Archive for September, 2016

$GWRS Declares Monthly #Dividend

PHOENIX, Ariz., Sept. 30, 2016  — Global Water Resources, Inc. (NASDAQ:GWRS), (TSX:GWR), a pure-play water resource management company, has declared, under its dividend policy, a monthly cash dividend in the amount of $0.022 per common share (an annualized amount of $0.264 per share), which will be payable on October 31, 2016, to holders of record at the close of business on October 17, 2016.

About Global Water Resources, Inc.
Global Water Resources, Inc. is a comprehensive water resource management company based in Phoenix, Arizona. It manages the entire water cycle by owning and operating water, wastewater and recycled water utilities. For more information about Global Water Resources, visit www.gwresources.com.

Company Contact for Global Water Resources
Michael J. Liebman 
Chief Financial Officer and Corporate Secretary 
(480) 999-5104 
mike.liebman@gwresources.com

Investor Relations for Global Water Resources:
Ronald A. Both
Liolios Investor Relations
(949) 574-3860
gwrs@liolios.com
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$CQH #Buyout Offer by $LNG

HOUSTON, Sept. 30, 2016  — Cheniere Energy Partners LP Holdings, LLC (“Cheniere Partners Holdings”) (NYSE MKT: CQH) announced today that its board of directors has received a proposal from Cheniere Energy, Inc. (“Cheniere”) (NYSE MKT: LNG) pursuant to which Cheniere would acquire the publicly held shares of Cheniere Partners Holdings not already owned by Cheniere in a stock for stock exchange. Subject to negotiation and execution of a definitive agreement, Cheniere is proposing consideration of 0.5049 Cheniere shares for each issued and outstanding publicly-held share of Cheniere Partners Holdings as part of a transaction that would be structured as a merger of Cheniere Partners Holdings with a wholly-owned subsidiary of Cheniere. The proposed consideration represents a value of $21.90 per common share of Cheniere Partners Holdings, or a premium of approximately 3.0% over the closing price of Cheniere Partners Holdings’ shares, based on the closing prices of Cheniere Partners Holdings’ shares and of Cheniere’s shares as of September 29, 2016, or a premium of approximately 7.0% over the 30-trading day average CQH / LNG exchange ratio as of September 29, 2016.

Cheniere owns 80.1% of the issued and outstanding shares of Cheniere Partners Holdings.

The proposed transaction is subject to the negotiation and execution of a definitive agreement and approval of such definitive agreement and transactions contemplated thereunder by the board of directors of Cheniere, the board of directors of Cheniere Partners Holdings and a conflicts committee established by the board of directors of Cheniere Partners Holdings, and the consummation of the proposed transaction would be subject to customary closing conditions. There can be no assurance that any such approvals will be forthcoming, that a definitive agreement will be executed or that any transaction will be consummated.

About Cheniere Partners Holdings

Cheniere Partners Holdings owns a 55.9% limited partner interest in Cheniere Energy Partners, L.P. (NYSE MKT: CQP) (“Cheniere Partners”), a publicly traded limited partnership. Cheniere Partners Holdings’ only business consists of owning Cheniere Partners units and, accordingly, its results of operations and financial condition are dependent on the performance of Cheniere Partners. Cheniere Partners owns and operates liquefied natural gas (“LNG”) regasification facilities and, adjacent to these facilities, plans to construct over time up to six natural gas liquefaction trains (“Trains”) with an expected aggregate nominal production capacity of approximately 27 mtpa. Trains 1 and 2 have achieved substantial completion. Train 3 is undergoing commissioning, Trains 4 and 5 are under construction, and Train 6 is fully permitted.

For additional information, please refer to the Cheniere Partners Holdings website at www.cheniere.com and Quarterly Report on Form 10-Q for the quarter ended June 30, 2016, filed with the Securities and Exchange Commission.

Forward-Looking Statements

This press release includes “forward-looking statements”. In particular, statements using words such as “may,” “will,” “could,” “should,” “expect,” “plan,” “project,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” “pursue,” “target,” “continue,” the negative of such terms or other comparable terminology generally involve forward-looking statements. The forward-looking statements contained herein (including statements regarding the proposed transaction and its effects, benefits and costs, savings, opinions, forecasts, projections, expected timetable for completion, expected distribution, and any other statements regarding Cheniere Partners Holdings’ and Cheniere’s future expectations, beliefs, plans, objectives, financial conditions, assumptions or future events or performance that are not statements of historical fact) are largely based on our expectations, which reflect estimates and assumptions made by our management. These estimates and assumptions reflect our best judgment based on currently known market conditions and other factors. Although we believe that such estimates are reasonable, they are inherently uncertain and involve a number of risks and uncertainties beyond our control. In addition, assumptions may prove to be inaccurate. We caution that the forward-looking statements contained herein are not guarantees of future performance and that such statements may not be realized or the forward-looking statements or events may not occur. Actual results may differ materially from those anticipated or implied in forward-looking statements as a result of numerous factors, including, but not limited to, the negotiation and execution, and the terms and conditions, of a definitive agreement relating to the proposed transaction and the ability of Cheniere or Cheniere Partners Holdings to enter into or consummate such an agreement; the risk that the proposed merger does not occur; negative effects from the pendency of the proposed merger; the ability to realize expected cost savings and benefits; failure to obtain the required vote of Cheniere Partners Holdings’ shareholders; the timing to consummate the proposed transaction; the impact of regulatory changes; and other factors affecting future results disclosed in Cheniere’s and Cheniere Partners Holdings’ respective filings with the SEC (available at the SEC’s website at www.sec.gov), including but not limited to those discussed under Item 1A, “Risk Factors”, in Cheniere’s Annual Report on Form 10-K for the year ended December 31, 2015 and Cheniere Partners Holdings’ Annual Report on Form 10-K for the year ended December 31, 2015. These forward-looking statements speak only as of the date made, and other than as required by law, we undertake no obligation to update or revise any forward-looking statement or provide reasons why actual results may differ, whether as a result of new information, future events or otherwise.

Additional Information and Where to Find It

This communication does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of a proxy or of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed transaction between Cheniere and Cheniere Partners Holdings. In the event that the parties enter into a definitive agreement with respect to the proposed transaction, the parties intend to file a registration statement on Form S-4, containing a proxy statement/prospectus (the “S-4”) with the SEC. This communication is not a substitute for the registration statement, definitive proxy statement/prospectus or any other documents that Cheniere or Cheniere Partners Holdings may file with the SEC or send to shareholders in connection with the proposed transaction. INVESTORS AND SHAREHOLDERS OF CHENIERE PARTNERS HOLDINGS ARE URGED TO READ ALL RELEVANT DOCUMENTS FILED WITH THE SEC, INCLUDING THE PROXY STATEMENT/PROSPECTUS IF AND WHEN FILED, BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION.

When available, investors and security holders will be able to obtain copies of the S-4, including the proxy statement/prospectus and any other documents that may be filed with the SEC in the event that the parties enter into a definitive agreement with respect to the proposed transaction free of charge at the SEC’s website at http://www.sec.gov. Copies of documents filed with the SEC by Cheniere will also be made available free of charge on Cheniere’s website at www.cheniere.com. Copies of documents filed with the SEC by Cheniere Partners Holdings will also be made available free of charge on Cheniere Partners Holdings’ website at www.cheniere.com.

Participants in the Solicitation

Cheniere, Cheniere Partners Holdings and their respective directors and executive officers may be deemed to be participants in any solicitation of proxies from Cheniere Partners Holdings’ shareholders with respect to the proposed transaction. Information about Cheniere Partners Holdings’ directors and executive officers is set forth in Cheniere Partners Holdings’ 2015 annual report on Form 10-K, which was filed with the SEC on February 19, 2016, and in Cheniere Partners’ Holdings current reports on Form 8-K, which were filed with the SEC on May 12, 2016, June 6, 2016, and September 19, 2016. Information about Cheniere’s directors and executive officers is set forth in Cheniere’s proxy statement for its 2016 Annual Meeting of Shareholders, which was filed with the SEC on April 21, 2016, and in Cheniere’s current reports on Form 8-K, which were filed with the SEC on May 12, 2016, June 6, 2016, and September 19, 2016. Other information regarding the participants in the proxy solicitation and a description of their direct and indirect interests, by security holdings or otherwise, will be contained in the proxy statement/prospectus and other relevant materials to be filed with the SEC regarding the proposed transaction if and when they become available. Investors should read the proxy statement/prospectus carefully if and when it becomes available before making any voting or investment decisions.

CONTACTS:

Investors: Randy Bhatia: 713-375-5479
Media: Faith Parker: 713-375-5663

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$ASCMA Monitronics Rebrands as #MONI Begins New Era Of Smart #HomeSecurity

New Name Reflects the Company’s Evolution as a Smart Home Security Solutions Organization with Faster, More Personalized Offerings

DALLAS, Sept. 30, 2016  — Monitronics, a subsidiary of Ascent Capital Group, Inc. (Nasdaq: ASCMA) today unveiled its new name: “MONI,” beginning a new era of smart home security that brings increased speed and personalization to the market.

The Company has been the “secret sauce” behind more than 600 independent alarm companies’ successes for the past two decades, with a cutting-edge monitoring solution that secures more than one million residential customers and commercial client accounts in the US.  However, “Monitronics” was intentionally unbranded in the eyes of the consumer, allowing independent dealer brands to take center stage. The new MONI brand will be marketed directly to consumers and supported by direct-to-consumer sales and customer support. This will not only enable MONI’s expert custom solutions to flow directly into the home, but is designed to nurture MONI’s trusted dealer network by showing consumers the strength behind the individual dealer brands. The new branding will also provide dealers with the national marketing, sales and customer service support that they need to compete more effectively in their regional markets.

“As a leader in home security solutions for more than 20 years, professionally installed and monitored smart home security has always remained at the core of our business,” said Jeff Gardner, president and CEO of MONI. “Home and business security needs are as unique and individualized as each customer. Solution offerings and customer service throughout the industry must change as we enter a new era of smart home security that emphasizes a customized approach to comprehensive safety and protection.”

MONI sees the new era of smart home security as one where personal safety takes priority in the connected home. This is enabled by:

  • Simplified “Smart” Homes
    • Delivering leading products that integrate with existing systems and packages, enabling mainstream home automation features that emphasize complete security and control
  • Customer-Centric Personalization
    • Personalized solutions that are truly tailored to the needs of each individual consumer, allowing them to customize not only equipment and services, but the entire customer experience for greater control, confidence and security
  • Faster Response
    • Faster response times to alarm events – managing the personal and home security concerns that matter most in seconds for true peace of mind

“Whether it is a routine situation or lives are on the line, MONI knows that every moment matters,” continued Gardner. “Over the last two decades we have built our business on the ability to listen and respond. Customers have spoken, and they are calling for a new approach to smart home security, a new era of customer-centric personalization with solutions designed to meet the needs of each individual, and MONI is poised to deliver.”

To learn more about MONI and the full suite of personalized security solutions available, visit www.mymoni.com.

About MONI
MONI, the new Monitronics, is a subsidiary of Ascent Capital Group, Inc. (NASDAQ: ASCMA) and is one of the largest home security alarm monitoring companies in the U.S. Headquartered in the Dallas Fort-Worth area, MONI secures more than one million residential customers and commercial client accounts with monitored home and business security system services. The company is supported by the nation’s largest network of independent Authorized Dealers, providing products and support to customers in the U.S., Canada and Puerto Rico.

Contact: Lindsay Lougee
MONI Smart Security
Tel: 972-243-7443, ext. 73121
E-mail: llougee@mymoni.com

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$SVVC Portfolio Company #Nutanix Goes Public

SAN JOSE, Calif., Sept. 30, 2016  — Firsthand Technology Value Fund, Inc. (NASDAQ:SVVC) (the “Fund”), a publicly traded venture capital fund that invests in technology and cleantech companies, announced today that Nutanix, a Fund holding since May 2015, went public today through an initial public offering (“IPO”). The IPO was priced last evening at $16.00 per share, resulting in proceeds to the company of approximately $238 million. The shares, which now trade on the NASDAQ under the ticker symbol “NTNX”, opened their first day of trading at $26.50.

“In what has been a challenging environment for tech IPOs, we are excited about the successful public debut for Nutanix,” stated Kevin Landis, Firsthand’s CEO.  “This marks the 7th IPO for our fund since its inception in 2011 and follows the successful exits of Mattson and Tapad earlier this year.”

The Fund holds 459,772 shares of Nutanix common stock as of September 30, 2016, at an approximate average cost of $16.04 per share. The Fund’s shares are subject to a customary 180-day lockup provision.

Nutanix is a provider of so-called “hyperconverged” data center equipment that merges computing, storage, and networking capabilities in a single piece of equipment. The company’s products offer corporate customers access to technologies similar to those used by Google, Amazon, and Facebook in their own data centers.

About Firsthand Technology Value Fund
Firsthand Technology Value Fund, Inc. is a publicly traded venture capital fund that invests in technology and cleantech companies. More information about the Fund and its holdings can be found online at www.firsthandtvf.com.

The Fund is a non-diversified, closed-end investment company that elected to be treated as a business development company under the Investment Company Act of 1940. The Fund’s investment objective is to seek long-term growth of capital. Under normal circumstances, the Fund will invest at least 80% of its total assets for investment purposes in technology and cleantech companies.  An investment in the Fund involves substantial risks, some of which are highlighted below.  Please see the Fund’s public filings for more information about fees, expenses and risk.  Past investment results do not provide any assurances about future results.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS: This press release contains “forward-looking statements” as defined under the U.S. federal securities laws. Generally, the words “believe,” “expect,” “intend,” “estimate,” “anticipate,” “project,” “will,” and similar expressions identify forward-looking statements, which generally are not historical in nature. Forward-looking statements are subject to certain risks and uncertainties that could cause actual results to materially differ from the Fund’s historical experience and its present expectations or projections indicated in any forward-looking statement. These risks include, but are not limited to, changes in economic and political conditions, regulatory and legal changes, technology and cleantech industry risk, valuation risk, non-diversification risk, interest rate risk, tax risk, and other risks discussed in the Fund’s filings with the SEC. You should not place undue reliance on forward-looking statements, which speak only as of the date they are made. The Fund undertakes no obligation to publicly update or revise any forward-looking statements made herein. There is no assurance that the Fund’s investment objectives will be attained. We acknowledge that, notwithstanding the foregoing, the safe harbor for forward-looking statements under the Private Securities Litigation Reform Act of 1995 does not apply to investment companies such as us.

Contact:

Heather Hohlowski
Firsthand Capital Management, Inc. 
(408) 624-9525
vc@firsthandtvf.com
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$ITUS Demonstrates Efficacy of #Cchek in #Ovarian #Cancer

LOS ANGELES, CA–(September 30, 2016) – ITUS Corporation (“ITUS“) (NASDAQ: ITUS), today announced that it has successfully utilized its Cchek™ early cancer detection platform to identify the presence of Ovarian Cancer. There is currently no sufficiently accurate test for the early detection of Ovarian Cancer, which has a 5-year survival rate of only 46%.

Cchek™ is ITUS’s early cancer detection technology which measures a patient’s immunological response to a malignancy by detecting the presence, absence, and quantity of certain unique immune system cells that exist in and around a tumor and that enter the blood stream. As part of the ongoing development of ITUS’s Cchek diagnostic platform, the company has successfully used Cchek to detect the presence of Ovarian Cancer in patients that have been diagnosed via conventional means such as invasive procedures like surgical biopsies.

Approximately 250,000 new cases of Ovarian Cancer are diagnosed each year worldwide, and Ovarian Cancer causes approximately 140,000 deaths. Overall, only 15% of Ovarian Cancer cases are diagnosed at a local stage, for which the 5-year survival rate is 92%. The company previously announced success with Cchek detecting Breast Cancer, Lung Cancer, Colorectal Cancer and Melanoma.

ITUS Corporation
ITUS funds, develops, acquires, and licenses emerging technologies in areas such as biotechnology. The Company is developing a platform called Cchek™, a series of non-invasive, blood tests for the early detection of solid tumor based cancers, which is based on the body’s immunological response to the presence of a malignancy. Additional information is available at www.ITUScorp.com.

Forward-Looking Statements: Statements that are not historical fact may be considered forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are not statements of historical facts, but rather reflect ITUS Corporation’s current expectations concerning future events and results. We generally use the words “believes,” “expects,” “intends,” “plans,” “anticipates,” “likely,” “will” and similar expressions to identify forward-looking statements. Such forward-looking statements, including those concerning our expectations, involve risks, uncertainties and other factors, some of which are beyond our control, which may cause our actual results, performance or achievements, or industry results, to be materially different from any future results, performance, or achievements expressed or implied by such forward-looking statements. These risks, uncertainties and factors include, but are not limited to, those factors set forth in “Item 1A – Risk Factors” and other sections of our Annual Report on Form 10-K for the fiscal year ended October 31, 2015 as well as in our Quarterly Reports on Form 10-Q and Current Reports on Form 8-K. We undertake 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. You are cautioned not to unduly rely on such forward-looking statements when evaluating the information presented in this press release.

ITUS Corporation: FOCUSED ON INNOVATION™

Contact:
Dean Krouch
310-484-5184
dkrouch@ITUScorp.com

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$EFOI Fixtures Qualified for #USNavy Use on New Ships

Entire family of 2-ft Tubular LEDs and fixtures are first competitive choice for Navy in nearly 70 years

SOLON, Ohio, Sept. 29, 2016  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, today announced that the U.S. Navy Naval Sea Systems Command has qualified the entire family of Energy Focus 2-ft. tubular LEDS (TLEDs) and fixtures for use on new ship construction. Approval of the single-, double- and triple-tube 2-ft. fixtures was granted on Sept. 22.

“For nearly 70 years, new vessel development has depended on only one manufacturer for fixtures,” said Dave Bina, Energy Focus Senior Vice President of Military and Maritime Sales. “Now, new ships will have a competitive choice between the legacy standards and Energy Focus’ cutting-edge LED lighting technology.”

Since 2007, when Energy Focus became the first company to develop, qualify and install LED products on Navy vessels, Energy Focus has provided LED lighting for every surface ship in the fleet. Through this partnership, Energy Focus has developed, qualified and installed more than a half-million LED lighting products, including TLEDs, floodlights, waterline security lights, HAZLOC globes and berth lights, on U.S. Navy vessels.

In the military, there is a constant need to go farther, stay longer and deliver more firepower. Energy Focus contributes to this need as the premier supplier to the U.S. Navy for qualified LED lighting for the fleet. Compared to legacy manufacturer’s LED fixtures, Energy Focus LEDs consume one-third less energy and weigh 25-percent less. On a ship with thousands of light fixtures, Energy Focus fixtures could save significant unnecessary weight on the vessels that protect American interests around the world.

“We are very pleased to have received another critical recognition from the U.S. Navy to enable us to serve the LED lighting needs for new Navy ships,” said James Tu, CEO and President of Energy Focus. “This new family of LED lighting fixtures, with extremely competitive value proposition from quality, performance and price standpoints, will be able to address new ship construction segments of not only U.S. and foreign allied navies but also the broader commercial marine market.”

About Energy Focus, Inc. 

Energy Focus, Inc. is a leading provider and innovator of energy efficient LED lighting products. As the creator of the only 100-percent flicker-free LED products on the market, Energy Focus products provide extensive energy savings, aesthetics, safety and health benefits over conventional and fluorescent lighting. As a long standing partner with the US Government providing energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets, Energy Focus products go through rigorous testing in the most adverse conditions possible and still have a zero percent failure rate. In the commercial sphere, customers include national, state and local U.S. government agencies as well as Fortune 500 companies across education, healthcare, retail and manufacturing. Energy Focus is headquartered in Solon, Ohio, with additional sales offices in Washington, D.C., New York and Taiwan.

