-----BEGIN PRIVACY-ENHANCED MESSAGE----- Proc-Type: 2001,MIC-CLEAR Originator-Name: webmaster@www.sec.gov Originator-Key-Asymmetric: MFgwCgYEVQgBAQICAf8DSgAwRwJAW2sNKK9AVtBzYZmr6aGjlWyK3XmZv3dTINen TWSM7vrzLADbmYQaionwg5sDW3P6oaM5D3tdezXMm7z1T+B+twIDAQAB MIC-Info: RSA-MD5,RSA, KFAZ7+s0GUkL8GtFwsZaHeLX2eIZYfEXkwsfd3ntm3aFYqsFyO+fQZDEx8qnN1sj QzJ2MeFsLKkueJVAmY/+lw== 0000950129-05-005320.txt : 20050516 0000950129-05-005320.hdr.sgml : 20050516 20050516070056 ACCESSION NUMBER: 0000950129-05-005320 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050516 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050516 DATE AS OF CHANGE: 20050516 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: 05831321 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 v09228e8vk.htm CYTRX CORPORATION - MAY 16, 2005 e8vk
 

 
 

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): May 16, 2005

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 Blvd., Suite 650
Los Angeles, CA
(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 provision (see General Instruction A.2 below):

¨     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))

 
 

 


 

Item 2.02. Results of Operations and Financial Condition.

     CytRx Corporation on May 16, 2005 issued a press release regarding its financial results for the quarter ended March 31, 2005. A copy of the press release is attached as Exhibit 99.1.

     The information in this report and the exhibit attached hereto shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, nor shall they be deemed incorporated by reference in any filing with the Securities and Exchange Commission under the Securities Exchange Act of 1934 or the Securities Act of 1933, except as shall be expressly set forth by specific reference in such filing.

Item 9.01. Financial Statements and Exhibits.

     The exhibit listed on the accompanying Index to Exhibits is filed herewith.

 


 

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
 
 
 
  By:   /s/ STEVEN A. KRIEGSMAN    
    Steven A. Kriegsman   
    President and Chief Executive Officer   
 

Dated: May 16, 2005

 


 

INDEX TO EXHIBITS

     
Exhibit   Description
 
99.1
  Press Release dated May 16, 2005

 

EX-99.1 2 v09228exv99w1.htm EXHIBIT 99.1 exv99w1
 

(CYTRX LOGO)

For Additional Information:

     
CytRx Corporation:
Ed Umali
Director of Corporate Communications
(310) 826-5648, ext. 309
eumali@cytrx.com
  Investor Relations Contacts:
Lippert/Heilshorn & Associates
Jody Cain (jcain@lhai.com)
Bruce Voss (bvoss@lhai.com)
(310) 691-7100

CytRx Corporation Reports First Quarter Financial Results

LOS ANGELES (May 16, 2005) – CytRx Corporation (Nasdaq: CYTR), a biopharmaceutical company engaged in the development and commercialization of human therapeutics primarily in the area of small molecules and ribonucleic acid interference (RNAi), today reported financial results for the quarter ended March 31, 2005.

“This has been a very busy and productive period,” said CytRx President and CEO Steven A. Kriegsman. “Among our achievements, we completed a financing that supports our planned entry into Phase II clinical trials with our lead compound arimoclomol. More recently, arimoclomol was granted orphan drug designation by the U.S. Food and Drug Administration (FDA) for the treatment of amyotrophic lateral sclerosis, also known as ALS or Lou Gehrig’s disease. In the quarter, we made substantial progress toward our planned initiation of a Phase II clinical trial for arimoclomol, which further marks CytRx’s maturation into a drug development company.”

Mr. Kriegsman noted, “Also, in collaboration with University of Massachusetts Medical School (UMMS) and Advanced Bioscience Laboratories (ABL), we moved ahead in a Phase I clinical trial using a DNA-based HIV vaccine technology, and enrollment in the study was completed approximately six months ahead of schedule.”

Review of Financial Results
For the first quarter of 2005, CytRx reported a net loss of $3.5 million, or $(0.07) per share, compared with a net loss of $3.8 million, or $(0.11) per share, for the comparable period in 2004.

Research and development (R&D) expenses were $1.9 million in the first quarter of 2005, compared with $2.3 million for the corresponding period in 2004. The decline in R&D expenses relates to a $1.1 million non-cash charge related to consulting services that was incurred in the first quarter of 2004 for which there was no corresponding expense incurred in the first quarter of 2005. This was substantially off-set during the first quarter of 2005 by our increased support of research activities conducted by UMMS, increased research and development activities occurring at CytRx Laboratories and preparatory activities associated with our planned initiation of our Phase II clinical trial for arimoclomol.

 


 

General and administrative expenses remained relatively unchanged at $1.7 million for the first quarters of 2005 and 2004. During the first quarter of 2005, the Company expensed $239,000 of common stock, stock options and warrants for general and administrative services compared with $454,000 for the corresponding period in 2004.

As of March 31, 2005, cash, cash equivalents and short-term investments totaled $19.5 million, compared with $3.0 million at December 31, 2004. Working capital was $17.7 million at March 31, 2005, compared with $1.3 million at December 31, 2004.

