FORM 6-K
SECURITIES AND EXCHANGE COMMISSION
Washington, D.C. 20549
REPORT OF FOREIGN PRIVATE ISSUER
Pursuant to Rule 13a-16 or 15d-16 of
The Securities Exchange Act of 1934
For the month of July 2000
Commission File Number 0-29350
VASOGEN INC.
(Translation of Registrant's name into English)
2155 Dunwin Drive, Suite 10, Mississauga, Ontario, L5L 4M1
(Address of principal executive offices)
(Indicate by check mark whether the registrant files or will file annual reports
under cover Form 20-F or Form 40-F.)
Form 20-F X Form 40-F
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(Indicate by check mark whether the registrant by furnishing the information
contained in this Form is also thereby furnishing the information to the
Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of
1934.)
Yes No X
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This Form 6-K consists of:
Interim Finanical Statements for the period ending May 31, 2000.
SIGNATURE
Pursuant to the requirements of the Securities Exchange Act of 1934, the
Registrant has duly caused this report to be signed on its behalf by the
undersigned, thereunto duly authorized.
VASOGEN INC.
By
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(Name: Christopher Waddick)
(Title: Vice-President, Finance & CFO)
Date: July 27, 2000
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TO OUR SHAREHOLDERS
During the second quarter, Vasogen continued to achieve important
milestones with the receipt of regulatory approvals for the commencement of
clinical trials in congestive heart failure and leukemia patients. The
commencement of these two important initiatives brings the total number of
indications in clinical development to five. The Company also presented
important findings at two major medical conferences, added an internationally
recognized oncologist to the Scientific Advisory Board and made a key
appointment to the Board of Directors.
The U.S. Food and Drug Administration granted regulatory approval to
proceed with a two-center clinical trial of VAS991, Vasogen's immune modulation
therapy for the treatment of congestive heart failure (CHF). CHF is a
progressive and often fatal cardiac condition that affects nearly five million
Americans and its prevalence is growing at ten percent per year. As a
non-pharmaceutical approach to the treatment of CHF, VAS991 offers the potential
to beneficially impact the progression of this disease without increasing the
large number of drugs taken by these patients. CHF represents an important
extension of the Company's cardiovascular disease program, which also includes
ongoing clinical trials with patients suffering from peripheral vascular disease
(PVD). Results from the PVD trials are expected prior to year-end.
Health Canada granted Vasogen regulatory approval to initiate its first
clinical trial in the area of cancer at the Princess Margaret Hospital,
University of Toronto. This trial is designed to investigate the safety and
efficacy of Vasogen's VAS981 cell-processing technology in preventing
graft-versus-host disease (GvHD) - a potentially life-threatening complication
of bone marrow transplantation used in the treatment of leukemia patients.
Complications associated with GvHD cost healthcare systems in excess of $500
million annually and severely limit the number of donor bone marrow transplant
procedures that can be performed. Overcoming this problem offers the possibility
of extending life-saving bone marrow transplantation to thousands more cancer
patients each year.
<PAGE>
At the 49th Annual Scientific Session of the American College of
Cardiology, held in Anaheim, California, University of Toronto researchers
presented results of experimental studies demonstrating the ability of Vasogen's
VasoCare(TM) therapy to reduce inflammation and retard the development of
atherosclerotic plaque by up to 75%. Atherosclerosis, the major cause of
cardiovascular disease, is a progressive condition leading to arterial blockage
with reduced blood flow resulting from the build-up of cholesterol-containing
plaque within the blood vessel wall. Recent research has shown that inflammation
within the blood vessel wall contributes significantly to both the development
and instability of atherosclerotic plaques. Reduction of inflammation and the
resulting stabilization of atherosclerotic plaques has, therefore, become an
important target in the treatment of atherosclerosis. In the United States more
than 20 million people have cardiovascular disease; 14 million suffer from
coronary heart disease, 2 million have peripheral vascular disease, and 4
million suffer the effects of stroke. These conditions lead to more than 500,000
deaths each year in North America and cost the healthcare system in excess of
$150 billion annually.
At the 61st Annual Meeting of The Society for Investigative Dermatology,
held in Chicago, Illinois, University of Toronto researchers presented evidence
demonstrating that interleukin-10 (IL-10) is a key factor in the
anti-inflammatory mechanism of Vasogen's immune modulation therapies. IL-10 has
been shown to play a significant role in beneficially modulating a number of
inflammatory conditions, including ischemia/reperfusion injury and autoimmune
diseases such as psoriasis. The data presented provide direct evidence of an
immune-mediated mechanism that explains the marked anti-inflammatory effects
seen with Vasogen's immune modulation therapies, a fundamental finding that is
the subject of a newly filed patent application in the United States.
