|By PR Newswire||
|March 13, 2014 06:30 AM EDT||
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."
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.
- 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|
|Cash and cash equivalents||25,220,328||19,323,541|
|Total current assets||27,689,568||21,668,842|
|Property and equipment||532,459||409,248|
|Total non-current assets||532,459||409,248|
|Liabilities And Shareholders' Equity|
|Accounts payable and accrued liabilities||6,008,661||7,291,310|
|Total current liabilities||6,008,661||7,291,310|
|Issued: December 31, 2013 - 84,803,818|
|December 31, 2012 - 76,710,285||228,612,564||198,155,091|
|Accumulated other comprehensive loss||79,698||(57,115)|
|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,||
|Research and development||18,506,064||31,402,625||23,386,685|
|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|
|Loss before income taxes||(23,527,239)||(36,343,047)||(29,004,701)|
|Income tax expense||(5,408)||(30,474)||(40,000)|
Other comprehensive income items that may
be reclassified to net loss
|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|
|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,||
|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)|
|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|
|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.
By now most people have either created their configuration management solution or are just embarking on this journey. In his session at @DevOpsSummit at 19th Cloud Expo, Marco Ceppi, a DevOps Engineer working at Canonical, will discuss how to take configuration management to the next level with modelling and orchestration. He will also discuss how and why people are moving from a machine-centric view to a service/application-oriented view of deployments, and how you can leverage the knowledge a...
Oct. 27, 2016 09:00 AM EDT Reads: 2,009
@ThingsExpo has been named the Top 5 Most Influential M2M Brand by Onalytica in the ‘Machine to Machine: Top 100 Influencers and Brands.' Onalytica analyzed the online debate on M2M by looking at over 85,000 tweets to provide the most influential individuals and brands that drive the discussion. According to Onalytica the "analysis showed a very engaged community with a lot of interactive tweets. The M2M discussion seems to be more fragmented and driven by some of the major brands present in the...
Oct. 27, 2016 08:45 AM EDT Reads: 11,583
In the 21st century, security on the Internet has become one of the most important issues. We hear more and more about cyber-attacks on the websites of large corporations, banks and even small businesses. When online we’re concerned not only for our own safety but also our privacy. We have to know that hackers usually start their preparation by investigating the private information of admins – the habits, interests, visited websites and so on. On the other hand, our own security is in danger bec...
Oct. 27, 2016 08:15 AM EDT Reads: 471
Enterprises have been using both Big Data and virtualization for years. Until recently, however, most enterprises have not combined the two. Big Data's demands for higher levels of performance, the ability to control quality-of-service (QoS), and the ability to adhere to SLAs have kept it on bare metal, apart from the modern data center cloud. With recent technology innovations, we've seen the advantages of bare metal erode to such a degree that the enhanced flexibility and reduced costs that cl...
Oct. 27, 2016 07:45 AM EDT Reads: 492
Fact: storage performance problems have only gotten more complicated, as applications not only have become largely virtualized, but also have moved to cloud-based infrastructures. Storage performance in virtualized environments isn’t just about IOPS anymore. Instead, you need to guarantee performance for individual VMs, helping applications maintain performance as the number of VMs continues to go up in real time. In his session at Cloud Expo, Dhiraj Sehgal, Product and Marketing at Tintri, wil...
Oct. 27, 2016 07:30 AM EDT Reads: 1,931
As software becomes more and more complex, we, as software developers, have been splitting up our code into smaller and smaller components. This is also true for the environment in which we run our code: going from bare metal, to VMs to the modern-day Cloud Native world of containers, schedulers and microservices. While we have figured out how to run containerized applications in the cloud using schedulers, we've yet to come up with a good solution to bridge the gap between getting your conta...
