VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended June 30, 2019. The Company also reported key clinical and corporate developments achieved during the quarter.
Clinical and Corporate Developments included:
- CEL-SCI’s Phase 3 head and neck cancer study continued to follow all 928 patients who were enrolled. The Company is now awaiting final study results. All that remains to be done in this pivotal Phase 3 study, the largest in the world in head and neck cancer, is to continue to track patient survival until it can be determined if the primary endpoint of the study, a 10% improvement in overall survival of the Multikine* treatment regimen plus Standard of Care (SOC) vs. SOC alone will be met. The primary endpoint will be determined after a total of 298 events (deaths) have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could be available soon since the last cancer patients were treated in September 2016, and the first cancer patients in the study were treated in early 2011.
- On May 11, 2019 and July 3, 2019, new data was presented on CEL-SCI’s experimental LEAPS therapeutic antigen-specific treatment for rheumatoid arthritis. The work was performed in conjunction with researchers at Rush University Medical Center, Chicago, Illinois.
- On June 3-6, 2019, CEL-SCI was an exhibitor and showcased its presentation at the BIO International Convention. CEL-SCI was selected to be part of the Innovation Zone sponsored by the U.S. National Institutes of Health (NIH). The focus was the Company’s experimental LEAPS platform technology and CEL-SCI’s ongoing development of a LEAPS based therapeutic antigen-specific treatment for rheumatoid arthritis. The NIH has funded research studies for CEL-SCI’s LEAPS technology in the treatment of rheumatoid arthritis through a $1.5 million grant. There was a lot of corporate interest in the LEAPS technology for rheumatoid arthritis.
- On June 28, 2019, CEL-SCI joined the broad-market Russell 3000® Index that was effective after the US market opened on July 1, 2019.
- Following this quarter, between July 1, 2019 and August 13, 2019, the Company received over $2.5 million through the exercise of warrants to purchase shares of the Company's common stock.
“We look forward to the readout of our Phase 3 data, as we believe Multikine immunotherapy may increase the success rate of the first ‘intent to cure’ cancer treatment regimen by adding the tumor cell killing ability of the still healthy immune system to the known anti-tumor effects of surgery, radiation and chemotherapy. Multikine is unique in cancer immunotherapy because it can potentially be effective when administered for just three weeks, right after diagnosis and prior to surgery, as compared to other immuno-oncology drugs on the market today that are used to treat people with recurrent cancer, or end stage disease,” stated CEL-SCI CEO, Geert Kersten. “Our experimental LEAPS vaccine platform continues to show promise as we continue IND-enabling studies in conjunction with the NIH.”
CEL-SCI reported a net loss of $17.3 million for the nine months ended June 30, 2019 versus a net loss of $16.9 million for the nine months ended June 30, 2018. The net loss increase was in large part due to the change in value of the non-cash derivative instruments that were caused mainly by fluctuation in the share price of the Company’s common stock.
During the three months ended June 30, 2019, the Company’s cash increased by approximately $4.0 million, as compared to the second quarter of fiscal 2019, to $9.5 million. Significant components of this increase included net proceeds from the exercise of warrant and stock options of approximately $8.4 million and the purchase of common stock by officers and directors of approximately $0.2 million. The increase was offset by net cash used to fund the Company’s regular operations, including its Phase 3 clinical trial, of approximately $4.6 million.
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 treats patients who are newly diagnosed with advanced primary squamous cell carcinoma of the head and neck with Multikine first, BEFORE they receive 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's 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 are treated with the Multikine treatment regimen for 3 weeks prior to the Standard of Care (SOC) which involves surgery, chemotherapy and/or radiation. 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 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. 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.
The Company's experimental LEAPS technology is currently being developed as a potential therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near 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, 2018. 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 NINE MONTHS ENDED JUNE 30, 2019 AND 2018 (UNAUDITED) |
|||||
|
2019 |
|
2018 |
||
Grant income |
$ |
386,121 |
$ |
297,045 |
|
Operating Expenses: |
|||||
Research and development |
|
7,956,203 |
|
7,713,873 |
|
General and administrative |
|
6,981,079 |
|
5,823,694 |
|
|
|
||||
Total operating expenses |
|
14,937,282 |
|
13,537,567 |
|
|
|
||||
Operating loss |
|
(14,551,161) |
|
(13,240,522) |
|
Other income |
|
54,575 |
|
52,984 |
|
(Loss) gain on derivative instruments |
|
(3,316,384) |
|
187,967 |
|
Other non-operating gain (loss) |
|
1,877,197 |
|
(171,468) |
|
Interest expense, net |
|
(1,350,774) |
|
(3,739,494) |
|
|
|
||||
Net loss available to common shareholders |
$ |
(17,286,547) |
$ |
(16,910,533) |
|
Net loss per common share |
|||||
Basic and Diluted |
$ |
(0.58) |
$ |
(1.17) |
|
Weighted average common shares outstanding |
|||||
Basic and Diluted |
|
30,046,241 |
|
14,486,351 |
|
CEL-SCI CORPORATION CONDENSED STATEMENTS OF OPERATIONS THREE MONTHS ENDED JUNE 30, 2019 AND 2018 (UNAUDITED) |
|||||
|
2019 |
|
2018 |
||
Grant income |
$ |
108,938 |
$ |
86,459 |
|
Operating Expenses: |
|||||
Research and development |
|
2,298,555 |
|
2,425,562 |
|
General and administrative |
|
3,020,482 |
|
1,748,971 |
|
|
|
||||
Total operating expenses |
|
5,319,037 |
|
4,174,533 |
|
|
|
||||
Operating loss |
|
(5,210,099) |
|
(4,088,074) |
|
Other income |
|
18,448 |
|
17,711 |
|
Loss on derivative instruments |
|
(7,905,519) |
|
(8,618) |
|
Other non-operating gain (loss) |
|
1,455,844 |
|
(149,359) |
|
Interest expense, net |
|
(443,442) |
|
(1,786,228) |
|
|
|
||||
Net loss available to common shareholders |
$ |
(12,084,768) |
$ |
(6,014,568) |
|
Net loss per common share |
|||||
Basic and Diluted |
$ |
(0.37) |
$ |
(0.36) |
|
Weighted average common shares outstanding |
|||||
Basic and Diluted |
|
33,051,888 |
|
16,651,297 |
|
