|By Marketwired .||
|May 15, 2014 04:00 PM EDT||
RESEARCH TRIANGLE PARK, NORTH CAROLINA -- (Marketwired) -- 05/15/14 -- Adherex Technologies Inc. (TSX:AHX)(OTCQB:ADHXF) today reported its financial results and recent developments for the first quarter ended March 31, 2014. All amounts are in US dollars unless otherwise specified.
As reported, the two Phase 3 clinical trials studying Sodium Thiosulfate (STS) for prevention of hearing loss in children receiving cisplatin chemotherapy have been accepted for presentation at the 2014 American Society of Clinical Oncology (ASCO) Annual Meeting in Chicago, Illinois. The US based Children Oncology Group (COG) ACCL0431 study completed enrollment of 135 patients in February 2012. David Freyer, DO, MS, Childrens Hospital Los Angeles, COG ACCL0431 Study Chair, will present, "The Effects of Sodium Thiosulfate (STS) on Cisplatin-induced Hearing Loss: A Report from the Children's Oncology Group," in an oral presentation on June 1, 2014. The European based SIOPEL 6 study, "A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulfate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma," has been accepted for the "trials in progress" poster session on June 2, 2014. Edward A. Neuwelt, M.D., Professor at Oregon Health & Science University, will present the poster on behalf of the SIOPEL 6 investigators and support team.
The enrollment of SIOPEL 6 Study is almost complete, as 103 patients have been randomized. The first three interim safety analyses were conducted after 20, 40 and 60 patients, and in each case, the Independent Data Monitoring Committee (IDMC) recommended continuation of the study. An additional interim safety analysis for 80 patients is expected to be performed shortly.
Cash and cash equivalents totaled $1.3 million at March 31, 2014, compared to $1.7 million at December 31, 2013. At March 31, 2014, the Company had working capital balance totaling approximately $1.2 million compared to $1.4 million as of December 31, 2013.
The Company reported a net loss from operations of $0.5 million excluding the $2.7 million non- cash loss on derivatives for the first quarter ended March 31, 2014, compared to a net loss from operations of $0.5 million excluding the non-cash gain of $3.6 million in the same period in 2013. Operating net loss for the quarter ended March 31, 2014 remained the same as compared to the first quarter in 2013. There was a large reduction in research and development expenses over the same period in the prior year, however this reduction was offset by the increase in general and administrative expenses associated with our November 2013 financing.
The selected financial data presented below is derived from our unaudited condensed consolidated financial statements which were prepared in accordance with U.S. generally accepted accounting principles. The complete interim consolidated financial statements for the period ended March 31, 2014 and management's discussion and analysis of financial condition and results of operations will be available via www.sec.gov and www.sedar.com.
Adherex Technologies Inc. Selected Financial Data (U.S. Dollars in thousands except per share amounts) March 31, December 31, 2014 2013 Interim Unaudited Condensed Consolidated Balance Sheets: Assets: Cash and cash equivalents 1,338 1,663 Other current assets 57 89 ------------------------ Total assets 1,395 1,752 ------------------------ ------------------------ Liabilities and stockholders' equity: Current liabilities 211 344 Derivative liabilities 5,518 2,863 Other long-term liabilities - - Total stockholders' equity (4,334) (1,455) ------------------------ Total liabilities and stockholders' equity (deficiency) 1,395 1,752 ------------------------ ------------------------ ---------------------------------------------------------------------------- ---------------------------------------------------------------------------- Three Months Ended ------------------------ Interim Unaudited Condensed Consolidated March 31, March 31, Statements of Operations: 2014 2013 ------------------------ Revenue $ - $ - Operating expenses Research and development 32 178 General and administrative 505 359 ------------------------ Loss from operations (537) (537) ------------------------ Unrealized (loss) (2,655) (3,573) Interest (expense)/income and other (2) 2 ------------------------ Net (loss) and comprehensive (loss) $ (3,194) $ (4,108) ------------------------ ------------------------ Basic and diluted net loss per common share $ (0.11) $ (0.16) ------------------------ ------------------------
Except for historical information described in this press release, all other statements are forward-looking. Forward-looking statements are subject to certain risks and uncertainties inherent in the Company's business that could cause actual results to vary, including such risks that regulatory and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company's patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company's products will not be as large as expected, the Company's products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital requirements in different countries and municipalities, and other risks detailed from time to time in the Company's filings with the Securities and Exchange Commission including its Annual Report on Form 10-K for the year ended December 31, 2013. Adherex Technologies, Inc. disclaims any obligation to update these forward-looking statements except as required by law.
About Sodium Thiosulfate (STS)
STS is a chemoprotectant being developed by Adherex to reduce or prevent hearing loss in oncology patients resulting from treatment with platinum-based chemotherapy drugs. The initial focus is on the pediatric market. Hearing loss following cisplatin exposure affect approximately 2,000 children in the US every year. STS has received Orphan Drug Designation in the United States for the prevention of platinum-based ototoxicity in pediatric patients. In addition, Adherex has licensed intellectual property rights for the use of STS as a chemoprotectant from Oregon Health & Science University.
STS is a water-soluable thiol compound and acts as a chemical reducing agent. It is FDA approved for the treatment of cyanide poisoning and has been used in oncology to prevent cisplatin nephrotoxicity. It is thought that hearing loss caused by platinum compounds result from the deposition of protein-bound platinum in the cochlea and STS binds platinum/protein complexes thereby potentially minimizing their toxicity. At a bolus dose of 20 g/m2 over 15 minutes, STS has sufficient high plasma concentrations to rapidly, covalently bind to any residual extracellular cisplatin and thereby possibly prevent ototoxicity. Because STS is to be administered six hours after cisplatin, antitumor efficacy of cisplatin should not be compromised.
