Archive for October, 2015

(AMTX) Feedstock Tax Barrier Removed by India Government

CUPERTINO, CA–(Oct 23, 2015) – Aemetis, Inc. (NASDAQ: AMTX), an advanced renewable fuels and biochemicals company, announced that the Government of India Revenue Department removed an important tax barrier to expanding biodiesel production in India, issuing an exemption on excise tax for feedstock. Biodiesel is a non-excise product, but a 12.5% tax had been charged on all feedstock and other inputs. The removal of the “inverted excise tax” enables rapid expansion of biodiesel production in India using both domestic and imported feedstock.

Prime Minister Modi has demonstrated visionary leadership by taking three major steps to advance the biodiesel industry in India. In October 2014, about $10 billion of annual subsidies for petroleum diesel was ended. In August 2015, biodiesel manufacturers were allowed to directly sell biodiesel to bulk customers, bypassing the government-owned oil marketing companies (OMCs) who control the retail outlets throughout India. In October 2015, the excise duty on the raw materials used in producing biodiesel was eliminated.

“With this prohibitive tax barrier to purchasing feedstock and other components removed, we believe Aemetis can, through our Indian subsidiary Universal Biofuels Private Ltd. (UBPL), achieve full production of biodiesel capacity in 2016,” said Eric McAfee, Chairman and Chief Executive Officer of Aemetis. “This supportive tax policy for biodiesel shows the commitment of PM Modi to cleaner air, lower carbon emissions, increased foreign investment, expanded skilled jobs and decreased diesel imports.” About 80% of the petroleum diesel consumed in India is imported.

“With the key tax notification now in place, we believe the entire biodiesel industry in India will benefit. As a market leader in India, UBPL will move aggressively to source feedstocks from different suppliers in India and across the globe to achieve our revenue and profitability goals,” said Sanjeev Gupta, Managing Director, Universal Biofuels subsidiary of Aemetis, based in Hyderabad.

The India diesel market is currently estimated at about 25 billion gallons per year (BGY), which upon achievement of a 20% biodiesel blend would result in a biodiesel market of about 5 BGY. The current biodiesel production capacity in India is estimated at 250 million gallons per year (MGY). Aemetis owns and operates a biodiesel production facility with a capacity of approximately 50 MGY (190 million liters) per year near the port city of Kakinada, located on the East Coast of India, and plans expansion to 100 million gallons per year.

About Aemetis

Headquartered in Cupertino, California, Aemetis is an advanced renewable fuels and renewable chemicals company focused on the acquisition, development and commercialization of innovative technologies that replace traditional petroleum-based products by the conversion of first-generation ethanol and biodiesel plants into advanced biorefineries. Founded in 2006, Aemetis owns and operates a 60 million gallon per year ethanol production facility in the California Central Valley town of Keyes. Aemetis also owns and operates a 50 million gallon per year renewable chemical and advanced fuel production facility on the East Coast of India, producing high quality distilled biodiesel and refined glycerin for customers in India and Europe. Aemetis operates a research and development laboratory at the Maryland Biotech Center, and holds a portfolio of patents and related technology licenses for the production of renewable fuels and biochemicals. For additional information about Aemetis, please visit www.aemetis.com.

Safe Harbor Statement

This news release contains forward-looking statements, including statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events or other statements that are not historical facts. Forward-looking statements in this news release include, without limitation, statements regarding our growth opportunities, our ability to grow and expand our business in India, the size of the market for biodiesel in India, the effect of the elimination of the excise duty on inputs on the biodiesel industry in India, UBPL’s achievement of full production of biodiesel capacity, our plans to source feedstocks and expand our facility in India and achievement of our revenue and profitability goals. Words or phrases such as “anticipates,” “may,” “will,” “should,” “believes,” “estimates,” “expects,” “intends,” “plans,” “predicts,” “projects,” “targets,” “will likely result,” “will continue” or similar expressions are intended to identify forward-looking statements. These forward-looking statements are based on current assumptions and predictions and are subject to numerous risks and uncertainties. Actual results or events could differ materially from those set forth or implied by such forward-looking statements and related assumptions due to certain factors, including, without limitation, competition in the ethanol and other industries in which we operate, commodity market risks including those that may result from current weather conditions, financial market risks, counter-party risks, risks associated with changes to government policy or regulation, and other risks detailed in our reports filed or to be filed with the Securities and Exchange Commission, including our Annual Report on Form 10-K for the year ended December 31, 2014 and in our subsequent filings with the SEC. We are not obligated, and do not intend, to update any of these forward-looking statements at any time unless an update is required by applicable securities laws.

Company, Investor Relations & Media:
Satya Chillara
(408) 213-0939
schillara@aemetis.com

Friday, October 23rd, 2015 Uncategorized Comments Off on (AMTX) Feedstock Tax Barrier Removed by India Government

(TXN) First Zero-Drift, 36-V Instrumentation Amplifier

Lowest drift with no 1/f corner provides pinpoint accuracy

DALLAS, Oct. 22, 2015  — Texas Instruments (TI) (NASDAQ:TXN) today introduced the industry’s first zero-drift, 36-V instrumentation amplifier. The INA188 delivers high accuracy for precise DC and low-frequency measurements in applications such as test and measurement, medical, and industrial process control equipment. It also eliminates the 1/f corner and features best-in-class offset drift to enable accurate measurement over the full extended industrial temperature range. For more information, see www.ti.com/ina188-pr.

Key features and benefits of the INA188:

  • Industry’s lowest offset drift optimizes long-term temperature stability: The zero-drift architecture used in the INA188 delivers high accuracy for high-voltage precision-measurement applications. Compared to competitive solutions, it enables an offset voltage of 25 µV and a 33 percent lower offset-voltage drift of 80 nV/ºC to provide long-term temperature stability over the lifetime of the end equipment.
  • No 1/f corner and low DC noise enable precise measurements at low frequencies: The INA188 generates only 250 nVPP of noise from 0.1 Hz to 10 Hz, with no 1/f corner frequency between broadband and near-DC. When combined with the INA188’s broadband noise floor of 12.5 nV/√Hz, the amplifier provides unrivaled precision for low-frequency applications.
  • High voltage ensures signal integrity: Capable of operating at up to 36 V, the INA188 helps maintain signal integrity over the full extended temperature range by allowing larger gains than lower voltage instrumentation amplifiers.

Tools and support to cultivate design
Engineers designing with the INA188 amplifier can quickly achieve optimum precision for their systems with the following support tools:

  • Evaluation module (EVM): Evaluate the performance of the INA188 with the universal instrumentation amplifier EVM (SO8), available for a suggested retail price of US$25 from the TI store and authorized distributors.
  • Macromodel: Verify board-level signal integrity requirements and device behavior with a free TINA-TI™ SPICE macromodel.
  • TI Designs reference design: A three-terminal PLC reference design featuring the INA188 converts +/-10-V or +/-20-mA inputs to a single-ended output voltage for 5-V analog-to-digital converters (ADCs). Additionally, the design features the REF3225 precision voltage reference integrated circuit (IC).
  • Support: Visit the TI Precision Amplifier Forum in the TI E2E™ Community to search for solutions, get help, share knowledge, and solve problems with fellow engineers and TI experts.
  • Vcm vs. Vout calculator: A standalone downloadable tool for instrumentation amplifiers plots the Vcm versus Vout curve given the designer’s specific design requirements, including single- or dual-supply, gain and reference voltage.

Pricing and availability
The INA188 is available now in a 4.9-mm-by-3.91-mm small outline integrated circuit (SOIC) package for a suggested retail price of US$1.85 in 1,000-unit quantities. It will be available in early 4Q15 in a 4-mm-by-4-mm very thin small outline no lead (WSON) package.

Powering the INA188
TI offers a full portfolio of power management products that can support the INA188, including the TPS65130 split-rail DC/DC converter or the LMR70503 SIMPLE SWITCHER® buck-boost converter to achieve dual-supply operation. For single-supply operation, the INA188 with the LM7705 negative bias generator offers true zero output.

Learn more about TI’s precision amplifiers:

About Texas Instruments
Texas Instruments Incorporated (TI) is a global semiconductor design and manufacturing company that develops analog ICs and embedded processors. By employing the world’s brightest minds, TI creates innovations that shape the future of technology. TI is helping more than 100,000 customers transform the future, today. Learn more at www.ti.com.

Trademarks
SIMPLE SWITCHER is a registered trademark and TI E2E and TINA-TI are trademarks of Texas Instruments. All registered trademarks and other trademarks belong to their respective owners.

Thursday, October 22nd, 2015 Uncategorized Comments Off on (TXN) First Zero-Drift, 36-V Instrumentation Amplifier

(BNTC) Abstract Accepted for Presentation at the AASLD Liver Meeting 2015

SYDNEY, Oct. 22, 2015  — Benitec Biopharma Limited (NASDAQ: BNTC; NASDAQ: BNTCW; ASX: BLT) is pleased to announce that clinical data on its Phase I/IIa study of TT-034 for hepatitis C will be presented in the ‘late-breaking poster’ session at The Liver Meeting® 2015, the 66th Annual Meeting of the American Association for the Study of Liver Disease (AASLD) being held in San Francisco on November 13-17, 2015.

The abstract, which has been published on the conference website, details interim results from patients in the first three cohorts in Benitec’s Phase I/IIa study of TT-034, a DNA-directed RNA interference agent (ddRNAi). The primary endpoint that this study is monitoring is safety of this first-in-man gene therapy-based gene silencing drug. Key findings include:

  • The three doses of TT-034 administered to date have been well tolerated in human subjects infected with the hepatitis C virus (HCV) and there have been no reported serious adverse events related to administration of the study drug;
  • The initial dose (4E10 vg/kg) resulted in very low levels of transduction as expected.
  • The second dose (1.25E11 vg/kg) resulted in the detection of substantially higher levels of TT-034 in the hepatocytes, the predominant cell type in the liver, yielding 0.48, 3.65 and 10.44 copies of TT-034 DNA per cell in the three patients respectively;
  • The first subject administered with the third dose (4.00E11 vg/kg) had 17.74 copies of TT-034 per cell, indicating that a significant portion of their hepatocytes may have been transduced, and expression of anti-HCV shRNAs was clearly detected in the transduced hepatocytes.

Benitec’s Chief Scientific Officer, Dr David Suhy said, “We are pleased to be given the opportunity to present this interim data at the AASLD Liver Meeting next month. The results show that a single infusion of TT-034 is reaching the liver and that it has a very favourable safety profile at the doses tested to date. In the patient that has received the highest dose to date, we are able to detect that anti-HCV shRNAs have been expressed in the liver without any drug-related serious adverse effects, indicating that so far the trial is achieving its primary outcome. We are pleased with the progress of the trial to date.”

To read the full abstract, please visit: http://www.aasld.org/sites/default/files/TLM-2015-LakeBreakingAbstracts.pdf

This announcement has been prepared for publication in Australia and may not be released in the United States. This announcement does not constitute an offer to sell, or a solicitation of an offer to buy, securities in the United States or any other jurisdiction.

For further information regarding Benitec and its activities, please contact the persons below, or visit the Benitec website at www.benitec.com.

Company Investor relations
Carl Stubbings
Chief Business Officer
Tel: +61 (2) 9555 6986
Email: cstubbings@benitec.com
Kyahn Williamson
Buchan Consulting
Tel: +61 (3) 8866 1200
Email: kwilliamson@buchanwe.com.au

More detail on the TT-034 trial:
TT-034 is a ddRNAi-based therapeutic, designed to treat and potentially cure hepatitis C (HCV) with a single administration. TT-034 targets the hepatitis C viral RNA at three separate, highly conserved sites. As such it acts as a “triple therapy” even though it is a monotherapy, and minimises the ability of the virus to mutate and escape the therapy. Once it reaches the liver cells it enters the nucleus and produces three separate short hairpin RNAs continuously for the life time of the cell. Thus it has the potential to not only treat the existing HCV infection but to guard against reinfection for months to years without the need to re-treat. It has been extensively tested in pre-clinical in vivo studies and no adverse effects were seen at any therapeutic dose.  However, as it is regulated as a gene therapy, the trial design is to primarily ensure that treatment with TT-034 is safe, hence the gradual dose escalation.

About Benitec Biopharma Limited:
Benitec Biopharma Limited is a biotechnology company (ASX: BLT; OTC: BTEBY), which has developed a patented gene silencing technology delivered by gene therapy, called DNA directed RNA interference (ddRNAi) that has the potential to produce ‘one-shot’ cures for a range of diseases. The company is developing ddRNAi-based therapeutics for chronic and life-threatening human conditions including hepatitis C and B, drug resistant lung cancer and wet age-related macular degeneration. Benitec has also licensed ddRNAi to other biopharmaceutical companies for applications including HIV/AIDS, Huntington’s disease, chronic neuropathic pain and retinitis pigmentosa. For more information visit www.benitec.com

Thursday, October 22nd, 2015 Uncategorized Comments Off on (BNTC) Abstract Accepted for Presentation at the AASLD Liver Meeting 2015

(IILG) Hyatt Vacation Ownership Appoints Jim Hansen Senior VP

Hyatt Vacation Ownership (HVO), operator of Hyatt Residence Club and an operating business of Interval Leisure Group (Nasdaq:IILG), announced the appointment of Jim Hansen as senior vice president of sales and local marketing. Hansen is based in HVO’s headquarters in St. Petersburg, Florida, and reports to Larry Shulman, the company’s chief sales and marketing officer.

An industry veteran with more than 25 years of experience, Hansen is responsible for all sales activities, as well as local marketing at Hyatt Residence Club’s six current sales centers in the continental U.S. In addition, he oversees all sales and local marketing activities associated with new projects as they come online.

Most recently, Hansen served as regional vice president for Hilton Grand Vacations, where he directed regional sales and marketing for the company. He also managed the fee-for-service developer partnerships in several key markets. Prior to that, he held positions of increasing responsibility with Marriott Vacation Club, including vice president of sales and marketing and regional project director.

“We’re delighted to welcome such a talented executive to our team. Jim brings a fresh perspective to our sales practices and techniques as we ramp up to grow our business,” said John Burlingame, president of Hyatt Vacation Ownership. “We’re confident that he will make important contributions.”

Over the course of his career, Hansen has been recognized with a number of honors for his sales and marketing achievements, including Resort of the Year and several leadership and productivity awards.

Hansen graduated cum laude from Washington State University with a bachelor’s degree in hotel and restaurant administration.

About Hyatt Vacation Ownership

Hyatt Vacation Ownership (HVO) has been developing, marketing, and managing shared ownership resorts in diverse vacation destinations since 1994. Headquartered in St. Petersburg, Florida, HVO operates Hyatt Residence Club (HRC), a flexible points-based program with approximately 30,000 members who have access to 16 HRC resorts, along with hundreds of Hyatt hotels and resorts worldwide via the popular Hyatt Gold Passport guest loyalty program. HRC members also have exchange privileges through Interval International’s network of more than 2,900 other resorts in over 80 countries, as well as additional benefits and services. HVO is an operating business of Interval Leisure Group, Inc. (Nasdaq: IILG), a leading global provider of non-traditional lodging, encompassing a portfolio of leisure businesses from exchange and vacation rental to vacation ownership. ILG and its subsidiaries independently own and manage the Hyatt Residence Club program and use the Hyatt Vacation Ownership name and other Hyatt marks under license from affiliates of Hyatt Hotels Corporation. www.HyattResidenceClub.com.

 

Hyatt Vacation Ownership
Yvette Batalla, 305-925-6519
Corporate Communications
news@hyattvoi.com

Thursday, October 22nd, 2015 Uncategorized Comments Off on (IILG) Hyatt Vacation Ownership Appoints Jim Hansen Senior VP

(OCLR) to Participate in the Needham Next-Gen Storage/Networking Conference

SAN JOSE, Calif., Oct. 22, 2015  — Oclaro, Inc. (Nasdaq: OCLR), a leading provider and innovator of optical communications solutions, today announced that management is scheduled to participate in the Needham Next-Gen Storage/Networking Conference on November 5, 2015 in New York City.

Event: Needham Next-Gen Storage/Networking Conference
Date: Thursday, November 5, 2015
Presentation Time: 11:30 am Eastern Time
Location: Millennium Broadway Hotel – New York City

A webcast of the Needham conference presentation will be available in the investor relations section of the Company’s website at www.oclaro.com.

About Oclaro
Oclaro, Inc. (Nasdaq: OCLR), is a leader in optical components, modules and subsystems for the core optical, enterprise and data center markets. Leveraging more than three decades of laser technology innovation, photonics integration, and subsystem design, Oclaro’s solutions are at the heart of the fast optical networks and high-speed interconnects driving the next wave of streaming video, cloud computing, voice over IP and other bandwidth-intensive and high-speed applications. For more information, visit www.oclaro.com or follow on Twitter at @OclaroInc.

Copyright 2015. All rights reserved. Oclaro, the Oclaro logo, and certain other Oclaro trademarks and logos are trademarks and/or registered trademarks of Oclaro, Inc. or its subsidiaries in the US and other countries. All other trademarks are the property of their respective owners. Information in this release is subject to change without notice.

Contact
Jim Fanucchi
Darrow Associates, Inc.
(408) 404-5400
ir@oclaro.com

Thursday, October 22nd, 2015 Uncategorized Comments Off on (OCLR) to Participate in the Needham Next-Gen Storage/Networking Conference

(SPRO) to Acquire SmartPros, Expand Continuing Education Offering

Kaplan, Inc., the global education services company and largest subsidiary of Graham Holdings (NYSE:GHC), has agreed to acquire SmartPros, Ltd. (NASDAQ-CM:SPRO), a leading provider of accredited professional education and training, primarily in accountancy. Kaplan will pay approximately $16.9 million in cash or $3.57 per share.

SmartPros offers a broad suite of services and content in accountancy continuing education. These include its well-known Financial Management Network (FMN), CPA Report (CPAR) and SmartPros Advantage (SPA) accounting subscription products. Its Financial Campus product and Banking library delivers continuing education to the financial services industry. SmartPros also offers accountancy training to accounting professionals and corporations through its Loscalzo Associates unit that qualifies practitioners for CPE credits in accounting, auditing and assurance topics. Its library of over 2,800 hours of primarily online education programming is delivered via a modern, proprietary learning management system (LMS) that enables clients to tailor their training requirements.

SmartPros recently launched its Audit Management System (AMS), which delivers a robust regulatory compliance solution for banks, broker-dealers and insurance companies to carry out branch audits and systematically help minimize regulatory and compliance risks.

“SmartPros’ continuing education courses in accountancy for professionals in the U.S. will provide a domestic complement to our existing global accountancy training programs,” said Dr. Andrew Temte, CFA and President of Kaplan Professional Education, who noted that Kaplan is a recognized leader in accountancy training in the U.K., Singapore and Hong Kong. “In addition, SmartPros’ continuing education offerings in the financial services field fit well with Kaplan’s existing Firm Element and Insurance CE products, which will enable us to deliver enhanced value to current and future customers.”

“We believe that combining SmartPros with Kaplan will strengthen our product offerings and allow the combined entity to better meet the needs of the changing professional development marketplace. We think this transaction is good for SmartPros’ customers, employees and shareholders,” said Allen S. Greene, CEO and Chairman of the Board for SmartPros. “It is a marriage of two well-regarded leaders in continuing education for accountants and financial service professionals.”

SmartPros reported $13.5 million in revenue for 2014.