In support of the Company's new clinical initiatives, Richard G. Margolese,
MD, was appointed to the Scientific Advisory Board (SAB). Dr. Margolese is
internationally recognized for his leadership in both cancer research and
treatment. He is the Herbert Black Professor of Surgical Oncology at McGill
University, Director of Oncology at Sir Mortimer B. Davis-Jewish General
Hospital in Montreal, and is a recipient of the Order of Canada.
<PAGE>
The Company also appointed William R. Grant as Vice-Chairman of the Board
of Directors. Mr. Grant has served on Vasogen's Board since 1998 and is Chairman
of Galen Associates, a New York-based private equity and investment firm which
he co-founded in 1987 and which focuses solely on the healthcare industry. Mr.
Grant has more than 40 years of experience in the investment banking and
healthcare fields, including 25 years with Smith Barney, ultimately as Chairman
and President, and 24 years as a director of SmithKline Beecham from which he
recently retired as Vice-Chairman.
With five products now in clinical trials, a solid financial position and a
strong research pipeline to support future growth, Vasogen remains well
positioned to advance the commercial development of its products and continue to
enhance shareholder value.
/s/ William A. Cochrane /s/ David G. Elsley
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William A. Cochrane David G. Elsley
Chairman of the Board President and CEO
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CONSOLIDATED BALANCE SHEETS
(in thousands of Canadian dollars)
As at May 31 2000 1999
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Assets
Current assets:
Cash and cash equivalents $ 3,487 $ 2,568
Marketable securities 21,171 8,158
Inventory 331 212
Prepaid expenses and receivables 1,084 148
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26,073 11,086
Capital assets 366 198
Less accumulated amortization (139) (78)
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227 120
Acquired technology 4,082 3,711
Less accumulated amortization (2,183) (1,904)
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1,899 1,807
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Total Assets $ 28,199 $ 13,013
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable &
accrued liabilities $ 420 $ 412
Shareholders' equity:
Share capital 69,883 45,542
Deficit (42,104) (32,941)
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27,779 12,601
Total Liabilities and
shareholders' equity $ 28,199 $ 13,013
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CONSOLIDATED STATEMENTS OF OPERATIONS AND DEFICIT
(in thousands of Canadian dollars except per share amounts)
For the six months
ended May 31 2000 1999
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Expenses:
Research and development $ 2,860 $ 2,040
Salaries 564 601
Professional fees 468 296
General and administration 869 592
Amortization of capital assets 33 18
Loss for the period (4,794) (3,547)
Deficit, beginning of period (37,310) (29,394)
Deficit, end of period (42,104) (32,941)
Loss per share $ (0.12) $ (0.12)
*See accompanying notes.
<PAGE>
CONSOLIDATED STATEMENTS OF CASHFLOWS
(in thousands of Canadian dollars)
For the six months
ended May 31 2000 1999
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Cash provided by (used for):
Operations:
Loss for the period $(4,794) $(3,547)
Items not involving cash:
Amortization of capital assets
and technology 159 119
Services provided for common shares 233 259
Changes in non-cash working capital (1,406) (337)
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(5,808) (3,506)
Financing:
Shares issued for cash 15,525 9,825
Warrants exercised for cash 4,752 163
Options exercised for cash 1,849 55
Share issue costs (228) (898)
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21,898 9,145
Investing:
Increase in acquired technology - (70)
Maturities (purchases) of
marketable securities (13,595) (4,030)
Increase in capital assets (67) (39)
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(13,662) (4,139)
Foreign exchange gain (loss)
on cash held in foreign currency 28 (5)
Increase (decrease) in cash and
cash equivalents 2,456 1,495
Cash and cash equivalents,
beginning of period 1,031 1,073
-----------------------
Cash and cash equivalents,
end of period $ 3,487 $ 2,568
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Notes to the Consolidated Financial Statements
(1) Share Capital:
Number Outstanding
Security Description at May 31, 2000
--------------------------------------------------------------
Common Shares 41,418,198
Options 1,422,550
Warrants 1,684,249
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(2) Subsequent to quarter end the issued 2,012,500 Common Company Shares at a
price of $10.00 per share for net proceeds of $18.7 million.
