Oncolytics Biotech today announced its financial results and operational highlights for the quarter ended September 30, 2017.
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CALGARY, and SAN DIEGO, CA, Nov. 8, 2017 /PRNewswire/ - Oncolytics Biotech Inc., a biotech company developing REOLYSIN®, an intravenously delivered immuno-oncolytic virus that activates the innate and adaptive immune systems to turn 'cold' tumors 'hot', today announced its financial results and operational highlights for the quarter ended September 30, 2017. "Towards the end of the third quarter we made a very important announcement regarding feedback from the FDA following our End-of-Phase 2 meeting. The favorable meeting resulted in the support of our proposed target patient population of hormone receptor positive, HER2 receptor negative metastatic breast cancer patients for our registration study," said Dr. Matt Coffey, President and CEO of Oncolytics Biotech. "With this support and guidance outlining a single, four hundred patient study, we have prepared to file for breakthrough designation which we expect to do very soon, prepared for communications with the European regulators, conducted preliminary preparations to file for a special protocol assessment, or SPA, and advanced our business development activities. We expect to be able to announce the results of these filings and communications with the European regulators over the next several months as we continue to prepare the company to relist its shares on NASDAQ in 2018." Selected Highlights from Q2 and through the end of July 2017 Clinical Updates
Corporate Updates
Anticipated Milestones • First quarter 2018: Results from regulatory filings
• First half of 2018: Update on our exploration of strategic and regional alliances
NASDAQ
Preliminary MUK eleven data
• Mid-2018: Initiate phase 3 registration study in mBC
Q3 2017 Financial Results
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)
September 30, December 31,
2017 2016
$ $
--- ---
Assets
Current assets
Cash and cash equivalents 14,033,644 12,034,282
Short-term investments - 2,088,800
Accounts receivable 33,129 54,406
Prepaid expenses 438,150 260,841
---------------- ------- -------
Total current assets 14,504,923 14,438,329
-------------------- ---------- ----------
Non-current assets
Property and equipment 343,307 319,955
---------------------- ------- -------
Total non-current assets 343,307 319,955
------------------------ ------- -------
Total assets 14,848,230 14,758,284
============ ========== ==========
Liabilities And
Shareholders' Equity
Current Liabilities
Accounts payable and
accrued liabilities 2,781,932 4,068,664
-------------------- --------- ---------
Total current liabilities 2,781,932 4,068,664
------------------------- --------- ---------
Shareholders' equity
Share capital
Authorized: unlimited
Issued:
September 30, 2017 - 140,671,722
December 31, 2016 - 121,258,222 270,899,669 262,321,825
Warrants 3,617,900 -
Contributed surplus 26,887,579 26,643,044
Accumulated other
comprehensive income 361,726 554,060
Accumulated deficit (289,700,576) (278,829,309)
------------------- ------------ ------------
Total shareholders' equity 12,066,298 10,689,620
-------------------------- ---------- ----------
Total liabilities and
equity 14,848,230 14,758,284
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)
Three Three Nine Nine
Month Month Month Month
Period Period Period Period
Ending Ending Ending Ending
September September September September
30, 2017 30, 2016 30, 2017 30, 2016
$ $ $ $
--- --- --- ---
Expenses
Research and development 1,726,726 2,141,737 6,913,470 6,358,822
Operating 1,309,607 1,222,447 4,054,450 3,708,317
--------- --------- --------- --------- ---------
Operating loss (3,036,333) (3,364,184) (10,967,920) (10,067,139)
Interest 31,759 31,691 96,637 136,849
-------- ------ ------ ------ -------
Loss before income taxes (3,004,574) (3,332,493) (10,871,283) (9,930,290)
Income tax expense 168 19 16 333
------------------ --- --- --- ---
Net loss (3,004,406) (3,332,474) (10,871,267) (9,929,957)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment (126,846) 32,545 (192,334) (268,341)
---------------------- -------- ------ -------- --------
Net comprehensive loss (3,131,252) (3,299,929) (11,063,601) (10,198,298)
====================== ========== ========== =========== ===========
