On May 6, 2016 Oncolytics Biotech Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) ("Oncolytics" or the "Company") reported its financial results and operational highlights for the first quarter ended March 31, 2016 (Filing, Q1, Oncolytics Biotech, 2016, MAY 6, 2016, View Source [SID:1234512055]).
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"We recently reported data from two sponsored, randomized Phase 2 studies, highlighting reduced tumor burden in ovarian cancer and improved longer term survival in pancreatic cancer," said Dr. Brad Thompson. "The data from these studies will be very useful in identifying potential indications and study designs that we could advance into later stage studies in the future."
Selected Highlights
Since January 1, 2016, selected highlights announced by the Company include:
Clinical Program
· Treatment of the first patients in a Phase Ib 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;
· Updated results from a randomized Phase 2 clinical trial of its lead product, REOLYSIN, in combination with paclitaxel in patients with ovarian cancer (GOG-0186H), where an intent-to-treat analysis, as assessed by CA-125 antigen levels, showed statistically significantly reduction in tumor burden;
· 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
· 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;
Financial
· Entry into an "at-the-market" equity distribution agreement with Canaccord Genuity Corp. permitting Oncolytics at its sole discretion, from time to time and until March 16, 2018, to sell common shares having an aggregate offering value of up to $4.6 million; and
· At March 31, 2016 the Company reported $22.3 million in cash, cash equivalents and short-term investments. At May 5, 2016, the Company had approximately $21.4 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 as well as both a run-in and a registration study in muscle-invasive bladder cancer.
ONCOLYTICS BIOTECH INC.
INTERM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
As at March 31,
2016
$ December 31,
2015
$
Assets
Current assets
Cash and cash equivalents 20,233,408 24,016,275
Short-term investments 2,088,800 2,060,977
Accounts receivable 59,648 340,059
Prepaid expenses 229,288 506,669
Total current assets 22,611,144 26,923,980
Non-current assets
Property and equipment 411,762 459,818
Total non-current assets 411,762 459,818
Total assets 23,022,906 27,383,798
Liabilities And Shareholders’ Equity
Current Liabilities
Accounts payable and accrued liabilities 2,554,338 2,709,492
Total current liabilities 2,554,338 2,709,492
Shareholders’ equity
Share capital
Authorized: unlimited
Issued:
March 31, 2016 – 118,697,122
December 31, 2015 – 118,151,622 261,224,148 261,324,692
Contributed surplus 26,359,606 26,277,966
Accumulated other comprehensive income 590,919 760,978
Accumulated deficit (267,706,105) (263,689,330)
Total shareholders’ equity 20,468,568 24,674,306
Total liabilities and equity 23,022,906 27,383,798
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
2016 2015
For the three month period ending March 31 $ $
Expenses
Research and development 2,726,129 2,425,539
Operating 1,360,412 1,182,734
Operating loss (4,086,541) (3,608,273)
Interest 69,621 56,435
Loss before income taxes (4,016,920) (3,551,838)
Income tax expense 145 —
Net loss (4,016,775) (3,551,838)
Other comprehensive income items that may be
reclassified to net loss
Translation adjustment (170,059) 225,591
Net comprehensive loss (4,186,834) (3,326,247)
Basic and diluted loss per common share (0.03) (0.04)
Weighted average number of shares (basic and diluted) 118,199,985 99,557,654
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
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 comprehensive income — — 225,591 (3,551,838) (3,326,247)
Issued, pursuant to Share Purchase
Agreement 1,925,596 — — — 1,925,596
Issued, pursuant to "At the Market"
Agreement 14,636,918 — — — 14,636,918
Share based compensation — 114,970 — — 114,970
As at March 31, 2015 254,219,570 25,963,399 505,634 (253,518,173) 27,170,430
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 comprehensive income — — (170,059) (4,016,775) (4,186,834)
Issued, pursuant to Share Purchase
Agreement
— — — — —
Issued, pursuant to "At the Market"
Agreement (100,544) — — — (100,544)
Share based compensation — 81,640 — — 81,640
As at March 31, 2016 261,224,148 26,359,606 590,919 (267,706,105) 20,468,568
ONCOLYTICS BIOTECH INC.
INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS
2016 2015
For the three month period ending March 31 $ $
Operating Activities
Net loss for the period (4,016,775) (3,551,838)
Amortization – property and equipment 45,942 45,130
Share based compensation 81,640 114,970
Impact of unrealized foreign exchange (gains) losses 141,295 (305,156)
Net change in non-cash working capital 724,655 949,705
Cash used in operating activities (3,023,243) (2,747,189)
Investing Activities
Acquisition of property and equipment — (11,940)
Purchase of short-term investments (27,823) (29,292)
Cash used in investing activities (27,823) (41,232)
Financing Activities
Proceeds from Share Purchase Agreement — 1,925,596
Proceeds from "At the Market" equity distribution agreement (100,544) 14,636,918
Cash provided by financing activities (100,544) 16,562,514
(Decrease) increase in cash (3,151,610) 13,774,093
Cash and cash equivalents, beginning of period 24,016,275 14,152,825
Impact of foreign exchange on cash and cash equivalents (631,257) 651,105
Cash and cash equivalents, end of period 20,233,408 28,578,023
To view the Company’s Fiscal 2016 First 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