CALGARY, March 14, 2013 /PRNewswire/ – Oncolytics Biotech Inc. (TSX:ONC)
(NASDAQ:ONCY) (“Oncolytics” or the “Company”) today announced its
financial results and operational highlights for the year ended
December 31, 2012.
“We were very pleased to present our first randomized clinical data from
our head and neck cancer clinical study in 2012,” said Dr. Brad
Thompson, President and CEO of Oncolytics. “In addition, in order to
support our program, which now includes seven randomized studies in
different indications, we completed two financings over the last 14
months raising gross proceeds in excess of $50 million.”
Selected Highlights
Since January 1, 2012, the Company has made a number of significant
announcements including:
Clinical Trial Results
-
Reporting initial positive top line data from the first endpoint in the
double-blinded randomized Phase III clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in second-line patients
with platinum-refractory, taxane-naïve head and neck cancers (REO 018).
The endpoint examined initial percentage tumour changes between the
pre-treatment and first post-treatment scans (typically performed at
six weeks post-first treatment) of all patients enrolled in the study
and was designed to assess early differences in response between
loco-regional tumours and metastatic tumours, as classified and
observed by the investigators; -
Reaching the primary 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 subsequently reporting
positive percent overall tumour shrinkage data; -
Poster presentations at the EORTC-NCI-AACR Symposium on Molecular
Targets and Cancer Therapeutics reporting positive clinical data from a
study in a Phase 2 clinical trial using 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) and a U.S. Phase 2 clinical trial
using intravenous administration of REOLYSIN in combination with gemcitabine (Gemzar®) in patients with advanced pancreatic cancer (REO 017); -
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;
Clinical Trial Program
-
Expansion of enrollment in the first stage of a Phase III head and neck
cancer clinical trial (REO 18) to include 167 patients and introduction
of an additional patient segregation to differentiate between patients
with local recurrent disease, with or without metastases, and patients
with distal metastases while maintaining the blind; -
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); -
Completion of patient enrollment in a U.S. Phase 2 clinical trial using
intravenous administration of REOLYSIN in combination with gemcitabine
(Gemzar®) in patients with advanced or metastatic pancreatic cancer (REO 017); -
Completion of enrollment in a U.K. Phase I clinical trial using
intravenously-administered REOLYSIN in combination with
cyclophosphamide in patients with advanced malignancies (REO 012); -
Completion of enrollment in a U.S. Phase 1 clinical trial using
intravenously-administered REOLYSIN in combination with FOLFIRI in
patients with colorectal cancer (REO 022); -
Entry into multiple agreements whereby the NCIC Clinical Trials Group
(CTG) at Queen’s University in Kingston, Ontario, will sponsor and
conduct randomized Phase II studies of REOLYSIN in patients with
recurrent or metastatic castration resistant prostate cancer, advanced
or metastatic colorectal cancer, advanced or metastatic non-small cell
lung cancer, and advanced or metastatic breast cancer;
Management
- Appointment of Mr. Kirk Look to the role of Chief Financial Officer;
-
Appointment of Dr. Alan Tuchman to the role of Chief Medical Officer and
Senior Vice President, Clinical and Medical Development;
Financial
-
Closing of a bought deal financing in February 2012, which was increased
post-announcement from $15 million to $18.5 million, for gross proceeds
of $21.3 million following the full exercise of the over-allotment
option by the syndicate of underwriters; and -
Subsequent to year-end, closing of an underwritten public offering of
8.0 million common shares, at a public offering price of US$4.00 per
common share for aggregate gross proceeds from the offering, before
deducting underwriting discounts and commissions and offering expenses,
of approximately US$32.0 million.
| ONCOLYTICS BIOTECH INC. | ||||||
| CONSOLIDATED STATEMENTS OF FINANCIAL POSITION | ||||||
| December 31, | December 31, | |||||
| 2012 | 2011 | |||||
| $ | $ | |||||
| Assets | ||||||
| Current assets | ||||||
| Cash and cash equivalents | 19,323,541 | 32,918,751 | ||||
| Short-term investments | 1,969,228 | 1,936,787 | ||||
| Accounts receivable | 44,979 | 55,392 | ||||
| Prepaid expenses | 331,094 | 721,576 | ||||
| Total current assets | 21,668,842 | 35,632,506 | ||||
| Non-current assets | ||||||
| Property and equipment | 409,248 | 392,111 | ||||
| Total non-current assets | 409,248 | 392,111 | ||||
| Total assets | 22,078,090 | 36,024,617 | ||||
| Liabilities And Shareholders’ Equity | ||||||
| Current Liabilities | ||||||
| Accounts payable and accrued liabilities | 7,291,310 | 6,504,238 | ||||
