- Highlights Accomplishments -
WALTHAM, Mass., March 14 /PRNewswire/ --
AltaRex Corp. (OTC: ALXFF) (TSE: AXO), a developer of antigen-targeted
monoclonal antibodies for the treatment of certain cancers, today announced
its financial results for the fourth quarter and for the year ending
December 31, 2000. All dollars reported are Canadian.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
In summary, the Company reported a net loss for the fourth quarter of 2000
of $5.4 million or $0.29 per share compared to a net loss of $4.4 million or
$0.32 per share for the fourth quarter of 1999. The net loss for the year
ended December 31, 2000 was $17.7 million or $1.08 per share compared to a net
loss of $24.0 million or $2.32 per share for the year ended December 31, 1999.
As of December 31, 2000, the Company's cash and short-term investments totaled
$13.3 million which was increased on February 13, 2001 by the net proceeds of
approximately $7.2 million from the sale of 4.4 million common shares in a
public offering.
"The positive news in the last quarter of 2000 and into 2001 from our
studies of OvaRex(R) and BrevaRex(R) MAbs demonstrates a consistency of
findings and a growing basis of data to support the final stages of
development of OvaRex(R) and the advancement of BrevaRex(R) into further
clinical study," commented Richard Bagley, President and CEO of AltaRex. "The
recent announcements of our U.S. patent allowance and the extension of our
technology platform into prostate cancer and infectious disease are indicative
of what we believe to be growing value for shareholders of AltaRex."
In the fourth quarter of 2000 and into 2001, the Company announced
developments in clinical trials, partnering, intellectual property and
funding, all reflecting the successful achievement of a number of important
milestones:
* Data announced from clinical trials of OvaRex(R) MAb and BrevaRex(R)
MAb support the Company's belief that its antibodies induce
therapeutically beneficial, robust immune responses with a benign
safety profile. The apparent lack of significant toxicity
demonstrated in these trials differentiates OvaRex(R) MAb and
BrevaRex(R) MAb from current chemotherapeutic choices and could
contribute positively to patients' quality of life.
-- In an interim analysis of its lead 345-patient double blind,
placebo-controlled Phase IIb OvaRex(R) trial, the Company
announced more than doubling in time to relapse among ovarian
cancer patients who mounted an immune response to OvaRex(R) MAb.
-- In results from our Phase II OvaRex(R) trials in Vancouver and
Dallas, the Company announced a survival benefit comparable to
"salvage" chemotherapy without the severe side effects seen with
such chemotherapy.
-- In studies of both OvaRex(R) MAb and BrevaRex(R) MAb, the Company
has noted the broad activation of T-cells and the cellular arm of
the immune system.
-- BrevaRex(R) clinical results, in combination with the results of a
laboratory study published in the journal Blood (Blood 2000,
96:3147), provide strong rationale to pursue the treatment of
multiple myeloma with BrevaRex(R) MAb.
OvaRex(R) MAb continues in late stage development for the treatment of
ovarian cancer, with two potentially pivotal trials scheduled for primary
analysis during 2001. Results from a total of six trials will form the
foundation of data for the Company's U.S. Biologics License Application (BLA),
expected to begin by year end 2001, under Fast Track provisions granted
OvaRex(R) MAb by the U.S. Food and Drug Administration. The benefit to the
Company of Fast Track designation is the ability to bring OvaRex(R) MAb to
market at an earlier stage of clinical development than otherwise allowed.
More specifically, the Company plans to seek approval of OvaRex(R) MAb
based on results from Phase II/IIb clinical trials, with a post-approval
commitment for additional patient study.
* The Company's intellectual property position has been significantly
strengthened. The Company received notice of allowance of claims for
a cornerstone "multi-epitopic" patent that is initially applicable to
OvaRex(R) MAb. The allowed claims cover the Company's novel
technology of administering a low-dose foreign antibody (OvaRex(R)
MAb) to any patient expressing the target antigen (CA125) and thereby
activating an anti-tumor immune response unique to that individual.
This "multi-epitopic" patent allowance has positive implications for
the Company's entire antibody pipeline. The Company has filed, and
continues to file, multiple patent applications in the U.S. and
internationally that will enable it to protect its proprietary
technology.
* The Company announced the formation of a strategic alliance with
regional leader Dompe Farmaceutici S.p.A. for the commercialization of
its lead product OvaRex(R) MAb in Italy, Spain, Portugal, Switzerland,
Austria and certain Eastern European countries. Under the terms of
the Memorandum of Understanding dated November 15, 2000, Dompe also
has the right of first offer in these territories for additional
cancer antibodies being developed by AltaRex. In connection with this
alliance, Dompe purchased 3.5 million AltaRex common shares in a
private placement at $2.20 per share, for net proceeds to the Company
of approximately $7.75 million.
