|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.
The basic integration architecture, as defined by ESBs, hasn’t changed for more than a decade. Most cloud integration providers still rely on an ESB architecture and their proprietary connectors. As a result, enterprise integration projects suffer from constraints of availability and reliability of these connectors that are not re-usable across other integration vendors. However, the rapid adoption of APIs and almost ubiquitous availability of APIs amongst most SaaS and Cloud applications are rapidly redefining traditional integration approaches and their reliance on proprietary connectors. ...
Jul. 2, 2015 03:18 PM EDT Reads: 548
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 addressed this very serious issue of profound change in the industry.
Jul. 2, 2015 02:30 PM EDT Reads: 1,195
Internet of Things is moving from being a hype to a reality. Experts estimate that internet connected cars will grow to 152 million, while over 100 million internet connected wireless light bulbs and lamps will be operational by 2020. These and many other intriguing statistics highlight the importance of Internet powered devices and how market penetration is going to multiply many times over in the next few years.
Jul. 2, 2015 02:15 PM EDT Reads: 2,200
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 wi...
Jul. 2, 2015 02:00 PM EDT Reads: 1,048
Internet of Things (IoT) will be a hybrid ecosystem of diverse devices and sensors collaborating with operational and enterprise systems to create the next big application. In their session at @ThingsExpo, Bramh Gupta, founder and CEO of robomq.io, and Fred Yatzeck, principal architect leading product development at robomq.io, discussed how choosing the right middleware and integration strategy from the get-go will enable IoT solution developers to adapt and grow with the industry, while at the same time reduce Time to Market (TTM) by using plug and play capabilities offered by a robust IoT ...
Jul. 2, 2015 12:00 PM EDT Reads: 2,024
"We have a tagline - "Power in the API Economy." What that means is everything that is built in applications and connected applications is done through APIs," explained Roberto Medrano, Executive Vice President at Akana, in this SYS-CON.tv interview at 16th Cloud Expo, held June 9-11, 2015, at the Javits Center in New York City.
Jul. 2, 2015 11:15 AM EDT Reads: 1,053
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 @ThingsExpo, James Kirkland, Red Hat's Chief Architect for the Internet of Things and Intelligent Systems, described how to revolutionize your archit...
Jul. 2, 2015 09:30 AM EDT Reads: 836
WebRTC converts the entire network into a ubiquitous communications cloud thereby connecting anytime, anywhere through any point. In his session at WebRTC Summit,, Mark Castleman, EIR at Bell Labs and Head of Future X Labs, will discuss how the transformational nature of communications is achieved through the democratizing force of WebRTC. WebRTC is doing for voice what HTML did for web content.
Jul. 2, 2015 09:24 AM EDT Reads: 606
It is one thing to build single industrial IoT applications, but what will it take to build the Smart Cities and truly society-changing applications of the future? The technology won’t be the problem, it will be the number of parties that need to work together and be aligned in their motivation to succeed. In his session at @ThingsExpo, Jason Mondanaro, Director, Product Management at Metanga, discussed how you can plan to cooperate, partner, and form lasting all-star teams to change the world and it starts with business models and monetization strategies.
Jul. 2, 2015 08:00 AM EDT Reads: 2,311
To many people, IoT is a buzzword whose value is not understood. Many people think IoT is all about wearables and home automation. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed some incredible game-changing use cases and how they are transforming industries like agriculture, manufacturing, health care, and smart cities. He will discuss cool technologies like smart dust, robotics, smart labels, and much more. Prepare to be blown away with a glimpse of the future.
Jul. 2, 2015 07:30 AM EDT Reads: 923
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...
Jun. 29, 2015 12:15 PM EDT Reads: 2,734
There will be 150 billion connected devices by 2020. New digital businesses have already disrupted value chains across every industry. APIs are at the center of the digital business. You need to understand what assets you have that can be exposed digitally, what their digital value chain is, and how to create an effective business model around that value chain to compete in this economy. No enterprise can be complacent and not engage in the digital economy. Learn how to be the disruptor and not the disruptee.
Jun. 29, 2015 11:00 AM EDT Reads: 2,215
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.
Jun. 29, 2015 09:45 AM EDT Reads: 2,569
Business as usual for IT is evolving into a "Make or Buy" decision on a service-by-service conversation with input from the LOBs. How does your organization move forward with cloud? In his general session at 16th Cloud Expo, Paul Maravei, Regional Sales Manager, Hybrid Cloud and Managed Services at Cisco, discusses how Cisco and its partners offer a market-leading portfolio and ecosystem of cloud infrastructure and application services that allow you to uniquely and securely combine cloud business applications and services across multiple cloud delivery models.
Jun. 28, 2015 11:00 AM EDT Reads: 2,269
In his General Session at 16th Cloud Expo, David Shacochis, host of The Hybrid IT Files podcast and Vice President at CenturyLink, investigated three key trends of the “gigabit economy" though the story of a Fortune 500 communications company in transformation. Narrating how multi-modal hybrid IT, service automation, and agile delivery all intersect, he will cover the role of storytelling and empathy in achieving strategic alignment between the enterprise and its information technology.
Jun. 27, 2015 10:00 AM EDT Reads: 2,287
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 peeled 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 fillin...
Jun. 26, 2015 12:00 PM EDT Reads: 2,275
Growth hacking is common for startups to make unheard-of progress in building their business. Career Hacks can help Geek Girls and those who support them (yes, that's you too, Dad!) to excel in this typically male-dominated world. Get ready to learn the facts: Is there a bias against women in the tech / developer communities? Why are women 50% of the workforce, but hold only 24% of the STEM or IT positions? Some beginnings of what to do about it! In her Opening Keynote at 16th Cloud Expo, Sandy Carter, IBM General Manager Cloud Ecosystem and Developers, and a Social Business Evangelist, d...
Jun. 26, 2015 10:00 AM EDT Reads: 2,154
Converging digital disruptions is creating a major sea change - Cisco calls this the Internet of Everything (IoE). IoE is the network connection of People, Process, Data and Things, fueled by Cloud, Mobile, Social, Analytics and Security, and it represents a $19Trillion value-at-stake over the next 10 years. In her keynote at @ThingsExpo, Manjula Talreja, VP of Cisco Consulting Services, discussed IoE and the enormous opportunities it provides to public and private firms alike. She will share what businesses must do to thrive in the IoE economy, citing examples from several industry sectors.
Jun. 25, 2015 02:00 PM EDT Reads: 2,055
In his keynote at 16th Cloud Expo, Rodney Rogers, CEO of Virtustream, discussed the evolution of the company from inception to its recent acquisition by EMC – including personal insights, lessons learned (and some WTF moments) along the way. Learn how Virtustream’s unique approach of combining the economics and elasticity of the consumer cloud model with proper performance, application automation and security into a platform became a breakout success with enterprise customers and a natural fit for the EMC Federation.
Jun. 25, 2015 01:30 PM EDT Reads: 2,211
SYS-CON Events announced today that the "Second Containers & Microservices Conference" will take place November 3-5, 2015, at the Santa Clara Convention Center, Santa Clara, CA, and the “Third Containers & Microservices Conference” will take place June 7-9, 2016, at Javits Center in New York City. Containers and microservices have become topics of intense interest throughout the cloud developer and enterprise IT communities.
Jun. 22, 2015 02:15 PM EDT Reads: 2,870