- Highlights Accomplishments Year to Date -
WALTHAM, Mass., May 24 /PRNewswire/ -- AltaRex Corp.
(Toronto: AXO, OTC: ALXFF), a developer of antigen-targeted antibody-based
cancer therapeutics, today announced its financial results for the first
quarter ended March 31, 2001. All dollars reported are Canadian.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
In summary, the Company recorded a net loss of $6.3 million or $0.26 per
share for the three months ended March 31, 2001 compared to a net loss of $3.9
million, or $0.28 per share, for the same period in 2000. The increased net
loss is due primarily to the increased spending in manufacturing and clinical
development for the Company's lead product, OvaRex(R) MAb for ovarian cancer.
The Company is scaling up antibody production under a development and
commercial supply agreement with Abbott Laboratories, while OvaRex(R) MAb is
being studied in six phase II/IIb clinical trials.
At March 31, 2001, the Company's cash and short-term investments totaled
$15.2 million as compared to $13.3 million at December 31, 2000. This
increase reflects the sale of 4.4 million common shares for net proceeds of
$7.2 million in February and the net cash burn of the Company from its
operations.
The decrease in the net loss per share reflects the impact of an increase
in the weighted average number of shares outstanding from 14,037,786 shares
for the first quarter of 2000 to 24,282,170 shares for the first quarter of
2001. This increase is due to the issuance of common shares in public
offerings in August 2000 and February 2001 and several private placements of
common shares related to corporate partnering collaborations in 2000.
"The Company's tremendous progress year-to-date has us enthusiastically
looking to our most important milestone - the filing of the Company's first
Biologics License Application (BLA) with the U.S. Food and Drug Administration
(FDA) for approval of OvaRex(R) MAb for the treatment of ovarian cancer," said
Richard E. Bagley, President and CEO of AltaRex.
In the first quarter and into the second quarter of 2001, the Company
announced progress in many areas and the successful achievement of a number of
important milestones:
OvaRex(R) Clinical Progress
-- Interim analysis of the lead 345-patient double-blind placebo-
controlled (dbpc) trial, and preliminary results from a 55-patient dbpc
trial provide insight into the importance of CA 125 levels for patients
following successful primary therapy. The findings suggest that CA 125
levels are strongly predictive of the course of ovarian cancer. In the
lead trial interim analysis of 252 patients, high risk patients
(elevated CA 125 levels) who received OvaRex(R) MAb experienced a
statistically significant benefit (p<.0357) in 6-month disease free
progression versus high risk patients receiving placebo.
-- Results from the 55-patient dbpc trial, now preliminarily reported for
primary analysis, confirm our observation from other OvaRex(R) studies
of a significant correlation between OvaRex(R) induced immune response
(HAMA, Ab2) and clinical benefit as measured by time to disease
relapse.
-- Further, the Company demonstrated in two studies for patients at a very
advanced stage of ovarian cancer (disease is recurrent and/or no longer
responsive to chemotherapy), that even at this late stage, patients are
able to mount a clinically beneficial immune response induced by
OvaRex(R) MAb, without the toxicity associated with "salvage"
chemotherapy.
-- Particularly exciting is the Company's clinical demonstration of T-cell
immune responses; a rare demonstration, we believe, of drug-activated
cytolytic T cell (CTL) and T helper cell responses that are functional
to promote tumor killing.
Scientific Presentations
-- Our clinical and immunology advances have been presented at a number of
key scientific meetings including the Annual Meetings of the Society of
Gynecologic Oncologists (SGO), the American Association for Cancer
Research (AACR), and the American Society of Clinical Oncology (ASCO),
as well as the International Myeloma Workshop, the Cancer Vaccines
Conference, the Keystone Symposium on Dendritic Cells, and the Helene
Harris Memorial Trust Ovarian Cancer Forum in conjunction with the MD
Anderson Cancer Center.
Intellectual Property
-- The Company expanded its intellectual property portfolio by obtaining
an exclusive worldwide license for a family of four U.S. issued patents
and foreign counterparts from the Alberta Research Council, Inc.
These patents extend the Company's vision beyond its current cancer
focus to promising and synergistic therapeutic areas, specifically
autoimmune and inflammatory diseases.
Manufacturing and Quality Assurance
-- The Company entered into an agreement with Abbott Laboratories for
OvaRex(R) MAb antibody manufacturing. The transfer of its proprietary
cell culture manufacturing processes from Lonza Biologics plc to Abbott
allows the Company to leverage the expertise and know-how of Lonza with
the scalability of large pharma. The cell culture process is a very
low cost method of manufacturing.
Company Exposure
-- Notable exposure was gained in the investment community with Toronto-
based Yorkton Securities' initiation of analyst coverage of AltaRex
Corp. Analyst David Martin's report titled "Unique Cancer Vaccine
Platform - Near-term Approval Expected" was issued April 30th. Yorkton
Securities rates AltaRex Corp. a TOP PICK.
Clinical data from the lead OvaRex(R) trial, along with five complementary
and supporting trials, will form the basis for a simultaneous filing for
OvaRex(R) MAb approval with both the U.S. and Canadian regulatory authorities.
This filing is anticipated to begin by year end, assuming the timely scale-up
of cell culture manufacturing and the completion of the necessary
pharmacokinetic trial to establish comparability.
Additional information about AltaRex research and development, news and
events can be found on its web site at http://www.altarex.com. AltaRex Corp. is
traded on the Toronto Stock Exchange under the symbol AXO, and over-the-
counter in the United States under the symbol ALXFF. Clinical information can
be found at http://www.centerwatch.com. Additional information about ovarian cancer
can be found at http://www.nci.nih.gov, http://www.ovarian.org., http://www.ovariancancer.org and
at http://www.ovariancanada.org. Additional information about multiple myeloma can be
found at http://www.multiplemyeloma.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, such as the results referred to above, which may not be indicative of
results that will be obtained in ongoing or future clinical trials, new
corporate alliances, the establishment of manufacturing processes and the
scale up of cell culture material, 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
March 31, March 31,
2001 2000
REVENUE $185,369 $ 91,841
EXPENSES
Research and development 5,069,452 2,434,951
General and administration 1,453,646 1,544,041
6,523,098 3,978,992
Net loss for the period $ (6,337,729) $ (3,887,151)
Net loss per common share $(0.26) $(0.28)
Weighted average number of
common shares outstanding 24,282,170 14,037,786
CONDENSED CONSOLIDATED BALANCE SHEET
(In Canadian dollars, unaudited)
As at March 31,
2001 2000
ASSETS
Cash and cash equivalents $ 11,480,514 $4,728,191
Short-term investments 3,755,052 5,254,327
Other current assets 319,191 124,716
Capital assets, net 497,021 819,299
Other assets 595,855 351,208
$ 16,647,633 $ 11,277,741
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $4,792,092 $2,399,660
Deferred lease credit -- 39,371
Shareholders' equity 11,855,541 8,838,710
$ 16,647,633 $ 11,277,741
SOURCE AltaRex Corp.
 back to top
Related links:
http://www.altarex.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, shenrichon@altarex.com; or Wayne Hendry,
Investor Relations of The Equicom Group, Inc, 416-815-0700 ext.
238, whendry@equicomgroup.com
|