Its existing customer base consists of approximately 3,000 companies, which primarily includes corporate, accounting and financial services firms. Additionally, SmartPros serves broker-dealers, securities and banking firms as well as state CPA societies and other professional groups and associations.

Practitioners can earn professional education credits for CPA, CMA, CFM, and CIA designations, and continuing legal education (CLE) credits.

The transaction is expected to close by year-end, subject to SmartPros’ shareholder approval.

About Kaplan

Kaplan, Inc. serves over 1.2 million students globally each year through its array of higher education, test preparation, professional education, English-language training, and university preparation, and offerings to individuals, institutions, and businesses. Across its 75-plus year history, first as small test-prep pioneer and then an early online education leader and now a global education provider, Kaplan has been recognized for expanding educational access and using technology and learning science innovations to continually improve outcomes for its students and partners. Kaplan has operations in over 30 countries, employs more than 19,000 full- and part-time professionals, and maintains relationships and partnerships with more than 1,000 school districts, colleges, and universities, and over 2,600 corporations and businesses.

Kaplan Professional Education helps professionals obtain in-demand certifications, licensing and designations that enable them to advance and succeed in their careers. Through live and online instruction, Kaplan Professional Education provides test preparation, licensing, continuing education, and professional development programs to businesses and individuals in the accounting, insurance, securities, real estate, financial planning, and information technology, industries.

Kaplan is a subsidiary of Graham Holdings Company (NYSE:GHC) and its largest division. For more information, please visit www.kaplan.com.

About SmartPros

Founded in 1981, SmartPros Ltd. is an industry leader in the field of accredited professional education and corporate training. Its products and services are primarily focused in the accredited professional areas of corporate accounting, financial management, public accounting, governmental and not for-profit accounting, financial services, banking, engineering, legal, ethics and compliance, and information technology. SmartPros is a leading provider of professional education products to Fortune 500 companies, as well as the major firms and associations in each of its professional markets. SmartPros provides education and content publishing and development services in a variety of media including Web, CD-ROM, video and live seminars and events. The company’s subscription libraries feature hundreds of course titles and 2,800 plus hours of accredited education. SmartPros’ proprietary Professional Education Center (PEC) Learning Management System (LMS) offers enterprise distribution and administration of education content and information. In addition, SmartPros produces a popular news and information portal for accounting and finance professionals serving more than one million ads and distributing more than 200,000 subscriber email newsletters each month. SmartPros’ network of Web sites averages more than 1 million monthly visits, serving a user base of more than 1.5 million profiled members. Visit: www.smartpros.com.

 

Kaplan
Mark Harrad, 212-974-6231
mark.harrad@kaplan.com
or
SmartPros
Shane Gillispie, 914-829-4974
shanegillispie@smartpros.com

Thursday, October 22nd, 2015 Uncategorized Comments Off on (SPRO) to Acquire SmartPros, Expand Continuing Education Offering

(SYPR) and NEC Introduce Keyless Security Architecture at Dell World

SiOMetrics™ Enabled Dell “Edge Gateway” with NEC’s “Magic Cloud”

Sypris Electronics, LLC, a subsidiary of Sypris Solutions, Inc. (Nasdaq/NM: SYPR), announced today that it will be demonstrating a new technology concept called the “Secure Multi-Cloud Gateway” using its SiOMetrics™ keyless high-security architecture integrated with the new Dell Edge Gateway 5000 series and NEC’s “Magic Cloud” security to provide end-to-end trust in the Internet of Things (IoT), from sensors through gateways to the cloud, at Dell World October 20-22.

SiOMetrics™ is a breakthrough technology that enables the construction of a truly keyless high-security solution that does not require the generation, storage or reconstruction of a private key. This unique capability, in combination with other cryptographic features associated with using silicon-intrinsic, anti-tamper, hardware-based identity, eliminates many of the vulnerabilities, costs and complexities associated with today’s security solutions.

SiOMetrics™ hardware root-of-trust security architecture is set to be a game-changer for IoT developers and virtually any organization that places a high priority on trust, including attestation capable identity authentication, integrity and privacy of data, autonomous critical event processing of secure data, distributed peer-to-peer transaction processing and secure data storage.

According to Dr. Paul Wang, Chief Technology Officer of the Global Safety Division of NEC Corporation, “SiOMetrics™ combined with Dell’s Edge Gateway, compliment NEC’s innovative suite of cloud solutions that seamlessly secure sensitive files and data over heterogeneous clouds. Governments and enterprises utilizing this technology can then be assured of the safe sharing of information resources online via private and public cloud storage domains.”

Commenting on the announcement, Scott Peters, Director of the Sypris Research Center at Purdue University said, “SiOMetrics™ provides the end-to-end trust that is essential for the IoT. We will demonstrate the power of SiOMetrics™ in a cloud-based environment, including keyless authentication of field sensors, Dell Edge Gateways and backend servers, and the storage of secure data with keyless “Magic Cloud” security by NEC.”

Added Chris Rezendes, President and founder of INEX Advisors, “SiOMetrics™ is the rare contributor to the IoT whose disruptive technology brings stability to IoT deployment operations. Many IoT evaluators see the potential gains from new instrumentation of their operations, but they cannot achieve desired ROI without the ability to close the feedback loop digitally. This often means autonomy at the edge. And that simply cannot be considered without a technically proven, operationally relevant and financially feasible approach to securing a broad population of edge nodes in IoT solutions. Enter, SiOMetrics™.”

“We are pleased to be working with Dell and to be a part of Dell World 2015,” stated John Walsh, President of Sypris Electronics. “As the Cyber threat continues to move center stage globally, the security of things is a more critical aspect of realizing the benefits of the “connected world.” We are looking forward to continuing to work with our partners to introduce this proven, “first-of-its-kind” security architecture for enabling end-to-end trust in IoT, the enterprise and other applications securing endpoints, critical assets, event processing, cloud storage and privacy.”

Sypris is a global, integrated security solutions provider serving the Government and Commercial sectors. Sypris is well known for leadership in cryptography, key management, identity authentication and access management, cyber security operations, and associated professional services. Sypris promotes an agile, innovative culture and state-of-the-art solution sets by strategically partnering with leading‐edge technology companies, agencies and universities. With 50 years of experience, Sypris is proud to develop, manufacture and integrate leading technologies that secure our global partners’ interests. For more information, please visit www.sypriselectronics.com.

This press release contains “forward-looking” statements within the meaning of federal securities laws. Actual results could differ materially from those projected in such forward-looking statements as a result of certain risk factors, including but not limited to: various risks that the SiOMetricsTM solution is, or becomes, vulnerable to cyber security threats which are capable of circumventing the protection offered by that technology, as well as those risk factors set forth in the Annual Report on Form 10-K, dated and filed March 31, 2015 with the Securities and Exchange Commission (SEC) by our parent company, Sypris Solutions, Inc. and other filings that Sypris makes with the SEC from time to time.

Sypris Electronics, LLC
Michelle Long, 813-972-6202

Wednesday, October 21st, 2015 Uncategorized Comments Off on (SYPR) and NEC Introduce Keyless Security Architecture at Dell World

(WGBS) Successful Completion of $17.25 Million Public Offering

Proceeds to be Used Primarily for Research and Development Initiatives and ICELL8(TM) Single-Cell System Commercialization Activities

FREMONT, Calif., Oct. 21, 2015  — WaferGen Bio-systems, Inc. (NASDAQ:WGBS) today announced that the Company has completed the previously announced underwritten public offering.

Due to the exercise in full of the underwriters’ over-allotment option, the Company received gross proceeds of $17.25 million and issued a total of 6,170,000 shares of common stock, shares of preferred stock convertible into 11,080,000 shares of common stock and warrants to purchase 17,250,000 shares of common stock. The preferred stock issued in this transaction includes a beneficial ownership blocker, but has no dividend rights (except to the extent dividends are also paid on the common stock), liquidation preference or other preferences over common stock.

Ladenburg Thalmann & Co. Inc., a subsidiary of Ladenburg Financial Services Inc., acted as sole book-running manager for the offering, and Chardan Capital Markets, LLC, and Dougherty & Company acted as co-managers.

The net proceeds of the offering are estimated to be approximately $15.7 million, after deducting underwriting discounts and commissions and estimated offering expenses. WaferGen intends to use the net proceeds from the offering for research and development initiatives, ICELL8™ Single-Cell System-related commercialization activities and for general corporate and working capital purposes.

A registration statement relating to the offering of common stock was declared effective by the Securities and Exchange Commission (SEC) on October 15, 2015. A final prospectus relating to this offering has been filed with the SEC, and may be obtained at the SEC’s website at www.sec.gov, or by contacting Ladenburg Thalmann & Co. Inc., 570 Lexington Avenue, 11th Floor, New York, NY 10022, or by email at prospectus@ladenburg.com. 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 an offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of such state or jurisdiction.

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 and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the anticipated closing of our underwritten public offering, the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

CONTACT: Investor Contacts:

         LifeSci Advisors, LLC
         Brian Ritchie
         BRitchie@LifeSciAdvisors.com

         WaferGen Bio-systems, Inc.
         Rollie Carlson
         Rollie.Carlson@wafergen.com
Wednesday, October 21st, 2015 Uncategorized Comments Off on (WGBS) Successful Completion of $17.25 Million Public Offering

(NWBO) Enters Agreement For $30 Million Of New Equity Funding

BETHESDA, Md., Oct. 21, 2015  — Northwest Biotherapeutics (NASDAQ: NWBO) (“NW Bio”), a U.S. biotechnology company developing DCVax® personalized immune therapies for solid tumor cancers, announced today that the Company has entered into agreement for funding of $30 million from Woodford Investment Management in the UK (“Woodford”).

Woodford will purchase $30 million of the Company’s common stock at $5.50 per share, for a total of 5,454,545 shares, raising Woodford’s total holdings to 25,915,937 shares, or about 28.1% of the Company.  The purchase will take place in a closing on or before October 22, 2015.

NW Bio also announced that it has engaged Ondra Partners (www.ondra.com), a London-based corporate finance firm with a focus on value creation and an integrated approach to medium and long term financing and related initiatives.

In connection with this financing, the Company has issued 0.7 million shares to Cognate BioServices on the same terms as Woodford’s stock purchase, for certain current payment obligations, as well as completing the issuance of shares to Cognate that were approved and reported in November 2014, but had not yet been issued.

“NW Bio has reported encouraging interim clinical data from both its DCVax-L and DCVax-Direct clinical programs, both last spring and recently, with patient survival exceeding expectations.  With this new funding from Woodford we look forward to moving these clinical programs ahead vigorously while continuing to build our organization” commented Linda Powers, CEO of NW Bio.

About Northwest Biotherapeutics

Northwest Biotherapeutics is a biotechnology company focused on developing immunotherapy products to treat cancers more effectively than current treatments, without toxicities of the kind associated with chemotherapies, and on a cost-effective basis, in both the United States and Europe.  The Company has a broad platform technology for DCVax dendritic cell-based vaccines.  The Company’s lead program is a 348-patient Phase III trial in newly diagnosed Glioblastoma multiforme (GBM), which is on a partial clinical hold in regard to new screening of patients.  GBM is the most aggressive and lethal form of brain cancer, and is an “orphan disease.”  The Company is under way with a 60-patient Phase I/II trial with DCVax-Direct for all inoperable solid tumors cancers, with a primary efficacy endpoint of tumor regression.  It has completed enrollment in the Phase I portion of the trial.  The Company previously received clearance from the FDA for a 612-patient Phase III trial in prostate cancer.  The Company conducted a Phase I/II trial with DCVax for metastatic ovarian cancer together with the University of Pennsylvania.  In Germany, the Company has also received approval of a 5-year Hospital Exemption for the treatment of all gliomas (brain cancer) patients outside the clinical trial.

Disclaimer

Statements made in this news release that are not historical facts, including statements concerning future treatment of patients using DCVax and future clinical trials, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995.  Words such as “expect,” “believe,” “intend,” “design,” “plan,” “continue,” “may,” “will,” “anticipate,” and similar expressions are intended to identify forward-looking statements.  Actual results may differ materially from those projected in any forward-looking statement.  Specifically, there are a number of important factors that could cause actual results to differ materially from those anticipated, such as risks related to the Company’s ongoing ability to raise additional capital, risks related to the Company’s ability to enroll patients in its clinical trials and complete the trials on a timely basis, uncertainties about the clinical trials process, uncertainties about the timely performance of third parties, risks related to whether the Company’s products will demonstrate safety and efficacy, risks related to the Company’s and Cognate’s abilities to carry out the intended manufacturing and expansions contemplated in the Cognate Agreements, risks related to the Company’s ability to carry out the Hospital Exemption program and risks related to possible reimbursement and pricing.  Additional information on these and other factors, including Risk Factors, which could affect the Company’s results, is included in its Securities and Exchange Commission (“SEC”) filings.  Finally, there may be other factors not mentioned above or included in the Company’s SEC filings that may cause actual results to differ materially from those projected in any forward-looking statement.  You should not place undue reliance on any forward-looking statements.  The Company assumes no obligation to update any forward-looking statements as a result of new information, future events or developments, except as required by securities laws.

Wednesday, October 21st, 2015 Uncategorized Comments Off on (NWBO) Enters Agreement For $30 Million Of New Equity Funding

(NEO) signs Definitive Agreement to acquire Clarient, Inc.

GE Healthcare retains significant stake in NeoGenomics and Parties agree to collaborate on Bioinformatics Initiative

FORT MYERS, Fla., Oct. 21, 2015  — NeoGenomics, Inc. (NASDAQ: NEO), a leading provider of cancer-focused genetic testing services, announced today that it has reached an agreement to acquire Clarient, Inc., and its wholly-owned subsidiary Clarient Diagnostic Services, Inc., a provider of comprehensive cancer diagnostic testing to hospitals, physicians and the pharmaceutical industry (together “Clarient”).  Clarient, a unit of GE Healthcare’s Life Sciences business, is based in Aliso Viejo, California and Houston, Texas and has approximately 415 employees.  Clarient had 2014 revenue of $127 million and Adjusted EBITDA(1) of approximately $13 million.

The acquisition will allow NeoGenomics to broaden its offering of innovative cancer diagnostic tests to hospitals and physicians across the country, and to accelerate its growth in the fast-growing worldwide market for pharmaceutical clinical trials and research.  The complementary product offerings and expanded geographical reach of the combined companies are expected to provide customers with substantial benefits and create a significantly larger and more diversified provider of precision oncology diagnostics.

Clarient’s outstanding pathology services and capabilities in the analysis of solid tumor cancers of the breast, colon and lung are highly complementary to NeoGenomics’ industry-leading molecular testing services and extensive expertise in testing for hematologic cancers.  Hospital, physician, and pharmaceutical industry clients will benefit from the combined company’s ability to offer a wider range of world-class tests, closer geographical access to services, and enhanced service capabilities.    The acquisition will allow the combined company to further leverage its existing laboratory facilities and infrastructure to drive productivity and lower operating costs.

The transaction purchase price includes $80 million in cash, $110 million in Preferred Stock, and 15 million shares of NeoGenomics Common Stock, subject to customary adjustments for working capital at close.  The Preferred Stock will be issued at $7.50 per share and is redeemable at the option of NeoGenomics at any time over its ten year term along with any accrued dividends(2) at the original issue price with certain incentives for early redemption(3).  After three years, GE Healthcare will have the option to convert the Preferred Stock and any accrued dividends to NeoGenomics Common Stock at $7.50 per share if the volume weighted average price of NeoGenomics’ Common Stock is above $8.00 per share for thirty consecutive trading days.  If still outstanding on the tenth anniversary, the Preferred Stock and any accrued dividends will automatically convert into common stock at $7.50 per share.

The transaction is subject to approval by the relevant anti-trust authorities and NeoGenomics’ shareholders and is anticipated to close in Quarter 4, 2015.  On a fully diluted basis, assuming full conversion of the preferred stock, GE Healthcare will beneficially own approximately 32% of NeoGenomics.  As part of the transaction, the NeoGenomics Board of Directors will be expanded with the appointment of a new director from GE Healthcare.  In addition, NeoGenomics and GE Healthcare have agreed to collaborate on a new bioinformatics initiative that combines their shared interest in precision oncology.

NeoGenomics’ Chairman and CEO, Mr. Douglas VanOort, commented, “Our vision is to become America’s premier cancer testing laboratory, and this acquisition is a major step forward in achieving that vision.  We have always respected Clarient’s outstanding capabilities, and are very pleased to be able to combine them with our own outstanding service offering.  Hospital, physician, and pathology clients will benefit from our ability to offer the “best of the best” products and services available from each company.  We are particularly pleased to add Clarient’s sizable and fast-growing clinical trial support business to further strengthen our own initiatives in this area.”

Mr. VanOort continued, “Providing there are no unexpected changes to reimbursement in 2016, we expect our revenue to more than double to approximately $240 – $250 million and our Adjusted EBITDA to more than triple to between $33 and $38 million on a pro forma basis in 2016.  This will be a deliberately executed integration, and we expect synergy realization to begin modestly with approximately $4-6 million of realized synergies in 2016.  However, by the end of year 3, we expect $20-$30 million per year of realized synergies as we strive to be the high-quality and low-cost provider in cancer genetic testing.  Our increased scale will also enhance our ability to innovate in new areas of precision medicine.  Of all the possible acquisition candidates we have reviewed, Clarient is by far the best fit for NeoGenomics.”

Mr. VanOort concluded, “In addition, NeoGenomics and GE Healthcare have agreed to collaborate on a new bioinformatics initiative that combines their shared interest in precision oncology.  The collaboration will explore the potential for new products that combine genomic and imaging data, with the aim of helping reduce healthcare costs and improving the care of patients with cancer.”

Ms. Cindy Collins, CEO of  Clarient Diagnostic Services, said, “We’re proud of the highly talented and dedicated people at Clarient, who deliver an outstanding level of service to physicians and to leading players in the pharmaceutical industry, helping guide patient treatment and supporting the discovery and development of new medicines.  We believe the business will benefit from the focus that will come from being part of NeoGenomics, while allowing GE Healthcare Life Sciences to focus on its core long-term growth areas in bioprocessing, cell therapy and disease imaging.”

(1)      Adjusted EBITDA is a non-GAAP measure and is defined as earnings before interest, taxes, depreciation, amortization, non-recurring charges and non-cash stock-based compensation expenses.  Clarient’s historical Adjusted EBITDA also includes certain other adjustments to make Clarient’s historical financials consistent with the business and operations being acquired by NeoGenomics.  The full details of such adjustments will be included in the Proxy Statement for this transaction.

(2)      Beginning one year after issuance, the Preferred Stock will start to accrue payment-in-kind (“PIK”) dividends at the rate of 4% per annum.  To the extent such Preferred Stock has not been redeemed by NeoGenomics prior to the 4th anniversary of issuance, the dividend rate will be increased to 5% per annum in year 5 and increased by an additional 1% per annum per year thereafter until reaching 10% in year 10.

(3)      As an incentive to redeem the Preferred Stock in a timely manner, the redemption provisions provide for the following discounts if redemption occurs in the first four years.  Partial redemptions will include an equivalent percentage discount of the amounts indicated below.

