Archive for June, 2014
(CGEN) Cancer Immunotherapy Results and Discovery of Two New Candidates
CGEN-15052 shown to inhibit T cell activation and to be expressed in multiple cancers including high expression in lung cancer tissues Predictive discovery of two new checkpoint candidates increases to eleven the number discovered by the Company
Compugen Ltd. (NASDAQ: CGEN) disclosed today positive experimental results for CGEN-15052, a novel immune checkpoint candidate for cancer immunotherapy, which in several experimental settings demonstrated robust inhibition of T cell activation, both as a membrane protein and as an Fc fusion protein. Initial testing of human cancer tissue samples with a polyclonal antibody indicated that CGEN-15052 is expressed in multiple epithelial cancers, with particularly high expression in lung cancer samples. These positive findings support CGEN-15052’s involvement in tumor immunology and its potential as a target for cancer immunotherapy.
Compugen also disclosed today the predictive discovery of two new B7-like immune checkpoint candidates, increasing to eleven the total number of such candidates discovered to date by the Company in this area of high medical and pharmaceutical industry interest. The predictive discovery of these two new immune checkpoint candidates was accomplished utilizing the same predictive models and algorithms that led to the identification of nine novel candidates in the Company’s earlier discovery efforts, but followed enhancement of these models and algorithms through incorporation of additional information obtained from those initial efforts.
Dr. Anat Cohen Dayag, Compugen’s President and CEO, stated, “Our disclosures today of successful experimental results for another of our initial nine checkpoint discoveries, and of new discoveries from a follow-on run utilizing the same predictive models, but enhanced with information from such initial discovery efforts, provide excellent validation of the value and uniqueness of our predictive discovery capabilities. After more than a decade of extensive multidisciplinary research to gain deeper understanding of key biological phenomena, providing the basis for the creation of our predictive models and discovery platforms, it is very rewarding to see these promising results from our first focused use of this powerful capability.”
About Immune Checkpoints
Immune checkpoints are inhibitory receptors and their ligands, which are crucial for the maintenance of self-tolerance (that is, the prevention of autoimmunity) and for the protection of tissues from damage when the immune system is responding to pathogenic infection or other injuries. These immune checkpoints, which are “highjacked” by tumors to block the ability of the immune system to destroy the tumor (immune resistance), have lately emerged as “game changers” and promising targets for cancer immunotherapy. Therapeutic blockade of immune checkpoints can boost anti-tumor immunity, enabling the patient’s immune system to recognize and attack the tumor cells, and mount durable anti-tumor responses and tumor destruction. The blockade of immune checkpoints unleashes the potential of the anti-tumor immune response in a fashion that is transforming cancer therapeutics. Checkpoint-blocking antibodies have lately demonstrated impressive clinical benefits and long-term survival, even for end-stage patients, raising hopes that this novel approach will lead to effective therapeutic strategies and valuable additions in the fight against cancer.
About Compugen
Compugen is a leading drug discovery company focused on therapeutic proteins and monoclonal antibodies to address important unmet needs in the fields of immunology and oncology. The Company utilizes a broad and continuously growing integrated infrastructure of proprietary scientific understandings and predictive platforms, algorithms, machine learning systems and other computational biology capabilities for the in silico (by computer) prediction and selection of product candidates, which are then advanced in its Pipeline Program. The Company’s business model includes collaborations covering the further development and commercialization of product candidates at various stages from its Pipeline Program and various forms of research and discovery agreements, in both cases providing Compugen with potential milestone payments and royalties on product sales or other forms of revenue sharing. Compugen’s wholly-owned U.S. subsidiary located in South San Francisco is developing oncology and immunology monoclonal antibody therapeutic candidates against its drug targets. For additional information, please visit Compugen’s corporate website at http://www.cgen.com/.
This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements related to the potential of CGEN-15052 for cancer immunotherapy. Forward-looking statements can be identified by the use of terminology such as “will,” “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of Compugen to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the inability to reach mutually agreeable terms and conditions with respect to potential new collaborations; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are discussed in the “Risk Factors” section of Compugen’s most recent Annual Report on Form 20-F as filed with the Securities and Exchange Commission as well as other documents that may be subsequently filed by Compugen from time to time with the Securities and Exchange Commission. In addition, any forward-looking statements represent Compugen’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Compugen does not assume any obligation to update any forward-looking statements unless required by law.
(DPZ) Launches Voice Ordering for its iPhone® and Android™ Apps
ANN ARBOR, Mich., June 16, 2014 — Domino’s Pizza (NYSE: DPZ), the recognized world leader in pizza delivery, continues to advance technology. In conjunction with Nuance Communications (NASDAQ: NUAN), Domino’s is launching voice ordering for its iPhone and Android apps.
“There will be a day when typing on keyboards or with thumbs on mobile devices will come to a close; we want to be the ones who continue to advance the technology experience – hand-in-hand with our customers,” said Patrick Doyle, Domino’s Pizza president and CEO. “Our mobile app users who are a part of this launch are truly helping set the foundation for the innovations of today, that will soon enough become the standards of tomorrow.”
The platform, in partnership with Nuance, will redefine technology convenience – and puts Domino’s at the forefront of an intuitive ordering method that is a true first within both traditional and e-commerce retail.
Domino’s new voice ordering platform is powered by Nuance’s Nina Mobile, an intelligent virtual assistant that leverages speech recognition, speech synthesis and natural language understanding technologies. Together, the platform delivers a human-like, conversational customer service experience that allows users to speak an order and quickly add items to their cart. The platform launches today in beta format, which will allow for additional enhancements as customers become familiar with the new ordering feature.
“Whether ordering pizzas, booking a flight or transferring money into a bank account – convenience is what translates to increased sales and customer satisfaction,” said Robert Weideman, Nuance executive vice president and general manager, enterprise division. “Our Nina platform is enabling organizations like Domino’s to do just that, and we are very proud to be a part of offering this convenience to their growing number of mobile app users.”
The Domino’s ordering apps for iPhone and Android, which have been downloaded more than 10 million times, are both available for free from the App Store on iPhone (www.itunes.com/appstore) or the Google Play store on Android devices. Existing iPhone and Android app users will need the latest update to be able to utilize the voice ordering feature.
About Domino’s Pizza®
Founded in 1960, Domino’s Pizza is the recognized world leader in pizza delivery, with a significant business in carryout pizza. It ranks among the world’s top public restaurant brands with its global enterprise of more than 10,900 stores in over 70 international markets. Domino’s had global retail sales of over $8.0 billion in 2013, comprised of nearly $3.8 billion in the U.S. and over $4.2 billion internationally. In the first quarter of 2014, Domino’s had global retail sales of over $2.0 billion, comprised of $0.9 billion in the U.S. and $1.1 billion internationally. Its system is made up of franchise owner-operators who accounted for over 96% of the Domino’s Pizza stores as of the first quarter of 2014. The emphasis on technology innovation helped Domino’s generate approximately 40% of sales in the U.S. from its digital channels in 2013, as well as reach an estimated $3 billion annually in global digital sales. Domino’s recently launched its ordering app for iPad®, adding to an existing ordering app lineup that covers nearly 95% of the U.S. smartphone market. Continuing its focus on menu enhancement, Domino’s launched Specialty Chicken in April 2014.
Order – www.dominos.com
Mobile – http://mobile.dominos.com
Info – www.dominosbiz.com
Twitter – http://twitter.com/dominos
Facebook – http://www.facebook.com/dominos
YouTube – http://www.youtube.com/dominos
About Nuance Communications, Inc.
Nuance Communications, Inc. (NASDAQ : NUAN) is a leading provider of voice and language solutions for businesses and consumers around the world. Its technologies, applications and services make the user experience more compelling by transforming the way people interact with devices and systems. Every day, millions of users and thousands of businesses experience Nuance’s proven applications. For more information, please visit: www.nuance.com.
(SBLK) and Oceanbulk Agree to Create the Largest U.S. Listed Dry Bulk Company
ATHENS, GREECE–(Jun 16, 2014) – Star Bulk Carriers Corp. (“Star Bulk” or the “Company”) (NASDAQ: SBLK) announced today that it has entered into definitive agreements with entities affiliated with Oaktree Capital Management, L.P. (the “Oaktree Investors”) and Star Bulk’s Non-Executive Chairman, Mr. Petros Pappas, and certain of his immediate family members, including Milena Maria Pappas, one of Star Bulk’s directors (the “Pappas Investors”), pursuant to which Oceanbulk Shipping LLC and Oceanbulk Carriers LLC (the “Oceanbulk Companies”) and entities controlled by the Pappas Investors are expected to become indirect wholly-owned subsidiaries of Star Bulk in consideration for the issuance to the Oaktree Investors and the Pappas Investors of 54.104 million shares of common stock of Star Bulk (the “Transaction”).
Transaction Overview
Through the Transaction, Star Bulk is acquiring an operating fleet of 15 dry bulk carrier vessels, with an average age of 5.6 years and an aggregate capacity of approximately 1.75 million dwt, including five Capesize vessels, two post-Panamax vessels, six Kamsarmax vessels and two Supramax vessels and contracts for the construction of 26 fuel-efficient, eco-design newbuilding dry bulk vessels including eight Newcastlemax vessels, eight Capesize vessels and ten Ultramax vessels each being built at shipyards in Japan and China. The newbuild vessels are scheduled to be delivered in 2014, 2015 and 2016.
Upon completion of the Transaction, the Oaktree Investors will own 61.3% of Star Bulk’s shares of common stock and the Pappas Investors will own 12.5% of Star Bulk’s common stock. In connection with the Transaction, the Company has agreed to enter into shareholders agreements with the Oaktree Investors and the Pappas Investors providing for certain voting restrictions, standstill obligations and ownership limitations and, for the Oaktree Investors, certain rights to make Board nominations and to appoint officers of the Company. As part of the Transaction, the Oaktree Investors, the Pappas Investors and the Company have agreed that Mr. Petros Pappas will become the Chief Executive Officer of the Company and Mr. Spyros Capralos will become Non-Executive Chairman of the Board.
Benefits of the Transaction, Upon Completion:
- Creates the largest, diversified, ultra-modern U.S. listed dry bulk company with a fully delivered fleet of 69 vessels approximating 8.7 million deadweight tons, including 33 Capesize and Newcastlemax vessels. The combined fleet is one of the largest eco fleets in the world with 39 eco and 7 semi-eco vessels and the acquired ships were built or will be built at reputable Japanese and Chinese shipyards.
- The combined Company will be a prominent market player with a strong shareholder base and a significant platform well positioned to be an industry consolidator. Following the Transaction, the Company intends to pursue additional accretive acquisition transactions.
- The combined Company’s size provides it with a substantial commercial presence and provides additional economies of scale on technical operations. The combined fleet will be technically managed by the Company’s in-house technical management operation and all vessels are expected to utilize the commercial services of Interchart, a company affiliated with family members of Mr. Pappas in which the Company owns a 33% interest.
- Enhanced fleet profile positions the Company to benefit from expanding major bulk commodity trade, especially via long haul voyages. The combined fleet profile with a significant number of Capesize and Newcastlemaxes bulk carriers coupled with the current Company chartering strategy provides significant earnings and cash flow upside in strong markets.
- Significantly increases the market capitalization. Based on 54.104 million newly issued shares, the combined market capitalization, assuming the June 13, 2014 closing share price of $12.07 per share, would be $1,009 million.
The Transaction has been approved by the Board of Directors of Star Bulk, based upon the recommendation of a transaction committee of disinterested directors established by the Board of Directors of Star Bulk (the “Transaction Committee”), which negotiated the Transaction on behalf of Star Bulk. The Transaction Committee is composed of Tom Softeland, a director of Star Bulk since the inception of the Company, and Roger Schmitz, a director since July 2013 and a senior investment professional with Monarch Alternative Capital LP (“Monarch”). The Transaction Committee negotiated the Transaction value on a net asset value for net asset value basis using the average of three reputable appraisal providers. As part of this negotiation, there was a $35 million adjustment to net asset value in favor of Star Bulk.
Petros Pappas, Chairman of Star Bulk Carriers Corp., commented: “We are excited to announce this transformational Transaction that, when completed, will create the largest U.S. listed dry bulk owner and operator. I would like to thank Spyros Capralos for his leadership and stewardship of the business as President and CEO, and I am pleased that Spyros will continue to provide leadership in his role of Non-Executive Chairman of the Board following the closing of the Transaction. I am looking forward to assuming the CEO role and will focus on, among other things, maximizing the performance of the existing fleet, overseeing the successful delivery of the significant existing newbuilding program, and positioning the Company to grow quickly and significantly in the highly fragmented dry bulk sector”.
Spyros Capralos, President & CEO of Star Bulk, commented: “The Transaction marks an important next step in the evolution for Star Bulk. Since 2013, Star Bulk has dramatically improved its market capitalization and liquidity through the successful completion of the rights offering and add-on equity offering, modernized its existing fleet and placed a series of significant newbuilding orders to position the Company for the future. With this Transaction the Company creates the largest U.S. listed dry bulk company with a strong shareholder base.
We believe that the Transaction is accretive to earnings, cash flow, and net asset value, and also has additional benefits as it will dramatically increase the market capitalization and asset base, enhance the on-the-water fleet portfolio, increase the newbuilding portfolio by combining two similar newbuild strategies, and improve access to capital to fund the current and assumed capital expenditure obligations. In addition, the combined business will be well positioned to capitalize on an improving dry bulk market with significant operating leverage to rising rates.
I would like to thank the Transaction Committee of disinterested directors that have spent significant time negotiating the Transaction on Star Bulk’s behalf, and I look forward to assuming my role as Non-Executive Chairman of the Board.”
The Transaction is expected to close within the next 30 days subject to customary conditions, including the affirmative vote of a majority of Star Bulk’s shareholders that are not affiliated with the Oaktree Investors or the Pappas Investors to approve the Transaction at a special meeting of shareholders (“Special Meeting”). Star Bulk expects to hold the Special Meeting on July 11, 2014. The Board of Directors has established June 17, 2014 as the record date for such meeting.
In connection with the Special Meeting, the investment funds controlled by Monarch, which owns 20.9% of the outstanding shares of Star Bulk and represents 28.1% of the shareholders that are not affiliated with the Oaktree Investors and Pappas Investors, have entered into a voting agreement with the Oaktree Investors and Pappas Investors to vote all of their Star Bulk shares in favor of the Transaction.
Seward & Kissel LLP is serving as legal counsel to Star Bulk in connection with the Transaction, Paul, Weiss, Rifkind, Wharton & Garrison LLP is serving as Oceanbulk’s legal counsel and Willkie, Farr & Gallagher LLP is serving as Monarch’s legal counsel. Evercore is serving as financial advisor to the Transaction Committee of the Star Bulk Board of Directors and Wachtell Lipton Rosen & Katz is serving as the Transaction Committee’s legal counsel.
For further information about the Transaction, please refer to the proxy materials to be furnished by the Company to the U.S. Securities and Exchange Commission.
Post-Transaction Star Bulk On-The-Water Fleet | |||||
Vessel Name | Type | Yard | Country | DWT | Year Built |
Obelix | Capesize | Imabari | Japan | 181,433 | 2011 |
Pantagruel | Capesize | Imabari | Japan | 180,181 | 2004 |
Star Borealis | Capesize | Hanjin Subic | Phillipines | 179,678 | 2011 |
Star Polaris | Capesize | Hanjin Subic | Phillipines | 179,600 | 2011 |
Big Fish | Capesize | Mitsui | Japan | 177,662 | 2004 |
Kymopolia | Capesize | Namura | Japan | 176,990 | 2006 |
Big Bang | Capesize | SWS | China | 174,109 | 2007 |
Star Aurora | Capesize | Koyo | Japan | 171,199 | 2000 |
Star Mega | Capesize | Mitsubishi HI | Japan | 170,631 | 1994 |
Star Big | Capesize | Halla Samho | Korea | 168,404 | 1996 |
Star Sirius | Post panamax | Tsuneishi Zoushan | China | 98,681 | 2011 |
Star Vega | Post panamax | Tsuneishi Zoushan | China | 98,681 | 2011 |
Amami | Post Panamax | Tsuneishi Zoushan | China | 98,681 | 2011 |
Madredeus | Post Panamax | Tsuneishi Zoushan | China | 98,681 | 2011 |
ABYO Angelina | Kamsarmax | Tsuneishi | Japan | 82,981 | 2006 |
Pendulum | Kamsarmax | Tsuneishi | Japan | 82,619 | 2006 |
ABYO Oprah | Kamsarmax | Tsuneishi | Japan | 82,551 | 2006 |
Mercurial Virgo | Kamsarmax | Longxue | China | 81,545 | 2013 |
Magnum Opus | Kamsarmax | JMU | Japan | 81,022 | 2014 |
Tsu Ebisu | Kamsarmax | JMU | China | 81,001 | 2014 |
Star Challenger | Ultramax | Iwagi Zosen | Japan | 61,462 | 2012 |
Star Fighter | Ultramax | Iwagi Zosen | Japan | 61,455 | 2013 |
Maiden Voyage | Supramax | Kawasaki | Japan | 58,722 | 2012 |
Strange Attractor | Supramax | Mitsui | Japan | 55,742 | 2006 |
Star Omicron | Supramax | Imabari | Japan | 53,489 | 2005 |
Star Gamma | Supramax | Oshima | Japan | 53,098 | 2002 |
Star Zeta | Supramax | Oshima | Japan | 52,994 | 2003 |
Star Delta | Supramax | Tsuneishi | Japan | 52,434 | 2000 |
Star Theta | Supramax | Tsuneishi Cebu | Phillipines | 52,425 | 2003 |
Star Epsilon | Supramax | Tsuneishi Cebu | Phillipines | 52,402 | 2001 |
Star Cosmo | Supramax | Yangzhou Dayang | China | 52,247 | 2005 |
Star Kappa | Supramax | Sanoyas HM | Japan | 52,055 | 2001 |
Total | 32 | 3,304,855 |
Post-Transaction Star Bulk Newbuildings | |||||
Vessel Name | Type | Yard | Country | DWT | Expected Delivery Date |
HN NE166 | Newcastlemax | NACKS | China | 209,000 | May-15 |
HN NE167 | Newcastlemax | NACKS | China | 209,000 | Jun-15 |
HN NE184 | Newcastlemax | NACKS | China | 209,000 | Jul-15 |
Hull NE 198 | Newcastlemax | NACKS | China | 209,000 | Mar-16 |
N/B 1359* | Newcastlemax | SWS | China | 208,000 | Sep-15 |
Hull 1372* | Newcastlemax | SWS | China | 208,000 | Nov-15 |
N/B 1360* | Newcastlemax | SWS | China | 208,000 | Dec-15 |
Hull 1342 | Newcastlemax | SWS | China | 208,000 | Jan-16 |
Hull 1371* | Newcastlemax | SWS | China | 208,000 | Feb-16 |
N/B 1361* | Newcastlemax | SWS | China | 208,000 | Mar-16 |
Hull 1343 | Newcastlemax | SWS | China | 208,000 | Apr-16 |
N/B 1362* | Newcastlemax | SWS | China | 208,000 | May-16 |
N/B 1363* | Newcastlemax | SWS | China | 208,000 | Jun-16 |
HN 5016 | Capesize | JMU | Japan | 182,160 | Oct-14 |
HN 213 | Capesize | JMU | Japan | 182,000 | Jul-14 |
HN 214 | Capesize | JMU | Japan | 182,000 | Aug-14 |
HN 5017 | Capesize | JMU | Japan | 182,000 | Mar-15 |
HN 5055 | Capesize | JMU | Japan | 182,000 | Jul-15 |
HN 5056 | Capesize | JMU | Japan | 182,000 | Aug-15 |
HN 1312 | Capesize | SWS | China | 180,000 | Aug-15 |
HN 1313 | Capesize | SWS | China | 180,000 | Sep-15 |
Hull 1338 | Capesize | SWS | China | 180,000 | Oct-15 |
Hull 1339 | Capesize | SWS | China | 180,000 | Jan-16 |
HN 1061* | Ultramax | Yangzijiang | China | 64,000 | Jan-15 |
HN 1062* | Ultramax | Yangzijiang | China | 64,000 | Mar-15 |
HN 1063* | Ultramax | Yangzijiang | China | 64,000 | Apr-15 |
HN 1064* | Ultramax | Yangzijiang | China | 64,000 | May-15 |
HN 1080 | Ultramax | Yangzijiang | China | 64,000 | Jul-15 |
HN 1081 | Ultramax | Yangzijiang | China | 64,000 | Aug-15 |
HN 1082 | Ultramax | Yangzijiang | China | 64,000 | Sep-15 |
HN 1083 | Ultramax | Yangzijiang | China | 64,000 | Oct-15 |
HN NE164 | Ultramax | NACKS | China | 61,000 | Apr-15 |
HN NE165 | Ultramax | NACKS | China | 61,000 | Apr-15 |
Hull NE 196 | Ultramax | NACKS | China | 61,000 | Oct-15 |
Hull NE 197 | Ultramax | NACKS | China | 61,000 | Nov-15 |
Hull 5040 | Ultramax | JMU | Japan | 60,000 | Jun-15 |
Hull 5043 | Ultramax | JMU | Japan | 60,000 | Sep-15 |
Total | 37 | 5,396,160 | |||
Grand Total OTW Fleet | 32 | 3,304,855 | |||
Grand Total NBs | 37 | 5,396,160 | |||
Grand Total Fully Delivered | 69 | 8,701,015 |
*Acquired via Bareboat Hire Purchase (BBHP) structure
Conference Call
Our management team will host a conference call to discuss the transaction on Monday, June 16, 2014 at 5 p.m. Eastern Time (ET).
