|By Marketwired .||
|November 8, 2012 02:00 AM EST||
LEUVEN, BELGIUM -- (Marketwire) -- 11/08/12 -- TiGenix NV (EURONEXT BRUSSELS: TIG)
- ChondroCelect Sales EUR 3.2 Million for First Nine Months
- Cx611 RA Program on Track to Report Preliminary Results in Q4
- Cx601 Partnering Discussions On-going
- Company Sufficiently Financed to Keep Executing on Plan
TiGenix NV (EURONEXT BRUSSELS: TIG), the European leader in cell therapy, gives an update of its business activities and provides the financial highlights for the third quarter ending September 30, 2012.
- ChondroCelect sales benefit from continued uptake in Belgium and in the Netherlands
- Progress development pipeline
- ADMIRE-CD Phase III trial (Cx601) enrollment on-going
- Cx601 Phase II study published in international peer-reviewed journal
- Cx611 Phase IIa in rheumatoid arthritis (RA) to report preliminary results in Q4
- Jean Stéphenne appointed chairman & Russell Greig appointed member of the board of directors
- European central facility obtains EMA approval for commercial production of ChondroCelect
- Partnering discussion for lead program Cx601 on-going
- ChondroCelect sales for the first nine months of 2012 amounted to EUR 3.2 million, comprising of EUR 2.5 million from 2012 sales, up 130% compared to same period of last year, and EUR 0.7 million of deferred sales from 2011
- ChondroCelect sales of the third quarter amounted to EUR 1.1 million, a 152% increase compared to the same period of 2011
- EUR 8 million cash on hand
"We are very pleased with our continued progress on all fronts," says Eduardo Bravo, CEO of TiGenix. "We anticipate delivering on a number of key milestones in the months ahead, such as reimbursement of ChondroCelect in at least one major market, partnering of Cx601, and preliminary and final results of our state-of-the-art Cx611 Phase II trial in RA. Based on our current cash position, and achieving our short-term milestones we are sufficiently financed to reach the end of 2013"
ChondroCelect sales up substantially
ChondroCelect sales for the third quarter of 2012 amounted to EUR 1.1 million, compared to sales of EUR 0.4 million in the same period of last year, reflecting the continued uptake in Belgium and the Netherlands. For the nine months ended September 30, ChondroCelect sales have grown 130% to EUR 2.5 million, compared to EUR 1.1 million in the same period of last year, excluding deferred sales of 2011.
Discussions to obtain national reimbursement keep advancing in Spain, France, and Germany, and the company expects a positive decision in at least one of these countries in the months ahead.
Patient enrollment on plan in ADMIRE-CD Phase III trial (Cx601) in complex perianal fistulas
Since July, after enrolling the first patient in the ADMIRE-CD trial, its pivotal Phase III clinical trial with Cx601, enrollment is progressing on plan. Cx601 is an adipose derived allogeneic stem cell suspension for the treatment of complex perianal fistulas in Crohn's disease patients. ADMIRE-CD is a multicenter, randomized, double-blind, placebo-controlled Phase III trial that will enroll approximately 278 patients at 46 centers across 7 European countries and Israel. The main objectives of the study are to demonstrate safety and superior efficacy over placebo in perianal fistulas in Crohn's disease patients who failed to respond to previous treatment(s), in most cases biologicals, and to confirm the strong safety and efficacy results from the Phase II trial completed in 2011. Final results of the trial are expected in H2 2014, and, if positive, will allow the Company to file for marketing authorization with the European Medicines Agency.
In early October, the study results of the Phase II trial of Cx601 were published online ahead of print in the peer-reviewed International Journal of Colorectal Disease.
Cx611 Phase IIa in rheumatoid arthritis to report preliminary safety results in Q4
On August 8, the Company completed enrollment in its Phase IIa trial of Cx611 in rheumatoid arthritis (RA). This is the most advanced clinical trial in the world with stem cells in RA and the Company expects to report preliminary results in Q4 and final results no later than April 2013. Although the primary objective is to demonstrate safety, feasibility, tolerance and optimal dosing, this 53-subject, randomized, placebo controlled, multicenter study will follow patients for 6 months after three injections of Cx611. It will therefore provide a strong first indication of the duration of the efficacy of Cx611 in this very difficult patient population -- enrolled patients have previously failed to respond to at least one biological -- and will set the stage not only for the further development of Cx611 in RA, but also in a wide range of other autoimmune disorders.
