|By Marketwired .||
|December 18, 2012 11:41 AM EST||
LOS ANGELES, CA -- (Marketwire) -- 12/18/12 -- ArQule, Inc. engages in the research and development of cancer therapeutics directed toward molecular targets and biological processes.
The firm's lead product candidate Tivantinib (ARQ 197) is an inhibitor of the c-Met receptor tyrosine kinase, which is in Phase 3 clinical trial for the treatment of liver cancer and colorectal cancer (CRC). The company also develops ARQ 621, an inhibitor of the Eg5 kinesin motor protein that has completed Phase I trial; ARQ 736, an inhibitor of the RAF kinases, which is in Phase I clinical trial; ARQ 761, an activator of the E2F-1 damage response/checkpoint pathway; and ARQ 087, an inhibitor of fibroblast growth factor receptor that is in pre-clinical stage. It has partnership agreement with Daiichi Sankyo Co., Ltd. and Kyowa Hakko Kirin Co., Ltd.
The lead product candidate is Tivantinib (ARQ 197), an orally administered, small molecule inhibitor of the c-Met receptor tyrosine kinase. C-Met is a promising target for cancer therapy based on its multiple roles in cancerous cell proliferation, tumor spread, new blood vessel formation and resistance to certain drug therapies. ArQule and its partners, Daiichi Sankyo Co., Ltd. and Kyowa Hakko Kirin Co., Ltd, are implementing a clinical development program designed to realize the broad potential of Tivantinib as a well-tolerated single agent and in combination with other anti-cancer therapies in a number of disease indications. The company's strategy is to focus on the most promising indications within the clinical programs based upon data that is continually generated. Its leading indications include liver cancer, non-small cell lung cancer, and colorectal cancer. The company is also completing earlier-stage combination therapy trials with Tivantinib and other anti-cancer agents that may provide data to support later-stage trials in additional indications.
On October 16, 2012, the company announced a Special Protocol Assessment agreement with the U.S. Food and Drug Administration for the design of a pivotal Phase III trial of Tivantinib in patients with HCC. The Phase III trial will be a randomized, double-blinded study of Tivantinib as single agent therapy in previously treated patients with MET diagnostic-high inoperable HCC. The primary endpoint is overall survival in the intent-to-treat population, and the secondary endpoint is progression free survival in the same population. Approximately 300 patients are planned to be enrolled at approximately 120 centers worldwide.
ArQule has advanced into Phase III clinical with ARQ 197. C-Met is a promising target for cancer therapy, as evidence suggests that it plays multiple roles in cancerous cell proliferation, tumor spread, new blood vessel formation and drug resistance. The company believes that the inappropriate expression of c-Met in many cancers and its involvement in multiple signal transduction pathways affecting tumor growth and metastasis render it a compelling target for cancer therapy.
Oncology research and development activities are increasingly focused on kinases, which play pivotal roles in modulating diverse cellular activities and have been implicated as important mediators of certain forms of cancer and other diseases. The success of kinase inhibitors such as Gleevec and Nexavar has focused attention on the kinase field, resulting in the increased development of next-generation inhibitors that target cancers and other diseases such as inflammation. The current market for protein kinase inhibitors is estimated to exceed $7 billion, and by 2020, small-molecule kinase inhibitors are projected to generate collectively annual revenues greater than $25 billion.
ArQule has extensively studied the mechanism by which ARQ 197 selectively inhibits its target c-Met receptor kinase. These studies have revealed the molecular and structural basis by which ARQ 197 targets c-Met. ARQ 197 inhibits c-Met autophosphorylation and is selective for the inactive or unphosphorylated form of c-Met. Elucidation of this novel mode of inhibition of c-Met has opened up the opportunity for the design and development of similar selective inhibitors for other kinases.
Drug discovery at ArQule utilizes a proven innovative and efficient drug discovery engine which employs a proprietary structure-based drug design technology known as the ArQule Kinase Inhibitor Platform (AKIP). This platform targets inactive forms of kinases that have pivotal roles in cancer and other diseases. AKIP integrates in silico drug design, parallel robotic chemistry, and novel assay development expertise to create non-ATP competitive inhibitors that interact with these kinases in novel binding modes. Inhibitors identified through AKIP are optimized into drug candidates having the appropriate efficacy and selectivity for their target with minimal side effects.
