-----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, FHMwdOIag/SyzjMQ1YQk7GG0y8R+FcTCSwol1nbdMaPLiGnNJI5jGz8viom4qkdh gpJGlUnGUcLYrY2POYNqlQ== 0000950135-06-002662.txt : 20060426 0000950135-06-002662.hdr.sgml : 20060426 20060426091630 ACCESSION NUMBER: 0000950135-06-002662 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 3 CONFORMED PERIOD OF REPORT: 20060426 ITEM INFORMATION: Results of Operations and Financial Condition ITEM INFORMATION: Financial Statements and Exhibits FILED AS OF DATE: 20060426 DATE AS OF CHANGE: 20060426 FILER: COMPANY DATA: COMPANY CONFORMED NAME: OXIGENE INC CENTRAL INDEX KEY: 0000908259 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 133679168 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-21990 FILM NUMBER: 06779641 BUSINESS ADDRESS: STREET 1: 321 ARSENAL STREET CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 6176737800 8-K 1 b60624oie8vk.htm OXIGENE, INC. e8vk
Table of Contents

 
 
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 26, 2006
OXiGENE, INC.
(Exact name of registrant as specified in its charter)
         
Delaware
(State or other jurisdiction
of incorporation)
  0-21990
(Commission
File Number)
  13-3679168
(I.R.S. Employer
Identification No.)
230 Third Avenue, Waltham, MA 02451
 
(Address of principal executive offices)
Registrant’s telephone number, including area code: (781) 547-5900
Check the appropriate box below if the Form 8-K filing is intended to simultaneously satisfy the obligation of the registrant under any of the following provisions:
o  Written communication 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))
 
 

 


EX-99.1 Press Release dated, 4/26/06


Table of Contents

Item 2.02   Results of Operations and Financial Condition.
On April 26, 2006, OXiGENE, Inc. issued a press release announcing its financial results for the first quarter ended March 31, 2006. A copy of the press release is furnished as Exhibit 99.1 to this report and is incorporated herein by reference. This information shall not be deemed to be “filed” for the purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”) and shall not be deemed to be incorporated by reference in any filing under the Securities Act of 1933, as amended, or the Exchange Act, except as expressly set forth by specific reference in such a filing.
Item 9.01   Financial Statements and Exhibits.
     (d) The following exhibits are furnished with this report:
     
Exhibit Number
  Description
 
 
 
 
   
99.1
  Press Release dated April 26, 2006, reporting OXiGENE’s financial results for the first quarter ended March 31, 2006.

 


Table of Contents

SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, as amended, the registrant has duly caused this report to be signed on its behalf by the undersigned hereunto duly authorized.
         
     
Date: April 26, 2006  /s/ James B. Murphy    
  James B. Murphy, Vice President and    
  Chief Financial Officer   

 


Table of Contents

         
EXHIBITS
     
Exhibit Number
  Description
 
 
 
 
   
99.1
  Press Release dated April 26, 2006, reporting OXiGENE’s financial results for the first quarter ended March 31, 2006.

 

EX-99.1 2 b60624oiexv99w1.htm EX-99.1 PRESS RELEASE DATED, 4/26/06 exv99w1
 

Exhibit 99.1
(OXIGENE LOGO)
OXiGENE REPORTS FIRST-QUARTER 2006 OPERATIONAL AND FINANCIAL RESULTS
—OXiGENE Secures Regulatory Clearance in Russia for its Ongoing Myopic Macular
Degeneration (MMD) Phase II Clinical Trial; Patient Screening To Begin Shortly—
Company Highlights First Quarter Accomplishments, Including:
    Initiation of a Phase II Clinical Trial in the United States in Stage IIIa/IIIb Non Small Cell Lung Cancer (NSCLC)
 
