|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.
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, November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Learn what is going on, contribute to the discussions, and ensure that your enterprise is as "IoT-Ready" as it can be.
Sep. 3, 2015 08:30 PM EDT Reads: 140
Containers are not new, but renewed commitments to performance, flexibility, and agility have propelled them to the top of the agenda today. By working without the need for virtualization and its overhead, containers are seen as the perfect way to deploy apps and services across multiple clouds. Containers can handle anything from file types to operating systems and services, including microservices. What are microservices? Unlike what the name implies, microservices are not necessarily small, but are focused on specific tasks. The ability for developers to deploy multiple containers – thous...
Sep. 3, 2015 08:00 PM EDT Reads: 164
Too often with compelling new technologies market participants become overly enamored with that attractiveness of the technology and neglect underlying business drivers. This tendency, what some call the “newest shiny object syndrome,” is understandable given that virtually all of us are heavily engaged in technology. But it is also mistaken. Without concrete business cases driving its deployment, IoT, like many other technologies before it, will fade into obscurity.
Sep. 3, 2015 04:30 PM EDT Reads: 432
The 3rd International WebRTC Summit, to be held Nov. 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA, announces that its Call for Papers is now open. Topics include all aspects of improving IT delivery by eliminating waste through automated business models leveraging cloud technologies. WebRTC Summit is co-located with 15th International Cloud Expo, 6th International Big Data Expo, 3rd International DevOps Summit and 2nd Internet of @ThingsExpo. WebRTC (Web-based Real-Time Communication) is an open source project supported by Google, Mozilla and Opera that aims to enable bro...
Sep. 3, 2015 03:00 PM EDT Reads: 1,605
As more and more data is generated from a variety of connected devices, the need to get insights from this data and predict future behavior and trends is increasingly essential for businesses. Real-time stream processing is needed in a variety of different industries such as Manufacturing, Oil and Gas, Automobile, Finance, Online Retail, Smart Grids, and Healthcare. Azure Stream Analytics is a fully managed distributed stream computation service that provides low latency, scalable processing of streaming data in the cloud with an enterprise grade SLA. It features built-in integration with Azur...
Sep. 3, 2015 02:45 PM EDT Reads: 390
With the proliferation of connected devices underpinning new Internet of Things systems, Brandon Schulz, Director of Luxoft IoT – Retail, will be looking at the transformation of the retail customer experience in brick and mortar stores in his session at @ThingsExpo. Questions he will address include: Will beacons drop to the wayside like QR codes, or be a proximity-based profit driver? How will the customer experience change in stores of all types when everything can be instrumented and analyzed? As an area of investment, how might a retail company move towards an innovation methodolo...
Sep. 3, 2015 02:30 PM EDT Reads: 515
SYS-CON Events announced today that HPM Networks will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. For 20 years, HPM Networks has been integrating technology solutions that solve complex business challenges. HPM Networks has designed solutions for both SMB and enterprise customers throughout the San Francisco Bay Area.
Sep. 3, 2015 02:30 PM EDT Reads: 963
SYS-CON Events announced today the Containers & Microservices Bootcamp, being held November 3-4, 2015, in conjunction with 17th Cloud Expo, @ThingsExpo, and @DevOpsSummit at the Santa Clara Convention Center in Santa Clara, CA. This is your chance to get started with the latest technology in the industry. Combined with real-world scenarios and use cases, the Containers and Microservices Bootcamp, led by Janakiram MSV, a Microsoft Regional Director, will include presentations as well as hands-on demos and comprehensive walkthroughs.
Sep. 3, 2015 02:15 PM EDT Reads: 418
Contrary to mainstream media attention, the multiple possibilities of how consumer IoT will transform our everyday lives aren’t the only angle of this headline-gaining trend. There’s a huge opportunity for “industrial IoT” and “Smart Cities” to impact the world in the same capacity – especially during critical situations. For example, a community water dam that needs to release water can leverage embedded critical communications logic to alert the appropriate individuals, on the right device, as soon as they are needed to take action.
Sep. 3, 2015 01:30 PM EDT
WebRTC services have already permeated corporate communications in the form of videoconferencing solutions. However, WebRTC has the potential of going beyond and catalyzing a new class of services providing more than calls with capabilities such as mass-scale real-time media broadcasting, enriched and augmented video, person-to-machine and machine-to-machine communications. In his session at @ThingsExpo, Luis Lopez, CEO of Kurento, will introduce the technologies required for implementing these ideas and some early experiments performed in the Kurento open source software community in areas ...