The company believes it has within this platform the capability to rationally design novel kinase inhibitors that encompass new chemical spaces and allow for an expanding intellectual property estate. It anticipates that these novel kinase inhibitors, when targeted against selected therapeutically relevant kinases, will have utility in a broad range of human diseases in addition to cancer.
The company is seeking to expand the applications of this proprietary drug discovery platform through collaborative research programs as well as through our own internal discovery and development activities in multiple therapeutic areas.
ArQule has a collaboration with Daiichi Sankyo Co., Ltd. to apply its AKIP technology in the discovery of therapeutic compounds that selectively inhibit certain kinases in the field of oncology.
It is also independently applying AKIP to the discovery of inhibitors of fibroblast growth factor receptor (FGFR). Progress to date has resulted in a series of small molecule inhibitors of FGFR that are not ATP-competitive and show potent anti-tumor activity in FGFR-driven human and animal cancer models.
Daiichi Sankyo (DS) is ArQule's co-development worldwide partner for ARQ 197, (except Asia) and paid ArQule $60M upfront, with another $560M due for potential milestones and tiered double-digit royalties. The most recent milestone was a $25M payment for the initiation of the MARQUEE Phase III trial. DS retains all ex-Asia commercial rights, with ArQule retaining the US co-commercialization rights. There has been some speculation that DS is considering acquiring ArQule, but I have yet to hear from a real source on this front regarding this.
Right off the bat, it seems to me that ArQule is very undervalued speculation wise, with its current market cap of $178.30M.
Balance Sheet Total Cash (mrq): 120M (estimated) Total Cash Per Share (mrq): 1.33 Total Debt (mrq): 1.70M Total Debt/Equity (mrq): 1.99 Current Ratio (mrq): 2.11 Book Value Per Share (mrq): 1.37 Cash Flow Statement Operating Cash Flow (ttm): -41.54M (Yearly) Levered Free Cash Flow (ttm): -16.95M
Right off the bat, it seems to us that ArQule is undervalued with its current market cap of $178.30M.
Potential catalyst trade:
Phase II top-line data covering CRC is due out by the end of this year/early next year for ARQ 197. The data release will estimate the difference in progression-free survival (PFS) between the study and control arms in subjects with CRC with wild-type KRAS who have received front-line therapy. Positive data here would likely gap the stock up considerably, so traders should keep an eye out for this.
Wi an Eg5 Inhibitor, a BRAF Inhibitor, an FGFR Inhibitor, and an AKT Inhibitor -- a deep pipeline along with the near term catalyst event of top line Phase II data, makes the company's $178.30M market cap undervalued for a mid-stage Oncology biotech in my opinion, and also makes for a good catalyst trade opportunity.
Net Institutional Purchases - Prior Qtr to Latest Qtr Shares Net Shares Purchased 5,640,490 % Change in Institutional Shares Held 10.48%
Institutions have increased their stake by over 10% in the company lately, which is always a good sign.
Also of note, Edison Investment Research values ArQule at $5.40 a share, which equates to a market cap of about $376M, more than double the company's current market cap.
This chart was taken from Robert Pedone's Street article published a couple of weeks ago. I spoke to Robert yesterday to get his updated take on the charts, and we both agree that if the stock breaks past $3 on decent volume, we could see an upwards gap fill to $4 rather quickly. With the data release expected any day now, I feel ArQule is a good long side trade for the short term, and with good data, possibly a longer term buy and hold.
The Biopharma segment of the market is rather hot these days with companies like Sarepta and Acadia recently seeing large price gaps up on positive data releases.
Our short term price target opinion is $4 a share, and a 1 year target over $10 if the company's platform proves successful in 2013.
Disclosure: Author Scott Matusow @scottmatusow is LONG ARQL
The full report including charts and technical analysis is available at:
Healthcare investors and Biotech traders interested in accessing BioMedReports' new complete database of clinical trials and upcoming FDA and world-wide regulatory decisions which can be used to make more profitable trades and see upcoming catalysts can go to: http://biomedreports.com/fdacal.html
News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports
BioMedReports is a news and research portal covering financial biotech news for the entire Healthcare Sector of the market. BioMedReports is not paid or compensated to report the news and developments of publicly traded companies. BioMedReports sells a premium product for subscribers and full disclosures and information about the stocks and news mentioned in this news release are available at BioMedReports.Com.
Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=2185286
Media Contacts Only:
e-mail: Email Contact
Tel: +1 323 472 4480
Fax: +1 888 210 3556
The definition of IoT is not new, in fact it’s been around for over a decade. What has changed is the public's awareness that the technology we use on a daily basis has caught up on the vision of an always on, always connected world. If you look into the details of what comprises the IoT, you’ll see that it includes everything from cloud computing, Big Data analytics, “Things,” Web communication, applications, network, storage, etc. It is essentially including everything connected online from hardware to software, or as we like to say, it’s an Internet of many different things. The difference ...
Nov. 22, 2014 10:00 PM EST Reads: 944
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world.
Nov. 22, 2014 05:30 PM EST Reads: 1,238
An entirely new security model is needed for the Internet of Things, or is it? Can we save some old and tested controls for this new and different environment? In his session at @ThingsExpo, New York's at the Javits Center, Davi Ottenheimer, EMC Senior Director of Trust, reviewed hands-on lessons with IoT devices and reveal a new risk balance you might not expect. Davi Ottenheimer, EMC Senior Director of Trust, has more than nineteen years' experience managing global security operations and assessments, including a decade of leading incident response and digital forensics. He is co-author of t...
Nov. 22, 2014 05:30 PM EST Reads: 1,007
ARMONK, N.Y., Nov. 20, 2014 /PRNewswire/ -- IBM (NYSE: IBM) today announced that it is bringing a greater level of control, security and flexibility to cloud-based application development and delivery with a single-tenant version of Bluemix, IBM's platform-as-a-service. The new platform enables developers to build ap...
Nov. 22, 2014 05:30 PM EST Reads: 1,341
The major cloud platforms defy a simple, side-by-side analysis. Each of the major IaaS public-cloud platforms offers their own unique strengths and functionality. Options for on-site private cloud are diverse as well, and must be designed and deployed while taking existing legacy architecture and infrastructure into account. Then the reality is that most enterprises are embarking on a hybrid cloud strategy and programs. In this Power Panel at 15th Cloud Expo (http://www.CloudComputingExpo.com), moderated by Ashar Baig, Research Director, Cloud, at Gigaom Research, Nate Gordon, Director of T...
Nov. 22, 2014 07:00 AM EST Reads: 1,322
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 Internet of @ThingsExpo, James Kirkland, Chief Architect for the Internet of Things and Intelligent Systems at Red Hat, described how to revolutioniz...
Nov. 21, 2014 09:15 PM EST Reads: 1,241
Technology is enabling a new approach to collecting and using data. This approach, commonly referred to as the "Internet of Things" (IoT), enables businesses to use real-time data from all sorts of things including machines, devices and sensors to make better decisions, improve customer service, and lower the risk in the creation of new revenue opportunities. In his General Session at Internet of @ThingsExpo, Dave Wagstaff, Vice President and Chief Architect at BSQUARE Corporation, discuss the real benefits to focus on, how to understand the requirements of a successful solution, the flow of ...
Nov. 21, 2014 08:00 PM EST Reads: 1,320
The security devil is always in the details of the attack: the ones you've endured, the ones you prepare yourself to fend off, and the ones that, you fear, will catch you completely unaware and defenseless. The Internet of Things (IoT) is nothing if not an endless proliferation of details. It's the vision of a world in which continuous Internet connectivity and addressability is embedded into a growing range of human artifacts, into the natural world, and even into our smartphones, appliances, and physical persons. In the IoT vision, every new "thing" - sensor, actuator, data source, data con...
Nov. 21, 2014 08:00 PM EST Reads: 1,258
"BSQUARE is in the business of selling software solutions for smart connected devices. It's obvious that IoT has moved from being a technology to being a fundamental part of business, and in the last 18 months people have said let's figure out how to do it and let's put some focus on it, " explained Dave Wagstaff, VP & Chief Architect, at BSQUARE Corporation, in this SYS-CON.tv interview at @ThingsExpo, held Nov 4-6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 21, 2014 07:00 PM EST Reads: 1,196
Focused on this fast-growing market’s needs, Vitesse Semiconductor Corporation (Nasdaq: VTSS), a leading provider of IC solutions to advance "Ethernet Everywhere" in Carrier, Enterprise and Internet of Things (IoT) networks, introduced its IStaX™ software (VSC6815SDK), a robust protocol stack to simplify deployment and management of Industrial-IoT network applications such as Industrial Ethernet switching, surveillance, video distribution, LCD signage, intelligent sensors, and metering equipment. Leveraging technologies proven in the Carrier and Enterprise markets, IStaX is designed to work ac...
