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Oncolytics Biotech Inc
Symbol C : ONC
Shares Issued 84,758,818
Close 2013-03-13 C$ 3.08
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Oncolytics Biotech loses $36.37-million in 2012

2013-03-14 07:10 ET - News Release

Dr. Brad Thompson reports

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."

Selected highlights

Since Jan. 1, 2012, the company has made a number of significant announcements including:

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.

Management

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.

Financial

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
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) 
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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