Welcome!

Web 2.0 Authors: Bernard Golden, Greg Ness, Roger Strukhoff, Lori MacVittie, Carmen Gonzalez

News Feed Item

OncoGenex Pharmaceuticals, Inc. Reports Financial Results for Second Quarter 2014

Conference call to be held on Thursday, August 7, 2014 at 4:30 p.m. Eastern Time

BOTHELL, Wash. and VANCOUVER, British Columbia, Aug. 7, 2014 /PRNewswire/ -- OncoGenex Pharmaceuticals, Inc. (NASDAQ: OGXI) today provided a summary of clinical developments and announced second quarter 2014 financial results.

Clinical Developments and Anticipated Milestones

  • Apatorsen
    • The OncoGenex apatorsen development program includes seven Phase 2 trials in four tumor types, including bladder, lung, pancreatic and prostate cancers. Apatorsen is a once-weekly intravenous (IV) experimental drug that is designed to inhibit production of Hsp27 to disable cancer cells' defenses and overcome treatment resistance.
      • The Company announced initiation of the Cedar™ clinical trial in July 2014, an investigator-sponsored, randomized, open-label Phase 2 trial evaluating apatorsen in previously untreated patients with advanced squamous cell lung cancer. Cedar is being conducted and funded primarily by the UK National Cancer Research Network and the UK Experimental Cancer Medicine Network and will include approximately 20 centers in the United Kingdom.
      • The Company provided an update on timing of the randomized, placebo-controlled Phase 2 Borealis-1™ trial of apatorsen in combination with first-line gemcitabine and cisplatin in patients with metastatic bladder cancer.  Final results are expected to be announced in the first quarter of 2015.
  • Custirsen
    • Enrollment continues in two Phase 3 trials, AFFINITY and ENSPIRIT, evaluating custirsen in combination with chemotherapy in second-line metastatic castrate-resistant prostate cancer (CRPC) and non-small cell lung cancer (NSCLC), respectively. Fast Track designation has been granted to custirsen in both of these clinical trials.
      • AFFINITY is designed to evaluate a survival benefit for custirsen in combination with cabazitaxel treatment as second-line chemotherapy in patients with CRPC. Completion of enrollment of approximately 630 men is expected in the second half of 2014.
      • The ENSPIRIT Phase 3 trial is evaluating a survival benefit for custirsen in combination with docetaxel treatment as second-line chemotherapy in patients with NSCLC. The first interim futility analysis is expected to be conducted before the end of this year.

Financial Update and Results

  • Revenue for the three and six months ended June 30, 2014 was $4.9 million and $16.7 million, respectively.  This compares with $6.3 million and $11.4 million, respectively, in the same periods in 2013. Revenue earned in the second quarter of 2014 consists of reimbursable clinical trial, manufacturing and preclinical costs incurred by OncoGenex under the collaboration agreement with Teva. 
  • Total operating expenses for the three and six months ended June 30, 2014 were $12.6 million and $32.2 million, respectively, compared with $15.7 million and $29.1 million, respectively, in the same periods in 2013. The decrease in the second quarter of 2014 as compared to the same period in 2013 was due primarily to purchases of combination drugs used in the AFFINITY trial during the second quarter of 2013. The increase for the six months ended June 30, 2014 was predominantly the result of higher clinical trial expenses associated with patient enrollment and treatment in the AFFINITY and apatorsen investigator-sponsored trials.     
  • Net loss for the three and six months ended June 30, 2014 was $7.0 million, or $0.47 per diluted common share, and $15.7 million, or $1.05 per diluted common share, respectively. Comparatively, net loss for the three and six months ended June 30, 2013 was $8.4 million, or $0.57 per diluted common share, and $15.1 million, or $1.03 per diluted common share, respectively.
  • The company had $40.6 million in cash, cash equivalents and short-term investments as of June 30, 2014, compared to $39.2 million as of December 31, 2013.
  • In July 2014, we completed an underwritten registered direct offering and received net proceeds of approximately $22.4 million, after deducting the underwriting discount and offering expenses. Of the $22.4 million in net proceeds, $3.2 million was received in advance of the completion of the transaction on June 30, 2014.
  • Based on current expectations, the company believes its capital resources as of June 30, 2014 in combination with the $22.4 million of net proceeds from its July 2014 offering, will be sufficient to fund its currently-planned operations into the third quarter of 2016, and through:
    • the expected release of final survival results from the Borealis-1 trial in the first quarter of 2015;
    • the expected completion of enrollment in 2014 and expected release of final results in late 2015 or early 2016 in the AFFINITY trial; and
    • the expected completion of enrollment for the apatorsen Spruce and Rainier clinical trials in 2015.
  • At August 7, 2014, OncoGenex had 21,137,038 shares outstanding.