Media Contact:
Michael Miller
Content Strategist
Energy Focus, Inc.
msmiller@energyfocusinc.com
(440) 715-1300 Office
(734) 945-6359 Cell

Investor Contact:
Darrow Associates, Inc.
Peter Seltzberg
pseltzberg@darrowir.com
516-419-9915
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$ABUS Interim Results #Phase2 #ClinicalTrial of #ARB1467 in #HBV

  • Single Dose Data Demonstrate Significant Reduction in Serum HBsAg
  • Additive Reductions in Serum HBsAg Observed with Repeat Dosing over 3 Months
  • 5 of 6 Patients in Cohort 1 Had Serum HBsAg Reductions of Greater Than 0.5 log10 After 3 Doses
  • Additional Multi-Dose ARB-1467 Data Expected in 4Q16
  • Company to Host Conference Call Today at 5 pm ET to Discuss Results

VANCOUVER, British Columbia and DOYLESTOWN, Pa., Sept. 29, 2016 — Arbutus Biopharma Corporation (Nasdaq:ABUS), an industry-leading hepatitis B virus (HBV) therapeutic solutions company, today reported interim results from the first two cohorts of the ongoing ARB-1467 Phase II multi-dose clinical trial in chronically infected HBV patients.  The first two cohorts enrolled patients with hepatitis B e-antigen (HBeAg) negative chronic HBV infection. At this time, serum HBsAg data are available following single doses for both Cohort 1 and Cohort 2 and following multiple doses for Cohort 1.

Single dose ARB-1467 results for Cohorts 1 and 2 demonstrate significant reductions in serum HBsAg levels. Importantly, multiple dose results from Cohort 1 show a step-wise, additive reduction in serum HBsAg. These multiple dose results are the first of their kind for an RNAi product candidate in patients with chronic HBV infection. Treatment with ARB-1467 has been generally well tolerated to date.

      Single Dose HBsAg Reduction
(log10 IU/mL)
Multiple Dose HBsAg Reduction
(log10 IU/mL)
Cohort N  ARB-1467
(mg/kg)
 Mean  Mean Maximum  Maximum  Mean  Mean Maximum  Maximum
1 6 0.2 -0.3 -0.4 -1.0 -0.6 -0.7 -1.3
2 6 0.4 -0.2 -0.3 -0.8 NA NA NA
 Placebo  4 0.0 0.0 -0.1 0.0 0.0 -0.1
aThe mean serum HBsAg reduction is the nadir value of the arithmetic mean of all values observed at each time point.
bThe mean maximum HBsAg reduction is the mean of each patient’s maximum reduction in serum HBsAg.
cMaximum HBsAg reduction is the best single reduction among all patients in a cohort.
dSingle dose placebo results are based on four subjects (two from each cohort). Multiple dose placebo results are based on the two placebo subjects in Cohort 1.

“The interim ARB-1467 data demonstrate significant serum HBsAg reduction following the first dose, which is enhanced with repeat dosing. This is a very important finding because it suggests that even greater reductions in serum HBsAg levels may be observed with continued dosing of ARB-1467,” said Dr. Douglas T. Dieterich, Professor of Medicine in the Division of Liver Disease at Icahn School of Medicine at Mount Sinai Medical Center. “These exciting data demonstrate the antiviral effect of ARB-1467 and the potential to include this agent as a component of a combination therapy regimen for the treatment of chronic HBV infection.”

“We are excited about these HBV efficacy data from our ongoing ARB-1467 Phase II trial demonstrating substantial reductions in serum HBsAg, which is an important first step towards one day curing chronic HBV infection. We believe that further study of ARB-1467 will help determine the optimal protocol to produce maximal reductions in serum HBsAg,” said Dr. Mark J. Murray, Arbutus’ President and CEO. “We plan to release additional multi-dose data later this year. We believe that ultimately curing HBV will require combination therapy and we are developing a portfolio of HBV assets with complementary mechanisms of action to accomplish this goal.”

ARB-1467 Phase 2 Trial Design
The Phase II trial is a multi-dose study in chronic HBV patients who are also receiving stable nucleot(s)ide analog therapy. The trial consists of three cohorts, each enrolling eight subjects; six receiving three monthly doses of ARB-1467, and two receiving placebo. The first two cohorts include HBeAg- patients, followed by a third cohort in HBeAg+ patients.

About ARB-1467
Arbutus’ RNAi candidate ARB-1467 comprises three RNAi triggers that target all four HBV transcripts, and has been shown in preclinical studies to reduce all viral antigen levels as well as cccDNA and HBV DNA.  ARB-1467 utilizes Arbutus’ proprietary lipid nanoparticle (LNP) platform, a clinically validated delivery technology which has been tested in hundreds of patients.

Conference Call Today
Arbutus will hold a conference call and webcast today, September 29, 2016, at 2:00 p.m. Pacific Time (5:00 p.m. Eastern Time) to provide interim results from the ongoing ARB-1467 Phase II clinical trial. A live webcast of the call can be accessed through the Investor section of Arbutus’ website at www.arbutusbio.com. Or, alternatively, to access the conference call, please dial 1-914-495-8556 or 1-866-393-1607.

An archived webcast will be available on the Arbutus website after the event. Alternatively, you may access a replay of the conference call by calling 1-404-537-3406 or 1-855-859-2056 and referencing conference ID 91182747.

About Arbutus
Arbutus Biopharma Corporation is a biopharmaceutical company dedicated to discovering, developing and commercializing a cure for patients suffering from chronic HBV infection.  Arbutus is headquartered in Vancouver, BC, Canada with offices in Doylestown, PA, USA. For more information, visit www.arbutusbio.com.

Forward Looking Statements and Information
This press release contains forward-looking statements within the meaning of the Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, and forward looking information within the meaning of Canadian securities laws (collectively, “forward-looking statements”). Forward-looking statements in this press release include statements about possibly even greater reductions in serum HBsAg levels with continued dosing of ARB-1467; the potential to include ARB-1467 as a component of a combination therapy regimen for the treatment of chronic HBV infection; determining the optimal protocol to produce maximal reductions in serum HBsAg through further study of ARB-1467; releasing additional multi-dose data later this year; and developing a portfolio of HBV assets to ultimately cure HBV through combination therapy.

With respect to the forward-looking statements contained in this press release, Arbutus has made numerous assumptions regarding, among other things: the effectiveness and timeliness of clinical trials, and the usefulness of the data; the continued demand for Arbutus’ assets; and the stability of economic and market conditions. While Arbutus considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.

Additionally, there are known and unknown risk factors which could cause Arbutus’ actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: anticipated clinical trials may be more costly or take longer to complete than anticipated, and may never be initiated or completed, or may not generate results that warrant future development of the tested drug candidate; Arbutus may not receive the necessary regulatory approvals for the clinical development of Arbutus’ products; economic and market conditions may worsen; and market shifts may require a change in strategic focus.

A more complete discussion of the risks and uncertainties facing Arbutus appears in Arbutus’ Annual Report on Form 10-K and Arbutus’ continuous disclosure filings, which are available at www.sedar.com and at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Arbutus disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.

Contact Information 
Investors
Adam Cutler
Senior Vice President, Corporate Affairs
Phone: 604.419.3200 
Email: acutler@arbutusbio.com

Helia Baradarani
Senior Manager, Investor Relations
Phone: 604.419.3200
Email: hbaradarani@arbutusbio.com

Media
Please direct all media inquiries to: media@arbutusbio.com
Thursday, September 29th, 2016 Uncategorized Comments Off on $ABUS Interim Results #Phase2 #ClinicalTrial of #ARB1467 in #HBV

$NXPI Delivers Enhanced Anti-Cloning Security Solution

NXP adds PUF Anti-Cloning technology to its next generation SmartMX2 microcontroller enabling electronic identification solutions to thrive in the age of Smart Cities

EINDHOVEN, Netherlands, Sept. 29, 2016  — NXP Semiconductors N.V. (NASDAQ:NXPI) today unveiled its next generation of SmartMX2 P60 Step-Up! that offers customers unique security features such as PUF (Physical Unclonable Function) anti-cloning technology for higher encryption key protection.

Today, many Smart City initiatives seek to make urban living simpler, safer and healthier. These initiatives drive greater demand for secure technologies to protect individual and financial credentials. To address this demand, NXP’s new SmartMX2 P60 Step-Up! Secure Element provides secure authentication and confidential data exchange.

To be first in market in smart cards, NXP is collaborating with MaskTech, the leading independent provider of high security smart card operating systems for electronic identification cards, travel documents and authentication solutions. Together, the companies will add PUF anti-cloning technology to secure smart cards for applications like ePassports, eID cards, driving licenses, health cards, payment cards and embedded security.

“Security and convenience for smart city solutions are of paramount importance,” said Managing Director at MaskTech, Dr. Hans Hanauer. “By adding the support for the PUF feature in the new MTCOS version, MaskTech stays at the leading edge of high security smart card technology. PUF is a completely new technology for the protection of credentials. We’re pleased to work with NXP, the leader in secure identification solutions, to deliver these smarter cards into the market.”

“NXP has a relentless commitment to develop state-of-the art products that meet the high-end security requirements for sensitive applications like payment, e-government and access management,” said Sébastien Clamagirand, Senior Director and General Manager Secure Identification at NXP. “Seeing the first roll-out of SmartMX with PUF technology is a great milestone and addresses the market need for high secure identification solutions.”

SmartMX2 P60 Step-Up!
The latest SmartMX2 generation builds on the groundbreaking IntegralSecurityTM architecture and includes a series of new security enhancements:

  • PUF support to secure the keys against new attack scenarios via unique “silicon fingerprint” with each single circuit
  • Hardware-support for dedicated cryptography in certain regions: SEED (Korea), OSSCA (China)
  • End-to-end encryption, AES and DES coprocessors for high resistance to side-channel attacks
  • Mature Development Tool kit SmartICE based on a true Bondout Chip with identical-to-product hardware for a safe and application-compliant implementation with full planning reliability
  • Soft Masking Device for early functional prototypes based on identical-to-product hardware to reduce the development cycle time via an approved physical reference instance
  • Full amount of SmartMX2 security features, including NXP-patented SecureFetch and GlueLogic for optimum relief of operation system countermeasures and safe and fast composite certifications and approvals.

The new SmartMX2 platform also received comprehensive 3rd party recognition:

  • Common Criteria EAL6+ certificate (EAL 5+ with MIFARE and/or DESFire EV1 inclusion)
  • EMVCo Approval
  • UL Letter of Conformance for MIFARE functionality

About the SmartMX Family
SmartMX, the platform of choice for high secure and fast data transactions, is a proven solution for contact, contactless and dual interface applications with over 6 billion IC´s sold. Serving banks all over the world, from Shanghai to London and New York to Berlin, NXP’s SmartMX secures transactions on over one third of the chip-based payment cards in circulation. NXP’s SmartMX products are also the core component in a variety of digital identity schemes and are deployed in close to 120 out of 145 countries implementing e-government programs. Used in many sovereign electronic documents such as ePassports, citizen cards, national ID cards, driving licenses, social security cards and, health cards, SmartMX-based services protect citizens from identity theft and reduce fraud via the products’ world class security features. The SmartMX family is also the preferred technology for the secure element of NFC-enabled phones.

About MTCOS
MTCOS Protects identities in more than 65 countries. MTCOS has been designed for smart card and embedded security ICs with crypto-coprocessor and contactless-, contact based- or dual interface. MTCOS is a true multiapplication OS with advanced public key support. It is compliant to all relevant open ISO/IEC standards for smart cards and contains a unique range of eID applications already built-in the OS. MTCOS is certified Common Criteria EAL4+/5+ on different high secure semiconductor types.

About NXP
NXP Semiconductors N.V. (NASDAQ:NXPI) enables secure connections and infrastructure for a smarter world, advancing solutions that make lives easier, better and safer. As the world leader in secure connectivity solutions for embedded applications, NXP is driving innovation in the secure connected vehicle, end-to-end security & privacy and smart connected solutions markets. Built on more than 60 years of combined experience and expertise, the company has 44,000 employees in more than 35 countries and posted revenue of $6.1 billion in 2015. Find out more at www.nxp.com.

About MaskTech
MaskTech is the leading independent manufacturer and supplier of high security smart card operating systems (MTCOS) for government and industry use. MaskTech’s portfolio includes generic and customized mask solutions for state-of-the-art Common Criteria certified smart card and contactless cryptographic chipsets. The company supplies more than 30 major passport manufacturers and system integrators and holds a leading position in all of its primary product categories. Find out more at www.masktech.com.         

For more information, please contact:

Americas
Tate Tran	
Tel: +1 408-802-0602
Email:tate.tran@nxp.com

Europe 
Martijn van der Linden
Tel: +31 6 10914896
Email: martijn.van.der.linden@nxp.com

Greater China / Asia 
Esther Chang
Tel: +886 2 8170 9990
Email: esther.chang@nxp.com
Thursday, September 29th, 2016 Uncategorized Comments Off on $NXPI Delivers Enhanced Anti-Cloning Security Solution

$CATB & $SRPT Joint Research #Collaboration in #MuscularDystrophy

Catabasis Pharmaceuticals, Inc. (NASDAQ:CATB), a clinical-stage biopharmaceutical company (“Catabasis”), and Sarepta Therapeutics, Inc. (NASDAQ:SRPT), a commercial-stage developer of innovative RNA-targeted therapeutics (“Sarepta”), today announced a joint research collaboration to explore a combination drug treatment approach for Duchenne muscular dystrophy (DMD). The two companies will contribute their respective expertise to study an exon skipping treatment developed by Sarepta, together with an oral NF-kB inhibition treatment developed by Catabasis in a mouse model of DMD.

“We are excited to work with Sarepta on this joint research collaboration, which to our knowledge is the first time two companies are testing a combination of investigational therapies to treat Duchenne. Although we believe edasalonexent (CAT-1004) has the potential to be a disease-modifying monotherapy, we think there is benefit to exploring innovative ways to make the most meaningful difference in this devastating disease”, said Jill C. Milne, Ph.D., chief executive officer of Catabasis. “In addition to our continued development of edasalonexent, we are pleased to take the first step via this collaboration to determine if edasalonexent may be complementary to an exon-skipping treatment strategy in the treatment of DMD using a preclinical model.”

“We recognize the extreme unmet medical need in DMD and are committed to determining the best treatment strategies for patients affected by Duchenne,” said Edward Kaye, M.D., Sarepta’s chief executive officer. “We believe exon skipping has the potential to target the underlying genetic cause of the disease by restoring the mRNA reading frame to produce dystrophin in skeletal muscle. We are pleased to initiate activities with Catabasis to evaluate a potential combination treatment approach of exon-skipping and NF-kB inhibition in DMD.”

NF-kB inhibition and exon-skipping represent two novel investigational treatment strategies in Duchenne, each with the potential for disease-modifying effects when used as monotherapy. The objective of the joint research is to study the safety and efficacy of combining these two treatment strategies using a mouse model of DMD, including evaluating the potential for additional or synergistic benefits.

About Catabasis
At Catabasis Pharmaceuticals, our mission is to bring hope and life-changing therapies to patients and their families. Our SMART (Safely Metabolized And Rationally Targeted) linker drug discovery platform enables us to engineer molecules that simultaneously modulate multiple targets in a disease. We are applying our SMART linker platform to build an internal pipeline of product candidates for rare diseases and plan to pursue partnerships to develop additional product candidates. For more information on the Company’s drug discovery platform and pipeline of drug candidates, please visit www.catabasis.com.

About Edasalonexent (CAT-1004)
Edasalonexent (CAT-1004) is an oral small molecule that has the potential to be a disease-modifying therapy for all patients affected by Duchenne muscular dystrophy (DMD or Duchenne), regardless of the underlying mutation. Edasalonexent inhibits NF-kB, a protein that is activated in Duchenne and drives inflammation and fibrosis, muscle degeneration and suppresses muscle regeneration. In animal models of DMD, edasalonexent inhibited NF-kB, reduced muscle degeneration and improved muscle regeneration and function, and beneficial effects were observed in skeletal, diaphragm and cardiac muscle. The FDA has granted orphan drug, fast track and rare pediatric disease designations and the European Commission has granted orphan medicinal product designation to edasalonexent for the treatment of DMD. We have previously reported safety, tolerability and reduction in NF-kB activity in Phase 1 trials in adults. We are currently conducting the MoveDMD® trial of edasalonexent in 4-7 year-old boys affected by Duchenne. From Part A of the MoveDMD trial, we have reported that edasalonexent was generally well tolerated with no safety signals observed and we observed successful NF-kB target engagement. Pharmacokinetic results demonstrated edasalonexent plasma exposure levels consistent with those previously observed in adults at which inhibition of NF-kB was observed.

About Sarepta Therapeutics
Sarepta Therapeutics is a commercial-stage biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare neuromuscular diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including EXONDYS 51, designed to skip exon 51 and approved under the accelerated approval pathway. For more information, please visit us at www.sarepta.com.

About Duchenne Muscular Dystrophy
DMD is an X-linked rare degenerative neuromuscular disorder causing severe progressive muscle loss and premature death. One of the most common fatal genetic disorders, DMD affects approximately one in every 3,500-5,000 males worldwide. A devastating and incurable muscle-wasting disease, DMD is associated with specific errors in the gene that codes for dystrophin, a protein that plays a key structural role in muscle fiber function. Progressive muscle weakness in the lower limbs spreads to the arms, neck and other areas. Eventually, increasing difficulty in breathing due to respiratory muscle dysfunction requires ventilation support, and cardiac dysfunction can lead to heart failure. The condition is universally fatal, and death usually occurs before the age of 30.

Forward-Looking Statements
Any statements in this press release about future expectations, plans and prospects for Catabasis and/or Sarepta, including statements about future clinical trial plans and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “may” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements include statements regarding the joint research collaboration plans of Sarepta and Catabasis to explore a combination drug treatment approach for DMD and the potential benefit of the products being researched in DMD. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: uncertainties inherent in the initiation and completion of preclinical studies and clinical trials and clinical development of Catabasis’ or Sarepta’s product candidates; availability and timing of results from preclinical studies and clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or the results of future trials; expectations for regulatory approvals to conduct trials or to market products; availability of funding sufficient for Catabasis’ or Sarepta’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the availability or commercial potential of Catabasis’ or Sarepta’s product candidates; and general economic and market conditions and other factors discussed in the “Risk Factors” section of each of Catabasis’ and Sarepta’s Quarterly Report on Form 10-Q for the period ended June 30, 2016, which are each on file with the Securities and Exchange Commission, and in other filings that Catabasis or Sarepta may make with the Securities and Exchange Commission in the future. In addition, the forward-looking statements included in this press release represent Catabasis’ and Sarepta’s views as of the date of this press release. Each of Catabasis and Sarepta anticipates that subsequent events and developments will cause their respective views to change. However, while either Catabasis or Sarepta may elect to update these forward-looking statements at some point in the future, each company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the views of either Catabasis or Sarepta as of any date subsequent to the date of this release.

