Archive for February, 2016

(NNVC) Anti-Virus Technology Published in Handbook of Clinical Nanomedicine

SHELTON, Conn., Feb. 22, 2016  — NanoViricides, Inc. (NYSE MKT: NNVC (the “Company”) announced today that information on its novel, proprietary anti-virus platform technology has been published in the book “Handbook of Clinical Nanomedicine, Vol. 1. Nanoparticles, Imaging, Therapy, and Clinical Applications“, a CRC Press publication. The chapter entitled “Nanoviricides: Targeted Anti-Viral Nanomaterials” provides an in-depth presentation of the NanoViricides platform technology, evidence for how nanoviricides® are believed to act plus dramatic results of nanoviricides specifically targeting certain viral diseases, such as Influenza.

This chapter introduces the novel NanoViricides nanotechnology that possesses potent antiviral efficacy by targeting the mechanisms by which viruses attach or bind to cells.  A nanoviricide is believed to act like a decoy of a human cell. When the virus sees the appropriate mimic of its cell binding site displayed on a nanoviricide, the virus binds to it. The Company believes that the flexible nanoviricide enables cooperative binding of the nanoviricide to additional sites on the virus surface in a velcro-like effect. This maximization of virus binding would lead to the nanoviricide  spreading onto the virus particle, fusing with the virus surface, and then engulfing the virus. In the process, the coat proteins that the virus uses for binding to cells would be expected to become unavailable, and could fall off the virus surface.  This highly targeted attack would lead to the loss of the viral coat proteins and the nanoviricide may further dismantle the engulfed virus capsid.  The loss of virus particle integrity would neutralize the virus, making the virus non-infectious.

The Handbook of Clinical Nanomedicine, Vol. 1. Nanoparticles, Imaging, Therapy, and Clinical Applications, edited by Raj Bawa, PhD, Gerald F. Audette, PhD, and Israel Rubinstein, MD, is the first volume in a two volume set published by CRC Press; it is part of the Pan Stanford Series on Nanomedicine. The publisher states that Volume 1 “provides a comprehensive roadmap of basic research in nanomedicine as well as clinical applications. It not only highlights current advances in diagnostics and therapies but also explores related issues like nomenclature, terminology, historical developments, and regulatory aspects. While bridging the gap between basic biomedical research, engineering, medicine and law, the handbook provides a thorough understanding of nano’s potential to address (i) medical problems from both the patient and health provider’s perspective, and (ii) current applications and their potential in a healthcare setting.” The CRC Press lists the official publication date as February 28, 2016. (https://www.crcpress.com/Handbook-of-Clinical-Nanomedicine-Two-Volume-Set/Bawa-Audette-Rubinstein/9789814316170).

About NanoViricides:
NanoViricides, Inc. (www.nanoviricides.com) is a development stage company that is creating special purpose nanomaterials for antiviral therapy. The Company’s novel nanoviricide® class of drug candidates are designed to specifically attack enveloped virus particles and to dismantle them. The Company is developing drugs against a number of viral diseases including H1N1 swine flu, H5N1 bird flu, seasonal Influenza, HIV, oral and genital Herpes, viral diseases of the eye including EKC and herpes keratitis, Hepatitis C, Rabies, Dengue fever, and Ebola virus, among others.

This press release contains forward-looking statements that reflect the Company’s current expectation regarding future events. Actual events could differ materially and substantially from those projected herein and depend on a number of factors. Certain statements in this release, and other written or oral statements made by NanoViricides, Inc. are “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond the Company’s control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. The Company assumes no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. Important factors that could cause actual results to differ materially from the company’s expectations include, but are not limited to, those factors that are disclosed under the heading “Risk Factors” and elsewhere in documents filed by the company from time to time with the United States Securities and Exchange Commission and other regulatory authorities.  Although it is not possible to predict or identify all such factors, they may include the following: demonstration and proof of principle in pre-clinical trials that a nanoviricide is safe and effective; successful development of our product candidates; our ability to seek and obtain regulatory approvals, including with respect to the indications we are seeking; the successful commercialization of our product candidates; and market acceptance of our products.

Monday, February 22nd, 2016 Uncategorized Comments Off on (NNVC) Anti-Virus Technology Published in Handbook of Clinical Nanomedicine

(OGES) Powered MARTAC Demonstration Huge Success

Palm Bay, Florida, Feb. 22, 2016 — Oakridge Global Energy Solutions, Inc.
Info@oakg.net

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Oakridge Powered MARTAC Demonstration Huge Success

FOR IMMEDIATE RELEASE

http://www.globenewswire.com/NewsRoom/AttachmentNg/02628f31-b17d-4b5f-96c4-7240195dbc23
MANTAS Unmanned Surface Vessel

Oakridge Global Energy Solutions, Inc. (OTCQB: “OGES”) is excited to announce that Maritime Tactical Systems, Inc., MARTAC recently conducted very successful field trials on the Intercoastal waterway in Palm Bay, Florida.  MARTAC is a Melbourne, Florida based company that designs and produces the Man-Portable Tactical Autonomous Systems (MANTAS) that can reach extreme high speeds and operate anywhere in the world.  These vehicles are designed to be used in numerous applications including naval fleet protection, mine warfare, port and harbor security patrol, anti-piracy, search and rescue, and many others.

“The custom battery design for MARTAC was quite challenging while at the same time exciting for our team,” said OGES Executive Chairman and CEO, Steve Barber. “We are pleased to have been a part of this huge success for the MARTAC team and look forward to working with them as we both move forward.  We at Oakridge truly enjoy working with fantastic teams and exciting products, and MARTAC has both.  We congratulate MARTAC on this successful field trial.”

On January 25 through January 28, 2016 MARTAC held field trials for a major defense
contractor utilizing several different sizes of their high speed maritime vessels in the Indian River in Palm Bay, Florida, powered by custom-tailored, high performance, Oakridge batteries, designed and produced by Oakridge specifically for Martac’s application.  These trials were a major success and left all participants exceptionally pleased with the results.

“We were ecstatic with the custom Oakridge Energy Units designed for and utilized on the MANTAS platforms. They have taken our energy requirements and brought them to a whole new level in terms of density, efficiency, reliability and longevity” says MARTAC President/CEO Bruce Hanson.  “Oakridge stepped up to the plate and knocked it out of the park.   They have greatly expanded the effective range of the MANTAS while at the same time providing us a much safer vessel that can be utilized in many environments where present energy technology is not allowed due to safety concerns. This is a winning combo.”

http://www.globenewswire.com/NewsRoom/AttachmentNg/1429f362-0af1-4169-8f6b-8b122727f5a3
OGES Custom Propulsion Energy Units Installed in MANTAS

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of approximately USD $ 200,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakridgeglobalenergy.com

Forward-Looking Statements Disclaimer: This press release 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. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakridgeglobalenergy.com
3520 Dixie Highway
Palm Bay, 32905, Florida, USA
Ph: (321) 610-7959
Email: ir@oakg.net

Investor Inquiries:

Benchmark Advisory Partners LLC
Timothy Connor
Toll Free: (866) 703-4778
admin@bmarkadvisory.com

And:

Dutch DeWaard
Business Development
DreamTeamNetwork (DTN)
Austin, TX
www.DreamTeamNetwork.com
512.758.8877 Office
480.734.5834 Mobile
Dutch@DTN.fm

Monday, February 22nd, 2016 Uncategorized Comments Off on (OGES) Powered MARTAC Demonstration Huge Success

(MENT) Announces Repurchase of Shares from Icahn Group

WILSONVILLE, Ore., Feb. 19, 2016  — Mentor Graphics Corporation (NASDAQ: MENT) today announced that it has entered into an agreement to repurchase 8,060,145 shares of Mentor Graphics common stock beneficially owned by Carl C. Icahn and certain of his affiliates, at a purchase price of $18.12 per share, the NASDAQ official closing price of Mentor Graphics common stock on February 18, 2016.  The total purchase price for the shares will be $146 million and will be funded from Mentor Graphics cash and cash equivalents on hand.  The transaction is expected to be completed on February 26, 2016.

“Our decision to repurchase these shares reflects Mentor’s belief in the value of our industry-leading technologies, new market franchises and strong financial position,” said Walden C. Rhines, chairman and CEO of Mentor Graphics. “These positions provide us with a strong foundation to deliver long-term share value.”

Inclusive of this transaction, since the third quarter of fiscal 2016 earnings release on November 19, 2015, Mentor Graphics has repurchased approximately 12.2 million shares, approximately 10 percent, of our fully diluted shares outstanding.

The repurchase announced today was made outside of Mentor Graphics’ existing share repurchase program and approximately $90 million remains available for repurchase under this program.

The company anticipates announcing financial results for its fiscal year ended January 31, 2016 in early March and will discuss current share count and earnings per share guidance at the time of the earnings release and conference call.

About Mentor Graphics
Mentor Graphics Corporation is a world leader in electronic hardware and software design solutions, providing products, consulting services and award-winning support for the world’s most successful electronic, semiconductor and systems companies. Established in 1981, the company reported revenues for the fiscal year ending January 31, 2015, of approximately $1.2 billion. Corporate headquarters are located at 8005 S.W. Boeckman Road, Wilsonville, Oregon 97070-7777. World Wide Web site: http://www.mentor.com.

(Mentor Graphics is a registered trademark of Mentor Graphics Corporation. All other company or product names are the registered trademarks or trademarks of their respective owners.)

For more information, please contact:
Joe Reinhart
Vice President of Corporate Development and Investor Relations
Mentor Graphics
503-685-1462
joe_reinhart@mentor.com

Friday, February 19th, 2016 Uncategorized Comments Off on (MENT) Announces Repurchase of Shares from Icahn Group

(MCFT) Announces Share Repurchase Activities

VONORE, Tenn., Feb. 19, 2016 — MCBC Holdings, Inc. (NASDAQ:MCFT) “MasterCraft,” the parent of MasterCraft Boat Company, world-renowned designer, manufacturer and marketer of premium performance sport boats, announced today that its Board of Directors has authorized share repurchase activities utilizing a portion of the company’s growing cash balance.

“The Board and senior management strongly believe that MasterCraft’s free cash flow, growth prospects and long-term strategy are not reflected by the company’s current stock price,” said Frederick Brightbill, Chairman of the Board of MasterCraft.

The Board has authorized an up to $15 million stock repurchase program under which the company may repurchase common shares from time to time in open-market purchases, accelerated share repurchase transactions or privately negotiated transactions, in each case subject to market conditions and other factors. The stock buyback program is effective immediately and may be utilized through the end of fiscal year 2017.

Brightbill commented, “MasterCraft has delivered a solid fiscal 2016 first half, and we expect to continue to drive profitable organic growth and generate free cash flow for the remainder of fiscal 2016. Furthermore, we have a strong balance sheet with no outstanding debt and significant liquidity. Therefore, the Board has concluded that a share repurchase program is a prudent use of cash at this time.”

As part of the stock repurchase program, the Board announced that it has authorized the company to purchase 362,094 shares of common stock for an aggregate purchase price of $4.1 million from certain members of the company’s senior management, who are selling the shares to satisfy tax liabilities related to the vesting of restricted stock. As disclosed in the company’s registration statement related to its July 2015 IPO, prior to the IPO certain members of senior management were awarded shares of restricted stock, which vested in January 2016.

Brightbill stated, “We believe this transaction will allow us to retire a significant number of the company’s outstanding shares in a single transaction at an attractive price.” The shares will be purchased at a price of $11.37, which reflects the volume-weighted average price for the five-day trading period ended February 18, 2016. Following the close of the transaction, the company will have approximately 18.6 million fully diluted common shares outstanding. This repurchase will reduce the availability for future purchase under the stock repurchase program to $10.9 million.

“The Board’s decision to authorize the stock repurchase program and purchase of vested shares was made in connection with our regular review of the company’s strategic options,” continued Brightbill. “The actions announced today reflect the Board’s view that the company’s shares are undervalued and do not inhibit our ability to pursue our strategic growth initiatives. As MasterCraft continues to deliver sustainable, profitable revenue and margin growth, we will continue to evaluate the most prudent use of the company’s strong balance sheet and free cash flow with the goal of maximizing long-term shareholder value.”

About MCBC Holdings, Inc.
Headquartered in Vonore, Tenn., MCBC Holdings, Inc. (NASDAQ:MCFT) is the parent of MasterCraft Boat Company, a world-renowned innovator, designer, manufacturer, and marketer of premium performance sport boats. Founded in 1968, MasterCraft has cultivated its iconic brand image through a rich history of industry-leading innovation, and more than four decades after the original MasterCraft made its debut the company’s goal remains the same – to continue building the world’s best ski, wakeboard, wakesurf and luxury performance powerboats. For more information, visit www.mastercraft.com.

Forward-Looking Statements
This press release includes forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995). Forward-looking statements can often be identified by such words and phrases as “believes,” “anticipates,” “expects,” “intends,” “estimates,” “may,” “will,” “should,” “continue” and similar expressions, comparable terminology or the negative thereof, and include statements in this press release concerning our anticipated financial performance for fiscal 2016 and our use of the described share repurchase authority.

Forward-looking statements are subject to risks, uncertainties and other important factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, including general economic conditions, demand for our products, changes in consumer preferences, competition within our industry, our reliance on our network of independent dealers, our ability to manage our manufacturing levels and our large fixed cost base, and the successful introduction of our new products. These and other important factors discussed under the caption “Risk Factors” in our Annual Report on Form 10-K for the fiscal year ended June 30, 2015, filed with the Securities and Exchange Commission (the “SEC”) on September 18, 2015 and our other filings with the SEC could cause actual results to differ materially from those indicated by the forward-looking statements. The discussion of these risks is specifically incorporated by reference into this press release.

Any such forward-looking statements represent management’s estimates as of the date of this press release. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release. We undertake no obligation (and we expressly disclaim any obligation) to update or supplement any forward-looking statements that may become untrue or cause our views to change, whether because of new information, future events, changes in assumptions or otherwise. Comparison of results for current and prior periods are not intended to express any future trends or indications of future performance, unless expressed as such, and should only be viewed as historical data.

CONTACT:
Tim Oxley
Chief Financial Officer
(423) 884-2221
Tim.Oxley@mastercraft.com

Matt Sullivan
(612) 455-1709
Matt.Sullivan@padillacrt.com
Friday, February 19th, 2016 Uncategorized Comments Off on (MCFT) Announces Share Repurchase Activities

(CEMI) Awarded Grant From Paul G. Allen Family Foundation

MEDFORD, N.Y., Feb. 19, 2016  — Chembio Diagnostics, Inc. (Nasdaq:CEMI), a leader in point-of-care (POC) diagnostic tests for infectious diseases, has been awarded a grant from philanthropist and entrepreneur Paul G. Allen to immediately initiate development of simple, cost-effective POC diagnostic tests to identify Zika virus and related febrile illnesses. The grant is managed by Mr. Allen’s company, Vulcan Inc., and the funds come from the Paul G. Allen Family Foundation.

Under the $550,000 catalyst grant, Chembio will use its patented Dual Path Platform (DPP®) technology to develop a stand-alone POC assay to detect Zika virus, and a multiplex POC assay to simultaneously detect Zika, Dengue, and Chikungunya viruses.  In addition, Chembio will add Zika to the POC DPP® Fever Panel that is currently under development through a separate grant from the Paul G. Allen Ebola Program.  Sparked by the global Zika outbreak and Mr. Allen’s rapid response, Chembio is now in discussions with a number of health and government organizations in an effort to secure additional funding to support accelerated product development, as well as clinical trial and regulatory approval for the company’s Zika products.

Chembio has been selected for this grant due to the characteristics of its patented DPP® technology, its track record of rapid development of POC tests for Ebola and other febrile illnesses, and the current collaboration with the Paul G. Allen Ebola Program to develop a DPP® Fever Panel Assay, capable of simultaneously detecting Malaria, Dengue, Chikungunya, Ebola, Lassa, and Marburg with a single drop of blood from the fingertip.

Javan Esfandiari, Chief Science and Technology Officer of Chembio commented, “Chembio’s patented DPP® technology is ideally-suited for the development of these highly-sensitive, specific and affordable point-of-care assays for Zika virus and related febrile illnesses. We are well-positioned to act quickly, given our ongoing collaborations with Centers for Disease Control and Prevention (CDC), Brazil’s Ministry of Health, and the global scientific community. We believe Chembio’s family of DPP® Zika Assays will become important tools in the battle against emerging disease worldwide.”

