AVANT Immunotherapeutics Reports First Quarter 2001 Financial Results

Apr 25, 2001, 01:00 ET from AVANT Immunotherapeutics, Inc.

    NEEDHAM, Mass., April 25 /PRNewswire/ -- AVANT Immunotherapeutics, Inc.
 (Nasdaq:   AVAN) today reported financial results for the first quarter ended
 March 31, 2001.  The Company reported a net loss of $4.0 million, or $.07 per
 share, for the first quarter of 2001 compared to a net loss of $2.1 million,
 or $.04 per share, for the first quarter of 2000.  The results for the first
 quarter of 2001 primarily reflect an increase in research and development
 expense compared to the same period in 2000.  This increase resulted from
 increased clinical trials costs and clinical materials costs incurred in
 connection with the Company's TP10 and CETi-1 clinical programs, as well the
 addition of the operating costs of Megan Health, which AVANT acquired in
 December 2000.  The Company ended the quarter with cash and cash equivalents
 of $45.1 million.
     "These financial results are in line with our plans for the Company," said
 Avery W. Catlin, Senior Vice President and Chief Financial Officer of AVANT
 Immunotherapeutics, Inc.  "We are making strong progress in developing our own
 lead programs: TP10, our complement inhibitor in infants and adults undergoing
 cardiac surgery; CETi-1, our novel therapeutic vaccine approach for
 cholesterol management; and our single dose, oral cholera vaccine, Peru-15,
 the first in our portfolio of travelers' vaccines."
     During the quarter, AVANT announced the start of the first of two Phase
 IIb studies of its lead complement inhibitor, TP10.  This first study is in
 babies born with hypoplastic left heart syndrome who often have high morbidity
 and mortality after heart surgery.  The second study, which is being conducted
 in a lower risk infant population undergoing pediatric cardiac surgery, will
 begin shortly.
     After discussions with the Food and Drug Administration (FDA), AVANT
 announced during the quarter that it has made protocol changes to the Phase
 IIb trials of TP10 and has agreed to monitor patients for six months following
 treatment as well as the previously planned 60-day follow-up.  These protocol
 changes will result in longer clinical trials, with completion of the two
 Phase IIb trials now expected in the first half of 2002.  Following further
 meetings with the FDA after the end of the Phase IIb trials, AVANT expects to
 initiate a pivotal Phase III trial of TP10 in the high-risk infant population.
 AVANT's ongoing Phase II study of TP10 in adults undergoing cardiac surgery
 remains on track and these protocol changes only affect the pediatric trials.
     Also during the quarter, AVANT announced encouraging results from the
 Phase I safety study of its therapeutic vaccine, CETi-1, for cholesterol
 management.  The vaccine was very well tolerated by the adult volunteers who
 participated in the study.  Further, AVANT announced preliminary results from
 an extension of this Phase I study in which the volunteers received a second
 dose of CETi-1.  These results showed measurable antibody titers in all dose
 groups treated with study medication and suggested a dose-response
 relationship.  These data will be extremely helpful in designing a Phase II
 study, planned to begin this summer.
     Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM EDT on
 Thursday, April 26, 2001 to discuss the First Quarter 2001 financial results.
 To access the conference call, dial 800-818-9097 (within the United States),
 or 785-749-3918 (if calling from outside the U.S.).  An audio replay will be
 available immediately following the call for approximately one week and can be
 accessed by dialing 800-938-0998 (within the U.S.), or 402-220-1550 (if
 calling from outside the U.S.).
     The call will also be broadcast via the Company's website:
 www.avantimmune.com and via the PRNewswire video website:
 www.videonewswire.com/AVANT/042601.  In order to access the webcast, your PC
 must have a sound card, speakers and RealPlayer software.  It is recommended
 that you configure your PC in advance of the webcast as the software download
 and installation can take several minutes.
     AVANT Immunotherapeutics, Inc. is engaged in the discovery, development
 and commercialization of products that harness the human immune response to
 prevent and treat disease.  The Company's most advanced therapeutic program
 focuses on compounds with the potential to inhibit inappropriate activation of
 the complement cascade, a vital part of the body's immune defense system.
 AVANT is also developing on its own a portfolio of oral vaccines aimed at
 protecting travelers from diseases endemic in developing areas, as well as a
 proprietary therapeutic vaccine for the management of cholesterol.  Through
 corporate collaborations, the company is additionally developing a variety of
 infectious disease vaccines.
     Additional information on AVANT Immunotherapeutics, Inc. can be obtained
 through our site on the World Wide Web:  http://www.avantimmune.com.
 
