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 October 1999
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:
A 1999 Third Quarter issued by Vasogen Inc. on August 31, 1999.
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: October 29, 1999
<PAGE>
Since the last quarter, Vasogen received approval from the U.S. Food and Drug
Administration (FDA) and Health Canada to move two additional products into
clinical trials, appointed two experienced U.S. health care executives to its
Board of Directors, and listed its common shares on the Toronto Stock Exchange.
In September, Vasogen announced that it received FDA approval to proceed with a
clinical trial of VAS971 for the prevention of complications during major
vascular surgery. VAS971 is a proprietary immune modulation therapy designed to
protect organs and tissues against ischemia/reperfusion (I/R) injury. I/R
injury, which results from an interruption in blood flow, is the major cause of
organ damage during vascular surgery leading to increased death, disability, and
post-surgical recovery times. The VAS971 placebo-controlled, double blind trial
is being conducted at Baylor College of Medicine in Houston, Texas, one of the
world's leading cardiovascular surgery centers.
FDA clearance to proceed with clinical trials reflects the safety and
therapeutic potential of VAS971. The Baylor trial has been designed to
demonstrate the safety and effectiveness of VAS971 in protecting vital organs
during aortic aneurysm repair surgery, a major vascular surgical procedure to
repair a potential life-threatening weakness in the wall of the largest artery
leading from the heart. The initiation of the Baylor study follows the
successful pre-clinical research conducted at the University of Montreal that
demonstrated the ability of VAS971 to protect multiple organs against I/R
injury.
Vasogen also received approval from Health Canada to proceed with a clinical
trial to assess the safety and effectiveness of its VAS972 immune modulation
therapy in the treatment of psoriasis. This trial will be conducted at the
Sunnybrook Health Sciences Centre, under the direction of Dr. Daniel Sauder,
Professor and Chief of Dermatology at the University of Toronto.
Psoriasis is one of the most common dermatological diseases, occurring in up to
2% of the population worldwide. In the United States alone, between 150,000 and
250,000 new cases of psoriasis occur annually. Costs in terms of treatment and
care exceed US $3 billion annually. Psoriasis is a serious skin disorder
characterized by immune-related inflammation and excessive skin cell growth. It
is a lifelong condition with chronic recurrent exacerbations and remissions that
are emotionally and physically debilitating. Powerful immunosuppressive drugs
are currently used to treat psoriasis. These drugs, while effective in the
treatment of psoriasis, have significant adverse side effects, including kidney
toxicity and increased incidence of malignancies.
Clinical trials on Vasogen's VasoCare(TM) therapy for the treatment of
cardiovascular disease are proceeding on schedule. The Company's
placebo-controlled double-blind clinical trial in advanced peripheral vascular
disease patients at the University of Lund in Sweden will be reporting prior to
year-end and the multi-center clinical trial in peripheral vascular disease
patients in the United Kingdom has now reached 90% enrollment.
The development of VAS981 for the prevention of Graft-versus-Host Disease in
cancer patients receiving bone marrow transplants has completed the pre-clinical
phase. Based on the results of this work, the Company is now preparing
submissions to the requisite regulatory authorities to commence clinical trials
in leukemia patients.
During the quarter, the Company further enhanced the health care industry
experience of the Board of Directors with the appointment of two U.S. health
care executives.
Donald Grilli, of Boston, has held senior executive positions across seven
Johnson & Johnson (J&J) companies during his thirty-year career with this
diversified health care product company. Most recently, as President of Johnson
& Johnson Professional, Inc., his leadership resulted in a three-fold increase
in revenues to over $1 billion and positioned the company as the worldwide
market leader.
Terrance Gregg, of Los Angeles, is the President and Chief Operating Officer of
MiniMed Inc., a world leader in diabetes management systems. Mr. Gregg has led
MiniMed to a four-fold increase in revenue and a 15-fold increase in market
capitalization since 1996. Prior to joining MiniMed, Mr. Gregg served in
executive positions with Smith & Nephew plc. and Allergan Inc.
