Full Press Release Details
Biotech Inc. Announces 2015 Third Quarter Results
Nov. 5, 2015 /CNW/ - Oncolytics Biotech Inc. (TSX:ONC, OTCQX:ONCY) ("Oncolytics" or the "Company")
today announced its financial results and operational highlights for the third quarter ended September 30, 2015.
the quarter, we announced exciting initial clinical data from our multiple myeloma study showing statistically significant increases
in the production of caspase-3 and upregulation of PD-L1 along with an early objective response rate of 100%," said Dr. Brad
Thompson, President and CEO of Oncolytics. "We also announced one and two-year survival data versus historical controls from
our pancreatic (REO 017) cancer trial. This data is very often suggestive of broader immune system involvement which led us to
file a US Phase 1b study in pancreatic adenocarcinoma; the first to examine REOLYSIN in combination with the checkpoint
inhibitor KEYTRUDA ."
July 1, 2015, selected highlights announced by the Company include:
A poster presentation at the 15th International
Myeloma Workshop titled "Combination Carfilzomib and the Viral Oncolytic Agent REOLYSIN in Patients with
Relapsed Multiple Myeloma: A Pilot Study Investigating Viral Proliferation," highlighting data including 100% of patients
(8 of 8) experiencing an objective response as measured by changes in blood monoclonal protein and 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, 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 two 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 and IND 209 is a study
of REOLYSIN in combination with chemotherapy in patients with recurrent or metastatic castration resistant prostate
Subsequent to quarter end, confirmation that, following
submission to the U.S. Food and Drug Administration ("FDA") for review, the Investigational New Drug Application containing
the protocol titled "A Phase Ib study of pembrolizumab (KEYTRUDA ) in combination with REOLYSIN
(pelareorep) and chemotherapy in patients with advanced pancreatic adenocarcinoma", the Company's first trial examining
REOLYSIN in combination with a checkpoint inhibitor, was active; and
At September 30, 2015 the Company reported $30.0
million in cash, cash equivalents and short-term investments. At November 5, 2015, the Company had approximately $28.7 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. INTERIM CONSOLIDATED STATEMENTS OF FINANCIAL POSITION (unaudited) | ||||
| September 30, | December 31, | |||
| 2015 | 2014 | |||
| $ | $ | |||
| Assets | ||||
| Current assets | ||||
| Cash and cash equivalents | 27,962,462 | 14,152,825 | ||
| Short-term investments | 2,060,977 | 2,031,685 | ||
| Accounts receivable | 53,040 | 191,751 | ||
| Prepaid expenses | 480,611 | 291,553 | ||
| Total current assets | 30,557,090 | 16,667,814 | ||
| Non-current assets | ||||
| Property and equipment | 443,468 | 525,376 | ||
| Total non-current assets | 443,468 | 525,376 | ||
| Total assets | 31,000,558 | 17,193,190 | ||
| Liabilities And Shareholders' Equity | ||||
| Current Liabilities | ||||
| Accounts payable and accrued liabilities | 3,276,279 | 3,373,997 | ||
| Total current liabilities | 3,276,279 | 3,373,997 | ||
| Shareholders' equity | ||||
| Share capital | ||||
| Authorized: unlimited | ||||
| Issued: | ||||
| September 30, 2015 - 117,981,672 | ||||
| December 31, 2014 - 93,512,494 | 261,229,719 | 237,657,056 | ||
| Contributed surplus | 26,029,865 | 25,848,429 | ||
| Accumulated other comprehensive income | 657,103 | 280,043 | ||
| Accumulated deficit | (260,192,408) | (249,966,335) | ||
| Total shareholders' equity | 27,724,279 | 13,819,193 | ||
| Total liabilities and equity | 31,000,558 | 17,193,190 |
| ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS (unaudited) | ||||||
| Three Month Period Ending September 30, 2015 | Three Month Period Ending September 30, 2014 | Nine Month Period Ending September 30, 2015 | Nine Month Period Ending September 30, 2014 | |||
| $ | $ | $ | $ | |||
| Expenses | ||||||
| Research and development | 1,704,784 | 3,571,939 | 6,601,877 | 11,305,328 | ||
| Operating | 1,176,023 | 1,105,274 | 3,780,812 | 3,706,343 | ||
| Operating loss | (2,880,807) | (4,677,213) | (10,382,689) | (15,011,671) | ||
| Interest | 52,756 | 39,937 | 153,313 | 178,177 | ||
| Loss before income taxes | (2,828,051) | (4,637,276) | (10,229,376) | (14,833,494) | ||
| Income tax expense | 4,074 | 668 | 3,303 | (6,728) | ||
