0001654954-22-005667.txt : 20220429 0001654954-22-005667.hdr.sgml : 20220429 20220429160940 ACCESSION NUMBER: 0001654954-22-005667 CONFORMED SUBMISSION TYPE: DEFA14A PUBLIC DOCUMENT COUNT: 2 FILED AS OF DATE: 20220429 DATE AS OF CHANGE: 20220429 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CEL SCI CORP CENTRAL INDEX KEY: 0000725363 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 840916344 STATE OF INCORPORATION: CO FISCAL YEAR END: 0930 FILING VALUES: FORM TYPE: DEFA14A SEC ACT: 1934 Act SEC FILE NUMBER: 001-11889 FILM NUMBER: 22875372 BUSINESS ADDRESS: STREET 1: 8229 BOONE BLVD . STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 BUSINESS PHONE: 7035069460 MAIL ADDRESS: STREET 1: 8229 BOONE BLVD. STREET 2: SUITE 802 CITY: VIENNA STATE: VA ZIP: 22182 FORMER COMPANY: FORMER CONFORMED NAME: INTERLEUKIN 2 INC DATE OF NAME CHANGE: 19880317 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

 

GRAPHIC 2 cvm_defa14aimg1.jpg begin 644 cvm_defa14aimg1.jpg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