CALGARY, May 9, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC,
NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its
financial results and operational highlights for the quarter ended
March 31, 2013.
“We recently reported positive data from our squamous cell carcinoma of
the lung study both with respect to the study’s primary endpoint and
tumour shrinkage, which supports the conduct of further studies in this
indication,” said Dr. Brad Thompson, President and CEO of Oncolytics.
“In late February we were also able to substantially strengthen our
balance sheet through an offering of common shares for gross proceeds
of US$32.0 million that will be principally used to fund our ongoing
clinical program.”
Selected Highlights
Since January 1, 2013, the Company has made a number of significant
announcements including:
Clinical Trial Results
-
Reaching the primary overall statistical endpoint in the first stage of
a U.S. Phase 2 clinical trial in patients with squamous cell carcinoma
of the lung (SCCLC) using intravenous administration of REOLYSIN in
combination with carboplatin and paclitaxel (REO 021) and reporting
positive percent overall tumour shrinkage data. The primary endpoint
was met if nine or more patients in both stages combined had a partial
response (PR) or better. This endpoint was met after 21 evaluable
patients were treated on study, nine of which exhibited PRs, while a
further nine showed stable disease (SD) and three, progressive disease
(PD), for a response rate of 42.8% and a disease control rate (complete
response (CR) + PR + SD) of 85.7%; -
Reporting positive preliminary results from a Phase I study examining
the intravenous administration of REOLYSIN in combination with FOLFIRI
in patients with metastatic colorectal cancer (REO 022) in a poster
presentation at the ASCO Gastrointestinal Cancers Symposium. Of the 18
patients evaluable for response there was one PR and nine had SD. The
combined overall progression free survival (PFS) of FOLFIRI-naïve and
FOLFIRI-failed patients was 7.4 months. The authors concluded that the
combination of REOLYSIN and FOLFIRI was safe and well tolerated and
resulted in disease control in the majority of evaluable patients,
including patients that had previously progressed on Irinotecan;
Clinical Trial Program
-
Completion of patient enrollment in a U.S. Phase 2 clinical trial
evaluating intravenous administration of REOLYSIN in combination with
paclitaxel and carboplatin in patients with non-small cell lung cancer
(NSCLC) with Kras or EGFR-activated tumours (REO 016);
Management
- Appointment of Dr. Jeremy Grushcow to the role of General Counsel; and
Financial
-
Closing of a U.S. underwritten public offering of 8.0 million common
shares, at a price of US$4.00 per common share for gross proceeds,
before deducting underwriting commissions and offering expenses, of
approximately US$32.0 million.
| ONCOLYTICS BIOTECH INC. | ||||||||||
| INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||||||
| (unaudited) | ||||||||||
|
March 31, 2013 |
December 31, 2012 |
|||||||||
| Assets | ||||||||||
| Current assets | ||||||||||
| Cash and cash equivalents | 41,519,657 | 19,323,541 | ||||||||
| Short-term investments | 2,001,644 | 1,969,228 | ||||||||
| Accounts receivable | 77,976 | 44,979 | ||||||||
| Prepaid expenses | 273,184 | 331,094 | ||||||||
| Total current assets | 43,872,461 | 21,668,842 | ||||||||
| Non-current assets | ||||||||||
| Property and equipment | 399,805 | 409,248 | ||||||||
| Total non-current assets | 399,805 | 409,248 | ||||||||
| Total assets | 44,272,266 | 22,078,090 | ||||||||
| Liabilities And Shareholders’ Equity | ||||||||||
| Current Liabilities | ||||||||||
| Accounts payable and accrued liabilities | 5,625,227 | 7,291,310 | ||||||||
| Total current liabilities | 5,625,227 | 7,291,310 | ||||||||
| Shareholders’ equity | ||||||||||
| Share capital | ||||||||||
| Authorized: unlimited | ||||||||||
| Issued: | ||||||||||
| March 31, 2013 – 84,758,818 | ||||||||||
| December 31, 2012 – 76,710,285 | 228,501,829 | 198,155,091 | ||||||||
| Warrants | 376,892 | 376,892 | ||||||||
| Contributed surplus | 24,212,434 | 24,126,265 | ||||||||
| Accumulated other comprehensive loss | (22,927) | (57,115) | ||||||||
| Accumulated deficit | (214,421,189) | (207,814,353) | ||||||||