Redemption Period on or Before                       Discount on Full Redemption

The first anniversary of issuance:                                    $10.0 million
The second anniversary of issuance:                               $7.5 million
The third anniversary of issuance:                                   $5.0 million
The fourth anniversary of issuance:                                 $2.5 million

Conference Call

NeoGenomics has scheduled a web-cast and conference call to discuss this acquisition with research analysts and investors today at 11:00 AM EDT.  Interested investors should dial (877) 407-0782 (domestic) and (201) 689-8567 (international) at least five minutes prior to the call and ask for Conference ID Number 13623193.  A replay of the conference call will be available until 11:59 PM on November 3, 2015 and can be accessed by dialing (877) 660-6853 (domestic) and (201) 612-7415 (international).  The playback conference ID Number is 13623193.  The web-cast may be accessed visiting the link https://www.webcaster4.com/Webcast/Page/1219/11294 and can be viewed after the web-cast under the Investor Relations section of our website at www.neogenomics.com. An archive of the web-cast will be available until 11:59 PM on January 20, 2016.

About NeoGenomics, Inc.

NeoGenomics, Inc. is a high-complexity CLIA–certified clinical laboratory that specializes in cancer genetics diagnostic testing, the fastest growing segment of the laboratory industry.  The company’s testing services include cytogenetics, fluorescence in-situ hybridization (FISH), flow cytometry, immunohistochemistry, anatomic pathology and molecular genetic testing.

Headquartered in Fort Myers, FL, NeoGenomics has laboratories in Nashville, TN, Irvine, Fresno and West Sacramento CA, Tampa and Fort Myers, FL.  NeoGenomics services the needs of pathologists, oncologists, other clinicians and hospitals throughout the United States. For additional information about NeoGenomics, visit http://www.neogenomics.com.

Forward Looking Statements

Except for historical information, all of the statements, expectations and assumptions contained in the foregoing are forward-looking statements.  These forward looking statements involve a number of risks and uncertainties that could cause actual future results to differ materially from those anticipated in the forward looking statements, Actual results could differ materially from such statements expressed or implied herein. Factors that might cause such a difference include, among others, the company’s ability to continue gaining new customers, offer new types of tests, and otherwise implement its business plan. As a result, this press release should be read in conjunction with the company’s periodic filings with the SEC.

Additional Information

NeoGenomics will solicit the required approval of its stockholders by means of a proxy statement, which will be mailed to stockholders upon completion of the required Securities and Exchange Commission (“SEC”) filing and review process. The proxy statement will contain information about NeoGenomics, Clarient, the proposed transaction and related matters. NeoGenomics stockholders are urged to read the proxy statement carefully when it is available, as it will contain important information that stockholders should consider before making a decision about the transaction. In addition to receiving the proxy statement from NeoGenomics in the mail, stockholders will also be able to obtain the proxy statement, as well as other filings containing information about NeoGenomics, without charge, at the SEC’s web site, www.sec.gov, or from NeoGenomics at its website, www.neogenomics.com, or by mailing NeoGenomics, Inc., 12701 Commonwealth Drive, Suite 9, Fort Myers, Florida 33913 Attention: Fred Weidig, Corporate Secretary.

Participants in Solicitation

NeoGenomics and its executive officers and directors may be deemed to be participants in the solicitation of proxies from NeoGenomics’ stockholders with respect to the proposed transaction. Information regarding any interests that NeoGenomics’ executive officers and directors may have in the transaction will be set forth in the proxy statement.

Wednesday, October 21st, 2015 Uncategorized Comments Off on (NEO) signs Definitive Agreement to acquire Clarient, Inc.

(CNCK) Spotlighted in Top Non-Prescription and Nutritional Industries Publication

LOS ANGELES, CA–(Oct 21, 2015) – ContentChecked Holdings, Inc. (OTCQB: CNCK) today highlights its coverage in leading trade publication, “The Tan Sheet.” As part of its broader coverage of the non-prescription pharmaceutical and nutritional industries, “The Tan Sheet” featured ContentChecked’s recently announced and unique partnership with Troy Healthcare in the October 9th issue.

ContentChecked and Troy Healthcare recently teamed up to apply their innovative products, MigraineChecked and Stopain® Migraine, respectively, as a convenient tool for consumers to access preventative information and fast-acting relief from migraines.

MigraineChecked is a unique, free mobile app that scans food bar codes to help consumers detect and avoid the more than 250,000 packaged foods known to trigger migraines. MigraineChecked users can set up profiles and favorites for themselves, as well as for family members or friends who may also experience migraines. Stopain Migraine is a topical gel that provides safe, fast and effective migraine pain relief without pills, known side effects or the risk of drug interaction. Stopain Migraine does not include aspirin, caffeine or acetaminophen, and can be used alone or in conjunction with other medications since there are no known drug interactions.

“The Tan Sheet” is a weekly trade magazine that provides customers with essential regulatory, business and clinical information concerning the healthcare industry. As the over-the-counter (OTC) industry’s leading source of analysis, information and news, “The Tan Sheet” is read by a growing audience of executives, marketers, consultants and investors. Coverage in “The Tan Sheet” provides both ContentChecked and Troy Healthcare with considerable exposure among these invaluable demographics.

“We’re honored to be featured in such a reputable, industry-leading publication,” says Kris Finstad, CEO of ContentChecked, the developer of MigraineChecked, SugarChecked and ContentChecked, a family of health apps for people with dietary restrictions and/or food preferences. “As we continue to advance exposure and availability of the ContentChecked brand, exposure of this nature is highly favorable to our growth initiatives and to spreading the word of our innovative and exciting technologies.”

About ContentChecked Holdings, Inc.

ContentChecked has created a revolutionary marketplace for people with dietary restrictions and the organizations who cater to them by creating and introducing the ContentChecked, MigraineChecked and SugarChecked smartphone applications to the market. ContentChecked and MigraineChecked applications are the first applications with comprehensive and accurate content information, and in-depth allergen and migraine definitions for most U.S. food products. SugarChecked gives consumers the ability to scan the barcodes of grocery store products and determine what kind of sugars are contained within. This enables the applications to meet the needs of millions of people in the United States. As a result, ContentChecked has created a pivotal way for food producers to, at the point of purchase, be able to showcase their products to consumers who are actively seeking them.

Designed for use by those who suffer from food allergies, dietary intolerances, migraines and chronic headaches, ContentChecked and MigraineChecked applications have reached wide adoption levels. In the U.S. alone there are 15 million people who suffer from food allergies and 38 million from migraine and chronic headaches. The food allergy market currently has an estimated value of $6 billion USD. Both applications give the ability to scan a product’s bar code and determine if it is safe for consumption, and if not the apps will recommend a suitable alternative per the user’s specific dietary profile.

SugarChecked identifies four main types of sugars that consumers can avoid, including added sugars, artificial sweeteners, natural low-calorie sweeteners and sugar alcohols. This application is an easy shopping tool for consumers to decipher often-misleading food labels, and receive recommendations for healthier alternative products as they shop in real time.

ContentChecked has created a robust database of allergens, migraine triggers, and food ingredients that directly correlate with food allergies, intolerances, migraines and chronic headaches. There are currently hundreds of thousands of products in its database that is updated regularly. ContentChecked’s applications are highly scalable and can expand into new geographic areas and product categories with limited modifications and investment.

For more information on ContentChecked, please visit its social media channels via Facebook (http://www.facebook.com/contentchecked) Instagram (http://www.instagram.com/contentchecked), or YouTube (http://www.youtube.com/channel/UCMihoaZILlRZ2C3hmx5vXhQ). You may also visit the social media channels of MigraineChecked on Facebook (http://www.facebook.com/migrainechecked) or Instagram (http://www.instagram.com/migrainechecked/).

Forward-Looking Statements:

Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements. Forward-looking statements may include, without limitation, statements regarding (i) the plans and objectives of management for future operations, including plans or objectives relating to the design, development and commercialization of the Company’s mobile applications, (ii) a projection of income (including income/loss), earnings (including earnings/loss) per share, capital expenditures, dividends, capital structure or other financial items, (iii) the Company’s future financial performance and (iv) the assumptions underlying or relating to any statement described in points (i), (ii) or (iii) above. Such forward-looking statements are not meant to predict or guarantee actual results, performance, events or circumstances and may not be realized because they are based upon the Company’s current projections, plans, objectives, beliefs, expectations, estimates and assumptions and are subject to a number of risks and uncertainties and other influences, many of which the Company has no control over. Actual results and the timing of certain events and circumstances may differ materially from those described by the forward-looking statements as a result of these risks and uncertainties. Factors that may influence or contribute to the inaccuracy of the forward-looking statements or cause actual results to differ materially from expected or desired results may include, without limitation, the Company’s inability to obtain adequate financing, the significant length of time and resources associated with the development of our products and related insufficient cash flows and resulting illiquidity, the Company’s inability to expand the Company’s business, significant government regulation of the healthcare industry, lack of product diversification, existing or increased competition, results of arbitration and litigation, stock volatility and illiquidity, and the Company’s failure to implement the Company’s business plans or strategies. These and other factors are identified and described in more detail in the Company’s filings with the SEC, including, the Company’s Annual Report on Form 10-K filed with the SEC on July 13, 2015. The Company does not undertake to update these forward-looking statements.

Contact:

Investor Relations
Mike Bowdoin
Bowdoin Group
407-590-6995
Mike@BowdoinGrp.com

Wednesday, October 21st, 2015 Uncategorized Comments Off on (CNCK) Spotlighted in Top Non-Prescription and Nutritional Industries Publication

(EGHT) Tapped by (N) as New Enterprise Cloud Communications Provider

8×8 Dials Up Global Service Across Nine Locations in Three Countries in Record-Breaking Six-Week Initial Deployment

8×8, Inc. (NASDAQ:EGHT), a leading provider of cloud-based unified communications and contact center solutions, today announced that NetSuite Inc. (NYSE: N), the industry’s leading provider of cloud-based financials / ERP and omnichannel commerce software suites, selected 8×8 as its new global, unified cloud partner to standardize its enterprise-class business telephony service, replacing all existing legacy communication systems. This latest customer win for 8×8 continues to demonstrate the company’s strategic move up-market, global footprint of its Enterprise Communications-as-a-Service (ECaaS) solution, and growing enterprise roster.

Following an extensive multi-vendor, technical review and proof of concept (POC) process, NetSuite selected 8×8 as its new cloud communications solutions provider and 8×8’s flagship Virtual Office business telephony solution to address its evolving global communications requirements. With more than 4,500 employees worldwide, 8×8 worked with NetSuite to onboard the first 2,400 employees by the end of August across nine locations – delivering a record-breaking six-week deployment in the final seven sites. The initial deployment spans three countries, including large offices in the Philippines. The remaining offices are expected to be fully deployed by 2016.

“We needed a true enterprise communications partner that could seamlessly and rapidly migrate our entire phone service to the cloud – while unifying our worldwide offices with a secure, reliable solution that works across the globe,” said Doug Brown, NetSuite CIO. “As we looked at enterprise communications providers, we found that 8×8 offered the highest levels of uptime and security to successfully run our global business. 8×8 offers the critical efficiencies we need from a full-featured desktop and mobile solution that will help us drive a new level of service as we scale our worldwide presence.”

Enterprise-Ready: Elite Touch Service and Award-Winning Product

8×8’s Elite Touch™ rapid enterprise on-boarding program served as a critical element for NetSuite’s decision. Elite Touch offers extensive experience in accelerating successful enterprise deployment, from kick-off through post-deployment support. 8×8’s proven methodology helps ensure the fastest time to value—even for customers with large, complex requirements that typically involve multiple sites, global implementations or integration with CRM or other critical back-end systems. In addition to 8×8’s high-end service, rapid enterprise on-boarding and support, 8×8’s Virtual Office provides essential enterprise-class telephony and unified communications features, including auto attendants, an online dashboard, soft phones and mobile apps. Chat, presence management, third party CRM and ERP integrations, and powerful analytics are also a core part of 8×8’s award-winning business telephony solution.

“We are pleased to team with NetSuite to help them reach a new level of success and efficiency with their global business communications,” said Vik Verma, 8×8 CEO. “This deployment demonstrates a strong commitment to our existing partnership and marks a major corporate milestone as we continue to prove that 8×8 is truly enterprise-ready. NetSuite is a phenomenal partner and leading cloud innovator, and we are committed to helping them achieve continued success as they scale their business. 8×8 continues to demonstrate that we can truly deliver an extensive, multi-country enterprise deployment from PO to deployment in a few weeks. We are proud to be one of NetSuite’s trusted partners as we help accelerate its business transformation on a global scale.”

About 8×8, Inc.

8×8, Inc. (NASDAQ:EGHT) is the trusted provider of secure and reliable enterprise cloud communications solutions to more than 40,000 businesses operating in over 100 countries across six continents. 8×8’s out-of-the-box cloud solutions replace traditional on-premises PBX hardware and software-based systems with a flexible and scalable Software as a Service (SaaS) alternative, encompassing cloud business phone service, contact center solutions, and conferencing. For additional information, visit www.8×8.com, www.8×8.com/UK or connect with 8×8 on LinkedIn, Twitter, Google+ and Facebook.

NOTE: NetSuite and the NetSuite logo are service marks of NetSuite Inc.

 

8×8, Inc.
Jodi Guilbault, 415-987-4970
jodi.guilbault@8×8.com

Tuesday, October 20th, 2015 Uncategorized Comments Off on (EGHT) Tapped by (N) as New Enterprise Cloud Communications Provider

(EPAX) Announces Dissolution Date and Initial Liquidating Distribution

SPOKANE, Wash., Oct. 20, 2015  — Ambassadors Group, Inc. (NASDAQ:EPAX) announced today that the company intends to file a certificate of dissolution with the Delaware Secretary of State and to close its stock transfer books and discontinue recording transfers of its common stock as of the close of business on October 23, 2015.  The company also plans to file a Form 25 with the Securities and Exchange Commission on such date to delist its common stock from The NASDAQ Stock Market.

The dissolution of the company was approved by its stockholders at a special meeting held on October 13, 2015. In connection with the dissolution, the company’s Board of Directors has approved an initial liquidating distribution of $2.85 per share of the company’s common stock.  The distribution will be paid on or about October 29, 2015 to stockholders of record as of the effective date of the certificate of dissolution (including trades through the effective date that settle after the effective date).

Subject to uncertainties inherent in the winding up of its business, Ambassadors Group may make one or more additional liquidating distributions, as the company’s required contingency reserves may be released over time. However, no assurances can be made as to the ultimate amounts to be distributed, if any, or the timing of any such distributions. Any additional liquidating distributions will be made to the stockholders of record as of the effective date of the certificate of dissolution (including trades through the effective date that settle after the effective date).

Cautionary Statement Regarding Forward-Looking Statements

This press release contains “forward-looking statements.”  These statements are not historical facts but instead represent the Company’s belief or plans regarding future events, many of which, by their nature, are inherently uncertain and outside of the Company’s control.  The Company’s forward-looking statements are subject to various risks and uncertainties, including the risks and other factors identified herein and in other public disclosures made by the Company from time to time, including in the Company’s periodic and current reports and other filings made by the Company with the Securities and Exchange Commission.  As a result, the Company’s actual results may differ materially from those expressed or implied by these forward-looking statements.  Forward-looking statements include, without limitation: statements regarding the proposed dissolution and liquidation of the Company and the delisting of the Company’s common stock, including the anticipated timing of filing the certificate of dissolution and the Form 25, and the initial liquidating distribution to be paid to stockholders.  Forward-looking statements involve known and unknown risks, uncertainties and other important factors that could cause our actual results, performance or achievements, or industry results, to differ materially from the Company’s expectations of future results, performance or achievements expressed or implied by such forward-looking statements.  Although the Company believes that the expectations reflected in any forward-looking statements are reasonable, it cannot guarantee future events or results.  Except as may be required under federal law, the Company undertakes no obligation to update any forward-looking statements for any reason, even if new information becomes available or other events occur.

ABOUT AMBASSADORS GROUP, INC.

Ambassadors Group, Inc. (NASDAQ:EPAX), located in Spokane, Washington, was an education and student travel company.

 

Contact:
Lisa Netz
509-568-7800
Tuesday, October 20th, 2015 Uncategorized Comments Off on (EPAX) Announces Dissolution Date and Initial Liquidating Distribution

(CRBP) FDA Orphan Drug Designation, Fast Track Status of Resunab(TM)

Second Orphan Drug Designation and Fast Track Status Granted to Resunab for Treatment of a Rare Inflammatory Disease

NORWOOD, MA–(Oct 20, 2015) – Corbus Pharmaceuticals Holdings, Inc. (NASDAQ: CRBP) (“Corbus” or the “Company”), a clinical stage drug development company targeting rare, chronic, and serious inflammatory and fibrotic diseases, announced today that the U.S. Food and Drug Administration (“FDA”) has designated as a Fast Track development program and granted Orphan Drug Designation to the Company’s investigational new drug Resunab™ for the treatment of cystic fibrosis (“CF”).

“These Orphan Drug and Fast Track Designations for Resunab in CF are another noteworthy milestone in our development and regulatory strategy and follow the launch of our Phase 2 clinical study in CF last month,” stated Yuval Cohen, Ph.D., Chief Executive Officer of the Company. “Resunab has now received Orphan Drug and Fast Track Designation for the treatment of both systemic sclerosis and CF. We are pleased with the progression of our strategy focused on the treatment of significant unmet medical needs in rare inflammatory diseases.”

The Company recently initiated an international, multi-center, Phase 2, double-blinded, randomized, placebo-control clinical study with multiple doses of Resunab in CF supported by a $5 million development award from Cystic Fibrosis Foundation Therapeutics, Inc. The study will enroll approximately 70 adults with CF, irrespective of their CFTR mutation.

“Resunab has demonstrated efficacy in pre-clinical models of inflammation and fibrosis, including a CF model, and to date, has a promising clinical safety profile in Phase 1 and 2 testing in humans,” added Barbara White, M.D., Chief Medical Officer of the Company. “We believe Resunab has the potential to provide clinical benefit for individuals with CF and look forward to reporting top-line safety and efficacy results from our Phase 2 study in CF at the end of 2016.”

The FDA Orphan Drug Designation program provides a special status to drugs and biologics intended to treat, diagnose or prevent diseases and disorders that affect fewer than 200,000 people in the U.S. This designation provides for a seven-year marketing exclusivity period against competition, as well as certain incentives, including federal grants, tax credits and a waiver of PDUFA filing fees.

A Fast Track designation enables more frequent interactions with the FDA to expedite the development and review process for drugs intended to treat serious or life-threatening conditions and that demonstrate the potential to address unmet medical need.

For more information on the Phase 2 study with Resunab for the treatment of cystic fibrosis, please visit ClinicalTrials.gov and reference Identifier NCT02465450.

About Cystic Fibrosis
Cystic Fibrosis (“CF”) is a chronic, life-threatening, genetic disease caused by inheriting two dysfunctional CFTR genes that normally regulate salt and water movement across cells in the respiratory and digestive systems. People with CF have thick, sticky mucus that clogs their airways, with recurrent bacterial infections and chronic inflammation in their lungs. In the gastrointestinal tract, they also have mucus accumulation, bacterial overgrowth, and inflammation. The dysfunctional CFTR genes cause an exaggerated inflammatory response that compounds the damage from a coexisting infection in the lungs and gut. CF results in destruction of lung tissue, lung fibrosis, pancreatic insufficiency, CF-related diabetes, malabsorption, malnutrition, growth retardation, and liver disease, including cirrhosis. The harmful inflammation and accompanying fibrosis in CF damages multiple organs, impairs organ function, reduces health-related quality of life, and can lead to death.

