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CALGARY, Nov. 3, 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 third quarter ended September 30, 2016.
“During the quarter we reported additional statistically significant, randomized clinical data that further strengthened the linkage between genetic status and survival outcomes in patients with adenocarcinoma of the lung,” said Dr. Matt Coffey, Interim President and CEO of Oncolytics Biotech. “In parallel with reporting data from sponsored Phase 2 randomized studies, we continued to push ahead with preparations for a registration study.”
Selected Highlights
Since July 1, 2016, selected highlights announced by the Company include:
Clinical Program
- Additional data from a randomized, sponsored Phase II clinical study of REOLYSIN® in non-small cell lung cancer (IND 211), which showed that:
- progression free survival (“PFS”) was statistically significantly better for female patients in the test arm (n=20) than for those in the control arm (n=16) in patients with adenocarcinoma. Median PFS was 5.39 months compared with 3.02 months, respectively (p=0.0201);
- evolving overall survival (“OS”) demonstrated a strong trend towards survival benefit for female patients in the test arm with adenocarcinoma (n=20, six of whom remained alive at the time of the analysis) over those in the control arm (n=16, three of whom remained alive at the time of the analysis). Median OS was 10.68 months compared with 7.59 months, respectively (p=0.145) (Figure B). By contrast, no PFS or OS benefit was noted for the male patients with adenocarcinoma; and
- patients with adenocarcinoma treated with REOLYSIN® with one or more target biomarkers (EGFR, Hras, Kras, Nras, Braf and/or p53 mutations) had a greater PFS (p=0.039) and OS (p=0.031) than patients treated with REOLYSIN® without any of these biomarkers. The presence of these biomarkers may account, at least in part, for the difference between the survival outcomes for male and female patients; target biomarkers were present in a higher proportion of the female patients in the study than the male patients (66.7% versus 43.6%). As a result, pre-screening for target biomarkers in patients with adenocarcinoma of the lung is warranted.
Financial
At September 30, 2016, the Company reported $17.7 million in cash, cash equivalents and short-term investments. At November 2, 2016, the Company had approximately $16.7 million in cash, cash equivalents and short-term investments.
ONCOLYTICS BIOTECH INC. |
|||
September 30, |
December 31, |
||
Assets |
|||
Current assets |
|||
Cash and cash equivalents |
15,612,729 |
24,016,275 |
|
Short-term investments |
2,088,800 |
2,060,977 |
|
Accounts receivable |
44,991 |
340,059 |
|
Prepaid expenses |
356,741 |
506,669 |
|
Total current assets |
18,103,261 |
26,923,980 |
|
Non-current assets |
|||
Property and equipment |
333,926 |
459,818 |
|
Total non-current assets |
333,926 |
459,818 |
|
Total assets |
18,437,187 |
27,383,798 |
|
Liabilities And Shareholders’ Equity |
|||
Current Liabilities |
|||
Accounts payable and accrued liabilities |
2,809,008 |
2,709,492 |
|
Total current liabilities |
2,809,008 |
2,709,492 |
|
Shareholders’ equity |
|||
Share capital |
|||
Authorized: unlimited |
|||
Issued: |
|||
September 30, 2016 – 120,873,222 |
|||
December 31, 2015 – 118,151,622 |
262,218,228 |
261,324,692 |
|
Contributed surplus |
26,536,601 |
26,277,966 |
|
Accumulated other comprehensive income |
492,637 |
760,978 |
|
Accumulated deficit |
(273,619,287) |
(263,689,330) |
|
Total shareholders’ equity |
15,628,179 |
24,674,306 |
