Archive for July, 2015

(NYMX) Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint

HASBROUCK HEIGHTS, N.J., July 27, 2015  — Nymox Pharmaceutical Corporation (NASDAQ:NYMX) announced today that the Company’s U.S. long-term extension prospective double-blind Phase 3 BPH studies NX02-0017 and NX02-0018 of fexapotide triflutate (NX-1207) for BPH have successfully met the pre-specified primary endpoint of long-term symptomatic statistically significant benefit superior to placebo. Fexapotide showed an excellent safety profile with no evidence of drug-related short-term or long-term toxicity nor any significant related molecular side effects in the 2 studies (n=978).

The Company now intends to meet with authorities and to proceed to file where possible in due course for regulatory approvals for fexapotide triflutate in various jurisdictions and territories.

The Company will present a public webinar and conference call today July 27 at 4:30 p.m. EDT (see below).

The primary endpoint variable of the long-term study was improvement in the AUA BPH Symptom Score which was statistically significant (p<.02) in fexapotide-treated patients compared to placebo, at a median duration of 42 months (3.5 years) after a single double-blind injection treatment of fexapotide vs. saline placebo. In addition, responder analysis for the primary endpoint variable met the prespecified endpoint (p<.01). All subjects from both studies with 2 years or more duration follow-up after a single painless injection were eligible, however all documented treatment failures of any duration in the studies from day 1 onward were also included in the data as treatment failures. Patients were followed double-blind up to 65 months (5.4 years) after a single injection.

Highlights of the pivotal Phase 3 extension top-line results are summarized as follows:

  • Median duration of 3.5 years from a single injection treatment mean improvement of 5.3 points in AUA BPH Symptom Score. Statistically significant (mean p<.025; median p<.02) vs saline placebo injection.
  • Mean improvement of 7.1 points in AUA BPH Symptom Score (primary endpoint variable) after median duration of 3.5 years in first-line BPH treatment of fexapotide treated subjects (p<.025 vs placebo).
  • Patient responder rate: Statistically significant higher proportion (64%) of long-term improved patients in AUA BPH Symptom Score (primary outcome variable) after a single injection in fexapotide treated subjects vs controls (p<.005).
  • Improvement of nocturia: Percentage of patients with stabilization or improvement of frequency of nocturia in fexapotide treatment superior to placebo (p<.03).

The Company also reported on new Phase 3 data of lowered incidence of surgery in patients in Phase 3 studies NX02-0020 and NX02-0022.

  • Reduced incidence of surgery: Subjects in Phase 3 studies NX02-0020 and NX02-0022 with 1 or 2 injections of fexapotide had statistically significant reduction of BPH surgery within 24 months of fexapotide treatment (1.7% incidence of surgery in 2 years) (p<.02 vs placebo).

In addition, the following advantages of the new drug are highlighted:

  • Safety profile highly superior to existing treatments. Minimal or no sexual, hormonal or cardiovascular or other debilitating side effects.
  • Reduced cancer risk in Phase 2 data: U.S. Phase 2 data showing therapeutic effect of fexapotide on prostate cancer. Phase 2 data showed fexapotide treated low grade localized prostate cancer (Gleason 3+3 or less) had statistically significant less progression compared to controls. By comparison, some commonly used older approved BPH treatments have been linked to increased cancer risk.
  • Enhanced compliance and patient convenience compared to oral medications. Fexapotide is given as a single painless office treatment injectable. Older approved oral medications generally involve daily pills intended for the rest of the patient’s life.

Conference 4:30pm: To participate in the conference please go to: http://bit.ly/nymox_7_15_reg. Registration is required. After registration, a link is provided to the webcast. For registration prior to 30 minutes before the webcast, bookmark the page, or save the link to access the page at the time of the conference. Questions may be submitted at any time by using the form under the player window.  Time may not allow us to address all questions. For best results, close other applications prior to going to the webcast page. The webcast is also viewable on mobile devices. If using a desktop, Flash 10 is required, which may be downloaded at http://get.adobe.com/flashplayer/. Mobile devices without Flash are also supported.

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Nymox, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements regarding the need for new options to treat BPH, the potential of NX-1207 to treat BPH and the estimated timing of further developments for NX-1207. Such forward-looking statements involve substantial risks and uncertainties that could cause our clinical development program, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of Nymox’s regulatory filings, Nymox’s substantial dependence on NX-1207, Nymox’s commercialization plans and efforts and other matters that could affect the availability or commercial potential of NX-1207. Nymox undertakes no obligation to update or revise any forward-looking statements. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Nymox in general, see Nymox’s current and future reports filed with the U.S. Securities and Exchange Commission, including its Annual Report on Form 20-F for the year ended December 31, 2014, and its Quarterly Reports.

Contact:
Paul Averback
Nymox Pharmaceutical Corporation
800-93NYMOX
www.nymox.com
Monday, July 27th, 2015 Uncategorized Comments Off on (NYMX) Pivotal Phase 3 NX-1207 BPH Extension Trial Successfully Meets Primary Endpoint

(CSRE) Ultra-Thin Bluetooth® Smart Solution Powers New BrilliantTS Smart Multi-Payment Card

Tiny CSR1013™ Package and Ultra-Low Power Consumption is Ideal for Connected Credit Cards and Wearables

CSR plc (LSE: CSR; NASDAQ: CSRE) today announced that its CSR1013™ technology has been used by BrilliantTS, a leading manufacturer of smart hardware and software solutions, to create a multi-payment card. This enables simple and secure credit and debit card payments by connecting to a smartphone using Bluetooth®. The CSR1013 at just 0.35mm is the thinnest Bluetooth Smart System on a Chip (SoC) available in a 2.4mm x 2.6mm Wafer Level Chip Scale Package (WL-CSP). BrilliantTS took advantage of the small footprint, ultra-thin form factor and low power consumption to develop a smart card that is the same size as a standard EMV (Europay, Mastercard, Visa) card, ensuring it is compatible with existing POS and ATM systems.

Designed to reduce the amount of cards in a wallet, the All-in-One Smart Card can register over 30 cards. This includes both credit and debit as well as supporting public transport travel, magnetic and near field communications (NFC), one time password (OTP) as well as a wide variety of applications, such as security door keys.

Alongside the CSR1013 ultra-thin package, the Bluetooth 4.1 solution also offers low power consumption, 128KB memory and low external bill of materials (eBom). This makes the SoC ideal for next generation payment and security cards and a wide variety of other smart devices such as sports equipment and wearables, and is priced to enable devices at all levels of the price scale.

“Customers often need to carry multiple cards around with them, which adds an element of frustration when shopping. We wanted to make this all-in-one card thinner and improve the overall consumer experience,” said Jaehun Bae, CEO at BrilliantTS. “To make this possible we needed to develop a card which was the same size as a standard EMV card and did not need to be constantly charged. CSR1013 helped us to achieve this with the built-in security that Bluetooth Smart provides.”

Anthony Murray, Senior Vice President, Business Group at CSR, said: “The IoT is driving a need for smaller devices with low power consumption as developers bring connectivity to everything from mobile phones to watches and smart cards. By taking advantage of the small form factor and high performance of the CSR1013, BrilliantTS is creating an all-in-one, connected, smart card, that brings powerful new functionality to consumers.”

The CSR1013 CSP is part of the proven line of CSR μEnergy single-mode Bluetooth low energy platforms. CSR1013 CSP increases application code and data space for greater application development flexibility. The CSR1013 example design is available now and CSR will produce modules that can be used with the existing CSR101x development kits.

About CSR

At CSR we push every boundary™ to solve challenges and deliver innovations that help customers differentiate and win in the fast-evolving consumer electronics market. Our technologists are improving people’s lifestyles and unlocking the true potential of seamless connectivity and the Internet of Things by developing and integrating silicon, software and services for customers in Voice & Music, Connectivity and Bluetooth® Smart, Automotive Infotainment, Document Imaging and Location. For more information, visit www.csr.com, our blog, YouTubeFacebook or Twitter. For more information on aptX®, the audio codec that has revolutionized the wireless listening experience, visit www.aptx.com

About BrilliantTS

BrilliantTS understands the market with hardware and changes the world with software. Established in 2012, we have developed our strengths in smart devices such as smart TVs, IoT home devices, skin analysis system and software business using the smart devices. Now BrilliantTS developed multi-smart cards that can shake the entire payment system. We are ready to surprise the market, taking another leap into a global technology company.

CAUTIONARY NOTE ON FORWARD LOOKING STATEMENTS

This press release contains certain statements (including statements concerning plans and objectives of management for future operations or performance, or assumptions related thereto) that are not historical facts and constitute ‘forward looking statements’ within the meaning of the United States Private Securities Litigation Reform Act of 1995 in relation to the CSR1013 technology, and its performance characteristics in consumer electronic products, including the BrilliantTS smart multi-payment card, and other future events and their potential effects on CSR. These forward-looking statements can be identified by words such as ‘will,’ ‘can deliver,’ offers’, ‘allows’, ‘to enhance,’ ‘enables,’ ‘designed to’ and other similar expressions regarding the performance characteristics of the CSR1013 technology, and its performance characteristics in consumer electronics products, including the BrilliantTS smart multi-payment card, and their potential effects on CSR. Any future release of the CSR1013 technology or consumer electronics products containing such technology, related products or modifications to such products’ capability, functionality or features are subject to ongoing evaluation by CSR and its customers, and may or may not be implemented and should not be considered firm commitments by CSR or its customers and should not be relied upon in making purchasing decisions. Such forward-looking statements represent the current expectations and beliefs of management of CSR, and are based upon numerous assumptions regarding CSR’s business strategies and the environment in which CSR will operate and therefore involve a number of known and unknown risks, contingencies, uncertainties and other factors, many of which are beyond the control of CSR, including, but not limited to, those detailed from time to time in CSR’s periodic reports (whether under the caption Risk Factors or Forward Looking Statements or elsewhere), which are available at the SEC’s web site http://www.sec.gov. Each forward looking statement speaks only as of the date hereof. CSR does not undertake to release publicly any updates or revisions to any forward looking statements contained herein, otherwise than required by law.

Bluetooth® and the Bluetooth logos are trademarks owned by Bluetooth SIG, Inc. and licensed to CSR.

Wi-Fi®, Wi-Fi Alliance®, WMM®, Wi-Fi Protected Access®, WPA®, WPA2®, Wi-Fi Protected Setup™ and Wi-Fi Multimedia™ are trademarks of the Wi-Fi Alliance.

Other products, services and names used in this document may have been trademarked by their respective owners.

 

US:
March Communications
James Gerber, +1-617-960-9875
csr@marchpr.com
or
UK:
Octopus Group
Russell Lindsey, +44(0)845 370 7024
csr@weareoctopusgroup.net

Friday, July 24th, 2015 Uncategorized Comments Off on (CSRE) Ultra-Thin Bluetooth® Smart Solution Powers New BrilliantTS Smart Multi-Payment Card

(RNWK) to Sell Slingo, Social Casino Business to Gaming Realms for $18 Million

SEATTLE, July 24, 2015  — RealNetworks, Inc. (NASDAQ: RNWK) today announced an agreement to sell the Slingo and Social Casino portion of its games business to Gaming Realms plc (LSE: GMR), a publicly-traded, London-based online gaming company, for $18 million.

Under the terms of the agreement, RealNetworks will sell certain assets used in its social games business, including its U.S. and Canadian game studios, and social and mobile freemium portfolio games, such as Slingo Adventure, Slingo Shuffle and GameHouse Casino Plus. The sale also includes the Slingo brand and patents; Mahjong.com, Sudoku.com and Slingo.com domains; a short term license to the GameHouse brand; and a perpetual license to the GameHouse Promotion Network.

RealNetworks remains committed to its traditional casual games business, which it runs worldwide under the GameHouse brand and which features a subscription business with over 100,000 subscribers and a portfolio of excellent games led by the Delicious casual games franchise. This business and team, which is headquartered in Eindhoven in the Netherlands, is unaffected by the pending sale to Gaming Realms.

“With this transaction, we are accomplishing three key objectives,” said Rob Glaser, RealNetworks Chairman and CEO. “We are deriving value from our Slingo and Social Casino business; we are pairing this team and business with an excellent partner in Gaming Realms who will leverage our great Slingo and casino assets into real money gaming; and we are redoubling our focus on our traditional casual games business which we believe is financially stable and poised for success.”

Consideration for the sale is expected to be $18 million, $10 million of which will be paid in cash at closing, with the remainder payable either all in cash or a mix of cash and Gaming Realms stock, at RealNetworks’ election, on the first and second anniversaries of closing. The structure of this deal allows Real to participate in the economic upside of Gaming Realms’ future success while providing a floor value for the transaction. The closing of the transaction is expected to occur in the third quarter and is subject to a financing contingency, as well as other customary closing conditions.

“We believe that our social gaming business will enjoy significant synergy with Gaming Realms’ real money and social gaming operations as we have already seen with Gaming Realms’ early market success of Slingo Riches,” said Atul Bali, President of RealNetworks’ games division.

As part of the sale, approximately sixty employees of the business will become employees of Gaming Realms. Mr. Bali will split his time between RealNetworks’ casual games business and overseeing the acquired business as an executive director of Gaming Realms. Mr. Bali is currently a non-executive director of Gaming Realms.

About RealNetworks, Inc.
RealNetworks creates innovative products and services that make it easy for people to connect with and enjoy digital media. RealNetworks invented the streaming media category and continues to connect consumers with their digital media both directly and through partners, aiming to support every network, device, media type, and social network. Find RealNetworks corporate information at www.realnetworks.com. RealNetworks and its respective logos are trademarks, registered trademarks, or service marks of RealNetworks. Other products and company names mentioned are the trademarks of their respective owners.

About Gaming Realms Plc
Gaming Realms Plc develops, operates and markets a number of mobile related casino and bingo brands in the UK real money gambling space, operating under a UK gambling license.

The company was formed 3 years ago and has in that time bought marketing and bingo affiliate businesses in its stated desire to be become a leading ‘mobile focused’  gaming operator and developer in both the UK and worldwide. The company is currently based in London, UK and St Peter Port, Guernsey.

Forward Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including statements relating to plans and expectations resulting from RealNetworks’ sale of its social gaming business, including the potential success of the business as part of the buyer’s business and future economic benefits to RealNetworks, and statements relating to the current and expected future performance of RealNetworks’ casual games business. All statements contained in this press release that do not relate to matters of historical fact should be considered forward-looking statements. Actual results may differ materially from the results predicted. Factors that could cause actual results to differ from the results predicted include effectiveness of the integration of the divested business into the business of the acquiring company, and competitive factors such as the emergence of new entrants in the market. More information about potential risk factors that could affect RealNetworks’ business is included in RealNetworks’ annual report on Form 10-K for the most recent year ended December 31, its quarterly reports on Form 10-Q and in other reports and documents filed by RealNetworks from time to time with the Securities and Exchange Commission. The company assumes no obligation to update any forward-looking statements or information, which are in effect as of their respective dates.

Friday, July 24th, 2015 Uncategorized Comments Off on (RNWK) to Sell Slingo, Social Casino Business to Gaming Realms for $18 Million

(MDGN) First Patient Enrolled in Phase 2 Trial of TARGT-EPO for Anemia

PHILADELPHIA, July 15, 2015  — Medgenics, Inc. (NYSE:MDGN), the developer of a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides in patients using ex vivo gene therapy and their own tissue for the treatment of rare and orphan diseases, today announced that the first patient has been enrolled in its U.S.-based Phase 2 clinical trial of MDGN-201 (TARGTEPOTM), an investigational gene therapy for the treatment of anemia in end stage renal disease (ESRD) patients undergoing peritoneal dialysis.

“Enrolling our first patient in the U.S. represents a significant achievement for the Company,” commented Garry Neil, MD, Chief Scientific Officer of Medgenics. “We look forward to progressing the study and continuing the advancement of this unique gene therapy platform.”

About the Trial (MG-EP-RF-04)

The objective of this Phase 2, open-label study is to evaluate the safety and biologic activity of MDGN-201 TARGTEPO treatment when maintaining hemoglobin levels within the targeted range of 9-12 g/dl. Biological activity assessments will include duration of TARGTEPO secretion as measured by serum EPO levels above baseline. Each patient will be administered with a targeted dose of EPO delivered via TARGTEPO. The targeted doses will be determined according to two cohorts as follows: Group A (18-25 IU/Kg/day), Group B (35-45 IU/Kg/day). Additional details may be found on www.clinicaltrials.gov using identifier NCT02468414.

About Medgenics, Inc.

Medgenics is developing the TARGT (Transduced Autologous Restorative Gene Therapy) system, a proprietary platform for the sustained production and delivery of therapeutic proteins and peptides using ex vivo gene therapy and the patient’s own tissue for the treatment of orphan and rare diseases. For more information, visit the Company’s website at www.medgenics.com.

Forward-looking Statements

This release contains 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 as that term is defined in the Private Securities Litigation Reform Act of 1995, which include all statements other than statements of historical fact, including (without limitation) those regarding the Company’s financial position, its development and business strategy, its product candidates and the plans and objectives of management for future operations. The Company intends that such forward-looking statements be subject to the safe harbors created by such laws. Forward-looking statements are sometimes identified by their use of the terms and phrases such as “estimate,” “project,” “intend,” “forecast,” “anticipate,” “plan,” “planning,” “expect,” “believe,” “will,” “will likely,” “should,” “could,” “would,” “may” or the negative of such terms and other comparable terminology. All such forward-looking statements are based on current expectations and are subject to risks and uncertainties. Should any of these risks or uncertainties materialize, or should any of the Company’s assumptions prove incorrect, actual results may differ materially from those included within these forward-looking statements. Accordingly, no undue reliance should be placed on these forward-looking statements, which speak only as of the date made. The Company expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statements contained herein to reflect any change in the Company’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based. As a result of these factors, the events described in the forward-looking statements contained in this release may not occur.

