-----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, MQy8u17e/xqDXsKOisO87KT39VJoH8CfZFD0Bo5xf8+vdXi8zeOn5DO51yM1qHWP Wmx5nBRxS5QpVvSugBj+YQ== 0000950129-05-008260.txt : 20050815 0000950129-05-008260.hdr.sgml : 20050815 20050815161823 ACCESSION NUMBER: 0000950129-05-008260 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20050815 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20050815 DATE AS OF CHANGE: 20050815 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: 051026880 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 v11760e8vk.htm CYTRX CORPORATION e8vk
Table of Contents

 
 
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): August 15, 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):
o   Written communications pursuant to Rule 425 under the Securities Act (17 CFR 230.425)
o   Soliciting material pursuant to Rule 14a-12 under the Exchange Act (17 CFR 240.14a-12)
o   Pre-commencement communications pursuant to Rule 14d-2(b) under the Exchange Act (17 CFR 240.14d-2(b))
o   Pre-commencement communications pursuant to Rule 13e-4(c) under the Exchange Act (17 CFR 240.13e-4(c))
 
 

 


TABLE OF CONTENTS

Item 2.02. Results of Operations and Financial Condition.
Item 9.01. Financial Statements and Exhibits.
SIGNATURES
INDEX TO EXHIBITS
EX-99.1
Item 2.02. Results of Operations and Financial Condition.
     CytRx Corporation on August 15, 2005 issued a press release regarding its financial results for the quarter ended June 30, 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.

 


Table of Contents

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/ MATTHEW NATALIZIO    
    Matthew Natalizio   
    Chief Financial Officer   
 
Dated: August 15, 2005

 


Table of Contents

INDEX TO EXHIBITS
     
Exhibit   Description
 
   
99.1
  Press Release dated August 15, 2005.

 

EX-99.1 2 v11760exv99w1.htm EX-99.1 exv99w1
 

(CytRx Corporation Logo)
     
For Additional Information:
   
CytRx Corporation:
  Lippert/Heilshorn & Associates
Ed Umali
  Investor Contact:
Director of Corporate Communications
  Jody Cain (jcain@lhai.com)
(310) 826-5648, ext. 309
  Mariann Ohanesian (mohanesian@lhai.com)
eumali@cytrx.com
  Media Contact:
 
  Mark Stuart (mstuart@lhai.com)
 
  (310) 691-7100
CYTRX CORPORATION REPORTS SECOND QUARTER FINANCIAL RESULTS
LOS ANGELES (August 15, 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 June 30, 2005.
“We are fully committed to the clinical development of our oral drug candidate arimoclomol as a treatment for those suffering from the debilitating and life threatening consequences of ALS, also known as Lou Gehrig’s disease. We were pleased to have filed our investigational new drug (IND) application with the U.S. Food and Drug Administration (FDA) in May and we view the subsequent placement of this trial on clinical hold as only a delay as we provide additional information to the FDA. Our focus is squarely on providing a prompt, yet comprehensive response to the FDA’s information request,” said CytRx President and CEO Steven A. Kriegsman.
“While preparing our response to the FDA, which we expect to submit within the coming weeks, we are simultaneously undertaking steps necessary in preparation for entering the clinic with the goal of beginning this trial as soon as possible,” he added. “Our expectation is for trial initiation this year, and possibly even later in the current quarter.”
Review of Financial Results
For the second quarter of 2005, CytRx reported a net loss of $4.5 million, or $0.08 per share, compared with a net loss of $4.1 million, or $0.12 per share, for the comparable period in 2004. For the six months ended June 30, 2005, CytRx reported a net loss of $8.0 million, or $0.14 per share, compared with a net loss of $7.8 million, or $0.23 per share, for the six months ended June 30, 2004.
Research and development (R&D) expenses were $2.9 million in the second quarter of 2005, compared with $1.4 million for the corresponding period in 2004. The increase during the second quarter of 2005 was due primarily to 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 (G&A) expenses were $1.5 million for the second quarter of 2005 versus $2.6 million in the second quarter of 2004. The higher expenses incurred during the three month period ended June 30, 2004 primarily resulted from accounting fees associated with the Company’s change in auditors in 2004, severance payments to certain former executives, and legal fees related to both of the foregoing during those periods. During the second quarter of 2005, the Company expensed $77,000 of common stock, stock options and warrants for general and administrative services, compared with $375,000 for the corresponding period in 2004.
As of June 30, cash, cash equivalents and short-term investments totaled $15.8 million, compared with $3.0 million at December 31, 2004. The increase reflects completion of a private placement with net proceeds of $19.4 million in January 2005. Working capital was $13.4 million at June 30, 2005.
Recent Highlights
Updates on CytRx’s clinical program with arimoclomol for the treatment of ALS include:
  In May, CytRx filed an IND application with the FDA to initiate a Phase II clinical trial for arimoclomol for the treatment of ALS.
 
