VIENNA, Va., Dec. 12 The following letter is being released by CEL-SCI CORPORATION (NYSE Alternext US: CVM) to its shareholders:
Dear Fellow Shareholders:
Recently we have had two pieces of important news for CEL-SCI Corporation and its shareholders. First, the U.N. World Health Organization's Agency for Research on Cancer report, in reference to the "cancer burden" wrote that "the global burden doubled in the last 30 years of the 20th Century, and it is estimated that this will double again between 2000 and 2020 and nearly triple by 2030". Cancer will soon become the Number One killer in the world, ahead of heart disease. Those increases are much greater than many people had expected and clearly make our non-toxic Multikine cancer product even more important to develop. Second, we need your help with a legislative proposal advocated by the Biotechnology Industry Organization (BIO) which would help CEL-SCI bring Multikine to market faster. Last, what percentage of people do you think will get cancer and how many of them will die from it? The answer may shake you (see below).
Now let me share with you a staggering statistic. In a June 5, 2007 interview in the Wall Street Journal Genentech's CEO, Dr. Arthur Levinson, stated that that "42% of everybody out there is going to get cancer. And half of those 42% are going to die of cancer." That means that almost every 1 in 2 persons will get cancer. I have devoted my life to finding a new and better way of treating cancer, but I had no idea that the number was going to be that big. The effects on patients and their families from cancer are devastating. We must try to do better!
With that in mind I want to highlight a very recent effort by The Biotechnology Industry Organization (BIO) to help American biotechnology companies get through the current financial crisis. BIO is lobbying Congress to include tax provisions in fiscal stimulus legislation to help small, capital-intensive companies, such as CEL-SCI. The name of the proposal is "One Time Refund of NOLs in Lieu of Other Tax Benefits to Sustain Critical R&D During Financial Distress". The proposal is not a hand-out. It calls for Congress to allow small companies to "temporarily elect to receive a refund of their accumulated net operating losses (NOLs) at a discounted rate in lieu of claiming qualified research expenses." The plan, which applies only to tax year 2008, requires that refunds be reinvested in U.S. - based research. Refund recipients would permanently forgo the ability to claim all NOLs involved in the computation of the refund. This plan would really help CEL-SCI and might allow us to launch our very important Phase III clinical trial much faster. I ask you to please contact your Congressperson and Senator to express support for this
proposal. This is very important to everyone's life because, unfortunately, I do not know of any family that has escaped the devastating effects of cancer. Congresspersons and Senators listen to you, their constituents. I have already written to my own representatives.
Please write to your representatives right away and make a personal difference in the fight against cancer. Please tell them that you support the "One Time Refund of NOLs in Lieu of Other Tax Benefits to Sustain Critical R&D During Financial Distress" proposed by the Biotechnology Industry Organization (BIO). This is a critical bill and it needs your lobbying to become reality.
The internet address for contacting your Congressperson is: https://writerep.house.gov/writerep/welcome.shtml
The internet address for contacting your Senators is: http://www.senate.gov/general/contact_information/senators_cfm.cfm
We thank you for your support.
Chief Executive Officer
When used in this report, the words "intends," "believes," "anticipated" 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, 2007. 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.
In this letter I also want to review the general status of our Multikine cancer drug: 1. In the last few months we have hit major milestones. We signed a Multikine licensing agreement with Teva Pharmaceuticals, a multinational pharmaceutical company, which will participate in and pay for part of our Phase III trial, we took delivery of our new manufacturing facility in Baltimore (see the pictures at www.cel-sci.com and click on Updated Pictures of Manufacturing Facility), and we extended our existing Multikine partnership with Orient Europharma (OEP) of Taiwan to cover a larger territory. OEP, like Teva, will participate in and pay for part of the Phase III clinical trial. We also presented very promising results on a newly discovered rheumatoid arthritis vaccine. 2. Cancer, our main target for Multikine, is quickly becoming the number one killer, surpassing heart disease. Cancer treatment is not a discretionary expenditure and therefore pharmaceutical companies and investors alike are attracted to cancer therapies. 3. Many pharmaceutical companies are making cancer research a priority. This is a change from their prior focus on life style, mass marketed drugs. After the Vioxx debacle and other issues discovered later, it has become significantly more difficult to receive FDA approval for life style drugs. Recently Eli Lilly purchased the cancer company Imclone for $6.5 billion, Pfizer announced that it would focus on cancer and biologics (Multikine is a biologic for the treatment of cancer) and Roche is trying to purchase the half of the cancer company Genentech that it does not own for about $45 billion. 4. As a late stage Phase III cancer company focusing on a large unmet medical need, we believe that CEL-SCI is well positioned to partner Multikine with other companies and thereby pay for future development costs. 5. The reason we believe that Multikine is an attractive cancer therapy is because we have shown very good clinical data: a. 12% of patients receiving Multikine have no tumor left before the normal treatment has even started, b. overall the Multikine treated patients have 50% less tumor cells before the normal treatment has even started, and c. long-term survival improvement was 33%, all without Multikine induced toxicity. We believe that Multikine is able to achieve these excellent results for three reasons: a. Multikine is the first immunotherapy drug to be used before the immune system is destroyed by radiation and chemotherapy. Up to now other immunotherapy drugs have been given after radiation and chemotherapy, a time when the immune system is severely weakened. b. Multikine is also able to circumvent the tumor's defense mechanisms by creating a new and different attack through CD-4 cells instead of the usual CD-8 cells which the tumor has learned to shut down. c. Multikine renders the remaining tumor cells susceptible to the effect of the follow-on radiation and chemotherapy, thereby potentially increasing the effectiveness of these treatments. 6. Only one pivotal Phase III trial is needed to get to approval from the FDA and if approved, Multikine would become the first line standard of care in head and neck cancer, a multi-billion market.
SOURCE CEL-SCI Corporation