On November 3, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the third quarter ended September 30, 2016 (Filing, Q3, Oncolytics Biotech, 2016, NOV 3, 2016, View Source [SID1234516308]).

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"During the quarter we reported additional statistically significant, randomized clinical data that further strengthened the linkage between genetic status and survival outcomes in patients with adenocarcinoma of the lung," said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. "In parallel with reporting data from sponsored Phase 2 randomized studies, we continued to push ahead with preparations for a registration study."

Selected Highlights

Since July 1, 2016, selected highlights announced by the Company include:

Clinical Program

· Additional data from a randomized, sponsored Phase II clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed that:
· progression free survival ("PFS") was statistically significantly better for female patients in the test arm (n=20) than for those in the control arm (n=16) in patients with adenocarcinoma. Median PFS was 5.39 months compared with 3.02 months, respectively (p=0.0201);
· evolving overall survival ("OS") demonstrated a strong trend towards survival benefit for female patients in the test arm with adenocarcinoma (n=20, six of whom remained alive at the time of the analysis) over those in the control arm (n=16, three of whom remained alive at the time of the analysis). Median OS was 10.68 months compared with 7.59 months, respectively (p=0.145) (Figure B). By contrast, no PFS or OS benefit was noted for the male patients with adenocarcinoma; and
· patients with adenocarcinoma treated with REOLYSIN with one or more target biomarkers (EGFR, Hras, Kras, Nras, Braf and/or p53 mutations) had a greater PFS (p=0.039) and OS (p=0.031) than patients treated with REOLYSIN without any of these biomarkers. The presence of these biomarkers may account, at least in part, for the difference between the survival outcomes for male and female patients; target biomarkers were present in a higher proportion of the female patients in the study than the male patients (66.7% versus 43.6%). As a result, pre-screening for target biomarkers in patients with adenocarcinoma of the lung is warranted.
Financial
At September 30, 2016, the Company reported $17.7 million in cash, cash equivalents and short-term investments. At November 2, 2016, the Company had approximately $16.7 million in cash, cash equivalents and short-term investments.

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
(unaudited)

September 30,
2016
$ December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 15,612,729 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 44,991 340,059
Prepaid expenses 356,741 506,669
Total current assets 18,103,261 26,923,980
Non-current assets
Property and equipment 333,926 459,818
Total non-current assets 333,926 459,818

Total assets 18,437,187 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,809,008 2,709,492
Total current liabilities 2,809,008 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
September 30, 2016 – 120,873,222
December 31, 2015 – 118,151,622 262,218,228 261,324,692
Contributed surplus 26,536,601 26,277,966
Accumulated other comprehensive income 492,637 760,978
Accumulated deficit (273,619,287) (263,689,330)
Total shareholders’ equity 15,628,179 24,674,306
Total liabilities and equity 18,437,187 27,383,798

ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
(unaudited)

Three
Month
Period
Ending
September
30, 2016
$ Three
Month
Period
Ending
September
30, 2015
$ Nine Month
Period
Ending
September
30, 2016
$ Nine Month
Period
Ending
September 30,
2015
$
Expenses
Research and development 2,141,737 1,704,784 6,358,822 6,601,877
Operating 1,222,447 1,176,023 3,708,317 3,780,812
Operating loss (3,364,184) (2,880,807) (10,067,139) (10,382,689)
Interest 31,691 52,756 136,849 153,313
Loss before income taxes (3,332,493) (2,828,051) (9,930,290) (10,229,376)
Income tax expense 19 4,074 333 3,303
Net loss (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Other comprehensive income items that may be
reclassified to net loss

Translation adjustment 32,545 192,586 (268,341) 377,060

Net comprehensive loss (3,299,929) (2,631,391) (10,198,298) (9,849,013)
Basic and diluted loss per common share (0.03) (0.02) (0.08) (0.09)
Weighted average number of shares (basic and
diluted) 120,552,638 117,963,979 119,455,440 110,757,811

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


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2014 237,657,056 25,848,429 280,043 (249,966,335) 13,819,193
Net loss and other comprehensive income — — 377,060 (10,226,073) (9,849,013)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,267,267 — — — 19,267,267
Share based compensation — 181,436 — — 181,436
As at September 30, 2015 261,229,719 26,029,865 657,103 (260,192,408) 27,724,279

Share Capital
$ Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$ Total
$
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 852,536 — — — 852,536
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
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

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

Three
Month
Period
Ending
September
30, 2016
$ Three
Month
Period
Ending
September
30, 2015
$ Nine Month
Period
Ending
September
30, 2016
$ Nine Month
Period
Ending
September
30, 2015
$

Operating Activities
Net loss for the period (3,332,474) (2,823,977) (9,929,957) (10,226,073)
Amortization – property and equipment 44,014 44,761 134,631 134,743
Share based compensation 98,369 10,791 299,635 181,436
Unrealized foreign exchange gain (49,400) (182,131) (152,019) (485,653)
Net change in non-cash working capital 216,611 92,792 978,847 (327,690)
Cash used in operating activities (3,022,880) (2,857,764) (8,668,863) (10,723,237)
Investing Activities
Acquisition of property and equipment (4,851) (17,695) (10,553) (47,292)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (4,851) (17,695) (38,376) (76,584)
Financing Activities
Proceeds from Share Purchase Agreement — — — 4,305,396
Proceeds from "At the Market" equity distribution agreement 242,706 213,742 852,536 19,267,267
Cash provided by financing activities 242,706 213,742 852,536 23,572,663
(Decrease) increase in cash (2,785,025) (2,661,717) (7,854,703) 12,772,842
Cash and cash equivalents, beginning of period 18,320,981 30,018,217 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 76,773 605,962 (548,843) 1,036,795
Cash and cash equivalents, end of period 15,612,729 27,962,462 15,612,729 27,962,462