VIENNA, Va.--(BUSINESS WIRE)--CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2018.
- 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 has been met. 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 determined after a total of 298 events have occurred in the two main comparator arms of the study and have been recorded in the study database. These final results could come soon since the last patients were treated in September 2016.
- The U.S. Patent and Trademark Office issued two new patents for CEL-SCI’s LEAPS platform technology. The inventions relate to methods for diagnosing, preventing, and treating disease by generating or modulating immune response through the use of specific peptides.
- During the first quarter, CEL-SCI’s LEAPS platform technology continued its development program as a therapeutic vaccine for rheumatoid arthritis under a $1.5 million grant from the U.S. National Institutes of Health (NIH).
- Between January 1, 2019 and February 13, 2019, the Company received approximately $2.1 million through the exercise of warrants to purchase shares of the Company's common stock.
“During the first quarter of fiscal 2019, we continued to follow patients in our Phase 3 head and neck cancer trial, as we await a readout of topline results from this pivotal study, which may result in the first new approved first line therapy for advanced primary (not yet treated) head and neck cancer in over 60 years. Concurrently, we continue to advance our LEAPS platform through studies with the NIH while fortifying our intellectual property around this unique vaccine technology,” stated CEL-SCI CEO, Geert Kersten.
CEL-SCI reported a net income of $1.2 million for the quarter ended December 31, 2018 versus a net loss of $6.2 million for the quarter ended December 31, 2017. The net income increase was mainly due to the non-cash derivative gain of approximately $5.6 million for the three months ended December 31, 2018 versus a loss on derivative instruments of approximately $1.0 million for the three months ended December 31, 2017. Net interest expense also decreased by approximately $0.6 million for the three months ended December 31, 2018 compared to the three months ended December 31, 2017. The total operating expense remained constant for the quarter ended December 31, 2018 versus the quarter ended December 31, 2017.
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 the 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 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 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 Company's LEAPS technology is currently being developed as a 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.
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.
|CONDENSED STATEMENTS OF OPERATIONS|
|THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017|
|Research and development||3,132,188||2,326,014|
|General & administrative||2,028,688||2,699,313|
|Total operating expenses||5,160,876||5,025,327|
|Gain (loss) on derivative instruments||5,556,306||(958,230||)|
|Other non-operating gains||1,152,176||746,701|
|Interest expense, net||(446,029||)||(1,064,871||)|
|Net income (loss) available to common shareholders||$||1,245,902||$||(6,187,830||)|
|Net income (loss) per common share|
|Weighted average common shares outstanding|