Messages to Shareholders various dates, most recent and earlier 
CEL-SCI Corporation CEO, Geert Kersten

 


CEL-SCI Corporation Releases Letter to Shareholders Wednesday March 30, 10:25 am ET VIENNA, Va., March 30 /PRNewswire-FirstCall/ -- The following letter is being released by CEL-SCI CORPORATION (Amex: CVM - News) to its shareholders: Dear Fellow Shareholders: Great Britain's highly regarded Prime Minister in the mid-1800s, Benjamin Disraeli, said: "Nurture your mind with great thoughts, for you will never go any higher than you think." When we set out to develop our immunotherapy drug MultikineŽ, we had great thoughts. Since that time our thoughts for Multikine and its potential impact on the treatment of cancer have remained great and high. The filing of the Phase III application with the U.S. Food and Drug Administration ("FDA") for Multikine at the end of last year is expected to lead us to the last phase of this very important mission. While we are one of hundreds of companies working on a cancer therapy, we are trying to achieve something different from most. Shareholders should understand our mission as it impacts on their investment. The best of missions would be to develop a method of prevention for cancer. However, since that is not currently feasible, CEL-SCI's mission is to make the first cancer treatment more effective, to ensure that the tumor will not recur. We question whether the hugely expensive interventions in the treatments of terminal patients make sense, whether they add to the quality of life of the patients and whether they are affordable to the already overburdened and ever-growing healthcare system. Are we not better off investing in making the first cancer treatment more successful, thereby reducing the number of terminal cancer patients? This approach seems better for both the patient as well as the financial health of the healthcare system. Clearly, considering the budget pressures faced by most governments, new drug development will have to move in this direction. CEL-SCI hopes to be in the forefront of developing products that can prosper in this changed environment. Our ultimate goal is to have Multikine added as an adjuvant to the first line cancer therapy of many different cancers to increase the success rate of that first-line therapy. The Phase III protocol that was submitted to FDA is for the treatment of advanced primary squamous cell carcinoma of the oral cavity (head & neck cancer). The protocol was designed in consultation with a group of recognized experts in the field of head & neck cancer therapy. It was designed to develop the conclusive evidence of the safety and efficacy of Multikine in the treatment of advanced primary squamous cell carcinoma of the oral cavity that would be required to license the product. This protocol needs to be discussed with the regulators to ensure that it meets all of their requirements and to obtain their concurrence. We hope to have this completed in the second quarter of 2005. The proposed Phase III trial, which is expected to enroll about 500 patients, will test the hypothesis that Multikine treatment prior to the surgical resection of the tumor and involved lymph nodes followed by radiotherapy or radiotherapy together with concurrent chemotherapy, will enhance local / regional control, reduce the rate of disease progression and extend the time of progression free survival in patients with advanced oral squamous cell carcinoma. We believe that Multikine's unique mechanism of action will be beneficial to cancer patients. Multikine is different and distinct from current standard therapies and imparts anti-tumor immune activation which constitutes an additional anti-tumor mechanism of action not available to patients through surgery, radiotherapy and chemotherapy. Multikine may also enhance the success of radiotherapy and chemotherapy. Also, unlike most current cancer therapies, Multikine has been remarkably well tolerated by patients who have received it and no major toxicities have been associated with its use. In closing, we view Multikine as a unique weapon added to the existing anti-cancer treatments with the goal of improving the patient's chance for a cure. This is clearly a very exciting time for all of us. We will keep you updated as we learn more. Thank you for your support during many trying years. Geert Kersten Maximilian de Clara Chief Executive Officer President Dear Fellow Shareholders: Imagine that you come across a company with a unique cancer drug which, following just a few weeks of non-toxic treatment, kills a large number of cancer cells, renders the remaining cancer cells more susceptible to follow-on radiation and chemotherapy, appears to reduce the cancer recurrence and even appears to lower cholesterol levels in the blood. On top of this you learn that the company has just submitted to FDA a Phase III head & neck cancer clinical trial protocol designed to produce the data required for approval to market the drug. If this company were private and ready to go public, its valuation might be a few hundred million dollars. But, since it has been public for years, the initial excitement has worn off and the company's valuation is much lower. The company I just described is our company, CEL-SCI. I believe that there are times when investors shun biotech stocks or, vice-a-versa, fall in love with them for no apparent reason, and that these emotional investment "waves" represent opportunities for investors willing to take risks. I further believe that the stage of entering Phase III clinical trials is a very important one for CEL-SCI, for the investment community as well as for partnering negotiations. During the many years I have been in this business, I have seen a number of biotech companies, now very successful, in a similar position. Based upon the fact that biotech stocks are currently not "in fashion," but most likely will be at some point in the future, the fact that we are entering such an important stage and my own personal