    Completion of Patient Enrollment in a Phase II Clinical Trial in Solid Tumors
 
    A Newly Granted Patent for Combretastatin A4P (CA4P)
Waltham, MA—April 26, 2006OXiGENE, Inc. (NASDAQ: OXGN, XSSE: OXGN), an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases, today reported operational and financial results for the first quarter ended March 31, 2006.
“Following what we believe was a very strong conclusion to fiscal year-end 2005, the first quarter of 2006 was marked with clinical progress and operational successes,” stated Frederick Driscoll, President and Chief Executive Officer of OXiGENE. “We remain steadfast in our commitment to achieving the requisite steps necessary to begin patient enrollment later this year in our U.S. and European clinical trials in NSCLC, and we continue to concentrate our efforts on driving patient enrollment in OXiGENE’s core clinical programs in oncology and ophthalmology indications.”
Financial Results
The Company’s net loss for the three months ended March 31, 2006 was $3.3 million or $0.12 per share, compared with a net loss of $2.0 million, or $0.12 per share, in the first quarter of 2005.
On January 1, 2006, OXiGENE adopted SFAS 123R, “Share-Based Payment,” requiring the expense recognition of the estimated fair value of all share-based payments issued to employees. Prior to this, the estimated fair value associated with such awards was not recorded as an expense, but rather was disclosed in a footnote to the Company’s financial statements. For the three months ended March 31, 2006, OXiGENE recorded approximately $315,000 of expense associated with share-based payments as a result of SFAS 123R. In addition, the Company recorded an expense of $160,000 for restricted stock awards for the three months ended March 31, 2006, compared to $0 for the three months ended March 31, 2005.

 


 

OXiGENE Reports First Quarter 2006 Operational and Financial Results / 2
At March 31, 2006, OXiGENE had cash, cash equivalents and marketable securities of approximately $55.4 million, compared with approximately $58.9 million at December 31, 2005.
Clinical Progress: Ophthalmology
OXiGENE announced today that it has received clearance from regulatory authorities in Russia to initiate its ongoing Phase II clinical trial with CA4P for the treatment of Myopic Macular Degeneration. Russia’s top five ophthalmology clinics have elected to participate in the trial. Regional oversight boards have granted the required ethics approvals and patient screening is expected to begin shortly.
“With our sights squarely focused on the on-time completion of patient enrollment in this indication, we have elected to initiate this trial in an area of the world where the current, approved treatment for MMD is cost prohibitive, making it inaccessible for most individuals afflicted,” stated Mr. Driscoll. “With these sites ready to commence patient screening, and in combination with the ongoing activity in centers in the US, Canada and Taiwan, we remain confident that we will achieve our target of completing patient enrollment in the first half of this year.”
Mr. Driscoll added, “We believe that clearance to commence this trial in Russia is an important and strategically significant regulatory achievement for OXiGENE as we contemplate the potential next steps in this indication. This clearance may create regulatory and potential registrational opportunities for CA4P in Russia, as well as other geographic areas in eastern Europe, not only in this indication, but also for other indications, such as oncology.”
Clinical Progress: Oncology
OXiGENE advanced its lead therapeutic candidate, CA4P, into a Phase II clinical trial in the United States for the treatment of patients with Stage IIIa/IIIb NSCLC. The trial, which was cleared to proceed by the United States Food and Drug Administration (FDA) in February 2006, is currently recruiting participation from clinical trial sites. OXiGENE expects patient enrollment to begin on schedule, in the third quarter of 2006.
OXiGENE also announced this quarter that patient enrollment is now complete in a Phase II clinical trial of CA4P in imageable, solid tumors. The trial, which is being conducted in the United States under OXiGENE’s Investigational New Drug (IND) application on file with the FDA, is designed to evaluate the safety and anti-cancer activity of the triple combination of CA4P with the widely-used chemotherapy agents, carboplatin and paclitaxel. The objectives of this trial are to assess the safety of several dose levels of CA4P in combination with the two chemotherapeutic agents, gather data on anti-tumor activity and establish a recommended Phase II/III dose. Additionally, the study is designed to assess, by Magnetic Resonance Imaging (MRI), changes in tumor blood flow, which may provide additional insight into the biological activity of CA4P. With several patients enrolled in this trial continuing to receive prolonged therapy, OXiGENE anticipates that top-line data from this trial will be available later in 2006.

