CEL-SCI Corporation Reports Second Quarter Fiscal 2014 Financial Results

Business Wire

VIENNA, Va.--(BUSINESS WIRE)--

CEL-SCI Corporation (NYSE MKT: CVM) today reported financial results for the quarter ended March 31, 2014.

Recent key corporate and clinical developments include:

  • Reported March and April 2014 as new record months for patient enrollment in the Company’s Phase III head and neck cancer trial.
  • The Investigational Review Board (IRB) of the U.S. Naval Medical Center, San Diego approved the start of a Phase I study of Multikine* (Leukocyte Interleukin, Injection) in HIV/HPV co-infected men and women with peri-anal warts.
  • Added the first expansion site in the U.S. at 21st Century Oncology in Greenville, North Carolina to the Phase III head and neck cancer trial.
  • Added a large number of clinical centers to the Phase III head and neck cancer trial around the world.
  • Listed warrants issued in connection with the October and December 2013 public offerings (NYSE MKT: CVM WS).

CEL-SCI reported an operating loss of ($6,226,435) for the quarter ended March 31, 2014 versus an operating loss of ($4,239,824) for the quarter ended March 31, 2013. The operating loss for the six months ended March 31, 2014 was ($12,160,745) versus ($9,283,337) during the six months ended March 31, 2013. The rise in operating loss was mostly attributable to an increase in research and development expenses to $8,173,539 in the first half of fiscal 2014 compared to $5,439,363 in the first half of fiscal year 2013. R&D expenses increased because of the expansion of the Company’s Phase III clinical study for head and neck cancer to additional clinical sites and an associated increase in patient enrollment.

CEL-SCI's net loss available to common shareholders for the quarter ended March 31, 2014 was ($13,365,580) or ($0.24) per basic share, versus ($713,371) or ($0.02) per basic share during the quarter ended March 31, 2013. The net loss available to common shareholders for the six months ended March 31, 2014 was ($18,817,445) or ($0.36) per basic share, versus ($3,023,617) or ($0.10) per basic share during the same six months ended March 31, 2013. The increase in net loss for the three and six month periods of 2014 as compared to the same periods in 2013 was primarily attributable to a non-cash charge for the change in value of derivative instruments caused by an increase in the Company’s common stock share price.

On March 31, 2014 the Company had approximately $10,600,000 in cash and cash equivalents. In April 2014, the Company raised an additional $9.84 million in net proceeds through the sale of common stock and warrants in a public offering and from the exercise of previously issued and outstanding warrants.

“We were again able to strengthen our cash position by securing an additional $13 million during March and April 2014. In addition, the enrollment in our Phase III trial continues to increase rapidly, culminating in a record number of patients enrolled in March, which was quickly surpassed by another record number enrolled in April. We expect to continue to build enrollment through the remainder of 2014. We also anticipate patient enrollment to begin soon in a Phase I study conducted by the U.S. Navy to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts,” stated CEL-SCI Chief Executive Officer Geert Kersten.

About Multikine

Multikine (Leukocyte Interleukin, Injection) is an immunotherapeutic agent that is being tested in an open-label, randomized, controlled, global pivotal Phase III clinical trial as a potential first-line treatment for advanced primary head and neck cancer. If approved for use following completion of CEL-SCI's clinical development program for head and neck cancer, Multikine would be a different type of therapy in the fight against cancer; one that appears to have the potential to work with the body's natural immune system in the fight against tumors. CEL-SCI is aiming to complete enrollment of subjects to the Phase III head and neck cancer study by the end of 2015. The trial is expected to expand into a total of approximately 100 clinical centers in about 20 countries.

In October 2013, CEL-SCI announced that it had signed a CRADA (Cooperative Research and Development Agreement) with the U.S. Naval Medical Center, San Diego, to develop Multikine as a potential treatment for HIV/HPV co-infected men and women with peri-anal warts. CEL-SCI also announced that it entered into two new co-development agreements with Ergomed to further clinically develop Multikine for cervical dysplasia/neoplasia in women who are co-infected with HIV and HPV and for peri-anal warts in men and women who are co-infected with HIV and HPV.

