Archive for November, 2015

(CASM) to Present at LD Micro Main Event

BRANFORD, Conn., Nov. 19, 2015  — CAS Medical Systems, Inc. (NASDAQ:CASM) (CASMED), a leader in medical devices for non-invasive patient monitoring, announces that Thomas M. Patton, President and Chief Executive Officer, will present at the LD Micro Main Event on Wednesday, December 2, 2015, at 9:30 a.m. Pacific time. The conference will be held at the Luxe Sunset Boulevard Hotel in Los Angeles.

Mr. Patton will be available for one-on-one meetings with the investment community on Wednesday, December 2. Please contact LD Micro via the conference website if you would like to arrange a meeting.

Interested parties can access the audio webcast with slide presentation at www.casmed.com or directly at http://wsw.com/webcast/ldmicro9/casm. An archived presentation will be available for 90 days.

About CASMED® – Monitoring What’s Vital

CASMED products are designed to provide unique non-invasive monitoring solutions that are vital to patient care. The Company’s FORE-SIGHT® Cerebral Oximeters provide a highly accurate, non-invasive measurement of tissue oxygenation in the brain. Direct monitoring of tissue oxygenation can provide a superior and powerful tool to alert clinicians to otherwise unrecognized and dangerously low levels of oxygen in the brain and empower them to improve patient care. In addition to FORE-SIGHT Oximeters and accessories, the Company also provides proprietary non-invasive blood pressure monitoring solutions for OEM use and neonatal intensive care supplies. For further information regarding CASMED, visit the Company’s website at www.casmed.com.

Company Contact
CAS Medical Systems, Inc.
Jeffery A. Baird
Chief Financial Officer
(203) 315-6303
ir@casmed.com

Investors

LHA
Bruce Voss / Jody Cain
(310) 691-7100
bvoss@lhai.com / jcain@lhai.com
@LHA_IR_PR
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(ICLD) Awarded New Contracts Valued at Over $2.3 Million

Revenue Up $13 Million Year Over Year for the First Three Quarters of 2015

NEW YORK, Nov. 19, 2015  — InterCloud Systems, Inc. (the “Company” or “InterCloud”) (NASDAQ:ICLD), a leading provider of cloud networking orchestration and automation solutions and services, today announced that it was recently awarded over $2.3 million in new contracts.

Mark Munro, CEO of InterCloud Systems stated: “Our Company continues to grow in disproportion to our stock price and market cap.  InterCloud has reached so many positive milestones thus far in 2015 and below are just a few of the most important for shareholders to review”

Revenue is up 23% to $65 Million through Q-3 2015

Gross Profit percentage has risen to 33% and is up to $21 Million through Q-3 2015

New contracts announced since July 1, 2015 totals over $36.5 Million

Adjusted EBITDA of $1.9 Million through 9 months of 2015 versus a loss of $(3.1M) for 2014

Mr. Munro continues: “Our sales pipeline of new opportunities has been steady in the $140 Million range for almost a year now and gives us the foresight that our growth should continue into 2016. InterCloud has double digit revenue growth in 2015, gross profit margin increases to 33%, adjusted EBITDA growth of over $5 Million since 2014, brand name fortune 100 customers, and operating divisions performing at their highest levels. InterCloud has paid down and extinguished approximately $3.4 Million of senior debt in 2015 and today only has $4.2 Million of senior debt against approximately $18 Million in accounts receivable. Our team has done an extraordinary job in lowering operational expenses through operational synergies and technology integration savings. The Company is a far better business today than it was a year ago and we believe we have created an extremely valuable next-gen IT solutions company with highly valuable services and assets. Our management team continues to execute at the highest levels and has launched new products and solutions to deliver additional future value for our shareholders. We thank you for your support and look forward to finishing strong in Q-4 2015 and on into 2016.

About InterCloud Systems, Inc.

InterCloud Systems, Inc. is a leading provider of cloud networking orchestration and automation, for Software Defined Networking (SDN) and Network Function Virtualization (NFV) cloud environments to the telecommunications service provider (carrier) and corporate enterprise markets through cloud solutions and professional services. InterCloud’s cloud solutions offer enterprise and service-provider customers the opportunity to adopt an operational expense model by outsourcing cloud deployment and management to InterCloud rather than the capital expense model that has dominated in recent decades in IT infrastructure management. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.

CONTACT:
Investor Relations
InterCloud Systems, Inc.
561-988-1988
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(UNXL) Receives Initial Mass Production Order from Japanese PC Manufacturer

Providing XTouch sensors for new 10 inch tablet

SANTA CLARA, Calif., Nov. 19, 2015  — UniPixel, Inc. (NASDAQ: UNXL), a provider of Performance Engineered Films™ to the touchscreen and flexible electronics markets, announced today the receipt of an initial mass production order from a leading PC manufacturing company based in Japan for a 10-inch tablet product. UniPixel expects the initial delivery of XTouch sensors to this new customer to occur in the current quarter and the first quarter of 2016. The Company expects the lifetime of the product to be in the range of three to four quarters.

Jeff Hawthorne, president and CEO of UniPixel, commented, “This is an important award for UniPixel at this stage in our development as an emerging supplier in the PC touchscreen market. This order validates our belief that we offer leading-edge technology that can help major PC manufacturers create devices that are thinner, lighter, faster, and more cost effective to produce. We are pleased that our ongoing engagement with this customer and their supply chain partners has resulted in one of the world’s leading PC manufacturers choosing UniPixel technology for their new tablet. We look forward to working with them and their supply chain partners on the development of future products.”

Mr. Hawthorne continued, “This order represents the first step in expanding our customer base among the top PC manufacturers. Our products continue to be evaluated by other major OEMs throughout the world and we expect to win more awards in the years to come. Having just completed our second quarter as a focused sales and manufacturing organization, this award exemplifies the significant progress achieved in introducing our highly differentiated products to major PC manufacturers in the U.S. and Asia.”

About UniPixel
UniPixel, Inc. (NASDAQ: UNXL) develops and markets Performance Engineered Films for the touch screen and flexible electronics markets. The company’s roll-to-roll electronics manufacturing process patterns fine line conductive elements on thin films. The company markets its technologies for touch panel sensor, cover glass replacement, and protective cover film applications under the XTouch™ and Diamond Guard™ brands. For further information, visit www.unipixel.com.

Forward-looking Statements
All statements in this news release that are not based on historical fact are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including the statements regarding expected initial delivery of XTouch sensors and the lifetime for the product, and the ability to win more awards in the future.  While management has based any forward-looking statements contained herein on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties, and other factors, many of which are outside of the Company’s control, which could cause actual results to materially differ from such statements. Such risks, uncertainties, and other factors include, but are not necessarily limited to, those set forth under Item 1A “Risk Factors” in our Annual Report on Form 10-K for the year ended December 31, 2014. UniPixel operates in a highly competitive and rapidly changing environment, thus new or unforeseen risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. The Company disclaims any intention to, and undertakes no obligation to, update or revise any forward-looking statements. Readers are also urged to carefully review and consider the other various disclosures in the company’s Annual Report on Form 10-K, quarterly reports on Form 10-Q and Current Reports on Form 8-K.

Trademarks in this release are the property of their respective owners

Contact:
Joe Diaz, Robert Blum, Joe Dorame
Lytham Partners, LLC
602-889-9700
unxl@lythampartners.com

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(APDNW) Identifies Suspects in Short Attack

Persons of Interest Reported to State and Federal Authorities

STONY BROOK, NY–(November 19, 2015) – Applied DNA Sciences, Inc. (NASDAQ: APDN) (Twitter: @APDN), a provider of DNA-based anti-counterfeiting and anti-theft technology, product genotyping and product authentication solutions, announced that working with former law enforcement officials, it has identified two persons of interest believed to be involved in the short attack on the company that was perpetrated October 29, 2015. The identities of the suspects have been reported to federal authorities and will be reported to states Attorneys General.

APDN believes that the misstatements in the short attack were a deliberate effort to manipulate the stock price coincident with a quadrupling of the short positions.

Furthermore, the forensic IT investigation revealed that one of the suspects has a background in finance and has been previously fined and ordered to cease and desist operation of an unlicensed investment advisory firm. Given the suspects’ backgrounds, the research dedicated to the short attack, and the false and misleading statements and innuendos stated in the short attack, APDN’s management believes the short attack is an example of a coordinated, organized stock manipulation to achieve personal gain by the attackers.

About Applied DNA Sciences

Applied DNA Sciences makes life real and safe by providing biotechnology-driven solutions to help protect products, brands, entire supply chains, and intellectual property of companies, governments and consumers from theft, counterfeiting, fraud and diversion. Patented botanical DNA solutions can be used to identify, tag, track, and trace products, to help assure authenticity, traceability and quality of products. SigNature DNA is at the heart of a family of uncopyable, security and authentication solutions such as SigNature® T and fiberTyping®, targeted toward textiles and apparel, DNAnet®, for anti-theft and loss prevention, and digitalDNA®, providing powerful track and trace. All provide a forensic chain of evidence, and can be used to prosecute perpetrators.

Go to adnas.com for more information, events and to learn more about how Applied DNA Sciences makes life real and safe. Common stock listed on NASDAQ under the symbol APDN, and warrants are listed under the symbol APDNW.

Forward Looking Statements

The statements made by APDN in this press release may be “forward-looking” in nature within the meaning of the Private Securities Litigation Act of 1995. Forward-looking statements describe APDN’s future plans, projections, strategies and expectations, and are based on assumptions and involve a number of risks and uncertainties, many of which are beyond the control of APDN. Actual results could differ materially from those projected due to our short operating history, limited financial resources, limited market acceptance, market competition and various other factors detailed from time to time in APDN’s SEC reports and filings, including our Annual Report on Form 10-K filed on December 15, 2014, as amended on March 6, 2015, and our subsequent quarterly reports on Form 10-Q filed on February 9, 2015, May 11,2015 and August 10, 2015, which are available at www.sec.gov. APDN undertakes no obligation to update publicly any forward-looking statements to reflect new information, events or circumstances after the date hereof to reflect the occurrence of unanticipated events, unless otherwise required by law.

Investor contact:
Debbie Bailey
631-240-8817
debbie.bailey@adnas.com

Media contact:

Susan Forman
Dian Griesel Int’l.
212-825-3210
sforman@dgicomm.com

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(NLST) Strategic Partnership With Samsung For New Storage Class Memory

Partnership to Deliver NVDIMM-P, the Fastest Non-Volatile Memory-Storage Solution for Cloud Computing, Analytics and Other Data Intensive Applications

IRVINE, Calif., Nov. 19, 2015  — Netlist, Inc. (NASDAQ: NLST), today announced that it has entered into a five year Joint Development and License Agreement (the “Agreement”) with Samsung Electronics Co., Ltd., to produce a new class of NVDIMM-P (NV-P) memory solutions based on Samsung’s industry leading NAND Flash and DRAM, and Netlist’s pioneering work on HyperVault®. The companies will work to create a standardized product interface to facilitate rapid market adoption and bring the compelling benefits of this new technology to a large group of customers in cloud computing, big data, and server and storage markets.

Under the terms of the Agreement, which includes licensing of each company’s respective patent portfolios, Netlist will receive $23 million, consisting of $8 million in cash from Samsung Electronics and $15 million in the form of investment from Samsung Venture Investment Corporation. The Agreement calls for additional exchange of consideration as progress is made toward market introduction of the product. The companies plan to sample NV-P products with select customers in 2016.

NV-P is an emerging industry standard for a new class of NAND-based storage which operates in the memory channel, the fastest data path in a computer. With HyperVault®, Netlist created the industry’s first unified memory-storage architecture where low cost, high density NAND storage can achieve the performance of high cost, high speed DRAM memory. This breakthrough patented architecture will be combined with Samsung’s industry leading DRAM and NAND, to produce NV-P solutions that deliver cost and performance benefits vastly superior to those of traditional storage solutions.

“At Samsung, we are taking the lead in defining the right standards for storage class memory with industry partners, and creating new markets for DRAM and NAND flash memory based on the new standards. By using a standardized hybrid storage solution, our customers will be able to efficiently extract intelligence from large amounts of data in storage systems,” said Dr. Jung-Bae Lee, Senior Vice President of Memory Product Planning and Application Engineering Team, Samsung Electronics. “We are pleased to partner with Netlist, a company with a long-history of innovative memory technology solutions and IP, to productize and drive broad market adoption of this new standard,” he added.

“This is a transformational partnership that validates our unique IP and provides an accelerated path for delivering NV-P to the mainstream market. Samsung is the unparalleled leader in memory and recognizes the value of disruptive technology in this sector,” said C.K. Hong, President and CEO of Netlist. “Samsung’s leadership in memory and Netlist’s expertise in hybrid storage are highly complementary, and together create a powerful platform for driving broad market adoption of this new storage class memory solution.”

“Computer architecture is going through important changes fueled by the advent of a new memory layer based on alternative memory types,” said Jim Handy, General Director of Objective Analysis, a leading independent research firm. “This brings to computing a much faster kind of storage that can harness the raw speed of the memory bus through the NVDIMM-P memory module format. Objective Analysis projects that the market for such modules in servers could grow to $2 billion by 2019.”

NVDIMM-P is nomenclature adopted by the Storage Network Industry Association to describe storage class memory products that combine the functionalities of persistent DRAM and block accessed NAND Flash, and operate in the memory channel. HyperVault®, a “superset” of NVDIMM-P, further expands the capabilities of NAND so that they achieve near-DRAM performance and DDR4 compatibility with no system software modifications. NV-P solutions are expected to be initially targeted at the fastest tiers of storage where data throughput and latency are critical. These applications include big data analytics, virtualization, in-memory database, online transaction processing and high performance database.

Additional details regarding the transaction are available in Netlist’s Current Report on Form 8-K filed concurrently with the issuance of this release.

About Netlist, Inc.