Consolidated Statements of Loss

(In thousands, except per share and share data)

(unaudited)
























Three months ended June 30,


Six months ended June 30,




2014


2013


2014


2013





















Collaboration revenue



$                  4,929


$                  6,340


$               16,660


$               11,416











Operating expenses:










  Research and development



9,883


13,263


26,786


24,118

  General and administrative



2,676


2,473


5,433


4,973

    Total operating expenses



12,559


15,736


32,219


29,091

Loss from operations



(7,630)


(9,396)


(15,559)


(17,675)

  Other income (expense)



615


976


(92)


2,558

Net loss



$               (7,015)


$               (8,420)


$             (15,651)


$             (15,117)











Basic and diluted net loss per share



$                  (0.47)


$                  (0.57)


$                  (1.05)


$                  (1.03)











Weighted average number of basic and diluted common shares



14,987,706


14,673,771


14,855,338


14,667,244





















Consolidated Balance Sheets

(In thousands)


















 June 30, 


 December 31, 








2014


2013








 (unaudited) 



Assets:










  Cash, cash equivalents, short term investments and restricted cash







$               40,865


$               39,536

  Interest receivable







-


218

  Amounts receivable







4,951


8,657

  Prepaid expenses and other current assets







2,288


5,770

  Property, equipment and other assets







1,628


1,508

Total assets







$               49,732


$               55,689











Liabilities and stockholders' equity:










  Accounts payable and accrued liabilities







$               15,571


$               13,628

  Current portion of long-term obligations







1,106


1,092

  Warrant liability







320


214

  Advanced proceeds







3,174



  Long-term liabilities







3,096


3,544

  Stockholders' equity







26,465


37,211

Total liabilities and stockholders' equity







$               49,732


$               55,689

 

Conference Call Details
OncoGenex will host a conference call at 4:30 p.m. Eastern Time today, Thursday, August 7, 2014, to provide a business update and discuss the second quarter 2014 results. A live event will be available on the Investor Relations section of the OncoGenex Web site at www.OncoGenex.com. Alternatively, you may access the live conference call by dialing (877) 606-1416 (U.S. & Canada) or 707-287-9313 (International). A replay of the webcast will be available approximately two hours after the call and will be archived for 90 days.

About OncoGenex
OncoGenex is a biopharmaceutical company committed to the development and commercialization of new therapies that address treatment resistance in cancer patients. OncoGenex has a diverse oncology pipeline, with each product candidate having a distinct mechanism of action and representing a unique opportunity for cancer drug development. OncoGenex and Teva Pharmaceutical Industries Ltd. (NYSE: TEVA) have entered a global collaboration and licensing agreement to develop and commercialize OncoGenex' lead drug candidate, custirsen. Custirsen is currently in Phase 3 clinical development as a treatment in men with metastatic castrate-resistant prostate cancer and in patients with advanced, unresectable non-small cell lung cancer. Apatorsen is in Phase 2 clinical development and OGX-225 is currently in pre-clinical development. More information is available at www.OncoGenex.com and at the company's Twitter account: https://twitter.com/OncoGenex_IR.

OncoGenex' Forward Looking Statements
This press release contains forward-looking statements within the meaning of the "safe harbor" provisions of the Private Securities Litigation Reform Act of 1995, including, but not limited to, statements concerning our anticipated product development activities, such as expected clinical trial completion and design, statements regarding the potential benefits and potential development of our product candidates and statements regarding our expected financial results and expected cash requirements. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management's current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements. Such forward-looking statements are subject to risks and uncertainties, including, among others, the risk that our product candidates will not demonstrate the hypothesized or expected benefits, the risk of delays in our expected clinical trials, the risk that new developments in the rapidly evolving cancer therapy landscape require changes in our clinical trial plans or limit the potential benefits of our product, the risk that our cash resources are insufficient to fund our planned activities for the time period expected and the other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including the Company's Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. The Company undertakes no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

SOURCE OncoGenex Pharmaceuticals, 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.