| Total shareholders’ equity | 38,647,039 | 14,786,780 | ||||||||
| Total liabilities and equity | 44,272,266 | 22,078,090 | ||||||||
| ONCOLYTICS BIOTECH INC. | ||||||||||
| INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | ||||||||||
| (unaudited) | ||||||||||
| For the three month period ending March 31, |
2013 $ |
2012 $ |
||||||||
| Expenses | ||||||||||
| Research and development | 5,117,044 | 7,490,544 | ||||||||
| Operating | 1,564,751 | 1,088,051 | ||||||||
| Operating loss | (6,681,795) | (8,578,595) | ||||||||
| Interest | 74,959 | 120,067 | ||||||||
| Loss before income taxes | (6,606,836) | (8,458,528) | ||||||||
| Income tax expense | — | — | ||||||||
| Net loss | (6,606,836) | (8,458,528) | ||||||||
| Other comprehensive income items that may be reclassified to net loss | ||||||||||
| Translation adjustment | 34,188 | (34,259) | ||||||||
| Net comprehensive loss | (6,572,648) | (8,492,787) | ||||||||
| Basic and diluted loss per common share | (0.08) | (0.11) | ||||||||
| Weighted average number of shares (basic and diluted) | 79,766,258 | 74,552,824 | ||||||||
| ONCOLYTICS BIOTECH INC. | |||||||||||||
| INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY | |||||||||||||
| (unaudited) | |||||||||||||
| Share Capital |
Contributed Surplus |
Warrants |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total | ||||||||
| $ | $ | $ | $ | $ | $ | ||||||||
| As at December 31, 2011 | 177,282,566 | 21,142,519 | 2,653,627 | (117,501) | (171,440,832) | 29,520,379 | |||||||
| Net loss and comprehensive loss | — | — | — | (34,259) | (8,458,528) | (8,492,787) | |||||||
| Issued, pursuant to a bought deal financing | 19,418,551 | — | 376,892 | — | — | 19,795,443 | |||||||
| Exercise of stock options | 670,719 | (208,136) | — | — | — | 462,583 | |||||||
| Share based compensation | — | 13,853 | — | — | — | 13,853 | |||||||
| As at March 31, 2012 | 197,371,836 | 20,948,236 | 3,030,519 | (151,760) | (179,899,360) | 41,299,471 | |||||||
| Share Capital |
Contributed Surplus |
Warrants |
Accumulated Other Comprehensive Loss |
Accumulated Deficit |
Total | ||||||||
| $ | $ | $ | $ | $ | $ | ||||||||
| As at December 31, 2012 | 198,155,091 | 24,126,265 | 376,892 | (57,115) | (207,814,353) | 14,786,780 | |||||||
| Net loss and comprehensive loss | — | — | — | 34,188 | (6,606,836) | (6,572,648) | |||||||
| Issued, pursuant to a public offering | 30,207,062 | — | — | — | — | 30,207,062 | |||||||
| Exercise of stock options | 139,676 | (34,687) | — | — | — | 104,989 | |||||||
| Share based compensation | — | 120,856 | — | — | — | 120,856 | |||||||
| As at March 31, 2013 | 228,501,829 | 24,212,434 | 376,892 | (22,927) | (214,421,189) | 38,647,039 | |||||||
| ONCOLYTICS BIOTECH INC. | ||||||||
| INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||||
| (unaudited) | ||||||||
| For the three month period ending March, |
2013 $ |
2012 $ |
||||||
| Operating Activities | ||||||||
| Net loss for the period | (6,606,836) | (8,458,528) | ||||||
| Amortization – property and equipment | 24,581 | 28,061 | ||||||
| Share based compensation | 120,856 | 13,853 | ||||||
| Unrealized foreign exchange loss | (307,653) | (45,009) | ||||||
| Net change in non-cash working capital | (1,641,170) | (39,453) | ||||||
| Cash used in operating activities | (8,410,222) | (8,501,076) | ||||||
| Investing Activities | ||||||||
| Acquisition of property and equipment | (15,138) | (31,932) | ||||||
| Purchase of short-term investments | (32,416) | (32,441) | ||||||
| Cash used in investing activities | (47,554) | (64,373) | ||||||
| Financing Activities | ||||||||
| Proceeds from exercise of stock options and warrants | 104,989 | 462,583 | ||||||
| Proceeds from public offering | 30,207,062 | 19,795,443 | ||||||
| Cash provided by financing activities | 30,312,051 | 20,258,026 | ||||||
| Increase in cash | 21,854,275 | 11,692,577 | ||||||
| Cash and cash equivalents, beginning of period | 19,323,541 | 32,918,751 | ||||||
| Impact of foreign exchange on cash and cash equivalents | 341,841 | 10,750 | ||||||
| Cash and cash equivalents, end of period | 41,519,657 | 44,622,078 | ||||||
To view the Company’s Fiscal 2013 First Quarter 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/financials.
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 2013 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 May 9, 2013