News / Events

CEL-SCI Corporation Reports Second Quarter Fiscal 2019 Financial Results

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.

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

Source: CEL-SCI Corporation