 

Catabasis Investor and Media Contact:
Catabasis Pharmaceuticals, Inc.
Andrea Matthews, 617-349-1971
amatthews@catabasis.com
or
Sarepta Therapeutics, Inc.
Media and Investors:
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Brian Reid, 212-257-6725
breid@w2ogroup.com

Thursday, September 29th, 2016 Uncategorized Comments Off on $CATB & $SRPT Joint Research #Collaboration in #MuscularDystrophy

$BIOC #TargetSelector Platform Performance to be Presented at the 2016 #ESMO

SAN DIEGO, Sept. 29, 2016  — Biocept, Inc. (NASDAQ: BIOC), a molecular diagnostics company commercializing and developing blood-based liquid biopsies to provide information to physicians to improve the diagnosis and treatment of cancer, announces that clinical results featuring its liquid biopsy platform will be presented at the 2016 European Society For Medical Oncology (ESMO) Annual Congress, taking place October 7-11 in Copenhagen, Denmark. Study results highlighting the concordance and clinical utility of detecting actionable biomarkers in patients with advanced non-small cell lung cancer (NSCLC) will be presented by Lourdes Barrera, Ph.D., Diagnostics Manager, AstraZeneca Oncology BU, Mexico. An abstract for the presentation can be found at: https://cslide.ctimeetingtech.com/library/esmo/browse/search/546#2z95w

Presentation Details:

Title: Clinical evaluation of the utility of a liquid biopsy (circulating tumoral cells and ctDNA) to determine the mutational profile (EGFR, KRAS, ALK, ROS1 and BRAF) in advanced NSCLC patients
Date and Time: Sunday, October 9, 2016, 4:30 p.m. CEST (Central European Summer Time) Basic Science and Translational Research; Poster Discussion Session: Berlin Room, Central Hall

About Biocept

Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma. The Company uses its proprietary liquid biopsy technology to provide physicians with information for treating and monitoring patients diagnosed with cancer. The Company’s patented Target Selector™ liquid biopsy technology platform captures and analyzes tumor-associated molecular markers in both circulating tumor cells (CTCs) and in plasma (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.

Physicians interested in ordering Biocept’s liquid biopsy tests for cancer biomarkers should contact Customer Service at 858-320-8206, or visit http://biocept.com/medical-professionals/.

Forward-Looking Statements Disclaimer Statement

This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to our ability to improve the diagnosis and treatment of cancer, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.

Thursday, September 29th, 2016 Uncategorized Comments Off on $BIOC #TargetSelector Platform Performance to be Presented at the 2016 #ESMO

$APTI Announces Closing Of #IPO

BELLEVUE, Wash., Sept. 28, 2016  — Apptio, Inc. (NASDAQ: APTI), the leading provider of cloud-based Technology Business Management, or TBM, software, today announced the closing of its initial public offering of 6,900,000 shares of Class A common stock at a price to the public of $16.00 per share, which includes the full exercise of the underwriters’ option to purchase 900,000 additional shares. The company estimates net proceeds from the offering to be approximately $99.4 million, after deducting underwriting discounts and commissions and estimated offering expenses. The shares began trading on the NASDAQ Global Market under the ticker symbol “APTI” on September 23, 2016.

Goldman, Sachs & Co., J.P. Morgan Securities LLC and BofA Merrill Lynch acted as joint lead bookrunners for the offering, while Barclays Capital Inc., Jefferies LLC, RBC Capital Markets, LLC and Pacific Crest Securities, a division of KeyBanc Capital Markets Inc., acted as bookrunners.

The offering was made only by means of a prospectus forming part of the effective registration statement. Copies of the final prospectus related to the offering may be obtained from Goldman, Sachs & Co., Attn: Prospectus Department, 200 West Street, New York, NY 10282, or by telephone at (866) 471-2526, or by e-mail at prospectus-ny@ny.email.gs.com; J.P. Morgan Securities LLC, c/o Broadridge Financial Solutions, 1155 Long Island Avenue, Edgewood, NY 11717, or by telephone at (866) 803-9204; and BofA Merrill Lynch, NC1-004-03-43, 200 North College Street, 3rd floor, Charlotte, NC  28255-0001, Attn: Prospectus Department, or by email at dg.prospectus_requests@baml.com.

A registration statement relating to these securities has been filed with the Securities and Exchange Commission and was declared effective on September 22, 2016. Copies of the registration statement, as amended, can be accessed through the SEC’s website at www.sec.gov. This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

Wednesday, September 28th, 2016 Uncategorized Comments Off on $APTI Announces Closing Of #IPO

$EFOI Launches Network-Ready Lighting Solutions

Innovative retrofit 100-percent flicker-free TLED lighting options create opportunity for vast energy savings

SOLON, Ohio, Sept. 28, 2016  — Energy Focus, Inc. (NASDAQ:EFOI), a leader in LED lighting technologies, today announced the launch of two new products, 500NR Network-Ready Series LED Tube and Intellitube® NR Network-Ready Tube.

Created with high-quality components, these are the first retrofit TLEDs on the market to put dimming technology directly inside the tubes. This Internet of Things technology enables the UL-approved tubes to be directly connected to and controlled by the building’s automation system or lighting control system. In addition to the 50-percent energy savings of switching to LED, building owners can save approximately 20-percent more by utilizing the dimming feature.

“At Energy Focus we are devoted to engineering products that make our customers’ lives easier and more efficient,” said Jeremy Heilman, Vice President of Research and Development. “Our network-ready, 100-percent flicker-free tubes ensure our customers are using the least amount of power to produce a bright amount of healthy light, and result in over 50-percent energy savings.”

The Intellitube® NR Network-Ready Tube adds Network Readiness to the Intellitube’s® innovative features, making it easier than ever for companies to meet their lighting needs with controllable LED solutions. Launched in 2015, the Intellitube® is Energy Focus’s commercial adaptation of the LED lighting solution the company developed in cooperation with DARPA for use in combat-ready Navy ships. The Intellitube’s® patented dual-mode design makes retrofit of old fluorescent light fittings with new LED lighting tubes easy and safe. The Intellitube® is compatible with a wide variety of fluorescent ballasts, a necessary component needed to regulate the current to fluorescent lighting. Intellitubes® can also work without a ballast, utilizing its integrated, auto-ranging universal line LED driver.

The 500NR Network-Ready Series LED Tube is an upgrade on Energy Focus’s 500D direct wire solution, which operates without a ballast. The 500NR is engineered so that all the circuitry needed to operate the tube is located inside the tube, eliminating the need for the costly and inefficient external drivers and other components. Eliminating the ballast allows a building owner to save five to ten additional watts per fixture, which contributes to incremental savings.

Both the Intellitube® NR Network-Ready Tube and the 500NR Network-Ready Series LED Tube come in various lengths ranging from 2’/24” to 4’/48”, several color temperature and maximum brightness options, and integrated LED drivers. Performance is maintained across the board, with 150lm/W for all powers, all colors, in the clear lens, and 140lm/W with the frosted diffusing lens, reducing the power required to provide equivalent light levels of a 4-foot fluorescent tube from 28-32 watts to merely 11 watts.

These solutions continue Energy Focus’s commitment to high-performance, low-cost retrofit and both provide a pathway to eliminate ballasts from the lighting system, either at the time of installation or during normal maintenance. Building owners are saving the risk and cost of replacing an exterior ballast and the additional energy and cost savings that come from eliminating the inefficiency of a ballast.

To learn more about the UL-approved 500NR Network Ready Series LED Tube and the Intellitube® Network Ready Tube, please call 1-800-327-7877 or visit energyfocus.com.

About Energy Focus, Inc. 

Energy Focus, Inc. is a leading provider and innovator of energy efficient LED lighting products. As the creator of the only 100-percent flicker-free LED products on the market, Energy Focus products provide extensive energy savings, aesthetics, safety and health benefits over conventional and fluorescent lighting. As a long standing partner with the US Government providing energy efficient LED lighting products to the U.S. Navy and the Military Sealift Command fleets, Energy Focus products go through rigorous testing in the most adverse conditions possible and still have a zero percent failure rate. In the commercial sphere, customers include national, state and local U.S. government agencies as well as Fortune 500 companies across education, healthcare, retail and manufacturing. Energy Focus is headquartered in Solon, Ohio, with additional sales offices in Washington, D.C., New York and Taiwan.

Media and Investor Contacts:

Michael Miller
Content Strategist, Energy Focus, Inc.
msmiller@energyfocusinc.com
(440) 715-1300 Office or (734) 945-6359 Cell
Or
Peter Seltzberg, Darrow Associates, Inc.
pseltzberg@darrowir.com
516-419-9915
Wednesday, September 28th, 2016 Uncategorized Comments Off on $EFOI Launches Network-Ready Lighting Solutions

$AEGR #JUXTAPID Capsules Approved in #Japan for #HoFH

CAMBRIDGE, Mass., Sept. 28, 2016  — Aegerion Pharmaceuticals, Inc. (NASDAQ:AEGR), a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases, today announced that Japan’s Ministry of Health, Labor & Welfare (MHLW) has approved JUXTAPID for patients with homozygous familial hypercholesterolemia (HoFH).

HoFH is a serious, rare genetic disease that impairs the function of the receptor responsible for removing LDL-C (“bad” cholesterol) from the body. A loss of LDL receptor function results in extreme evaluation of blood cholesterol levels. HoFH patients often develop premature and progressive atherosclerosis, a narrowing or blocking of the arteries.

Chief Executive Officer of Aegerion Mary Szela said, “This approval marks a significant milestone in our ongoing efforts to maximize the value of JUXTAPID. Japan is an important market and since lomitapide was granted orphan drug designation for HoFH in 2013, we have worked to establish disease awareness among the HoFH community. We look forward to the opportunity to provide an additional therapeutic option for patients with this severe rare disease. Our team is focused on the upcoming commercial launch, assuming reimbursement approval, and working with Japanese healthcare providers to identify and serve those patients appropriate for JUXTAPID therapy.”

The MHLW based its approval of JUXTAPID on Aegerion’s Phase III study in Japanese patients, which evaluated the safety and efficacy of the medicine to reduce LDL-C levels in nine patients with HoFH. The findings were consistent with the known safety and efficacy profile of JUXTAPID.

JUXTAPID is approved in the United States as an adjunct to a low-fat diet and other lipid lowering treatments, including apheresis where available, to reduce low-density lipoprotein cholesterol (LDL-C), total cholesterol (TC), apolipoprotein B (apo B), and non-high-density lipoprotein cholesterol (non-HDL-C) in adult patients with HoFH.  In the U.S., JUXTAPID carries a boxed warning for the risk of hepatotoxicity. The boxed warning also states that JUXTAPID should only be prescribed to patients with a clinical or laboratory diagnosis consistent with HoFH, and that the safety and effectiveness of JUXTAPID have not been established in patients with hypercholesterolemia who do not have HoFH. Because of the risk of hepatotoxicity and the importance of JUXTAPID only being prescribed to patients with a clinical or laboratory diagnosis consistent with HoFH, JUXTAPID is only available through the JUXTAPID REMS Program.  The effect of JUXTAPID on cardiovascular morbidity and mortality has not been determined.

Important Safety Information from U.S. Prescribing Information, including BOXED WARNING which states:

WARNING: RISK OF HEPATOTOXICITY

JUXTAPID can cause elevations in transaminases. In the JUXTAPID clinical trial, 10 (34%) of the 29 patients treated with JUXTAPID had at least one elevation in alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3x upper limit of normal (ULN). There were no concomitant clinically meaningful elevations of total bilirubin, international normalized ratio (INR), or alkaline phosphatase.

JUXTAPID also increases hepatic fat, with or without concomitant increases in transaminases. The median absolute increase in hepatic fat was 6% after both 26 and 78 weeks of treatment, from 1% at baseline, measured by magnetic resonance spectroscopy. Hepatic steatosis associated with JUXTAPID treatment may be a risk factor for progressive liver disease, including steatohepatitis and cirrhosis.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment and then ALT and AST regularly as recommended. During treatment, adjust the dose of JUXTAPID if the ALT or AST are ≥3x ULN. Discontinue JUXTAPID for clinically significant liver toxicity.

Because of the risk of hepatotoxicity, JUXTAPID is available only through a restricted program under a Risk Evaluation and Mitigation Strategy (REMS) called the JUXTAPID REMS PROGRAM.

CONTRAINDICATIONS

  • Pregnancy
  • Concomitant administration of moderate or strong CYP3A4 inhibitors
  • Moderate or severe hepatic impairment or active liver disease including unexplained persistent elevations of serum transaminases

WARNINGS AND PRECAUTIONS

JUXTAPID can cause elevations in transaminases and hepatic steatosis. Although cases of hepatic failure have not been reported, there is concern that JUXTAPID could induce steatohepatitis, which can progress to cirrhosis over several years. Modify the dose of JUXTAPID if elevations of transaminases are observed and discontinue JUXTAPID for persistent or clinically significant elevations. If transaminase elevations are accompanied by clinical symptoms of liver injury, such as nausea, vomiting, abdominal pain, fever, jaundice, lethargy, flu-like-symptoms, increases in bilirubin ≥2x ULN, or active liver disease, discontinue treatment with JUXTAPID and identify the probable cause. Use JUXTAPID with caution when co-administered with agents known to be hepatotoxic. Alcohol may increase levels of hepatic fat and induce or exacerbate liver injury.

Measure ALT, AST, alkaline phosphatase, and total bilirubin before initiating treatment. During the first year, measure liver-related tests (ALT and AST, at a minimum) prior to each increase in dose or monthly, whichever occurs first. After the first year, do these tests at least every three months and before any increase in dose.

Females of reproductive potential should have a negative pregnancy test before starting Juxtapid and should use effective contraception during therapy with Juxtapid. The recommended maximum dosage of Juxtapid is 40 mg daily when used concomitantly with oral contraceptives.

Given its mechanism of action in the small intestine, JUXTAPID may reduce the absorption of fat-soluble nutrients. Patients treated with JUXTAPID should take daily supplements that contain 400 international units vitamin E and at least 200 mg linoleic acid, 210 mg alpha-linolenic acid (ALA), 110 mg eicosapentaenoic acid (EPA), and 80 mg docosahexaenoic acid (DHA).

Gastrointestinal adverse reactions are common and may lead to treatment discontinuation. To reduce the risk of gastrointestinal adverse reactions, patients should adhere to a low-fat diet supplying less than 20% of energy from fat and the dosage of JUXTAPID should be increased gradually.

Weak CYP3A4 inhibitors can increase the exposure of lomitapide approximately two-fold; therefore, when JUXTAPID is administered with weak CYP3A4 inhibitors, the dose of JUXTAPID should be decreased by half and the recommended maximum dosage of JUXTAPID is 30 mg daily. The recommended maximum dosage is 40 mg daily when used concomitantly with oral contraceptives. Strong and moderate CYP3A4 inhibitors should not be used with Juxtapid.  Patients taking JUXTAPID 5 mg daily may continue with the same dosage.
Due to risk of myopathy associated with simvastatin or lovastatin, doses of these agents should be limited when co-administered with JUXTAPID.

JUXTAPID increases the plasma concentrations of warfarin. Increases or decreases in the dose of JUXTAPID may lead to supra- or subtherapeutic anticoagulation, respectively. Patients taking warfarin should undergo regular monitoring of the INR, especially after any changes in JUXTAPID dosage.

Avoid use of JUXTAPID in patients with rare hereditary disorders of galactose intolerance.

About Aegerion Pharmaceuticals, Inc.
Aegerion Pharmaceuticals is a biopharmaceutical company dedicated to the development and commercialization of innovative therapies for patients with debilitating rare diseases.  For more information about the company, please visit www.aegerion.com.

Forward Looking Statements:

This press release contains forward-looking statements, including statements regarding the potential for launch and commercialization of JUXTAPID in Japan. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements. In particular, the risks and uncertainties include, among other factors; the risk that we may not be able to obtain pricing and reimbursement approval in Japan at acceptable levels or at all; the risk that JUXTAPID may not gain market acceptance in Japan; and the other risks inherent in the commercialization process. For additional disclosure regarding these and other risks we face, see the disclosure contained in the “Risk Factors” section of Aegerion’s Quarterly Report on Form 10-Q filed on August 9, 2016, and our other public filings with the Securities and Exchange Commission, available on the SEC’s website at http://www.sec.gov. We undertake no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Investors and others should note that we communicate with our investors and the public using our company website (www.aegerion.com) and our investor relations website (http://ir.aegerion.com), including but not limited to company disclosures; investor presentations and FAQs; Securities and Exchange Commission filings; press releases; public conference calls and webcasts. The information that we post on these websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested to review the information that we post there on a regular basis. The contents of our website shall not be deemed incorporated by reference in any filing under the Securities Act of 1933, as amended.

CONTACT:
Aegerion Pharmaceuticals, Inc.                                                        
Amanda Murphy, Associate Director, Investor & Public Relations                                 
857-242-5024  
Amanda.murphy@aegerion.com
Wednesday, September 28th, 2016 Uncategorized Comments Off on $AEGR #JUXTAPID Capsules Approved in #Japan for #HoFH

$AVXL Compound to be Tested in $BIIB #Neuroprotectant Model

NEW YORK, Sept. 28, 2016  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, today announced that it has signed a material transfer agreement with Biogen (Cambridge, MA) under which Biogen will test Anavex’s lead drug candidate, ANAVEX 2-73 in an oligodendrocyte precursor cell (OPC) differentiation assay. A satisfactory result from the OPC assay study may lead to an in vivo remyelination study using a chemical demyelination model.

“Battling demyelinating diseases such as multiple sclerosis requires an understanding of the processes that cause remyelination to fail.  Remyelination of demyelinated axons is typically a function of oligodendrocyte precursor cells. These studies will examine the therapeutic role ANAVEX 2-73 may play in permitting remyelination in the brain,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.

About Biogen

Through cutting-edge science and medicine, Biogen (Nasdaq:BIIB) discovers, develops and delivers worldwide innovative therapies for people living with serious neurological, autoimmune and rare diseases. Founded in 1978, Biogen is one of the world’s oldest independent biotechnology companies and patients worldwide benefit from its leading multiple sclerosis and innovative hemophilia therapies. For more information, please visit www.biogen.com. Follow us on Twitter.

About Anavex Life Sciences Corp.

Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of differentiated therapeutics for the treatment of neurodegenerative and neurodevelopmental diseases including Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer. Anavex’s lead drug candidate, ANAVEX 2-73, is currently in a Phase 2a clinical trial for Alzheimer’s disease. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean safety profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. The Michael J. Fox Foundation for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. ANAVEX 3-71, also targeting sigma-1 and M1 muscarinic receptors, is a promising preclinical drug candidate demonstrating disease modifications against the major Alzheimer’s hallmarks in transgenic (3xTg-AD) mice, including cognitive deficits, amyloid and tau pathologies, and also with beneficial effects on neuroinflammation and mitochondrial dysfunctions. Further information is available at www.anavex.com.

Forward-Looking Statements

Statements in this press release that are not strictly historical in nature are forward-looking statements. These statements are only predictions based on current information and expectations and involve a number of risks and uncertainties. Actual events or results may differ materially from those projected in any of such statements due to various factors, including the risks set forth in the Company’s most recent Annual Report on Form 10-K filed with the SEC. Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement and Anavex Life Sciences Corp. undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof.

 

For Further Information:

Anavex Life Sciences Corp.
Research & Business Development
Toll-free: 1-844-689-3939
Email:  info@anavex.com

Investors:
Matthew Haines
River East Investor Relations, LLC
917-733-9297
mhaines@rivereastir.com

Media:
Dennis Dobson, Jr.
Dobson Media Group
(203) 258-0159
dennisdobsonjr@dobsonmediagroup.com
Wednesday, September 28th, 2016 Uncategorized Comments Off on $AVXL Compound to be Tested in $BIIB #Neuroprotectant Model

$IPDN Discusses Impact of #ReverseStockSplit on #SelfTender Offer

CHICAGO, Sept. 28, 2016  — Professional Diversity Network, Inc. (“PDN” or “the Company”) (NASDAQ:IPDN), a developer and operator of online networks that provide networking and access to employment opportunities for women and other diverse professionals in the United States, today provided an overview of its recent reverse stock split and its partial self-tender offer.