CONTACT: Medgenics, Inc.
         John Leaman
         john.leaman@medgenics.com

         Brian Piper
         Brian.piper@medgenics.com

         Stern Investor Relations
         Beth DelGiacco
         212-362-1200
         Beth@sternir.com
Friday, July 24th, 2015 Uncategorized Comments Off on (MDGN) First Patient Enrolled in Phase 2 Trial of TARGT-EPO for Anemia

(NTIP) Announces Settlement Of Patent Litigation with Shoretel, Inc.

Shoretel Agrees to License Network-1’s Remote Power Patent for Power over Ethernet Products through March 2020

NEW YORK, July 24, 2015  — Network-1 Technologies, Inc. (NYSE MKT: NTIP) announced today that it agreed to settle its patent litigation against Shoretel, Inc. (“Shoretel”) pending in the United States District Court for the Eastern District of Texas, Tyler Division, for infringement of Network-1’s Remote Power Patent (U.S. Patent No. 6,218,930). Shoretel was one of sixteen (16) original defendants named in the litigation.

As part of the settlement, Shoretel entered into a settlement agreement and non-exclusive license agreement for the Remote Power Patent. Under the terms of the license, Shoretel will license the Remote Power Patent for its full term which expires in March 2020, and pay a license initiation fee and quarterly royalties based on its sales of Power over Ethernet (“PoE”) products, including those PoE products which comply with the Institute of Electrical and Electronic Engineers (“IEEE”) 802.3af and 802.3at Standards.

In September 2011, the Company initiated patent litigation against sixteen (16) data networking equipment manufacturers in the United States District Court for the Eastern District of Texas, Tyler Division, for infringement of its Remote Power Patent. Network-1 previously reached settlement and license agreements with seven (7) of the original defendants. The remaining eight (8) defendants in the lawsuit are Alcatel-Lucent USA, Inc., Avaya Inc., AXIS Communications Inc., Dell, Inc., Hewlett-Packard Company, Juniper Networks, Inc., Polycom Inc., and Sony Electronics, Inc. Network-1 seeks monetary damages based upon reasonable royalties.

The Remote Power Patent covers the remote delivery of power over Ethernet networks and has generated licensing revenue in excess of $76 million from May 2007 through March 31, 2015.  Network-1 currently has nineteen (19) license agreements with respect to its Remote Power Patent, which include, among others, license agreements with Cisco Systems, Inc., Extreme Networks, Inc., Netgear Inc., Microsemi Corporation, Motorola Solutions, Inc., NEC Corporation, Samsung Electronics Co., Ltd. and several other data networking vendors.

ABOUT NETWORK-1 TECHNOLOGIES, INC.

Network-1 Technologies, Inc. is engaged in the development, licensing and protection of its intellectual property and proprietary technologies. Network-1 works with inventors and patent owners to assist in the development and monetization of their patented technologies. Network-1 currently owns twenty-four (24) patents covering various telecommunications and data networking technologies as well as technologies relating to document stream operating systems and the identification of media content. Network-1’s current strategy includes continuing to pursue licensing opportunities for its Remote Power Patent and its efforts to monetize two patent portfolios (the Cox and Mirror Worlds patent portfolios) acquired by Network-1 in 2013. Network-1’s acquisition strategy is to focus on acquiring high quality patents which management believes have the potential to generate significant licensing opportunities as Network-1 has achieved with respect to its Remote Power Patent.

This release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. These statements address future events and conditions concerning Network-1’s business plans. Such statements are subject to a number of risk factors and uncertainties as disclosed in the Network-1’s Annual Report on Form 10-K for the year ended December 31, 2014 and its Quarterly Report on Form 10-Q for the quarterly period ended March 31, 2015 filed with the Securities and Exchange Commission, including, among others, the continued validity of Network-1’s Remote Power Patent, the ability of Network-1 to successfully execute its strategy to acquire high quality patents with significant licensing opportunities, Network-1’s ability to achieve revenue and profits from the Mirror Worlds Patent Portfolio and the Cox Patent Portfolio as well as intellectual property it may acquire in the future, the ability of Network-1 to enter into additional license agreements, the ability of Network-1 to continue to receive material royalties from its existing license agreements for its Remote Power Patent, the uncertainty of patent litigation and proceedings at the United States Patent and Trademark Office, the difficulty in Network-1 verifying royalty amounts owed to it by its licensees, Network-1’s ability to enter into strategic relationships with third parties to license or otherwise monetize their intellectual property, the continued viability of the PoE market, future economic conditions and technology changes and legislative, regulatory and competitive developments. Except as otherwise required to be disclosed in periodic reports, Network-1 expressly disclaims any future obligation or undertaking to update or revise any forward-looking statement contained herein.

Corey M. Horowitz, Chairman and CEO
Network-1 Technologies, Inc.
(212) 829-5770

Friday, July 24th, 2015 Uncategorized Comments Off on (NTIP) Announces Settlement Of Patent Litigation with Shoretel, Inc.

(QLIK) and AFAS Software Partner to Deliver Visual Analytics Platform to 560,000 Users

Cloud-based ERP powered by Qlik Sense allows users to see the whole story in their data

Qlik® (NASDAQ: QLIK), a leader in visual analytics, today announced that AFAS Software, a fast-growing ERP software provider, will integrate Qlik® Sense into its online product to provide world-class visual analytics to their more than 7,000 AFAS Software clients. By integrating Qlik, more than 560,000 AFAS users will be able to leverage the benefits of enterprise-ready business intelligence (BI) within their ERP suite. This multi-million dollar investment underpins AFAS’ strategy of creating a single and integrated software solution for its customers.

The upcoming release of AFAS’ online product, powered by Qlik Sense, will include an intuitive drag-and-drop interface supported by rich visual analytics, reporting, and dashboarding capabilities as a fully integrated part of the AFAS solution. With just a few clicks, users will be able to see the whole story in their data, including historical patterns and correlations through engaging visualizations.

Bas van der Veldt, CEO of AFAS Software, commented: “As we set high standards for our offering, building an in-house BI solution was not an option. It would take years and we wanted to give our customers the best experience the market offers. Qlik proved to be the disruptive platform we were looking for. Where other ERP providers offer a BI module as a paid plug-in, we offer it for free to our customers.”

“We are very pleased with the strategic choice AFAS Software has made in Qlik,” said Lars Björk, Qlik CEO. “This partnership responds to the growing demand from companies to empower their business with a powerful and flexible visual analytics platform that tells the whole story in their data. Qlik and AFAS are leading what many organizations see as a culture change; a desire not just to modernize certain working practices, such as administration, but to actually leapfrog other professional services by adopting the most innovative and intuitive solutions.”

About AFAS Software

AFAS Software is a Dutch ERP software developer and supplier for the corporate market. AFAS Software automates over 10,000 companies and organizations from all industries with complete and modern (online) business software. AFAS is primary sponsor of Dutch major league soccer team AZ, the AFAS Tennis Classics and AFAS Circus Theater in the Hague. In addition, AFAS also has branches in Curaçao and in Belgium.

About Qlik

Qlik (NASDAQ: QLIK) is a leader in visual analytics. Its portfolio of products meets customers’ growing needs from reporting and self-service visual analysis to guided, embedded and custom analytics. Approximately 36,000 customers rely on Qlik solutions to gain meaning out of information from varied sources, exploring the hidden relationships within data that lead to insights that ignite good ideas. Headquartered in Radnor, Pennsylvania, Qlik has offices around the world with more than 1700 partners covering more than 100 countries.

© 2015 QlikTech International AB. All rights reserved. Qlik®, Qlik® Sense, QlikView®, QlikTech®, Qlik® Cloud, Qlik® DataMarket, Qlik® Analytics Platform and the QlikTech logos are trademarks of QlikTech International AB which have been registered in multiple countries. Other marks and logos mentioned herein are trademarks or registered trademarks of their respective owners.

Media Contact:
For Qlik
Amanda Keane, 617-520-7260
akeane@webershandwick.com

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(IDI) Announces $10 Million Registered Direct Offering

Investment Significantly Accelerates Company’s Growth Plans in Data Fusion Industry

IDI, Inc. (the “Company”) (NYSE MKT: IDI), an information solutions provider, today announced that it has entered into an agreement with an institutional investor to purchase $10.0 million of the Company’s common stock in a registered direct offering and a concurrent private placement of warrants to purchase common stock.

The Company entered into a definitive purchase agreement with the investor pursuant to which the Company agreed to sell 1,280,410 shares of its common stock at a per share price of $7.81 in a registered direct offering. Additionally, in a concurrent private placement, the Company agreed to issue to the investor warrants to purchase 0.5 share of common stock for each share of common stock purchased in the registered direct offering at an exercise price of $10.00 per share, for a total of 640,205 shares of common stock. The warrants will be exercisable six months from the date of issuance and will expire 36 months from the date of issuance. The closing of the registered direct offering and the concurrent private placement is expected to take place on or about July 28, 2015, subject to the satisfaction of customary closing conditions.

“We believe this financing serves to significantly accelerate the long-term development of the Company,” stated Mr. Derek Dubner, Co-CEO of IDI, Inc. “We continue to devote our resources towards the development and implementation of next-generation information solutions to meet the diverse needs of the data fusion market. We recently launched idiBASIC™, our location and verification product, and continue to aggressively move ahead with the build-out of our full investigative solution, idiCORE™, that further leverages our unique linking technology and advanced systems architecture.”

Chardan Capital Markets acted as the exclusive placement agent for this transaction.

A shelf registration statement (File No. 333-205614) relating to the shares of common stock issued in the registered direct offering was filed with and declared effective by the Securities and Exchange Commission (the “SEC”). A prospectus supplement relating to the registered direct offering will be filed by the Company with the SEC. Copies of the prospectus supplement, together with the accompanying prospectus, can be obtained at the SEC’s website at http://www.sec.gov, from request at Chardan Capital Markets, LLC, at 17 State Street, Suite 1600, NY, NY 10004 or from IDI, Inc.

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Company in the registered direct offering or the concurrent private placement. There shall not be any offer, solicitation of an offer to buy, or sale of securities in any state or jurisdiction in which such an offering, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About IDI, Inc.

IDI, Inc. is an information solutions provider focused on the multi-billion dollar data fusion market. IDI delivers otherwise unattainable insight into the ever-expanding universe of consumer- and business-centric data. Through proprietary linking technology, advanced systems architecture, and a massive data repository, IDI will address the rapidly growing need for actionable intelligence to support the entirety of the risk management industry, for purposes including due diligence, risk assessment, fraud detection and prevention, authentication and verification, and more. Additionally, IDI’s cross-functional core systems and processes are designed to deliver products and solutions to the marketing industry and to enable the public and private sectors to layer our solutions over their unique data sets, providing otherwise unattainable insight.

RELATED LINKS http://ididata.com/

Additional Information

Statements made in this press release include forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, regarding, but not limited to, the amount and use of proceeds the Company expects to receive from the sale of the shares of common stock in the registered direct offering and the closing of the transactions. Forward-looking statements can be identified by the use of words such as “may,” “will,” “plan,” “should,” “expect,” “anticipate,” “estimate,” “continue,” or comparable terminology. Such forward-looking statements, including whether this financing significantly accelerates the long-term development of the Company, are inherently subject to certain risks, trends and uncertainties, many of which the Company cannot predict with accuracy and some of which the Company might not even anticipate, and involve factors that may cause actual results to differ materially from those projected or suggested. Readers are cautioned not to place undue reliance on these forward-looking statements and are advised to consider the factors listed above together with the additional factors under the heading “Forward-Looking Statements” and “Risk Factors” in the Company’s Annual Reports on Form 10-K, as may be supplemented or amended by the Company’s Quarterly Reports on Form 10-Q. The Company assumes no obligation to update or supplement forward-looking statements that become untrue because of subsequent events, new information or otherwise.

 

IRTH Communications
Media and Investor Relations Contact:
Andrew Haag, 877-368-3566
Managing Partner
800-377-9893
idi@irthcommunications.com
or via email at info@rjfalkner.com

Friday, July 24th, 2015 Uncategorized Comments Off on (IDI) Announces $10 Million Registered Direct Offering

(MATR) to Raise $16.2M in Registered Direct Offering

CHICAGO, IL–(Jul 23, 2015) – Mattersight Corporation (NASDAQ: MATR) announced today that it has agreed to sell 2,728,712 shares of its common stock to certain investors and certain officers and directors in a registered direct offering. Mattersight Corporation (the “Company”) expects to raise approximately $16.2 million in gross proceeds by selling 2,563,238 shares of its common stock to certain investors at a price of $5.93 per share and by selling 165,474 shares of its common stock to certain officers and directors (including certain of their affiliates) at a price equal to $6.11 per share. The offering is anticipated to close on or about July 23, 2015, subject to customary closing conditions.

The shares of common stock offered by the Company were sold pursuant to a prospectus supplement dated as of July 22, 2015, in connection with a takedown from the Company’s effective shelf registration statement on Form S-3 (File No. 333-202744), which was filed with the Securities and Exchange Commission (the “Commission”) on March 13, 2015 and declared effective by the Commission on April 8, 2015. Craig-Hallum Capital Group LLC acted as Mattersight’s financial advisor for the offering.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

Safe Harbor for Forward-Looking Statements

Statements in this press release that are not historical facts are “forward-looking statements” that are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. These forward-looking statements, which may be identified by use of words such as “plan,” “may,” “might,” “believe,” “expect,” “intend,” “could,” “would,” “should,” and other words and terms of similar meaning, involve risks and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. In addition to other factors and matters contained or incorporated in this document, important factors that could cause actual results or events to differ materially from those indicated by such forward-looking statements include, among other things, the risks detailed from time to time in Mattersight’s SEC filings. You can locate these filings on the Investor Relations page of Mattersight’s website, www.mattersight.com. Statements included or incorporated by reference into this press release are based upon information known to Mattersight as of the date of this press release, and the company assumes no obligation to publicly revise or update any forward-looking statement for any reason.

About Mattersight

Mattersight’s mission is to help brands have more effective and effortless conversations with their customers. Using a suite of innovative personality-based software applications, Mattersight can analyze and predict customer behavior based on the language exchanged during service and sales interactions. This insight can then facilitate real-time connections between customers and the agents best capable of handling their needs. Mattersight’s patented stack of SaaS applications has influenced hundreds of millions of shorter, more satisfying customer interactions. Organizations across the Financial Services, Healthcare, and Telco industries rely on Mattersight to drive customer retention, employee engagement, and operating efficiency. An independent research study documents the average return on investment for these organizations is 344%. To learn more about how Mattersight can help your company, please visit www.mattersight.com.

Contact
Sheau-ming K. Ross
Chief Financial Officer
312.454.3594
ir@mattersight.com

Thursday, July 23rd, 2015 Uncategorized Comments Off on (MATR) to Raise $16.2M in Registered Direct Offering

(CUR) US District Court Rules In Favor Of Neuralstem In Patent Infringement Case

GERMANTOWN, Md., July 23, 2015  — Neuralstem, Inc. (Nasdaq: CUR), a biopharmaceutical company using neural stem cell technology to develop small molecule and cell therapy treatments for central nervous system diseases, announced that the U.S. District Court for the District of Maryland dismissed StemCells, Inc.’s patent infringement case with prejudice in StemCells, Inc. v. Neuralstem, Inc. in favor of Neuralstem, on July 22, 2015.

The District Court held a bench trial on the issue of standing in December of 2014.  In its 29-page Memorandum Opinion, the U.S. District Court for the District of Maryland ruled that a third-party  scientist is a co-owner and co-inventor of the patents-in-suit.  As a result, StemCells, Inc. lacked standing on its own to bring its patent infringement claims against Neuralstem, Inc. and the case was dismissed with prejudice.

About Neuralstem

Neuralstem’s patented technology enables the commercial-scale production of multiple types of central nervous system stem cells, which are under development for the potential treatment of central nervous system diseases and conditions.

Neuralstem’s ability to generate human neural stem cell lines for chemical screening has led to the discovery and patenting of compounds that Neuralstem believes may stimulate the brain’s capacity to generate neurons, potentially reversing pathologies associated with certain central nervous system (CNS) conditions. The company has completed Phase Ia and Ib trials evaluating NSI-189, its first neurogenic small molecule product candidate, for the treatment of major depressive disorder (MDD), and is expecting to initiate a Phase II study for MDD and a Phase Ib study for cognitive deficit in schizophrenia in 2015.

Neuralstem’s first stem cell product candidate, NSI-566, a spinal cord-derived neural stem cell line, is under development for treatment of amyotrophic lateral sclerosis (ALS). Neuralstem has completed two clinical studies, in a total of thirty patients, that met primary safety endpoints. In addition to ALS, NSI-566 is also in a Phase I trial in chronic spinal cord injury at UC San Diego School of Medicine, as well as in clinical development to treat ischemic stroke.

Neuralstem’s next generation stem cell product, NSI-532.IGF, consists of human cortex-derived neural stem cells that have been engineered to secrete human insulin-like growth factor 1 (IGF-1). In animal data presented at the Congress of Neurological Surgeons 2014 Annual Meeting, the cells rescued spatial learning and memory deficits in an animal model of Alzheimer’s disease.

For more information, please visit www.neuralstem.com or connect with us on Twitter, Facebook and LinkedIn

Cautionary Statement Regarding Forward Looking Information:

This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995.  Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2014, Form 10-Q for the period ended March 31, 2015, and in other reports filed with the SEC.

