0001654954-18-003636.txt : 20180405 0001654954-18-003636.hdr.sgml : 20180405 20180404174634 ACCESSION NUMBER: 0001654954-18-003636 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 5 CONFORMED PERIOD OF REPORT: 20180403 ITEM INFORMATION: Material Modifications to Rights of Security Holders ITEM INFORMATION: Other Events ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20180405 DATE AS OF CHANGE: 20180404 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: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 001-11889 FILM NUMBER: 18738383 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 8-K 1 cvm_8k.htm CURRENT REPORT Blueprint
 
 

UNITED STATES
SECURITIES AND EXCHANGE COMMISSION
WASHINGTON, D.C. 20549
 
FORM 8-K
 
CURRENT REPORT
 
Pursuant to Section 13 or 15(d) of the
Securities Exchange Act of 1934
 
Date of Report (date of earliest event reported): April 3, 2018
 
CEL-SCI CORPORATION
(Exact name of Registrant as specified in its charter)
 
 Colorado
 
 001-11889
 
 84-0916344
 (State or other jurisdiction of incorporation)
 
 (Commission File No.)
 
 (IRS Employer Identification No.)
 
8229 Boone Boulevard, Suite 802
Vienna, Virginia  22182
 (Address of principal executive offices, including Zip Code)
 
Registrant’s telephone number, including area code:    (703) 506-9460
 
N/A
(Former name or former address if changed since last report)
 
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligations of the registrant under any of the following provisions:
 
Written communications pursuant to Rule 425 under the Securities Act (17CFR 230.425)
 
Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
 
Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b)
 
Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-14c))
 
Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§203.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§204.12b-2 of this chapter.
 
Emerging growth company ☐
 
If an emerging growth company, indicate by check mark if the registrant has elected not to use the extended transition period for complying with any new or revised financial accounting standards provided pursuant to Section 13(a) of the Exchange Act. ☐
 

 
 
 
Item 3.03.    Material Modification to Rights of Security Holders.
 
On April 3, 2018 the exercise price of the Company’s outstanding Series S warrants (CUSIP number 150837177), that are publicly traded under the symbol “CVM WS” on the NYSE American, was changed to $1.75 per share until June 11, 2018. After this date, the exercise price will revert back to $31.25 per share of common stock. As a result of the reverse stock split which became effective on the NYSE American on June 15, 2017, 25 Series S warrants are required to purchase one share of common stock. The Series S warrants expire on October 11, 2018.
 
The Company issued a press release, filed as Exhibit 99.1, announcing the repricing of the exercise price of the Series S warrants.
 
Item 8.01    Other Events.
 
On April 4, 2018, the Company issued a press release, filed as Exhibit 99.2, providing an updated on the status of the Phase 3 clinical study and the arbitration suit the Company filed against the former clinical research organization for our Phase 3 trial.
 
Item 9.01.    Financial Statements and Exhibits.

Exhibit
 
Description
 
 
 
 
Press Release dated April 3, 2018
 
 
  
 
Press Release dated April 4, 2018
 
 
2
 
 
SIGNATURES
 
Pursuant to the requirements of the Securities Exchange Act of 1934, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
 
 
 
 CEL-SCI CORPORATION
 
 
 
 
 
Date: April 4, 2018
By:  
/s/ Geert Kersten
 
 
 
Geert Kersten
 
 
 
Chief Executive Officer
 

 
 
 
 
                  

 
3
EX-99.1 2 cvm_ex991.htm PRESS RELEASE Blueprint
Exhibit 99.1
 
NEWS RELEASE
 

8229 Boone Boulevard, Suite 802
Vienna, VA 22182. USA
Telephone (703) 506-9460
www.cel-sci.com
COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
 
CEL-SCI ANNOUNCES ADJUSTMENT TO WARRANT EXERCISE PRICE
 
Vienna, VA, April 3, 2018 – CEL-SCI Corporation (NYSE American: CVM) announced today that the outstanding Series S warrants (CUSIP number 150837177) that are publicly traded under the symbol “CVM WS” on the NYSE American have been repriced to $1.75 per share of common stock until June 11, 2018. After this date, the exercise price will revert back to $31.25 per share of common stock. Twenty-five (25) warrants are required to purchase one share of common stock. The warrants expire on October 11, 2018.
 
About CEL-SCI Corporation
 
CEL-SCI is a Phase 3 cancer immunotherapy company. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection), BEFORE they have received surgery, radiation and/or chemotherapy, at a time when the immune system should be at its strongest. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma.
 
The Company’s LEAPS technology is being developed as a potential therapeutic vaccine for rheumatoid arthritis and is supported by a grant from the National Institute of Arthritis and Musculoskeletal and Skin Diseases of the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
 
Forward-Looking Statements
 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, 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 that 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’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2017. 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.
 
