ONCOLYTICS BIOTECH INC. 
By CALGARY, March 13, 2014 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2014.
"In 2013, we reported data from a number of clinical studies, which included our first data correlating specific biomarkers with survival in NSCLC lung cancer patients and culminated with the reporting of our first randomized data in head and neck cancer," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our randomized clinical program continues to move ahead with six sponsored studies currently enrolling patients in a range of indications. Each of these studies will advance in parallel with our ongoing head and neck program which we are currently in the process of designing a follow-on registration study for discussion with regulators."
Selected Highlights
Since January 1, 2013, specific highlights announced by the Company include:
Clinical Trial Results
-- Top-line data for the endpoints in a double blinded, randomized
clinical study examining REOLYSIN® in combination with
carboplatin and paclitaxel in patients with second-line
platinum-refractory, taxane-naïve head and neck cancers (REO
018).An analysis was performed on an intent-to-treat basis of
118 patients with loco-regional head and neck cancer, with or
without metastases. Patients in the control arm were treated
with carboplatin and paclitaxel, while patients in the test arm
were treated with carboplatin, paclitaxel and REOLYSIN. The
analysis showed a median progression free survival (PFS) of 94
days (13.4 weeks) in the test arm (n=62), versus 50 days (7.1
weeks) in the control arm (n=56). The test arm maintained a PFS
benefit over the control arm through five cycles of therapy. An
analysis of 88 loco-regional patients that did not receive
additional therapy following discontinuation of study treatment
showed a median overall survival (OS) of 150 days (21.4 weeks)
in the test arm (n=50), versus 115 days (16.4 weeks) in the
control arm (n=38). REOLYSIN was deemed safe and well-tolerated
by patients. The side effects experienced by patients in the
test arm of the study were consistent with expectations based
on outcomes of earlier clinical studies using REOLYSIN.
Patients on the test arm of the study experienced a higher
incidence of flu-like symptoms consistent with treatment with a
virus, most commonly mild fever, chills, nausea and diarrhea,
on both a per-patient and a per-cycle basis. Fewer patients
required dose reductions of paclitaxel due to neuropathy or
neurotoxicity on the test arm than the control arm (zero in the
test arm versus six in the control arm; p=0.028). On this
basis, the Company intends to explore the potential
chemoprotective and neuroprotective properties of REOLYSIN in
future clinical studies;
-- Positive final results from a U.S. Phase 2 study examining the
use of REOLYSIN in combination with carboplatin and paclitaxel
in patients with stage IV non-small cell lung cancer (NSCLC)
with Kras or EGFR-activated tumors (REO 016). Response
evaluation for 36 evaluable patients showed 11 partial
responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras,
three; EGFR mutated, one), 21 stable disease (SD), and four
progressive disease (PD). The data also correlated a number of
molecular abnormalities with best response, PFS and one-year
survival. Current data in these patients demonstrates that 20
of 36 evaluable patients (56%) survived a year or more. There
were 13 patients with only EGFR mutations or amplifications, of
whom nine (69.2%) survived a year or longer. Four of four
(100%) patients with BRAF and EGFR amplification survived a
year or longer;
-- Final tumor response and PFS data from a U.S. Phase 2 clinical
trial in patients with squamous cell carcinoma of the lung
(SCCLC) using intravenous administration of REOLYSIN in
combination with carboplatin and paclitaxel (REO 021). Of the
25 evaluable patients who had more than one cycle of therapy,
23 (92%) exhibited overall tumor shrinkage. When evaluated for
best response, which is the best percentage response recorded
on study compared to baseline, 10 patients (40%) had PR, while
a further 14 (56%) showed SD, and one (4%), had PD. Using
RECIST criteria to evaluate best overall response, 10 patients
(40%) had PRs, 12 (48%) showed SD and three (12%), had PD.
31.8% of patients with sufficient follow up had a PFS greater
than six months;
-- Reaching the stage 1 endpoint in a U.S. Phase 2 clinical trial
in patients with metastatic melanoma (REO 020) after only 14
patients were enrolled. The primary objective of this Phase 2
trial was to assess the antitumor effect of the treatment
regimen in the study population in terms of objective response
rates. The secondary objectives were to assess progression-free
survival and overall survival for the treatment regimen; the
disease control rate (complete response (CR) plus PR plus SD)
and duration, and to assess the safety and tolerability of the
treatment regimen in the study population. Three of the 14
patients exhibited a PR, and an additional seven patients had
SD for a disease control rate of 71.5%; and
-- Positive preliminary results from a Phase 1 study examining the
intravenous administration of REOLYSIN in combination with
FOLFIRI in patients with metastatic colorectal cancer (REO 022)
in a poster presentation at the ASCO Gastrointestinal Cancers
Symposium. Of the 18 patients evaluable for response there was
one PR and nine had SD. The combined overall PFS of
FOLFIRI-naïve and FOLFIRI-failed patients was 7.4 months. The
authors concluded that the combination of REOLYSIN and FOLFIRI
was safe and well tolerated and resulted in disease control in
the majority of evaluable patients, including patients that had
previously progressed on Irinotecan.
Financial
-- At December 31, 2013 the Company reported $27.2 million in
cash, cash equivalents and short-term investments; and
-- Subsequent to year end, entry into a share purchase agreement
with Lincoln Park Capital Fund, LLC that will provide an
initial investment in Oncolytics of US$1.0 million and make
available additional periodic investments of up to US$25.0
million over a 30-month term.