 

Thursday, July 23rd, 2015 Uncategorized Comments Off on (CUR) US District Court Rules In Favor Of Neuralstem In Patent Infringement Case

(CARA) Announces Positive Results From Phase 2 Trial in Uremic Pruritus

Novel peripheral kappa opioid I.V. CR845 achieved statistically-significant results on primary endpoint of reducing worst itch intensity

Trial demonstrated statistically significant results on secondary endpoint of quality of life improvements with additional positive trend on itch-related sleep disturbances

I.V. CR845 found to be safe and well-tolerated in dialysis patients

Conference call today at 8:30 a.m. ET to discuss results and next steps

SHELTON, Conn., July 23, 2015  — Cara Therapeutics, Inc. (Nasdaq:CARA), a biotechnology company focused on developing and commercializing new chemical entities designed to selectively target peripheral kappa opioid receptors, today announced statistically significant topline results from its Phase 2 trial of its lead kappa opioid agonist, CR845, for the treatment of moderate to severe uremic pruritus (UP). Uremic pruritus is a chronic systemic itch condition in patients with renal failure, often receiving hemodialysis. There are currently no approved products in the United States for the condition.

“These results demonstrate the potential of our lead candidate CR845 to address an additional indication of significant unmet need beyond our lead I.V. CR845 program in acute pain,” said Derek Chalmers, Ph.D., D.Sc., President and Chief Executive Officer of Cara Therapeutics. “With this encouraging data, we plan to engage the FDA in a formal meeting to guide the structure of a potential Phase 3 pivotal trial, which we would expect to begin in 2016.”

The Phase 2 trial was a double‐blind, randomized, placebo‐controlled trial designed to evaluate the efficacy of I.V. CR845 compared to placebo in reducing the intensity of itch in dialysis patients over a two-week dosing period. The trial enrolled 65 dialysis patients at multiple sites in the United States.

The primary endpoint of the Phase 2 trial was the change from baseline of the average worst itching during the second week of treatment, as recorded on a visual analog scale (VAS). Patients receiving I.V. CR845 experienced a 54 percent greater reduction in worst itch scores than those receiving placebo (p-value = 0.016), with an average reduction of -48 percent from baseline as measured by the VAS. I.V. CR845-treated patients exhibited statistically significant reductions in both daytime (-51 percent, p=0.03) and nighttime (-75 percent, p=0.007) worst itch scores compared to placebo treatment.

Secondary endpoints focused on quality of life measures associated with pruritus using a series of previously validated self-assessment scales, including the Skindex 10 score. Patients receiving I.V. CR845 experienced a 71 percent greater reduction in the average total Skindex 10 score at the end the two-week treatment period than those receiving placebo (p-value=0.031). The total score average included positive trends in patients receiving I.V. CR845 for each of the three Skindex 10 domains: disease, mood/emotional distress (statistically significant reduction, p-value = 0.046) and social functioning. Another secondary measure, itch-related sleep disturbances based on the Itch MOS Sleep Problems Index II, showed a positive trend in patients receiving I.V. CR845, with a 62 percent improvement compared to placebo, although this trend was not observed to be statistically significant.

I.V. CR845 was shown to be safe and well tolerated during the study with no CR845-related serious adverse events (AEs) reported. The most common AEs were transient numbness and dizziness, with no episodes of the CNS side effects (e.g., dysphoria and hallucinations) that have impeded the development of centrally-acting kappa opioids.

“The results of the CR845 Phase 2 study are very encouraging. The data demonstrate a robust effect of reducing both daytime and nocturnal itching by an objective scoring system as well as anecdotal quality of life histories,” said Dr. James Tumlin, Professor, Department of Medicine, University of Tennessee and a Principal Investigator on the trial. “With no approved therapy and the limited efficacy of current options, CR845 provides an opportunity to alleviate the pain and discomfort of this persistent clinical problem among ESRD patients.”

There are more than 400,000 patients in the United States and 2.2 million globally undergoing hemodialysis and it is estimated that as many as 50 percent of these patients suffer from renal or uremic pruritus. Currently, there are no approved products in the United States for the condition, which can often be severe and resistant to treatment with traditional itch treatments, such as corticosteroids and antihistamines.

“We are excited by these topline results in uremic pruritus, which show that I.V. CR845 holds significant clinical potential in this indication of significant unmet need for dialysis patients,” said Joseph Stauffer, D.O., M.B.A., Chief Medical Officer of Cara Therapeutics. “I.V. CR845 demonstrated a statistically significant effect, not only on our primary endpoint of reducing the itch intensity for dialysis patients, but also in important quality of life measurements, along with a favorable safety and tolerability profile.”

Conference Call

Cara management will host a conference call today at 8:30 a.m. ET to discuss the UP trial results and next steps for the program.

To participate in the conference call, please dial 855-445-2816 (domestic) or 484-756-4300 (international) and refer to conference ID 93878802. A live webcast of the call can be accessed under “Events and Presentations” in the News & Investors section of the Company’s website at www.CaraTherapeutics.com.

An archived webcast recording will be available on the Cara website beginning approximately two hours after the call.

About CR845

CR845 is a peripherally acting kappa opioid receptor agonist currently in development for the treatment of acute and chronic pain and pruritus. In multiple randomized, double-blind, placebo-controlled Phase 2 trials in patients undergoing laparoscopic hysterectomy or bunionectomy procedures, I.V. CR845 treatment resulted in statistically significant reductions in pain intensity and opioid-related side effects. In more than 440 subjects dosed to date, I.V. CR845 was found to be safe and well tolerated, without incurring the dysphoric and psychotomimetic side effects that have been reported with centrally acting (CNS-active) kappa opioid receptor agonists. Cara expects to initiate its Phase 3 Program of I.V. CR845 for acute pain with a first adaptive pivotal trial in laparoscopic abdominal surgery in 3Q’15. In addition, a Phase 2 trial of CR845 in osteoarthritis patients using an oral tablet formulation is planned for 3Q’15.

About Cara Therapeutics

Cara Therapeutics is a clinical-stage biotechnology company focused on developing and commercializing new chemical entities designed to alleviate pain and pruritus by selectively targeting kappa opioid receptors. Cara is developing a novel and proprietary class of product candidates that target the body’s peripheral nervous system and have demonstrated efficacy in patients with moderate-to-severe pain without inducing many of the undesirable side effects typically associated with currently available pain therapeutics.

Forward-looking Statements

Statements contained in this press release regarding matters that are not historical facts are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Examples of these forward-looking statements include statements concerning the expected timing for meeting with the FDA regarding the results of the Company’s Phase 2 trial of I.V. CR845 in in dialysis patients experiencing uremic pruritus, the potential for the advancement of I.V. CR845 to advance into a pivotal trial program, the potential future successful clinical and regulatory development of I.V. CR845 for uremic pruritus, and the expected timing of planned clinical trials for the Company’s other development programs. Because such statements are subject to risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Risks are described more fully in Cara Therapeutics’ filings with the Securities and Exchange Commission, including the “Risk Factors” section of the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 and its other documents subsequently filed with or furnished to the Securities and Exchange Commission. All forward-looking statements contained in this press release speak only as of the date on which they were made. Cara Therapeutics undertakes no obligation to update such statements to reflect events that occur or circumstances that exist after the date on which they were made.

CONTACT: CORPORATE CONTACT:
         Derek Chalmers, Ph.D., D.Sc.
         President & CEO
         Cara Therapeutics, Inc.
         203-567-1500

         MEDIA CONTACT:
         Annie Starr
         6 Degrees
         973-415-8838
         astarr@6degreespr.com

         INVESTOR CONTACT:
         Jesse Baumgartner
         Stern Investor Relations, Inc.
         212-362-1200
         Jesse@sternir.com
Thursday, July 23rd, 2015 Uncategorized Comments Off on (CARA) Announces Positive Results From Phase 2 Trial in Uremic Pruritus

(IDN) California Military Department Awards Contract for Secure Site Access Control

Defense ID Will Enhance Security at Army National Guard Locations Across the State

Intellicheck Mobilisa, Inc. (NYSE MKT: IDN), the industry leader in identity authentication and validation solutions, today announced it has been awarded an initial purchase contract in excess of $300 thousand by the California Military Department for Intellicheck’s Defense ID® system. The field proven site security solution will provide real-time identity awareness and secure access control for persons seeking entrance to a number of the California Army National Guard’s facilities across the state.

Under the new contract, security personnel will have the ability to positively identify and credential every individual who seeks access to California Army National Guard facilities using handheld mobile units communicating with a single installation control server. The purchase agreement for the recently feature-enhanced solution includes the ability to query information from the National Crime Information Center (NCIC). This capability enhances security personnel’s ability to thoroughly scrutinize and evaluate those visitors requesting access and assess whether they potentially pose threats to our service personnel and their facilities.

The California Military Department supports the operations for more than 23,000 troops with a diverse organization including the California Army National Guard, the California Air National Guard, the California State Military Reserve and the California Youth and Community Programs. Led by the Adjutant General, the California National Guard is responsible for the command, leadership and management of the state’s Army National Guard and Air National Guard. The National Guard has both a federal and state mission with a dual role of both assisting state government in times of disaster and the country when fighting overseas. The California Military Department maintains a headquarters complex in Sacramento and facilities throughout the state.

Unlike competitive solutions that lack full regulatory compliance, the highest degree of accuracy, and real-time capabilities on both mobile and existing fixed infrastructures, Intellicheck’s technology uniquely provides accurate, real-time identification authentication and situational awareness that is fully regulatory compliant, can be deployed on mobile devices, and is easily integrated and customized into existing infrastructures. The Defense ID security system scans and authenticates driver licenses from all 50 U.S. states, all Canadian provinces and most Mexican States, as well as military and other identification documents issued by government agencies. The system initially determines if the identification document is fake or stolen, and then alerts security officers of a potential threat in real-time by comparing a visitor’s identification card information with information available from both public and confidential government data sources. This information includes whether the person is on Be-On-the-Lookout (BOLO) lists, the subject of law enforcement wants and warrants, or listed for military base debarments and driving suspensions. Defense ID’s durable handheld mobile devices assure base personnel maximum flexibility regardless of whether a device is dropped or exposed to adverse weather conditions.

Intellicheck CEO Dr. William Roof commented, “We are confident that Defense ID will provide a heightened level of situational awareness and security for the service personnel and citizens in the California Military Department facilities and surrounding communities. Having the real-time capability to determine whether visitors and vendors seeking access to these facilities are legitimate, or present a threat, can save lives.” Dr. Roof, a 30-year military veteran, pointed out that Intellicheck’s field-proven security solution is currently deployed to protect 23 military installations and 16 U.S. ports across the country. “We are very optimistic about the growing adoption of our situational awareness and site security solutions. I am confident that our ability to provide a superior level of real-time identification authentication, situational awareness and customer support will provide significant results,” he said.

Intellicheck’s robust patent portfolio of 20 patents includes many pertaining to identification technology. Its identity solutions support customers in the national defense, law enforcement, retail, hospitality and financial markets. The Company’s products scan, authenticate and analyze components of identity documents including driver licenses, military identification cards and other government forms of identification. Once extracted from the identity card, the information can be used to provide safety, security and efficiencies throughout these markets.

About Intellicheck Mobilisa

Intellicheck Mobilisa is an industry leader in identity authentication and validation systems. The Company holds 20 patents including many pertaining to identification technology. Its identity solutions support customers in the law enforcement, national defense, hospitality, retail and financial markets. The Company’s products scan, authenticate and analyze components of identity documents including driver licenses, military identification cards and other government forms of identification. For more information on Intellicheck Mobilisa and ICMOBIL, please visit www.icmobile.com.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward looking statements including, without limitation, the statements regarding Intellicheck Mobilisa’s proposed offering, 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 general market conditions, development and product commercialization activities, and the success of its research, development and expansion of sales and marketing team, plans and strategies. These and other risks and uncertainties are identified and described in more detail in Intellicheck Mobilisa’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2014, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Intellicheck Mobilisa undertakes no obligation to publicly update or revise any forward-looking statements.

Intellicheck Mobilisa, Inc.
Sharon Schultz, 302-539-3747

Thursday, July 23rd, 2015 Uncategorized Comments Off on (IDN) California Military Department Awards Contract for Secure Site Access Control

(ITEK) Positive End-of-Phase 2 Meeting with FDA Over Glaucoma Treatment Trabodenoson

–Pivotal Studies Designed to Show Superiority to Placebo–

–1st Phase 3 Study to Commence in 4Q15 with Top-line Data In 2016–

–Conference Call Scheduled for 8:30AM ET–

Inotek Pharmaceuticals Corporation (NASDAQ: ITEK), a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for ocular diseases, today announced the Phase 3 development strategy of its lead glaucoma drug, trabodenoson, a first-in-class selective adenosine mimetic designed to restore the eye’s natural pressure control mechanism. Based on feedback from a recent End of Phase 2 meeting with the US Food and Drug Administration (FDA), Inotek is in final preparation stages to commence its first Phase 3 trial to support a New Drug Application (NDA) for trabodenoson.

“Our End-of-Phase 2 meeting was a critical milestone for advancing the development of trabodenoson. We are pleased with the agency’s guidance on the pivotal trial design which will enable a more efficient registration path to potentially bring this novel glaucoma therapy to market for the benefit of patients,” said David P. Southwell, President and Chief Executive Officer. “We expect to commence our first Phase 3 trial in 4Q and look forward to data in 2016.”

The trial design for the first pivotal study is a five-arm superiority trial that will include three doses of trabodenoson. These doses were selected to optimize lowering of intraocular pressure while maintaining the good tolerability observed in Phase 2 trials. The primary efficacy endpoint of the study is the reduction of intraocular pressure (IOP), statistically superior as compared to placebo. A comparator arm of timolol will also be included for study validation, but not for statistical comparison.

“There is a major unmet medical need for a well-tolerated and effective therapy with a new mechanism of action for glaucoma,” said Rudolf Baumgartner, M.D, Chief Medical Officer of Inotek. “Our overall program will consist of three clinical trials encompassing a total subject exposure of 1300 patients. Our previous Phase 2 studies have demonstrated that trabodenoson’s efficacy improves over time, and with increases in dose. A benefit of the Phase 3 superiority design is that we can investigate more than one dose of trabodenoson, allowing us to further optimize the drug’s clinical and safety profile.”

In Phase 2 trials, trabodenoson demonstrated a dose-response for intraocular pressure lowering in ocular hypertension and primary open angle glaucoma patients. After 14 days of treatment, both the 200mg and 500mg doses of trabodenoson demonstrated a statistically significant reduction (P<0.05) in IOP relative to the matched placebo group. After 28 days of treatment, the 500mg dose continued to demonstrate a statistically significant reduction in IOP relative to placebo, in the range of other glaucoma therapies. Across all trials, the efficacy of trabodenoson has remained consistent, with no waning effect observed, and the IOP reduction was consistent across different patient sub-populations. Trabodenoson has also been well tolerated with no serious adverse events. In patients with glaucoma or ocular hypertension, the rate of conjunctival hyperemia (redness in the eye), a side-effect commonly associated with other mechanisms used to treat glaucoma, was not affected by trabodenoson treatment.

William McVicar, Ph.D., Chief Scientific Officer, commented, “Glaucoma is an optic nerve neuropathy, where vision is lost due to the death of the retinal ganglion cells which carry the visual signal from the retina to the brain. While trabodenoson data indicated IOP reductions in the range of current therapies, we have also demonstrated in animals that trabodenoson can protect these neural cells from high ocular pressure injury. This data supports that A1 agonism not only reduces IOP but may also have a neuroprotective role in the retina. If we are able to demonstrate the same neuroprotective effects of trabodenoson in humans, we believe trabodenoson has the potential to significantly change how glaucoma is managed, potentially supporting earlier intervention in a substantially larger population of patients.”

Conference Call Information
Inotek will host a conference call and webcast today, July 23, 2015, at 8:30 am (EDT) to discuss the trabodenoson development strategy. To participate in the conference call, please dial (866) 430-2017 (U.S.) or (704) 908-0413 (international) five minutes prior to the start of the call and provide the Conference ID: 93395336, or access the listen-only webcast by visiting the Company’s website www.inotekpharma.com.

An archive of today’s conference call will be available shortly after the conclusion of the call and accessed by dialing (855) 859-2056 (U.S.) or (404) 537-3406 and referencing the Conference ID: 93395336, or by visiting Inotek’s website. The audio replay will be available for two weeks following the call and the webcast for thirty days.

About Inotek Pharmaceuticals Corporation
Inotek Pharmaceuticals is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of therapies for glaucoma and other eye diseases. Our lead product candidate, trabodenoson, is a first-in-class selective adenosine mimetic developed in Inotek’s laboratories designed to restore the eye’s natural pressure control mechanism. The development of trabodenoson monotherapy delivered in a once-daily eye drop formulation will be followed by a fixed-dose combination of trabodenoson with latanoprost. Additionally, the Company is evaluating the potential for selective adenosine mimetics to address optic neuropathies and other degenerative retinal diseases.

Forward-Looking Statements

This press release contains forward-looking statements, which are subject to substantial risks, uncertainties and assumptions. You should not place reliance on these statements. Forward-looking statements include information concerning the proposed offerings. These statements often include words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate,” “seek,” “will,” “may” or similar expressions. Although the Company believes that the expectations reflected in the forward-looking statements are reasonable, the Company cannot guarantee such outcomes. Accordingly, you should not place undue reliance on these forward-looking statements. All such statements speak only as of the date made, and the Company undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise.

Inotek Contact:
Claudine Prowse, Ph.D., 781-552-4305
Vice President, Strategy and Investor Relations Officer
cprowse@inotekpharma.com
or
Media Contact:
MacDougall Biomedical
Karen Sharma, 781-235-3060
ksharma@macbiocom.com

Thursday, July 23rd, 2015 Uncategorized Comments Off on (ITEK) Positive End-of-Phase 2 Meeting with FDA Over Glaucoma Treatment Trabodenoson

(ESEA) Announces Completion of Reverse Stock Split

MAROUSSI, ATHENS, GREECE–(Jul 23, 2015) –  Euroseas Ltd. (NASDAQ: ESEA) (the “Company”), an owner and operator of drybulk and container carrier vessels and a provider of seaborne transportation for drybulk and containerized cargoes, announces that it has completed a 1-for-10 reverse stock split, effective at the close of trading on July 22, 2015. The Company’s common shares will begin trading on a split-adjusted basis on July 23, 2015.

