VIENNA, Va.–(BUSINESS WIRE)–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. | ||||||||
Contacts
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460