  In June, CytRx responded to an FDA request for additional information regarding arimoclomol.
 
  In July, the FDA announced the placement of a clinical hold on the Phase II trial pending review of additional information.
Other corporate announcements include:
  Release by the Massachusetts State Ethics Commission from a preliminary conflict of interest inquiry without a finding of any wrongdoing based on the Company’s retention of a consultant who had introduced the Company to UMMS. CytRx has a strategic relationship with UMMS.
 
  Management presentations at the UBS 2005 Global Pharmaceuticals Conference and the Rodman & Renshaw 2nd Annual Healthcare Conference, both held in May.
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 STATEMENTS OF OPERATIONS
(Unaudited)
                                 
    Three Months Ended     Six Months Ended  
    June 30,     June 30,  
    2005     2004     2005     2004  
Revenues:
                               
License fees
  $     $ 228,164     $ 1,500     $ 328,164  
 
                       
Total Revenues
          228,164       1,500       328,164  
 
                       
Expenses:
                               
Research and development (includes $38,000 and $90,000 of non-cash stock-based expense for the three and six month periods ended June 30, 2005, respectively, and $167,000 and $1,294,000 of non-cash stock-based expense for the three and six month periods ended June 30, 2004, respectively)
    2,915,969       1,356,876       4,829,989       3,641,880  
Depreciation and amortization
    62,288       25,478       100,412       41,808  
Common stock, stock options and warrants issued for general and administrative services
    77,012       374,511       316,064       805,287  
Selling, general and administrative
    1,537,683       2,582,904       2,955,843       3,782,699  
 
                       
 
    4,592,952       4,339,769       8,202,308       8,271,674  
 
                       
Loss before other income (expense)
    (4,592,952 )     (4,111,605 )     (8,200,808 )     (7,943,510 )
Other income (expense):
                               
Interest income
    41,066       16,447       83,730       39,753  
Minority interest in losses of subsidiary
    42,753       34,329       81,452       69,257  
 
                       
Net loss
  $ (4,509,133 )   $ (4,060,829 )   $ (8,035,626 )   $ (7,834,500 )
 
                       
Basic and diluted:
                               
Loss per common share
  $ (0.08 )   $ (0.12 )   $ (0.14 )   $ (0.23 )
 
                       
Weighted average shares outstanding
    57,542,340       34,954,360       55,509,421       34,641,735  
 
                       

 


 

CYTRX CORPORATION
CONDENSED CONSOLIDATED BALANCE SHEETS
(Unaudited)
                 
    June 30,     December 31,  
    2005     2004  
ASSETS
               
Current assets:
               
Cash and short-term investments
  $ 15,772,758     $ 2,999,409  
Prepaid and other current assets
    419,073       956,146  
 
           
Total current assets
    16,191,831       3,955,555  
Property and equipment, net
    411,493       447,579  
Molecular library, net
    417,730       447,567  
Goodwill
    183,780        
Prepaid insurance and other assets
    147,326       198,055  
 
           
Total assets
  $ 17,352,160     $ 5,048,756  
 
           
LIABILITIES AND STOCKHOLDERS’ EQUITY
               
Current liabilities:
               
Accounts payable
  $ 410,477     $ 1,661,104  
Accrued expenses and other current liabilities.
    2,379,688       1,074,146  
 
           
Total current liabilities
    2,790,165       2,735,250  
Accrued loss on facility abandonment
    154,033       206,833  
Deferred gain on sale of building
    51,948       65,910  
Deferred revenue
    275,000       275,000  
 
           
Total liabilities
    3,271,146       3,282,993  
 
           
Minority interest in subsidiary
          170,671  
 
           
Commitments and contingencies
           
Stockholders’ equity:
               