 


 

OXiGENE Reports First Quarter 2006 Operational and Financial Results / 3
OXiGENE’s second clinical candidate, OXi4503, continues to be evaluated in a Phase I dose-escalating safety trial in solid tumors. Since the initiation of this clinical trial, clinical investigators have increased the dose of OXi4503 to several times the compound’s initial dosing level, and have yet to achieve the maximum tolerated dose in humans. Depending on when maximum tolerated dose is reached, OXiGENE anticipates that this trial will be concluded by year’s end.
Presentation of Data
OXiGENE anticipates that clinical investigators will present data at scientific conferences later this year. More specifically, the Company expects interim clinical trial data to be presented in June 2006 at the American Society for Clinical Oncology (ASCO) conference from an ongoing Phase II clinical trial evaluating CA4P as a monotherapy for treatment of advanced Anaplastic Thyroid Cancer. The Company also believes that data will be presented from the recently completed Phase II clinical trial combining CA4P with carboplatin and paclitaxel in imageable, solid tumors at the Conference of the Tumor Microenvironment (TME) in September.
Operational Update
In the first quarter, OXiGENE announced the issuance of U.S. Patent No. 7,018,987 for novel methods of synthesizing its lead therapeutic candidate, CA4P. This award provides patent coverage for at least 13 years, through 2019. The patent award also provides broad-based patent protection for additional salt-form compositions of CA4P. The patent was granted to Arizona State University, where researchers discovered and isolated CA4P and other Combretastatin compounds. OXiGENE has exclusive, worldwide rights to the manufacturing and commercialization of products based on select Combretastatins.
About OXiGENE, Inc.
OXiGENE is an emerging pharmaceutical company developing novel small-molecule therapeutics to treat cancer and eye diseases. The Company’s major focus is the clinical advancement of drug candidates that selectively disrupt abnormal blood vessels associated with solid tumor progression and visual impairment. OXiGENE is dedicated to leveraging its intellectual property position and therapeutic development expertise to bring life saving and enhancing medicines to patients.
Safe Harbor Statement
Certain statements in this news release concerning OXiGENE’s business are considered “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include, but are not limited to: the timing and success of Phase II and Phase III clinical trials of CA4P for NSCLC and a Phase II clinical trial of CA4P for imageable, solid tumors; OXiGENE’s ability to enroll patients in a Phase II clinical trial for myopic macular degeneration in a timely manner; the potential tumor killing effect of OXi4503 and its promise as a candidate for advanced cancers; and, the timing, success or advancement of OXiGENE’s ongoing preclinical research and clinical trials. Any or all of the forward-looking statements in this press release may turn out to be wrong. They can be affected by inaccurate assumptions OXiGENE might make or by known or unknown risks and uncertainties, including, but not limited to: the early stage of product development; the ability to secure necessary patents; uncertainties as to the future success of ongoing and planned clinical trials; and the unproven safety and efficacy of products under development. Consequently, no forward-looking statement can be guaranteed, and actual results may vary materially. Additional information concerning factors that could cause actual results to materially differ from those in the forward-looking statements is contained in OXiGENE’s reports to the

 


 

OXiGENE Reports First Quarter 2006 Operational and Financial Results / 4
Securities and Exchange Commission, including OXiGENE’s reports on Form 10-Q, 8-K and 10-K. However, OXiGENE undertakes no obligation to publicly update forward-looking statements, whether because of new information, future events or otherwise.
Contact:
Susan Hager
OXiGENE, Inc.
Director of Communications
(781) 547-5900
shager@oxigene.com

 


 

OXiGENE Reports First Quarter 2006 Operational and Financial Results / 5
OXiGENE, Inc.
Condensed Balance Sheets
(All amounts in 000’s)
(Unaudited)
                 
    March 31,     December 31,  
    2006     2005  
Assets
               
 
               
Cash, cash equivalents and marketable securities
  $ 55,391     $ 58,855  
Licensing agreement
    849       873  
Other assets
    771       540  
 
               
 
           
Total assets
  $ 57,011     $ 60,268  
 
           
 
               
Liabilities and stockholders’ equity
               
 
               
Accounts payable
  $ 392     $ 693  
Accrued expenses
    2,954       3,041  
Total stockholders’ equity
    53,665       56,534  
 
               
 
           
Total liabilities and stockholders’ equity
  $ 57,011     $ 60,268  
 
           

 


 

