ViRexx Reports 2004 Results and Provides Update.EDMONTON Edmonton (ĕd`məntən), city (1991 pop. 616,741), provincial capital, central Alta., Canada, on the North Saskatchewan River. The center of the largest metropolitan area in Alberta, Edmonton, known as the "Gateway to the North," is located , Alberta Alberta (ălbûr`tə), province (2001 pop. 2,974,807), 255,285 sq mi (661,188 sq km), including 6,485 sq mi (16,796 sq km) of water surface, W Canada. -- ViRexx Medical Corp. (TSX TSX Toronto Stock Exchange (TSE before April, 2002) TSX Transfer from Stack Pointer to Index TSX True Space Extension :VIR VIR Virtual VIR Virgin Islands (ISO Country code) VIR Virginia International Raceway VIR Vascular and Interventional Radiology VIR Vehicle Inspection Report VIR Virtual Interface (Alteon) ) a company focused on immunotherapy Immunotherapy The treatment of cancer by improving the ability of a tumor-bearing individual (the host) to reject the tumor immunologically. There are molecules on the surface of tumor cells, and perhaps in their interior, that are recognized as different from and embolotherapy treatments of cancer and chronic hepatitis Chronic hepatitis Long lasting inflammation of the liver due to viruses or other causes. Mentioned in: Tube Compression of the Esophagus and Stomach chronic hepatitis B and C, today announced its fourth quarter and 2004 fiscal year operational and financial results. Highlights Over the past twelve months, the Company has accomplished: - Completion of manufacturing and initiation of Occlusin(TM) 50 Injection Phase I clinical trial Noun 1. phase I clinical trial - a clinical trial on a few persons to determine the safety of a new drug or invasive medical device; for drugs, dosage or toxicity limits should be obtained phase I - Addition of a late-stage clinical product, OvaRex(R), and oncology oncology /on·col·o·gy/ (ong-kol´ah-je) the sum of knowledge regarding tumors; the study of tumors. on·col·o·gy n. platform through acquisition of AltaRex Medical Corp. - Strengthening of distribution capabilities for OvaRex(R) with signing of distribution agreement with Dompe International S.A. for territories that include, include Italy Italy (ĭt`əlē), Ital. Italia, officially Italian Republic, republic (2005 est. pop. 58,103,000), 116,303 sq mi (301,225 sq km), S Europe. , Spain, Portugal, Hungary, Poland, Czech Republic Czech Republic, Czech Česká Republika (2005 est. pop. 10,241,000), republic, 29,677 sq mi (78,864 sq km), central Europe. It is bordered by Slovakia on the east, Austria on the south, Germany on the west, and Poland on the north. , Switzerland, Austria as well as other Eastern European European emanating from or pertaining to Europe. European bat lyssavirus see lyssavirus. European beech tree fagussylvaticus. European blastomycosis see cryptococcosis. countries - Strengthening of management team with the addition of Marc Canton Canton, cities, United States Canton. 1 City (1990 pop. 13,922), Fulton co., W central Ill., in the corn belt; inc. 1849. It is a trade and industrial center for a coal and farm area. 2 Town (1990 pop. 18,530), Norfolk co. , President and COO (Cell Of Origin) See mobile positioning. , and Irwin Griffith, VP Drug Development, Infectious Diseases infectious diseases: see communicable diseases. - Transition to state-of-the-art office and laboratory facility with capacity to handle growth needs for coming years - Successful public offering of $8.8mm on TSX Venture Exchange TSX Venture Exchange Originally called the Canadian Venture Exchange (CDNX), this was a result of the merger of the Vancouver and Alberta stock exchanges. The goal of TSX Venture Exchange is to provide venture companies with effective access to capital while protecting investors. in April and graduation Graduation is the action of receiving or conferring an academic degree or the associated ceremony. The date of event is often called degree day. The event itself is also called commencement, convocation or invocation. to the Toronto Stock Exchange Toronto Stock Exchange (TSE) Canada's largest stock exchange, trading approximately 1,200 company stocks and 33 options. in December "Over the past year, ViRexx has transformed itself from a pre-clinical stage company to a company with a broad product pipeline, including a Phase III Noun 1. phase III - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the FDA product, for the treatment of cancer and viral infections viral infection, n