Archive for December, 2014

(UBIC) Development of an AI-Based IP Property Valuation Tool w/ Toyota

TOKYO, Dec. 18, 2014  — UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) (“UBIC” or “the Company”), a leading provider of international litigation support and big-data analysis services, has commenced development of an AI-based intellectual property valuation tool in a joint project with Toyota Technical Development Corporation (“TTDC”).

In recent years, patent surveys in the manufacturing industry have seen a wider range of technology information subject to surveys, resulting in the necessity to study larger amounts of data. This is particularly true for electronic control technologies in the automotive industry, the research and development field of which has recently witnessed remarkable expansion. In addition, competition has been fierce in the automotive technology field relating to safety performance and fuel efficiency among other things, as well as in research and development for next-generation mobility. Accordingly, patent surveys for establishing rights to new technologies end up being labor-intensive processes.

In response to these trends, UBIC is partnering with TTDC in a joint effort to develop the Intellectual Property Virtual Data Scientist (VDS), an AI-based tool for intellectual property valuation. The Virtual Data Scientist, which is under development by UBIC, utilizes artificial intelligence capable of analyzing big data and learning from specialists’ decisions. Above all, the tool is able to learn outstanding tacit knowledge for analyses. It also learns from the discerning judgments made by specialists in a specific business domain and from the know-how accumulated in the domain through actual surveys. Therefore, UBIC expects that Intellectual Property VDS will significantly improve the efficiency of patent valuation operations of a company which employs intellectual property specialists (such as people from R&D and intellectual property departments and patent attorneys) by reducing the time spent on the evaluation operations.

Through the development of Intellectual Property VDS, UBIC will help create an environment which allows people working in intellectual property-related functions to concentrate on higher-level survey operations, thereby contributing to the development of the intellectual property field.

About TTDC

Since Toyota Technical Development Corporation (TTDC)’s establishment in 2006 as Toyota Motor Corporation (TMC)’s technological development partner, TTDC has played a key role in vehicle development.

On November 26, 2014, TMC and TTDC have agreed to reorganize TTDC on January 1, 2016.

The reorganization will enable TTDC to focus solely on development support such as intellectual property and effectively utilize its accumulated practical expertise. TTDC will be able to expand its services to support other members of the Toyota Group, thus helping to strengthen the vehicle development capabilities across the entire group.

For more information please visit: URL: http://www.toyota-td.jp/.

About UBIC

UBIC, Inc. (Nasdaq:UBIC) (TSE:2158) is a leading provider of e-discovery and digital forensic services for Asia and the world. UBIC has extensive experience working with electronically stored information composed in Chinese, Japanese and Korean (CJK) languages and utilizes that expertise for clients involved in cross-border litigation, corporate investigations, intellectual property disputes and much more. At the forefront of e-discovery innovation, UBIC’s proprietary Lit i View® platform is moving the industry from “fact discovery” to “future discovery” by allowing clients to analyze e-mail messages and digital communications found in big-data to reveal patterns in human thought and behavior.

For more information about UBIC, contact usinfo@ubicna.com

Safe Harbor Statement

This announcement contains forward-looking statements. These forward-looking statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. These statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, the amount of data that UBIC expects to manage this year and the potential uses for UBIC’s new service in intellectual property-related litigation, contain forward-looking statements. UBIC may also make written or oral forward-looking statements in its reports filed with, or furnished to, the U.S. Securities and Exchange Commission, in its annual reports to shareholders, in press releases and other written materials and in oral statements made by its officers, directors or employees to third parties. Statements that are not historical facts, including statements about UBIC’s beliefs and expectations, are forward-looking statements. Forward-looking statements involve inherent risks and uncertainties. A number of factors could cause actual results to differ materially from those contained in any forward-looking statement, including but not limited to the following: UBIC’s goals and strategies; UBIC’s expansion plans; the expected growth of the data center services market; expectations regarding demand for, and market acceptance of, UBIC’s services; UBIC’s expectations regarding keeping and strengthening its relationships with customers; UBIC’s plans to invest in research and development to enhance its solution and service offerings; and general economic and business conditions in the regions where UBIC provides solutions and services. Further information regarding these and other risks is included in UBIC’s reports filed with, or furnished to the Securities and Exchange Commission. UBIC does not undertake any obligation to update any forward-looking statement, except as required under applicable law. All information provided in this press release and in the attachments is as of the date of this press release, and UBIC undertakes no duty to update such information, except as required under applicable law.

CONTACT: Yukari Nakajima
         UBIC North America, Inc.
         Tel: (212) 924-8242
         yukari_nakajima@ubic.co.jp
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(TLOG) Initiation Of Phase 2 Clinical Trial of SHAPE in Cutaneous T-Cell Lymphoma

MALVERN, Pa., Dec. 18, 2014  — TetraLogic Pharmaceuticals Corporation (Nasdaq:TLOG) today announced the initiation of a randomized Phase 2 clinical trial of SHAPE in subjects with early stage cutaneous T‑cell lymphoma (“CTCL”).

SHAPE has been evaluated in a randomized, dose escalation, placebo-controlled Phase 1 clinical trial in early-stage CTCL subjects that met safety endpoints and demonstrated clinical activity. Four of fifteen patients receiving SHAPE attained an objective response as measured by a greater than 50% improvement in their Composite Assessment of Index Lesion Severity, or CAILS, score during and after 28 days of dosing. No placebo patients responded.

The randomized Phase 2 trial will be conducted in approximately sixty subjects with Stage IA-IIA CTCL. The objectives of the Phase 2 clinical trial are to evaluate the dose, clinical effect at 6 months (based on CAILS score), time to response, and tolerability of treatment of >2% body surface area.

“We are excited to advance our second molecule into a randomized Phase 2 trial,” said J. Kevin Buchi, President and Chief Executive Officer of TetraLogic. “SHAPE’s Phase 1 data suggests that it may provide significant clinical benefit over existing CTCL therapies, and we are hopeful that those data are replicated over a longer duration and a broader body surface area.”

About SHAPE

SHAPE is an HDAC inhibitor being developed for topical use for the treatment of cutaneous T‑cell lymphoma, or CTCL. SHAPE is a novel therapeutic designed to maximize HDAC inhibition locally in the skin with limited systemic exposure. As a result, SHAPE has characteristics that could allow it to be used topically over large body surface areas with minimal systemic absorption. SHAPE’s composition of matter patent in the U.S. extends until at least 2028; in addition, SHAPE has been granted U.S. orphan drug designation for CTCL. We have acquired worldwide development and commercialization rights to SHAPE for all indications.

