Welcome!

Microsoft Cloud Authors: Dana Gardner, David Bermingham, Jayaram Krishnaswamy, Pat Romanski, Adine Deford

News Feed Item

Near Term Catalyst Has ArQule Poised for a Move Up

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:

http://www.biomedreports.com/20121218116847/arqule-a-strong-speculative-biopharma-poised-for-a-quick-move-up-on-near-term-catalyst.html

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

Follow Us

News developments and live healthcare sector updates are available constantly via twitter at: http://twitter.com/BioMedReports

About BioMedReports.Com

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

Add to Digg Bookmark with del.icio.us Add to Newsvine

Media Contacts Only:
Mary Davila
Assistant Editor
BioMedReports.Com
e-mail: Email Contact
Tel: +1 323 472 4480
Fax: +1 888 210 3556

More Stories By Marketwired .

Copyright © 2009 Marketwired. All rights reserved. All the news releases provided by Marketwired are copyrighted. Any forms of copying other than an individual user's personal reference without express written permission is prohibited. Further distribution of these materials is strictly forbidden, including but not limited to, posting, emailing, faxing, archiving in a public database, redistributing via a computer network or in a printed form.

@ThingsExpo Stories
With an estimated 50 billion devices connected to the Internet by 2020, several industries will begin to expand their capabilities for retaining end point data at the edge to better utilize the range of data types and sheer volume of M2M data generated by the Internet of Things. In his session at @ThingsExpo, Don DeLoach, CEO and President of Infobright, will discuss the infrastructures businesses will need to implement to handle this explosion of data by providing specific use cases for filte...
Fortunately, meaningful and tangible business cases for IoT are plentiful in a broad array of industries and vertical markets. These range from simple warranty cost reduction for capital intensive assets, to minimizing downtime for vital business tools, to creating feedback loops improving product design, to improving and enhancing enterprise customer experiences. All of these business cases, which will be briefly explored in this session, hinge on cost effectively extracting relevant data from ...
SYS-CON Events announced today that VAI, a leading ERP software provider, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. VAI (Vormittag Associates, Inc.) is a leading independent mid-market ERP software developer renowned for its flexible solutions and ability to automate critical business functions for the distribution, manufacturing, specialty retail and service sectors. An IBM Premier Business Part...
SYS-CON Events announced today that Alert Logic, Inc., the leading provider of Security-as-a-Service solutions for the cloud, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Alert Logic, Inc., provides Security-as-a-Service for on-premises, cloud, and hybrid infrastructures, delivering deep security insight and continuous protection for customers at a lower cost than traditional security solutions. Ful...
SYS-CON Events announced today that Interoute, owner-operator of one of Europe's largest networks and a global cloud services platform, has been named “Bronze Sponsor” of SYS-CON's 18th Cloud Expo, which will take place on June 7-9, 2015 at the Javits Center in New York, New York. Interoute is the owner-operator of one of Europe's largest networks and a global cloud services platform which encompasses 12 data centers, 14 virtual data centers and 31 colocation centers, with connections to 195 ad...
As enterprises work to take advantage of Big Data technologies, they frequently become distracted by product-level decisions. In most new Big Data builds this approach is completely counter-productive: it presupposes tools that may not be a fit for development teams, forces IT to take on the burden of evaluating and maintaining unfamiliar technology, and represents a major up-front expense. In his session at @BigDataExpo at @ThingsExpo, Andrew Warfield, CTO and Co-Founder of Coho Data, will dis...
SYS-CON Events announced today that Commvault, a global leader in enterprise data protection and information management, has been named “Bronze Sponsor” of SYS-CON's 18th International Cloud Expo, which will take place on June 7–9, 2016, at the Javits Center in New York City, NY, and the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Commvault is a leading provider of data protection and information management...
The cloud promises new levels of agility and cost-savings for Big Data, data warehousing and analytics. But it’s challenging to understand all the options – from IaaS and PaaS to newer services like HaaS (Hadoop as a Service) and BDaaS (Big Data as a Service). In her session at @BigDataExpo at @ThingsExpo, Hannah Smalltree, a director at Cazena, will provide an educational overview of emerging “as-a-service” options for Big Data in the cloud. This is critical background for IT and data profes...