As part of its Year 2000 program, the Company has evaluated the impact of the
Year 2000 issue with respect to its product, its computer systems and other
equipment, and its suppliers. Year 2000 compliance has been substantially
completed and contingency plans have been implemented where appropriate. The
Company does not expect Year 2000 issues to have a material adverse effect on
its operations.
With products now in clinical trials for the prevention and treatment of
cardiovascular disease, autoimmune disease, and the reduction of complications
during vascular surgery, Vasogen has made significant progress towards its goal
of commercializing a series of immune modulation therapies to advance the
treatment of disease.
William A. Cochrane (signed) David G. Elsley (signed)
Chairman of the Board President and CEO
<PAGE>
Vasogen Inc.
Consolidated Statements of Operations and Deficit
For the nine months ended August 31
<TABLE>
<CAPTION>
(in thousands of dollars except per share amounts) 1999 1998
Expenses:
<S> <C> <C>
Research and development $ 3,034 $ 3,073
Salaries 900 849
Professional fees 802 608
General and administration 901 684
Amortization 32 13
--------------- ---------------
Loss for the period (5,669) (5,227)
Deficit, beginning of period, as restated (note 1) (29,394) (22,083)
--------------- ---------------
Deficit, end of period (35,063) (27,310)
=============== ===============
Loss per share $ (0.19) $ (0.20)
=============== ===============
</TABLE>
See accompanying notes
<PAGE>
Vasogen Inc.
Consolidated Statements of Cash Flows
For the nine months ended August 31
<TABLE>
<CAPTION>
(in thousands of dollars) 1999 1998
<S> <C> <C>
Cash provided by (used for):
Operations:
Loss for the period $ (5,669) $ (5,227)
Items not involving cash:
Amortization of capital assets and technology 185 166
Services provided for common shares 259 55
Changes in non-cash working capital (201) (465)
--------------- ---------------
$ (5,426) (5,471)
Financing:
Shares issued for cash 9,825 5,043
Warrants exercised for cash 493 253
Options exercised for cash 172 58
Share issue costs (770) (384)
--------------- ---------------
9,720 4,970
Investing:
Increase in acquired technology (300) (159)
Maturities (purchase) of marketable securities (3,657) 732
Increase in capital assets (129) (18)
--------------- ---------------
(4,086) 555
Increase (decrease) in cash and cash
equivalents 208 54
Cash and cash equivalents,
beginning of period 1,073 455
--------------- ---------------
Cash and cash equivalents,
end of period $ 1,281 $ 509
=============== ===============
</TABLE>
<PAGE>
Vasogen Inc.
Consolidated Balance Sheets
As at August 31
<TABLE>
<CAPTION>
(in thousands of dollars) 1999 1998
Assets
Current assets:
<S> <C> <C>
Cash and cash equivalents $ 1,281 $ 509
Marketable securities 7,785 6,296
Inventory 136 266
Prepaid expenses and advances 51 -
--------------- ---------------
9,253 7,071
Capital assets 287 200
Less accumulated amortization (92) (158)
--------------- ---------------
195 42
Acquired technology (note 1) 1,986 1,869
--------------- ---------------
1,986 1,869
Total Assets $ 11,434 $ 8,982
=============== ===============
Liabilities and Shareholders' Equity
Current liabilities:
Accounts payable & accrued liabilities $ 380 $ 96
Shareholders' equity:
Share capital 46,117 36,196
Deficit (35,063) (27,310)
--------------- ---------------
11,054 8,886
Total Liabilities and shareholders' equity $ 11,434 $ 8,982
=============== ===============
</TABLE>
See accompanying notes
<PAGE>
Vasogen Inc.
Notes to the Consolidated Financial Statements
(1) Prior to 1998, the Company did not amortize its acquired technology.
Commencing in 1998, the Company is amortizing this technology using the
straight-line method over 20 years. This change in accounting policy has
been applied retroactively such that the carrying value of the acquired
technology previously reported has been reduced by, and the deficit
increased by, $1,955,902 and $1,751,732 as at August 31, 1999 and 1998,
respectively, these amounts representing the accumulated amortization as at
each quarter end date; amortization expense, classified within research and
development costs on the consolidated statements of operations and deficit,
increased by $153,126 for each of the quarters ended August 31, 1999 and
1998.
