Welcome!

News Feed Item

Oncolytics Biotech® Inc. Announces 2013 Year End Results

CALGARY, March 13, 2014 /PRNewswire/ - Oncolytics Biotech Inc. (TSX:ONC, NASDAQ:ONCY) ("Oncolytics" or the "Company") today announced its financial results and operational highlights for the year ended December 31, 2014.

"In 2013, we reported data from a number of clinical studies, which included our first data correlating specific biomarkers with survival in NSCLC lung cancer patients and culminated with the reporting of our first randomized data in head and neck cancer," said Dr. Brad Thompson, President and CEO of Oncolytics. "Our randomized clinical program continues to move ahead with six sponsored studies currently enrolling patients in a range of indications. Each of these studies will advance in parallel with our ongoing head and neck program which we are currently in the process of designing a follow-on registration study for discussion with regulators."

Selected Highlights

Since January 1, 2013, specific highlights announced by the Company include:

Clinical Trial Results

  • Top-line data for the endpoints in a double blinded, randomized clinical study examining REOLYSIN® in combination with carboplatin and paclitaxel in patients with second-line platinum-refractory, taxane-naïve head and neck cancers (REO 018). An analysis was performed on an intent-to-treat basis of 118 patients with loco-regional head and neck cancer, with or without metastases. Patients in the control arm were treated with carboplatin and paclitaxel, while patients in the test arm were treated with carboplatin, paclitaxel and REOLYSIN. The analysis showed a median progression free survival (PFS) of 94 days (13.4 weeks) in the test arm (n=62), versus 50 days (7.1 weeks) in the control arm (n=56). The test arm maintained a PFS benefit over the control arm through five cycles of therapy. An analysis of 88 loco-regional patients that did not receive additional therapy following discontinuation of study treatment showed a median overall survival (OS) of 150 days (21.4 weeks) in the test arm (n=50), versus 115 days (16.4 weeks) in the control arm (n=38). REOLYSIN was deemed safe and well-tolerated by patients. The side effects experienced by patients in the test arm of the study were consistent with expectations based on outcomes of earlier clinical studies using REOLYSIN. Patients on the test arm of the study experienced a higher incidence of flu-like symptoms consistent with treatment with a virus, most commonly mild fever, chills, nausea and diarrhea, on both a per-patient and a per-cycle basis. Fewer patients required dose reductions of paclitaxel due to neuropathy or neurotoxicity on the test arm than the control arm (zero in the test arm versus six in the control arm; p=0.028). On this basis, the Company intends to explore the potential chemoprotective and neuroprotective properties of REOLYSIN in future clinical studies;
  • Positive final results from a U.S. Phase 2 study examining the use of REOLYSIN in combination with carboplatin and paclitaxel in patients with stage IV non-small cell lung cancer (NSCLC) with Kras or EGFR-activated tumors (REO 016). Response evaluation for 36 evaluable patients showed 11 partial responses (PR) (30%) (EGFR amplified, five; BRAF two; Kras, three; EGFR mutated, one), 21 stable disease (SD), and four progressive disease (PD). The data also correlated a number of molecular abnormalities with best response, PFS and one-year survival. Current data in these patients demonstrates that 20 of 36 evaluable patients (56%) survived a year or more. There were 13 patients with only EGFR mutations or amplifications, of whom nine (69.2%) survived a year or longer. Four of four (100%) patients with BRAF and EGFR amplification survived a year or longer;
  • Final tumor response and PFS data from a U.S. Phase 2 clinical trial in patients with squamous cell carcinoma of the lung (SCCLC) using intravenous administration of REOLYSIN in combination with carboplatin and paclitaxel (REO 021). Of the 25 evaluable patients who had more than one cycle of therapy, 23 (92%) exhibited overall tumor shrinkage. When evaluated for best response, which is the best percentage response recorded on study compared to baseline, 10 patients (40%) had PR, while a further 14 (56%) showed SD, and one (4%), had PD. Using RECIST criteria to evaluate best overall response, 10 patients (40%) had PRs, 12 (48%) showed SD and three (12%), had PD.  31.8% of patients with sufficient follow up had a PFS greater than six months;
  • Reaching the stage 1 endpoint in a U.S. Phase 2 clinical trial in patients with metastatic melanoma (REO 020) after only 14 patients were enrolled.  The primary objective of this Phase 2 trial was to assess the antitumor effect of the treatment regimen in the study population in terms of objective response rates. The secondary objectives were to assess progression-free survival and overall survival for the treatment regimen; the disease control rate (complete response (CR) plus PR plus SD) and duration, and to assess the safety and tolerability of the treatment regimen in the study population.  Three of the 14 patients exhibited a PR, and an additional seven patients had SD for a disease control rate of 71.5%; and
  • Positive preliminary results from a Phase 1 study examining the intravenous administration of REOLYSIN in combination with FOLFIRI in patients with metastatic colorectal cancer (REO 022) in a poster presentation at the ASCO Gastrointestinal Cancers Symposium. Of the 18 patients evaluable for response there was one PR and nine had SD. The combined overall PFS of FOLFIRI-naïve and FOLFIRI-failed patients was 7.4 months. The authors concluded that the combination of REOLYSIN and FOLFIRI was safe and well tolerated and resulted in disease control in the majority of evaluable patients, including patients that had previously progressed on Irinotecan.