Netlist creates solutions that accelerate turning data into information. We design and manufacture controller and software-based memory solutions for our OEM and Hyperscale customers in the server and storage space. Flagship products NVvault® and EXPRESSvault™ accelerate system performance and provide mission critical fault tolerance. HyperVault®, Netlist’s next-generation architecture, expands the performance and capacity of memory channel storage. The company holds a portfolio of patents, many seminal, in the area of hybrid memory, rank multiplication and load-reduction, among others. To learn more, visit www.netlist.com

Safe Harbor Statement:

This news release contains forward-looking statements regarding future events and the future performance of Netlist. These forward-looking statements involve risks and uncertainties that could cause actual results to differ materially from those expected or projected. These risks and uncertainties include, but are not limited to, risks associated with the joint development efforts with Samsung described above; the launch and commercial success of our products, programs and technologies; the success of product partnerships; continuing development, qualification and volume production of HyperVault™, EXPRESSvault™, NVvault®, HyperCloud® and VLP Planar-X RDIMM; the timing and magnitude of the decrease in sales to our key customer; our ability to leverage our NVvault® and EXPRESSvault™ technology in a more diverse customer base; the rapidly-changing nature of technology; risks associated with intellectual property, including risks associated with the inherent uncertainty of the litigation process, patent infringement litigation against us as well as the costs and unpredictability of litigation over infringement of our intellectual property and the possibility of our patents being reexamined by the United States Patent and Trademark office; volatility in the pricing of DRAM ICs and NAND; changes in and uncertainty of customer acceptance of, and demand for, our existing products and products under development, including uncertainty of and/or delays in product orders and product qualifications; delays in the Company’s and its customers’ product releases and development; introductions of new products by competitors; changes in end-user demand for technology solutions; the Company’s ability to attract and retain skilled personnel; the Company’s reliance on suppliers of critical components and vendors in the supply chain; fluctuations in the market price of critical components; evolving industry standards; and the political and regulatory environment in the People’s Republic of China. Other risks and uncertainties are described in the Company’s annual report on Form 10-K filed on March 27, 2015, and subsequent filings with the U.S. Securities and Exchange Commission made by the Company from time to time. Except as required by law, Netlist undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

For more information, please contact:
Investors: Press:
Brainerd Communicators, Inc. Brainerd Communicators, Inc.
Mike Smargiassi/Jenny Perales Sharon Oh
NLST@braincomm.com NLST@braincomm.com
(212) 986-6667 (212) 986-6667
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(RITT) Forms Strategic Alliance With Yoga Automation Private Limited

Global Leader in Smart Building Automation to Provide RiT’s Converged Infrastructure Management and Physical Connectivity Solutions

TEL AVIV, Israel, Nov. 18, 2015  — RiT Technologies (NASDAQ:RITT), a leading provider of converged infrastructure management solutions that enable companies to maximize the utilization and security of their network infrastructure announced today that it has entered into a strategic alliance with Yoga Automation Private Limited (Yoga), a leader in smart building automation, to provide RiT’s solutions locally in India, with a several USD millions sales commitment. This collaboration will enable the parties to offer immediate access and availability to RiT’s products, services and support through Yoga’s offices and logistic centers in Mumbai, Bangalore, New Delhi and Ahmedabad. As a result, RiT will be positioned to achieve wider market exposure of enterprise, carrier, and data center customers. According to Gartner, “India’s spending on IT infrastructure is expected to reach $72.3 Billion in 2016, with IT budgets growing at 11.7 percent, compared with the world average of one percent.”

“The significance of RiT’s strategic agreement with Yoga is that it allows us to act as a local company, enabling us to effectively provide sales and support services closer to our customers,” says Assaf Skolnik, VP Regional Sales at RiT. “Yoga’s market and technology leadership, combined with our advanced converged infrastructure management and physical connectivity solutions, will enable India’s enterprises to improve data center agility, optimize capacity, reduce downtime, enforce best-practice policies and reduce operational costs.”

“This strategic alliance is a result of our shared vision of how smart technology can improve efficiency for IT infrastructure to improve productivity and create competitive advantage for Indian enterprises,” said Kamlesh Avasare, Director Sales with Yoga Automations Private Limited. “RiT’s set of wide range of solutions is enabling IoT to the data center.”

RiT’s converged infrastructure management enable users to centrally plan, map and automate communications and IT infrastructure planning to maximize utilization, reliability and security of the network, while minimizing unplanned downtime. These solutions include full visibility of network configurations, work flow management, asset utilization, environment and power IT consumption, and track the exact location of all IP-based equipment automatically. RiT’s high performance, end-to-end structured cabling solutions include high quality cables, outlets, connectors, patch panels and adapters suited for next-generation networks.

Yoga Automations Private Limited solutions include a cloud-based Internet of Things(IoT) platform for smart homes and smart building automation and as Access floors solution for data centers. Already installed at Indiabulls (www.indiabulls.com) and Edelwiess (www.edelweissfin.com), two of India’s leading financial services companies, Yoga boasts 10% market presence in India in Automation and 25% Access Floors.

About Yoga Automation Private Limited

YOGA Automation specializes in Automation of lighting, air conditioning, multimedia, security systems, and access controls via Mobile and Web applications using neural network technologies.

Yoga provides automation and security solutions to Residential and Commercial and brings world class technology and rich experience in this domain including strong access to Data Centers in the Indian market based on our Access Floors product.

About RiT Technologies

RiT Technologies (NASDAQ:RITT) is a leading provider of converged IT infrastructure management and connectivity solutions. RiT offers a platform that provides a unified way to manage converged systems and services to improve network utilization, streamline infrastructure operations, reduce network operation cost, optimize future investments and enhance data security.

RiT’s connectivity solutions includes IIM – Intelligent Infrastructure Management, high performance end-to-end structured cabling solutions.

RiT Technologies’ subsidiary RiT Wireless Ltd. produces a range of optical wireless solutions under the Beamcaster brand, which provide high speed, highly secure data communications across indoor open spaces.

Deployed around the world in data centers, large corporations, government agencies, financial institutions, telecommunications, airport authorities, healthcare organizations and educational facilities. RiT’s shares are traded on the NASDAQ Capital Market under the symbol RITT.

Safe Harbor Statement

In this press release, all statements that are not purely about historical facts, including, but not limited to, those in which we use the words “believe,” “anticipate,” “expect,” “plan,” “intend,” “estimate”, “forecast”, “target”, “could” and similar expressions, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. While these forward-looking statements represent our current judgment of what may happen in the future, actual results may differ materially from the results expressed or implied by these statements due to numerous important factors, including, but not limited to, those described under the heading “Risk Factors” in our most recent Annual Report filed with the Securities and Exchange Commission (SEC) on Form 20-F, which may be revised or supplemented in subsequent reports filed with the SEC. These factors include, but are not limited to, the following: our ability to raise additional financing, if required; the continued development of market trends in directions that benefit our sales; our ability to maintain and grow our revenues; our dependence upon independent distributors, representatives and strategic partners; our ability to develop new products and enhance our existing products; the availability of third-party components used in our products; the economic condition of our customers; the impact of government regulation; and the economic and political situation in Israel. Except as otherwise required by applicable law, we expressly disclaim any obligation to update the forward-looking statements in this press release, whether as a result of new information, future events or otherwise.

CONTACT: Kobi Haggay
         VP Products and Marketing
         M: +972.54.4338382
         kobi.haggay@rittech.com
         www.rittech.com

         Monica Maron
         Spicetree Communications
         Mobile: +972-54-5429529
         monica.maron@spicetreecom.com
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(OSIS) Receives Order for RTT Hold Baggage Screening Systems

OSI Systems, Inc. (NASDAQ:OSIS) today announced that HTDS, its French distributor for Rapiscan Systems, has received a multi-year framework contract to provide the RTT® 110 (Real Time Tomography) explosives detection system (EDS) to Charles de Gaulle and Orly international airports located near Paris, France. The company stated that it has received an initial order to deliver four units, and that it has not received any indication of additional orders under this framework agreement at this time.

The RTT employs a proprietary, solid-state approach to create high-resolution, 3-D imaging and its stationary gantry design enables baggage to be screened at higher speeds, allowing the RTT to be installed “in-line” within an airport’s existing baggage handling network without slowing that system down.

About OSI Systems, Inc.

OSI Systems, Inc. is a vertically integrated designer and manufacturer of specialized electronic systems and components for critical applications in the homeland security, healthcare, defense and aerospace industries. It combines more than 30 years of electronics engineering and manufacturing experience with offices and production facilities in more than a dozen countries to implement a strategy of expansion into selective end product markets. For more information on OSI Systems, Inc. or any of its subsidiary companies, visit www.osi-systems.com. News Filter: OSIS-G

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Forward-looking statements relate to the Company’s current expectations, beliefs, projections and similar expressions concerning matters that are not historical facts and are not guarantees of future performance. Forward-looking statements involve uncertainties, risks, assumptions and contingencies, many of which are outside the Company’s control that may cause actual results to differ materially from those described in or implied by any forward-looking statements. All forward-looking statements are based on currently available information and speak only as of the date on which they are made. The Company assumes no obligation to update any forward-looking statement made in this press release that becomes untrue because of subsequent events, new information or otherwise, except to the extent it is required to do so in connection with its ongoing requirements under Federal securities laws. For a further discussion of these and other factors that could cause the Company’s future results to differ materially from any forward-looking statements, see the section entitled “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended June 30, 2015 and other risks described in documents filed by the Company from time to time with the Securities and Exchange Commission.

 

OSI Systems, Inc.
Ajay Vashishat
Vice President, Business Development
310-349-2237
avashishat@osi-systems.com

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(VCYT) to Present at Piper Jaffray 27th Annual Healthcare Conference

SOUTH SAN FRANCISCO, Calif., Nov. 18, 2015  — Veracyte, Inc. (NASDAQ: VCYT) today announced that Bonnie H. Anderson, president and chief executive officer, will participate in a fireside chat discussion at the Piper Jaffray 27th Annual Healthcare Conference on Wednesday, December 2, 2015 at 11:00 a.m. ET in New York, NY.

The live audio webcast and subsequent replay may be accessed by visiting Veracyte’s website at http://investor.veracyte.com. The webcast will be available shortly after conclusion of the presentation and archived on the company’s website for 90 days following the presentation.

About Veracyte

Veracyte (NASDAQ: VCYT) is pioneering the field of molecular cytology, offering genomic solutions that resolve diagnostic ambiguity and enable physicians to make more informed treatment decisions at an early stage in patient care. By improving preoperative diagnostic accuracy, the company aims to help patients avoid unnecessary invasive procedures while reducing healthcare costs. Veracyte’s Afirma® Thyroid FNA Analysis centers on the proprietary Afirma Gene Expression Classifier (GEC) and is becoming a new standard of care in thyroid nodule assessment. The Afirma test is recommended in leading practice guidelines and is covered for nearly 155 million lives in the United States, including through Medicare and many commercial insurance plans. Veracyte is expanding its molecular cytology franchise to other clinical areas, beginning with difficult-to-diagnose lung diseases. In April 2015, the company launched the Percepta™ Bronchial Genomic Classifier, a test to evaluate patients with lung nodules that are suspicious for cancer. Veracyte is developing a second product in pulmonology, targeting interstitial lung diseases, including idiopathic pulmonary fibrosis. For more information, please visit www.veracyte.com.

Veracyte, Afirma, Percepta, the Veracyte logo, and the Afirma logo are trademarks or registered trademarks of Veracyte, Inc.

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(AVXL) Preparation of Regulatory Filings Based on Guidance From the FDA

NEW YORK, Nov. 18, 2015  — Anavex Life Sciences Corp. (“Anavex” or the “Company”) (Nasdaq:AVXL), a clinical-stage biopharmaceutical company developing drug candidates to treat Alzheimer’s disease, other central nervous system (CNS) diseases, pain and various types of cancer, announces that it is moving forward with the development program for ANAVEX 2-73.  Guidance received from the FDA confirms the Company’s strategy to advance ANAVEX 2-73 for the treatment of Alzheimer’s disease in a larger double-blinded, randomized, placebo-controlled Phase 2/3 trial.

“Working with a highly vulnerable patient population, the Company is proceeding in a rational, step-wise process.  Armed with the necessary data from the Phase 2a study to optimally design future trials, we look forward to expanding our development program,” said Kristina M. Capiak, Vice President Regulatory Affairs of Anavex.

“The utilization of Adaptive Design and Population Pharmacokinetics/Pharmacodynamics (PK/PD) modeling is a major strength of the Phase 2a study.  By implementing a different, innovative trial design for ANAVEX 2-73 in Alzheimer’s treatment, it is believed that this is more efficient than a conventional Phase 2 study since it is designed to reduce the risk of a Phase 3 trial failure, as well as receiving the best quality information we can about ANAVEX 2-73,” said Christopher U. Missling, PhD, President and Chief Executive Officer of Anavex.  “The advantage of having Population PK/PD data is of value for the development of ANAVEX 2-73 in Alzheimer’s disease and also for other potential CNS indications.”

About Alzheimer’s Disease
Today, Alzheimer’s disease remains the largest unmet medical need in neurology. More than 25 million people are currently diagnosed with Alzheimer’s, with the associated cost of care estimated to exceed $200 billion annually. By 2050, 100 million people are expected to be living with the disease. Alzheimer’s disease is a neurological disorder generally characterized by memory loss and cognitive decline. A neurodegenerative form of dementia, the disease begins with mild symptoms and becomes progressively worse.

About Anavex Life Sciences Corp.
Anavex Life Sciences Corp. (Nasdaq:AVXL) is a publicly traded biopharmaceutical company dedicated to the development of novel drug candidates to treat central nervous system (CNS) diseases and various types of cancer. Anavex’s lead drug candidates, ANAVEX 2-73 and ANAVEX PLUS, the combination of ANAVEX 2-73 and donepezil (Aricept®), are currently in a Phase 2a clinical trial for Alzheimer’s disease. The drug combination ANAVEX PLUS produced up to 80% greater reversal of memory loss in Alzheimer’s disease models versus when the drugs were used individually. ANAVEX 2-73 is an orally available drug candidate that targets sigma-1 and muscarinic receptors and successfully completed Phase 1 with a clean data profile. Preclinical studies demonstrated its potential to halt and/or reverse the course of Alzheimer’s disease. It has also exhibited anticonvulsant, anti-amnesic, neuroprotective and anti-depressant properties in convulsive epileptic animal models, indicating its potential to treat additional CNS disorders, including epilepsy and others. Michael J. Fox Foundation (MJFF) for Parkinson’s Research has awarded Anavex a research grant to develop ANAVEX 2-73 for the treatment of Parkinson’s disease to fully fund a preclinical study, which could justify moving ANAVEX 2-73 into a Parkinson’s disease clinical trial. Further information is available at www.anavex.com.

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

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

Shareholder & Media Relations
Toll-free: 1-866-505-2895
Outside North America: +1 (416) 489-0092
Email: ir@anavex.com
www.anavex.com
Wednesday, November 18th, 2015 Uncategorized Comments Off on (AVXL) Preparation of Regulatory Filings Based on Guidance From the FDA

(VNRX) Granted Its Second U.S. Patent

NAMUR, Belgium, Nov. 17, 2015 — VolitionRx Limited (NYSE MKT: VNRX), a life sciences company focused on developing blood tests for a broad range of cancer types and other conditions, today announced the grant of U.S. Patent Number 9187780 entitled “Method for Detecting Nucleosome Adducts.”

The new U.S. patent, issued today and expiring in December 2032, relates to VolitionRx’s Nucleosomics® platform for the detection of changes in fragments of chromosomes, called nucleosomes. Scientists at VolitionRx have discovered that cancer-related proteins that form bonds with chromosomes in living cancer cells can also be detected and measured bound to nucleosomes circulating in the blood of cancer patients. The newly issued patent covers the methods for measuring these nucleosome-protein complexes, known as “adducts.”

Dr. Jake Micallef, Chief Scientific Officer of VolitionRx, remarked, “This is a core technology patent for VolitionRx that we believe has an enormous potential application for non-invasive blood testing in cancer — including the measurement of Estrogen Receptor Adducts and Androgen Receptor Adducts, which should be pivotal for the detection breast and prostate cancer disease respectively. The award of this second U.S. patent for the detection of proteins bound to nucleosomes, follows the recent award of our first U.S. patent covering measurement of cancerous changes to the nucleosomes themselves. The new patent is a further milestone in VolitionRx’s progress to build up a world-wide portfolio of intellectual property to protect its Nucleosomics® technology. We continue towards our goal of bringing accurate and affordable detection of early-stage cancer in simple blood tests to market and helping as many patients as possible.”

Cameron Reynolds, Chief Executive Officer of VolitionRx, added, “With the grant of a second patent in the U.S., VolitionRx is making progress toward commercializing our proprietary Nucleosomics® platform. The company is developing a world-wide portfolio of broad-reaching, wholly-owned and royalty-free patents to help protect the company’s intellectual property estate and shareholder value. The VolitionRx-owned patent portfolio currently extends to eight patent families of issued and pending patents in market territories worldwide. Our scientific team is continuing to expand our patent portfolio and we expect further U.S. and other patent grants moving forward. I would also like to congratulate our Chief Scientific Officer, Dr. Micallef, who authored this patent, for his tireless work and vision during the past 6 years — work that is now coming to fruition.”

