TORONTO, Nov. 14 /PRNewswire-FirstCall/ - Viventia Biotech Inc. today reported financial and operational results for the third quarter ended September 30, 2005.
Highlights for the quarter: - Received clearance from both the U.S. Food and Drug Administration (FDA) and Health Canada to begin a Phase II study evaluating Proxinium(TM) for the treatment of patients with chemotherapy-refractory recurrent head and neck cancer. - Expanded ongoing Phase I/II bladder cancer trial for Vicinium(TM) to include additional patients.
“Our third quarter was highlighted by the progress we made with regulatory authorities for our lead drug, Proxinium(TM). Our planned Phase II trial is expected to involve more than ten sites across North America and we are on track to initiate patient dosing before the end of the year,” said Nick Glover, President and CEO of Viventia. “Our Vicinium(TM) bladder cancer trial also remains on track. We have completed enrollment of the Phase I arm and expect to initiate the Phase II roll-in arm by the end of the year.”
Financial Results:
Total research, development and operating expenditures for the third quarter of 2005 increased to $5.8 million compared to $2.8 million for the third quarter of 2004. For the first nine months of 2005, total research, development and operating expenditures were $16.5 million compared to $9.3 million for the corresponding period in 2004. Of these expenditures, research related activities increased to $3.7 million for the third quarter of 2005 compared to $1.2 million for the corresponding period in 2004, primarily attributable to increased clinical trial activities and the costs associated with them. Salaries and benefits increased to $1.6 million for the third quarter of 2005 compared with $1.2 million for the third quarter of 2004, due to higher staffing levels. The balance of the research, development and operating expenditures were related to occupancy costs for the Company’s Winnipeg manufacturing facility and other operating expenses.
General and administrative expenditures increased to $0.4 million for the third quarter of 2005 compared to $0.3 million for the third quarter of 2005. General and administrative expenditures for the first nine months of 2005 were $2.0 million compared to $1.0 million for the first nine months of 2005. These increases were primarily attributable to one-time legal and accounting fees, activities related to the Company’s application for a U.S. listing, The Board of Directors of the Company has determined not to pursue the listing on the Amex Stock Exchange and has suspended it’s efforts to raise private equity capital in the United States due to unfavourable market conditions. The remainder of the variance is related to human resource consulting fees and recruitment fees as well as costs related to increased business activities.
Interest expense increased to $0.4 million for the third quarter of 2005 compared to $0.2 million for the third quarter of 2004. Interest expense increased to $1.1 million for the first nine months of 2005 compared to $0.5 million for the corresponding period in 2004. These increases were primarily attributable to convertible debentures issued in November 2004.
For the third quarter ended September 30, 2005 Viventia reported a net loss of $7.3 million or ($0.25) per share compared with a net loss of $3.8 million or ($0.13) per share for the same period in 2004. For the nine months ended September 30, 2005 the Company reported a net loss of $21.1 million or ($0.72) per share compared to $12.6 million or ($0.43) per share for the corresponding period in 2004.
As at September 30, 2005 the Company had cash and cash equivalents of approximately $239,000 and current liabilities of $23.8 million compared to $2.7 million and $3.8 million respectively at December 31, 2004.
During the three months ended September 30, 2005, the Company received $7.0 million in bridge financing loans from Leslie Dan. Subsequent to the end of the quarter, the Company received $3.4 million in bridge financing loans from Mr. Dan. Since January 1, 2005, the Company has received bridge financing loans in the aggregate amount of $21.0 million from Mr. Dan or an entity controlled by him. These loans bear interest at 4.5% per annum and are repayable on demand.
Since January 1, 2000, the Company has financed substantially all of its operations through the sale of equity securities, bridge loan financings from Mr. Leslie Dan or entities affiliated with Mr. Dan, and the issuance of secured convertible debentures to Mr. Dan and Ms. Andrea Dan-Hytman, Viventia’s two principal shareholders. Although the Company actively continues to seek additional sources of funding to finance its operation into the future, the Company can not provide assurances that additional financing sources will be available.
About Viventia Biotech
Viventia Biotech Inc. is a biopharmaceutical company developing Armed Antibodies(TM), powerful and precise anti-cancer drugs designed to overcome various forms of cancer. Viventia’s lead products, Proxinium(TM) and Vicinium(TM), combine a cytotoxic protein payload significantly more powerful than traditional chemotherapies with the highly precise tumour-targeting characteristics of a monoclonal antibody. Proxinium(TM) is entering Phase II clinical trials for the treatment of head and neck cancer, and Vicinium(TM) is currently enrolling patients in a Phase I/II clinical trial for the treatment of bladder cancer.