About TetraLogic Pharmaceuticals Corporation

TetraLogic is a clinical-stage biopharmaceutical company focused on discovering and developing novel small molecule therapeutics in oncology and infectious diseases. TetraLogic has two clinical-stage product candidates in development: birinapant and SHAPE. Birinapant is currently being tested in Phase 1 and Phase 2 clinical trials for hematological malignancies and solid tumors, and is also being tested in a Phase 1b/2a clinical trial in hepatitis B. SHAPE is currently being tested in a Phase 2 clinical trial for early-stage cutaneous T‑cell lymphoma.

Forward Looking Statements

Some of the statements in this release are forward looking statements within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Securities Exchange Act of 1934 and the Private Securities Litigation Reform Act of 1995, which involve risks and uncertainties. These statements relate to future events or TetraLogic’s pre-clinical and clinical development of birinapant, SHAPE and other clinical programs, future expectations, plans and prospects. Although TetraLogic believes that the expectations reflected in such forward-looking statements are reasonable as of the date made, expectations may prove to have been materially different from the results expressed or implied by such forward-looking statements. TetraLogic has attempted to identify forward looking statements by terminology including ”believes,” ”estimates,” ”anticipates,” ”expects,” ”plans,” ”projects,” ”intends,” ”potential,” ”may,” ”could,” ”might,” ”will,” ”should,” ”approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. These statements are only predictions and involve known and unknown risks, uncertainties, and other factors, including those discussed under the heading “Risk Factors” in our Annual Report on Form 10-K filed with the U.S. Securities and Exchange Commission (SEC) on March 19, 2014 and in our form 10-Q filed with the SEC on November 5, 2014. Any forward-looking statements contained in this release speak only as of its date. We undertake no obligation to update any forward-looking statements contained in this release to reflect events or circumstances occurring after its date or to reflect the occurrence of unanticipated events.

CONTACT: Company Contact:
         Pete A. Meyers
         Chief Financial Officer and Treasurer
         TetraLogic Pharmaceuticals Corporation
         (610) 889 - 9900, x103
         Pete.meyers@tlog.com

         Investor Relations Contact:
         Ami Bavishi
         Burns McClellan, Inc.
         (212) 213-0006
         abavishi@burnsmc.com
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(STEM) Transplants First Participant in Phase II Clinical Trial in Cervical Spinal Cord Injury

Pathway Study to Assess the Potential of Human Neural Stem Cells to Restore Motor Function

NEWARK, Calif., Dec. 18, 2014  — StemCells, Inc. (Nasdaq:STEM), a world leader in the research and development of cell-based therapeutics for the treatment of disorders of the central nervous system, announced today that it has transplanted the first subject in its Phase II Pathway® Study assessing the efficacy of its proprietary HuCNS-SC® (purified human neural stem cells) platform technology for the treatment of cervical spinal cord injury (SCI). The transplant was performed at the University of Miami Hospital within the Miller School of Medicine, home to The Miami Project to Cure Paralysis, one of the world’s most comprehensive spinal cord injury research centers dedicated to finding effective treatments for paralysis.

“The participant tolerated the procedure well and is recovering from the surgery as expected,” said Allan D. Levi, M.D., Ph.D., F.A.C.S., Robert M. Buck Distinguished Chair in Neurological Surgery at the University of Miami Miller School of Medicine and Principal Investigator for the center. “Our center is a leader in clinical research aimed at curing paralysis, and we are excited to be participating in this breakthrough approach to spinal cord injury repair. The Pathway study is designed to measure the potential of these human neural stem cells, HuCNS-SC, as a possible treatment for repairing some aspects of spinal cord injury. Restoring or improving motor function would be life changing for these patients.”

The Pathway Study is the first clinical trial designed to evaluate both the safety and efficacy of transplanting human neural stem cells into patients with cervical spinal cord injury. Traumatic injuries to the cervical (neck) region of the spinal cord, also known as tetraplegia or quadriplegia, impair sensation and motor function of the hands, arms, legs, and trunk. The trial will be conducted as a randomized, controlled, single-blind study and efficacy will be primarily measured by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms, and shoulders. The trial will follow the participants for one year and will enroll up to 52 subjects.

“We are working with all due speed to pioneer a revolutionary therapeutic approach for victims of spinal cord injury, a debilitating condition that has significant unmet need and no effective treatment,” said Stephen Huhn, M.D., FACS, FAAP, Vice President, Clinical Research and CMO at StemCells, Inc. “Enrollment of the first patient with cervical injury is an important step in our clinical development, which ultimately has the goal of improving motor function and restoring a level of independence for individuals living with chronic spinal cord injury. The Pathway Study is a natural evolution from our Phase I/II trial in thoracic spinal cord injury.”

The Company completed enrollment and dosing in its open-label Phase I/II study in thoracic spinal cord injury in May 2014 and has reported interim results on all 12 subjects. Post-transplant gains in sensory function below the level of injury were demonstrated in half of the subjects. Two subjects converted from a complete injury (AIS A) to an incomplete injury (AIS B). The interim results also continue to confirm the favorable safety profile of the cells and the surgical procedure.

About the Pathway Spinal Cord Injury Clinical Trial

The StemCells, Inc. Pathway Phase II clinical trial, titled “Study of Human Central Nervous System (CNS) Stem Cell Transplantation in Cervical Spinal Cord Injury,” will evaluate the safety and efficacy of transplanting the Company’s proprietary human neural stem cells (HuCNS-SC cells), into patients with traumatic injury in the cervical region of the spinal cord. Conducted as a randomized, controlled, single-blind study, the trial will measure efficacy by assessing motor function according to the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI). The primary efficacy outcome will focus on change in upper extremity strength as measured in the hands, arms and shoulders. The trial will enroll approximately 52 subjects and follow the patients for 12 months post-transplant.

Information about the Company’s spinal cord injury program can be found on the StemCells, Inc. website at:

http://www.stemcellsinc.com

Patient testimonials from the Phase I/II study can be found at:

http://www.stemcellsinc.com/News-Events/Video-Library.htm

Information for patients interested in participating in the study is available at the Pathway website at:

http://www.sciresearchstudy.com

Additional information about the clinical trial is available at:

http://clinicaltrials.gov/ct2/show/NCT02163876?term=stem+cells+cervical+spinal+cord+injury&rank=1

About HuCNS-SC Cells

StemCells, Inc. has demonstrated human safety data from completed and ongoing clinical studies in which its proprietary HuCNS-SC cells have been transplanted directly into all three components of the central nervous system: the brain, the spinal cord and the eye. StemCells, Inc. clinicians and scientists believe that HuCNS-SC cells may have broad therapeutic application for many diseases and disorders of the CNS. Because the transplanted HuCNS-SC cells have been shown to engraft and survive long-term, there is the possibility of a durable clinical effect following a single transplantation. The HuCNS-SC platform technology is a highly purified composition of human neural stem cells (tissue-derived or “adult” stem cells). Manufactured under cGMP standards, the Company’s HuCNS-SC cells are purified, expanded in culture, cryopreserved and then stored as banks of cells, ready to be made into individual patient doses when needed.

