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 September 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 [ ]
(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 ]
This Form 6-K consists of:
Interim Financial Statements for the period ending August 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 /s/ Christopher Waddick
------------------------
(Name: Christopher Waddick)
(Title: Vice-President, Finance & CFO)
Date: September 25, 2000
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TO OUR SHAREHOLDERS
During the quarter, the Company's clinical trials in psoriasis and
peripheral vascular disease reached full enrollment and results from these
studies are expected during the fourth quarter. Ongoing clinical trials
addressing the treatment or prevention of congestive heart failure,
ischemia/reperfusion injury, and graft-versus-host disease remain on schedule to
report during the first half of next year. Appointments to Vasogen's senior
management team, the completion of a $20 million financing, and important
research findings in support of new therapeutic targets, rounded out the
quarter's significant events.
Millions of patients with atherosclerosis, or "hardening of the
arteries", have impaired function of the endothelium (the cellular lining of
blood vessels), which contributes to the progression of the disease, leading to
heart attack, stroke, symptoms of peripheral vascular disease, and other
cardiovascular complications. The American Heart Association lists
cardiovascular disease as the leading cause of death in the United States, with
atherosclerosis cited as the major cause of this condition. On June 7th, the
Company announced results of a pre-clinical study supporting the ability of
Vasogen's immune modulation therapy, VasoCare(TM), to significantly improve the
function of the vascular endothelium. The results of this research, carried out
at McMaster University, Hamilton, and St. Michael's Hospital, University of
Toronto, under the direction of Dr. David Courtman, Director of Research,
Division of Cardiovascular and Thoracic Surgery at St. Michael's Hospital, are
the subject of an abstract recently submitted to the 73rd Scientific Session of
the American Heart Association.
Findings of the McMaster study also support previously reported
results from a double-blind, placebo-controlled clinical trial in patients with
atherosclerosis conducted during 1999 at the University of Lund, Sweden, that
demonstrated significant improvements in blood flow recovery times following
temporary occlusion in patients receiving VasoCare(TM) therapy.
The Journal of Cutaneous Medicine and Surgery (Vol. 4, No. 3, 2000)
published pre-clinical results showing a significant beneficial effect of
Vasogen's VAS972 immune modulation therapy. The published research, conducted
under the direction of Daniel Sauder, MD, Professor and Chief of Dermatology at
the University of Toronto, utilizing a well-known model of inflammatory skin
disease, demonstrated a significant inhibition of immune-mediated inflammation
by VAS972. This decrease in inflammation is comparable to that seen using a
number of powerful but toxic immunosuppressive agents, such as cyclosporine,
which are widely used to treat moderate to severe psoriasis and other autoimmune
diseases. These findings, together with results previously presented at the 61st
Annual Meeting of the Society for Investigative Dermatology in Chicago,
demonstrating
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that the key regulatory cytokine IL-10 is an important mediator of the
anti-inflammatory mechanism of VAS972, suggest a therapeutic potential across a
wide range of autoimmune and inflammatory diseases including psoriasis,
rheumatoid arthritis, multiple sclerosis, and inflammatory bowel disease.
In support of the Company's clinical program and business
development initiatives, Vasogen announced two additions to its senior
management team. Clive Ward-Able, MD, was appointed Vice-President of Research &
Development and Tamar Howson was appointed Director of Business Development.
Dr. Ward-Able holds overall responsibility for directing the
Company's research and development program. Dr. Ward-Able has built a successful
international pharmaceutical career in South Africa, Switzerland, and the United
Kingdom. He most recently held the position of Medical and Healthcare Director
for Roche Products, U.K., where he was responsible for a wide range of
activities, including medical affairs, clinical trials management, medical
support for strategic marketing and new product introductions. Dr. Ward-Able
holds a Bachelor degree in Pharmacy from Rhodes University and a Medical degree
from the University of Stellenbosch, both located in South Africa.