an infection by a pathogenic virus. A virus acts on the cell nucleus, taking over the genetic material within the nucleus and replicating itself. . This transformation into a leader in immunotherapy and embolotherapy forms the foundation for the future growth of the company," commented Dr. Antoine Noujaim, Chairman and CEO (1) (Chief Executive Officer) The highest individual in command of an organization. Typically the president of the company, the CEO reports to the Chairman of the Board. . "With anticipated milestones from each of our platform technologies including completion of enrollment of the OvaRex(R) Phase III trial, we see the coming twelve months to be an exciting time for ViRexx". Upcoming Milestones ViRexx anticipates the following milestones in the coming twelve months: - Initiate HepaVaxx B GMP GMP (guanosine monophosphate): see guanine. Manufacturing (Q2 2005) - Initiate HepaVaxx B Phase I Clinical Trial (Q3 2005) - Complete Occlusin(TM) 50 Injection Phase I liver cancer Liver Cancer Definition Liver cancer is a relatively rare form of cancer but has a high mortality rate. Liver cancers can be classified into two types. clinical trial (Q4 2005) - Select HepaVaxx C clinical candidate (Q4 2005) - Complete enrollment in OvaRex(R) Phase III trial (Q1 2006) Financial Highlights (All amounts reported are in Canadian dollars Noun 1. Canadian dollar - the basic unit of money in Canada; "the Canadian dollar has the image of loon on one side of the coin" loonie dollar - the basic monetary unit in many countries; equal to 100 cents unless otherwise stated) The Company recorded a net loss for the twelve months ended December 31, 2004 of $3,398,477or $0.13 per share, as compared to a net loss of $1,458,386 or $0.16 per share for the year ended December 31, 2003. The expenditure increase is due to increased preclinical preclinical /pre·clin·i·cal/ (-klin´i-k'l) before a disease becomes clinically recognizable. pre·clin·i·cal adj. 1. , product development, clinical trial activity and additional costs and resources associated with operating as a public company. In 2004, the Company completed preclinical activities and initiated a Phase I clinical trial for Occlusin(TM) Injection and accelerated preclinical activity (including manufacturing) for HepaVaxx B. Revenue for the twelve months ended December 31, 2004 totaled $992,158, an increase of $829,881 from the $162,277 recorded for the year ended December 31, 2003. Revenue related to interest from investments, Industrial Research Assistance Program ("IRAP IRAP Industrial Research Assistance Program (National Research Council, Canada) IRAP Imposta Regionale sulle Attività Produttive (Italy) IRAP Interleukin-1 Receptor Antagonist Protein ") grants from the National Research Council of Canada The National Research Council Canada (NRC) is Canada's leading organization for scientific research and development. History NRC was established in 1916, mainly to advise the government. Then, in the early 1930s, laboratories were built in Ottawa. ("NRC NRC abbr. 1. National Research Council 2. Nuclear Regulatory Commission Noun 1. NRC - an independent federal agency created in 1974 to license and regulate nuclear power plants ") and a technology commercialization award from the Alberta Heritage Foundation for Medical Research ("AHFMR AHFMR Alberta Heritage Foundation for Medical Research "). The increase in revenue is attributed to increased interest earned on investments due to higher cash resources and the continued and increased levels of IRAP support and the technology commercialization award from the AHFMR. Research and development expenses for the year ended December 31, 2004, totaled $2,348,355, an increase of $1,284,203 from the $1,064,152 incurred for the year ended December 31, 2003. The increase of research and development expenses due to: - Increase in number of staff members and salary increases awarded to staff - Elevated use of third party consultants to accelerate HepaVaxx B preclinical activities (initial manufacturing) - Completion of Occlusin(TM) Injection preclinical activities (including manufacturing) and initiation of Phase I clinical trial (costs associated with contract research organization and regulatory filing) General and administrative expenses for the year ended December 31, 2004 totaled $1,577,263, an increase of $896,527 from the $680,736 recorded for the year ended December 31, 2003. The increase of general and administrative expenses due to: - Consulting and professional fees associated with investor relations Investor relations The process by which the corporation communicates with its investors. and corporate communication activities - Increase in number of staff members and salary increases awarded to staff - Lease and relocation RELOCATION, Scotch law, contracts. To let again to renew a lease, is called a relocation. 