HIGHLIGHTS:

  • As previously announced, at the Annual Meeting of Stockholders held on September 26, 2016, the Company’s stockholders approved the proposal authorizing the Board of Directors to implement the reverse stock split at a ratio within the range from 1-for-2 to 1-for-15, and to amend the Company’s Amended and Restated Certificate of Incorporation to effect the reverse stock split and to proportionately reduce the number of shares of common stock the Company is authorized to issue.
  • The Board of Directors approved a final 1-for-8 ratio immediately following the Annual Meeting of Stockholders.
  • The reverse stock split was effective as of 12:01 a.m. EDT on September 27, 2016.  The Company’s shares continue to trade, on a post-split basis, under ticker symbol IPDN on the NASDAQ Capital Market.
  • The reverse stock split reduced the Company’s outstanding shares from approximately 14.5 million to approximately 1.8 million, and its authorized shares from 25 million to approximately 3.1 million.
  • The reverse stock split proportionally affects the number of shares expected to be issued at the closing of the Company’s previously-announced transaction with Cosmic Forward Limited (“CFL”), as well as the number of shares the Company is seeking to purchase in its previously-announced partial self-tender offer and the per-share transaction prices.
  • The CFL transaction would still result in the purchase by CFL of 51% of the Company’s outstanding shares, on a fully-diluted basis, but the purchase of the shares will be at $9.60 per share rather than the previously-announced $1.20 share (which reflected an approximately 126% premium over the closing price of the common stock on August 12, 2016, the day on which the CFL transaction was announced).
  • The partial self-tender offer will now be for up to 312,500 shares of the Company’s common stock at a price of $9.60 per share, net to the seller in cash, less any applicable withholding taxes and without interest, upon the terms and conditions set forth in the offer to purchase dated September 28, 2016.

About Professional Diversity Network, Inc.

The Professional Diversity Network platform provides employers that value diversity with access to diverse talent to meet their hiring needs. Professional Diversity Network owns and operates professional networking communities including: www.iHispano.com for Hispanic professionals, www.BlackCareerNetwork.com for African-American professionals, www.WomensCareerChannel.com for professional women, www.Military2Career.com for Veterans, http://www.ProAble.net for professionals with disabilities, www.OutProNet.com for professionals in the LGBT community, and www.AsianCareerNetwork.com for Asian-American professionals.  In addition, the Company operates the National Association of Professional Women, at www.napw.com, the country’s largest networking organization dedicated to professional women.  For more information, visit: www.prodivnet.com.

Forward Looking Statements: This press release contains certain forward-looking statements based on our current expectations, forecasts and assumptions.  Forward-looking statements can be identified by forward-looking words such as “anticipate,” “believe,” “could,” “estimate,” “expect,” “intend,” “may,” “should,” “will” and “would” or similar words, and include, without limitation, statements regarding the shares to be issued to CFL. Forward-looking statements involve risks and uncertainties and our actual results may differ materially from those stated or implied in such forward-looking statements. Factors that could contribute to such differences include, but are not limited to: the ability to meet the closing conditions to the completion of the sale of shares to CFL; potential failure by the Company to increase its total market capitalization following the reverse stock split, failure to maintain the increased per-share stock price over the long term, failure to generate investor interest, potential adverse effect of the reduced number of shares outstanding following the reverse stock split on the liquidity of the Company’s common stock; and the risk factors disclosed in our Annual Report on Form 10-K filed on March 30, 2016, Quarterly Report on Form 10-Q filed on August 15, 2016 and any subsequent filings made by us with the SEC.  We assume no obligation to update the information included in this press release, whether as a result of new information, future events or otherwise. The Form 10-K filed on March 30, 2016 and the Form 10-Q filed on August 15, 2016 together with this press release, are available on our website, www.prodivnet.com. Please click on “Investor Relations.”

Additional Information and Where to Find It

This presentation does not constitute an offer to sell or the solicitation of an offer to buy any securities of PDN or a solicitation of any vote or approval. In connection with the proposed CFL transaction, PDN has filed with the SEC and mailed to stockholders a proxy statement on Schedule 14A.  Stockholders are urged to read the proxy statement and other relevant materials (including any amendments or supplements thereto) because they contain important information.

The tender offer is being made only through the offer to purchase and related materials, which PDN will file with the SEC. Stockholders are urged to read these materials when they become available because they will contain important information.

The proxy statement and other relevant materials and the offer to purchase and related tender offer materials, and any other documents filed by PDN with the SEC, may be obtained free of charge at the SEC’s website at www.sec.gov. In addition, security holders may obtain free copies of the proxy statement and tender offer materials  from PDN by contacting Christopher Wesser by telephone at 516-659-8560, or by mail to Professional Diversity Network, Inc., Attention: Secretary, 801 W. Adams Street, Suite 600, Chicago, Illinois 60607 or by going to the “Investor Relations” page of PDN’s corporate website at www.prodivnet.com.  Tender offer materials can also be obtained free of charge from Continental Stock Transfer & Trust, the Depositary for the tender offer, by telephone at (917) 262-2378, or by mail to Continental Stock Transfer & Trust Company, Inc., 17 Battery Place, 8th Floor, New York, NY 10004.

PDN
Christopher Wesser, EVP & Secretary
(516) 659-8560
investor@prodivnet.com
Wednesday, September 28th, 2016 Uncategorized Comments Off on $IPDN Discusses Impact of #ReverseStockSplit on #SelfTender Offer

$XXII Overwhelming Physician & Consumer Support for #X22 Quit #Smoking Aid

22nd Century Group, Inc. (NYSE MKT:XXII), a plant biotechnology company that is a leader in tobacco harm reduction, announced results from two separate independent surveys showing that strong consumer demand mirrors physicians’ willingness to prescribe the Company’s X-22 smoking cessation aid in development.

X-22 is a Very Low Nicotine tobacco-based botanical medical product for smoking cessation. Independent clinical studies have demonstrated that combustible cigarettes containing 22nd Century’s Very Low Nicotine tobacco with non-addictive levels of nicotine enable smokers to disassociate the act of smoking from the rapid intake of nicotine. X-22 involves the same smoking behavior as conventional cigarettes and does not expose the smoker to any new drugs or new side effects. 22nd Century has an active Investigational New Drug (IND) application with the U.S. Food and Drug Administration (FDA) relating to the X-22 smoking cessation product.

To assess consumer reaction to X-22, the first survey, conducted by Survata, an independent market research firm based in San Francisco, California, questioned 501 current smokers in the United States, who have tried to quit at least once, about their failed quit attempts. Participants were then given a brief overview of 22nd Century’s X-22 Very Low Nicotine cigarettes designed for use as a prescription smoking cessation aid. Overall, the vast majority of smokers expressed strong enthusiasm for 22nd Century’s X-22 product to become available at U.S. pharmacies. Indeed, of the 501 smokers surveyed, if X-22 were currently available:

  • 89% said X-22 would be their top or first choice to help them quit smoking.
  • 88% indicated that they would have attempted to quit smoking sooner if X-22 had been available when they first considered quitting.
  • 85% would pursue a prescription for X-22 from their doctor to help them quit smoking.

22nd Century also commissioned surveys (conducted by Survata and by Dobrin Consulting in Richmond, Virginia) of 136 practicing physicians who have experience in helping patients quit smoking. Physicians reviewed detailed information regarding the use and efficacy of X-22, including published results from several of the numerous independent clinical trials that have been conducted with cigarettes made with 22nd Century’s proprietary Very Low Nicotine tobacco. Most importantly, of the 136 physicians surveyed:

  • 89% said that they would prescribe X-22 cigarettes to help their patients quit smoking.
  • 75% selected the descriptive phrase: “addresses the behavioral aspects of smoking” as the most appealing aspect of X-22.
  • 70% listed “reduces cravings” as a highly appealing feature of X-22.
  • More than 50% mentioned “no new side effects” among the most compelling reasons to recommend X-22 to their patients.

“When you have hard data asserting that 89% of physicians will prescribe your product – paired with rapidly growing support in the scientific community – I think we conclusively put to rest any questions about the potential for X-22 as a blockbuster smoking cessation drug,” explained James Vail, Director of Business Development at 22nd Century Group.

Mr. Vail will share more detailed consumer and physician survey results October 5-7 at BioNetwork’s Partnering Summit in Laguna Niguel, California. BioNetwork’s annual event brings together the decision-makers and business development executives from the pharmaceutical and biotechnology industries to initiate strategic partnerships. Mr. Vail will also share an overview of the now 15 completed and 19 on-going independent clinical research studies using the Company’s Very Low Nicotine tobacco. Since 2015, the number of published studies using 22nd Century’s proprietary Very Low Nicotine tobacco has more than doubled. The results of these studies have been overwhelmingly favorable. Of notable importance, an independent clinical study, funded in part by the FDA, and published in the October 2015 issue of The New England Journal of Medicine, found that smokers of 22nd Century’s VLN cigarettes consumed far fewer cigarettes per day and doubled their quit attempts versus smokers of conventional cigarettes.

“Given the opportunity, a vast majority of informed physicians report that they will prescribe X-22 to patients who wish to quit,” explained Henry Sicignano, III, President and CEO of 22nd Century Group. “Considering this enthusiasm, in conjunction with the fact that nearly 90% of surveyed smokers indicate that they are eager to try X-22, we have all of the ingredients for a tremendous commercial success… indeed, a success that will save millions of lives and billions of dollars in healthcare costs.”

Phase II and Phase III clinical results collected by scientific researchers around the world have demonstrated the safety and efficacy of 22nd Century’s proprietary Very Low Nicotine tobacco cigarettes. Independent clinical trials utilizing 22nd Century’s Very Low Nicotine cigarettes to treat more than 4,000 total smokers have shown increased quit rates, whether the Very Low Nicotine cigarettes were used alone; used concurrently with nicotine replacement therapies, such as nicotine gums, nicotine patches, and nicotine lozenges; or used concurrently with Pfizer’s Chantix®. A summary of 34 independent clinical research studies and 10 scientific opinion pieces related to 22nd Century’s Very Low Nicotine tobacco are available on the Company’s Heracles Pharmaceuticals’ website at: http://heraclespharma.com/clinical-trials-2/

About 22nd Century Group, Inc.

22nd Century is a plant biotechnology company focused on technology which allows it to increase or decrease the level of nicotine in tobacco plants and the level of cannabinoids in cannabis plants through genetic engineering and plant breeding. The Company’s primary mission is to reduce the harm caused by smoking. 22nd Century currently owns or exclusively controls more than 200 issued patents and more than 50 pending patent applications around the world. Visit www.xxiicentury.com and www.heraclespharma.com for more information.

Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release, including but not limited to our future revenue expectations. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2015, filed on February 18, 2016, including the section entitled “Risk Factors,” and our other reports filed with the U.S Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.

Investor Relations:
IRTH Communications
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399

Tuesday, September 27th, 2016 Uncategorized Comments Off on $XXII Overwhelming Physician & Consumer Support for #X22 Quit #Smoking Aid

$OASM Annual General Meeting 2016 Communique

Oasmia Pharmaceutical AB (publ.), with VAT no SE556332-667601, held its Annual General Meeting for the fiscal year 2015/2016 on Monday, September 26, 2016, where and the following main resolutions were made. For detailed information about the content of the resolutions, see the complete notice for Annual General Meeting which is available on Oasmia’s website www.oasmia.com, together with the complete proposals for the resolutions below.

Uppsala, Sweden, Sept. 27, 2016  — Establishment of Balance Sheet and Income Statement
The Annual General Meeting established the Balance Sheet, Income Statement, Consolidated Accounts and Financial report. It was resolved that the share premium reserve of SEK 941 960 675, accumulated result of SEK -489 921 393 and result for the year SEK -141 673 259, in total SEK 310 366 023, shall be carried forward.

The Board of Directors and auditors
The Annual General Meeting discharged the Board of Directors and the Chief Executive Officer from liability for the fiscal year 2015/2016. The resolution also included the Members of the Board who resigned during the year. The Annual General Meeting made a resolution that the Board shall consist of six regular members without deputies. The Annual General Meeting re-elected the Board members Julian Aleksov, Bo Cederstrand, Horst Domdey, Alexander Kotsinas, Hans Sundin and Lars Bergkvist. Julian Aleksov was elected as Executive Chairman of the Board. Ernst & Young AB, with principal auditor Fredrik Norman, was elected as auditors.

Remuneration to the Board and auditors
The Annual General Meeting established that a member of the Board, not employed by the company, shall receive remuneration amounting to SEK 150,000. The Chairman of the Board shall receive payment of SEK 175,000. Remuneration to a Board member may, by special agreement with Oasmia Pharmaceutical AB, be invoiced by a company wholly-owned by the Board member. In that case, the invoiced fee will be increased by the amount of social security contributions and VAT. Remuneration to the auditors shall be paid according to bill.

Guidelines for remuneration to senior managers
The Annual General Meeting approved the guidelines for remuneration to senior managers proposed by the Board.

Nomination committee
The Annual General Meeting approved the proposal concerning criteria for the selection of a nomination committee for the Annual General Meeting 2017.

The Board’s proposal for the authorization of repurchase and transfer the company’s own shares
The Annual General Meeting made a resolution to authorize the Board of Directors to resolve to repurchase, on one or several occasions prior to the next Annual General Meeting, as many shares as may be purchased without the company’s holding at any time exceeds 10 per cent of the total number of shares in the company. The shares shall be purchased on NASDAQ Stockholm and only at a price within the price range registered at any given time, i.e. the range between the highest bid price and the lowest offer price.

The Board of Directors was also authorized to resolve, on one or several occasions during the period until the next annual general meeting, to transfer all shares held by the company, via NASDAQ Stockholm or in connection with the acquisition of companies, businesses or parts thereof on market terms, however, not to a price lower than the current stock market value. Transfer of shares on the NASDAQ Stockholm may be made at a price within the price range registered at any given time, i.e. the range between the highest bid price and the lowest offer price.

Authorization for the Board to propose new issue of share, warrants and convertibles
The Annual General Meeting made a resolution, in accordance with the proposal by the Board, to authorize The Board to, on one or several occasions for the period up to the next Annual General Meeting, resolve on an issue of shares, warrants and/or convertible instruments with or without deviation from the shareholders’ pre-emption rights and/or an issue in kind or an issue by way of set-off or otherwise on such terms and conditions as referred to in Chapter 2, Section 5, second paragraph, points 1-3 and 5, of the Swedish Companies Act. The board of directors shall however not be entitled to make resolutions which entail that the share capital is increased with more than SEK 3,500,000.

The new shares, warrants and/or convertible instruments shall, in the event of a deviation from the shareholders’ pre-emption rights, be issued at a subscription price which connects to the stock price at the time of the issue, decreased by a market rate discount that the board of directors deems necessary (if any).

Other information
For the sake of clarity, no other new information, not previously communicated to the market, was released at the meeting.

About Oasmia Pharmaceutical AB
Oasmia Pharmaceutical AB develops, manufactures, markets and sells new generations of drugs in the field of human and veterinary oncology. The company’s product development aims to create and manufacture novel nanoparticle formulations and drug-delivery systems based on well-established cytostatics which, in comparison with current alternatives, show improved properties, reduced side-effects, and expanded applications. The company’s product development is based on its proprietary in-house research and company patents. Oasmia is listed on NASDAQ Capital Markets (OASM.US), Frankfurt Stock Exchange (OMAX.GR, ISIN SE0000722365) and NASDAQ Stockholm (OASM.ST).

Mikael Asp, CEO
Tel: +46 18 50 54 40
E-mail: mikael.asp@oasmia.com

Tuesday, September 27th, 2016 Uncategorized Comments Off on $OASM Annual General Meeting 2016 Communique

$INVT, #Pabellon #ProofOfConcept via Fortune 100 Company Engagement

First Commercial Engagement by One of the Partners of the Inventergy Innovations Subsidiary

CAMPBELL, CA–(Sep 27, 2016) – Inventergy Global, Inc. (NASDAQ: INVT), (“Inventergy”) an intellectual property licensing company, announced today that Pabellon, Inc. (“Pabellon”), one of the new partners of Inventergy Innovations, LLC, Inventergy’s recently launched subsidiary, is currently engaged with a Fortune 100 company to create a proof of concept (POC) to demonstrate its breakthrough Surface Plane Magnetic Technology™ to continuously charge remote internet devices. The power, sent via Pabellon’s surface plane magnetics will be extracted by miniaturized, patented Pabellon receivers mounted on sensory devices. Power is delivered to remote sensing devices and return path data is extracted from these devices to create “smart” sensing environments for many applications.

As part of the engagement, Pabellon plans to demonstrate power, data and sensory applications, which are enabled using Pabellon’s surface plane magnetic technology. Importantly, data can be transmitted via secure modulation techniques using Pabellon’s technology. Miniaturized receivers can also sense disturbances for security applications.

Joe Beyers, CEO of Inventergy, stated, “Launching this POC demonstrates the significant value opportunity we create for our partners through a unique monetization model that can quickly provide commercialization opportunities on a much larger scale. In less than 10 weeks after forming a partnership with Inventergy Innovations, Pabellon is now heavily engaged with a large multi-national company. We will continue to seek opportunities with targeted investment, shorter time for execution, lower up-front capital outlays and lower operating costs, generating higher returns that can expand our revenue opportunities for our stakeholders.”

“We believe that Pabellon’s technology can remove barriers impairing the conventional wireless power transfer industry, enabling last mile complete solutions. Pabellon’s patented technology opens up unprecedented connectivity for non-radiative power, data and sensing applications,” stated Ken Cannizzaro, President of Inventergy Innovations. “The market opportunity for this technology is growing rapidly in a number of potential multi-billion dollar market segments.”

“We are confident that this POC will have a positive outcome and demonstrate the value of our innovative technology,” said Alex Rubin, CEO and Founder of Pabellon, Inc. “We are also delighted with our engagement with Inventergy. They have helped us to enrich and enhance our IP protection, and refine and focus our value proposition, leading up to this exciting new engagement.”

About Inventergy Global, Inc.
Inventergy Global, Inc. is a Silicon Valley-based intellectual property company dedicated to identifying, acquiring and licensing patented technologies of market-significant technology leaders. Led by IP industry pioneer and veteran Joe Beyers, the Company leverages decades of corporate experience, market and technology expertise, and industry connections to assist Fortune 500 and other technology companies in leveraging the value of their innovations to achieve greater returns. For more information about Inventergy, visit www.inventergy.com.

About Pabellon, Inc.
Pabellon’s technology enables connector-less, wireless power /data transfer and remote sensing applications for mobile, IoT (Internet of Things) and lighting applications. Pabellon’s Surface Plane Magnetic Technology™ sends an oscillating magnetic field along the surface of objects such as desks, walls, pipes and fabrics to miniaturized receiver devices that can extract power and data. Disturbances in the field are detectable by the receiver devices, enabling sensory applications such as human presence detection and touch-free controls.

Pabellon’s technology is aimed at the markets for wearables, intrusion detection, as well as toys and lighting which each offers multiple billion dollar addressable markets. According to research firm MarketsandMarkets, the wearable technology market is expected to reach $31.3 billion by 2020, at a CAGR of 17.8% between 2015 and 2020. MarketsandMarkets reported that the global intrusion detection system/intrusion prevention (IDS/IPS) security market was estimated at $2.7 billion in 2014 and is expected to grow to $5.0 billion in 2019.

Cautionary Statement Regarding Forward-Looking Statements
This press release contains statements, estimates, forecasts and projections with respect to future performance and events, which constitute 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. Those statements include statements regarding the intent and belief or current expectations of the Company and its affiliates and subsidiaries and their respective management teams. These statements may be identified by the use of words like “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “will,” “should,” “seek” and similar expressions and include any projections or estimates set forth herein. Investors and prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties, that actual results may differ materially from those projected in the forward-looking statements.