|
Total liabilities and equity |
18,437,187 |
27,383,798 |
ONCOLYTICS BIOTECH INC. |
|||||||||
Three |
Three |
Nine Month |
Nine Month |
||||||
Expenses |
|||||||||
Research and development |
2,141,737 |
1,704,784 |
6,358,822 |
6,601,877 |
|||||
Operating |
1,222,447 |
1,176,023 |
3,708,317 |
3,780,812 |
|||||
Operating loss |
(3,364,184) |
(2,880,807) |
(10,067,139) |
(10,382,689) |
|||||
Interest |
31,691 |
52,756 |
136,849 |
153,313 |
|||||
Loss before income taxes |
(3,332,493) |
(2,828,051) |
(9,930,290) |
(10,229,376) |
|||||
Income tax expense |
19 |
4,074 |
333 |
3,303 |
|||||
Net loss |
(3,332,474) |
(2,823,977) |
(9,929,957) |
(10,226,073) |
|||||
Other comprehensive income items that may be reclassified to net loss |
|||||||||
Translation adjustment |
32,545 |
192,586 |
(268,341) |
377,060 |
|||||
Net comprehensive loss |
(3,299,929) |
(2,631,391) |
(10,198,298) |
(9,849,013) |
|||||
Basic and diluted loss per common share |
(0.03) |
(0.02) |
(0.08) |
(0.09) |
|||||
Weighted average number of shares (basic and |
120,552,638 |
117,963,979 |
119,455,440 |
110,757,811 |
ONCOLYTICS BIOTECH INC. |
||||||||||
Share Capital $ |
Contributed $ |
Accumulated $ |
Accumulated $ |
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 |
|||||
Share Capital |
Contributed |
Accumulated $ |
Accumulated |
Total |
||||||
As at December 31, 2015 |
261,324,692 |
26,277,966 |
760,978 |
(263,689,330) |
24,674,306 |
|||||
Net loss and other comprehensive loss |
— |
— |
(268,341) |
(9,929,957) |
(10,198,298) |
|||||
Issued, pursuant to “At the Market” Agreement |
852,536 |
— |
— |
— |
852,536 |
|||||
Issued, pursuant to incentive share award plan |
41,000 |
(41,000) |
— |
— |
— |
|||||
Share based compensation |
— |
299,635 |
— |
— |
299,635 |
|||||
As at September 30, 2016 |
262,218,228 |
26,536,601 |
492,637 |
(273,619,287) |
15,628,179 |
ONCOLYTICS BIOTECH INC. |
|||||||||
Three |
Three |
Nine Month |
Nine Month |
||||||
Operating Activities |
|||||||||
Net loss for the period |
(3,332,474) |
(2,823,977) |
(9,929,957) |
(10,226,073) |
|||||
Amortization – property and equipment |
44,014 |
44,761 |
134,631 |
134,743 |
|||||
Share based compensation |
98,369 |
10,791 |
299,635 |
181,436 |
|||||
Unrealized foreign exchange gain |
(49,400) |
(182,131) |
(152,019) |
(485,653) |
|||||
Net change in non-cash working capital |
216,611 |
92,792 |
978,847 |
(327,690) |
|||||
Cash used in operating activities |
(3,022,880) |
(2,857,764) |
(8,668,863) |
(10,723,237) |
|||||
Investing Activities |
|||||||||
Acquisition of property and equipment |
(4,851) |
(17,695) |
(10,553) |
(47,292) |
|||||
Purchase of short-term investments |
— |
— |
(27,823) |
(29,292) |
|||||
Cash used in investing activities |
(4,851) |
(17,695) |
(38,376) |
(76,584) |
|||||
Financing Activities |
|||||||||
Proceeds from Share Purchase Agreement |
— |
— |
— |
4,305,396 |
|||||
Proceeds from “At the Market” equity distribution agreement |
242,706 |
213,742 |
852,536 |
19,267,267 |
|||||
Cash provided by financing activities |
242,706 |
213,742 |
852,536 |
23,572,663 |
|||||
(Decrease) increase in cash |
(2,785,025) |
(2,661,717) |
(7,854,703) |
12,772,842 |
|||||
Cash and cash equivalents, beginning of period |
18,320,981 |
30,018,217 |
24,016,275 |
14,152,825 |
|||||
Impact of foreign exchange on cash and cash equivalents |
76,773 |
605,962 |
(548,843) |
1,036,795 |
|||||
Cash and cash equivalents, end of period |
15,612,729 |
27,962,462 |
15,612,729 |
27,962,462 |
To view the Company’s Fiscal 2016 Third 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.
Released November 3, 2016