About VolitionRx

VolitionRx is a life sciences company focused on developing blood-based diagnostic tests for different types of cancer. The tests are based on the science of Nucleosomics which is the practice of identifying and measuring nucleosomes in the bloodstream — an indication that cancer is present.

VolitionRx’s goal is to make the tests as common and simple to use, for both patients and doctors, as existing diabetic and cholesterol blood tests. VolitionRx’s research and development activities are currently centred in Belgium as the company focuses on bringing its diagnostic products to market first in Europe, then in the U.S. and ultimately, worldwide.

Visit VolitionRx’s website (www.volitionrx.com) or connect with us on Twitter, LinkedIn, Facebook or YouTube.

Media Contacts

Anita Heward, VolitionRx
a.heward@volitionrx.com
Telephone: +44 (0) 7756 034243

Kirsten Thomas, The Ruth Group
kthomas@theruthgroup.com
Telephone: +1 (646) 536-7014

Investor Contacts

Scott Powell, VolitionRx
S.Powell@volitionrx.com
Telephone: +1 (646) 650-1351

Lee Roth, The Ruth Group
lroth@theruthgroup.com
Telephone: +1 (646) 536-7012

Safe Harbor Statement

Statements in this press release may be “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, that concern matters that involve risks and uncertainties that could cause actual results to differ materially from those anticipated or projected in the forward-looking statements. Words such as “expects,” “anticipates,” “intends,” “plans,” “aims,” “targets,” “believes,” “seeks,” “estimates,” “optimizing,” “potential,” “goal,” “suggests,” “could,” “would,” “should,” “will” and similar expressions identify forward-looking statements.  These forward-looking statements relate to the effectiveness of the Company’s bodily-fluid-based diagnostic tests as well as the Company’s ability to develop and successfully commercialize such test platforms for early detection of cancer. The Company’s actual results may differ materially from those indicated in these forward-looking statements due to numerous risks and uncertainties. For instance, if we fail to develop and commercialize diagnostic products, we may be unable to execute our plan of operations. Other risks and uncertainties include the Company’s failure to obtain necessary regulatory clearances or approvals to distribute and market future products in the clinical IVD market; a failure by the marketplace to accept the products in the Company’s development pipeline or any other diagnostic products the Company might develop; the Company will face fierce competition and the Company’s intended products may become obsolete due to the highly competitive nature of the diagnostics market and its rapid technological change; and other risks identified in the Company’s most recent Annual Report on Form 10-K and Quarterly Reports on Form 10-Q, as well as other documents that the Company files with the Securities and Exchange Commission. These statements are based on current expectations, estimates and projections about the Company’s business based, in part, on assumptions made by management. These statements are not guarantees of future performance and involve risks, uncertainties and assumptions that are difficult to predict. Forward-looking statements are made as of the date of this release, and, except as required by law, the Company does not undertake an obligation to update its forward-looking statements to reflect future events or circumstances.

Tuesday, November 17th, 2015 Uncategorized Comments Off on (VNRX) Granted Its Second U.S. Patent

(HDNG) Collaborates on Integrating 3D Printing Technology With Traditional Machining

Developing Hybrid Additive/Subtractive Manufacturing Technology in Partnership With RIT, Hybrid Manufacturing Technologies and IPG Photonics

ELMIRA, N.Y., Nov. 17, 2015  — Hardinge Inc. (NASDAQ:HDNG), a leading international provider of advanced metal-cutting solutions and accessories, announced today that Rochester Institute of Technology (RIT) recently acquired a Bridgeport GX 250 5-axis vertical machining center for use in a collaborative partnership to integrate additive manufacturing functions into the GX 250 traditional machining platform. In addition to RIT and Hardinge, partners on the project include Hybrid Manufacturing Technologies, based in Dallas, Texas, and IPG Photonics, of Oxford, Mass.

Mr. James Langa, Hardinge’s Senior Vice President of Machine Solutions, commented, “Manufacturers are constantly in search of new processes that are flexible, improve part quality and reduce overall cost. We believe that the combination of additive and subtractive technology coupled with precise five-axis machine tool capability has strong potential for real-world industrial applications. Adopting, adapting and advancing cutting edge technologies for the benefit of our customers is vital to our growth strategy.” Hardinge will be providing field service, design and applications engineering for the program.

Ronald Aman, project lead and assistant professor of Industrial and Systems Engineering in RIT’s Kate Gleason College of Engineering, noted, “Today there is no commercial software that can reliably generate the tool paths that are necessary to control both additive and subtractive processes in five-axis equipment. This presents a real challenge for mainstream adoption.  We will be addressing this challenge by focusing on improving process planning and tool path generation, developing new materials, advancing overall process development and identifying new applications, as well as fundamental research aimed at radically changing the way we think of materials in a part.”

The GX 250 is a multi-axis machining center that produces precision parts through traditional manufacturing processes. A high precision process, the machine mechanically cuts away material from a block using exacting motion control of rotating tools.  RIT researchers will incorporate additive manufacturing, or 3D printing, capabilities to the original machine to take advantage of the geometric freedom afforded by additive manufacturing while meeting aerospace tolerance requirements.

Integration of multiple processes, such as laser additive manufacturing and milling or turning, into a single platform is a new and rapidly growing field referred to as hybrid manufacturing. The hybrid manufacturing process has many advantages such as lower costs and improved accuracy, but also has unique capabilities such as dynamically changing a part’s material composition as it is being built.

As part of the integration process, the researchers will be incorporating multiple powder feeders to blow metal or ceramic powder into the melt-pool, a type of 3D-printing function known as directed energy deposition. Multiple powder feeders will allow the use of more than one material for a product, including a combination of metals and ceramics or two or more metals.

“Imagine the power of smoothly transitioning materials, such as from copper to tool steel, or even ceramics in the future.  This eliminates the abrupt material composition change that is nearly always the failure point for materials that have vastly different mechanical or thermal characteristics,” said Professor Aman, who has expertise in the development of direct-metal additive manufacturing processes. He also has background in researching and developing the hybrid additive and subtractive metal manufacturing processes of single and multi-materials systems. “There are not, to my knowledge, any other processes that will have the capabilities of this system,” he added.

Professor Aman and Mr. Langa jointly concluded, “The partnership between RIT and Hardinge is a critical step to advance the hybrid ideas out of the laboratory and make it possible for companies to apply this new technology in production processes.”

The Bridgeport GX 250, which was installed in the Brinkman Machine Tools and Manufacturing Lab located in RIT’s Kate Gleason College of Engineering, will be part of the lab’s extensive series of high-precision machining tools and equipment.  It will also be used to support research in the AMPrint Center for Advanced Technology, a new university-corporate partnership focusing on expanding additive manufacturing and multi-functional printing capabilities, considered key economic drivers in New York State.

About Hardinge

Hardinge is a leading global designer and manufacturer of high precision, computer-controlled machine tool solutions developed for critical, hard-to-machine metal parts and of technologically advanced workholding accessories. The Company’s strategy is to leverage its global brand strength to further penetrate global market opportunities where customers will benefit from the technologically advanced, high quality, reliable products Hardinge produces. With approximately two thirds of its sales outside of North America, Hardinge serves the worldwide metal working market. Hardinge’s machine tool and accessory solutions can also be found in a broad base of industries to include aerospace, agricultural, automotive, construction, consumer products, defense, energy, medical, technology and transportation.

Hardinge applies its engineering design and manufacturing expertise in high performance machining centers, high-end cylindrical and jig grinding machines, SUPER-PRECISION® and precision CNC lathes and technologically advanced workholding accessories. Hardinge has manufacturing operations in China, France, Germany, India, Switzerland, Taiwan, the United Kingdom and the United States.

The Company regularly posts information on its website: http://www.hardinge.com.

Safe Harbor Statement

This news 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). Such statements are based on management’s current expectations that involve risks and uncertainties. Any statements that are not statements of historical fact or that are about future events may be deemed to be forward-looking statements. For example, words such as “may,” “will,” “should,” “estimates,” “predicts,” “potential,” “continue,” “strategy,” “believes,” “anticipates,” “plans,” “expects,” “intends,” and similar expressions are intended to identify forward-looking statements. The Company’s actual results or outcomes and the timing of certain events may differ significantly from those discussed in any forward-looking statements. The Company undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

CONTACT: For more information, contact:

         Company:
         Douglas J. Malone
         Chief Financial Officer
         Phone: (607) 378-4140

         Product:
         James Langa
         Sr. VP, Metal-cutting Machine Solutions &
         President, Milling & Turning
         Phone:  (607) 378-4247

         Investor Relations:
         Deborah K. Pawlowski, Kei Advisors LLC
         Phone: (716) 843-3908
         Email: dpawlowski@keiadvisors.com

         Rochester Institute of Technology:
         Michelle Cometa
         Senior Staff Writer
         University News Services
         Phone:  (585) 475-4954
         Email:  macuns@rit.edu
Tuesday, November 17th, 2015 Uncategorized Comments Off on (HDNG) Collaborates on Integrating 3D Printing Technology With Traditional Machining

(WLFC) Modified Dutch Tender Offer to Repurchase $8M in Common Shares

NOVATO, Calif., Nov. 17, 2015  — Willis Lease Finance Corporation (the “Company”) (NASDAQ:WLFC), today announced that it has commenced a modified “Dutch auction” tender offer repurchase for cash up to 516,129 of shares of its common stock at a price not less than $15.50 per share nor greater than $18.00 per share, for an aggregate purchase price not to exceed $8 million (the “Tender Offer”). The Tender Offer is subject to the conditions set forth in the offer to purchase, dated November 17, 2015 (the “Offer to Purchase”), and in the related Letter of Transmittal (which together, may be amended or supplemented from time to time). The Tender Offer, as approved by the Company’s Board of Directors, will expire at 5:00 p.m., New York City time, on December 16, 2015.

Pursuant to the conditions set forth in the Offer to Purchase and in the related Letter of Transmittal, the Company’s stockholders may tender all or a portion of their shares (1) at a price specified by the tendering stockholder of not less than $15.50 per share nor greater than $18.00 per share or (2) without specifying a purchase price, in which case their shares will be purchased at the purchase price determined in accordance with terms of the Tender Offer. When the Tender Offer expires, the Company will determine the lowest price within the range of prices specified above (the “Purchase Price”) that will enable the Company to purchase up to 516,129 shares of its common stock, for an aggregate purchase price not to exceed $8 million. Up to 516,129 shares validly tendered at prices at or below the Purchase Price, and not validly withdrawn, will be eligible for purchase in the Tender Offer. Shares validly tendered will not be purchased if the price specified by the stockholder is greater than the Purchase Price. Stockholders that validly tender their shares will receive the net cash amount of the Purchase Price, subject to applicable withholding tax and without interest, for shares tendered at prices equal to or less than the purchase price, subject to the conditions of the Tender Offer, including the provisions relating to proration, “odd lot” priority and conditional tenders. The Company also reserves the right to purchase up to an additional 2% of its outstanding common shares without extending the Tender Offer.

The Tender Offer will not be conditioned upon any minimum number of shares being tendered; however, the Tender Offer will be subject to a number of other terms and conditions specified in the Offer to Purchase filed with the Securities and Exchange Commission (“SEC”). Stockholders must validly tender their shares prior to the expiration of the Tender Offer, but may withdraw such tender at any time prior to the expiration. In connection with the Tender Offer, Merrill Lynch, Pierce, Fenner & Smith Incorporated is acting as dealer manager, D.F. King & Co., Inc. is serving as information agent and American Stock Transfer & Trust Company, LLC is acting as the depositary.

The Company’s Board of Directors has authorized the Tender Offer. However, none of the Company, the Company’s Board of Directors, the dealer manager, the information agent or the depositary makes any recommendation to stockholders as to whether to tender or refrain from tendering their shares or as to the price or prices at which stockholders may choose to tender their shares. No person is authorized to make any such recommendation. Stockholders must make their own decision as to whether to tender their shares and, if so, how many shares to tender and the price or prices at which their shares should be tendered. In doing so, stockholders should read carefully the information in, or incorporated by reference in, the Offer to Purchase and in the Letter of Transmittal (as they may be amended or supplemented), including the purposes and effects of the Tender Offer. Stockholders are urged to discuss their decisions with their own tax advisors, financial advisors and/or brokers.

News Release for Informational Purposes Only

This news release is for informational purposes only and is not an offer to buy or the solicitation of an offer to sell any shares of the Company’s common stock. The Tender Offer is being made solely by the Offer to Purchase and the related Letter of Transmittal, which together, may be amended or supplemented from time to time. Stockholders and investors are urged to read the Company’s Tender Offer statement on Schedule TO filed today with the SEC in connection with the Tender Offer, which will include as exhibits the Offer to Purchase, the related Letter of Transmittal and other Tender Offer materials, as well as any amendments or supplements to the Schedule TO when they become available, because they each contain important information. Each of these documents will be filed with the SEC, and investors may obtain them for free from the SEC at its website (www.sec.gov) or from D.F. King & Co., Inc., the information agent for the Tender Offer, by telephone at: (866) 796-7181 (toll-free), or in writing to: infoagent@dfking.com.

About Willis Lease Finance Corporation

Willis Lease Finance Corporation leases large and regional spare commercial aircraft engines, auxiliary power units and aircraft to airlines, aircraft engine manufacturers and maintenance, repair and overhaul providers in 120 countries. These leasing activities are integrated with engine and aircraft trading, engine lease pools supported by cutting edge technology, as well as various end-of-life solutions for aircraft, engines and aviation materials provided through its subsidiary, Willis Aeronautical Services, Inc.

Forward Looking Statements

This press release contains forward-looking statements that are based on current expectations, estimates, forecasts and projections of future performance based on management’s judgment, beliefs, current trends, and anticipated product performance. These statements include, but are not limited to, the terms and expiration date of the modified “Dutch auction” Tender Offer. Do not unduly rely on forward-looking statements, which give only expectations about the future and are not guarantees. Forward-looking statements speak only as of the date they are made, and we undertake no obligation to update them. Our actual results may differ materially from the results discussed in forward-looking statements. Factors that might cause such a difference include, but are not limited to: the effects on the airline industry and the global economy of events such as terrorist activity, changes in oil prices and other disruptions to the world markets; trends in the airline industry and our ability to capitalize on those trends, including growth rates of markets and other economic factors; risks associated with owning and leasing jet engines and aircraft; our ability to successfully negotiate equipment purchases, sales and leases, to collect outstanding amounts due and to control costs and expenses; changes in interest rates and availability of capital, both to us and our customers; our ability to continue to meet the changing customer demands; regulatory changes affecting airline operations, aircraft maintenance, accounting standards and taxes; the market value of engines and other assets in our portfolio; and risks detailed in the Company’s Annual Report on Form 10-K and other continuing reports filed with the SEC.

CONTACT: Charles F. Willis
         Chairman & CEO
         (415) 408-4700
Tuesday, November 17th, 2015 Uncategorized Comments Off on (WLFC) Modified Dutch Tender Offer to Repurchase $8M in Common Shares

(OPCO) Named ‘Company of the Month’ in November Issue of The Bowser Report

FAIRPORT HARBOR, OH–(November 17, 2015) – OurPet’s Company (OTCQX: OPCO) was featured in the November issue of The Bowser Report as the Company of the Month. Regular readers of the report are likely already familiar with OPCO, as the company has been recommended multiple times in the publication dating all the way back to May 2007. Recently, the company has caught the attention of researchers by reporting consistent and sustainable growth, and that performance has Bowser recommending OPCO as an addition to portfolios for the third time in less than a decade.