Basic and diluted loss per common share (0.02) (0.03) (0.08) (0.08)
======================================= ===== ===== ===== =====
Weighted average number of shares (basic and 139,515,885 120,552,638 129,441,461 119,455,440
diluted)
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
(unaudited)
Share Capital Warrants Contributed Accumulated Accumulated Total
Surplus Other Deficit
$ $ Comprehensive $
$ Income $
$
---
As at December 31, 2015 261,324,692 - 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and other comprehensive loss - - - (268,341) (9,929,957) (10,198,298)
Issued pursuant to "At the Market" Agreement 1,339,378 - - - - 1,339,378
Issued pursuant to incentive share award plan 41,000 - (41,000) - - -
Share issue costs (486,842) - - - - (486,842)
Share based compensation - - 299,635 - - 299,635
------------------------ --- --- ------- --- --- -------
As at September 30, 2016 262,218,228 - 26,536,601 492,637 (273,619,287) 15,628,179
======================== =========== === ========== ======= ============ ==========
Share Warrants Contributed Accumulated Accumulated Total
Capital Surplus Other Deficit $
$ $ $ Comprehensive $
Income
$
---
As at December 31, 2016 262,321,825 - 26,643,044 554,060 (278,829,309) 10,689,620
Net loss and other comprehensive loss - - - (192,334) (10,871,267) (11,063,601)
Issued pursuant to "At the Market" Agreement 1,479,065 - - - - 1,479,065
Issued pursuant to public offering 7,893,600 3,617,900 - - - 11,511,500
Issued pursuant to stock option plan 536,949 - (193,509) - - 343,440
Share issue costs (1,331,770) - - - - (1,331,770)
Share based compensation - - 438,044 - - 438,044
------------------------ --- --- ------- --- --- -------
As at September 30, 2017 270,899,669 3,617,900 26,887,579 361,726 (289,700,576) 12,066,298
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ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
(unaudited)
Three Three Nine Month Nine Month
Month Month Period Period
Period Period Ending Ending
Ending Ending September September
September September 30, 2017 30, 2016
30, 2017 30, 2016 $ $
$ $
--- ---
Operating Activities
Net loss for the period (3,004,406) (3,332,474) (10,871,267) (9,929,957)
Amortization -property and
equipment 20,591 44,014 70,315 134,631
Share based compensation 148,447 98,369 438,044 299,635
Unrealized foreign exchange gain (6,414) (49,400) (119,058) (152,019)
Net change in non-cash
working capital (331,590) 216,611 (1,186,142) 978,847
---------------------- -------- ------- ---------- -------
Cash used in operating
activities (3,173,372) (3,022,880) (11,668,108) (8,668,863)
---------------------- ---------- ---------- ----------- ----------
Investing Activities
Acquisition of property and
equipment (9,451) (4,851) (95,337) (10,553)
Redemption (purchase) of
short-term investments - - 2,088,800 (27,823)
------------------------ --- --- --------- -------
Cash (used in) provided by
investing activities (9,451) (4,851) 1,993,463 (38,376)
-------------------------- ------ ------ --------- -------
Financing Activities
Proceeds from "At the
Market" equity
distribution agreement 733,171 242,706 1,292,698 852,536
Proceeds from public
offering - - 10,366,098 -
Proceeds from exercise of
options 48,090 - 343,440 -
------------------------- ------ --- ------- ---
Cash provided by financing
activities 781,261 242,706 12,002,236 852,536
-------------------------- ------- ------- ---------- -------
(Decrease) increase in cash (2,401,562) (2,785,025) 2,327,591 (7,854,703)
Cash and cash equivalents,
beginning of period 16,676,298 18,320,981 12,034,282 24,016,275
Impact of foreign exchange
on cash and cash
equivalents (241,092) 76,773 (328,229) (548,843)
-------------------------- -------- ------ -------- --------
Cash and cash equivalents,
end of period 14,033,644 15,612,729 14,033,644 15,612,729
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To view the Company's Fiscal 2017 Third Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings, which will be available under the Company's profile at www.sedar.com and on Oncolytics' website at http://www.oncolyticsbiotech.com/investor-centre/financials/. About Oncolytics Biotech Inc. 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 2017 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. |
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Company Codes: OtherOTC:ONCYF, Toronto:ONC |
