CALGARY, March 11, 2016 /PRNewswire/ – Oncolytics Biotech® Inc. (TSX: ONC) (OTCQX: ONCYF) (FRA: ONY) (“Oncolytics” or the
“Company”) today announced its financial results and operational
highlights for the year ended December 31, 2015.
“In 2015 we continued to advance our clinical program, reporting
survival data from single arm Phase 2 studies in non-small cell lung
and pancreatic cancers, as well as early data from a pilot study in
multiple myeloma,” said Dr. Brad Thompson, President and CEO of
Oncolytics. “During the year we began combination therapy studies with
REOLYSIN® and agents that modulate the immune system. Enrollment in a GM-CSF and
REOLYSIN® combination therapy study in pediatric patients with gliomas began, and
we recently announced our first study looking at REOLYSIN® in combination with an immunotherapeutic checkpoint inhibitor in
pancreatic cancer.”
Selected Highlights
Since January 1, 2015, 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; -
Start of enrollment in a Phase Ib study of REOLYSIN® combined with standard doses of bortezomib and dexamethasone in patients
with relapsed or refractory multiple myeloma (REO 019); -
A poster presentation at the 57th American Society of Hematology titled “REOLYSIN® Combined with Carfilzomib for Treatment of Relapsed Multiple Myeloma
Patients,” which disclosed updated findings (originally presented at
the 15th International Myeloma Workshop) from a pilot study (NCI-9603) in
patients with relapsed or refractory multiple myeloma treated using the
combination of carfilzomib and REOLYSIN®. These findings included that all seven patients treated at the full
clinical dose had a clinical response, as well as significant increases
in the production of caspase-3 (p=0.005) and upregulation of PD-L1
(p=0.005); -
An oral presentation at the International Association for the Study of
Lung Cancer (IASLC) 16th World Conference on Lung Cancer titled “Oncolytic Reovirus in
Combination with Paclitaxel/Carboplatin in NSCLC Patients with Ras
Activated Malignancies, Long Term Results,” covering updated results,
including one- and two-year survival data (57% and 30%, respectively),
from the Company’s REO 016 Phase 2 study in Non-Small Cell Lung Cancer
(NSCLC); -
Presentation of final data from a single arm clinical study examining
the use of REOLYSIN® in combination with gemcitabine in patients with advanced pancreatic
cancer (REO 017), which showed an increase in median overall survival,
as well as an approximate two-fold increase in one-year survival rates,
and a five-fold increase in two-year survival rates when compared to
gemcitabine therapy alone as seen in historical data; -
Completion of enrollment in three randomized Phase 2 studies sponsored
and conducted by the NCIC Clinical Trials Group; IND 211 is a study of
REOLYSIN® in combination with chemotherapy in patients with previously treated
advanced or metastatic non-small cell lung cancer; IND 210 is a study
of REOLYSIN® in patients with advanced or metastatic colorectal cancer; and IND 209
is a study of REOLYSIN® in combination with chemotherapy in patients with recurrent or
metastatic castration resistant prostate cancer; -
An update on the planned registration program for REOLYSIN® including an initial focus on two indications: the neoadjuvant
treatment of muscle-invasive bladder cancer and the treatment of
glioblastoma; -
Activation of an Investigational New Drug Application containing the
protocol titled “MC1472: Phase 1 Study of Replication Competent
Reovirus (REOLYSIN®) in Combination with GM-CSF in Pediatric Patients with Relapsed or
Refractory Brain Tumors”; -
Presentation of data showing up-regulation of PD-1 and PD-L1 from a
