CALGARY, May 6, 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 first quarter ended March 31, 2016.
"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 |
|
|
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|
|
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 |
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|
|
|
|
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 |
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|
|
|
|
| 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 |
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ONCOLYTICS BIOTECH INC. |
INTERIM CONSOLIDATED STATEMENTS OF CHANGES IN EQUITY |
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| 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 |
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|
|
|
|
|
|
|
|
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 |
|
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|
|
|
|
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|
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| 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 |
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| 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) |
|
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|
|
|
Investing Activities |
|
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|
|
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) |
|
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|
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Financing Activities |
|
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|
|
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 |
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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 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.