@ThingsExpo Stories
Samsung VP Jacopo Lenzi, who headed the company's recent SmartThings acquisition under the auspices of Samsung's Open Innovaction Center (OIC), answered a few questions we had about the deal. This interview was in conjunction with our interview with SmartThings CEO Alex Hawkinson. IoT Journal: SmartThings was developed in an open, standards-agnostic platform, and will now be part of Samsung's Open Innovation Center. Can you elaborate on your commitment to keep the platform open? Jacopo Lenzi: Samsung recognizes that true, accelerated innovation cannot be driven from one source, but requires a...
Explosive growth in connected devices. Enormous amounts of data for collection and analysis. Critical use of data for split-second decision making and actionable information. All three are factors in making the Internet of Things a reality. Yet, any one factor would have an IT organization pondering its infrastructure strategy. How should your organization enhance its IT framework to enable an Internet of Things implementation? In his session at Internet of @ThingsExpo, James Kirkland, Chief Architect for the Internet of Things and Intelligent Systems at Red Hat, will describe how to revoluti...
The Internet of Things will greatly expand the opportunities for data collection and new business models driven off of that data. In her session at Internet of @ThingsExpo, Esmeralda Swartz, CMO of MetraTech, will discuss how for this to be effective you not only need to have infrastructure and operational models capable of utilizing this new phenomenon, but increasingly service providers will need to convince a skeptical public to participate. Get ready to show them the money! Speaker Bio: Esmeralda Swartz, CMO of MetraTech, has spent 16 years as a marketing, product management, and busin...
SYS-CON Events announced today that Red Hat, the world's leading provider of open source solutions, will exhibit at Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Red Hat is the world's leading provider of open source software solutions, using a community-powered approach to reliable and high-performing cloud, Linux, middleware, storage and virtualization technologies. Red Hat also offers award-winning support, training, and consulting services. As the connective hub in a global network of enterprises, partners, a...
P2P RTC will impact the landscape of communications, shifting from traditional telephony style communications models to OTT (Over-The-Top) cloud assisted & PaaS (Platform as a Service) communication services. The P2P shift will impact many areas of our lives, from mobile communication, human interactive web services, RTC and telephony infrastructure, user federation, security and privacy implications, business costs, and scalability. In his session at Internet of @ThingsExpo, Robin Raymond, Chief Architect at Hookflash Inc., will walk through the shifting landscape of traditional telephone a...
SYS-CON Events announced today that Matrix.org has been named “Silver Sponsor” of Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Matrix is an ambitious new open standard for open, distributed, real-time communication over IP. It defines a new approach for interoperable Instant Messaging and VoIP based on pragmatic HTTP APIs and WebRTC, and provides open source reference implementations to showcase and bootstrap the new standard. Our focus is on simplicity, security, and supporting the fullest feature set.
BSQUARE is a global leader of embedded software solutions. We enable smart connected systems at the device level and beyond that millions use every day and provide actionable data solutions for the growing Internet of Things (IoT) market. We empower our world-class customers with our products, services and solutions to achieve innovation and success. For more information, visit www.bsquare.com.
How do APIs and IoT relate? The answer is not as simple as merely adding an API on top of a dumb device, but rather about understanding the architectural patterns for implementing an IoT fabric. There are typically two or three trends: Exposing the device to a management framework Exposing that management framework to a business centric logic • Exposing that business layer and data to end users. This last trend is the IoT stack, which involves a new shift in the separation of what stuff happens, where data lives and where the interface lies. For instance, it’s a mix of architectural style...
SYS-CON Events announced today that SOA Software, an API management leader, will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. SOA Software is a leading provider of API Management and SOA Governance products that equip business to deliver APIs and SOA together to drive their company to meet its business strategy quickly and effectively. SOA Software’s technology helps businesses to accelerate their digital channels with APIs, drive partner adoption, monetize their assets, and achieve a...
From a software development perspective IoT is about programming "things," about connecting them with each other or integrating them with existing applications. In his session at @ThingsExpo, Yakov Fain, co-founder of Farata Systems and SuranceBay, will show you how small IoT-enabled devices from multiple manufacturers can be integrated into the workflow of an enterprise application. This is a practical demo of building a framework and components in HTML/Java/Mobile technologies to serve as a platform that can integrate new devices as they become available on the market.
SYS-CON Events announced today that Utimaco will exhibit at SYS-CON's 15th International Cloud Expo®, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Utimaco is a leading manufacturer of hardware based security solutions that provide the root of trust to keep cryptographic keys safe, secure critical digital infrastructures and protect high value data assets. Only Utimaco delivers a general-purpose hardware security module (HSM) as a customizable platform to easily integrate into existing software solutions, embed business logic and build s...
Connected devices are changing the way we go about our everyday life, from wearables to driverless cars, to smart grids and entire industries revolutionizing business opportunities through smart objects, capable of two-way communication. But what happens when objects are given an IP-address, and we rely on that connection, sometimes with our lives? How do we secure those vast data infrastructures and safe-keep the privacy of sensitive information? This session will outline how each and every connected device can uphold a core root of trust via a unique cryptographic signature – a “bir...
Internet of @ThingsExpo Silicon Valley announced on Thursday its first 12 all-star speakers and sessions for its upcoming event, which will take place November 4-6, 2014, at the Santa Clara Convention Center in California. @ThingsExpo, the first and largest IoT event in the world, debuted at the Javits Center in New York City in June 10-12, 2014 with over 6,000 delegates attending the conference. Among the first 12 announced world class speakers, IBM will present two highly popular IoT sessions, which will take place November 4-6, 2014 at the Santa Clara Convention Center in Santa Clara, Calif...
Almost everyone sees the potential of Internet of Things but how can businesses truly unlock that potential. The key will be in the ability to discover business insight in the midst of an ocean of Big Data generated from billions of embedded devices via Systems of Discover. Businesses will also need to ensure that they can sustain that insight by leveraging the cloud for global reach, scale and elasticity.
WebRTC defines no default signaling protocol, causing fragmentation between WebRTC silos. SIP and XMPP provide possibilities, but come with considerable complexity and are not designed for use in a web environment. In his session at Internet of @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, will discuss how Matrix is a new non-profit Open Source Project that defines both a new HTTP-based standard for VoIP & IM signaling and provides reference implementations.