Tuesday, September 27th, 2016 Uncategorized Comments Off on $INVT, #Pabellon #ProofOfConcept via Fortune 100 Company Engagement

$KTOV Successful Results #KIT302 Pharmacokinetic Bioequivalence Study

KIT-302 Successfully Meets U.S. Food and Drug Administration Bioequivalence Standards for 2.5 mg Amlodipine Dose

TEL AVIV, Israel, September 27, 2016  —

Kitov Pharmaceuticals Holdings Ltd. (NASDAQ/TASE: KTOV), an innovative biopharmaceutical company focused on late stage drug development, announced today that its lead drug candidate KIT-302 has successfully completed an additional pharmacokinetic (PK) bioequivalence (BE) study and once more successfully met the U.S. Food and Drug Administration’s (FDA) standards for establishing bioequivalence to the reference drugs. The current study evaluated a lower dosage (2.5 mg) of amlodipine than in Kitov’s previous PK bioequivalence study for the KIT-302 product containing 10 mg of amlodipine, the results of which were announced by Kitov on May 10, 2016.

“We are pleased with the results of our additional pharmacokinetic BE study, which brings us closer towards submitting our New Drug Application to the FDA for KIT-302 as planned,” stated Dr. J. Paul Waymack, Chairman of Kitov’s Board and Chief Medical Officer.

The study compared the PK of Kitov’s combination drug KIT-302 in a fixed dose combination consisting of 200 mg of celecoxib, indicated for osteoarthritis pain, and 2.5 mg of amlodipine, indicated for high blood pressure, to off-the-shelf branded 200 mg celecoxib capsules and 2.5 mg amlodipine tablets. These evaluations were conducted under both fed and fasted conditions. The results demonstrated that for both the Cmax (the maximum blood level achieved) and Area Under the Curve (the area under the concentration time curve for drug levels), the 90% confidence intervals for both the amlodipine and celecoxib components of KIT-302 were documented to be between 80% and 125% of the values obtained with the off-the-shelf drugs.  With these study results, Kitov has again met the FDA standard for demonstrating BE under both fed and fasted conditions.

About KIT-302

KIT-302 is intended to treat pain caused by osteoarthritis (OA), as well as simultaneously treat hypertension, which is a common side effect of certain stand-alone drugs that treat osteoarthritis pain, as well as a common concomitant preexisting condition. KIT-302 is comprised of two U.S. Food and Drug Administration (FDA) approved drugs, celecoxib (the active ingredient in Pfizer’s Celebrex®), for the treatment of pain caused by osteoarthritis and amlodipine besylate (the active ingredient in Pfizer’s Norvasc®), a drug designed to treat hypertension. Kitov expects to submit a New Drug Application for KIT-302, which successfully completed a pivotal Phase III trial, with the U.S. Food and Drug Administration within the coming months.

Celebrex® is a registered trademark of G.D. Searle LLC (a subsidiary of Pfizer Inc.).  Norvasc® is a registered trademark of Pfizer Inc.

About Kitov Pharmaceuticals

Kitov Pharmaceuticals (NASDAQ/TASE: KTOV) is an innovative biopharmaceutical company focused on late-stage drug development. Leveraging deep regulatory and clinical-trial expertise, Kitov’s veteran team of healthcare professionals maintains a proven track record in streamlined end-to-end drug development and approval. Kitov’s pipeline currently features two combination drugs intended to treat osteoarthritis pain and hypertension simultaneously, including one that achieved the primary efficacy endpoint for its Phase III clinical trial. By lowering development risk and cost through fast-track regulatory approval of novel late-stage therapeutics, Kitov plans to deliver rapid ROI and long-term potential to investors, while making a meaningful impact on people’s lives. For more information on Kitov, the content of which is not part of this press release, please visit http://www.kitovpharma.com.

Forward-Looking Statements and Kitovs Safe Harbor Statement

Certain statements in this press release are forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Forward-looking statements can be identified by the use of forward-looking words such as “believe”, “expect”, “intend”, “plan”, “may”, “should”, “could”, “might”, “seek”, “target”, “will”, “project”, “forecast”, “continue” or “anticipate” or their negatives or variations of these words or other comparable words or by the fact that these statements do not relate strictly to historical matters. You should not place undue reliance on these forward-looking statements, which are not guarantees of future performance. Forward-looking statements reflect our current views, expectations, beliefs or intentions with respect to future events, and are subject to a number of assumptions, involve known and unknown risks, many of which are beyond our control, as well as uncertainties and other factors that may cause our actual results, performance or achievements to be significantly different from any future results, performance or achievements expressed or implied by the forward-looking statements. Important factors that could cause or contribute to such differences include, among others, risks relating to: the fact that drug development and commercialization involves a lengthy and expensive process with uncertain outcomes; our ability to successfully develop and commercialize our pharmaceutical products; the expense, length, progress and results of any clinical trials; the lack of sufficient funding to finance the clinical trials; the impact of any changes in regulation and legislation that could affect the pharmaceutical industry; the difficulty in receiving the regulatory approvals necessary in order to commercialize our products; the difficulty of predicting actions of the U.S. Food and Drug Administration or any other applicable regulator of pharmaceutical products; the regulatory environment and changes in the health policies and regimes in the countries in which we operate; the uncertainty surrounding the actual market reception to our pharmaceutical products once cleared for marketing in a particular market; the introduction of competing products; patents attained by competitors; dependence on the effectiveness of our patents and other protections for innovative products; our ability to obtain, maintain and defend issued patents with protective claims; the commencement of any patent interference or infringement action; our ability to prevail, obtain a favorable decision or recover damages in any such action; and the exposure to litigation, including patent litigation, and/or regulatory actions, and other factors that are discussed in our Registration Statement on Form F-1 filed with the  U.S. Securities and Exchange Commission (the “SEC) (file number 333-211477), in our Annual Report on Form 20-F for the year ended December 31, 2015 and in our other filings with the SEC, including our cautionary discussion of risks and uncertainties under Risk Factors in our Registration Statements and Annual Reports. These are factors that we believe could cause our actual results to differ materially from expected results. Other factors besides those we have listed could also adversely affect us. Any forward-looking statement in this press release speaks only as of the date which it is made. We disclaim any intention or obligation to publicly update or revise any forward-looking statement, or other information contained herein, whether as a result of new information, future events or otherwise, except as required by applicable law. You are advised, however, to consult any additional disclosures we make in our reports to the SEC, which are available on the SEC’s website, http://www.sec.gov.

Contact:
Simcha Rock
Chief Financial Officer
+972-3-9333121 ext. #105
simcha@kitovpharma.com

Bob Yedid
Managing Director
LifeSci Advisors, LLC
+1-646-597-6989
bob@LifeSciAdvisors.com

Tuesday, September 27th, 2016 Uncategorized Comments Off on $KTOV Successful Results #KIT302 Pharmacokinetic Bioequivalence Study

$DRIO Launches New Digital Platform and #OnlineStore in #Canada

Collaborative partnership with A&D Medical and Diabetes Express to expand distribution of Dario in Canada with online platform for sales and prescription processing

BOSTON, Sept. 27, 2016  — DarioHealth Corp. (NASDAQ:DRIO), a leader in digital health and mobile health solutions and the developer of the Dario™ Smart Diabetes Management Solution, today announced the launch of an online store in Canada. This is in collaboration with A&D Medical, a global leader in connected health and biometric measurement devices and services, and Bayshore Specialty Rx Ltd.’s online pharmacy Diabetes Express.

While Dario is widely accepted under reimbursement in Canada, this partnership with Bayshore Specialty Rx Ltd. allows for a complete online experience for Dario products and supplies. The full service provided by Diabetes Express, a division of Bayshore Specialty Rx Ltd., includes all handling of the prescription and interaction with the insurers. The new online store’s URL will be http://mydario.ca and be operated in collaboration with DarioHealth, Diabetes Express and A&D. DarioHealth is responsible for the digital marketing and Diabetes Express will handle reimbursement and the prescription process.

“We are thrilled with these partnership agreements and our launch of a Canadian online store as an implementation of our strategy to make the life of people with diabetes easier,” said Erez Raphael, DarioHealth’s Chairman and Chief Executive Officer. “Our team at DarioHealth has developed strong direct digital marketing capabilities and combined with our partners’ complete end-to-end digital pharmacy capabilities, including prescription processing and reimbursement, we will offer a complete and robust offering to the diabetes population in Canada.”

Aleksandra Filipovic, Director of Bayshore Diabetes, stated, “I am confident that the combination of a highly-digital and engaging product like Dario and our online direct to consumer platform will provide an extremely valuable experience for patients with diabetes.”

Terry Duesterhoeft, President and CEO of A&D, stated, “Dario is one of the featured products in our Canadian portfolio and we look forward to boosting Dario sales through our digital pharmacy platform.”

About A&D Medical

Since 1977, A&D Medical has manufactured and distributed a full line of advanced biometric monitoring solutions including blood pressure monitors, weight scales, activity monitors, and other health monitoring devices for consumer and professional use. A&D Medical is the worldwide leader in connected health and biometric measurement devices and services for consumer wellness and chronic condition management, marketing under the A&D brand globally and also the LifeSource brand in North America. A&D Medical is a division of A&D Company, a global manufacturer of measurement equipment, with operations in Asia, Europe, Australia, Russia, North America, and South America.

For general information about A&D Medical, please visit www.andonline.com.

About Bayshore Specialty Rx Ltd.

A division of Bayshore HealthCare, a premier healthcare provider and a proudly Canadian company since 1966, Bayshore Specialty Rx Ltd., provides a wide-range of patient support programs that include services such as data management support, specialty nursing, specialty pharmacy, reimbursement services and call centre. Bayshore operates more than 45 infusion clinics and pharmacies across the country with the goal to improve patient outcomes through integrated support of complex therapies and community services.

Diabetes Express, A Division of Bayshore Specialty Rx Ltd., is the diabetes focused business unit which works directly with manufacturers, diabetes education clinics and patients to provide the best diabetes product support, access and information within every province in Canada.

About DarioHealth Corp.

DarioHealth is a leader in digital health self-management solutions. DarioHealth delivers the ability to combine and analyze consumer health data to personalize treatment and advance medical knowledge. The Dario™ Smart Diabetes Management Solution is a platform for diabetes management that combines the Dario Blood Glucose Monitoring System all-in-one blood glucose meter, native smart phone app, website portal and a wide variety of treatment tools to support more proactive and better informed decisions by users living with diabetes, their doctors and healthcare systems.  Having recently launched in the largest market in the world for glucose monitoring, U.S. sales are expected to have a significant impact on revenues and gross margins. With marketing clearance in Europe and the U.S., the Dario iOS mobile app recently launched with reimbursement in the United Kingdom, Australia, Israel, Italy, and Canada, and has also launched in New Zealand, Netherlands, Italy, and Belgium.  For more information, visit http://mydario.investorroom.com/

Cautionary Note Regarding Forward-Looking Statements

This news release and the statements of representatives and partners of DarioHealth Corp. (the “Company”) related thereto contain or may contain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Statements that are not statements of historical fact may be deemed to be forward-looking statements. Without limiting the generality of the foregoing, words such as “plan,” “project,” “potential,” “seek,” “may,” “will,” “expect,” “believe,” “anticipate,” “intend,” “could,” “estimate” or “continue” are intended to identify forward-looking statements.  For example, when the Company describes the impact on sales and distribution from the new online store, and says that U.S. sales are expected to have a significant impact on the Company’s revenues and gross margins, it is using forward-looking statements. Readers are cautioned that certain important factors may affect the Company’s actual results and could cause such results to differ materially from any forward-looking statements that may be made in this news release. Factors that may affect the Company’s results include, but are not limited to, regulatory approvals, product demand, market acceptance, impact of competitive products and prices, product development, commercialization or technological difficulties, the success or failure of negotiations and trade, legal, social and economic risks, and the risks associated with the adequacy of existing cash resources. Additional factors that could cause or contribute to differences between the Company’s actual results and forward-looking statements include, but are not limited to, those risks discussed in the Company’s filings with the U.S. Securities and Exchange Commission. Readers are cautioned that actual results (including, without limitation, the timing for and results of the Company’s commercial and regulatory plans for Dario™) may differ significantly from those set forth in the forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

DarioHealth Corporate and Media Contact
Shmuel Herschberg
Marketing Director
Shmuel@mydario.com
+1-800-896-9062

DarioHealth Investor Relations Contact
Hayden IR
Rob Fink / Brett Maas
DRIO@HaydenIR.com
+1-646-415-8972 / +1-646-536-7331

Tuesday, September 27th, 2016 Uncategorized Comments Off on $DRIO Launches New Digital Platform and #OnlineStore in #Canada

$NETE Dunkin’ Donuts $DNKN Becomes a #PayOnline Client in #Russia

PayOnline Enables Online Ordering and Payments for One of the World’s Largest Coffee and Baked Goods Chains

MIAMI, FL–(Sep 27, 2016) – Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a provider of global mobile payment technology solutions and value-added transactional services, today announces that its wholly owned PayOnline subsidiary has signed an agreement with Dunkin’ Donuts, enabling payment acceptance for online ordering and delivery services in Russia for one of the world’s largest coffee and baked goods chains.

Dunkin’ Donuts is one of the world’s most recognized coffee brands, operating over 11,500 coffee houses in 40 countries and serving more than 3 million customers per day. The company sells 52 varieties of donuts and more than a dozen coffee beverages, as well as an array of bagels, breakfast sandwiches and other baked goods.

In 2010, Dunkin’ Donuts successfully entered the Russian market, and within six years opened 33 coffee houses in Moscow. Catering to the busy lifestyle of this demographic, Dunkin’ Donuts earlier this year launched online ordering and delivery services on its official site on the Russian Internet.

Under the new agreement, PayOnline will help the brand better serve its growing customer base in the Russian Federation by enabling easy and secure payment acceptance for online ordering and delivery services.

Online payment ordering on the site of Dunkin’ Donuts is made possible using “TLS,” a secure cryptographic protocol of PayOnline on the hosted payment page. Dunkin’ Donuts customers are now able to place orders and make payments conveniently on the go from smartphones or any other device as PayOnline’s payment form automatically adopts to any screen size of any device. Customers are able to use all common payment methods including: Russian national payment cards “Mir”, Visa, Visa Electron, MasterCard and Maestro.

“In the busy metropolis, devoted admirers of our products do not always have an ability to regularly visit our shops. With PayOnline, we are able to meet the requests of our guests and implement the service of delivery of delicious donuts and organic coffee through online ordering,” comments Stanislav Petrushin, a marketing department specialist of Dunkin’ Donuts. “Easy ordering and fast delivery required an advanced and absolutely reliable service for online payments. When choosing a payment partner, the determining factors for us were: a favorable cost factor, good image of the partner in the market, and a positive feedback from existing clients. In addition, it is critical for us to provide ease-of-use and loyalty to our clients. As a result, friendly and adaptive payment interface and around-the-clock support for payers finally persuaded us to choose Net Element’s PayOnline as our payments partner. We have successfully started cooperation and believe that working with PayOnline will be as enjoyable to us and our clients as eating our wonderful donuts.”

About Dunkin’ Donuts
Founded in 1950, Dunkin’ Donuts is America’s favorite all-day, everyday stop for coffee and baked goods. Dunkin’ Donuts is a market leader in the hot regular/decaf/flavored coffee, iced coffee, donut, bagel and muffin categories. Dunkin’ Donuts has earned the No. 1 ranking for customer loyalty in the coffee category by Brand Keys for nine years running. The company has more than 11,500 restaurants in 40 countries worldwide. Based in Canton, Mass., Dunkin’ Donuts is part of the Dunkin’ Brands Group, Inc. family of companies. For more information visit: http://www.dunkinbrands.com/about/donuts.

About Net Element
Net Element, Inc. (NASDAQ: NETE) operates a payments-as-a-service transactional and value-added services platform for small to medium enterprise (“SME”) in the US and selected emerging markets. In the US, we are growing transactional revenue with innovative services including our cloud based, restaurant point-of-sale solution Aptito. Internationally, Net Element’s strategy is to leverage its omni-channel platform to deliver flexible offerings to emerging markets with diverse banking, regulatory and demographic conditions such as UAE, Kazakhstan, Kyrgyzstan and Azerbaijan where initiatives have been recently launched. Further information is available at www.netelement.com.

Forward-Looking Statements
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. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether the relationship with Dunkin Donuts will be beneficial to the Company, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Media Contact:
Net Element, Inc.
info@netelement.com
(786) 923-0502

Tuesday, September 27th, 2016 Uncategorized Comments Off on $NETE Dunkin’ Donuts $DNKN Becomes a #PayOnline Client in #Russia

$CWST Announces Plans for Potential #Debt #Refinancing

RUTLAND, Vt., Sept. 26, 2016  — Casella Waste Systems, Inc. (NASDAQ:CWST), a regional solid waste, recycling and resource management services company (the “Company”), today announced that it has invited certain prospective lenders to a meeting scheduled for September 27, 2016 for purposes of considering a potential debt refinancing, pursuant to which the Company intends to enter into a new term loan B facility in an amount of approximately $350,000,000 and a revolving line of credit facility in an amount of approximately $150,000,000 (the “Potential Refinancing”).  The proceeds of the Potential Refinancing, if effected, would be used for the redemption of all of the Company’s outstanding 7.75% Senior Subordinated Notes due 2019 (the “Senior Subordinated Notes”), the repayment in full of the Company’s existing senior secured asset-based revolving credit and letter of credit facility, which matures on February 26, 2020 (or November 2018 if the Senior Subordinated Notes are not refinanced by then), transaction related fees and expenses, working capital and other purposes.  The timing, size and terms of the Potential Refinancing and the use of proceeds thereof are subject to market and other conditions, and the Company makes no assurance that such actions will take place at any specific time, or at all.

In conjunction with the Potential Refinancing, the Company will provide the following updated guidance for the year ending December 31, 2016 to prospective lenders:

Outlook

Given the Company’s strong pricing and operational performance during the first two months of the third quarter, the Company is increasing its Adjusted EBITDA* guidance for the year ending December 31, 2016 by estimating results in the following range:

  • Adjusted EBITDA between $115 million and $117 million (increased from a range of $111 million to $115 million as first announced on March 1, 2016).

The Company reaffirms its Revenue guidance and has established Normalized Free Cash Flow* guidance for the year by estimating results in the following ranges:

  • Revenues between $550 million and $560 million; and
  • Normalized Free Cash Flow between $20 million and $24 million.

The Company has shifted from the previously announced Free Cash Flow guidance to Normalized Free Cash Flow guidance to eliminate the impact of cash interest timing differences related to the Potential Refinancing.

The Company does not provide reconciling information for forward-looking periods because such information is not available without an unreasonable effort.  The Company believes that such information is not significant to an understanding of its non-GAAP financial measures for forward-looking periods because its methodology for calculating such non-GAAP financial measures is based on sensitivity analysis compared to budget at the business unit level rather than on differences from GAAP financial measures.

About Casella Waste Systems, Inc.

Casella Waste Systems, Inc., headquartered in Rutland, Vermont, provides solid waste management services consisting of collection, transfer, disposal, and recycling services in the northeastern United States.  For further information, investors contact Ned Coletta, Chief Financial Officer at (802) 772-2239; media contact Joseph Fusco, Vice President at (802) 772-2247; or visit the Company’s website at http://www.casella.com.

*Non-GAAP Financial Measures

In addition to disclosing financial results prepared in accordance with Generally Accepted Accounting Principles in the United States (“GAAP”), the Company also discloses earnings before interest, taxes, and depreciation and amortization, adjusted for accretion, depletion of landfill operating lease obligations, gains on asset sales, development project charge write-offs, contract settlement charges, legal settlement costs, tax settlement costs, bargain purchase gains, asset impairment charges, environmental remediation charges, severance and reorganization costs, expenses from divestiture, acquisition and financing costs, gains on the settlement of acquisition related contingent consideration, fiscal year-end transition costs, proxy contest costs, as well as impacts from divestiture transactions (“Adjusted EBITDA”), which is a non-GAAP measure.