Participants should dial into the call 10 minutes before the scheduled time using the following numbers: 1(866) 819-7111 (from the US), 0(800) 953-0329 (from the UK) or+ (44) (0) 1452 542 301 (from outside the US). Please quote “Star Bulk.”
A replay of the conference call will be available until June 23, 2014. The United States replay number is 1(866) 247- 4222; from the UK 0(800) 953-1533; the standard international replay number is (+44) (0) 1452 550 000 and the access code required for the replay is: 3128607#.
Slides and audio webcast:
There will also be a simultaneous live webcast over the Internet, through the Star Bulk website (www.starbulk.com). Participants to the live webcast should register on the website approximately 10 minutes prior to the start of the webcast.
About Star Bulk
Star Bulk is a global shipping company providing worldwide seaborne transportation solutions in the dry bulk sector. Star Bulk’s vessels transport major bulks, which include iron ore, coal and grain and minor bulks which include bauxite, fertilizers and steel products. Star Bulk was incorporated in the Marshall Islands on December 13, 2006 and maintains executive offices in Athens, Greece. Its common stock trades on the Nasdaq Global Select Market under the symbol “SBLK”. Star Bulk has an operating fleet of seventeen dry bulk carriers, consisting of five Capesize, two Post Panamax, two Ultramax and eight Supramax dry bulk vessels with a combined cargo carrying capacity of 1,610,935 deadweight tons and an average age of approximately 9.0 years. In addition, Star Bulk provides vessel management services to fourteen third party dry bulk vessels, including five Capesize, two Post Panamax, two Kamsarmax, two Panamax and three Supramax vessels with a combined cargo carrying capacity of 1,569,255 deadweight tons. We have also entered into agreements for the construction of eleven fuel efficient dry bulk vessels, consisting of five Newcastlemax vessels, two Capesize vessels and four Ultramax vessels, with a combined cargo carrying capacity of 1,643,000 deadweight tons. All of the newbuilding vessels are expected to be delivered during 2015 and early 2016.
Star Bulk’s common stock is listed for trading on the NASDAQ Global Select Market under the symbol “SBLK.”
About Oceanbulk Companies
The Oceanbulk Companies are international shipping companies that own and operate a fleet of dry bulk carrier vessels. On a fully delivered basis, the Oceanbulk Companies will have a fleet of 37 vessels consisting primarily of Capesize as well as Kamsarmax and Ultramax vessels with a carrying capacity between 55,000 dwt and 209,000 dwt. The Oceanbulk Companies’ fleet includes 12 vessels in the water (five Capesize vessels, two post-Panamax vessel, three Kamsarmax vessels and two Supramax vessels), with aggregate cargo carrying capacity of approximately 1.5 million deadweight tons and 25 fuel-efficient “Eco-type” vessels currently under construction at leading shipyards in Japan and China for delivery in 2014 and 2015, with an aggregate cargo carrying capacity of 3.5 million deadweight tons. Oceanbulk Companies’ vessels transport a broad range of major and minor bulk commodities, including ores, coal, grains and fertilizers, along worldwide shipping routes. In the Transaction, (i) Star Bulk will acquire the Oceanbulk Companies through a merger of their immediate parent companies with two Star Bulk subsidiaries, and (ii) Star Bulk has agreed to acquire, upon successful future delivery, two 2006 built Tsuneishi (Japan) Kamsarmax vessels to be distributed to Oceanbulk Shipping LLC from its Heron Ventures Ltd. joint venture. The shares for this acquisition are included in the 54.104 million shares being issued in total for the Transaction..
About Pappas Investors
Entities controlled by the Pappas Investors, which will be acquired by Star Bulk in the Transaction, currently own a 2014 built Kamsarmax dry bulk carrier and a contract for the construction of a newbuilding Capesize dry bulk carrier scheduled to be delivered in 2014.
Forward-Looking Statements
Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.
The Company desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intends,” “estimate,” “forecast,” “project,” “plan,” “potential,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements.
Forward-looking statements include, without limitation, statements regarding:
- The effectuation of Star Bulk’s subsidiary merger transaction;
- The delivery to and operation of assets by Star Bulk;
- Star Bulk’s future operating or financial results;
- Future, pending or recent acquisitions, business strategy, areas of possible expansion, and expected capital spending or operating expenses; and
- Dry bulk market trends, including charter rates and factors affecting vessel supply and demand.
The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, examination by the Company’s management of historical operating trends, data contained in its records and other data available from third parties. Although the Company believes that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond the Company’s control, the Company cannot assure you that it will achieve or accomplish these expectations, beliefs or projections.
In addition to these important factors, other important factors that, in the Company’s view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values, changes in demand for dry bulk shipping capacity, changes in the Company’s operating expenses, including bunker prices, drydocking and insurance costs, the market for the Company’s vessels, availability of financing and refinancing, changes in governmental rules and regulations or actions taken by regulatory authorities, potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, vessels breakdowns and instances of off-hires and other factors. Please see our filings with the Securities and Exchange Commission for a more complete discussion of these and other risks and uncertainties. The information set forth herein speaks only as of the date hereof, and the Company disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this communication.
Additional Information
Nothing contained in this press release constitutes a solicitation of materials of any vote or approval in respect of the proposed merger or the proposed transactions involving Star Bulk or otherwise contemplated herein. In connection with the proposed merger and the proposed transaction, a special stockholder meeting is expected to held on or about July 11, 1014, to obtain stockholder approval. In connection with the merger and the proposed transactions, Star Bulk intends to furnish relevant materials, including a proxy statement, with the Securities and Exchange Commission (the “SEC”) on Form 6-K. Investors and security holders of Star Bulk are urged to read the proxy statement and other relevant materials when they become available because they will contain important information about Star Bulk, Oceanbulk, the Merger and the proposed transactions. The proxy statement and other relevant materials (when they become available), and any other documents filed by Star Bulk with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov, at Star Bulk’s website at www.starbulk.com, or by sending a written request to Star Bulk at c/o Star Bulk Management Inc. 40, Agiou Konstantinou Str., Maroussi 15124, Athens, Greece, Attention: Investor Relations.
Star Bulk and its directors, executive officers, and certain other members of management and employees may be deemed to be participants in soliciting proxies from the stockholders of Star Bulk in favor of the Merger. Information regarding the persons who may be considered to be participants in the solicitation of Star Bulk’s stockholders in connection with the proposed transaction and their ownership of Star Bulk’s common stock will be set forth in Star Bulk’s proxy statement for its special meeting. Investors can find more information about Star Bulk and its executive officers and directors in its Annual Report on Form 20-F for the fiscal year ended December 31, 2013 and in its proxy statement, when available, that will be furnished to the SEC on Form 6-K.
Contacts: Company:
Simos Spyrou
CFO
Star Bulk Carriers Corp.
c/o Star Bulk Management Inc.
40 Ag. Konstantinou Av.
Maroussi 15124
Athens, Greece
www.starbulk.com
Investor Relations / Financial Media:
Nicolas Bornozis
President
Capital Link, Inc.
230 Park Avenue, Suite 1536
New York, NY 10169
Tel. (212) 661-7566
E-mail: starbulk@capitallink.com
www.capitallink.com
(DARA) KRN5500 Orphan Drug Designation by FDA in Multiple Myeloma
Second Orphan Drug Designation Received in 2014 for Key Development Asset
RALEIGH, NC–(June 16, 2014) – DARA BioSciences, Inc. (NASDAQ: DARA), an oncology supportive care specialty pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments, today announced the U.S. Food and Drug Administration (FDA) has granted Orphan Drug Designation to the experimental compound KRN5500 for the treatment of multiple myeloma.
KRN5500 is a novel, intravenous, non-opioid, non-narcotic compound currently in Phase 2 clinical development. Earlier this year, KRN5500 received orphan status to be developed for the parenteral treatment of painful, chronic, chemotherapy-induced peripheral neuropathy (CCIPN) that is refractory to conventional analgesics in patients with cancer. In 2011, the FDA designated KRN5500 as a Fast Track program which expedites the development pathway and consideration for priority review. Orphan Drug Designation provides DARA with seven years market exclusivity from the time of approval, tax credits, and the waiver of PDUFA filing fees, as well as access to federal grants.
“This second orphan drug designation for our key development asset KRN5500 allows us to approach the actual treatment of multiple myeloma, whereas the CCIPN designation is specific to neuropathy. It is noteworthy in this regard that up to 20% of myeloma patients have intrinsic peripheral neuropathy, an incidence that increases to the range of 75% in patients treated with neurotoxic drugs such as thalidomide or bortezomib. We believe this myeloma-specific orphan designation enhances both the viability and the future market opportunity for this valuable pipeline product,” said David J. Drutz, M.D., Chief Executive Officer and Chief Medical Officer of DARA BioSciences.
The favorable consideration of myeloma as an orphan indication for KRN5500 was supported by a comprehensive publication in 2012 by an independent group of academic investigators, which demonstrated its therapeutic potential in both in vitro and in vivo experiments in which KRN5500, a spicamycin derivative, exhibited anti-myeloma effects through impairing both myeloma cells and osteoclasts.
Dr. Drutz continued, “We greatly appreciate the expeditious review and approval of this additional KRN5500 orphan designation application by the FDA’s Office of Orphan Product Development, which provides an important step towards the potential treatment of multiple myeloma and one of its major complications. This second orphan drug designation underscores the value of this asset and strengthens DARA’s resolve and positioning in the ongoing pursuit of partnering opportunities to assist in funding the clinical advancement and development pathway of KRN5500.”
Multiple myeloma is a hematologic cancer (or cancer of the blood) and the second most common blood cancer after non-Hodgkin’s lymphoma. The American Cancer Society estimates that more than 24,000 new cases of the disease will be diagnosed in 2014. The FDA grants orphan drug designation to therapeutics intended to treat diseases that affect fewer than 200,000 people in the United States.
About DARA BioSciences, Inc.
DARA BioSciences Inc. of Raleigh, North Carolina, is an oncology supportive care pharmaceutical company dedicated to providing healthcare professionals a synergistic portfolio of medicines to help cancer patients adhere to their therapy and manage side effects arising from their cancer treatments.
DARA holds exclusive U.S. marketing rights to both Soltamox® (tamoxifen citrate) oral solution and Gelclair®. DARA licensed the U.S. rights to Soltamox® from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair® from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%).
Soltamox® (tamoxifen citrate) oral solution, the only liquid form of tamoxifen, is indicated for the treatment of metastatic breast cancer, the adjuvant treatment of node-positive breast cancer in postmenopausal women, the reduction in risk of invasive breast cancer in women with ductal carcinoma in situ (DCIS), and for the reduction of the incidence of breast cancer in women at high risk for breast cancer. Currently, there are more than 1.8 million prescriptions of tamoxifen written on an annual basis in the United States. Between 30 and 70 percent of patients fail to complete their prescribed course of treatment, thereby diminishing its benefits in reducing the risk of breast cancer recurrence.
Tamoxifen Important Safety Information
Tamoxifen citrate is contraindicated in women who require concomitant coumadin-type anticoagulant therapy, in women with a history of deep vein thrombosis or pulmonary embolus, and in women with known hypersensitivity to the drug or any of its ingredients.
Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism.
The most common adverse reactions to tamoxifen treatment are (incidence > 20%) hot flashes, fluid retention, vaginal discharge, vaginal bleeding, vasodilatation, nausea, irregular menses, weight loss, and musculoskeletal events.
Tamoxifen carries the following Boxed Warning:
WARNING – For Women with Ductal Carcinoma in Situ (DCIS) and Women at High Risk for Breast Cancer: Serious and life-threatening events associated with tamoxifen in the risk reduction setting (women at high risk for cancer and women with DCIS) include uterine malignancies, stroke and pulmonary embolism. Incidence rates for these events were estimated from the NSABP P-1 trial (see CLINICAL PHARMACOLOGY, Clinical Studies, Reduction in Breast Cancer Incidence In High Risk Women). Uterine malignancies consist of both endometrial adenocarcinoma (incidence rate per 1,000 women-years of 2.20 for tamoxifen vs. 0.71 for placebo) and uterine sarcoma (incidence rate per 1,000 women-years of 0.17 for tamoxifen vs. 0.0 for placebo)*. For stroke, the incidence rate per 1,000 women-years was 1.43 for tamoxifen vs. 1.00 for placebo**. For pulmonary embolism, the incidence rate per 1,000 women-years was 0.75 for tamoxifen versus 0.25 for placebo**. Some of the strokes, pulmonary emboli, and uterine malignancies were fatal. Health care providers should discuss the potential benefits versus the potential risks of these serious events with women at high risk of breast cancer and women with DCIS considering tamoxifen to reduce their risk of developing breast cancer. The benefits of tamoxifen outweigh its risks in women already diagnosed with breast cancer.
*Updated long-term follow-up data (median length of follow-up is 6.9 years) from NSABP P-1 study. See WARNINGS, Effects on the Uterus-Endometrial Cancer and Uterine Sarcoma in Prescribing Information. **See Table 3 under CLINICAL PHARMACOLOGY, Clinical Studies in Prescribing Information.
The full Prescribing Information for Soltamox is available at www.soltamox.com/prescribing-information.
Gelclair® is an alcohol-free bioadherent oral rinse gel for rapid and effective relief of pain associated with oral mucositis caused by chemotherapy and radiation treatment. Gelclair should not be used by patients with a known or suspected hypersensitivity to the product or any of its ingredients. DARA licensed the U.S. rights to Soltamox from UK-based Rosemont Pharmaceuticals, Ltd., and Gelclair from the Helsinn Group in Switzerland. Under an agreement with Innocutis, DARA also markets Bionect® (hyaluronic acid sodium salt, 0.2%) a topical treatment for skin irritation and burns associated with radiation therapy, in U.S. oncology/radiology markets. Bionect should not be used by patients with known hypersensitivity to any of its ingredients. For further information on Gelclair and Bionect and the Full Prescribing Information please visit www.Gelclair.com and www.Bionect.com.
DARA is focused on expanding its portfolio of oncology supportive care products in the United States, via in-licensing and/or partnering of complementary late-stage and approved products. In addition, the company wishes to identify a strategic partner for the clinical development of KRN5500, currently in Phase 2 for the treatment of chronic, treatment refractory, chemotherapy-induced peripheral neuropathy (CCIPN). The FDA has designated KRN5500 as a Fast Track Drug, and has granted DARA two separate Orphan Drug Designations for the treatment of multiple myeloma and for the treatment of painful, chronic chemotherapy-induced peripheral neuropathy that is refractory to conventional analgesics (CCIPN).
In early 2014, DARA kicked off its new partnership with Alamo Pharma Services, a subsidiary of Mission Pharmacal, in deploying a dedicated 20-person national sales team in the U.S. oncology market. In addition to promoting DARA’s products Soltamox, Gelclair and Bionect, this specialized oncology supportive care sales team also provides clinicians with access to three Mission Pharmacal products: Ferralet® 90 (for anemia), BINOSTO® (alendronate sodium effervescent tablet indicated for the treatment of osteoporosis), and Aquoral® (for chemotherapy/radiation therapy-induced dry mouth).
Important Safety Information and full Prescribing Information for Mission Pharmacal’s products may be found at: www.Ferralet.com, www.Binosto.com, and www.Aquoral.com.
For more information please visit our web site at www.darabio.com.