The reverse stock split was undertaken with the objective of meeting the minimum $1.00 per share requirement for listing the Company’s common stock on the Nasdaq Capital Market.

No fractional shares were issued in connection with the reverse stock split. Instead, the Company has issued one full share of the post-reverse stock split common stock to any shareholder who would otherwise have been entitled to receive a fractional share as a result of the reverse stock split. Each common shareholder holds the same percentage of the outstanding common shares after the completion of the reverse stock split as that shareholder did immediately prior to the reverse stock split, except for minor adjustment due to the additional net share fraction that was issued as a result of the treatment of fractional shares. The reverse stock split was authorized by the Company’s shareholders on June 19, 2015.

About Euroseas Ltd.
Euroseas Ltd. was formed on May 5, 2005 under the laws of the Republic of the Marshall Islands to consolidate the ship owning interests of the Pittas family of Athens, Greece, which has been in the shipping business over the past 136 years. Euroseas trades on the Nasdaq Capital Market under the ticker symbol ESEA.

Euroseas operates in the dry cargo, drybulk and container shipping markets. Euroseas’ operations are managed by Eurobulk Ltd., an ISO 9001:2008 certified affiliated ship management company, which is responsible for the day-to-day commercial and technical management and operations of the vessels. Euroseas employs its vessels on spot and period charters and through pool arrangements.

The Company has a fleet of 15 vessels, including 4 Panamax drybulk carriers and 1 Handymax drybulk carrier, 3 Intermediate containerships, 5 Handysize containerships, and 2 Feeder containerships. Euroseas’ 5 drybulk carriers have a total cargo capacity of 338,540 dwt, and its 10 containerships have a cargo capacity of 17,587 teu. The Company has also signed contracts for the construction of two Ultramax (63,500 dwt) fuel efficient drybulk carriers, and two Kamsarmax (82,000 dwt) fuel efficient drybulk carriers. Including the four new-buildings, the total cargo capacity of the Company’s drybulk vessels will be 629,540 dwt.

Visit our website www.euroseas.gr

Company Contact
Tasos Aslidis
Chief Financial Officer
Euroseas Ltd.
11 Canterbury Lane,
Watchung, NJ 07069
Tel. (908) 301-9091
E-mail: aha@euroseas.gr

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: euroseas@capitallink.com

Thursday, July 23rd, 2015 Uncategorized Comments Off on (ESEA) Announces Completion of Reverse Stock Split

(CPRX) Initiates Rolling NDA Submission of Firdapse for LEMS

Expects to Complete Full NDA Submission in the Fourth Quarter of 2015

CORAL GABLES, Fla., July 22, 2015  — Catalyst Pharmaceuticals, Inc. (Nasdaq:CPRX), a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, today announced the initiation of a rolling submission of a New Drug Application (NDA) to the United States (U.S.) Food and Drug Administration (FDA) for Firdapse® for the treatment of Lambert-Eaton Myasthenic Syndrome (LEMS). Firdapse® has received Breakthrough Therapy Designation from the FDA for the treatment of LEMS, as well as orphan drug designations for LEMS and congenital myasthenic syndromes (CMS).

“Our start of the NDA submission for Firdapse® marks an important step forward in our efforts to provide a safe and effective, FDA approved, treatment option for patients in the U.S. who develop LEMS, a rare, debilitating disease,” said Patrick J. McEnany, Chief Executive Officer of Catalyst.  “We expect to complete the submission of the NDA in the fourth quarter of 2015, at which time we will be requesting a Priority Review of our application. We will continue to work closely with the FDA as we seek approval of the NDA.  As part of our commitment to ensure that eligible patients have access to Firdapse® as we pursue U.S. approval, we will continue to provide access to Firdapse® through an expanded access program.”

The Breakthrough Therapy Designation is designed to convey all of the fast track program features, as well as more intensive FDA guidance on an efficient drug development program. The Fast Track Designation is designed to facilitate the development and expedite the review of drugs that treat serious, life-threatening conditions and that address unmet medical needs.  The Fast Track process allows a company to submit individual modules of its NDA for review by the FDA as they are completed.

About Catalyst Pharmaceuticals

Catalyst Pharmaceuticals is a biopharmaceutical company focused on developing and commercializing innovative therapies for people with rare debilitating diseases, including Lambert-Eaton myasthenic syndrome (LEMS), congenital myasthenic syndromes (CMS), infantile spasms, and Tourette’s Disorder. Catalyst’s lead candidate, Firdapse® for the treatment of LEMS, recently completed testing in a global, multi-center, pivotal Phase 3 trial resulting in positive top-line data. Firdapse® for the treatment of LEMS has received Breakthrough Therapy Designation from the U.S. Food and Drug Administration (FDA) and orphan drug designation for LEMS and CMS. Firdapse® is the first and only European approved drug for symptomatic treatment in adults with LEMS.

Catalyst is also developing CPP-115 to treat infantile spasms, epilepsy and other neurological conditions associated with reduced GABAergic signaling, like post-traumatic stress disorder and Tourette’s Disorder. CPP-115 has been granted U.S. orphan drug designation for the treatment of infantile spasms by the FDA and has been granted E.U. orphan medicinal product designation for the treatment of West Syndrome by the European Commission. 

Forward-Looking Statements

This press release contains forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which may cause Catalyst’s actual results in future periods to differ materially from forecasted results. A number of factors, including whether the receipt of breakthrough therapy designation for Firdapse® will expedite the development and review of Firdapse® by the FDA or the likelihood that the product will be found to be safe and effective, what clinical trials and studies will be required before Catalyst can submit an NDA for Firdapse® for the treatment of CMS and whether any such required clinical trials and studies will be successful, whether an NDA for Firdapse® will ever be accepted for filing by the FDA, the timing of any such NDA filing or acceptance, whether, if an NDA for Firdapse® is accepted for filing, such NDA will be given a priority review by the FDA, whether Catalyst will be the first company to receive approval for amifampridine (3,4-DAP), giving it 7-year marketing exclusivity for its product, whether CPP-115 will be determined to be safe for humans, whether CPP-115 will be determined to be effective for the treatment of infantile spasm, post-traumatic stress disorder, Tourette’s Disorder or any other indications, whether any of Catalyst’s product candidates will ever be approved for commercialization or successfully commercialized, and those other factors described in Catalyst’s Annual Report on Form 10-K for the fiscal year 2014 and its other filings with the U.S. Securities and Exchange Commission (SEC), could adversely affect Catalyst. Copies of Catalyst’s filings with the SEC are available from the SEC, may be found on Catalyst’s website or may be obtained upon request from Catalyst. Catalyst does not undertake any obligation to update the information contained herein, which speaks only as of this date.

Investor Contact
Brian Korb
The Trout Group LLC
(646) 378-2923
bkorb@troutgroup.com

Company Contact
Patrick J. McEnany
Catalyst Pharmaceuticals
Chief Executive Officer
(305) 529-2522
pmcenany@catalystpharma.com

Media Contacts
David Schull
Matt Middleman, M.D.
Russo Partners
(212) 845-4271
(212) 845-4272
david.schull@russopartnersllc.com
matt.middleman@russopartnersllc.com
Wednesday, July 22nd, 2015 Uncategorized Comments Off on (CPRX) Initiates Rolling NDA Submission of Firdapse for LEMS

(RXDX) Boosts Leadership Capacity with Appointment of Bernard Parker as CCO

Ignyta, Inc. (Nasdaq: RXDX), a precision oncology biotechnology company, announced today that Bernard Parker has been appointed to the newly-created role of Chief Commercial Officer.

“We are excited to expand our leadership capacity at Ignyta with the addition of Bernard to our executive team,” said Jonathan Lim, M.D., Chairman and CEO of Ignyta. “Bernard brings a wealth of commercial experience to Ignyta from a variety of senior roles spanning sales, marketing, reimbursement, global brand management and regional business unit leadership at several leading pharmaceutical companies. His broad, international expertise and demonstrated ability to execute will be valuable to us as we prepare to transition into a commercial stage company with STARTRK-2, a potential registration-enabling study for entrectinib, a key step forward in our quest to provide new treatment options for cancer patients.”

Mr. Parker was most recently Head of the EMEA Pharmaceuticals Franchise for the Alcon division of Novartis, a position he held since 2013. In this role, he was responsible for all commercial initiatives for Alcon’s ophthalmic pharmaceuticals and over-the-counter business. Prior to Alcon, Mr. Parker was Global Brand Director, Biopharmaceuticals Portfolio for the Sandoz division of Novartis, a position he held from 2009 to 2013. At Sandoz, Mr. Parker led all commercial and lifecycle management activities for the oncology biosimilars granulocyte colony-stimulating factor (G-CSF) portfolio, including the launch of Zarzio®, the top prescribed biosimilar G-CSF product in the world. From 2008 to 2009, Mr. Parker was a management consultant at Bain & Company, working on growth strategy and profit improvement projects across a variety of industries. Prior to Bain, Mr. Parker gained experience in the U.S. in various marketing and sales roles at Amgen, Pfizer and Parke-Davis, where his work spanned the oncology, cardiovascular, diabetes and neurology therapeutic areas and included assisting with the launch of Lipitor® as a sales representative. Bernard holds an M.B.A. from Harvard Business School and a B.A. in biology magna cum laude from Hampton University, where he was a President’s Eminent Scholar and was awarded a biomedical research fellowship funded by the National Institutes of Health to conduct research in cell biology.

On July 22, 2015, Mr. Parker will receive an inducement stock option award under Ignyta’s 2015 Employment Inducement Incentive Award Plan, which was adopted July 17, 2015 and provides for the granting of equity awards to new employees of Ignyta. The inducement award consists of an option to purchase an aggregate of 200,000 shares of Ignyta common stock. The option has a ten-year term and an exercise price equal to the closing price per share of Ignyta’s common stock on the Nasdaq Capital Market on the date of grant. The option vests over a four-year period, with 25% of the option vesting on the first anniversary of the date of hire and the remainder vesting in equal monthly installments over the three years thereafter. The award was approved by the compensation committee of Ignyta’s board of directors and was granted as an inducement material to Mr. Parker entering into employment with Ignyta in accordance with Nasdaq Marketplace Rule 5635(c)(4).

About Ignyta, Inc.

Ignyta, Inc., located in San Diego, California, is a precision oncology biotechnology company pursuing an integrated therapeutic (Rx) and companion diagnostic (Dx) strategy for treating cancer patients. The company’s goal with this Rx/Dx approach is to discover, develop and commercialize new drugs that target activated cancer genes and pathways for the customized treatment of cancer, as well as novel chemotherapeutics that can potentially provide additional benefit to cancer patients. It aims to achieve this goal by pairing its product candidates with biomarker-based companion diagnostics that are designed to identify, at the molecular level, the patients who are most likely to benefit from the precisely targeted drugs the company develops. For more information, please visit: www.ignyta.com.

Forward-Looking Statements

This press release contains forward-looking statements about Ignyta as that term is defined in Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Statements in this press release that are not purely historical are forward-looking statements. Such forward-looking statements include, among other things, references to the potential for Ignyta to provide new treatment options for patients with its proprietary oncology drug development programs. Actual results could differ from those projected in any forward-looking statements due to numerous factors. Such factors include, among others, the potential for results of current or future clinical trials of entrectinib or other product candidates to differ from preliminary or expected results; the inherent uncertainties associated with developing new products or technologies and operating as a development stage company; Ignyta’s ability to develop, complete preclinical studies and clinical trials for, obtain approvals for and commercialize any of its product candidates; changes in Ignyta’s plans to develop and commercialize its product candidates; the potential for the company to fail to maintain the CLIA registration of its diagnostic laboratory or to fail to achieve full CLIA accreditation of such laboratory; Ignyta’s ability to raise any additional funding it will need to continue to pursue its business and product development plans; regulatory developments in the United States and foreign countries; Ignyta’s ability to obtain and maintain intellectual property protection for its product candidates; the risk that orphan drug exclusivity may not be maintained or may not effectively protect a product from competition; the loss of key scientific or management personnel; competition in the industry in which Ignyta operates; and market conditions. These forward-looking statements are made as of the date of this press release, and Ignyta assumes no obligation to update the forward-looking statements, or to update the reasons why actual results could differ from those projected in the forward-looking statements. Investors should consult all of the information set forth herein and should also refer to the risk factor disclosure set forth in the reports and other documents the company files with the SEC available at www.sec.gov, including without limitation Ignyta’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent Quarterly Reports on Form 10-Q.

 

Ignyta, Inc.
Jacob Chacko, M.D.
CFO
858-255-5959
jc@ignyta.com

Wednesday, July 22nd, 2015 Uncategorized Comments Off on (RXDX) Boosts Leadership Capacity with Appointment of Bernard Parker as CCO

(FNJN) Participation in Open Register of Patent Ownership

EAST PALO ALTO, CA–(Jul 22, 2015) – Finjan Holdings, Inc. (NASDAQ: FNJN) a cybersecurity company, today announced its patents have been certified and included as a founding member of the Open Register of Patent Ownership (ORoPO). ORoPO, a voluntary non-profit agency, serves as the world’s first open register of patent ownership offering a simple solution to the long-standing complex issue involving the accuracy of patent ownership. Other ORoPO founding members include leading technology companies IBM, Microsoft, ARM, BAE Systems, Shazam, Patent Properties, and Conversant. They support ORoPO to create an online platform where information about patent holders can be accessed.

“As part of our commitment to Finjan’s Licensing Best Practices, we appreciate the formation of ORoPO and we are pleased to be joining forces with such high caliber partners to initiate the Open Register of Patent Ownership to protect global patents,” commented Julie Mar-Spinola, Finjan’s Chief Intellectual Property Officer and VP, Legal. “Patent transparency remains critical and the voluntary listing through ORoPO will allow its founding members including Finjan to lead by example and help ensure that the patent system runs optimally and continues to promote innovation worldwide.”

According to research done by CIPHER AISTEMOS, a London-based IP business intelligence and strategy company, IP assets now account for up to 70% of enterprise value. Prior to the ORoPO platform, information on who owned the world’s patents was recorded disparately across 160+ patent offices worldwide. ORoPO estimates that 25% of information held in these offices is either out of date, incomplete or inaccurate leading to various challenges for people seeking information about intellectual property assets.

ABOUT OROPO
ORoPO (Open Register of Patent Ownership) was launched in June 2015 by organizations united in a common goal — to achieve greater transparency around patent ownership on a global scale. ORoPO provides an open data register of patents, accessible to all at no cost. For more information, please visit www.oropo.net

ABOUT FINJAN
Created nearly 20 years ago, Finjan is recognized globally as a cybersecurity pioneer and leader. Finjan’s investment in innovation is evidenced by its patent portfolio and focuses on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan’s innovations detect malicious code and protects end users from identity and data theft, spyware, malware, phishing, trojans, and other online threats. To date, Finjan has successfully licensed its intellectual property to major technology companies for more than $150 million. For more information about Finjan, please visit www.finjan.com.

Follow Finjan Holdings, Inc.:
Twitter: @FinjanHoldings
LinkedIn: linkedin.com/company/finjan
Facebook: facebook.com/FinjanHoldings
Finjan Mobile Defense Challenge 2015: contest.finjan.com

Cautionary Note Regarding Forward-Looking Statements
Except for historical information, the matters set forth herein that are forward-looking statements involve certain risks and uncertainties that could cause actual results to differ. Potential risks and uncertainties include, but are not limited to, the outcome of pending or future enforcement actions, our ability to expand our technology portfolio, the enforceability of our patents, the continued use of our technologies in the market, our stock price, changes in the trading market for our securities, regulatory developments, general economic and market conditions, the market acceptance and successful business, technical and economic implementation of Finjan Holdings’ intended plan; and the other risk factors set forth from time to time in our filings with the SEC, including our Annual Report on Form 10-K for the year ended December 31, 2014, and the Company’s periodic filings with the SEC, copies of which are available free of charge at the SEC’s website at www.sec.gov or upon request from Finjan Holdings, Inc. All forward-looking statements herein reflect our opinions only as of the date of this release, and Finjan Holdings undertakes no obligation, and expressly disclaims any obligation, to update forward-looking statements herein in light of new information or future events.

Wednesday, July 22nd, 2015 Uncategorized Comments Off on (FNJN) Participation in Open Register of Patent Ownership

(FCSC) Announces Pricing of Public Offering of Common Stock

EXTON, Pa., July 22, 2015  — Fibrocell Science, Inc., (NASDAQ:FCSC), an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet needs, today announced the pricing of an underwritten public offering of 2.6 million shares of its common stock at a price of $5.80 per share. In addition, Fibrocell has granted the underwriters a 30-day option to purchase up to an additional 0.4 million shares of common stock.

All shares in the offering are being sold by Fibrocell, with expected net proceeds to Fibrocell of approximately $13.6 million, after deducting underwriting discounts and commissions and estimated offering expenses and not including any proceeds to be received by Fibrocell if the underwriters were to exercise the 30-day option. The offering is expected to close on or about July 27, 2015, subject to satisfaction of customary closing conditions.

Fibrocell intends to use the net proceeds of the offering for the continued clinical and preclinical development of its product candidates and for other general corporate purposes.

Wells Fargo Securities, LLC is acting as sole book-running manager and representative of the underwriters for the offering. Roth Capital Partners and Griffin Securities are acting as co-managers for the offering.