belief in our team and science, I once again have added significantly to my CEL-SCI stock position in the past year. Robert Collier, the well-known author, said that, "Success is the sum of small efforts, repeated day in and out ... ." I want to tell you how I, as the Chief Executive Officer of the Company, see the rapid accumulation of small efforts at CEL-SCI starting to pay off. It has been a long road. During the past 10+ years we spent close to $40 million on the development of a validated manufacturing process for our immunotherapy drug Multikine(R). Also during the past 10 years we conducted multiple clinical studies with Multikine to determine how to best administer it. The studies were designed to determine the optimal dose to administer, the best route of administration, how frequently to give Multikine and for how long. They took a long time to complete because answers to one question needed to be found before the next question could be addressed. Based on this work we have determined how to best administer Multikine, its effects, its mechanism of action and even that it appears to reduce cholesterol levels in the blood. Our initial findings were published in December 2003 in The Laryngoscope and in June 2004 at the very prestigious American Society of Clinical Society (ASCO) conference. This, along with a lot of other work, culminated in the year-end submission to FDA of our Phase III protocol for advanced primary squamous cell carcinoma of the oral cavity. What may look like an old story to many investors has changed substantially in the past year. The question naturally arises as to the expected key events with regard to Multikine in 2005. I am hopeful that we will be cleared to enter a pivotal clinical study with Multikine by the second quarter of 2005. This approximately 500 patient study may be conducted in conjunction with our Asian partner Orient EuroPharma in the U.S. and internationally. The final details are all dependent on the regulators' requirements. I am further hopeful that we will receive one or more patents on Multikine. These patents will serve to enhance our most important protection from competitors, namely the unique manufacturing process. I also expect to see one or more important publications on Multikine during the year. My experience in the industry tells me that most data is not considered to be real until published. With regard to the L.E.A.P.S.(TM) technology, our other project that is funded mostly by government grants, I am hopeful that it may hold a few surprises as well. Our vision for Multikine is that it will some day be used as an addition to many different cancer treatments and for many different types of cancer to increase the survival rate of patients. We believe that Multikine contributes unique attributes to a combined cancer therapy that surgery, radiation or chemotherapy alone or in combination with one another cannot provide. While some patients seem to have no tumor remaining after Multikine treatment (ASCO June 2004), it is unreasonable to presume that any single cancer treatment modality alone will defeat a disease as insidious as cancer. It is for this reason that the proposed Phase III clinical trial was designed to add Multikine to a regimen of surgery followed by radiation or surgery followed by concurrent radiation and chemotherapy (standard therapy), with the control group receiving the standard therapy. Once this concept of using Multikine to enhance standard therapy has been proven in squamous cell carcinoma of the oral cavity (head & neck cancer), it can be tested in many other types of cancer since Multikine is not tumor specific. We have shown by pathology that Multikine by itself can reduce the number of, or in some cases, eliminate the cancer cells. This finding alone suggests that the combined treatment should be more successful. However, it has been discovered that in addition Multikine also appears to render remaining cancer cells more susceptible to follow-on radiation and chemotherapy (The Laryngoscope, December 2003). This additional effect should be particularly valuable to patients receiving combined treatment with radiation or concurrent radiation and chemotherapy. Preliminary follow-up data collected by one doctor outside of the Phase II protocol suggests that Multikine reduced the cancer recurrence rate in patients treated at one center. The controlled Phase III clinical trial we plan to initiate is designed to develop the statistically meaningful data to confirm this finding. If our initial findings are confirmed and the addition of Multikine to the existing cancer therapies gives substantial benefit to the patients, we expect Multikine to become a very important drug. During 2004 we also discovered that Multikine may have important uses beyond cancer. I was not surprised because I believe that the immune system is central to our health and therefore a drug like Multikine may be able to influence diseases in ways we cannot even imagine, yet. Multikine was shown in a meta-analysis to lower total cholesterol in clinical studies involving 120 head & neck cancer patients. This reduction in total cholesterol was considered to be highly statistically significant (p<0.0001). Most of the patients were treated with Multikine for 2 or 3 weeks, but some of them were treated for up to 24 weeks. A meta-analysis is a statistical procedure to combine a number of existing studies. Through such a procedure, effects which are hard or impossible to discern in the original smaller studies can be made visible as the meta- analysis is, in the ideal case, equivalent to a single study with the combined size of all the original studies. We are very interested in testing this new application for Multikine further, but we will only do so after we have entered pivotal clinical trials in head & neck cancer. In closing, I invested more money in CEL-SCI last year because I believe in the need for an immune system component of cancer therapy to enhance the success rate of the