* 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
 
 

 
EX-99.2 3 cvm_ex992.htm PRESS RELEASE Blueprint
 Exhibit 99.2
NEWS RELEASE
 
 

 
8229 Boone Boulevard, Suite 802
Vienna, VA 22182. USA
Telephone (703) 506-9460
www.cel-sci.com
 COMPANY CONTACT:
Gavin de Windt
CEL-SCI Corporation
(703) 506-9460
 
CEL-SCI CORPORATION ISSUES LETTER TO SHAREHOLDERS
 
Vienna, VA, April 4, 2018 -- CEL-SCI Corporation (NYSE American: CVM) today issued a letter to its shareholders.
 
Dear Fellow Shareholders,
 
We have achieved significant progress towards completing and reporting results on our Phase 3 head and neck cancer study for our lead investigational immunotherapy Multikine* (Leukocyte Interleukin, Injection). The study is fully enrolled. We are following the study subjects for outcomes and will be able to analyze all of the data for safety and efficacy when 298 deaths have occurred in the two main comparator arms of the study and the corresponding data have been recorded in the study database. Based on overall survival data available in the scientific literature for the study’s patient population, advanced primary head and neck cancer patients, and the fact that all of the patients in our Phase 3 study were enrolled between 2011 and September 2016, the time when 298 deaths will be reached in the combined comparator arms of the study should be near.
 
The primary efficacy endpoint of the study is a 10% improvement in overall survival of the Multikine treatment regimen plus Standard of Care (SOC) vs. Standard of Care alone. Late last year, the study’s Independent Data Monitoring Committee (IDMC) completed a review of the data from all 928 patients enrolled in the study and found no evidence of any significant safety questions and recommended the study continue as constituted. Once completed, should the study meet its primary efficacy endpoint of 10% improvement in overall survival, CEL-SCI plans to apply for regulatory approval in major markets including the United States and the European Union. Head and neck cancer accounts for about 6% of all cancers worldwide.
 
In the $50 million-plus arbitration suit we filed against the former clinical research organization (CRO) for our Phase 3 trial, we are pleased to report that during the past few months, both parties have filed their closing briefs and subsequently also their responsive briefs. That only leaves the closing arguments which are scheduled to be delivered this month, April 2018. This final stage of the arbitration will take place on two consecutive days, with one party presenting their closing arguments one day and the other party presenting the next day. The arbitration suit was filed in October 2013 by CEL-SCI, seeking at least $50 million from the CRO that originally ran the Phase 3 head and neck cancer study. CEL-SCI's arbitration claim alleges (i) breach of contract, (ii) fraud in the inducement, and (iii) common law fraud. We look forward to a productive end to the arbitration suit in the near term.
 
CEL-SCI’s clinical development program for our LEAPS (Ligand Epitope Antigen Presentation System) vaccine platform technology continues to advance with the support of a $1.5 million grant from the U.S. National Institutes of Health (NIH) to develop CEL-4000, our rheumatoid arthritis candidate treatment vaccine, the first product based on our LEAPS platform. Data from pre-clinical studies currently being conducted will be used in support of an Investigational New Drug (IND) application we plan to file with the FDA for CEL-4000. CEL-SCI was recently issued a patent from the US Patent and Trademark Office for our LEAPS platform technology.
 
 
1
 
 
In the near term, we look forward to the completion of our arbitration suit against the former CRO and we also look forward to receiving results on both the completion and corresponding top line data on our Phase 3 head and neck cancer trial.
 
We thank you for your continued support of our Company.
 
Sincerely,
 
Geert Kersten
Chief Executive Officer
 
About CEL-SCI Corporation
 
CEL-SCI is a Phase 3 cancer immunotherapy company. The Phase 3 study is fully enrolled with 928 patients. When it comes to cancer immunotherapy, CEL-SCI believes it is most logical to boost the patient’s immune system while it is still intact in order to have the greatest possible impact on survival. Therefore, CEL-SCI treats patients who are newly diagnosed with head and neck cancer with its lead investigational immunotherapy Multikine (Leukocyte Interleukin, Injection), BEFORE they have received surgery, radiation and/or chemotherapy. This approach is unique. Most other cancer immunotherapies are used only after conventional therapies have been tried and/or failed. Head and neck cancer represents about 6% of all cancers. Multikine has received Orphan Drug designation from the FDA for the treatment of head and neck cancer patients with advanced squamous cell carcinoma. CEL-SCI has received patents for Multikine from the US, Europe, China and Japan.
 
The Company’s LEAPS technology is being developed as a therapeutic vaccine for rheumatoid arthritis and is supported by grants from the National Institutes of Health. The Company has operations in Vienna, Virginia, and in/near Baltimore, Maryland.
 
Forward-Looking Statements
 
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. When used in this press release, 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 that 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’s filings with the Securities and Exchange Commission, including but not limited to its report on Form 10-K for the year ended September 30, 2017. 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.
 
* 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. Moreover, no definitive conclusions can be drawn from the early-phase, clinical-trials data involving the investigational therapy Multikine. Further research is required, and early-phase clinical trial results must be confirmed in the Phase 3 clinical trial of this investigational therapy that is in progress.
 
 

 
2
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