single arm clinical study examining the use of REOLYSIN® in patients with primary glioblastomas or brain metastases (REO 013b)
at the Royal Society of Medicine’s Immuno-oncology: Using the Body’s
Own Weapons Conference, held in London, UK;
Regulatory
-
Granting of Orphan Drug Designation from the U.S. Food and Drug
Administration (FDA) for REOLYSIN® in the treatment of pancreatic, gastric, ovarian, primary peritoneal,
and fallopian tube cancers, as well as malignant gliomas; -
Granting of Orphan Drug Designation by the European Medicines Agency for
REOLYSIN® in the treatment of ovarian and pancreatic cancers;
Basic Research
-
Presentation of preclinical data at the 9th International Conference on Oncolytic Virus Therapeutics in Boston, MA,
including findings around REOLYSIN®‘s mechanism of action and its potential in new indications including
chronic lymphocytic leukemia; -
Presentation of clinical and preclinical data at the 2015 Immune
Checkpoint Inhibitors Meeting in Boston, MA, including content showing
the combination of REOLYSIN®, GM-CSF, anti-PD-1 and anti-CTLA-4 improved survival in immune
competent mice versus REOLYSIN® and GM-CSF alone, and REOLYSIN® and GM-CSF plus either one of the checkpoint inhibitors alone; -
A series of presentations made by the Company’s research collaborators
at the American Association for Cancer Research Annual Meeting held in
Philadelphia, PA covering preclinical research in a range of
indications, with a variety of treatment combinations including
REOLYSIN®;
Financial
-
At December 31, 2015 the Company reported $26.1 million in cash, cash
equivalents and short-term investments. At March 10, 2016, the Company
had approximately $23.6 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; and -
Subsequent to year-end, 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.
|
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF FINANCIAL POSITION |
|||||
| As at December 31, |
2015 $ |
2014 $ |
|||
| Assets | |||||
| Current assets | |||||
| Cash and cash equivalents | 24,016,275 | 14,152,825 | |||
| Short-term investments | 2,060,977 | 2,031,685 | |||
| Accounts receivable | 340,059 | 191,751 | |||
| Prepaid expenses | 506,669 | 291,553 | |||
| Total current assets | 26,923,980 | 16,667,814 | |||
| Non-current assets | |||||
| Property and equipment | 459,818 | 525,376 | |||
| Total non-current assets | 459,818 | 525,376 | |||
| Total assets | 27,383,798 | 17,193,190 | |||
|
Liabilities And Shareholders’ Equity |
|||||
| Current Liabilities | |||||
| Accounts payable and accrued liabilities | 2,709,492 | 3,373,997 | |||
| Total current liabilities | 2,709,492 | 3,373,997 | |||
|
Shareholders’ equity |
|||||
| Share capital | |||||
|
Authorized: unlimited Issued: December 31, 2015 – 118,151,622 December 31, 2014 – 93,512,494 |
261,324,692 | 237,657,056 | |||
| Contributed surplus | 26,277,966 | 25,848,429 | |||
| Accumulated other comprehensive income | 760,978 | 280,043 | |||
| Accumulated deficit | (263,689,330) | (249,966,335) | |||
| Total shareholders’ equity | 24,674,306 | 13,819,193 | |||
| Total liabilities and equity | 27,383,798 | 17,193,190 | |||
|
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS |
|||||||
| For the years ending December 31, |
2015 $ |
2014 $ |
2013 $ |
||||
| Expenses | |||||||
| Research and development | 8,601,864 | 13,824,252 | 18,506,064 | ||||
| Operating | 5,315,837 | 4,998,694 | 5,392,660 | ||||
| Loss before the following | (13,917,701) | (18,822,946) | (23,898,724) | ||||
| Interest | 197,859 | 210,390 | 371,485 | ||||
| Loss before income taxes | (13,719,842) | (18,612,556) | (23,527,239) | ||||
| Income tax (expense) recovery | (3,153) | (6,779) | (5,408) | ||||
| Net loss | (13,722,995) | (18,619,335) | (23,532,647) | ||||
