If we are able to replicate the promising results seen in our earlier studies and prove that Multikine increases the overall survival of cancer patients by 10% (the study’s primary end point) or more, how much value will this create for our shareholders? No one knows exactly, but it should be significant. By way of example, in 2011 we witnessed the largest acquisition ever of a company with products still in clinical development, not yet on the market. Gilead Sciences bought Pharmasset (Hepatitis C) for about $11 billion in cash. The take home message from this acquisition is clear. Established pharmaceutical companies are willing to pay very large amounts of money for products that address both a large market and represent an unmet medical need. They prefer to wait until most of the risk has been taken off the table. Multikine addresses advanced primary (not yet treated) head and neck cancer, about 5-6% of the world’s cancer cases, clearly a large market. Advanced primary head and neck cancer also represents a clear unmet medical need.
The processes of manufacturing of biological substances and running clinical trials in cancer are extremely complex. We are able to do both because we have assembled a team of world experts who share our vision to help cancer patients. We thank you for your continued support and wish you a very happy, healthy and prosperous 2012.
|Geert Kersten||Maximilian de Clara|
|Chief Executive Officer||President|
* 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 report, 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, 2011. 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.