The Company also discloses net cash provided by operating activities, less capital expenditures (excluding acquisition related capital expenditures), less payments on landfill operating lease contracts, plus proceeds from divestiture transactions, plus proceeds from the sale of property and equipment, plus proceeds from property insurance settlement, less contributions from (distributions to) noncontrolling interest holders plus certain cash outflows associated with landfill closure, site improvement and remediation expenditures, plus certain cash outflows associated with new contract and project capital expenditures, plus cash (inflows) outflows associated with certain business dissolutions, plus cash interest outflows associated with the timing of refinancing transactions (“Normalized Free Cash Flow”), which is a non-GAAP measure.

Adjusted EBITDA is reconciled to net loss, while Normalized Free Cash Flow is reconciled to net cash provided by operating activities.

The Company presents Adjusted EBITDA and Normalized Free Cash Flow because it considers them important supplemental measures of its performance and believes they are frequently used by securities analysts, investors and other interested parties in the evaluation of the Company’s results.  Management uses these non-GAAP measures to further understand the Company’s “core operating performance.” The Company believes its “core operating performance” is helpful in understanding its ongoing performance in the ordinary course of operations. The Company believes that providing Adjusted EBITDA and Normalized Free Cash Flow to investors, in addition to corresponding income statement and cash flow statement measures, affords investors the benefit of viewing its performance using the same financial metrics that the management team uses in making many key decisions and understanding how the core business and its results of operations has performed. The Company further believes that providing this information allows its investors greater transparency and a better understanding of its core financial performance. In addition, the instruments governing the Company’s indebtedness use EBITDA (with additional adjustments) to measure its compliance with covenants.

Non-GAAP financial measures are not in accordance with or an alternative for GAAP.  Adjusted EBITDA and Normalized Free Cash Flow should not be considered in isolation from or as a substitute for financial information presented in accordance with GAAP, and may be different from Adjusted EBITDA or Normalized Free Cash Flow presented by other companies.

Safe Harbor Statement

Certain matters discussed in this press release, including, but not limited to, the statements regarding financial guidance, the Company’s plans, strategies and objectives for the Potential Refinancing and the Company’s expectations regarding the use of proceeds of the Potential Refinancing, are “forward-looking statements” intended to qualify for the safe harbors from liability established by the Private Securities Litigation Reform Act of 1995. These forward-looking statements can generally be identified as such by the context of the statements, including words such as “believe,” “expect,” “anticipate,” “plan,” “may,” “would,” “intend,” “estimate,” “guidance” and other similar expressions, whether in the negative or affirmative. These forward-looking statements are based on current expectations, estimates, forecasts and projections about the industry and markets in which we operate and management’s beliefs and assumptions. There can be no assurance that the Company will be able to complete the Potential Refinancing. We cannot guarantee that we actually will achieve the financial results, plans, intentions, expectations or guidance disclosed in the forward-looking statements made. Such forward-looking statements, and all phases of our operations, involve a number of risks and uncertainties, any one or more of which could cause actual results to differ materially from those described in our forward-looking statements. Such risks and uncertainties include or relate to, among other things: conditions in financial and capital markets, including the impact of prospective interest rate increases, could impact the Company’s ability to complete the Potential Refinancing on favorable terms, if at all; adverse weather conditions that have negatively impacted and may continue to negatively impact our revenues and our operating margin; current economic conditions that have adversely affected and may continue to adversely affect our revenues and our operating margin; we may be unable to increase volumes at our landfills or improve our route profitability; our need to service our indebtedness may limit our ability to invest in our business; we may be unable to reduce costs or increase pricing or volumes sufficiently to achieve estimated Adjusted EBITDA and other targets; landfill operations and permit status may be affected by factors outside our control; groundwater contamination discovered near our Southbridge landfill may delay our permitting activities at that landfill and result in costs and liabilities as well as impacting our disposal revenues at that site, each of which could impact our results of operations; we may be required to incur capital expenditures in excess of our estimates; fluctuations in energy pricing or the commodity pricing of our recyclables may make it more difficult for us to predict our results of operations or meet our estimates; we may incur environmental charges or asset impairments in the future; and actions of activist investors and the cost and disruption of responding to those actions. There are a number of other important risks and uncertainties that could cause our actual results to differ materially from those indicated by such forward-looking statements. These additional risks and uncertainties include, without limitation, those detailed in Item 1A, “Risk Factors” in our Form 10-K for the fiscal year ended December 31, 2015.

We undertake no obligation to update publicly any forward-looking statements whether as a result of new information, future events or otherwise, except as required by law.

Investors:
Ned Coletta
Chief Financial Officer 
(802) 772-2239 

Media:
Joseph Fusco
Vice President 
(802) 772-2247

http://www.casella.com
Monday, September 26th, 2016 Uncategorized Comments Off on $CWST Announces Plans for Potential #Debt #Refinancing

$SMMT Receives #FDA #FastTrack Designation for #Ezutromid in #MuscularDystrophy

OXFORD, United Kingdom, Sept. 26, 2016  — Summit Therapeutics plc (NASDAQ:SMMT) (AIM:SUMM), the drug discovery and development company advancing therapies for Duchenne muscular dystrophy (‘DMD’) and Clostridium difficile infection, today announces it has received Fast Track designation from the US Food and Drug Administration (‘FDA’) for ezutromid in the treatment of DMD. Ezutromid is a utrophin modulator and represents a potential disease modifying treatment for all patients with the fatal muscle wasting disease DMD.

“Fast Track designation underscores the importance that the FDA places on developing new treatments for life-threatening disorders, such as DMD, and aligns well with our recently outlined strategy to accelerate the development of ezutromid to market,” said Glyn Edwards, Chief Executive Officer of Summit. “As a utrophin modulator, ezutromid has the potential to significantly advance the state of care for all patients with DMD, regardless of their underlying genetic fault. We look forward to ezutromid’s continued progress in our ongoing Phase 2 clinical trial, PhaseOut DMD.”

Fast Track is a process designed to facilitate the development and expedite the review of drugs to treat serious conditions that address an unmet medical need. Advantages of Fast Track designation include opportunities for more frequent interactions with the FDA during all aspects of development, submission of a New Drug Application (‘NDA’) on a rolling basis, and eligibility for accelerated approval and priority review. This designation is in addition to ezutromid being granted Orphan Drug designation by the FDA and the European Medicines Agency.

About Utrophin Modulation in DMD
DMD is a progressive muscle wasting disease that affects around 50,000 boys and young men in the developed world. The disease is caused by different genetic faults in the gene that encodes dystrophin, a protein that is essential for the healthy function of all muscles. There is currently no cure for DMD and life expectancy is into the late twenties. Utrophin protein is functionally and structurally similar to dystrophin. In preclinical studies, the continued expression of utrophin has a meaningful, positive effect on muscle performance. Summit believes that utrophin modulation has the potential to slow down or even stop the progression of DMD, regardless of the underlying dystrophin gene mutation. Summit also believes that utrophin modulation could potentially be complementary to other therapeutic approaches for DMD. The Company’s lead utrophin modulator, ezutromid, is an orally administered, small molecule. DMD is an orphan disease, and the US Food and Drug Administration and the European Medicines Agency have granted Orphan Drug designation to ezutromid. Orphan drugs receive a number of benefits including additional regulatory support and a period of market exclusivity following approval. In addition, ezutromid has been granted Fast Track designation by the FDA.

About Summit Therapeutics
Summit is a biopharmaceutical company focused on the discovery, development and commercialisation of novel medicines for indications for which there are no existing or only inadequate therapies. Summit is conducting clinical programs focused on the genetic disease Duchenne muscular dystrophy and the infectious disease C. difficile infection. Further information is available at www.summitplc.com and Summit can be followed on Twitter (@summitplc).

Forward-looking Statements
Any statements in this press release about Summit’s future expectations, plans and prospects, including but not limited to, statements about the clinical and preclinical development of Summit’s product candidates, the therapeutic potential of Summit’s product candidates, and the timing of initiation, completion and availability of data from clinical trials, and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from on-going and future clinical trials and the results of such trials, whether preliminary results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials or preclinical studies will be indicative of the results of later clinical trials, expectations for regulatory approvals, availability of funding sufficient for Summit’s foreseeable and unforeseeable operating expenses and capital expenditure requirements and other factors discussed in the “Risk Factors” section of filings that Summit makes with the Securities and Exchange Commission including Summit’s Annual Report on Form 20-F for the fiscal year ended January 31, 2016. Accordingly readers should not place undue reliance on forward looking statements or information. In addition, any forward looking statements included in this press release represent Summit’s views only as of the date of this release and should not be relied upon as representing Summit’s views as of any subsequent date. Summit specifically disclaims any obligation to update any forward-looking statements included in this press release.

-END-

For more information, please contact:

Summit
Glyn Edwards / Richard Pye (UK office)
Tel: +44 (0)1235 443 951
Erik Ostrowski / Michelle Avery (US office)
Tel: +1 617 225 4455

Cairn Financial Advisers LLP
(Nominated Adviser)
Liam Murray / Tony Rawlinson
Tel: +44 (0)20 77148 7900

N+1 Singer 
(Broker)
Aubrey Powell / Jen Boorer        
Tel: +44 (0)20 7496 3000

MacDougall Biomedical Communications
(US media contact)
Chris Erdman / Karen Sharma	
Tel: +1 781 235 3060
cerdman@macbiocom.com /
ksharma@macbiocom.com 

Consilium Strategic Communications
(Financial public relations, UK)
Mary-Jane Elliott / Sue Stuart /
Jessica Hodgson / Lindsey Neville
Tel: +44 (0)20 3709 5700
summit@consilium-comms.com
Monday, September 26th, 2016 Uncategorized Comments Off on $SMMT Receives #FDA #FastTrack Designation for #Ezutromid in #MuscularDystrophy

$GWPH #Epidiolex #Pivotal #Trial #Phase3 Positive

– Primary endpoint achieved in both Epidiolex doses with high statistical significance compared to placebo –

– Today’s data represents the third positive Phase 3 pivotal trial for Epidiolex reported in 2016 –

– Data reinforce the potential of Epidiolex to be an important new medicine for patients who suffer from this treatment-resistant childhood-onset epilepsy –

– Company to hold investor conference call today at 8:00 a.m. EDT/13:00 BST –

LONDON, Sept. 26, 2016  — GW Pharmaceuticals plc (Nasdaq:GWPH) (AIM:GWP) (“GW,” “the Company” or “the Group”), a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform, announces positive results of the second randomized, double-blind, placebo-controlled Phase 3 clinical trial of its investigational medicine Epidiolex® (cannabidiol or CBD) for the treatment of seizures associated with Lennox-Gastaut syndrome (LGS), a rare and severe form of childhood-onset epilepsy. In this trial, Epidiolex, when added to the patient’s current treatment, achieved the primary endpoint for both dose levels with high statistical significance. During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).

This trial follows the announcement in June 2016 of positive results in the first pivotal Phase 3 trial of Epidiolex for the treatment of seizures associated with LGS, and the March 2016 announcement of positive results in the treatment of seizures associated with Dravet syndrome.  GW expects to submit a New Drug Application (NDA) to the U.S. Food & Drug Administration (FDA) in the first half of 2017.

“The positive outcome in this second trial of Epidiolex in patients with Lennox-Gastaut syndrome demonstrates the effectiveness of this product in this particularly difficult to treat, childhood-onset epilepsy,” stated Orrin Devinsky, M.D., of New York University Langone Medical Center’s Comprehensive Epilepsy Center and principal investigator in the trial. “The data from the Epidiolex Dravet and LGS studies offers the prospect of an FDA-approved CBD medicine that shows both clinically meaningful seizure reduction and a consistent safety and tolerability profile. I believe Epidiolex has the potential to become an important new option within the field of treatment-resistant epilepsy.”

“Today brings great news for the Lennox-Gastaut Syndrome community,” said Christina SanInocencio, Executive Director of the Lennox-Gastaut Syndrome Foundation. “The announcement of a second set of positive results with Epidiolex is exciting as they offer much needed hope for patients and their families living with this debilitating condition where new treatment options are desperately needed.”

“The Epilepsy Foundation is thrilled to learn about the recent preliminary results for an innovative new therapy from GW for LGS. LGS in so many cases is extremely difficult to treat, and is an incredible challenge for children and families. We feel a tremendous sense of urgency to stop seizures, and believe that the pursuit of new therapies offers hope to individuals who have no currently available therapy to effectively stop their seizures. The Epilepsy Foundation will continue to be a champion for GW’s efforts to pursue this innovative new therapy as studies progress. We thank GW and all our partners who invest in a better tomorrow for people with epilepsy,” stated Philip Gattone, President and Chief Executive Officer of the Epilepsy Foundation.

“We are very pleased to report this second positive Phase 3 trial in seizures associated with Lennox-Gastaut Syndrome. This is the third positive Phase 3 trial for Epidiolex reported in 2016. All three trials provide GW with robust evidence to support the efficacy and safety of Epidiolex. This latest trial also shows that Epidiolex likely has an effective dose range, allowing for dose flexibility to address individual patient needs. These compelling results make us more determined than ever to make this important new medicine available to patients who suffer from these treatment-resistant childhood-onset epilepsies,” stated Justin Gover, GW’s Chief Executive Officer.

Trial Overview and Result

Patients aged 2-55 years with a confirmed diagnosis of drug-resistant LGS currently uncontrolled on one or more concomitant anti-epileptic drugs (AEDs) were eligible to participate in this Phase 3, randomized, double-blind placebo-controlled trial. The trial randomized 225 patients into three arms, where Epidiolex 20mg/kg/day (n=76), Epidiolex 10mg/kg/day (n=73) or placebo (n=76) was added to current AED treatment. On average, patients were taking approximately three AEDs, having previously tried and discontinued an average of seven other AEDs. The average age of trial participants was 16 years (30 percent were 18 years or older). The median drop seizure frequency over the 4 week baseline period was 85.

The primary efficacy endpoint of this trial was a comparison between Epidiolex and placebo in the percentage change in the monthly frequency of drop seizures during the 14 week treatment period (two week dose escalation period followed by 12 weeks of maintenance) compared to the 4 week baseline period before randomization. Drop seizures were defined as atonic, tonic or tonic-clonic seizures involving the entire body, trunk or head that led or could have led to a fall, injury, slumping in a chair or hitting the patient’s head on a surface.

During the treatment period, patients taking Epidiolex 20mg/kg/day achieved a median reduction in monthly drop seizures of 42 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0047), and patients taking Epidiolex 10mg/kg/day achieved a median reduction in monthly drop seizures of 37 percent compared with a reduction of 17 percent in patients taking placebo (p=0.0016).

A series of sensitivity analyses of the primary endpoint for both dose groups confirmed the robustness of these results. In both dose groups, the difference between Epidiolex and placebo emerged during the first month of treatment and was sustained during the entire treatment period. Results from secondary efficacy endpoints in both dose groups reinforced the overall effectiveness observed with Epidiolex.

Epidiolex was generally well tolerated in this trial.  The pattern of adverse events was consistent with that reported in the previous two Phase 3 studies. One patient on 10mg/kg Epidiolex discontinued treatment due to an adverse event compared with six patients on 20mg/kg and one patient on placebo.

Of the 84 percent of 10mg/kg patients who experienced an adverse event, 89 percent of them deemed it to be mild or moderate.  Of the 94 percent of 20mg/kg patients who experienced an adverse event, 88 percent of them reported it to be mild or moderate. 72 percent of patients on placebo experienced an adverse event.

The most common adverse events (occurring in greater than 10 percent of Epidiolex-treated patients) in the 10mg/kg group were: somnolence, decreased appetite, upper respiratory infection, diarrhea, and status epilepticus. None of the cases of status epilepticus in the 10mg/kg group was deemed treatment-related. The most common adverse events (occurring in greater than 10 percent of Epidiolex-treated patients) in the 20mg/kg group were: somnolence, decreased appetite, diarrhea, upper respiratory infection, pyrexia, vomiting, and nasopharyngitis.

Thirteen patients on Epidiolex 10mg/kg experienced a serious adverse event (two of which were deemed treatment-related) compared with thirteen patients on 20mg/kg (five of which were deemed treatment-related) and eight patients on placebo (none of which were deemed treatment-related).

There were no deaths in this trial.

Of the patients who completed this trial, 99 percent have opted to continue into an open-label extension trial.

Further data will be presented in future publications and medical meetings.

Epidiolex New Drug Application (NDA)

Following the success of the first Dravet syndrome Phase 3 trial earlier this year, GW requested a pre-NDA meeting with the FDA to discuss a proposed Dravet syndrome NDA. This meeting took place in July 2016 and also included some discussion of data from the first Phase 3 LGS trial. As a result of this constructive meeting, GW believes the guidance received enables the Company’s proposed filing strategy to submit a single NDA that includes Phase 3 data from one Dravet trial and two LGS trials,  and which remains on track for a submission in the first half of 2017. Subject to satisfactory review, GW now anticipates a simultaneous decision on both indications and does not expect to wait for results from the second trial in Dravet syndrome prior to this submission.

In order to support GW’s NDA, the Company expects to provide the FDA with data from ten Phase 1 and Phase 2 studies, as well as safety data in over 1,800 patients from both the expanded access program and pivotal programs, including over 450 patients with one year or more of Epidiolex continuous exposure. This data is in addition to the pivotal efficacy data.

Epidiolex has Orphan Drug Designation from the FDA for the treatment of LGS, Dravet syndrome, Tuberous Sclerosis Complex and Infantile Spasms.

GW Clinical Trial Programs in Dravet Syndrome, Tuberous Sclerosis Complex and Infantile Spasms

In March 2016, GW announced positive results of the first pivotal Phase 3 trial of Epidiolex in Dravet syndrome. GW continues to enroll a second Phase 3 trial of Epidiolex in Dravet syndrome and will report these results upon completion. GW has commenced a Phase 3 trial of Epidiolex in Tuberous Sclerosis Complex and expects to initiate a Phase 3 trial of Epidiolex in Infantile Spasms in the fourth quarter of this year.

Investor Conference Call and Webcast Information

GW Pharmaceuticals will host a conference call and webcast for analysts and investors to discuss the results from this initial Phase 3 trial today at 8:00 a.m. EDT /13:00 BST. To participate in the conference call, please dial 877-407-8133 (toll free from the U.S. and Canada), or 0800-756-3429 (toll free from the UK) or 201-689-8040 (international). Investors may also access a live audio webcast of the call via the investor relations section of the Company’s website at http://www.gwpharm.com. A replay of the call will also be available through the GW website shortly after the call and will remain available for 90 days. Replay Numbers: (toll free): 1-877-660-6853, (international): 1-201-612-7415. For both dial-in numbers please use conference ID # 13646262.

About Lennox-Gastaut Syndrome

The peak onset of LGS typically occurs between ages of 3 to 5 years and can be caused by a number of conditions, including brain malformations, severe head injuries, central nervous system infections, and inherited degenerative or metabolic conditions. In up to 30 percent of patients, no cause can be found. Patients with LGS commonly have multiple seizure types including non-convulsive, convulsive and drop seizures, which frequently lead to falls and injuries. Drug resistance is one of the main features of LGS. Most children with LGS experience some degree of impaired intellectual functioning, as well as developmental delays and behavioral disturbances. Latest estimates are that there are more than 30,000 patients with LGS in the United States.

About Epidiolex

Epidiolex, GW’s lead cannabinoid product candidate, is an oral pharmaceutical formulation of CBD, which is in development for the treatment of a number of rare childhood-onset epilepsy disorders. GW has conducted extensive pre-clinical research of CBD in epilepsy since 2007. This research has shown that CBD has significant anti-epileptiform and anticonvulsant activity using a variety of in vitro and in vivo models and reduced seizures in various acute animal models of epilepsy. To date, GW has received Orphan Drug Designation from the FDA for Epidiolex for the treatment of Dravet syndrome, LGS, Tuberous Sclerosis Complex and Infantile Spasms. Additionally, GW has received Fast Track Designation from the FDA and Orphan Designation from the European Medicines Agency for Epidiolex for the treatment of Dravet syndrome. GW is currently evaluating additional clinical development programs in other orphan seizure disorders.

