Oncolytics Biotech® Inc. Announces 2015 Third Quarter Results

Nov 05, 2015, 06:30 ET from Oncolytics Biotech Inc.

CALGARY, Nov. 5, 2015 /PRNewswire/ - 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.

"During 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®."

Selected Highlights

Since July 1, 2015, selected highlights announced by the Company include:

Clinical Program

  • 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 cancer;
  • 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

Financial

  • 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

 

To 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 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 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 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.

SOURCE Oncolytics Biotech Inc.