Safe Harbor Statement
All statements in this press release that are not historical are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, and are subject to risks and uncertainties. Forward-looking statements are based on the current expectations, estimates, forecasts and projections regarding management’s beliefs and assumptions. In some cases, you can identify forward looking statements by terminology such as “may,” “will,” “should,” “hope,” “expects,” “intends,” “plans,” “anticipates,” “contemplates,” “believes,” “estimates,” “predicts,” “projects,” “potential,” “continue,” and other similar terminology or the negatives of those terms. Such forward-looking statements are subject to factors that could cause actual results to differ materially for DARA from those projected. Important factors that could cause actual results to differ materially from the expectations described in these forward-looking statements are set forth under the caption “Risk Factors” in DARA’s most recent Annual Report on Form 10-K, filed with the SEC on February 4, 2014, and DARA’s other filings with the SEC from time to time. Those factors include risks and uncertainties relating to DARA’s ability to realize the desired benefits of Orphan Drug Designation and Fast Track designation for KRN5500, DARA’s ability to timely commercialize and generate revenues or profits from Soltamox, Gelclair, Bionect or other products given that DARA only recently hired its initial sales force and DARA’s lack of history as a revenue-generating company, DARA’s ability to achieve the desired results from the agreements with Mission and Alamo, FDA and other regulatory risks relating to DARA’s ability to market Soltamox, Gelclair, Bionect or other products in the United States or elsewhere, DARA’s ability to in-license and/or partner products, DARA’s current cash position and its need to raise additional capital in order to be able to continue to fund its operations, DARA’s ability to raise sufficient capital and on favorable terms and the stockholder dilution that may result therefrom, the current regulatory environment in which DARA sells its products, the market acceptance of those products, dependence on partners, successful performance under collaborative and other commercial agreements, competition, the strength of DARA’s intellectual property and the intellectual property of others, the potential delisting of DARA’s common stock from the NASDAQ Capital Market, and other risk factors identified in the documents DARA has filed, or will file, with the Securities and Exchange Commission (“SEC”). Copies of DARA’s filings with the SEC may be obtained from the SEC Internet site at http://www.sec.gov.
All forward-looking statements are expressly qualified in their entirety by this cautionary notice. You are cautioned not to place undue reliance on any forward-looking statements, which speak only as of the date of this release. We have no obligation, and expressly disclaim any obligation, to update, revise or correct any of the forward-looking statements, whether as a result of new information, future events or otherwise.
Media Contact:
David Connolly
LaVoieHealthSciences
617-374-8800, Ext. 108
dconnolly@lavoiegroup.com
Corporate Contact:
Jim Polson
FTI Consulting
312 553 6730
Jim.polson@fticonsulting.com
(NWBO) Named To Two Russell Indexes
BETHESDA, Md., June 16, 2014 — Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that it has been added to two prestigious Russell Indexes: the Russell Global and the Russell 3,000 Indexes. The preliminary announcement was made on Saturday, June 14, 2014, and becomes effective on June 27, 2014.
The Russell 3,000 Index covers both the Russell 2,000 Index for small-cap growth stocks and the Russell 1000 Index for larger-cap companies. The Russell Global Indexes reflect the performance of over 10,000 securities in 47 countries.
Selection for inclusion in these indexes is based upon market capitalization and other market factors relating to a company and its stock. Membership in these indexes is updated annually, and remains in place for one year.
Russell Indexes are widely used by investment managers and institutional investors for index funds and as benchmarks for active investment strategies. Approximately $5.2 trillion in assets currently are benchmarked to Russell Indexes.
“We are very gratified to be added to both the Russell Global and the Russell 3000 Indexes,” commented Linda Powers, CEO of NW Bio. “It is an important reflection of NW Bio’s strong progress and accelerating momentum on multiple fronts (both on the science and clinical fronts and on the business and finance fronts). Inclusion in these indexes will also increase awareness of NW Bio’s strong performance among institutional fund managers both in the US and abroad.”
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain cancer) patients outside the clinical trial.
About Russell
Russell Investments (Russell) is a global asset manager and one of only a few firms that offers actively managed multi-asset portfolios and services that include advice, investments and implementation. Russell stands with institutional investors, financial advisors and individuals working with their advisors — using the firm’s core capabilities that extend across capital market insights, manager research, portfolio construction, portfolio implementation and indexes to help each achieve their desired investment outcomes.
Russell has more than $259 billion in assets under management (as of 3/31/2014) and works with over 2,500 institutional clients, independent distribution partners and individual investors globally. As a consultant to some of the largest pools of capital in the world, Russell has $2.4 trillion in assets under advisement (as of 6/30/2013). It has four decades of experience researching and selecting investment managers and meets annually with more than 2,200 managers around the world. Russell traded more than $1.6 trillion in 2013 through its implementation services business. Russell also calculates approximately 700,000 benchmarks daily covering 98% of the investable market globally, including more than 80 countries and more than 10,000 securities. Approximately $5.2 trillion in assets are benchmarked (as of 12/31/2013) to the Russell Indexes, which have provided investors with 30 years of smarter beta.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
(VSTA) Canadian Patent Expanding Stem Cell Technology Platform
SOUTH SAN FRANCISCO, CA–(Jun 16, 2014) – VistaGen Therapeutics, Inc. (OTCQB: VSTA), a biotechnology company applying pluripotent stem cell technology for drug rescue and regenerative medicine, today announces that the Canadian Intellectual Property Office has issued a Notice of Allowance for Canadian patent No. 2,684,022, entitled “Mesoderm and Definitive Endoderm Cell Populations.” This patent, which is licensed exclusively to VistaGen by the Icahn School of Medicine at Mount Sinai in New York, will expand VistaGen’s intellectual property portfolio for pluripotent stem cell culture systems that produce human cells of the endoderm lineage, including liver, lung, pancreas, parathyroid and thyroid cells.
“This important Canadian patent allowance extends our core intellectual property protection in a market that has been strategically significant to us for many years,” stated Shawn K. Singh, JD, VistaGen’s chief executive officer. “In a manner similar to our recently announced Notice of Allowance for its counterpart, U.S. Patent Application 12/836,275, this new Canadian patent allowance and our world-class differentiation and assay formulation expertise put us in a strong position to pursue additional stem cell research projects in Canada, especially innovative projects involving liver biology, customized drug metabolism assays, and pilot nonclinical studies using pancreatic beta-islet cells for drug and regenerative cell therapies for diabetes.”
About VistaGen Therapeutics
VistaGen, a stem cell company headquartered in South San Francisco, California, is focused on drug rescue and regenerative medicine. We believe better cells lead to better medicines™ and that the key to making better cells is precisely controlling the differentiation of human pluripotent stem cells, which are the building blocks of all cells of the human body. For over 15 years, our stem cell research and development teams and collaborators have developed proprietary methods for controlling the differentiation of human pluripotent stem cells and the production and maturation of numerous specific types of adult human cells. Our drug rescue activities are focused on combining our stem cell technology and assay development expertise with medicinal chemistry to generate Drug Rescue Variants™. These are novel, proprietary and safer chemical variants of once-promising small molecule drug candidates discovered and developed by pharmaceutical or biotechnology companies, the U.S. National Institutes of Health, or academic laboratories, which have positive efficacy data supporting their therapeutic and commercial potential, but have been discontinued due to unexpected heart or liver safety concerns.
With $8.8 million of grant funding awarded from the U.S. National Institutes of Health, VistaGen has successfully completed Phase 1 development of AV-101, an orally available, non-sedating, small molecule prodrug candidate. AV-101 is aimed at the multi-billion dollar neurological disease and disorders market, including neuropathic pain, a serious and chronic condition causing pain after an injury or disease of the peripheral or central nervous system, epilepsy and depression and Parkinson’s disease. Our AV-101 IND application on file at the FDA covers clinical development for neuropathic pain.
Visit VistaGen at http://www.VistaGen.com, follow VistaGen at http://www.twitter.com/VistaGen or view VistaGen’s Facebook page at http://www.facebook.com/VistaGen.
Cautionary Statement Regarding Forward-Looking Statements
The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to the success of VistaGen’s drug and regenerative medicine research, discovery, development and rescue activities, its ability to enter into strategic licensing and partnering arrangements, risks and uncertainties relating to its protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the foregoing activities. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.
For more information:
Shawn K. Singh, J.D.
Chief Executive Officer
VistaGen Therapeutics, Inc.
www.VistaGen.com
650-577-3613
Investor.Relations@VistaGen.com
Mission Investor Relations
IR Communications
Atlanta, Georgia
www.MissionIR.com
404-941-8975
Investors@MissionIR.com
(TEDU) Cooperation Agreements with Six Universities and Colleges
BEIJING, June 13, 2014 — Tarena International, Inc. (NASDAQ: TEDU) (“Tarena” or the “Company”), a leading provider of professional education services in China, today announced that it has signed cooperation agreements with six universities and colleges in Jiangsu Province, namely Yangzhou University, Jiangsu Normal University, Huaihai Institute of Technology, Huaiyin Institute of Technology, Taihu University of Wuxi, and Xuhai College, China University of Mining and Technology to offer joint major programs in software engineering and computer science.
Pursuant to the cooperation agreements, these six universities and colleges will offer their students options to enroll in joint major programs with Tarena and include Tarena’s selected courses in their standard undergraduate curriculum. In return, Tarena will receive the portion of students’ tuition that are attributable to Tarena courses. Each of these six schools and Tarena will also jointly establish an internship and training center to increase their students’ competiveness in the job market and improve post-graduation placement results.
“We are very pleased to partner with these six schools in Jiangsu province to provide their students with the practical training necessary to succeed in the increasingly competitive job markets in China,” said Shaoyun Han, Founder, CEO and Chairman of Tarena. “Today’s announcement is a strong endorsement of our credibility and reputation in the industry and our recent momentum since becoming a public company to forge more in-depth cooperation with universities and colleges in China. Consistent with Chinese government and Ministry of Education’s policies to encourage higher education institutions in China to incorporate practical training courses into their curricula, we expect more and more universities and colleges to explore and establish close cooperation relationships with service providers such as Tarena. As a leader in China’s professional education industry, we believe Tarena is well positioned to capture such market opportunities.”
About Tarena International, Inc.
Tarena International, Inc. (NASDAQ: TEDU) is a leading provider of professional education services in China. The Company is the largest provider of IT professional education services in China with a market share of 8.3% as measured by revenues in 2013 according to IDC, a third-party research firm. Through its innovative education platform combining live distance instruction, classroom-based tutoring and online learning modules, Tarena offers courses in nine IT subjects and two non-IT subjects. Its courses provide students with practical education to prepare them for jobs in industries with significant growth potential and strong hiring demand. Since its inception in 2002, Tarena has trained over 140,000 students, cooperated with more than 500 universities and colleges and placed students with approximately 39,000 corporate employers in a variety of industries. For further information, please visit http://ir.tarena.com.cn .
For investor and media inquiries, please contact:
Tarena International, Inc.
Christina Zhu
Tel: +86-10-5621-9451
Email: zhumy@tarena.com.cn
(TGTX) TG-1101 in Combination With Ibrutinib
- 90% overall response rate (ORR) at first efficacy assessment for combination of TG-1101 and Ibrutinib
- No patients have progressed on the combination to date
- Combination appears well tolerated with few Grade 3/4 events reported to date
- Updated data on single agent TGR-1202 demonstrates 89% nodal response in CLL patients
NEW YORK, June 13, 2014 — TG Therapeutics, Inc. (Nasdaq:TGTX), an innovative, clinical-stage biopharmaceutical company today announced preliminary clinical results from its ongoing Phase 2 study of TG-1101 (ublituximab), the Company’s novel glycoengineered anti-CD20 monoclonal antibody, in combination with ibrutinib (IMBRUVICA™), the oral BTK inhibitor from Pharmacyclics/Janssen. Data from the Phase 2 study is being presented during the 19th Annual European Hematology Association (EHA) meeting being held in Milan, Italy.
The poster presentation includes data from 28 patients with relapsed and/or refractory CLL or MCL treated with TG-1101 at doses of 600 mg or 900 mg, in combination with ibrutinib at an oral daily dose of 420 mg for patients with CLL and 560 mg for patients with MCL.
Overview of the data presented on TG-1101 + ibrutinib:
Safety and Tolerability
TG-1101 in combination with ibrutinib was well tolerated in the 28 patients evaluable for safety, with Day 1 infusion related reactions (IRR) being the most frequently reported adverse event for TG-1101. All but one IRR were Grade 1 or 2 in severity and were manageable without dose reductions. Ibrutinib related adverse events included diarrhea and rash with one patient discontinuing treatment due to ibrutinib related diarrhea (only patient to discontinue from the study to date).
Clinical Activity
The overall response rate (ORR) at the first planned efficacy assessment for the 10 evaluable patients was 90%. The breakdown of responses is as follows:
- CLL patients (including 4 with high risk cytogenetics such as 17p del and 11q del): 86% (6/7) achieved a partial response (PR) at the first assessment, with the remaining one patient achieving a 40% nodal reduction coupled with a >50% reduction in ALC pending next response assessment; and
- MCL patients: 100% (3/3) achieved a response (1 CR and 2 PRs).
The addition of TG-1101 appears to abrogate ibrutinib related lymphocytosis in patients with CLL, with patients experiencing a median ~80% reduction in their absolute lymphocyte count (ALC) by month 4 following initiation of combination therapy.
Of the 28 patients enrolled on study to date, including patients with high risk CLL, no patients have progressed while on the combination, with patients on study now for upwards of 5 months.
Dr. Jeff Sharman, Medical Director of Hematology Research for the US Oncology Network, and Study Chair for the Phase 2 trial stated: “We are impressed with the clinical activity and safety profile seen with ublituximab in combination with ibrutinib to date. We believe there is an important role for combination therapy with the newer agents in CLL. Ublituximab is specifically designed to overcome specific weaknesses of traditional anti-CD20 therapy. This data shows ublituximab can safely be combined with ibrutinib and may both accelerate and deepen the response compared to prior trials of ibrutinib alone.”
Michael S. Weiss, the Company’s Executive Chairman and Interim CEO commented on the data, “From the inception of TG Therapeutics, we have been focused on developing novel combination therapies with the goal of driving very high response rates without the toxicity associated with chemotherapy. We believe that today’s data represent early evidence that we can achieve that goal. The rapid and deep responses seen in 9 out of 10 patients evaluable for response at the first assessment compares quite favorably to published data on ibrutinib monotherapy at early efficacy assessments. While still early, we are very encouraged by the results seen thus far and look forward to presenting data on additional patients with longer-term follow-up at ASH at year’s end.”
Overview of other data presented on TG-1101 and TGR-1202:
In addition to the data from the ongoing TG-1101 plus ibrutinib combination study, the Company is also presenting data from ongoing single agent studies of TG-1101 and TGR- 1202, the Company’s novel, oral PI3K delta inhibitor, both of which, as previously reported at ASCO, were well tolerated and demonstrated significant single agent response rates in patients with relapsed and/or refractory B-cell malignancies. The Company’s presentation for TGR-1202 includes updates from the ASCO data cutoff, where it was previously reported that 78% (7/9) CLL patients treated at 800 mg QD or higher had achieved a nodal partial response or a partial response. Updated data presented at the EHA meeting demonstrates an 89% nodal response rate with 8/9 CLL patients now achieving a nodal or partial response on TGR-1202 monotherapy at doses ≥ 800 mg.
Mr. Weiss added “We are also excited to note the evolving responses seen in our Phase 1 single-agent study of TGR-1202, with an additional CLL patient achieving a nodal PR, bringing our nodal response rate in CLL patients treated at 800mg or higher to nearly 90%. These encouraging results, coupled with the ibrutinib combination data, drive our confidence in our proprietary combination of TG-1101 and TGR-1202, which we will report data for at the Pan Pacific Lymphoma Conference in July 2014.”
Presentation details for all posters presented at EHA are as follows:
Title: Ublituximab (TG-1101) a novel glycoengineered anti-CD20 monoclonal antibody in combination with ibrutinib in patients with CLL and MCL; Results of an ongoing Phase 2 trial
- Abstract Number: P880
- Presentation Date & Time: Saturday, June 14 2014, 5:45 PM – 7:00 PM CEST
- Poster Session: Chronic lymphocytic leukemia and related disorders – Clinical 2
- Poster Display: Poster Area (NW – Level 0)
- Lead Author: Jeff Sharman, MD, Willamette Valley Cancer Institute/US Oncology Research
- Link to Poster: www.tgtherapeutics.com/EHA2014-PosterP880.pdf
Title: Ublituximab (TG-1101), a novel anti-CD20 monoclonal for rituximab relapsed/refractory B-cell malignancies
- Abstract Number: P444
- Presentation Date & Time: Friday, June 13, 2014, 5:45 PM – 7:00 PM CEST
- Poster Session: Indolent Non-Hodgkin lymphoma – Clinical
- Poster Display: Poster Area (NW – Level 0)
- Lead Author: Owen A. O’Connor, MD, PhD, Columbia University Medical Center, New York, NY
- Link to Poster: www.tgtherapeutics.com/EHA2014-PosterP444.pdf
Title: TGR-1202, a novel once-daily PI3K delta inhibitor, demonstrates promising clinical activity with a favorable safety profile in patients with relapsed or refractory hematologic malignancies
- Abstract Number: P250
- Presentation Date & Time: Friday, June 13, 2014, 5:45 PM – 7:00 PM CEST
- Poster Session: Chronic lymphocytic leukemia and related disorders – Clinical 1
- Poster Display: Poster Area (NW – Level 0)
- Lead Author: Howard A. Burris, MD, Sarah Cannon Research Institute, Nashville, TN
- Link to Poster: www.tgtherapeutics.com/EHA2014-PosterP250.pdf
ABOUT TG THERAPEUTICS, INC.
TG Therapeutics is an innovative, clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of medically important pharmaceutical products for the treatment of cancer and other underserved therapeutic needs. Currently, the company is developing two therapies targeting hematological malignancies. TG-1101 (ublituximab) is a novel, glycoengineered monoclonal antibody that targets a specific and unique epitope on the CD20 antigen found on mature B-lymphocytes. TG Therapeutics is also developing TGR-1202, an orally available PI3K delta inhibitor. The delta isoform of PI3K is strongly expressed in cells of hematopoietic origin and is believed to be important in the proliferation and survival of B‐lymphocytes. Both TG-1101 and TGR-1202 are in clinical development for patients with hematologic malignancies. TG Therapeutics is headquartered in New York City.