About GW Pharmaceuticals plc

Founded in 1998, GW is a biopharmaceutical company focused on discovering, developing and commercializing novel therapeutics from its proprietary cannabinoid product platform in a broad range of disease areas. GW is advancing an orphan drug program in the field of childhood-onset epilepsy with a focus on Epidiolex® (cannabidiol), which is in Phase 3 clinical development for the treatment of Dravet syndrome, LGS and Tuberous Sclerosis Complex. GW successfully developed the world’s first plant-derived cannabinoid prescription drug, Sativex®, which is approved for the treatment of spasticity due to multiple sclerosis in 28 countries outside the United States. GW has a deep pipeline of additional cannabinoid product candidates which includes compounds in Phase 1 and 2 trials for glioma, schizophrenia and epilepsy. For further information, please visit www.gwpharm.com.

Forward-looking statements

This news release may contain forward-looking statements that reflect GWs current expectations regarding future events, including statements regarding the therapeutic benefit, safety profile and commercial value of the Company’s investigational drug Epidiolex, the development and commercialization of Epidiolex, plans and objectives for product development, plans and objectives for present and future clinical trials and results of such trials, plans and objectives for regulatory submissions and approvals. Forward-looking statements involve risks and uncertainties.  Actual events could differ materially from those projected herein and depend on a number of factors, including (inter alia), the success of the GW’s research strategies, the applicability of the discoveries made therein, the successful and timely completion of uncertainties related to the regulatory process, and the acceptance of Sativex, Epidiolex, if approved, and other products which we may commercialize by consumer and medical professionals. A further list and description of risks, uncertainties and other risks associated with an investment in GW can be found in GW’s filings with the U.S. Securities and Exchange Commission. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. GW undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Contacts:

GW Pharmaceuticals plc	
Stephen Schultz, VP Investor Relations
401 500 6570 / 917 280 2424

FTI Consulting (UK Media)	
Ben Atwell / Simon Conway
+ 44 20 3727 1000

FleishmanHillard (U.S. Media)	
Paddi Hurley / Adam Silverstein
212 453 2382 / 212 453 2493
Monday, September 26th, 2016 Uncategorized Comments Off on $GWPH #Epidiolex #Pivotal #Trial #Phase3 Positive

$ACTA to #Sell #GovDelivery to #VistaEquityPartners Led Group

RADNOR, Pa., Sept. 26, 2016  — Actua Corporation (Nasdaq:ACTA) today announced that it has entered into a definitive agreement with an investor group led by Vista Equity Partners under which it will sell GovDelivery, the leading provider of cloud-based government communications software solutions, for $153 million in cash, subject to certain adjustments, including working capital, cash, debt and other items. The transaction is subject to customary closing conditions and is expected to close in the fourth quarter of 2016.

“This transaction demonstrates the significant value Actua delivers in growing SaaS businesses,” said Walter Buckley, Actua’s Chief Executive Officer. “Under the strong leadership of CEO Scott Burns, we have transformed GovDelivery into a valuable, high growth company, and are confident that the company will continue its impressive growth trajectory.  Since our acquisition of the business in 2009 for $20 million, GovDelivery has assembled a first-class management team and built out an industry-leading platform for digital government communications with a strong competitive moat. Through the execution of a highly effective growth strategy, GovDelivery has increased revenues by nearly 600 percent.”

Upon completion of the transaction, Actua expects to realize net cash proceeds of approximately $132 million. A portion of the proceeds will be held in escrow and will be subject to potential indemnification claims. Actua does not expect to owe any non-reimbursable income taxes in connection with the transaction.  Actua intends to use its proceeds from the transaction to enhance shareholder value, remaining focused on building our leading vertical cloud businesses and repurchasing shares.

About Actua
Actua Corporation (Nasdaq:ACTA), the multi-vertical cloud company, brings the power of the cloud to vertical markets and processes.  Actua is pioneering the second wave of the SaaS revolution – the vertical wave – by growing cloud businesses that are transforming their markets.  With over 900 employees delivering unrivaled domain knowledge, agility and responsiveness to our customers, Actua’s rapidly growing vertical cloud businesses are positioned to lead this wave.  For the latest information about Actua and its brands, please go to www.actua.com.

About GovDelivery
Over one thousand public sector organizations use GovDelivery’s highly-secure cloud solutions every day to enhance the citizen experience for more than 100 million people. GovDelivery offers leading solutions for managing government communications, internal and external learning, and open data. The GovDelivery Network offers a unique and impactful way for public sector organizations to work together to cross promote content and increase digital reach. Organizations using GovDelivery see higher utilization of citizen services and greater citizen engagement. GovDelivery is an Actua company.

About Vista Equity Partners
Vista Equity Partners, a U.S.-based private equity firm with offices in Austin, Chicago and San Francisco, with more than $26 billion in cumulative capital commitments, currently invests in software, data and technology-based organizations led by world-class management teams with long-term perspective. Vista is a value-added investor, contributing professional expertise and multi-level support towards companies realizing their full potential. Vista’s investment approach is anchored by a sizable long-term capital base, experience in structuring technology-oriented transactions, and proven management techniques that yield flexibility and opportunity in private equity investing. For more information, please visit www.vistaequitypartners.com.

Safe Harbor Statement under Private Securities Litigation Reform Act of 1995

The statements contained in this press release that are not historical facts are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  These forward-looking statements involve certain risks and uncertainties, including, but not limited to, risks associated with our ability to compete successfully in highly-competitive, rapidly-developing markets, the valuation of public and private cloud-based businesses by analysts, investors and other market participants, the effect of economic conditions generally, capital spending by our customers, our ability to retain existing customer relationships and revenue streams and secure new ones, developments in the markets in which we operate and our ability to respond to those changes in a timely and effective manner, the availability, performance and security of our cloud-based technology, particularly in light of increased cybersecurity risks and concerns, our ability to retain key personnel, our ability to deploy capital effectively and on acceptable terms, our ability to successfully integrate any acquired business, the impact of any potential acquisitions, dispositions or other strategic transactions, our ability to have continued access to capital and to manage capital resources effectively, and other risks and uncertainties detailed in Actua’s filings with the U.S. Securities and Exchange Commission. These and other factors may cause actual results to differ materially from those projected.

Investor inquiries:
Karen Greene
Actua
Investor Relations
610.727.6900
IR@actua.com
Monday, September 26th, 2016 Uncategorized Comments Off on $ACTA to #Sell #GovDelivery to #VistaEquityPartners Led Group

$ARRY & #PierreFabre Primary Endpoint #COLUMBUS #Phase3 #Melanoma

– Demonstrated statistically significant results with median PFS on combination of encorafenib plus binimetinib 14.9 months versus 7.3 months on vemurafenib – – Generally well-tolerated and safety profile overall consistent with prior encorafenib plus binimetinib clinical trial results – – Global regulatory submissions planned for 2017 –

BOULDER, Colo., Sept. 26, 2016  — Array BioPharma (Nasdaq: ARRY) and Pierre Fabre today jointly announced top-line results from Part 1 of the Phase 3 COLUMBUS (Combined LGX818 Used with MEK162 in BRAF Mutant Unresectable Skin Cancer) study evaluating LGX818 (encorafenib), a BRAF inhibitor, and MEK162 (binimetinib), a MEK inhibitor, in patients with BRAF-mutant advanced, unresectable or metastatic melanoma. The study met its primary endpoint, significantly improving progression free survival (PFS) compared with vemurafenib, a BRAF inhibitor, alone.

“The COLUMBUS Part 1 trial results demonstrate a robust PFS benefit associated with the combination of binimetinib plus encorafenib versus vemurafenib in patients with BRAF-mutant melanoma,” said Ron Squarer, Chief Executive Officer, Array BioPharma. “We look forward to working with global regulatory authorities as they evaluate our planned submission.”

In the analysis of the primary endpoint, the median PFS for patients treated with the combination of encorafenib plus binimetinib (“combination”) was 14.9 months versus 7.3 months for patients treated with vemurafenib; HR (0.54), [95% CI 0.41-0.71], p<0.001. The combination was generally well-tolerated and reported adverse events were overall consistent with previous combination encorafenib plus binimetinib clinical trial results in BRAF-mutant melanoma patients.

“The preliminary results from Part 1 of COLUMBUS suggest that the combination of encorafenib plus binimetinib represents a potentially unique therapy for the BRAF-mutant melanoma population,” said Keith T. Flaherty, M.D., Director of the Termeer Center for Targeted Therapy, Massachusetts General Hospital and Professor of Medicine, Harvard Medical School. “In addition to the robust activity observed in Part 1, the combination appeared to be generally well-tolerated.”

Analysis of a secondary endpoint comparing the PFS of patients treated with combination to patients treated with encorafenib showed a median of 14.9 months versus 9.6 months with HR (0.75), [95% CI 0.56-1.00], p=0.051, which did not reach statistical significance. A complete analysis of these results will be provided to global regulatory authorities as part of planned submissions. In addition, data from Part 2 of the COLUMBUS trial are anticipated in mid 2017 and will also be provided to global health authorities as part of planned regulatory submissions for approval of these product candidates.

Further results from Part 1 of the COLUMBUS trial, including objective response rates, disease control rates, safety endpoints, exploratory analyses such as a Part 1 PFS comparison of encorafenib to vemurafenib and pre-specified subgroup analyses including outcomes in patients who received prior treatment with immunotherapy will be presented at an upcoming medical meeting. Analysis of the secondary endpoint of overall survival (OS) was not planned as part of these initial results.

Frédéric Duchesne, Chief Executive Officer Pharmaceutical Division, Pierre Fabre remarked, “We are very pleased with the COLUMBUS Part 1 results and look forward to the possibility that, if approved, the combination of encorafenib plus binimetinib could offer a new treatment option for patients suffering from this devastating disease.”

About the Phase 3 COLUMBUS Study
The COLUMBUS trial, (NCT01909453), is a two-part, international, randomized, open label Phase 3 study evaluating the efficacy and safety of the combination of encorafenib plus binimetinib to vemurafenib and encorafenib monotherapy in 921 patients with locally advanced, unresectable or metastatic melanoma with BRAF V600 mutation. Prior immunotherapy treatment was allowed. Over 200 sites across North America, Europe, South America, Africa, Asia and Australia participated in the study. Patients were randomized into two parts:

  • In Part 1, 577 patients were randomized 1:1:1 to receive the combination of 450mg encorafenib plus 45mg binimetinib, 300mg encorafenib alone, or 960mg vemurafenib alone. The primary endpoint for the COLUMBUS trial was a PFS comparison of the combination versus vemurafenib. PFS is determined based on tumor assessment (RECIST version 1.1 criteria) by a Blinded Independent Review Committee. Secondary endpoints include a comparison of the PFS of encorafenib monotherapy to that of the combination and a comparison of OS for the combination to that of vemurafenib alone.
  • In Part 2, 344 patients were randomized 3:1 to receive 300mg encorafenib plus 45mg binimetinib or 300mg encorafenib alone. Part 2 is designed to provide additional data to help evaluate the contribution of binimetinib to the combination. While formal statistical analysis of Part 2 is only planned if both the comparison of PFS between combination versus vemurafenib and the combination versus encorafenib achieve statistical significance in Part 1, data from Part 2 are anticipated in mid 2017 and will be provided to global health authorities as part of planned regulatory submissions in 2017.

Binimetinib and encorafenib are investigational medicines and are not currently approved in any country.

Array BioPharma Conference Call Information
Array will hold a conference call on Monday, September 26, 2016 at 9:00 a.m. Eastern Time to discuss these results.

Date: Monday, September 26, 2016
Time: 9:00 a.m. Eastern Time
Toll-Free: (844) 464-3927
Toll: (765) 507-2598
Pass Code: 88687420
Webcast, including Replay and Conference Call Slides:  http://edge.media-server.com/m/p/f2gpqhkz

About BRAF-Mutant Melanoma
Melanoma is the fifth most common cancer among men and the seventh most common cancer among women in the United States, with more than 76,000 new cases and over 10,000 deaths from the disease expected in 2016. Novel therapies that target the RAS/RAF/MEK/ERK pathway have a strong scientific rationale for activity in this disease, as up to 50 percent of patients with metastatic melanoma have activating BRAF mutations, the most common gene mutation in this patient population. Current marketed MEK/BRAF combination agents have a run rate forecasted to approach $1 billion in annual worldwide sales.

About Binimetinib & Encorafenib
MEK and BRAF are key protein kinases in the MAPK signaling pathway (RAS-RAF-MEK-ERK). Research has shown this pathway regulates several key cellular activities including proliferation, differentiation, survival and angiogenesis. Inappropriate activation of proteins in this pathway has been shown to occur in many cancers, such as melanoma, colorectal and thyroid cancers. Binimetinib is a late-stage small molecule MEK inhibitor and encorafenib is a late-stage small molecule BRAF inhibitor, both of which target key enzymes in this pathway.

Binimetinib and encorafenib are being studied in clinical trials in advanced cancer patients, including the recently initiated Phase 3 BEACON CRC trial that will study encorafenib in combination with cetuximab with or without binimetinib in patients with BRAF V600E-mutant colorectal cancer. Array submitted a New Drug Application (NDA) for binimetinib in NRAS-mutant melanoma to the FDA at the end of June 2016. The FDA accepted the NDA with a target action date under the Prescription Drug User Fee Act (PDUFA) of June 30, 2017.

Array BioPharma retains exclusive rights to binimetinib and encorafenib in key markets including the U.S. and Japan.

About Array BioPharma
Array BioPharma Inc. is a biopharmaceutical company focused on the discovery, development and commercialization of targeted small molecule drugs to treat patients afflicted with cancer. Five registration studies are currently advancing related to three cancer drugs. These programs include binimetinib (MEK162), encorafenib (LGX818) and selumetinib (AstraZeneca). For more information on Array, please go to http://www.arraybiopharma.com/.

About Pierre-Fabre
Pierre Fabre is a French private pharmaceuticals and dermo-cosmetics company founded in 1962 by Mr. Pierre Fabre.  Its turnover reached over 2.2 billion Euros in 2015, spread over 130 countries. The company is structured around two divisions: Pharmaceuticals (prescription drugs, consumer health care) and Dermo-cosmetics (including the Europe and Asia market-leader brand Eau Thermale Avène). Pierre Fabre employs some 13,000 people worldwide and owns subsidiaries in 43 countries. In 2015, the company allocated 16% of its pharmaceuticals sales to R&D with a focus on 4 therapeutic areas: oncology, dermatology, CNS and consumer health care.

Pierre Fabre Oncology, a business unit of the Pierre Fabre company, is supported by over 1,000 employees with a strong focus on European markets.  In 2015, worldwide annual sales of Pierre Fabre Oncology products surpassed $200 million on the strength of the Oral Navelbine, Javlor and Busilvex brands.

Through the Group’s controlling company Pierre Fabre Participations, Pierre Fabre is 86% owned by the Pierre Fabre Foundation, a recognized public-interest organization since 1999. Up to 8% of the remaining shares are held by the company’s employees and the remaining balance is held as treasury stock.

To find out more about Pierre Fabre, please go to www.pierre-fabre.com

Array BioPharma Forward-Looking Statement
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the future development plans of binimetinib and encorafenib, and the timing of the announcement of further results of clinical trials for binimetinib and encorafenib; expectations regarding the timing of regulatory filings for binimetinib and encorafenib and regarding approval of binimetinib and encorafenib for BRAF-mutant melanoma; expectations that events will occur that will result in greater value for Array; and the potential for the results of current and further clinical trials to support regulatory approval or the marketing success of binimetinib and encorafenib. Specifically, there is no assurance that results from the COLUMBUS study, including Parts 1 and 2, will satisfy the requirements of regulatory authorities necessary to file an application for marketing approval, or that if such application is accepted, that it will be approved.  These statements involve significant risks and uncertainties, including those discussed in our most recent annual report filed on Form 10-K, in our quarterly reports filed on Form 10-Q, and in other reports filed by Array with the Securities and Exchange Commission. Because these statements reflect our current expectations concerning future events, our actual results could differ materially from those anticipated in these forward-looking statements as a result of many factors. These factors include, but are not limited to, the determination by the FDA that results from clinical trials are not sufficient to support registration or marketing approval of binimetinib and encorafenib; our ability to effectively and timely conduct clinical trials in light of increasing costs and difficulties in locating appropriate trial sites and in enrolling patients who meet the criteria for certain clinical trials; risks associated with our dependence on third-party service providers to successfully conduct clinical trials within and outside the United States; our ability to achieve and maintain profitability and maintain sufficient cash resources; and our ability to attract and retain experienced scientists and management. We are providing this information as of September 26, 2016. We undertake no duty to update any forward-looking statements to reflect the occurrence of events or circumstances after the date of such statements or of anticipated or unanticipated events that alter any assumptions underlying such statements.

CONTACTS: Tricia Haugeto
(303) 386-1193
thaugeto@arraybiopharma.com
Valerie Roucoules
Valerie.Roucoules@pierre-fabre.com
Monday, September 26th, 2016 Uncategorized Comments Off on $ARRY & #PierreFabre Primary Endpoint #COLUMBUS #Phase3 #Melanoma

$AMS to Present at #MicroCapClub Hosted #MicroCap Leadership Summit

AMERICAN SHARED HOSPITAL SERVICES (NYSE MKT:AMS) (the “Company”), a leading provider of turnkey technology solutions for advanced radiosurgical and radiation therapy services, announced that it is presenting today at the inaugural MicroCap Leadership Summit, hosted by MicroCapClub, at the Westin Chicago Northwest Hotel in Itasca, Illinois.

AMS’s presentation is accessible on the “Investor Center” page of the American Shared Hospital Services website, www.ashs.com.

For more information about the MicroCap Leadership Summit, please visit www.microcapclub.com/summit.

About MicroCapClub

MicroCapClub is an exclusive forum for experienced microcap investors focused on microcap companies (sub $300m market cap) trading on United States, Canadian, and UK markets. MicroCapClub was created to be a platform for experienced microcap investors to share and discuss stock ideas. Investors can join our community by applying to become a member or subscribing to gain instant view only access. MicroCapClub’s mission is to foster the highest quality microcap investor Community, produce Educational content for investors, and promote better Leadership in the microcap arena. For more information, visit www.microcapclub.com.

About AMS

American Shared Hospital Services provides turnkey technology solutions for advanced radiosurgical and radiation therapy services. AMS is the world leader in providing Gamma Knife radiosurgery equipment, a non-invasive treatment for malignant and benign brain tumors, vascular malformations and trigeminal neuralgia (facial pain). The Company also offers proton therapy, the latest IGRT and IMRT systems, as well as its proprietary Operating Room for the 21st CenturySM concept. AMS owns a common stock investment in Mevion Medical Systems, Inc., developer of the compact MEVION S250 Proton Therapy System.

 

American Shared Hospital Services
Ernest A. Bates, M.D., (415) 788-5300
Chairman and Chief Executive Officer
eabates@ashs.com
or
Berkman Associates
Neil Berkman, (310) 477-3118
President
info@berkmanassociates.com

Friday, September 23rd, 2016 Uncategorized Comments Off on $AMS to Present at #MicroCapClub Hosted #MicroCap Leadership Summit

$EFUT Enters Into #Definitive #Merger Agreement w/ #BeijingShiji

BEIJING, Sept. 23, 2016 — eFuture Holding Inc. (Nasdaq:EFUT) (the “Company” or “eFuture”), a leading software and solution provider and a mobile business enabler to China’s retail and consumer goods industries, today announced it has entered into an agreement and plan of merger (the “Merger Agreement”) with Shiji (Hong Kong) Limited (“Parent”) and eFuture CI Limited (“Merger Subsidiary”), a wholly-owned subsidiary of Parent.  Parent and Merger Subsidiary are indirect, wholly-owned subsidiaries of Beijing Shiji Information Technology Co Ltd. (“Shiji”), a joint-stock company listed on the Shenzhen Stock Exchange of the PRC.

