Navigation Links
Oncolytics Biotech Inc. Announces 2008 Third Quarter Results
Date:11/4/2008

CALGARY, Nov. 4 /PRNewswire-FirstCall/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results for the three and nine-month periods ended September 30, 2008.

Recent Pivotal Trial Decision

Oncolytics made a decision in early November to pursue a pivotal (Phase II/III) randomized trial using the combination of REOLYSIN(R) with paclitaxel/carboplatin in refractory patients with head and neck cancers. The decision was made following a review of results by the Company's Board of Directors from the Company's ongoing U.K. Phase I and Phase II combination REOLYSIN(R) and paclitaxel/carboplatin clinical trials. The results were presented November 1, 2008 at the International Society for Biological Therapy of Cancer (iSBTc) annual meeting in San Diego, CA.

Selected Third Quarter Highlights:

- Treatment of the 200th patient in clinical studies with REOLYSIN(R);

- Completion of patient enrolment in the dose escalation portion of its

U.K. clinical trial to evaluate the anti-tumour effects of systemic

administration of REOLYSIN(R) in combination with docetaxel

(Taxotere(R)) in patients with advanced cancers including bladder,

prostate, lung and upper gastro-intestinal;

- The U.S. National Cancer Institute (NCI), part of the National

Institutes of Health, started enrolment in a Phase II clinical trial

for patients with metastatic melanoma using systemic administration

of REOLYSIN(R);

- The start of patient enrolment in a U.S. Phase II clinical trial

using intravenous administration of REOLYSIN(R) in combination with

paclitaxel and carboplatin in patients with advanced head and neck

cancers;

- Initiation of a U.S. Phase II clinical trial using intravenous

administration of REOLYSIN(R) in combination with paclitaxel and

carboplatin in patients with NSCLC with K-RAS or EGFR-activated

tumours;

- The grant of the Company's 28th U.S. patent which covers methods of

purifying reassorted reovirus from an FDA-approved cell line.

Latest Highlights

Subsequent to quarter end, the Company announced:

- Eight of nine refractory head and neck cancer patients treated to

date have experienced either a partial response or stabilization of

disease in our Phase I and Phase II U.K. combination REOLYSIN(R) and

carboplatin/paclitaxel trials;

- Nine of eleven evaluable patients have experienced stable disease or

better for at least four cycles in our U.K. combination REOLYSIN(R)

and docetaxel trial;

- The selection of refractory head and neck cancers for the Company's

first pivotal trial;

- Results of two preclinical studies which demonstrated synergy in

vitro and in vivo with the combination of REOLYSIN(R) and

chemotherapy;

- Results of a preclinical study demonstrating that a single IV

administration of ReoT3D can result in substantial tumor growth delay

in melanoma-bearing nude mice;

- The grant of the Company's 29th U.S. patent, which covers methods of

selectively removing cancer cells ex vivo from blood stem cells and

other organs using reovirus; and,

- Successful completion of initial scale-up of its manufacturing

process for REOLYSIN(R) to the 100L commercial scale from the current

40L level.

Oncolytics Biotech Inc.

CONSOLIDATED BALANCE SHEETS

(unaudited)

As at,

September 30, December 31,

2008 2007

$ $

(Restated)

-------------------------------------------------------------------------

ASSETS

Current

Cash and cash equivalents 12,680,162 6,715,096

Short-term investments - 18,498,733

Accounts receivable 47,891 80,085

Prepaid expenses 307,697 260,300

-------------------------------------------------------------------------

13,035,750 25,554,214

Property and equipment 235,542 201,103

Intellectual property 271,125 542,250

-------------------------------------------------------------------------

13,542,417 26,297,567

-------------------------------------------------------------------------

-------------------------------------------------------------------------

LIABILITIES AND SHAREHOLDERS' EQUITY

Current

Accounts payable and accrued liabilities 2,800,857 2,821,227

-------------------------------------------------------------------------

Shareholders' equity

Share capital

Authorized: unlimited number of common shares

Issued: 41,180,748 (December 31, 2007

- 41,180,748) 92,759,665 92,759,665

Warrants 5,346,260 5,346,260

Contributed surplus 10,431,917 10,376,962

Deficit (97,796,282) (85,006,547)

-------------------------------------------------------------------------

10,741,560 23,476,340

-------------------------------------------------------------------------

13,542,417 26,297,567

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Oncolytics Biotech Inc.

CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS

(unaudited)

Cumulative

from

Three Month Three Month Nine Month Nine Month inception

Period Period Period Period on April 2,

Ending Ending Ending Ending 1998 to

September September September September September

30, 2008 30, 2007 30, 2008 30, 2007 30, 2008

$ $ $ $ $

(Restated) (Restated) (Restated)

-------------------------------------------------------------------------

Revenue

Rights

revenue - - - - 310,000

-------------------------------------------------------------------------

- - - - 310,000

-------------------------------------------------------------------------

Expenses

Research

and

develop-

ment 3,210,294 3,134,340 9,650,595 9,621,760 70,750,311

Operating 880,438 812,939 3,250,830 2,711,962 23,856,466

Stock based

compen-

sation 17,339 38,909 54,955 142,878 4,759,760

Foreign

exchange

loss/gain 29,026 18,917 (20,059) 2,829 637,651

Amortization

- intellec-

tual

property 90,375 90,375 271,125 271,125 3,343,875

Amortization

- property

and

equipment 11,853 10,197 35,233 30,061 483,630

-------------------------------------------------------------------------

4,239,325 4,105,677 13,242,679 12,780,615 103,831,693

-------------------------------------------------------------------------

Loss

before

the

follow-

ing: 4,239,325 4,105,677 13,242,679 12,780,615 103,521,693

Interest

income (98,493) (319,221) (452,944) (946,826) (6,467,693)

Gain on

sale of

BCY

LifeSciences

Inc. - - - - (299,403)

Loss on

sale of

Transition

Therapeutics

Inc. - - - - 2,156,685

-------------------------------------------------------------------------

Loss before

income

taxes 4,140,832 3,786,456 12,789,735 11,833,789 98,911,282

Future

income

tax

recovery - - - - (1,115,000)

-------------------------------------------------------------------------

Net loss

and

compre-

hensive

loss for

the

period 4,140,832 3,786,456 12,789,735 11,833,789 97,796,282

-------------------------------------------------------------------------

-------------------------------------------------------------------------

Basic and

diluted

loss per

share 0.10 0.09 0.31 0.29

------------------------------------------------------------

------------------------------------------------------------

Weighted

average

number of

shares

(basic

and

diluted) 41,180,748 41,120,748 41,180,748 40,181,777

------------------------------------------------------------

------------------------------------------------------------

Oncolytics Biotech Inc.

CONSOLIDATED STATEMENTS OF CASH FLOWS

(unaudited)

Cumulative

from

Three Month Three Month Nine Month Nine Month inception

Period Period Period Period on April 2,

Ending Ending Ending Ending 1998 to

September September September September September

30, 2008 30, 2007 30, 2008 30, 2007 30, 2008

$ $ $ $ $

(Restated) (Restated) (Restated)

-------------------------------------------------------------------------

OPERATING

ACTIVITIES

Net loss

for the

period (4,140,832) (3,786,456) (12,789,735) (11,833,789) (97,796,282)

Deduct

non-cash

items

Amorti-

zation -

intel-

lectual

property 90,375 90,375 271,125 271,125 3,343,875

Amorti-

zation -

property

and

equip-

ment 11,853 10,197 35,233 30,061 483,630

Stock

based

compen-

sation 17,339 38,909 54,955 142,878 4,759,760

Other

non-cash

items - - - - 1,383,537

Net changes

in non-cash

working

capital (1,217,916) 316,534 (35,573) (46,262) 2,445,269

-------------------------------------------------------------------------

(5,239,181) (3,330,441) (12,463,995) (11,435,987) (85,380,211)

-------------------------------------------------------------------------

INVESTING

ACTIVITIES

Capital

assets (10,927) (11,386) (69,672) (49,691) (771,839)

Purchase

of short-

term

investments (62,435) (255,688) (314,631) (742,853) (49,383,594)

Redemption

of short-

term

invest-

ments 9,813,364 - 18,813,364 - 48,965,110

Investment

in BCY

LifeSciences

Inc. - - - - 464,602

Investment

in

Transition

Therapeutics

Inc. - - - - 2,532,343

-------------------------------------------------------------------------

9,740,002 (267,074) 18,429,061 (792,544) 1,806,622

-------------------------------------------------------------------------

FINANCING

ACTIVITIES

Proceeds

from

exercise

of

warrants

and stock

options - - - - 15,259,468

Proceeds

from

private

placements - - - - 38,137,385

Proceeds

from

public

offerings - - - 12,063,394 42,856,898

-------------------------------------------------------------------------

- - - 12,063,394 96,253,751

-------------------------------------------------------------------------

Increase

(decrease)

