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CEL-SCI Corporation Reports Third Quarter Fiscal Year 2018 Financial Results

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CEL-SCI Corporation (NYSE:CVM) today reported financial
results for the quarter ended June 30, 2018. The Company also reported
key clinical and corporate developments achieved during the quarter.

Clinical and Corporate Developments included:

  • CEL-SCI's Phase 3 head and neck cancer study continued to follow all
    928 patients. Enrollment was completed in September of 2016. Based on
    published survival data, we believe top line results may be available
    as soon as early 2019. 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 deaths have occurred in the two main comparator arms of
    the study and have been recorded in the study database.
  • The US Patent and Trademark Office allowed two new patents to CEL-SCI
    for the Company's LEAPS platform technology. Titled "Method for
    Inducing an Immune Response and Formulations Thereof" and " Method for
    Inducing an Immune Response against avian, swine, Spanish, H1N1, H5N9
    influenza viruses and formulations", these patents relate to methods
    for diagnosing, preventing, and treating disease by generating or
    modulating the immune response through the use of specific peptides.
  • CEL-SCI won the arbitration against the clinical research organization
    (CRO) that ran the Phase 3 head and neck cancer study from 2011-2013.
    The arbitrator ruled that the CRO materially breached its contract
    with CEL-SCI. The arbitrator's decision has vindicated CEL-SCI. Many
    investment funds and analysts did not like the legal risk of this
    arbitration and now that the arbitration has been resolved in
    CEL-SCI's favor, this should no longer be an impediment to investors
    and should result in renewed investment interest in CEL-SCI. With the
    arbitration completed, CEL-SCI moves forward with a clean slate.

"We are proud of having run the largest head and neck cancer Phase 3
study in the world, in an indication that has not seen a new drug
approved by the FDA in over 60 years. This has not been easy for many
reasons, including the fact that our approach to immunotherapy involves
treating the patient when they first get diagnosed instead of using
immunotherapy as a last ditch option for survival. Our approach meant a
longer clinical trial period, with nearly one thousand patients
enrolled. Despite the many challenges of this study, we believe the
potential to bring a new immunotherapy to help save the lives of newly
diagnosed cancer patients has been worth it," said CEL-SCI's Chief
Executive Officer, Geert Kersten. "As we look forward to a readout of
the endpoint data which may happen in early 2019, we also continue to
develop our LEAPS technology platform with the support of the U.S.
National Institutes of Health. Should our Phase 3 results lead to
marketing approval in head and neck cancer, we will also have the
opportunity to purse clinical development and marketing approval of our
immunotherapy in other cancer indications."

During the nine months ended June 30, 2018, the Company's cash remained
constant. Cash used in operations of approximately $9.1 million was
offset by approximately $9.1 million in cash provided by financing
activities. Sources of financing during the nine months included
approximately $7.0 million in proceeds from the issuance of common stock
and warrants and $2.1 million in proceeds from the exercise of warrants.

CEL-SCI reported an operating loss of ($4,070,363) for the quarter ended
June 30, 2018 versus an operating loss of ($4,758,719) for the quarter
ended June 30, 2017. The operating loss was ($13,187,538) for the nine
months ended June 30, 2018 versus an operating loss of ($17,603,283) for
the nine months ended June 30, 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. 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

CONDENSED STATEMENTS OF OPERATIONS

THREE MONTHS ENDED JUNE 30, 2018 AND 2017

(unaudited)

 
2018 2017
 
Grant and other income $ 104,170 $ 17,389
 
Operating Expenses:
Research and development 2,425,562 3,180,401
General & administrative   1,748,971     1,595,707  
 
Total operating expenses   4,174,533     4,776,108  
 
Operating loss (4,070,363 ) (4,758,719 )
 
(Loss) gain on derivative instruments (8,618 ) 790,365
 
Interest expense, net   (1,935,587 )   (495,709 )
 
Net loss available to common shareholders $ (6,014,568 ) $ (4,464,063 )
 
 
Net loss per common share
Basic and diluted $ (0.36 ) $ (0.53 )
 
Weighted average common shares outstanding
Basic and diluted 16,651,297 8,405,790
 
   

CEL-SCI CORPORATION

CONDENSED STATEMENTS OF OPERATIONS

NINE MONTHS ENDED JUNE 30, 2018 AND 2017

(unaudited)

 
 
2018 2017
 
Grant and other income $ 350,029 $ 51,822
 
Operating Expenses:
Research and development 7,713,873 13,307,275
General & administrative   5,823,694     4,347,830  
 
Total operating expenses   13,537,567     17,655,105  
 
Operating loss (13,187,538 ) (17,603,283 )
 
Gain on derivative instruments 187,967 9,669,977
 
Interest expense, net   (3,910,962 )   (1,436,095 )
 
Net loss available to common shareholders $ (16,910,533 ) $ (9,369,401 )
 
 
Net loss per common share
Basic $ (1.17 ) $ (1.29 )
Diluted $ (1.17 ) $ (1.34 )
 
Weighted average common shares outstanding
Basic 14,486,351 7,235,140
Diluted 14,486,351 7,292,715

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