“OurPet’s, now a three-time recommendation, is the model for steady sales growth,” the report stated. “At current values, OPCO is fairly valued from a price-to-earnings perspective, but with the company’s steady growth potential, it could be a long-term winner.”

Taking a look at the markets in which OPCO operates, this growth potential is further illustrated. In 2013, the pet products and services market was valued at $71.3 billion, and additional industry growth is expected in the coming years. OPCO is capitalizing on these market conditions with a two-pronged branding strategy — including OurPets® for the pet specialty channel and PetZone® for the food, drug and mass retail channels. Through these brands, the company has secured roughly 250 distribution customers, including nationwide retailers such as Walmart, PetSmart, Petco and Kroger.

In the past four years, OPCO has leveraged its defined branding strategy and extensive intellectual property portfolio to record a 20.8 percent increase in sales. Likewise, the company’s earnings have grown from $120,674 to $1.1 million since 2011. In recent months, OPCO has attempted to build on this performance by increasing the overall visibility of its stock. The company recently joined the OTCQX, the highest tier of the OTC Markets platform, in an effort to continue pushing toward new 52-week highs.

The Bowser Report has been covering the most intriguing mini-priced stocks for just under 40 years. Utilizing a proprietary rating system and investing game plan, the report highlights the most promising stocks for long-term investment. Since 1976, The Bowser Report‘s effectiveness has attracted tens of thousands of investors to the subscription-only newsletter.

For more information, visit www.ourpets.com

Contact:
Peter Ostapowicz
postapowicz@ourpets.com

Tuesday, November 17th, 2015 Uncategorized Comments Off on (OPCO) Named ‘Company of the Month’ in November Issue of The Bowser Report

(ETAK) Slots Robert H. Turner at Exec. Chairman, ETNA President Tim Payne at Interim CEO

– Robert H. Turner, Former Executive at AT&T and BellSouth Communications, Inc., Brings 40-Years of Global Telecom and Communications Technology Leadership to Company to Drive Growth and Expansion –

NEW YORK CITY, Nov. 17, 2015  — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced that the Company has appointed Robert H. Turner (“Hal Turner”) as Executive Chairman and Tim Payne, the current President of Elephant Talk North America (“ETNA”), as interim CEO. Together, both appointees will be responsible for managing and growing Elephant Talk’s global operations. Mr. Steven van der Velden has stepped down as Chairman, CEO and a director of the Company.

Mr. Turner brings over 40 years of international C-level global telecom and communications technology experience to Elephant Talk gained through a career leading and servicing major Tier 1, 2, and 3, incumbent and competitive (MVNO/CLEC/ISP/Cable) wireless and wired operators. Mr. Turner’s expertise includes decades of P&L leadership, M&A, joint ventures, strategic alliances and global partnerships gained through a career including Senior Sales and Marketing roles at AT&T, President and Chief Operating Officer of BellSouth Communications, Inc. (now AT&T) and serving as Chairman, CEO and President of several international voice and data services/networking companies including PTT Telecom Netherlands US, Inc. (now KPN), TeleZone, Inc. (Toronto, Canada) and Davnet Limited (Sydney, Australia).

“On behalf of the Board and the entire management team at Elephant Talk, we are excited to welcome Hal Turner to the Company. We believe he has the ideal mix of business strategy, global management and technology expertise that is needed to advance our industry-leading solutions and add to our growing global customer base that includes Tier 1 customers in the US, Brazil, Europe and the Middle East,” said Mr. Carl Stevens, Member of the Board. “Supported by a dedicated and focused team along with technology that is delivering the highest performance and most reliable services in the industry, Hal will play a vital role in further scaling-up the organization while managing its growth and cost structure ensuring we deliver value for our shareholders.”

“This is an exciting time to be joining a company like Elephant Talk which has created and delivered remarkable technology solutions to MNOs and MVNOs. Elephant Talk’s products are at the leading edge of performance and reliability, leveraging technologies such as SDN, NFV and the cloud to overcome the critical cost and competitive issues now facing mobile operators around the globe,” said Robert H. Turner, newly appointed Executive Chairman of the Board of Elephant Talk Communications Corp. “Thanks to the work done by the Board and the senior team at Elephant Talk, the Company is now well positioned to deliver on the promise of its proprietary technology and it is my goal to ensure that the business capitalizes on this opportunity to supply its best-in-class products and customer support, and do so efficiently and profitably.”

“We would also like to thank Steven van der Velden for his many years of hard work and dedication to Elephant Talk. We look forward to Steven remaining a very large shareholder of the Company and wish him much success in all his future endeavors,” continued Mr. Carl Stevens, on behalf of the Board of Directors.

Recently, Mr. Turner served as Chairman of Pandora Networks, Inc. (now named Panterra Networks), CEO at Pac West Telecomm, Inc. and for the past 28 years, founder at Turner Telecom Holdings Group, LLC, an executive management and board services consultancy and advisory firm focused on serving leading-edge telecom, software and technology companies from start-ups to turnaround, worldwide. Mr. Turner is a featured contributor to key publications in the wireless, networking and technology industries and is also a guest lecturer at The Darla Moore School of Business at The University of South Carolina.

Mr. Payne has been President of Elephant Talk North America since April 2014. Tim has over 20 years of domestic US telecom experience driving sales and distribution programs at top telecommunication companies including serving as Senior National Sales Leader at Verizon Telematics, National Sales Manager at Networkfleet, General Manager at Clearwire and District Manager at Sprint Nextel.

About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.

About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.

Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Elephant Talk’s plans and objectives, projections, expectations and intentions (including, without limitation, Elephant Talk’s plans regard its ValidSoft subsidiary). These forward-looking statements are based on current expectations, estimates and projections about Elephant Talk’s industry, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Elephant Talk may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Elephant Talk also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Elephant Talk’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Elephant Talk.

Contacts:

Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com

Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net

Tuesday, November 17th, 2015 Uncategorized Comments Off on (ETAK) Slots Robert H. Turner at Exec. Chairman, ETNA President Tim Payne at Interim CEO

(JAGX) Positive Results from Proof-of-Concept Study of Neonorm

Product Launching at the American Association of Equine Practitioners Annual Convention December 5-9th

Jaguar Animal Health, Inc. (NASDAQ:JAGX) (“Jaguar” or the “Company”), an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals, announced positive results today for its Neonorm Foal proof-of-concept study. Neonorm Foal is a non-drug product comprised of an orally-administered paste formulation of a standardized botanical extract derived from the Croton lechleri tree, in combination with a third-party probiotic.

The objective of the randomized, multi-site, blind-controlled study was to evaluate the safety, tolerability, and efficacy of Neonorm Foal for treatment of foals suffering from secretory or watery diarrhea. Sixty foals participated in the study, which consisted of a 72-hour treatment period followed by an observation period. Each participating foal was placed into one of three groups: a group that received treatment twice a day (the BID group), a group that received treatment four times a day (the QID group), and a placebo-treated group. Physicals, ultrasounds and the collection of blood samples took place at intervals throughout the study, which took place in Argentina during foaling season.

During the treatment period, 68% of foals in the BID group were identified as clinical responders versus 35% of placebo-treated foals, with a p-value of 0.03. For the purposes of the study, clinical responders were defined as foals that achieved a formed stool by the end of the reported period. Within the period that included treatment and 24-hours of observation, 79% of foals in the BID group were identified as clinical responders versus 47% of placebo-treated foals, with a p-value of 0.03. At the 120-hour point for a subset of the QID group which was comprised of the sickest foals enrolled in the study—animals that would be expected to take longer to recover—statistically significant results indicated that sicker foals may benefit from more frequent treatment. Within the period that included treatment and 48-hours of observation, 94% of foals in this QID group subset were identified as clinical responders versus 46% of placebo-treated foals, with a p-value of 0.02.

Resolution of diarrhea was attained in 74% of foals in the BID group within the treatment period versus 41% of placebo-treated foals, with a p-value of 0.09. For the purposes of the study, resolution of diarrhea was defined as a foal that produced a formed stool at any point during the reported period. Within the period that included treatment and 24-hours of observation, resolution of diarrhea was attained in 84% of foals in the BID group versus 53% of placebo-treated foals, with a p-value of 0.07. Within the period including treatment and 48-hours of observation, resolution of diarrhea was attained in 94% of foals in the QID group versus 62% of placebo-treated foals, with a p-value of 0.06.

“We are excited to share these top-line results from our foal study, which we believe establish the supportive benefits of our non-prescription Neonorm product in yet another species. Neonorm and crofelemer, which are both derived from the sustainably harvested Croton lechleri tree, act at the same last step in a physiological pathway generally present in mammals. Clinical research investigating this unique Mechanism of Action have provided efficacy results with significance in people, calves, dogs, and now horses,” stated Conte. “The results of our foal study support our belief that the first-in-class anti-secretory properties of Neonorm will redefine the standard of care for the management of gut health, stool formation and the normalization of hydration in foals.”

Diarrhea is one of the most common clinical complaints in foals, especially within the first 30 days of life, and to the Company’s knowledge there are currently no commercially available products with anti-secretory properties for foals. The crippling effects of dehydration that often occur as a result of secretory diarrhea in foals can manifest quickly, precipitate adverse health effects and result in death.

Jaguar will be launching Neonorm Foal and exhibiting the study results at the American Association of Equine Practitioners Annual Convention in Las Vegas from December 5-9th. Members of Jaguar’s management team will be available for meetings at the event.

Neonorm Calf, the Company’s lead non-drug product, contains the same standardized botanical extract as Neonorm Foal and has been clinically demonstrated to address the normalization of stool formation and ion and water flow in the intestinal lumen of pre-weaned dairy calves. Jaguar currently owns enough of this extract to formulate a combination of approximately one million treatments of Neonorm Calf or Neonorm Foal.

About Jaguar Animal Health, Inc.

Jaguar Animal Health, Inc. is an animal health company focused on developing and commercializing first-in-class gastrointestinal products for companion and production animals. Canalevia is Jaguar’s lead prescription drug product candidate for the treatment of various forms of diarrhea in dogs. Neonorm Calf is the Company’s lead non-drug product. Canalevia is a canine-specific formulation of crofelemer, an active pharmaceutical ingredient isolated and purified from the Croton lechleri tree, which is sustainably harvested. Neonorm is a standardized botanical extract derived from the Croton lechleri tree. Canalevia and Neonorm are distinct products that act at the same last step in a physiological pathway generally present in mammals. Jaguar has nine active investigational new animal drug applications, or INADs, filed with the FDA and intends to develop species-specific formulations of Neonorm in six additional target species, and formulations of Canalevia for cats, horses and dogs.

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

Forward-Looking Statements

Certain statements in this press release constitute “forward-looking statements.” These include statements regarding the expected commercial launch of Neonorm Foal this December, the Company’s belief that the unique anti-secretory properties of Neonorm Foal will redefine the standard of care for the management of gut health, stool formation and the normalization of hydration in foals, the Company’s belief that sicker foals may benefit from more frequent treatment with Neonorm Foal, Jaguar’s intention to develop species-specific formulations of Neonorm in additional target species, and the Company’s plan to develop formulations of Canalevia for cats, horses and dogs. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” “expect,” “plan,” “aim,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplate,” “believe,” “estimate,” “predict,” “potential” or “continue” or the negative of these terms or other similar expressions. The forward-looking statements in this release are only predictions. Jaguar has based these forward-looking statements largely on its current expectations and projections about future events. These forward-looking statements speak only as of the date of this release and are subject to a number of risks, uncertainties and assumptions, some of which cannot be predicted or quantified and some of which are beyond Jaguar’s control. Except as required by applicable law, Jaguar does not plan to publicly update or revise any forward-looking statements contained herein, whether as a result of any new information, future events, changed circumstances or otherwise.

Jaguar-JAGX

 

KCSA Strategic Communications
Garth Russell, 212-896-1250
grussell@kcsa.com
or
Allison Soss, 212-896-1267
asoss@kcsa.com

Monday, November 16th, 2015 Uncategorized Comments Off on (JAGX) Positive Results from Proof-of-Concept Study of Neonorm

(FNJN) Signs Licensing Agreement With Avast Software

EAST PALO ALTO, CA–(Nov 16, 2015) –  Finjan Holdings, Inc. (NASDAQ: FNJN), a cybersecurity company, today announced that on November 15, 2015, Finjan, Inc. (“Finjan”), a wholly-owned subsidiary of Finjan Holdings, Inc., entered into a Confidential Patent License, Settlement and Release Agreement (the “Agreement”), with Avast Software s.r.o., a company organized and existing under the laws of the Czech Republic (“AVAST”). The terms of the Agreement are confidential.

With its 20 year history in cybersecurity, Finjan’s investments in innovation are captured in its rich portfolio of patents that are centered around proactively detecting previously unknown and emerging threats on a behavior-based basis. Finjan welcomes Avast to its growing list of stellar cybersecurity software and technology licensees.

ABOUT FINJAN
Established nearly 20 years ago, Finjan is a globally recognized leader in cybersecurity. Finjan’s inventions are embedded within a strong portfolio of patents focusing on software and hardware technologies capable of proactively detecting previously unknown and emerging threats on a real-time, behavior-based basis. Finjan continues to grow through investments in innovation, strategic acquisitions, and partnerships promoting economic advancement and job creation. For more information, please visit www.finjan.com.

Follow Finjan Holdings, Inc.:
Twitter: @FinjanHoldings
LinkedIn: linkedin.com/company/finjan

Media Contact:
Nicholas Gaffney
Zumado Public Relations
(415) 732-7801
ngaffney@zumado.com

Investor Contact:
Vanessa Winter
Finjan
Alan Sheinwald or Valter Pinto
Capital Markets Group LLC
(650) 282-3245
investors@finjan.com

Monday, November 16th, 2015 Uncategorized Comments Off on (FNJN) Signs Licensing Agreement With Avast Software

(LGCY) LP Announces $900 Million Borrowing Base

MIDLAND, Texas, Nov. 16, 2015  — Legacy Reserves LP (“Legacy”) (NASDAQ:LGCY) today announced the semi-annual borrowing base review under its $1.5 billion secured revolving credit facility has resulted in a revised borrowing base of $900 million, a $50 million reduction from the previous figure.

Legacy also announced today that Paul Horne, President and Chief Executive Officer, and Dan Westcott, Executive Vice President and Chief Financial Officer, will participate in a discussion panel at the 2015 RBC Capital Markets’ MLP Conference in Dallas on Wednesday, November 18, 2015, at 10:20 a.m. Central Time. Presentation slides will be available on Legacy’s website at www.LegacyLP.com.

About Legacy Reserves LP

Legacy Reserves LP is a master limited partnership headquartered in Midland, Texas, focused on the acquisition and development of oil and natural gas properties primarily located in the Permian Basin, East Texas, Rocky Mountain, and Mid-Continent regions of the United States. Additional information is available at www.LegacyLP.com.

CONTACT: Legacy Reserves LP
         Dan Westcott
         Executive Vice President and Chief Financial Officer
         432-689-5200
Monday, November 16th, 2015 Uncategorized Comments Off on (LGCY) LP Announces $900 Million Borrowing Base

(SMLR) to Present at the LD Micro Main Event

PORTLAND, Ore., Nov. 16, 2015  — Semler Scientific, Inc. (Nasdaq: SMLR), a company that provides diagnostic and testing services to healthcare insurers and physician groups, today announced that it will be presenting at the 8th annual LD Micro Main Event on Thursday, December 3rd at 9:00 AM PST / 12:00 PM EST. Doug Murphy-Chutorian, M.D., chief executive officer of Semler, will be giving the presentation. The presentation will be webcast live and may be accessed using this link:  http://wsw.com/webcast/ldmicro9/smlr.  The webcast will be archived for 90 days following the live presentation.