About StemCells, Inc.

StemCells, Inc. is currently engaged in clinical development of its HuCNS-SC (purified human neural stem cells) platform technology, as a potential treatment for diseases and disorders of the central nervous system. Interim data from the Company’s Phase I/II clinical trial in thoracic spinal cord injury shows measurable gains involving multiple sensory modalities and segments in half of the subjects, two of whom converted from complete injury (AIS A) to incomplete injury (AIS B), post-transplant. Enrollment has recently commenced in the Company’s Phase II clinical trial in cervical SCI. StemCells, Inc. has also completed enrollment and treatment in its Phase I/II clinical trial in geographic atrophy of age-related macular degeneration (GA-AMD), the most severe form of dry AMD, which is the leading cause of blindness in the elderly. Interim results for those subjects with 12 month follow-up post transplantation of HuCNS-SC cells into the eye, show a reduction in the rate of disease progression as compared to the control (untreated) eye and to the expected natural history of the disease. In a Phase I clinical trial in Pelizaeus-Merzbacher disease (PMD), a fatal myelination disorder in children, the Company showed preliminary evidence of progressive and durable donor-derived myelination in all four patients transplanted with HuCNS-SC cells. Further information about StemCells, Inc. is available at http://www.stemcellsinc.com.

Apart from statements of historical fact, the text of this press release constitutes forward-looking statements within the meaning of the U.S. securities laws, and is subject to the safe harbors created therein. These statements include, but are not limited to, statements regarding whether the improvements in sensory function seen in the Company’s Phase I/II clinical study of spinal cord injury will persist and whether they will prove to be clinically meaningful; the prospect for evaluating trial patients for changes in their sensation, motor function and bowel/bladder function; the potential of the Company’s HuCNS-SC cells to treat spinal cord injury and other central nervous system disorders; and the future business operations of the Company, including its ability to conduct clinical trials as well as its other research and product development efforts. These forward-looking statements speak only as of the date of this news release. The Company does not undertake to update any of these forward-looking statements to reflect events or circumstances that occur after the date hereof. Such statements reflect management’s current views and are based on certain assumptions that may or may not ultimately prove valid. The Company’s actual results may vary materially from those contemplated in such forward-looking statements due to risks and uncertainties to which the Company is subject, including the fact that additional trials will be required to demonstrate the safety and efficacy of the Company’s HuCNS-SC cells for the treatment of any disease or disorder; uncertainty as to whether the FDA or other applicable regulatory agencies will permit the Company to continue clinical testing in spinal cord injury or in future clinical trials of proposed therapies for other diseases or conditions; uncertainties regarding the Company’s ability to recruit the patients required to conduct its clinical trials or to obtain meaningful results; uncertainties regarding the Company’s ability to manufacture viable cells sufficient to enroll the patients planned for the Company’s Phase II studies; uncertainties regarding the Company’s ability to obtain the increased capital resources needed to continue its current and planned research and development operations; uncertainty as to whether HuCNS-SC cells and any products that may be generated in the future in the Company’s cell-based programs will prove safe and clinically effective and not cause tumors or other adverse side effects; and other factors that are described under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013, and in its subsequent reports on Form 10-Q and Form 8-K.

CONTACT: Greg Schiffman
         StemCells, Inc.
         Chief Financial Officer
         (510) 456-4128

         Andrea Flynn
         Russo Partners
         (646) 942-5631
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(AGEN) Positive Phase 3 Study, (GSK) Shingles Vaccine w/ Agenus Adjuvant

  • GSK’s ZOE-50 Phase 3 study meets primary endpoint of reducing the risk of shingles in people aged 50 and older
  • Agenus is entitled to receive royalties on potential commercial sales of HZ/su

LEXINGTON, Mass., Dec. 18, 2014 — Agenus Inc. (Nasdaq:AGEN), an immuno-oncology company developing a broad portfolio of checkpoint modulators (CPMs) and heat shock protein peptide-based vaccines as well as adjuvants, announced that its partner GlaxoSmithKline (NYSE:GSK) reported that the ZOE-50 Phase 3 study met its primary endpoint. Analysis of the primary endpoint showed that HZ/su reduced the risk of shingles by 97.2 per cent in adults aged 50 years and older compared to placebo.

HZ/su is a novel candidate vaccine that combines gE, a protein found on the varicella-zoster virus that causes shingles, with GSK’s Adjuvant System, AS01B, which serves to stimulate a stronger immunological response to the vaccine. Agenus’ QS-21 Stimulon® adjuvant is one of the key components of AS01, which is used in other vaccine candidates undergoing clinical development.

Agenus is entitled to receive royalties on potential commercial sales of HZ/su.

We are thrilled with the results of this important study,” said Garo Armen, Ph.D., Chief Executive Officer of Agenus, “The results indicate unprecedented protection against shinglesHZ/su is the second candidate vaccine containing QS-21 saponin to produce positive phase 3 results.”

The study, which started in August 2010, is a randomized, placebo-controlled, multicenter, international study involving 16,136 adults aged 50 and older. An additional GSK trial to evaluate the ability of HZ/su to prevent shingles is underway in adults aged 70 and older (ZOE-70). This study will provide additional information on the efficacy of HZ/su vaccine candidate in preventing some of the complications of shingles, the most common being chronic neuropathic pain, also known as post-herpetic neuralgia (PHN)i.

Data from GSK’s ZOE-50 study are expected to be presented at a forthcoming scientific conference and will be submitted for publication in a peer-reviewed journal.

About shingles

Shingles typically presents as a painful, itchy rash that develops on one side of the body, as a result of reactivation of latent chickenpox virus (varicella-zoster virus, VZV). Complications from shingles can include scarring, vision complications, secondary infection, nerve palsies and PHN, the most common complication. The lifetime risk of developing shingles is approximately 1 in 3.