Financial

  • At December 31, 2013 the Company reported $27.2 million in cash, cash equivalents and short-term investments; and
  • Subsequent to year end, entry into a share purchase agreement with Lincoln Park Capital Fund, LLC that will provide an initial investment in Oncolytics of US$1.0 million and make available additional periodic investments of up to US$25.0 million over a 30-month term.


ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF FINANCIAL POSITION
 
as at     December 31,
2013
$
    December 31,
2012
$
Assets            
Current assets            
Cash and cash equivalents     25,220,328     19,323,541
Short-term investments     2,001,644     1,969,228
Accounts receivable     105,853     44,979
Prepaid expenses     361,743     331,094
Total current assets     27,689,568     21,668,842
             
Non-current assets            
Property and equipment     532,459     409,248
Total non-current assets     532,459     409,248
             
Total assets     28,222,027     22,078,090
             
Liabilities And Shareholders' Equity            
Current Liabilities            
Accounts payable and accrued liabilities     6,008,661     7,291,310
Total current liabilities     6,008,661     7,291,310
             
Shareholders' equity              
             
Share capital   
           
  Authorized: unlimited            
  Issued:  December 31, 2013 - 84,803,818            
  December 31, 2012 - 76,710,285     228,612,564     198,155,091
Warrants     376,892     376,892
Contributed surplus     24,491,212     24,126,265
Accumulated other comprehensive loss     79,698     (57,115)
Accumulated deficit     (231,347,000)     (207,814,353)
Total shareholders' equity     22,213,366     14,786,780
Total liabilities and equity     28,222,027     22,078,090


 
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF LOSS AND COMPREHENSIVE LOSS
 
For the years ending December 31,     2013
$
    2012
$
    2011
$
                   
Expenses                  
Research and development     18,506,064     31,402,625     23,386,685
Operating     5,392,660     5,285,425     5,334,582
Loss before the following     (23,898,724)     (36,688,050)     (28,721,267)
Write down of asset available for sale             (735,681)
Change in fair value of warrant liability             36,000
Interest     371,485     345,003     416,247
Loss before income taxes     (23,527,239)     (36,343,047)     (29,004,701)
Income tax expense     (5,408)     (30,474)     (40,000)
Net loss     (23,532,647)     (36,373,521)     (29,044,701)
Other comprehensive income items that may
be reclassified to net loss
                 
                       
  Translation adjustment     136,813     60,386     39,159
                   
Net comprehensive loss     (23,395,834)     (36,313,135)     (29,005,542)
Basic and diluted loss per common share     (0.28)     (0.48)     (0.41)
                   
Weighted average number of shares (basic and diluted)     83,530,981     76,102,062     70,911,526



 
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, 2010     155,439,610   4,108,652   19,399,489   (156,660)   (142,396,131)   36,394,960
                           