| Net loss | (2,823,977) | (4,636,608) | (10,226,073) | (14,840,222) | ||
| Other comprehensive income items that may be | ||||||
| reclassified to net loss | ||||||
| Translation adjustment | 192,586 | 100,461 | 377,060 | 108,442 | ||
| Net comprehensive loss | (2,631,391) | (4,536,147) | (9,849,013) | (14,731,780) | ||
| Basic and diluted loss per common share | (0.02) | (0.05) | (0.09) | (0.17) | ||
| Weighted average number of shares (basic and | 117,963,979 | 88,592,863 | 110,757,811 | 86,786,937 | ||
| diluted) |
| ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY (unaudited) | ||||||||
| Share Capital | Contributed Surplus | Warrants | Accumulated Other Comprehensive Income (Loss) | Accumulated Deficit | Total | |||
| $ | $ | $ | $ | $ | $ | |||
| As at December 31, 2013 | 228,612,564 | 24,491,212 | 376,892 | 79,698 | (231,347,000) | 22,213,366 | ||
| Net loss and other comprehensive income | - | - | - | 108,442 | (14,840,222) | (14,731,780) | ||
| Issued, pursuant to Share Purchase Agreement | 6,427,899 | - | - | - | - | 6,427,899 | ||
| Expired warrants | - | 376,892 | (376,892) | - | - | - | ||
| Share based compensation | - | 870,423 | - | - | - | 870,423 | ||
| As at September 30, 2014 | 235,040,463 | 25,738,527 | - | 188,140 | (246,187,222) | 14,779,908 | ||
| Share Capital | Contributed Surplus | Warrants | 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 other comprehensive income | - | - | - | 377,060 | (10,226,073) | (9,849,013) | ||
| Issued, pursuant to Share Purchase Agreement | 4,305,396 | - | - | - | - | 4,305,396 | ||
| Issued, pursuant to "At the Market" | ||||||||
| Agreement | 19,267,267 | - | - | - | - | 19,267,267 | ||
| Share based compensation | - | 181,436 | - | - | - | 181,436 | ||
| As at September 30, 2015 | 261,229,719 | 26,029,865 | - | 657,103 | (260,192,408) | 27,724,279 |
| ONCOLYTICS BIOTECH INC. INTERIM CONSOLIDATED STATEMENTS OF CASH FLOWS ( unaudited) | ||||||
| Three Month Period Ending September 30, 2015 | Three Month Period Ending September 30, 2014 | Nine Month Period Ending September 30, 2015 | Nine Month Period Ending September 30, 2014 | |||
| $ | $ | $ | $ | |||
| Operating Activities | ||||||
| Net loss for the period | (2,823,977) | (4,636,608) | (10,226,073) | (14,840,222) | ||
| Amortization - property and equipment | 44,761 | 39,904 | 134,743 | 118,073 | ||
| Share based compensation | 10,791 | 199,821 | 181,436 | 870,423 | ||
| Unrealized foreign exchange loss (gain) | (182,131) | 243,290 | (485,653) | 193,301 | ||
| Net change in non-cash working capital | 92,792 | (261,622) | (327,690) | (2,701,103) | ||
| Cash used in operating activities | (2,857,764) | (4,415,215) | (10,723,237) | (16,359,528) | ||
| Investing Activities | ||||||
| Acquisition of property and equipment | (17,695) | (113,782) | (47,292) | (131,001) | ||
| Purchase of short-term investments | - | - | (29,292) | (30,041) | ||
| Cash used in investing activities | (17,695) | (113,782) | (76,584) | (161,042) | ||
| Financing Activities | ||||||
| Proceeds from Share Purchase Agreement | - | 2,736,749 | 4,305,396 | 6,427,899 | ||
| Proceeds from "At the Market" equity distribution | ||||||
| agreement | 213,742 | - | 19,267,267 | - | ||
| Cash provided by financing activities | 213,742 | 2,736,749 | 23,572,663 | 6,427,899 | ||
| Increase in cash | (2,661,717) | (1,792,248) | 12,772,842 | (10,092,671) | ||
| Cash and cash equivalents, beginning of period | 30,018,217 | 16,880,730 | 14,152,825 | 25,220,328 | ||
| Impact of foreign exchange on cash and cash | ||||||
| equivalents | 605,962 | (75,514) | 1,036,795 | (114,689) | ||
| Cash and cash equivalents, end of period | 27,962,462 | 15,012,968 | 27,962,462 | 15,012,968 |
view the Company's Fiscal 2015 Third Quarter 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 on www.sedar.com and
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.
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 2015 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.
Oncolytics Biotech Inc.
information: NATIONAL Equicom, Nick Hurst, 800 6th Ave. SW, Suite 1600, Calgary, Alberta T2P 3G3, Tel: 403.218.2835, Fax:
403.218.2830, nhurst@national.ca; NATIONAL Equicom, Michael Moore, San Diego, CA, Tel: 858.886.7813, mmoore@national.ca; Dian
Griesel, Inc., Susan Forman, 335 West 38th Street, 3rd Floor, New York, NY 10018, Tel: 212.825.3210, Fax: 212.825.3229, sforman@dgicomm.com
Oncolytics Biotech Inc.