About Resunab
Resunab™ is a novel synthetic oral endocannabinoid-mimetic drug that preferentially binds to the CB2 receptor expressed on activated immune cells and fibroblasts. CB2 activation triggers endogenous pathways that resolve inflammation and halt fibrosis. Pre-clinical and Phase 1 studies have shown Resunab to have a favorable safety, tolerability and pharmacokinetic profile. It has also demonstrated promising potency in pre-clinical models of inflammation and fibrosis. Resunab triggers the production of “Specialized Pro-resolving Lipid Mediators” that activate an endogenous cascade responsible for the resolution of inflammation and fibrosis, while reducing production of pro-inflammatory eicosanoids and cytokines. Resunab has direct effects on fibroblasts to halt tissue scarring. In effect, Resunab triggers endogenous pathways to turn “off” chronic inflammation and fibrotic processes, without causing immunosuppression.

About Corbus
Corbus Pharmaceuticals Holdings, Inc. is a clinical stage pharmaceutical company focused on the development and commercialization of novel therapeutics to treat rare, chronic and serious inflammatory and fibrotic diseases. Our lead product candidate, Resunab™ is a novel synthetic oral endocannabinoid-mimetic drug that resolves chronic inflammation, bacterial infections, and fibrotic processes. Resunab is currently in Phase 2 studies for the treatment of cystic fibrosis, diffuse cutaneous systemic sclerosis and skin-predominant dermatomyositis.

For more information, please visit www.CorbusPharma.com and connect with the Company on Twitter, LinkedIn, Google+ and Facebook.

Forward-Looking Statements
This press release contains certain forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 and Private Securities Litigation Reform Act, as amended, including those relating to the Company’s product development, clinical and regulatory timelines, market opportunity, competitive position, possible or assumed future results of operations, business strategies, potential growth opportunities and other statement that are predictive in nature. 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 current beliefs and assumptions.

These statements may be identified by the use of forward-looking expressions, including, but not limited to, “expect,” “anticipate,” “intend,” “plan,” “believe,” “estimate,” “potential,” “predict,” “project,” “should,” “would” and similar expressions and the negatives of those terms. These statements relate to future events or our financial performance and involve known and unknown risks, uncertainties, and other factors which may cause actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include those set forth in the Company’s filings with the Securities and Exchange Commission. Prospective investors are cautioned not to place undue reliance on such forward-looking statements, which speak only as of the date of this press release. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Investor Contact
Jenene Thomas
Jenene Thomas Communications, LLC
Phone: +1 (908) 938-1475
Email: Email Contact

Media Contact
David Schull or Marissa Goberdhan
Russo Partners, LLC
Phone: +1 (858) 717-2310
Email: Email Contact
Email: Email Contact

Tuesday, October 20th, 2015 Uncategorized Comments Off on (CRBP) FDA Orphan Drug Designation, Fast Track Status of Resunab(TM)

(MNGA) Installs Second Production Facility to Accommodate MagneGas2® Demand

Factory Backlog Exceeds 2,000 Cylinders; Third Production Facility Planned for Early 2016

TAMPA, Florida, October 20, 2015  —

MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA) a leading technology company that counts among its inventions a patented process that converts liquid waste into MagneGas2® fuel, announced today that due to growing demand for MagneGas2® fuel that has created a substantial backlog, a second production facility will be operational this week. The second production unit is expected to fulfill the increased demand and the Company plans to have a third unit in operation in early 2016 to handle the continued expected high demand for its MagneGas2® industrial fuel.

The Company believes the additional demand is a direct result of its sales penetration into key vertical market segments including utilities, demolition companies, first responder markets as well as government and military sectors. The Company has also aggressively worked to expand its distribution network and in-house sales and marketing programs.

MagneGas2® has consistently received positive feedback from end users for its advantages over acetylene. Industries ranging from demolition companies, utility companies, first responders and fabricators have been praising and ordering MagneGas2® because of its proven faster cutting speed, demonstrated safety attributes, eco-friendly aspects, smaller heat affected zone and lower cost.  In addition, MagneGas2® is produced in the USA versus acetylene which is made from calcium carbide imported primarily from China and other countries.

“We continue to be very pleased with the positive feedback received from customers and distributors regarding MagneGas2®.  The product is a faster cutting fuel, which offers our customers numerous other savings from increased flexibility, smaller heat affected zone, reduced grinding and ability to cut layered and complex steel like no other fuel on the market. We look forward to seeing the impact of these new facilities on revenue in the coming months as we continue to expand nationwide. A third facility is under construction and is expected to be operational in early 2016 as the Company moves into its new headquarters.” commented Ermanno Santilli, CEO, MagneGas Corporation.

The MagneGas IR App is now available for free in Apple’s App Store for the iPhone or iPad http://bit.ly/AfLYww and at Google Play http://bit.ly/Km2iyk for Android mobile devices.

To be added to the MagneGas investor email list, please email pcarlson@kcsa.com with MNGA in the subject line.

About MagneGas Corporation

MagneGas® Corporation (NASDAQ: MNGA). The Company owns a patented process that converts various liquid wastes into hydrogen based fuels. These fuels can be used as a replacement to natural gas or for metal cutting. The Company’s testing has shown the fuels are faster, cleaner and more productive than other alternatives on the market. They are also cost effective and safe to use with little changeover costs.  The Company currently sells MagneGas® into the metal working market as a replacement to acetylene.

The MagneGas fuel production systems can be set-up locally using various types of feedstock. The Company believes this flexibility can give them an advantage in the Government/Military marketplace as fuels can be manufactured on site from raw materials found locally worldwide and eliminates the time and expense of shipping to the specific military theater.  The Company is planning to establish joint ventures with third parties to construct these supply facilities worldwide.

The Company also sells equipment for the sterilization of bio-contaminated liquid waste for various industrial and agricultural markets.  In addition, the Company is developing a variety of ancillary uses for MagneGas® fuels utilizing its high flame temperature for co-combustion of hydrocarbon fuels and other advanced applications.  For more information on MagneGas®, please visit the Company’s website at http://www.MagneGas.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events, including our ability to raise capital, or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels of activity, performance, or achievements to be materially different from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The Company is currently using virgin vegetable oil to produce fuel while it configures its systems to properly process waste within local regulatory requirements.

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Investor Contacts:
KCSA Strategic Communications
Philip Carlson / Brad Nelson
+1-212-896-1233 / +1-212-896-1217
pcarlson@kcsa.com / bnelson@kcsa.com

Tuesday, October 20th, 2015 Uncategorized Comments Off on (MNGA) Installs Second Production Facility to Accommodate MagneGas2® Demand

(OGES) Oakridge Announces Addition of Three Independent Board Members

Oakridge Global Energy Solutions: A New Era In Battery Manufacturing

Melbourne, FL, Oct. 20, 2015  — Oakridge Global Energy Solutions, Inc.
OGES

Oakridge Global Energy Solutions:
A New Era In Battery Manufacturing

Oakridge Announces Addition of Three Independent Board Members

FOR IMMEDIATE RELEASE

Oakridge Global Energy Solutions, Inc. (OGES) is pleased to announce the upcoming addition of three new, independent board members as part of its forthcoming move from the OTC QB to the main board of NASDAQ, and as is required in accordance with the NASDAQ listing rules.  These three board members, Theo Lianos, Vic Psaltis, and John Dinkel each bring vast experience in their respective industries including financial, risk management and the vehicle/transportation sectors.  With Oakridge’s current rapid growth in size and new product development, the skill sets added to the company by these three new independent directors is important.

The Company is honored to have these three outstanding professionals agreeing to serve on the Board of Directors and participate in its strategic and carefully planned growth.

“To be able to have these three top-level individuals on our board is an absolute win for Oakridge,” said OGES Executive Chairman and CEO, Steve Barber. “John Dinkel was editor of Road & Track Magazine and has a tremendous level of experience and contacts to the Company in the motor vehicle and transportation sectors.  Vic Psaltis brings more than 35 years experience in foreign exchange, money markets, and the major scale utility markets and is a recognized expert at risk management.  Theo is a leading business optimizer, corporate restructurer, strategic problem solver, and was a partner for many years at BDO Chartered Accountants.  By adding these three dynamic individuals to our board of directors, we have significantly strengthened the corporate structure of our company and our depth of reach into our target markets.”

John Dinkel

John Dinkel earned BS and MS degrees in mechanical engineering from the University of Michigan and is an automotive industry expert with over 40 years experience.  His areas of expertise include engineering, journalism, testing and analysis, product development, product planning, advertising, marketing, website development and content, internet automotive retailing and public relations.

John was a competitive race driver for the Bakeracing Corvette team (two SCCA Championships), worked directly with Goodyear in the development of the Gatorback tire for showroom stock racing and developed the first computerized road testing equipment in the automotive industry.  Dinkel was Editor of Road & Track, one of the most popular consumer automobile magazines in America, developed some of the earliest Internet-based automotive material and helped create an automotive website.  Dinkel is author of the Road & Track Illustrated Automotive Dictionary and has written three books on Mazda and a comprehensive history of Toyota.  He is a member of SAE, SCCA, Road Racing Drivers Club and the Motor Press Guild, serving as this organization’s president in 1991.  Dinkel is also a regular contributor to several AAA publications and a variety of automotive magazines and websites.

Vic Psaltis

Vic Psaltis earned a Bachelor of Arts (majors in Accounting, Economics and Political Studies) from Macquarie University in Australia.  Vic has extensive experience in a range of market environments, including foreign exchange, money markets, futures and the utility sector, including in power marketing and associated risk management. Between 1980 to 1996 he held the positions of Senior or Chief Corporate Dealer in financial institutions such as Barclays, Bank of New Zealand and Societe Generale. From 1996, Vic joined KMPG Consulting as a Director in the Banking and Finance practice. In 2000 Vic, with Theo Lianos, formed Venture Exchange Pty Limited, through with Vic has authored 31 Business Continuity Plans covering 6 Business Units across 22 locations.

Theo Lianos

Theo Lianos is one of Australia’s leading corporate restructurers, and is a strategic and hands-on problem solver with over 30 years’ experience internationally in corporate finance, operational reviews, corporate restructuring, profit improvement programs, and computer systems implementations.

He has been a principal of Venture Exchange for 13 years and was formerly a Liquidator, a Trustee in Bankruptcy and a partner with BDO Chartered Accountants in its Insolvency Division.

Theo holds a Bachelor of Business (NSW Institute of Technology) and an MBA (University of Technology, Sydney, Australia), and is a Chartered Accountant.

“Having John, Vic and Theo join the Oakridge board represents the final step in the completion of our 18 month restructuring of Oakridge,” says Steve Barber.  “We will utilize the considerable depth of skills and knowledge, not to mention their incredible contact bases, of these new board members to help us to continue to develop Oakridge into the major player in the global world of battery manufacturing and product development that we have positioned it to become.  They are an excellent addition to our team and we are again very pleased to welcome them to the board, and I know they are all looking forward to playing an active role in helping us build Oakridge!”

About Oakridge Global Energy Solutions, Inc.

Oakridge Global Energy Solutions Inc., is a publicly traded company, trading symbol: OGES on the OTCQB with a market capitalization of over USD $ 400,000,000, whose primary business is the development, manufacturing and marketing of energy storage products. Additional information can be accessed on the company’s website www.oakg.net.

Forward-Looking Statements Disclaimer: This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. In some cases, you can identify forward-looking statements by the following words: “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “ongoing,” “plan,” “potential,” “predict,” “project,” “should,” “will,” “would,” or the negative of these terms or other comparable terminology, although not all forward-looking statements contain these words. Forward-looking statements are not a guarantee of future performance or results, and will not necessarily be accurate indications of the times at, or by, which such performance or results will be achieved. Forward-looking statements are based on information available at the time the statements are made and involve known and unknown risks, uncertainties and other factors that may cause our results, levels of activity, performance or achievements to be materially different from the information expressed or implied by the forward-looking statements in this press release. This press release should be considered in light of all filings of the Company that are contained in the Edgar Archives of the Securities and Exchange Commission at www.sec.gov.

Contact:
Oakridge Global Energy Solutions, Inc.
www.oakg.net
Info@oakg.net
3520 Dixie Highway, NE
Palm Bay, Florida 32905 USA
Phone (321) 610-7959

Investor Inquiries:

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

And:

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

Tuesday, October 20th, 2015 Uncategorized Comments Off on (OGES) Oakridge Announces Addition of Three Independent Board Members

(PDII) Positive Impact of PancraGEN™ in Pancreatic Cysts

PARSIPPANY, N.J., Oct. 19, 2015  — PDI, Inc. (NASDAQ: PDII) subsidiary, Interpace Diagnostics, announced data that were presented in two posters during the American College of Gastroenterology (ACG) Annual Scientific Meeting and Postgraduate Course, October 16-21, 2015, Honolulu, Hawaii. The data presented demonstrated that PancraGEN™ can improve the detection of malignant or highly aggressive pancreatic cysts over current guideline criteria in patient management.

Many pancreatic cyst surgeries are unnecessarily performed in patients with benign disease. Recently released 2015 American Gastroenterological Association (AGA) guideline criteria for managing cystic lesions have proposed to alleviate this problem by suggesting patients meet highly specific clinical criteria for malignancy before surgery is performed. The first poster demonstrates that PancraGEN, a DNA-based molecular diagnostic test for pancreatic cyst risk stratification, provides a more optimal positive and negative predictive value (NPV) for detecting false negatives malignancy than first-line test criteria in the new AGA guidelines. The AGA criteria alone could have <50% sensitivity for malignancy while PancraGEN had a sensitivity of 87%. PancraGEN was better at detecting malignant cysts in those designated as benign by the AGA criteria, thereby decreasing the number of “false negative cases.” In this new analysis with PancraGEN there was an increase in sensitivity and NPV without jeopardizing the more optimal PPV for malignancy. This work received one of the prestigious ACG Presidential Poster Awards.

Results of the second analysis show that the use of PancraGEN improved patient outcomes in real-life management decisions.  PancraGEN testing benefited patients more than solely relying on International Consensus Guideline (ICG/Sendai) recommended use of imaging, cytology and fluid chemistry results.  When the ICG (Sendai) guidelines recommended surveillance but PancraGEN testing indicated these patients were at high risk for pancreatic cancer, 88% of these patients went to surgery within a year and 57% of these patients had malignant outcomes. When the guidelines recommended surgery but PancraGEN indicated low risk for pancreatic cancer, 55% underwent surveillance and 99% had benign outcomes at a median of three years follow up.

“PancraGEN identified nearly 80% of cases of pancreatic malignancy missed by the consensus guideline criteria without drastically over-diagnosing malignancy in patients with benign lesions,” said Dr. David Loren, Department of Medicine, Jefferson Digestive Disease Institute, Thomas Jefferson University, Philadelphia, PA. “These analyses show that PancraGEN testing can provide a more optimal approach for detecting the malignant potential of pancreatic cystic lesions and thereby benefit patients and improve outcomes.”

According to Nancy Lurker, CEO of PDI, Inc. “We are pleased to see the additional supporting evidence on the value of PancraGEN to patients and physicians, enabling better-informed medical decisions. Pancreatic cancer is a complex disease, and unnecessary pancreatic surgery can lead to serious life-long health complications and even death. These results add to the growing body of evidence demonstrating the value of PancraGEN in helping to balance the need for surgery with risk of malignancy.”

Interpace Diagnostics ACG Poster Details and Links

POSTER P202: Validation of the AGA 2015 Guideline Criteria for Managing Patients With Pancreatic Cystic Lesions Lacking Frankly Malignant Cytology Results

Session Date/Time:
Sunday, October 18, 2015
[2:30 – 4:30 p.m. HST (8:30 – 10:30 p.m. EST)]

POSTER P203: Integrated Molecular Pathology Impacts Real-Life Management Decisions for Patients With Pancreatic Cystic Lesions

Session Date/Time:
Sunday, October 18, 2015
[2:30 – 4:30 p.m. HST (8:30 – 10:30 p.m. EST)]

About Pancreatic Cysts
More than 120,000 pancreatic cysts are detected annually in the U.S. Most of them are identified incidentally by imaging studies targeted at identifying other conditions. Given the high mortality rate associated with pancreatic cancer, it is critical that these cysts are quickly identified as either having low or high potential for malignancy.

About PancraGEN

PancraGEN has 90%accuracy in stratifying patients for risk of pancreatic cancer with better accuracy than standard guideline-recommended tests alone. PancraGEN utilizes the PathFinderTG® platform to assess multiple tumor suppressor and oncogene DNA abnormalities. The test then integrates this DNA analysis with clinical features of pancreatic cysts. All patients with pancreatic cysts, except those with clear cytological malignancy, are ideal candidates for testing with PancraGEN. PancraGEN provides information that enables physicians to make more informed management decisions for patients with pancreatic cysts, including whether surgery or surveillance is the most appropriate approach. Due to the limitations of standard first-line tests, up to 80% of surgeries on pancreatic cyst patients are potentially unnecessary. Such overtreatment can cause lifelong consequences to patients, including diabetes.

About PDI, Inc. and Interpace Diagnostics
PDI is a leading healthcare commercialization company providing go-to-market strategy and execution to established and emerging pharmaceutical, biotechnology, diagnostics and healthcare companies in the United States through its Commercial Services business, and developing and commercializing molecular diagnostic tests through its Interpace Diagnostics business. PDI’s Commercial Services is focused on providing outsourced pharmaceutical, biotechnology, medical device and diagnostic sales teams to its corporate customers. PDI’s Interpace Diagnostics is focused on developing and commercializing molecular diagnostic tests, leveraging the latest technology and personalized medicine for better patient diagnosis and management. For more information about us, please visit www.pdi-inc.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, relating to our future financial and operating performance. PDI has attempted to identify forward looking statements by terminology including “believes,” “estimates,” “anticipates,” “expects,” “plans,” “projects,” “intends,” “potential,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements.  These statements are based on current expectations, assumptions and uncertainties involving judgments about, among other things, future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond PDI’s control. These statements also involve known and unknown risks, uncertainties and other factors that may cause PDI’s actual results to be materially different from those expressed or implied by any forward-looking statement. Known and unknown risks, uncertainties and other factors include, but are not limited to, the market’s acceptance of our molecular diagnostic tests; projections of future revenues, growth, gross profit and anticipated internal rate of return on investments; the loss, early termination or significant reduction of any of our existing service contracts; the failure to meet performance goals in PDI’s incentive-based arrangements with customers; the inability to secure additional business; or our inability to develop more predictable, higher margin business through sales of our molecular diagnostic tests, in-licensing or other means. Additionally, all forward-looking statements are subject to the risk factors detailed from time to time in PDI’s periodic filings with the Securities and Exchange Commission (SEC), including without limitation, the Annual Report on Form 10-K filed with the SEC on March 5, 2015 and in PDI’s Form 10-Q filed with the SEC on May 12, 2015. Because of these and other risks, uncertainties and assumptions, undue reliance should not be placed on these forward-looking statements. In addition, these statements speak only as of the date of this press release and, except as may be required by law, PDI undertakes no obligation to revise or update publicly any forward-looking statements for any reason.

i Al-Haddad MA, Kowalski T, Siddiqui A, et al.; Integrated molecular pathology accurately determines the malignant potential of pancreatic cysts.  DOI: http://dx.doi.org/10.1055/s-0034-1390742; Published online: 14.10.2014; Endoscopy 2015; 47: 136–142; © Georg Thieme Verlag KG;  Stuttgart · New York;  ISSN 0013-726X

Monday, October 19th, 2015 Uncategorized Comments Off on (PDII) Positive Impact of PancraGEN™ in Pancreatic Cysts

(ICAD) 5-Year Positive Clinical Data, Xoft System for Early-Stage Breast Cancer

iCAD to feature in-booth clinician presentations and showcase latest in technology during meeting.