Net loss and comprehensive income           39,159   (29,044,701)   (29,005,542)
Exercise of warrants     21,487,080   (1,455,025)         20,032,055
Exercise of stock options     355,876     (62,473)       293,403
Share based compensation         1,805,503       1,805,503
As at December 31, 2011     177,282,566   2,653,627   21,142,519   (117,501)   (171,440,832)   29,520,379
                           
Net loss and comprehensive income           60,386   (36,373,521)   (36,313,135)
Issued, pursuant to a bought deal financing     19,386,903   376,892         19,763,795
Expiry of warrants       (2,653,627)   2,653,627      
Exercise of stock options     1,485,622     (400,632)       1,084,990
Share based compensation         730,751       730,751
As at December 31, 2012     198,155,091   376,892   24,126,265   (57,115)   (207,814,353)   14,786,780
                           
Net loss and comprehensive income           136,813   (23,532,647)   (23,395,834)
Issued, pursuant to a bought deal financing     30,218,796           30,218,796
Expiry of warrants              
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

  

 
ONCOLYTICS BIOTECH INC.
CONSOLIDATED STATEMENTS OF CASH FLOWS
 
For the years ending December 31,     2013
$
    2012
$
    2011
$
                   
Operating Activities                  
Net loss for the year     (23,532,647)     (36,373,521)     (29,044,701)
  Amortization - property and equipment     131,623     109,275     92,590
  Share based compensation     424,384     730,751     1,805,503
  Change in fair value of warrant liability             (36,000)
  Write down of asset available for sale             735,681
  Unrealized foreign exchange loss     (89,721)     89,890     115,234
Net change in non-cash working capital     (1,374,172)     1,187,967     3,790,510
Cash used in operating activities     (24,440,533)     (34,255,638)     (22,541,183)
                     
Investing Activities                        
Acquisition of property and equipment     (254,834)     (126,412)     (257,790)
Redemption (purchase) of short-term investments     (32,416)     (32,441)     1,672,459
Cash provided by (used in) investing activities     (287,250)     (158,853)     1,414,669
                   
Financing Activities                        
Proceeds from exercise of stock options and warrants     179,240     1,084,990     14,824,658
Proceeds from public offering     30,218,796     19,763,795    
Cash provided by financing activities     30,398,036     20,848,785     14,824,658
Increase (decrease) in cash     5,670,253     (13,565,706)     (6,301,856)
Cash and cash equivalents, beginning of year     19,323,541     32,918,751     39,296,682
Impact of foreign exchange on cash and cash equivalents     226,534     (29,504)     (76,075)
Cash and cash equivalents, end of year     25,220,328     19,323,541     32,918,751


To view the Company's Fiscal 2013 Consolidated Financial Statements, related Notes to 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 human trials including a Phase III trial in head and neck cancers 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 2014 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.

More Stories By PR Newswire

Copyright © 2007 PR Newswire. All rights reserved. Republication or redistribution of PRNewswire content is expressly prohibited without the prior written consent of PRNewswire. PRNewswire shall not be liable for any errors or delays in the content, or for any actions taken in reliance thereon.