About QS-21 Stimulon

Agenus’ flagship adjuvant, QS-21 Stimulon® adjuvant, is a saponin extracted from the bark of the Quillaja saponaria tree, also known as the soap bark tree, an evergreen tree native to warm temperate central Chile. Agenus’ QS-21 Stimulon has become a key component in the development of investigational preventive vaccine formulations across a wide variety of infectious diseases and in several investigational therapeutic vaccines intended to treat cancer and degenerative disorders. QS-21 Stimulon has been widely studied in approximately 50,000 people. Agenus is generally entitled to receive milestone payments as QS-21 Stimulon containing programs advance, as well as royalties for 10 years after commercial launch, with some exceptions.

About Agenus

Agenus is an immuno-oncology company developing a portfolio of checkpoint modulators (CPMs), heat shock protein peptide-based vaccines and adjuvants. Agenus’ checkpoint modulator programs target GITR, OX40, CTLA-4, LAG-3, TIM-3 and PD-1. The company’s proprietary discovery engine Retrocyte Display® is used to generate fully human and humanized therapeutic antibody drug candidates. The Retrocyte Display platform uses a high-throughput approach incorporating IgG format human antibody libraries expressed in mammalian B-lineage cells. Agenus’ heat shock protein vaccines for cancer and infectious disease are in Phase 2 studies. The company’s QS-21 Stimulon® adjuvant platform is extensively partnered with GlaxoSmithKline and Janssen and includes several vaccine candidates in Phase 2 and Phase 3 clinical trials. For more information, please visit www.agenusbio.com, or connect with the company on Facebook, LinkedIn, Twitter and Google+.

Forward-Looking Statement

This press release contains forward-looking statements that are made pursuant to the safe harbor provisions of the federal securities laws, including statements regarding research and development and clinical trial activities and results, the presentation and publication of data, potential revenue streams, and the potential application of the Company’s and its licensee’s technologies and product candidates in the prevention and treatment of diseases. These forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from those projected. These risks and uncertainties include, among others, the factors described under the Risk Factors section of our most recently filed Quarterly Report on Form 10-Q with the Securities and Exchange Commission. Agenus cautions investors not to place considerable reliance on the forward-looking statements contained in this release. These statements speak only as of the date of this document, and Agenus undertakes no obligation to update or revise the statements, other than to the extent required by law. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. Agenus’ business is subject to substantial risks and uncertainties, including those identified above. When evaluating Agenus’ business and securities, investors should give careful consideration to these risks and uncertainties.

Agenus includes its affiliates for purposes of this press release. Retrocyte Display and Stimulon are registered trademarks of Agenus Inc. and its subsidiaries.

i Johnson, RW et al N Engl J Med 2014;371:1526-33

CONTACT: Brad Miles
         BMC Communications
         646-513-3125
         bmiles@bmccommunications.com
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(OBCI) CEO Explains Its New Disinfectant, Effective and Safe against Viruses, Germs, Bacteria

Launching Product in Numerous Huge Markets

FORT LAUDERDALE, Fla., Dec. 18, 2014 — Ocean Bio-Chem, Inc. (NASDAQ: OBCI) said today in an interview with CEOLIVE.TV that its new product, Performacide®, kills bacteria, mold, mildew and non-enveloped viruses that the CDC has issued guidance on including a disinfectant for Ebola.

Performacide® has been approved and registered with the United States Environmental Protection Agency, as well as all 50 state environmental agencies. The CEO interview can be viewed in its entirety at: https://www.youtube.com/watch?v=qeSLD2juFzk. Ocean Bio-Chem owns 100 percent of the patents for the chlorine dioxide generating system which allows retail as well as commercial applications to safely and efficiently use Performacide®. The product has already been sent to Africa to aid in the fight against the Ebola virus.

Ocean Bio-Chem. Inc. President and CEO Peter Dornau in the interview said the Company has added a Vice President of Sales & Marketing to market and sell this product to potential large markets, including hospitals, cruise ship lines, veterinary offices, food processing and the household retail sector.

Jeff Barocas, CFO, said, “There will be no patent royalty payments and no partners. One hundred percent of the profit from the sale of the products will accrue to Ocean Bio-Chem after buying out our partners earlier in the year.”

Mr. Dornau also explained that Performacide® can safely kill the microorganisms that prematurely destroy food and that the Company is studying applications in that sector also.

Ocean Bio-Chem, Inc. is principally engaged in the manufacturing, marketing and distribution of a broad line of appearance and maintenance products for boats, recreational vehicles, automobiles, power sports, outdoor power equipment and motorcycle markets under the Star brite® StarTron® and other trademarks within the United States of America and Canada. In addition, the Company produces private label formulations of many of its products for various customers and provides custom blending and packaging services for these and other products. It manufactures its products in a 300,000 square foot facility in Montgomery, Alabama, from which they are distributed across the globe.

The Company trades publicly under NASDAQ Capital Markets, Ticker Symbol: OBCI.

The Company’s web sites are:
www.oceanbiochem.com, www.Starbrite.com, www.Startron.com, www.nos-guard.com, and www.performacide.com

About CEOLIVE.TV:

CEOLIVE is an investor media provider featuring publicly traded companies. Presentations address topics related to the company’s business performance and strategy but are not intended to provide the first announcement of material information or developments. They will discuss matters announced through other channels or that are not themselves considered material information under securities laws, even though the matters may be important to shareholders. To find out more, please visit: http://www.ceolive.tv.

Forward-looking Statements:
Certain statements contained in this Press Release including without limitation expectations as to future sales and operating results, constitute forward-looking statements. For this purpose, any statements contained in this report that are not statements of historical fact may be deemed forward-looking statements. Without limiting the generality of the foregoing, words such as “believe,” “may,” “will,” “expect,” “anticipate,” “intend,” “could” including the negative or other variations thereof or comparable terminology are intended to identify forward-looking statements. These statements involve known and unknown risks, uncertainties and other factors which may cause our actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Factors that may affect these results include, but are not limited to, the highly competitive nature of our industry, reliance on certain key customers, changes in consumer demand for marine, recreational vehicle and automotive products, advertising and promotional efforts, exposure to market risks for changes in interest rates and in foreign exchange rates, and other factors.

Contacts:

Peter Dornau
President & CEO
pdornau@starbrite.com
954-587-6280

Jeff Barocas
Vice President & CFO
Jbarocas@starbrite.com
954-587-6280

Paul Knopick
E & E Communications
pknopick@eandecommunications.com
940-262-3584

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(RBY) Begins Stockpiling Mill Feed for Projected Production Commencing Mid-2015

TORONTO, ONTARIO–(Dec 18, 2014) – Rubicon Minerals Corporation (TSX:RMX)(NYSE MKT:RBY) (“Rubicon” or the “Company“) is pleased to announce that the construction of the Phoenix Gold Project (“Project“) in Red Lake, Ontario, Canada continues on schedule for projected initial production in mid-2015 and remains well-funded to completion. Underground development rates have improved significantly in October and November, to the point where the stockpiling of mineralized development material from the first planned stopes has begun.