“We are very excited to have Semler Scientific present for the first time at the Main Event,” commented Chris Lahiji, President of LD Micro.

The conference will be held at the Luxe Sunset Bel Air Hotel and will feature 230 companies in the small / micro-cap space.

About LD Micro
LD Micro is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published reports on select companies throughout the year. The firm also hosts the LD Micro Invitational in June. It is a non-registered investment advisor. For more information, please contact 408-457-1042 or visit www.ldmicro.com

About Semler Scientific, Inc.
Semler Scientific, Inc., is a company that provides diagnostic and testing services to healthcare insurers and physician groups. Its mission is to develop, manufacture and market innovative proprietary products and services that assist healthcare providers in evaluating and treating chronic diseases. The company’s first patented and U.S. Food and Drug Administration, or FDA, cleared product, introduced commercially in 2011, measured arterial blood flow in the extremities to aid in the diagnosis of peripheral arterial disease. In March 2015, the FDA granted 510(k) clearance for the next generation version of this product named QuantaFlo™, which was commercially launched in August 2015. In April 2015, the company launched its multi-test service offering, WellChec™, to more comprehensively evaluate patients for chronic disease. Additional information about Semler can be found at http://semlerscientific.com.

Monday, November 16th, 2015 Uncategorized Comments Off on (SMLR) to Present at the LD Micro Main Event

(OCRX) Positive Phase 1 Results for Oral OCR-002

Preliminary Pharmacokinetic Data Demonstrate Promising Extended-Release Profiles

PALO ALTO, Calif. and RESEARCH TRIANGLE PARK, N.C., Nov. 16, 2015  — Ocera Therapeutics, Inc. (NASDAQ:OCRX), a clinical stage biopharmaceutical company focused on acute and chronic orphan liver diseases, today announced positive results from the Company’s Phase 1 study of the oral formulation of OCR-002, ornithine phenylacetate, in healthy subjects.  OCR-002 exhibited encouraging extended-release properties, demonstrated a desirable pharmacokinetic (PK) profile and was well-tolerated.

The open-label, single-dose, five-treatment, five-period crossover study evaluated the PK, safety and tolerability of three prototype, extended-release oral formulations of OCR-002 compared to an immediate release oral solution of OCR-002 and the ammonia-lowering agent, glycerol phenylbutyrate (RAVICTI®), a pre-pro-drug of phenylacetate, a component of OCR-002.

The results demonstrated a robust, extended-release pattern for all three pilot OCR-002 extended-release formulations, with mean plasma phenylacetate (PAA) concentrations exceeding those achieved with RAVICTI at all timepoints for at least 12 hours post-dose. In addition, mean plasma phenylacetylglutamine (PAGN) concentrations and urinary PAGN excretion were greater for all three OCR-002 extended release dosage forms than for RAVICTI at an equivalent molar PAA dose. PAGN is formed by conjugation of PAA with glutamine, an end product of the ammonia scavenging activity of PAA.

“We are extremely encouraged by both the PAA exposure profiles and urinary PAGN excretion of the extended-release oral forms of OCR-002 in this evaluation, and believe these findings support the potential for convenient twice-daily dosing,” said Linda Grais, M.D., president and chief executive officer of Ocera.  “The strength of these results and the prior clinical proof of concept established with RAVICTI in preventing hepatic encephalopathy (HE) in patients suffering from liver cirrhosis provide clear validation for the continued development of oral OCR-002 in this indication. Our next step will be to further optimize the formulations to enhance controlled delivery of the drug under various conditions.”

Complete results from this Phase 1 study in healthy subjects will be submitted for presentation at an upcoming scientific conference.

Ocera is currently conducting a Phase 2b clinical trial, STOP-HE, to evaluate the safety and efficacy of intravenously-administered OCR-002 in resolving neurocognitive symptoms of acute HE in hospitalized patients with elevated ammonia. The Company expects to complete enrollment in the trial in the second half of 2016.

About Hepatic Encephalopathy

Hepatic encephalopathy, or HE, is a debilitating and progressive complication of liver cirrhosis or liver failure, marked by mental changes including confusion, impaired motor skills, disorientation, and in its more severe form, stupor, coma and even death.

About Ocera

Ocera Therapeutics, Inc. is a clinical stage biopharmaceutical company focused on the development and commercialization of OCR-002 (ornithine phenylacetate) in both intravenous and oral formulations. OCR-002 is an ammonia scavenger and has been granted orphan drug designation and Fast Track status by the U.S. Food and Drug Administration (FDA) for the treatment of hyperammonemia and resultant hepatic encephalopathy in patients with acute liver failure and acute-on-chronic liver disease. For additional information, please see www.ocerainc.com.

Forward-Looking Statements

This press release contains “forward-looking” statements, including, without limitation, all statements related to the OCR-002 clinical development program, including but not limited to the potential benefits of OCR-002 to help patients with hepatic encephalopathy, the timing of clinical and enrollment milestones, and the anticipated next steps for oral OCR-002. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believe,” “expected,” “hope,” “plan,” “potential,” “will” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon Ocera’s current expectations. Forward-looking statements involve risks and uncertainties and Ocera’s actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, including those risks and uncertainties discussed under the heading “Risk Factors” in Ocera’s Annual Report on Form 10-K for the year ended December 31, 2014 and subsequent filings with the SEC. All information in this press release is as of the date of the release, and Ocera undertakes no duty to update this information unless required by law.

Susan Sharpe
Ocera Therapeutics, Inc.
contact@ocerainc.com
919-328-1109
Monday, November 16th, 2015 Uncategorized Comments Off on (OCRX) Positive Phase 1 Results for Oral OCR-002

(ETAK) Reports 2015 Third Quarter Financial Results and Conference Call

NEW YORK, Nov. 16, 2015  — Elephant Talk Communications Corp. (NYSE MKT: ETAK) (“Elephant Talk” or the “Company”), a global provider of Software Defined Network Architecture (ET Software DNA® 2.0) platforms and cyber security solutions, today announced its financial results for the third quarter ending September 30, 2015. A conference call will be held on Tuesday, November 17, 2015 at 4:15pm EDT.

Revenue totaled approximately $3.5 million for the quarter ended September 30, 2015 as compared to restated revenue of $4.4 million recorded in the third quarter of 2014. Revenue in the quarter also reflects the negative impact of exchange rates in the amount of approximately $550,000. Non-GAAP revenue* decreased to approximately $3.4 million in the third quarter of 2015 as compared to approximately $7.7 million for the same period of the prior year. Net loss for the third quarter of 2015 was approximately $4.2 million as compared to a restated loss of approximately $5.2 million reported in the third quarter of 2014. Adjusted EBITDA* loss was approximately $1.2 million for the third quarter of 2015 as compared to approximately a restated $1.4 million profit in the same quarter of the prior year.

The decrease in 2015 third quarter revenue reflects the impact of the termination of the Company’s relationship with Iusacell and the Iusacell settlement agreement dated June 12, 2015 which provided the Company with net proceeds of $12.6 million. The termination of the Iusacell contract resulted in the loss of approximately $3.9 million of anticipated quarterly cash flow (based on historical monthly billings). The Company continued to transition the business, following the Iusacell settlement, without any significant revenue benefit during the quarter of new customer additions which included the wholesale division of a Tier 1 Mobile Operator in the United States and a Tier 1 license holder in Brazil. Restructuring initiatives will be ongoing and shareholders will be updated as progress is achieved. The Company anticipates a return to revenue and EBITDA growth taking place in 2016.

Operational Update:

  • During the third quarter, Elephant Talk continued its global expansion:
    • In Brazil, the Company was selected as the platform provider for EU TV/Surf Telecom. Given the platform’s proven ability to reduce operating expenses significantly, while greatly accelerating time to market, the Company believes that our software is the ideal solution to address the business model challenges now faced by operators in this market.
    • Shortly following the end of the third quarter, Elephant Talk signed a Cloud Service and Software License Agreement with the wholesale division of a Tier 1 US Mobile Operator. Feedback from its partner on the value proposition being offered is very positive and the two companies are collaborating in the sales process, having already partnered on pursuing 8 MVNO opportunities, in addition to responding to multiple new leads being generated each week.
  • ValidSoft momentum continued during the quarter:
    • ValidSoft added AurionPro as a new channel partner. AurionPro is a technology products and solutions provider serving enterprises, financial services, government and logistics companies in 22 different countries. AurionPro has added the Company’s voice biometric technology into their product portfolio and recently demonstrated it in their unique ‘bank in a box’ kiosk that was shown at the Money2020 conference and is scheduled to be rolled out across a number of developing countries in the coming year.
    • ValidSoft was selected by the European Union as the voice biometrics provider to the ‘Octave Project’ which is part of its latest Horizon2020 program. The program is focused on the development of a cloud based voice biometric user authentication solution. The project, which is now underway, includes a consortium of technology providers and leading research institutes and has received funding from the European Union for the further development of the solution.
Conference Call Information:
Date: Tuesday, November 17, 2015
Time: 4:15 p.m. EDT
Domestic Dial-in number: 719-325-4832
Live webcast: http://public.viavid.com/index.php?id=117346

All interested in participating should dial in approximately 5 to 10 minutes prior to the 4:15 p.m. EST conference call. Participants should ask for the Elephant Talk 2015 third quarter conference call.

* Non-GAAP financial measures

In order to provide investors additional information regarding our financial results, the Company is disclosing Adjusted EBITDA, a non-GAAP financial measures. Adjusted EBITDA is defined as earnings before income and income taxes, depreciation and amortization, share-based compensation, changes in deferred revenue, income interest and expenses, expenses from derivative accounting, such as debt discount and conversion feature expensing, changes in fair value of the conversion feature and warrant liabilities, amortization of deferred financing cost, loss on extinguishment of debt, impairment of tangible and intangible assets and impairments of loans. Adjusted EBITDA further eliminates share-based compensation. Adjusted EBITDA is designed to show a measure of the Company’s operating performance. The Company uses Adjusted EBITDA because it removes the impact of items not directly resulting from the Company’s core operations, allowing the Company to better assess whether the elements of the Company’s growth strategy are yielding the desired results. Accordingly, the Company believes that Adjusted EBITDA provide useful information for investors and others which allow them to better understand and evaluate the Company’s operating results.

Non-GAAP revenue is defined as GAAP revenue adjusted for changes in deferred revenue.

In particular, as a result of the characteristics of our services, the long term nature of the contracts and the small customer base, new and substantial sales will remain unnoticed to investors due to the fact that most of these sales will need to be deferred over a period of 3-5 years. The Company therefore adds back to the revenue in the income statement the revenues that were invoiced in the reporting period. At the same time the Company removes from the revenue in the income statement the revenues that have been recognized as a result of sales prior to the reporting period. These two adjustments we refer to us as changes in deferred revenue.

A reconciliation of GAAP Revenue to Non-GAAP Revenue, for each of the periods indicated, is as follows:

Three months ended September 30,
Non-GAAP Revenue 2015 2014 restated Variance
Revenues $ 3,485,624 $ 4,445,239 $ (959,615)
Deferred Revenue adjustments (117,710) 3,217,974 (3,335,684)
$ 3,367,914 $ 7,663,213 $ (4,295,299)

A reconciliation of GAAP Net Loss to Non-GAAP Adjusted EBITDA, for each of the periods indicated, is as follows:

Three months ended
September 30,
EBITDA (adjusted) 2015 2014 (restated)
Net loss $ (4,156,337) $ (5,246,6870
(Benefit) / provision for income taxes 6,964 (44,938)
Depreciation and amortization 1,781,478 1,900,251
Stock-based compensation 937,100 862,419
Interest income and expenses 252,128 223,611
Interest expense related to debt discount and conversion feature 125,086 1,287,717
Changes in fair value of warrant liabilities 103,311
(Gain) on extinguishment of debt (626,534)
Other income & (expense) (82,760) (301,199)
Amortization of deferred financing costs 41,224 73,789
Changes in deferred revenue (117,710) 3,217,974
Adjusted EBITDA $ (1,212,827) $ 1,449,714

About Elephant Talk Communications Corp.:
Elephant Talk Communications Corp. (NYSE MKT: ETAK) is a global provider of mobile proprietary Software Defined Network Architecture (ET Software DNA® 2.0) platforms for the telecommunications industry. The Company empowers Mobile Network Operators (MNOs), Mobile Virtual Network Operators (MVNOs), Enablers (MVNEs) and Aggregators (MVNAs) with a full suite of applications, reliable industry expertise and high quality customer service without the need for substantial upfront investment. Elephant Talk counts several of the world’s leading MNOs and technology companies amongst its customers and partners, including Vodafone, T-Mobile, Zain, HP and Affirmed Networks. Visit: www.elephanttalk.com.

About ValidSoft UK Ltd.:
ValidSoft, a subsidiary of Elephant Talk Communications Corp., secures transactions using personal authentication and device assurance. We enable our customers to enhance their security while improving their user experience, utilising our multi-factor authentication platform, Voice Biometric engine and Device Trust technology, all of which may be used as ‘stand-alone’ or integrated into multi-vendor solutions. ValidSoft serves multiple clients across the financial services, government and enterprise sectors and is the only company to have been granted four European Privacy Seals, reflecting its commitment to strong data privacy. Visit: www.validsoft.com.

Cautionary Note Regarding Forward-Looking Statements:
Certain statements contained herein constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements may include, without limitation, statements with respect to Elephant Talk’s plans and objectives, projections, expectations and intentions (including, without limitation, Elephant Talk’s plans with regard to its ValidSoft subsidiary). These forward-looking statements are based on current expectations, estimates and projections about Elephant Talk’s industry, operations, management’s beliefs and certain assumptions made by management. Readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict. Because such statements involve risks and uncertainties, the actual results and performance of Elephant Talk may differ materially from the results expressed or implied by such forward-looking statements. Given these uncertainties, readers are cautioned not to place undue reliance on such forward-looking statements. Unless otherwise required by law, Elephant Talk also disclaims any obligation to update its view of any such risks or uncertainties or to announce publicly the result of any revisions to the forward-looking statements made here. Additional information concerning certain risks and uncertainties that could cause actual results to differ materially from those projected or suggested in Elephant Talk’s filings with the Securities and Exchange Commission, copies of which are available from the SEC or may be obtained upon request from Elephant Talk.

Investor Contact:
Alan Sheinwald or Valter Pinto
Capital Markets Group, LLC
(914) 669-0222
valter@capmarketsgroup.com
www.CapMarketsGroup.com

Public Relations:
Michael Glickman
MWGCO, Inc.
917-397-2272
mike@mwgco.net

Monday, November 16th, 2015 Uncategorized Comments Off on (ETAK) Reports 2015 Third Quarter Financial Results and Conference Call

(ISCO) Announces Operating Results for Q3

CARLSBAD, CA–(November 16, 2015) – International Stem Cell Corporation (OTCQB: ISCO) (www.internationalstemcell.com) (“ISCO” or “the Company”), a California-based biotechnology company developing novel stem cell-based therapies and biomedical products, today provided a business update and announced operating results for the three and nine months ended September 30, 2015.