Jean Stéphenne appointed chairman & Russell Greig appointed member of the board of directors
On September 20, TiGenix appointed Jean Stéphenne chairman and Russell Greig member of the board of directors. Both are former members of the Corporate Executive Team of GlaxoSmithKline (GSK), and have a sterling track record that will be of immense value as TiGenix enters into a pivotal phase of its growth with the commercial roll-out of ChondroCelect and the advanced clinical development of its cell therapy programs.
European production facility obtains EMA approval
On October 9, TiGenix obtained approval from the European Medicines Agency to manufacture ChondroCelect at its European manufacturing plant in Sittard-Geleen in the Netherlands. The state-of-the-art manufacturing site is unique in Europe as it is 100% geared towards the production of innovative cell therapy products. The plant provides TiGenix with manufacturing capabilities to support the anticipated growth in demand for ChondroCelect.
Partnering discussion for lead program Cx601 on-going
TiGenix keeps advancing its discussions with a number of parties regarding the commercial rights to Cx601 to maximize the value of its lead program.
Financial results for the first nine months of 2012
ChondroCelect sales for the first 9 months of EUR 3.2 million
ChondroCelect sales for the first nine months of 2012 amounted to EUR 3.2 million, comprising of EUR 2.5 million of sales from 2012, and EUR 0.7 million in deferred sales from 2011. Sales for Q3 2012 were EUR 1.1 million, representing a 152% increase compared to Q3 2011.
Cash position of EUR 8 million on September 30, 2012
On September 30, the Company had a cash position of EUR 8 million. Net cash used during the first nine months of 2012 was EUR 11.7 million, in line with management's guidance. Based on its current cash position, anticipated commercial revenues from ChondroCelect sales, partnering of Cx601, already allocated grants, and new grants, the company believes it is sufficiently financed to keep executing on its business plan.
Outlook next 12 months
- National reimbursement decisions in major European countries for ChondroCelect
- ChondroCelect distribution agreements in selected countries
- First commercial batches of ChondroCelect produced at Sittard-Geleen manufacturing facility
- Preliminary results of Cx611 in Rheumatoid Arthritis in Q4, 2012
- Partnering agreement for Cx601
- Final results of Cx611 in RA in April, 2013
TiGenix NV (EURONEXT BRUSSELS: TIG) is a leading European cell therapy company with a marketed cell therapy product for cartilage repair, ChondroCelect®, and a strong pipeline with clinical stage allogeneic adult stem cell programs for the treatment of autoimmune and inflammatory diseases. TiGenix is based out of Leuven (Belgium) and has operations in Madrid (Spain), and Sittard-Geleen (the Netherlands). For more information please visit www.tigenix.com.
This document may contain forward-looking statements and estimates with respect to the anticipated future performance of TiGenix and the market in which it operates. Certain of these statements, forecasts and estimates can be recognised by the use of words such as, without limitation, "believes", "anticipates", "expects", "intends", "plans", "seeks", "estimates", "may", "will" and "continue" and similar expressions. They include all matters that are not historical facts. Such statements, forecasts and estimates are based on various assumptions and assessments of known and unknown risks, uncertainties and other factors, which were deemed reasonable when made but may or may not prove to be correct. Actual events are difficult to predict and may depend upon factors that are beyond TiGenix' control. Therefore, actual results, the financial condition, performance or achievements of TiGenix, or industry results, may turn out to be materially different from any future results, performance or achievements expressed or implied by such statements, forecasts and estimates. Given these uncertainties, no representations are made as to the accuracy or fairness of such forward-looking statements, forecasts and estimates. Furthermore, forward-looking statements, forecasts and estimates only speak as of the date of the publication of this document. TiGenix disclaims any obligation to update any such forward-looking statement, forecast or estimates to reflect any change in TiGenix' expectations with regard thereto, or any change in events, conditions or circumstances on which any such statement, forecast or estimate is based, except to the extent required by Belgian law.
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 ...
Oct. 10, 2015 01:00 AM EDT Reads: 750
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.
