0000799698-17-000019.txt : 20170613 0000799698-17-000019.hdr.sgml : 20170613 20170613171841 ACCESSION NUMBER: 0000799698-17-000019 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20170607 ITEM INFORMATION: Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers: Compensatory Arrangements of Certain Officers ITEM INFORMATION: Regulation FD Disclosure ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20170613 DATE AS OF CHANGE: 20170613 FILER: COMPANY DATA: COMPANY CONFORMED NAME: CYTRX CORP CENTRAL INDEX KEY: 0000799698 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 581642750 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-15327 FILM NUMBER: 17909645 BUSINESS ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 BUSINESS PHONE: 310-826-5648 MAIL ADDRESS: STREET 1: 11726 SAN VICENTE BOULEVARD STREET 2: SUITE 650 CITY: LOS ANGELES STATE: CA ZIP: 90049 8-K 1 form8k_06132017.htm ANNOUNCES RESHAPING OF CLINICAL AND REGULATORY EXECUTIVE TEAM


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 (Earliest Event Reported): June 7, 2017

CYTRX CORPORATION
(Exact Name of Registrant as Specified in its Charter)

Delaware
(State or Other Jurisdiction of Incorporation)

000-15327
(Commission File Number)
58-1642740
(I.R.S. Employer Identification No.)
   
11726 San Vicente Boulevard, Suite 650
Los Angeles, California
(Address of Principal Executive Offices)
 
90049
(Zip Code)
   
(310) 826-5648
(Registrant's Telephone Number, Including Area Code)
 
______________________________

Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the filing obligation of the Registrant under any of the following provisions:

 Written communications pursuant to Rule 425 under the Securities Act (17 CFR 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-4(c))

Indicate by check mark whether the registrant is an emerging growth company as defined in Rule 405 of the Securities Act of 1933 (§230.405 of this chapter) or Rule 12b-2 of the Securities Exchange Act of 1934 (§240.12b-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 5.02
Departure of Directors or Certain Officers; Election of Directors; Appointment of Certain Officers – Compensatory Arrangements of Certain Officers.
    The disclosures made below under Item 7.01, Regulation FD Disclosure, are incorporated by reference into this Item 5.02.
Item 7.01.   Regulation FD Disclosure
Shanta Chawla, M.D., is being promoted to Senior Vice President of Drug Development of CytRx Corporation ('we," "us," "our," "CytRx," or the "company"), effective June 13, 2017. Since joining CytRx in 2014, Dr. Chawla has served as our Vice President of Clinical Development. She will now assume the leadership of CytRx's on-going drug development and regulatory functions. The terms of her new employment agreement are being negotiated.
Dr. Chawla (69) is a board certified Internist with extensive experience in all phases of oncology drug development. For 11 years prior to joining CytRx in 2014, Dr. Chawla managed both oncology and non-oncology clinical trials at Spectrum Pharmaceuticals in Irvine, CA. She oversaw the development of belinostat (a pan HDAC inhibitor), which was approved by the FDA and is marketed as a second line therapy for T-cell lymphoma. Dr. Shanta Chawla is not related to our board member Anita Chawla, Ph.D., or to Dr. Sant Chawla, the principal investigator of CytRx's global Phase 3 clinical trial of aldoxorubicin for soft tissue sarcoma.
The position of Chief Operating Officer and Chief Medical Officer is being eliminated. Daniel Levitt, M.D, Ph.D., Chief Operating Officer and Chief Medical Officer, notified us on June 7, 2017 that he will be stepping down effective July 7, 2017. Scott Wieland, Ph.D., the company's Senior Vice President – Drug Development notified us on June 11, 2017 that he will also be stepping down, effective June 30, 2017.
On June 13, 2017, we issued a press release announcing the reshaping of CytRx's clinical and regulatory executive team as discussed in the previous paragraphs. A copy of the press release is attached hereto as Exhibit 99 and incorporated herein by reference.
The information in this Item 7.01 and Exhibit 99 attached hereto is being furnished and shall not be deemed "filed" for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended ("Exchange Act"), or otherwise subject to the liability of that section, nor shall such information be deemed incorporated by reference in any filing under the Exchange Act or the Securities Act of 1933, as amended, regardless of the general incorporation language of such filing, except as shall be expressly set forth by specific reference in such filing.
Item 9.01.    Financial Statements and Exhibits
   (d)           Exhibits
There is filed as part of this report, the exhibit listed on the accompanying Exhibit Index, which information is incorporated herein by reference.

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.
 
 
  CYTRX CORPORATION  
       
June 13, 2017
By:
/s/ JOHN Y. CALOZ  
    John Y. Caloz  
    Chief Financial Officer  
       
 
 

EXHIBIT INDEX

Exhibit No.
 