Nov. 20, 2014 09:15 PM EST Reads: 1,307
"There is a natural synchronization between the business models, the IoT is there to support ,” explained Brendan O'Brien, Co-founder and Chief Architect of Aria Systems, in this SYS-CON.tv interview at the 15th International Cloud Expo®, held Nov 4–6, 2014, at the Santa Clara Convention Center in Santa Clara, CA.
Nov. 20, 2014 07:30 PM EST Reads: 1,484
C-Labs LLC, a leading provider of remote and mobile access for the Internet of Things (IoT), announced the appointment of John Traynor to the position of chief operating officer. Previously a strategic advisor to the firm, Mr. Traynor will now oversee sales, marketing, finance, and operations. Mr. Traynor is based out of the C-Labs office in Redmond, Washington. He reports to Chris Muench, Chief Executive Officer. Mr. Traynor brings valuable business leadership and technology industry expertise to C-Labs. With over 30 years' experience in the high-tech sector, John Traynor has held numerous...
Nov. 20, 2014 06:00 PM EST Reads: 1,259
Bit6 today issued a challenge to the technology community implementing Web Real Time Communication (WebRTC). To leap beyond WebRTC’s significant limitations and fully leverage its underlying value to accelerate innovation, application developers need to consider the entire communications ecosystem.
Nov. 20, 2014 04:45 PM EST Reads: 1,033
The 3rd International @ThingsExpo, co-located with the 16th International Cloud Expo - to be held June 9-11, 2015, at the Javits Center in New York City, NY - announces that it is now accepting Keynote Proposals. The Internet of Things (IoT) is the most profound change in personal and enterprise IT since the creation of the Worldwide Web more than 20 years ago. 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.
Nov. 20, 2014 01:00 PM EST Reads: 1,496
The Internet of Things is not new. Historically, smart businesses have used its basic concept of leveraging data to drive better decision making and have capitalized on those insights to realize additional revenue opportunities. So, what has changed to make the Internet of Things one of the hottest topics in tech? In his session at @ThingsExpo, Chris Gray, Director, Embedded and Internet of Things, discussed the underlying factors that are driving the economics of intelligent systems. Discover how hardware commoditization, the ubiquitous nature of connectivity, and the emergence of Big Data a...
Nov. 20, 2014 12:30 PM EST Reads: 1,739
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.
Nov. 18, 2014 09:00 PM EST Reads: 1,978
SYS-CON Events announced today that Windstream, a leading provider of advanced network and cloud communications, has been named “Silver Sponsor” of SYS-CON's 16th International Cloud Expo®, which will take place on June 9–11, 2015, at the Javits Center in New York, NY. Windstream (Nasdaq: WIN), a FORTUNE 500 and S&P 500 company, is a leading provider of advanced network communications, including cloud computing and managed services, to businesses nationwide. The company also offers broadband, phone and digital TV services to consumers primarily in rural areas.
Nov. 18, 2014 08:15 PM EST Reads: 1,547
SYS-CON Events announced today that IDenticard 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. IDenticard™ is the security division of Brady Corp (NYSE: BRC), a $1.5 billion manufacturer of identification products. We have small-company values with the strength and stability of a major corporation. IDenticard offers local sales, support and service to our customers across the United States and Canada. Our partner network encompasses some 300 of the world's leading systems integrators and security s...
Nov. 18, 2014 08:15 PM EST Reads: 1,491
IoT is still a vague buzzword for many people. In his session at @ThingsExpo, Mike Kavis, Vice President & Principal Cloud Architect at Cloud Technology Partners, discussed the business value of IoT that goes far beyond the general public's perception that IoT is all about wearables and home consumer services. He also discussed how IoT is perceived by investors and how venture capitalist access this space. Other topics discussed were barriers to success, what is new, what is old, and what the future may hold. Mike Kavis is Vice President & Principal Cloud Architect at Cloud Technology Pa...
Nov. 18, 2014 01:30 PM EST Reads: 1,977
Cloud Expo 2014 TV commercials will feature @ThingsExpo, which was launched in June, 2014 at New York City's Javits Center as the largest 'Internet of Things' event in the world. The next @ThingsExpo will take place November 4-6, 2014, at the Santa Clara Convention Center, in Santa Clara, California. Since its launch in 2008, Cloud Expo TV commercials have been aired and CNBC, Fox News Network, and Bloomberg TV. Please enjoy our 2014 commercial.
Nov. 13, 2014 05:00 AM EST Reads: 3,518