current cancer treatments and I believe that we may have the answer. I also believe that the fact that we have been around for a long time works against us because the "story is old". This means that we have a harder time being noticed on Wall Street, but it also creates more opportunity. The world is full of 10 or 20 year "overnight successes" and I can assure you that our great team is working hard to make us one of those. We wish you much health and happiness in 2005. Sincerely, Geert Kersten Chief Executive Officer Mr. Kersten is not recommending the purchase of CEL-SCI stock. He simply states that he purchased it and explains why. Dear Fellow Shareholders: There are times in the stock market when the baby gets thrown out with the bath water. Somehow we seem to have stumbled into one of those times. It appears that momentum investors have decided to leave the small cap and the biotech sectors and, as a result, almost every biotech company I know has seen a significant drop in its valuation, ours included. I can understand corrections of stock prices following bad results, but I have never understood the rapid and massive group movements of biotech stocks for no apparent reason. Judged by the phone calls from shareholders, there is the misconception that some negative news must have been released by our Company. This is not true!!!! The only news released by the Company has highlighted the recent very positive results of our research. Therefore I am one more time perplexed by the illogical herd mentality of the investors. Accordingly, this week I added to my already very sizable CEL-SCI stock position, purchasing over 125,000 shares of CEL-SCI stock in the open market. Overshadowed so quickly by the issue of the ever-changing stock price is the fact that there still exists a great need for a drug that will enhance the cure rate of the first cancer treatment. The company that succeeds in addressing that need will leave its shareholders very happy and help huge numbers of patients. Our immunotherapy drug Multikine(R) has shown results that may make this important goal possible, initially in head & neck cancer, and later on hopefully in other cancers too since Multikine is not tumor specific. To highlight what CEL-SCI has accomplished, let me reiterate the key findings with Multikine: 1) Phase II clinical trial data published by CEL-SCI in the Proceedings of the 40th ASCO Annual Meeting, June 5-8, 2004, describe a new, and seemingly more effective, way of activating a patient's immune response against cancer. This new finding may enable physicians to direct the immune response of a cancer patient in a way that defeats the tumor's defenses. The study showed a 42% response rate with a 12% cure rate after only three weeks of treatment prior to the standard therapy, surgery and radiation. We believe that the addition of this response to the clinical benefit conferred by surgery and radiation will increase the overall success rate seen in a combined therapy of Multikine/surgery/radiation when compared to surgery and radiation alone. 2) The publication of a clinical trial with Multikine in The Laryngoscope in December 2003 showed that Multikine may significantly increase the "kill rate" of cancer cells through radiation. This alone may make the surgery/radiation treatment more successful. 3) Follow-up data on disease recurrence is currently available for only 8 of the 27 patients treated with Multikine. For these 8 patients who were sequentially treated at one center, no disease recurrence was observed at 24 months post treatment. This contrasts with the scientific literature which reports that up to 50% of primary head and neck cancer patients will have a recurrence of the cancer within 18 to 24 months after surgery and/or radiation therapy. 4) Multikine has an excellent safety profile. 5) Additional papers will give more information. We are working on an FDA submission for a pivotal clinical trial to prove Multikine's utility as an anti-cancer agent. My own feeling, as well as the opinion of oncologists we have conferred with during the past months, is that we have collected excellent clinical data, have elucidated two mechanisms of action of Multikine and have shown great safety in a population of patients who have high levels of cancer recurrence. Our other technology, L.E.A.P.S.(R), with the peptide CEL-1000 as its lead product, is also doing well. Studies in the fields of bio-defense, vaccinia, viral encephalitis, herpes and autoimmune myocarditis are all ongoing with grant money from the U.S. government. These studies are being conducted at the U.S. Army, Johns Hopkins Medical Institutions, University of Nebraska and Northeastern Ohio Universities College of Medicine. Malaria vaccine work is ongoing at the U.S. Navy under a CRADA (Cooperative Research and Development Agreement). Various studies have shown very encouraging results, leading me to hope for future government grants to follow up the current results. The results will be announced to the shareholders through publication/presentation for the best scientific impact. It is also important for you to know that CEL-SCI is currently better financed that it has been in a long time since Wachovia, the third largest U.S. full-service brokerage firm and investment bank, helped us raise $5.25 million in equity capital in May of 2004. In short, since CEL-SCI is a small company in a very volatile sector, changes in the stock price often do not correlate with changes in the underlying business, up or down. I very much believe in the Company's science and its dedicated employees and have put even more of my own money into the Company. We are executing our plans and believe that we are taking all of the right steps in the development of our very important cancer drug. As I said before, if we are right, our shareholders will be very happy and we will help a huge numbers of patients. I thank you for your continued support. Sincerely, Geert Kersten Chief Executive Officer May 6, 2003