“We are pleased to announce that underground development rates have significantly improved since September and we are realizing better productivity and cost savings,” stated Michael A. Lalonde, President and Chief Executive Officer for Rubicon. “Our operations team began stockpiling mineralized material from underground stope development last week, ahead of schedule. One of the stopes being developed is a trial stope located between the 305- and 244-metre levels, which will utilize the Alimak longhole method. This trial stope will provide us with valuable information with regard to dilution, recovery, and productivity as we march forward to projected initial production in mid-2015. Underground stope development will accelerate in January as several new stopes are being developed.”

The Phoenix Gold Project Development and Construction Update

Mill Construction

Mill construction is on budget and on schedule. The Company expects that the mill will be fully commissioned in the second quarter of 2015. The drive train for the ball mill has been installed and aligned and the drive train for the SAG mill is currently being installed. The Knelson concentrators, which recover gold via gravity, are currently being installed. All structural steel in the mill, with the exception of the installation of the stairwells, is complete. The carbon-in-leach (“CIL“) tank shells have been welded and the top rings and platforms are being installed. The paste plant filters and vacuum receivers have been placed and are ready to be installed. The construction of the refinery, mill thickener and cyanide destruction circuits are progressing as planned.

Rubicon has approximately C$27 million (as at November 30, 2014) of mill capital expenditures remaining to projected initial production.

Stockpiling, Underground Development and Construction

The Company began to stockpile mineralized material on surface from underground stope development on the 244- and 305-metre levels. Some of the stockpiled material will be fed to the mill during the commissioning phase and the remainder will be used for the projected production phase.

Underground development rates have improved month-over-month since September at an accelerated pace. The Company surpassed its monthly development target for November. Rubicon crews have exceeded productivity levels achieved by previous contractors, as they develop the 122-, 183- and 244-metre levels. The new contractors have also outperformed previous contractors, as they develop 305- and 610-metre levels, the 685-metre loading pocket and the vertical raises.

The trial stope will utilize the Alimak longhole method (horizontal holes), as recommended by SRK Consulting in the Preliminary Economic Assessment. This method does not require sublevel development between main levels, which the Company believes will reduce overall underground development requirements from the original plan. The Alimak longhole method also has the potential to increase productivity, reduce costs and speed up stope cycle time. See Figure 1 for a diagram of the Alimak longhole method.

As of November 30, 2014, Rubicon has completed 3,586 m of the planned 8,023 m (or 45%) of total underground development (lateral and vertical) at the 685-metre level and above. Overall underground development has tracked behind the original schedule by 948 m. Management believes it has identified approximately 430 m of off-ramp development that can be eliminated from the development plan. This, combined with the accelerated pace of development, is expected to bring the underground development back on schedule in the first quarter of 2015. Summary of the total underground development is displayed in Figure 2. There is approximately C$29 million (as at November 30, 2014) of total underground development capital remaining to the start of projected initial production.

Surface Infrastructure and On-Site Construction

The construction of the crushed ore bin, with a design capacity of 2,500 tonnes, has been completed. The tailings management facility (“TMF“) is ready to receive tailings for up to a year of potential production and will have the capacity to handle two years of potential production in early 2015. Rubicon has approximately C$19 million (as at November 30, 2014) of on-site construction remaining to completion.

See Figure 3 for pictures of the construction and development progress of the Project. For more up to date pictures of the construction and development progress, please visit our website at http://www.rubiconminerals.com/Investors/Photo-Galleries/default.aspx.

Project Capital and Timeline to Projected Initial Production

As of November 30, 2014, Rubicon estimates that capital expenditures to projected initial production is C$85 million (which includes C$14 million of contingency). A breakdown of the capital expenditures remaining can be seen in Table 1. Rubicon has approximately C$140 million in cash and cash equivalents (C$110 million in working capital) on its balance sheet as of November 30, 2014 and expects to receive an additional US$12 million from the Royal Gold streaming transaction in early 2015, as spending on construction and development approaches completion. The Phoenix Gold Project remains well-funded to complete construction and remains on schedule for projected initial production in mid-2015.

Table 1: Capital Expenditures to Projected Initial Production – as at November 30, 2014

Project capex spent, October 1, 2011 to November 30, 2014 ~C$299 million
Remaining capex to projected initial production
Mill ~C$27 million
Underground development ~C$29 million
On-site construction ~C$19 million
Indirects & definition drilling ~C$10 million
Total remaining capex to projected production (with contingency) ~C$85 million

Credit Facility

As Rubicon approaches the completion of the construction phase of the Project, the Company is evaluating its working capital requirements beyond projected production. In this regard, the Company is currently evaluating debt alternatives for approximately C$50 million.

About Rubicon Minerals Corporation

Rubicon Minerals Corporation is an advanced stage gold development company. The Company is focused on responsible and environmentally sustainable development of its Phoenix Gold Project in Red Lake, Ontario. The start of potential gold production is projected in mid-2015, based on current forecasts. The Phoenix Gold Project is fully permitted for initial production at 1,250 tonnes per day. In addition, Rubicon controls over 100 square miles of prime exploration ground in the prolific Red Lake gold district which hosts Goldcorp’s high-grade, world class Red Lake Mine. Rubicon’s shares are listed on the NYSE MKT (RBY) and the Toronto Stock Exchange (RMX).

RUBICON MINERALS CORPORATION

Mike Lalonde, President and Chief Executive Officer

Cautionary Statement regarding Forward-Looking Statements and other Cautionary Notes

Forward-Looking Statements

This news release contains statements that constitute “forward-looking statements” and “forward looking information” (collectively, “forward-looking statements”) within the meaning of applicable Canadian and United States securities legislation. Forward-looking statements include, but are not limited to statements regarding the anticipated composition and timeline of the underground development of the Phoenix Gold Project and potential production being achieved in mid-2015.

Forward-looking statements are based on the opinions and estimates of management as of the date such statements are made and represent management’s best judgment based on facts and assumptions that management considers reasonable. The material assumptions upon which such forward-looking statements are based include, among others, that: the demand for gold and base metal deposits will develop as anticipated; the price of gold will remain at levels that will render the Phoenix Gold Project economic; operating and capital plans will not be disrupted by operational issues, power supply, labour disturbances, or adverse weather conditions; Rubicon will meet its estimated timeline for the development of the Phoenix Gold Project; Rubicon will continue to have the ability to attract and retain skilled staff; the mineral resource estimate as disclosed in the Preliminary Economic Assessment with an effective date of June 25, 2013 and with an issue date of February 28, 2014 (the “PEA“) will be realized; and there are no material unanticipated variations in the cost of energy or supplies, or in the pre-production capital and operating cost estimate as disclosed in the PEA.

