash increased by approximately $11.7 million. Significant components of this increase include approximately $14.0 million in net proceeds from the sale of common stock through public offerings, approximately $12.1 million in proceeds from the exercise of warrants and options and employee stock purchases of approximately $0.2 million, offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $11.7 million, approximately $1.6 million of equipment and leasehold improvement expenditures, approximately $0.7 million for payments of stock issuance costs and approximately $0.6 million in lease payments.
CEL-SCI reported a net loss of $24.7 million for the nine months ended June 30, 2020 versus a net loss of $17.3 million for the nine months ended June 30, 2019. CEL-SCI reported a net loss of $10.2 million for the quarter ended June 30, 2020 versus a net loss of $12.1 million for the quarter ended June 30, 2019.
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, radiation and/or chemotherapy. 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 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 first – for 3 weeks 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 events have occurred among the two main comparator groups. This study milestone occurred in late April 2020. The study is currently in the database lock and analysis phase.
The Company’s LEAPS technology is being developed for rheumatoid arthritis and as a potential treatment of COVID-19 in hospitalized and at-high-risk patients. 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, including statements with respect to Multikine and the Phase 3 clinical trial of Multikine in patients with advanced primary squamous cell carcinoma of the head and neck. 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. Factors that could cause or contribute to such differences include an inability to duplicate the clinical results demonstrated in clinical trials or nonclinical 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 amended report on Form 10-K/A for the year ended September 30, 2019. 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.
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CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS NINE MONTHS ENDED JUNE 30, 2020 AND 2019 (UNAUDITED) |
|||||||
|
|
2020 |
|
|
2019 |
|
||
|
Grant income |
$ |
530,106 |
|
$ |
386,121 |
|
|
|
Operating Expenses: |
|||||||
|
Research and development |
|
12,511,830 |
|
|
9,269,772 |
|
|
|
General and administrative |
|
8,389,821 |
|
|
5,667,510 |
|
|
|
Total operating expenses |
|
20,901,651 |
|
|
14,937,282 |
|
|
|
|
|
||||||
|
Operating loss |
|
(20,371,545 |
) |
|
(14,551,161 |
) |
|
|
Other income |
|
38,741 |
|
|
54,575 |
|
|
|
Loss on derivative instruments |
|
(3,565,347 |
) |
|
(3,316,384 |
) |
|
|
Warrant inducement expense |
|
(805,753 |
) |
|
– |
|
|
|
Other non-operating gains |
|
774,245 |
|
|
1,877,197 |
|
|
|
Interest expense, net |
|
(777,898 |
) |
|
(1,350,774 |
) |
|
|
Net loss |
|
(24,707,557 |
) |
|
(17,286,547 |
) |
|
|
Modification of warrants |
|
(21,734 |
) |
|
– |
|
|
|
Net loss available to common shareholders |
$ |
(24,729,291 |
) |
$ |
(17,286,547 |
) |
|
|
Net loss per common share – basic and diluted |
$ |
(0.68 |
) |
$ |
(0.58 |
) |
|
|
Weighted average common shares outstanding – basic and diluted |
|
36,230,092 |
|
|
30,046,241 |
|
|
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CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2020 AND 2019 (UNAUDITED) |
|||||||
|
|
2020 |
|
|
2019 |
|
||
|
Grant income |
$ |
195,874 |
|
$ |
108,938 |
|
|
|
Operating Expenses: |
|||||||
|
Research and development |
|
3,912,870 |
|
|
2,965,512 |
|
|
|
General and administrative |
|
3,192,403 |
|
|
2,353,525 |
|
|
|
Total operating expenses |
|
7,105,273 |
|
|
5,319,037 |
|
|
|
|
|
||||||
|
Operating loss |
|
(6,909,399 |
) |
|
(5,210,099 |
) |
|
|
Other income |
|
1,845 |
|
|
18,448 |
|
|
|
Loss on derivative instruments |
|
(1,282,829 |
) |
|
(7,905,519 |
) |
|
|
Warrant inducement expense |
|
(805,753 |
) |
|
– |
|
|
|
Other non-operating (losses) gains |
|
(950,935 |
) |
|
1,455,844 |
|
|
|
Interest expense, net |
|
(273,708 |
) |
|
(443,442 |
) |
|
|
Net loss available to common shareholders |
$ |
(10,220,779 |
) |
$ |
(12,084,768 |
) |
|
|
Net loss per common share – basic and diluted |
$ |
(0.27 |
) |
$ |
(0.37 |
) |
|
|
Weighted average common shares outstanding – basic and diluted |
|
37,453,539 |
|
|
33,051,888 |
|
|
Contacts
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460