Dr. Sandra Laney, Deputy Director of Innovation for Vulcan Philanthropy, said, “We are excited to expand our partnership with Chembio to develop the diagnostic tools critically needed for detecting Zika, Ebola and other febrile illnesses. This work is an example of how the lessons from the recent Ebola crisis are sparking innovations in how the global health community tackles outbreaks.”

John Sperzel, Chembio’s Chief Executive Officer, commented, “We are delighted to again partner with the Paul G. Allen Family Foundation and we believe this grant will serve as a catalyst for additional funding to accelerate the development of our POC DPP® Zika assays. It is essential that government, industry, and regulatory agencies work together to address the global health emergencies posed by emerging diseases such as Zika virus. Our success developing the DPP® Ebola and DPP® Malaria-Ebola Assays in 2015, which are currently deployed in West Africa, provides confidence that we can achieve similar success responding to the global need for rapid POC tests to detect Zika virus.”

About Zika Virus

Zika virus is a mosquito-borne virus that was first identified in Uganda in 1947. It is transmitted to humans through the bite of an infected mosquito from the Aedes genus, mainly Aedes aegypti, the same mosquito that transmits dengue, chikungunya and yellow fever. Outbreaks have been recorded in Africa, the Americas, Asia and the Pacific, with symptoms similar to other arbovirus infections such as dengue, and include fever, skin rashes, conjunctivitis, muscle and joint pain, malaise, and headache. During large outbreaks in French Polynesia and Brazil in 2013 and 2015 respectively, national health authorities reported potential neurological and auto-immune complications of Zika virus. Recently, in Brazil, local health authorities have observed an increase in Guillain-Barré syndrome which coincided with Zika virus infections in the general public, as well as an increase in babies born with microcephaly in northeast Brazil. On January 22, 2016, CDC activated its Emergency Operations Center (EOC) to respond to outbreaks of Zika occurring in the Americas and increased reports of birth defects and Guillain-Barré syndrome in areas affected by Zika. On February 1, 2016, the World Health Organization declared a Public Health Emergency of International Concern (PHEIC) because of clusters of microcephaly and other neurological disorders in some areas affected by Zika. On February 8, 2016, CDC elevated its EOC activation to a Level 1, the highest level.

About Chembio Diagnostics

Chembio Diagnostics, Inc. develops, manufactures, licenses and markets proprietary rapid diagnostic tests in the growing $8.0 billion point-of-care testing market. Chembio markets its DPP® HIV 1/2 Assay and HIV 1/2 STAT-PAK® Assay in the U.S. and internationally. The Company’s SURE CHECK® HIV 1/2 Assay is marketed exclusively in the U.S. as Clearview® Complete by a single entity. Outside the U.S., Chembio markets its SURE CHECK® HIV 1/2 Assay primarily through distributors.

Chembio has developed a patented point-of-care (POC) test platform technology, the Dual Path Platform (DPP®) technology, which has significant advantages over lateral-flow technologies. This technology is providing Chembio with a significant pipeline of business opportunities for the development and manufacture of new products.

Headquartered in Medford, NY, Chembio is licensed by the U.S. Food and Drug Administration (FDA) as well as the U.S. Department of Agriculture (USDA), and is certified for the global market under the International Standards Organization (ISO) directive 13485. Chembio Diagnostic Systems, Inc. is a wholly-owned subsidiary of Chembio Diagnostics, Inc. For more information, please visit: www.chembio.com.

Forward-Looking Statements
Statements contained herein that are not historical facts may be forward-looking statements within the meaning of the Securities Act of 1933, as amended. Forward-looking statements include statements regarding the intent, belief or current expectations of the Company and its management. Such statements, which are estimates only, reflect management’s current views, are based on certain assumptions, and involve risks and uncertainties. Actual results, events, or performance may differ materially from the above forward-looking statements due to a number of important factors, and will be dependent upon a variety of factors, including, but not limited to Chembio’s ability to obtain additional financing and to obtain regulatory approvals in a timely manner, as well as the demand for Chembio’s products. Chembio undertakes no obligation to publicly update these forward-looking statements to reflect events or circumstances that occur after the date hereof or to reflect any change in Chembio’s expectations with regard to these forward-looking statements or the occurrence of unanticipated events. Factors that may impact Chembio’s success are more fully disclosed in Chembio’s most recent public filings with the U.S. Securities and Exchange Commission.

CONTACTS:

Chembio Diagnostics
Susan Norcott
(631) 924-1135, ext. 125
snorcott@chembio.com

Vida Strategic Partners (investor relations)
Stephanie C. Diaz
(415) 675-7401
sdiaz@vidasp.com
Friday, February 19th, 2016 Uncategorized Comments Off on (CEMI) Awarded Grant From Paul G. Allen Family Foundation

(LFVN) Announces Intent to Launch Protandim Nrf1 Synergizer Product

Company to expand Protandim product line to include Nrf1 and Nrf2 Synergizer products that work synergistically to naturally reduce cellular stress

SALT LAKE CITY, Feb. 19, 2016  — LifeVantage Corporation (Nasdaq:LFVN), has announced its intent to launch Protandim Nrf1 Synergizer moments ago during its Elite Academy in Nashville, TN. The company intends to host a live cyber-launch in the fourth quarter of fiscal 2016 that will broadcast worldwide through the company’s website.

“We will continue to strategically introduce new products that align with our objective to have a cohesive product offering that is unique and exclusive to LifeVantage, and provides optimal health for everyone,” said LifeVantage President and Chief Executive Officer, Darren Jensen. “The Protandim NFR1 Synergizer is formulated to strengthen the mitochondria, which are the power house of all cells for better cellular health. It is designed to work in tandem with our flagship Protandim Nrf2 Synergizer product and further enhance our body’s ability to naturally produce antioxidants and reduce the effects of cellular stress on its own.” Jensen continues, “Our advances in Nrf1 and Nrf2 Synergizer science continues to position LifeVantage on the leading-edge of Nutrigenomics.”

About LifeVantage Corporation

LifeVantage Corporation (Nasdaq:LFVN), is a science based network marketing company dedicated to visionary science that looks to transform health, wellness and anti-aging internally and externally at the cellular level. The company is the maker of Protandim®, the Nrf2 Synergizer® patented dietary supplement, the TrueScience™ Anti-Aging Skin Care Regimen, Canine Health, the AXIO™ energy product line and the PhysIQ™ smart weight management system. LifeVantage was founded in 2003 and is headquartered in Salt Lake City, Utah.

Forward Looking Statements

This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believe”, “hopes”, “intends”, “estimates”, “expects”, “projects”, “plans”, “anticipates”, “look forward to”, “goal”, “ideal fit”, and variations thereof, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements we make regarding our leadership in the global market, future growth and financial performance. Such forward-looking statements are not guarantees of performance and the Company’s actual results could differ materially from those contained in such statements. These forward-looking statements are based on the Company’s current expectations and beliefs concerning future events affecting the Company and involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein. These risks and uncertainties include, among others, those discussed in greater detail in the Company’s Annual Report on Form 10-K and the Company’s Quarterly Report on Form 10-Q under the caption “Risk Factors,” and in other documents filed by the Company from time to time with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this document, except as required by law.

 

Company Relations Contact: 
John Genna (801) 432-9172
Vice President of Communications 
& Corporate Partnerships

Investor Relations Contact:
Cindy England (801) 432-9036
Director of Investor Relations
-or-
John Mills (646) 277-1254
Partner, ICR INC
-or-
Scott Van Winkle (617) 956-6736
Managing Director, ICR INC
Friday, February 19th, 2016 Uncategorized Comments Off on (LFVN) Announces Intent to Launch Protandim Nrf1 Synergizer Product

(TTPH) to Host Conference Call on February 23

WATERTOWN, Mass., Feb. 19, 2016  — Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced that company management will report fourth quarter and full year financial results after the close of U.S. financial markets on February 23, 2016, and will host a conference call on Tuesday, February 23 at 4:30 p.m. Eastern Time to discuss the financial results and provide a corporate update.

The call can be accessed by dialing (844) 831-4023 (U.S. and Canada) or (731) 256-5215 (international) and entering passcode 55430612. To access the live audio webcast, or the subsequent archived recording, visit the “Investor Relations — Events & Presentations” section of the Tetraphase website at www.tphase.com. The webcast will be recorded and available for replay on the Tetraphase website for 30 days following the call.

About Tetraphase Pharmaceuticals, Inc.
Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening MDR bacterial infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the CDC. Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Tetraphase’s pipeline includes three antibiotic candidates: eravacycline, its late-stage clinical candidate, TP-271 and TP-6076. Please visit www.tphase.com for more company information.

Investor Contacts:
Tetraphase Pharmaceuticals
Teri Dahlman
617-600-7040
tdahlman@tphase.com

Argot Partners
Argot Partners
Susan Kim
212-600-1902
susan@argotpartners.com

Media Contact:
Sam Brown Inc.
Mike Beyer 
312-961-2502
mikebeyer@sambrown.com
Friday, February 19th, 2016 Uncategorized Comments Off on (TTPH) to Host Conference Call on February 23

(FSAM) Announces Agreement with RiverNorth Capital Management

FSC Plans to Repurchase at Least $50 Million of Common Stock by the End of 2016

GREENWICH, CT, Feb. 19, 2016  — Fifth Street Finance Corp. (NASDAQ:FSC) (“FSC” or the “Company”) today announced that it has entered into an agreement with RiverNorth Capital Management, LLC (“RiverNorth”), which, including its director nominees, is the beneficial owner of approximately 8.7% of FSC’s common stock.  Under the terms of the agreement, RiverNorth will not contest FSC’s slate of director nominees at the 2016 Annual Meeting of Stockholders.  Additionally, RiverNorth has agreed to withdraw its binding proposal to terminate FSC’s Investment Advisory Agreement with Fifth Street Management LLC, which is partially and indirectly owned by Fifth Street Asset Management Inc. (NASDAQ:FSAM) (“FSAM”).

“We are pleased that this matter has been resolved in a manner that serves the best interests of all FSC stockholders and avoids a costly and time-consuming proxy contest,” said Todd G. Owens, Chief Executive Officer of FSC, adding, “We continue to appreciate the input of our stockholders and plan to repurchase at least $50 million of FSC common stock during 2016.  The buyback, coupled with our previously announced reduction in the base management fee, are important steps to enhance value for all stockholders.”

As part of FSC’s previously announced $100 million stock repurchase authorization, FSC today announced plans to repurchase $25 million of its common stock beginning as soon as practicable, and plans to repurchase an additional $25 million of its common stock, for a total of at least $50 million, by the end of calendar 2016.

“We are pleased to have constructively engaged with the Board and management team at FSC to reach this agreement,” said Patrick Galley, Chief Investment Officer of RiverNorth, adding, “We are encouraged by the steps the Company has taken to improve its fee structure as well as its commitment to execute against its share repurchase program.  We view these shareholder-friendly actions as positive developments for all FSC stockholders.”

In a separate agreement also announced today, RiverNorth, including its director nominees, will sell its holdings of FSC common stock to a combination of an affiliate of FSAM and FSAM’s Chairman and Chief Executive Officer, Leonard M. Tannenbaum.  In addition, an affiliate of FSAM has agreed to settle the FSC common stock swap arrangements held by RiverNorth.  Further, RiverNorth has agreed to abide by certain standstill provisions through FSC’s 2017 Annual Meeting of Stockholders.

About Fifth Street Finance Corp.

Fifth Street Finance Corp. is a leading specialty finance company that provides custom-tailored financing solutions to small and mid-sized companies, primarily in connection with investments by private equity sponsors.  The company originates and invests in one-stop financings, first lien, second lien, mezzanine debt and equity co-investments.  FSC’s investment objective is to maximize its portfolio’s total return by generating current income from its debt investments and capital appreciation from its equity investments. The company has elected to be regulated as a business development company and is externally managed by a subsidiary of Fifth Street Asset Management Inc. (NASDAQ:FSAM), a nationally recognized credit-focused asset manager with over $5 billion in assets under management across multiple public and private vehicles.  With a track record of over 17 years, Fifth Street’s platform has the ability to hold loans up to $250 million and structure and syndicate transactions up to $500 million.  Fifth Street received the 2015 ACG New York Champion’s Award for “Lender Firm of the Year,” and other previously received accolades include the ACG New York Champion’s Award for “Senior Lender Firm of the Year,” “Lender Firm of the Year” by The M&A Advisor and “Lender of the Year” by Mergers & Acquisitions.  FSC’s website can be found at fsc.fifthstreetfinance.com.

Forward-Looking Statements

This press release may contain, and certain oral statements made by our representatives from time to time may contain, forward-looking statements, including statements with regard to the future performance of FSC and actions by FSC and third parties.  Words such as “believes,” “expects,” “estimates,” “projects,” “anticipates,” “intends,” “plans,” and “future” or similar expressions are intended to identify forward-looking statements.  These forward-looking statements are subject to the inherent uncertainties in predicting future results and conditions.  Certain factors could cause actual results to differ materially from those projected in these forward-looking statements, and these factors are identified from time to time in FSC’s filings with the Securities and Exchange Commission (“SEC”).  FSC common stock repurchases are planned to be made during calendar 2016 through open market, privately negotiated transactions or otherwise at times, and in such aggregate amounts, as FSC management deems appropriate, subject to various factors, including company performance, capital availability, liquidity, general economic and market conditions, regulatory requirements and other considerations, as determined by FSC management from time to time.  FSC undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

Participants in the Solicitation

FSC, its directors and certain of its executive officers and employees, and the executive officers and employees of each of Fifth Street Management LLC and FSAM that provide services to FSC and its subsidiaries pursuant to the Amended and Restated Investment Advisory Agreement, may be deemed to be participants in the solicitation of proxies from stockholders in connection with FSC’s 2016 Annual Meeting of Stockholders (the “2016 Annual Meeting”).

Additional Information and Where to Find It

FSC plans to file a definitive proxy statement with the SEC in connection with the solicitation of proxies for the 2016 Annual Meeting (the “2016 Proxy Statement”). Additional information regarding the identity of these potential participants, none of whom owns in excess of 2% of the shares of FSC common stock (other than Leonard M. Tannenbaum, the Chairman and Chief Executive Officer of FSAM, who (i) beneficially owns approximately 8.5% of the shares of FSC common stock and (ii) has an obligation to purchase, together with an affiliate of FSAM, an additional approximately 6.1% of the shares of FSC common stock currently beneficially owned by RiverNorth Capital Management, LLC and certain of its investment funds and its former director nominees, in each case, based upon 150,262,924 shares of FSC common stock outstanding, as of February 8, 2016, the total number of shares of FSC common stock outstanding as reported in FSC’s Quarterly Report on Form 10-Q for the quarter ended December 31, 2015), and their direct or indirect interests, by security holdings or otherwise, will be set forth in the 2016 Proxy Statement and other materials to be filed with the SEC in connection with the 2016 Annual Meeting. This information can also be found in (i) FSC’s definitive proxy statement for its 2015 Annual Meeting of Stockholders (the “2015 Proxy Statement”), filed with the SEC on February 5, 2015, (ii) FSC’s Annual Report on Form 10-K for the year ended September 30, 2015, filed with the SEC on December 1, 2015 (the “Form 10-K”), (iii) FSAM’s definitive proxy statement for its 2015 Annual Meeting of Stockholders (the “FSAM 2015 Proxy Statement”), filed with the SEC on April 21, 2015, and (iv) FSAM’s Annual Report on Form 10-K for the year ended December 31, 2014, filed with the SEC on March 30, 2015 (the “FSAM Form 10-K”).  To the extent holdings by these potential participants of the shares of FSC common stock have changed since the amounts printed in the 2015 Proxy Statement, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC.

STOCKHOLDERS ARE URGED TO READ THE 2016 PROXY STATEMENT (INCLUDING ANY AMENDMENTS OR SUPPLEMENTS THERETO), THE 2015 PROXY STATEMENT, THE FORM 10-K, THE FSAM 2015 PROXY STATEMENT, THE FSAM FORM 10-K AND ANY OTHER RELEVANT DOCUMENTS THAT FSC OR FSAM HAS FILED OR WILL FILE WITH THE SEC BECAUSE THEY CONTAIN IMPORTANT INFORMATION.