“Overall I am satisfied with the Company’s progress in Q3. We are maintaining our position as a leader in regenerative medicine field and the overall operating income of our biomedical businesses continues to grow,” said Andrey Semechkin, Ph.D., CEO and Co-Chairman of ISCO. “We really look forward to beginning the enrolment of patients in our pending Parkinson’s Disease clinical trial before the end of 2015.”

Third Quarter 2015 Business Highlights

  • Developed a robust innovative technology designed to generate functional articular cartilage from the patient’s own skin or adipose tissue with the potential to treat osteoarthritis.
  • Entered into the second phase of the existing research agreement with Rohto Pharmaceutical Co., Ltd., a global Japanese pharmaceutical company.
  • Presented comprehensive findings from Parkinson’s disease program at the Society for Neuroscience Annual Meeting, Neuroscience 2015.
  • Named Ms. Mahnaz Ebrahimi as Chief Financial Officer.
  • Completed clinical testing of a new compound, which the Company intends to utilize in substantially new skin care products to be marketed by the Company’s wholly-owned subsidiary Lifeline Skin Care, Inc. starting December 2015.
  • Lifeline Skin Care launched its ProPlus+ professional line of products that will be available exclusively through Lifeline’s network of dermatologists, aestheticians and med spas.

Third Quarter 2015 Financial Highlights

  • Total consolidated revenue for the third quarter of 2015 was $2.14 million, an increase of $173,000, or 9%, compared to the third quarter of 2014 of $1.96 million.
    • Lifeline Cell Technology sales increased by 22%, or $220,000, and
    • Lifeline Skin Care sales decreased by 5%, or $47,000
  • Both of wholly-owned Company subsidiaries remain profitable.
  • Consolidated net loss for the third quarter of 2015 was $539,000, compared to consolidated net loss of $2.0 million for the third quarter of 2014.

Year-to-Date Financial Highlights:

  • Total consolidated revenue for the nine months ended September 30, 2015 was $5.57 million, an increase of $373,000, or 7%, compared to the nine months ended September 30, 2014 of $5.20 million.
    • Lifeline Cell Technology sales increased by 9%, or $244,000, and
    • Lifeline Skin Care sales decreased by 5%, or $129,000
  • Consolidated net loss for the nine months ended September 30, 2015 was $1.1 million compared to consolidated net loss of $7.9 million for the nine months ended September 30, 2014, partially due to the completion of our multiple preclinical studies during the first six months of 2015.

Balance Sheet Highlights:

  • The Company ended the third quarter of 2015 with cash balance of $599,000.
  • Stockholders’ equity totaled $834,000 as of September 30, 2015.

About International Stem Cell Corporation

International Stem Cell Corporation is focused on the therapeutic applications of human parthenogenetic stem cells (hpSCs) and the development and commercialization of cell-based research and cosmetic products. ISCO’s core technology, parthenogenesis, results in the creation of pluripotent human stem cells from unfertilized oocytes (eggs). hpSCs avoid ethical issues associated with the use or destruction of viable human embryos. ISCO scientists have created the first parthenogenetic, homozygous stem cell line that can be a source of therapeutic cells for hundreds of millions of individuals of differing genders, ages and racial background with minimal immune rejection after transplantation. hpSCs offer the potential to create the first true stem cell bank, UniStemCell™. ISCO also produces and markets specialized cells and growth media for therapeutic research worldwide through its subsidiary Lifeline Cell Technology (www.lifelinecelltech.com), and stem cell-based skin care products through its subsidiary Lifeline Skin Care (www.lifelineskincare.com). More information is available at www.internationalstemcell.com.

To subscribe to receive ongoing corporate communications, please click on the following link: http://www.b2i.us/irpass.asp?BzID=1468&to=ea&s=0

To like our Facebook page or follow us on Twitter for company updates and industry related news, visit: www.facebook.com/InternationalStemCellCorporation and www.twitter.com/intlstemcell

Safe harbor statement

Statements pertaining to anticipated developments, expected clinical studies (including timing and results), progress of research and development, and other opportunities for the company and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates,”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, regulatory approvals, need and ability to obtain future capital, application of capital resources among competing uses, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the company’s business, particularly those mentioned in the cautionary statements found in the company’s Securities and Exchange Commission filings. The company disclaims any intent or obligation to update forward-looking statements.

International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Balance Sheets
(in thousands, except share data)
September 30, December 31,
2015 2014
Assets (Unaudited)
Cash and cash equivalents 599 $ 1,111
Accounts receivable, net of allowance for doubtful accounts of $18 and $19 at September 30, 2015 and December 31, 2014, respectively 615 453
Inventory, net 1,874 1,517
Prepaid expenses and other current assets 505 485
Restricted cash 50
Total current assets 3,593 3,616
Property and equipment, net 459 714
Intangible assets, net 3,121 2,795
Deposits and other assets 57 54
Total assets $ 7,230 $ 7,179
Liabilities and Stockholders’ Equity
Accounts payable $ 526 $ 670
Accrued liabilities 1,373 1,711
Related party payable 2,893 11
Advances 250 250
Fair value of warrant liability 1,354 4,216
Total current liabilities 6,396 6,858
Commitments and contingencies
Stockholders’ Equity
Series B Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, 300,000 issued and outstanding, with liquidation preferences of $435 and $421 at September 30, 2015 and December 31, 2014, respectively
Series D Convertible Preferred stock, $0.001 par value, 50 shares authorized, 43 issued and outstanding, with liquidation preference of $4,320
Series G Convertible Preferred stock, $0.001 par value, 5,000,000 shares authorized, issued and outstanding, with liquidation preference of $5,000 5 5
Series H-1 Convertible Preferred stock, $0.001 par value, 2,000 shares authorized, 0 and 1,482 issued and outstanding at September 30, 2015 and December 31, 2014, respectively
Series H-2 Convertible Preferred stock, $0.001 par value, 500 shares authorized, issued and outstanding
Common stock, $0.001 par value, 720,000,000 shares authorized, 2,147,773 and 1,596,195 shares issued and outstanding at September 30, 2015 and December 31, 2014, respectively (1) 2 2
Additional paid-in capital 96,679 95,063
Accumulated deficit (95,852 ) (94,749 )
Total stockholders’ equity 834 321
Total liabilities and stockholders’ equity $ 7,230 $ 7,179

(1) All common shares and per share amounts reported have been adjusted for the 150-for-1 reverse stock split effected on July 29, 2015.

International Stem Cell Corporation and Subsidiaries
Condensed Consolidated Statements of Operations
(in thousands, except per share data)
(Unaudited)
Three Months Ended Nine Months Ended
September 30, September 30,
2015 2014 2015 2014
Revenues
Product sales $ 2,136 $ 1,963 $ 5,573 $ 5,200
Total revenue 2,136 1,963 5,573 5,200
Expenses
Cost of sales 565 518 1,499 1,366
Research and development 508 1,392 2,193 3,761
Selling and marketing 712 745 1,968 2,093
General and administrative 973 1,342 3,438 4,322
Total expenses 2,758 3,997 9,098 11,542
Loss from operating activities (622 ) (2,034 ) (3,525 ) (6,342 )
Other income (expense)
Change in fair value of warrant liability 87 2,468 1,894
Warrant exchange inducement expense (3,445 )
Miscellaneous (8 ) (8 )
Interest expense (4 ) (7 ) (2 )
Warrant modification expense (40 )
Sublease income 8 1 24
Total other income (expense), net 83 2,422 (1,537 )
Loss before income taxes (539 ) (2,034 ) (1,103 ) (7,879 )
Provision for income taxes
Net loss $ (539 ) $ (2,034 ) $ (1,103 ) $ (7,879 )
Net loss applicable to common stockholders $ (539 ) $ (2,034 ) $ (1,103 ) $ (7,879 )
Net loss per common share-basic (1) $ (0.27 ) $ (1.40 ) $ (0.61 ) $ (6.53 )
Net loss per common share-diluted (1) $ (0.28 ) $ (1.40 ) $ (1.69 ) $ (6.53 )
Weighted average shares-basic (1) 1,962 1,456 1,801 1,207
Weighted average shares-diluted (1) 2,218 1,456 2,117 1,207

(1) All common shares and per share amounts reported have been adjusted for the 150-for-1 reverse stock split effected on July 29, 2015.

Contacts:
International Stem Cell Corporation
Denise Boyajian
Phone: 760-940-6383
Email: ir@intlstemcell.com

Media:

Christopher R. Hippolyte
Phone: +1-646-942-5634
Email: chris.hippolyte@russopartnersllc.com

Tony Russo, Ph.D.
Phone: (212) 845-4251
Email: tony.russo@russopartnersllc.com

Monday, November 16th, 2015 Uncategorized Comments Off on (ISCO) Announces Operating Results for Q3

(JNP) Adds Three New Products to its Proprietary Pipeline

BOSTON and NEW YORK, Nov. 13, 2015  — Juniper Pharmaceuticals, Inc. (Nasdaq: JNP) (“Juniper” or the “Company”), announced details of its portfolio pipeline, focused on three new product candidates to treat women’s health conditions, at its Investor Day Wednesday.

The three new product candidates utilize the Company’s proprietary multi-segment intra-vaginal ring (IVR):

  • JNP-0101, an oxybutynin IVR for the treatment of overactive bladder;
  • JNP-0201, a combination IVR delivering estrogen and progesterone hormone replacement therapy (HRT); and,
  • JNP-0301, a progesterone IVR for the prevention of preterm birth.

The new IVR product candidates complement COL-1077, the Company’s sustained-release 10% lidocaine bioadhesive gel intended for the treatment of gynecologic procedure-related pain.  A Phase 2b trial is currently enrolling female patients and results from this clinical trial are expected in mid-2016.

Frank Condella, the Company’s Chief Executive Officer, stated, “We are very pleased to announce the advancement of these new product candidates. They represent significant potential commercial opportunities for Juniper in the United States and globally.”

Summaries of the IVR product candidates and their target indications follow.  For more detailed information, please access the replay of the Investor Day webcast at www.juniperpharma.com or click here. The archived webcast will be available for 90 days.

About JNP-0101 Oxybutynin IVR

Overactive bladder (OAB) is a widespread, chronic condition caused by involuntary contraction of the detrusor muscles before the bladder is full. OAB affects approximately 20 million women in the United States, with an estimated nine million receiving pharmacotherapy to treat the condition.1,2,3 In 2014, the U.S. OAB market was estimated to be $1.3 billion, comprised of branded and generic products. 4 More than 70% of women discontinue first line treatments within the first year due to adverse events or inadequate efficacy.5,6,7,8

Juniper’s oxybutynin IVR has the potential to address the most pressing unmet needs in the market by offering more localized absorption, reduced side effects and sustainable delivery. Juniper plans to submit an Investigational New Drug (“IND”) application to the FDA and initiate clinical studies with JNP-0101 in the second half of 2016.

About JNP-0201 Estrogen + Progesterone IVR

Approximately 45 million American women are menopausal or approaching menopause. In 2014, the U.S. Hormone Replacement Therapy (HRT) market was estimated at $2.2 billion.10 Juniper’s combination estrogen and progesterone IVR candidate has the potential to offer patients multiple benefits as compared with currently available therapies, including: integrated administration of natural progesterone and estrogen; improved patient compliance; improved side effect profile; and vaginal delivery of natural hormones, while eliminating the need for daily administration.

About JNP-0301 Progesterone IVR

Preterm birth is a significant public health issue, with an estimated 1.3 million women in the United States at risk for preterm birth due to short cervical length (“SCL”).11 Clinical data supports the use of vaginal progesterone to prevent preterm birth.12,13,14  Despite the medical need and cost savings associated with prevention of preterm birth, no products are FDA approved to prevent preterm birth in women at risk due to a short cervix.

Juniper’s progesterone IVR may offer meaningful benefits to women with SCL. By providing continuous, consistent, local delivery of natural progesterone, this product candidate may increase patient compliance as compared to current off-label progestogens, which require daily administration, thereby potentially improving overall outcomes. Juniper expects JNP-0301 development will be facilitated by development of JNP-0201 for HRT.

About Juniper Pharmaceuticals

Juniper Pharmaceuticals, Inc. is focused on developing therapeutics that address unmet medical needs in women’s health.  Juniper has a commercial product, CRINONE® 8% (progesterone gel), which is marketed by Allergan, Inc. in the U.S. and by Merck KGaA, Darmstadt, Germany, in over 90 countries worldwide. The Company is advancing a pipeline of proprietary drug candidates leveraging novel delivery technologies.  Please visit www.juniperpharma.com for more information.

Juniper Pharmaceuticals™ is a trademark of Juniper Pharmaceuticals, Inc., in the U.S. and EU.

CRINONE® is a registered trademark of Allergan, Inc. in the U.S. and of Merck KGaA, Darmstadt, Germany, outside the U.S.

Forward Looking Statements

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995: This communication contains forward-looking statements, which statements are usually indicated by the words “may,” “will,” “plans,” “believes,” “expects,” “anticipates,” “potential,” “should,” or similar expressions, and which are generally not historical in nature. These include all statements relating to expected product development and the timing thereof; potential benefits of Juniper’s product candidates; and.  Management believes that these forward-looking statements are reasonable as and when made.  However, such forward-looking statements involve known and unknown risks, uncertainties, and other factors that may cause actual results to differ materially from those projected in the forward-looking statements.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date on which they are made. These statements are based on management’s current expectations and Juniper Pharmaceuticals does not undertake any responsibility to revise or update any forward-looking statements contained herein, except as expressly required by law.  For a discussion of certain risks and uncertainties associated with Juniper Pharmaceuticals’ forward-looking statements, please review the Company’s reports filed with the SEC, including, but not limited to, its Annual Report on Form 10-K for the period ended December 31, 2014 and 10-Q for the period ended September 30, 2015.

Contact

Amy Raskopf
Director, Corporate Communications
Juniper Pharmaceuticals
(917) 673-5775
ir@juniperpharma.com

Follow us on LinkedIn

 

1 Milsom I, et al., How widespread are the symptoms of an overactive bladder and how are they managed? A population-based prevalence study. BJU Int. 2001; 87(9): 760-6.
2 Stewart WF, et al., Prevalence and burden of overactive bladder in the United States. World J Urol. 2003; 20(6): 327-36.
3 Griebling, TL, et al., Worldwide prevalence estimates of lower urinary tract symptoms, overactive bladder, urinary incontinence and bladder outlet obstruction. BJUI. 2011; 108(7): 1132-8.
4 Technavio Insights, 2014. Global Overactive Bladder Therapeutics Market Report.  Available from http://www.technavio.com/report/global-overactive-bladder-therapeutics-market-2014-2018
5 Yu YF, et al., Persistence and adherence of medications for chronic overactive bladder/urinary incontinence in the California Medicaid program. Value Health. 2005; 8: 495–505.
6 Shaya FT, et al., Persistence with overactive bladder pharmacotherapy in a Medicaid population. Am J Manag Care. 2005; 11(4 Suppl): S121–9.
7 Gopal M, et al., Discontinuation rates of anticholinergic medications used for the treatment of lower urinary tract symptoms. Obstet Gynecol. 2008; 112: 1311–8.
8 Krhut J, et al., Persistence with first line anticholinergic medication in treatment-naïve overactive bladder patients. Scand J Urol. 2014; 48: 79–83.
9 U.S. Census Bureau, Population Division. Table 2. Projections of the Population by Selected Age Groups and Sex for the United States: 2015 to 2060 (NP2012-T2). Release date: December 2012.
10 Symphony Health Solutions Report.
11 Estimated based on Iams JD et al. N Engl J Med. 1996;334(9): 567-572
12 Fonseca EB et al., Progesterone and the risk of preterm birth among women with a short cervix. N Engl J Med. 2007 Aug 2;357(5):462-9.
13 Hassan SS et al., Vaginal progesterone reduces the rate of preterm birth in women with a sonographic short cervix: a multicenter, randomized, double-blind, placebo-controlled trial. Ultrasound Obstet Gynecol. 2011 Jul;38(1):18-31. doi: 10.1002/uog.9017. Epub 2011 Jun 15.
14 Maher MA et al., Prevention of preterm birth: a randomized trial of vaginal compared with intramuscular progesterone. Acta Obstet Gynecol Scand 2012; 91:DOI: 10.1111/aogs.12017.

