|By PR Newswire||
|November 5, 2012 07:30 PM EST||
VANCOUVER, Nov. 5, 2012 /PRNewswire/ - Allon Therapeutics Inc. (TSX: NPC) today announced its unaudited operating results for the three and nine-month periods ended September 30, 2012. Allon also reported that it is on track to advance toward commercialization of its lead neuroprotective drug candidate davunetide as a potential treatment for progressive supranuclear palsy (PSP), a rapidly progressing and fatal degenerative brain disease.
Gordon McCauley, President and CEO of Allon Therapeutics, said the quarter's progress has kept the company on track to meet its schedule of completing patient treatment as well as analysis and release of top-line data before the end of 2012 for the multinational phase 2/3 pivotal clinical trial that is evaluating davunetide in more than 300 PSP patients.
"Our shareholders stand with thousands of patients, caregivers, families, and health professionals in search of a treatment for this debilitating and fatal disease," McCauley said.
Allon estimates the market potential for the first approved treatment for PSP will exceed $700 million in the U.S. and Europe. PSP affects approximately 25,000 people in the United States and 40,000 people in the European Union. Patients are typically diagnosed when they are between 45 and 65 years of age.
Allon's pivotal trial is proceeding under a Special Protocol Assessment with the U.S. Food and Drug Administration. This multi-national study is being conducted in the United States, Canada, the United Kingdom, France, Germany and Australia. The trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and positive biomarker data.
PSP is considered a tauopathy, involving the tau protein in brain cells. Allon has previously demonstrated, in both preclinical and clinical studies, that davunetide has an impact on the tau pathology. The current evaluation of davunetide in a pivotal clinical trial as a potential treatment for PSP makes it the most advanced tau therapy in the world.
The Company believes that success in treating PSP with davunetide would define the opportunity to evaluate davunetide in other tau-related diseases, such as Alzheimer's, subtypes of frontotemporal dementia, as well as other neurodegenerative diseases such as schizophrenia and Parkinson's.
Results of operations
Allon reported a net loss of $1,847,863 ($0.01 per share) for the three months ended September 30, 2012, compared to a net loss of $2,983,887 ($0.04 per share) for the three months ended September 30, 2011, representing a decrease in net loss of $1,136,024. For the nine months ended September 30, 2012, the Company reported a net loss of $7,869,780 ($0.07 per share), compared to a net loss of $8,877,797 ($0.11 per share) for the nine months ended September 30, 2011. This decrease in net loss is explained in the following description of significant variances from the comparable periods in 2011.
For the three and nine months ended September 30, 2012, research and development expenses were $1,292,607 and $5,688,077 compared to $2,235,554 and $6,448,571 for the three and nine months ended September 30, 2011. Research and development expenses were lower compared to the same period in 2011 due to less clinical trial activities related to PSP as the clinical trial nears completion. Research and development expenses for the three and nine months ended September 30, 2012 also included amortization and depreciation expenses of $127,136 and $381,961 (2011 - $127,401 and $382,753) and share-based compensation of $17,013 and $55,597 (2011 - $15,434 and $39,620).
For the three and nine months ended September 30, 2012, general and administrative expenses were $568,986 and $2,024,416 compared to $665,722 and $2,204,706 for the three and nine months ended September 30, 2011. General and administrative expenses for the three and nine months ended September 30, 2012 were lower compared to the same periods in 2011 primarily due to lower corporate development activities and lower general overhead expenses partly offset by higher compensation expenses. Included in general and administrative expenses for the three and nine months ended September 30, 2012 were share-based compensation of $77,566 and $231,068 (2011 - $44,440 and $139,642) and amortization and depreciation expenses of $1004 and $6,007 (2011 - $3,169 and $10,249).
The Company's other income and expenses are comprised of loss on debt repayment, interest income/expense and foreign exchange gains/losses.
Allon Therapeutics Inc. is a clinical-stage biotechnology company focused on bringing to market innovative central nervous system therapies. Allon's lead drug davunetide is proceeding in a pivotal clinical trial in an orphan indication, progressive supranuclear palsy (PSP), under a Special Protocol Assessment (SPA) with the U.S. Food and Drug Administration (FDA). The trial is fully enrolled and on track to complete the study, analyse the data and release top-line results before the end of 2012. This pivotal trial is based upon statistically significant human efficacy demonstrated in patients with amnestic mild cognitive impairment, cognitive impairment associated with schizophrenia, and in positive biomarker data.
The Company is listed on the Toronto Stock Exchange under the trading symbol "NPC".
