CEL-SCI Corporation Reports First Quarter Fiscal 2020 Financial Results
February 10 2020 - 8:00AM
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.
CEL-SCI CORPORATION
CONDENSED STATEMENTS OF
OPERATIONS
THREE MONTHS ENDED DECEMBER 31,
2019 AND 2018
(UNAUDITED)
2019
2018
Grant income
$
35,506
$
126,414
Operating Expenses:
Research and development
4,196,613
3,471,714
General and administrative
2,638,896
1,689,162
Total operating expenses
6,835,509
5,160,876
Operating loss
(6,800,003
)
(5,034,462
)
Other income
18,448
17,911
Gain on derivative instruments
766,509
5,556,306
Other non-operating gains
790,669
1,152,176
Interest expense, net
(250,783
)
(446,029
)
Net (loss) income available to common
shareholders
$
(5,475,160
)
$
1,245,902
Net (loss) income per common share
BASIC
$
(0.16
)
$
0.04
DILUTED
$
(0.16
)
$
0.02
Weighted average common shares
outstanding
BASIC
35,084,279
27,985,327
DILUTED
35,098,608
29,929,353
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version on businesswire.com: https://www.businesswire.com/news/home/20200210005143/en/
Gavin de Windt CEL-SCI Corporation (703) 506-9460
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