Friday, November 13th, 2015 Uncategorized Comments Off on (JNP) Adds Three New Products to its Proprietary Pipeline

(GDEF) & National Security Systems, Adjournment of Special Meeting

RESTON, Va., Nov. 12, 2015  — Global Defense & National Security Systems, Inc. (“GDEF” or the “Company“) (NASDAQ:GDEF) today announced that it convened and adjourned, without conducting any business, its special meeting in lieu of the 2015 annual meeting of stockholders (the “Special Meeting“), held on November 12, 2015, at 11:00 a.m. Eastern Time until Friday, November 13, 2015 at 9:00 a.m. Eastern Time, at which time GDEF’s stockholders will vote on the proposals to be considered at the Special Meeting, including a proposal to approve GDEF’s business combination with STG Group, Inc. (the “Business Combination Proposal“) as described on the proxy statement (the “Proxy Statement“) that GDEF filed with the Securities and Exchange Commission on October 22, 2015. The Special Meeting will still be held at 2000 Pennsylvania Avenue, N.W. Suite 6000, Washington, D.C. 20006.

Stockholders of record at the close of business on October 21, 2015 are entitled to receive notice of the special meeting and to vote the shares of common stock of GDEF owned by them at the Special Meeting. If you have already returned a validly executed proxy card, your shares will remain voted unless you revoke your prior proxy before the Special Meeting. You may change your vote by submitting a subsequent proxy. You may change your vote by submitting a later-dated, executed proxy card by mail or following the voting instructions (including any telephone or Internet voting instructions) provided by your broker or bank if your shares are held in ”street name,” in each case in accordance with the instructions provided under ”Special Meeting in Lieu of 2015 Annual Meeting of GDEF Stockholders” in the Proxy Statement prior to the special meeting or attending the special meeting in person and voting. You also may revoke your proxy by sending a notice of revocation to our secretary, which must be received by our secretary prior to the special meeting.

As more fully described in the Proxy Statement, the stockholders who intend to exercise their redemption rights must check the box on the proxy card provided for that purpose and return the proxy card in accordance with the instructions provided. In connection with tendering your shares for redemption, you must elect either to physically tender your stock certificates to American Stock Transfer & Trust Company, LLC, our transfer agent, at American Stock Transfer & Trust Company, LLC, 6201 15th Avenue, Brooklyn, New York 11219, Attn: AST Proxy Department, by two business days prior to the special meeting or to deliver your shares to the transfer agent electronically using The Depository Trust Company’s DWAC (Deposit/Withdrawal At Custodian) System, which election would likely be determined based on the manner in which you hold your shares. Certificates that have not been tendered in accordance with these procedures by two business days prior to the special meeting will not be redeemed for cash. In the event that you tender your shares and decide prior to the special meeting that you do not want to redeem your shares, you may withdraw the tender at any time prior to the time that the Business Combination Proposal is approved.

Additional Information About the Transaction and Where to Find It

In connection with the transaction between the Company and STG pursuant to the Stock Purchase Agreement, dated as of June 8, 2015, by and among the Company, STG, the stockholders of STG, and Simon Lee as Stockholders’ Representative, the Company filed a definitive proxy statement with the Securities and Exchange Commission (the “SEC”) on October 22, 2015. The Company also filed a preliminary proxy statement with the SEC on November 2, 2015 for its proposal to amend and restate its amended and restated certificate of incorporation to extend the amount of time it has to complete the business combination from 25 months to 26 months (the “Extension Proposal”) and will file a definitive proxy statement. Investors are urged to read the preliminary proxy statement for the Extension Proposal and the definitive proxy statement for the proposed transaction and the Extension Proposal when it becomes available (including all amendments and supplements), because they contain important information. Investors may obtain free copies of these proxy statements, as well as other filings containing information about the Company, without charge, at the SEC’s Internet site (http://www.sec.gov). The definitive proxy statement for the proposed transaction has been, and the definitive proxy statement for the Extension Proposal will be, mailed to stockholders of the Company after a record date to be established for voting upon the proposed transaction and Extension Proposal, respectively. These documents may also be obtained for free from the Company’s Investor Relations web site (http://investor.gdef.com/) or by directing a request to the Company at: Global Defense & National Security Systems, Inc., 11921 Freedom Drive, Suite 550, Two Fountain Square, Reston, VA 20190.

The Company and its officers and directors may be deemed to be participants in the solicitation of proxies from the Company’s stockholders. Information about the Company’s executive officers and directors is set forth in its Annual Report on Form 10-K, which was filed with the SEC on March 25, 2015. Investors may obtain more detailed information regarding the direct and indirect interests of the Company and its respective executive officers and directors in the transaction by reading the preliminary proxy statement regarding the transaction, which has been filed with the SEC, and the definitive proxy statement regarding the transaction, which will be filed with the SEC.

Forward Looking Statements

This written communication contains forward-looking statements that involve risks and uncertainties, including risks and uncertainties concerning the Company’s proposed Business Combination, STG’s expected financial performance, as well as STG’s strategic and operational plans. Forward-looking statements relate to expectations, beliefs, projections, future plans and strategies, anticipated events or trends and similar expressions concerning matters that are not historical facts. Terms such as “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “might,” “plan,” “possible,” “potential,” “predict,” “should,” “would” and similar expressions may identify forward-looking statements, but the absence of these words does not mean that a statement is not forward-looking. Actual events or results may differ materially from those described in this written communication due to a number of risks and uncertainties. The potential risks and uncertainties include, among others, the possibility that the proposed business combination transaction will not close or that the closing may be delayed; the reaction of customers to the transaction; general economic conditions; the possibility that the Company may be unable to obtain stockholder approval as required for the transaction or that the other conditions to the closing of the transaction may not be satisfied; the transaction may involve unexpected costs, liabilities or delays; the outcome of any legal proceedings related to the transaction; the occurrence of any event, change or other circumstances that could give rise to the termination of the transaction agreement. In addition, please refer to the documents that the Company files with the SEC on Forms 10-K, 10-Q and 8-K. The filings by the Company identify and address other important factors that could cause its financial and operational results to differ materially from those contained in the forward-looking statements set forth in this written communication. The Company is under no duty to update any of the forward-looking statements after the date of this written communication to conform to actual results.

CONTACT: Joele Frank, Wilkinson Brimmer Katcher
         Jamie Moser / Andrew Siegel / Leigh Parrish
         212-355-4449
Friday, November 13th, 2015 Uncategorized Comments Off on (GDEF) & National Security Systems, Adjournment of Special Meeting

(EDAP) Records First Three U.S. Orders for Ablatherm HIFU

First HIFU Devices to be Shipped to the U.S. Next Week

LYON, France, Nov. 12, 2015  — EDAP TMS SA (Nasdaq:EDAP), the global leader in therapeutic ultrasound, today announced that it signed contracts for the sale of three Ablatherm® HIFU devices to prominent U.S. urology groups.

The Company expects to start shipping systems from its manufacturing facility in France to U.S. locations within the next ten days.

Marc Oczachowski, Chief Executive Officer of EDAP commented: “We are extremely pleased to announce that we have in-hand our first orders in the U.S., with three sales contracts signed and being executed. Since FDA clearance of our Ablatherm Robotic HIFU device, we have been receiving a significant number of queries from urologists and other stakeholders in the urology community. Thanks to our established sales and services network in the U.S., we are diligently responding to this strong demand.”

Oczachowski concluded: “We are very excited to see that our commercialization plans are showing immediate results and that our technology is generating such positive feedback from the U.S. market.”

About EDAP TMS SA

EDAP TMS SA markets today Ablatherm® for high-intensity focused ultrasound (HIFU) for prostate tissue ablation in the U.S. and for treatment of localized prostate cancer in the rest of the world. HIFU treatment is shown to be a minimally invasive and effective option for prostatic tissue ablation with a low occurrence of side effects. Ablatherm-HIFU is generally recommended for patients with localized prostate cancer (stages T1-T2) who are not candidates for surgery or who prefer an alternative option, or for patients who failed radiotherapy treatment. Ablatherm-HIFU is approved for commercial distribution in Europe and some other countries including Mexico and Canada, and has received 510(k) clearance by the U.S. FDA. The Company also markets an innovative robot-assisted HIFU device, the Focal One®, dedicated to focal therapy of prostate cancer. Focal One® is CE marked but is not FDA approved. The Company also develops its HIFU technology for the potential treatment of certain other types of tumors. EDAP TMS SA also produces and distributes medical equipment (the Sonolith® lithotripters’ range) for the treatment of urinary tract stones using extra-corporeal shockwave lithotripsy (ESWL) in most countries including Canada and the U.S. For more information on the Company, please visit http://www.edap-tms.com, and http://www.hifu-planet.com.

Forward-Looking Statements

In addition to historical information, this press release may contain forward-looking statements. Such statements are based on management’s current expectations and are subject to a number of risks and uncertainties, including matters not yet known to us or not currently considered material by us, and there can be no assurance that anticipated events will occur or that the objectives set out will actually be achieved. Important factors that could cause actual results to differ materially from the results anticipated in the forward-looking statements include, among others, the clinical status and market acceptance of our HIFU devices and the continued market potential for our lithotripsy device. Factors that may cause such a difference also may include, but are not limited to, those described in the Company’s filings with the Securities and Exchange Commission and in particular, in the sections “Cautionary Statement on Forward-Looking Information” and “Risk Factors” in the Company’s Annual Report on Form 20-F.

CONTACT: Blandine Confort
         Investor Relations / Legal Affairs
         EDAP TMS SA
         +33 4 72 15 31 72
         bconfort@edap-tms.com

         Investors:
         Lee Roth
         The Ruth Group
         646-536-7012
         lroth@theruthgroup.com
Friday, November 13th, 2015 Uncategorized Comments Off on (EDAP) Records First Three U.S. Orders for Ablatherm HIFU

(LPCN) Adopts Stockholder Rights Plan

SALT LAKE CITY, Nov. 13, 2015  — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that on November 12, 2015 its board of directors adopted a stockholder rights plan designed to deter coercive takeover tactics, including the accumulation of shares in the open market or through private transactions and to prevent an acquirer from gaining control of without offering a fair price to all of the its stockholders.

The plan, similar to plans adopted by many other companies, was not adopted in response to any current hostile takeover attempt.

“The rights plan is designed to ensure that our stockholders realize the long-term value of their investment in the company and is similar to those adopted by many other companies,” commented Lipocine Chief Executive Officer Mahesh V. Patel.  “The plan will not prevent a takeover attempt, but should encourage anyone seeking to acquire the company to negotiate fair value directly with the board of directors.”

Under the terms of the rights plan, preferred stock purchase rights will be distributed as a dividend at the rate of one Right for each share of Lipocine’s common stock held by stockholders of record as of the close of business on November 30, 2015.  The plan would be triggered if a person or group acquires beneficial ownership of 15% or more of the Company’s common stock other than pursuant to a board-approved tender or exchange offer or commences, or publicly announces an intention to commence, a tender or exchange offer upon consummation of which such person or group would beneficially own 15% or more of the Company’s common stock.

Details of the stockholder rights plan are outlined in a letter that will be mailed to all Company stockholders as of the record date.  In addition, a copy of the rights plan will be filed with the Securities and Exchange Commission as an exhibit to the Company’s Current Report on Form 8-K.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA.  Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.

Forward-Looking Statements

This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to the Lipocine’s common stock and preferred stock, the FDA review process relating to our product candidates and the outcome of such process, clinical trials, the potential uses and benefits of the Lipocine’s product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA’s review of our NDA for LPCN 1021, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, the risks related to market conditions for Lipocine’s common stock and other risks detailed in Lipocine’s filings with the SEC, including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

Contact:

Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383
Email: mb@lipocine.com

John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com
Friday, November 13th, 2015 Uncategorized Comments Off on (LPCN) Adopts Stockholder Rights Plan

(SYPR) Awarded Long-Term Contract with Volvo Group North America

Sypris to Supply Axle Shafts on Mack® Proprietary Axles

Sypris Technologies, Inc. (Sypris), a subsidiary of Sypris Solutions, Inc. (Nasdaq/GM: SYPR), announced today that it has been awarded a long-term contract with Volvo Group North America LLC and Mack Trucks, Inc. for the supply of axle shafts for use on Volvo’s Mack branded axle through 2018.

Commenting on the announcement, Paul Larochelle, Vice President of Sales and Strategic Initiatives, stated, “Sypris has been providing axle shafts to Volvo for over a decade as a tier two supplier. We are pleased to continue the supply of these components now directly to Volvo as a tier one supplier. We are excited for the opportunity to expand and extend our strategic relationship with Volvo and collaborate on other products where we can bring value to their supply chain.”

Sypris Technologies is a premier manufacturer and supplier of drivetrain and other critical components for the commercial vehicle, automotive, recreational vehicle, mining, agriculture and energy markets. Sypris is headquartered in Louisville, Kentucky. With facilities located throughout North America, Sypris continues to meet the needs of the industry after more than 80 years of service.

Mack Trucks, Inc. is part of the Volvo Group, one of the world’s leading manufacturers of trucks, buses, construction equipment and marine and industrial engines. The Group also provides complete solutions for financing and service. The Volvo Group, which employs about 100,000 people, has production facilities in 19 countries and sells its products in more than 190 markets. In 2014, the Volvo Group’s sales amounted to about $38.2 billion. The Volvo Group is a publicly-held company headquartered in Gothenburg, Sweden. Volvo shares are listed on Nasdaq Stockholm and are traded OTC in the U.S.

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: any early termination of the supply contract or any of 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 Technologies, Inc.
Kevin Kramer, 502-420-1229
Director, Business Development & Marketing

Friday, November 13th, 2015 Uncategorized Comments Off on (SYPR) Awarded Long-Term Contract with Volvo Group North America

(YOD) & CNTV to Partner Exclusively for IPTV SVOD/TVOD

NEW YORK, Nov. 12, 2015  — YOU On Demand Holdings, Inc. (NASDAQ: YOD) (“YOU On Demand” or “YOD”), a leading Video On Demand (“VOD”) service provider in China delivering Hollywood movies and premium content to TV and mobile screens, announced today an exclusive distribution and service partnership agreement with China Network Television’s (“CNTV”) IPTV operating entity Ai Shang Media (“CHINA IPTV”).

Under existing government regulations, CNTV is the sole national broadcast controller of all of the country’s IPTV platforms across all 31 provinces.  In each region, the local telecom operators provide 2-tiered service of bundled broadband and IPTV services, which carry both live TV and on demand content from CNTV and local provincial TV stations.  For example, over the last several years, China Telecom, one of the big 3 telecom operators in China, has expanded to 40 million IPTV subscriber homes in southern China.

