Vasogen Announces 2002 Year-end Results
07:02 EST Thursday, March 13, 2003
TORONTO, March 13 /PRNewswire-FirstCall/ - Vasogen Inc. (TSX:VAS; AMEX:VSV)
today reported the results of operations for the fiscal year ended November 30, 2002.
All dollar amounts referenced herein are Canadian dollars unless otherwise noted.
At November 30, 2002, the Company had cash, cash equivalents, and marketable
securities held to maturity totaling $42.7 million, compared to $39.5 million
in 2001. During 2002, cash resources used by the Company were more than offset
by a financing that was completed during the period. The Company incurred a net
loss for the year of $19.5 million, or $0.40 per common share, compared with a
net loss of $14.4 million, or $0.32 per common share for the previous year.
The increased loss resulted mainly from higher costs associated with the
expansion of the Company's clinical programs.
In 2002, research and development expenditures rose by 38 per cent to
$12.7 million from $9.2 million in 2001. The costs of Vasogen's clinical
programs increased by $2.8 million in 2002, compared to 2001. The Company's
clinical programs in chronic heart failure (CHF) and peripheral arterial
disease (PAD) were the key drivers behind this increase. The costs associated
with Vasogen's preclinical research in neuroinflammatory disease increased
by $0.4 million in 2002. The significant growth in Vasogen's patent portfolio
resulted in expenses increasing by $0.3 million in fiscal 2002, compared
to 2001. Further information about the Company's research and development
programs appears below.
General and administrative expenditures were $7.8 million in 2002, compared
to $7.2 million in 2001, an increase of approximately 8 per cent. This
increase is largely due to expenses relating to corporate development,
marketing, and business development activities associated with increasing
the awareness of immune modulation therapy in the Canadian and U.S. medical
communities.
Interest income totaled $1.0 million in 2002, compared with $2.1 million
in 2001. Investment income was lower in 2002, compared to the prior year,
primarily due to the decline in market yields available on short-term
investments.
2002 Highlights
- Results from Vasogen's double-blind, placebo-controlled trial in 73
patients with advanced CHF were presented at the annual scientific
sessions of the American Heart Association and the Heart Failure
Society of America. The results demonstrated a significant reduction
in the risk of both death and hospitalization, and significant
improvements in a clinical composite score and key electrocardiogram
measures for patients receiving Vasogen's immune modulation therapy,
compared to placebo. In addition, the therapy was well tolerated, with
no reports of treatment-related serious adverse events or patient
withdrawals.
- Vasogen received FDA clearance to initiate a pivotal phase III trial
of its immune modulation therapy in up to 2,000 patients with advanced
CHF. The ACCLAIM (Advanced Chronic Heart Failure CLinical Assessment
of Immune Modulation Therapy) trial is Vasogen's second phase III
clinical program targeting inflammation in cardiovascular disease, and
will be conducted at leading cardiac centers throughout the United
States and Canada. The primary outcome measure of the ACCLAIM trial is
the composite endpoint of all-cause mortality or cardiovascular
hospitalization (time to first event). The trial will conclude when a
minimum of 701 events has occurred and all patients have been followed
for at least six months.
- James Young, MD, Medical Director of the Kaufman Center for Heart
Failure and Head of the Section of Heart Failure and Cardiac
Transplant Medicine at The Cleveland Clinic, a world-renowned heart
center, was named chairman of the ACCLAIM study's Steering Committee
and Global Principal Investigator. Guillermo Torre-Amione, MD, PhD,
Medical Director of the Heart Transplant Service at Baylor College of
Medicine and the DeBakey Heart Center of The Methodist Hospital in
Houston, Texas, is Principal Investigator for the U.S. arm of the
study, and Jean-Lucien Rouleau, MD, Head, Division of Cardiology,
University Health Network at the University of Toronto, is Principal
Investigator for the Canadian arm of the trial.
- Findings from Vasogen's double-blind, placebo-controlled phase II
clinical trial of its immune modulation therapy in patients with
advanced peripheral arterial disease were published in the European
Journal of Vascular and Endovascular Surgery. The results from this
trial formed the basis for Vasogen's ongoing 500-patient, North
American pivotal phase III trial in PAD.
- Results from preclinical research demonstrating that Vasogen's immune
modulation therapy significantly reduced the progression of
atherosclerosis in a model of chronic vascular disease were published
in Atherosclerosis. This research showed that Vasogen's immune
modulation therapy decreased the progression of atherosclerosis and
may stabilize atherosclerotic plaques by reducing inflammation.
Chronic inflammation is now widely accepted as an important mechanism
in the progression and rupture of atherosclerotic plaques.
- Results from Vasogen's preclinical studies in neuroinflammation, an
underlying mechanism in Alzheimer's disease and other degenerative
neurological conditions, were published in NeuroImmunoModulation. This
research was conducted under the direction of Professor Marina Lynch,
PhD, at the Department of Physiology, Trinity College, Dublin,
Ireland. Findings demonstrated the ability of Vasogen's immune
modulation therapy to significantly reduce key measures of
inflammation and cell death in the brain and to improve physiological
measurements that correlate with memory and learning.