This press release contains forward-looking statements, which are subject to risks and uncertainties inherent to the process of developing and commercializing human therapeutic products. Actual results could differ materially from those projected in this release. Certain statements included in this press release constitute forward looking statements. When used in this press release, the words “anticipate”, “believe”, “plan”, “estimate”, “expect”, “intend”, “will”, “may”, “should” and similar expressions, as they relate to us or our management, are intended to identify forward-looking statements. These forward-looking statements are not historical facts but reflect our current expectations concerning future results and events. These statements include, without limitation, statements with respect to the clinical and developmental timelines associated with Proxinium.
The Toronto Stock Exchange has neither approved nor disapproved the information contained herein. FINANCIAL STATEMENTS VIVENTIA BIOTECH INC. FOR THE THIRD QUARTER ENDED SEPTEMBER 30, 2005 --------------------- Balance Sheets (in thousands of Canadian dollars) September December (unaudited) 30, 2005 31, 2004 As at --------------------- Assets $ $ Current Cash and cash equivalents 239 2,715 Short-term investments 50 52 Miscellaneous receivables 111 144 Prepaid expenses, deposits and supplies 876 500 ------------------------------------------------------------------------- Total Current Assets 1,276 3,411 ------------------------------------------------------------------------- Deferred financing expenses, net 122 201 Licensed technology, net 109 174 Capital assets, net 4,880 3,053 ------------------------------------------------------------------------- Total Assets 6,387 6,839 ------------------------------------------------------------------------- ------------------------------------------------------------------------- Liabilities Accounts payable and accrued liabilities 5,421 3,137 Current portion of capital lease obligations 202 59 Current portion of deferred income 52 70 Current portion of term loan due to related parties 531 509 Bridge financing loans due to related parties 17,600 - ------------------------------------------------------------------------- Total Current Liabilities 23,806 3,775 ------------------------------------------------------------------------- Capital lease obligation 501 93 Deferred income - 29 Term loan due to related party 654 1,050 Convertible debentures due to related parties 23,147 23,147 ------------------------------------------------------------------------- Total liabilities 48,108 28,094 ------------------------------------------------------------------------- Shareholders’ Deficiency Capital stock 63,262 63,262 Contributed surplus 10,291 9,655 Deficit (115,274) (94,172) ------------------------------------------------------------------------- Total Shareholders’ Deficiency (41,721) (21,255) ------------------------------------------------------------------------- TOTAL LIABILITIES AND SHAREHOLDERS’ DEFICIENCY 6,387 6,839 ------------------------------------------------------------------------- ------------------------------------------------------------------------- ------------------------------------------------------------------------- Statements of Loss and Deficit (in thousands of Canadian dollars, except per share data) For the periods ended (unaudited) 3 Months 3 Months 9 Months 9 Months to to to to September September September September 30, 2005 30, 2004 30, 2005 30, 2004 $ $ $ $ ------------------------------------------------------------------------- Expenses Research and development activities: Research activities 3,745 1,249 9,895 4,009 Salaries and benefits 1,574 1,198 4,878 4,140 Occupancy 219 176 672 588 Other operating expenses 302 155 990 547 Amortization of licensed technology 22 22 65 65 ------------------------------------------------------------------------- 5,862 2,800 16,500 9,349 General and administrative 398 291 1,994 988 Amortization of capital assets 387 104 870 281 Amortization of deferred financing expenses 28 68 79 24 Stock based compensation expense 228 186 636 215 Interest expense 443 222 1,085 530 ------------------------------------------------------------------------- Loss - before the under noted (7,344) (3,671) (21,164) (11,387) ------------------------------------------------------------------------- Write off of deferred financing expenses - (122) - (1,286) Miscellaneous income 18 1 62 53 ------------------------------------------------------------------------- Net loss for the period (7,326) (3,792) (21,102) (12,620) Deficit - Beginning of period (107,948) (85,828) (94,172) (77,000) ------------------------------------------------------------------------- Deficit - End of period (115,274) (89,620) (115,274) (89,620) ------------------------------------------------------------------------- ------------------------------------------------------------------------- Basic and diluted loss per common share (0.25) (0.13) (0.72) (0.43)
Viventia Biotech Inc.
CONTACT: James Smith, Tel. (416) 815-0700 x 229, Fax. (416) 815-0080,Email: jsmith@viventia.com
