CEL-SCI Corporation Reports First Quarter Fiscal 2019 Financial Results

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.

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
THREE MONTHS ENDED DECEMBER 31, 2018 AND 2017
(UNAUDITED)
 
 
2018 2017
 
Grant income $ 126,414 $ 96,315
 
Operating Expenses:
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  
 
Operating loss (5,034,462 ) (4,929,012 )
 
Other income 17,911 17,582
 
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
BASIC $ 0.04 $ (0.53 )
DILUTED $ 0.02 $ (0.53 )
 
Weighted average common shares outstanding
BASIC 27,985,327 11,636,730
DILUTED 29,929,353 11,636,730
 

Contacts

Gavin de Windt
CEL-SCI Corporation
(703) 506-9460

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