Stockholders will be able to obtain, free of charge, copies of the 2016 Proxy Statement (when available), the 2015 Proxy Statement, the Form 10-K and any other documents filed or to be filed by FSC with the SEC in connection with the 2016 Annual Meeting at the SEC’s website (http://www.sec.gov) or at FSC’s website (http://fsc.fifthstreetfinance.com) or by writing to FSC’s Secretary at 777 West Putnam Avenue, 3rd Floor, Greenwich, Connecticut 06830.  No information contained on any website referenced in this press release is incorporated by reference herein.

CONTACT:

Investor Contact:
Robyn Friedman, Senior Vice President, Head of Investor Relations
(203) 681-3720
ir@fifthstreetfinance.com

Media Contact:
Michael Freitag / James Golden / Andrew Squire
Joele Frank Wilkinson Brimmer Katcher
(212) 355-4449
Friday, February 19th, 2016 Uncategorized Comments Off on (FSAM) Announces Agreement with RiverNorth Capital Management

(STB) Awarded Additional Contracts in Greater Los Angeles Area

Customer Service, Safety and Alternative Fueled Vehicles Key

WALL, N.J., Feb. 18, 2016  — Student Transportation Inc. (STI) (TSX:STB) (NASDAQ:STB), the largest independent provider of student transportation and management services in North America, today announced that its subsidiary, Student Transportation of America, Inc. (STA), has been selected and awarded new contracts, that will add approximately $10.5 million in annual revenue to its existing base of operations, to provide new transportation services in the greater Los Angeles area.

The Los Angeles Unified School District (LAUSD), the second largest school district in the U.S., awarded STA a five-year contract beginning July 1, 2016 with a renewal option for additional new routes that are being added to the LAUSD transportation system. This contract features a fleet of 68 new clean-burning, propane powered, wheelchair lift equipped buses that will operate from a new location to be located within the LAUSD boundaries. STA currently operates over 230 vehicles under various long term contracts with LAUSD and the new routes will add to the regional density the company has built for many school district customers it serves in southern California.

“LAUSD was asking for new, specialized equipment for added service requirements. We have an excellent relationship with them so it was great to be chosen for the new contract. We were able to secure pricing above our existing rates, which is a good sign, and also will look to see about locking in fuel at the current low rates,” stated Don Kissell, Senior Vice President of Operations for STA in the Western Region. “The district will take advantage of all that STA has to offer including our focus on safety, exceptional customer service, advanced technology and alternative fueled vehicles. Our folks are always excited to expand and grow here. We have built a tremendous reputation for the company here.”

In addition to being awarded the LAUSD contract, STA has been selected to provide services to North Los Angeles County Regional Center (NLACRC) with 38 routes beginning July 1, 2016 for a five-year contract period. NLACRC is one of 21 private, non-profit organizations under contract with the California Department of Developmental Services (DDS) to coordinate and provide community-based services to persons with developmental disabilities in the Antelope Valley communities of Palmdale and Lancaster. STA will be transporting those passengers to various sites in the area. The contract provides for year round service versus the company’s normal school year contract.

STA was also chosen as the transportation provider for a unique three and a half year contract with the Porter Ranch community near Los Angeles with service having commenced on January 12, 2016. This special contract came about as a result of the national news story regarding a leaking underground natural gas well in Porter Ranch with residents having to be relocated and two LAUSD schools closed due to respiratory health concerns. In mid-December, LAUSD put out a rapid emergency procurement request for buses to transport students from Porter Ranch to schools in other areas. The local STA team rose to the occasion and offered 8 buses immediately to help and were chosen a week later for the multi-year contract.

“We continue to be committed to our communities and helping where and when we can. We have been expanding our North American footprint on a targeted and strategic basis and look forward to working with all of these customers to provide safe, reliable service,” added Kissell.

To learn more about Student Transportation Inc., please visit www.RideSTBus.com.

About Student Transportation Inc.

Founded in 1997, Student Transportation Inc. (STI) is North America’s largest independent and most trusted provider of student transportation solutions, operating nearly 13,000 vehicles. STI’s family of local companies delivers safe, reliable and cost-effective transportation, management, logistics and technology solutions to a wide range of customers throughout the U.S. and Canada. Services are delivered by drivers, dispatchers, maintenance technicians, terminal managers, information technology professionals and others, who are caring members of their local communities. For more information, please visit www.RideSTBus.com.

 

Company contact:
Doug Coupe
Director of Communications & Investor Relations 
(843) 884-2720
dcoupe@ridesta.com

Investor Relations contact:
The Equity Group Inc.
Fred Buonocore 
(212) 836-9607/fbuonocore@equityny.com 
Alex Kovtun
(212) 836-9620/akovtun@equityny.com
Thursday, February 18th, 2016 Uncategorized Comments Off on (STB) Awarded Additional Contracts in Greater Los Angeles Area

(ERW) The Janus Equal Risk Weighted Large Cap ETF Portfolio Liquidates

OKLAHOMA CITY, Feb. 18, 2016  — Effective at the close of business on February 17, 2016, the Janus Equal Risk Weighted Large Cap ETF (NASDAQ: ERW) portfolio was liquidated and will no longer be tracking its Index, the Janus Equal Risk Weighted Large Cap Index. As a result of the liquidation, the NAV now represents a 100% cash position and an intraday portfolio value will no longer be calculated or disseminated. The NAV may be found here.

The Fund will stop trading on the NASDAQ as of the close of business on Wednesday, February 24.

Whether shares are sold or are automatically redeemed, they will generally recognize a capital gain (or loss) equal to the amount received for shares above (or below) an adjusted cost basis in such shares.

For additional information, please call 877-583-5624 or visit https://www.janus.com/advisor/exchange-traded-funds/janus-equal-risk-weighted-large-cap-etf.

Thursday, February 18th, 2016 Uncategorized Comments Off on (ERW) The Janus Equal Risk Weighted Large Cap ETF Portfolio Liquidates

(COYN) to Present at the SeeThruEquity & The Brewer Group 2nd Annual

DALLAS, TX / February 18, 2016 / COPsync, Inc. (NASDAQ: COYN), which operates the nation’s only law enforcement in-car information sharing and communication network, today announced that the Company will be presenting at the 2nd Annual Innovations Investor Conference in Miami, FL on Monday, February 22, 2016 at the Ritz-Carlton South Beach, presented by SeeThruEquity and The Brewer Group. Please click here for a list of presenting companies.

Ron Woessner, CEO of COPsync, will give a 30-minute presentation about the company and its solutions, and will schedule one-on-one meetings with current and future investors. “The Company’s COPsync Network helps keep law enforcement officers safer and gives them 21st-century tools to help them catch terrorists, cop killers, smugglers, kidnappers and others that pose a threat. Our COPsync911 companion service connects schools, government buildings, energy centers, hospitals and other potentially at-risk facilities directly to the closest patrol officers, regardless of agency jurisdiction, and provides the first responders up-to-the-second situational information through the on-line portal feature. My presentation at the conference will discuss how these services, both provided via a SaaS business model, offer a unique and potentially lucrative investment opportunity.”

Conference registration: complimentary for qualified investors and equity research analysts.
In order to register as an attendee of the conference, please click HERE.

About SeeThruEquity

Since the company’s founding in 2011, SeeThruEquity (STE) has been committed to its core mission: providing impactful, high-quality research on uncovered and undercovered microcap stocks and hosting investor conferences throughout the year. STE has been able to grow its research universe to over 176 names.

STE conferences are the ultimate event for publicly traded companies with less than $1 billion in market capitalization because it augments the conference experience with the firm’s research which is part of Wall Street consensus and available across industry-leading platforms including Thomson First Call, FactSet, S&P CapitalIQ, Yahoo! Finance and Bloomberg to name a select few. STE has hosted 20 investor conferences which have showcased over 350 companies, attracted over 4500 attendees and have included over 1,700 1-on-1 meetings.

For more information, please visit www.steconference.com.

About The Brewer Group

The Brewer Group, Inc. (TBG) is an industry agnostic investment and consulting company with assets ranging numerous sectors. TBG’s relationships with key international decision makers spanning government development agencies, financial institutions, multinational corporations, NGOs and numerous leaders in sports and entertainment place TBG in a unique position to grow its portfolio. TBG takes pride in identifying companies whose goal is to make a social impact on the communities in which they serve. For further information, please visit www.thebrewergroup.com.

About COPsync

COPsync, Inc. (COYN) is a technology company that improves communication between and among law enforcement officers and agencies from differing jurisdictions to help them prevent and respond more quickly to crime. The COPsync Network™ connects law enforcement officers and agencies to a common communications system, which gives officers instant access to actionable, mission-critical data and enables them to share information and communicate in real-time with other officers and agencies, even those hundreds and thousands of miles away. The Network’s companion, COPsync911™ threat-alert system, enables schools, courts, hospitals, government buildings, energy, telecommunications and other potentially at-risk facilities to automatically and silently send threat-alerts directly to local law enforcement officers in their patrol cars in the event of a crisis, thereby speeding first responder response times and saving minutes when seconds count. The COPsync Network saves officer and citizen lives, reduces unsolved crimes and assists in apprehending criminals and interdicting criminal behavior — through such features as a nationwide officer safety alert system, GPS/auto vehicle location and distance-based alerts for crimes in progress, such as school crisis situations, child abductions, bank robberies and police pursuits. The COPsync Network also eliminates manual processes and increases officer productivity by enabling officers to write electronic tickets, accident reports, DUI forms, arrest forms and incident and offense reports. The company also sells VidTac®, an in-vehicle, software-driven video system for law enforcement. Visit www.copsync.com and www.copsync911.com for more information.

Contact:

For COPsync:
Ronald A. Woessner
Chief Executive Officer
972-865-6192
invest@copsync.com

Media:
Fred Sommer
Senior Consultant
Investor Relations
Ascendant Partners, LLC.
732-410-9810
fred@ascendantpartnersllc.com

Thursday, February 18th, 2016 Uncategorized Comments Off on (COYN) to Present at the SeeThruEquity & The Brewer Group 2nd Annual

(OUTR) Engaged Capital Sends Letter to Outerwall Board Outlining Immediate Strategy

  • Believe OUTR’s underperformance and current depressed valuation is a direct result of the Board’s failed strategies, flawed capital allocation policies, and misaligned governance.
  • Encourages shareholders to voice their concern directly to the Board.

Engaged Capital, LLC (together with its affiliates, “Engaged Capital”), an investment firm specializing in enhancing the value of small and mid-cap North American equities, and a 14.6% shareholder of Outerwall Inc. (“OUTR” or the “Company”) (NASDAQ:OUTR), announced today that it has delivered a letter and presentation to the Board of Directors (the “Board”) of OUTR. The letter and presentation outline Engaged Capital’s concerns regarding the governance and management of the Company’s assets and recommends a series of actions aimed at creating significant, and lasting, shareholder value.

In the letter, Engaged Capital asserts its belief that OUTR’s underperformance and current depressed valuation is a direct result of the Board’s failed strategies, flawed capital allocation policies, and misaligned governance. Over the last four years, OUTR’s Board has squandered approximately $1.2 billion of shareholder capital, a staggering sum representing approximately 2.5x the Company’s current market value.

In addition, Engaged Capital believes that on at least three occasions in the last year the Board refused to engage with potential acquirers by either insisting the Company was not for sale or simply failing to respond at all to the interested party. If true, these actions represent a dereliction of the Board’s fiduciary duty to shareholders as the pecuniary interests of individual directors and management appear to have been placed above that of the Company’s shareholders. The Board’s interests are clearly misaligned with shareholders as evidenced by the miniscule collective ownership position of OUTR’s independent directors (less than 0.3% of shares outstanding).

Engaged Capital believes there is a path to create immediate and sustainable value for all OUTR shareholders, and that the fix is largely under the Board and management’s control. Due to Chairman Nelson Chan’s refusal to meet with Engaged Capital in a timely fashion, Engaged Capital felt it was necessary to share its views more broadly to encourage swift action by the Board. Specifically, Engaged Capital recommends the Company:

  • Cease all growth investments;
  • Aggressively manage both Redbox and Coinstar for cash;
  • Sell or shut down the ecoATM business;
  • Halt the Company’s share repurchase program;
  • Use the majority of free cash flow to pay a large annual dividend (ie. a $125 million annual dividend which equates to a 25% yield at current prices) and reduce debt; and
  • Immediately retain financial advisors and begin a sales process with the goal of taking OUTR private.

Engaged Capital strongly encourages OUTR’s shareholders to directly contact Mr. Chan, as well as the other directors, and insist the Board of OUTR immediately take the steps outlined in the letter and presentation available at the link below. Engaged Capital will remain vigilant in ensuring the Company enacts these recommendations and will not hesitate to use every method available to shareholders to hold the Board accountable, including nominating new directors at the 2016 annual meeting in June.

The full text of the letter and presentation can be found here:
Letter: http://engagedcapital.com/press/OUTR-BOD-letter.pdf
Presentation: http://engagedcapital.com/press/OUTR-presentation.pdf

About Engaged Capital:

Engaged Capital, LLC (“Engaged Capital”) was established in 2012 by a group of professionals with significant experience in activist investing in North America and was seeded by Grosvenor Capital Management, L.P., one of the oldest and largest global alternative investment managers. Engaged Capital is a limited liability company owned by its principals and formed to create long-term shareholder value by bringing an owner’s perspective to the managements and boards of undervalued public companies. Engaged Capital manages both a long-only and long/short North American equity fund. Engaged Capital’s efforts and resources are dedicated to a single investment style, “Constructive Activism” with a focus on delivering superior, long-term, risk-adjusted returns for investors. Engaged Capital is based in Newport Beach, California.

 

Investors:
Morrow & Co., LLC
Tom Ball, 203-658-9400
tomball@morrowco.com
or
John Ferguson, 203-658-9400
jferguson@morrowco.com
or
Media:
Bayfield Strategy, Inc.
Riyaz Lalani, 416-907-9365
rlalani@bayfieldstrategy.com

Thursday, February 18th, 2016 Uncategorized Comments Off on (OUTR) Engaged Capital Sends Letter to Outerwall Board Outlining Immediate Strategy

(NYNY) Announces $290 Million Closing of Rights Offering and Backstop Purchase

Empire Resorts, Inc. (NASDAQ-GM:NYNY) (the “Company”) announced its rights offering (the “Rights Offering”) and standby purchase of shares not sold in the Rights Offering, which generated approximately $290 million in gross proceeds for the Company closed on Wednesday, February 17, 2016. The Company issued a total of 20,138,888 shares of common stock at $14.40 per share. This includes 176,086 shares issued to holders upon exercise of their basic subscription rights and 13,136,817 shares issued to Kien Huat Realty III Limited (“Kien Huat”), our largest stockholder, upon exercise of its basic subscription rights. Kien Huat also acquired the remaining 6,825,985 shares not sold in the Rights Offering pursuant to the terms of a standby purchase agreement. The Company paid Kien Huat a fee of $1,450,000 for its commitment pursuant to the standby purchase agreement and reimbursed Kien Huat for its expenses related to the standby purchase agreement in an amount of $50,000.

The Company anticipates using the net proceeds of the Rights Offering towards the development of Montreign Resort Casino (the “Casino Project”), to redeem the Series E Preferred Stock of the Company, towards the development of the Golf Course and Entertainment Village that, along with the Casino Project, are part of the initial phase of the Adelaar project, and towards the working capital needs of the Company.

Upon consummation of the Rights Offering, a $17.4 million convertible note held by Kien Huat was converted into 1,332,058 shares of common stock of the Company in accordance with the conversion provisions of such note (the “Note Conversion”). After giving effect to the Rights Offering and Note Conversion, Kien Huat owns approximately 88.7% of the outstanding shares of the Company’s common stock.

