SECURITIES AND EXCHANGE COMMISSION
Form 6-K
Report of Foreign Private Issuer
Pursuant to Rule 13a-16 or 15d-16
of the Securities Exchange Act of 1934
For the month of March, 2005
Commission File Number 000-31062
Oncolytics Biotech Inc.
Suite 210, 1167 Kensington Crescent NW
Calgary, Alberta, Canada T2N 1X7
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 o | Form 40-F þ |
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(1): o
Note: Regulation S-T Rule 101(b)(1) only permits the submission in paper of a Form 6-K if submitted solely to provide an attached annual report to security holders.
Indicate by check mark if the registrant is submitting the Form 6-K in paper as permitted by Regulation S-T Rule 101(b)(7): o
Note: Regulation S-T Rule 101(b)(7) only permits the submission in paper of a Form 6-K if submitted to furnish a report or other document that the registrant foreign private issuer must furnish and make public under the laws of the jurisdiction in which the registrant is incorporated, domiciled or legally organized (the registrants home country), or under the rules of the home country exchange on which the registrants securities are traded, as long as the report or other document is not a press release, is not required to be and has not been distributed to the registrants security holders, and, if discussing a material event, has already been the subject of a Form 6-K submission or other Commission filing on EDGAR.
Indicate by check mark whether by furnishing the information contained in this Form, the registrant is also thereby furnishing the information to the Commission pursuant to Rule 12g3-2(b) under the Securities Exchange Act of 1934.
Yes o | No þ |
If Yes is marked, indicate below the file number assigned to the registrant in connection with Rule 12g3-2(b): 82 -
Signatures | ||||||||
Press Release |
SIGNATURES
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.
Oncolytics
Biotech Inc. (Registrant) |
||||
Date: March 4, 2005 | By: | /s/ Doug Ball, CFO
Doug Ball, CFO Chief Financial Officer |
210, 1167 Kensington Cr. N.W. Calgary, Alberta Canada T2N 1X7 |
FOR IMMEDIATE RELEASE
Oncolytics Biotech Inc. Reports Highlights and Financial Results for 2004
Calgary, AB, March 4, 2005 Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) (Oncolytics or the Company) today reported its financial results for the year ended December 31, 2004.
Selected Highlights:
| Expanded the clinical program to the United Kingdom with the approval and commencement of a Phase I systemic administration trial; |
| Received approval in February 2005 to commence a Phase I study examining the use of REOLYSIN® in combination with radiation therapy in the U.K.; |
| Received clearance in February 2005 to commence a Phase I/II study examining the use of REOLYSIN® in patients with recurrent malignant gliomas (brain cancers) in the U.S.; |
| Reported final results from the T2 prostate cancer clinical trial; |
| Successfully transferred the manufacturing process to a supplier located in the U.K.; |
| Expanded the intellectual property base with the issue of three U.S. patents, including patents covering manufacturing technology and other cellular proliferative diseases; and, |
| Raised net proceeds of $23.5 million to expand and accelerate the clinical trial program. |
During 2004, Oncolytics advanced the development of REOLYSIN® in a number of important areas, said Dr. Brad Thompson, President and CEO of Oncolytics Biotech Inc. We made progress in expanding our clinical trial program internationally, particularly in the United Kingdom, adding to our intellectual property portfolio and strengthening our financial resources to support our expanding clinical program.
Oncolytics Biotech Inc.
BALANCE SHEETS
As at December 31
2004 | 2003 | |||||||
$ | $ | |||||||
ASSETS |
||||||||
Current |
||||||||
Cash and cash equivalents |
12,408,516 | 2,641,127 | ||||||
Short-term investments |
21,510,707 | 18,111,608 | ||||||
Accounts receivable |
47,767 | 64,224 | ||||||
Prepaid expenses |
250,365 | 156,837 | ||||||
34,217,355 | 20,973,796 | |||||||
Capital assets |
5,259,286 | 4,965,379 | ||||||
Investments |
12,000 | 111,425 | ||||||
39,488,641 | 26,050,600 | |||||||
LIABILITIES AND SHAREHOLDERS EQUITY |
||||||||
Current |
||||||||
Accounts payable and accrued liabilities |
949,258 | 884,928 | ||||||
Alberta Heritage Foundation loan |
150,000 | 150,000 | ||||||
Commitments and contingency |
||||||||
Shareholders equity |
||||||||
Share capital |
||||||||
Authorized: unlimited |
||||||||
Issued: 31,915,496 (2003 27,208,262) |
66,643,325 | 44,712,589 | ||||||
Warrants |
3,347,630 | 1,598,250 | ||||||
Contributed surplus |
6,349,139 | 3,699,425 | ||||||
Deficit |
(37,950,711 | ) | (24,994,592 | ) | ||||
38,389,383 | 25,015,672 | |||||||
39,488,641 | 26,050,600 | |||||||
Oncolytics Biotech Inc.