* The private placement of 3.5 million common shares with Dompe was
followed by the closing of the sale of 4.4 million common shares for
net proceeds of approximately $7.2 million in a public offering in
February, 2001. In this offering, the Company again attracted
institutional investors in both the U.S. and Canada and increased its
visibility throughout the institutional investment community. The
completion of this offering was preceded by the implementation in
November, 2000 of a previously approved one-for-four share
consolidation.
The increase in net loss of $1.0 million for the fourth quarter of 2000 as
compared to the fourth quarter of 1999 was due primarily to the increased
costs associated with clinical trials of OvaRex(R) MAb. The decrease in net
loss of $6.3 million for the year ended December 31, 2000 as compared to the
year ended December 31, 1999 reflected the effect of cost reduction activities
implemented in late 1999 on research and development as well as general and
administrative expenses, and the lack of litigation expense that was prominent
in 1999. The decrease in net loss per share for both the fourth quarter and
the year ended December 31, 2000, as compared to the same periods in 1999,
also reflect the increase in the weighted average number of common shares
outstanding as a result of various issuances of common shares which raised a
net total of $22.5 million in capital in 2000 and $17.6 million in 1999.
Additional information about AltaRex research and development, news and
events can be found on its web site at http://www.altarex.com . Clinical information
can also be found at http://www.centerwatch.com . Additional information about
ovarian cancer can be found at http://www.nci.nih.gov , http://www.ovariancanada.org and at
http://www.ovarian.org .
This news release contains forward-looking statements that involve risks
and uncertainties, which may cause actual results to differ materially from
the statements made. For this purpose, any statements that are contained
herein that are not statements of historical fact may be deemed to be
forward-looking statements. Without limiting the foregoing, the words
"believes," "anticipates," "plans," "intends," "expects" and similar
expressions are intended to identify forward-looking statements. Such risks
and uncertainties include, but are not limited to our need for capital and the
risk that the Company can not raise funds on a timely basis on satisfactory
terms or at all, changing market conditions, completion of clinical trials,
patient enrollment rates, uncertainty of pre-clinical, retrospective and early
clinical trial results, which may not be indicative of results that will be
obtained in ongoing or future clinical trials, the establishment of
manufacturing processes and new corporate alliances, the timely development,
regulatory approval and market acceptance of the Company's products,
uncertainty as to whether patents will issue from pending patent applications
and, if issued, as to whether such patents will be sufficiently broad to
protect the Company's technology, and other risks detailed from time-to-time
in the Company's filings with the United States Securities and Exchange
Commission and Canadian securities authorities.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE
INFORMATION CONTAINED HEREIN.
CONDENSED CONSOLIDATED STATEMENT OF OPERATIONS
(In Canadian dollars, unaudited)
Three Months Ended Twelve Months Ended
December 31, December 31,
2000 1999 2000 1999
Revenue $81,807 $115,153 $ 389,826 $ 687,710
Expenses
Research and
development 3,586,631 2,872,129 12,022,218 12,828,617
General and
administration 1,895,316 1,587,043 6,091,686 6,802,546
Settlement costs -- 59,002 -- 5,074,714
5,481,947 4,518,174 18,113,904 24,705,877
Net loss for the
period $(5,400,140) $(4,403,021) $(17,724,078) $(24,018,167)
Net loss per common
share $(0.29) $(0.32) $(1.08) $(2.32)
Weighted average number
of Common shares
outstanding 18,854,087 13,903,153 16,433,031 10,347,434
CONDENSED CONSOLIDATED BALANCE SHEET
(In Canadian dollars, unaudited)
December 31,
2000 1999
ASSETS
Cash and short-term investments $13,256,510 $7,206,680
Other current assets 429,704 153,900
Capital assets, net 490,115 934,893
Other assets 578,227 271,956
$14,754,556 $8,567,429
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $3,793,766 $2,302,960
Deferred lease credit and other liabilities -- 46,513
Shareholders' equity 10,960,790 6,217,956
$14,754,556 $8,567,429
SOURCE AltaRex Corp.
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Related links:
http://www.altarex.com
http://www.nci.nih.gov http://www.ovariancanada.org
http://www.ovarian.org http://www.centerwatch.com
Photo Notes:
NewsCom:
http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO
AP Archive: http://photoarchive.ap.org
PRN Photo Desk, 888-776-6555 or 201-369-3467
Company News On-Call:
http://www.prnewswire.com/comp/128163.html or fax,
800-758-5804, ext. 128163
CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex Corp.,
781-672-0138, ext. 1510, or shenrichon@altarex.com; or Wayne
Hendry, Investor Relations of The Equicom Group, Inc,
416-815-0700, ext. 238, or whendry@equicomgroup.com
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