As a result of Kien Huat’s increased proportionate ownership following the consummation of the Rights Offering and the Note Conversion, at the request of the Company, Kien Huat and the Company entered a letter agreement today, pursuant to which Kien Huat has agreed neither it nor its affiliates (Kien Huat together with its affiliates, the “Kien Huat Parties”) will take certain actions in furtherance of a “going-private” transaction involving the Company unless such transaction is subject to the approval of (x) a majority of the voting stock of the Company held by stockholders other than the Kien Huat Parties and (x) either (A) a majority of disinterested members of the Board of Directors of the Company (the “Board”) or (y) a committee of the Board composed of disinterested members of the Board. In addition, the Company and Kien Huat have agreed to cooperate to ensure that, to the greatest extent possible, the Board includes no fewer than three (3) independent directors. The terms of this letter agreement shall be valid beginning immediately and terminating on the earlier of (i) the three year anniversary of the closing of the Rights Offering and (ii) the one year anniversary of the opening of the Casino Project.

Cautionary Statement Regarding Forward Looking Information

Statements in this press release that are not historical facts are “forward-looking statements” that may involve material risks and uncertainties. The company wishes to caution readers not to place undue reliance on such forward-looking statements, which statements are made pursuant to the Private Securities Litigation Reform Act of 1995, and as such, speak only as of the date made. For a full discussion of risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see “Risk Factors” in the company’s registration statement on Form S-3 and the prospectus relating to the rights offering, dated January 4, 2016.

About Empire Resorts

Empire Resorts owns and operates, through its subsidiary Monticello Raceway Management, Inc., the Monticello Casino & Raceway, a harness racing track and casino located in Monticello, New York, and is 90 miles from midtown Manhattan. Further information is available at www.empireresorts.com.

As a result of the award of a gaming facility license from the New York State Gaming Commission, the Company, through its subsidiary Montreign Operating Company, LLC, will begin construction of Montreign Resort Casino – an 18-story casino, hotel and entertainment complex with approximately 102 table games, 2,150 state of the art slot machines and 332 luxury rooms, which includes 12 penthouse suites, 8 garden suites and 7 two-story villas, designed to meet 5-star and 5-diamond standards. For additional information, please visit www.montreign.com.

 

Empire Resorts, Inc.
Charles Degliomini, 845-807-0001
cdegliomini@empireresorts.com

Thursday, February 18th, 2016 Uncategorized Comments Off on (NYNY) Announces $290 Million Closing of Rights Offering and Backstop Purchase

(ROSG) Receives Approval from New York State on Thyroid Cancer Diagnostic Assay

Conditional Approval makes RosettaGX Reveal™ Available in all 50 States

Rosetta Genomics Ltd. (NASDAQ:ROSG), a leading developer and provider of microRNA-based and other molecular diagnostic testing services, announces conditional approval status for RosettaGX Reveal™, its novel microRNA classifier for the diagnosis of indeterminate thyroid Fine Needle Aspirate (FNA) smears from the New York State Department of Health (NYSDOH) under the Company’s Molecular Oncology permit. RosettaGX Reveal is the only molecular test in the thyroid market that has been validated in a multicenter, international, blinded study using convenient, routinely prepared cytology slides.

The assay is CLIA certified, but New York requires an additional license from the NYSDOH for CLIA-certified tests to be offered to patients in the state. With this conditional approval, RosettaGX Reveal is now available in all 50 states. In making the assay available pending final approval, the NYSDOH requires the Company to provide any additional information that it may request within 60 business days.

“We are very pleased to have approval to market this important cancer diagnostic for the benefit of physicians and patients in the vast New York market,” stated Kenneth A. Berlin, President and Chief Executive Officer of Rosetta Genomics. “It is estimated that nearly 550,000 FNAs are performed on thyroid nodules each year in the U.S. and that approximately 740,000 are performed annually in Europe. Interpretation of FNA samples is not always straightforward, leading to an indeterminate result in up to 30% of the samples. Many patients with indeterminate results undergo surgery as a precaution despite the fact that up to 80% of these cases are benign. This exposes patients to unnecessary surgical risk and costs the healthcare system hundreds of millions of dollars. Through an analysis of our validation study data, we believe we can help prevent up to 75% of unnecessary thyroid surgeries.”

“In addition to this expanded geographic access, recent managed care contracting initiatives have resulted in covered lives for RosettaGX Reveal exceeding 150 million in the U.S. These increases in geographic and health insurance access, along with the potential health economic benefits the RosettaGX Reveal assay can bring by avoiding unnecessary surgeries, should enhance adoption into a market valued at more than $350 million annually in the U.S. alone. This market is one that continues to see accelerating penetration of molecular classifiers such as RosettaGX Reveal, which we expect to continue over the next several years,” added Mr. Berlin.

About Rosetta Genomics

Rosetta develops and commercializes a full range of microRNA-based and other molecular diagnostics. Rosetta’s integrative research platform combining bioinformatics and state-of-the-art laboratory processes has led to the discovery of hundreds of biologically validated novel human microRNAs. Building on its strong patent position and proprietary platform technologies, Rosetta is working on the application of these technologies in the development and commercialization of a full range of microRNA-based diagnostic tools. Through the acquisition of PersonalizeDx, the Company now offers core FISH, IHC and PCR-based testing capabilities and partnerships in Pathology, Oncology and Urology that provide additional content and platforms that complement Rosetta’s microRNA and Next-Gen Sequencing offerings. RosettaGX Reveal™, a Thyroid microRNA Classifier for the diagnosis of indeterminate thyroid FNA smears, as well as the full RosettaGX™ portfolio of cancer testing services are commercially available through the Company’s Philadelphia, PA- and Lake Forest, CA-based CAP-accredited, CLIA-certified labs, respectively. For more information visit www.rosettagx.com.

Forward-Looking Statement Disclaimer

Various statements in this release concerning Rosetta’s future expectations, plans and prospects including, but not limited to statements relating to potential health economic benefits of Rosetta tests, adoption of the Rosetta Genomics tests or penetration of those tests into the marketplace, benefits to physicians and patients, and Rosetta Genomics achieving New York State final approval for any or all of its tests, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including those risks more fully discussed in the “Risk Factors” section of Rosetta’s Annual Report on Form 20-F for the year ended December 31, 2014 as filed with the SEC. In addition, any forward-looking statements represent Rosetta’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. Rosetta does not assume any obligation to update any forward-looking statements unless required by law.

Rosetta Genomics
Ken Berlin, President & CEO
267.298.1159
investors@rosettagenomics.com
or
Rosetta Genomics Investor:
LHA
Anne Marie Fields
(212) 838-3777
afields@lhai.com

Thursday, February 18th, 2016 Uncategorized Comments Off on (ROSG) Receives Approval from New York State on Thyroid Cancer Diagnostic Assay

(SEMI) Solidifies Polysilicon Supply

ST. PETERS, Mo., Feb. 18, 2016  — SunEdison Semiconductor Limited (NASDAQ:SEMI) (“SunEdison Semiconductor” or the “Company”) today provided additional details of its comprehensive strategy for the procurement of electronic-grade polysilicon, one of the key raw materials used in the production of semiconductor wafers.

Over the past several months, the company has been working on several initiatives to improve contingency planning for polysilicon supply and manage the transition to multiple sources of poly.  These initiatives include:

  • Building significant polysilicon inventory from the Pasadena facility;
  • Negotiating backup supply agreements for polysilicon from additional suppliers at acceptable prices; and,
  • Supporting the early stages of the production ramp at SMP, and starting customer qualifications

“Over the last several months, we have successfully de-risked our polysilicon supply chain,” said Shaker Sadasivam, President & CEO. “These improvements will be sufficient to meet all of our polysilicon requirements.  I want to thank our R&D, Supply Chain and Operations teams who have worked diligently to accomplish this goal.”

Forward Looking Statements

Certain matters discussed in this news release are forward-looking statements which represent the Company’s judgment as of the date of this release.  The Company disclaims, however, any intent or obligation to update these forward-looking statements.

About SunEdison Semiconductor

SunEdison Semiconductor is a global leader in the manufacture and sale of silicon wafers to the semiconductor industry. For over 55 years, SunEdison Semiconductor has been a pioneer in the design and development of silicon wafer technologies. With R&D and manufacturing facilities in the U.S., Europe, and Asia, SunEdison Semiconductor enables the next generation of high performance semiconductor devices. SunEdison Semiconductor’s common stock is listed on the NASDAQ OMX Global Select Market under the symbol “SEMI.”

Investor & Media Contact

Chris Chaney
Director, Investor Relations & Corporate Communications
SunEdison Semiconductor Limited
cchaney@sunedisonsemi.com
+1 636 474 5226
Thursday, February 18th, 2016 Uncategorized Comments Off on (SEMI) Solidifies Polysilicon Supply

(STAF) Officially Rebrands The JM Group Division in the UK

The JM Group Undergoes Comprehensive Rebranding, Including the Refreshment of Its Corporate Website

NEW YORK, NY–(February 16, 2016) – Staffing 360 Solutions, Inc. (NASDAQ: STAF), a public company executing a global buy-and-build strategy through the acquisition of staffing organizations with operations in the US and UK, today announced that The JM Group operations will be undergoing its previously announced rebranding.

The official rebranding of The JM Group will take place this week, including a refreshment of its website with the new logo. The JM Group’s rebranding and new logo design falls in line with Staffing 360’s Intelligent Integration strategy.

“We are pleased to announce the official rebranding of The JM Group,” said Matt Briand, President and CEO of Staffing 360 Solutions. “The JM Group team has proven to be a great addition to quickly growing operations in the United Kingdom, adding over $25 million in annualized revenues. We believe The JM Group’s expertise in the IT staffing space will be a fantastic driver of new business and higher margin opportunities.”

The logo for The JM Group now follows the same layout and design of Staffing 360’s other subsidiaries, by adding a strapline below the historical brand, as well as a customized 360 orb, reflecting the unique characteristics of The JM Group. At the same time, the original logo, which customers have come to know over the company’s three decades of operations in the UK, remains intact above the strapline. This is a key aspect of Staffing 360’s Intelligent Integration approach, as it maintains the strong brand recognition and goodwill The JM Group has gained over the years, while also providing an enhanced logo and stronger connection with the rest of the Staffing 360 family.

Founded in 1981, The JM Group has been one of the UK’s leading recruitment firms for over three decades and now boasts a run-rate of approximately $25 million in annualized revenue. The JM Group has over 25 employees in its London office who are keen to help individuals find the right job at the right organization. Over 60% of revenue comes from organizations that have been clients for more than 5 years. Two global Fortune 500 companies were the firm’s first clients in 1981 and remain clients today.

“The JM Group has been servicing the greater London market for the last 34 years,” continued Mr. Briand. “Despite the fact that the branding has evolved with a slight refresh, our steadfast commitment to candidates and clients will remain unchanged. The JM Group will continue to provide qualified professionals to a growing universe of IT and professional clients across the United Kingdom and we are thrilled with our combined future growth opportunities now that the JM Group has become an integral part of Staffing 360 Solutions.”

To view the refreshed website for The JM Group, which includes the new logo, sector specific news items, job search functionality and more, please visit: www.thejmgroup.com

About Staffing 360 Solutions, Inc.

Staffing 360 Solutions, Inc. (NASDAQ: STAF) is a public company in the staffing sector engaged in the execution of a global buy-and-build strategy through the acquisition of domestic and international staffing organizations with operations in the US and UK. The Company believes the staffing industry offers opportunities for accretive acquisitions that will drive its annual revenues to $300 million. As part of its targeted consolidation model, the Company is pursuing acquisition targets in the finance and accounting, administrative, engineering and IT staffing space. For more information, please visit: www.staffing360solutions.com.

Follow Staffing 360 Solutions on Facebook, LinkedIn and Twitter.

Forward-Looking Statements

Certain matters discussed within this press release are forward-looking statements including, but not limited to the timing and ability to enter into any additional acquisitions, as well as the size of future revenue. Although Staffing 360 Solutions, Inc. believes the expectations reflected in such forward-looking statements are based on reasonable assumptions, it can give no assurance that its expectations will be attained. Specifically, in order for the Company to achieve annualized revenues of $300 million, the Company will need to successfully raise sufficient capital, to consummate additional target acquisitions, successfully integrate any newly acquired companies, organically grow its business, successfully defend current and any potential future litigation, as well as various additional contingencies, many of which are unknown at this time and generally out of the Company’s control. The Company can give no assurance that it will be able to achieve these objectives. Staffing 360 Solutions does not undertake any duty to update any statements contained herein (including any forward-looking statements), except as required by law. Factors that could cause actual results to differ materially from expectations include general industry considerations, regulatory changes, changes in local or national economic conditions and other risks detailed from time to time in Staffing 360 Solutions’ reports filed with the SEC, including quarterly reports on Form 10-Q, reports on Form 8-K and annual reports on Form 10-K.

Image Available: http://www.marketwire.com/library/MwGo/2016/2/16/11G082953/Images/JM_S360_Logo_RGB_Final-f50e04be716d88a4b26eee95f4244956.jpg

Investor Relations Firm:

PCG Advisory Group
Stephanie Prince
Managing Director
646.762.4518
Email contact


Corporate Investor Contact:

Staffing 360 Solutions, Inc.
Darren Minton
Executive Vice President
212.634.6413
Email contact


Financial Contact:

Staffing 360 Solutions, Inc.
Wade Pearson
Senior Vice President of Finance
212.634.6423
Email contact

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(RMTI) Enters Into Exclusive License Agreement With Wanbang Biopharma

Rockwell to Receive $39 Million in Upfront and Milestone Payments Plus Ongoing Earnings From Product Sales

WIXOM, Mich., Feb. 16, 2016  — Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that it has signed exclusive licensing and manufacturing supply agreements with Wanbang Biopharmaceutical Co., Ltd. (Wanbang), a subsidiary of Shanghai Fosun Pharmaceutical (Group) Co., Ltd. (Fosun Pharma, SHA: 600196 and HKG: 02196), for the rights to commercialize Rockwell’s Triferic and Calcitriol for End-Stage-Renal-Disease (ESRD) patients, that also includes new therapeutic indications for Triferic, in the People’s Republic of China. Triferic is Rockwell’s proprietary iron replacement and hemoglobin maintenance drug for treating anemia. Calcitriol is Rockwell’s generic (active vitamin D) injection for treatment of secondary hyperparathyroidism in dialysis patients.

Under the terms of the agreement, Wanbang will become the exclusive distributor for Triferic and Calcitriol in China for an initial commercial term of 10 years, with an extended term of 10 or more years based on achievement of annual minimum purchase requirements. In consideration for the exclusive rights, Rockwell will receive from Wanbang an upfront fee plus regulatory and revenue milestone payments totaling USD$39 million in aggregate. Notably, Rockwell will receive ongoing earnings from product sales of Triferic and Calcitriol, and other additional Triferic therapeutic indications. Rockwell retains manufacturing responsibility of all products. Wanbang is required to achieve annual minimum purchase requirements to retain exclusive commercialization rights. In addition to the hemodialysis indication, Wanbang has the exclusive right to develop and commercialize Triferic for new therapeutic indications for the Chinese market. Wanbang is responsible for all clinical, regulatory and marketing expenses for Triferic and Calcitriol in China as well as development and regulatory costs for new Triferic indications.

“We are thrilled to establish this strategic partnership with Wanbang,” stated Robert L. Chioini, Founder, Chairman and CEO of Rockwell. “China has been a top priority in our global Triferic licensing strategy, and this agreement further validates Triferic’s potential for becoming the world-wide standard of care in iron maintenance therapy for the treatment of anemia. This commercialization arrangement enables Rockwell to enter into and capitalize on what is projected to become the largest dialysis market in the world. There are about 300,000 dialysis patients currently receiving hemodialysis in China and that market is expected to double over the next few years as the Chinese government, in conjunction with the private sector, establishes the infrastructure to serve the nearly 2 million patients who are presently in need of hemodialysis but lack access. We are very pleased with this commercialization arrangement in which our primary economic value will be derived from product sales in this fast-growing Chinese market.” Mr. Chioini further stated, “We are excited to work with Wanbang, a leading company in the Chinese healthcare market and one of the key suppliers of biosimilar ESA product and other drugs in the renal space. Wanbang, and their experienced team, is highly skilled and intensely focused on leveraging their business into the forefront of the rapidly growing domestic dialysis market in China, and we expect them to have great success selling Triferic and Calcitriol.”

