ONCOLYTICS BIOTECH INC. ANNOUNCES 2012 YEAR END RESULTS
Oncolytics Biotech Inc. has released its
financial results and operational highlights for the year ended
Dec. 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 chief executive officer 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."
Since Jan. 1, 2012, the company has made a number of significant
Clinical trial results
The company reported initial positive top-line data from the first end point 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-naive head and neck cancers.
The end point examined initial percentage tumour changes between the
pretreatment and first posttreatment scans (typically performed at
six weeks after 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.
The company reached the primary end point in the first stage of a United States 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 and subsequently reported
positive per cent overall tumour shrinkage data.
The company presented 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 and a U.S. phase 2 clinical trial
using intravenous administration of Reolysin in combination with gemcitabine (Gemzar) in patients with advanced pancreatic cancer.
The company published a paper entitled "Cell carriage, delivery and selective
replication of an oncolytic virus in tumour in patients," in the June
13, 2012, issue of the journal Science Translational Medicine, covering findings from a United Kingdom translational clinical
trial 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 tumours in 90 per cent of the patients, even though all
patients treated had had a pre-existing immunity to the virus.
Clinical trial program
The company expanded enrolment 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.
The company completed patient enrolment 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.
The company completed patient enrolment 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.
The company completed enrolment in a U.K. phase I clinical trial using
intravenously administered Reolysin in combination with
cyclophosphamide in patients with advanced malignancies.
The company completed enrolment in a U.S. phase 1 clinical trial using
intravenously administered Reolysin in combination with Folfiri in
patients with colorectal cancer.
The company entered into multiple agreements whereby the NCIC Clinical Trials Group
(CTG) at Queen's University in Kingston, Ont., 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.
The company appointed Kirk Look to the role of chief financial officer.
The company appointed Dr. Alan Tuchman to the role of chief medical officer and
senior vice-president, clinical and medical development.
The company closed a bought deal financing in February, 2012, which was increased
postannouncement from $15-million to $18.5-million, for gross proceeds
of $21.3-million following the full exercise of the overallotment
option by the syndicate of underwriters.
Subsequent to year-end, the company closed an underwritten public offering of
eight million common shares, at a public offering price of $4 (U.S.) per
common share for aggregate gross proceeds from the offering, before
deducting underwriting discounts and commissions and offering expenses,
of approximately $32-million (U.S.).
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the years ending Dec. 31,
2012 2011 2010
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)
Writedown of asset available for sale (loss) - (735,681) -
Change in fair value of warrant liability (loss) - 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)
We seek Safe Harbor.
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