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F. OPERATIONS AND FINANCING
6 Months Ended
Mar. 31, 2015
Notes to Financial Statements  
F. OPERATIONS, FINANCING

The Company has incurred significant costs since its inception in connection with the acquisition of certain patented and unpatented proprietary technology and know-how relating to the human immunological defense system, patent applications, research and development, administrative costs, construction of laboratory facilities, and clinical trials.  The Company has funded such costs with proceeds from loans and the public and private sale of its common and preferred stock.  The Company will be required to raise additional capital or find additional long-term financing in order to continue with its research efforts.  To date, the Company has not generated any revenue from product sales.  The ability of the Company to complete the necessary clinical trials and obtain US Food & Drug Administration (FDA) approval for the sale of its product candidates is uncertain. Ultimately, the Company must complete the development of its product candidates, obtain the appropriate regulatory approvals and obtain sufficient revenues from the sale of such product candidates, once approved, to support its cost structure.

 

The Company is currently running a large multi-national Phase 3 clinical trial for head and neck cancer with its partners TEVA Pharmaceuticals and Orient Europharma. This trial is currently primarily under the management of two clinical research organizations, or CROs, Aptiv Solutions, Inc., or Aptiv, and Ergomed Clinical Research Limited, or Ergomed. On March 31, 2015, the Company had approximately $2.6 million in cash on hand. During the six months ended March 31, 2015, the Company raised $6.4 million of net proceeds from several institutional investors. To finance the completion of its Phase 3 study and other clinical studies, the Company plans to raise additional capital in the form of corporate partnerships, debt and/or equity financings. On May 6, 2015, the Company announced that it has commenced an underwritten public offering of $35.0 million of its common stock. However, there is no assurance that the offering will be completed on these terms or at all, or that the Company will be successful in raising additional funds or that such funds will be available to the Company on acceptable terms or at all.  If the Company does not raise the necessary amounts of money, the Company will either have to slow down or delay the Phase 3 clinical trial or even significantly curtail its operations until such time as it is able to raise the required funding.

 

The Company estimates that the total remaining cost of the Phase 3 trial, excluding any costs that will be paid by our partners, will be approximately $24.4 million after March 31, 2015. This is in addition to the approximately $20.2 million that we have spent on the trial as of March 31, 2015. It should be noted that this estimate is only an estimate based on the information currently available in CEL-SCI’s contracts with its partners, including the CROs responsible for managing the Phase 3 trial. This number can be affected by the speed of enrollment, foreign currency exchange rates and many other factors, some of which cannot be foreseen today. It is therefore possible that the cost of the Phase 3 trial will be higher than currently estimated.

 

On July 15, 2014, the Company was awarded a Phase 1 Small Business Innovation Research (SBIR) grant in the amount of $225,000 from the National Institute of Arthritis Muscoskeletal and Skin Diseases, which is part of the National Institutes of Health. The grant will fund the further development of CEL-SCI’s LEAPS technology as a potential treatment for rheumatoid arthritis, an autoimmune disease of the joints. The Company recognizes revenue as the expenses are incurred. The amount of the grant earned during the six months ended March 31, 2015 was $92,073. As of March 31, 2015, the Company collected $81,176 of this grant and recorded a receivable of $10,897. The balance of the funds is expected to be collected by June 30, 2015.

 

The financial statements have been prepared assuming that the Company will continue as a going concern, but due to recurring losses from operations and future liquidity needs, there is substantial doubt about the Company’s ability to continue as a going concern. The financial statements do not include any adjustments that might result from the outcome of this uncertainty.