     Safe Harbor Statement Under the Private Securities Litigation Reform Act
 of 1995: This release includes forward-looking statements which reflect
 AVANT's current views with respect to future events and financial performance.
 The words "believe," "expect," "anticipate," and similar expressions identify
 forward-looking statements.  Investors should not rely on forward-looking
 statements because they are subject to a variety of risks, uncertainties, and
 other factors that could cause actual results to differ materially from those
 expressed in any such forward-looking statements.  These factors include, but
 are not limited to:  (1) the ability to successfully complete development and
 commercialization of products, including the cost, timing, scope and results
 of pre-clinical and clinical testing; (2) the ability to successfully complete
 product research and further development, including animal, pre-clinical and
 clinical studies; (3) the ability of the Company to manage multiple late stage
 clinical trials for a variety of product candidates; (4) the volume and
 profitability of product sales of Megan(R)Vac 1 and other future products; (5)
 changes in existing and potential relationships with corporate collaborators;
 (6) the cost, delivery and quality of clinical and commercial grade materials
 supplied by contract manufacturers (7) the timing, cost and uncertainty of
 obtaining regulatory approvals; (8) the ability to obtain substantial
 additional funding; (9) the ability to develop and commercialize products
 before competitors; (10) the integration of Megan Health's business and
 programs; (11) the ability to retain certain members of management; and (12)
 other factors detailed from time to time in filings with the Securities and
 Exchange Commission.
 
 
                         AVANT IMMUNOTHERAPEUTICS, INC.
 
  CONSOLIDATED STATEMENT                                     Quarter
  OF OPERATIONS DATA                                       Ended March 31,
                                                        2001           2000
                                                            (Unaudited)
      OPERATING REVENUE
      Product Development
        and Licensing Agreements                     $737,700       $153,800
      Product Sales                                   121,300              -
 
      Total Operating Revenue                         859,000        153,800
 
      OPERATING EXPENSE
      Research and Development                      3,976,600      1,817,300
      Selling, General and Administrative           1,214,300      1,102,400
      Cost of Product Sales                            10,100              -
 
      Legal Settlements                                     -      (500,000)
      Amortization of Acquired Intangible Assets      344,000        137,300
 
      Total Operating Expense                       5,545,000      2,557,000
 
      Operating Loss                              (4,686,000)    (2,403,200)
 
      Investment Income, Net                          682,400        279,800
 
      Net Loss                                  $ (4,003,600)  $ (2,123,400)
 
      Basic and Diluted Net Loss per
       Common Share                                   $(0.07)        $(0.04)
      Weighted Average Common
       Shares Outstanding                          57,252,200     49,799,100
 
 
 
  CONSOLIDATED BALANCE
  SHEET DATA                                       March 31,     December 31,
                                                     2001             2000
                                                          (Unaudited)
      Cash, Cash Equivalents and
       Marketable Securities                      $45,105,700    $50,177,000
      Working Capital                              42,785,100     46,408,600
      Accumulated Deficit                         159,324,000    155,320,400
      Total Stockholders' Equity                   50,216,200     53,932,000
 
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X31247472
 
 