The offering is being made by Fibrocell pursuant to a shelf registration statement on Form S-3 previously filed with the Securities and Exchange Commission (SEC), which the SEC declared effective on August 28, 2013. A final prospectus supplement related to the offering will be filed with the SEC and will be available on the website of the SEC at www.sec.gov. Copies of the final prospectus supplement may also be obtained, when available, from Wells Fargo Securities, LLC, Attention: Equity Syndicate Department, 375 Park Avenue, 4th Floor, New York, NY 10152, by email at cmclientsupport@wellsfargo.com, or by calling 1-800-326-5897.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of, these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such state or jurisdiction.

About Fibrocell Science, Inc.

Fibrocell is an autologous cell and gene therapy company focused on developing first-in-class treatments for rare and serious skin and connective tissue diseases with high unmet medical needs. Fibrocell’s most advanced product candidate, azficel-T, uses its proprietary autologous fibroblast technology and is in a Phase II clinical trial for the treatment of chronic dysphonia resulting from vocal cord scarring. In collaboration with Intrexon Corporation, a leader in synthetic biology, Fibrocell is also developing gene therapies for skin diseases using gene-modified autologous fibroblasts. Fibrocell has submitted an IND application to the FDA for FCX-007, its lead orphan gene-therapy product candidate, for the treatment of recessive dystrophic epidermolysis bullosa (RDEB). Fibrocell is in pre-clinical development of FCX-013, its second gene-therapy product candidate, for the treatment of linear scleroderma.

Forward-Looking Statements

This press release contains, and our officers and representatives may from time to time make, statements that are “forward-looking statements” within the meaning of the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements relate to a variety of matters, including, without limitation, Fibrocell’s expectations regarding the completion, timing and size of the proposed public offering, Fibrocell’s anticipated proceeds from the offering and its use of those proceeds and other statements that are not purely statements of historical fact.

These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of Fibrocell’s control. Important factors that could cause our actual results and financial condition to differ materially from those indicated in the forward-looking statements include, among others: varying interpretation of research data; the outcome of regulatory review of the IND; uncertainties relating to the initiation and completion of clinical trials; and whether clinical trial results will validate and support the safety and efficacy of our product candidates, as well as those set forth under the caption “Item 1A. Risk Factors” in Fibrocell’s most recent Form 10-K filing.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. In addition, Fibrocell operates in a highly competitive and rapidly changing environment, and new risks may arise. Accordingly, you should not place any reliance on forward-looking statements as a prediction of actual results. Fibrocell disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statement. You are also urged to carefully review and consider the various disclosures in Fibrocell’s most recent annual report on Form 10-K, our most recent Form 10-Q as well as other public filings with the SEC since the filing of Fibrocell’s most recent annual report.

CONTACT: Investor Contact:
         Karen Casey
         Fibrocell
         Tel: +1 (484) 713-6133
         kcasey@fibrocellscience.com
Wednesday, July 22nd, 2015 Uncategorized Comments Off on (FCSC) Announces Pricing of Public Offering of Common Stock

(VALU) FY Earnings of $0.74 Per Share, up 7.7% from Prior Fiscal Year

Value Line, Inc., (NASDAQ: VALU) reports results for the fiscal year ended April 30, 2015.

During the twelve months ended April 30, 2015, the Company’s net income of $7,292,000, or $0.74 per share, was $524,000 or 7.7% above net income of $6,768,000, or $0.69 per share, for the twelve months ended April 30, 2014. During the twelve months ended April 30, 2015 there were 9,813,623 average common shares outstanding as compared to 9,839,155 average common shares outstanding during the twelve months ended April 30, 2014. Income from operations of $2,399,000 for the twelve months ended April 30, 2015 which included additional depreciation and amortization expense of $630,000 including accelerated amortization of $138,000 related to obsolete software recorded in the fourth quarter of fiscal 2015 was $102,000 below income from operations of $2,501,000 for the twelve months ended April 30, 2014. During the fourth quarter ended April 30, 2015, the Company’s reported loss from operations of $560,000 was the result of 12 weeks of print revenues recorded in the fourth quarter of fiscal 2015 as compared to 13 weeks recorded in the fourth quarter of fiscal 2014, an additional direct marketing campaign in the fourth quarter of fiscal 2015, and the accelerated write-off of obsolete software. Total product line circulation at April 30, 2015 was 5.8% above total product line circulation at April 30, 2014, continuing a positive trend of increased subscribers with the product mix including increased sales of our introductory-level services. The Company has been successful in growing revenues from digitally-delivered investment periodicals within the institutional area and in our consumer-oriented introductory offerings. Institutional Sales total sales orders for the twelve months ended April 30, 2015 were $481,000 or 3.7%, above comparable total sales orders for the twelve months ended April 30, 2014.

Shareholders’ equity of $34,439,000 at April 30, 2015 compares favorably to shareholders’ equity of $33,298,000 at April 30, 2014. As of April 30, 2015, retained earnings and liquid assets were $34,587,000 and $15,506,000, respectively.

The Company recently announced a 6.7% increase in its quarterly dividend from $0.15 per common share to $0.16 per common share and the Board of Directors re-affirmed the Company’s Common Stock Repurchase program.

The Company’s annual report on Form 10-K has been filed with the SEC and is available on the Company’s website at www.valueline.com/About/corporate_filings.aspx. Shareholders may receive a printed copy, free of charge upon request.

Value Line, Inc. is a leading New York based provider of investment research. The Value Line Investment Survey is one of the most widely used sources of independent equity investment research. Value Line also publishes a range of proprietary investment research in both print and digital formats including research in the areas of Mutual Funds, Options and Convertible securities. Value Line’s acclaimed research also enables the Company to provide specialized products such as Value Line Select, Value Line Special Situations, Value Line Select: Dividend Income & Growth, and copyright data, distributed under copyright agreements for fees, including certain proprietary ranking system information and other proprietary information used in third party products. Investment Management services are provided through its substantial non-controlling and non-voting interests in EULAV Asset Management, the investment advisor to The Value Line Family of Mutual Funds. Value Line’s products are available to individual investors by mail, at www.valueline.com or through 1-800-VALUELINE or 1-800-535-9648, while institutional-level services for professional investors, advisers, corporate, academic, municipal and legal libraries are offered at www.ValueLinePro.com and at 1-800-531-1425.

Cautionary Statement Regarding Forward-Looking Information

This report contains statements that are predictive in nature, depend upon or refer to future events or conditions (including certain projections and business trends) accompanied by such phrases as “believe”, “estimate”, “expect”, “anticipate”, “will”, “intend” and other similar or negative expressions, that are “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995, as amended. Actual results for Value Line, Inc. (“Value Line” or “the Company”) may differ materially from those projected as a result of certain risks and uncertainties, including but not limited to the following:

  • maintaining revenue from subscriptions for the Company’s digital and print published products;
  • changes in market and economic conditions, including global financial issues;
  • protection of intellectual property rights;
  • dependence on non-voting revenues and non-voting profits interests in EULAV Asset Management, a Delaware statutory trust (“EAM” or “EAM Trust”), which serves as the investment advisor to the Value Line Funds and engages in related distribution, marketing and administrative services;
  • fluctuations in EAM’s assets under management due to broadly based changes in the values of equity and debt securities, redemptions by investors and other factors, and the effect these changes may have on the valuation of EAM’s intangible assets;
  • dependence on key personnel;
  • competition in the fields of publishing, copyright data and investment management;
  • the impact of government regulation on the Company’s and EAM’s businesses;
  • availability of free or low cost investment data through discount brokers or generally over the internet;
  • terrorist attacks, cyber security attacks and natural disasters;
  • other risks and uncertainties, including but not limited to the risks described in Item 1A, “Risk Factors” of the Company’s Annual Report on Form 10-K for the year ended April 30, 2015; and
  • other risks and uncertainties arising from time to time.

These factors are not necessarily all of the important factors that could cause actual results to differ materially from those expressed in any of our forward-looking statements. Other unknown or unpredictable factors which may involve external factors over which we may have no control or changes in our plans, strategies, objectives, expectations or intentions, which may happen at any time at our discretion, could also have material adverse effects on future results. Except as otherwise required to be disclosed in periodic reports required to be filed by public companies with the SEC pursuant to the SEC’s rules, we have no duty to update these statements, and we undertake no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise. In light of these risks and uncertainties, current plans, anticipated actions, and future financial conditions and results may differ from those expressed in any forward-looking information contained herein.

 

Value Line, Inc.
Howard A. Brecher, (212) 907-1500
www.valueline.com
www.ValueLinePro.com
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Wednesday, July 22nd, 2015 Uncategorized Comments Off on (VALU) FY Earnings of $0.74 Per Share, up 7.7% from Prior Fiscal Year

(BZUN) Signs Cooperation Agreement With Alibaba Group’s Logistics Arm Cainiao

SHANGHAI, China, July 22, 2015  — Baozun Inc. (Nasdaq:BZUN) (“Baozun” or the “Company”), the leading brand e-commerce solutions provider in China, today announced that the Company has signed a cooperation agreement with Alibaba Group Holding Limited’s (“Alibaba”) (NYSE:BABA) logistics arm Cainiao Network Technology Co., Ltd. (“Cainiao”). The agreement is part of the Company’s plan to strengthen its logistics network in southern China by opening its sixth and newest logistics warehouse (“Guangzhou warehouse”) in Guangzhou’s Alibaba Cainiao Logistics Park.

Cainiao was founded in 2013 by Alibaba and a consortium of logistics companies in China. Cainiao operates a proprietary logistics platform that links third-party warehouses and distribution centers with logistics providers in order to enable greater efficiency across the entire delivery process. Cainiao’s platform plugs directly into the back-end of numerous e-commerce platforms, allowing each party to share and integrate confidential information on orders, inventory levels and delivery status.

According to the terms of the agreement, Baozun’s Guangzhou warehouse will sync directly with Cainiao’s platform, allowing the Company to improve the experience for both its brand e-commerce partners and buyers by closely monitoring and improving each step of the fulfillment process.

Mr. Vincent Qiu, Baozun’s CEO, commented, “With the signing of this agreement, we will be able to use Cainiao’s platform to provide our brand partners with better overall e-commerce logistics. By leveraging on our Guangzhou warehouse’s geographical location and Cainiao’s platform, we will be able to reduce transportation costs and inventory levels, shorten delivery times, and increase overall efficiency across southern China. Improving our logistical capabilities through agreements with platforms such as Cainiao’s directly supports our long-term growth by providing our clients with a better overall e-commerce solution.”

Safe Harbor Statements

This news release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates,” “target,” “going forward,” “outlook” and similar statements. Such statements are based upon management’s current expectations and current market and operating conditions, and relate to events that involve known or unknown risks, uncertainties and other factors, all of which are difficult to predict and many of which are beyond the Company’s control, which may cause the Company’s actual results, performance or achievements to differ materially from those in the forward-looking statements. Further information regarding these and other risks, uncertainties or factors is included in the Company’s filings with the U.S. Securities and Exchange Commission. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under law.

About Baozun Inc.

Baozun is the leading brand e-commerce solutions provider in China that helps brand partners execute their e-commerce strategies. The Company’s integrated capabilities encompass all aspects of the e-commerce value chain, covering IT solutions, store operations, digital marketing, customer services, warehousing and fulfillment. With e-commerce in China growing rapidly in both scale and complexity, brands look to Baozun as a trusted partner and rely on its local knowledge and industry expertise to execute their e-commerce strategies.

For more information, please visit http://ir.baozun.com

CONTACT: For investor and media inquiries, please contact:

         Baozun Inc.
         ir@baozun.com

         Christensen
         In China
         Mr. Christian Arnell
         Phone: +86-10-5900-1548
         E-mail: carnell@christensenir.com

         In US
         Ms. Linda Bergkamp
         Phone: +1-480-614-3004
         Email: lbergkamp@ChristensenIR.com
Wednesday, July 22nd, 2015 Uncategorized Comments Off on (BZUN) Signs Cooperation Agreement With Alibaba Group’s Logistics Arm Cainiao

(ADK) Enters Into Agreements for All 40 Facilities; Sublease Remaining Properties

ATLANTA, July 21, 2015  — AdCare Health Systems, Inc. (NYSE MKT: ADK) (NYSE MKT: ADK.PRA), a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term healthcare, today announced that it has reached an important milestone in its strategic transition to a property holding and leasing company. AdCare has entered into agreements for all 40 of its facilities.

  • On July 20, 2015, AdCare signed an agreement to sublease two Georgia facilities to affiliates of Wellington Health Services L.L.C. Affiliates of Wellington currently sublease two of AdCare’s facilities. The sublease agreement for the two additional facilities represents initial year cash rent of $2.0 million, which is subject to an annual escalator of approximately 3%. The initial term of the sublease agreement is ten years with two renewal options, subject to renewal of the master lease under which AdCare leases the facilities. The transfer of operations under the sublease agreement is scheduled to be completed in the third quarter of 2015, subject to the receipt of landlord consent, required licenses and other state regulatory approvals. AdCare expects initial year cash rent, net of initial year cash rent expense, to be approximately $0.2 million.
  • On July 17, 2015, AdCare signed an agreement to sublease one Arkansas facility to an affiliate of Aria Health Group, LLC. Affiliates of Aria currently sublease eight of AdCare’s facilities. The sublease agreement has a seven-year initial term, with a 3% per annum escalator and a five-year renewal option and represents initial year cash rent of $600,000. The transfer of operations under the sublease agreement is scheduled to be completed in the third quarter of 2015, subject to the receipt of required licenses and other state regulatory approvals.

“Today is an important milestone in the Company’s strategic transition. By entering into agreements on these three facilities, we have now executed agreements to lease, manage, or sell all 40 of our facilities,” commented Bill McBride, AdCare’s Chairman and Chief Executive Officer. “Already, 24 facilities have completed the operations transfer to third party operators, with additional facilities scheduled to transition within the next 90 days as other approvals are received.”

“I am encouraged with our progress to date, and as we remain focused on diligently transitioning operations to third party operators, we are simultaneously identifying attractive property acquisition opportunities for growth,” continued Mr. McBride. “We have a growing pipeline that we are actively evaluating to put capital to work and increase shareholder value. Our progress to date gave the Board of Directors confidence to increase the dividend on our common stock by 10%, as we recently announced, reaffirming our commitment to return cash to our shareholders as we execute our business plan.”

Since the Board of Directors approved the strategic plan to transition AdCare’s business from an owner and operator of healthcare facilities to a healthcare property holding and leasing company, AdCare has entered into agreements for all 40 of its healthcare facilities. Of these 40 healthcare facilities:

  • Twenty-seven facilities have transferred operations to third-party operators or are under a management contract with an indefinite term;
  • One facility in Arkansas has been sold;
  • Of the remaining 12 facilities pending transfer:
    • Of the five facilities in Ohio, AdCare has received HUD approval on four, and one facility does not require HUD approval. AdCare expects to transfer operations to a third-party operator for these five facilities on August 1, 2015;
    • The transfer of two facilities in Georgia is expected to occur in the third quarter of 2015, subject to receipt of landlord consent, required licenses and other state regulatory approvals;
    • AdCare expects to transition one facility in Arkansas to a third-party operator in the third quarter of 2015, subject to receipt of required licenses and other state regulatory approvals;
    • AdCare expects to transition two facilities in Oklahoma to a third-party operator during the third quarter of 2015, subject to receipt of required licenses;
    • The transfer of one facility in Georgia is subject to HUD approval and is expected to occur in the third quarter of 2015; and
    • AdCare expects to close the sale of one facility in Oklahoma in the third quarter, subject to certain termination provisions and closing conditions.

About AdCare Health Systems

AdCare Health Systems, Inc. (NYSE MKT: ADK) (NYSE MKT: ADK.PRA) is a self-managed healthcare real estate investment company that invests primarily in real estate purposed for senior living and long-term healthcare through facility lease and sub-lease transactions. The Company currently owns, leases or manages for third parties 39 facilities, primarily in the Southeast. For more information about AdCare, visit www.adcarehealth.com.

Important Cautions Regarding Forward-Looking Statements

Statements contained in this press release that are not historical facts may be forward-looking statements within the meaning of federal law. Such statements can be identified by the use of forward-looking terminology, such as “believes,” “expects,” “plans,” “intends,” “anticipates” and variations of such words or similar expressions, but their absence does not mean that the statement is not forward-looking. Statements in this press release that are forward-looking include, among other things, statements regarding the Company’s transition to a healthcare facilities holding and leasing company, statements regarding the transfer of operations to third party operators, statements regarding acquisition opportunities, and statements regarding any dividend. Such forward-looking statements reflect management’s beliefs and assumptions and are based upon information currently available to management and involve known and unknown risks, results, performance or achievements of AdCare, which may differ materially from those expressed or implied in such statements. Such factors are identified in the public filings made by AdCare with the Securities and Exchange Commission, including AdCare’s Annual Report on Form 10-K for the year ended December 31, 2014. There is no assurance that such factors or other factors will not affect the accuracy of such forward-looking statements. Except where required by law, AdCare undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

References to the consolidated company and its assets and activities, as well as the use of terms such as “we,” “us,” “our,” and similar verbiage, is not meant to imply that AdCare Health Systems, Inc. has direct operating assets, employees or revenue or that any of the facilities, the home health business or other related businesses are operated by the same entity.

Tuesday, July 21st, 2015 Uncategorized Comments Off on (ADK) Enters Into Agreements for All 40 Facilities; Sublease Remaining Properties

(MSON) BoneScalpel™ Workshop Draws More Than 70 Surgeons At IMAST Meeting

FARMINGDALE, N.Y., July 21, 2015  — Misonix, Inc. (NASDAQ: MSON), an international ultrasonic surgical device company that designs, manufactures and markets innovative therapeutic ultrasonic instruments for spine surgery, neurosurgery and other surgical specialties, hosted a successful BoneScalpel Hands-On Workshop during the International Meeting on Advanced Spine Technologies (“IMAST”) in Kuala Lumpur, Malaysia last week.  More than 70 surgeons attended the workshop and were trained on advanced spine surgical techniques utilizing the BoneScalpel.

