CEL-SCI Corporation Reports First Quarter Fiscal 2018 Financial Results

CEL-SCI Corporation (NYSE American: CVM) today reported financial results for the quarter ended December 31, 2017. The Company also reported key clinical and corporate developments achieved during the quarter.

Clinical and Corporate Developments included:

The Phase 3 head and neck cancer study's Independent Data Monitoring Committee (IDMC) completed a review of the data from all 928 patients enrolled in the study and recommended continuing the study as constituted, as there was no evidence of any significant safety questions.
It was determined that CEL-SCI’s Phase 3 head and neck cancer study is fully enrolled. All 928 patients are now being followed per the protocol. The primary endpoint of the study, a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone, will be determined after a total of 298 deaths have occurred in these two main comparator arms of the study and have been recorded in the study database. All that remains to be done in this pivotal Phase 3 study is to continue to track patient survival until the primary endpoint has been met.
The testimony phase of the arbitration concluded, and all that remained at the trial level as of early November 2017 were closing statements and post-trial submissions in CEL-SCI’s $50 million-plus arbitration suit against its former clinical research organization (CRO).
CEL-SCI fortified its patent portfolio with three new patents for LEAPS and Multikine.
CEL-SCI added a new member to its board of directors, Robert Watson, who has over 35 years of experience in the healthcare IT industry as a CEO, board member and advisor to multiple companies.

“We are proud of having completed enrollment and treatment in the world’s largest Phase 3 study in head and neck cancer. If the study meets its primary endpoint, our investigational immunotherapy Multikine could become the first FDA approved treatment for advanced primary head and neck cancer in over 60 years,” said CEL-SCI’s Chief Executive Officer, Geert Kersten.

“We are also pleased to advance our second product, our LEAPS vaccine technology, through two new patents, one for the platform technology itself, and another specifically for LEAPS’s treatment indication in rheumatoid arthritis. During the first quarter, our scientific team has been working on the preclinical studies funded by a recently awarded $1.5 million grant from the National Institutes of Health to advance our LEAPS rheumatoid arthritis vaccine towards human studies,” Kersten concluded.

CEL-SCI reported an operating loss of ($4,911,430) for the quarter ended December 31, 2017 versus an operating loss of ($4,938,008) for the quarter ended December 31, 2016. The research and development expenses decreased by approximately $1.2 million compared to the three months ended December 31, 2016 since the Phase 3 study is fully enrolled. The general and administrative expenses increased by approximately $1.3 million compared to the three months ended December 31, 2016. This increase is primarily due to an increase of approximately $1.1 million in equity based compensation related to the Company’s shareholder approved 2014 Incentive Stock Bonus Plan related to meeting the milestone of full enrollment of the Phase 3 trial, and an increase of approximately $200,000 in accounting fees.

About CEL-SCI Corporation

CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine (Leukocyte Interleukin, Injection), BEFORE they have received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma.

The Company’s LEAPS technology is 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.

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. 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, 2017. 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

STATEMENTS OF OPERATIONS

THREE MONTHS ENDED DECEMBER 31, 2017 AND 2016

(UNAUDITED)

2017 2016 Grant and other income

113,897

17,258

Operating Expenses: Research and development 2,326,014 3,548,257 General & administrative 2,699,313 1,407,009 Total operating expenses 5,025,327 4,955,266 Operating Loss (4,911,430 ) (4,938,008 ) (Loss) Gain on derivative instruments (958,230 ) 8,928,312 Interest expense, net (318,170 ) (469,151 ) Net (Loss) Income available to common shareholders

(6,187,830

)

3,521,153

NET (LOSS) INCOME PER COMMON SHARE BASIC

(0.53

)

0.59

DILUTED

(0.53

)

0.32

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING