Oncolytics Biotech® Inc. Announces Second Quarter 2011 Results

CALGARY, AB, July 28, 2011 /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, 2011.

"We continue to build upon and progress through our research and development in an effort to maximize the future commercial potential of REOLYSIN®. In Q2, we focused our efforts on expanding our Phase III clinical trial in head and neck cancer, and expanding our clinical trial program by announcing a U.S. National Cancer Institute-sponsored clinical trial in multiple myeloma," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also received positive data from early stage studies in metastatic colorectal and non-small cell lung cancer studies, and secured a leading manufacturer for the clinical and commercial supply of REOLYSIN®, both significant steps forward in our plans to expand our development program."

Selected Highlights

Since April 1, 2011 the Company has announced:

Clinical Trial Results

    --  Interim data 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. On initial histological analysis of the 10 treated patients,
        there was evidence of selective delivery of virus to tumour versus
        normal liver and viral replication in the majority (seven) of patients;
    --  A presentation covering interim preliminary results from 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 at the
        International Association for the Study of Lung Cancer World Conference
        on Lung Cancer. Response evaluation as of the date of presentation in 21
        patients showed six partial responses (PR) (28.6%), 13 stable disease
        (SD) (61.9%), and two progressive disease (PD) (9.5%), translating into
        a clinical benefit rate (complete response (CR)+PR+SD) of 90.5% and a
        response rate (CR+PR) of 28.6%;

Ongoing Clinical Program

    --  The Cancer Therapy Evaluation Program, Division of Cancer Treatment and
        Diagnosis, U.S. National Cancer Institute (NCI), which is part of the
        National Institutes of Health, has agreed to sponsor a Phase I study of
        REOLYSIN alone in patients with relapsed multiple myeloma;
    --  A commercial supply agreement with SAFC, a Division of Sigma-Aldrich
        Corporation, for the commercial manufacture of REOLYSIN. Under the terms
        of the agreement, SAFC will perform process validation of the product,
        will continue to supply clinical requirements and will supply commercial
        material upon approval of the product; and

Corporate

    --  The appointment of George M. Gill, MD as Chief Medical Officer. Dr. Gill
        has been Senior Vice President of Clinical Safety and Regulatory Affairs
        and an officer of Oncolytics since 2002.


                                    ONCOLYTICSBIOTECH INC.
                         CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
                                          (unaudited)

                                         June 30,   December 31,    January 1,
                                           2011         2010           2010
As at,                                       $            $              $

Assets

Current assets

Cash and cash                            46,640,231    39,296,682    32,448,939
equivalents

Short-term                                1,929,306     3,609,246     1,679,937
investments

Accounts receivable                          51,421       284,988        64,787

Prepaid expenses                            840,444       278,934       507,408

Total current assets                     49,461,402    43,469,850    34,701,071

Non-current assets

Property and                                228,751       226,911       208,320
equipment

Long term investment                                                  684,000

Total non-current                           228,751       226,911       892,320
assets

Asset held for sale                                      735,681             

Total assets                             49,690,153    44,432,442    35,593,391

Liabilities And Shareholders Equity

Current Liabilities

Accounts payable and accrued              4,186,139     2,500,682     4,226,933
liabilities

Warrant liability                                      5,536,800     1,023,051

Total current liabilities                 4,186,139     8,037,482     5,249,984

Shareholders equity

Share capital
Authorized: unlimited
Issued:
June 30, 2011 - 71,214,318
December 31, 2010 - 67,958,302
January 1, 2010 - 61,549,969            177,179,742   155,439,610   131,908,274

Warrants                                  2,653,627     4,108,652     2,437,460

Contributed surplus                      19,397,121    19,399,489    13,734,743

Accumulated other comprehensive
loss                                      (194,991)     (156,660)             

Deficit                               (153,531,485) (142,396,131) (117,737,070)

Total shareholders equity               45,504,014    36,394,960    30,343,407

Total Liabilities And Equity             49,690,153    44,432,442    35,593,391






                                   ONCOLYTICSBIOTECH INC.
                   CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
                                        (unaudited)

                      ThreeMonth    ThreeMonth    SixMonth           Six
                     PeriodEnding  PeriodEnding PeriodEnding, MonthPeriodEnding,
                     June 30, 2011 June30, 2010 June30, 2011    June 30, 2010
                           $            $             $               $

Expenses

Research and             5,483,131    3,237,216     8,454,742          6,279,030
development

Operating                1,068,623    1,147,940     2,195,634          2,112,249

                         6,551,754    4,385,156    10,650,376          8,391,279

Loss before the        (6,551,754)  (4,385,156)  (10,650,376)        (8,391,279)
following

Write down of asset
available for sale       (735,681)                 (735,681)                  

Change in fair
value of warrant
liability                              391,000        36,000          (150,489)

Interest                   123,197        9,304       214,703             19,123

Loss before income     (7,164,238)  (3,984,852)  (11,135,354)        (8,522,645)
taxes

Income taxes                                                                

Net loss               (7,164,238)  (3,984,852)  (11,135,354)        (8,522,645)

Other comprehensive
loss - translation
adjustment                (75,211)       23,878      (38,331)          (121,029)

Net comprehensive      (7,239,449)  (3,960,974)  (11,173,685)        (8,643,674)
loss

Basic and diluted
loss per share              (0.10)       (0.06)        (0.16)             (0.14)

Weighted average
number of shares
(basic and diluted)     71,209,164   61,556,343    70,586,073         61,553,173







                                            ONCOLYTICS BIOTECH INC.
                                 CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
                                                  (unaudited)

                                    For the six month period ending, June 30, 2011

                                                   Accumulated
                                                      Other
                  Share   Contributed             Comprehensive
                 capital    Surplus     Warrants     Income         Deficit   Total Equity

                     $           $           $             $             $            $

As at         155,439,610  19,399,489   4,108,652     (156,660) (142,396,131)   36,394,960
December 31,
2010

Net loss and                                        (38,331)  (11,135,354) (11,173,685)
comprehensive
loss for the
period

Exercise of    21,487,080            (1,455,025)                             20,032,055
warrants

Exercise of       253,052    (45,710)                                           207,342
stock options

Stock based                   43,342                                            43,342
compensation

As at June    177,179,742  19,397,121   2,653,627     (194,991) (153,531,485)   45,504,014
30, 2011

                                    For the six month period ending, June 30, 2010

                                                   Accumulated
                                                      Other
                  Share   Contributed             Comprehensive                   Total
                 capital    Surplus     Warrants     Income         Deficit      Equity

                     $           $           $             $             $           $

As at January 131,908,274  13,734,743   2,437,460              (117,737,070)  30,343,407
1, 2010

Net loss and                                       (121,029)   (8,522,645) (8,643,674)
comprehensive
loss for the
period

Expired                    2,438,000 (2,438,000)                                     
warrants

Exercise of        72,000    (18,000)                                           54,000
stock options

Stock based                    2,428                                            2,428
compensation

Other                                       540                                   540

As at June    131,980,274  16,157,171                (121,029) (126,259,715)  21,756,701
30, 2010




                                       ONCOLYTICS BIOTECH INC.
                                CONSOLIDATED STATEMENTS OF CASH FLOWS
                                             (unaudited)

                   Three Month   ThreeMonth    Six Month   SixMonthPeriodEnding,
                   PeriodEnding PeriodEnding PeriodEnding,     June 30, 2010
                   June 30,2011 June 30,2010 June 30, 2011           $
                        $            $             $

Cash Flows

Operating
Activities

Net loss for the    (7,164,238)  (3,984,852)  (11,135,354)           (8,522,645)
period

Amortization -           29,992       14,621        47,267                29,506
property and
equipment

Stock based              40,469        1,399        43,342                 2,428
compensation

Change in fair                    (391,000)      (36,000)               150,489
value of warrant
liability

Write down of           735,681                   735,681                     
asset available
for sale

Unrealized               28,978    (293,534)       220,127              (74,546)
foreign exchange
loss (gain)

Net change in         1,417,496      384,452     1,357,514             (792,229)
non-cash working
capital

Cash used in        (4,911,622)  (4,268,914)   (8,767,423)           (9,206,997)
operating
activities

Investing
Activities

Redemption of         1,679,940                 1,679,940                     
short-term
investments

Acquisition of         (33,831)     (39,851)      (49,107)              (43,498)
property and
equipment

Cash provided by      1,646,109     (39,851)     1,630,833              (43,498)
(used in)
investing
activities

Financing
Activities

Proceeds from            23,300       54,000    14,738,597                54,000
exercise of stock
options and
warrants

Cash provided by         23,300       54,000    14,738,597                54,000
financing
activities

Increase            (3,242,213)  (4,254,765)     7,602,007           (9,196,495)
(decrease) in
cash

Cash and cash        49,912,873   27,143,314    39,296,682            32,448,939
equivalents,
beginning of
period

Impact of foreign
exchange on cash
and cash
equivalents            (30,429)      410,378     (258,458)                46,483

Cash and cash        46,640,231   23,298,927    46,640,231            23,298,927
equivalents, end
of period



To view the Company's Second Quarter 2011 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 3 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 2011 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.

 

 

 

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