Cautionary Statement
Some of the statements included in this press release, particularly those anticipating future clinical trials, the timing of commencing, completing or reporting such trials, the business prospects for TG-1101 and TGR-1202, the potential benefits of combining TG-1101 and TGR-1202 and the potential benefits that might be achieved with the micronized formulation and fed-state dosing may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. Among the factors that could cause our actual results to differ materially are the following: our ability to successfully and cost-effectively complete pre-clinical and clinical trials for TG-1101 and TGR-1202; the risk that early pre-clinical and clinical results that supported our decision to move forward with TG-1101 and TGR-1202 will not be reproduced in additional patients or in future studies; the risk that the enhanced absorption seen in the healthy human volunteer bioequivalence studies will not be seen in whole or in part when the modified formulation and fed-state dosing are studied in patients with B-cell malignancies; the risk that TGR-1202 will not produce satisfactory safety and efficacy results to warrant further development following the completion of the current phase 1 study; the risk that the data (both safety and efficacy) from future clinical trials will not coincide with the data produced from prior pre-clinical and clinical trials; the risk that trials will take longer to enroll than expected; our ability to achieve the milestones we project over the next year; our ability to manage our cash in line with our projections, and other risk factors identified from time to time in our reports filed with the Securities and Exchange Commission. Any forward-looking statements set forth in this press release speak only as of the date of this press release. We do not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. This press release and prior releases are available at www.tgtherapeutics.com. The information found on our website is not incorporated by reference into this press release and is included for reference purposes only.
TGTX – G
CONTACT: Jenna Bosco Director- Investor Relations TG Therapeutics, Inc. Telephone: 212.554.4351 Email: ir@tgtxinc.com
(TLOG) Conference Call on TetraLogic Infectious Disease Program
MALVERN, Pa., June 13, 2014 — TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) (“Company”) today announced that it will host a conference call and live audio webcast on Monday, June 16, 2014 at 08:00 a.m. Eastern Time with Dr. Marc Pellegrini, Laboratory Head, Infection and Immunity Division, Walter and Eliza Hall Institute of Medical Research, Melbourne, Australia. Dr. Pellegrini will review preclinical studies indicating the potential for broad applicability of TetraLogic’s lead compound, birinapant, in models of infectious disease, including Hepatitis B. The Company will also discuss future planned clinical activities, including a Phase 1 clinical trial of birinapant in patients with chronic Hepatitis B infection, which the Company intends to commence in late 2014 and for which Dr. Pellegrini will play a key leadership role.
To access the conference call, please dial (888) 734-0328 (U.S.) or (678) 894-3054 (International) using the Conference ID 61183614. The conference call will be webcast via the Investor Relations page on the Company’s website at www.tlog.com. Approximately two hours following the live event, a webcast replay of the conference call will be accessible on the Company’s website; the webcast replay will be available for 30 days.
About the Walter and Eliza Hall Institute
The Walter and Eliza Hall Institute is Australia’s oldest medical research institute. It is home to almost 750 researchers who are working to understand, prevent and treat diseases including infectious diseases, cancers and immune disorders. It is located in Parkville, Melbourne, and is closely associated with The University of Melbourne and The Royal Melbourne Hospital.
About Birinapant
Birinapant (TL32711) is a potent, bivalent SMAC mimetic that binds with differential affinity to multiple members of the IAP family including cIAP1, cIAP2, XIAP, and ML-IAP. Birinapant is differentiated from other SMAC mimetics in that it results in the selective degradation of cIAP1 bound to TRAF-2 in the TNF receptor complex, sparing non–TRAF-2 bound cIAP1. This unique IAP antagonism profile of birinapant may result in the improved tolerability and therapeutic index observed with this agent.
About TetraLogic
TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and suberohydroxamic acid phenyl ester (SHAPE). Birinapant is currently being tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors. SHAPE is entering Phase 2 trials for early-stage CTCL.
Forward Looking Statements
Some of the statements in this release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic’s pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward-looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the Securities and Exchange Commission on March 19, 2014 and our Quarterly Report of Form 10-Q filed with the Securities and Exchange Commission on May 8, 2014. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.
CONTACT: Company Contact: Pete A. Meyers Chief Financial Officer and Treasurer TetraLogic Pharmaceuticals Corporation (610) 889-9900, x103 pete.meyers@tlog.com Investor Relations Contact: Ami Bavishi Burns McClellan, Inc. (212) 213-0006 abavishi@burnsmc.com
(ICLD) VMware Partner, Opening of a New England Sales Office
SHREWSBURY, N.J., June 13, 2014 — InterCloud Systems, Inc. (Nasdaq:ICLD) (the “Company” or “InterCloud”), a cloud-centric solutions and services company serving enterprise and service provider customers, announced that it has become a VMware partner and has opened a new sales office in New England. The New England team brings tremendous VMware and cloud mobility experience to the InterCloud.
InterCloud Executive Vice President of Sales and Marketing, Scott Davis said, “Our mission is to partner with our customers in building a next-generation cloud-centric IT organization. Gartner estimates the cloud computing market will grow from $68.3 billion to $148.8 billion by 2015, and VMware offers industry-leading Software Defined Enterprise solutions to support our mission. We have made a significant investment in top talent in the New England market to support this crucial focus area. Our customers will have the assurance of knowing that our team will have unmatched cloud-centric product expertise coupled with the highest level of sales and technical certifications for VMware.”
In today’s business dynamic, enterprises require a robust and agile IT organization. Cloud-centric solutions and services empower next generation IT organizations to deliver high-impact business transformation. InterCloud intends to partner with additional vendors like VMware to assist customers in radically simplifying cloud strategies and implementations. The Company prides itself on having a highly-certified VMware team of experts delivering cloud-centric IT strategy, implementation, and integration solutions and services.
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a single-source provider of end-to-end information technology (IT) and next-generation network solutions to the telecommunications service provider (carrier) and corporate enterprise markets through cloud platforms and professional services. InterCloud offers cloud and managed services, professional consulting and staffing services, and voice, data and optical solutions to assist its customers in meeting their changing technology demands. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
Forward-looking statements:
The above news release contains forward-looking statements. The statements contained in this document that are not statements of historical fact, including but not limited to, statements identified by the use of terms such as “anticipate,” “appear,” “believe,” “could,” “estimate,” “expect,” “hope,” “indicate,” “intend,” “likely,” “may,” “might,” “plan,” “potential,” “project,” “seek,” “should,” “will,” “would,” and other variations or negative expressions of these terms, including statements related to expected market trends and the Company’s performance, are all “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and involve a number of risks and uncertainties. These statements are based on assumptions that management believes are reasonable based on currently available information, and include statements regarding the intent, belief or current expectations of the Company and its management. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performances, and are subject to a wide range of external factors, uncertainties, business risks, and other risks identified in filings made by the company with the Securities and Exchange Commission. Actual results may differ materially from those indicated by such forward-looking statements. The Company expressly disclaims any obligation or undertaking to update or revise any forward-looking statement contained herein to reflect any change in the company’s expectations with regard thereto or any change in events, conditions or circumstances upon which any statement is based except as required by applicable law and regulations.
CONTACT: Investor Relations RedChip Companies, Inc. Mike Bowdoin, Vice President Mike@redchip.com
(OPEN) Agrees to Acquire OpenTable, Inc.
The Priceline Group to hold a conference call today at 8:30 a.m. ET to discuss this transaction at http://ir.priceline.com
NORWALK, Conn. and SAN FRANCISCO, June 13, 2014 — The Priceline Group Inc. (NASDAQ: PCLN) and OpenTable, Inc. (NASDAQ: OPEN) today announced that they have entered into a definitive agreement whereby The Priceline Group will acquire OpenTable for $103 per share in an all cash transaction valued at $2.6 billion.
“OpenTable is a great match for The Priceline Group. They provide us with a natural extension into restaurant marketing services and a wonderful and highly-valued booking experience for our global customers,” said Darren Huston, President & CEO of The Priceline Group. “We look forward to helping the OpenTable team accelerate their global expansion, increase the value offered to their restaurant partners, and enhance the end-to-end experience for our collective customers across desktop and mobile devices.”
With more than 15 million diners seated per month across more than 31,000 restaurants, OpenTable is the world’s leading provider of online restaurant reservations. OpenTable has seated more than 125 million diners worldwide through its mobile solutions, which were introduced in 2008. OpenTable’s brand is built on helping diners discover and book the perfect table and helping restaurants connect directly with their customers.
The Priceline Group is the world’s leading accommodation booking platform. Every night, an average of more than 1 million guests stay in accommodations booked through one of The Priceline Group brands in over 480,000 properties in over 200 countries and territories worldwide.
“The Priceline Group is a leader in e-commerce innovation with global expertise in online marketing and digital customer conversion across devices, and they have an exceptional track record of customer service in dozens of languages around the world,” said Matt Roberts, CEO of OpenTable. “We couldn’t be more excited to join a group of brands leading in their space, and we look forward to the next chapter of our own journey as we continue to enhance the dining experience for our customers worldwide.”
The Boards of Directors of The Priceline Group and OpenTable have unanimously approved the transaction, which will be effected through a tender offer and is expected to close in the 3rd quarter of 2014, subject to the satisfaction of customary closing conditions, including the receipt of regulatory clearance.
OpenTable will continue to be headquartered in San Francisco, CA and will operate as an independent business led by its current management team within The Priceline Group.
Conference Call to Discuss Transaction
Darren Huston, President and CEO and Daniel Finnegan, Chief Financial Officer of The Priceline Group will discuss the transaction during a conference call on Friday, June 13, 2014 at 8:30 am ET. A live webcast of the conference call will be accessible at http://ir.priceline.com
Information About Forward-Looking Statements
This communication contains forward-looking statements. These forward-looking statements reflect the views of The Priceline Group’s and OpenTable’s management regarding current expectations and projections about future events and the ability of The Priceline Group and OpenTable to complete the transactions contemplated by the merger agreement, including the parties’ ability to satisfy the conditions to the consummation of the tender offer and the other conditions set forth in the merger agreement, and are based on currently available information and current foreign currency exchange rates. These forward-looking statements are not guarantees of future performance and are subject to risks, uncertainties and assumptions that are difficult to predict; therefore, actual results may differ materially from those expressed, implied or forecasted in any such forward-looking statements. Expressions of future goals and similar expressions including, “may,” “will,” “should,” “could,” “expects,” “plans,” “anticipates,” “intends,” “believes,” “estimates,” “predicts,” “potential,” “targets,” or “continue,” reflecting something other than historical fact are intended to identify forward-looking statements. The proposed transaction has not closed, and the following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: the possibility that expected benefits of the transaction may not be achieved in a timely manner or at all; revenues following the transaction may be lower than expected; disruption from the transaction may adversely affect OpenTable’s relationships with its customers, business partners or employees; the conditions to the completion of the transaction may not be satisfied in a timely manner or at all; and the other factors described in The Priceline Group’s and OpenTable’s most recent Quarterly Report on Form 10-Q and Annual Report on Form 10-K filed with the Securities and Exchange Commission. Unless required by law, neither The Priceline Group nor OpenTable undertakes any obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise.
Additional Information
The tender offer described in this communication (the “Offer”) has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of OpenTable or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the United States Securities and Exchange Commission (the “SEC”) by The Priceline Group and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by OpenTable. The offer to purchase shares of OpenTable common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by The Priceline Group, Inc. and Rhombus, Inc., a wholly-owned subsidiary of the Priceline Group, and the solicitation/recommendation statement will be filed with the SEC by OpenTable. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement.
About The Priceline Group
The Priceline Group Inc. (NASDAQ: PCLN) is the world leader in online travel, serving consumers and partners through five primary brands – Booking.com, priceline.com, Agoda.com, KAYAK and rentalcars.com. For more information, visit PricelineGroup.com.
About OpenTable
OpenTable is the world’s leading provider of online restaurant reservations, seating more than 15 million diners per month via online bookings across more than 31,000 restaurants. The OpenTable network connects restaurants and diners, helping diners discover and book the perfect table and helping restaurants deliver personalized hospitality to keep guests coming back. The OpenTable service enables diners to see which restaurants have available tables, select a restaurant based on verified diner reviews, menus, and other helpful information, and easily book a reservation. In addition to the company’s website and mobile apps, OpenTable powers online reservations for nearly 600 partners, including many of the Internet’s most popular global and local brands. For restaurants, the OpenTable hospitality solutions enable them to manage their reservation book, streamline their operations, and enhance their service levels. Since its inception in 1998, OpenTable has seated more than 620 million diners around the world. The Company is headquartered in San Francisco, California, and the OpenTable service is available throughout the United States, as well as in Canada, Germany, Japan, Mexico, and the UK. More information is available on http://www.opentable.com.
(KPTI) Data of Selinexor With Low-Dose Dexamethasone in Multiple Myeloma
Six Data Presentations at the European Hematology Association’s 19th Congress
NATICK, Mass., June 13, 2014 — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced initial Phase 1 data from patients with multiple myeloma treated with Karyopharm’s lead selective inhibitor of nuclear export (SINE), Selinexor (KPT-330), in combination with “low-dose” (20 mg twice weekly) dexamethasone. Among eight patients, the best responses were one stringent complete response (sCR), three partial responses (PRs), two minor responses (MRs), one progressive disease and one non-evaluable. Accordingly, the clinical benefit response rate (sCR+PR+MR) is 75% and the overall response rate (sCR+PR) is 50%. These new results will be reported at the 19th Congress of the European Hematology Association (EHA) in a poster presentation on Saturday, June 14th from 5:45 – 7:00 PM CEST (Abstract #5580).
As part of Karyopharm’s Phase 1 clinical trial of Selinexor in patients with advanced hematological malignancies, patients with multiple myeloma were treated with either single-agent Selinexor or Selinexor in combination with low-dose dexamethasone. Eight patients with multiple myeloma, whose disease was relapsed and/or refractory to all available classes of approved therapies and progressing on study entry, were treated with 45 mg/m2 of oral Selinexor and 20 mg of dexamethasone, each dosed twice weekly. Patients had received a median of 5.5 prior lines of therapy. All had received prior therapy with a proteasome inhibitor and an immunomodulatory agent, while seven of the eight patients also received stem cell transplantations. Five of the six responding patients remain on study as of June 5, 2014, the data cut-off date. An additional 12 patients with multiple myeloma may be dosed with Selinexor in combination with dexamethasone in this arm of Karyopharm’s ongoing phase 1 hematology study.
Adverse events in patients receiving single-agent Selinexor were generally low-grade, consistent with events observed in patients with other hematological malignancies and responsive to standard supportive care. Compared with Selinexor given alone, fewer adverse events in patients receiving Selinexor in combination with dexamethasone were reported, consistent with dexamethasone’s reduction in Selinexor’s main side effects of nausea, anorexia, and fatigue.
“We have observed patients with multiple myeloma receiving durable responses on Selinexor single-agent therapy. We are particularly excited to see that Selinexor with low-dose dexamethasone shows marked activity with rapid M-protein reductions and good tolerability, even in patients with disease refractory to pomalidomide and/or carfilzomib,” stated Dr. Sharon Shacham, Karyopharm’s Founder, President and CSO. “While we have seen safety and efficacy data to date with Selinexor as a single-agent therapy, we also believe that Selinexor may have strong synergistic potential with both existing and novel therapies.”
In addition to the myeloma data, three presentations on Selinexor in acute myeloid leukemia (AML) will be given at EHA:
- An oral presentation on Sunday, June 15th from 11:15 – 11:30 AM CEST will focus on the activity of single-agent Selinexor in patients with heavily pretreated AML in the ongoing phase 1 study (Abstract #5591).
- Preclinical data from the combination of Selinexor with the FLT3 inhibitor quizartinib will be reported in a poster presented on Saturday, June 14th from 5:45 – 7:00 PM CEST (Abstract #5575).
- Preclinical data from the Ohio State University providing evidence that Selinexor restores topoisomerase IIα (Topo IIα) to the nucleus and sensitizes resistant AML blasts to Topo IIα inhibitors including adriamycin will be reported in a poster presented on Saturday, June 14th from 5:45 – 7:00 PM CEST (Abstract #5296).
Clinical and preclinical data on Selinexor in patients with double hit diffuse large B-Cell lymphoma (DLBCL) will be presented in a poster on Friday, June 13th from 5:45 – 7:00 PM CEST (Abstract #5378). New preclinical data include in vitro evidence of XPO1 overexpression in DLBCL cells along with cytotoxicity in DLBCL cell lines of multiple subtypes, including double hit DLBCL. Analyses of DLBCL cell lines show Selinexor can reduce cytoplasmic BCL2/BCL6 and c-MYC mRNAs, which likely contributes to Selinexor’s activity in DLBCL. In the ongoing phase 1 study in patients with DLBCL treated with 3-80 mg/m2 of Selinexor, responses were observed across GCB, non-GCB, and double-hit subtypes, and were also independent of prior therapies.
An additional poster presentation on Saturday, June 14th from 5:45 – 7:00 PM CEST will provide results of Phase 1 and Phase 2 clinical trials of related SINE drug candidate Verdinexor (KPT-335) in spontaneous canine cancers, particularly lymphomas (Abstract #4791).
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export (SINE) compound. Selinexor functions by binding with the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. To date, over 300 patients have been treated with Selinexor in Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Additional Phase 1 and Phase 2 studies are ongoing or currently planned and three registration-directed clinical trials in hematological indications are expected to begin enrollment during 2014. The latest clinical trial information for Selinexor is available at www.clinicaltrials.gov.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel first-in-class drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. SINE compounds have shown biological activity in models of cancer, autoimmune disease, certain viruses, and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in Natick, Massachusetts. For more information about Karyopharm, please visit www.karyopharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that any of Karyopharm’s SINE compounds, including Selinexor (KPT-330), or any other drug candidate that Karyopharm is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Annual Report on Form 10-K for the year ended December 31, 2013, which is on file with the Securities and Exchange Commission (SEC), and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Paul Brannelly paul@karyopharm.com 508-975-4820
(EMAN) First Ever Ultra-High Brightness DPD Color OLED Microdisplay
eMagin Corporation (NYSE MKT:EMAN) has demonstrated the first ever full color ultra-high brightness DPD brand OLED microdisplay. The new full color DPD display, designated OLED-ULT, provides brightnesses that meet or exceed the requirements of the wearable Smartglass market, more than 30 times greater than eMagin’s current largest selling display, while providing 5 times the power efficiency. Power efficiency is a key advantage in selecting eMagin’s OLED microdisplay versus an LCD or LCOS solution.