OXiGENE Reports First Quarter 2006 Operational and Financial Results / 6
OXiGENE, Inc.
Condensed Statements of Operations
(All amounts in 000’s except per share amounts)
(Unaudited)
                 
    Three months ended  
    March 31,  
    2006     2005  
 
               
License revenue
  $     $  
 
               
Costs and expenses:
               
 
               
Research and development
    2,321       1,217  
 
               
General and administrative
    1,621       997  
 
           
 
               
Total costs and expenses:
    3,942       2,214  
 
               
Operating loss
    (3,942 )     (2,214 )
 
               
Investment income
    612       181  
 
               
Other (expense) income, net
    (6 )     5  
 
               
Net loss
  $ (3,336 )   $ (2,028 )
 
           
 
               
Basic and diluted net loss per common share
  $ (0.12 )   $ (0.12 )
 
               
Weighted average number of common shares outstanding
    27,517       17,604  

 

GRAPHIC 3 b60624oib6062400.gif GRAPHIC begin 644 b60624oib6062400.gif M1TE&.#EAR0`X`.8``%E965555:*BHG5U=6)B8J:FII^?GTE)29J:FJRLK):6 MEH*"@I*2DI24E#,S,V5E96EI:9RGI MZ?GY^SL[.[N[O7U]>+BXLG)R;*RLK>WM]K:VN/CX\_/S\+"PLO+ MR[Z^ON#@X-_?W_GY^='1TWKR\O&QL;+2TM-75U.CW]^/%>,D):7F)F:FYR=GI^" M?C$O4$.-GWY85&$?C.ZAWY12UUHM<;'R,FR+3Y/ M,KN"-2`;!M"11U]NULK-X5O*BH.,;QK,%7;W_#Q\I]"2FDSIS<. M*B)^IS%6@&AY-Z^@P8.%POQ0@R\2$@1"&HDR\B,+0808,\+SL6+-*7\2_5Q9 M44FCR9/?_/1A4<20'S$K[%Q$2;/F*R=*XDPIA(-%$!LV@YX$Z0J6GSLK^#3\ M8R/("C`FB2J;"8DJ,JFN;'!9\N1-G3=I9+2P^BB*%Q8Y!MUA`6,&)S]$_\"\ MX.'B&:H6,GSTH?,%2)TQ+H3L(,L+R]P;-Y(DUH&$,"\Q-![1",,#C(X(BB>+$+MK("#7C1I`>.UJUJ-*&11DLC@OY6>*SD0T6*^3$'E1CQ8JTJ(Z\ M65(D"HT6-82\H+,BB"<_4WR[X,%#1Q4VPP,(5,SRQ0AUN M?0(#"P.^Y08+0D`R`QF?M`##"A'ZT41VVRFQ@O\.%\'@`B@]K`!B*$#](04+ M'D'"`PM>1+B)'\P!,01N8KQR8XZ;U*!$%Y;X<09Y0D(8RW9G/,@#04#H`.6' M+D'!0I6/V##DE)W8X1L9*["@)RA#HJG)6C@H(R21142`)Q$XSJ,%E1(4\(2PG MQ`[B1WMK68')L5[4X"RT^\'J*"98L#`'-Y->L<2_4-S7R78["-(";3"8HFX9 MYVX"ZA/_+F&$$7]TP<+_$I@$35N$P8XV2>V]E^RP0JV0<%0KDD/&<`H3/0X,Q!&$U&`>?