- Highlights Accomplishments During Period -
WALTHAM, Mass., Nov. 1 /PRNewswire/ -- AltaRex Corp. (AXO.TO, ALXFF.OTC),
a developer of foreign antibodies that activate the immune system to treat
cancer, announced its financial results for the third quarter ended
September 30, 2001. All dollars reported are Canadian.
(Photo: http://www.newscom.com/cgi-bin/prnh/20000831/ALTREXLOGO )
The Company recorded a net loss of $9.9 million, or $0.35 per share, for
the three months ended September 30, 2001 compared to a net loss of
$4.3 million, or $0.27 per share, for the same period in 2000. For the
nine month period ended September 30, 2001, the Company recorded a net loss of
$23.7 million, or $0.90 per share, compared to a net loss of $12.3 million, or
$0.79 per share, for the same period in 2000. The increased net loss in both
periods is due primarily to the increased spending in manufacturing and
clinical development for the Company's lead product, OvaRex(R) MAb
(oregovomab) for ovarian cancer.
At September 30, 2001, the Company's cash, cash equivalents and short-term
investments totaled $8.4 million as compared to $10.6 million at September 30,
2000 and $13.3 million at December 31, 2000. Subsequent to the third quarter,
on October 31, 2001, the Company closed a private placement of
7,200,000 Special Units to acquire an equal number of common shares and common
share purchase warrants of the Company for estimated net proceeds of
$11.2 million, of which $3.15 million is being held in escrow pending the
Company obtaining a receipt from applicable Canadian securities regulatory
authorities for a prospectus qualifying the distribution of the common shares
and warrants. AltaRex believes that this financing will allow it to continue
ongoing OvaRex(R) clinical trials and manufacturing development. The Company
will continue to pursue additional funding from strategic collaborations with
pharmaceutical and/or biotechnology companies as well as equity or debt
financing, and will closely manage costs in collaboration with Abbott
Laboratories and other service providers consistent with the Company's goal of
advancing OvaRex(R) MAb as the Company awaits additional clinical data,
including the results of the planned pharmacokinetic study to be initiated in
early 2002.
During the third quarter and into the fourth, the Company demonstrated
continued progress in several key areas of its clinical development program
for OvaRex(R) MAb. The Company:
* Completed its lead designated pivotal 345-patient OvaRex(R) clinical
trial. Primary endpoint analysis results are expected to be announced
by year-end.
* Reported final results and met the primary endpoint of a
well-controlled OvaRex(R) trial of 55 patients in "biochemical relapse"
(rising CA125, no measurable tumor) following primary surgery and
chemotherapy.
-- 52% of OvaRex(R)-treated patients generated an immune response and
experienced a significant increase in time to disease relapse
versus non-immune responders (median 3.4 months vs. 1.6 months;
p=0.0129 logrank test).
* Reported positive quality of life data from a validated survey of
patients who participated in the 55-patient trial, where on four major
domains, OvaRex(R) MAb compared as well as or better than placebo.
-- On three of four domains (Functional Well Being, Social/Family Well
Being and Emotional Well Being) there was actually a statistically
significant difference in favor of OvaRex(R) MAb over placebo
(p=0.032, p=0.005 and p=0.046, respectively).
* Reported positive long-term survival and safety results from a
completed study of OvaRex(R) MAb in 44 relapsed ovarian cancer
patients. The common expectation for survival in this population is
approximately one year from disease recurrence.
-- Twenty-five patients (57%) in the 44-patient study survived more
than one year and 15 patients (34%) survived more than two years
from first treatment. Among the 15 patients with survival greater
than two years, five (11%) survived five years or longer from first
treatment.
* Reported early findings from an OvaRex(R) MAb/second-line chemotherapy
trial (20 patients with recurrent disease) demonstrating a favorable
outcome in concurrent therapy with good response to chemotherapy and
the preserved ability of OvaRex(R) to induce robust immune responses to
CA125 and the patients' own tumor.
* Published in a peer-reviewed journal (Cancer Biotherapy and
Radiopharmaceuticals, Vol. 16, Number 3, 2001), presenting evidence for
antibody (OvaRex(R))-mediated antigen processing and presentation of
tumor associated antigen (CA125) with immune recognition that results
in multi-epitopic, antigen (CA125)-specific B and T cell responses that
are correlated with survival benefit.
* Presented at key public and invited scientific, clinical oncology and
investor meetings in the United States, Canada and Europe.
More about AltaRex research and development of antigen-targeted
anti-cancer antibodies, clinical trials, news and events can be found on the
website http://www.altarex.com .
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, uncertainties regarding the
timely and successful completion of clinical trials, patient enrollment rates,
uncertainty of pre-clinical, retrospective, early and interim clinical trial
results, which may not be indicative of results that will be obtained in
ongoing or future clinical trials, whether the Company will file for
regulatory approval on a timely basis, uncertainties as to when, if at all,
the FDA will approve the Company's regulatory filings for its products, the
need to establish and scale-up manufacturing processes, the need to obtain and
maintain corporate alliances, uncertainty as to the timely development 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 Company does not assume any obligation to update any
forward-looking statement.
THE TORONTO STOCK EXCHANGE HAS NOT APPROVED OR DISAPPROVED OF THE
INFORMATION CONTAINED HEREIN.
FINANCIAL TABLES TO FOLLOW
Condensed Consolidated Statement of Operations
(In Canadian dollars, Unaudited)
Three months ended Nine months ended
Sept. 30, Sept. 30, Sept. 30, Sept. 30,
2001 2000 2001 2000
Revenues $126,751 $120,110 $453,358 $308,019
Expenses
Research &
development 7,815,869 3,053,348 18,558,219 8,435,587
General &
administration 2,209,945 1,325,722 5,601,849 4,196,370
10,025,814 4,379,070 24,160,068 12,631,957
Net loss for
the period $(9,899,063) $(4,258,960) $(23,706,710) $(12,323,938)
Net loss per
common share $(0.35) $(0.27) $(0.90) $(0.79)
Weighted average
number of
common shares
outstanding 28,586,029 15,827,227 26,442,278 15,620,065
Condensed Consolidated Balance Sheet
(In Canadian dollars, Unaudited)
As of As of
Sept. 30, Dec. 31,
2001 2000
ASSETS
Cash and cash equivalents $6,029,824 $9,665,187
Short-term investments 2,376,123 3,591,323
Other current assets 749,334 429,704
Capital assets, net 628,048 490,115
Other assets 235,671 578,227
Total assets $10,019,000 $14,754,556
LIABILITIES AND SHAREHOLDERS' EQUITY
Current liabilities $7,603,806 $3,793,766
Deferred lease credit
and other liabilities -- --
Total shareholder's equity 2,415,194 10,960,790
Total liabilities and
shareholders' equity $10,019,000 $14,754,556
SOURCE AltaRex Corp.
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Related links:
http://www.altarex.com
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CONTACT:
Sondra Henrichon, Director, Investor
Relations and Corporate Communications of AltaRex,
+1-781-672-0138, ext. 1510, or shenrichon@altarex.com; or Wayne
Hendry, Investor Relations, The Equicom Group, +1-416-815-0700,
ext. 238, or whendry@equicomgroup.com
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