Sep. 3, 2015 01:15 PM EDT Reads: 110
SYS-CON Events announced today that Pythian, a global IT services company specializing in helping companies leverage disruptive technologies to optimize revenue-generating systems, has been named “Bronze Sponsor” of SYS-CON's 17th Cloud Expo, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. 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 DevOps to advance innovation and increase agility. Specializing in designing, imple...
Sep. 3, 2015 01:00 PM EDT Reads: 371
Consumer IoT applications provide data about the user that just doesn’t exist in traditional PC or mobile web applications. This rich data, or “context,” enables the highly personalized consumer experiences that characterize many consumer IoT apps. This same data is also providing brands with unprecedented insight into how their connected products are being used, while, at the same time, powering highly targeted engagement and marketing opportunities. In his session at @ThingsExpo, Nathan Treloar, President and COO of Bebaio, will explore examples of brands transforming their businesses by t...
Sep. 3, 2015 12:30 PM EDT Reads: 289
In his session at @ThingsExpo, Lee Williams, a producer of the first smartphones and tablets, will talk about how he is now applying his experience in mobile technology to the design and development of the next generation of Environmental and Sustainability Services at ETwater. He will explain how M2M controllers work through wirelessly connected remote controls; and specifically delve into a retrofit option that reverse-engineers control codes of existing conventional controller systems so they don't have to be replaced and are instantly converted to become smart, connected devices.
Sep. 3, 2015 12:00 PM EDT Reads: 258
With the Apple Watch making its way onto wrists all over the world, it’s only a matter of time before it becomes a staple in the workplace. In fact, Forrester reported that 68 percent of technology and business decision-makers characterize wearables as a top priority for 2015. Recognizing their business value early on, FinancialForce.com was the first to bring ERP to wearables, helping streamline communication across front and back office functions. In his session at @ThingsExpo, Kevin Roberts, GM of Platform at FinancialForce.com, will discuss the value of business applications on wearable ...
Sep. 3, 2015 10:45 AM EDT Reads: 103
SYS-CON Events announced today that Micron Technology, Inc., a global leader in advanced semiconductor systems, will exhibit at the 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Micron’s broad portfolio of high-performance memory technologies – including DRAM, NAND and NOR Flash – is the basis for solid state drives, modules, multichip packages and other system solutions. Backed by more than 35 years of technology leadership, Micron's memory solutions enable the world's most innovative computing, consumer,...
Sep. 3, 2015 10:00 AM EDT Reads: 288
17th Cloud Expo, taking place Nov 3-5, 2015, 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 enterprises are using some form of XaaS – software, platform, and infrastructure as a service.
Sep. 3, 2015 10:00 AM EDT Reads: 1,603
As more intelligent IoT applications shift into gear, they’re merging into the ever-increasing traffic flow of the Internet. It won’t be long before we experience bottlenecks, as IoT traffic peaks during rush hours. Organizations that are unprepared will find themselves by the side of the road unable to cross back into the fast lane. As billions of new devices begin to communicate and exchange data – will your infrastructure be scalable enough to handle this new interconnected world?
Sep. 3, 2015 09:30 AM EDT Reads: 206
While many app developers are comfortable building apps for the smartphone, there is a whole new world out there. In his session at @ThingsExpo, Narayan Sainaney, Co-founder and CTO of Mojio, will discuss how the business case for connected car apps is growing and, with open platform companies having already done the heavy lifting, there really is no barrier to entry.
Sep. 3, 2015 09:30 AM EDT Reads: 216
SYS-CON Events announced today that the "Second Containers & Microservices Expo" will take place November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Sep. 3, 2015 09:30 AM EDT Reads: 654
Manufacturing connected IoT versions of traditional products requires more than multiple deep technology skills. It also requires a shift in mindset, to realize that connected, sensor-enabled “things” act more like services than what we usually think of as products. In his session at @ThingsExpo, David Friedman, CEO and co-founder of Ayla Networks, will discuss how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the data to create additional revenue streams, such as improved warranties or premium features. Or slash...
Sep. 3, 2015 09:15 AM EDT