*>,$70FQ(;4PQ]AK/"# M54F@^AQM'_K&Y-6=Q/`#"V@_4L4*;P09MKI>:A(##,`-PH2,>[3WA]M[$NH' M4%.X6+`E'/F0W0Q`L/"HB,?);YJD!R0ZN*RQ`A7%C,$# ME%*Z-,;%EK1`Q0^`;M(Y"W?XX6<$NR-4'U M_Q@TS$'.)^D:DN\/Y#I2!0NZ>;+C"BX?N\+GGC3ZW!ZN8;_"&$$Z"^T0Q(G' M0>4037!*'@*&BO2I*Q)#`T(3'-&4.8Q%5GQ801Y"\8689,LW6,,$$8*@KXX5 M`G8`]`0-`A2]010K$S&(PY.`$06GK.!\GDC#"F8XB,*9JCF_*L00AF-"3F3A M!TH@PB!Z\H-B>")1(<2$%MZP@B>LJ"A_<%H*.\$$WV2!$%KX'2=0]S9!.*&# M..P$&5@`I$'$P`@H05]&`7,[`"EG;C!RVX2`P7 M]$0,BM"J-W0A"3E(0A>`\`,QON4(N`G"%>Q`ACG$H?\*;ZE>'VQ`$+@`(8V: MV%P'E3`&,MCA"D^8D+K\D(4>Y.$*5@A+MB(A!!8HI1!;"$(2.3&%'!Q!"ES( M@1)!X0H0C=!,,$>1&*6="`#A+<1A5^8,&W1(*`K]BE2P9:SU06%!Q83`D9 MO!!"/QR+0T*)J$1+Y8-V7,0/9O""R";*T8Y&X@5UL,@EPG`V@7KTI,GP@QS* MX+),#&$/VD"I3#.RN3R(`:"8H`$2Q-"XF?K4&WXXPA4BDAV,YD&D/TVJ,J+0 MA1NT\!,V\($:BJC4JH)B!C3_$((8>(`&DPYB"SU8@Q82:=6R6A,,5SC#+XRQ MA208(7)FC2M"O"K7NMKUKGC-JU[WRM>^^O6O@(TH5F0S6-E4Y:(@P>D_I9+8 MD,0FL:DDI&)EA=C"-O8516#"YGRV@RU$P@<*0(`VC.2"TMY@+,K\`PWHXH(B MT*`1(_I#%$B917GYPPJA?5,AL!`!!9`AL7%H0`%TX8<;R$L+I2UM5Q5F`YL) M8@H":$`9&N&$Y+I`"\``0R.(\-H_`"<&1_I#%2;H!QD8H`%\:,0.KA>))$AD M![_(P0M>X((7=$L'KQT";8&SK@0P0`.T#5$7&F``<]+2LX(80G(5%@7ZEC8+ M)7B5_P\(H`[?^D$(!RB``B@`2BI((``9$,$`_+``=^W@PR$F0"-((`@C+*`1 M;&B)'R)@`@$@X`"-&40+2,``#)P@57[@``$TH(<+Z`(.D2H`!0+`Y`/!`6TO M\(`@9#`"#A2`!!7PPP\VP.0`?,$1!!!$`A#0B##_`0L/<$L'IGN$$72@`!GX M0,5&3+<+2`0$3/O#!"X@@0Q<0'0!.)(!&%!F0="`!"#0P`!(T-)(:.`$!:B` M"'(6B06P8!`"6'(`#H`Q(WP8Q"Q@@X0=H``_**`Q5X##$&C0U3]0H0,&,X$6 M2OR''9C9#T;^`XO_8`0'Q,$/,0;/`3*3@S`0P@DCP($-?/_A!RO8.1)V$`22 M_U``#!24`!FH090%H8!J2$C+$?CG(\R<``=TP0]F%H(*"+UF$B>@$30XP3,` MH$0/,.@//````':!!QX&0(D&<$!CPNR'`G1`(H@P1&"#800^$,-$;#"+OP@@!&@@`2Z,0`+/B+M))-`#X06!`$8$`(7 M2%G7073%#P"@!SU\$7[@`P<' M!"K0&'>@!%VE``W@:K!&"#&G8C.F`2L6"490:@R@`BU!`R)@!*+``%%G1@8P M!1T`-L(!$$<"!$5P"1(']^T-"&;^@$(A`* M`K`!)B`!!3!T/@``![`!"X`/<'`^"1!\@TAT!O`'<_!I`=``."`O3`!*<+$% M(#$$I]4(30!*A(`%+D,#.2`1.2`O9A`)35`P?C`$'=,+9D!4LF$#/*!9$H$& M/-`MD1`&Q8!<\_4"IA"1D3!XT)$$#>%,#A8&1HA%#O5<-IB1@A`#:8$R\Y21 M,KD++?!U?E`$$K$%#'D$5>(FK3`$1U)>ZL($+]`>0^6A1`(`#L_ ` end
-----END PRIVACY-ENHANCED MESSAGE-----