Forward-looking statements involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievements of Rubicon to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements. Such factors include, among others: possible variations in mineralization, grade or recovery rates; actual results of current exploration activities; actual results of reclamation activities; conclusions of future economic evaluations; changes in project parameters as plans continue to be refined; failure of equipment or processes to operate as anticipated; accidents and other risks of the mining industry; delays and other risks related to construction activities and operations; timing and receipt of regulatory approvals of operations; the ability of Rubicon and other relevant parties to satisfy regulatory requirements; the availability of financing for proposed transactions and programs on reasonable terms; the ability of third-party service providers to deliver services on reasonable terms and in a timely manner; market conditions and general business, economic, competitive, political and social conditions.

The PEA is preliminary in nature as it includes inferred mineral resources that are considered too speculative geologically to have the economic considerations applied to them that would enable them to be categorized as mineral reserves and there is no certainty that the PEA will be realized. Mineral resources that are not mineral reserves do not have demonstrated economic viability. The estimate of mineral resources may be materially affected by environmental, permitting, legal, title, taxation, socio-political, marketing, or other relevant issues. The quantity and grade of reported inferred resources referred to in the PEA are uncertain in nature and there has been insufficient exploration to define these inferred resources as an indicated or measured mineral resource category.

It is important to note that the information provided in this news release is preliminary in nature. There is no certainty that a potential mine will be realized. A mine production decision that is not based on a feasibility study demonstrating economic and technical viability does not provide adequate disclosure of the increased uncertainty and specific risks of failure associated with such a production decision. While no production decision has been made, there are inherent risks in proceeding with the development of the project and the company’s planning for the project and these include, gold price forecasts, capital cost overruns, availability of skilled labor, environmental compliance and restrictions, community matters, potential operating cost estimates, mining costs, development costs, underground mining and geotechnical risks, metal recoverability, milling costs, and related matters.

Forward-looking statements contained herein are made as of the date of this news release and Rubicon disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or results or otherwise, except as required by applicable securities laws. There can be no assurance that forward-looking statements will prove to be accurate, as actual results and future events could differ materially from those anticipated in such statements. Accordingly, readers should not place undue reliance on forward-looking statements.

Cautionary Note to U.S. Readers Regarding Estimates of Indicated and Inferred Resources

This news release uses the terms “measured” and “indicated” mineral resources and “inferred” mineral resources. The Company advises U.S. investors that while these terms are recognized and required by Canadian securities administrators, they are not recognized by the SEC. The estimation of “measured” and “inferred” mineral resources involves greater uncertainty as to their existence and economic feasibility than the estimation of proven and probable reserves. The estimation of “inferred” resources involves far greater uncertainty as to their existence and economic viability than the estimation of other categories of resources. It cannot be assumed that all or any part of a “measured”, “inferred” or “indicated” mineral resource will ever be upgraded to a higher category.

Under Canadian rules, estimates of “inferred mineral resources” may not form the basis of feasibility studies, pre-feasibility studies or other economic studies, except in prescribed cases, such as in a preliminary economic assessment under certain circumstances. The SEC normally only permits issuers to report mineralization that does not constitute “reserves” as in-place tonnage and grade without reference to unit measures. Under U.S. standards, mineralization may not be classified as a “reserve” unless the determination has been made that the mineralization could be economically and legally produced or extracted at the time the reserve determination is made. U.S. investors are cautioned not to assume that any part or all of a “measured”, “indicated” or “inferred” mineral resource exists or is economically or legally mineable. Information concerning descriptions of mineralization and resources contained herein may not be comparable to information made public by U.S. companies subject to the reporting and disclosure requirements of the SEC.

Mineral Resources

Mineral resources that are not mineral reserves do not have demonstrated economic viability. The estimate of mineral resources may be materially affected by environmental, permitting, legal, title, taxation, socio-political, marketing, or other relevant issues. The quantity and grade of reported inferred resources in this estimation are uncertain in nature and there has been insufficient exploration to define these inferred resources as an indicated or measured mineral resource and it is uncertain if further exploration will result in upgrading them to an indicated or measured mineral resource category. The inclusion of inferred mineral resources are considered too speculative geologically to have the economic considerations applied to enable them to be categorized as mineral reserves. The mineral resources in this press release were reported using CIM Standards.

Qualified Persons

The content of this news release has been read and approved by Dan Labine, P.Eng., Vice President, Operations and Mark Ross, B.Sc., P.Geo., Chief Mine Geologist for Rubicon. Both are Qualified Persons as defined by NI 43-101.

To view “Figure 1: Conceptual Diagram of the Alimak Longhole Stoping Method” please visit: http://media3.marketwire.com/docs/984742fig1.png.

To view “Figure 2: Cumulative Underground Development Advancement (as of November 30, 2014)” please visit: http://media3.marketwire.com/docs/984742fig2.png.

To view “Figure 3: Pictures of Project Mill and On-Site Construction” please visit the following links:

Panoramic view inside the mill building: http://media3.marketwire.com/docs/984742fig3.1.jpg.

SAG and ball mill installation: http://media3.marketwire.com/docs/984742fig3.2.png.

Knelson concentrators installation: http://media3.marketwire.com/docs/984742fig3.3.png.

CIL tank construction: http://media3.marketwire.com/docs/984742fig3.4.jpg.

Mill thickener: http://media3.marketwire.com/docs/984742fig3.5.png.

Crushed ore bin: http://media3.marketwire.com/docs/984742fig3.6.jpg.

The Toronto Stock Exchange has not reviewed and does not accept responsibility for the adequacy or accuracy of this release

Rubicon Minerals Corporation
Allan Candelario
Director of Investor Relations
+1 (866) 365-4706
ir@rubiconminerals.com
www.rubiconminerals.com

Thursday, December 18th, 2014 Uncategorized Comments Off on (RBY) Begins Stockpiling Mill Feed for Projected Production Commencing Mid-2015

(DLNG) Announces Transfer of Listing of Common Units to NYSE

ATHENS, GREECE–(Dec 17, 2014) – Dynagas LNG Partners LP (“Dynagas Partners” or the “Partnership”) (NASDAQ: DLNG) announced today that it is voluntarily transferring the listing of its common units representing limited partnership interests (the “Common Units”) to the New York Stock Exchange (the “NYSE”) from the NASDAQ Global Select Market (“NASDAQ”). The Partnership expects its Common Units to cease trading on NASDAQ effective at the close of business on December 29, 2014, and to commence trading on the NYSE on December 30, 2014, when the market opens. The Partnership will retain its current ticker symbol “DLNG” when trading begins on the NYSE.