Oct. 27, 2016 07:30 AM EDT Reads: 1,609
19th Cloud Expo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, will feature technical sessions from a rock star conference faculty and the leading industry players in the world. Cloud computing is now being embraced by a majority of enterprises of all sizes. Yesterday's debate about public vs. private has transformed into the reality of hybrid cloud: a recent survey shows that 74% of enterprises have a hybrid cloud strategy. Meanwhile, 94% of enterpri...
Oct. 27, 2016 07:00 AM EDT Reads: 5,013
Amazon has gradually rolled out parts of its IoT offerings, but these are just the tip of the iceberg. In addition to optimizing their backend AWS offerings, Amazon is laying the ground work to be a major force in IoT - especially in the connected home and office. In his session at @ThingsExpo, Chris Kocher, founder and managing director of Grey Heron, explained how Amazon is extending its reach to become a major force in IoT by building on its dominant cloud IoT platform, its Dash Button strat...
Oct. 27, 2016 07:00 AM EDT Reads: 4,933
You have great SaaS business app ideas. You want to turn your idea quickly into a functional and engaging proof of concept. You need to be able to modify it to meet customers' needs, and you need to deliver a complete and secure SaaS application. How could you achieve all the above and yet avoid unforeseen IT requirements that add unnecessary cost and complexity? You also want your app to be responsive in any device at any time. In his session at 19th Cloud Expo, Mark Allen, General Manager of...
Oct. 27, 2016 06:45 AM EDT Reads: 1,062
SYS-CON Events announced today that Streamlyzer will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Streamlyzer is a powerful analytics for video streaming service that enables video streaming providers to monitor and analyze QoE (Quality-of-Experience) from end-user devices in real time.
Oct. 27, 2016 06:45 AM EDT Reads: 1,090
Without lifecycle traceability and visibility across the tool chain, stakeholders from Planning-to-Ops have limited insight and answers to who, what, when, why and how across the DevOps lifecycle. This impacts the ability to deliver high quality software at the needed velocity to drive positive business outcomes. In his general session at @DevOpsSummit at 19th Cloud Expo, Eric Robertson, General Manager at CollabNet, will discuss how customers are able to achieve a level of transparency that e...
Oct. 27, 2016 06:00 AM EDT Reads: 1,035
Cloud based infrastructure deployment is becoming more and more appealing to customers, from Fortune 500 companies to SMEs due to its pay-as-you-go model. Enterprise storage vendors are able to reach out to these customers by integrating in cloud based deployments; this needs adaptability and interoperability of the products confirming to cloud standards such as OpenStack, CloudStack, or Azure. As compared to off the shelf commodity storage, enterprise storages by its reliability, high-availabil...
Oct. 27, 2016 05:45 AM EDT Reads: 1,265
The IoT industry is now at a crossroads, between the fast-paced innovation of technologies and the pending mass adoption by global enterprises. The complexity of combining rapidly evolving technologies and the need to establish practices for market acceleration pose a strong challenge to global enterprises as well as IoT vendors. In his session at @ThingsExpo, Clark Smith, senior product manager for Numerex, will discuss how Numerex, as an experienced, established IoT provider, has embraced a ...
Oct. 27, 2016 05:30 AM EDT Reads: 1,216
DevOps theory promotes a culture of continuous improvement built on collaboration, empowerment, systems thinking, and feedback loops. But how do you collaborate effectively across the traditional silos? How can you make decisions without system-wide visibility? How can you see the whole system when it is spread across teams and locations? How do you close feedback loops across teams and activities delivering complex multi-tier, cloud, container, serverless, and/or API-based services?
Oct. 27, 2016 05:15 AM EDT Reads: 1,140
Today every business relies on software to drive the innovation necessary for a competitive edge in the Application Economy. This is why collaboration between development and operations, or DevOps, has become IT’s number one priority. Whether you are in Dev or Ops, understanding how to implement a DevOps strategy can deliver faster development cycles, improved software quality, reduced deployment times and overall better experiences for your customers.
Oct. 27, 2016 05:15 AM EDT Reads: 991