Oct. 10, 2015 12:00 AM EDT Reads: 176
SYS-CON Events announced today that Dyn, the worldwide leader in Internet Performance, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3-5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. Dyn is a cloud-based Internet Performance company. Dyn helps companies monitor, control, and optimize online infrastructure for an exceptional end-user experience. Through a world-class network and unrivaled, objective intelligence into Internet conditions, Dyn ensures traffic gets delivered faster, safer, and more reliably than ever.
Oct. 9, 2015 11:00 PM EDT Reads: 653
Today air travel is a minefield of delays, hassles and customer disappointment. Airlines struggle to revitalize the experience. GE and M2Mi will demonstrate practical examples of how IoT solutions are helping airlines bring back personalization, reduce trip time and improve reliability. In their session at @ThingsExpo, Shyam Varan Nath, Principal Architect with GE, and Dr. Sarah Cooper, M2Mi's VP Business Development and Engineering, will explore the IoT cloud-based platform technologies driving this change including privacy controls, data transparency and integration of real time context w...
Oct. 9, 2015 10:15 PM EDT Reads: 144
Who are you? How do you introduce yourself? Do you use a name, or do you greet a friend by the last four digits of his social security number? Assuming you don’t, why are we content to associate our identity with 10 random digits assigned by our phone company? Identity is an issue that affects everyone, but as individuals we don’t spend a lot of time thinking about it. In his session at @ThingsExpo, Ben Klang, Founder & President of Mojo Lingo, will discuss the impact of technology on identity. Should we federate, or not? How should identity be secured? Who owns the identity? How is identity ...
Oct. 9, 2015 10:00 PM EDT Reads: 456
The IoT market is on track to hit $7.1 trillion in 2020. The reality is that only a handful of companies are ready for this massive demand. There are a lot of barriers, paint points, traps, and hidden roadblocks. How can we deal with these issues and challenges? The paradigm has changed. Old-style ad-hoc trial-and-error ways will certainly lead you to the dead end. What is mandatory is an overarching and adaptive approach to effectively handle the rapid changes and exponential growth.
Oct. 9, 2015 10:00 PM EDT Reads: 248
The buzz continues for cloud, data analytics and the Internet of Things (IoT) and their collective impact across all industries. But a new conversation is emerging - how do companies use industry disruption and technology enablers to lead in markets undergoing change, uncertainty and ambiguity? Organizations of all sizes need to evolve and transform, often under massive pressure, as industry lines blur and merge and traditional business models are assaulted and turned upside down. In this new data-driven world, marketplaces reign supreme while interoperability, APIs and applications deliver un...
Oct. 9, 2015 08:00 PM EDT Reads: 321
Electric power utilities face relentless pressure on their financial performance, and reducing distribution grid losses is one of the last untapped opportunities to meet their business goals. Combining IoT-enabled sensors and cloud-based data analytics, utilities now are able to find, quantify and reduce losses faster – and with a smaller IT footprint. Solutions exist using Internet-enabled sensors deployed temporarily at strategic locations within the distribution grid to measure actual line loads.
Oct. 9, 2015 06:30 PM EDT Reads: 144
The Internet of Everything is re-shaping technology trends–moving away from “request/response” architecture to an “always-on” Streaming Web where data is in constant motion and secure, reliable communication is an absolute necessity. As more and more THINGS go online, the challenges that developers will need to address will only increase exponentially. In his session at @ThingsExpo, Todd Greene, Founder & CEO of PubNub, will explore the current state of IoT connectivity and review key trends and technology requirements that will drive the Internet of Things from hype to reality.
Oct. 9, 2015 05:30 PM EDT Reads: 122
The Internet of Things (IoT) is growing rapidly by extending current technologies, products and networks. By 2020, Cisco estimates there will be 50 billion connected devices. Gartner has forecast revenues of over $300 billion, just to IoT suppliers. Now is the time to figure out how you’ll make money – not just create innovative products. With hundreds of new products and companies jumping into the IoT fray every month, there’s no shortage of innovation. Despite this, McKinsey/VisionMobile data shows "less than 10 percent of IoT developers are making enough to support a reasonably sized team....