2005 and Recent Highlights
Highlights of the first three months of 2005 include the following:

•   CytRx substantially increased its liquid assets during the quarter through a private placement of 17,334,494 shares of its common stock, with net proceeds of $19.4 million. The company also issued five year warrants to purchase an additional 8,667,247 shares of common stock at an exercise price of $2.00 per share. The Company plans to use these funds to advance its clinical development of its lead compounds and fund its operations.
 
•   UMMS investigators completed enrollment and began inoculating the final group of volunteers in a Phase I clinical trial using a DNA-based HIV vaccine technology. The HIV vaccine was developed by UMMS and ABL and funded by a grant of approximately $16 million from the National Institute of Allergy and Infectious Diseases part of the National Institutes of Health. The HIV vaccine is licensed exclusively to CytRx by UMMS and ABL.
 
•   The Office of Orphan Products Development of the U.S. Food and Drug Administration (FDA) granted orphan drug status designation to the Company’s lead small molecule drug candidate, arimoclomol, for ALS.
 
•   CytRx continued with plans to file an IND with the FDA during the second quarter to its planned Phase II clinical trial using its compound arimoclomol for the treatment of ALS.

About CytRx Corporation

CytRx Corporation is a biopharmaceutical research and development company engaged in the development of products, primarily in the area of small molecules and ribonucleic acid interference (RNAi), in a variety of therapeutic categories. The Company owns three clinical-stage compounds based on its small molecule molecular “chaperone” co-induction technology, as well as a targeted library of 500 small molecule drug candidates that may be used to screen for new drug candidates. The Company expects to enter a Phase II clinical trial with its lead orally-administered small molecule drug candidate, arimoclomol, for the treatment of ALS (Lou Gehrig’s disease). CytRx also has a broad-based strategic alliance with the University of Massachusetts Medical School (UMMS) to develop novel compounds in the areas of ALS, obesity, type 2 diabetes and cytomegalovirus (CMV) using RNAi technology. CytRx also licensed from UMMS the rights to a DNA-based HIV vaccine technology currently in a Phase I clinical trial. The Company has a research program with

 


 

Massachusetts General Hospital, Harvard University’s teaching hospital, to use RNAi technology to develop a drug for the treatment of ALS. For more information, visit CytRx’s Web site at www.cytrx.com.

Forward-Looking Statements

     This press release may contain forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, that 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 or uncertainties related to the early stage of CytRx’s diabetes, obesity, CMV and ALS research, the need for future clinical testing of any RNAi-based products and small molecules that may be developed by CytRx, uncertainties regarding the scope of the clinical testing that may be required by regulatory authorities for its molecular chaperone co-induction drug candidates and other products and the outcomes of those tests, the significant time and expense that will be incurred in developing any of the potential commercial applications for CytRx’s RNAi technology or small molecules, CytRx’s need for additional capital to fund its ongoing working capital needs, including ongoing research and development expenses related to its molecular chaperone co-induction drug candidates, risks relating to the enforceability of any patents covering CytRx’s products and to the possible infringement of third party patents by those products, and the impact of third party reimbursement policies on the use of and pricing for CytRx’s products. Additional uncertainties and risks are described in CytRx’s most recently filed SEC documents, such as its most recent annual report on Form 10-K, all quarterly reports on Form 10-Q and any current reports on Form 8-K filed since the date of the last Form 10-K. 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.

[Tables to Follow]

 


 

CytRx Corporation
Condensed Consolidated Balance Sheets
(unaudited)

                 
    March 31,     December 31,  
    2005     2004  
Cash and short-term investments
  $ 19,522,000     $ 3,000,000  
 
Prepaids and other assets
    631,000       1,000,000  
 
           
 
Total Current assets
    20,153,000       4,000,000  
 
Non-current assets
    1,152,000       1,049,000  
 
           
 
Total assets
  $ 21,305,000     $ 5,049,000  
 
           
 
Current Liabilities
  $ 2,457,000     $ 2,735,000  
 
Non-current liabilities
    514,000       548,000  
 
           
 
Total liabilities
    2,971,000       3,283,000  
 
           
 
Minority interest
    132,000       171,000  
 
Shareholders equity
    18,202,000       1,595,000  
 
           
 
Total liabilities and stockholders’ equity
  $ 21,305,000     $ 5,049,000  
 
           
 
Working capital
  $ 17,696,000     $ 1,265,000  
 
           

 


 

CytRx Corporation
Condensed Consolidated Statement of Operations
(unaudited)

                 
    Quarter ended March 31,  
    2005     2004  
Revenues
  $ 2,000     $ 100,000  
 
           
 
Research and Development Expenses
    1,914,000       2,262,000  
 
General and administrative expenses
    1,695,000       1,670,000  
 
           
 
 
    3,609,000       3,932,000  
 
           
 
Loss before other income
    (3,607,000 )     (3,832,000 )
 
Other income
    81,000       58,000  
 
           
 
Net loss
  $ (3,526,000 )   $ (3,774,000 )
 
           
 
Loss per share of common stock
  $ (0.07 )   $ (0.11 )
 
           
 
Weighted average shares outstanding
    53,325,092       34,215,007  
 
           

 

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