About CEL-SCI Corporation

CEL-SCI is dedicated to research and development directed at improving the treatment of cancer and other diseases by utilizing the immune system, the body's natural defense system. Its lead investigational therapy is Multikine (Leukocyte Interleukin, Injection), currently being studied in a pivotal global Phase III clinical trial. CEL-SCI is also investigating an immunotherapy (LEAPS-H1N1-DC) as a possible treatment for H1N1 hospitalized patients and as a vaccine (CEL-2000) for Rheumatoid Arthritis (currently in preclinical testing) using its LEAPS technology platform. The investigational immunotherapy LEAPS-H1N1-DC treatment involves non-changing regions of H1N1 Pandemic Flu, Avian Flu (H5N1), and the Spanish Flu, as CEL-SCI scientists are very concerned about the possible emergence of a new more virulent hybrid virus through the combination of H1N1 and Avian Flu, or maybe Spanish Flu. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.

For more information, please visit www.cel-sci.com.

* Multikine is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with our 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 (Leukocyte Interleukin, Injection). Further research is required, and early-phase clinical trial results must be confirmed in the well-controlled, Phase III clinical trial of this investigational therapy that is currently in progress.

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 which 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 Corporation's SEC filings, including but not limited to its report on Form 10-K for the year ended September 30, 2013. 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.

   
CEL-SCI CORPORATION
STATEMENTS OF OPERATIONS
THREE MONTHS ENDED MARCH 31, 2014 AND 2013
(unaudited)
 
2014 2013
 
OTHER INCOME $ 67,157 $ 15,405
 
OPERATING EXPENSES:

Research and development (excluding R&D depreciation of $41,718 and $55,957, respectively, included below)

4,153,998 2,515,585
Depreciation and amortization 51,444 90,413
General & administrative   2,088,150     1,649,231  
 
Total operating expenses   6,293,592     4,255,229  
 
OPERATING LOSS (6,226,435 ) (4,239,824 )
 
(LOSS) GAIN ON DERIVATIVE INSTRUMENTS (7,132,348 ) 3,538,264
 
INTEREST INCOME 30,882 30,952
 
INTEREST EXPENSE   (37,679 )   (42,763 )
 
NET LOSS $ (13,365,580 ) $ (713,371 )
 
NET LOSS PER COMMON SHARE
BASIC $ (0.24 ) $ (0.02 )
 
DILUTED $ (0.24 ) $ (0.14 )
 

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

BASIC 56,239,562 30,901,177
 
DILUTED 56,239,562 30,901,177
 
   
CEL-SCI CORPORATION
STATEMENTS OF OPERATIONS
SIX MONTHS ENDED MARCH 31, 2014 AND 2013
(unaudited)
 
2014 2013
 
OTHER INCOME $ 180,301 $ 30,405
 
OPERATING EXPENSES:

Research and development (excluding R&D depreciation of $83,391 and $160,820 respectively, included below)

8,173,539 5,439,363
Depreciation and amortization 108,143 223,863
General & administrative   4,059,364     3,650,516  
 
Total operating expenses   12,341,046     9,313,742  
 
OPERATING LOSS (12,160,745 ) (9,283,337 )
 
(LOSS) GAIN ON DERIVATIVE INSTRUMENTS (5,521,531 ) 6,284,462
 
INTEREST INCOME 62,639 60,367
 
INTEREST EXPENSE   (80,361 )   (85,109 )
 
NET LOSS (17,699,998 ) (3,023,617 )
 
ISSUANCE OF ADDITIONAL SHARES DUE TO RESET PROVISIONS   (1,117,447 )   -  
 
NET LOSS AVAILABLE TO COMMON SHAREHOLDERS $ (18,817,445 ) $ (3,023,617 )
 
NET LOSS PER COMMON SHARE
BASIC $ (0.36 ) $ (0.10 )
 
DILUTED $ (0.36 ) $ (0.31 )
 

WEIGHTED AVERAGE COMMON SHARES OUTSTANDING

BASIC 52,183,654 29,592,161
 
DILUTED 52,183,654 29,592,161
 

Contact:
CEL-SCI Corporation
Gavin de Windt, 703-506-9460

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