CEL-SCI Corporation (NYSE American: CVM) today reported
financial results for the quarter ended March 31, 2019. The Company
also reported key clinical and corporate developments achieved
during the quarter.
Clinical and Corporate Developments included:
- At the end of March 2019, the IDMC
(Independent Data Monitoring Committee) had an official review of
the Phase 3 study and recommended to “continue the trial until the
appropriate number of events has occurred”.
- 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
(deaths) 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 Journal of Clinical & Cellular
Immunology published an article titled, “Why Don’t We Have a
Vaccine Against Autoimmune Diseases?” co-written by Dr. Ken
Rosenthal of Roseman University College of Medicine, and CEL-SCI’s
Roy Carambula, Research Associate and Daniel Zimmerman Ph.D.,
Senior Vice President of Research, Cellular Immunology. As
presented in the article, vaccines for autoimmune diseases need to
be therapeutic and focused on cellular immunity as CEL-SCI’s LEAPS
vaccine platform does, as compared to most current vaccines that
elicit a specific antibody response.
- On May 11, 2019, Dr. Zimmerman
presented new data for its LEAPS therapeutic antigen-specific
treatment for rheumatoid arthritis at the American Association of
Immunologists 103rd Annual Meeting. The work was performed in
conjunction with researchers at Rush University Medical Center,
Chicago, Illinois.
- CEL-SCI’s LEAPS platform technology was
selected by the U.S. National Institutes of Health (NIH) for
sponsorship to exhibit and showcase its presentation at the BIO
International Convention, to be held June 3-6, 2019 in
Philadelphia.
- The U.S. Patent and Trademark Office
issued two patents to CEL-SCI for its LEAPS platform vaccine
technology. One is titled “Method for inducing an immune response
and formulations thereof” and the other is titled “Method for
inducing an immune response for treatment of cancer and autoimmune
diseases or conditions”.
- Between April 1, 2019 and May 13, 2019,
the Company received approximately $7.6 million through the
exercise of warrants to purchase shares of the Company's common
stock.
“During the second quarter of fiscal 2019, we were pleased to
receive the IDMC’s recommendation to continue with our Phase 3
study until the appropriate number of events have occurred. Since
the IDMC reviews study data that is blinded to us, we believe their
recommendation affirms the study’s potential to meet the primary
survival endpoint. We believe this is a very positive sign,” stated
CEL-SCI CEO, Geert Kersten. “In addition to the Phase 3 head and
neck cancer, we continue to advance the development of our LEAPS
vaccine platform through new patents, new published scientific
papers, and ongoing studies with the National Institutes of
Health.”
CEL-SCI reported a net loss of $5.2 million for the six months
ended March 31, 2019 versus a net loss of $10.9 million for the six
months ended March 31, 2018. CEL-SCI reported a net loss of $6.4
million for the quarter ended March 31, 2019 versus a net loss of
$4.7 million for the quarter ended March 31, 2018.
During the six months ended March 31, 2019, the Company’s cash
decreased by approximately $4.8 million. Significant components of
this decrease included net cash used to fund the Company’s regular
operations, including its Phase 3 clinical trial, of approximately
$7.8 million and approximately $0.2 million to purchase long term
assets. The decrease was offset by net proceeds from the exercise
of warrants of approximately $3.3 million.
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 receiving the Standard of Care (SOC), which
involves surgery, radiation and/or 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 it is better able to mount an attack on the tumor. The aim
of treatment with Multikine is to increase the body’s immune system
against the tumor prior to SOC.
The Company’s LEAPS technology is currently being developed as a
therapeutic antigen-specific treatment 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 SIX MONTHS ENDED MARCH 31, 2019 AND 2018 (UNAUDITED)
2019 2018 Grant income $
277,183 $ 210,586 Operating Expenses: Research and
development 5,657,648 5,288,311 General & administrative
3,960,597 4,074,723 Total operating
expenses 9,618,245 9,363,034
Operating loss (9,341,062 ) (9,152,448 ) Other income 36,127
35,273 Gain on derivative instruments 4,589,135 196,585
Other non-operating gain (loss) 421,353 (22,109 )
Interest expense, net (907,332 ) (1,953,266 )
Net loss available to common shareholders $ (5,201,779 ) $
(10,895,965 ) Net loss per common share BASIC $ (0.18
) $ (0.81 ) DILUTED $ (0.19 ) $ (0.81 ) Weighted average
common shares outstanding BASIC 28,543,417 13,403,878 DILUTED
28,548,818 13,403,878 See notes to condensed financial
statements.
CEL-SCI CORPORATION CONDENSED STATEMENTS OF
OPERATIONS THREE MONTHS ENDED MARCH 31, 2019 AND 2018 (UNAUDITED)
2019 2018 Grant income $
150,769 $ 114,271 Operating Expenses: Research and
development 2,525,460 2,962,297 General & administrative
1,931,909 1,375,410 Total operating
expenses 4,457,369 4,337,707
Operating loss (4,306,600 ) (4,223,436 ) Other income 18,216
17,691 (Loss) gain on derivative instruments (967,171 )
1,154,815 Other non-operating loss (730,823 ) (768,810 )
Interest expense, net (461,303 ) (888,395 )
Net loss available to common shareholders $ (6,447,681 ) $
(4,708,135 ) Net loss per common share BASIC $ (0.22
) $ (0.31 ) DILUTED $ (0.22 ) $ (0.31 ) Weighted average
common shares outstanding BASIC 29,113,910 15,210,296 DILUTED
29,113,910 15,210,296 See notes to condensed financial
statements.
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Gavin de WindtCEL-SCI Corporation(703) 506-9460
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