VIENNA, Va.–(BUSINESS WIRE)–CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2019.
- In 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) performed 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. The IDMC reviewed “progression free and overall survival and limited demographic and safety data available for the aforementioned protocol.”
- The Company is now awaiting final study results for the Phase 3 trial, which is the largest study in the world in head and neck cancer. All that remains to be done is to continue to track patient survival until the required number of events have occurred and all of the data have been reviewed and recorded in the study database to allow a determination to be made if the primary endpoint has been met. The primary endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus standard of care (SOC) vs. SOC alone, the two main comparator arms of the study.
“Our study has now been running for 9 years with the last patients being enrolled in September 2016. We believe that the delay in reaching 298 events is a good sign for the study because patients appear to be living longer than was expected when the study was planned. However, we would be surprised if the study did not end soon. Since the study is well controlled and the SEER data base shows no improvement in the survival of patients treated with standard of care since the study began, it seems illogical that the patients living longer than expected would be patients receiving the standard of care therapies only. We are therefore preparing for commercial scale production of Multikine at our manufacturing facility,” stated CEL-SCI CEO, Geert Kersten.
In December 2019, the Company raised gross proceeds of approximately $5.5 million through an underwritten public offering of 606,395 shares of its common stock at a price of $9.07 per share. In January 2020, the underwriters fully exercised the over-allotment option of an additional 90,959 shares of common stock at a price of $9.07 per share bringing the total gross proceeds to approximately $6.325 million.
CEL-SCI reported a net loss of approximately $5.5 million for the quarter ended December 31, 2019 versus net income of approximately $1.2 million for the quarter ended December 31, 2018. The net income decrease was mainly due to the non-cash derivative gain of approximately $0.8 million for the three months ended December 31, 2019 versus a gain on derivative instruments of approximately $5.6 million for the three months ended December 31, 2018. Net interest expense also decreased by approximately $0.2 million for the three months ended December 31, 2019 compared to the three months ended December 31, 2018.
CEL-SCI’s total operating expense increased by approximately $1.6 million for the quarter ended December 31, 2019 versus the quarter ended December 31, 2018. General and administrative expenses increased by approximately $0.9 million compared to the three months ended December 31, 2018. Approximately $0.7 million of the change relates to an increase in the non-cash employee stock compensation expense. Research and development expenses increased by approximately $0.7 million compared to the three months ended December 31, 2018. Major components of this increase include approximately $0.7 million of cost incurred preparing the manufacturing facility for the potential commercial manufacture of Multikine, $0.5 million increase in non-cash employee stock option expense and $0.2 million increase in depreciation expense on the manufacturing facility as a result of adopting the new leasing standard. These increases were offset by a decrease of approximately $0.7 million in expenses related to the Company’s on-going Phase 3 clinical trial.
About CEL-SCI Corporation
CEL-SCI believes that boosting a cancer 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 newly diagnosed patients with advanced primary head and neck cancer with its investigational product Multikine right after diagnosis, BEFORE they received surgery, radiation and/or chemotherapy, the current standard of care for this indication. This approach is unique. Most other cancer immunotherapies are administered only after surgery etc. 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, about 6% of the world’s cancer cases. Per the study’s protocol, newly diagnosed, treatment naïve patients with advanced primary head and neck cancer are treated with the Multikine treatment regimen for 3 weeks prior to receiving the standard of care (SOC) which involves surgery plus radiation or surgery plus 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 to fight the tumor 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, in 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, 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 trials or nonclinical 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/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 |
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CONDENSED STATEMENTS OF OPERATIONS |
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THREE MONTHS ENDED DECEMBER 31, 2019 AND 2018 |
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(UNAUDITED) |
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2019 |
2018 |
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Grant income |
$ |
35,506 |
|
$ |
126,414 |
|
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Operating Expenses: |
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Research and development |
|
4,196,613 |
|
|
3,471,714 |
|
||
|
General and administrative |
|
2,638,896 |
|
|
1,689,162 |
|
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Total operating expenses |
|
6,835,509 |
|
|
5,160,876 |
|
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|
|
|
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Operating loss |
|
(6,800,003 |
) |
|
(5,034,462 |
) |
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Other income |
|
18,448 |
|
|
17,911 |
|
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Gain on derivative instruments |
|
766,509 |
|
|
5,556,306 |
|
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Other non-operating gains |
|
790,669 |
|
|
1,152,176 |
|
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Interest expense, net |
|
(250,783 |
) |
|
(446,029 |
) |
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|
|
|
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Net (loss) income available to common shareholders |
$ |
(5,475,160 |
) |
$ |
1,245,902 |
|
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Net (loss) income per common share |
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|
BASIC |
$ |
(0.16 |
) |
$ |
0.04 |
|
||
|
DILUTED |
$ |
(0.16 |
) |
$ |
0.02 |
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Weighted average common shares outstanding |
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BASIC |
|
35,084,279 |
|
|
27,985,327 |
|
||
|
DILUTED |
|
35,098,608 |
|
|
29,929,353 |
|
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Contacts
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460