About STS Clinical Studies
Study ACCL0431: "A Randomized Phase III Study of Sodium Thiosulfate for the Prevention of Cisplatin-Induced Ototoxicity in Children", conducted by the Children's Oncology Group (COG), finished enrollment of 135 patients in Q1 2012. These patients had been previously diagnosed with one of five rare childhood cancers typically treated with intensive cisplatin therapy, including hepatoblastoma, germ cell tumor, osteosarcoma, neuroblastoma, and medulloblastoma.
SIOPEL 6: "A Multicenter Open Label Randomized Phase III Trial of the Efficacy of Sodium Thiosulfate in Reducing Ototoxicity in Patients Receiving Cisplatin Chemotherapy for Standard Risk Hepatoblastoma" is being conducted by The International Childhood Liver Tumor Strategy Group, SIOPEL. As of this date, the study has enrolled 103 patients. SIOPEL 6 is studying STS in standard risk hepatoblastoma patients where the effectiveness of the platinum treatment is known to be very high.
Adherex Technologies Inc.
Chief Executive Officer
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies adopt disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Founded in 1997, Pythian is a global IT services company that helps companies compete by adopting disruptive technologies such as cloud, Big Data, advanced analytics, and DevO...
Feb. 6, 2016 11:15 AM EST Reads: 117
SYS-CON Events announced today that Men & Mice, the leading global provider of DNS, DHCP and IP address management overlay solutions, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. The Men & Mice Suite overlay solution is already known for its powerful application in heterogeneous operating environments, enabling enterprises to scale without fuss. Building on a solid range of diverse platform support,...
Feb. 6, 2016 11:15 AM EST Reads: 107
One of the bewildering things about DevOps is integrating the massive toolchain including the dozens of new tools that seem to crop up every year. Part of DevOps is Continuous Delivery and having a complex toolchain can add additional integration and setup to your developer environment. In his session at @DevOpsSummit at 18th Cloud Expo, Miko Matsumura, Chief Marketing Officer of Gradle Inc., will discuss which tools to use in a developer stack, how to provision the toolchain to minimize onboa...
Feb. 6, 2016 11:00 AM EST
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
Feb. 6, 2016 11:00 AM EST
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Feb. 6, 2016 11:00 AM EST
Cognitive Computing is becoming the foundation for a new generation of solutions that have the potential to transform business. Unlike traditional approaches to building solutions, a cognitive computing approach allows the data to help determine the way applications are designed. This contrasts with conventional software development that begins with defining logic based on the current way a business operates. In her session at 18th Cloud Expo, Judith S. Hurwitz, President and CEO of Hurwitz & ...
Feb. 6, 2016 11:00 AM EST Reads: 147
The principles behind DevOps are not new - for decades people have been automating system administration and decreasing the time to deploy apps and perform other management tasks. However, only recently did we see the tools and the will necessary to share the benefits and power of automation with a wider circle of people. In his session at DevOps Summit, Bernard Sanders, Chief Technology Officer at CloudBolt Software, explored the latest tools including Puppet, Chef, Docker, and CMPs needed to...
Feb. 6, 2016 10:00 AM EST Reads: 222
SYS-CON Events announced today that AppNeta, the leader in performance insight for business-critical web applications, will exhibit and present at SYS-CON's @DevOpsSummit at Cloud Expo New York, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. AppNeta is the only application performance monitoring (APM) company to provide solutions for all applications – applications you develop internally, business-critical SaaS applications you use and the networks that deli...
Feb. 6, 2016 09:45 AM EST Reads: 316
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
Feb. 6, 2016 09:00 AM EST
Advances in technology and ubiquitous connectivity have made the utilization of a dispersed workforce more common. Whether that remote team is located across the street or country, management styles/ approaches will have to be adjusted to accommodate this new dynamic. In his session at 17th Cloud Expo, Sagi Brody, Chief Technology Officer at Webair Internet Development Inc., focused on the challenges of managing remote teams, providing real-world examples that demonstrate what works and what do...
Feb. 6, 2016 08:00 AM EST Reads: 159
It's easy to assume that your app will run on a fast and reliable network. The reality for your app's users, though, is often a slow, unreliable network with spotty coverage. What happens when the network doesn't work, or when the device is in airplane mode? You get unhappy, frustrated users. An offline-first app is an app that works, without error, when there is no network connection.
Feb. 6, 2016 07:45 AM EST Reads: 119
In most cases, it is convenient to have some human interaction with a web (micro-)service, no matter how small it is. A traditional approach would be to create an HTTP interface, where user requests will be dispatched and HTML/CSS pages must be served. This approach is indeed very traditional for a web site, but not really convenient for a web service, which is not intended to be good looking, 24x7 up and running and UX-optimized. Instead, talking to a web service in a chat-bot mode would be muc...
Feb. 6, 2016 07:30 AM EST Reads: 148
Father business cycles and digital consumers are forcing enterprises to respond faster to customer needs and competitive demands. Successful integration of DevOps and Agile development will be key for business success in today’s digital economy. In his session at DevOps Summit, Pradeep Prabhu, Co-Founder & CEO of Cloudmunch, covered the critical practices that enterprises should consider to seamlessly integrate Agile and DevOps processes, barriers to implementing this in the enterprise, and pr...
Feb. 6, 2016 07:30 AM EST Reads: 273
More and more companies are looking to microservices as an architectural pattern for breaking apart applications into more manageable pieces so that agile teams can deliver new features quicker and more effectively. What this pattern has done more than anything to date is spark organizational transformations, setting the foundation for future application development. In practice, however, there are a number of considerations to make that go beyond simply “build, ship, and run,” which changes ho...
Feb. 6, 2016 07:15 AM EST Reads: 123
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
Feb. 6, 2016 05:00 AM EST Reads: 316