NASHUA, N.H. and SAN ANTONIO, Oct. 19, 2015  — (Booth #423) – iCAD, Inc. (Nasdaq: ICAD), an industry-leading provider of advanced image analysis, workflow solutions and radiation therapy for the early identification and treatment of cancer, will present updated clinical data, host in-booth clinician presentations and showcase the latest in radiation technology at the American Society for Radiation Oncology (ASTRO) meeting in San Antonio, TX from October 18-21, 2015.

“ASTRO 2015 represents an important milestone where researchers are sharing the most recent, and longest-term data available supporting the use of the Xoft System for the treatment of both early-stage breast cancer and nonmelanoma skin cancer (NMSC),” said Ken Ferry, CEO of iCAD. “iCAD is committed to remaining at the forefront of innovation and research, and we look forward to sharing with our colleagues new data showing the advantages of the Xoft System for the treatment of an even wider variety of cancers.”

At the meeting, Dr. Ajay Bhatnagar and Dr. Parag Sanghvi will present posters with updated data on the use of eBx in the treatment of NMSC. Their data reflect treatment with the Xoft System for a total of 342 patients with 466 NMSC lesions, resulting in excellent cosmesis and few recurrences, with a mean follow up time of 16.5 months and 11.8 months, respectively.

Dr. Alam M. Nisar Syed and Dr. Adam Dickler will also present posters with data supporting use of the Xoft System for the treatment of early-stage breast cancer. Their data reflect treatment of 136 breast cancer lesions with the Xoft System, showing positive clinical results, excellent to good cosmesis, few recurrences, and a low rate of low-grade adverse events.

Posters will be presented in Poster Hall A from 10 am to 5 pm throughout the meeting; the Poster Viewing Reception will be from 5:30 pm to 6:45 pm on Monday, October 19.

  • Electronic brachytherapy for the treatment of Non-Melanoma Skin Cancer: Results up to 5 years
    Poster # 3598
    Ajay Bhatnagar, MD, MBA, Medical Director, 21st Century Oncology of Arizona, Adjunct Assistant Professor of Radiation Oncology, University of Pittsburgh School of Medicine
  • Clinical and Cosmetic Outcomes in Patients Treated With High Dose Rate Electronic Brachytherapy for Nonmelanoma Skin Cancer
    Poster #3589
    Parag Sanghvi, MD, MSPH, Assistant Professor, Radiation Oncology, University of California San Diego, San Diego, CA
  • Feasibility and Early Outcomes of a Multi-Center Trial of Intra-Operative Radiation Therapy Using Electronic Brachytherapy at the Time of Breast Conservation Surgery for Early Stage Breast Cancer
    Poster #3464
    Alam M. Nisar Syed, MD, Medical Director, Radiation Oncology & Endocurietherapy,
    Memorial Care Cancer Institute Long Beach Memorial Medical Center
  • Five Year Results of a Multi-Center Trial Utilizing Electronic Brachytherapy to Deliver Intraoperative Radiation Therapy in the Treatment of Early-Stage Breast Cancer
    Poster #2061
    Adam Dickler, MD, Medical Director of CyberKnife Cancer Institute of Chicago, Little Company of Mary Hospital

Gary Proulx MD, Medical Director, Exeter Hospital Radiation Oncology, Clinical Associate Professor, Massachusetts General Hospital, will discuss his clinical experience with IORT and the Xoft System at the Xoft booth in presentations at 12:30 pm and 3:50 pm on Monday, October 19.

The Xoft System will be available at booth #423 for demonstration purposes.  The Xoft System’s cervical applicator, which is now commercially available, will also be showcased in the booth.  Visitors will also have an opportunity to see  an investigational line of applicators for intraoperative radiation therapy (IORT) that are being shown as works in progress for the treatment of prostate, head/neck, abdominal, and brain cancers, among others.

#HighTechHope: High Tech = High Hope
As part of its commitment to being a leader in medical technology, during ASTRO 2015 iCAD is launching a social media campaign aimed at supporting the ThriveWell Cancer Foundation, a San Antonio cancer support center. As this year’s ASTRO meeting theme is High Tech = High Hope, iCAD is encouraging attendees to share what “high tech” innovations are giving them “high hope,” using the tag @XoftiCAD and the hashtag #HighTechHope in social media posts. For each tweet or Facebook post using #HighTechHope, Xoft will make a donation to the ThriveWell Cancer Foundation, a San Antonio cancer support center, on your behalf. For more information about this campaign, visit http://www.xoftinc.com/hightechhope.htm.

For updates throughout ASTRO, follow the Xoft Twitter handle, @XoftiCAD. For additional information regarding iCAD and the technologies being discussed at ASTRO 2015, please visit www.xoftinc.com/ASTRO.htm. If you have a question about iCAD products, please contact us.

Tweets, retweets, mentions and replies, and Facebook posts and shares using the #HighTechHope hashtag during ASTRO 2015 (10/18/15 to 10/20/15) are eligible for donation.

Xoft, a subsidiary of iCAD, maintains a presence on Facebook, Twitter, LinkedIn and YouTube but is not affiliated with these social media sites and has no control over how these sites or other third parties will use the information shared on the site.  Neither the information, nor any opinion, on Facebook, Twitter, LinkedIn or YouTube constitutes a solicitation or offer by iCAD or its affiliates to buy or sell any securities. iCAD is not responsible for third parties that may be linked to its Facebook, Twitter, LinkedIn and YouTube pages, including but not limited to content posted by third parties, or for the products or services offered by any third party.

About Xoft Axxent Electronic Brachytherapy System
The Xoft System is an isotope-free radiation treatment that is FDA cleared, CE marked, and licensed in Canada for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. It utilizes a proprietary miniaturized x-ray as the radiation source that delivers precise treatment directly to cancerous areas while sparing healthy tissue and organs. The Xoft System requires only minimal shielding and therefore does not require room redesign or construction investment. Minimal shielding also allows medical personnel to remain in the room with the patient during treatment. The mobility of the Xoft System makes it easy to treat patients at multiple locations and to easily store the system when not in use. Xoft is a wholly owned subsidiary of iCAD, Inc. For more information about Xoft visit www.xoftinc.com, like us on Facebook or follow us on Twitter at @xofticad.

About iCAD, Inc.
iCAD delivers innovative cancer detection and radiation therapy solutions and services that enable clinicians to find and treat cancers earlier and faster while improving patient outcomes. iCAD offers a comprehensive range of upgradeable computer aided detection (CAD) and workflow solutions to support rapid and accurate detection of breast, prostate and colorectal cancers. iCAD’s Xoft® Axxent® Electronic Brachytherapy (eBx®) System® is a painless, non-invasive technology that delivers high dose rate, low energy radiation, which targets cancer while minimizing exposure to surrounding healthy tissue. The Xoft System is FDA cleared, CE marked, and licensed in Canada for the treatment of cancer anywhere in the body, including treatment of early-stage breast cancer, gynecological cancers and non-melanoma skin cancer. The comprehensive iCAD technology platforms include advanced hardware and software as well as management services designed to support cancer detection and radiation therapy treatments. For more information, visit or www.icadmed.com or www.xoftinc.com.

“Safe Harbor” Statement under the Private Securities Litigation Reform Act of 1995
Certain statements contained in this News Release constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements involve a number of known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of the Company to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, but are not limited to the Company’s ability to defend itself in litigation matters, to achieve business and strategic objectives, the risks of uncertainty of patent protection, the impact of supply and manufacturing constraints or difficulties, uncertainty of future sales levels, protection of patents and other proprietary rights, the impact of supply and manufacturing constraints or difficulties, product market acceptance, possible technological obsolescence of products, increased competition, litigation and/or government regulation, changes in Medicare or other reimbursement policies, risks relating to our existing and future debt obligations, competitive factors, the effects of a decline in the economy or markets served by the Company; and other risks detailed in the Company’s filings with the Securities and Exchange Commission. The words “believe”, “demonstrate”, “intend”, “expect”, “estimate”, “will”, “continue”, “anticipate”, “likely”, “seek”, and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on those forward-looking statements, which speak only as of the date the statement was made. The Company is under no obligation to provide any updates to any information contained in this release. For additional disclosure regarding these and other risks faced by iCAD, please see the disclosure contained in our public filings with the Securities and Exchange Commission, available on the Investors section of our website at http://www.icadmed.com and on the SEC’s website at http://www.sec.gov.

Contact:

For iCAD investor relations:

The Ruth Group
Zack Kubow, 646-536-7030
www.theruthgroup.com
iCAD@theruthgroup.com

or

For iCAD media inquiries:

Berry & Company Public Relations, LLC
Jessica Burns, 212-253-8881
jburns@berrypr.com

Monday, October 19th, 2015 Uncategorized Comments Off on (ICAD) 5-Year Positive Clinical Data, Xoft System for Early-Stage Breast Cancer

(DHRM) Wins Medical Equipment Procurement Bid Financed by China Development Bank

BEIJING, Oct. 19, 2015  — Dehaier Medical Systems Ltd. (Nasdaq: DHRM) (“Dehaier” or the “Company”), which develops, markets and sells medical devices and wearable sleep respiratory products in China, today announced that it has won a medical device distribution bid for a new rural healthcare construction project supported by China Development Bank Corp (“CDB”). According to the agreement, Dehaier will provide its proprietary C-arm X-Ray machine and defibrillator monitor to Dongsheng Hospital of Ordos, Inner Mongolia. The procurement project is funded by CDB, one of China’s three national policy banks.

In conjunction with Chinese State Council’s “Agriculture, Farmer and Village” policy, which is aimed at improving rural living conditions, CDB has earmarked approximately $1.5 billion in loans each year since 2007 for the implementation of national rural healthcare initiatives and the upgrade of medical institutions in nearly 2,900 counties, cities and districts across China. A key objective of this project is the development of new medical facilities in areas lacking adequate healthcare infrastructure.

“We are pleased to be awarded this procurement project funded by CDB, which has been a major part of our key account procurement business. The continued development of China’s healthcare system is critical to our country’s future, and we believe that this program is an important step forward,” said Mr. Ping Chen, CEO of Dehaier. “China’s government has placed a major emphasis on the improvement of rural healthcare infrastructure through the establishment of basic medical facilities in each county and township, creating a tremendous growth opportunity in rural China. Our portfolio includes our patented and distributed high quality products at a variety of price points, including products that fit project requirements for smaller facilities that are found in rural areas. We are confident that these government policies and nationwide programs will help create new opportunities for Dehaier to grow sales as we work to expand our business and deliver our healthcare solutions across China.”

About Dehaier Medical Systems Ltd.

Dehaier is an emerging leader in the development, marketing and sale of medical products, including medical devices and wearable sleep respiratory products. The company develops and assembles its self-branded medical devices and sleep respiratory products from third-party components. The company also distributes products designed and manufactured by other companies, including medical devices from IMD (Italy), HEYER (Germany) and Timesco (UK). Dehaier’s technology is based on six patents and eleven software copyrights. More information may be found at http://www.dehaier.com.cn.

Forward-looking Statements

This news release contains forward-looking statements as defined by the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements that are other than statements of historical facts. These statements are subject to uncertainties and risks including, but not limited to, product and service demand and acceptance, fulfillment of bids and contracts, changes in technology, economic conditions, the impact of competition and pricing, government regulation, and other risks contained in reports filed by the company with the Securities and Exchange Commission. All such forward-looking statements, whether written or oral, and whether made by or on behalf of the company, are expressly qualified by the cautionary statements and any other cautionary statements which may accompany the forward-looking statements. In addition, the company disclaims any obligation to update any forward-looking statements to reflect events or circumstances after the date hereof.

For more information, please contact:

Dehaier Medical Systems Limited
Janice Wang
+86 10-5166-0080 ext.211
investors@dehaier.com.cn

Monday, October 19th, 2015 Uncategorized Comments Off on (DHRM) Wins Medical Equipment Procurement Bid Financed by China Development Bank

(ERII) Signs 15-Year License With Schlumberger

Deal Includes $125 Million in Upfront Payments Paid in Stages to Energy Recovery

SAN LEANDRO, Calif., Oct. 19, 2015  — Energy Recovery, Inc. (NASDAQ:ERII), the leader in pressure energy technology for industrial fluid flows, today announced a 15-year deal with Schlumberger Technology Corporation, the world’s leading supplier of geoscience, engineering, drilling, and data management software products and computing services for the exploration and production industry. The agreement provides exclusive rights to Energy Recovery’s VorTeq™ hydraulic pumping system, the first hydraulic fracturing manifold (“missile”) built to isolate hydraulic fracturing pumps from abrasive proppants that cause pump failure.

The VorTeq system is a hydraulic pumping system that replaces the missiles traditionally used in hydraulic fracturing. In current operations, the missile routes water, proppants (sand or ceramics) and chemicals downhole at treating pressures up to 15,000 psi. However, the proppants cause frequent failures in the high pressure hydraulic fracturing pumps. With VorTeq, high-pressure hydraulic fracturing pumps will process clean or proppant-free water and transfer the hydraulic energy to the hydraulic fracturing fluid within the VorTeq missile.

Under the terms of the agreement, Schlumberger will pay a $75 million exclusivity fee immediately. Schlumberger will also pay two separate $25 million milestone payments (for a total of $50 million) subject to the Company satisfying certain key performance indicators expected to occur in 2016. The agreement also includes continuing annual royalties for the duration of the license agreement subject to the Company satisfying certain key performance indicators.

Energy Recovery’s President and Chief Executive Officer Joel Gay stated, “We are thrilled to be working with Schlumberger, the world’s largest oil field services company, and a leading supplier of technology associated with hydraulic fracturing solutions. We believe VorTeq is a paradigm shift for the hydraulic fracturing industry as it significantly reduces maintenance costs associated with pumping downtimes and provides considerable redundancy efficiencies.”

“We believe this technology offers Schlumberger the immediate benefit of reducing wear and tear on its pumps, as well as reducing downtime. In the medium-term, we believe it provides Schlumberger additional savings associated with eliminating redundant equipment onsite,” said Gay. “For a company in this market who wants to keep producing but needs to be mindful of costs, this technology tackles these challenges and delivers meaningful results.”

The heart of the VorTeq system is Energy Recovery’s Pressure Exchanger technology, which is the leading pressure energy recovery device in desalination with over 16,000 devices deployed globally. The technology works by capturing and recycling otherwise wasted pressure energy in fluid flows, by a clean liquid-to-liquid energy exchange between high pressure and low pressure fluids. With a single moving part made of tungsten carbide, one of the most abrasion resistant materials on the planet, the system has been engineered to withstand tremendous pressure and harsh conditions, and transfers up to 95% of the hydraulic energy from one fluid to the next.

Conference Call

The Company will host a teleconference at 5:30 a.m. (Pacific Time) on Tuesday, October 20th, 2015 to discuss the deal. To listen to the live call, individuals can access the conference call by dialing 877-415-3185, passcode #64509095 approximately 10 minutes before the scheduled start time. For those who cannot listen to the live broadcast, replays will be available shortly after the call on the Company’s website.

About Energy Recovery

Energy Recovery (NASDAQ:ERII) recycles and converts wasted pressure energy into a usable asset and preserves pumps that are subject to hostile processing environments.  With award winning technology, Energy Recovery simplifies complex industrial systems while improving productivity, profitability, and efficiency within the oil & gas, chemical processing, and water industries.  Energy Recovery products save clients more than $1.5 billion (USD) annually.  Headquartered in the Bay Area, Energy Recovery has offices in Ireland, Shanghai, and Dubai.  For more information about the Company, please visit our website at www.energyrecovery.com.

Forward-Looking Statements

This press release contains forward-looking statements that reflect management’s current expectations, assumptions and estimates of future performance and economic conditions. Such statements are made in reliance upon the safe harbor provisions of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. The company cautions investors that any forward-looking statements are subject to risks and uncertainties that may cause actual results and future trends to differ materially from those matters expressed in or implied by such forward-looking statements. Statements about our expectations as to receipt of milestone payments, and future revenue growth related to royalty payments are forward-looking and involve risks and uncertainties including but not limited to the meeting of key milestones, adoption rates, and deflationary oil pricing. Energy Recovery disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

CONTACT: FTI Consulting
         Marc Cunningham
         ir@energyrecovery.com
         (713) 353-5407
Monday, October 19th, 2015 Uncategorized Comments Off on (ERII) Signs 15-Year License With Schlumberger

(LFVN) Announces 7:1 Reverse Stock Split

Company Reiterates Fiscal Year 2016 Guidance

SALT LAKE CITY, Oct. 16, 2015  — LifeVantage Corporation (NASDAQ:LFVN) (“LifeVantage” or the “Company”) today announced a 7:1 reverse split of its common stock, which is expected to be effective as of 12:01 a.m. Mountain Daylight Time on October 19, 2015. Beginning with the opening of trading on October 19, 2015, the Company expects its common stock will trade on the Nasdaq Capital Market on a split adjusted basis.

At LifeVantage’s fiscal year 2016 annual meeting of shareholders on October 15, 2015, the Company’s shareholders authorized the Board of Directors to amend the Company’s Amended and Restated Articles of Incorporation to effect a reverse stock split at a ratio of not less than 3:1 nor greater than 8:1, with the final ratio to be selected by the Company’s Board of Directors in its discretion following shareholder approval.  The Board of Directors engaged an investment banking firm to provide advice regarding the split ratio and, following the annual meeting on October 15, 2015, approved the reverse stock split and determined the ratio to be 7:1.

Upon the effectiveness of the reverse stock split, every seven (7) shares of LifeVantage common stock outstanding will automatically be combined into one (1) share of common stock with no change in par value per share. Proportionate adjustments will be made to (i) the per share exercise price and the number of shares of common stock that may be purchased upon exercise of outstanding stock options and warrants to purchase shares of the Company’s common stock and (ii) the number of authorized shares of common stock reserved for future issuance under the Company’s equity compensation plans.

The Company’s common stock will continue to trade on NASDAQ under the symbol “LFVN.” The new CUSIP number for the common stock following the reverse stock split is 53222K205.

No fractional shares will be issued following the reverse stock split. Any fractional shares resulting from the reverse stock split will be rounded up to the next whole share.

Registered stockholders holding their shares of common stock in book-entry or through a bank, broker or other nominee form do not need to take any action in connection with the reverse stock split. For those stockholders holding physical stock certificates, the Company’s transfer agent, Computershare, will send instructions for exchanging those certificates for new certificates representing the post-split number of shares. Computershare can be reached at (800) 962-4284.

Additional information about the reverse stock split can be found in the Company’s definitive proxy statement filed with the Securities and Exchange Commission on September 11, 2015, a copy of which is also available at www.sec.gov or at www.lifevantage.com under Financial Information on the Investor Relations page.

Reiterating Fiscal Year 2016 Guidance

The Company is reiterating its fiscal year 2016 annual guidance; earnings per share outlook is updated based on the adjusted share count following effectiveness of the reverse stock split. The Company continues to expect to generate revenue in the range of $195 million to $210 million in fiscal year 2016 and to achieve operating margin in the range of 8.5% to 10.5%. Following the reverse stock split, the Company now expects earnings per diluted share in the range of $0.56 to $0.77, based on an estimated 14.3 million diluted shares and a 36% effective tax rate. The Company’s previous earnings per share range was $0.08 to $0.11, based on an estimated 100 million diluted shares.