| Total current liabilities | 7,291,310 | 6,504,238 | ||||
| Shareholders’ equity | ||||||
| Share capital | ||||||
| Authorized: unlimited | ||||||
| Issued: | ||||||
| December 31, 2012 – 76,710,285 | ||||||
| December 31, 2011 – 71,251,335 | 198,155,091 | 177,282,566 | ||||
| Warrants | 376,892 | 2,653,627 | ||||
| Contributed surplus | 24,126,265 | 21,142,519 | ||||
| Accumulated other comprehensive loss | (57,115) | (117,501) | ||||
| Accumulated deficit | (207,814,353) | (171,440,832) | ||||
| Total shareholders’ equity | 14,786,780 | 29,520,379 | ||||
| Total liabilities and equity | 22,078,090 | 36,024,617 | ||||
| ONCOLYTICS BIOTECH INC. | ||||||
| CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS | ||||||
| 2012 | 2011 | 2010 | ||||
| For the years ending December 31, | $ | $ | $ | |||
| Expenses | ||||||
| Research and development | 31,402,625 | 23,386,685 | 13,882,565 | |||
| Operating | 5,285,425 | 5,334,582 | 6,003,870 | |||
| Loss before the following | (36,688,050) | (28,721,267) | (19,886,435) | |||
| Write down of asset available for sale | — | (735,681) | — | |||
| Change in fair value of warrant liability | — | 36,000 | (4,841,949) | |||
| Interest | 345,003 | 416,247 | 76,934 | |||
| Loss before income taxes | (36,343,047) | (29,004,701) | (24,651,450) | |||
| Income tax expense | (30,474) | (40,000) | (7,611) | |||
| Net loss | (36,373,521) | (29,044,701) | (24,659,061) | |||
| Other comprehensive gain (loss) – translation adjustment | 60,386 | 39,159 | (156,660) | |||
| Net comprehensive loss | (36,313,135) | (29,005,542) | (24,815,721) | |||
| Basic and diluted loss per common share | (0.48) | (0.41) | (0.39) | |||
| Weighted average number of shares (basic and diluted) | 76,102,062 | 70,911,526 | 62,475,403 | |||
| ONCOLYTICS BIOTECH INC. | ||||||||||||
| CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY | ||||||||||||
| Share Capital | Warrants |
Contributed Surplus |
Accumulated Other Comprehensive Income |
Accumulated Deficit |
Total | |||||||
| $ | $ | $ | $ | $ | $ | |||||||
| As at December 31, 2010 | 155,439,610 | 4,108,652 | 19,399,489 | (156,660) | (142,396,131) | 36,394,960 | ||||||
| Net loss and comprehensive income | — | — | — | 39,159 | (29,044,701) | (29,005,542) | ||||||
| Exercise of warrants | 21,487,080 | (1,455,025) | — | — | — | 20,032,055 | ||||||
| Exercise of stock options | 355,876 | — | (62,473) | — | — | 293,403 | ||||||
| Share based compensation | — | — | 1,805,503 | — | — | 1,805,503 | ||||||
| As at December 31, 2011 | 177,282,566 | 2,653,627 | 21,142,519 | (117,501) | (171,440,832) | 29,520,379 | ||||||
| Net loss and comprehensive income | — | — | — | 60,386 | (36,373,521) | (36,313,135) | ||||||
| Issued, pursuant to a bought deal financing | 19,386,903 | 376,892 | — | — | — | 19,763,795 | ||||||
| Expiry of warrants | — | (2,653,627) | 2,653,627 | — | — | — | ||||||
| Exercise of stock options | 1,485,622 | — | (400,632) | — | — | 1,084,990 | ||||||
| Share based compensation | — | — | 730,751 | — | — | 730,751 | ||||||
| As at December 31, 2012 | 198,155,091 | 376,892 | 24,126,265 | (57,115) | (207,814,353) | 14,786,780 | ||||||
| ONCOLYTICS BIOTECH INC. | ||||||
| CONSOLIDATED STATEMENTS OF CASH FLOWS | ||||||
| For the years ending December 31, |
2012 $ |
2011 $ |
2010 $ |
|||
| Operating Activities | ||||||
| Net loss for the year | (36,373,521) | (29,044,701) | (24,659,061) | |||
| Amortization – property and equipment | 109,275 | 92,590 | 63,156 | |||
| Share based compensation | 730,751 | 1,805,503 | 3,251,041 | |||
| Change in fair value of warrant liability | — | (36,000) | 4,841,949 | |||
| Write down of asset available for sale | — | 735,681 | — | |||
| Unrealized foreign exchange loss | 89,890 | 115,234 | 343,821 | |||
| Net change in non-cash working capital | 1,187,967 | 3,790,510 | (1,717,978) | |||
| Cash used in operating activities | (34,255,638) | (22,541,183) | (17,877,072) | |||
| Investing Activities | ||||||
| Acquisition of property and equipment | (126,412) | (257,790) | (81,846) | |||
| Acquisition of investment | — | — | (51,681) | |||
| Redemption (purchase) of short-term investments | (32,441) | 1,672,459 | (1,929,309) | |||
| Cash provided by (used in) investing activities | (158,853) | 1,414,669 | (2,062,836) | |||
| Financing Activities | ||||||
| Proceeds from exercise of stock options and warrants | 1,084,990 | 14,824,658 | 528,211 | |||
| Proceeds from public offering | 19,763,795 | — | 26,759,921 | |||
| Cash provided by financing activities | 20,848,785 | 14,824,658 | 27,288,132 | |||
| Increase (decrease) in cash | (13,565,706) | (6,301,856) | 7,348,224 | |||
| Cash and cash equivalents, beginning of year | 32,918,751 | 39,296,682 | 32,448,939 | |||
| Impact of foreign exchange on cash and cash equivalents | (29,504) | (76,075) | (500,481) | |||
| Cash and cash equivalents, end of year | 19,323,541 | 32,918,751 | 39,296,682 | |||
To view the Company’s Fiscal 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 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 March 14, 2013