CHINA IPTV, created as a joint venture by CNTV and Shanghai Media Group, is the only integrated for-profit IPTV platform operating nationwide under CNTV’s authorization.   As of today, CHINA IPTV has consolidated more than a dozen local IPTV platforms covering 15 million subscriber homes and aims to accomplish its mission of covering all IPTV users, existing and new, by the end of 2017.

Under the terms of the agreement, CHINA IPTV and YOD will work exclusively to provide Hollywood movie content to all IPTV users in China. YOD will have the first right of refusal on all movie content distribution, so that any content that CHINA IPTV looks to distribute will always be sourced first from YOU On Demand.

“CHINA IPTV selected YOU On Demand as one of our most favored content partners based on the fact that YOD is already a recognized name with established service partnerships with some of the leading IPTV and OTT operators in China,” stated Ms. Jing Jing He, the Chief Editor and Executive Vice President of CHINA IPTV, “We also believe that YOD can help, with its rich experience in both content distribution operations and marketing, to expedite our integration with local IPTV platforms.”

CEO Weicheng Liu, commenting on the partnership, stated, “Aligning YOD’s content alongside such a strong, centralized national platform, will help strengthen both the YOD brand as well as its reach. This deal is particularly significant to YOD on multiple levels.  First, it makes YOU On Demand the exclusive gatekeeper of Hollywood movie content to potentially 40+ million IPTV users.  Second, it provides YOD, in addition to the typical SVOD and TVOD revenue split, a separate and additional recurring revenue that will be tied to its heavy involvement in CHINA IPTV operations and marketing and how those engines drive CHINA IPTV growth and expansion.”

About YOU On Demand Holdings, Inc. (http://corporate.yod.com)

YOU On Demand (NASDAQ: YOD), is a leading multi-platform entertainment service company delivering premium content, including leading Hollywood movie titles, to customers across China via Subscription Video On Demand and Transactional Video On Demand. The Company has secured alliances with leading global media operators and content developers.  YOU On Demand has content distribution agreements in place with many of Hollywood’s top studios including Disney Media Distribution, Paramount Pictures, NBC Universal and Twentieth Century Fox Television Distribution, Miramax, as well as a broad selection of the best content from Chinese filmmakers. The Company has a comprehensive end-to-end secure delivery system, governmental partnerships and approvals and offers additional value-added services. YOU On Demand has strategic partnerships with the largest media entities in China, a highly experienced management team with international background and expertise in Cable, Television, Film, Digital Media, Internet and Telecom. YOU On Demand is headquartered in both New York, NY and Beijing, China.

Safe Harbor Statement

This press release contains certain statements that may include “forward looking statements.” All statements other than statements of historical fact included herein are “forward-looking statements.” These forward looking statements are often identified by the use of forward-looking terminology such as “believes,” “expects” or similar expressions, involve known and unknown risks and uncertainties. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in the Company’s periodic reports that are filed with the Securities and Exchange Commission and available on its website (http://www.sec.gov). All forward-looking statements attributable to the Company or persons acting on its behalf are expressly qualified in their entirety by these factors. Other than as required under the securities laws, the Company does not assume a duty to update these forward-looking statements.

CONTACT:
Jason Finkelstein
YOU On Demand
212-206-1216
jason.finkelstein@yod.com
@youondemand
corporate.yod.com

Thursday, November 12th, 2015 Uncategorized Comments Off on (YOD) & CNTV to Partner Exclusively for IPTV SVOD/TVOD

(HOTR) Announces Grand Opening of BGR the Burger Joint in Springfield, VA

CHARLOTTE, NC–(November 12, 2015) – Chanticleer Holdings, Inc. (NASDAQ: HOTR) (Chanticleer Holdings, or the “Company”), owner and operator of multiple restaurant brands internationally and domestically, today announced that the grand opening of its new BGR the Burger Joint (“BGR”) at the Springfield Town Center in Springfield, Virginia will take place the weekend of November 13, 2015. This is the twenty-third BGR location.

One of the largest malls in northern Virginia, the Springfield Town Center reopened, bigger and better, in October 2014 after a two-year renovation. The mall is located at the famed “Mixing Bowl” interchange of Interstate 95, Interstate 395, and Interstate 495, one of the busiest highway junctions in the U.S. This is a prime location for BGR as it expands its footprint in the Washington D.C. area where its better-burger concept has been voted “Best Burger Restaurant in DC” by Business Insider, “Best Burger Restaurant in DC” by Washingtonian Magazine and “Best Burger Patty” by The Washington Post.

“The Springfield Town Center is an ideal location for the expansion of BGR in the D.C. area and we are especially excited about opening BGR’s first food court location, timed to capture the holiday shopping season,” stated Nate Ripley, President of BGR the Burger Joint. “The quality of our menu, highlighted by our prime, dry-aged burgers, is well known in the area and we’re excited to give our customers another premier location to enjoy the BGR experience.”

“Consumers are embracing the better burger concept and we’re pleased to be growing the BGR footprint in a region where this brand is already a proven success. As we actively pursue additional DC market locations for next year, we look forward to the continued growth of BGR with a strategy of adding corporate-owned locations when the opportunity arises, and opening locations with our franchise partners in both domestic and international markets,” said Mike Pruitt, CEO of Chanticleer Holdings, Inc.

Chanticleer Holdings has 62 locations worldwide including fifteen Hooters restaurants, five American Burger Co. restaurants, seven Just Fresh locations, twenty-three BGR the Burger Joint locations (including 13 franchise locations), four BT’s Burger Joint locations and eight Little Big Burger locations.

About BGR: The Burger Joint

BGR: The Burger Joint is helping lead the better burger market with a menu designed around our commitment to using only the highest quality ingredients. BGR’s menu is designed around an exclusive blend of Prime, Dry-aged burgers, grilled over an open flame. BGR operates stores domestically and internationally, with franchise opportunities in both markets. For more information, visit www.bgrtheburgerjoint.com, or follow us on Facebook (/BGRBurgerJoint) or Twitter (@BGRBurgerJoint).

About Chanticleer Holdings, Inc

Headquartered in Charlotte, NC, Chanticleer Holdings (HOTR), together with its subsidiaries, owns and operates restaurant brands in the United States and internationally. The Company is a franchisee owner of Hooters® restaurants in international markets including Australia, South Africa, and Europe, and two Hooters restaurants in the United States. The Company also owns and operates American Burger Co., BGR the Burger Joint, BT’s Burger Joint, Little Big Burger, and owns a majority interest in Just Fresh restaurants in the U.S.

For further information, please visit www.chanticleerholdings.com

Facebook: www.Facebook.com/ChanticleerHOTR

Twitter: http://Twitter.com/ChanticleerHOTR

Google+: https://plus.google.com/u/1/b/118048474114244335161/118048474114244335161/posts

Forward-Looking Statements:

Any statements that are not historical facts contained in this release are “forward-looking statements” as that term is defined under the Private Securities Litigation Reform Act of 1995 (PSLRA), which statements may be identified by words such as “expects,” “plans,” “projects,” “will,” “may,” “anticipates,” “believes,” “should,” “intends,” “estimates,” and other words of similar meaning. Such forward-looking statements are based on current expectations, involve known and unknown risks, a reliance on third parties for information, transactions or orders that may be cancelled, and other factors that may cause our actual results, performance or achievements, or developments in our industry, to differ materially from the anticipated results, performance or achievements expressed or implied by such forward-looking statements. Factors that could cause actual results to differ materially from anticipated results include risks and uncertainties related to the fluctuation of global economic conditions, the performance of management and our employees, our ability to obtain financing or required licenses, competition, general economic conditions and other factors that are detailed in our periodic reports and on documents we file from time to time with the Securities and Exchange Commission. The forward-looking statements contained in this press release speak only as of the date the statements were made, and the companies do not undertake any obligation to update forward-looking statements. We intend that all forward-looking statements be subject to the safe-harbor provisions of the PSLRA.

Press Information:
Chanticleer Holdings, Inc.
Investor Relations
Phone: 704.366.5122
ir@chanticleerholdings.com

Investor Relations
John Nesbett/Jennifer Belodeau
Institutional Marketing Services (IMS)
Phone 203.972.9200
jnesbett@institutionalms.com

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(LPCN) Announces PDUFA Goal Date for LPCN 1021 NDA

SALT LAKE CITY, Nov. 12, 2015  — Lipocine Inc. (NASDAQ:LPCN), a specialty pharmaceutical company, today announced that the U.S. Food and Drug Administration (“FDA”) has assigned a Prescription Drug User Fee Act (“PDUFA”) goal date of June 28, 2016 for completion of the review of the New Drug Application (“NDA”) for LPCN 1021, an oral testosterone product candidate for testosterone replacement therapy (“TRT”) in adult males for conditions associated with a deficiency or absence of endogenous testosterone (“hypogonadism”). Additionally, the 74-day filing communication letter did not mention a need to convene an Advisory Committee for advice on the NDA for LPCN 1021 and we confirmed in subsequent communication with the FDA that an Advisory Committee is not planned.

About LPCN 1021

LPCN 1021 is a novel twice-a-day, oral testosterone replacement therapy product candidate with three simple oral dosing options that Lipocine expects will overcome the major shortcomings of existing products. The current testosterone market is dominated by topical products that carry FDA “black box” warnings related to inadvertent transfer of testosterone and by injectable products. The IMS Health database shows that an average of half a million prescriptions a month has been dispensed so far in 2015 for TRT.

About Lipocine

Lipocine Inc. is a specialty pharmaceutical company developing innovative pharmaceutical products for use in men’s and women’s health using its proprietary drug delivery technologies. LPCN 1021 demonstrated positive efficacy and safety results in Phase 3 testing, is targeted for testosterone replacement therapy and has a NDA under review with the FDA. Additional pipeline candidates include LPCN 1111, a next generation oral testosterone replacement therapy product with once daily dosing, that is currently in Phase 2 testing, and LPCN 1107, which has the potential to become the first oral hydroxyprogesterone caproate product indicated for the prevention of recurrent preterm birth with orphan drug designation, that is currently in Phase 1 testing.

Forward-Looking Statements

This release contains “forward looking statements” that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and include statements that are not historical facts relating to expectations regarding the FDA review process relating to our NDA for LPCN 1021 and the outcome of such process, clinical trials, the potential uses and benefits of Lipocine’s product candidates, product development and commercialization efforts and the projected timing and outcome of regulatory filings and actions. Investors are cautioned that all such forward-looking statements involve risks and uncertainties, including, without limitation, the risks related to our products, expected product benefits, clinical and regulatory expectations and plans, regulatory developments and requirements, risks related to the FDA’s review of our NDA for LPCN 1021, the receipt of regulatory approvals, the results of clinical trials, patient acceptance of Lipocine’s products, the manufacturing and commercialization of Lipocine’s products, and other risks detailed in Lipocine’s filings with the U.S. Securities and Exchange Commission (the “SEC”), including, without limitation, its Form 10-K and other reports on Forms 8-K and 10-Q, all of which can be obtained on the Company’s website at www.lipocine.com or on the SEC website at www.sec.gov. Lipocine assumes no obligation to update or revise publicly any forward-looking statements contained in this release, except as required by law.

 

CONTACT:                                                                                 
Morgan Brown
Executive Vice President & Chief Financial Officer
Phone: (801) 994-7383 
Email: mb@lipocine.com

John Woolford
Phone: (443) 213-0500
john.woolford@westwicke.com
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(MNKD) Announces Pricing of Registered Direct Offering

VALENCIA, Calif., Nov. 12, 2015  — MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) today announced the pricing of its previously announced registered direct offering of its common stock to selected investment funds in Israel, as well as the total number of shares to be purchased in the offering. The purchasers in the offering have committed to purchase an aggregate of 13,852,435 shares of common stock at a price per share equal to $2.61 (based upon the exchange rate between the New Israeli Shekel and the U.S. Dollar on November 12, 2015). The gross proceeds from this offering are expected to be $36.2 million, before deducting placement agent fees, escrow agent fees and other estimated offering expenses payable by MannKind. The offering is expected to close on or about November 12, 2015, subject to customary closing conditions.

“We are very pleased with the dual listing in the Tel Aviv Stock Exchange. This listing offers a great opportunity for MannKind, allowing it to continue to leverage its business and clinical operations together with expanding its current investor base and creating opportunities for corporations with the local biomed industry. We would like to thank the Tel Aviv Stock Exchange for the opportunity to be listed for trade. We are committed to creating value for the current and new investors as one,” stated MannKind’s Chief Financial Officer, Matthew Pfeffer. Mr. Pfeffer went on to note, “A portion of the index funds’ required holdings have now been purchased directly from the company. These transactions provide MannKind with needed near term liquidity to support Afrezza operations and Technosphere developments, while minimizing shareholder dilution. Remaining demand from the TASE index funds’ long-term holding requirements are expected to be satisfied through open market purchases, which must be completed before Sunday, November 15, 2015.”

Sunrise Securities Corp. acted as MannKind’s exclusive placement agent in connection with the offering.  The shares were offered pursuant to MannKind’s effective registration statement on Form S-3 (File No. 333-333-206778) and a related prospectus supplement filed with the Securities and Exchange Commission (SEC) on November 9, 2015. Copies of the prospectus supplement and accompanying prospectus are available on the SEC’s website located at http://www.sec.gov and may also be obtained by contacting MannKind at 25134 Rye Canyon Loop, Suite 300, Valencia, CA 91355, Attn: Investor Relations, or by telephone at (661) 775-5300. 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, the shares in any state or other jurisdiction which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

Stock Exchange Listings 

MannKind’s common stock is listed on The Nasdaq Global Market and the Tel Aviv Stock Exchange (TASE). Investors should note that trading on The Nasdaq Global Market occurs Monday through Friday, 9:30 am to 4:00 pm Eastern Time, except on Nasdaq trading holidays, and trading on the TASE occurs Sunday from 8:30 am to 4:30 pm Israel time and Monday to Thursday from 8:30 am to 5:30 Israel time, except on TASE trading holidays. The TASE Clearing House is electronically linked to the Depository Trust Company, a subsidiary of the Depository Trust & Clearing Corporation, to automate the cross-border settlement of shares listed on both the TASE and a U.S. Exchange.

About MannKind Corporation

MannKind Corporation (Nasdaq:MNKD) (TASE:MNKD) focuses on the discovery and development of therapeutic products for patients with diseases such as diabetes. MannKind maintains a website at http://www.mannkindcorp.com to which MannKind regularly posts copies of its press releases as well as additional information about MannKind. Interested persons can subscribe on the MannKind website to e-mail alerts that are sent automatically when MannKind issues press releases, files its reports with the SEC or posts certain other information to the website.

Forward-Looking Statements

Statements contained in this press release that are not strictly historical in nature are forward-looking statements that involve risks and uncertainties. Words such as “believes”, “anticipates”, “plans”, “expects”, “intend”, “will”, “goal”, “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements are based upon the MannKind’s current expectations. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, the satisfaction of customary closing conditions, fluctuations in the New Israeli Shekel-to-U.S. Dollar exchange rate, MannKind’s dependency on Sanofi for commercialization of Afrezza, MannKind’s need and ability to raise additional capital and other risks detailed in MannKind’s filings with the SEC, including the Annual Report on Form 10-K for the year ended December 31, 2014, subsequently filed periodic reports on Form 10-Q and current reports on Form 8-K. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this press release. All forward-looking statements are qualified in their entirety by this cautionary statement, and MannKind undertakes no obligation to revise or update any forward-looking statements to reflect events or circumstances after the date of this press release.

CONTACT: Company Contact:
         Matthew J. Pfeffer
         Chief Financial Officer
         661-775-5300
         mpfeffer@mannkindcorp.com
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