Tamar Howson is responsible for directing the Company's licensing
and corporate partnering initiatives. Ms. Howson has developed a worldwide
network of pharmaceutical and healthcare industry contacts and has extensive
licensing and business development experience. She recently held the position of
Senior Vice-President and Director of Worldwide Business Development at
SmithKline Beecham. Ms. Howson holds an MBA in Finance and International
Business from Columbia University, an MSc from City College of New York, and a
BSc in Chemical Engineering from Technion in Israel.
Finally, the Company concluded a $20 million bought deal financing
with senior institutional investors, bringing Vasogen's cash position at the end
of the third quarter to $42 million. With five indications in clinical trials, a
solid financial position, and a strong research pipeline to support future
growth, Vasogen remains committed to enhancing shareholder value through the
commercial development of its proprietary immune modulation therapy for the
treatment of a number of autoimmune and inflammatory diseases.
/s/ William A. Cochrane /s/ David G. Elsley
----------------------- -------------------
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 August 31 2000 1999
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Assets
Current assets:
Cash and cash equivalents $ 2,455 $ 1,281
Marketable securities 39,824 7,785
Inventory 424 136
Prepaid expenses and receivables 510 51
----------------------------
43,213 9,253
Capital assets 402 287
Less accumulated amortization (157) (92)
----------------------------
245 195
Acquired technology 4,081 3,941
Less accumulated amortization (2,246) (1,955)
----------------------------
1,835 1,986
Total Assets $ 45,293 $ 11,434
============================
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable &
accrued liabilities $ 639 $ 380
Shareholders' equity:
Share capital 88,952 46,117
Deficit (44,298) (35,063)
----------------------------
44,654 11,054
Total Liabilities and
shareholders' equity $ 45,293 $ 11,434
============================
CONSOLIDATED STATEMENTS
OF OPERATIONS AND DEFICIT
(in thousands of Canadian dollars except per share amounts)
For the nine months
ended August 31 2000 1999
-----------------------------------------------------------------------
Expenses:
Research and development $ 4,556 $ 3,255
General and administration 3,233 2,635
----------------------------
(7,789) (5,890)
Investment income 801 221
----------------------------
Loss for the period (6,988) (5,669)
Deficit, beginning of period (37,310) (29,394)
----------------------------
Deficit, end of period (44,298) (35,063)
Loss per share $ (0.17) $ (0.19)
============================
*See accompanying notes.
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*See accompanying notes.
<PAGE>
CONSOLIDATED STATEMENTS OF CASH FLOWS
(in thousands of Canadian dollars)
For the nine months
ended August 31 2000 1999
-----------------------------------------------------------------------
Cash provided by (used for):
Operations:
Loss for the period $ (6,988) $ (5,669)
Items not involving cash:
Amortization of capital assets
and technology 241 185
Services provided for common shares 233 259
Changes in non-cash working capital (684) (199)
----------------------------
(7,198) (5,424)
Financing:
Shares issued for cash 35,650 9,825
Warrants exercised for cash 5,169 493
Options exercised for cash 1,946 172
Share issue costs (1,798) (770)
----------------------------
40,967 9,720
Investing:
Increase in acquired technology - (300)
Maturities (purchases) of
marketable securities (32,248) (3,657)
Increase in capital assets (103) (129)
----------------------------
(32,351) (4,086)
Foreign exchange gain (loss)
on cash held in foreign currency 6 (2)
Increase (decrease) in cash and
cash equivalents 1,424 208
Cash and cash equivalents,
beginning of period 1,031 1,073
Cash and cash equivalents,
end of period $ 2,455 $ 1,281
============================
Notes to the Consolidated Financial Statements
(1) Share Capital:
Number Outstanding
Security Description at August 31, 2000
-----------------------------------------------------------------------
Common Shares 43,681,698
Options 1,517,550
Warrants 1,483,249
(2) Certain amounts in the prior period have been reclassified to conform
with the presentation used in the current period.