Preferred Stock, $.01 par value, 5,000,000 shares authorized, including 5,000 shares of Series A Junior Participating Preferred Stock; no shares issued and outstanding
           
Common stock, $.001 par value, 100,000,000 shares authorized; 58,824,000 and 40,190,000 shares issued at June 30, 2005 and December 31, 2004, respectively
    58,824       40,190  
Additional paid-in capital
    130,531,241       110,028,327  
Treasury stock, at cost (633,816 shares held at June 30, 2005 and December 31, 2004)
    (2,279,238 )     (2,279,238 )
Accumulated deficit
    (114,229,813 )     (106,194,187 )
 
           
Total stockholders’ equity
    14,399,514       1,595,092  
 
           
Total liabilities and stockholders’ equity.
  $ 17,352,160     $ 5,048,756  
 
           
###

 

GRAPHIC 3 v11760v1176000.gif GRAPHIC begin 644 v11760v1176000.gif M1TE&.#EA?P`H`.8``-CS^F2;F?G__\?DZU>7HDB8I?+____^_NO\_C>9H)C' MU4::FK?DZV>AI.+]_K3;Y=3M],?J\&>EM?_\_EJBI5F5FGNRQ8>UQC6@G:'* MV6R@GOS__ZK5XO_^_#V=GJ32V4Z?GK;5WG:LQ/_Z_G2DKC*H46@H8:[T/_\_(2NM__^^8G%V.#W^\'.CB>&CCB1B[O>[9.PR&"2LOG[^&&;O>GT^*W?Y%>.C____R'Y!``````` M+`````!_`"@```?_@'^"@X1_&PQ)[)R(*'Q]4@@<=&W\'!YR;N8.'M;J[PH:',7\"(29(`9`^ M)A60(`=+//A`0D%.CC\QO6K;(`#M+01W_R"$ MP@65UI\5!%SX\/'&QI\9,7*Q%;P!0-.B=345\0)!U+%:?Y:`!-%%P@8B.T8< M<%"`P@(?#>0HJ;7CWK`-'6P-$+*&A@6[4'5]J=#`AP:B:`EO&*-#1\P_4,I$ MV65:&`XI4B!LV#%APX0QD;M@`(&!B7.V3X`O:`#B1>4_FN\5%_^7BX`,:&#T MZ*&&YX8I`K@<`%#&A087+AJ@Q@B[%YL#8F!!0FZY=,`%%QT`(<`&0.@P1B[- M[4!$$G_4$$99$"`%Q`2815:`!QXDD`(NM=QBPP(@;46!`:+PLUQ@N4"X0P=3 M3#"#`&P(P,$=3?3!``YT;8/3'Q,(8$(&(G1LT=PMP? M1Z0!@`A9M%4<<3$J08`&B&J`!`(S3"$?)QLD!<$#-D!@*00X#!#"`(?4$`$$ M5%"A!@0#"&``%$*@T(!6$BBPP@H?,/@'$V"@X`$*3)#8`6\U\``"2"@0@$!J M,=ES`%)CV#,%3J+L,,88.PBP`A10``G57%$@D:@+,OSQA%J\=/"'&5CD4881 M<4!R!A9OM)5!$V6<,80$0LAA@A4)8/""!QCHZP$8&`1A@"(I[(M"";G*MZ88 M0E#0!0H8$"!`!\;LDA3_+QL8T!9-`(EBBQ4-V*>!$1791.@.!@P@@[;WN8`$ M!U3(9,`=TKC\P0!02+$.B&<&$0081``14`M%!UUG`LP2@+21S`L9"EU9"7?3Y4`,$?7#A':#`&:*$! M:"XS1`87(VQ@P336'C/`.Q`'P8`!B+P)T1`6(3C,` MW+D`8`0210EV``)A=.