The Company plans to report first quarter fiscal year 2016 financial results during the first week of November 2015.

About LifeVantage Corporation

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

Forward Looking Statements

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

 

Investor Relations Contact:
Cindy England (801) 432-9036
Director of Investor Relations
-or-
John Mills (646) 277-1254
Partner, ICR INC
Monday, October 19th, 2015 Uncategorized Comments Off on (LFVN) Announces 7:1 Reverse Stock Split

(OGES) MissionIR Exclusive Audio Interview With CEO Steve Barber

ATLANTA, GA–(Oct 19, 2015) – MissionIR today announces the online availability of its interview with Oakridge Global Energy Solutions, Inc. (OTCQB: OGES) Chief Executive Officer Steve Barber.

The full audio interview is available at http://OGES.MissionIR.com/interview.html

Oakridge is focused on the design, development and manufacture of American-made high-quality cells, batteries and power systems. Its innovative product line includes multiple lithium-ion technologies and form factors optimized to address four high-demand target markets: stationary power storage units and power back up systems for homes and living space applications; motive applications such as electric vehicles (especially including golf cars, local area electric vehicles, and fleet vehicles); remote control sector batteries for civilian and military applications (for drones and unmanned aerial vehicles, unmanned underwater vehicles, and unmanned cars and boats); as well as starter motor batteries for motorcycles, jet-skis, snow mobiles, and boats, together with specialty applications such as military, aerospace, marine, medical and telecom backup.

Mr. Barber begins the MissionIR interview by describing Oakridge’s business model and recent visit from Florida Governor Rick Scott to celebrate the opening of its new headquarters.

“[Governor Scott] was here to not only himself personally open our new headquarters, which is our expansion facility because we outgrew our initial starting point from two years ago, but he also announced a… $33 million incentive package from a combination of the state of Florida, the local county [Brevard County]… and the city of Palm Bay, which is where our corporate headquarters is. I think that really got everybody’s attention quite nicely,” says Steve Barber.

Mr. Barber then briefly details Oakridge’s ongoing restructuring initiatives and how the Company is now aptly positioned to expand its market reach in the global lithium-ion batteries market, which is expected to reach approximately $70 billion by 2020.

In addition to his executive position with Oakridge, Mr. Barber is the chairman and chief investment officer of a private office family fund, Precept, which searches out “the next great new thing” in which to invest. It was through Precept that Barber noticed the incredible growth of the lithium-ion battery space, along with the need for American-made and commercialized batteries of superior quality.

In 2014, Precept took control of Oakridge, which at the time was a shell company, polished it up, and with a new management team decided how to best utilize the patents for lithium ion battery technology it holds.

“Through our family fund we searched around and about two years ago we found Oakridge and decided to invest in and take control of it,” Barber explains. “And that’s another good thing for investors, because as a family fund we’ve got our two parallel funds… and we own almost 90% of the company, which means that we can do the restructure that we needed to do successfully, reposition the company how it needs to be repositioned, inject fresh capital — which has been, in total, around about $40 million. We really put our money where our mouth is with this one. And of course, we’re long-term holders… we aren’t going anywhere anytime soon.”

Today, Oakridge is the only pure-play “Made in the USA” manufacturer of lithium-ion batteries available for purchase. The company’s battery products are designed for golf cars, jet skis, motorcycles, boats, home energy storage and many more exciting applications.

“Batteries are boring unless you wrap them in cool stuff, so we make batteries for cool stuff,” explains Mr. Barber.
The CEO also names and explains the qualifications of key members of its leadership team and recent corporate milestones before concluding with an overview of what’s to come in the near future.

“It’s extremely important to us, in creating a successful company, that you have the right team. That’s really what we’ve spent the last 18 months to two years doing. We restructured the company completely, cleaned it up… We’ve filed for NASDAQ — which the company expects to achieve when the share price climbs to $4. The company is also gearing up to order new equipment to expand its existing production to become fully operational by spring of 2016, positioning the company among the top 10 battery manufacturers by capacity in the world,” he says.

About Oakridge Global Energy Solutions, Inc.
Oakridge Global Energy Solutions is an integrated, “made in USA” energy storage solutions company that uses state-of-the-art technology to focus on making and developing advanced, high-quality cells, batteries and power systems. The company’s solutions are used in consumer, government, industrial and military applications.

Oakridge’s strategy is to simultaneously deliver innovation and build an industrial scale platform that includes multiple lithium-ion technologies and form factors that are optimized to address four target markets:

  • The Freedom Series for stationary and grid storage, telecom backup and living space power for RVs, trucks and boats;
  • The Pro Series for motive applications including fleet vehicles, Local Area Electric Vehicles and Hybrid Electric Vehicles, especially golf cars;
  • The Patriot Series for specialty applications including Remote Control Civilian and Military Aerial, Land and Underwater vehicles, including the hobby market;
  • The Liberty Series for starter motor batteries for motorcycles, jet skis, ski mobiles and boats.

Oakridge’s technology team is strongly engineering driven, with core capabilities in materials, product design, process control, manufacturing technology, quality and safety. The management team is comprised of individuals with long-term experience in both innovative startup companies and large industrial entities with worldwide operations in Chemical and Energy related sectors. Oakridge maintains its headquarters in the USA where it also has established product development and low volume manufacturing infrastructure. The company plans to expand in the US, EU, and Asia.

For additional information, please visit the Company’s corporate website: www.OakG.net

This press release may contain “forward-looking statements.” Expressions of future goals and similar expressions reflecting something other than historical fact are intended to identify forward-looking statements, but are not the exclusive means of identifying such statements. These forward-looking statements may include, without limitation, statements about our market opportunity, strategies, competition, expected activities and expenditures as we pursue our business plan. Although we believe that the expectations reflected in any forward-looking statements are reasonable, we cannot predict the effect that market conditions, customer acceptance of products, regulatory issues, competitive factors, or other business circumstances and factors described in our filings with the Securities and Exchange Commission may have on our results. The company undertakes no obligation to revise or update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this press release.

Contact:
Mission Investor Relations
Atlanta, Georgia
http://www.MissionIR.com
404-941-8975
Investors@MissionIR.com

Monday, October 19th, 2015 Uncategorized Comments Off on (OGES) MissionIR Exclusive Audio Interview With CEO Steve Barber

(PRTA) to Initiate PRONTO, a Global Trial of NEOD001 in Patients With AL Amyloidosis

  • Accelerates Development Timeline and Potential Path to Patients
  • Prothena to Host Investor Conference Call and Webcast Today at 4:30 p.m. ET

DUBLIN, Ireland, Oct. 15, 2015  — Prothena Corporation plc (NASDAQ:PRTA), a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies, today announced it will initiate PRONTO, a global trial of NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction. The primary endpoint of the trial is a cardiac functional biomarker, defined by NT-proBNP best response over 12 months.

“In addition to the VITAL Amyloidosis Study, which remains on-track to provide data for full registration, the PRONTO trial enables us to explore an accelerated path forward to address the high unmet need for therapies that improve organ function in patients with AL amyloidosis,” said Dale Schenk, PhD, President and Chief Executive Officer of Prothena. “NT-proBNP response is a widely validated functional biomarker that predicts survival in patients with AL amyloidosis. Demonstrating significant improvements in this key cardiac functional biomarker, along with supporting trends in key secondary endpoints, will expedite our development timeline and provide an additional opportunity to engage with European regulators on a dialogue around conditional approval for NEOD001.”

The PRONTO trial was designed to align with feedback from the European Medicines Agency (EMA) related to The VITAL Amyloidosis Study, a global Phase 3 registrational trial. When combined with data from the ongoing NEOD001 Phase 1/2 trial, the PRONTO trial has the potential to expedite patient access.

In addition to the ongoing Phase 1/2 clinical trial, The VITAL Amyloidosis Study is evaluating NEOD001 in newly-diagnosed, treatment-naïve patients with AL amyloidosis with cardiac dysfunction, and will assess a composite of all-cause mortality or cardiac hospitalizations in addition to biomarker, functional and quality of life endpoints. The PRONTO trial will evaluate NEOD001 in patients with AL amyloidosis and persistent cardiac dysfunction who have been previously-treated and are not eligible for The VITAL Amyloidosis Study.

“We are encouraged with the continued consensus of leading physicians regarding NT-proBNP as a surrogate endpoint for clinical trials as exemplified by the recently announced Amyloid Research Consortium (ARC) white paper,” said Gene Kinney, PhD, Chief Scientific Officer and Head of Research and Development of Prothena. “We believe an ongoing dialogue, such as the Amyloidosis Patient Forum organized by ARC on November 16 with U.S. Food and Drug Administration, may accelerate further alignment on important topics such as the use of functional biomarkers as surrogate endpoints to expedite new therapeutic options for patients.”

PRONTO Registration-Directed Trial Design

The global, multi-center, randomized, double-blind, placebo-controlled Phase 2b trial further exemplifies Prothena’s commitment to provide disease-modifying therapeutic alternatives for patients suffering from AL amyloidosis. The trial is designed to enroll approximately 100 patients with a primary diagnosis of AL amyloidosis and persistent cardiac dysfunction despite previous treatment with off-label, plasma cell directed therapy. Patients will be randomized on a 1:1 basis to receive 24 mg/kg of NEOD001 or placebo via infusion every 28 days.

The primary endpoint is NT-proBNP best response as measured over 12 months. Secondary endpoints include evaluations of Short-form 36 (SF-36, quality of life measure), six-minute walk test, and renal function as assessed by proteinuria. Prothena designed the study with 80% power to detect a difference of 26.5% in NT-proBNP best response rate between the treatment and placebo groups with a two-sided alpha of 0.05.

Expansion Cohort of Phase 1/2 Trial

Prothena increased enrollment to 42 patients from the originally planned 25 patients in the expansion cohort of the ongoing NEOD001 Phase 1/2 trial based on an increased level of interest from physicians and patients following data presentations at the American Society of Clinical Oncology (ASCO) and European Hematology Association (EHA) conferences in June 2015.

Enrollment is now complete and includes 15 patients with cardiac dysfunction, 16 patients with renal dysfunction and 11 patients with peripheral neuropathy. All patients receive 24 mg/kg NEOD001 by intravenous infusion every 28 days. The expansion cohort will continue to evaluate safety, tolerability, pharmacokinetics and immunogenicity of NEOD001 as well as the specific clinical activity against cardiac and renal functional biomarkers, and a modified neuropathy impairment score. Given the increase in enrollment, topline results for the expansion cohort of the Phase 1/2 trial are expected to be announced in the second quarter of 2016 when the trial is complete and patients have been on therapy for a minimum of 9 months.  Full results are expected to be presented at a medical conference around mid-2016.

Conference Call Details

Prothena management will discuss the PRONTO trial design for NEOD001, in a live audio webcast and conference call today, Thursday, October 15 at 4:30 p.m. ET. The webcast and slide presentation will be made available on the Company’s website atwww.prothena.com under the Investors tab in the Events and Presentations section. Following the live audio webcast, a replay of the webcast will be available on the Company’s website for at least 90 days.

To access the call via dial-in, please dial: (877) 887-5215 (U.S. toll free) or (315) 625-3069 (international) five minutes prior to the start time and refer to conference ID number 45152199. The webcast will be available at http://ir.prothena.com. A replay of the call will be available for at least 90 days via dial-in at (855) 859-2056  (U.S. toll free) or (404) 537-3406  (international), Conference ID Number 45152199.

About NEOD001

NEOD001 is a humanized monoclonal antibody that specifically targets the circulating soluble amyloid and deposited insoluble amyloid that accumulates in both the AL and AA forms of amyloidosis. Patients with AL amyloidosis may be eligible to enroll in one of two clinical trials for NEOD001. The VITAL Amyloidosis Study, a double-blind, placebo-controlled, global Phase 3 registrational trial, is evaluating NEOD001 in newly-diagnosed, treatment-naïve patients with AL amyloidosis, and will assess a composite of all-cause mortality or cardiac hospitalizations in addition to biomarker, functional and quality of life endpoints. The PRONTO trial, a double-blind, placebo-controlled, global Phase 2b registration-directed trial, will evaluate NEOD001 in previously-treated patients with AL amyloidosis and persistent cardiac dysfunction, and will assess NT-proBNP best response over 12 months in addition to other functional biomarker, and quality of life endpoints. More information on The VITAL Amyloidosis Study and the PRONTO trial is available or will be provided at www.clinicaltrials.gov.

About AL Amyloidosis

Systemic amyloidoses are a complex group of progressive diseases caused by tissue deposition of misfolded proteins that result in progressive organ damage. The most common type, AL amyloidosis or primary amyloidosis, involves a hematological disorder caused by plasma cells that produce misfolded immunoglobulin light chain resulting in deposits of abnormal AL protein (amyloid) in the tissues and organs of individuals with this disease. There are no approved treatments for AL amyloidosis, and none that directly target potentially toxic forms of the AL protein. AL amyloidosis is a rare disorder and it is estimated that about 30,000 to 45,000 patients in the U.S. and Europe suffer from this disease. Both the causes and origins of AL amyloidosis remain poorly understood. For more information on AL amyloidosis, please visit the websites of the Amyloidosis Support Group and theAmyloidosis Foundation. For information on the recently announced white paper and regulatory meeting please visit the website of the Amyloid Research Consortium.

About Prothena

Prothena Corporation plc is a late-stage clinical biotechnology company focused on the discovery, development and commercialization of novel protein immunotherapies for the potential treatment of diseases that involve amyloid or cell adhesion. The Company is developing antibody-based product candidates that target a number of potential indications including AL amyloidosis (NEOD001), Parkinson’s disease and other related synucleinopathies (PRX002), and psoriasis and other inflammatory diseases (PRX003).
For more information, please visit the Company’s web site at www.prothena.com.

Forward-looking Statements

This press release contains forward-looking statements. These statements relate to, among other things, the potential for the PRONTO clinical trial and use of NT-proBNP as a primary endpoint to provide a basis for conditional approval of NEOD001 and accelerate its development timeline and commercial path to patients; the PRONTO trial design; future progress on The VITAL Amyloidosis Study; the possibility that use of functional biomarkers as surrogate endpoints may accelerate; and the expected timing for announcing results from the expansion portion of the Phase 1/2 clinical trial. These statements are based on estimates, projections and assumptions that may prove not to be accurate, and actual results could differ materially from those anticipated due to known and unknown risks, uncertainties and other factors, including but not limited to the risks, uncertainties and other factors described in the “Risk Factors” sections of our Annual Report on Form 10-K filed with the Securities and Exchange Commission (SEC) on March 13, 2015 and our subsequent Quarterly Reports on Form 10-Q filed with the SEC. Prothena undertakes no obligation to update publicly any forward-looking statements contained in this press release as a result of new information, future events or changes in Prothena’s expectations.

Contacts

Investors: Tran Nguyen, CFO
650-837-8535, IR@prothena.com

Media: Ellen Rose, Head of Communications
650-922-2405, ellen.rose@prothena.com

Thursday, October 15th, 2015 Uncategorized Comments Off on (PRTA) to Initiate PRONTO, a Global Trial of NEOD001 in Patients With AL Amyloidosis

(XXII) New Cannabis Research Collaboration with Anandia Laboratories

Initial focus will include cannabinoid-free cannabis for commercial hemp industry and high levels of non-THC cannabinoids, such as CBD, for legal medical marijuana markets.

22nd Century Group, Inc. (NYSE MKT:XXII), a leader in tobacco harm reduction, announced today an important new initiative in plant biotechnology: 22nd Century has entered into a new cannabis research collaboration with strategic partner Anandia Laboratories, Inc. (Anandia), based in Vancouver, Canada. As a part of this research collaboration, Anandia will develop and grow cannabis strains that express highly desirable characteristics and will lead to exciting commercialization opportunities. Dr. Paul Rushton, 22nd Century’s new Vice President of Plant Biotechnology, will have responsibility for this partnership with Anandia.

The Company last year announced that Botanical Genetics, LLC (a wholly owned subsidiary of 22nd Century Group) entered into a worldwide license agreement with Anandia that granted exclusive rights to 22nd Century in the United States to four genes required for cannabinoid production in the cannabis plant. The license also granted 22nd Century co-exclusive rights with Anandia to this proprietary technology in all countries outside of the U.S. and Canada. Anandia retained exclusive rights in Canada.

The proprietary technology licensed from Anandia allows for the development of cannabis strains that demonstrate either an increase or decrease in the production and content of all, or certain subsets of, cannabinoids. The long-term goals of the Company’s research activities relating to cannabis are to develop, protect and commercially produce unique cannabis plant varieties that include high levels of non-THC cannabinoids, such as CBD, for the legal medical marijuana markets, as well as virtually cannabinoid-free cannabis for the commercial hemp industry.

Jonathan Page, Ph.D., Co-Founder, CEO and Chief Scientific Officer of Anandia – and the inventor of some of 22nd Century’s powerful transcription factor technology in the tobacco plant – is an internationally-recognized pioneer and leader in cannabis science who co-led the team that first sequenced the cannabis genome and has made fundamental discoveries about cannabinoid biosynthesis. Applying Dr. Page’s expertise and Anandia’s patented technology, the Anandia team will use modern plant breeding approaches and genomics to create next-generation cannabis strains.

Dr. Page stated, “Anandia benefits from an excellent relationship with 22nd Century and we are excited to be expanding our relationship through this research collaboration aimed at creating unique cannabis strains with highly desirable traits that can be commercialized quickly.”

Henry Sicignano, III, President and CEO of 22nd Century explained, “In much the same way that we enjoy a monopoly on the nicotinic biosynthetic pathway of tobacco, our license agreement and research activities with Anandia will facilitate 22nd Century’s control of the cannabinoid biosynthetic pathway in cannabis throughout the U.S. market.” Mr. Sicignano continued, “Though not directly related to our main tobacco businesses, the exclusivity in, and control of, ‘next generation cannabis strains’ could ultimately be worth hundreds of millions of dollars to 22nd Century.”

About 22nd Century Group, Inc.

22nd Century Group is a plant biotechnology company focused on technology that 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 185 issued patents and more than 50 pending patent applications around the world. The Company’s strong IP position led to a licensing agreement with British American Tobacco (“BAT”), the world’s second largest tobacco company. Visit www.xxiicentury.com for more information.

About Anandia Laboratories Inc.

Anandia Laboratories, Inc. is the emerging leader in cannabis genetics and variety improvement. Building on the pioneering research of Co-Founder Dr. Jonathan Page and utilizing its world-leading intellectual property position, Anandia is applying modern plant breeding approaches and genomics to create next-generation cannabis strains optimized to address grower and consumer challenges. Anandia also continues to contribute to the evolution of the cannabis industry by helping partners through shared knowledge, analytical testing, and genomic analysis services. Visit www.anandialabs.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. 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 year ended December 31, 2014, filed on February 6, 2015, 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 for 22nd Century Group, Inc.:
Andrew Haag, 866-976-4784
xxii@irthcommunications.com
or
Redington, Inc.
Tom Redington, 203-222-7399
or
Investor Relations for Anandia Laboratories, Inc.:
John Coleman, 604-822-0253
jcoleman@anandialabs.com

Thursday, October 15th, 2015 Uncategorized Comments Off on (XXII) New Cannabis Research Collaboration with Anandia Laboratories

(RMTI) Introduces New Video Demonstrating Triferic(R)

Video Demonstrates How Triferic Effectively Treats Ongoing Iron Loss in Dialysis Patients and Its Advantages and Clinical Benefits Over Current Iron Therapy

WIXOM, Mich., Oct. 15, 2015  — Rockwell Medical, Inc. (NASDAQ:RMTI), a fully-integrated biopharmaceutical company targeting end-stage renal disease (ESRD) and chronic kidney disease (CKD) with innovative products and services for the treatment of iron replacement, secondary hyperparathyroidism and hemodialysis, announced today that its new Triferic mode-of-action (MOA) video has been unveiled on the Triferic website at www.triferic.com. The new MOA video shows how Triferic addresses the ongoing iron loss that hemodialysis patients experience during their weekly dialysis treatments and how Triferic overcomes the functional-iron-deficiency that results from IV iron administration. Triferic is the only FDA approved iron product indicated to replace iron and maintain hemoglobin in hemodialysis patients in the United States.

