On August 4, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the second quarter ended June 30, 2016 (Filing, Q2, Oncolytics Biotech, 2016, AUG 4, 2016, View Source [SID:1234514385]).

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"The key highlights for the quarter were preliminary data from randomized Phase 2 studies in colorectal and non-small cell lung cancer, which together suggested a possible linkage between gender, genetic status and survival outcomes in these common cancers," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our ongoing randomized Phase 2 program continues to provide important data as to indications, patient populations and pre-screening methodologies that we can use to advance our later-stage clinical program."

Selected Highlights

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

Clinical Program

· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), presented following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which correlated both patient gender (female) and genetic status to improved progression free and overall survival;
· Preliminary data from a randomized, sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the American Society of Clinical Oncology (ASCO) (Free ASCO Whitepaper) annual meeting, which showed a statistically significant improvement in objective response rates in female patients (female patients in the test arm had an objective response rate of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)) and those patients of either gender with liver metastases (those treated with REOLYSIN had objective tumour response rates of 55% (n=40), versus 28.6% (n=42) for those who did not receive REOLYSIN (p=0.0077));
· Submission to the U.S. Food and Drug Administration of an Investigational New Drug Application containing the protocol titled "Phase 2 study of REOLYSIN (pelareorep) in combination with FOLFOX6, bevacizumab and pembrolizumab in female patients with KRAS-mutant colorectal cancer metastatic to the liver", which is now active;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with carboplatin and paclitaxel in patients with pancreatic cancer (NCI-8601), where an intent-to-treat analysis of overall survival on patients with confirmed treatment regimes, as assessed by the percentage of patients surviving for two years, showed a statistically significantly higher percentage of patients surviving two years in the test arm versus the control arm (p = 0.001), the crossover arm versus the control arm (p = 0.03) and the test plus crossover arms versus the control arm (p = 0.0004);
Basic Research

· A poster presentation covering preclinical work in squamous cell carcinoma of the head and neck being made at the 2016 American Society of Gene and Cell Therapy annual meeting;
· Two poster presentations covering preclinical work in multiple myeloma and colorectal cancer being made by the Company’s research collaborators at the 2016 American Association of Cancer Research annual meeting;
Corporate

· Formation of a Science and Technology Committee charged with supporting REOLYSIN’s further development in the context of the broader oncology space with an ultimate focus on reaching a commercial endpoint; and
Financial

· At June 30, 2016 the Company reported $20.4 million in cash, cash equivalents and short-term investments. At August 3, 2016, the Company had approximately $19.5 million in cash, cash equivalents and short-term investments, which is expected to provide sufficient funds to support several small early-stage immunotherapy combination studies and other clinical studies.

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


June 30,
2016
$

December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 18,320,981 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,633 340,059
Prepaid expenses 530,470 506,669
Total current assets 20,994,884 26,923,980

Non-current assets
Property and equipment 372,854 459,818
Total non-current assets 372,854 459,818

Total assets 21,367,738 27,383,798

Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,780,705 2,709,492
Total current liabilities 2,780,705 2,709,492

Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
June 30, 2016 – 118,900,812
December 31, 2015 – 118,151,622 261,975,522 261,324,692
Contributed surplus 26,438,232 26,277,966
Accumulated other comprehensive loss 460,092 760,978
Accumulated deficit (270,286,813) (263,689,330)
Total shareholders’ equity 18,587,033 24,674,306
Total liabilities and equity 21,367,738 27,383,798

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

Three
Month
Period
Ending
June 30,
2016
$ Three
Month
Period
Ending
June 30,
2015
$ Six Month
Period
Ending
June 30,
2016
$ Six Month
Period
Ending
June 30,
2015
$
Expenses
Research and development 1,490,956 2,471,554 4,217,085 4,897,093
Operating 1,125,458 1,422,055 2,485,870 2,604,789
Operating (loss) (2,616,414) (3,893,609) (6,702,955) (7,501,882)
Interest income 35,537 44,122 105,158 100,557
Loss before income taxes (2,580,877) (3,849,487) (6,597,797) (7,401,325)
Income tax 169 (771) 314 (771)
Net (loss) (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (130,827) (41,117) (300,886) 184,474

Net comprehensive (loss) (2,711,535) (3,891,375) (6,898,369) (7,217,622)
Basic and diluted (loss) per common share (0.02) (0.03) (0.06) (0.07)
Weighted average number of shares (basic and diluted) 119,601,638 114,549,532 118,900,812 107,095,007

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


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
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 comprehensive loss — — 184,474 (7,402,096) (7,217,622)
Issued, pursuant to Share Purchase Agreement 4,305,396 — — — 4,305,396
Issued, pursuant to "At the Market" Agreement 19,053,525 — — — 19,053,525
Share based compensation — 170,645 — — 170,645
As at June 30, 2015 261,015,977 26,019,074 464,517 (257,368,431) 30,131,137


Share Capital
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Loss
$
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 comprehensive loss — — (300,886) (6,597,483) (6,898,369)
Issued, pursuant to "At the Market" Agreement 609,830 — — — 609,830
Issued, pursuant to incentive share award plan 41,000 (41,000) — — —
Share based compensation — 201,266 — — 201,266
As at June 30, 2016 261,975,522 26,438,232 460,092 (270,286,813) 18,587,033

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

Three Month
Period Ending
June 30,
2016
$ Three Month
Period Ending
June 30,
2015
$ Six Month
Period Ending
June 30,
2016
$ Six Month
Period Ending
June 30,
2015
$

Operating Activities
Net loss for the period (2,580,708) (3,850,258) (6,597,483) (7,402,096)
Amortization – property and equipment 44,675 44,852 90,617 89,982
Share based compensation 119,626 55,675 201,266 170,645
Unrealized foreign exchange loss (gain) (243,914) 1,634 (102,619) (303,522)
Net change in non-cash working capital 37,581 (1,370,187) 762,236 (420,482)
Cash used in operating activities (2,622,740) (5,118,284) (5,645,983) (7,865,473)
Investing Activities
Acquisition of property and equipment (5,702) (17,657) (5,702) (29,597)
Purchase of short-term investments — — (27,823) (29,292)
Cash used in investing activities (5,702) (17,657) (33,525) (58,889)
Financing Activities
Proceeds from Share Purchase Agreement — 2,379,800 — 4,305,396
Proceeds from "At the Market" equity distribution agreement 710,374 4,416,607 609,830 19,053,525
Cash provided by financing activities 710,374 6,796,407 609,830 23,358,921
Increase (decrease) in cash (1,918,068) 1,660,466 (5,069,678) 15,434,559
Cash and cash equivalents, beginning of period 20,233,408 28,578,023 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents 5,641 (220,272) (625,616) 430,833
Cash and cash equivalents, end of period 18,320,981 30,018,217 18,320,981 30,018,217

To view the Company’s Fiscal 2016 Second Quarter Consolidated Financial Statements, related Notes to the Consolidated Financial Statements, and Management’s Discussion and Analysis, please see the Company’s quarterly filings, which will be available under the Company’s profile at www.sedar.com and on Oncolytics’ website at View Source