>!%``4LG@)9V+0`GC!?)``!2^`(!I:,9"Q00T9!-$% M_PBW5A'!5P1T40`':E29F"!3_!&"%2*W74,NN>.#0!EW(S3<"(I8`;KFP"PR M_$$,82A:P.Y'"'&1R4P8\$`?:H"#"%@@""`*@@G>1B'Y\$:-X()G"VNL3/!BI!E/T0D;]AC&$#40A`D@*``!L9P`I&6-*0,"*&T_5+ M"C40UR">%ST,5&$!=CB'K1+P`T'P1S`)^D,+H%]E*!#PB"`TAH`$RXD).<..!"(DF.:9AXI@50H`5" MZ->M4+`BLSW(;*5)BA)">*L29$4(''#+<@9E$<@`X/]0]G%!!>Y@I=+LPEAL MV=L?M*"7L9C@&%JHP.]FO("1([%C-4V#@`(HT@-B1-K[ M"A&.6US`"MLB@7/<2(A]*,(0!U#;W<82C0HLR8"#X,([/9"]%TA!#8-J000] MH$^TC$``6/#`1Q:``CDX`"'"K%_#`"5!;*$,Q<@`E8"%1MVF/*3DA M`"*`@@-)',$?+*##_,0!"23_*(UI1.H`#W1!)$%@H#W-=+`JIN8/'*B"2!:` M@6.V42VZN)%*(88"*01.J$:YA0$D$$J$7"`WN]B!(CC0A*?HX@ZT0Y01LA&8 MBKZS,RPYZ2;FB@(JXH(,1=JB.D(BA[?-0&Y+-(!!1>B!5^+5%PMB0QR-<)_[ M$.!MQ#(6*G-1MS?\C@S97!NB&A`*?_0RHV'0`$V#\+9:I.8?E"U!%0^@F3CR M(%^VV@K4\D&(*(31`ZA#@>'J`<[39N`S=SO(P$BS`?DP*R=0,,(;^'`/!1QJ M*-F(5CWU(;L@-&"X?;!2#)*PJS^<8*48&)$`FA,_"3QL`5W\W2^.]8<(""$( M:#!H_[_&UT-HS1>OS7%"?>Z3$"Z0B)RHN=@=RN"#.`AJ($;(#SLGD"/3M`6! MBE*'?@8QE_\N@*0CPLPF(5".,_&+`E9:$%+$$`05`+4'*D#!KX)PEG!8LRZF M3*^V7!:`6>`"1ADS`_^X12)=;("5083:9TV3%`&$H0%(N%5E!O`!)-QO#@;E MEP>F]P1C274)/``P&,[WA*1L8(L2*U(!7D`!"8"`#K\#`A`.X&&\.J;!0XF# M!!K@!QD,H`8&<``.'J`%B#:@+YK8@I=^D5,KBDL$XR-K";"!R""#@#@:V)WH015,`$#;N`&'I2)7Q!;@`0R MV8'F_*&?_=J7"F[``0L40`7>`4$(SG,"6WF&`DB0`@R`Y.$GUR488F#S"DRP MA7EM`18#R`0NBK0!J#"L)XA:+/'`SD8)T0JL`#(?``#*K3N13^P`+G M.-P]B!#7+>PD`#,:@J@'F,(3=+$%6>*""`LJKT:.I24V,!,!.ZFZQC36EHS- M`0%X9X/&QD`&J\RA!F*8P]T1<'?_Q"%`#`;8`-X)?WP`C4``5L`!<>0!Q^@!@.P!YF4`3D0`31@!7\@`47P`$M0%*53 M!!P``V'`_Q`M4`0?,`0*@!H;$`:O%`,AD`8M$`)*")-A`"```# M;M`6-]`'`,`0""`T,3`"WB,!`D"/4D`#J-$#4D`"61`&;S.(LD,#$$"*,X`@ M`I`&#@`#B7<#:)`'&U`V2P6-%V$V,F$/EQX!L$'`&<60"MW@':?`' M&?`V5M`>-R`&,\`"QB`"^75'(L@$`F`#0K,!1-D6#\"(1U`4$&"(5SD("L"( M-\`H`"`$KV$/3>F4`>$QMC`CY+0F?Z#3!A;PF!=0`X-E`DYP`1;@BF'98'OP M!R:`.9C1`0[P`Q>0`21@`FU!BW^0!1_P`"64>3#E`&8@@@`@@DI0!@!Y`1*` M.6'@`)U8!('F#P]IF-K`$:Y((AN0CP[0%C/0!GIP(Q#0!LG9'!]I`#5P!P`P M8'$T,`;`?PG8#7^``PB@!@``!#6`4L=Y@W
-----END PRIVACY-ENHANCED MESSAGE-----