Forward Looking Statements
Statements contained herein, other than those which are strictly statements of historical fact may include forward-looking information. Such statements will typically contain words such as "believes", "may", "plans", "will", "estimate", "continue", "anticipates", "intends", "expects", and similar expressions. While forward-looking statements represent management's outlook based on assumptions that management believes are reasonable, forward-looking statements by their nature are subject to known and unknown risks, uncertainties and other factors that may cause the actual results, events or developments to be materially different from any future results, events or developments expressed or implied by them. Such factors include, among others, the inherent uncertainty involved in scientific research and drug development, Allon's early stage of development, lack of product revenues, its additional capital requirements, the risks associated with successful completion of clinical trials and the long lead-times and high costs associated with obtaining regulatory approval to market any product which Allon may eventually develop. Other risk factors include the limited protections afforded by intellectual property rights, rapid technology and product obsolescence in a highly competitive environment and Allon's dependence on collaborative partners and contract research organizations. These factors can be reviewed in Allon's public filings at www.sedar.com and should be considered carefully. Readers are cautioned not to place undue reliance on such forward-looking statements. Similarly, nothing in this press release is meant to promote a pharmaceutical product or make a regulated claim of efficacy.
SOURCE Allon Therapeutics Inc.
SYS-CON Events announced today that BMC will exhibit at SYS-CON's 16th International Cloud Expo®, which will take place on June 9-11, 2015, at the Javits Center in New York City, NY. BMC delivers software solutions that help IT transform digital enterprises for the ultimate competitive business advantage. BMC has worked with thousands of leading companies to create and deliver powerful IT management services. From mainframe to cloud to mobile, BMC pairs high-speed digital innovation with robust IT industrialization – allowing customers to provide amazing user experiences with optimized IT per...
May. 27, 2015 11:30 AM EDT Reads: 405
As the Internet of Things unfolds, mobile and wearable devices are blurring the line between physical and digital, integrating ever more closely with our interests, our routines, our daily lives. Contextual computing and smart, sensor-equipped spaces bring the potential to walk through a world that recognizes us and responds accordingly. We become continuous transmitters and receivers of data. In his session at @ThingsExpo, Andrew Bolwell, Director of Innovation for HP's Printing and Personal Systems Group, discussed how key attributes of mobile technology – touch input, sensors, social, and ...
May. 27, 2015 11:30 AM EDT Reads: 4,256
All major researchers estimate there will be tens of billions devices - computers, smartphones, tablets, and sensors - connected to the Internet by 2020. This number will continue to grow at a rapid pace for the next several decades. With major technology companies and startups seriously embracing IoT strategies, now is the perfect time to attend @ThingsExpo, June 9-11, 2015, at the Javits Center in New York City. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be
May. 27, 2015 11:15 AM EDT Reads: 2,768
The Internet of Things is not only adding billions of sensors and billions of terabytes to the Internet. It is also forcing a fundamental change in the way we envision Information Technology. For the first time, more data is being created by devices at the edge of the Internet rather than from centralized systems. What does this mean for today's IT professional? In this Power Panel at @ThingsExpo, moderated by Conference Chair Roger Strukhoff, panelists will addresses this very serious issue of profound change in the industry.
May. 27, 2015 10:30 AM EDT Reads: 1,291
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 @ThingsExpo, Matthew Hodgson, technical co-founder of the Matrix.org, discussed 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.
May. 27, 2015 10:30 AM EDT Reads: 5,466
Buzzword alert: Microservices and IoT at a DevOps conference? What could possibly go wrong? In this Power Panel at DevOps Summit, moderated by Jason Bloomberg, the leading expert on architecting agility for the enterprise and president of Intellyx, panelists will peel away the buzz and discuss the important architectural principles behind implementing IoT solutions for the enterprise. As remote IoT devices and sensors become increasingly intelligent, they become part of our distributed cloud environment, and we must architect and code accordingly. At the very least, you'll have no problem fil...
May. 27, 2015 10:00 AM EDT Reads: 2,239
"People are a lot more knowledgeable about APIs now. There are two types of people who work with APIs - IT people who want to use APIs for something internal and the product managers who want to do something outside APIs for people to connect to them," explained Roberto Medrano, Executive Vice President at SOA Software, in this SYS-CON.tv interview at Cloud Expo, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
May. 27, 2015 09:30 AM EDT Reads: 4,607
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.
May. 27, 2015 09:30 AM EDT Reads: 7,120
The 4th International Internet of @ThingsExpo, co-located with the 17th International Cloud Expo - to be held November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA - announces that its Call for Papers is open. The Internet of Things (IoT) is the biggest idea since the creation of the Worldwide Web more than 20 years ago.
May. 27, 2015 09:00 AM EDT Reads: 2,323
In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect at GE, and Ibrahim Gokcen, who leads GE's advanced IoT analytics, focused on the Internet of Things / Industrial Internet and how to make it operational for business end-users. Learn about the challenges posed by machine and sensor data and how to marry it with enterprise data. They also discussed the tips and tricks to provide the Industrial Internet as an end-user consumable service using Big Data Analytics and Industrial Cloud.
