CALGARY, Aug. 7, 2014 /CNW/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the second quarter ended June 30, 2014.
"Our randomized clinical program continued to advance during the quarter as we recently reported the completion of enrollment in a Phase II study using REOLYSIN® in combination with carboplatin and paclitaxel in pancreatic cancer patients," said Dr. Brad Thompson, President and CEO of Oncolytics. "We also strengthened our board, adding two directors with significant financial and public company experience."
Selected Highlights
Since April 1, 2014, selected highlights announced by the Company include:
Clinical and Preclinical Data
- Completion of patient enrollment in a two-arm randomized phase II study of carboplatin, paclitaxel plus REOLYSIN® versus carboplatin and paclitaxel alone in the first line treatment of patients with recurrent or metastatic pancreatic cancer (OSU-10045);
- Early results from a translational study looking at intravenous administration of REOLYSIN® to patients with primary or metastatic brain tumors was presented at the ASCO Annual Meeting in Chicago, IL;
- Final data from the Company's randomized, double-blinded clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in patients with second-line, platinum-refractory, taxane-naïve head and neck cancers;
- A series of presentations by research collaborators at the 8th Annual International Conference on Oncolytic Virus Therapeutics held in Oxford, UK covering:
- early clinical research showing that intravenously delivered REOLYSIN® can cross the blood brain barrier to access tumours in the brains of humans;
- preclinical research examining the synergies associated with treatment in animal models with GM-CSF prior to administering REOLYSIN®;
- preclinical research focused on identifying biomarkers predictive of sensitivity/resistance to reovirus in head and neck cancer cell lines; and
- preclinical research into the treatment of hepatocellular carcinoma associated with infection by Hepatitis B and Hepatitis C.
Governance
- The nomination and election of Ms. Linda Hohol and Ms. Angela Holtham to the Company's board of directors; and
Financial
- At June 30, 2014 the Company reported $18.9 million in cash, cash equivalents and short-term investments.
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ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
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June 30,
2014
$
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December 31,
2013
$
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|
Assets
|
|
|
|
|
Current assets
|
|
|
|
|
Cash and cash equivalents
|
16,880,730
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|
25,220,328
|
|
Short-term investments
|
2,031,685
|
|
2,001,644
|
|
Accounts receivable
|
54,391
|
|
105,853
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|
Prepaid expenses
|
609,538
|
|
361,743
|
|
Total current assets
|
19,576,344
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|
27,689,568
|
|
|
|
|
|
Non-current assets
|
|
|
|
|
Property and equipment
|
470,217
|
|
532,459
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|
Total non-current assets
|
470,217
|
|
532,459
|
|
|
|
|
|
Total assets
|
20,046,561
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|
28,222,027
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Liabilities And Shareholders' Equity
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Current Liabilities
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|
|
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Accounts payable and accrued liabilities
|
3,667,076
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|
6,008,661
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Total current liabilities
|
3,667,076
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|
6,008,661
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|
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Shareholders' equity
|
|
|
|
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|
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Share capital
Authorized: unlimited Issued:
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|
|
|
June 30, 2014 – 87,537,397
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|
|
|
December 31, 2013 – 84,803,818
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232,303,714
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|
228,612,564
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|
Warrants
|
—
|
|
376,892
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|
Contributed surplus
|
25,538,706
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|
24,491,212
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|
Accumulated other comprehensive loss
|
87,679
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|
79,698
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|
Accumulated deficit
|
(241,550,614)
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|
(231,347,000)
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Total shareholders' equity
|
16,379,485
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|
22,213,366
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Total liabilities and equity
|
20,046,561
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28,222,027
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
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Three Month
Period
Ending June
30, 2014
$
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Three Month
Period
Ending June
30, 2013
$
|
|
Six Month
Period
Ending June
30, 2014
$
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|
Six Month
Period
Ending June
30, 2013
$
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|
|
|
|
|
|
|
|
|
Expenses
|
|
|
|
|
|
|
|
|
Research and development
|
3,555,055
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|
3,804,307
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|
7,733,389
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|
8,921,351
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|
Operating
|
1,209,815
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|
1,320,742
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|
2,601,069
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|
2,885,493
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Operating loss
|
(4,764,870)
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|
(5,125,049)
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(10,334,458)
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|
(11,806,844)
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Interest
|
50,253
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|
105,368
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|
138,240
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|
180,327
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|
Loss before income taxes
|
(4,714,617)
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|
(5,019,681)
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|
(10,196,218)
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|
(11,626,517)
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|
Income tax expense
|
(3,546)
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|
—
|
|
(7,396)
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|
—
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|
Net loss
|
(4,718,163)
|
|
(5,019,681)
|
|
(10,203,614)
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|