“We are extremely pleased to see this degree of interest from international spine surgeons.  The key opinion leaders that presented at this year’s workshop focused on the clinical benefits of using the BoneScalpel and prepared the workshop attendees for future use in their own practices.  Training this many surgeons at one event is an exciting way to kick off our new fiscal year,” said Michael A. McManus, Jr., President and Chief Executive Officer of Misonix.

The Ultrasonics in Spine Surgery: BoneScalpel Hands-On Workshop was moderated and facilitated by the following group of leading spine surgeons:

  • Dr. Peter Newton, Rady Children’s Hospital in San Diego, CA;
  • Dr. Juan Uribe, University of South Florida in Tampa, FL; and
  • Dr. Greg Mundis, Scripps Memorial Hospital in La Jolla, CA.

The surgeon presenters discussed their surgical techniques and clinical evidence on the application of the BoneScalpel in Minimally-Invasive Spine Surgery, AIS Posterior Release, Cervical Laminoplasty and other degenerative procedures.

The faculty agreed that the use of the BoneScalpel leads to a safer, more efficient surgical experience with repeatable reduction in blood loss and an increase in the amount of viable autogenous bone graft harvested. Dr. Juan Uribe commented on his experience in adopting the technology, “I was immediately enthused by the added safety offered by the BoneScalpel when cutting bone near the dura and nerves.  In my minimally-invasive, transforaminal lumbar interbody fusion (tlif) procedures, I have achieved surgical efficiencies, safer facectomies, less blood loss and more viable autograft bone.”

Dr. Greg Mundis explained, “Adding the BoneScalpel to my procedures has positively impacted my surgical practice.  For example, when I perform a deformity correction, my patients will now lose less blood, need fewer transfusions and go to the recovery room faster than they had in the past.”

“It was easy to recognize the clinical value that the BoneScalpel brings to spine surgery within the first few cases of using it.  It allows me to remove bone safely and reduce blood loss.  We now use it in every deformity procedure,” concluded Dr. Peter Newton.

The IMAST meeting is a three-day international forum with leading spine surgeons discussing and demonstrating innovative surgical technologies that help improve patient care. This year’s meeting was attended by over 775 delegates.

About Misonix

Misonix, Inc. designs, develops, manufactures and markets therapeutic ultrasonic medical devices. Misonix’s therapeutic ultrasonic platform is the basis for several innovative medical technologies. Addressing a combined market estimated to be in excess of $1.5 billion annually; Misonix’s proprietary ultrasonic medical devices are used for wound debridement, cosmetic surgery, neurosurgery, laparoscopic surgery, and other surgical and medical applications. Additional information is available on the Company’s Web site at www.misonix.com.

Safe Harbor Statement

With the exception of historical information contained in this press release, content herein may contain “forward looking statements” that are made pursuant to the Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and are subject to uncertainty and changes in circumstances. Investors are cautioned that forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from the statements made. These factors include general economic conditions, delays and risks associated with the performance of contracts, risks associated with international sales and currency fluctuations, uncertainties as a result of research and development, acceptable results from clinical studies, including publication of results and patient/procedure data with varying levels of statistical relevancy, risks involved in introducing and marketing new products, potential acquisitions, consumer and industry acceptance, litigation and/or court proceedings, including the timing and monetary requirements of such activities, the timing of finding strategic partners and implementing such relationships, regulatory risks including approval of pending and/or contemplated 510(k) filings, the ability to achieve and maintain profitability in the Company’s business lines, and other factors discussed in the Company’s Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. The Company disclaims any obligation to update its forward-looking relationships.

Corporate Contact Investor Contact
Richard Zaremba Joe Diaz
Chief Financial Officer Lytham Partners
631-694-9555 602-889-9700
invest@misonix.com mson@lythampartners.com
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(SYN) Announces Closing of Recent Equity Offering

ROCKVILLE, Md., July 21, 2015  — Synthetic Biologics, Inc. (NYSE MKT: SYN), a clinical-stage company focused on developing therapeutics to protect the microbiome while targeting pathogen-specific diseases, today announced that it has closed the public offering of 15.3 million shares of common stock, including the fully exercised over-allotment option by the underwriters covering 2.0 million shares, at an offering price of $3.00 per share. The total gross proceeds of the offering, including the exercise in full of the over-allotment option, were approximately $46.0 million. Net proceeds to the Company, after deducting the underwriters’ discount and other estimated expenses, are expected to be approximately $42.6 million.

The Company anticipates using the net proceeds from the offering to fund its clinical programs including Phase 2 clinical candidates, SYN-004 for the prevention of C. difficile and SYN-010 for the treatment of irritable bowel syndrome with constipation (IBS-C), research & development, potential licensing and acquisition of intellectual property, investments in and acquisition of complementary businesses or partnerships, and for general corporate purposes.

William Blair & Company, L.L.C. and RBC Capital Markets, L.L.C. are the joint book-running managers for the offering. BTIG, LLC is serving as co-manager for the offering.

A preliminary prospectus supplement and a final prospectus supplement relating to these securities have been filed with the SEC and are available at the SEC’s website at www.sec.gov. Copies of the preliminary prospectus supplement and the final prospectus supplement may also be obtained from William Blair & Company, L.L.C., Attention: Prospectus Department, 222 West Adams Street, Chicago, Illinois 60606, by telephone at (800) 621-0687, or by email at prospectus@williamblair.com. RBC Capital Markets, L.L.C., Attention: Equity Syndicate, 200 Vesey Street, 8th Floor, New York, NY 10281-8098, or by telephone at (877) 822-4098.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of such jurisdiction.

About Synthetic Biologics, Inc.

Synthetic Biologics, Inc. (NYSE MKT: SYN) is a microbiome-focused, clinical-stage company developing therapeutics to protect the microbiome while targeting pathogen-specific diseases. The Company’s lead candidates in Phase 2 development include SYN-004 which is designed to protect the gut microbiome from the effects of certain commonly used intravenous (IV) antibiotics for the prevention of C. difficile infection and antibiotic-associated diarrhea (AAD), and SYN-010 which is intended to reduce the impact of methane producing organisms in the gut microbiome to treat the underlying cause of irritable bowel syndrome with constipation (IBS-C). In addition, the Company is developing a Phase 2 oral estriol drug for the treatment of relapsing-remitting multiple sclerosis (MS) and cognitive dysfunction in MS, and a monoclonal antibody combination for the treatment of Pertussis. For more information, please visit Synthetic Biologics’ website at www.syntheticbiologics.com.

This release includes forward-looking statements on Synthetic Biologics’ current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and are subject to a number of risks and uncertainties, many of which are difficult to predict and include statements with respect to this offering and the successful execution of the Company’s business strategy, including its intended use of proceeds. The forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those set forth or implied by any forward-looking statements. Important factors that could cause actual results to differ materially from those reflected in Synthetic Biologics’ forward-looking statements include, among others, the additional clinical studies and results not meeting expectations, the inability to commence and complete clinical trials when anticipated and other factors described in Synthetic Biologics’ report on Form 10-K for the year ended December 31, 2014 and any other filings with the SEC. The information in this release is provided only as of the date of this release, and Synthetic Biologics undertakes no obligation to update any forward-looking statements contained in this release on account of new information, future events, or otherwise, except as required by law.

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(CUI) Announces Additional IRIS® Purchase Order

TUALATIN, Ore., July 21, 2015  — CUI Global, Inc. (NASDAQ: CUI) announced today that its wholly-owned UK energy subsidiary, Orbital Gas Systems Ltd., has received approval from one of the UK’s largest pipeline operators to install and commission four of its previously purchased IRIS kiosks. Further, the company has received a purchase order from the same customer for additional IRIS kiosks to be produced at its UK facility for installation and commissioning later this year.

In addition, the company can confirm that several customers have now successfully completed testing of its other proprietary natural gas technologies, the GasPT® Analyzer and VE Technology®, and that it (the company) has received multiple purchase orders for those products.  These purchase orders come from several large energy producers/transporters in various geographic areas, including, but not limited to: a large North American gas transportation and compression company; a Fortune 100 energy company for projects in both Australia and North America; a major European gas transmission company; an Asian gas turbine manufacturer; and others.

CUI Global’s President & CEO, William Clough commented, “The commissioning of the previously purchased IRIS kiosks, along with the ordering of new kiosks demonstrates the efficiencies, control, and other benefits this exciting technology provides to the pipeline operator. This makes us even more confident regarding a larger deployment of the technology in the future. Meanwhile, over the past several months, we are beginning to see many of the tests in which our technologies have participated over the past weeks, months, and, in some cases, years, actually starting to ‘bear fruit’ in the form of purchase orders from some of the industry’s most iconic players.”

“While there is still much work to do, this transition from testing to sales demonstrates the value and viability of our energy technologies and bodes well for the company, its employees, and its shareholders,” Clough concluded.

About CUI Global, Inc.
Delivering Innovative Technologies for an Interconnected World . . . . .

CUI Global, Inc. is a publicly traded company dedicated to maximizing shareholder value through the acquisition and development of innovative companies, products and technologies. From Orbital Gas Systems’ advanced GasPT2 platform targeting the energy sector, to CUI Inc.’s digital power platform serving the networking and telecom space, CUI Global and its subsidiaries have built a diversified portfolio of industry leading technologies that touch many markets. As a publicly traded company, shareholders are able to participate in the opportunities, revenues, and profits generated by the products, technologies, and market channels of CUI Global and its subsidiaries. But most importantly, a commitment to conduct business with a high level of integrity, respect, and philanthropic dedication allows the organization to make a difference in the lives of their customers, employees, investors and global community.

For more information please visit www.cuiglobal.com

About Orbital Gas Systems Ltd.

Orbital Gas Systems Ltd (“Orbital-UK”) is the largest natural gas systems integrator in the United Kingdom. For over 30 years, Orbital-UK has developed its portfolio of products, services and resources to offer a diverse range of personalized gas engineering solutions to the gas utilities, power generation, emissions, manufacturing and automotive industries. Orbital-UK’s internationally recognized expertise in the natural gas industry, including bringing together the patented VE-technology with the ground-breaking GasPTi device, offers natural gas operators and users a comprehensive engineering array for the next generation of energy metering systems. Orbital-UK is a wholly owned subsidiary of CUI Global, Inc.

For more information, please visit www.orbital-uk.com or www.orbitalgassystems.com.

Important Cautions Regarding Forward Looking Statements
This document contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Such statements are subject to risks and uncertainties that could cause actual results to vary materially from those projected in the forward-looking statements. The company may experience significant fluctuations in future operating results due to a number of economic, competitive, and other factors, including, among other things, our reliance on third-party manufacturers and suppliers, government agency budgetary and political constraints, new or increased competition, changes in market demand, and the performance or reliability of our products. These factors and others could cause operating results to vary significantly from those in prior periods, and those projected in forward-looking statements. Additional information with respect to these and other factors, which could materially affect the company and its operations, are included in certain forms the company has filed with the Securities and Exchange Commission.

Tuesday, July 21st, 2015 Uncategorized Comments Off on (CUI) Announces Additional IRIS® Purchase Order

(UEC) Harry Anthony Elected President of Uranium Producers of America

SANTA FE, NM, July 21, 2015  – The Uranium Producers of America (UPA) announced today that Harry Anthony, a senior advisor with Uranium Energy Corp (UEC), has been elected as president of the national organization. The group, founded in 1985, works to promote a sustainable and strong domestic uranium mining and conversion industry by fostering free and fair competition.

Anthony, a resident of Kingsville, Texas, for almost 40 years, is a past Board Member and Chief Operating Officer of UEC, a publicly traded company based in Corpus Christi, Texas. The company is a leader in the field of uranium exploration, development and production. Mr. Anthony, an internationally recognized expert in the uranium industry, has been active in the energy arena for over 45 years and has been a Texas Registered Professional Engineer for over 35 years.

Amir Adnani, President and CEO of Uranium Energy Corp, said, “UEC has garnered tremendous benefit from Harry Anthony’s leadership and experience. With his service to UPA, the entire country will now benefit from his extensive knowledge of the uranium industry. We are pleased  that the UEC team continues to participate at the highest levels of the US uranium industry, including, among other appointments, our Executive VP Scott Melbye having earlier served as president of UPA.”

Prior to joining UEC, Mr. Anthony was a senior officer and director of Uranium Resources Inc.  During his 20-year tenure at URI, he was responsible for all technical aspects of mine development. He has also provided technical consulting services for many international energy production companies and is a sought-after speaker on uranium and related issues, having written and presented numerous reference papers on behalf of leading internationally recognized bodies including the International Atomic Energy Agency.

Mr. Anthony has a Bachelor’s and Master’s degree in Engineering Mechanics from Pennsylvania State University. He is the Past President of the Kingsville Chamber of Commerce, the Kingsville United Way, the Kingsville Rotary Club and the Kingsville Navy League.

Jon Indall, UPA’s Legal Counsel, said, “Harry Anthony is a proven leader in the uranium industry and we are grateful for his extensive experience. He understands that for the United States to become energy independent and for national security reasons, it is vital that domestic uranium serves as a prominent and stable component of our country’s nuclear fuel supply.”

About Uranium Producers of America

The Uranium Producers of America (“UPA”) was founded in 1985 to promote a sustainable and strong domestic uranium mining and conversion industry by fostering free and fair competition while being environmentally sensitive to the communities in which we live and work. UPA believes for the United States to become energy independent and for national security reasons, it is vital that domestic uranium serves as a prominent and stable component of our country’s nuclear fuel supply. Please go to www.theupa.org for more information on Uranium Producers of America.

About Uranium Energy Corp

Uranium Energy Corp is a U.S.-based uranium mining and exploration company. The Company’s fully-licensed Hobson processing plant is central to all of its projects in South Texas, including the Palangana in-situ recovery (ISR) mine, the permitted Goliad ISR project and the development-stage Burke Hollow ISR project. Additionally, the Company controls a pipeline of advanced-stage projects in Arizona, Colorado and Paraguay. The Company’s operations are managed by professionals with a recognized profile for excellence in their industry, a profile based on many decades of hands-on experience in the key facets of uranium exploration, development and mining. Please go to www.uraniumenergy.com for more information on Uranium Energy Corp.

Safe Harbor Statement

Except for the statements of historical fact contained herein, the information presented in this news release constitutes “forward-looking statements” as such term is used in applicable United States and Canadian laws.  Such forward looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements.  Important factors that may cause actual results to differ materially and that could impact the Company and the statements contained in this news release can be found in the Company’s filings with the Securities and Exchange Commission. For forward-looking statements in this news release, the Company claims the protection of the safe harbor for forward-looking statements contained in the Private Securities Litigation Reform Act of 1995. The Company assumes no obligation to update or supplement any forward-looking statements whether as a result of new information, future events or otherwise. This press release shall not constitute an offer to sell or the solicitation of an offer to buy securities.

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(NEOG) Reports Record Revenues And Earnings

LANSING, Mich., July 21, 2015  — Neogen Corporation (NASDAQ: NEOG) announced today that net income for the fourth quarter of its 2015 fiscal year, which ended May 31, increased 25% to $9,384,000, or $0.25 per fully diluted share, from $7,537,000, $0.20 per share, in fiscal 2014.

Neogen’s fourth quarter revenues were $78,611,000, a 17% increase over revenues from 2014’s final quarter. Neogen’s revenues for its 2015 fiscal year increased 14% to $283,074,000, up from $247,405,000 in the company’s previous fiscal year. On an organic basis, growth for the company was 14% for the quarter, and 8% for the full year. Net income for the 2015 fiscal year increased 19% from the previous year to $33,526,000, or $0.90 per share, compared to the prior year’s $0.76 per share. Revenues and net income for the fourth quarter, and the 2015 fiscal year, established new all-time highs for the 33-year-old company.

“We are pleased to report a strong finish to our 2015 fiscal year, and increased momentum as we begin our new fiscal year. In our fourth quarter, we exceeded our goal of producing double-digit organic growth for both our Food and Animal Safety segments,” said James Herbert, Neogen’s chief executive officer and chairman. “Neogen is uniquely positioned to grow and prosper by helping the world’s food producers and processors meet ever-increasing challenges — whether inside the farm gate, or anywhere along the processing and distribution chain.”

The fourth quarter was the 93rd of the past 98 quarters that Neogen reported revenue increases as compared with the previous year — including all consecutive quarters in the last 10 years.

“Neogen’s increasing momentum has been the result of creating and expanding opportunities in our diverse global markets through the introduction of new products and services, and improving our operational capabilities,” said Richard Calk, Neogen’s president and chief operating officer. “For example, with the recent development of our improved ATP hygiene monitor, AccuPoint® Advanced, we significantly upgraded our manufacturing technology and now also have a better product.”

Neogen’s gross margin was 49.4% in its 2015 fiscal year, compared to 49.6% for fiscal 2014. Operating expenses grew by 9% in 2015, less than revenue growth of 14%. Operating income as a percentage of revenues was 18.8% in the current year, as compared to 17.5% in the company’s 2014 fiscal year.

“We were adversely impacted by currency fluctuations in the fiscal year, particularly the second half of the year, as the strength of the U.S. dollar resulted in comparatively lower values for the euro, the British pound, the Brazilian real, and the Mexican peso,” said Steve Quinlan, Neogen’s chief financial officer. “These currency fluctuations negatively impacted both our top and bottom lines in the 2015 fiscal year, making our financial results even more impressive. Neogen experienced a strong year of cash generation, and our inventory control efforts showed progress, as we held inventory levels essentially flat for the year as our revenues increased 14%.”