2. When a tenant holds over after the expiration of his lease, with the consent of his landlord, this will amount to a relocation. costs associated with new office and laboratory facility - Elevated insurance premiums and expanded insurance coverage (director & officer insurance) - TSX and TSX Venture Exchange filing and listing fees At December 31, 2004, the Company's cash and cash equivalents totalled $10,121,988 as compared to $2,708,599 at December 31, 2003. The Company believes that its available cash and cash equivalents, interest earned thereon there·on adv. 1. On or upon this, that, or it. 2. Archaic Following that immediately; thereupon. Adv. 1. thereon - on that; "text and commentary thereon" on it, on that should be sufficient to finance its operations and capital needs into the second quarter of 2006. At December 31, 2004, the Company had 53,276,477 common shares outstanding. The number of stock options and warrants outstanding at December 31, 2004 is 6,369,168 and 12,543,095 respectively and could generate proceeds of $18,448,389 if exercised. ViRexx is an Edmonton, Alberta based biotechnology company focused on the development of novel therapeutic products for the treatment of cancer and chronic viral infections. ViRexx's most advanced programs include drug candidates for the treatment of ovarian cancer ovarian cancer Malignant tumour of the ovaries. Risk factors include early age of first menstruation (before age 12), late onset of menopause (after age 52), absence of pregnancy, presence of specific genetic mutations, use of fertility drugs, and personal history of breast , chronic Hepatitis B & C & solid tumors. ViRexx's lead product, OvaRex(R) MAb MAB See: Master Air Waybill , a therapy for the treatment of late-stage ovarian cancer, is currently the subject of a Phase III clinical trial Noun 1. phase III clinical trial - a large clinical trial of a treatment or drug that in phase I and phase II has been shown to be efficacious with tolerable side effects; after successful conclusion of these clinical trials it will receive formal approval from the funded by ViRexx's partner United Therapeutics therapeutics Treatment and care to combat disease or alleviate pain or injury. Its tools include drugs, surgery, radiation therapy, mechanical devices, diet, and psychiatry. Corporation (NASDAQ NASDAQ in full National Association of Securities Dealers Automated Quotations U.S. market for over-the-counter securities. Established in 1971 by the National Association of Securities Dealers (NASD), NASDAQ is an automated quotation system that reports on : UTHR). For additional information about ViRexx, please see www.virexx.com. Summary financial statements attached:
ViRexx Medical Corp.
Consolidated Balance Sheet
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(Canadian dollars)
As at As at
December 31, December 31,
2004 2003
$ $
Assets (Restated)
Current assets:
Cash and cash equivalents 10,121,988 2,708,599
Accounts receivable 18,527 52,082
Goods and services tax recoverable 94,903 56,231
Share subscription receivable - 37,500
Investment tax credits recoverable - 447,013
Prepaid expenses and other assets 383,143 4,958
--------------------------
10,618,561 3,306,383
Property and equipment 533,202 173,800
Licenses 17,016 19,100
Intangible assets 33,336,552 -
--------------------------
44,505,331 3,499,283
--------------------------
--------------------------
Liabilities
Current liabilities:
Accounts payable and accrued liabilities 744,805 1,131,154
Convertible debenture 1,056,423 480,365
--------------------------
1,801,228 1,611,519
Amount due to related party - 35,341
Future income taxes 6,065,718 -
--------------------------
7,866,946 1,646,860
Shareholders' Equity
Share capital 41,802,454 5,808,817
Contributed Surplus 3,010,575 85,000
Equity component of convertible
debenture 59,118 59,118
Deficit (8,233,762) (4,100,512)
--------------------------
36,638,385 1,852,423
--------------------------
44,505,331 3,499,283
--------------------------
--------------------------
ViRexx Medical Corp.