Mr. Yifang Wu, Chief Operating Officer of Fosum Pharma, Chairman and CEO of Wanbang, added, “We are very excited to have partnered with Rockwell Medical and to be able to have the opportunity to offer such great drugs to the Chinese hemodialysis market. We believe Triferic is a revolutionary iron replacement product that will greatly improve the lives of Chinese dialysis patients and we intend to work in partnership with Rockwell management to offer it to patients as fast as possible. The opportunity to market Triferic in other therapeutic indications is exciting as well. Wanbang is committed to addressing the needs of patients and healthcare providers with a comprehensive range of therapeutic options across home, in-center and hospital settings. This partnership enhances Wanbang’s product portfolio with the addition of Rockwell’s high-quality drug products.”

Wanbang Biopharmaceuticals is a leading pharmaceutical company in China that specializes in research, production and marketing of medicines for endocrinology, cardiovascular disease and renal diseases. Wanbang is a subsidiary of Fosun Pharma, which is listed on the Shanghai Stock Exchange (SHA: 600196) and the Stock Exchange of Hong Kong Limited (HKG: 02196). Fosun Pharma, one of the major shareholders of Sino Pharma (HKG:1099) who is the largest drug distributor in China, is part of the Fosun Group, the leading non-state owned enterprise group in China, which is listed on the Hong Kong stock exchange (HKG:0656). In addition to its comprehensive therapeutic product portfolio, Wanbang and Fosun Pharma have sound relationships with public healthcare institutions and providers and directly own and operate a network of private hospitals in China.

About Triferic
Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. Triferic delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin). Please visit www.triferic.com.

About Rockwell Medical
Rockwell Medical is a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis.

Rockwell’s Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin without increasing iron stores (ferritin).

Rockwell’s FDA approved generic drug Calcitriol is for treating secondary hyperparathyroidism in dialysis patients. Calcitriol (active vitamin D) injection is indicated in the management of hypocalcemia in patients undergoing chronic renal dialysis. It has been shown to significantly reduce elevated parathyroid hormone levels. Reduction of PTH has been shown to result in an improvement in renal osteodystrophy.

Rockwell is also an established manufacturer and leader in delivering high-quality hemodialysis concentrates/dialysates to dialysis providers and distributors in the U.S. and abroad. As one of the two major suppliers in the U.S., Rockwell’s products are used to maintain human life by removing toxins and replacing critical nutrients in the dialysis patient’s bloodstream. Rockwell has three U.S. manufacturing/distribution facilities.

Rockwell’s exclusive renal drug therapies support disease management initiatives to improve the quality of life and care of dialysis patients and are intended to deliver safe and effective therapy, while decreasing drug administration costs and improving patient convenience. Rockwell Medical is developing a pipeline of drug therapies, including extensions of Triferic for indications outside of hemodialysis. Please visit www.rockwellmed.com for more information.

Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws, including, but not limited to, Rockwell’s intention to launch Calcitriol and Triferic following FDA approval. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan”, “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While Rockwell Medical believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in Rockwell Medical’s SEC filings. Thus, actual results could be materially different. Rockwell Medical expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.

Triferic® is a registered trademark of Rockwell Medical, Inc.

Michael Rice, Investor Relations; 646-597-6979
Tuesday, February 16th, 2016 Uncategorized Comments Off on (RMTI) Enters Into Exclusive License Agreement With Wanbang Biopharma

(ETRM) Named One of Fast Company’s Top Ten Most Innovative in Biotech

ST. PAUL, Minn., Feb. 16, 2016  — EnteroMedics Inc. (NASDAQ: ETRM), the developer of medical devices using neuroblocking technology to treat obesity, metabolic diseases and other gastrointestinal disorders, today announced that Fast Company has recognized EnteroMedics among the Top 10 Most Innovative Companies in Biotech for 2016.

Dan Gladney, President and Chief Executive Officer of EnteroMedics, stated, “Having brought to market the first new medical device approved by the FDA for the treatment of obesity in over 10 years, EnteroMedics’ inclusion on Fast Company‘s list is validation of the work we have accomplished to date and the vision we have for the future. We continue to work to bring this unique and safe alternative for obesity treatment to patients underserved by the therapeutic options currently available to them.”

Most Innovative Companies is one of Fast Company‘s most significant and highly anticipated editorial efforts of the year, honoring leading enterprises and rising newcomers that exemplify the best in nimble business and impactful innovation. The Most Innovative Companies issue (March 2016) is now available online at www.fastcompany.com/MIC as well as in app form via iTunes, and on newsstands beginning February 23, 2016.

About EnteroMedics Inc.

EnteroMedics is a medical device company focused on the development and commercialization of its neuroscience based technology to treat obesity and metabolic diseases. vBloc® Neurometabolic Therapy, delivered by a pacemaker-like device called the Maestro® Rechargeable System, is designed to intermittently block the vagus nerves using high-frequency, low-energy, electrical impulses. EnteroMedics’ Maestro Rechargeable System has received U.S. Food and Drug Administration approval, CE Mark and is listed on the Australian Register of Therapeutic Goods.

Information about the Maestro® Rechargeable System and vBloc® Neurometabolic Therapy

You should not have an implanted Maestro Rechargeable System if you have cirrhosis of the liver, high blood pressure in the veins of the liver, enlarged veins in your esophagus or a significant hiatal hernia of the stomach; if you need magnetic resonance imaging (MRI); if you have a permanently implanted, electrical medical device; or if you need a diathermy procedure using heat.  The most common related adverse events that were experienced during clinical study of the Maestro Rechargeable System included pain, heartburn, nausea, difficulty swallowing, belching, wound redness or irritation, and constipation.

Talk with your doctor about the full risks and benefits of vBloc Therapy and the Maestro Rechargeable System. For additional prescribing information, please visit www.enteromedics.com.

If you are interested in learning more about vBloc Therapy, please visit www.vbloc.com  or call 1-800-MY-VBLOC.

Forward-Looking Safe Harbor Statement:

This press release contains forward-looking statements about EnteroMedics Inc. Our actual results could differ materially from those discussed due to known and unknown risks, uncertainties and other factors including our limited history of operations; our losses since inception and for the foreseeable future; our lack of commercial sales experience with our Maestro® Rechargeable System for the treatment of obesity in the United States or in any foreign market other than Australia and the European Community; our ability to comply with the Nasdaq continued listing requirements; our ability to commercialize our Maestro System; our dependence on third parties to initiate and perform our clinical trials; the need to obtain regulatory approval for any modifications to our Maestro System; physician adoption of our Maestro System and vBloc® Neurometabolic Therapy; our ability to obtain third party coding, coverage or payment levels; ongoing regulatory compliance; our dependence on third party manufacturers and suppliers; the successful development of our sales and marketing capabilities; our ability to raise additional capital when needed; international commercialization and operation; our ability to attract and retain management and other personnel and to manage our growth effectively; potential product liability claims; potential healthcare fraud and abuse claims; healthcare legislative reform; and our ability to obtain and maintain intellectual property protection for our technology and products. These and additional risks and uncertainties are described more fully in the Company’s filings with the Securities and Exchange Commission, particularly those factors identified as “risk factors” in the annual report on Form 10-K filed March 13, 2015. We are providing this information as of the date of this press release and do not undertake any obligation to update any forward-looking statements contained in this document as a result of new information, future events or otherwise.

Tuesday, February 16th, 2016 Uncategorized Comments Off on (ETRM) Named One of Fast Company’s Top Ten Most Innovative in Biotech

(PSTI) NIAID Initiating Dose Evaluation Studies in PLX-R18

Second Hematologic Indication Being Developed in the U.S. for PLX-R18

HAIFA, Israel, Feb. 16, 2016  — Pluristem Therapeutics Inc. (Nasdaq:PSTI) (TASE:PLTR), a leading developer of placenta-based cell therapy products, today announced that the National Institute of Allergy and Infectious Diseases (NIAID), a part of the U.S. National Institutes of Health (NIH), will initiate studies in large animals to evaluate dosing for Pluristem’s PLX-R18 as a medical counter measure in the treatment of the hematologic components of Acute Radiation Syndrome (ARS). Once the optimal dose is determined in large animals, a pivotal trial could be conducted and the results used to support a Biologics License Application (BLA) submission of PLX-R18 for this indication under the Animal Rule regulatory pathway. In September 2015, the FDA had confirmed that data from earlier trials conducted by NIAID were sufficient for the future design of studies in Pluristem’s development path for PLX-R18. NIAID is supporting and collaborating on the dosing studies, and Pluristem is supplying PLX-R18.

ARS is caused by exposure to very high levels of radiation, such as those that could occur in a nuclear catastrophe. The syndrome can cause severe illness or death. When human trials are not ethical or feasible, as in this indication, the FDA’s Animal Rule regulatory pathway allows for the determination of the efficacy of drugs using animal efficacy studies and human safety data.

“We are very pleased to receive the support and collaboration of the NIH for the development of PLX-R18 as a medical countermeasure in the treatment of ARS, which is the first indication we are targeting in the defense technology space,” stated Pluristem Chairman and CEO Zami Aberman.

Pluristem recently received FDA clearance to initiate a Phase I trial of PLX-R18 to treat incomplete hematopoietic recovery following Hematopoietic Cell Transplantation (HCT). This trial is scheduled to begin in the first half of 2016 in the U.S. Additionally, Pluristem has entered into a Memorandum of Understanding (MOU) with Japan’s Fukushima Medical University, Fukushima Global Medical Science Center to develop PLX-R18 for the treatment of ARS and for morbidities following radiotherapy in cancer patients.

Previous NIH/NIAID studies of PLX-R18 in ARS

The NIH has supported and completed two mouse studies of PLX-R18 as a potential treatment of the component of ARS that affects bone marrow function. ARS involves severe, potentially lethal damage to the bone marrow’s ability to produce blood cells and platelets, as well as to other systems and organs. Severe damage to bone marrow quickly makes victims vulnerable to life-threatening hemorrhage, infection and anemia. A recently concluded NIH/NIAID study showed that administration of PLX-R18 resulted in a statistically significant improvement in the recovery of white blood cell, red blood cell, and platelet levels in animals exposed to high levels of radiation, and described the treatment’s mechanism of action. The NIH/NIAID’s first study of PLX-R18 showed a substantial, statistically significant improvement in 30-day survival and overall survival of irradiated rodents given PLX-R18 versus a control group.

About PLX-R18

PLX-R18 is Pluristem’s second cell therapy product in development. It is designed to treat bone marrow that is unable to produce enough blood cells due to a variety of causes including ARS, certain cancers or cancer treatments, or immune-mediated bone marrow failure. Pluristem received FDA clearance to initiate a Phase I trial of PLX-R18 in incomplete bone marrow recovery following hematopoietic cell transplantation. With its capabilities, PLX-R18 could potentially treat a broad range of hematologic indications, which together constitute a substantial global market.

About Pluristem Therapeutics

Pluristem Therapeutics Inc. is a leading developer of placenta-based cell therapy products. The Company has reported robust clinical trial data in multiple indications for its patented PLX cells. The cells release a cocktail of therapeutic proteins in response to inflammation, ischemia, hematological disorders, and radiation damage. PLX cell products are grown using the Company’s proprietary three-dimensional expansion technology. They are off-the-shelf, requiring no tissue matching prior to administration.

Pluristem has a strong intellectual property position; Company-owned and operated, GMP-certified manufacturing and research facilities; strategic relationships with major research institutions; and a seasoned management team.

Safe Harbor Statement

This press release contains forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995 and federal securities laws. For example, we are using forward-looking statements when we discuss the expected NIAID study, continued support of the NIH, when we discuss the results of the study and its potential use to apply for marketing authorization PLX-R18, the possibility to use results of the study in question to conduct a pivotal study and facilitating the development of PLX-R18 in other hematologic indications, when we discuss our plan to begin a Phase I trial to treat incomplete hematopoietic recovery following HCT in the first half of 2016, and when we discuss PLX-R18’s potential to treat a broad range of hematologic indications, which together constitute a substantial global market. These forward-looking statements and their implications are based on the current expectations of the management of Pluristem only, and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. The following factors, among others, could cause actual results to differ materially from those described in the forward-looking statements: changes in technology and market requirements; we may encounter delays or obstacles in launching and/or successfully completing our clinical trials; our products may not be approved by regulatory agencies, our technology may not be validated as we progress further and our methods may not be accepted by the scientific community; we may be unable to retain or attract key employees whose knowledge is essential to the development of our products; unforeseen scientific difficulties may develop with our process; our products may wind up being more expensive than we anticipate; results in the laboratory may not translate to equally good results in real clinical settings; results of preclinical studies may not correlate with the results of human clinical trials; our patents may not be sufficient; our products may harm recipients; changes in legislation; inability to timely develop and introduce new technologies, products and applications; loss of market share and pressure on pricing resulting from competition, which could cause the actual results or performance of Pluristem to differ materially from those contemplated in such forward-looking statements. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission. Except as otherwise required by law, Pluristem undertakes no obligation to publicly release any revisions to these forward-looking statements to reflect events or circumstances after the date hereof or to reflect the occurrence of unanticipated events. For a more detailed description of the risks and uncertainties affecting Pluristem, reference is made to Pluristem’s reports filed from time to time with the Securities and Exchange Commission.

 

Contact:

Pluristem Therapeutics Inc.
Karine Kleinhaus, MD, MPH
Divisional VP, North America
1-914-512-4109
karinek@pluristem.com
Tuesday, February 16th, 2016 Uncategorized Comments Off on (PSTI) NIAID Initiating Dose Evaluation Studies in PLX-R18

(FLXN) Reports Primary Endpoint Met in Pivotal Phase 3 Trial of Zilretta

  • Primary endpoint at week 12 against placebo achieved p value of <0.0001; statistically significant and clinically meaningful pain relief demonstrated at weeks 1 through 16
  • Zilretta also achieved statistical significance on WOMAC® A (pain), WOMAC B (stiffness) and WOMAC C (function) through week 12 against both placebo and immediate-release triamcinolone acetonide
  • Zilretta patients experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12 
  • Zilretta, an investigational non-opioid/non-NSAID, has received Fast-Track designation by FDA; planned NDA submission on track for second half of 2016
  • Conference call tomorrow, February 17, at 9:00 a.m. ET 

BURLINGTON, Mass., Feb. 16, 2016  —  Flexion Therapeutics, Inc. (Nasdaq:FLXN) today reported that the Phase 3 clinical trial for its lead drug candidate Zilretta (also known as FX006) met its primary endpoint at week 12, demonstrating highly significant (p<0.0001), durable and clinically meaningful pain relief against placebo in patients with moderate to severe osteoarthritis (OA) knee pain. In addition, Zilretta achieved statistically significant analgesia against placebo at weeks 1 through 16 and patients treated with Zilretta experienced, on average, a 50 percent reduction in pain from baseline over weeks 1 through 12. In pre-specified analyses, Zilretta achieved statistical significance against placebo in validated OA and quality of life secondary measures through week 12.

In pre-specified secondary measures, compared to immediate-release triamcinolone acetonide (TCA), the most commonly injected intra-articular (IA) corticosteroid, Zilretta achieved statistical significance through 12 weeks on WOMAC A1 (pain), WOMAC B (stiffness) and WOMAC C (function) and the validated Knee injury and Osteoarthritis Outcome Score (KOOS) quality of life subscale and was numerically superior at weeks 2 through 12 on the daily pain rating scale, although it did not achieve statistical significance in that measure.

The frequency of treatment-related side effects was comparable across all treatment arms in the trial. No drug-related serious adverse events were observed and no patients treated with Zilretta were discontinued from the study due to a treatment-related side effect.

“We are extremely gratified with these Phase 3 data that strongly reinforce Zilretta’s previous clinical efficacy results, which are consistent with substantial and durable pain relief,” said Flexion Therapeutics President and Chief Executive Officer Michael Clayman, M.D. “We believe that Zilretta has the potential to become an important new non-opioid treatment in a therapeutic area that hasn’t seen meaningful innovation in many years. More than 12 million people in the U.S. suffer from the painful and debilitating effects of knee OA and many have not found effective relief with existing therapies. We look forward to working closely with the U.S. Food and Drug Administration (FDA) as we prepare to submit our New Drug Application (NDA) for Zilretta.”