May. 27, 2015 07:30 AM EDT Reads: 5,728
Building low-cost wearable devices can enhance the quality of our lives. In his session at Internet of @ThingsExpo, Sai Yamanoor, Embedded Software Engineer at Altschool, provided an example of putting together a small keychain within a $50 budget that educates the user about the air quality in their surroundings. He also provided examples such as building a wearable device that provides transit or recreational information. He then reviewed the resources available to build wearable devices at home including open source hardware, the raw materials required and the options available to power s...
May. 27, 2015 04:30 AM EDT Reads: 4,323
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 styles ...
May. 27, 2015 03:00 AM EDT Reads: 6,001
We certainly live in interesting technological times. And no more interesting than the current competing IoT standards for connectivity. Various standards bodies, approaches, and ecosystems are vying for mindshare and positioning for a competitive edge. It is clear that when the dust settles, we will have new protocols, evolved protocols, that will change the way we interact with devices and infrastructure. We will also have evolved web protocols, like HTTP/2, that will be changing the very core of our infrastructures. At the same time, we have old approaches made new again like micro-services...
May. 27, 2015 02:30 AM EDT Reads: 5,665
Connected devices and the Internet of Things are getting significant momentum in 2014. In his session at Internet of @ThingsExpo, Jim Hunter, Chief Scientist & Technology Evangelist at Greenwave Systems, examined three key elements that together will drive mass adoption of the IoT before the end of 2015. The first element is the recent advent of robust open source protocols (like AllJoyn and WebRTC) that facilitate M2M communication. The second is broad availability of flexible, cost-effective storage designed to handle the massive surge in back-end data in a world where timely analytics is e...
May. 27, 2015 02:00 AM EDT Reads: 6,415
Collecting data in the field and configuring multitudes of unique devices is a time-consuming, labor-intensive process that can stretch IT resources. Horan & Bird [H&B], Australia’s fifth-largest Solar Panel Installer, wanted to automate sensor data collection and monitoring from its solar panels and integrate the data with its business and marketing systems. After data was collected and structured, two major areas needed to be addressed: improving developer workflows and extending access to a business application to multiple users (multi-tenancy). Docker, a container technology, was used to ...
May. 27, 2015 01:00 AM EDT Reads: 2,621
The true value of the Internet of Things (IoT) lies not just in the data, but through the services that protect the data, perform the analysis and present findings in a usable way. With many IoT elements rooted in traditional IT components, Big Data and IoT isn’t just a play for enterprise. In fact, the IoT presents SMBs with the prospect of launching entirely new activities and exploring innovative areas. CompTIA research identifies several areas where IoT is expected to have the greatest impact.
May. 26, 2015 09:00 PM EDT Reads: 5,280
The Industrial Internet revolution is now underway, enabled by connected machines and billions of devices that communicate and collaborate. The massive amounts of Big Data requiring real-time analysis is flooding legacy IT systems and giving way to cloud environments that can handle the unpredictable workloads. Yet many barriers remain until we can fully realize the opportunities and benefits from the convergence of machines and devices with Big Data and the cloud, including interoperability, data security and privacy.
May. 26, 2015 05:00 PM EDT Reads: 5,011
The Internet of Things is tied together with a thin strand that is known as time. Coincidentally, at the core of nearly all data analytics is a timestamp. When working with time series data there are a few core principles that everyone should consider, especially across datasets where time is the common boundary. In his session at Internet of @ThingsExpo, Jim Scott, Director of Enterprise Strategy & Architecture at MapR Technologies, discussed single-value, geo-spatial, and log time series data. By focusing on enterprise applications and the data center, he will use OpenTSDB as an example t...
May. 26, 2015 02:00 PM EDT Reads: 6,748
Scott Jenson leads a project called The Physical Web within the Chrome team at Google. Project members are working to take the scalability and openness of the web and use it to talk to the exponentially exploding range of smart devices. Nearly every company today working on the IoT comes up with the same basic solution: use my server and you'll be fine. But if we really believe there will be trillions of these devices, that just can't scale. We need a system that is open a scalable and by using the URL as a basic building block, we open this up and get the same resilience that the web enjoys.
May. 26, 2015 01:00 PM EDT Reads: 7,359
We are reaching the end of the beginning with WebRTC, and real systems using this technology have begun to appear. One challenge that faces every WebRTC deployment (in some form or another) is identity management. For example, if you have an existing service – possibly built on a variety of different PaaS/SaaS offerings – and you want to add real-time communications you are faced with a challenge relating to user management, authentication, authorization, and validation. Service providers will want to use their existing identities, but these will have credentials already that are (hopefully) i...
May. 26, 2015 01:00 PM EDT Reads: 4,655