Latest Stories
Keeping pace with advancements in software delivery processes and tooling is taxing even for the most proficient organizations. Point tools, platforms, open source and the increasing adoption of private and public cloud services requires strong engineering rigor - all in the face of developer demands to use the tools of choice. As Agile has settled in as a mainstream practice, now DevOps has emerged as the next wave to improve software delivery speed and output. To make DevOps work, organization...
"MathFreeOn.com is a line coding platform for engineers and scientists. When they want to solve an engineering problem and they have to use software - they have to pay a lot of money for licenses - but with MathFreeOn you don't have to pay a lot of money. Just go to our site and write the code and you can check the result right away," explained Simon Lee, CMO of MathFreeOn, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Cla...
Enterprise IT has been in the era of Hybrid Cloud for some time now. But it seems most conversations about Hybrid are focused on integrating AWS, Microsoft Azure, or Google ECM into existing on-premises systems. Where is all the Private Cloud? What do technology providers need to do to make their offerings more compelling? How should enterprise IT executives and buyers define their focus, needs, and roadmap, and communicate that clearly to the providers?
The many IoT deployments around the world are busy integrating smart devices and sensors into their enterprise IT infrastructures. Yet all of this technology – and there are an amazing number of choices – is of no use without the software to gather, communicate, and analyze the new data flows. Without software, there is no IT. In this power panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, Dave McCarthy, Director of Products at Bsquare Corporation; Alan Williamson, Principal...
Video experiences should be unique and exciting! But that doesn’t mean you need to patch all the pieces yourself. Users demand rich and engaging experiences and new ways to connect with you. But creating robust video applications at scale can be complicated, time-consuming and expensive. In his session at @ThingsExpo, Zohar Babin, Vice President of Platform, Ecosystem and Community at Kaltura, discussed how VPaaS enables you to move fast, creating scalable video experiences that reach your aud...
Get deep visibility into the performance of your databases and expert advice for performance optimization and tuning. You can't get application performance without database performance. Give everyone on the team a comprehensive view of how every aspect of the system affects performance across SQL database operations, host server and OS, virtualization resources and storage I/O. Quickly find bottlenecks and troubleshoot complex problems.
President Obama recently announced the launch of a new national awareness campaign to "encourage more Americans to move beyond passwords – adding an extra layer of security like a fingerprint or codes sent to your cellphone." The shift from single passwords to multi-factor authentication couldn’t be timelier or more strategic. This session will focus on why passwords alone are no longer effective, and why the time to act is now. In his session at 19th Cloud Expo, Chris Webber, security strateg...
Amazon has gradually rolled out parts of its IoT offerings in the last year, but these are just the tip of the iceberg. In addition to optimizing their back-end AWS offerings, Amazon is laying the ground work to be a major force in IoT – especially in the connected home and office. Amazon is extending its reach by building on its dominant Cloud IoT platform, its Dash Button strategy, recently announced Replenishment Services, the Echo/Alexa voice recognition control platform, the 6-7 strategic...
"We are an all-flash array storage provider but our focus has been on VM-aware storage specifically for virtualized applications," stated Dhiraj Sehgal of Tintri in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
"We are a leader in the market space called network visibility solutions - it enables monitoring tools and Big Data analysis to access the data and be able to see the performance," explained Shay Morag, VP of Sales and Marketing at Niagara Networks, in this SYS-CON.tv interview at 19th Cloud Expo, held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA.
Whether your IoT service is connecting cars, homes, appliances, wearable, cameras or other devices, one question hangs in the balance – how do you actually make money from this service? The ability to turn your IoT service into profit requires the ability to create a monetization strategy that is flexible, scalable and working for you in real-time. It must be a transparent, smoothly implemented strategy that all stakeholders – from customers to the board – will be able to understand and comprehe...
More and more brands have jumped on the IoT bandwagon. We have an excess of wearables – activity trackers, smartwatches, smart glasses and sneakers, and more that track seemingly endless datapoints. However, most consumers have no idea what “IoT” means. Creating more wearables that track data shouldn't be the aim of brands; delivering meaningful, tangible relevance to their users should be. We're in a period in which the IoT pendulum is still swinging. Initially, it swung toward "smart for smart...
Complete Internet of Things (IoT) embedded device security is not just about the device but involves the entire product’s identity, data and control integrity, and services traversing the cloud. A device can no longer be looked at as an island; it is a part of a system. In fact, given the cross-domain interactions enabled by IoT it could be a part of many systems. Also, depending on where the device is deployed, for example, in the office building versus a factory floor or oil field, security ha...
An IoT product’s log files speak volumes about what’s happening with your products in the field, pinpointing current and potential issues, and enabling you to predict failures and save millions of dollars in inventory. But until recently, no one knew how to listen. In his session at @ThingsExpo, Dan Gettens, Chief Research Officer at OnProcess, discussed recent research by Massachusetts Institute of Technology and OnProcess Technology, where MIT created a new, breakthrough analytics model for s...
In IT, we sometimes coin terms for things before we know exactly what they are and how they’ll be used. The resulting terms may capture a common set of aspirations and goals – as “cloud” did broadly for on-demand, self-service, and flexible computing. But such a term can also lump together diverse and even competing practices, technologies, and priorities to the point where important distinctions are glossed over and lost.