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
December 31, December 31,
2013 2012
as at $ $
Assets
Current assets
Cash and cash equivalents 25,220,328 19,323,541
Short-term investments 2,001,644 1,969,228
Accounts receivable 105,853 44,979
Prepaid expenses 361,743 331,094
Total current assets 27,689,568 21,668,842
Non-current assets
Property and equipment 532,459 409,248
Total non-current assets 532,459 409,248
Total assets 28,222,027 22,078,090
Liabilities And Shareholders'
Equity
Current Liabilities
Accounts payable and accrued
liabilities 6,008,661 7,291,310
Total current liabilities 6,008,661 7,291,310
Shareholders' equity
Share capital
Authorized: unlimited
Issued: December 31, 2013 -
84,803,818
December 31, 2012 - 76,710,285 228,612,564 198,155,091
Warrants 376,892 376,892
Contributed surplus 24,491,212 24,126,265
Accumulated other comprehensive
loss 79,698 (57,115)
Accumulated deficit (231,347,000) (207,814,353)
Total shareholders' equity 22,213,366 14,786,780
Total liabilities and equity 28,222,027 22,078,090
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
For the years ending 2013 2012 2011
December 31, $ $ $
Expenses
Research and
development 18,506,064 31,402,625 23,386,685
Operating 5,392,660 5,285,425 5,334,582
Loss before the
following (23,898,724) (36,688,050) (28,721,267)
Write down of asset
available for sale -- -- (735,681)
Change in fair value
of warrant liability -- -- 36,000
Interest 371,485 345,003 416,247
Loss before income
taxes (23,527,239) (36,343,047) (29,004,701)
Income tax expense (5,408) (30,474) (40,000)
Net loss (23,532,647) (36,373,521) (29,044,701)
Other comprehensive
income items that
may
be reclassified to
net loss
Translation
adjustment 136,813 60,386 39,159
Net comprehensive
loss (23,395,834) (36,313,135) (29,005,542)
Basic and diluted
loss per common
share (0.28) (0.48) (0.41)
Weighted average
number of shares
(basic and diluted) 83,530,981 76,102,062 70,911,526
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY
Accumulated
Other
Share Contributed Comprehensive Accumulated
Capital Warrants Surplus Income Deficit Total
$ $ $ $ $ $
As at
December 31,
2010 155,439,610 4,108,652 19,399,489 (156,660) (142,396,131) 36,394,960
Net loss and
comprehensive
income -- -- -- 39,159 (29,044,701) (29,005,542)
Exercise of
warrants 21,487,080 (1,455,025) -- -- -- 20,032,055
Exercise of
stock options 355,876 -- (62,473) -- -- 293,403
Share based
compensation -- -- 1,805,503 -- -- 1,805,503
As at
December 31,
2011 177,282,566 2,653,627 21,142,519 (117,501) (171,440,832) 29,520,379
Net loss and
comprehensive
income -- -- -- 60,386 (36,373,521) (36,313,135)
Issued,
pursuant to a
bought deal
financing 19,386,903 376,892 -- -- -- 19,763,795
Expiry of
warrants -- (2,653,627) 2,653,627 -- -- --
Exercise of
stock options 1,485,622 -- (400,632) -- -- 1,084,990
Share based
compensation -- -- 730,751 -- -- 730,751
As at
December 31,
2012 198,155,091 376,892 24,126,265 (57,115) (207,814,353) 14,786,780
Net loss and
comprehensive
income -- -- -- 136,813 (23,532,647) (23,395,834)
Issued,
pursuant to a
bought deal
financing 30,218,796 -- -- -- -- 30,218,796
Expiry of
warrants -- -- -- -- -- --
Exercise of
stock options 238,677 -- (59,437) -- -- 179,240
Share based
compensation -- -- 424,384 -- -- 424,384
As at
December 31,
2013 228,612,564 376,892 24,491,212 79,698 (231,347,000) 22,213,366
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
For the years ending 2013 2012 2011
December 31, $ $ $
Operating Activities
Net loss for the
year (23,532,647) (36,373,521) (29,044,701)
Amortization -
property and
equipment 131,623 109,275 92,590
Share based
compensation 424,384 730,751 1,805,503
Change in fair
value of warrant
liability -- -- (36,000)
Write down of
asset available
for sale -- -- 735,681
Unrealized foreign
exchange loss (89,721) 89,890 115,234
Net change in
non-cash working
capital (1,374,172) 1,187,967 3,790,510
Cash used in
operating activities (24,440,533) (34,255,638) (22,541,183)
Investing Activities
Acquisition of
property and
equipment (254,834) (126,412) (257,790)
Redemption
(purchase) of
short-term
investments (32,416) (32,441) 1,672,459
Cash provided by
(used in) investing
activities (287,250) (158,853) 1,414,669
Financing Activities
Proceeds from
exercise of stock
options and warrants 179,240 1,084,990 14,824,658
Proceeds from public
offering 30,218,796 19,763,795 --
Cash provided by
financing activities 30,398,036 20,848,785 14,824,658
Increase (decrease)
in cash 5,670,253 (13,565,706) (6,301,856)
Cash and cash
equivalents,
beginning of year 19,323,541 32,918,751 39,296,682
Impact of foreign
exchange on cash and
cash equivalents 226,534 (29,504) (76,075)
Cash and cash
equivalents, end of
year 25,220,328 19,323,541 32,918,751
To view the Company's Fiscal 2013 Consolidated Financial Statements, related Notes to Consolidated Financial Statements, and Management's Discussion and Analysis, please see the Company's annual filings which will be available on www.sedar.com and on www.oncolyticsbiotech.com/for-investors/financials.
About Oncolytics Biotech Inc.
Oncolytics is a Calgary-based biotechnology company focused on the
development of oncolytic viruses as potential cancer therapeutics.
Oncolytics' clinical program includes a variety of human trials
including a Phase III trial in head and neck cancers using REOLYSIN,
its proprietary formulation of the human reovirus. For further
information about Oncolytics, please visit: www.oncolyticsbiotech.com.
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 2014 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.
