-----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, HJUsXmR5YMgmkTm2vcoT1oimIBuVx3yenyPGJIk+nh55dEAcvTCgTnL8jV82EQtR cA/SSlcqYVWpCDuMMjq3Jw== 0001193125-04-084396.txt : 20040511 0001193125-04-084396.hdr.sgml : 20040511 20040511102429 ACCESSION NUMBER: 0001193125-04-084396 CONFORMED SUBMISSION TYPE: 8-K PUBLIC DOCUMENT COUNT: 2 CONFORMED PERIOD OF REPORT: 20040510 ITEM INFORMATION: ITEM INFORMATION: Financial statements and exhibits FILED AS OF DATE: 20040511 FILER: COMPANY DATA: COMPANY CONFORMED NAME: V I TECHNOLOGIES INC CENTRAL INDEX KEY: 0001040017 STANDARD INDUSTRIAL CLASSIFICATION: BIOLOGICAL PRODUCTS (NO DIAGNOSTIC SUBSTANCES) [2836] IRS NUMBER: 113238476 STATE OF INCORPORATION: DE FISCAL YEAR END: 1231 FILING VALUES: FORM TYPE: 8-K SEC ACT: 1934 Act SEC FILE NUMBER: 000-24241 FILM NUMBER: 04795189 BUSINESS ADDRESS: STREET 1: 134 COOLIDGE AVE CITY: WATERTOWN STATE: MA ZIP: 02472 BUSINESS PHONE: 5167527314 MAIL ADDRESS: STREET 1: 134 COOLIDGE AVE CITY: WATERTOWN STATE: MA ZIP: 02472 8-K 1 d8k.htm FORM 8-K Form 8-K

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 10, 2004

 


 

V. I. TECHNOLOGIES, INC.

(Exact name of registrant as specified in its charter)

 


 

Delaware   0-24241   11-3238476

(State or other jurisdiction of

incorporation or organization)

  (Commission File Number)  

(IRS employer

identification no.)

 

134 Coolidge Avenue

Watertown, Massachusetts 02472

(617) 926-1551

(Address, including zip code, and telephone number, including area code, of registrant’s principal executive offices)

 



ITEM 7. FINANCIAL STATEMENTS AND EXHIBITS

 

  (c) Exhibits:

 

  99.1 Press Release of V.I. Technologies, Inc. dated May 10, 2004

 

ITEM 12. DISCLOSURE OF RESULTS OF OPERATIONS AND FINANCIAL CONDITION

 

On May 10, 2004, V. I. Technologies, Inc. (“Vitex”) announced its financial results for the first quarter ended March 27, 2004. A copy of the Vitex press release dated May 10, 2004 is attached as Exhibit 99.1 to this current report on Form 8-K and is incorporated herein by reference.

 

This information shall not be deemed “filed” for purposes of Section 18 of the Securities Exchange Act of 1934, as amended (the “Exchange Act”), or otherwise subject to the liabilities of that section, nor shall it be deemed 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 filing.


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.

 

    V. I. TECHNOLOGIES, INC.
Dated: May 11, 2004   By:  

/s/ Thomas T. Higgins


       

Thomas T. Higgins,

Chief Financial Officer and

Executive Vice President, Operations


EXHIBIT INDEX

 

Exhibit No.

 

Description


99.1   Press Release of V.I. Technologies, Inc. dated May 10, 2004.
EX-99.1 2 dex991.htm PRESS RELEASE Press Release

Exhibit 99.1

 

Contacts

 

V.I. TECHNOLOGIES, INC. (VITEX)

JOHN R. BARR

617-926-1551

john.barr@vitechnologies.com

or

Thomas T. Higgins

617-926-1551

tom.higgins@vitechnologies.com

 

Vitex Reports First Quarter Financial Results for 2004

 

Watertown, MA (May 10, 2004) — V.I. Technologies, Inc. (Nasdaq: VITX) (“Vitex” or “the Company”), a biotechnology company dedicated to developing products that improve the safety of the blood supply by pathogen reduction, today announced its financial results for the first quarter ending March 27, 2004.

 

For the first quarter of 2004, Vitex reported a net loss of $3.7 million or $0.08 per share, compared to a net loss of $6.4 million or $0.28 per share for the first quarter of 2003. Research and Development (R&D) spending decreased from $5.2 million in Q1, 2003 to $2.6 million in Q1, 2004. The reduction in spending reflects the Company’s focused efforts on its Phase III trial, reduced headcount in R&D and the fact that major investments in key program areas to support the filing of a BLA such as the toxicology and pathogen reduction studies were made in prior periods.

 

Vitex’s cash balances at quarter-end were $14.0 million. The Company completed a $10.9 million private placement on February 11, 2004, and settled an outstanding term receivable related to the 2001 sale of its plasma operations for an additional $1.7 million in cash plus the return of 4.4 million Vitex shares. The cash balance at the end of Q1 represented slightly less than one year’s cash requirements given the Company’s current burn rate.