Zilretta was designed using proprietary microsphere technology and is intended to provide localized and long-lasting pain relief over a period of months while minimizing systemic exposure and avoiding serious side effects common to oral therapies prescribed for OA pain. Current oral treatment options for OA knee pain include non-steroidal anti-inflammatory drugs (NSAIDS), COX II inhibitors and opioids. All are labeled with black box warnings for serious, sometimes fatal, side effects. IA medicines, such as immediate-release corticosteroids and hyaluronic acid injected into the joint, are generally well-tolerated but fail to produce pain relief of sufficient magnitude or duration.

“There have been no major advances in the treatment of OA for decades and given the limited efficacy and the safety liabilities of available therapies, patients are in need of a new treatment option,” said Stan Cohen, M.D., Medical Director, Metroplex Clinical Research Center and Clinical Professor of Internal Medicine, UT Southwestern Medical School, Dallas. “These data suggest that Zilretta has the potential to be a significant advance in pain management for patients with OA of the knee.”

About the Phase 3 Trial

The randomized, double-blind Phase 3 placebo-controlled, active-comparator trial enrolled 486 patients at approximately 40 centers worldwide. Patients were randomized to one of three treatment groups (1:1:1) and received either a single IA injection of 40 mg of Zilretta, normal saline (placebo) or 40 mg of immediate-release TCA. Each patient was evaluated for efficacy and safety during seven outpatient visits over 24 weeks after receiving an injection. The primary objective of the study was to assess the magnitude of pain relief of Zilretta at 12 weeks against placebo. The secondary objectives of the study were to assess the magnitude and duration of pain relief and effect of Zilretta against placebo and immediate-release TCA in a variety of additional pre-specified measures.

Flexion plans to present detailed results from the Phase 3 clinical trial at an upcoming scientific meeting.

Conference Call

At 9:00 a.m. ET tomorrow, Flexion’s management will host a conference call to discuss the Phase 3 clinical results and provide a general update on the Zilretta program. The dial-in number for the conference call is (855) 770-0022 for U.S. participants and (908) 982-4677 for international participants, with Conference ID # 51030771. A live webcast of the conference call can also be accessed through the “Investors” tab on the Flexion Therapeutics website at www.flexiontherapeutics.com. A webcast replay will be available online after the call.

About Osteoarthritis of the Knee

OA is a common joint disease that affects 27 million Americans, and the prevalence of the disease is expected to significantly grow as a result of aging, obesity and sports injuries. OA is a type of degenerative arthritis that is caused by the progressive breakdown and eventual loss of cartilage in one or more joints. OA is characterized by pain, swelling, stiffness and decreased mobility of the affected joint. While OA is being diagnosed at increasingly younger ages, prevalence rises after age 45, and the knee is one of the most commonly affected joints. In 2014, more than 12 million Americans were diagnosed with OA of the knee. OA has a significant impact on the daily lives of patients, and it commonly affects large weight-bearing joints like the knees and hip but also occurs in the shoulders, hands, feet and spine. As the disease progresses, it becomes increasingly painful and debilitating, culminating, in many cases, in the need for total joint replacement.

Each year, at least five million OA patients in the U.S. receive immediate-release corticosteroid and hyaluronic acid IA injections for knee pain, but these injections generally provide limited relief, and no alternative injectable therapy has been approved in more than a decade. Opioids are another treatment option, and as many as 40 percent of Medicare patients are prescribed opioids for chronic OA pain.

About Zilretta

Zilretta is being investigated as the first IA sustained-release, non-opioid treatment for patients with moderate to severe OA pain. Zilretta employs proprietary microsphere technology combining TCA — a commonly administered, short-acting corticosteroid — with a polymer (PLGA) intended to provide persistent concentrations of drug locally to both amplify the magnitude and prolong the duration of pain relief.

To date, over 600 patients have been treated with Zilretta in clinical trials. No drug-related serious adverse events have been observed in these trials and adverse events have typically been localized, mild and comparable to those observed with immediate-release TCA and placebo. The data from these trials are consistent with Zilretta providing meaningful and durable pain relief.

About Flexion Therapeutics

Flexion is a specialty pharmaceutical company focused on the development and commercialization of novel, local therapies for the treatment of patients with musculoskeletal conditions, beginning with OA. The company’s lead product candidate, Zilretta, is being investigated for its potential to provide improved analgesic therapy for the millions of U.S. patients who receive IA injections for knee OA annually. The company is also investigating another product candidate, FX007, a locally administered TrkA receptor antagonist for post-operative pain.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including, but not limited to, statements relating to the future of Flexion; our ongoing development of Zilretta and our other product candidates; our interpretation of the data and results from our Zilretta clinical trials; our plans for, and the expected timing of, our Zilretta NDA submission with the FDA; our plans to commercialize Zilretta and its market potential; and the potential therapeutic and other benefits of Zilretta and our other product candidates, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks associated with the process of discovering, developing, manufacturing and obtaining regulatory approval for drugs that are safe and effective for use as human therapeutics; the fact that results of past clinical trials may not be predictive of subsequent trials; our reliance on third parties to manufacture and conduct clinical trials of Zilretta and our other product candidates, which could delay or limit their future development or regulatory approval; our ability to meet anticipated clinical trial commencement, enrollment and completion dates and regulatory filing dates for Zilretta; the fact that we will require additional capital, including prior to commercializing Zilretta or any of our other product candidates, and may be unable to obtain such additional capital in sufficient amounts or on terms acceptable to us; the risk that we may not be able to maintain and enforce our intellectual property, including intellectual property related to Zilretta and our other product candidates; competition from alternative therapies; regulatory developments and safety issues, including difficulties or delays in obtaining regulatory approvals to market Zilretta or our other product candidates; the risk that the FDA and foreign regulatory authorities may not agree with our interpretation of the data from our clinical trials of Zilretta and may require us to conduct additional clinical trials; Zilretta may not receive regulatory approval or be successfully commercialized, including as a result of the FDA’s or other regulatory authorities’ decisions regarding labeling and other matters that could affect its availability or commercial potential; risks related to key employees, markets, economic conditions, health care reform, prices and reimbursement rates; and other risks and uncertainties described in our filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in our most recent Annual Report on Form 10-K and subsequent filings with the SEC. The forward-looking statements in this press release speak only as of the date of this press release, and we undertake no obligation to update or revise any of the statements. We caution investors not to place considerable reliance on the forward-looking statements contained in this press release.

1 WOMAC (Western Ontario and McMaster Universities Arthritis Index) is a validated, widely used, proprietary set of standardized questionnaires used by health professionals to evaluate the condition of patients with osteoarthritis of the knee and hip, including pain, stiffness, and physical functioning of the joints.

Investor Contact
David Carey
Lazar Partners LTD
T: 212-867-1768 
dcarey@lazarpartners.com

Media Contact
Mariann Caprino
TogoRun
T: 917.242.1087  
M.Caprino@togorun.com

Corporate Contact
Fred Driscoll
Chief Financial Officer
Flexion Therapeutics, Inc.
T: 781-305-7763
fdriscoll@flexiontherapeutics.com
Tuesday, February 16th, 2016 Uncategorized Comments Off on (FLXN) Reports Primary Endpoint Met in Pivotal Phase 3 Trial of Zilretta

(OPCO) Expects New Product Line to Make Big Splash at Global Pet Expo

OurPet’s New Products Will Be Featured at Booth #2455

FAIRPORT HARBOR, OH –(February 16, 2016) – OurPet’s Company (OTCQX: OPCO) plans to unveil a new, first-of-its-kind line of products at Global Pet Expo in Orlando, Florida, March 16-18, 2016. The Global Pet Expo is the industry’s largest trade show featuring the newest, most innovative products in the marketplace. Last year’s show featured 1,051 exhibitors, 3,113 booths, and more than 3,000 new product launches.

“After the OurPets Catty Whack won ‘Best New Cat Product’ at SuperZoo last year, we knew that we had to build off of that momentum,” said Gabriella Chessman, VP of marketing at OurPet’s. “Our R&D team has been diligently working over the past year and we are really excited to finally show the world what we have been working on.”

OurPet’s has always been an innovator in the pet industry by focusing on making products that fulfill the instinctual needs of pets to strengthen the pet and pet parent bond, creating harmony in the home. OurPet’s will be at the Global Pet Expo booth #2455.

For more information on the OurPet’s Company, visit www.ourpets.com.

About The OurPet’s Company:

The OurPet’s Company (OTCQX: OPCO) designs, produces and markets a broad line of innovative, trend-setting pet products and accessories sold under the OurPets® and Pet Zone® brands domestically and internationally. OurPets® and Pet Zone® products are sold through leading pet specialty retailers, food, drug and mass merchandisers, direct-mail catalog and internet retailers. Since its founding in 1995, the OurPet’s Company has been building an extensive intellectual property portfolio with more than 160 patents in either issued or pending status all devoted to solving problems related to the human/pet bond. OurPet’s was named a Weatherhead Top 100 Fastest Growing Company in Northeast Ohio in 2013 and has been a Lake-Geauga County Fast Track 50 Hall of Fame local business success winner for the last eight consecutive years. In addition, the OurPet’s Company was named 2015 Business of the Year by the Painesville Area Chamber of Commerce. Investors and customers may visit www.ourpets.com and www.petzonebrand.com for more information about the Company, its products and brands.

Media Contact:

Peter Ostapowicz
Marketing Coordinator
postapowicz@ourpets.com

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(TBRA) Completes Patient Recruitment for ORION Phase 2a Study

SOUTH SAN FRANCISCO, Calif., Feb. 9, 2016  — Tobira Therapeutics, Inc. (NASDAQ: TBRA), a biopharmaceutical company developing novel treatments for non-alcoholic steatohepatitis (NASH) and other serious immuno-inflammatory and fibrotic diseases, announced that it has completed recruitment for the Phase 2a ORION study.

ORION is a randomized, double-blind, placebo-controlled study exploring the metabolic effects of cenicriviroc (CVC) in obese adults (BMI greater than or equal to 30 kg/m2) with prediabetes or diabetes and suspected non-alcoholic fatty liver disease (NAFLD). The primary outcome of ORION will measure changes in insulin sensitivity in peripheral and adipose tissue over a 24-week period and will include an interim analysis at 12 weeks. Tobira plans to announce the top-line 12-week interim analysis in the second quarter of 2016 and submit results for presentation at a scientific conference.

“Completion of enrollment in this mechanistic study marks another milestone for Tobira as we explore the full potential of CVC,” said Laurent Fischer, M.D., chief executive officer of Tobira. “In previous clinical and nonclinical studies, CVC has demonstrated anti-inflammatory and anti-fibrotic activity, impacting two key engines of disease progression in NASH. ORION allows us to explore CVC’s impact on insulin resistance, which plays a determining role in NASH.”

In obese patients, the over-expression of CCR2 and CCR5 receptors and their ligands in fat tissue has been shown to promote both inflammation and insulin resistance. Insulin resistance is associated with the development of NAFLD and is a key driver for disease progression to its more severe form, non-alcoholic steatohepatitis (NASH), as well as other diabetes-related complications.

Details about ORION can be found at www.clinicaltrials.gov using identifier NCT02330549.

About Cenicriviroc (CVC) and Non-alcoholic Steatohepatitis (NASH)
CVC is an oral, once-daily, potent immunomodulator that blocks two chemokine receptors, CCR2 and CCR5, which are intricately involved in the inflammatory and fibrogenic pathways in NASH that cause liver damage and often lead to cirrhosis, liver cancer or liver failure. Tobira believes this novel approach will establish CVC as both a single-agent and as a cornerstone treatment in multi-therapy regimens for NASH, for which there is currently no approved drug.

CVC is currently being evaluated in Tobira’s fully enrolled global Phase 2b CENTAUR study (identifier NCT02217475) and the company expects to announce the study’s primary endpoint in the third quarter of 2016. CENTAUR is comparing CVC to placebo in 289 patients with NASH and liver fibrosis. CVC has been granted Fast Track status in NASH in patients with liver fibrosis, the patient population at highest risk of progression to cirrhosis. The CENTAUR study includes surrogate endpoints identified as suitable for registrational studies in findings of an FDA-AASLD workshop reported in Hepatology. To date, approximately 600 subjects have been dosed in completed studies with CVC, including 115 HIV infected subjects on treatment for up to 48 weeks.

NASH is an emerging health crisis impacting 3% to 5% of the U.S. population and 2% to 4% globally. It is the fastest growing cause of liver cancer and liver transplant in the U.S. due to the rise in obesity. Additionally, this population is estimated to be three to five times larger than the size of the population with hepatitis C in the U.S.

About Tobira Therapeutics
Tobira is a clinical-stage biopharmaceutical company focused on the development and commercialization of therapies to treat liver disease, inflammation, fibrosis and HIV. The company’s lead product candidate, cenicriviroc (CVC), is a first-in-class immunomodulator and dual inhibitor of CCR2 and CCR5 being evaluated for the treatment of non-alcoholic steatohepatitis (NASH). Learn more about Tobira at www.tobiratherapeutics.com.

Tobira® is a registered trademark owned by Tobira Therapeutics, Inc.

©2016 Tobira Therapeutics, Inc. All Rights Reserved.

Forward Looking Statements
This release contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company’s clinical development of cenicriviroc (CVC), the potential timing and outcomes of clinical studies of CVC undertaken now or in the future; the ability of the company to timely source adequate supply of its development products from third party manufacturers on whom the company depends; the company’s limited cash reserves and its ability to obtain additional capital on acceptable terms, or at all; the company’s ability to successfully progress, partner or complete further development of its programs; the uncertainties inherent in clinical testing; the timing, cost and uncertainty of obtaining regulatory approvals; the company’s ability to protect its intellectual property; competition; changes in the regulatory landscape or the imposition of regulations that affect the company’s products; and other factors listed under “Risk Factors” in the company’s filings with the Securities and Exchange Commission.

Tobira Investor & Media Contact:
Ian Clements, Ph.D.
+1 (650) 351-5013
ir@tobiratherapeutics.com

Canale Communications Media Contact:
Pam Lord
+1 (619) 849-6003
pam@canalecomm.com

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(RAVE) Announces New Expansion Deal

Former Applebee’s CEO and family members sign on for 10 more locations

DALLAS, Feb. 12, 2016  — Pie Five Pizza is adding another expansion deal to its growing Circle of Crust. The brand known for fresh, custom, artisan pizzas served in under five minutes today announced plans to add up to 10 new Pie Five locations in Kansas City. Under the new development agreement, franchisee, Dave Goebel, along with sons Kevin and Kerry and daughter Lyssa, plan to strategically fill in trade areas in the Kansas City metro area on both the Kansas and Missouri sides. Additionally, the team is looking north of the city in St. Joseph, MO.

“Our family couldn’t be more pleased with our decision to be part of the Pie Five family — the first two and a half years with Pie Five have significantly exceeded our expectations and initial projections,” said Goebel. “Our guests have responded extremely well to this innovative approach to high quality, customized and fast pizza. We’re excited to extend our reach in the Kansas City, Lawrence, Topeka, Manhattan and St. Joseph areas in order to become even more convenient to pizza lovers.”

Goebel brings 35 years of experience in the retail, food service and hospitality segments and currently serves as president of KC Pie, LLC, a multi-unit franchise partner for Pie Five Pizza Co.  He is the former chief executive officer of casual-dining Applebee’s restaurants. KC Pie, LLC currently owns and operates eight Pie Five Pizza Co. locations with a ninth set to open next later this month.

“Additionally, we’re excited to continue our affiliation with Children’s Mercy Hospital,” said Goebel, who serves on the board at Children’s Mercy Hospital. “We are closing in on our goal of $100,000 in support for the outstanding work this organization does in the states of Kansas and Missouri.”

Throughout the year, KC Pies LLC has given 5% of their totals sales every Monday to Children’s Mercy Hospitals. They have donated over $80,000 to date.

This is the second Pie Five franchisee to add additional locations this year. Last month, franchise owner, Rob Byford, signed a development deal to add 7 new Pie Five location s in the Memphis market. The fast casual pizza leader currently has 400 locations in development.