The Partnership has decided to delist its Common Units from NASDAQ and transfer the listing to the NYSE because the Partnership believes that the NYSE will provide more flexible trading platforms for the Partnership’s securities and enhanced investor access.

The Partnership also announced today that it intends to list its $250.0 million aggregate principal amount 6.25% Senior Notes due 2019 (the “Notes”) for trading on the NYSE. The Partnership issued the Notes on September 15, 2014 in an underwritten public offering in which Dynagas Finance Inc., a wholly-owned subsidiary of the Partnership, acted as co-issuer. Prior to the expected listing on the NYSE, the Notes have not been listed for trading on any other securities exchange. The Partnership expects the Notes to commence trading on the NYSE on December 30, 2014. The Notes will trade under the symbol “DLNG 19”.

About Dynagas LNG Partners LP

Dynagas LNG Partners LP is a growth-oriented partnership formed by Dynagas Holding Ltd. to own, and operate liquefied natural gas (LNG) carriers employed on multi-year charters. The current fleet of Dynagas Partners consists of five LNG carriers, with an aggregate carrying capacity of approximately 759,100 cubic meters.

Forward-Looking Statements

Matters discussed in this press release may constitute forward-looking statements. The Private Securities Litigation Reform Act of 1995 provides safe harbor protections for forward-looking statements in order to encourage companies to provide prospective information about their business. Forward-looking statements include statements concerning plans, objectives, goals, strategies, future events or performance, and underlying assumptions and other statements, which are other than statements of historical facts.

The Partnership desires to take advantage of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and is including this cautionary statement in connection with this safe harbor legislation. The words “believe,” “anticipate,” “intend,” “estimate,” “forecast,” “project,” “plan,” “potential,” “may,” “should,” “expect,” “pending” and similar expressions identify forward-looking statements.

The forward-looking statements in this press release are based upon various assumptions, many of which are based, in turn, upon further assumptions, including without limitation, our management’s examination of historical operating trends, data contained in our records and other data available from third parties. Although we believe that these assumptions were reasonable when made, because these assumptions are inherently subject to significant uncertainties and contingencies which are difficult or impossible to predict and are beyond our control, we cannot assure you that we will achieve or accomplish these expectations, beliefs or projections. We undertake no obligation to update any forward-looking statement, whether as a result of new information, future events or otherwise.

Important factors that, in our view, could cause actual results to differ materially from those discussed in the forward-looking statements include the strength of world economies and currencies, general market conditions, including fluctuations in charter rates and vessel values as a result of changes in the general market conditions of the oil and natural gas industry which influence charter hire rates and vessel values, our operating expenses, including bunker prices, dry docking and insurance costs, governmental rules and regulations or actions taken by regulatory authorities as well as potential liability from pending or future litigation, general domestic and international political conditions, potential disruption of shipping routes due to accidents or political events, the availability of financing and refinancing, vessel breakdowns and instances of off-hire and other important factors described from time to time in the reports filed by the Partnership with the Securities and Exchange Commission.

Contact Information:
Dynagas LNG Partners LP
97 Poseidonos Avenue & 2 Foivis Street
Glyfada, 16674
Greece

Attention: Michael Gregos
Telephone: (011) 30 210 8917960
Email: management@dynagaspartners.com

Investor Relations / Financial Media:
Nicolas Bornozis
President
Capital Link, Inc.
230 Park Avenue, Suite 1536
New York, NY 10169
Tel. (212) 661-7566
E-mail: dynagas@capitallink.com

Wednesday, December 17th, 2014 Uncategorized Comments Off on (DLNG) Announces Transfer of Listing of Common Units to NYSE

(INS) to Explore Strategic Initiatives

NORCROSS, Ga., Dec. 17, 2014  — Intelligent Systems Corporation (NYSE MKT:INS) today confirmed that it intends to more actively explore strategic alternatives to enhance shareholder value. Management has historically articulated a strategy to both invest in new technologies or companies (and has supported an incubator program since the late ’90s) and to sell off assets or subsidiaries, either in whole or in part, when the Board and Management determine it is in our shareholders’ best interests. The company regularly considers a broad range of strategic alternatives with the goal of enhancing shareholder value.

Today, the company’s two major operating businesses are ChemFree Corporation and CoreCard Software, as well as minority investments in several other companies. Recently, the company has been approached with indications of interest for both of our major subsidiaries.  No due diligence has transpired nor have any agreements been reached. However, we believe there is sufficient interest that more comprehensive discussions are likely which may result in formal due diligence with respect to one or both businesses.

Because of the relative sizes of the two businesses, a transaction involving either one would have a substantial impact on the company in many ways. If a cash transaction occurred, the company would expect to have cash in excess of what is required for operating the remaining subsidiary. Therefore we would have to consider whether to invest in something new or return cash to our shareholders. If both businesses were sold in the near term (a prospect we do not consider likely but it cannot be dismissed), a decision would then be made as to whether to continue operations or to liquidate the company and provide the proceeds from the sale(s) to the shareholders.

One of the reasons for issuing this release at this time (in addition to recent indications of interest) is that TheStreet Ratings last week listed INS as a sell recommendation and we believe investors may not be aware of the regular and on-going management efforts to increase shareholder value.  Leland Strange, President and CEO, who is a significant holder of INS stock, stated, “I believe the intrinsic value of the company is higher than the current trading range of our shares would indicate, while recognizing that nothing is certain until a transaction proves otherwise.  We are constantly looking at ways to capitalize on our investments and will continue to do so.”

The company does not have a definitive timetable for exploring these strategic alternatives and it does not intend to provide updates or comment further regarding this process unless a specific transaction is approved by the Board of Directors or the review process is concluded.  It is possible that this consideration of strategic alternatives will lead to the conclusion that the company’s shareholders are best served by continuing to own and operate our current businesses for the present time.

For further information about our business, operating companies and industry sectors, investors may read the company’s Form 10-Q and Form 10-K filings at www.sec.gov or www.intelsys.com.

About Intelligent Systems Corporation

For over thirty five years, Intelligent Systems Corporation (NYSE MKT:INS) has identified, created, operated and grown early stage technology companies. The company has operations and investments in the information technology and industrial products industries. The company’s principal majority-owned subsidiaries are CoreCard Software, Inc. (www.corecard.com), a provider of software and services for prepaid and credit card processing, and ChemFree Corporation (www.chemfree.com), a leader in bioremediating parts washer equipment and supplies.  Further information is available on our website at www.intelsys.com or by calling us at 770-381-2900.