in cash

and cash

equiva-

lents

during

the

period 4,500,821 (3,597,515) 5,965,066 (165,137) 12,680,162

Cash and

cash

equiva-

lents,

beginning

of the

period 8,179,341 6,923,889 6,715,096 3,491,511 -

-------------------------------------------------------------------------

Cash and

cash

equiva-

lents,

end of

the

period 12,680,162 3,326,374 12,680,162 3,326,374 12,680,162

-------------------------------------------------------------------------

-------------------------------------------------------------------------

To view the 2008 Third Quarter Report which includes the Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's third quarter filings which will be available on http://www.sedar.com and on http://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 Phase I/II and Phase II human trials using REOLYSIN(R), its proprietary formulation of the human reovirus, alone and in combination with radiation or chemotherapy. For further information about Oncolytics please visit http://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(R) as a cancer therapeutic; the Company's expectations as to the success of its research and development programs in 2008 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(R) as a cancer treatment, the success and timely completion of clinical studies and trials, the Company's ability to successfully commercialize REOLYSIN(R), 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.
Copyright©2008 PR Newswire.
All rights reserved

Related biology technology :

1. Oncolytics Biotech Inc. Announces Issuance of 23rd U.S. Patent
2. Oncolytics Biotech Inc. Reports Positive Interim Results of U.K. Phase Ia/Ib Combination REOLYSIN(R) and Radiation Clinical Trial
3. Media Advisory - Oncolytics Biotech Inc. to Present at BioPartnering Europe
4. Media Advisory - Oncolytics Biotech Inc. to Present at BIO InvestorForum 2007
5. Oncolytics Biotech Inc. Announces Approval for U.K. Clinical Trial Investigating REOLYSIN(R) in Combination with Cyclophosphamide
6. Oncolytics Biotech Inc. Collaborators to Present Positive Interim Results of U.K. Phase Ia/Ib Combination REOLYSIN(R) and Radiation Clinical Trial
7. Oncolytics Biotech Inc. Announces 2007 Third Quarter Results
8. Media Advisory - Oncolytics Biotech Inc. to Present at Acumen BioFin Rodman & Renshaw 9th Annual Healthcare Conference
9. Media Advisory - Oncolytics Biotech Inc. to Present at Toronto CFA Society
10. Oncolytics Biotech Inc. Announces Issuance of 24th U.S. Patent
11. Oncolytics Biotech Inc. to Present at Annual Vaccine Production Conference
Post Your Comments:
*Name:
*Comment:
*Email:
(Date:6/27/2016)... (PRWEB) , ... June 27, 2016 , ... Parallel ... clinical trials, announced today the Clinical Reach Virtual Patient Encounter CONSULT module ... circle with the physician and clinical trial team. , Using the CONSULT module, patients ...
(Date:6/27/2016)... BOSTON , June 27, 2016   Ginkgo ... biology to industrial engineering, was today awarded as ... a selection of the world,s most innovative companies. ... at scale for the real world in the ... organism engineers work directly with customers including Fortune ...
(Date:6/24/2016)... NC (PRWEB) , ... June 24, 2016 , ... Researchers ... the most commonly-identified miRNAs in people with peritoneal or pleural mesothelioma. Their findings are ... to read it now. , Diagnostic biomarkers are signposts in the blood, lung ...
(Date:6/23/2016)... - FACIT has announced the creation of a ... Propellon Therapeutics Inc. ("Propellon" or "the Company"), to ... of first-in-class WDR5 inhibitors for the treatment of ... an exciting class of therapies, possessing the potential ... patients. Substantial advances have been achieved with the ...
Breaking Biology Technology:
(Date:4/15/2016)... , April 15, 2016 ... "Global Gait Biometrics Market 2016-2020,"  report to their ... ) , ,The global gait biometrics market ... 13.98% during the period 2016-2020. Gait ... which can be used to compute factors that ...
(Date:3/31/2016)... -- Genomics firm Nabsys has completed a financial  restructuring under ... M.D., who returned to the company in October 2015. ... including Chief Technology Officer, John Oliver , Ph.D., ... Vice President of Software and Informatics, Michael Kaiser ... Bready served as CEO of Nabsys from 2005-2014 and ...
(Date:3/22/2016)... , PROVO and ... -- Newborn Screening Ontario (NSO), which operates the highest ... for molecular testing, and Tute Genomics and UNIConnect, leaders ... technology respectively, today announced the launch of a project ... sequencing (NGS) testing panel. NSO has ...
Breaking Biology News(10 mins):