Consolidated Statement of Loss
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(Canadian dollars) For twelve months For twelve months
ended December 31, ended December 31,
2004 2003
$ $
(Restated)
Revenues
Interest income 127,728 7,497
Government grants and awards 864,430 154,780
----------------------------------------
992,158 162,277
Expenses
Research & development 2,348,355 1,064,152
Corporate administration
and marketing 1,577,263 680,736
Debenture interest 61,999 76,052
Stock based compensation 380,576 211,300
Deprecation and amortization 71,349 31,596
----------------------------------------
4,439,542 2,063,836
----------------------------------------
(3,447,384) (1,901,559)
----------------------------------------
Other income (expense)
Scientific research and
experimental development tax credits - 451,475
Contract revenue (net of expenses) 15,324 -
Gain (loss) on foreign exchange 31,628 4,401
Loss (gain) on sale of property
and equipment 1,955 (12,703)
----------------------------------------
48,907 443,173
----------------------------------------
Net loss for the period (3,398,477) (1,458,386)
----------------------------------------
Basic and diluted loss per share (0.13) (0.16)
----------------------------------------
Consolidated Statement of Deficit
---------------------------------------------------------------------
---------------------------------------------------------------------
(Canadian dollars) For twelve months For twelve months
ended December 31, ended December 31,
2004 2003
$ $
Balance - Beginning of period (3,857,886) (2,449,826)
Change in accounting policy (242,626) (167,802)
----------------------------------------
(4,100,512) (2,617,628)
Adjustment for stock-based
compensation (734,773) -
Assumed on business combination - (24,498)
Net loss for period (3,398,477) (1,458,386)
----------------------------------------
Balance - End of period (8,233,762) (4,100,512)
----------------------------------------
----------------------------------------
ViRexx Medical Corp.
Consolidated Statement of Cash Flows
---------------------------------------------------------------------
(Canadian dollars) For twelve months For twelve months
ended December 31, ended December 31,
2004 2003
$ $
(Restated)
Cash provided by (used in)
Operating activities
Net loss for the period (3,398,477) (1,458,386)
Items not affecting cash
Debenture interest 54,526 76,052
Depreciation and amortization 71,349 31,596
Loss (gain) on foreign
exchange adjustment (26,128) -
Stock based compensation 380,576 211,300
Loss (gain) on disposal of
property and equipment (1,955) 12,703
---------------------------------------
Net change in non-cash working
capital items (2,920,109) (1,126,735)
Decrease (increase) in accounts
receivable 42,471 (13,460)
Decrease (increase) in goods and
services tax recoverable (17,422) (27,784)
Decrease (increase) in share
subscriptions receivable 37,500 162,500
Decrease (increase) in investment
tax credits recoverable 447,013 (79,659)
Increase (decrease) in prepaid
expenses and deposits (337,114) 1,756
Decrease (increase) in income
taxes recoverable - 8,436
Increase (decrease) in accounts
payable and accrued liabilities (481,052) 587,370
---------------------------------------
(3,228,713) (487,576)
---------------------------------------
Financing activities
Issuance of share capital 7,367,527 3,117,710
Advances from shareholder - 575,000
Repayment of advances from
shareholder - (575,000)
Amounts due to related parties (35,341) 13,368
---------------------------------------
7,332,186 3,131,078
---------------------------------------
Investment activities
Acquisition of property
and equipment (403,364) (94,617)
Cash acquired on business
combinations 3,710,419 19,142
Proceeds on sale of capital assets 2,861 9,210
---------------------------------------
3,309,916 (66,265)
---------------------------------------
Increase in cash
Cash and cash equivalents
- Beginning of period 7,413,389 2,577,236
Cash and cash equivalents
- End of period 2,708,599 131,363
---------------------------------------
10,121,988 2,708,599
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THE TSX HAS NOT APPROVED OR DISAPPROVED OF THE INFORMATION CONTAINED HEREIN ViRexx Medical Corp. (TSX:VIR) |
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