Dear CEL-SCI shareholder:

You may remember that, one month ago, Northeastern Ohio Universities College
of Medicine and CEL-SCI received a $1.1 million grant from the National
Institutes of Health for the development of CEL-SCI's new compound,
CEL-1000, as a possible treatment for viral encephalitis.  Viral
encephalitis is a potentially lethal inflammation of the brain.

More than 100 different types of viruses can cause acute encephalitis.  In
the United States, the most frequently reported causes are herpes simplex
virus type 1 (HSV-1) and type 2 (HSV-2) and viruses spread by insects.
These include: 
The West Nile Virus and three viruses that the U.S. government has included
in the second highest level immediate risk category for use as biological
weapons - The Venezuelan Equine Encephalitis (VEE), the Eastern Equine
Encephalitis (EEE) and Western Equine Encephalitis (WEE).

Antiviral drugs are available for the treatment of herpes simplex virus
infections, but antiviral drugs are not available for other encephalitis
causing viruses.

Today's Health section of the Washington Post has an excellent write-up on
some of the diseases mentioned above.  You can access the Health section via
the internet at <http://www.washingtonpost.com/wp-dyn/health/>

Sincerely,

Geert Kersten
Maximilian de Clara
Chief Executive Officer
President



December 16, 2002

Dear Fellow CEL-SCI Shareholder:

As we approach the holiday season and the end of 2002, I want to give you a
quick summary style update on our activities and want to thank you for your
support this year. 

We have been able to accomplish a huge amount this year in the face of a
very strong adversity in the stock market.  One key accomplishment is the
completion of a multi-year and very expensive manufacturing validation
program for our lead product Multikine.  The effect of this is two fold.
One, we were able to significantly reduce our expenses without hurting the
viability of the Company.  Two, the conclusion of the manufacturing
validation work was a requirement for the filing for Phase III clinical
trials.

We also finished enrollment in our last Phase II clinical trial for head &
neck cancer.  Our current focus is the compilation of all of the
manufacturing and clinical data for submission to FDA with the ultimate goal
of a Phase III clinical trial approval for head & neck cancer.

Our new product, CEL-1000, is entering new animal work in malaria, herpes
and chlamydia.

Discussions with potential partners are ongoing at various stages.

During the year we were one of a small number of publicly held biotech
companies able to raise capital.  I have every hope and intention for
CEL-SCI to continue on the path of successful money raising.

We are currently working on the publication of what we believe to be very
significant clinical data from our last, and biggest, head & neck cancer
clinical trial.  Based upon those results, I  believe that our type of
therapy, designed to save patients by making the first cancer treatment more
successful, has the potential to save the lives of hundreds of thousands of
people. 

I wish you a very Happy Holiday Season and healthy and successful New Year.

Sincerely yours,

Geert Kersten
Chief Executive Officer


September 20, 2002

Dear CEL-SCI Shareholder,

I want to make you aware of an article on the front page of today's
"Washington Post".  The article is entitled "Immune Cells Used to Stop
Severe Cancer:  New Approach Brings Success to an Old Idea".  The basic idea
behind this work conducted by Dr. Rosenberg's group at the National Cancer
Institute is very similar to CEL-SCI's Multikine* immunotherapy, but we
believe that Multikine will be commercially much cheaper and easier to
administer than Dr. Rosenberg's individualized therapeutic approach.

However, potentially more important to the value of our shares in the near
future is the reported success of this work in the media and the recognition
it brings to immunotherapy companies such as CEL-SCI.  This can be a
significant driver for shareholder value.  In fact, in my opinion, the
investors' belief that a "general cancer treatment approach" has great
promise is one of the most important drivers of share value, other than
profits.  The Biotech industry has many such examples.  The one that comes
to mind is the monoclonal antibody story.  First, investors loved them
(1980's), then they dumped them, and, when two monoclonals finally came to
market and showed success, the whole group of monoclonal antibody companies
had a huge run-up in stock prices. 

Personally, I believe that the immune system can be made to fight
cancer.  I have seen it in the cancer patients treated with our own
Multikine immunotherapy.  These patients are believers too.  The press has
not been a believer for a long time, but maybe that is changing and that
thought alone is worth this little note to you.

Sincerely,

Geert Kersten
CEO,
CEL-SCI Corporation