CALGARY, Aug. 2, 2012 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its
financial results and operational highlights for the quarter ended
June 30, 2012.
“Early in the quarter, we announced that we had completed enrollment in
the first, 80-patient stage of our Phase III trial in head and neck
cancers,” said Dr. Brad Thompson, President and CEO of Oncolytics. “We
continued to make progress on this key clinical initiative during the
quarter with our independent Data Monitoring Committee recommending the
trial proceed based on a review of the safety data. We continue to
await the results of an ongoing data review which will enable us to
determine the next steps for the study.”
Selected Highlights
Since March 31, 2012, the Company has made a number of significant
announcements:
Clinical Trial Program
-
Completion of enrollment in the first, 80-patient stage of its Phase III
clinical trial examining REOLYSIN® in combination with paclitaxel and carboplatin in patients with
platinum-refractory head and neck cancers (REO 018); -
Review by Company’s independent Data Monitoring Committee (DMC) of the
safety data for the first stage of the Company’s Phase III trial in
head and neck cancers and received a recommendation that enrollment
continue in the study while awaiting the ongoing data review; -
Entry into an agreement whereby the NCIC Clinical Trials Group (CTG) at
Queen’s University in Kingston, Ontario, will sponsor and conduct a
randomized Phase II study of REOLYSIN in patients with advanced or
metastatic colorectal cancer enrolling up to 100 patients; -
Entry into an agreement whereby the NCIC CTG will sponsor and conduct a
randomized Phase II study of REOLYSIN in patients with advanced or
metastatic non-small cell lung cancer enrolling up to 150 patients; -
Entry into an agreement whereby the NCIC CTG will sponsor and conduct a
randomized Phase II study of REOLYSIN in patients with advanced or
metastatic breast cancer enrolling up to 100 patients; and
Clinical Trial Results
-
Publication of a paper entitled “Cell Carriage, Delivery, and Selective
Replication of an Oncolytic Virus in Tumor in Patients,” in the June
13, 2012 issue of the journal Science Translational Medicine (Vol. 4 Issue
138 138ra77), covering findings from a U.K. translational clinical
trial (REO 013) investigating intravenous administration of REOLYSIN in
patients with metastatic colorectal cancer prior to surgical resection
of liver metastases. The researchers found that
intravenously-administered reovirus could specifically target and
infect metastatic liver tumors in 90% of the patients, even though all
patients treated had had a pre-existing immunity to the virus.
| ONCOLYTICS BIOTECH INC. | |||||||||
| INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | |||||||||
| (unaudited) | |||||||||
| June 30, | December 31, | ||||||||
|
2012 $ |
2011 $ |
||||||||
| Assets | |||||||||
| Current assets | |||||||||
| Cash and cash equivalents | 33,802,813 | 32,918,751 | |||||||
| Short-term investments | 1,969,228 | 1,936,787 | |||||||
| Accounts receivable | 89,574 | 55,392 | |||||||
| Prepaid expenses | 699,348 | 721,576 | |||||||
| Total current assets | 36,560,963 | 35,632,506 | |||||||
| Non-current assets | |||||||||
| Property and equipment | 428,167 | 392,111 | |||||||
| Total non-current assets | 428,167 | 392,111 | |||||||
| Total assets | 36,989,130 | 36,024,617 | |||||||
| Liabilities And Shareholders’ Equity | |||||||||
| Current Liabilities | |||||||||
| Accounts payable and accrued liabilities | 5,302,680 | 6,504,238 | |||||||
| Total current liabilities | 5,302,680 | 6,504,238 | |||||||
| Shareholders’ equity | |||||||||
| Share capital | |||||||||
| Authorized: unlimited | |||||||||
| Issued: | |||||||||
| June 30, 2012 – 76,606,085 | |||||||||
| December 31, 2011 – 71,251,335 | 197,947,858 | 177,282,566 | |||||||
| Warrants | 3,030,519 | 2,653,627 | |||||||
| Contributed surplus | 20,821,795 | 21,142,519 | |||||||
| Accumulated other comprehensive loss | (35,560) | (117,501) | |||||||
| Accumulated deficit | (190,078,162) | (171,440,832) | |||||||
| Total shareholders’ equity | 31,686,450 | 29,520,379 | |||||||
| Total liabilities and equity | 36,989,130 | 36,024,617 | |||||||
| ONCOLYTICS BIOTECH INC. | |||||||||||||
| INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | |||||||||||||
| (unaudited) | |||||||||||||
|
Three Month Period Ending June 30, 2012 $ |
Three Month Period Ending June 30, 2011 $ |
Six Month Period Ending June 30, 2012 $ |
Six Month Period Ending June 30, 2011 $ |
||||||||||
| Expenses | |||||||||||||
| Research and development | 9,053,329 | 5,483,131 | 16,543,873 | 8,454,742 | |||||||||
| Operating | 1,222,090 | 1,068,623 | 2,310,141 | 2,195,634 | |||||||||