SOURCE AVANT Immunotherapeutics, Inc.
    NEEDHAM, Mass., April 25 /PRNewswire/ -- AVANT Immunotherapeutics, Inc.
 (Nasdaq:   AVAN) today reported financial results for the first quarter ended
 March 31, 2001.  The Company reported a net loss of $4.0 million, or $.07 per
 share, for the first quarter of 2001 compared to a net loss of $2.1 million,
 or $.04 per share, for the first quarter of 2000.  The results for the first
 quarter of 2001 primarily reflect an increase in research and development
 expense compared to the same period in 2000.  This increase resulted from
 increased clinical trials costs and clinical materials costs incurred in
 connection with the Company's TP10 and CETi-1 clinical programs, as well the
 addition of the operating costs of Megan Health, which AVANT acquired in
 December 2000.  The Company ended the quarter with cash and cash equivalents
 of $45.1 million.
     "These financial results are in line with our plans for the Company," said
 Avery W. Catlin, Senior Vice President and Chief Financial Officer of AVANT
 Immunotherapeutics, Inc.  "We are making strong progress in developing our own
 lead programs: TP10, our complement inhibitor in infants and adults undergoing
 cardiac surgery; CETi-1, our novel therapeutic vaccine approach for
 cholesterol management; and our single dose, oral cholera vaccine, Peru-15,
 the first in our portfolio of travelers' vaccines."
     During the quarter, AVANT announced the start of the first of two Phase
 IIb studies of its lead complement inhibitor, TP10.  This first study is in
 babies born with hypoplastic left heart syndrome who often have high morbidity
 and mortality after heart surgery.  The second study, which is being conducted
 in a lower risk infant population undergoing pediatric cardiac surgery, will
 begin shortly.
     After discussions with the Food and Drug Administration (FDA), AVANT
 announced during the quarter that it has made protocol changes to the Phase
 IIb trials of TP10 and has agreed to monitor patients for six months following
 treatment as well as the previously planned 60-day follow-up.  These protocol
 changes will result in longer clinical trials, with completion of the two
 Phase IIb trials now expected in the first half of 2002.  Following further
 meetings with the FDA after the end of the Phase IIb trials, AVANT expects to
 initiate a pivotal Phase III trial of TP10 in the high-risk infant population.
 AVANT's ongoing Phase II study of TP10 in adults undergoing cardiac surgery
 remains on track and these protocol changes only affect the pediatric trials.
     Also during the quarter, AVANT announced encouraging results from the
 Phase I safety study of its therapeutic vaccine, CETi-1, for cholesterol
 management.  The vaccine was very well tolerated by the adult volunteers who
 participated in the study.  Further, AVANT announced preliminary results from
 an extension of this Phase I study in which the volunteers received a second
 dose of CETi-1.  These results showed measurable antibody titers in all dose
 groups treated with study medication and suggested a dose-response
 relationship.  These data will be extremely helpful in designing a Phase II
 study, planned to begin this summer.
     Dr. Ryan and Mr. Catlin will host a conference call at 11:00 AM EDT on
 Thursday, April 26, 2001 to discuss the First Quarter 2001 financial results.
 To access the conference call, dial 800-818-9097 (within the United States),
 or 785-749-3918 (if calling from outside the U.S.).  An audio replay will be
 available immediately following the call for approximately one week and can be
 accessed by dialing 800-938-0998 (within the U.S.), or 402-220-1550 (if
 calling from outside the U.S.).
     The call will also be broadcast via the Company's website:
 www.avantimmune.com and via the PRNewswire video website:
 www.videonewswire.com/AVANT/042601.  In order to access the webcast, your PC
 must have a sound card, speakers and RealPlayer software.  It is recommended
 that you configure your PC in advance of the webcast as the software download
 and installation can take several minutes.
     AVANT Immunotherapeutics, Inc. is engaged in the discovery, development
 and commercialization of products that harness the human immune response to
 prevent and treat disease.  The Company's most advanced therapeutic program
 focuses on compounds with the potential to inhibit inappropriate activation of
 the complement cascade, a vital part of the body's immune defense system.
 AVANT is also developing on its own a portfolio of oral vaccines aimed at
 protecting travelers from diseases endemic in developing areas, as well as a
 proprietary therapeutic vaccine for the management of cholesterol.  Through
 corporate collaborations, the company is additionally developing a variety of
 infectious disease vaccines.
     Additional information on AVANT Immunotherapeutics, Inc. can be obtained
 through our site on the World Wide Web:  http://www.avantimmune.com.
 