- Vasogen announced preliminary results from an open-label pilot study
in patients with chronic lymphocytic leukemia. The study, which was
conducted in collaboration with the Toronto Sunnybrook Regional Cancer
Centre (TSRCC), evaluated the effects of Vasogen's technology
utilizing three treatment regimens. David Spaner, MD, PhD, FRCP(C),
Clinical Scientist at TSRCC and Sunnybrook and Women's College Health
Sciences Centre, University of Toronto, and the Principal Investigator
for the study, reported that in the group receiving the optimal
treatment regimen (administered over a two-week period), four out of
six patients reached the primary endpoint. Continued clinical
development of this indication is expected to be through a physician-
sponsored initiative.
- Vasogen announced the appointment of Surya N. Mohapatra, PhD,
President and Chief Operating Officer of Quest Diagnostics
Incorporated (NYSE: DGX), to its Board of Directors. Dr. Mohapatra
combines an exceptionally strong background in U.S. and international
operations, with a PhD in medical physics from the University of
London and The Royal College of Surgeons of England. Vasogen and Quest
Diagnostics have formed a strategic alliance for the commercialization
of Vasogen's immune modulation therapy in the United States.
- The U.S. Patent and Trademark Office issued a Notice of Allowance for
a patent application protecting the use of Vasogen's immune modulation
therapy in the treatment of chronic heart failure. Vasogen currently
has 11 U.S. patents, 35 patents granted in other jurisdictions, and
170 patent applications pending worldwide.
- On May 28, 2002, Vasogen closed a firm commitment/bought deal offering
of 5.2 million common shares at $4.85 per share, for gross proceeds of
approximately $25 million.
A conference call will be conducted on March 13, 2003, at 4:10 p.m. Eastern Time.
The conference may be accessed by calling 416-695-9753 or 1-877-667-7774 ten
minutes prior to the call. An audio web cast of the event will also be available
at www.vasogen.com.
Vasogen is focused on the research, development, and commercialization of
immune modulation therapy for the treatment of cardiovascular and other
inflammatory diseases.
This press 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 made pursuant to the safe harbor provisions of the Private Securities
Litigation Reform Act of 1995. Without limiting the foregoing, the words
"believes," "anticipates," "plans," "intends," "will," "should," "expects,"
"projects," and similar expressions are intended to identify forward-looking
statements. You are cautioned that such statements are subject to a multitude
of risks and uncertainties that could cause actual results, future circumstances,
or events to differ materially from those projected in the forward-looking
statements. These risks include, but are not limited to, those associated
with the success of research and development programs, the regulatory approval
process, competition, securing and maintaining corporate alliances, market
acceptance of the Company's products, the availability of government and
insurance reimbursements for the Company's products, the strength of
intellectual property, financing capability, the potential dilutive effects
of any financing, reliance on subcontractors and key personnel and other
risks detailed from time-to-time in the Company's public disclosure documents
or other filings with the Canadian and U.S. securities commissions or other
securities regulatory bodies. The forward-looking statements are made as of
the date hereof, and the Company disclaims any intention and has no obligation
or responsibility, except as required by law, to update or revise any
forward-looking statements, whether as a result of new information, future
events, or otherwise.
Financial Tables Below
The following financial data are derived from Vasogen's audited financial
statements:
Consolidated Balance Sheets
(In thousands of Canadian dollars)
As at November 30,
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2002 2001
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Assets
Current assets:
Cash and cash equivalents $ 2,024 $ 1,187
Marketable securities 35,605 36,859
Clinical supplies 2,645 1,832
Tax credits recoverable 1,379 1,259
Prepaid expenses 518 281
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42,171 41,418
Marketable securities 5,086 1,482
Capital assets 707 622
Less accumulated amortization 394 272
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313 350
Acquired technology 4,081 4,081
Less accumulated amortization 2,815 2,562
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1,266 1,519
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$ 48,836 $ 44,769
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Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable and accrued liabilities $ 3,330 $ 3,395
Shareholders' equity:
Share capital 126,673 103,034
Deficit accumulated during the
development stage (81,167) (61,660)
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45,506 41,374
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$ 48,836 $ 44,769
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Consolidated Statements of Operations and Deficit
(In thousands of Canadian dollars, except
per share amounts)
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Period from
December 1,
1987 to
Years ended November 30, November 30,
2002 2001 2000 2002
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Expenses:
Research and development $ 12,675 $ 9,208 $ 6,108 $ 49,201
General and administration 7,809 7,246 5,156 35,699
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Loss before the undernoted (20,484) (16,454) (11,264) (84,900)
Investment income 977 2,065 1,303 5,243
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Loss for the period (19,507) (14,389) (9,961) (79,657)
Deficit, beginning of period
(61,660) (47,271) (37,310)
(1,510)
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Deficit, end of period
$ (81,167) $ (61,660) $ (47,271) $ (81,167)
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Basic and diluted loss
per share $ (0.40) $ (0.32) $ (0.24)
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SOURCE Vasogen Inc. |
