VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) reported financial results for the fiscal year ended September 30, 2019. The Company also reported key clinical and corporate developments achieved during fiscal 2019.
Clinical and Corporate Developments included:
- In March and October 2019, the Independent Data Monitoring Committee (IDMC) for the Company's pivotal Phase 3 head and neck cancer study of its investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection) had an official review of the study data and recommended that the trial continue until the appropriate number of events has occurred. The data from all 928 enrolled patients were provided to the IDMC by the clinical research organization (CRO) responsible for data management of this Phase 3 study. At the most recent IDMC meeting in October 2019 the IDMC reviewed “progression free and overall survival and limited demographic and safety data available for the aforementioned protocol.”
- CEL-SCI is now awaiting final study results in its Phase 3 head and neck cancer trial. 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 were 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. In June 2019, CEL-SCI was also an exhibitor and showcased its presentation at the BIO International Convention where it 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 U.S. Patent and Trademark Office granted CEL-SCI two patents for its LEAPS technology during fiscal 2019. As announced in January 2019, the patents relate to methods for diagnosing, preventing, and treating disease by generating or modulating the immune response through the use of specific peptides.
- Two scientific articles regarding CEL-SCI’s LEAPS program were published in March and July 2019. The Journal of Clinical & Cellular Immunology published “Why Don’t We Have a Vaccine Against Autoimmune Diseases?” co-written by Dr. Ken Rosenthal of Roseman University College of Medicine, and CEL-SCI’s Roy Carambula, Research Associate and Daniel Zimmerman Ph.D., Senior Vice President of Cellular Immunology. International Immunopharmacology published “Lessons From Next Generation Influenza Vaccines For Inflammatory Disease Therapies” authored by Dr. Zimmerman and two other CEL-SCI scientists, along with Dr. Rosenthal of Northeast Ohio Medical University and Roseman University.
- 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.
- CEL-SCI raised approximately $14.5 million during fiscal 2019 through the exercise of warrants.
“Following the two most recent data reviews of our Phase 3 head and neck cancer trial, the Independent Data Monitoring Committee (IDMC) recommended we continue the study until the appropriate number of events (deaths) have occurred in the two main groups. We found this recommendation very encouraging because it has been almost nine years since our study started, and more patients in our trial are surviving longer than had been anticipated,” stated CEL-SCI CEO, Geert Kersten.
“Since CEL-SCI is blinded to the study results, we do not know what proportion of the patients who are living longer than expected were treated with the Multikine regimen and what proportion received Standard of Care. However, it seems reasonable that a significant proportion of the patients who are living longer than predicted would have received the Multikine regimen because, to our knowledge, there has been no reported improvement in survival of the Standard of Care patients since our study began. We also believe the IDMC would not have recommended that we continue with this Phase 3 study if, after review of the clinical data, they had not seen that Multikine helps these cancer patients.”
“The goal of our Phase 3 study is to keep patients alive longer by improving the current ‘intent to cure’ first line cancer treatment. We believe the delay in reaching the required number of events, 298, to conclude our study may be a predictor of a better overall survival outcome than we originally hypothesized. Yervoy, the first approved cancer immunotherapy blockbuster drug had a similar situation in its Phase 3 trial and this turned out to be a huge blessing for both patients and Bristol-Myers Squibb shareholders. At CEL-SCI, we are hoping for a similar outcome,” Kersten concluded.
CEL-SCI reported a net loss of $22.1 million in fiscal year 2019 versus a net loss of $31.8 million in fiscal 2018. The decreased net loss in 2019 was mainly due to the non-cash derivative loss of approximately $0.8 million and $8.6 million recorded during the years ended September 30, 2019 and 2018, respectively, and the decrease in net interest expense of approximately $2.4 million during the year ended September 30, 2019 compared to the year ended September 30, 2018. The decrease in interest expense was primarily due to interest incurred relating to CEL-SCI’s convertible debt, all of which was converted by September 30, 2018. The derivative loss variation was the result of the change in fair value of the derivative liabilities during the period which was caused by an increase in the share price of CEL-SCI’s common stock.
The Company’s audited financial statements contained an audit opinion from its independent registered public accounting firm that included an explanatory paragraph related to the Company’s ability to continue as a going concern.
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 the investigational product 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 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 are treated with the Multikine treatment regimen 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. 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 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, 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.
CEL-SCI CORPORATION |
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STATEMENTS OF OPERATIONS |
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YEARS ENDED SEPTEMBER 30, 2019 and 2018 |
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2019 |
|
2018 |
||||||
Grant income |
$ |
462,754 |
|
$ |
476,556 |
|
||
Operating expenses: |
||||||||
Research and development |
|
12,659,287 |
|
|
10,914,531 |
|
||
General & administrative |
|
7,998,573 |
|
|
6,334,271 |
|
||
Total operating expenses |
|
20,657,860 |
|
|
17,248,802 |
|
||
Operating loss |
|
(20,195,106 |
) |
|
(16,772,246 |
) |
||
Other income |
|
73,022 |
|
|
70,896 |
|
||
Loss on derivative instruments |
|
(760,603 |
) |
|
(8,643,561 |
) |
||
Other non-operating gain (loss) |
|
545,528 |
|
|
(2,276,604 |
) |
||
Interest expense, net |
|
(1,797,481 |
) |
|
(4,215,690 |
) |
||
Net loss |
|
(22,134,640 |
) |
|
(31,837,205 |
) |
||
Modification of warrants |
|
- |
|
|
(14,368 |
) |
||
|
|
|||||||
Net loss available to common shareholders |
$ |
(22,134,640 |
) |
$ |
(31,851,573 |
) |
||
Net loss per common share, basic and diluted |
$ |
(0.71 |
) |
$ |
(1.87 |
) |
||
Weighted average common shares outstanding, basic and diluted |
|
31,174,394 |
|
|
17,004,722 |
|
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