Demonstrations of OLED-ULT displays are currently being performed for key customers with interests in ultra-high brightness microdisplays for applications as diverse as aviation head mounted displays, smart glasses, and commercial augmented reality applications. “eMagin’s ultra-high brightness OLED-ULT technology was designed specifically for transparent near-to-eye applications demanding ultra-high brightness, full color imagery with extremely high contrast, compact size and very low power, such as avionics helmets and smart glasses applications” said Andrew G. Sculley, president and CEO of eMagin Corporation.
The active matrix OLED-ULT delivers crisp, high-contrast imagery via eMagin’s True BlackTM pixel technology. The screen turns on instantly at low temperatures without the need for heaters and is built to high commercial and military ruggedness standards. The OLED-ULT display exhibits much lower color shift with angle than standard OLED displays. This approach offers a high-resolution microdisplay with extended luminance performance without the need for a back light, illuminator, or separate drive circuitry which are necessary for LCOS or LCD technology microdisplays.
About eMagin Corporation
A leader in OLED microdisplay technology, OLED microdisplay manufacturing know-how and mobile display systems, eMagin manufactures high-resolution OLED microdisplays and integrates them with magnifying optics to deliver virtual images comparable to large-screen computer and television displays in portable, low-power, lightweight personal displays. eMagin microdisplays provide near-eye imagery in a variety of products from military, industrial, medical and consumer OEMs. More information about eMagin is available at www.emagin.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, including those regarding eMagin Corporation’s expectations, intentions, strategies and beliefs pertaining to future events or future financial performance. Actual events or results may differ materially from those in the forward-looking statements as a result of various important factors, including those described in the Company’s most recent filings with the SEC. Although we believe that the expectations reflected in the forward-looking statements are reasonable, such statements should not be regarded as a representation by the Company, or any other person, that such forward-looking statements will be achieved. The business and operations of the Company are subject to substantial risks which increase the uncertainty inherent in forward-looking statements. We undertake no duty to update any of the forward-looking statements, whether as a result of new information, future events or otherwise. In light of the foregoing, readers are cautioned not to place undue reliance on such forward-looking statements.
OLED-XL, Color OLED-XLS and True Black are trademarks of eMagin Corp. OLED-ULT is trademark pending. All other names are the products of their respective owners.
(BIND) to Present at JMP Securities Healthcare Conference
BIND Therapeutics, Inc. (NASDAQ: BIND), a clinical-stage nanomedicine platform company developing targeted and programmable therapeutics called AccurinsTM, announced today that Scott Minick, BIND’s President and CEO, is scheduled to present at the 9th Annual JMP Securities Healthcare Conference in New York on Tuesday, June 24, 2014 at 10:00 a.m. ET.
Interested parties may access a live webcast of the presentation by visiting the BIND Therapeutics website at www.bindtherapeutics.com. The webcasts will be archived on the BIND Therapeutics website following the event for one week.
About BIND Therapeutics
BIND Therapeutics is a clinical-stage nanomedicine platform company developing Accurins, its novel targeted therapeutics. BIND intends to leverage its medicinal nanoengineering platform to develop a pipeline of Accurins, initially in oncology, as well as Accurins in collaboration with biopharmaceutical companies. BIND’s lead drug candidate, BIND-014, is an Accurin that targets PSMA and contains docetaxel, a clinically-validated and widely used cancer chemotherapy drug. BIND-014 is currently in Phase 2 clinical trials for non-small cell lung cancer and metastatic castrate resistant prostate cancer.
BIND has announced collaborations with Amgen, Inc., Pfizer Inc. and AstraZeneca AB to develop Accurins based on therapeutic payloads from their product pipelines. BIND’s platform originated from the pioneering nanotechnology research at the Massachusetts Institute of Technology and Brigham and Women’s Hospital/Harvard Medical School of BIND’s scientific founders and directors Dr. Robert Langer and Dr. Omid Farokhzad. For more information, please visit the company’s web site at www.bindtherapeutics.com.
(LIVE) Ad Campaign Spark 250% Jump in Traffic
LiveDeal Inc. (NASDAQ:LIVE) (“LiveDeal” or the “Company”), a publicly traded company that operates livedeal.com, a geo-location based mobile marketing platform that enables restaurants to publish “real-time” and “instant offers” to nearby consumers, today announces its recent 35 city ad campaign has netted a 244 percent increase in site visits in its first week, compared to site traffic over the same period during the prior month.
A previously announced, LiveDeal’s 35-city ad campaign supports the restaurant owners who have collaborated with LiveDeal to create more than 10,000 deals in more than 8,000 restaurants where the campaign is targeted. The campaign was designed to increase user registration and drive traffic into those restaurant locations utilizing LiveDeal’s real-time “deal engine.”
“LiveDeal provides restaurants the opportunity to connect with more potential customers real time, and we are proud that this ad campaign has increased site visits so quickly,” said Jon Isaac, CEO of LiveDeal, Inc. “With such a significant early response, we are anxious to see the continued performance of this campaign, which will benefit our restaurant owner customers, and ultimately their customers as well.”
While about 85 percent of current traffic to the LiveDeal website is currently from new users, the company notes that the remaining 15 percent still represents a significant uptake in returning users compared to the prior month.
About LiveDeal, Inc.
LiveDeal Inc. provides marketing solutions that boost customer awareness and merchant visibility on the Internet. LiveDeal operates a deal engine, which is a service that connects merchants and consumers via an innovative platform that uses geo-location, enabling businesses to communicate real-time and instant offers to nearby consumers. In November 2012, LiveDeal commenced the sale of marketing tools that help local businesses manage their online presence under the Company’s Velocity Local™ brand. LiveDeal continues to actively develop, revise, and evaluate these products and services and its marketing strategies and procedures. For more information, visit www.livedeal.com.
Forward-Looking and Cautionary Statements
This press release contains “forward-looking” statements that are based on present circumstances and on LiveDeal’s predictions with respect to events that have not occurred, that may not occur, or that may occur with different consequences and timing than those now assumed or anticipated. Such forward-looking statements, including any statements regarding the plans and objectives of management for future operations or products, the market acceptance or future success of our products, and our future financial performance, are not guarantees of future performance or results and involve risks and uncertainties that could cause actual events or results to differ materially from the events or results described in the forward-looking statements. Forward-looking statements are made only as of the date of this release and LiveDeal does not undertake and specifically declines any obligation to update any forward-looking statements. Readers should not place undue reliance on these forward-looking statements.
(NFEC) Receives Major Turn Key Project Contract over Coal Boiler Retrofit
SHENYANG, China, June 12, 2014 — NF Energy Saving Corporation (NFEC) (“NF Energy” or the “Company”), a leading energy saving services and solutions provider for China’s power, petrochemical, coal, metallurgy, construction, and municipal infrastructure development industries, today announced that it has recently signed a RMB22 million (or $3.38 million) contract with an environmental protection company in Beijing for a major retrofit project over the industrial coal fired boilers owned by a Chinese aircraft manufacturing company.
According to the contract, NF Energy will provide and install boiler denitration, dust removal and desulfurization systems two sets of equipment at the project for sulfur dioxide and nitrogen oxide emissions reduction and dust removal. The Company’s services include system design, equipment fabrication, supply and installation, as well as start up adjustment .
Mr. Gang Li, Chairman, said , “as a result of the large emission of sulfur dioxide and nitrogen oxide from China’s thermal power plants, industrial and space heating boilers, which are primarily fired with coal, the country has been faced with the increasing challenge of poor air quality and environmental pollution, including the heavy smog which has hit vast areas in China recently. It has been mandated in China’s Energy Conservation and Emission Reduction Program for the 12th 5 year Plan Period that energy efficiency enhancements and dust removal retrofits shall be conducted on coal fired industrial boilers and emission intensive industries such as iron, steel and cement making. Therefore, the Company hopes that this project contract will be one of many opportunities “.
About NF Energy Saving Corporation
NF Energy Saving Corporation (NASDAQ: NFEC) is a China-based provider of integrated energy conservation solutions utilizing energy-saving equipment, technical services and energy management re-engineering project operations to provide energy saving services to clients. The Company’s customers are mainly concentrated in the electrical generation (large-scale thermal power generation, hydroelectric power, and nuclear power), water supply, and heat supply industries. The majority of revenues are from energy efficient flow control solutions including equipment and energy efficiency project services. For more information, visit http://www.nfenergy.com.
Safe Harbor Statement
The statements contained herein that are not historical facts are considered “forward-looking statements.” Such forward-looking statements may be identified by, among other things, the use of forward-looking terminology such as “believes,” “expects,” “may,” “will,” “should,” or “anticipates” or the negative thereof or other variations thereon or comparable terminology, or by discussions of strategy that involve risks and uncertainties. In particular, statements regarding the efficacy of investment in research and development are examples of such forward-looking statements. The forward-looking statements include risks and uncertainties, including, but not limited to, the effect of political, economic, and market conditions and geopolitical events; legislative and regulatory changes that affect our business; the availability of funds and working capital; the actions and initiatives of current and potential competitors; investor sentiment; and our reputation. We do not undertake any responsibility to publicly release any revisions to these forward-looking statements to take into account events or circumstances that occur after the date of this report. Additionally, we do not undertake any responsibility to update you on the occurrence of any unanticipated events, which may cause actual results to differ from those expressed or implied by any forward-looking statements. The factors discussed herein are expressed from time to time in our filings with the Securities and Exchange Commission available at http://www.sec.gov.
(MSLI) Announces Increase to Previously Announced Financing
TORONTO, ONTARIO–(Jun 12, 2014) – Merus Labs International Inc. (“the Company” or “Merus”) (TSX:MSL)(NASDAQ:MSLI) is pleased to announce that it has amended the terms of the previously announced bought deal public offering with a syndicate of investment dealers (the “Underwriters”) to increase the size of the offering by an additional 3,000,000 common shares (the “Additional Common Shares”). Under the amended terms of the offering, the Underwriters have agreed to purchase an aggregate of 16,000,000 common shares (“Common Shares”) of the Company for total gross proceeds of $27,200,000.
In addition, the Underwriters agreed to amend the terms of the offering to include the Additional Common Shares in deriving the number of Common Shares allowed under the over allotment option.
The net proceeds of the Offering will be used for future acquisitions and general working capital.
Closing of the Offering is expected to occur on or about June 19, 2014 and is subject to regulatory approval including that of the Toronto Stock Exchange and NASDAQ.
The Company has filed a base shelf prospectus with the Canadian Securities Administrators in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba and Ontario. The Shares will be offered by way of a prospectus supplement supplementing the base shelf prospectus in the provinces of British Columbia, Alberta, Saskatchewan, Manitoba and Ontario, and may be offered in the United States on a private placement basis pursuant to an exemption from the registration requirements of the United States Securities Act of 1933, as amended, and certain other jurisdictions.
This press release does not constitute an offer of securities for sale in the United States. The Shares have not been, nor will they be, registered under the United States Securities Act of 1933, as amended, and such securities may not be offered or sold within the United States absent U.S. registration or an applicable exemption from U.S. registration requirements.
About Merus
Merus is a specialty pharmaceutical company engaged in the acquisition and licensing of pharmaceutical products. The Company utilizes its expertise in pharmaceutical markets and its access to capital to acquire and license niche branded products. Merus further enhances the sale and distribution of these products by the introduction of a focused marketing and promotion plan.
COMMENTARY REGARDING FORWARD-LOOKING STATEMENTS
This news release may contain “forward-looking information” as defined in applicable Canadian securities legislation and “forward-looking statements” within the meaning of Section 21E (i) (1) of the United States Securities Exchange Act of 1934. All statements other than statements of historical fact, included in this release, including, without limitation, statements regarding future plans and objectives of Merus, the completion of the Offering and the use of proceeds of the Offering, constitute forward-looking information that involve various known and unknown risks, uncertainties, and other factors outside management’s control. Forward-looking information is based on a number of factors and assumptions which have been used to develop such information but which may prove to be incorrect. There can be no assurance that such information will prove to be accurate and actual results and future events could differ materially from those anticipated in such forward-looking information.
For additional information with respect to risk factors applicable to Merus, reference should be made to Merus’ continuous disclosure materials filed from time to time with securities regulators, including, but not limited to, Merus’ Annual Information Form. The forward-looking information contained in this release is made as of the date of this release and Merus does not undertake to update publicly or revise the forward-looking information contained in this release, whether as a result of new information, future events or otherwise, except as required by applicable securities laws.
No regulatory authority has approved or disapproved the adequacy or accuracy of this news release.
Merus Labs International Inc.
Investor relations department
(416) 593-3725
info@meruslabs.com
(XTLB) Receives Correspondence Regarding Nasdaq Listing Requirements
Company Must Remedy Noncompliance with Audit Committee Requirements as Set Forth in Listing Rule 5605
HERZLIYA, Israel, June 12, 2014 — XTL Biopharmaceuticals Ltd. (NASDAQ: XTLB, TASE: XTL) (“XTL” or the “Company”), a clinical-stage biopharmaceutical company focused on the acquisition, development and commercialization of pharmaceutical products for the treatment of unmet clinical needs, announced today that it received a letter from the Nasdaq Stock Market LLC (“Nasdaq”) dated June 9, 2014 relating to the May 19, 2014 resignation of director Marc Allouche.
As a result of Mr. Allouche’s resignation, the Company is no longer in compliance with Nasdaq Listing Rule 5605, which states:
Each Company must have, and certify that it has and will continue to have, an audit committee of at least three members, each of whom must: (i) be an Independent Director as defined under Rule 5605(a)(2); (ii) meet the criteria for independence set forth in Rule 10A-3(b)(1) under the Act (subject to the exemptions provided in Rule 10A-3(c) under the Act); (iii) not have participated in the preparation of the financial statements of the Company or any current subsidiary of the Company at any time during the past three years; and (iv) be able to read and understand fundamental financial statements, including a Company’s balance sheet, income statement, and cash flow statement.
Because Mr. Allouche served on XTL’s Audit Committee, his departure leaves the Company with less than the requisite three independent members. Consistent with Listing Rule 5606(c)(4), however, Nasdaq provided the Company with a cure period in order to regain compliance as follows:
- until the earlier of the Company’s next annual shareholders’ meeting or May 18, 2015; or
- if the next annual shareholders’ meeting is held before November 14, 2014, then the Company must provide evidence of compliance no later than November 14, 2014.
The Company intends to remedy the deficiency during the cure period allotted by Nasdaq.
About XTL Biopharmaceuticals, Ltd. (“XTL”)
XTL Biopharmaceuticals Ltd., a biopharmaceutical company, focuses on the acquisition, development, and commercialization of pharmaceutical products for the treatment of unmet clinical needs. XTL is focused on late stage clinical development of drugs for the treatment of lupus, multiple myeloma and schizophrenia.
XTL is a public company traded on the Nasdaq Capital Market (NASDAQ: XTLB) and the Tel Aviv Stock Exchange (TASE: XTL). XTL shares are included in the following indices: Tel-Aviv Biomed, Tel-Aviv MidCap, and Tel-Aviv Bluetech-50.
Cautionary Statement
Some of the statements included in this press release may be forward-looking statements that involve a number of risks and uncertainties. For those statements, we claim the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995.
Investor Contacts:
Jeffrey Goldberger / Garth Russell
KCSA Strategic Communications
Phone: 212-896-1249 / 212-896-1250
Email: jgoldberger@kcsa.com / grussell@kcsa.com
(NAVB) Lymphoseek® Preferential Accumulation in Tumor-Positive Sentinel Lymph Nodes
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB), a biopharmaceutical company focused on precision diagnostic radiopharmaceuticals, today announced results from a post-hoc analysis of patient data from the Company’s Phase 3 clinical trial (NEO3-06) of Lymphoseek in head and neck cancer. The ability of Lymphoseek to localize in sentinel lymph nodes is based on its ability to target specific CD206 mannose receptor sites in macrophages, a type of immune cell which resides in high concentration in lymph nodes. In the NEO3-06 Phase 3 study, Lymphoseek localization to lymph nodes showed a strong correlation with a full regional lymph node dissection and pathology analysis with a low false negative rate, a priority in identifying sentinel nodes. Lymphoseek was also observed to home preferentially to pathology-positive nodes at a higher rate than pathology-negative nodes. These results suggest that Lymphoseek not only effectively targets sentinel lymph nodes, but further that its ability to highlight tumor-positive lymph nodes may be augmented mechanistically by the recruitment of macrophages to cancer-harboring lymph nodes.
“The accurate detection of tumor-draining lymph nodes is fundamental for effective lymphatic mapping, to minimize lymph tissue removal, and to provide clinically useful information regarding potential cancer metastasis,” said Francisco J. Civantos, M.D., FCS, University of Miami School of Medicine, Miami, Fla. “Approximately 75% of patients with stage 1 and 2 oral cavity head and neck cancer may be substantially over-treated if they are subjected to elective neck dissection, which involves surgical removal of a regional lymph node chain involving 30 to 45 lymph nodes. Receptor-targeted radiopharmaceuticals such as Lymphoseek, that are designed to facilitate accurate and reliable diagnostic evaluation of specific sentinel lymph nodes, can help spare patients morbidity that may result from elective neck dissection procedures.”
“As a purpose-built, receptor-targeted radiopharmaceutical, Lymphoseek is designed to target and accumulate in macrophages present in tumor-draining lymphatic tissue,” said Frederick Cope, Ph.D., Senior Vice President and Chief Scientific Officer of Navidea. “Tumor-positive lymph nodes recruit cells called Tumor-Associated Macrophages, or TAM’s, which are rich in CD206 receptors. The ability of Lymphoseek to specifically target and accumulate in macrophages demonstrated in this study led to localization of the product in tumor-draining pathology-positive lymph nodes that was 18 times higher than in all disease-negative lymph nodes. In the clinic, this reliable uptake of Lymphoseek into appropriate tissue allows for accurate removal and assessment of lymph nodes at highest risk of harboring occult metastases.”
The analysis, based on data from the Phase 3 clinical trial for Lymphoseek in head and neck cancer (NEO3-06), evaluated 83 patients to determine whether Lymphoseek localization in pathology-positive lymph nodes was higher than its localization in pathology-negative nodes, and if those results were consistent with the overall sentinel lymph node population. Sentinel lymph nodes and/or non-sentinel lymph nodes (nodes removed in elective neck dissection, or END) were removed from patients undergoing sentinel lymph node biopsy for head and neck squamous cell carcinoma, and all lymph nodes were assessed for the presence of tumor. Intraoperative counts were obtained for all lymph nodes removed including END nodes. Average in vivo gamma counts for all lymph nodes removed indicated that the count ratio of pathology-positive nodes to pathology negative nodes was approximately 18:1 (p<0.0001). For sentinel lymph nodes only, the ratio was >2.5:1 (p<0.016). The results were presented in an oral session by Frederick Cope of Navidea Biopharmaceuticals, at the 2014 Annual Meeting of the Society of Nuclear Medicine and Molecular Imaging (SNMMI) in St. Louis, Mo.