SUNNYVALE, Calif., Oct. 20, 2014 /PRNewswire/ -- Spansion Inc. (NYSE: CODE), a global leader in embedded systems, today added 96 new products to the Spansion® FM4 Family of flexible microcontrollers (MCUs). Based on the ARM® Cortex®-M4F core, the new MCUs boast a 200 MHz operating frequency and support a diverse set of on-chip peripherals for enhanced human machine interfaces (HMIs) and machine-to-machine (M2M) communications. The rich set of periphera...

SYS-CON Events announced today that Aria Systems, the recurring revenue expert, has been named "Bronze Sponsor" of SYS-CON's 15th International Cloud Expo®, which will take place on November 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Aria Systems helps leading businesses connect their customers with the products and services they love. Industry leaders like Pitney Bowes, Experian, AAA NCNU, VMware, HootSuite and many others choose Aria to power their recurring revenue business and deliver exceptional experiences to their customers.
The Internet of Things (IoT) is going to require a new way of thinking and of developing software for speed, security and innovation. This requires IT leaders to balance business as usual while anticipating for the next market and technology trends. Cloud provides the right IT asset portfolio to help today’s IT leaders manage the old and prepare for the new. Today the cloud conversation is evolving from private and public to hybrid. This session will provide use cases and insights to reinforce the value of the network in helping organizations to maximize their company’s cloud experience.
The Internet of Things (IoT) is making everything it touches smarter – smart devices, smart cars and smart cities. And lucky us, we’re just beginning to reap the benefits as we work toward a networked society. However, this technology-driven innovation is impacting more than just individuals. The IoT has an environmental impact as well, which brings us to the theme of this month’s #IoTuesday Twitter chat. The ability to remove inefficiencies through connected objects is driving change throughout every sector, including waste management. BigBelly Solar, located just outside of Boston, is trans...
SYS-CON Events announced today that Matrix.org has been named “Silver Sponsor” of Internet of @ThingsExpo, which will take place on November 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA. Matrix is an ambitious new open standard for open, distributed, real-time communication over IP. It defines a new approach for interoperable Instant Messaging and VoIP based on pragmatic HTTP APIs and WebRTC, and provides open source reference implementations to showcase and bootstrap the new standard. Our focus is on simplicity, security, and supporting the fullest feature set.