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    SEC Form DEFA14A filed by Cel-Sci Corporation

    4/29/22 4:09:40 PM ET
    $CVM
    Biotechnology: Biological Products (No Diagnostic Substances)
    Health Care
    Get the next $CVM alert in real time by email
    DEFA14A 1 cvm_defa14a.htm DEFA-14A cvm_defa14a.htm

     

    UNITED STATES

    SECURITIES AND EXCHANGE COMMISSION

    WASHINGTON, D.C. 20549

     

    SCHEDULE 14A INFORMATION

     

    Proxy Statement Pursuant to Section 14(a) of the Securities Exchange Act of 1934

     

    Filed by the Registrant     ☒

    Filed by a Party other than the Registrant     ☐

     

    Check the appropriate box:

     

    ☐     Preliminary Proxy Statement 

    ☐     Confidential, For Use of the Commission Only (As Permitted by Rule 14a-6(e)(2)) 

    ☐     Definitive Proxy Statement 

    ☒     Definitive Additional Materials 

    ☐     Soliciting Material under Rule 14a-12 

      

    CEL-SCI CORPORATION

    (Name of Registrant as Specified In Its Charter)

     

    _________________________________

    (Name of Person(s) Filing Proxy Statement, if other than the Registrant)

     

    Payment of Filing Fee (Check the appropriate box):

     

    ☒     No fee required 

     

    ☐     Fee computed on table below per Exchange Act Rules 14a-6(i)(1) and 0-11. 

     

     

    (1)

    Title of each class of securities to which transaction applies:

     

    (2)

    Aggregate number of securities to which transaction applies:

     

    (3)

    Per unit price or other underlying value of transaction computed pursuant to Exchange Act Rule 0-11 (set forth the amount on which the filing fee is calculated and state how it was determined):

     

    (4)

    Proposed maximum aggregate value of transaction:

     

    (5)

    Total fee paid:

     

    ☐     Fee paid previously with preliminary materials. 

        

    ☐     Check box if any part of the fee is offset as provided by Exchange Act Rule 0-11(a)(2) and identify the filing for which the offsetting fee was paid previously. Identify the previous filing by registration statement number, or the form or schedule and the date of its filing. 

        

     

    (1)

    Amount Previously Paid:

     

    (2)

    Form, Schedule or Registration Statement No.:

     

    (3)

    Filing Party:

     

    (4)

    Date Filed:

      

     

     

      

    CEL-SCI CORPORATION

    8229 Boone Blvd., Suite 802

    Vienna, Virginia 22l82

    (703) 506-9460

     

    April 2022

     

    Dear Fellow Shareholders:

     

    Thirty-five years ago I joined CEL-SCI as its second employee. The idea was to help cancer patients by activating the immune system to fight cancer. I had no idea how long and how difficult this journey would be. Throughout those years I was joined by the most amazing group of people: smart, kind, loyal and incredibly persistent. Most of our senior team has been together for almost 30 years.

     

    In early-2011, we started the Phase 3 study for our Multikine* in advanced primary head and neck cancer. No new therapies for this disease had been approved by the FDA in many decades. We were determined to show that adding our Multikine immunotherapy to the standard treatments of surgery, radiation and sometimes also chemotherapy could help patients live longer and better lives. Little did we know how long and hard that path would be—but we have now completed the Phase 3 study.

     

    In June 2021 we announced that we saw a huge survival benefit in our Phase 3 study for Multikine patients who received surgery and radiation after our Multikine treatment. Since that time we have received many calls asking us for additional trial data explaining how our Multikine could help these head and neck cancer patients live so much longer when other studies by big pharmaceutical companies have failed to show any survival benefit. We filed that very important additional clinical trial data with www.clinicaltrials.gov, the U.S. Government website for clinical trials, on March 22, 2022 and hoped that it would be public by now so that we could add the results to this letter. The information, however, is not yet public and could therefore not be included in this letter, but we hope that you will have seen the data by the time you receive this letter. Yet additional data will be presented and published in peer reviewed scientific forums in the future.

     

    The biotech stock market has been undergoing the worst sell-off in my 35 years in this business. That does not make things easier for us nor does it make us happy. However, we have been through many brutal downturns in the biotechnology markets and have always recovered. I believe that we are well positioned to recover from this storm as well since 1) we have cash until about the end of 2023 and 2) we have a finished 10-year clinical trial that has shown large survival benefit in a large cancer population that represents an unmet medical need. We have hired leading experts in the field to help get Multikine approved for sale. We are also working on scientific publications and the validation of our full scale manufacturing facility dedicated to making Multikine.

     

     
    2

     

     

    This is not a process where we can easily give simple and regular updates, as we must respect the integrity and confidentiality of the regulatory review process. Please keep in mind that we have dedicated our lives to this important project and we will do everything possible to make this happen.

     

    Thank you for your support.

     

    Sincerely,

     

    Geert Kersten

    Chief Executive Officer

     

    * Multikine (Leukocyte Interleukin, Injection) is the trademark that CEL-SCI has registered for this investigational therapy, and this proprietary name is subject to FDA review in connection with the Company’s 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.

     

     
    3

     

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