About the Lymphoseek Phase 3 Clinical Trial (NEO3-06) in Head and Neck Cancer (Oral Cavity)
Navidea’s Phase 3 clinical trial (NEO3-06) of Lymphoseek was a prospective, open-label, multicenter, within-patient study of Lymphoseek® (technetium Tc 99m tilmanocept) Injection. It was designed to identify sentinel lymph nodes (SLNs) and determine the false negative rate (FNR) associated with Lymphoseek-identified SLNs relative to the pathological status of non-SLNs in head and neck and intraoral squamous cell carcinoma, which is the current “gold standard.” The findings indicate that Lymphoseek accurately identified SLNs in the trial subjects for assessment, and that it is likely to be predictive of overall node pathology status. Moreover, multiple level nodal dissections of patients in the trial with cancer-positive lymph nodes led to an average removal of 38 lymph nodes per patient, whereas Lymphoseek on average would have led to the removal of approximately 4 lymph nodes, representing a substantial reduction in potential morbidity for patients with head and neck cancer undergoing sentinel lymph node biopsy.
About Lymphoseek®
Lymphoseek® (technetium Tc 99m tilmanocept) Injection is a novel, receptor-targeted, small-molecule radiopharmaceutical used in lymphatic mapping procedures that are performed to help in the diagnostic evaluation of potential cancer spread for patients with breast cancer and melanoma. Lymphoseek is designed to identify the lymph nodes that drain from a primary tumor, which have the highest probability of harboring cancer. Lymphoseek was approved by the U.S. Food and Drug Administration (FDA) in March, 2013 for use in lymphatic mapping to assist in the localization of lymph nodes draining a primary tumor in patients with breast cancer or melanoma. The Company anticipates continuing development of Lymphoseek into other solid tumor areas that may include other head and neck cancers such as thyroid cancer, prostate cancer and cancers of the female reproductive system (e.g., cervix, endometrial and vulva cancer). Lymphoseek was granted Fast Track and Priority Review designation for its sNDA for sentinel lymph node detection in patients with head and neck cancer and is currently in review with the FDA.
Accurate diagnostic evaluation of cancer is critical, as it guides therapy decisions and determines patient prognosis and risk of recurrence. According to publicly available information, approximately 235,000 new cases of breast cancer, 76,000 new cases of melanoma and 69,500 new cases of head and neck/oral cancer are expected to be diagnosed in the United States in 2014, and approximately 367,000 new cases of breast cancer, 83,000 new cases of melanoma and 137,000 new cases of head and neck/oral cancer diagnosed in Europe annually.
U.S. Indication and Important Safety Information About Lymphoseek
Indication
Lymphoseek (technetium Tc 99m tilmanocept) Injection is a lymphatic mapping agent indicated for use with a hand-held gamma counter to assist in the localization of lymph nodes draining a primary tumor site in patients with breast cancer or melanoma.
Important Safety Information
In clinical trials with Lymphoseek, no serious hypersensitivity reactions were reported, however Lymphoseek may pose a risk of such reactions due to its chemical similarity to dextran. Serious hypersensitivity reactions have been associated with dextran and modified forms of dextran (such as iron dextran drugs).
Prior to the administration of Lymphoseek, patients should be asked about previous hypersensitivity reactions to drugs, in particular dextran and modified forms of dextran. Resuscitation equipment and trained personnel should be available at the time of Lymphoseek administration, and patients observed for signs or symptoms of hypersensitivity following injection.
The most common adverse reactions are injection site irritation and/or pain (<1%).
FULL LYMPHOSEEK PRESCRIBING INFORMATION CAN BE FOUND AT:
WWW.LYMPHOSEEK.COM
About Navidea Biopharmaceuticals Inc.
Navidea Biopharmaceuticals, Inc. (NYSE MKT:NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. Navidea is developing multiple precision diagnostic products and platforms, including NAV4694, NAV5001, Manocept™ and NAV1800 (RIGScan™), to help identify the sites and pathways of undetected disease and enable better diagnostic accuracy, clinical decision-making and, ultimately, patient care. Lymphoseek® (technetium Tc 99m tilmanocept) Injection, Navidea’s first commercial product from the Manocept platform, was approved by the FDA in March 2013. Navidea’s strategy is to deliver superior growth and shareholder return by bringing to market novel radiopharmaceutical agents and advancing the Company’s pipeline through selective acquisitions, global partnering and commercialization efforts. For more information, please visit www.navidea.com.
The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.
(RVLT) Selected by SL Green to Expand LED Lighting Retrofit
Revolution Lighting Technologies, Inc. (NASDAQ:RVLT) (“Revolution Lighting”), a leader in advanced LED lighting solutions, today announced that SL Green Realty Corp. (NYSE: SLG), New York City’s largest commercial property owner, has selected its Seesmart brand LED tube lamps for an LED retrofit at nine commercial office properties to save $370,000 annually in operating expenses.
“Revolution Lighting is excited to continue its relationship with SL Green to deliver significant energy efficiency and cost savings through our advanced LED lighting solutions,” said Charles J. Schafer, Revolution Lighting President and Chief Financial Officer. “SL Green’s continued use of our LED lighting products reflects market confidence in the LED industry, and our capability to deliver leading solutions through our strong distribution network.”
In 2012 and 2013, SL Green completed the first two phases of its retrofit, establishing one of the nation’s largest LED portfolio lighting retrofits totaling twenty-four commercial office properties, comprising more than fourteen million square feet. SL Green installed more than 24,000 units of Revolution Lighting’s LED products, replacing antiquated lighting technologies including incandescent, halogen and fluorescent lamps in order to save approximately $950,000 annually. SL Green’s success is already evident, having achieved a fixture failure rate of less than 0.3% of the LED lamps installed, and a project payback of only 2.5 years.
SL Green’s third phase, installing more than 6,000 units of Revolution Lighting’s LED products at nine properties totals 6.2 million square feet. Properties include 1350 Avenue of the Americas, 100 Park Avenue, 810 7th Avenue, 461 5th Avenue, 220 East 42nd Street, 100 Church Street, 180 Maiden Lane, 120 West 45th Street, and 555 West 57th Street in New York City.
“SL Green continues to work closely with Revolution Lighting and its regional distributor, Tri State LED, based out of Greenwich, Connecticut to support all facets of our project needs, including scope development, product specification, budgeting, and incentive procurement,” said Jay Black, SL Green’s Director of Sustainability. “The selection of Revolution Lighting allows us to stay ahead of the market in terms of technology adaptation, capitalizing on their premier customer service, and high quality lighting solutions that offer industry leading efficiency, longevity, and warranty.
About Revolution Lighting Technologies Inc.
Revolution Lighting Technologies, Inc. is a leader in the design, manufacture, marketing, and sale of light emitting diode (LED) lighting solutions focusing on the industrial, commercial and government markets in the United States, Canada, and internationally. Through advanced technology and aggressive new product development, Revolution Lighting has created an innovative, multi-brand, lighting company that offers a comprehensive advanced product platform. The company goes to market through its Seesmart brand, which designs, engineers and manufactures an extensive line of high-quality interior and exterior LED lamps and fixtures; Lighting Integration Technologies Inc., which sells and installs Seesmart products; Lumificient, which supplies LED illumination for the signage industry; Relume Technologies, a leading manufacturer of outdoor LED products; and Sentinel, a revolutionary patented and licensed monitoring and smart grid control system for outdoor lighting applications. Revolution Lighting Technologies markets and distributes its product through a network of independent sales representatives and distributors, as well as through energy savings companies and national accounts. Revolution Lighting Technologies trades on the NASDAQ under the ticker RVLT. For additional information, please visit: www.rvlti.com.
(AEHR) Announces Follow-On Orders for FOX Capacity Additions
FREMONT, Calif., June 11, 2014 — Aehr Test Systems (Nasdaq:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced it has received follow-on orders for increased FOX-15 wafer level burn-in and test system and WaferPak full wafer contactor capacity from a leading communication equipment manufacturer that will increase the manufacturer’s burn-in capacity by 250%.
“We are pleased to receive these orders to significantly expand capacity for this customer. This is another indication of the effectiveness and increasing use of wafer level burn-in for a variety of applications in the communications IC marketplace,” said Mark Allison, vice president of sales at Aehr Test Systems. “After purchasing a base configuration, additional capacity can be added at an attractive cost compared to traditional packaged part burn-in systems because in this case, the capacity of a single wafer slot of a FOX-15 system is similar to the capacity of an entire burn-in system for packaged parts.”
“According to IC Insights, the market for communications ICs is growing at over 14% a year, almost twice the growth rate of the IC market as a whole,” commented Carl Buck, vice president of marketing at Aehr Test Systems. “For this particular customer, aging of the IC is required to ensure that critical parameters have stabilized before the IC is assembled into the final product.”
FOX systems, using Aehr Test WaferPak contactors, allow parallel testing of thousands of die on a wafer with only a single touchdown. Aehr Test’s FOX family of products is focused on high reliability test needs and long-duration full wafer burn-in and test of products such as automotive ICs, memories and devices with embedded memories, including microcontrollers and smart card devices. The FOX-1 system offers high-throughput single-touchdown sort testing. The FOX-15 system has a capacity of up to 15 WaferPak single-touchdown full wafer contactors for burn-in and test of state-of-the-art integrated circuits. As each wafer contains thousands of ICs, the throughput and capacity of the systems are quite large and suitable for production as well as reliability qualification applications.
With the increasing popularity of stacked and multi-die packaging, each of the die in the package must be highly reliable in order to ensure the highest possible package part yields and to enable the multi-die package to meet the stringent reliability demands of automotive and enterprise server manufacturers. Aehr Test’s FOX systems provide full wafer contact parallel test and burn-in solutions for the die before they are assembled into the package.
About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTSTM and FOX families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both lower-power and higher-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.
Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. These statements typically may be identified by the use of forward-looking words or phrases such as “believe,” “expect,” “intend,” “anticipate,” “should,” “planned,” “estimated,” and “potential,” among others. Forward-looking statements include statements regarding the expected effect of orders on a customer’s burn-in capacity. These risks and uncertainties include, without limitation, acceptance by customers of the FOX and WaferPak contactor technologies, acceptance by customers of the WaferPak contactors shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing our business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.
CONTACT: Aehr Test Systems Carl Buck V.P. of Marketing (510) 623-9400 x381 cbuck@aehr.com MKR Group Inc. Todd Kehrli or Jim Byers Analyst/Investor Contact (323) 468-2300 aehr@mkr-group.com
(NWBO) DCVax®-Direct Trial Update Indicates Further Positive Responses
All 9 Out Of 9 Patients Who Have Reached 4 Injections Are Showing Tumor Cell Death, Tumor Shrinkage And/Or Stabilization Of Disease
BETHESDA, Md., June 11, 2014 — Northwest Biotherapeutics (NASDAQ: NWBO) (NW Bio), a biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that, in the ongoing Phase I/II clinical trial of DCVax-Direct for all types of inoperable solid tumors, all 9 out of 9 patients who have received 4 of the 6 planned injections are showing tumor cell death, tumor shrinkage, substantial immune cell accumulation in their tumors and/or stabilization (i.e., stopping the progression) of their advanced cancer. In addition, in 3 of these 9 patients, biopsies now show no live tumor cells in the injected tumor.
To date, 20 patients (including the 9 referenced above) have received at least 3 of the 6 total injections, and 13 of these 20 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of their disease. The Company plans to report more details when the patients are further along in the treatment regimen. The first 3 injections are given in the first 2 weeks of the 32-week treatment regimen (at Day 0, Day 7 and Day 14).
So far, 9 of the patients have received 4 of the 6 planned injections, and all 9 of these 9 patients are showing tumor cell death, tumor shrinkage, substantial accumulation of immune cells in the tumors, and/or stabilization of the patients’ disease. The 4th injection is administered in week 8 of the 32-week treatment regimen. (The overall treatment regimen includes 6 injections at Days 0, 7 and 14, and Weeks 8, 16 and 32.)
Also, in a new finding, biopsies taken in 3 of these 9 patients now show no live tumor cells in the tumor that was injected. These 3 cases include diverse, advanced and particularly aggressive cancers: 1 metastatic pancreatic cancer case, 1 metastatic colon cancer case and 1 metastatic sarcoma case. These patients’ tumors show some enlargement on imaging scans, but the biopsies show that live tumor cells are no longer detectable and immune cells are now found there. Each of these 3 patients was treated with the lowest dose level (2 million cells per treatment).
In these 3 patients, as well as the other patients in the trial, only one of their tumors has been injected with DCVax-Direct. The Company plans to inject multiple tumors in its further studies of DCVax-Direct.
“These early glimpses are indicating an increasingly encouraging picture – especially the absence of any live tumor cells in 3 of the patients who have received 4 of the 6 planned injections of DCVax-Direct,” commented Linda Powers, CEO of NW Bio. “The 4th injection is still quite early, as it is just 8 weeks into the 32-week treatment regimen. For patients with such advanced, metastatic, inoperable cancers, who have failed other existing treatments, these are exciting findings.”
“We are also quite encouraged to see the patients’ reactions growing as the treatments progress,” noted Ms. Powers. “As of the 3rd injection in week 2 of the treatments, we now have 65% of the patients (13 of 20) showing some positive effects, and as of the 4th injection in week 8 of the treatments, we now have 100% of the patients (9 of 9) showing some positive effects. The patients also report feeling significantly better.”
“Patience will be important as we move through the rest of the treatment regimen for all 36 patients in the Phase I portion of the trial, and proceed with the Phase II portion of the trial. The data may get either better or worse as more data is collected. However, something interesting and encouraging seems to be unfolding so far.”
This growing body of initial early data is a result of both imaging scans and biopsies. The 9 patients who have received 4 injections show a range of tumor reactions, from shrinkage to no growth to some enlargement. However, in all of these patients, the biopsies show substantial tumor cell death, and in the cases of enlargement, the biopsies show major infiltration and accumulation of immune cells in and around the tumors – potential indications of an immune response to the cancer.
DCVax-Direct is a personalized immune therapy for all types of inoperable solid tumor cancers, using dendritic cells (the master cells of the immune system) to mobilize the full immune system to attack the patient’s cancer. DCVax-Direct is administered by direct injection into the patient’s tumors, and can reach tumors in virtually any location in the body (with image guidance for interior locations).
About Northwest Biotherapeutics
Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe. The Company has a broad platform technology for DCVax® dendritic cell-based vaccines. The Company’s lead program is a 312-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM). GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.” The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers. The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer. The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania. In Germany, the Company recently received approval of a 5-year Hospital Exemption for treatment of glioma (brain cancer) patients outside the clinical trial.
Disclaimer
Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements. Actual results may differ materially from those projected in any forward-looking statement. Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing. Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings. Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement. You should not place undue reliance on any forward-looking statements. The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.
(ALDR) to Present at Two Conferences in June
BOTHELL, Wash., June 11, 2014 — Alder BioPharmaceuticals, Inc., (“Alder”) (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing therapeutic antibodies for the treatment of migraine, autoimmune and inflammatory diseases, today announced that members of Alder’s senior management team will present at two upcoming conferences in June:
- Wells Fargo Securities 2014 Healthcare Conference
Date: Tuesday, June 17, 2014
Time: 4:40 p.m. EDT
Location: Boston, MA - Washington Biotechnology & Biomedical Association (WBBA) 14th Annual Life Science Innovation Northwest
Date: Thursday, June 19, 2014
Time: 1:45 p.m. PDT
Location: Seattle, WA
A live webcast of the Wells Fargo Healthcare Conference presentation can be accessed from the Investors section of the Alder website at http://www.alderbio.com. An archived replay of the webcast will be available on Alder’s website for 30 days after the live event concludes.
About Alder BioPharmaceuticals
Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s wholly-owned therapeutic program, an investigational monoclonal antibody for migraine, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is now undergoing clinical testing. Alder plans to advance ALD403 into a Phase IIb trial in the second half of 2014. Clazakizumab, previously known as ALD518, is Alder’s investigational monoclonal antibody to the pro-inflammatory cytokine IL-6. Bristol-Myers Squibb is investigating Clazakizumab (as BMS-945429) in a Phase IIb clinical study in rheumatoid arthritis and other autoimmune indications based on a 2009 partnership. Alder’s management team combines decades of industry experience with a proven track record for identifying and developing novel antibody therapeutics and enabling partners through the out-licensing of its technologies. For more information, please visit http://www.alderbio.com.
CONTACT: Media Contacts: David Schull or Andrea Flynn, Ph.D. Russo Partners (212) 845-4271 (646) 942-5631 david.schull@russopartnersllc.com andrea.flynn@russopartnersllc.com Investor Relations Contact: Sarah McCabe Stern Investor Relations, Inc. (212) 362-1200 sarah@sternir.com
(BIOF) Enters Into Definitive Agreement To Acquire JBGL
DENVER, June 11, 2014 — BIOFUEL ENERGY CORP. (NASDAQ:BIOF) (the “Company”) announced today that it has entered into a definitive agreement (the “Agreement”) with certain affiliates of Greenlight Capital, Inc. (“Greenlight”) and James R. Brickman (“Brickman”) pursuant to which the Company will acquire the equity interests of JBGL Builder Finance LLC and certain subsidiaries of JBGL Capital, LP (collectively, “JBGL”) from Greenlight and Brickman. JBGL is a series of real estate entities involved in the purchase and development of land for residential purposes, construction lending and home building operations. JBGL is currently owned and controlled by Greenlight and Brickman.
Pursuant to the terms of the Agreement, the Company will acquire JBGL for $275 million, payable in cash and Company common stock. The cash portion of the purchase price will be funded from the proceeds of a $70 million rights offering to be conducted by the Company and approximately $150 million in debt financing provided to the Company by Greenlight.
In response to a proposal from Greenlight and Brickman on March 28, 2014, the board of directors of the Company formed a special committee of independent directors to evaluate the proposed transaction and possible alternatives for the Company. The Company’s board of directors, acting upon the unanimous recommendation of the special committee, approved the transaction, determined to exempt the transaction under the Company’s Section 382 rights plan and resolved to recommend that the Company’s stockholders vote to approve the transaction and related matters. The special committee negotiated the terms of the transaction with the assistance of its legal and financial advisors.