Pursuant to the Merger Agreement, Parent will acquire all the outstanding ordinary shares of the Company not currently owned by Parent and its affiliates for cash consideration equal to US$6.42 per share of the Company (each, a “Share”). This price represents an approximately 18% premium over the closing Share price as quoted by NASDAQ Capital Market (“NASDAQ”) on June 3, 2016, the last trading day immediately prior to the Company’s announcement on June 6, 2016 that it had received a preliminary non-binding proposal from Parent.

Subject to the terms and conditions set forth in the Merger Agreement, Merger Subsidiary will merge with and into the Company, with the Company continuing as the surviving company (the “Surviving Company”) and becoming a wholly-owned subsidiary of Parent (the “Merger”).  Each Share which is issued and outstanding immediately prior to the effective time of the Merger (the “Effective Time”) will be cancelled in consideration for the right to receive US$6.42 per Share, in cash, without interest, except for (i) Shares held by the Company or any of its subsidiaries (if any) and Shares beneficially owned by Parent, Merger Subsidiary or their affiliates, which Shares will be cancelled at the Effective Time for no consideration, or (ii) Shares owned by holders who have validly exercised and not effectively withdrawn or lost their rights to dissent from the Merger pursuant to Section 238 of the Companies Law of the Cayman Islands, which such Shares will be cancelled at the Effective Time for the right to receive the fair value of such Shares determined in accordance with the provisions of Section 238 of the Companies Law of the Cayman Islands.  The transactions contemplated by the Merger Agreement, including the Merger, will be financed by the equity capital of Parent and its affiliates.

At the Effective Time, (A) each option (the “Company Options”) to purchase Shares granted under the Company’s share incentive plans that is then vested, outstanding and unexercised will be cancelled and converted into the right to receive, net of any applicable withholding taxes, cash in an amount equal to (x) the total number of Shares issuable upon exercise of such Company Option immediately prior to the Effective Time multiplied by (y) the excess, if any, of (1) US$6.42 over (2) the exercise price payable per Share issuable under such Company Option; provided, however, that if the exercise price payable per Share issuable under any Company Option is greater than $6.42, such Company Option will be cancelled for no payment; (B) each Company Option that is then outstanding and not vested on or prior to the Effective Time will be cancelled and converted into a restricted cash incentive award (“RCA”) in an amount equal to (x) the total number of Shares issuable upon exercise of such Company Option immediately prior to the Effective Time multiplied by (y) the excess, if any, of (1) US$6.42 over (2) the exercise price per Share issuable under such Company Option; provided that each RCA will be subject to the same vesting terms and conditions applicable to the Company Option from which such RCA was converted; and (C) each restricted share granted under the Company’s share incentive plans (whether vested or unvested) that is then outstanding will be cancelled and converted into the right to receive, net of any applicable withholding taxes, cash in an amount equal to US$6.42.

The special committee of independent directors (the “Special Committee”) formed by the Board of Directors of the Company (the “Company Board”), with full power and authority delegated by the Company Board, unanimously approved the Merger Agreement, the plan of merger required to be filed with the Registrar of Companies of the Cayman Islands in connection with the Merger and the transactions contemplated thereby (the “Transactions”), including the Merger, and resolved to recommend that the Company’s shareholders vote to approve the Merger Agreement and the Transactions, including the Merger.   The Special Committee, which is composed entirely of independent directors, exclusively negotiated the terms of the Merger Agreement with Parent and Merger Subsidiary with the assistance of its independent financial and legal advisors.

The consummation of the Merger is subject to customary closing conditions, including the approval by an affirmative vote of Company shareholders holding two-thirds or more of the votes represented by the Shares present and voting in person or by proxy as a single class at the extraordinary general meeting, which will be convened to consider the approval of the Merger Agreement and the Transactions, including the Merger. If completed, the Transactions will result in the Company becoming a privately-held company and its Shares will no longer be listed on NASDAQ.

Concurrently with the execution of the Merger Agreement, Parent entered into a support agreement with the Company (the “Support Agreement”), pursuant to which Parent has agreed to vote all the Shares beneficially owned by it in favor of the authorization and approval of the Merger Agreement and the Merger.  As of the date of this press release, Parent beneficially owns Shares representing approximately 52.24% of the total voting power of the outstanding Shares (without taking into account any outstanding options or restricted shares granted pursuant to the Company’s share incentive plans).

The Company and certain other participants in the Transactions will prepare and file with the U.S. Securities and Exchange Commission (the “SEC”) a Schedule 13E-3 transaction statements, which will include a proxy statement of the Company.  The Schedule 13E-3 will include a description of the Merger Agreement and contain other important information about the Merger, the Company and the other participants in the Merger.

Duff & Phelps, LLC is serving as financial advisor to the Special Committee.  Gibson, Dunn & Crutcher LLP is serving as U.S. legal advisor to the Special Committee and Campbells is serving as Cayman Islands legal advisor to the Special Committee.  Blank Rome LLP is serving as U.S. legal advisor to the Company.

Cleary Gottlieb Steen & Hamilton LLP is serving as U.S. legal advisor to Parent and Maples and Calder is serving as Cayman Islands legal advisor to Parent.

ADDITIONAL INFORMATION ABOUT THE TRANSACTION

The Company will furnish to the Securities and Exchange Commission (the “SEC”) a report on Form 6-K regarding the Transactions, which will include the Merger Agreement and the Support Agreement. All parties desiring details regarding the Transactions are urged to review these documents, which are available at the SEC’s website (http://www.sec.gov). This press release is qualified in its entirety by the Merger Agreement and the Support Agreement, which are filed as exhibits to the Company’s Form 6-K.

In connection with the Transactions, the Company will prepare and mail a proxy statement to its shareholders. The proxy statement will be filed with or furnished to the SEC. INVESTORS AND SHAREHOLDERS ARE URGED TO READ CAREFULLY AND IN THEIR ENTIRETY THE PROXY STATEMENT AND OTHER MATERIALS FILED WITH OR FURNISHED TO THE SEC WHEN THEY BECOME AVAILABLE AS THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE COMPANY, THE TRANSACTIONS AND RELATED MATTERS. In addition to receiving the proxy statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the Transactions and related matters, without charge, from the SEC’s website (http://www.sec.gov) or at the SEC’s public reference room at 100 F Street, NE, Room 1580, Washington, D.C. 20549. In addition, these documents can be obtained, without charge, by contacting the Company at the following address and/or phone number:

eFuture Holding Inc.
Room A1103, A1105, A1106-07, Building A,
Chengjian Plaza, No. 18 Beitaipingzhuang Road, Beijing
People’s Republic of China
Tel: +86 10 50916123

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from our shareholders with respect to the Transactions. Information regarding the persons who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement relating to the Transactions when it is furnished with the SEC. Additional information regarding the interests of such potential participants will be included in the proxy statement and the other relevant documents filed or furnished with the SEC when they become available.

This announcement is neither a solicitation of proxy, an offer to purchase nor a solicitation of an offer to sell any securities and it is not a substitute for any proxy statement or other filings that may be made with the SEC should the Transactions proceed.

ABOUT EFUTURE HOLDING INC.

eFuture Holding Inc. (Nasdaq:EFUT) is a leading software and solution provider and a mobile business enabler to China’s retail and consumer goods industries. eFuture’s clients include 1,000+ active retailers with more than 50,000 physical stores across China, of which about 45% were ranked among the top 100 chain retailers during 2015. For more information about eFuture, please visit http://www.e-future.com.cn.

SAFE HARBOR

This announcement contains forward-looking statements. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. eFuture may also make written or oral forward-looking statements in periodic reports to the Securities and Exchange Commission (the “SEC”), in its annual report to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to second parties. Statements that are not historical facts, including statements about the Company’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: eFuture’s anticipated growth strategies; eFuture’s future business development, results of operations and financial condition; expected changes in the Company’s revenue and certain cost or expense items; eFuture’s ability to attract clients and leverage its brand; trends and competition in the software industry; the Company’s ability to control expenses and maintain profit margins; the Company’s ability to hire, train and retain qualified managerial and other employees; the Company’s ability to develop new software and pilot new business models at desirable locations in a timely and cost-effective manner; the performance of third parties under contracts with the Company; the expected growth of the Chinese economy software market in retail and consumer goods industries; and Chinese governmental policies relating to private managers and operators of software and applicable tax rates.

Further information regarding these and other risks will be included in eFuture’s annual report on Form 20-F and other documents filed with the SEC. All information provided in this press release and in the attachments is as of the date hereof, and the Company undertakes no duty to update such information or any other forward-looking information, except as required under applicable law.

Investor Contact:
Troe Wen, Company Secretary 
eFuture Holding Inc.
+86 10 50916128
ir@e-future.com.cn
Friday, September 23rd, 2016 Uncategorized Comments Off on $EFUT Enters Into #Definitive #Merger Agreement w/ #BeijingShiji

$ENDP Names #PaulCampanelli #President & #CEO

Brings Extensive Leadership and Operations Experience in Generics, OTC Drugs and Branded Products

Company Affirms Third Quarter and Full Year 2016 Financial Guidance

DUBLIN, Sept. 23, 2016  — Endo International plc (NASDAQ: ENDP) (TSX: ENL) today announced that its Board of Directors has named Paul V. Campanelli President and Chief Executive Officer, effective immediately. Mr. Campanelli currently serves as President of Endo’s Generic and OTC drugs business, Par Pharmaceutical, which accounts for approximately 60 percent of Endo’s total revenues through the first half of 2016. Campanelli, who will also join Endo’s Board of Directors, succeeds Rajiv De Silva, who has stepped down as President, CEO and a member of the Board.

Campanelli, 54, joined Endo in 2015 following Endo’s acquisition of Par Pharmaceutical, where he had served as Chief Executive Officer since 2012. While CEO of Par, Campanelli built a strong leadership team and an industry-leading generics business. Specifically, during his tenure, Par significantly increased total revenue, acquired JHP Pharmaceuticals and established a presence in the European generics market. Since joining Endo, Campanelli has overseen the Company’s U.S. Generic Pharmaceuticals business.

“Given the continued evolution of Endo’s business and Paul’s impressive track record of delivering strong operating results, the Board concluded that Paul is the right leader for Endo at this juncture as we focus on execution and increasing the value of our attractive U.S. Branded, U.S. Generic and International pharmaceutical assets,” stated Roger H. Kimmel, Chairman of the Board of Endo. “Paul has spent a significant portion of his career leading and operating complex generics businesses and overseeing Par’s branded business. The Board believes his experience positions him to drive a broad range of growth initiatives across Endo’s entire portfolio, generating better health outcomes for patients and creating value for Endo’s shareholders.”

“I am very excited to lead Endo at this important time and, together with a strong senior management team, address the challenges of today’s healthcare environment,” said Campanelli.  “Endo has differentiated operating businesses that provide diverse products ranging from high-value branded pharmaceuticals to cost-effective generics and is powered by a dedicated global workforce.  I look forward to working closely and collaboratively with our leadership team and Endo’s Board to build on our strengths and help position the Company to thrive over the long-term.”

“It has been a pleasure and an honor leading Endo, building a talented management team and working with our dedicated employees over the past three and a half years,” said De Silva. “Now, with an international footprint, one year after the acquisition of Par and with a new President at the helm of our U.S. Branded business, the time is right for me to move on to new professional opportunities. I am working closely with the Board, Paul and the entire senior leadership team to ensure a smooth transition and remain fully committed to Endo’s future success.”

Kimmel added, “On behalf of the Board, I would like to thank Rajiv De Silva for his leadership.  He played a critical role in assembling valuable assets, establishing a global footprint and in building strong teams, and we wish him all the best in his future endeavors.”

Prior to becoming CEO of Par in 2012, Campanelli served as Chief Operating Officer of Par Pharmaceutical, driving growth in both its branded and generic pharmaceutical businesses. Previously, he held roles of increasing responsibility at Par, including President, Par Generics, and Executive Vice President, Business Development & Licensing for branded and generic products.  Campanelli has more than 25 years of experience in the generics and branded pharmaceutical industry.

Third Quarter and Full Year 2016 Financial Guidance

Endo is affirming its third quarter and full year financial guidance:

Third Quarter 2016

  • Total revenues between $830 million and $870 million; and
  • Adjusted diluted EPS from continuing operations between $0.77 and $0.82.

Full Year 2016

  • Total revenues between $3.87 billion and $4.03 billion;
  • Adjusted diluted EPS from continuing operations between $4.50 and $4.80.

Conference Call and Webcast
Endo will host a conference call and webcast at 9:00 a.m. ET today.  Investors and other interested parties may call (866) 497-0462 (domestic) or (678) 509-7598 (international) and enter passcode 88046538.  Please dial in 10 minutes prior to the scheduled start time.

A replay of the call will be available from September 23, 2016 at 11:30 a.m. ET until 11:59pm ET on October 07, 2016 by dialing (855) 859-2056 (domestic) or (404) 537-3406 (international) and entering passcode 88046538.

A simultaneous webcast of the call may be accessed by visiting www.endo.com.  In addition, a replay of the webcast will be available until 11:59 ET on October 07, 2016. The replay can be accessed by clicking on “News & Events” in the Investor Relations section of the website.

About Endo International plc
Endo International plc is a global specialty pharmaceutical company focused on improving patients’ lives while creating shareholder value. Endo develops, manufactures, markets and distributes quality branded and generic pharmaceutical products as well as over-the-counter medications though its operating companies. Endo has global headquarters in Dublin, Ireland, and U.S. headquarters in Malvern, PA. Learn more at www.endo.com.

Cautionary Note Regarding Forward-Looking Statements
This press release contains “forward-looking statements,” including, but not limited to, the statements by Messrs. Kimmel, Campanelli and De Silva, as well as Endo’s expected, estimated or anticipated future results. Because forecasts are inherently estimates that cannot be made with precision, Endo’s performance at times differs materially from its estimates and targets, and Endo often does not know what the actual results will be until after the end of the applicable reporting period. Therefore, Endo will not report or comment on its progress during a current quarter except through public announcement. Any statement made by others with respect to progress during a current quarter cannot be attributed to Endo.  All forward-looking statements in this press release reflect Endo’s current analysis of existing trends and information and represent Endo’s judgment only as of the date of this press release.  If underlying assumptions prove inaccurate or unknown risks or uncertainties materialize, actual results could vary materially from Endo’s expectations and projections. Risks and uncertainties include, among other things, general industry and market conditions; technological advances and patents attained by competitors; challenges inherent in the research and development and regulatory processes; challenges related to product marketing, such as the unpredictability of market acceptance for new products and/or the acceptance of new indications for such products; inconsistency of treatment results among patients; potential difficulties in manufacturing; general economic conditions; and governmental laws and regulations affecting domestic and foreign operations. Endo expressly disclaims any intent or obligation to update these forward-looking statements except as required by law. Additional information concerning these and other risk factors can be found in Endo’s periodic reports filed with the U.S. Securities and Exchange Commission and in Canada on the System for Electronic Data Analysis and Retrieval (“SEDAR”), including current reports on Form 8-K, quarterly reports on Form 10-Q and annual reports on Form 10-K.  Additional information about Endo is available on the World Wide Web at www.endo.com or you can contact the Endo Investor Relations department by calling (484) 216-0000.

Friday, September 23rd, 2016 Uncategorized Comments Off on $ENDP Names #PaulCampanelli #President & #CEO

$AEHR #PrivatePlacement #CommonStock Prelim. Q1 FY17 Data

FREMONT, Calif., Sept. 23, 2016  — Aehr Test Systems (NASDAQ:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced that it has entered into a definitive purchase agreement for the sale of approximately $5.9 million in shares of its common stock in a private placement transaction with certain institutional and accredited investors.

Pursuant to the terms of the purchase agreement, Aehr Test Systems has agreed to sell an aggregate of 2,721,540 shares of common stock at a price of $2.15 per share to outside institutional and accredited investors.  Aehr Test Systems intends to use the net proceeds from the private placement for working capital and general corporate purposes.  The private placement is anticipated to close on or about September 28, 2016, subject to the satisfaction of customary closing conditions.

Craig-Hallum Capital Group LLC is acting as the sole placement agent for the private placement.

Aehr Test Systems also announced preliminary financial results for the first quarter of fiscal 2017, ended August 31, 2016:

  • Revenue is expected to be approximately $5.3 million, compared to $1.6 million in the fourth quarter of fiscal 2016.
  • GAAP net loss is expected to be between $800,000 and $900,000, compared to a GAAP net loss of $3.1 million in the fourth quarter of fiscal 2016.
  • Backlog is expected to be over $10 million as of August 31, 2016, compared to a backlog of $5.3 million as of May 31, 2016.
  • Bookings in the first quarter of fiscal 2017 are estimated to be over $10 million.

Aehr Test Systems has not finalized its financial statement review process for the first quarter of fiscal 2017.  As a result, the information in this release is preliminary and based upon information available to Aehr Test Systems as of the date of this release.  During the course of Aehr Test Systems’ review process, items may be identified that would require Aehr Test Systems to make adjustments, which could result in changes to our preliminary selected financial information above.  As a result, the preliminary selected financial information above is forward-looking information and subject to risks and uncertainties, including possible adjustments to such information.

Aehr Test Systems will provide a full report of its first quarter fiscal 2017 results during its previously announced conference call scheduled for Thursday, September 29, 2016 following the close of market, 5:00 p.m. Eastern Time (2:00 p.m. PT).

The shares of common stock of Aehr Test Systems sold in the private placement have not been registered under the Securities Act of 1933, as amended, and as such the shares may not be offered or sold in the United States absent registration under such act and applicable state securities laws or an applicable exemption from those registration requirements. The securities were offered and sold only to a limited number of institutional and accredited investors.

About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test Systems products in package and wafer level test. Aehr Test Systems has developed and introduced several innovative products, including the ABTSTM and FOX families of test and burn-in systems and WaferPak contactors. The ABTS systems are used in production and qualification testing of packaged parts for both low-power and high-power logic as well as memory devices. The FOX family of systems includes single and multi-wafer full wafer contact test and burn-in systems used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The WaferPak contactor contains a unique full wafer probe card capable of testing wafers up to 300mm that enables IC manufacturers to perform test and burn-in of full wafers on Aehr Test FOX systems. For more information, please visit Aehr Test Systems’ website at www.aehr.com.

Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test Systems as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding Aehr Test Systems’ expectations, beliefs, intentions or strategies regarding the future, including statements regarding future market opportunities and conditions, expected product shipment dates, customer orders or commitments and future operating results. The risks and uncertainties that could cause Aehr Test Systems’ results to differ materially from those expressed or implied by such forward-looking statements include, without limitation, general market conditions, customer demand and acceptance of Aehr Test Systems’ products and Aehr Test Systems’ ability to execute on its business strategy. See Aehr Test Systems’ recent reports on Form10-K, Form10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing Aehr Test Systems’ business. Aehr Test Systems disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.

 

Aehr Test Systems
Ken Spink
Chief Financial Officer
(510) 623-9400 x309

Investor Relations Contact:
Todd Kehrli or Jim Byers
MKR Group, Inc.
(323) 468-2300
aehr@mkr-group.com
Friday, September 23rd, 2016 Uncategorized Comments Off on $AEHR #PrivatePlacement #CommonStock Prelim. Q1 FY17 Data
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