STATEMENTS OF LOSS AND DEFICIT
For the periods ended December 31
Cumulative | ||||||||||||||||
from inception | ||||||||||||||||
on April 2, | ||||||||||||||||
1998 to | ||||||||||||||||
December 31, | ||||||||||||||||
2004 | 2003 | 2002 | 2004 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
Revenue |
||||||||||||||||
Rights revenue |
¾ | ¾ | ¾ | 310,000 | ||||||||||||
Interest income |
699,757 | 313,305 | 208,867 | 2,785,740 | ||||||||||||
699,757 | 313,305 | 208,867 | 3,095,740 | |||||||||||||
Expenses |
||||||||||||||||
Research and development |
7,107,998 | 2,818,962 | 4,251,025 | 23,526,528 | ||||||||||||
Operating |
2,803,669 | 2,449,478 | 2,102,870 | 10,005,794 | ||||||||||||
Stock based compensation |
2,668,570 | 996,707 | 32,718 | 3,697,995 | ||||||||||||
Foreign exchange loss (gain) |
358,068 | 2,881 | (598 | ) | 359,970 | |||||||||||
Amortization |
751,756 | 663,524 | 574,237 | 2,661,846 | ||||||||||||
13,690,061 | 6,931,552 | 6,960,252 | 40,252,133 | |||||||||||||
Loss before the following: |
12,990,304 | 6,618,247 | 6,751,385 | 37,156,393 | ||||||||||||
Gain on sale of BCY LifeSciences Inc. |
(34,185 | ) | (264,453 | ) | ¾ | (298,638 | ) | |||||||||
Loss on sale of Transition Therapeutics Inc. |
¾ | 2,156,685 | ¾ | 2,156,685 | ||||||||||||
Loss before taxes |
12,956,119 | 8,510,479 | 6,751,385 | 39,014,440 | ||||||||||||
Capital tax (recovery) |
¾ | 33,552 | (12,281 | ) | 51,271 | |||||||||||
Future income tax recovery |
¾ | ¾ | (647,618 | ) | (1,115,000 | ) | ||||||||||
Net loss for the period |
12,956,119 | 8,544,031 | 6,091,486 | 37,950,711 | ||||||||||||
Deficit, beginning of period |
24,994,592 | 16,450,561 | 10,359,075 | ¾ | ||||||||||||
Deficit, end of period |
37,950,711 | 24,994,592 | 16,450,561 | 37,950,711 | ||||||||||||
Basic and diluted loss per share |
(0.45 | ) | (0.35 | ) | (0.30 | ) | ||||||||||
Oncolytics Biotech Inc.
STATEMENTS OF CASH FLOWS
For the periods ended December 31
Cumulative | ||||||||||||||||
from inception | ||||||||||||||||
on April 2, | ||||||||||||||||
1998 to | ||||||||||||||||
December 31, | ||||||||||||||||
2004 | 2003 | 2002 | 2004 | |||||||||||||
$ | $ | $ | $ | |||||||||||||
OPERATING ACTIVITIES |
||||||||||||||||
Net loss for the year |
(12,956,119 | ) | (8,544,031 | ) | (6,091,486 | ) | (37,950,711 | ) | ||||||||
Deduct non-cash items |
||||||||||||||||
Amortization |
751,756 | 663,524 | 574,237 | 2,661,846 | ||||||||||||
Non-cash compensation |
2,668,570 | 996,707 | 32,718 | 3,697,995 | ||||||||||||
Gain on sale of BCY LifeSciences Inc. |
(34,185 | ) | (264,453 | ) | | (298,638 | ) | |||||||||
Cancellation of contingent payment
obligation settled in common shares |
150,000 | | | 150,000 | ||||||||||||
Loss on sale of Transition Therapeutics Inc. |
| 2,156,685 | | 2,156,685 | ||||||||||||
Foreign exchange loss |
264,080 | 2,881 | (598 | ) | 265,982 | |||||||||||
Future income tax recovery |
| | (647,618 | ) | (1,115,000 | ) | ||||||||||
Net changes in non-cash working capital |
(69,065 | ) | (489,051 | ) | (1,122,953 | ) | 508,233 | |||||||||
Cash used in operating activities |
(9,224,963 | ) | (5,477,738 | ) | (7,255,700 | ) | (29,923,608 | ) | ||||||||
INVESTING ACTIVITIES |
||||||||||||||||
Intellectual property |
(958,809 | ) | (1,045,869 | ) | (860,520 | ) | (3,623,635 | ) | ||||||||
Other capital assets |
(15,230 | ) | (50,729 | ) | (191,694 | ) | (526,202 | ) | ||||||||
Purchase of short-term investments |
(6,777,179 | ) | (18,111,608 | ) | | (24,888,787 | ) | |||||||||
Redemption of short-term investments |
3,114,000 | | | 3,114,000 | ||||||||||||
Investment in BCY LifeSciences Inc. |
133,609 | 450,151 | (127,123 | ) | 456,637 | |||||||||||
Investment in Transition Therapeutics Inc. |
| 2,552,695 | (20,352 | ) | 2,532,343 | |||||||||||
Cash used in investing activities |
(4,503,609 | ) | (16,205,360 | ) | (1,199,689 | ) | (22,935,644 | ) | ||||||||
FINANCING ACTIVITIES |
||||||||||||||||
Alberta Heritage Foundation loan |
¾ | ¾ | ¾ | 150,000 | ||||||||||||
Proceeds from exercise of stock options and
warrants |
8,121,296 | 700,882 | 34,000 | 11,582,281 | ||||||||||||