David Einhorn, president of Greenlight Capital, Inc. and a director of the Company, said today, “though it is bittersweet that its original business plan did not pan out, I am excited about the transformation of the Company to a well positioned and successful development and homebuilding platform, which will enable it to capitalize on the value of its remaining assets.”
Jim Brickman, co-founder of JBGL, who will become Chief Executive Officer and a director of the Company upon closing of the transaction, said “this deal will instantly transform the Company into a prominent real estate operator and benefit existing stockholders with significant development opportunities in some of the nation’s fastest growing regions.”
Consummation of the proposed transaction is subject to various conditions, including receipt of the approval of a majority of the Company’s stockholders (excluding Greenlight and its affiliates), the successful completion of the rights offering and the continued authorization for listing of the Company’s common stock on the Nasdaq Stock Market. Subject to the satisfaction of such conditions, the acquisition of JBGL by the Company is expected to be consummated in October 2014.
There can be no assurance that the transactions contemplated by the Agreement will be approved by the Company’s stockholders or completed.
Duff & Phelps, LLC is serving as independent financial advisor to the special committee. Richards, Layton & Finger, P.A. is serving as legal advisor to the special committee and Cravath, Swaine & Moore LLP is serving as legal advisor to the Company. Akin Gump Strauss Hauer & Feld LLP is serving as legal advisor to Greenlight and JBGL.
Additional Information about the Transaction
The Company will file with the Securities and Exchange Commission (the “SEC”) a report on Form 8-K regarding the proposed transaction, which will include the Agreement. All parties desiring details regarding the proposed transaction are urged to review these documents, which will be available at the SEC’s website (http://www.sec.gov).
In connection with the proposed transaction, the Company will prepare and mail a proxy statement to its stockholders. This document will be filed with the SEC. INVESTORS AND STOCKHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THESE MATERIALS AND OTHER MATERIALS FILED WITH OR FURNISHED TO THE SEC WHEN THEY BECOME AVAILABLE, AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE PROPOSED TRANSACTION AND RELATED MATTERS. In addition to receiving the proxy statement by mail, stockholders also will be able to obtain these documents, as well as other filings containing information about the Company, the proposed transaction and related matters, without charge, from the SEC’s website (http://www.sec.gov) or at the SEC’s public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549. In addition, these documents can be obtained, without charge, by contacting the Company at the following address and/or telephone number:
BioFuel Energy Corp.
1600 Broadway
Suite 1740
Denver, CO 80202
T: (303) 640-6500
The Company and certain of its directors, executive officers and other members of management and employees, Greenlight and/or Brickman may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from our stockholders with respect to the proposed transaction. Information regarding the persons who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement relating to the proposed transaction when it is filed with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and the other relevant documents filed with the SEC when they become available.
This release shall not constitute an offer to sell or the solicitation of an offer to sell or the solicitation of an offer to buy any securities, nor shall there be any sale of securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction. No offer of securities shall be made except by means of a prospectus meeting the requirements of Section 10 of the Securities Act of 1933, as amended.
This release contains certain forward-looking statements within the meaning of the Federal securities laws. Such statements include, among others, those concerning expected benefits of the proposed transaction; management plans relating to the proposed transaction; the expected timing of the completion of the transaction; the parties’ ability to complete the transaction considering the various closing conditions, as well as all assumptions, expectations, predictions, intentions or beliefs about future events. Such statements are based on management’s current expectations, estimates and projections, which are subject to a wide range of uncertainties and business risks. Forward-looking statements should not be read as a guarantee of future performance or results, and will not necessarily be accurate indications of whether, or the times by which, our performance or results may be achieved. Factors that could cause actual results to differ from those anticipated are discussed in our Annual Report on Form 10-K, filed with the SEC on March 26, 2014, as amended by Amendment No.1 to Annual Report on Form 10-K/A, filed with the SEC on April 30, 2014, and our other filings pursuant to the Securities Exchange Act of 1934, as amended.
Contact: | Kelly G. Maguire | For more information: |
Executive Vice President & | www.bfenergy.com | |
Chief Financial Officer | ||
(303) 640-6500 | ||
kmaguire@bfenergy.com |
(SGMS) Gavin Isaacs Named CEO
NEW YORK, June 10, 2014 — Scientific Games Corporation (Nasdaq: SGMS) (“Scientific Games” or the “Company”) today announced the appointment of Gavin Isaacs as President and Chief Executive Officer of Scientific Games, succeeding David L. Kennedy effective immediately. Mr. Kennedy will continue to serve as Executive Vice Chairman of the Board.
Mr. Isaacs is an accomplished gaming industry executive with more than 15 years of industry leadership experience. Most recently, he served as Chief Executive Officer of SHFL entertainment, Inc. from April 2011 through November 2013 when the company was acquired by Bally Technologies, Inc. Previously, Mr. Isaacs served as Executive Vice President and Chief Operating Officer of Bally Technologies from May 2006 through March 2011. Prior to joining Bally Technologies, he held senior roles at Aristocrat Leisure Limited, including Head of Global Marketing and Business Development, Managing Director of Aristocrat’s London-based European subsidiary and President of Aristocrat Technologies, Inc., Aristocrat’s Las Vegas-based subsidiary focused on North and South America. Mr. Isaacs is also a Trustee and former President of the International Association of Gaming Advisors.
“Gavin is a very talented and seasoned gaming industry executive with the necessary skills to lead our Company to the next level of growth and performance,” said Ronald O. Perelman, Chairman of the Board of Scientific Games. “He has an impressive track record of success and is recognized for his dynamic leadership. We believe his focus on customer relationships, strategic thinking and expertise in growing innovation-focused businesses make him the ideal choice to lead our efforts to achieve greater profitability and increased cash flow.”
Mr. Perelman continued, “We extend our thanks and appreciation to David for stepping up to lead the Company during the last six months and work with the Board to facilitate the CEO succession. We were fortunate to have a leader of David’s stature and experience at such an important time, and we are pleased that he will continue to serve the Company and our stockholders as Executive Vice Chairman.”
Mr. Isaacs commented, “I am tremendously enthused to join the Company at this exciting and challenging time and lead the business to the next level. Scientific Games has a skilled worldwide organization that is focused on improving performance and growth. In collaboration with the entire Scientific Games team, I look forward to working together as we concentrate on creating and distributing innovative products and services to our customers, completing the integration of WMS and enhancing stockholder value.”
On June 9, 2014, Mr. Isaacs was granted 85,935 restricted stock units (RSUs) and stock options to purchase 161,181 shares of the Company’s common stock (with an exercise price of $8.73 per share, representing the average of the high and low sales prices of the Company’s stock on June 6, 2014, and a ten-year term), which awards are scheduled to vest in one-fourth increments on each of the first four anniversaries of the date of grant. The RSUs and stock option grants were approved as employment inducement grants pursuant to Nasdaq Listing Rule 5635(c)(4).
Conference Call Today at 11:30 ET
Scientific Games will host a conference call today, June 10, at 11:30 am ET to welcome Gavin Isaacs and take questions. To access the call live via a listen-only webcast, please visit www.scientificgames.com and click on the webcast link under the Investor Information section. To access the call by telephone, please dial (877) 474-9504 (U.S. and Canada) or (857) 244-7557 (international). The conference ID is SGMS. A replay of the webcast will be archived in the Investor Information section on our website.
About Scientific Games
Scientific Games Corporation is a leading developer of technology-based products and services and associated content for worldwide gaming and lottery markets. The Company’s portfolio includes instant and draw-based lottery games; electronic gaming machines and game content; server-based lottery and gaming systems; sports betting technology; loyalty and rewards programs; and social, mobile and interactive content and services. For more information, please visit: www.scientificgames.com.
Company Contacts
Investor Relations:
Bill Pfund (847) 785-3167
Media Relations:
Mollie Cole (773) 961-1194
Forward-Looking Statements
In this press release, Scientific Games makes “forward-looking statements” within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements describe future expectations, plans, results or strategies and can often be identified by the use of terminology such as “may,” “will,” “estimate,” “intend,” “continue,” “believe,” “expect,” “anticipate,” “should,” “could,” “potential,” “opportunity,” or similar terminology. These statements are based upon management’s current expectations, assumptions and estimates and are not guarantees of timing, future results or performance. Actual results may differ materially from those contemplated in these statements due to a variety of risks and uncertainties and other factors, including, among other things: competition; U.S. and international economic and industry conditions; including declines or slow growth of lottery retail sales or gross gaming revenues and reductions in or constraints on capital spending by gaming or lottery operators; slow growth of new gaming jurisdictions; slow addition of casinos in existing jurisdictions; declines in the replacement cycle of gaming machines; ownership changes and consolidation in the casino industry; opposition to legalized gaming or the expansion thereof; ability to adapt to, and offer products that keep pace with, evolving technology; ability to develop successful gaming concepts and content; laws and government regulation, including those relating to gaming licenses and environmental laws; inability to identify and capitalize on trends and changes in the lottery and gaming industries, including the expansion of interactive gaming; dependence upon key providers in our social gaming business; retention and renewal of existing contracts and entry into new or revised contracts; level of our indebtedness; availability and adequacy of cash flows to satisfy obligations or future needs; restrictions and covenants in our debt agreements; protection of our intellectual property; ability to license third party intellectual property; intellectual property rights of others; security and integrity of our software and systems; reliance on or failures in our information technology systems; natural events that disrupt our operations or those of our customers, suppliers or regulators; inability to benefit from, and risks associated with, strategic equity investments and relationships; inability of our joint venture to meet the net income targets or otherwise to realize the anticipated benefits under its private management agreement with the Illinois lottery; inability of our joint venture to meet the net income targets or other requirements under its agreement to provide marketing and sales services to the New Jersey lottery or otherwise to realize the anticipated benefits under such agreement (including as a result of a protest); failure to realize the anticipated benefits related to the award to our consortium of an instant lottery game concession in Greece; failure to achieve the intended benefits of the WMS acquisition, including due to the inability to realize synergies in the anticipated amounts or within the contemplated time-frames or cost expectations, or at all; inability to complete and integrate future acquisitions; restructuring costs; revenue recognition standards; impairment charges; fluctuations in our results due to seasonality and other factors; dependence on suppliers and manufacturers; risks relating to foreign operations, including fluctuations in foreign currency exchange rates and restrictions on the import of our products; dependence on our employees; litigation and other liabilities relating to our business, including litigation and liabilities relating to our contracts and licenses, our products and systems, our employees, intellectual property and our strategic relationships; influence of certain stockholders; and stock price volatility. Additional information regarding risks and uncertainties and other factors that could cause actual results to differ materially from those contemplated in forward-looking statements is included from time to time in Scientific Games’ filings with the Securities and Exchange Commission (“SEC”) (including our Annual Report on Form 10-K filed with the SEC on March 17, 2014 and in our subsequent periodic reports), including under the heading “Risk Factors” in Scientific Games’ periodic reports. Forward-looking statements speak only as of the date they are made and, except for Scientific Games’ ongoing obligations under the U.S. federal securities laws, Scientific Games undertakes no obligation to publicly update any forward-looking statements whether as a result of new information, future events or otherwise.
(MEIP) High Response Rates Phase II Study Of Pracinostat In Acute Myeloid Leukemia
Study Meets Pre-Specified CR/CRi Rate in First Nine Patients
SAN DIEGO, June 10, 2014 — MEI Pharma, Inc. (Nasdaq: MEIP), an oncology company focused on the clinical development of novel therapies for cancer, today announced preliminary response data from the first stage of a two-stage, open-label Phase II clinical study of its investigational drug candidate Pracinostat in combination with Vidaza® (azacitidine) in elderly patients with newly diagnosed acute myeloid leukemia (AML) who are unsuitable for intensive chemotherapy.
Of the first nine patients enrolled in the multicenter study, two achieved a complete response (CR) and one achieved a complete response with incomplete blood count recovery (CRi), each following one or two treatment cycles. These data met the pre-specified CR/CRi rate required to advance to the second stage of the study. In addition, three patients achieved a partial response (PR) or a partial response with incomplete blood count recovery (PRi) after their initial or second treatment evaluation, for an overall response rate of 67%.
“We are very encouraged by these early data,” said Robert D. Mass, MD, Chief Medical Officer of MEI Pharma. “The protocol-specified CR/CRi rate with Vidaza alone in this patient population is 10%, so this early observed rate of 33% is particularly noteworthy. The similarity of the high response rate seen to date in this study with those observed in our pilot study in higher risk myelodysplastic syndrome (MDS) further increases our confidence in the combination of Pracinostat and Vidaza. This combination is also being assessed in our ongoing, placebo-controlled Phase II study in front line MDS. We look forward to sharing additional data from our front line AML study at a scientific conference later this year.”
The open-label Phase II study of Pracinostat and Vidaza in front line AML is a two-stage design, with progression to the second stage dependent upon achieving a pre-specified milestone. According to the study protocol, if three or more patients achieved a CR or a CRi within the first 27 patients, the trial will continue to enroll an additional 13 patients in the second stage, for a total of 40 evaluable patients. To date, 12 patients have been enrolled in the study, three of which are still too early for a clinical response assessment.
The combination of Pracinostat and Vidaza has been generally well tolerated in the study, with no new or more severe adverse events than previously reported, including fatigue, myelosuppresion and gastrointestinal toxicity (nausea, vomiting, diarrhea).
The Phase II study is being conducted in collaboration with Dr. Guillermo Garcia-Manero and the MD Anderson Cancer Center. The primary endpoint of the trial is CR/CRi rate. Secondary endpoints include overall response rate, complete cytogenetic/molecular response, duration of response, progression-free survival and overall survival. Additional information regarding the trial, including eligibility and locations, is available at www.clinicaltrials.gov.
About Pracinostat
Pracinostat is an oral histone deacetylase (HDAC) inhibitor that has been tested in a number of Phase I and Phase II clinical trials in advanced hematologic disorders and solid tumor indications in both adult and pediatric patients. Pracinostat has been generally well tolerated in more than 250 patients to date, with readily manageable side effects that are often associated with drugs of this class, including fatigue, myelosuppresion and gastrointestinal toxicity. In a Phase I dose-escalation trial, Pracinostat demonstrated evidence of single-agent activity in elderly AML patients, including two out of 14 (14%) who achieved a CR, with durable responses persisting 206+ and 362 days, respectively. In addition, results from a pilot study of Pracinostat in combination with Vidaza in patients with advanced MDS showed an overall response rate of 90% (nine out of 10), including eight patients who achieved either a CR or a CRi.
MEI Pharma owns exclusive worldwide rights to Pracinostat.
About AML
Acute myeloid leukemia (also known as acute myelogenous leukemia) is the most common acute leukemia affecting adults, and its incidence is expected to increase as the population ages. The American Cancer Society estimates about 14,590 new cases of AML per year in the U.S., with an average age of about 66. Treatment options for AML remain virtually unchanged over the past 30 years. Front line treatment consists primarily of chemotherapy, while the National Comprehensive Cancer Network (NCCN) Clinical Practice Guidelines in Oncology recommend Vidaza or Dacogen® (decitabine) as low intensity treatment options for AML patients over the age of 60 who are unsuitable for induction chemotherapy.
About MEI Pharma
MEI Pharma, Inc. (Nasdaq: MEIP) is a San Diego-based oncology company focused on the clinical development of novel therapies for cancer. The Company’s lead drug candidate is Pracinostat, a potential best-in-class, oral HDAC inhibitor currently being developed for MDS and AML. MEI Pharma is also developing ME-344, a mitochondrial inhibitor that has shown evidence of single-agent activity in a first-in-human clinical study in patients with refractory solid tumors, including eight of 21 evaluable patients (38%) who achieved stable disease or better. In September 2013, the Company further expanded its pipeline of drug candidates with the acquisition of PWT143, a highly selective PI3-kinase delta inhibitor. For more information, go to www.meipharma.com.
Under U.S. law, a new drug cannot be marketed until it has been investigated in clinical trials and approved by the FDA as being safe and effective for the intended use. Statements included in this press release that are not historical in nature are “forward-looking statements” within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. You should be aware that our actual results could differ materially from those contained in the forward-looking statements, which are based on management’s current expectations and are subject to a number of risks and uncertainties, including, but not limited to, our failure to successfully commercialize our product candidates; costs and delays in the development and/or FDA approval, or the failure to obtain such approval, of our product candidates; uncertainties or differences in interpretation in clinical trial results; our inability to maintain or enter into, and the risks resulting from our dependence upon, collaboration or contractual arrangements necessary for the development, manufacture, commercialization, marketing, sales and distribution of any products; competitive factors; our inability to protect our patents or proprietary rights and obtain necessary rights to third party patents and intellectual property to operate our business; our inability to operate our business without infringing the patents and proprietary rights of others; general economic conditions; the failure of any products to gain market acceptance; our inability to obtain any additional required financing; technological changes; government regulation; changes in industry practice; and one-time events. We do not intend to update any of these factors or to publicly announce the results of any revisions to these forward-looking statements.
(SYNA) Accelerates Mobile Display Leadership with Acquisition of Renesas SP Drivers
Acquisition Unites Industry Leaders to Further Synaptics’ Market Position as a Leading Human Interface Solution Provider
SAN JOSE, Calif., June 10, 2014 — Synaptics Inc. (NASDAQ: SYNA), a leading developer of human interface solutions, today announced that it has signed a definitive agreement to acquire all of the outstanding equity of Renesas SP Drivers, Inc., the industry leader in small and medium-sized display driver ICs (DDICs) for smartphones and tablets. With the acquisition, Synaptics expects to increase its addressable market opportunity by 1.5X and to accelerate its product roadmap for touch-and-display driver integration (TDDI). The combination enables platform-level solutions for select segments of the mobile market, while also extending its leadership position in Touch and DDIC product families.
The addition of Renesas SP Drivers positions Synaptics at the forefront of a tremendous growth opportunity with a complete portfolio of products to address a full spectrum of display market needs. The acquisition underscores Synaptics’ commitment to developing high-performance and cost effective solutions for its customers, backed by the unparalleled technical leadership, real-time local support, and systems level engineering expertise that its valued customers need.
“The acquisition of Renesas SP Drivers unites complementary and best-in-class technologies and brings on board a very experienced, highly skilled engineering team, strengthening Synaptics’ position as the number one touchscreen controller supplier to the mobile display market, with unmatched platform level technologies,” said Rick Bergman, President and CEO, Synaptics. “Upon closing the acquisition, we will have the scale to accelerate our technology roadmap and expand our broad portfolio of human interface product families including display integration solutions.”