Pie Five’s unique fast casual model allows patrons to customize a personal handcrafted pizza, choosing from a wide selection of fresh, artisan ingredients — all in under 5 minutes. Pie Five pizzas bake in just 145 seconds in a custom-designed, state-of-the-art oven. There are millions of possible pizza combinations Pie Five customers can create with four crusts (including artisan thin, classic pan, whole grain Neapolitan and gluten-free), seven sauces and 28 fresh toppings. Additionally, guests can add one of Pie Five’s freshly-tossed hand-made salads.

ABOUT PIE FIVE PIZZA CO.
Dallas-based Pie Five Pizza Co. is a subsidiary of RAVE Restaurant Group, Inc. (NASDAQ: RAVE). RAVE owns, franchises and supplies more than 300 Pie Five and Pizza Inn restaurants operating domestically and internationally. Pie Five Pizza Co. is the leading brand in the rapidly growing fast-casual pizza space, offering individual handcrafted pizzas with fresh ingredients made to order in less than five minutes. Named among Fast Casual’s Top “Movers & Shakers” for three consecutive years, 2015 “Best Franchise Deal” by QSR Magazine, 2012 Hot Concepts winner by Nation’s Restaurant News and one of “10 Hot New Restaurant Chains from Established Brands” by Forbes.com, the company currently has 86 locations in 24 states and the District of Columbia. For more information, please visit PieFivePizza.com.

Contact: Marcus Dockter, MWWPR
213-234-1746
mdockter@mww.com

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(ABCD) Participates in Providing Credit Facility for Cambium Learning

CHARLOTTE, N.C., Feb. 12, 2016  — Babson Capital Management, a global asset management firm with approximately $223 billion in assets under management, announced today that it led the Term Loan B issuance in a $135 million credit facility to Cambium Learning Inc. Babson also served as co-documentation agent on the transaction, which included revolving credit and term loan facilities.

Founded in 2003 and based in Dallas, Cambium Learning Inc. is an educational solutions and services company providing supplemental digital and print products to teachers and students from pre-K through high school in math, reading, science and other subjects. Cambium Learning Inc. is a wholly owned subsidiary of Cambium Learning Group Inc. (NASDAQ: ABCD), which is majority-owned by Veronis Suhler Stevenson (“VSS”).

“Babson added value through its ability to provide solutions across the capital structure and its flexibility and responsiveness in meeting the needs of both sponsor and borrower,” said David Bainbridge, Managing Director for Veronis Suhler Stevenson. “VSS appreciates Babson’s partnership in the refinancing of Cambium Learning Inc. and we look forward to working with them again soon.”

“Babson is excited to partner with VSS and the lending group on a financing solution for Cambium,” said Ian Fowler, Managing Director and Co-Head of Babson’s North American Private Finance Group. “With significantly lower cost of capital and continuing support from VSS, we believe Cambium is positioned to leverage its strong market position and capitalize on organic and strategic growth opportunities.”

About Veronis Suhler Stevenson

Veronis Suhler Stevenson is a leading private investment firm that invests in the information, tech-enabled business services, healthcare IT, and education industries in North America and Europe. With offices in New York and London, VSS provides capital for buyouts, recapitalizations, growth financings and strategic acquisitions to middle-market companies and management teams with the goal of building companies organically and through a focused add-on acquisition program. Since 1987, VSS has managed seven private investment funds with aggregate initial capital commitments totaling over $3 billion, including four equity funds and three structured capital funds. To date, VSS funds have invested in 74 platform companies, which have together completed over 330 add-on acquisitions. To learn more, visit www.vss.com.

About Babson Capital Management

Babson Capital Management LLC is one of the world’s leading asset management firms, with approximately $223 billion in assets under management as of December 31, 2015. Through proprietary research, analysis and a focus on investment fundamentals, the firm and its global affiliates develop products and strategies that leverage its broad expertise in global fixed income, structured products, middle market finance, commercial real estate, alternatives and equities. A member of the MassMutual Financial Group, Babson maintains a strong global footprint with operations on four continents and clients in 31 countries. Learn more at www.babsoncapital.com

Contact:
Brian Whelan, Babson Capital Management, 704.805.7244, bwhelan@babsoncapital.com
David Coburn, Luquire George Andrews, 704.552.6565, coburn@lgaadv.com

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(UUUU) Reports Production Updates

LAKEWOOD, CO, Feb. 12, 2016  – Energy Fuels Inc. (NYSE MKT:UUUU; TSX:EFR) (“Energy Fuels” or the “Company”), one of the largest producers of uranium in the United States, is pleased to announce that the Company has achieved several key licensing, development, and production milestones at its Nichols Ranch in situ recovery (“ISR”) Project in Wyoming.

The Company is pleased to announce that it has completed the construction and licensing of the previously announced elution circuit at the Nichols Ranch ISR Plant as scheduled.  The Company has received final notice from the U.S. Nuclear Regulatory Commission (“NRC”) that uranium recovery operations involving elution, precipitation, filter press, and slurry processes are authorized to commence.  Now that the elution circuit is completed and fully-licensed, Energy Fuels has 100% self-contained ISR processing capabilities.  The new elution circuit is expected to significantly lower the Company’s future costs of production on a per pound basis by avoiding 3rd party toll processing fees.  The elution circuit also provides the Company with operational flexibility as it executes its development plans and responds to future market conditions.

The Company is also increasing production at the Nichols Ranch Project on a controlled basis.  Through ongoing well-field development and drilling, the Company is confirming – and in certain cases increasing – its level of confidence in the uranium resource estimates contained in the most recent Technical Report and Preliminary Economic Assessment for the Nichols Ranch Uranium Project dated February 28, 2015, prepared in accordance with National Instrument 43-101 (the “Technical Report”).

A 6th header-house at the Nichols Ranch Project began production in November 2015.  It continues to maintain grades and produce uranium at higher-than-expected rates.  Furthermore, through the successful execution of slant hole drilling, the Company has been able to place significant additional resources under pattern at this 6th header-house that were previously thought to be inaccessible due to challenging terrain.

The Company is scheduled to place the 7th and 8th header-houses on-line at the Nichols Ranch Project in March 2016 and July 2016, respectively.  Drilling and installation of production wells for these two header-houses is proceeding at the current time.  The pattern for the 7th header-house was originally believed to have lower uranium grades.  However, drilling is now indicating that the high-grade zones identified in earlier patterns of the project are more continuous than originally estimated.  Indeed, the Company has recorded the 3rd highest intercept ever observed at Nichols Ranch (0.441% U3O8 with a thickness of 15.5 feet), in addition to other high-grade intercepts between 0.11% – 0.15% U3O8 with thicknesses of 9.0 – 14.5 feet.  Future drilling will confirm whether additional resources can be placed under pattern above the estimates contained in the current Technical Report.  Finally in late 2015, the Company successfully completed the installation of the monitor wells and began baseline and hydrological testing work in the next phase of the Nichols Ranch Project.  Energy Fuels expects to start development and uranium recovery operations in this next phase in the latter part of 2016.

Stephen P. Antony, President and CEO of Energy Fuels stated:  “Nichols Ranch continues to meet – and exceed – the high expectations we had when we acquired the project in June 2015.  Nichols Ranch is proving itself to be a reliable and scalable long-term U.S. uranium production center, which has large areas of high grade uranium resources that can be produced at an attractive cost.  The 6th header-house at Nichols Ranch is producing very well, and we have similarly high expectations for the 7th and 8th header-houses, which are scheduled to come online later this year.  While we expect uranium prices to increase in the coming years, Nichols Ranch has become vitally important for Energy Fuels as we navigate today’s challenging uranium price environment.  I wish to congratulate our permitting and technical teams for achieving these important milestones at Nichols Ranch.  Between our ISR team in Wyoming and our conventional mining teams in Utah and Arizona, I think it is clear that Energy Fuels has the right people and projects in place to solidify our position as a dominant uranium producer in the U.S.”

Stephen P. Antony, P.E., President & CEO of Energy Fuels, is a Qualified Person as defined by National Instrument 43-101 and has reviewed and approved the technical disclosure contained in this news release.

About Energy Fuels:  Energy Fuels is a leading integrated US-based uranium mining company, supplying U3O8 to major nuclear utilities.  Energy Fuels operates two of America’s key uranium production centers, the White Mesa Mill in Utah and the Nichols Ranch Processing Facility in Wyoming.  The White Mesa Mill is the only conventional uranium mill operating in the U.S. today and has a licensed capacity of over 8 million pounds of U3O8 per year.  The Nichols Ranch Processing Facility, acquired in the Company’s acquisition of Uranerz Energy Corporation, is an in situ recovery (“ISR”) production center with a licensed capacity of 2 million pounds of U3O8 per year.  Energy Fuels also has the largest NI 43-101 compliant uranium resource portfolio in the U.S. among producers, and uranium mining projects located in a number of Western U.S. states, including producing mines, mines on standby, and mineral properties in various stages of permitting and development.  The Company’s common shares are listed on the NYSE MKT under the trading symbol “UUUU”, and on the Toronto Stock Exchange under the trading symbol “EFR”.

Cautionary Note Regarding Forward-Looking Statements:  Certain information contained in this news release, including any information relating to the Company being one of the largest producers of uranium, the ability of Nichols Ranch to continue to meet or exceed expectations, the ability of the Company to reduce its cost of production and respond to market conditions, the ability of the Company to produce resources placed under pattern, the ability of the Company to increase resource estimates through future drilling, the Company’s position as a dominant uranium producer in the U.S., and any other statements regarding Energy Fuels’ future expectations, beliefs, goals or prospects constitute forward-looking information within the meaning of applicable securities legislation (collectively, “forward-looking statements”).  All statements in this news release that are not statements of historical fact (including statements containing the words “expects”, “does not expect”, “plans”, “anticipates”, “does not anticipate”, “believes”, “intends”, “estimates”, “projects”, “potential”, “scheduled”, “forecast”, “budget” and similar expressions) should be considered forward-looking statements.  All such forward-looking statements are subject to important risk factors and uncertainties, many of which are beyond Energy Fuels’ ability to control or predict.  A number of important factors could cause actual results or events to differ materially from those indicated or implied by such forward-looking statements, including without limitation factors relating to:  the Company being one of the largest producers of uranium, the ability of Nichols Ranch to continue to meet or exceed expectations, the ability of the Company to reduce its cost of production and respond to market conditions, the ability of the Company to produce resources placed under pattern, the ability of the Company to increase resource estimates through future drilling, the Company’s position as a dominant uranium producer in the U.S., and other risk factors as described in Energy Fuels’ most recent annual information forms and annual and quarterly financial reports.  Energy Fuels assumes no obligation to update the information in this communication, except as otherwise required by law.  Additional information identifying risks and uncertainties is contained in Energy Fuels’ filings with the various securities commissions which are available online at www.sec.gov and www.sedar.com.  Forward-looking statements are provided for the purpose of providing information about the current expectations, beliefs and plans of the management of Energy Fuels relating to the future.  Readers are cautioned that such statements may not be appropriate for other purposes.  Readers are also cautioned not to place undue reliance on these forward-looking statements, that speak only as of the date hereof.

Friday, February 12th, 2016 Uncategorized Comments Off on (UUUU) Reports Production Updates

(HEES) Reports Quarterly Cash Dividend

H&E Equipment Services, Inc. (NASDAQ: HEES) today announced that its Board of Directors declared a regular quarterly cash dividend to be paid to its stockholders. The Company announced a quarterly cash dividend of $0.275 per share of common stock to be paid on March 9, 2016 for stockholders of record as of the close of business on February 23, 2016.

About H&E Equipment Services, Inc.

The Company is one of the largest integrated equipment services companies in the United States with 77 full-service facilities throughout the West Coast, Intermountain, Southwest, Gulf Coast, Mid-Atlantic and Southeast regions. The Company is focused on heavy construction and industrial equipment and rents, sells and provides parts and services support for four core categories of specialized equipment: (1) hi-lift or aerial platform equipment; (2) cranes; (3) earthmoving equipment; and (4) industrial lift trucks. By providing equipment rental, sales, on-site parts, repair and maintenance functions under one roof, the Company is a one-stop provider for its customers’ varied equipment needs. This full service approach provides the Company with multiple points of customer contact, enabling it to maintain a high quality rental fleet, as well as an effective distribution channel for fleet disposal and provides cross-selling opportunities among its new and used equipment sales, rental, parts sales and services operations.

Forward-Looking Statements

Certain statements in this press release are “forward-looking statements” within the meaning of the federal securities laws. Statements that are not historical facts, including statements about our beliefs and expectations are forward-looking statements. Statements containing the words “may,” “could,” “would,” “should,” “believe,” “expect,” “anticipate,” “plan,” “estimate,” “target,” “project,” “intend” and similar expressions constitute forward-looking statements. Forward-looking statements involve known and unknown risks and uncertainties, which could cause actual results to differ materially from those contained in any forward-looking statement. Such factors include, but are not limited to, the following: (1) general economic conditions and construction and industrial activity in the markets where we operate in North America; (2) the pace of economic recovery in areas affecting our business (although we have experienced an upturn in our business activities from the most recent economic downturn and related decreases in construction and industrial activities, there is no certainty that this trend will continue; if the pace of the recovery slows or construction and industrial activities decline, our revenues and operating results may be severely affected); (3) the impact of conditions of the global credit markets and their effect on construction spending activity and the economy in general; (4) relationships with equipment suppliers; (5) increased maintenance and repair costs as we age our fleet and decreases in our equipment’s residual value; (6) our indebtedness; (7) risks associated with the expansion of our business; (8) our possible inability to effectively integrate any businesses we acquire; (9) competitive pressures; (10) compliance with laws and regulations, including those relating to environmental matters and corporate governance matters; and (11) other factors discussed in our public filings, including the risk factors included in the Company’s most recent Annual Report on Form 10-K. Investors, potential investors and other readers are urged to consider these factors carefully in evaluating the forward-looking statements and are cautioned not to place undue reliance on such forward-looking statements. Except as required by applicable law, including the securities laws of the United States and the rules and regulations of the SEC, we are under no obligation to publicly update or revise any forward-looking statements after the date of this release.

 

H&E Equipment Services, Inc.
Leslie S. Magee, 225-298-5261
Chief Financial Officer
lmagee@he-equipment.com
or
Corporate Communications, Inc. (CCI)
Kevin S. Inda, 941-792-1680
kevin.inda@cci-ir.com

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(GTIM) Bad Daddy’s Burger Bar Brings Bold Flavors to Village at the Peaks in Longmont

Popular gourmet burger bar expands Colorado presence north

Good Times Restaurants Inc. (Nasdaq: GTIM) is announcing that Bad Daddy’s Burger Bar, a chef-driven, full-service restaurant that uses a mix of artisanal ingredients and made-from-scratch sauces and dressings to create the most delicious, flavorful and downright baddest burgers around, is opening a new location in Longmont. The restaurant, which is set to open its doors on February 15, 2016, will be located in the Village at the Peaks shopping center at 1232 South Hover Road.

With six other established restaurants in Colorado, the new burger bar will be the first location north of the Denver metro area and will provide guests in Longmont a dining experience unlike any other within the popular shopping community. The Village at the Peaks location will feature fan-favorite menu items including its popular gourmet burgers, such as the Bacon Cheeseburger on Steroids and the Bad Ass Burger, as well as chopped salads, specialty sides and appetizers. Additionally, the restaurant offers a full gluten-free menu and regional chef specials that incorporate Colorado flavors and ingredients.

“We’ve opened three locations over the past five months in the Greater Denver area and we’re thrilled to open up another Bad Daddy’s location in Village at the Peaks. Our loyal fans have been the best part of this experience, and we can’t wait to bring our chef-driven menu to Longmont,” said Boyd Hoback, CEO of Bad Daddy’s Burger Bar. “In addition to our regularly featured favorites, throughout February we’ll be honoring the success of the Broncos with the `Omaha! Omaha! Burger,’ that comes complete with pulled pork, pepper jack cheese, onion straws and our housemade apple-bacon barbeque sauce. If our guests are feeling up to the challenge, it pairs well with the Cherry Chocolate milkshake or one of our rotating microbrewed craft beers that are featured each month.”