About Triferic

Triferic is a unique iron replacement product that is delivered to hemodialysis patients via dialysate, replacing the ongoing iron loss that occurs during their dialysis treatment. Triferic is added to the bicarbonate concentrate on-site at the dialysis clinic. Once in dialysate, Triferic crosses the dialyzer membrane and enters the blood where it immediately binds to transferrin and is transported to the erythroid precursor cells to be incorporated into hemoglobin. In completed clinical trials, Triferic has demonstrated that it can effectively deliver sufficient iron to the bone marrow and maintain hemoglobin, without increasing iron stores (ferritin). Please visit www.triferic.com or call Rockwell Medical at 800-449-3353 for more information.

About Rockwell Medical

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

Rockwell’s recent FDA approved drug Triferic is indicated for iron replacement and maintenance of hemoglobin in hemodialysis patients. Triferic delivers iron to patients during their regular dialysis treatment, using dialysate as the delivery mechanism. In completed clinical trials, Triferic has demonstrated that it safely and effectively delivers sufficient iron to the bone marrow and maintains hemoglobin, without increasing iron stores (ferritin). Rockwell intends to market Triferic to hemodialysis patients in the U.S. dialysis market.

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

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

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

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

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

CONTACT: Michael Rice, Investor Relations; 646-597-6979
Thursday, October 15th, 2015 Uncategorized Comments Off on (RMTI) Introduces New Video Demonstrating Triferic(R)

(SUPN) Announces Settlement With Par on Trokendi XR(R) Patent Litigation

ROCKVILLE, Md., Oct. 15, 2015  — Supernus Pharmaceuticals, Inc. (Nasdaq:SUPN) announced that it has entered into a settlement agreement with Par Pharmaceutical Companies, Inc. and Par Pharmaceutical, Inc. (collectively “Par”) involving the ongoing patent litigation regarding Par’s filing of an Abbreviated New Drug Application (ANDA) seeking approval to market a generic version of Supernus’ Trokendi XR® (extended-release topiramate) capsules. The settlement permits Par to begin selling a generic version of Trokendi XR® on April 1, 2025, or earlier under certain circumstances. The agreement is subject to entry of a consent judgment by the U.S. District Court for the District of New Jersey. In the consent judgment, Par acknowledges that the Orange Book-listed patents for Trokendi XR® owned by Supernus, namely United States Patent Nos. 8,298,576, 8,298,580, 8,663,683, 8,877,248, 8,889,191, and 8,992,989, are valid and enforceable with respect to Par’s ANDA product, and would be infringed by Par’s ANDA product. The agreement will be submitted to the applicable governmental agencies.

The patent litigation continues against Actavis and Zydus, the other two ANDA filers. Patent protection for Trokendi XR® expires no earlier than 2027 and Supernus intends to continue its vigorous enforcement of its patent rights.

Supernus is represented by attorneys from Frommer Lawrence and Haug LLP and its corporate counsel, Saul Ewing LLP.

About Supernus Pharmaceuticals, Inc.

Supernus Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on developing and commercializing products for the treatment of central nervous system, or CNS, diseases. The Company markets two products for epilepsy, Oxtellar XR® (extended-release oxcarbazepine) and Trokendi XR® (extended-release topiramate). The Company is also developing several product candidates in psychiatry to address large market opportunities in ADHD, including ADHD patients with impulsive aggression. These product candidates include SPN-810 for impulsive aggression in ADHD and SPN-812 for ADHD.

Forward Looking Statements

This press release contains forward-looking statements regarding the Company’s ability to defend and enforce its intellectual property rights covering Trokendi XR®. Actual results may differ materially from those in these forward-looking statements as a result of various factors, including, but not limited to, the ability of Supernus to finance potential litigation and to prevail in any such proceeding to successfully defend its intellectual property rights. For a further description of these and other risks facing the Company, please see the risk factors described in the Company’s Annual Report Form 10-K that was filed with the United States Securities and Exchange Commission on March 12, 2015 under the caption “Risk Factors”. Forward-looking statements speak only as of the date of this press release, and the Company undertakes no obligation to update or revise these statements, except as may be required by law.

CONTACT: Jack A. Khattar, President and CEO
         Gregory S. Patrick, Vice President and CFO
         Supernus Pharmaceuticals, Inc.
         301-838-2591

         Or

         Investor Contact:
         Peter Vozzo
         Westwicke Partners
         Office: (443) 213-0505
         Mobile: (443) 377-4767
         Email: peter.vozzo@westwicke.com
Thursday, October 15th, 2015 Uncategorized Comments Off on (SUPN) Announces Settlement With Par on Trokendi XR(R) Patent Litigation

(FPRX) & (BMY) Exclusive Worldwide License and Collaboration Agreement

Strategic immuno-oncology collaboration focused on development of CSF1R antibody (FPA008) in combination with Opdivo (nivolumab) and other therapies with the goal of bringing new treatment options to patients

Five Prime to receive up to $1.74 billion for FPA008, inclusive of $350 million upfront and potential development and regulatory milestone payments; additional double-digit royalties on future sales and option to co-promote in the U.S.

Five Prime to continue development of FPA008 in pigmented villonodular synovitis (PVNS) and in potential combinations with its own immuno-oncology candidates

Bristol-Myers Squibb Company (NYSE:BMY) and Five Prime Therapeutics, Inc. (Nasdaq:FPRX) today announced that they have entered into an exclusive worldwide license and collaboration agreement for the development and commercialization of Five Prime’s colony stimulating factor 1 receptor (CSF1R) antibody program, including FPA008 which is in Phase 1 development for immunology and oncology indications. This agreement replaces the companies’ existing clinical collaboration agreement to evaluate the safety, tolerability and preliminary efficacy of combining Opdivo (nivolumab), Bristol-Myers Squibb’s programmed-death 1 (PD-1) immune checkpoint inhibitor, with FPA008 in six tumor types.

“By blocking a key mediator of immunosuppression in the tumor microenvironment, CSF1R inhibition with FPA008 represents a potentially important complementary immuno-oncology mechanism of action to the T-cell directed antibodies and co-stimulatory molecules in our pipeline,” said Francis Cuss, MB BChir, FRCP, executive vice president and chief scientific officer of Bristol-Myers Squibb. “This agreement, which builds upon our existing relationship with Five Prime in immuno-oncology, is another important example of our commitment to expanding our presence in this space and to researching novel combination regimens.”

“We believe this transformational collaboration with Bristol-Myers Squibb for our CSF1R antibody program represents the best of both worlds in terms of maximizing the potential of FPA008,” said Lewis T. “Rusty” Williams, M.D., Ph.D., president and chief executive officer of Five Prime Therapeutics. “Bristol-Myers Squibb has undisputed leadership in the immuno-oncology landscape, deep clinical development and regulatory expertise, and an established commercial infrastructure to deliver important new therapies to patients. Bristol-Myers Squibb also has a rich pipeline of clinical candidates and approved products, a number of which may have therapeutic synergy when coupled with FPA008, given the potential of CSF1R inhibition to suppress the activity and survival of tumor associated macrophages. At the same time, Five Prime will continue to conduct trials in pigmented villonodular synovitis (PVNS) and immuno-oncology with FPA008, which is a product of our proprietary protein platform and our discovery of IL-34, one of the two ligands for CSF1R that FPA008 blocks.”

Under the terms of the license and collaboration agreement, Bristol-Myers Squibb will make an upfront payment of $350 million to Five Prime. Bristol-Myers Squibb will be responsible for development and manufacturing of FPA008 for all indications, subject to Five Prime’s option to conduct, at its own cost, certain future studies including registrational studies to support approval of FPA008 in PVNS and FPA008 in combination with Five Prime’s internal pipeline assets in immuno-oncology. Five Prime will continue to conduct the current Phase 1a/1b trial evaluating the combination of Opdivo and FPA008 in six tumor settings, which was announced as part of the companies’ initial clinical collaboration in November 2014, through to completion. Bristol-Myers Squibb will be responsible for global commercialization, and Five Prime will retain rights to a U.S. co-promotion option. In addition to the upfront payment, Five Prime will be eligible to receive up to $1.05 billion in development and regulatory milestone payments per anti-CSF1R product for oncology indications (including combinations with Opdivo and any other agent), and up to $340 million in development and regulatory milestone payments per anti-CSF1R product for non-oncology indications, as well as double digit royalties, such royalties to be enhanced in the U.S. in the event that Five Prime exercises its co-promotion option.

The effectiveness of the agreement is subject to clearance under the Hart-Scott-Rodino Antitrust Improvements Act.

About FPA008

FPA008 is an investigational antibody that inhibits CSF1R and has been shown in preclinical models to block the activation and survival of monocytes and macrophages. Early data have shown that inhibition of CSF1R in inflamed RA joints blocks the production of inflammatory cytokines by macrophages and inhibits osteoclasts, monocyte-lineage cells that can cause bone erosions and joint destruction. Inhibition of CSF1R in preclinical models of several cancers reduces the number of immunosuppressive tumor-associated macrophages (TAMs) in the tumor microenvironment, thereby facilitating an immune response against tumors. FPA008 is currently in phase 1 clinical trials in several immunology and oncology indications.

About Opdivo

Opdivo was the first PD-1 immune checkpoint inhibitor to receive regulatory approval anywhere in the world in July 2014, and currently has regulatory approval in more than 37 countries including the United States, Japan, and in the European Union.

In the U.S., Opdivo is indicated for patients with unresectable or metastatic melanoma and disease progression following Yervoy (ipilimumab) and, if BRAF V600 mutation positive, a BRAF inhibitor. Opdivo is also approved for use in combination with Yervoy, for the treatment of patients with BRAF V600 wild-type unresectable or metastatic melanoma. These indications are approved under accelerated approval based on tumor response rate and durability of response. Continued approval for this indication may be contingent upon verification and description of clinical benefit in confirmatory trials. Opdivo is also indicated in the U.S. for the treatment of patients with metastatic non-small cell lung cancer (NSCLC) with progression on or after platinum-based chemotherapy.

Bristol-Myers Squibb has a broad, global development program to study Opdivo in multiple tumor types consisting of more than 50 trials – as a monotherapy or in combination with other therapies – in which more than 8,000 patients have been enrolled worldwide.

IMPORTANT SAFETY INFORMATION

WARNING: IMMUNE-MEDIATED ADVERSE REACTIONS

YERVOY can result in severe and fatal immune-mediated adverse reactions due to T-cell activation and proliferation. These immune-mediated reactions may involve any organ system; however, the most common severe immune-mediated adverse reactions are enterocolitis, hepatitis, dermatitis (including toxic epidermal necrolysis), neuropathy, and endocrinopathy. The majority of these immune-mediated reactions initially manifested during treatment; however, a minority occurred weeks to months after discontinuation of YERVOY.

Assess patients for signs and symptoms of enterocolitis, dermatitis, neuropathy, and endocrinopathy and evaluate clinical chemistries including liver function tests (LFTs) and thyroid function tests at baseline and before each dose.

Permanently discontinue YERVOY and initiate systemic high-dose corticosteroid therapy for severe immune-mediated reactions.

Immune-Mediated Pneumonitis

Immune-mediated pneumonitis or interstitial lung disease, including fatal cases, occurred with OPDIVO treatment. Across the clinical trial experience with solid tumors, fatal immune-mediated pneumonitis occurred in 0.5% (5/978) of patients receiving OPDIVO as a single agent. In Checkmate 037, pneumonitis, including interstitial lung disease, occurred in 3.4% (9/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Immune-mediated pneumonitis occurred in 2.2% (6/268) of patients receiving OPDIVO; Grade 3 (n=1) and Grade 2 (n=5). In Checkmate 057, immune-mediated pneumonitis, including interstitial lung disease, occurred in 3.4% (10/287) of patients receiving OPDIVO as a single agent: Grade 3 (n=5), Grade 2 (n=2), and Grade 1 (n=3). Across the clinical trial experience in 188 patients with melanoma who received OPDIVO in combination with YERVOY, in Checkmate 069 (n=94) and an additional dose-finding study (n=94), fatal immune-mediated pneumonitis occurred in 0.5% (1/188) of patients. In Checkmate 069, there were six additional patients who died without resolution of abnormal respiratory findings. Monitor patients for signs with radiographic imaging and symptoms of pneumonitis. Administer corticosteroids for Grade 2 or greater pneumonitis. Permanently discontinue for Grade 3 or 4 and withhold until resolution for Grade 2. In Checkmate 069, pneumonitis, including interstitial lung disease, occurred in 10% (9/94) of patients receiving OPDIVO in combination with YERVOY and 2.2% (1/46) of patients receiving YERVOY. Immune-mediated pneumonitis occurred in 6% (6/94) of patients receiving OPDIVO in combination with YERVOY: Grade 5 (n=1), Grade 3 (n=2) and Grade 2 (n=3).

Immune-Mediated Colitis

Immune-mediated colitis can occur with OPDIVO treatment. Monitor patients for signs and symptoms of colitis. Administer corticosteroids for Grade 2 (of more than 5 days duration), 3, or 4 colitis. As a single agent, withhold OPDIVO for Grade 2 or 3 and permanently discontinue for Grade 4 or recurrent colitis upon restarting OPDIVO. In combination with YERVOY, withhold OPDIVO for Grade 2 and permanently discontinue for Grade 3 or 4 or recurrent colitis upon restarting OPDIVO. In Checkmate 037, diarrhea or colitis occurred in 21% (57/268) of patients receiving OPDIVO and 18% (18/102) of patients receiving chemotherapy. Immune-mediated colitis occurred in 2.2% (6/268) of patients receiving OPDIVO; Grade 3 (n=5) and Grade 2 (n=1). In Checkmate 057, diarrhea or colitis occurred in 17% (50/287) of patients receiving OPDIVO as a single agent. Immune-mediated colitis occurred in 2.4% (7/287) of patients: Grade 3 (n=3), Grade 2 (n=2), and Grade 1 (n=2). In Checkmate 069, diarrhea or colitis occurred in 57% (54/94) of patients receiving OPDIVO in combination with YERVOY and 46% (21/46) of patients receiving YERVOY. Immune-mediated colitis occurred in 33% (31/94) of patients receiving OPDIVO in combination with YERVOY: Grade 4 (n=1), Grade 3 (n=16), Grade 2 (n=9), and Grade 1 (n=5).

In a separate YERVOY Phase 3 study, severe, life-threatening, or fatal (diarrhea of ≥7 stools above baseline, fever, ileus, peritoneal signs; Grade 3-5) immune-mediated enterocolitis occurred in 34 (7%) patients. Across all YERVOY-treated patients in that study (n=511), 5 (1%) developed intestinal perforation, 4 (0.8%) died as a result of complications, and 26 (5%) were hospitalized for severe enterocolitis.

Immune-Mediated Hepatitis

Immune-mediated hepatitis can occur with OPDIVO treatment. Monitor patients for abnormal liver tests prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater transaminase elevations. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 immune-mediated hepatitis. In Checkmate 037, there was an increased incidence of liver test abnormalities in the OPDIVO-treated group as compared to the chemotherapy-treated group, with increases in AST (28% vs 12%), alkaline phosphatase (22% vs 13%), ALT (16% vs 5%), and total bilirubin (9% vs 0). Immune-mediated hepatitis occurred in 1.1% (3/268) of patients receiving OPDIVO; Grade 3 (n=2) and Grade 2 (n=1). In Checkmate 057, one patient (0.3%) developed immune-mediated hepatitis. In Checkmate 069, immune-mediated hepatitis occurred in 15% (14/94) of patients receiving OPDIVO in combination with YERVOY: Grade 4 (n=3), Grade 3 (n=9), and Grade 2 (n=2).

In a separate YERVOY Phase 3 study, severe, life-threatening, or fatal hepatotoxicity (AST or ALT elevations >5x the ULN or total bilirubin elevations >3x the ULN; Grade 3-5) occurred in 8 (2%) patients, with fatal hepatic failure in 0.2% and hospitalization in 0.4%.

Immune-Mediated Dermatitis

In a separate YERVOY Phase 3 study, severe, life-threatening, or fatal immune-mediated dermatitis (eg, Stevens-Johnson syndrome, toxic epidermal necrolysis, or rash complicated by full thickness dermal ulceration, or necrotic, bullous, or hemorrhagic manifestations; Grade 3-5) occurred in 13 (2.5%) patients. 1 (0.2%) patient died as a result of toxic epidermal necrolysis. 1 additional patient required hospitalization for severe dermatitis.

Immune-Mediated Neuropathies

In a separate YERVOY Phase 3 study, 1 case of fatal Guillain-Barré syndrome and 1 case of severe (Grade 3) peripheral motor neuropathy were reported.

Immune-Mediated Endocrinopathies

Hypophysitis, adrenal insufficiency, and thyroid disorders can occur with OPDIVO treatment. Monitor patients for signs and symptoms of hypophysitis, signs and symptoms of adrenal insufficiency during and after treatment, and thyroid function prior to and periodically during treatment. Administer corticosteroids for Grade 2 or greater hypophysitis. Withhold for Grade 2 or 3 and permanently discontinue for Grade 4 hypophysitis. Administer corticosteroids for Grade 3 or 4 adrenal insufficiency. Withhold for Grade 2 and permanently discontinue for Grade 3 or 4 adrenal insufficiency. Administer hormone replacement therapy for hypothyroidism. Initiate medical management for control of hyperthyroidism.

In Checkmate 069, hypophysitis occurred in 13% (12/94) of patients receiving OPDIVO in combination with YERVOY: Grade 3 (n=2) and Grade 2 (n=10). Adrenal insufficiency occurred in 1% (n=555) of patients receiving OPDIVO as a single agent. In Checkmate 069, adrenal insufficiency occurred in 9% (8/94) of patients receiving OPDIVO in combination with YERVOY: Grade 3 (n=3), Grade 2 (n=4), and Grade 1 (n=1). In Checkmate 069, hypothyroidism occurred in 19% (18/94) of patients receiving OPDIVO in combination with YERVOY. All were Grade 1 or 2 in severity except for one patient who experienced Grade 3 autoimmune thyroiditis. Grade 1 hyperthyroidism occurred in 2.1% (2/94) of patients receiving OPDIVO in combination with YERVOY. In Checkmate 037, Grade 1 or 2 hypothyroidism occurred in 8% (21/268) of patients receiving OPDIVO and none of the 102 patients receiving chemotherapy. Grade 1 or 2 hyperthyroidism occurred in 3% (8/268) of patients receiving OPDIVO and 1% (1/102) of patients receiving chemotherapy. In Checkmate 057, Grade 1 or 2 hypothyroidism, including thyroiditis, occurred in 7% (20/287) and elevated TSH occurred in 17% of patients receiving OPDIVO as a single agent. Grade 1 or 2 hyperthyroidism occurred in 1.4% (4/287) of patients.