(11,626,517)
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|
Other comprehensive income items that may be
reclassified to net loss
|
|
|
|
|
|
|
|
|
|
|
|
|
|
|
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Translation adjustment
|
26,675
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|
73,451
|
|
7,981
|
|
107,639
|
|
|
|
|
|
|
|
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Net comprehensive loss
|
(4,691,488)
|
|
(4,946,230)
|
|
(10,195,633)
|
|
(11,518,878)
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|
Basic and diluted loss per common share
|
(0.05)
|
|
(0.06)
|
|
(0.12)
|
|
(0.14)
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|
Weighted average number of shares
(basic and diluted)
|
86,581,854
|
|
84,758,818
|
|
85,869,008
|
|
82,276,330
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
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Share Capital
$
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Contributed
Surplus
$
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|
Warrants
$
|
|
Accumulated
Other
Comprehensive
Loss
$
|
|
Accumulated
Deficit
$
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|
Total
$
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|
As at December 31, 2012
|
198,155,091
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|
24,126,265
|
|
376,892
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|
(57,115)
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|
(207,814,353)
|
|
14,786,780
|
|
|
|
|
|
|
|
|
|
|
|
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Net loss and
comprehensive loss
|
—
|
|
—
|
|
—
|
|
107,639
|
|
(11,626,517)
|
|
(11,518,878)
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|
Issued, pursuant to a
bought deal financing
|
30,218,797
|
|
—
|
|
—
|
|
—
|
|
—
|
|
30,218,797
|
|
Exercise of stock options
|
139,676
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|
(34,687)
|
|
—
|
|
—
|
|
—
|
|
104,989
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share based compensation
|
—
|
|
250,853
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|
—
|
|
—
|
|
—
|
|
250,853
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|
As at June 30, 2013
|
228,513,564
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|
24,342,431
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|
376,892
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|
50,524
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|
(219,440,870)
|
|
33,842,541
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share Capital
$
|
|
Contributed
Surplus
$
|
|
Warrants
$
|
|
Accumulated
Other
Comprehensive
Loss
$
|
|
Accumulated
Deficit
$
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|
Total
$
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|
|
|
|
|
|
|
|
|
|
|
|
|
As at December 31, 2013
|
228,612,564
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|
24,491,212
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|
376,892
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|
79,698
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|
(231,347,000)
|
|
22,213,366
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|
|
|
|
|
|
|
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|
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Net loss and
comprehensive loss
|
—
|
|
—
|
|
—
|
|
7,981
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|
(10,203,614)
|
|
(10,195,633)
|
|
Issued, pursuant to Share
Purchase Agreement
|
3,691,150
|
|
—
|
|
—
|
|
—
|
|
—
|
|
3,691,150
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|
Expired warrants
|
—
|
|
376,892
|
|
(376,892)
|
|
—
|
|
—
|
|
—
|
|
|
|
|
|
|
|
|
|
|
|
|
|
Share based compensation
|
—
|
|
670,602
|
|
—
|
|
—
|
|
—
|
|
670,602
|
|
As at June 30, 2014
|
232,303,714
|
|
25,538,706
|
|
—
|
|
87,679
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|
(241,550,614)
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|
16,379,485
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
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Three Month
Period
Ending June
30, 2014
$
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|
Three Month
Period
Ending June
30, 2013
$
|
|
Six Month
Period
Ending June
30, 2014
$
|
|
Six Month
Period
Ending June
30, 2013
$
|
|
|
|
|
|
|
|
|
|
Operating Activities
|
|
|
|
|
|
|
|
|
Net loss for the period
|
(4,718,163)
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|
(5,019,681)
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|
(10,203,614)
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|
(11,626,517)
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Amortization - property and equipment
|
38,512
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|
25,565
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|
78,169
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|
50,146
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|
Share based compensation
|
366,005
|
|
129,997
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|
670,602
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|
250,853
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|
Unrealized foreign exchange loss
|
(74,059)
|
|
209,804
|
|
(49,989)
|
|
(97,849)
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|
Net change in non-cash working capital
|
(1,392,530)
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|
(455,283)
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|
(2,439,481)
|
|
(2,096,453)
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|
Cash used in operating activities
|
(5,780,235)
|
|
(5,109,598)
|
|
(11,944,313)
|
|
(13,519,820)
|
|
Investing Activities
|
|
|
|
|
|
|
|
|
Acquisition of property and equipment
|
(1,239)
|
|
(132,164)
|
|
(17,219)
|
|
(147,302)
|
|
Purchase of short-term investments
|
—
|
|
—
|
|
(30,041)
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|
(32,416)
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|
Cash used in investing activities
|
(1,239)
|
|
(132,164)
|
|
(47,260)
|
|
(179,718)
|
|
Financing Activities
|
|
|
|
|
|
|
|
|
Proceeds from exercise of stock options and
warrants
|
—
|
|
—
|
|
—
|
|
104,989
|
|
Proceeds from Share Purchase Agreement
|
2,502,708
|
|
—
|
|
3,691,150
|
|
—
|
|
Proceeds from public offering
|
—
|
|
11,735
|
|
—
|
|
30,218,797
|
|
Cash provided by financing activities
|
2,502,708
|
|
11,735
|
|
3,691,150
|
|
30,323,786
|
|
Increase in cash
|
(3,278,766)
|
|
(5,230,027)
|
|
(8,300,423)
|
|
16,624,248
|
|
Cash and cash equivalents, beginning of period
|
20,155,907
|
|
41,519,657
|
|
25,220,328
|
|
19,323,541
|
|
Impact of foreign exchange on cash and cash
equivalents
|
3,589
|
|
(136,353)
|
|
(39,175)
|
|
205,488
|
|
Cash and cash equivalents, end of period
|
16,880,730
|
|
36,153,277
|
|
16,880,730
|
|
36,153,277
|
To view the Company's Second Quarter 2014 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/for-investors/financials.
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 later-stage, randomized human trials in various indications 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 2014 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.
TMX Equicom, Nick Hurst, 300 - 5th Ave. SW, 10th Floor, Calgary, Alberta, T2P 3C4, Tel: 403.218.2835, Fax: 403.218.2830, nhurst@tmxequicom.com; Dian Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor, New York, NY, 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.comCopyright CNW Group 2014