“We are very excited about joining Synaptics. The combination of Synaptics and Renesas SP Drivers forms an even stronger market leader with a highly complementary combination of products and technologies,” said Ikuo Kudo, President and CEO, Renesas SP Drivers. “The well-matched technologies and enhanced scale will drive further innovations in mobile display.”
Synaptics will pay a purchase price of approximately JPY48.5B ($475 million) for 100% of Renesas SP Drivers, based on JPY52.5B ($515 million) enterprise value. The purchase price is based on cash and other adjustments and is subject to customary adjustments for net working capital, net debt, and third party expenses. The US dollar consideration is based on a yen conversion rate of 102.
For the year ended March 2014, Renesas SP Drivers’ revenue and cash flow were approximately $650 million and $100 million, respectively. The combined business of Synaptics and Renesas SP Drivers is expected to create significant revenue and investment scale to drive future growth and operating leverage. The acquisition will be immediately accretive to Synaptics’ non-GAAP EPS, excluding transaction related expenses. The acquisition is expected to close in the fourth calendar quarter of 2014, subject to customary closing conditions and regulatory reviews, as necessary. Synaptics intends to fund the transaction with cash and committed debt financing of $300 million. Additional details can be found in Synaptics’ Current Report on Form 8-K, filed today.
Investor Call
The company will host a teleconference and webcast at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) today, Tuesday, June 10, 2014, to provide additional commentary regarding the acquisition, during which the company may provide forward-looking information. To participate on the live call, analysts and investors should dial 1-888-500-6950 (719-325-2329 international) at least ten minutes prior to the call. A telephonic replay of the conference call will also be available until 5:00 pm PT on Sunday, June 15, 2014 by dialing 1- 888-203-1112 (719-457-0820 international) and entering the passcode: 5056156. Synaptics will also offer a live and archived webcast of the conference call, accessible from the “Investor Relations” section of the company’s website at www.synaptics.com. The acquisition presentation, that will be referred to on the conference call, can also be found in the “Investor Relations” section of the company’s website.
For up-to-the-minute Synaptics news, follow @SynaCorpon Twitter. For more information on Synaptics’ products and solutions please visit www.synaptics.com.
About Synaptics
As a leading developer of human interface solutions which enhance the user experience, Synaptics provides the broadest solutions portfolio in the industry. The ClearPad® family supports touchscreen solutions for devices ranging from entry-level mobile phones to flagship premium smartphones, tablets and notebook PCs. The TouchPad™ family, including ClickPad™ and ForcePad®, is integrated into the majority of today’s notebook PCs. Natural ID™ fingerprint sensor technology enables authentication, mobile payments, and touch-based navigation for smartphones, tablets, and notebook computers. Synaptics’ wide portfolio also includes ThinTouch® supporting thin and light keyboard solutions, as well as key technologies for next generation touch-enabled video and display applications. (NASDAQ: SYNA) www.synaptics.com.
About Renesas SP Drivers
Renesas SP Drivers, based in Tokyo, Japan, is the market leader in small and medium-sized LCD driver ICs and provides high performance display drivers to the world’s leading consumer device OEMs. Renesas SP Drivers’ best-in-class offerings are ranked number one in several markets, including smartphones, and are focused on differentiated development and design capabilities. The company has approximately 350 employees.
Forward-Looking Statements
This press release contains “forward-looking” statements about Synaptics, as that term is defined under the federal securities laws. Synaptics intends such forward-looking statements to be subject to the safe harbor created by those laws. Such forward-looking statements include, but are not limited to, statements regarding the anticipated financial results of the combined Synaptics and Renesas SP Drivers business. Synaptics cautions that these statements are qualified by important factors that could cause actual results to differ materially from those reflected by the forward-looking statements contained herein. Such factors include, but are not limited to, (a) demand for Synaptics’ and Renesas SP Drivers’ products, (b) market demand for OEMs’ products using Synaptics’ or Renesas SP Drivers’ solutions, (c) changing market demand trends in the markets Synaptics or Renesas SP Drivers serves, (d) the success of Synaptics’ and Renesas SP Drivers’ customers’ products that utilize Synaptics’ or Renesas SP Drivers’ product solutions, (e) the development and launch cycles of Synaptics’ and Renesas SP Drivers’ customers’ products, (f) market pressures on selling prices, (g) the market acceptance of Synaptics’ and Renesas SP Drivers’ product solutions compared with competitors’ solutions, (h) general economic conditions, including consumer confidence and demand, and (i) other risks as identified from time to time in Synaptics’ SEC reports, including Quarterly Reports on Form 10-Q and the Annual Report on Form 10-K for the fiscal year ended June 29, 2013. All forward-looking statements are based on information available to Synaptics on the date hereof, and Synaptics assumes no obligation to update such statements.
Synaptics, TouchPad, ClearPad, ClickPad, ForcePad, ThinTouch, Natural ID, TypeGuard and the Synaptics logo are trademarks of Synaptics in the United States and/or other countries. All other marks are the property of their respective owners.
For further information, please contact:
Ann Minooka, Synaptics, Inc.
408-904-1673
ann.minooka@synaptics.com
Public Relations:
Starlayne Meza, Text 100 Global Communications
415-593-8431
synaptics@text100.com
Investor Relations:
Jennifer Jarman, The Blueshirt Group
415-217-5866
jennifer@blueshirtgroup.com
(TRCH) Acquires Additional Husky Operated Hunton Assets and Cash
Reiterates Production Guidance of 500 BOEPD Net Q2 Exit Rate
PLANO, TX–(June 10, 2014) – Torchlight Energy Resources, Inc. (NASDAQ: TRCH) (“Torchlight” or “the Company”), a rapidly growing mid-continent oil and gas company, has announced the closing of the acquisition of certain oil and gas assets located in Oklahoma, including additional acreage, additional interests in three areas of mutual interest (“AMI”) and additional working interest (WI) in producing wells and wells currently being drilled. A wholly-owned subsidiary of the Company acquired the properties and also received $1.65 million in cash in the transaction.
Torchlight will issue 1,350,000 restricted shares as consideration for the assets and cash, valuing the transaction at Friday’s closing share price for TRCH ($4.39) at $5,926,500. The transaction closed on Friday, June 6, 2014 with an unaffiliated third party whom owns extensive assets in the same AMIs that Torchlight has interest in.
“This acquisition accomplishes many goals for Torchlight,” noted Willard McAndrew, COO of Torchlight, “We pick up cash for use in our drilling projects, we gain additional WI in three prolific AMIs with Husky Ventures, we acquired ownership in producing wells and interests in wells that are being drilled or are in the process of being stimulated for production. Any opportunity to continue to expand with Husky is something we will look to pursue, as they have demonstrated the ability to make great wells in the Hunton play.”
The oil and gas assets acquired include a 5% additional WI (bringing TRCH’s total to 30%) in two AMI’s and 2.7% additional WI (bringing our total to 18%) in a third AMI.
The company also acquired varying amounts of WI in ten producing wells, two wells that are drilled but waiting completion four wells that are either in the process of being drilled or stimulated. Each interest acquired increases Torchlight’s existing ownership in the subject wells, as the Company already has ownership exposure in each.
Torchlight reiterates its production guidance for Q2 (June 30, 2014) of an exit rate of 500 BOEPD net to Torchlight’s WI.
About Torchlight Energy
Torchlight Energy Resources, Inc. (NASDAQ: TRCH), based in Plano, Texas, is a high growth oil and gas company with a primary focus on acquisition and development of highly profitable domestic oil fields. The company currently holds interests in Texas, Kansas and Oklahoma where its targets are established plays such as the Eagle Ford Shale, Mississippi Limestone and Hunton Limestone trends. For additional information on the company, please visit www.torchlightenergy.com.
Forward Looking Statement
This news release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These statements may involve risks and uncertainties that could cause actual results to differ materially from those described in such statements. Such forward-looking statements involve known and unknown risks and uncertainties, including risks associated with the company’s ability to obtain additional capital in the future to fund planned expansion, the demand for oil and natural gas, general economic factors, competition in the industry and other factors that may cause actual results to be materially different from those described herein as anticipated, believed, estimated or expected. The company is under no obligation (and expressly disclaims any such obligation) to update or alter its forward-looking statements whether as a result of new information, future events or otherwise.
Contact:
Derek Gradwell
MZ Group
SVP Natural Resources
Phone: 512-270-6990
Email: dgradwell@mzgroup.us
Web: www.mzgroup.us
(ATEA) Partner Awarded Contract to Implement Astea Alliance
Reinforcing Astea’s Commitment to their Partner Ecosystem Growth Strategy
HORSHAM, Pa., June 10, 2014 — Astea International Inc. (NASDAQ: ATEA), the leader in service lifecycle management and mobility solutions announces today that a Global IT Services Company has selected the Astea Alliance service management solution suite to transform and strengthen their service business.
This competitive opportunity was won through Six-Axe Consultants, an Astea reseller and implementation partner in France. Six-Axe Consultants will be responsible for implementation and support for the Astea Alliance solution suite which provides end-to-end service management functionality, incorporating industry best practices all on a single platform, with ease of integration to Oracle. Astea’s solution will provide the Global IT Services Company with a comprehensive and robust mix of capabilities such as, field service, depot repair, customer self-service, sales order processing, logistics, third party vendor portal, and performance management that will help the Global IT Services Company to further drive and improve the efficiencies of their service supply chain.
“As many organizations look to reduce costs, improve productivity and streamline processes to compete in today’s dynamic service environment, software solutions become a key factor in accomplishing those goals. In this opportunity, the company was choosing between an ERP solution and our best-of-breed solution to address their service management requirements. While an ERP suite may seem attractive to many organizations, primarily due to the simplified integration message that they promote, it doesn’t always provide the robust solution that some service organizations truly need to transform their service delivery process. When companies go through an in-depth evaluation and compare our service management solution to both ERP and niche vendors, we consistently become the clear solution that meets their current as well as future needs and objectives,” stated Zack Bergreen, CEO of Astea International. “We are proud to have Six-Axe Consultants representing our solution suite in France. Six-Axe is one of our top performing partners, and they have strong expertise in both the field service industry and with our Astea Alliance solution suite.”
Whether on-premise or in the cloud, Astea is the only global solution provider that offers all the cornerstones of service lifecycle management: customer management; service management; asset management; forward and reverse logistics management; third party vendor management; and mobile workforce management with enhanced workforce planning, scheduling and optimization. Astea’s solutions are seamlessly orchestrated to share and leverage information throughout the service lifecycle – removing the traditional barriers between the field and back office. With Astea’s solution modularity, companies can introduce one module at a time or deploy a seamless information backbone across the entire service lifecycle continuum.
About Astea International
Astea International (NASDAQ: ATEA) is a global provider of software solutions that offer all the cornerstones of service lifecycle management, including customer management, service management, asset management, forward and reverse logistics management and mobile workforce management and optimization. Astea’s solutions link processes, people, parts, and data to empower companies and provide the agility they need to achieve sustainable value in less time, and successfully compete in a global economy. Since 1979, Astea has been helping more than 600 companies drive even higher levels of customer satisfaction with faster response times and proactive communication, creating a seamless, consistent and highly personalized experience at every customer relationship touch point. www.astea.com. Service Smart. Enterprise Proven.
About Six-Axe
Six-Axe was created in 1990. Its mission is focused on IT services for FieldService. The partnership with Astea began in 1995 helping deploying Astea solutions for BULL and ICL. In 2001, Six-Axe became the Astea distributor for France. Today, more than twenty employees are dedicated to this activity: Project Managers, Business Consultants, Technical Consultants, Developers and Support Team. Six-Axe has been responsible for developing Astea’s customers based in France, with a roster of new customers that include THALES, BT, and DAIKIN. www.six-axe.fr
(ACHN) Initiation of ACH-3422 Dosing in HCV-Infected Patients
Initial cohort of HCV-infected patients begin dosing with ACH-3422 for seven days
Clinical trials may continue evaluating 200 mg of sovaprevir for HCV-infected patients
Timelines for reporting proof-of-concept results with ACH-3422, a proprietary uridine-analog nucleotide polymerase inhibitor, during the fall of 2014 and initiating all-oral combination studies by the end of 2014 remain on track
NEW HAVEN, Conn., June 10, 2014 — Achillion Pharmaceuticals, Inc. (Nasdaq:ACHN) today announced the Company has begun dosing ACH-3422, a uridine-analog nucleotide polymerase inhibitor, for seven days in patients with genotype 1 chronic hepatitis C viral infection (HCV) in its ongoing Phase 1 clinical trial. Proof-of-concept results from this trial are expected to be reported during the fall of 2014. Furthermore, Achillion announced today that the U.S. Food and Drug Administration (FDA) has removed the clinical hold on sovaprevir, an NS3/4A protease inhibitor, to permit the conduct of trials in patients with HCV. Sovaprevir doses of 200 mg once daily, the previously evaluated dose that was well-tolerated with clinical activity in two completed Phase 2 studies, may be used in additional therapeutic clinical trials.
“We believe Achillion is uniquely positioned with clinical candidates in each of the nucleotide, NS5A and protease inhibitor categories needed to advance both dual and triple commercially competitive combination therapies that can treat the spectrum of patients with HCV. We remain focused on developing regimens utilizing ACH-3422 and ACH-3102, our second-generation Phase 2 NS5A inhibitor, and the second half of 2014 will feature multiple milestones in that program,” commented Milind Deshpande, Ph.D., President and Chief Executive Officer. “Our HCV pipeline also provides the opportunity to add a NS3/4A protease inhibitor, such as sovaprevir or ACH-2684, in order to explore triple-direct acting antiviral regimens that can potentially shorten treatment durations to less than 8 weeks. We will determine how best to integrate our protease inhibitors into our combination development programs as data from our on-going trials emerge.”
“With the start of patient dosing with ACH-3422, our Phase 1 uridine-analog nucleotide, we remain on track to report proof-of-concept results in the fall, and plan on initiating all oral combination studies with ACH-3422 by the end of 2014. We are also very pleased that the effort by the Achillion team, working in collaboration with the FDA, has resulted in this response for the sovaprevir program,” commented David Apelian, M.D., Ph.D., Executive Vice President and Chief Medical Officer.
Sovaprevir is a Phase 2 NS3/4A protease inhibitor being developed for the potential treatment of chronic HCV infection. To date, approximately 550 subjects have been exposed to sovaprevir with clinical activity reported in two Phase 2 12-week treatment duration studies, one in combination with pegylated-interferon/ribavirin and one in combination with ACH-3102 in which the combination achieved 100% SVR12 in patients with genotype 1b HCV. The FDA removed the clinical hold to permit the conduct of therapeutic trials with a maximum of 200 mg once daily of sovaprevir in HCV patients and in single dose trials in healthy volunteers, but maintained a partial clinical hold for multiple dose studies that may be conducted in healthy volunteers, requiring prior review and approval of the protocol by the FDA. Achillion expects to continue to work collaboratively with the FDA on the continued clinical development of sovaprevir.
About HCV
The hepatitis C virus is the most common cause of viral hepatitis, which is an inflammation of the liver. It is currently estimated that more than 150 million people are infected with HCV worldwide including more than 5 million people in the United States. Three-fourths of the HCV patient population is undiagnosed; it is a silent epidemic and a major global health threat. Chronic hepatitis, if left untreated, can lead to permanent liver damage that can result in the development of liver cancer, liver failure or death. Few therapeutic options currently exist for the treatment of HCV infection.
About Achillion Pharmaceuticals
Achillion is an innovative pharmaceutical company dedicated to bringing important new treatments to patients with infectious disease. Achillion’s discovery, clinical development, and commercial teams have advanced multiple novel product candidates with proven mechanisms of action into studies and toward the market. Achillion is focused on solutions for the most challenging problems in infectious disease including HCV and resistant bacterial infections. For more information on Achillion Pharmaceuticals, please visit www.achillion.com or call 1-203-624-7000.
Cautionary Note Regarding Forward-Looking Statements
This press release includes forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 that are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those indicated by such forward-looking statements, including statements with respect to: the Company’s expectations that the phase I study of ACH-3422 will inform the potential initiation of combination studies of ACH-3422 and ACH-3102; the Company’s expectations that it may report preliminary results from its Phase 1 program during the fall of 2014 and begin combination studies by the end of 2014; the Company’s goal to safely and expeditiously advance its all-oral regimens for the treatment of HCV and its expectation that the breadth of its portfolio could enable it to potentially develop commercially-competitive regimens that can be safe, effective, ribavirin-free and that can be used for eight weeks or less to potentially cure HCV. Achillion may use words such as “expect,” “anticipate,” “project,” “intend,” “plan,” “aim,” “believe,” “seek,” ” estimate,” “can,” “focus,” “will,” and “may” and similar expressions to identify such forward-looking statements. Among the important factors that could cause actual results to differ materially from those indicated by such forward-looking statements are risks relating to, among other things Achillion’s ability to: demonstrate in any current and future clinical trials the requisite safety, efficacy and combinability of its drug candidates; advance the preclinical and clinical development of its drug candidates, including ACH-3422, ACH-3102 and its protease inhibitors, under the timelines it projects in current and future clinical trials; satisfactorily respond to the partial clinical hold placed on sovaprevir by the FDA; obtain and maintain necessary regulatory approvals; obtain and maintain patent protection for its drug candidates and the freedom to operate under third party intellectual property; establish commercial manufacturing arrangements; identify, enter into and maintain collaboration agreements with appropriate third-parties; compete successfully with other companies that are seeking to develop improved therapies for the treatment of HCV; manage expenses; manage litigation; raise the substantial additional capital needed to achieve its business objectives; and successfully execute on its business strategies. These and other risks are described in the reports filed by Achillion with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K for the year ended December 31, 2013, and its subsequent SEC filings.
In addition, any forward-looking statement in this press release represents Achillion’s views only as of the date of this press release and should not be relied upon as representing its views as of any subsequent date. Achillion disclaims any duty to update any forward-looking statement, except as required by applicable law.
CONTACT: Company Contact: Glenn Schulman Achillion Pharmaceuticals, Inc. Tel. (203) 624-7000 gschulman@achillion.com Media: Emily Johnson Ogilvy PR Tel. (212) 880-5316 emily.johnson@ogilvy.com Investors: Mary Kay Fenton Achillion Pharmaceuticals, Inc. Tel. (203) 624-7000 mfenton@achillion.com Investors: Tricia Truehart The Trout Group, LLC Tel. (646) 378-2953 ttruehart@troutgroup.com
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