On March 10, 2017 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (Oncolytics or the Company) reported its financial results and operational highlights for the year ended December 31, 2016 (Filing, Q4/Annual, Oncolytics Biotech, 2016, MAR 10, 2017, View Source [SID1234518074]). Schedule your 30 min Free 1stOncology Demo! "It was a year of change for Oncolytics, highlighted by additional clinical data that saw our understanding of REOLYSIN’s mechanism of action evolve and grow," said Dr. Matt Coffey, President and CEO of Oncolytics. "Through this process, and with the help of our expanding senior team, we thoughtfully and deliberately put in place a plan that initially contemplates combinations with chemotherapy for late-stage clinical development, but will expand to include targeted immunotherapies over the longer term as we look to leverage the role of the immune system in patient treatment. In the coming months we will specifically define our first registration pathway. In the year ahead we expect data readouts from as many as five sponsored, randomized Phase 2 studies, including one in advanced or metastatic breast cancer."
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Selected Highlights
Since January 1, 2016, selected highlights announced by the Company include:
Clinical Results
· An abstract submitted to the American Association of Cancer Research Annual Meeting by Canadian Cancer Trials Group ("CCTG") at Queen’s University in Kingston, Ontario covering results from IND 213, an open-label, randomized, non-blinded Phase 2 study to assess the therapeutic combination of intravenously-administered REOLYSIN given in combination with paclitaxel versus paclitaxel alone in patients with advanced or metastatic breast cancer;
· A poster presentation by Dr. Kevin Kelly at the 58th American Society of Hematology (ASH) (Free ASH Whitepaper) Annual Meeting on the Phase 1b Study of REOLYSIN with Bortezomib and Dexamethasone in Patients with Relapsed/Refractory Multiple Myeloma, with preliminary data suggesting evidence of activity and that the treatment combination was well tolerated;
· Additional data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in non-small cell lung cancer (IND 211), which showed: a statistically significant improvement (p=0.0201) in progression free survival (PFS) for female patients with adenocarcinoma in the test arm versus the control arm, a strong trend to improved overall survival (OS) for female patients with adenocarcinoma in the test arm versus the control arm;
· Preliminary data from a randomized, CCTG-sponsored Phase 2 clinical study of REOLYSIN in advanced or metastatic colorectal cancer (IND 210), following an abstract for the 2016 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 overall response rate (ORR) of 63.2% (n=19) versus 23.8% (n=21) in the control arm (p=0.0054)), and a trend to improvement in median OS in female patients (female patients in the test arm had median OS of 19.3 months (n=19) versus 14.5 months (n=21) in the control arm);
· 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 doubling of patients surviving two years; 20% on the test arm versus 9% on the control arm;
· Treatment of the first patients in a Phase 1b study of pembrolizumab (KEYTRUDA) in combination with REOLYSIN and chemotherapy in patients with advanced pancreatic adenocarcinoma, the Company’s first trial examining REOLYSIN in combination with a checkpoint inhibitor;
Corporate
· The appointment of Oncolytics co-founder and long-serving senior executive Matt Coffey PhD, MBA, as President and CEO;
· The appointment of Andres Gutierrez, MD, PhD, with more than 25 years of senior clinical development expertise designing and implementing both early- and late-stage oncology clinical studies, to the role of Chief Medical Officer;
· 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 December 31, 2016, the Company reported $14.1 million in cash, cash equivalents and short-term investments. At March 9, 2017, the Company had approximately $11.3 million in cash, cash equivalents and short-term investments.