     Safe Harbor Statement Under the Private Securities Litigation Reform Act
 of 1995: This release includes forward-looking statements which reflect
 AVANT's current views with respect to future events and financial performance.
 The words "believe," "expect," "anticipate," and similar expressions identify
 forward-looking statements.  Investors should not rely on forward-looking
 statements because they are subject to a variety of risks, uncertainties, and
 other factors that could cause actual results to differ materially from those
 expressed in any such forward-looking statements.  These factors include, but
 are not limited to:  (1) the ability to successfully complete development and
 commercialization of products, including the cost, timing, scope and results
 of pre-clinical and clinical testing; (2) the ability to successfully complete
 product research and further development, including animal, pre-clinical and
 clinical studies; (3) the ability of the Company to manage multiple late stage
 clinical trials for a variety of product candidates; (4) the volume and
 profitability of product sales of Megan(R)Vac 1 and other future products; (5)
 changes in existing and potential relationships with corporate collaborators;
 (6) the cost, delivery and quality of clinical and commercial grade materials
 supplied by contract manufacturers (7) the timing, cost and uncertainty of
 obtaining regulatory approvals; (8) the ability to obtain substantial
 additional funding; (9) the ability to develop and commercialize products
 before competitors; (10) the integration of Megan Health's business and
 programs; (11) the ability to retain certain members of management; and (12)
 other factors detailed from time to time in filings with the Securities and
 Exchange Commission.
 
 
                         AVANT IMMUNOTHERAPEUTICS, INC.
 
  CONSOLIDATED STATEMENT                                     Quarter
  OF OPERATIONS DATA                                       Ended March 31,
                                                        2001           2000
                                                            (Unaudited)
      OPERATING REVENUE
      Product Development
        and Licensing Agreements                     $737,700       $153,800
      Product Sales                                   121,300              -
 
      Total Operating Revenue                         859,000        153,800
 
      OPERATING EXPENSE
      Research and Development                      3,976,600      1,817,300
      Selling, General and Administrative           1,214,300      1,102,400
      Cost of Product Sales                            10,100              -
 
      Legal Settlements                                     -      (500,000)
      Amortization of Acquired Intangible Assets      344,000        137,300
 
      Total Operating Expense                       5,545,000      2,557,000
 
      Operating Loss                              (4,686,000)    (2,403,200)
 
      Investment Income, Net                          682,400        279,800
 
      Net Loss                                  $ (4,003,600)  $ (2,123,400)
 
      Basic and Diluted Net Loss per
       Common Share                                   $(0.07)        $(0.04)
      Weighted Average Common
       Shares Outstanding                          57,252,200     49,799,100
 
 
 
  CONSOLIDATED BALANCE
  SHEET DATA                                       March 31,     December 31,
                                                     2001             2000
                                                          (Unaudited)
      Cash, Cash Equivalents and
       Marketable Securities                      $45,105,700    $50,177,000
      Working Capital                              42,785,100     46,408,600
      Accumulated Deficit                         159,324,000    155,320,400
      Total Stockholders' Equity                   50,216,200     53,932,000
 
 
                     MAKE YOUR OPINION COUNT -  Click Here
                http://tbutton.prnewswire.com/prn/11690X31247472
 
 SOURCE  AVANT Immunotherapeutics, Inc.