Along with the restaurant’s core menu items, guests can expect to see new burgers, sides, salads and shake specials created by executive chef Tim Kast each month. The restaurant will continue to place its focus on simple, high-quality ingredients executed at a high level, but Bad Daddy’s Burger Bar doesn’t just stop at burgers. The restaurant’s delicious starters, like their famous Fried Pickles and Back Yard Chicken Nachos, are huge guest favorites, along with the menu of handspun milkshakes. For the health-conscious crowd, the gourmet burger bar offers Giant Chopped Salads tossed to order with fresh ingredients and homemade dressings, as well as a Create Your Own salad option. The Longmont location will also offer craft beers from Longmont’s Left Hand Brewing Company, Lafayette’s Liquid Mechanics Brewery, and Boulder’s Avery Brewing Company.

The Village at the Peaks opening is one of three additional Colorado sites expected to open through early summer 2016.

About Good Times Restaurants Inc.

Good Times Restaurants Inc. (GTIM) operates Good Times Burgers & Frozen Custard, a regional chain of quickservice restaurants located primarily in Colorado, in its wholly owned subsidiary, Good Times Drive Thru Inc. Good Times provides a menu of high-quality all-natural hamburgers, 100% all-natural chicken tenderloins, fresh frozen custard, natural-cut fries, fresh lemonades and other unique offerings. Good Times currently operates and franchises 37 restaurants. For more information about Good Times, please visit www.goodtimesburgers.com. Connect with Good Times on Facebook, Twitter and Instagram. GTIM also owns and operates Bad Daddy’s Burger Bar restaurants. Bad Daddy’s Burger Bar is a full-service, upscale, “small box” restaurant concept featuring a chef-driven menu of gourmet signature burgers, chopped salads, appetizers and sandwiches with a full bar and a focus on a selection of craft microbrew beers in a high-energy atmosphere that appeals to a broad consumer base. GTIM currently owns, operates, franchises and licenses 17 restaurants. For more information about Bad Daddy’s, please visit www.baddaddysburgerbar.com. Connect with Bad Daddy’s on Facebook, Twitter and Instagram.

 

Good Times Restaurants Inc.
Investor Relations Contacts
Boyd E. Hoback, 303-384-1411
President and CEO
or
Christi Pennington, 303-384-1440
or
Jim Zielke, 303-384-1432
Chief Financial Officer

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(WIN) Appoints Jeannie H. Diefenderfer, Larry Laque to Board of Directors

LITTLE ROCK, Ark., Feb. 11, 2016  — Windstream Holdings, Inc. (NASDAQ:WIN) announced today the appointments of Jeannie H. Diefenderfer and Larry Laque to the company’s board of directors. The appointments are effective immediately.

Diefenderfer and Laque qualify as independent board members under Nasdaq-listing requirements. Diefenderfer will serve on the board’s governance committee, and Laque will serve on the audit committee.

“I am very pleased to welcome Jeannie and Larry to the board. Both have deep experience in communications and technology. Their expertise and insight will be beneficial to Windstream and our shareholders,” said Tony Thomas, president and chief executive officer of Windstream.

Jeannie Diefenderfer, 54, is founder and chief executive officer of courageNpurpose, LLC. She has nearly 30 years of technical and operational leadership experience with Verizon Communications. She served as senior vice president of customer care and operations for Verizon Business from 2010 to 2012. She also held senior leadership positions in global network engineering, planning and procurement at Verizon.

Diefenderfer is an independent director on the boards of MRV Communications, Inc. (NASDAQ:MRVC) and Westell Technologies, Inc. (NASDAQ:WSTL), an advisory board member of Vasona Networks, Inc. and a member of the Accenture Network Advisory Council. She also is a trustee of Tufts University.

She holds a bachelor of science in chemical engineering from Tufts University, and an MBA from Babson College.

Larry Laque, 57, serves as executive vice president of global real estate and facilities for Discovery Communications, Inc. With more than 30 years of experience in technical planning and operations, Laque is currently responsible for developing and implementing workplace strategy, including technical facility infrastructure across 82 offices in more than 35 countries for the global media company.

Laque previously served as executive vice president and co-chief information officer and co-head of enterprise operational services for Discovery, where he oversaw global IT infrastructure for the company.

Prior to joining Discovery, Laque served in various leadership positions in network planning, operations and customer service at MCI Communications Corporation.

Laque also serves on the board of Shepherd’s Table, a Silver Spring-based nonprofit organization that provides basic services to homeless and in-need individuals in the greater Washington, D.C. area.

Laque holds a bachelor of arts in business administration from North Carolina State University and an MBA from The George Washington University.

The company also announced that Judy K. Jones and William A. ‘Bill’ Montgomery will not stand for re-election in May and depart the board when their current terms expire. Jones and Montgomery have served as directors of Windstream since its formation in 2006.

“Judy and Bill have provided exceptional guidance while steering the company through tremendous change in our industry. They have been valuable contributors to Windstream’s success, and we appreciate their decade of service on our board,” said Jeffrey T. Hinson, chairman of the board of Windstream, on behalf of the board.

About Windstream

Windstream Holdings, Inc. (NASDAQ:WIN), a FORTUNE 500 company, is a leading provider of advanced network communications and technology solutions for consumers, small businesses, enterprise organizations and carrier partners across the U.S. Windstream offers bundled services, including broadband, security solutions, voice and digital TV to consumers. The company also provides data, cloud solutions, unified communications and managed services to business and enterprise clients. The company supplies core transport solutions on a local and long-haul fiber-optic network spanning approximately 125,000 miles. Additional information is available at windstream.com. Please visit our newsroom at news.windstream.com or follow us on Twitter at @WindstreamNews.

Media Contact:
David Avery, 501-748-5876
david.avery@windstream.com

Investor Contact:
Mary Michaels, 501-748-7578
mary.michaels@windstream.com
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(COLL) Announces Favorable Judgment by the District Court of Massachusetts

CANTON, Mass., Feb. 11, 2016  — Collegium Pharmaceutical, Inc. (Nasdaq:COLL) announced that the District Court of Massachusetts issued an order for final judgment in favor of Collegium and against plaintiffs Purdue Pharma L.P., The P.F. Laboratories, Inc., Purdue Pharmaceuticals L.P., and Rhodes Technologies. The judgment relates to Purdue’s three Orange Book-listed patents asserted against Collegium that were the cause of the 30 month stay imposed on our New Drug Application for Xtampza™ ER.

“We are excited to have resolved this litigation of the patents that was delaying the potential final approval of Xtampza. The termination of the 30 month stay is a significant milestone for the Company,” said Michael Heffernan, CEO of Collegium. “We intend to move forward with our request for the U.S. Food and Drug Administration to convert our Tentative Approval to a Final Approval.”

“This judgment provides additional clarity on the timing for the potential commercial launch of Xtampza. Our commercial leadership team has developed our commercialization strategy over the last 12 months,” said Barry Duke, Chief Commercial Officer of Collegium.  “Over the next few months, we will complete the hiring and training of our sales organization, as we prepare for a late second quarter launch.”

About Collegium Pharmaceutical, Inc.

Collegium is a specialty pharmaceutical company focused on developing a portfolio of products that incorporate its patent-protected DETERx technology platform for the treatment of chronic pain and other diseases. The DETERx oral drug delivery technology is designed to provide extended-release delivery, unique abuse-deterrent properties, and flexible dose administration options.

About Xtampza™ ER

Collegium’s lead product candidate, Xtampza ER, is an abuse-deterrent, extended-release, oral formulation of oxycodone, in development for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. Collegium developed Xtampza using its proprietary DETERx technology platform to address common methods of abuse, including chewing, crushing and/or dissolving, and then taking it orally or snorting or injecting.

The United States Food and Drug Administration (FDA) has granted tentative approval to the Company’s New Drug Application (NDA) for Xtampza ER for the management of pain severe enough to require daily, around-the-clock, long-term opioid treatment and for which alternative treatment options are inadequate. With a tentative approval, the FDA has determined that Xtampza ER meets required quality, safety and efficacy standards for approval but it is subject to an automatic stay of up to 30 months as a result of patent litigation filed by Purdue Pharma, L.P.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. We may, in some cases, use terms such as “predicts,” “believes,” “potential,” “proposed,” “continue,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that we will obtain final approval for Xtampza ER or any of our other product candidates from the FDA or foreign regulatory authorities; even if Xtampza ER obtains final approval, we may not be able to obtain the label claims that we are seeking from the FDA. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: our ability to commercialize our product candidates; the existence of any patent infringement or similar litigation relating to any of our products or product candidates, and costs and delays associated with such litigation; the size and growth potential of the markets for our product candidates, and our ability to service those markets; our ability to develop sales and marketing capabilities, whether alone or with potential future collaborators; the rate and degree of market acceptance of our product candidates; the success, cost and timing of our product development activities, studies and clinical trials; the success of competing products that are or become available; and our expectations regarding our ability to obtain and adequately maintain sufficient intellectual property protection for our product candidates. These and other risks are described under the heading “Risk Factors” in the registration statement on Form S-1 (commission file number 333-208641), which was declared effective by the Securities and Exchange Commission (“SEC”) on January 7, 2016, and those risks described from time to time in other reports which we file with the SEC. Any forward-looking statements that we make in this press release speak only as of the date of this press release. We assume no obligation to update our forward-looking statements whether as a result of new information, future events or otherwise, after the date of this press release.

 

Contact: 
Douglas Carlson
Vice President, Corporate Development
dcarlson@collegiumpharma.com
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(CRNT) to Showcase its 5G Wireless Backhaul Technologies

Ceragon’s microwave and millimeterwave backhaul technologies will enable communication service providers to prepare for next generation 5G networks

LITTLE FALLS, New Jersey, February 11, 2016  —

Ceragon Networks Ltd. (NASDAQ: CRNT), the #1 wireless backhaul specialist, today announced that it will showcase its 5G wireless backhaul technologies at Mobile World Congress 2016, in Barcelona, Spain. Commercial offering of 5G services in developed markets is expected to begin by 2020 and is expected to bring exponential growth in network capacity as well as the number and types of connected devices. 5G technology is also anticipated to enable a wide variety of new services, including IoT and M2M, changing the way networks are designed and built. A key requirement to meet 5G service demands is a flexible wireless backhaul infrastructure which meets more stringent performance, reliability, and operational efficiency targets. Ceragon Networks is developing robust technologies to meet the need for 100 times higher capacity at cell sites, at least five times denser cell-site grids, with large scale street-level deployments, network virtualization and optimization, as well as support for mission critical applications.

Powered by Ceragon’s multicore technologies which achieve faster time to market with higher performance at affordable costs by using in-house designed system on chips, which are integrated into Ceragon’s wireless backhaul solutions, Ceragon’s solutions are being optimized for 5G capacity, latency, service and network availability targets.

“Ceragon’s strategic investment in vertically integrated solutions, developing advanced microwave and millimeterwave systems on chips and integrating those into complete products, will allow communication service providers to meet their business objectives as their networks evolve to deliver 5G services,” said Ira Palti, president and CEO of Ceragon. “Supporting our customers today in their 4G deployments and their evolution from 3G to 4G, Ceragon is committed to delivering solutions that enable its customers to achieve the highest value both in operational efficiency and customer experience, while ensuring peace of mind by offering a highly reliable network able to evolve over time.”

Ceragon’s wireless backhaul technologies will enable communication service providers to:

  1. Deliver up to 10Gbps backhaul to cell sites using ultra-wide microwave frequency channels with LoS 4×4 MIMO technology at 6 – 42GHz, and millimeterwave compact radios – overcoming spectrum shortages and reducing site acquisition and related costs.
  2. Deploy cellular base stations and small cells exactly where needed, in any deployment scenario, by eliminating backhaul constraints caused by lack of spectrum and inability to reuse the microwave spectrum channels. Ceragon’s Advanced Frequency Reuse technology allows for reusing frequency channels twice as often as otherwise possible, ensuring the location of the cellular site is not compromised, that the cost of backhaul is as low as possible, and that the quality of service for customers is not compromised.
  3. Overcome microwave spectrum congestion by using multiband carrier aggregation of microwave and millimeterwave spectrum with Ceragon’s unique Multicarrier Adaptive Bandwidth Control technology. This technology meets capacity requirements, intelligently balancing traffic over microwave and millimeterwave channels and achieving service availability and reliability targets, while avoiding expensive trenching of fiber where it is not needed.
  4. Enable fast deployment of highly dense cellular base stations and small cell grids by use of Ceragon’s multicore MIMO technology for Non Line of Sight use cases at 6 – 42GHz. Developed by Ceragon, this unique multicore MIMO technology will allow high performance, predictable capacity in NLoS conditions, while simplifying service rollout, eliminating alternative backhaul costs and accelerate revenue generation.
  5. Adopt cost reduced network architecture with Cloud RAN by use of ultra-high capacity wireless backhaul (fronthaul) delivering 2.5Gbps to 10Gbps digital signaling between cloud baseband units and remote radio heads.
  6. Ensure optimal use of network resources using Software Defined networks (SDN) technologies with open interfaces for simple and quick network integration, overcoming barriers of the current wireless networks eco system. Ceragon’s SDN wireless backhaul technologies optimize resources by performing dynamic spectrum allocation, intelligent power consumption management, and dynamic service reroute to increase operational efficiency, maintain high network reliability and enhance customers’ quality of experience.
  7. Enable simplified evolution from 4G to 5G networks using IP-20 Platform technologies and capabilities, allowing maximum use of the Ceragon 4G wireless backhaul investments made today.

 

About Ceragon Networks Ltd.

Ceragon Networks Ltd. (NASDAQ: CRNT) is the world’s #1 wireless backhaul specialist. We help operators and other service providers worldwide increase operational efficiency and enhance end customers’ quality of experience with innovative wireless backhaul solutions. Our customers include wireless service providers, public safety organizations, government agencies and utility companies, which use our solutions to deliver 4G, mission-critical multimedia services and other applications at high reliability and speed. Ceragon’s unique multicore technology provides a highly reliable, high-capacity 4G wireless backhaul with minimal use of spectrum, power and other resources. It enables increased productivity, as well as simple and quick network modernization. We deliver a range of professional services that ensure efficient network rollout and optimization to achieve the highest value for our customers. Our solutions are deployed by more than 460 service providers, as well as hundreds of private network owners, in more than 130 countries.

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Ceragon Networks® and FibeAir® are registered trademarks of Ceragon Networks Ltd. in the United States and other countries. CERAGON ® is a trademark of Ceragon Networks Ltd., registered in various countries. Other names mentioned are owned by their respective holders.

Safe Harbor

This press release contains statements concerning Ceragon’s future prospects that are “forward-looking statements” under the Private Securities Litigation Reform Act of 1995. Examples of forward-looking statements include: projections of capital expenditures and liquidity, competitive pressures, revenues, growth prospects, product development, financial resources, restructuring costs, cost savings and other financial matters. You can identify these and other forward-looking statements by the use of words such as “may,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “expects,” “intends,” “potential” or the negative of such terms, or other comparable terminology. These forward-looking statements are subject to risks and uncertainties that may cause actual results to differ materially, including risks associated with the risk that Ceragon will not achieve the benefits it expects from its expense reduction and profit enhancement programs; the risk that Ceragons expectations regarding future revenues and profitability will not materialize; the risk that Ceragon will not continue to comply with the financial or other covenants in its agreements with its lenders; risks associated with doing business in Latin America, including currency export controls and recent economic concerns; risks relating to the concentration of our business in the Asia Pacific region and in developing nations; the risk of significant expenses in connection with potential contingent tax liability associated with Nera’s prior operations or facilities; and other risks and uncertainties detailed from time to time in Ceragon’s Annual Report on Form 20-F and Ceragon’s other filings with the Securities and Exchange Commission, and represent our views only as of the date they are made and should not be relied upon as representing our views as of any subsequent date. We do not assume any obligation to update any forward-looking statements.

Media Contact:
Matthew Krieger
GK Public Relations
Tel: +914-768-4219

matthew@gkpr.com

Company Contact:
Tanya Solomon
Ceragon Networks
Tel: +972-3-543-1163

tanyas@ceragon.com

Investor Contact:
Claudia Gatlin
Tel. +1-(212)-830-9080

claudiag@ceragon.com

Thursday, February 11th, 2016 Uncategorized Comments Off on (CRNT) to Showcase its 5G Wireless Backhaul Technologies