|
Other comprehensive income items that may be reclassified to net loss |
|||||||
| Translation adjustment | 480,935 | 200,345 | 136,813 | ||||
| Net comprehensive loss | (13,242,060) | (18,418,990) | (23,395,834) | ||||
| Basic and diluted loss per common share | (0.12) | (0.21) | (0.28) | ||||
| Weighted average number of shares (basic and diluted) | 112,613,845 | 87,869,149 | 83,530,981 | ||||
|
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, 2012 | 198,155,091 | 376,892 | 24,126,265 | (57,115) | (207,814,353) | 14,786,780 | ||||||
| Net loss and other comprehensive income | — | — | — | 136,813 | (23,532,647) | (23,395,834) | ||||||
| Issued, pursuant to a bought deal financing | 30,218,796 | — | — | — | — | 30,218,796 | ||||||
| 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 | ||||||
| Net loss and other comprehensive income | — | — | — | 200,345 | (18,619,335) | (18,418,990) | ||||||
| Issued, pursuant to Share Purchase Agreement | 7,830,409 | — | — | — | — | 7,830,409 | ||||||
| Issued, pursuant to “At the Market” Agreement | 1,214,083 | — | — | — | — | 1,214,083 | ||||||
| Expired warrants | — | (376,892) | 376,892 | — | — | — | ||||||
| Share based compensation | — | — | 980,325 | — | — | 980,325 | ||||||
| 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 | 4,305,396 | — | — | — | — | 4,305,396 | ||||||
| Issued, pursuant to “At the Market” Agreement | 19,362,240 | — | — | — | — | 19,362,240 | ||||||
| Share based compensation | — | — | 429,537 | — | — | 429,537 | ||||||
| As at December 31, 2015 | 261,324,692 | — | 26,277,966 | 760,978 | (263,689,330) | 24,674,306 | ||||||
|
ONCOLYTICS BIOTECH INC. CONSOLIDATED STATEMENTS OF CASH FLOWS |
||||||
| For the years ending December 31, |
2015 $ |
2014 $ |
2013 $ |
|||
| Operating Activities | ||||||
| Net loss for the year | (13,722,995) | (18,619,335) | (23,532,647) | |||
| Amortization – property and equipment | 180,411 | 163,501 | 131,623 | |||
| Share based compensation | 429,537 | 980,325 | 424,384 | |||
| Unrealized foreign exchange (gain) loss | (816,319) | 242,542 | (89,721) | |||
| Net change in non-cash working capital | (1,105,464) | (2,443,988) | (1,374,172) | |||
| Cash used in operating activities | (15,034,830) | (19,676,955) | (24,440,533) | |||
| Investing Activities | ||||||
| Acquisition of property and equipment | (108,268) | (152,750) | (254,834) | |||
| Redemption (purchase) of short-term investments | (29,292) | (30,041) | (32,416) | |||
| Cash used in investing activities | (137,560) | (182,791) | (287,250) | |||
| Financing Activities | ||||||
| Proceeds from exercise of stock options and warrants | — | — | 179,240 | |||
| Proceeds from Share Purchase Agreement | 4,305,396 | 7,830,409 | — | |||
| Proceeds from “At the Market” equity distribution agreement | 19,362,240 | 1,214,083 | — | |||
| Proceeds from public offering | — | — | 30,218,796 | |||
| Cash provided by financing activities | 23,667,636 | 9,044,492 | 30,398,036 | |||
| (Decrease) increase in cash | 8,495,246 | (10,815,254) | 5,670,253 | |||
| Cash and cash equivalents, beginning of year | 14,152,825 | 25,220,328 | 19,323,541 | |||
| Impact of foreign exchange on cash and cash equivalents | 1,368,204 | (252,249) | 226,534 | |||
| Cash and cash equivalents, end of year | 24,016,275 | 14,152,825 | 25,220,328 | |||
To view the Company’s Fiscal 2015 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 http://www.oncolyticsbiotech.com/investor-centre/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 later-stage,
randomized human trials in various indications 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 2016 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.
Released March 11, 2016