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
2016 2015
As at December 31, $ $
Assets
Current assets
Cash and cash equivalents 12,034,282 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 54,406 340,059
Prepaid expenses 260,841 506,669
Total current assets 14,438,329 26,923,980
Non-current assets
Property and equipment 319,955 459,818
Total non-current assets 319,955 459,818
Total assets 14,758,284 27,383,798
Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 4,068,664 2,709,492
Total current liabilities 4,068,664 2,709,492
Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
December 31, 2016 – 121,258,222
December 31, 2015 – 118,151,622 262,321,825 261,324,692
Contributed surplus 26,643,044 26,277,966
Accumulated other comprehensive income 554,060 760,978
Accumulated deficit (278,829,309) (263,689,330)
Total shareholders’ equity 10,689,620 24,674,306
Total liabilities and equity 14,758,284 27,383,798
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
2016 2015 2014
For the years ending December 31, $ $ $
Expenses
Research and development 9,770,007 8,601,864 13,824,252
Operating 5,524,500 5,315,837 4,998,694
Loss before the following (15,294,507) (13,917,701) (18,822,946)
Interest 163,902 197,859 210,390
Loss before income taxes (15,130,605) (13,719,842) (18,612,556)
Income tax recovery (expense) (9,374) (3,153) (6,779)
Net loss (15,139,979) (13,722,995) (18,619,335)
Other comprehensive income items that may be reclassified to net loss
Translation adjustment (206,918) 480,935 200,345
Net comprehensive loss (15,346,897) (13,242,060) (18,418,990)
Basic and diluted loss per common share (0.13) (0.12) (0.21)
Weighted average number of shares (basic and diluted) 119,880,200 112,613,845 87,869,149
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Share Capital
$
Warrants
$
Contributed
Surplus
$
Accumulated
Other
Comprehensive
Income
$
Accumulated
Deficit
$
Total
$
As at December 31, 2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366
Net loss and other comprehensive income — — — 200,345 (18,619,335) (18,418,990)
Issued, pursuant to Share Purchase Agreement 8,861,652 — — — — 8,861,652
Issued, pursuant to "At the Market" Agreement 1,468,668 — — — — 1,468,668
Expired warrants — (376,892) 376,892 — — —
Share based compensation — — 980,325 — — 980,325
Share issue costs (1,285,828) — — — — (1,285,828)
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 — — — 480,935 (13,722,995) (13,242,060)
Issued, pursuant to Share Purchase Agreement 4,371,687 — — — — 4,371,687
Issued, pursuant to "At the Market" Agreement 20,049,693 — — — — 20,049,693
Share based compensation — — 429,537 — — 429,537
Share issue costs (753,744) — — — — (753,744)
As at December 31, 2015 261,324,692 — 26,277,966 760,978 (263,689,330) 24,674,306
Net loss and other comprehensive income — — — (206,918) (15,139,979) (15,346,897)
Issued, pursuant to incentive share award plan 41,000 — (41,000) — — —
Issued, pursuant to "At the Market" Agreement 1,456,296 — — — — 1,456,296
Share based compensation — — 406,078 — — 406,078
Share issue costs (500,163) — — — — (500,163)
As at December 31, 2016 262,321,825 — 26,643,044 554,060 (278,829,309) 10,689,620
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
2016 2015 2014
For the years ending December 31, $ $ $
Operating Activities
Net loss for the year (15,139,979) (13,722,995) (18,619,335)
Amortization – property and equipment 162,233 180,411 163,501
Share based compensation 406,078 429,537 980,325
Unrealized foreign exchange (gain) loss (139,810) (816,319) 242,542
Net change in non-cash working capital 2,233,865 (1,105,464) (2,443,988)
Cash used in operating activities (12,477,613) (15,034,830) (19,676,955)
Investing Activities
Acquisition of property and equipment (23,527) (108,268) (152,750)
Redemption (purchase) of short-term investments (27,823) (29,292) (30,041)
Cash used in investing activities (51,350) (137,560) (182,791)
Financing Activities
Proceeds from Share Purchase Agreement — 4,305,396 7,830,409
Proceeds from "At the Market" equity distribution agreement 956,133 19,362,240 1,214,083
Cash provided by financing activities 956,133 23,667,636 9,044,492
(Decrease) increase in cash (11,572,830) 8,495,246 (10,815,254)
Cash and cash equivalents, beginning of year 24,016,275 14,152,825 25,220,328
Impact of foreign exchange on cash and cash equivalents (409,163) 1,368,204 (252,249)
Cash and cash equivalents, end of year 12,034,282 24,016,275 14,152,825
To view the Company’s Fiscal 2016 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 View Source