Proceeds from private placements |
6,223,763 | 9,844,700 | 1,769,877 | 22,741,983 | ||||||||||||
Proceeds from public offerings |
9,150,902 | 5,459,399 | ¾ | 30,793,504 | ||||||||||||
Cash provided by financing activities |
23,495,961 | 16,004,981 | 1,803,877 | 65,267,768 | ||||||||||||
Increase (decrease) in cash and cash
equivalents during the period |
9,767,389 | (5,678,117 | ) | (6,651,512 | ) | 12,408,516 | ||||||||||
Cash and cash equivalents, beginning of the
period |
2,641,127 | 8,319,244 | 14,970,756 | | ||||||||||||
Cash and cash equivalents, end of the period |
12,408,516 | 2,641,127 | 8,319,244 | 12,408,516 | ||||||||||||
Cash interest received |
459,757 | 187,843 | 218,129 | |||||||||||||
Cash taxes paid (net) |
¾ | 1,552 | 18,114 | |||||||||||||
To view the Notes to the Companys Financial Statements and Managements Discussion and Analysis, please see the Companys 2004 Annual Filings which will be on www.sedar.com.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the development of REOLYSIN®, its
proprietary formulation of the human reovirus, as a potential cancer therapeutic. Oncolytics
researchers have demonstrated that the reovirus is able to selectively kill cancer cells and, in
vitro, kill human cancer cells that are derived from many types of cancer including breast,
prostate, pancreatic and brain tumours, and have also demonstrated successful cancer treatment
results in a number of animal models. Phase I clinical trial results have indicated that REOLYSIN®
was well tolerated and that the reovirus demonstrated activity in tumours injected with REOLYSIN®.
This press release contains forward looking statements, within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended. Forward looking statements, including the Companys belief as to the potential of REOLYSIN® as a cancer therapeutic; the Companys expectations as to the success of its research and development programs in 2005 and beyond, the Companys planned expansion, the value of the additional patents and intellectual property; the Companys expectations related to the applications of the patented technology; the ability of the technology to strengthen the core technology; the Companys expectations as to adequacy of its existing capital resources; the design, timing, success of planned clinical trial programs and the Companys planned expansion of such programs; and other statements related to anticipated developments in the Companys business and technologies involve known and unknown risks and uncertainties, which could cause the Companys actual results to differ materially from those in the forward looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue research and development projects, the efficacy of REOLYSIN® as a cancer treatment, the success and timely completion of clinical studies and trials, the Companys ability to successfully commercialize REOLYSIN®, uncertainties related to the research and development of pharmaceuticals, uncertainties related to the regulatory process and general changes to the economic environment. Investors should consult the Companys quarterly and annual filings with the Canadian and U.S. securities commissions for additional information on risks and uncertainties relating to the forward looking statements. Investors are cautioned against placing undue reliance on forward looking statements. The Company does not undertake to update these forward looking statements.
FOR FURTHER INFORMATION PLEASE CONTACT:
For Canada:
|
For Canada: | For United States: | ||
Oncolytics Biotech Inc.
|
The Equicom Group Inc. | The Investor Relations Group | ||
Doug Ball, CFO
|
Joanna Longo | Gino De Jesus or Dian Griesel, Ph.D. | ||
210, 1167 Kensington Cr NW
|
20 Toronto Street | 11 Stone St, 3rd Floor | ||
Calgary, Alberta T2N 1X7
|
Toronto, Ontario M5C 2B8 | New York, NY 10004 | ||
Tel: 403.670.7377
|
Tel: 416.815.0700 ext. 233 | T: 212.825.3210 | ||
Fax: 403.283.0858
|
Fax: 416.815.0080 | F: 212.825.3229 | ||
info@oncolyticsbiotech.com
|
jlongo@equicomgroup.com | mail@investorrelationsgroup.com |
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