Revenues for the company’s Food Safety segment increased 13% during the fiscal year compared to the prior year. Sales of Neogen’s general microbiology products increased 40% in fiscal 2015 compared to the prior year, aided in large part by the Oct. 1, 2014 acquisition of BioLumix®. The company believes there is a strong synergistic relationship between the BioLumix and Soleris® test systems, as both systems allow for the accurate detection of spoilage organisms in much less time than traditional microbiology methods. Overall organic growth for the Food Safety segment was 10% for the year.

Sales of Neogen’s rapid tests for food allergens, such as gluten and peanuts, continued their strong performance in the fiscal year, growing approximately 18% compared to the prior year. The growth was aided by increasing global regulatory efforts and consumer demand to ensure products represented as being free of food allergens are correctly labeled. The increase was also due to Neogen’s effective response to the discovery of large-scale contamination of cumin, and other spice blends, with peanut and other known food allergens.

Neogen’s Animal Safety segment reported a revenue increase of 16% in its 2015 fiscal year when compared to 2014. The segment’s comparative increase was aided in part by three acquisitions made in the company’s 2014 fiscal year. Sales of the company’s rodenticides increased more than 20% in the current year compared to the prior year, as Neogen responded to a rodent outbreak in orchard crops throughout the northwest United States, and its products continue to make gains in the important global agricultural rodenticide market.

The Animal Safety segment also recorded a 29% increase in sales of its proprietary D3® detectable veterinary needles compared to the 2014 fiscal year, and a 40% increase in sales of its drug residue tests for the forensic market. Sales of Neogen’s small animal supplements increased 23% in the current year when compared to the prior year, as the company responded to a market need for supplements used for thyroid hormone replacement therapy in dogs.

Revenues from the company’s worldwide veterinary genomic products and services increased approximately 27% in fiscal year 2015 compared to fiscal 2014. This increase resulted from growing acceptance of its proprietary genomic products, especially in Europe, new poultry business, and by the increased operational capacity gained from the move into larger and upgraded facilities early in the company’s 2015 fiscal year.

Revenues from Neogen’s Scotland-based subsidiary increased 11% for the 2015 fiscal year in local currencies, and 9% after converting to U.S. dollars, recording higher sales of mycotoxin test kits, genomics services, and several other key product lines. Neogen Latinoamerica’s sales increased 151%, mainly due to the transfer of Animal Safety customers in Central America, while Neogen do Brasil’s revenues decreased 3%, primarily due to currency translations. Following its Dec. 8, 2014, acquisition of its China-based distributor, Anapure, Neogen recorded a significant increase in sales into China, albeit from a small base. Anapure had been a distributor of Neogen’s food safety products for more than 10 years, and had also offered Neogen’s veterinary genomic services in recent years.

Neogen Corporation develops and markets products dedicated to food and animal safety. The company’s Food Safety Division markets dehydrated culture media and diagnostic test kits to detect foodborne bacteria, natural toxins, food allergens, drug residues, plant diseases and sanitation concerns. Neogen’s Animal Safety Division is a leader in the development of animal genomics along with the manufacturing and distribution of a variety of animal healthcare products, including diagnostics, pharmaceuticals, veterinary instruments, wound care and disinfectants.

Certain portions of this news release that do not relate to historical financial information constitute forward-looking statements. These forward-looking statements are subject to certain risks and uncertainties. Actual future results and trends may differ materially from historical results or those expected depending on a variety of factors listed in Management’s Discussion and Analysis of Financial Condition and Results of Operations in the Company’s most recently filed Form 10-K.

 

NEOGEN CORPORATION UNAUDITED SUMMARIZED CONSOLIDATED OPERATING DATA(In thousands, except for per share and percentages)
         Quarter ended May 31        Year ended May 31
2015 2014 2015 2014
Revenue
Food Safety $    35,595 $    29,872 $   131,479 $  116,290
Animal Safety 43,016 37,390 151,595 131,115
Total revenue 78,611 67,262 283,074 247,405
Cost of sales 40,913 35,224 143,389 124,807
Gross margin 37,698 32,038 139,685 122,598
Operating expenses
Sales & marketing 14,140 12,903 51,757 46,432
Administrative 6,604 6,314 25,233 24,449
Research & development 2,332 1,830 9,577 8,326
Total operating expenses 23,076 21,047 86,567 79,207
Operating income 14,622 10,991 53,118 43,391
Other income (expense) (314) 163 (1,042) (360)
Income before tax 14,308 11,154 52,076 43,031
Income tax 4,875 3,600 18,500 15,000
Net income $      9,433 $      7,554 $    33,576 $    28,031
Net loss (income) attributable
to non-controlling interest
$         (49) $         (17) $         (50) $         127
Net income attributable to Neogen Corp $      9,384 $      7,537 $    33,526 $    28,158
Net income attributable to Neogen Corp
per diluted share $        0.25 $        0.20 $        0.90 $        0.76
Other information:
Shares to calculate per share 37,648 37,326 37,444 37,267
Depreciation & amortization $      2,797 $      2,539 $    10,649 $      9,180
Interest income 70 27 228 115
Gross margin (% of sales) 48.0% 47.6% 49.4% 49.6%
Operating income (% of sales) 18.6% 16.3% 18.8% 17.5%
Revenue increase vs. FY 2014 16.9% 14.4%
Net income vs. FY 2014 24.5% 19.1%

 

NEOGEN CORPORATION SUMMARIZED CONSOLIDATEDBALANCE SHEET DATA

(In thousands)

May 31 May 31
2015 2014
(Unaudited) (Audited)
Assets
Current assets
Cash & investments $    114,164 $    76,496
Accounts receivable 59,208 51,901
Inventory 51,601 51,178
Other current assets 6,222 9,171
Total current assets 231,195 188,746
Property & equipment, net 44,473 41,949
Goodwill & other assets 116,513 114,606
Total assets $    392,181 $  345,301
Liabilities & Equity
Current liabilities $      25,456 $    24,967
Other long-term liabilities 15,762 14,034
Equity: Shares outstanding
37,128 in 2015 & 36,732 in 2014
350,963 306,300
Total liabilities & equity $    392,181 $  345,301

 

CONTACT:  Steven J. Quinlan, Vice President and CFO
517/372-9200
Tuesday, July 21st, 2015 Uncategorized Comments Off on (NEOG) Reports Record Revenues And Earnings

(DSKX) Launches Spectral.Lash In Brazil’s Most Upscale Pharmacy Chain Drogaria Iguatemi

Pompano Beach, Fla., July 20, 2015  — DS Healthcare Group, Inc. (NASDAQ:DSKX), has launched its first campaign for its clinically proven eyelash stimulating product Spectral.Lash in Brazil’s Drogaria Iguatemi, the leading high-end retail drugstore chain in Sao Paulo and Rio de Janeiro, Brazil.

The campaign features Spectral.Lash in floor-to-ceiling displays throughout its premium high-traffic prestigious locations, showcases Spectral.Lash on the cover of its monthly magazine and features the product on the company’s home page. The campaign has marked the launch of the highly anticipated introduction of Spectral.Lash and has set sales records throughout key markets.

“The rollout of Spectral.Lash has blown away our greatest expectations. We believe this product will continue to drive considerable revenue going forward. This product alone could represent as much as 30% of sales in Brazil, given Brazilian’s obsession with their appearance” commented Leonardo Chiacchio CEO of DS Laboratories do Brasil. “We continue to increase our presence throughout Brazil’s leading pharmacy chains and expect to be present in over 1000 locations in the next 12 months” concluded Chiacchio.

Daniel Khesin, President and CEO of DS Healthcare added, “We expect Brazil to represent one of the largest growth drivers for DS Healthcare. With the Brazilian cosmetic market leading second only to the US in size it is an ideal market for our products”.

The Sao Paulo metropolitan area has a population of 20 million, in one of the fastest growing beauty markets in the world. According to a U.S. Department of Commerce report titled, Doing Business in Brazil, “Hair care products make up the largest segment of the Brazilian cosmetics and toiletries market. Shampoo sales, both imported and locally made, constitute about 50 percent of domestic sales; they are divided evenly between Brazilian and well-known multinational suppliers.”

Drogaria Iguatemi is Brazil’s most affluent chain of pharmacies. Selecting to carry only the most important brands in medicine, cosmetics, derma-cosmetics and skin care products in the world. http://www.drogariaiguatemi.com.br

In an independent clinical study, patients using Spectral.Lash, a cutting-edge treatment from DS Laboratories, resulted in 100% of users experiencing 25% thicker eyelashes within four weeks. Spectral.Lash deploys a breakthrough peptide complex, and scientists believe that peptides, composed of structural amino acids, work by stimulating the expression of keratin genes and by improving overall eyelid health. 

About DS Healthcare Group

DS Healthcare Group Inc. leads in the development of biotechnology for topical therapies. It markets through online and specialty retailers, distributors, cosmetics wholesalers, and salons. Its research has led to a highly innovative portfolio of personal care products and additional innovations in pharmaceutical projects. For more information on DS Health Group’s flagship brand, visit www.dslaboratories.com

Forward-looking statements

Except for statements of historical fact, the matters discussed in this press release are forward-looking and made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. “Forward-looking statements” describe future expectations, plans, results, or strategies, and are generally preceded by words such as “future,” “plan” or “planned,” “expects,” or “projected.” These forward-looking statements reflect numerous assumptions and involve a variety of risks and uncertainties, many of which are beyond the company’s control that may cause actual results to differ materially from stated expectations. These risk factors include, among others, limited operating history, difficulty in developing and marketing products, intense competition, and additional risks factors as discussed in reports filed by the company with the Securities and Exchange Commission, which are available at http://www.sec.gov

Abner Silva
DS Healthcare Group
407.342.4112
Abner@DSHealthgroup.com
Monday, July 20th, 2015 Uncategorized Comments Off on (DSKX) Launches Spectral.Lash In Brazil’s Most Upscale Pharmacy Chain Drogaria Iguatemi

(GPRO) Unveils Its Premium Content Licensing Portal

SAN MATEO, Calif., July 20, 2015  — GoPro, Inc. (NASDAQ: GPRO), enabler of some of today’s most engaging content, today announces the next step in rewarding the GoPro creator community with the launch of a premium content licensing portal for global advertising brands and agencies to license premiere video and images. The high-end offering is all about inspiring creative professionals to use beautiful imagery, incredible stories, and rich data created by GoPro and GoPro creators. Above all, it’s yet another way for GoPro to reward its inspirational creator community.

The portal is unique in that it offers high production value content, all accessible from one source. It also eliminates the pain points creative professionals have when sourcing content by helping them clear copyrights and likeness rights, easy access to creators’ content and organized, efficient, time-saving tools to search, download and preview content to license for use in advertising, news and other media and entertainment.

Key features include:

Discovery

  • Content Merchandising – showcasing new and popular content
  • Search & Filtering – enhanced discovery based on rich meta-data
  • Video Previews – at-a-glance video previews

Download

  • Lightbox – video preview sharing tool for creative team members
  • Downloads ability to download low and high resolution file formats with batch download functionality
  • Watermarking – visual watermarks ensure that the use of pre-licensed content is secure

License Request Workflow

  • Licensing – content licensing request workflow
  • Access Control – only approved agencies will be permitted to access and license content
  • Reporting – license request tracking and status reporting

If you are a creative professional and would like to request access, please visit the site to register.

About GoPro, Inc. (NASDAQ:GPRO) GoPro, Inc. is transforming the way people capture and share their lives. What began as an idea to help athletes self-document themselves engaged in their sport has become a widely adopted solution for people to capture themselves engaged in their interests, whatever they may be. From extreme to mainstream, professional to consumer, GoPro enables the world to capture and share its passion. And in turn, the world has helped GoPro become one of the most exciting and aspirational companies of our time.

For more information, visit www.gopro.com or connect with GoPro on YouTubeTwitterFacebookPinterestInstagram, or LinkedIn.

GOPRO® and HERO® are trademarks or registered trademarks of GoPro Inc. in the United States and other countries.

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(BSTC) Approval of XIAFLEX® in Japan for the Treatment of Dupuytren’s Contracture

LYNBROOK, N.Y., July 20, 2015  — BioSpecifics Technologies Corp. (NASDAQ: BSTC), a biopharmaceutical company developing first in class collagenase-based products, announced that Asahi Kasei Pharma Corporation (Asahi Kasei) has received approval for its regulatory application to the Japanese Pharmaceutical and Medical Device Agency (PMDA) for XIAFLEX® (collagenase clostridium histolyticum) for the treatment of patients with Dupuytren’s contracture in Japan. Asahi has the rights to develop and market XIAFLEX in Japan through an agreement with BioSpecifics’ partner Endo International plc (Endo). BioSpecifics will receive a milestone payment upon commercial launch in Japan.

“This approval in Japan marks another milestone in our globalization strategy for XIAFLEX and we look forward to the upcoming commercial launch. We believe Asahi Kasei’s strong development and commercialization organizations will greatly enhance the sales potential of XIAFLEX in this region,” commented Thomas L. Wegman, President of BioSpecifics. “We are very happy that these patients now have a minimally-invasive non-surgical treatment option available to them.”

About Dupuytren’s Contracture

Dupuytren’s contracture is caused by an abnormal accumulation of collagen in the palm of the hand characterized by the formation of nodules or lumps in the early stages. As the disease progresses, a cord is formed and the fingers may become progressively contracted.

About BioSpecifics Technologies Corp.

BioSpecifics Technologies Corp. is a biopharmaceutical company that has developed injectable collagenase for twelve clinical indications to date. Injectable collagenase is approved for marketing as XIAFLEX® (collagenase clostridium histolyticum or CCH) in the U.S. for the treatment of adult Dupuytren’s contracture patients with up to two palpable cords in the same palm and for Peyronie’s disease in men with a palpable plaque and a curvature deformity of 30 degrees or greater at the start of therapy. XIAFLEX is marketed in the U.S. by BioSpecifics’ partner, Endo International plc (Endo), following the acquisition of Auxilium Pharmaceuticals, Inc. by Endo. Endo has the following partnerships outside the U.S. for XIAFLEX in Dupuytren’s contracture and Peyronie’s disease: Swedish Orphan Biovitrum AB has marketing rights for XIAPEX® (the EU tradename for CCH) in 71 Eurasian and African countries, Actelion Pharmaceuticals Ltd. has rights in Canada, Australia, Mexico and Brazil, and Asahi Kasei Pharma Corporation in Japan. CCH is in clinical development for the treatment of several additional promising indications. Endo is managing the clinical development of CCH for frozen shoulder syndrome and cellulite as well as development in canine lipoma. BioSpecifics is currently managing the clinical development of CCH for the treatment of human lipoma and preclinical development for uterine fibroids. For more information, please visit www.biospecifics.com.

Forward-Looking Statements

This release includes “forward-looking statements” within the meaning of, and made pursuant to the safe harbor provisions of, the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact are “forward-looking statements.” The forward-looking statements include statements concerning, among other things, whether BioSpecifics will receive a milestone payment upon commercial launch in Japan and whether and to what extent Asahi Kasei’s development and commercialization organizations will enhance the sales potential of XIAFLEX in Japan. In some cases, these statements can be identified by forward-looking words such as “believe, and whether BioSpecifics “expect,” “anticipate,” “plan,” “estimate,” “likely,” “may,” “will,” “could,” “continue,” “project,” “predict,” “goal,” the negative or plural of these words, and other similar expressions. These forward-looking statements are predictions based on BioSpecifics’ current expectations and its projections about future events. There are a number of important factors that could cause BioSpecifics’ actual results to differ materially from those indicated by such forward-looking statements including, among other things, the ability of Endo and its partners, Asahi Kasei Pharma Corporation, Actelion Pharmaceuticals Ltd. and Swedish Orphan Biovitrum AB, to achieve their objectives for XIAFLEX in their applicable territories; the market for XIAFLEX in, and timing, initiation and outcome of clinical trials for, additional indications including frozen shoulder, cellulite, human lipoma, canine lipoma and uterine fibroids; the potential of CCH to be used in additional indications; Endo modifying their objectives or allocating resources other than to CCH; and other risk factors identified in BioSpecifics’ Quarterly Report on Form 10-Q for the first quarter ended March 31, 2015, its Annual Report on Form 10-K for the year ended December 31, 2014, and its Current Reports on Form 8-K filed with the Securities and Exchange Commission. All forward-looking statements included in this Report are made as of the date hereof, are expressly qualified in their entirety by the cautionary statements included in this Report and, except as may be required by law, the Company assumes no obligation to update these forward-looking statements.

Monday, July 20th, 2015 Uncategorized Comments Off on (BSTC) Approval of XIAFLEX® in Japan for the Treatment of Dupuytren’s Contracture

(SCON) Advances Development With SFCL Customers

Completes Qualification of Conductus Wire for Robinson’s Roebel Cable

AUSTIN, Texas, July 20, 2015  — Superconductor Technologies Inc. (STI) (Nasdaq:SCON), a world leader in the development and production of high temperature superconducting (HTS) materials and associated technologies, achieved positive results with multiple superconducting fault current limiter (SFCL) customers following the Conductus® wire evaluation and testing completed in June and July 2015. The SFCL results demonstrated dramatic improvement compared to tests completed earlier. In addition, STI successfully completed qualification testing with the Robinson Research Institute at Victoria University of Wellington. Conductus wire is now approved for use in making Roebel cable, a winding cable, which is used in high-field magnets, transformers, utility-scale generators and large motors.