| Operating loss | (10,275,419) | (6,551,754) | (18,854,014) | (10,650,376) | |||||||||
| Write down of asset available for sale | — | (735,681) | — | (735,681) | |||||||||
| Change in fair value of warrant liability | — | — | — | 36,000 | |||||||||
| Interest | 93,389 | 123,197 | 213,456 | 214,703 | |||||||||
| Loss before income taxes | (10,182,030) | (7,164,238) | (18,640,558) | (11,135,354) | |||||||||
| Income tax expense | 3,228 | — | 3,228 | — | |||||||||
| Net loss | (10,178,802) | (7,164,238) | (18,637,330) | (11,135,354) | |||||||||
| Other comprehensive loss (income) – translation adjustment | 116,200 | (75,211) | 81,941 | (38,331) | |||||||||
| Net comprehensive loss | (10,062,602) | (7,239,449) | (18,555,389) | (11,173,685) | |||||||||
| Basic and diluted loss per common share | (0.13) | (0.10) | (0.25) | (0.16) | |||||||||
| Weighted average number of shares (basic and diluted) | 76,542,861 | 71,209,164 | 75,547,842 | 70,586,073 | |||||||||
| ONCOLYTICS BIOTECH INC. | |||||||||||||
| INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS | |||||||||||||
| (unaudited) | |||||||||||||
|
Three Month Period Ending June 30, 2012 $ |
Three Month Period Ending June 30, 2011 $ |
Six Month Period Ending June 30, 2012 $ |
Six Month Period Ending June 30, 2011 $ |
||||||||||
| Operating Activities | |||||||||||||
| Net loss for the period | (10,178,802) | (7,164,238) | (18,637,330) | (11,135,354) | |||||||||
| Amortization – property and equipment | 29,510 | 29,992 | 57,571 | 47,267 | |||||||||
| Share based compensation | 58,343 | 40,469 | 72,196 | 43,342 | |||||||||
| Change in fair value of warrant liability | — | — | — | (36,000) | |||||||||
| Write down of asset available for sale | — | 735,681 | — | 735,681 | |||||||||
| Unrealized foreign exchange loss | 61,171 | 28,978 | 16,162 | 220,127 | |||||||||
| Net change in non-cash working capital | (1,174,059) | 1,417,496 | (1,213,512) | 1,357,514 | |||||||||
| Cash used in operating activities | (11,203,837) | (4,911,622) | (19,704,913) | (8,767,423) | |||||||||
| Investing Activities | |||||||||||||
| Acquisition of property and equipment | (61,695) | (33,831) | (93,627) | (49,107) | |||||||||
| Purchase of short-term investments | — | 1,679,940 | (32,441) | 1,679,940 | |||||||||
| Cash used in investing activities | (61,695) | 1,646,109 | (126,068) | 1,630,833 | |||||||||
| Financing Activities | |||||||||||||
| Proceeds from exercise of stock options and warrants | 422,886 | 23,300 | 885,469 | 14,738,597 | |||||||||
| Proceeds from public offering | (31,648) | — | 19,763,795 | — | |||||||||
| Cash provided by financing activities | 391,238 | 23,300 | 20,649,264 | 14,738,597 | |||||||||
| Increase in cash | (10,874,294) | (3,242,213) | 818,283 | 7,602,007 | |||||||||
| Cash and cash equivalents, beginning of period | 44,622,078 | 49,912,873 | 32,918,751 | 39,296,682 | |||||||||
| Impact of foreign exchange on cash and cash equivalents | 55,029 | (30,429) | 65,779 | (258,458) | |||||||||
| Cash and cash equivalents, end of period | 33,802,813 | 46,640,231 | 33,802,813 | 46,640,231 | |||||||||
To view the Company’s Second Quarter 2012 Consolidated Financial
Statements, related Notes to Consolidated Financial Statements, and
Management’s Discussion and Analysis, please see the Company’s
quarterly filings which will be available on www.sedar.com and on www.oncolyticsbiotech.com.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of oncolytic viruses as potential cancer therapeutics.
Oncolytics’ clinical program includes a variety of human trials
including a Phase III trial in head and neck cancers using REOLYSIN,
its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
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 Company’s belief as
to the potential of REOLYSIN as a cancer therapeutic; the Company’s
expectations as to the success of its research and development programs
in 2012 and beyond, the Company’s planned operations, the value of the
additional patents and intellectual property; the Company’s
expectations related to the applications of the patented technology;
the Company’s expectations as to adequacy of its existing capital
resources; the design, timing, success of planned clinical trial
programs; and other statements related to anticipated developments in
the Company’s business and technologies involve known and unknown risks
and uncertainties, which could cause the Company’s 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 Company’s 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 Company’s 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, except as
required by applicable laws.
SOURCE Oncolytics Biotech Inc.
Released August 2, 2012