Oct. 9, 2015 04:00 PM EDT Reads: 252
You have your devices and your data, but what about the rest of your Internet of Things story? Two popular classes of technologies that nicely handle the Big Data analytics for Internet of Things are Apache Hadoop and NoSQL. Hadoop is designed for parallelizing analytical work across many servers and is ideal for the massive data volumes you create with IoT devices. NoSQL databases such as Apache HBase are ideal for storing and retrieving IoT data as “time series data.”
Oct. 9, 2015 03:45 PM EDT Reads: 513
Today’s connected world is moving from devices towards things, what this means is that by using increasingly low cost sensors embedded in devices we can create many new use cases. These span across use cases in cities, vehicles, home, offices, factories, retail environments, worksites, health, logistics, and health. These use cases rely on ubiquitous connectivity and generate massive amounts of data at scale. These technologies enable new business opportunities, ways to optimize and automate, along with new ways to engage with users.
Oct. 9, 2015 02:00 PM EDT Reads: 194
The IoT is upon us, but today’s databases, built on 30-year-old math, require multiple platforms to create a single solution. Data demands of the IoT require Big Data systems that can handle ingest, transactions and analytics concurrently adapting to varied situations as they occur, with speed at scale. In his session at @ThingsExpo, Chad Jones, chief strategy officer at Deep Information Sciences, will look differently at IoT data so enterprises can fully leverage their IoT potential. He’ll share tips on how to speed up business initiatives, harness Big Data and remain one step ahead by apply...
Oct. 9, 2015 01:45 PM EDT Reads: 568
There will be 20 billion IoT devices connected to the Internet soon. What if we could control these devices with our voice, mind, or gestures? What if we could teach these devices how to talk to each other? What if these devices could learn how to interact with us (and each other) to make our lives better? What if Jarvis was real? How can I gain these super powers? In his session at 17th Cloud Expo, Chris Matthieu, co-founder and CTO of Octoblu, will show you!
Oct. 9, 2015 01:15 PM EDT
As a company adopts a DevOps approach to software development, what are key things that both the Dev and Ops side of the business must keep in mind to ensure effective continuous delivery? In his session at DevOps Summit, Mark Hydar, Head of DevOps, Ericsson TV Platforms, will share best practices and provide helpful tips for Ops teams to adopt an open line of communication with the development side of the house to ensure success between the two sides.
Oct. 9, 2015 01:00 PM EDT Reads: 621
SYS-CON Events announced today that ProfitBricks, the provider of painless cloud infrastructure, will exhibit at SYS-CON's 17th International Cloud Expo®, which will take place on November 3–5, 2015, at the Santa Clara Convention Center in Santa Clara, CA. ProfitBricks is the IaaS provider that offers a painless cloud experience for all IT users, with no learning curve. ProfitBricks boasts flexible cloud servers and networking, an integrated Data Center Designer tool for visual control over the cloud and the best price/performance value available. ProfitBricks was named one of the coolest Clo...
Oct. 9, 2015 01:00 PM EDT Reads: 808
SYS-CON Events announced today that IBM Cloud Data Services 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. IBM Cloud Data Services offers a portfolio of integrated, best-of-breed cloud data services for developers focused on mobile computing and analytics use cases.
Oct. 9, 2015 12:00 PM EDT Reads: 746
SYS-CON Events announced today that Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, will keynote 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.
Oct. 9, 2015 11:15 AM EDT
Developing software for the Internet of Things (IoT) comes with its own set of challenges. Security, privacy, and unified standards are a few key issues. In addition, each IoT product is comprised of at least three separate application components: the software embedded in the device, the backend big-data service, and the mobile application for the end user's controls. Each component is developed by a different team, using different technologies and practices, and deployed to a different stack/target - this makes the integration of these separate pipelines and the coordination of software upd...
Oct. 9, 2015 09:00 AM EDT Reads: 302
Mobile messaging has been a popular communication channel for more than 20 years. Finnish engineer Matti Makkonen invented the idea for SMS (Short Message Service) in 1984, making his vision a reality on December 3, 1992 by sending the first message ("Happy Christmas") from a PC to a cell phone. Since then, the technology has evolved immensely, from both a technology standpoint, and in our everyday uses for it. Originally used for person-to-person (P2P) communication, i.e., Sally sends a text message to Betty – mobile messaging now offers tremendous value to businesses for customer and empl...
Oct. 9, 2015 08:30 AM EDT Reads: 318