“As we rapidly approach final qualification, our customers are quickly providing detailed guidance that we believe will result in Conductus wire soon attaining all of the performance parameters required for SFCLs,” stated Jeff Quiram, STI’s president and chief executive officer. “We believe our SFCL customers have transitioned from a specification driven pass or fail testing methodology to a much more collaborative effort that involves business items such as forecasts, delivery lead times and price. Conductus wire is very close to passing all tests, and we are encouraged by our customers’ confidence that our wire will be qualified in the next few months. In parallel, we have initiated business discussions to ensure product availability matches demand.

“In conjunction with our partner, the Robinson Research Institute, we are engaged with multiple end use customers that plan to deploy Roebel cable in superconducting devices. With the successful qualification of Conductus for use in Robinson’s Roebel cable, we believe we are well positioned to continue to aggressively pursue numerous opportunities in Asia.”

Test Description

SFCL customers require Conductus wire to pass extensive engineering models and electrical testing that simulate characteristics of the wire performance in the SFCL device. The electrical tests replicate the thermal cycling of the superconducting wire in high-current operation. The latest results show that Conductus wire has made significant performance improvements in this area. Customers verified STI’s 550 Amp current handling performance and recognized that the mechanical properties of Conductus provide unsurpassed robustness. The goal of SFCL manufacturers is to standardize on high performance wire that will ensure they have the best in class product to protect the grid in a majority of existing substations.

About Superconductor Technologies Inc. (STI)

Superconductor Technologies Inc. is a global leader in superconducting innovation. Its Conductus® superconducting wire platform offers high performance, cost-effective and scalable superconducting wire. With 100 times the current carrying capacity of conventional copper and aluminum, superconducting wire offers zero resistance with extreme high current density. This provides a significant benefit for electric power transmission and also enables much smaller or more powerful magnets for motors, generators, energy storage and medical equipment. Since 1987, STI has led innovation in HTS materials, developing more than 100 patents as well as proprietary trade secrets and manufacturing expertise. For more than 20 years STI utilized its unique HTS manufacturing process for solutions to maximize capacity utilization and coverage for Tier 1 telecommunications operators. Headquartered in Austin, TX, Superconductor Technologies Inc.’s common stock is listed on the NASDAQ Capital Market under the ticker symbol “SCON.” For more information about STI, please visit http://www.suptech.com.

Safe Harbor Statement 

Statements in this press release regarding our business that are not historical facts are “forward-looking statements” that involve risks and uncertainties. Forward-looking statements are not guarantees of future performance and are inherently subject to uncertainties and other factors, which could cause actual results to differ materially from the forward-looking statements. These factors and uncertainties include, but are not limited to: our limited cash and a history of losses; our need to materially grow our revenues from commercial operations and/or to raise additional capital (which financing may not be available on acceptable terms or at all) in the very near future, before cash reserves are depleted (which reserves are expected to be sufficient into the fourth quarter of 2015), to implement our current business plan and maintain our viability; and the performance and use of our equipment to produce wire in accordance with our timetable; overcoming technical challenges in attaining milestones to develop and manufacture commercial lengths of our HTS wire; the possibility of delays in customer evaluation and acceptance of our HTS wire; the limited number of potential customers; the limited number of suppliers for some of our components and our HTS wire; there being no significant backlog from quarter to quarter; our market being characterized by rapidly advancing technology; the impact of competitive products, technologies and pricing; manufacturing capacity constraints and difficulties; our ability to raise sufficient capital to fund our operations (whether through registered direct offerings or otherwise), and the impact on our strategic wire initiative of any inability to raise such funds; the impact of any financing activity on the level of our stock price, which may decline in connection with the sales under registered direct offerings or otherwise; the dilutive impact of any issuances of securities to raise capital; and local, regional, and national and international economic conditions and events and the impact they may have on us and our customers.

Forward-looking statements can be affected by many other factors, including, those described in the “Business” and “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of STI’s Annual Report on Form 10-K for the year ended December 31, 2014 and in STI’s other public filings. These documents are available online at STI’s website, www.suptech.com, or through the SEC’s website, www.sec.gov. Forward-looking statements are based on information presently available to senior management, and STI has not assumed any duty to update any forward-looking statements.

Investor Relations Contact
Cathy Mattison or Kirsten Chapman
LHA      +1-415-433-3777       invest@suptech.com

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(EXEL) Positive Top-Line Results from METEOR Phase 3 Trial of Cabozantinib

– Study Met Primary Endpoint of Significantly Improving Progression-Free Survival –

– Cabozantinib Reduced the Risk of Disease Progression or Death by 42%; Hazard Ratio = 0.58, (p < 0.0001) Compared to Everolimus –

– Overall Survival Interim Analysis Showed a Trend Favoring Cabozantinib; Hazard Ratio = 0.67, (p = 0.005) Compared to Everolimus –

– Exelixis to Complete U.S. and EU Regulatory Filings in Early 2016 –

– Conference Call at 8:30 AM EDT / 5:30 AM PDT Today –

Exelixis, Inc. (NASDAQ:EXEL) today announced positive top-line results from the primary analysis of METEOR, the phase 3 pivotal trial comparing cabozantinib to everolimus in 658 patients with metastatic renal cell carcinoma (RCC) who have experienced disease progression following treatment with a VEGF receptor tyrosine kinase inhibitor (TKI).

The trial met its primary endpoint of demonstrating a statistically significant increase in progression-free survival (PFS) in the first 375 randomized patients as determined by an independent radiology committee (IRC). Cabozantinib reduced the risk of disease progression or death by 42 percent compared to the everolimus arm (hazard ratio [HR]=0.58, 95 percent CI 0.45-0.75, p<0.0001).

Data pertaining to overall survival (OS) in the entire study population of 658 patients, a secondary endpoint of the trial, were immature at the data cutoff. A prespecified interim analysis, triggered by the primary analysis for PFS, showed a trend in OS favoring cabozantinib (HR = 0.67, unadjusted 95 percent CI 0.51 – 0.89; p=0.005). At the time of the interim analysis, the pre-specified p-value of 0.0019 to achieve statistical significance was not reached. The trial will continue to the final analysis of OS anticipated in 2016.

METEOR’s primary analysis included a review of serious adverse event (SAE) data. Based on this analysis, the frequency of SAEs of any Grade regardless of causality was approximately balanced between study arms. The rate of treatment discontinuation due to adverse events was low (10%) in both study arms.

Detailed results of the trial will be submitted for presentation at an upcoming medical conference.

In April 2015, cabozantinib received Fast Track designation by the U.S. Food and Drug Administration (FDA) for the potential treatment of advanced RCC patients who have received one prior therapy. Based on the outcome of METEOR, Exelixis plans to complete regulatory filings in the United States and European Union in early 2016.

“We are eager to offer new treatment options for patients with metastatic RCC, particularly in the second-line setting where the most commonly utilized therapies have demonstrated a uniformly modest progression-free survival benefit,” said Toni K. Choueiri, M.D., clinical director of the Lank Center for Genitourinary Oncology at Dana-Farber Cancer Institute, and METEOR’s principal investigator. “The magnitude of the improvement in PFS observed with cabozantinib compared to everolimus in the METEOR trial is an exciting and important development — it suggests an opportunity to improve care and outcomes for patients with metastatic RCC.”

“The positive top-line results from METEOR represent strong progress for the kidney cancer community and for Exelixis, bringing us one step closer to our shared goal of delivering a new and meaningfully differentiated therapeutic option for the many metastatic RCC patients in need,” said Michael M. Morrissey, Ph.D., the company’s president and chief executive officer. “With these data now in hand, Exelixis’ highest corporate priority becomes the submission of U.S. and EU regulatory filings, which we intend to complete in early 2016.”

Dr. Morrissey continued, “Delivering these top-line results for METEOR is one of multiple clinical development and regulatory milestones that we have planned for this year. These milestones collectively have the potential to significantly enhance the opportunities before us and bring value to the multiple stakeholders we serve. We look forward to sharing the detailed results of METEOR with the oncology community at an upcoming medical conference, and we thank all of the patients, families, investigators, and clinical staff who made the trial possible.”

Conference Call and Webcast

Exelixis’ management will host a conference call to discuss the METEOR results beginning at 8:30 a.m. EDT/ 5:30 a.m. PDT today, July 20, 2015. To join the call, participants may dial 877-358-0169 (domestic) or 706-679-2029 (international) and provide the conference call passcode 90168151 to join by phone. To listen to a live webcast of the conference call, visit the Event Calendar page under Investors & Media at www.exelixis.com.

An archived replay of the webcast will be available on the Event Calendar page under Investors & Media at www.exelixis.com for at least thirty days. An audio-only phone replay will be available until 11:59 p.m. EDT on July 22, 2015. Access numbers for the phone replay are: 855-859-2056 (domestic) and 404-537-3406 (international); the passcode is 90168151.

About the METEOR Phase 3 Pivotal Trial

METEOR is an open-label, event-driven trial with the primary endpoint of progression-free survival (PFS). The target enrollment for METEOR was 650 patients, and 658 patients were ultimately randomized. The trial was conducted at approximately 200 sites in 26 countries, and enrollment was weighted toward Western Europe, North America, and Australia. Patients were randomized 1:1 to receive 60 mg of cabozantinib daily or 10 mg of everolimus daily, and were stratified based on the number of prior VEGF receptor TKI therapies received, and on commonly applied RCC risk criteria developed by Motzer et al. No cross-over was allowed between the study arms.

The trial protocol specified that the primary analysis of PFS would be conducted among the first 375 patients randomized. This design was employed to ensure sufficient follow up and a PFS profile that would not be primarily weighted toward early events. Such disproportionate weighting of events was a potential risk if the entire study population required for the secondary endpoint analysis of OS had also served as the population for the primary analysis of PFS. The analysis of PFS was event-driven, and was designed to observe 259 events, providing 90% power to detect a HR of 0.67 (assuming a median PFS of 5 months for the everolimus arm and 7.5 months for the cabozantinib arm). Enrollment of the first 375 patients was completed in June 2014 and the median follow-up for these patients was 13.4 months at the time of the data cut off for the primary analysis for PFS.

Secondary endpoints for METEOR include OS and objective response rate. The secondary endpoint of OS assumes a median of 15 months for the everolimus arm and 20 months for the cabozantinib arm. The study was designed to observe 408 deaths in the entire intent-to-treat population of 650 planned patients, providing 80% power to detect a HR of 0.75. An interim analysis of OS at the 2-sided 0.0019 level per the Lan-DeMets O’Brien-Fleming alpha-spending function was planned at the time of the primary analysis for PFS, if the trial met the primary PFS endpoint.

About Metastatic Renal Cell Carcinoma

The American Cancer Society’s 2015 statistics cite kidney cancer as among the top ten most commonly diagnosed forms of cancer among both men and women in the United States.1 Clear cell renal cell carcinoma is the most common type of kidney cancer in adults.2 If detected in its early stages, the five-year survival rate for RCC is high; however, the five-year survival rate for patients with advanced or late-stage metastatic RCC is under 10 percent, with no identified cure for the disease.3

Treatments for metastatic RCC had historically been limited to cytokine therapy (e.g., interleukin-2 and interferon) until the introduction of targeted therapies into the RCC setting a decade ago. In the second and later-line setting, which encompasses approximately 17,000 drug-eligible patients in the U.S. and 37,000 globally,4 two therapies have been approved for the treatment of patients who have received prior VEGF receptor TKIs. However, despite the availability of several therapeutic options, currently approved agents have shown little differentiation in terms of efficacy and have demonstrated only modest PFS benefit in patients refractory to sunitinib, a commonly-used first-line therapy.

The majority of clear cell RCC tumors exhibit down-regulation of von Hippel-Lindau (VHL) protein function, either due to gene inactivation or epigenetic silencing, resulting in a stabilization of the hypoxia-inducible transcription factors (HIFs) and consequent up-regulation of VEGF, MET, and AXL.5 The up-regulation of VEGF may contribute to the angiogenic nature of clear cell RCC, and expression of MET or AXL may be associated with tumor cell viability, a more invasive tumor phenotype, and reduced overall survival. 6 Up-regulation of MET and AXL in clear cell RCC has also been shown to occur in response to treatment with VEGF receptor TKIs in preclinical models, indicating a potential role for MET and AXL in the development of resistance to these therapies.7

About Cabozantinib

Cabozantinib inhibits the activity of tyrosine kinases including MET, VEGF receptors, AXL, and RET. These receptor tyrosine kinases are involved in both normal cellular function and in pathologic processes such as oncogenesis, metastasis, tumor angiogenesis, and maintenance of the tumor microenvironment.

COMETRIQ® (cabozantinib) is currently approved by the U.S. Food and Drug Administration for the treatment of progressive, metastatic medullary thyroid cancer (MTC).

The European Commission granted COMETRIQ conditional approval for the treatment of adult patients with progressive, unresectable locally advanced or metastatic MTC. Similar to another drug approved in this setting, the approved indication states that for patients in whom Rearranged during Transfection (RET) mutation status is not known or is negative, a possible lower benefit should be taken into account before individual treatment decisions.

Important Safety Information, including Boxed WARNINGS

WARNING: PERFORATIONS AND FISTULAS, and HEMORRHAGE

  • Serious and sometimes fatal gastrointestinal perforations and fistulas occur in COMETRIQ-treated patients.
  • Severe and sometimes fatal hemorrhage occurs in COMETRIQ-treated patients.
  • COMETRIQ treatment results in an increase in thrombotic events, such as heart attacks.
  • Wound complications have been reported with COMETRIQ.
  • COMETRIQ treatment results in an increase in hypertension.
  • Osteonecrosis of the jaw has been observed in COMETRIQ-treated patients.
  • Palmar-Plantar Erythrodysesthesia Syndrome (PPES) occurs in patients treated with COMETRIQ.
  • The kidneys can be adversely affected by COMETRIQ. Proteinuria and nephrotic syndrome have been reported in patients receiving COMETRIQ.
  • Reversible Posterior Leukoencephalopathy Syndrome has been observed with COMETRIQ.
  • Avoid administration of COMETRIQ with agents that are strong CYP3A4 inducers or inhibitors.
  • COMETRIQ is not recommended for use in patients with moderate or severe hepatic impairment.
  • COMETRIQ can cause fetal harm when administered to a pregnant woman.

Adverse Reactions – The most commonly reported adverse drug reactions (≥25%) are diarrhea, stomatitis, palmar-plantar erythrodysesthesia syndrome (PPES), decreased weight, decreased appetite, nausea, fatigue, oral pain, hair color changes, dysgeusia, hypertension, abdominal pain, and constipation. The most common laboratory abnormalities (≥25%) are increased AST, increased ALT, lymphopenia, increased alkaline phosphatase, hypocalcemia, neutropenia, thrombocytopenia, hypophosphatemia, and hyperbilirubinemia.

Please see full U.S. prescribing information, including Boxed WARNINGS, at www.COMETRIQ.com/downloads/Cometriq_Full_Prescribing_Information.pdf

Please refer to the full European Summary of Product Characteristics for full European Union prescribing information, including contraindication, special warnings and precautions for use at www.sobi.com once posted.

About Exelixis

Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on COMETRIQ® (cabozantinib), its wholly-owned inhibitor of multiple receptor tyrosine kinases. Another Exelixis-discovered compound, cobimetinib, a selective inhibitor of MEK, is being evaluated by Roche and Genentech (a member of the Roche Group) in a broad development program under a collaboration with Exelixis. For more information, please visit the company’s web site at www.exelixis.com.

Forward-Looking Statement Disclaimer

The statements in this press release that Exelixis plans to complete U.S. and EU regulatory filings in early 2016, that the trial will continue to the final analysis of OS which is anticipated in early 2016, that detailed results of the trial will be submitted for presentation at an upcoming medical conference, that the results of the trial suggest an opportunity to improve care and outcomes for patients with metastatic RCC, regarding the potential that delivering upon top-line results for METEOR and other planned clinical development and regulatory milestones for this year will significantly enhance the opportunities before Exelixis and bring value to the multiple stakeholders Exelixis serves, are forward-looking statements that are subject to risk and uncertainty. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, estimates and projections. Forward-looking statements involve risks and uncertainties. Actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of these risks and uncertainties, which include, without limitation: the clinical, therapeutic and commercial value of cabozantinib; the availability of data at the expected times; risks related to the potential failure of cabozantinib to demonstrate safety and efficacy in clinical study; Exelixis’ ability to conduct clinical trials of cabozantinib sufficient to achieve a positive completion; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; the general sufficiency of Exelixis’ capital and other resources; the uncertain timing and level of expenses associated with the development of cabozantinib; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on April 30, 2015, and in Exelixis’ other filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis, the Exelixis logo, and COMETRIQ are registered U.S. trademarks.

1 Cancer Facts & Figures 2015. American Cancer Society. Available at

http://www.cancer.org/acs/groups/content/@editorial/documents/document/acspc-044552.pdf

2 Jonasch et al., BMJ (2014) vol. 349, g4797.

3 http://www.cancer.org/cancer/kidneycancer/detailedguide/kidney-cancer-adult-survival-rates

4 ACS Cancer Facts and Figures 2015; Heng et al., Ann Oncol (2012) vol. 23 no. 6; internal data on file; Motzer et al., N Engl J Med (2007) vol. 356 no. 2; NCIN (UK) report, April 2014, Available at http://www.ncin.org.uk/view?rid=2676.

5 Harschman and Choueiri, Cancer J. 2013 v19 316-323; Rankin et al., PNAS, 2014.

6 Bommy-Reddi et al., PNAS, 2008; Gibney et al., Ann. Oncol. 2013 v24 343-349; Koochekpour et al., Mol. Cell. Biol. 1999, v19 5902-5912; Rankin et al., PNAS, 2014.

7 Ciamporcero et al., MolCancerTher, 2014; Rankin et al., PNAS, 2014.

 

Investors Contact:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor Relations and Corporate Communications
shubbard@exelixis.com
Media Contact:
For Exelixis, Inc.
Hal Mackins, 415-994-0040
hal@torchcommunications.com

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