In a separate YERVOY Phase 3 study, severe to life-threatening immune-mediated endocrinopathies (requiring hospitalization, urgent medical intervention, or interfering with activities of daily living; Grade 3-4) occurred in 9 (1.8%) patients. All 9 patients had hypopituitarism, and some had additional concomitant endocrinopathies such as adrenal insufficiency, hypogonadism, and hypothyroidism. 6 of the 9 patients were hospitalized for severe endocrinopathies.

Immune-Mediated Nephritis and Renal Dysfunction

Immune-mediated nephritis can occur with OPDIVO treatment. Monitor patients for elevated serum creatinine prior to and periodically during treatment. For Grade 2 or 3 increased serum creatinine, withhold and administer corticosteroids; if worsening or no improvement occurs, permanently discontinue. Administer corticosteroids for Grade 4 serum creatinine elevation and permanently discontinue. In Checkmate 037, there was an increased incidence of elevated creatinine in the OPDIVO-treated group as compared to the chemotherapy-treated group (13% vs 9%). Grade 2 or 3 immune-mediated nephritis or renal dysfunction occurred in 0.7% (2/268) of patients. In Checkmate 057, Grade 2 immune-mediated renal dysfunction occurred in 0.3% (1/287) of patients receiving OPDIVO as a single agent. In Checkmate 069, Grade 2 or higher immune-mediated nephritis or renal dysfunction occurred in 2.1% (2/94) of patients. One patient died without resolution of renal dysfunction.

Immune-Mediated Rash

Immune-mediated rash can occur with OPDIVO treatment. Monitor patients for rash. Administer corticosteroids for Grade 3 or 4 rash. Withhold for Grade 3 and permanently discontinue for Grade 4. In Checkmate 037 (n=268), the incidence of rash was 21%; the incidence of Grade 3 or 4 rash was 0.4%. In Checkmate 057, immune-mediated rash occurred in 6% (17/287) of patients receiving OPDIVO as a single agent including four Grade 3 cases. In Checkmate 069, immune-mediated rash occurred in 37% (35/94) of patients receiving OPDIVO in combination with YERVOY: Grade 3 (n=6), Grade 2 (n=10), and Grade 1 (n=19).

Immune-Mediated Encephalitis

Immune-mediated encephalitis can occur with OPDIVO treatment. Withhold OPDIVO in patients with new-onset moderate to severe neurologic signs or symptoms and evaluate to rule out other causes. If other etiologies are ruled out, administer corticosteroids and permanently discontinue OPDIVO for immune-mediated encephalitis. Across clinical trials of 8490 patients receiving OPDIVO as a single agent or in combination with YERVOY, <1% of patients were identified as having encephalitis. In Checkmate 057, fatal limbic encephalitis occurred in one patient (0.3%) receiving OPDIVO as a single agent.

Other Immune-Mediated Adverse Reactions

Based on the severity of adverse reaction, permanently discontinue or withhold treatment, administer high-dose corticosteroids, and, if appropriate, initiate hormone-replacement therapy. The following clinically significant immune-mediated adverse reactions occurred in <2% (n=555) of single-agent OPDIVO-treated patients: uveitis, pancreatitis, abducens nerve paresis, demyelination, polymyalgia rheumatica, and autoimmune neuropathy. Across clinical trials of OPDIVO administered as a single agent at doses 3 mg/kg and 10 mg/kg, additional clinically significant, immune-mediated adverse reactions were identified: facial nerve paralysis, motor dysfunction, vasculitis, diabetic ketoacidosis, and myasthenic syndrome. In Checkmate 069, the following additional immune-mediated adverse reactions occurred in 1% of patients treated with OPDIVO in combination with YERVOY: Guillain-Barré syndrome and hypopituitarism. Across clinical trials of OPDIVO in combination with YERVOY, the following additional clinically significant, immune-mediated adverse reactions were identified: uveitis, sarcoidosis, duodenitis, pancreatitis, and gastritis.

Infusion Reactions

Severe infusion reactions have been reported in <1% of patients in clinical trials of OPDIVO as a single agent. In Checkmate 057, Grade 2 infusion reactions occurred in 1% (3/287) of patients receiving OPDIVO as a single agent. In Checkmate 069, Grade 2 infusion reactions occurred in 3% (3/94) of patients receiving OPDIVO in combination with YERVOY. Discontinue OPDIVO in patients with severe or life-threatening infusion reactions. Interrupt or slow the rate of infusion in patients with mild or moderate infusion reactions.

Embryofetal Toxicity

Based on its mechanism of action, OPDIVO can cause fetal harm when administered to a pregnant woman. Advise pregnant women of the potential risk to a fetus. Advise females of reproductive potential to use effective contraception during treatment with OPDIVO-containing regimen and for at least 5 months after the last dose of OPDIVO.

Lactation

It is not known whether OPDIVO is present in human milk. Because many drugs, including antibodies, are excreted in human milk and because of the potential for serious adverse reactions in nursing infants from OPDIVO-containing regimen, advise women to discontinue breastfeeding during treatment.

Serious Adverse Reactions

In Checkmate 037, serious adverse reactions occurred in 41% of patients receiving OPDIVO. Grade 3 and 4 adverse reactions occurred in 42% of patients receiving OPDIVO. The most frequent Grade 3 and 4 adverse drug reactions reported in 2% to <5% of patients receiving OPDIVO were abdominal pain, hyponatremia, increased aspartate aminotransferase, and increased lipase. In Checkmate 057, serious adverse reactions occurred in 47% of patients receiving OPDIVO as a single agent. The most frequent serious adverse reactions reported in ≥2% of patients were pneumonia, pulmonary embolism, dyspnea, pleural effusion, and respiratory failure. In Checkmate 069, serious adverse reactions occurred in 62% of patients receiving OPDIVO; the most frequent serious adverse events with OPDIVO in combination with YERVOY, as compared to YERVOY alone, were colitis (17% vs 9%), diarrhea (9% vs 7%), pyrexia (6% vs 7%), and pneumonitis (5% vs 0).

Common Adverse Reactions

In Checkmate 037, the most common adverse reaction (≥20%) reported with OPDIVO was rash (21%). In Checkmate 057, the most common adverse reactions (≥20%) reported with OPDIVO as a single agent were fatigue (49%), musculoskeletal pain (36%), cough (30%), decreased appetite (29%), and constipation (23%). In Checkmate 069, the most common adverse reactions (≥20%) reported in patients receiving OPDIVO in combination with YERVOY vs YERVOY alone were rash (67% vs 57%), pruritus (37% vs 26%), headache (24% vs 20%), vomiting (23% vs 15%), and colitis (22% vs 11%).

In a separate YERVOY Phase 3 study, the most common adverse reactions (≥5%) in patients who received YERVOY at 3 mg/kg were fatigue (41%), diarrhea (32%), pruritus (31%), rash (29%), and colitis (8%).

Please see U.S. Full Prescribing Information for OPDIVO and YERVOY, including Boxed WARNING for YERVOY regarding immune-mediated adverse reactions.

About Bristol-Myers Squibb

Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. For more information, please visit www.bms.com or follow us on Twitter at http://twitter.com/bmsnews.

About Five Prime Therapeutics

Five Prime Therapeutics, Inc. discovers and develops innovative therapeutics to improve the lives of patients with serious diseases. Five Prime’s comprehensive discovery platform, which encompasses virtually every medically relevant extracellular protein, positions it to explore pathways in cancer, inflammation and their intersection in immuno-oncology, an area of oncology with significant therapeutic potential and a growing focus of the company’s R&D activities. Five Prime has entered into strategic collaborations with leading global pharmaceutical companies and has promising product candidates in clinical and late preclinical development.

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

Bristol-Myers Squibb Forward-Looking Statement

This press release contains “forward-looking statements” as that term is defined in the Private Securities Litigation Reform Act of 1995 regarding the research, development and commercialization of pharmaceutical products. Such forward-looking statements are based on current expectations and involve inherent risks and uncertainties, including factors that could delay, divert or change any of them, and could cause actual outcomes and results to differ materially from current expectations. No forward-looking statement can be guaranteed. Among other risks, there can be no guarantee that FPA008 will be successfully developed or approved for any of the indications described in this release or in combination with Opdivo. Forward-looking statements in this press release should be evaluated together with the many uncertainties that affect Bristol-Myers Squibb’s business, particularly those identified in the cautionary factors discussion in Bristol-Myers Squibb’s Annual Report on Form 10-K for the year ended December 31, 2014 in our Quarterly Reports on Form 10-Q and our Current Reports on Form 8-K. Bristol-Myers Squibb undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events or otherwise.

Five Prime Forward-Looking Statement

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Words such as “may,” “will,” “expect,” “plan,” “anticipate,” “estimate,” “intend” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements. These forward-looking statements are based on Five Prime’s expectations and assumptions as of the date of this press release. Each of these forward-looking statements involves risks and uncertainties. Actual results may differ materially from these forward-looking statements. Forward-looking statements contained in this press release include statements regarding (i) the planned clinical development of the combination of FPA008 with nivolumab; and (ii) Five Prime’s potential receipt of upfront and milestone payments and royalties. Many factors may cause differences between current expectations and actual results including unexpected safety or efficacy data observed during clinical studies, changes in expected or existing competition, changes in the regulatory, pricing or reimbursement environment, and unexpected litigation or other disputes. Other factors that may cause actual results to differ from those expressed or implied in the forward-looking statements in this press release are discussed in Five Prime’s filings with the U.S. Securities and Exchange Commission, including the “Risk Factors” contained therein. Except as required by law, Five Prime assumes no obligation to update any forward-looking statements contained herein to reflect any change in expectations, even as new information becomes available.

 

Bristol-Myers Squibb
Media:
Sarah Koenig, 609-252-4145
sarah.koenig@bms.com
or
Investors:
Ranya Dajani, 609-252-5330
ranya.dajani@bms.com
or
Five Prime Therapeutics:
Amy Kendall, 415-365-5776
amy.kendall@fiveprime.com

Thursday, October 15th, 2015 Uncategorized Comments Off on (FPRX) & (BMY) Exclusive Worldwide License and Collaboration Agreement

(SMTC) Boot Camps & IoT Applications Using LoRa® RF Long Range Wireless Technology

Semtech, along with select partners, will host boot camps to introduce LoRa® RF technology and its potential IoT applications, and give a hands-on tutorial with take-home starter kits

Semtech (Nasdaq: SMTC), a leading supplier of analog and mixed-signal semiconductors, will host a series of LoRa® boot camps through next year to showcase its unprecedented long-range, low-power Internet of Things (IoT) network solution and give participants a hands-on tutorial with a working starter kit. Select Semtech partners, depending on the boot camp location and date, will also present their LoRa-integrated solutions. Registration information is available at www.regonline.com/lora_bootcamp.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20151014005568/en/

The boot camps, led by Semtech’s LoRa team, provide participants with a wide range of use case scenarios, cover the main aspects of setting up a LoRaWAN™ network, and guide participants on how to best set up their IoT applications through hands-on tutorials. By the end of the day, boot camp attendees should have the information and material they need to expedite the setup of their own IoT applications, including a working starter kit.

After successful first events in Silicon Valley on July 23 and Neuchâtel, Switzerland on September 23, 2015, Semtech expanded its event schedule to include additional events in Asia, Europe and North America. The Company’s October 28 boot camp in Neuchâtel is already at capacity, but events in San Jose on November 18 and Shenzhen on December 9 are still available and additional boot camps into 2016 will be introduced soon.

  • SOLD OUT – October 28 – 08.30 – 17.30

Volkshaus in Zurich, Switzerland

Stauffacherstrasse 60, 8004 Zürich

http://www.volkshaus.ch/

  • November 18 – 8:30 a.m. – 5:30 p.m.

Semtech San Jose Office

2580 N. First Street, Suite 400

San Jose, California 95131

  • December 9 – 08.30 – 17.30

Semtech Shenzhen Office

Suite A408, TCL Building,

Gaoxin South First Street,

Nanshan District, Shenzhen,

Guangdong 518057, China

“We were motivated to expand these events after an overwhelmingly positive response to our first two,” said Hardy Schmidbauer, Director of Wireless Products at Semtech. “By giving companies the information and the starter kits they need to jumpstart their IoT solutions, we aim to increase the adoption of the LoRaWAN standard and catalyze the growth of IoT applications globally.”

LoRa RF Long Range Wireless Platform Overview

Semtech’s LoRa platform includes the SX1301 baseband processor embedded in base stations and the SX1272/3/6/7/8 transceiver chipsets embedded in sensors to provide long-range connectivity, operating on low power for long battery life. LoRaWAN is a standardized protocol that offers bi-directionality, security, mobility, accurate localization, and most importantly, interoperability between LPWAN networks and IoT, machine-to-machine (M2M) and smart city applications.

What’s in the Take-Home Starter Kits

The take-home starter kits include the following components: RaspberryPi B+ (or 2) with a LoRa IoT shield unit and pre-installed micro SD card, a SX1301-based concentrator reference design, an active GPS antenna, USB cables, a power adapter, and an example end-point (a LoRaMote or MBED shield unit) as a reference to confirm the kit’s functionality.

Registering for the Bootcamp

Companies interested in developing or connecting solutions into LoRaWAN networks can register up to three employees to attend for $1,000 per company. More information, including registration, is available at www.regonline.com/lora_bootcamp.

Key Features of LoRa RF Technology:

  • Long Range: A single LoRa base station enables deep penetration capability for dense urban environments and indoor coverage, while also providing the ability to connect to sensors more than 15-30 miles away in rural areas.
  • Low Cost: LoRa reduces both upfront infrastructure investments and operating costs, as well as end-node sensor costs.
  • Standardized: LoRaWAN ensures interoperability among applications, IoT solution providers and telecom operators to speed adoption and deployment.
  • Low Power: The LoRaWAN protocol was developed specifically for low power and enables unprecedented multi-year battery lifetime.

Resources:

About Semtech

Semtech Corporation is a leading supplier of analog and mixed-signal semiconductors for high-end consumer, enterprise computing, communications and industrial equipment. Products are designed to benefit the engineering community as well as the global community. The company is dedicated to reducing the impact it, and its products, have on the environment. Internal green programs seek to reduce waste through material and manufacturing control, use of green technology and designing for resource reduction. Publicly traded since 1967, Semtech is listed on the NASDAQ Global Select Market under the symbol SMTC. For more information, visit www.semtech.com.

Forward-Looking and Cautionary Statements

All statements contained herein that are not statements of historical fact, including statements that use the words “should,” “will,” “aim,” or other similar words or expressions, that describe Semtech Corporation’s or its management’s future plans, objectives or goals are “forward-looking statements” and are made pursuant to the Safe-Harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. Such forward-looking statements involve known and unknown risks, uncertainties and other factors that could cause the actual results of Semtech Corporation to be materially different from the historical results and/or from any future results or outcomes expressed or implied by such forward-looking statements. Such factors are further addressed in Semtech Corporation’s annual and quarterly reports, and in other documents or reports, filed with the Securities and Exchange Commission (http://www.sec.gov) including, without limitation, information under the captions “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors”. Semtech Corporation assumes no obligation to update any forward-looking statements in order to reflect events or circumstances that may arise after the date of this release, except as required by law.

Semtech, the Semtech logo, LoRa and LoRaWAN are registered trademarks or service marks, or trademarks or service marks, of Semtech Corporation and/or its affiliates. Third-party trademarks or service marks mentioned herein are the property of their respective owners.

Semtech Corporation
David Guerra, 805-480-2184
dguerra@semtech.com

Wednesday, October 14th, 2015 Uncategorized Comments Off on (SMTC) Boot Camps & IoT Applications Using LoRa® RF Long Range Wireless Technology

(NMIH) Reports $3.6 Billion of New Insurance Written in Third Quarter

EMERYVILLE, Calif., Oct. 14, 2015  — NMI Holdings, Inc., (NASDAQ: NMIH), the parent company of National Mortgage Insurance Corporation (National MI), today announced the following preliminary operating statistics for its third quarter ended Sep. 30, 2015:

  • New insurance written (NIW) for the third quarter was $3.63 billion, an increase of 42% over NIW of $2.55 billion in the prior quarter.
  • The company estimates that as of the end of the quarter it had 906 approved master policies with customers, up from 842 master policies as of the end of the prior quarter.
  • The company estimates that 391 customers generated NIW during the third quarter, up from 340 in the prior quarter.

The company also announced that it will report financial results for the third quarter after the market close on Tuesday, Oct. 27, 2015.  The company will hold a conference call and live webcast at 2:00 p.m. Pacific Time / 5:00 p.m. Eastern Time. The conference call will be available on the company’s website, www.nationalmi.com, in the “Investor Relations” section.  The call also can be accessed by dialing (888) 734-0328 inside the U.S., or (914) 495-8578 for international callers using Conference ID: 60950406, or by referencing NMI Holdings, Inc.

A replay of the webcast and the earnings press release will be available on the company’s website.

About National MI

National Mortgage Insurance Corporation (National MI), a subsidiary of NMI Holdings, Inc. (NASDAQ: NMIH), is a U.S.-based, private mortgage insurance company enabling low down payment borrowers to realize home ownership while protecting lenders and investors against losses related to a borrower’s default. To learn more, please visit www.nationalmi.com.

Investor Contact
John M. Swenson
Vice President, Investor Relations and Treasury
john.swenson@nationalmi.com
(510) 788-8417

Wednesday, October 14th, 2015 Uncategorized Comments Off on (NMIH) Reports $3.6 Billion of New Insurance Written in Third Quarter

(CTMX) Announces Closing of IPO

SOUTH SAN FRANCISCO, Calif., Oct. 14, 2015  — CytomX Therapeutics, Inc. (Nasdaq: CTMX) (the “Company”), a biopharmaceutical company developing Probody™ therapeutics for the treatment of cancer, today announced the closing of its initial public offering of 7,666,667 shares of common stock at an initial public offering price of $12.00 per share, before underwriting discounts and commissions, which includes the exercise in full by the underwriters of their option to purchase up to 1,000,000 additional shares of common stock. The Company’s common stock began trading on The NASDAQ Global Select Market on October 8, 2015, under the ticker symbol “CTMX.”

BofA Merrill Lynch, Jefferies LLC and Cowen and Company LLC acted as joint book-running managers for the offering. Oppenheimer & Co. served as manager for the offering.

A registration statement relating to the securities being sold in the offering was declared effective by the Securities and Exchange Commission on October 7, 2015. The offering was made solely by means of a prospectus, copies of which may be obtained from BofA Merrill Lynch, 222 Broadway, New York, NY 10038, Attention: Prospectus Department, or by email at dg.prospectus_requests@baml.com; Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, by telephone at (877) 821-7388 or by email at Prospectus_Department@Jefferies.com; or Cowen and Company, LLC, c/o Broadridge Financial Services, Attention: Prospectus Department, 1155 Long Island Avenue, Edgewood, NY 11717, by telephone at 631-274-2806 or by fax at 631-254-7140.

This press release shall not constitute an offer to sell or a 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.

Media Contacts:
Canale Communications
Ian Stone
ian@canalecomm.com
619-849-5388

Investor Contacts:
Trout Group
Pete Rahmer
prahmer@troutgroup.com
646-378-2973

Wednesday, October 14th, 2015 Uncategorized Comments Off on (CTMX) Announces Closing of IPO