Description
99
 
Press release of CytRx Corporation issued June 13, 2017

 
EX-99 2 exh99_pr06132017.htm PRESS RELEASE DATED JUNE 13, 2017
 
 
EXHIBIT 99

CytRx Announces Reshaping of Clinical and Regulatory Executive Team
- Dr. Shanta Chawla promoted to Senior Vice President of Drug Development -
LOS ANGELES – June 13, 2017 – CytRx Corporation (NASDAQ: CYTR), a biopharmaceutical research and development company specializing in oncology, today announced that Shanta Chawla, M.D., who has served as the Company's Vice President of Clinical Development since 2014, is being promoted to Senior Vice President of Drug Development and will assume the leadership of CytRx's on-going clinical drug development and regulatory functions.  Additionally, CytRx is supported by Hurley Consulting Associates who has been and will continue to assist in the preparations for the aldoxorubicin New Drug Application (NDA) for soft tissue sarcomas.
"Dr. Shanta Chawla who is a Board certified physician has played a key role in the late-stage development and NDA submissions of several oncology drugs and has been involved in the day-to-day clinical development of aldoxorubicin for more than three years," said Steven A. Kriegsman, CytRx's Chairman and CEO.   "Together with the rest of our clinical and regulatory team and external regulatory counsel Dr. Margaret Hurley, a renowned drug development strategist, we remain well-equipped to execute on the regulatory strategy for aldoxorubicin."
Daniel Levitt, M.D., Ph.D., CytRx's Chief Operating and Medical Officer, is stepping down effective July 7, 2017, and the position will be eliminated.  Scott Wieland, Ph.D., the Company's SVP of Drug Development, will also be stepping down effective June 30, 2017.
Dr. Shanta Chawla is not related to our Board Member Dr. Anita Chawla or Dr. Sant Chawla, the principal investigator of CytRx's global Phase 3 clinical trial for soft tissue sarcoma.
About Soft Tissue Sarcoma
Soft tissue sarcoma is a cancer occurring in muscle, fat, blood vessels, tendons, fibrous tissues and connective tissue.  It can arise anywhere in the body at any age.  STS remains a high unmet medical need because of the difficulty in treating the more than 50 types of this aggressive cancer.  According to the American Cancer Society, in 2016 more than 12,300 new cases were diagnosed in the U.S. and approximately 5,000 Americans died from this disease.  In addition, approximately 40,000 new cases and 13,000 deaths in the U.S. and Europe are part of a growing underserved market.
About Aldoxorubicin
Aldoxorubicin is a rationally-engineered cytotoxic which combines doxorubicin, a widely used chemotherapeutic agent, with a novel linker molecule that binds directly and specifically to circulating albumin, the most abundant protein in the bloodstream.  Protein-hungry tumors concentrate albumin, which facilitates the delivery of the linker molecule with the attached doxorubicin to tumor sites.  In the acidic environment of the tumor, but not the neutral environment of healthy tissues, doxorubicin is released. Typically, doxorubicin is delivered systemically and is highly toxic, which limits its dose to a level below its maximum therapeutic benefit. Doxorubicin also is associated with many side effects, especially the potential for damage to heart muscle at cumulative doses greater than 450 mg/m2. Using this acid-sensitive linker technology, aldoxorubicin delivers greater doses of doxorubicin (3 ½ to 4 times). To date, there has been no evidence of clinically significant effects of aldoxorubicin on heart muscle, even at cumulative doses of drug well in excess of 6,500 mg/m2 of doxorubicin equivalents. Aldoxorubicin is the first-ever single agent to show superiority over doxorubicin in a randomized clinical trial in first-line STS.

About CytRx Corporation
CytRx Corporation is a biopharmaceutical research and development company specializing in oncology. CytRx currently is focused on the clinical development of aldoxorubicin, its improved version of the widely used chemotherapeutic agent doxorubicin.  CytRx is also expanding its pipeline of oncology candidates at its laboratory facilities in Freiburg, Germany, through its LADR™ (Linker Activated Drug Release) technology platform, a discovery engine designed to leverage CytRx's expertise in albumin biology and linker technology for the development of a new class of anti-cancer therapies.
Forward-Looking Statements
This press release contains forward-looking statements. Such statements involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements, including risks and uncertainties relating to the preparation and submission of an NDA for aldoxorubicin for the treatment of STS and FDA acceptance and review of any NDA, the risk that CytRx may be unsuccessful in obtaining FDA approval or, if approval is obtained, in commercializing aldoxorubicin in the United States or elsewhere, and other risks and uncertainties described in the most recent annual and quarterly reports filed by CytRx with the Securities and Exchange Commission and current reports filed since the date of CytRx's most recent annual report. All forward-looking statements are based upon information available to CytRx on the date the statements are first published. CytRx undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
Company Contact:
CytRx Corporation
David J. Haen
Vice President, Business Development and Investor Relations
(310) 826-5648, ext 304
dhaen@cytrx.com

Media Contact:
Argot Partners
Eliza Schleifstein
(973) 361-1546
eliza@argotpartners.com

Investor Relations Contact:
Argot Partners
Michelle Carroll
(212) 600-1902
michelle@argotpartners.com

###
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