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...
SYS-CON Events announced today that Fusion, a leading provider of cloud services, will exhibit at SYS-CON's 18th International Cloud Expo®, which will take place on June 7-9, 2016, at the Javits Center in New York City, NY. Fusion, a leading provider of integrated cloud solutions to small, medium and large businesses, is the industry's single source for the cloud. Fusion's advanced, proprietary cloud service platform enables the integration of leading edge solutions in the cloud, including clou...
Most people haven’t heard the word, “gamification,” even though they probably, and perhaps unwittingly, participate in it every day. Gamification is “the process of adding games or game-like elements to something (as a task) so as to encourage participation.” Further, gamification is about bringing game mechanics – rules, constructs, processes, and methods – into the real world in an effort to engage people. In his session at @ThingsExpo, Robert Endo, owner and engagement manager of Intrepid D...
Eighty percent of a data scientist’s time is spent gathering and cleaning up data, and 80% of all data is unstructured and almost never analyzed. Cognitive computing, in combination with Big Data, is changing the equation by creating data reservoirs and using natural language processing to enable analysis of unstructured data sources. This is impacting every aspect of the analytics profession from how data is mined (and by whom) to how it is delivered. This is not some futuristic vision: it's ha...
WebRTC has had a real tough three or four years, and so have those working with it. Only a few short years ago, the development world were excited about WebRTC and proclaiming how awesome it was. You might have played with the technology a couple of years ago, only to find the extra infrastructure requirements were painful to implement and poorly documented. This probably left a bitter taste in your mouth, especially when things went wrong.
Learn how IoT, cloud, social networks and last but not least, humans, can be integrated into a seamless integration of cooperative organisms both cybernetic and biological. This has been enabled by recent advances in IoT device capabilities, messaging frameworks, presence and collaboration services, where devices can share information and make independent and human assisted decisions based upon social status from other entities. In his session at @ThingsExpo, Michael Heydt, founder of Seamless...
The IoT's basic concept of collecting data from as many sources possible to drive better decision making, create process innovation and realize additional revenue has been in use at large enterprises with deep pockets for decades. So what has changed? In his session at @ThingsExpo, Prasanna Sivaramakrishnan, Solutions Architect at Red Hat, discussed the impact commodity hardware, ubiquitous connectivity, and innovations in open source software are having on the connected universe of people, thi...
WebRTC: together these advances have created a perfect storm of technologies that are disrupting and transforming classic communications models and ecosystems. In his session at WebRTC Summit, Cary Bran, VP of Innovation and New Ventures at Plantronics and PLT Labs, provided an overview of this technological shift, including associated business and consumer communications impacts, and opportunities it may enable, complement or entirely transform.
For manufacturers, the Internet of Things (IoT) represents a jumping-off point for innovation, jobs, and revenue creation. But to adequately seize the opportunity, manufacturers must design devices that are interconnected, can continually sense their environment and process huge amounts of data. As a first step, manufacturers must embrace a new product development ecosystem in order to support these products.
There are so many tools and techniques for data analytics that even for a data scientist the choices, possible systems, and even the types of data can be daunting. In his session at @ThingsExpo, Chris Harrold, Global CTO for Big Data Solutions for EMC Corporation, showed how to perform a simple, but meaningful analysis of social sentiment data using freely available tools that take only minutes to download and install. Participants received the download information, scripts, and complete end-t...
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, discussed how when sensors start generating detailed real-world data about products and how they’re being used, smart manufacturers can use the dat...
When it comes to IoT in the enterprise, namely the commercial building and hospitality markets, a benefit not getting the attention it deserves is energy efficiency, and IoT’s direct impact on a cleaner, greener environment when installed in smart buildings. Until now clean technology was offered piecemeal and led with point solutions that require significant systems integration to orchestrate and deploy. There didn't exist a 'top down' approach that can manage and monitor the way a Smart Buildi...