Welcome!

Microsoft Cloud Authors: Janakiram MSV, Pat Romanski, Steven Mandel, John Basso, Liz McMillan

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
The 19th International Cloud Expo has announced that its Call for Papers is open. Cloud Expo, to be held November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, brings together Cloud Computing, Big Data, Internet of Things, DevOps, Digital Transformation, Microservices and WebRTC to one location. With cloud computing driving a higher percentage of enterprise IT budgets every year, it becomes increasingly important to plant your flag in this fast-expanding business opportuni...
19th Cloud Expo, taking place November 1-3, 2016, 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 enterpri...
Personalization has long been the holy grail of marketing. Simply stated, communicate the most relevant offer to the right person and you will increase sales. To achieve this, you must understand the individual. Consequently, digital marketers developed many ways to gather and leverage customer information to deliver targeted experiences. In his session at @ThingsExpo, Lou Casal, Founder and Principal Consultant at Practicala, discussed how the Internet of Things (IoT) has accelerated our abil...
With so much going on in this space you could be forgiven for thinking you were always working with yesterday’s technologies. So much change, so quickly. What do you do if you have to build a solution from the ground up that is expected to live in the field for at least 5-10 years? This is the challenge we faced when we looked to refresh our existing 10-year-old custom hardware stack to measure the fullness of trash cans and compactors.
The emerging Internet of Everything creates tremendous new opportunities for customer engagement and business model innovation. However, enterprises must overcome a number of critical challenges to bring these new solutions to market. In his session at @ThingsExpo, Michael Martin, CTO/CIO at nfrastructure, outlined these key challenges and recommended approaches for overcoming them to achieve speed and agility in the design, development and implementation of Internet of Everything solutions wi...
DevOps at Cloud Expo, taking place Nov 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. The widespread success of cloud computing is driving the DevOps revolution in enterprise IT. Now as never before, development teams must communicate and collaborate in a dynamic, 24/7/365 environment. There is no time to wait for long dev...
Cloud computing is being adopted in one form or another by 94% of enterprises today. Tens of billions of new devices are being connected to The Internet of Things. And Big Data is driving this bus. An exponential increase is expected in the amount of information being processed, managed, analyzed, and acted upon by enterprise IT. This amazing is not part of some distant future - it is happening today. One report shows a 650% increase in enterprise data by 2020. Other estimates are even higher....
I wanted to gather all of my Internet of Things (IOT) blogs into a single blog (that I could later use with my University of San Francisco (USF) Big Data “MBA” course). However as I started to pull these blogs together, I realized that my IOT discussion lacked a vision; it lacked an end point towards which an organization could drive their IOT envisioning, proof of value, app dev, data engineering and data science efforts. And I think that the IOT end point is really quite simple…
Today we can collect lots and lots of performance data. We build beautiful dashboards and even have fancy query languages to access and transform the data. Still performance data is a secret language only a couple of people understand. The more business becomes digital the more stakeholders are interested in this data including how it relates to business. Some of these people have never used a monitoring tool before. They have a question on their mind like “How is my application doing” but no id...
Identity is in everything and customers are looking to their providers to ensure the security of their identities, transactions and data. With the increased reliance on cloud-based services, service providers must build security and trust into their offerings, adding value to customers and improving the user experience. Making identity, security and privacy easy for customers provides a unique advantage over the competition.
Is the ongoing quest for agility in the data center forcing you to evaluate how to be a part of infrastructure automation efforts? As organizations evolve toward bimodal IT operations, they are embracing new service delivery models and leveraging virtualization to increase infrastructure agility. Therefore, the network must evolve in parallel to become equally agile. Read this essential piece of Gartner research for recommendations on achieving greater agility.
Smart Cities are here to stay, but for their promise to be delivered, the data they produce must not be put in new siloes. In his session at @ThingsExpo, Mathias Herberts, Co-founder and CTO of Cityzen Data, will deep dive into best practices that will ensure a successful smart city journey.
Internet of @ThingsExpo, taking place November 1-3, 2016, at the Santa Clara Convention Center in Santa Clara, CA, is co-located with 19th Cloud Expo and will feature technical sessions from a rock star conference faculty and the leading industry players in the world. 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 - comp...
SYS-CON Events announced today that Venafi, the Immune System for the Internet™ and the leading provider of Next Generation Trust Protection, will exhibit at @DevOpsSummit at 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Venafi is the Immune System for the Internet™ that protects the foundation of all cybersecurity – cryptographic keys and digital certificates – so they can’t be misused by bad guys in attacks...
SYS-CON Events announced today Telecom Reseller has been named “Media Sponsor” of SYS-CON's 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Telecom Reseller reports on Unified Communications, UCaaS, BPaaS for enterprise and SMBs. They report extensively on both customer premises based solutions such as IP-PBX as well as cloud based and hosted platforms.
For basic one-to-one voice or video calling solutions, WebRTC has proven to be a very powerful technology. Although WebRTC’s core functionality is to provide secure, real-time p2p media streaming, leveraging native platform features and server-side components brings up new communication capabilities for web and native mobile applications, allowing for advanced multi-user use cases such as video broadcasting, conferencing, and media recording.
Data is the fuel that drives the machine learning algorithmic engines and ultimately provides the business value. In his session at Cloud Expo, Ed Featherston, a director and senior enterprise architect at Collaborative Consulting, will discuss the key considerations around quality, volume, timeliness, and pedigree that must be dealt with in order to properly fuel that engine.
Pulzze Systems was happy to participate in such a premier event and thankful to be receiving the winning investment and global network support from G-Startup Worldwide. It is an exciting time for Pulzze to showcase the effectiveness of innovative technologies and enable them to make the world smarter and better. The reputable contest is held to identify promising startups around the globe that are assured to change the world through their innovative products and disruptive technologies. There w...
Akana has announced the availability of version 8 of its API Management solution. The Akana Platform provides an end-to-end API Management solution for designing, implementing, securing, managing, monitoring, and publishing APIs. It is available as a SaaS platform, on-premises, and as a hybrid deployment. Version 8 introduces a lot of new functionality, all aimed at offering customers the richest API Management capabilities in a way that is easier than ever for API and app developers to use.
SYS-CON Events announced today that 910Telecom will exhibit at the 19th International Cloud Expo, which will take place on November 1–3, 2016, at the Santa Clara Convention Center in Santa Clara, CA. Housed in the classic Denver Gas & Electric Building, 910 15th St., 910Telecom is a carrier-neutral telecom hotel located in the heart of Denver. Adjacent to CenturyLink, AT&T, and Denver Main, 910Telecom offers connectivity to all major carriers, Internet service providers, Internet backbones and ...