 

“The first quarter was a busy and productive quarter for Vitex,” said Mr. John Barr, President and CEO of Vitex. “We successfully concluded our latest fundraising round with shareholder approval of the PIPE in February. We continued to expand the number of sites participating in the Phase III clinical trial and we now have 16 sites actively screening and enrolling patients. We are gratified by the number and quality of institutions that have expressed a desire to participate in the study. We believe this reflects their view of the potential importance of INACTINE red cells.”


Significant highlights for the first quarter include:

 

  The Company expanded the number of sites participating in the Phase III INACTINE Red Blood Cell Acute transfusion study. The Company has now recruited 22 trial sites to participate in the trial. Sixteen (16) are actively enrolling patients, four (4) sites are in the IRB approval process, two (2) sites are being qualified. Beyond these sites, an additional three (3) more have expressed interest in participating in the study. These hospitals include some of the largest and most prestigious open heart surgery programs in the country and are spread throughout the U.S.

 

  The Company closed a $10.9 million private placement in February and received shareholder approval of the placement. The commitments for the placement were received in two tranches. Strong investor interest enabled the company to significantly improve the terms in the second tranche. A total of $14.9 million was raised by the Company between December 2003 and February 2004. Since that time, investors in those private placements have exercised an additional $1.3 million in options further increasing the total cash raised by Vitex to $16.2 million.

 

  The Company reached a settlement on an outstanding receivable from the 2001 sale of its plasma operations resulting in payment to Vitex of $1.7 million and the return of 4.4 million shares of Vitex common stock.

 

  In February of 2004, the Company announced a federal Phase I and Phase II fast track grant from the National, Heart, Lung and Blood Institute of the National Institutes of Health (NIH) for $885,000. This funding covers work in the ongoing effort in improving the INACTINE system for red blood cells with the potential to expand to the military and in restricted economies.


About Vitex

 

Vitex is developing products designed to improve the safety of the world’s blood supply. The Company’s proprietary INACTINE technology, currently in a Phase III clinical trial, is designed to inactivate a wide range of viruses, bacteria and parasites, and has demonstrated its ability to remove soluble prion proteins, while preserving the therapeutic properties of red blood cells. The technology works by binding to the RNA or DNA of the pathogen. Once bound, the compound forms an irreversible bond to the pathogenic nucleic acid, preventing replication and thereby “killing” the pathogens. The Company’s lead product is INACTINE Pathogen Reduction System for red blood cells. Over 40 million red cell units are transfused annually in the U.S., Europe and Japan, representing an over $4 billion market opportunity. For more information on Vitex, please visit our Web site at: www.vitechnologies.com.

 

Except for the historical information contained herein, the matters discussed are forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties, such as execution of the Company’s financing plans, quarterly fluctuations in operating results, anticipated clinical trial timelines or results, the timely availability of new products, market acceptance of the Company’s products, the impacts of competitive products and pricing, government regulation of the Company’s products and other risks and uncertainties set forth in the Company’s filings with the Securities and Exchange Commission. These risks and uncertainties could cause actual results to differ materially from any forward-looking statements made herein.

 

(Financial tables follow)


V.I. TECHNOLOGIES, INC.

 

CONDENSED STATEMENTS OF OPERATIONS

 

(In thousands, except for per share data)

 

(unaudited)

 

     Thirteen weeks ended

 
    

March 27,

2004


   

March 29,

2003


 

Revenues:

                

Research funding

   $ 129     $ 104  

Costs and expenses:

                

Research and development costs

     2,561       5,174  

General and administrative expenses

     1,263       1,275  
    


 


Total operating costs and expenses

     3,824       6,449  

Loss from operations

     (3,695 )     (6,345 )

Other income (expense), net

     (35 )     (19 )
    


 


Net loss

   $ (3,730 )   $ (6,364 )
    


 


Basic and diluted net loss per share

   $ (0.08 )   $ (0.28 )

Weighted average number of shares

     47,727       22,793  
V.I. TECHNOLOGIES, INC.                 
CONDENSED BALANCE SHEET                 
(in thousands)                 
(unaudited)                 
    

March 27,

2004


   

December 27,

2003


 

Cash, including restricted balances

   $ 14,029     $ 4,848  

Other current assets

     593       4,815  

Property and equipment, net

     2,936       3,119  

Goodwill and intangibles, net

     3,056       3,118  

Other assets

     —         1,379  
    


 


Total assets

   $ 20,614     $ 17,279  
    


 


Accounts payable and accrued expenses

   $ 1,790     $ 1,639  

Deferred revenue

     916       954  

Term debt obligations

     2,185       2,441  

Stockholders’ equity

     15,723       12,245  
    


 


Total liabilities and stockholders’ equity

   $ 20,614     $ 17,279  
    


 


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