In addition to historical information, this news release may contain forward-looking statements relating to Intelligent Systems Corporation and its subsidiary and affiliated companies. These statements include all statements that are not statements of historical fact regarding the intent, belief or expectations of Intelligent Systems Corporation and its management with respect to, among other things, results of operations, product plans, and financial condition. The words “may,” “will,” “anticipate,” “believe,” “intend,” “expect,” “estimate,” “plan,” “strategy” and similar expressions are intended to identify forward-looking statements. Prospective investors are cautioned that any such forward-looking statements are not guarantees of future performance and involve risks and uncertainties and that actual results may differ materially from those contemplated by such forward-looking statements. The company does not undertake to update or revise any forward-looking statements whether as a result of new developments or otherwise, except as required by law. Among the factors that could cause actual results to differ materially from those indicated by such forward-looking statements are instability in the financial markets, delays in product development, undetected software errors, competitive pressures, changes in customers’ requirements or financial condition, market acceptance of products and services, changes in the performance, financial condition or valuation of affiliate companies, the risks associated with investments in privately-held early stage companies and further declines in general economic and financial market conditions, particularly those that cause businesses to delay or cancel purchase decisions.

CONTACT: Bonnie Herron
         770-564-5504
         bherron@intelsys.com
Wednesday, December 17th, 2014 Uncategorized Comments Off on (INS) to Explore Strategic Initiatives

(OVAS) Advances All Three Fertility Treatment Options

OvaScienceSM (NASDAQ: OVAS), a global life sciences company focused on the discovery, development and commercialization of new fertility treatments, today announced the Company has achieved its 2014 corporate goals to advance the AUGMENTSM, OvaPrimeSM and OvaTureSM treatments for patients in need of new fertility treatment options.

“We are pleased to report that we have successfully matured human egg precursor cells into eggs in vitro. This is a major milestone for the first potential hormone-free fertility option, the OvaTure treatment. We have achieved this by designing an autologous, high throughput in vitro system, which we believe will accelerate further development of the OvaTure treatment, the only hormone-free fertility option,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience.

AUGMENT Treatment
The AUGMENT fertility treatment is available in select in vitro fertilization (IVF) clinics in Canada, the United Kingdom (UK), the United Arab Emirates (UAE) and Turkey. The AUGMENT treatment is not available in the United States. OvaScience has a further commitment from one of the largest IVF clinic networks in Japan, which plans to offer the treatment in 2015. For further information, please visit the new AUGMENT treatment website at www.augmenttreatment.com.

The AUGMENT treatment is specifically designed to improve egg health by using mitochondria from a patient’s own egg precursor (EggPCSM) cells during IVF. Improved egg health may offer the potential for better IVF success. OvaScience exceeded its AUGMENT patient treatment goal with more than 150 patients now receiving the treatment. The Company has started transitioning some of the IVF clinics to commercial centers.

OvaPrime Treatment
The OvaPrime treatment is a potential new fertility treatment that uses EggPC cells to increase a woman’s egg reserve. The OvaPrime treatment may provide an option for women who do not produce enough or any high-quality eggs. OvaScience plans to optimize the process and introduce the OvaPrime treatment in certain IVF clinics in select international regions outside of the United States by the end of 2015.

As anticipated, OvaScience has performed additional preclinical proof-of-concept work for the OvaPrime treatment that supports previously published research, which demonstrated that EggPC cells can mature into eggs in the ovary (in vivo).

OvaTure Treatment
The OvaTure treatment is a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without the need for hormone injections. The Company is the first to demonstrate that human EggPC cells can be matured into eggs outside of the body, and therefore has achieved human preclinical proof-of-concept with the OvaTure treatment. This is a major step toward being able to offer women with compromised eggs, who are unable to make eggs, or who may be unwilling or unable to undergo hormone hyperstimulation, a new treatment option.

“Our ability to demonstrate additional proof-of-concept for the OvaPrime and OvaTure treatments underscores the potential of our EggPC technology for developing new fertility treatments,” said Arthur Tzianabos, Ph.D., President of OvaScience. “We look forward to being able to provide women with more treatment options that may improve egg health and, importantly, would not require hormones.”

OvaScience Investor Day
The Company is hosting an Investor Day today, Wednesday, December 17, 2014 in New York beginning at 8:00 a.m. The event will feature presentations by guest speakers and Company management on the EggPC cell technology and the global fertility market as well as an update on OvaScience’s fertility treatments. A live audio webcast can be accessed by visiting the Investors section of the Company’s website at www.ovascience.com. A replay of the webcast will be archived on the OvaScience website for two weeks following the presentation.

About OvaScience
OvaScience (NASDAQ: OVAS) is a global life sciences company dedicated to improving fertility for women around the world. OvaScience is discovering, developing and commercializing new fertility treatments because we believe women deserve more options. Each OvaScience treatment is based on the Company’s proprietary technology platform that leverages the breakthrough discovery of egg precursor (EggPCSM) cells – immature egg cells found inside the protective ovarian lining. The AUGMENTSM treatment, a fertility option specifically designed to improve egg health, is available in certain IVF clinics in select international regions outside of the United States. OvaScience is developing the OvaPrimeSM treatment, which could increase a woman’s egg reserve, and the OvaTureSM treatment, a potential next-generation IVF treatment that could help a woman produce healthy, young, fertilizable eggs without hormone injections. For more information, please visit www.ovascience.com and connect with us on Twitter and Facebook.

Forward-Looking Statements
This press release includes forward-looking statements about the Company’s (i) plans for a launch of the AUGMENT treatment in Japan in 2015, (ii) plans to optimize the OvaPrime treatment and introduce it in select IVF clinics outside the United States by the end of 2015, (iii) plans to provide women with more treatment options that may improve egg health and not require hormones, and (iv) plans and treatment possibilities for the AUGMENT treatment and its two fertility treatments in development. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including risks related to: the possibility that international IVF clinics that we work with, including the IVF clinic in Japan that plans to offer the AUGMENT treatment in 2015, may determine not to begin or continue providing the AUGMENT treatment for commercial or other reasons; our expectation that the AUGMENT treatment and OvaPrime treatment meet the requirements of a class of products exempt from premarket review and approval under applicable regulations in those countries where we have launched or plan to introduce the AUGMENT treatment and plan to introduce the OvaPrime treatment; the science underlying our treatment and treatments in development (including the AUGMENT, OvaPrime and OvaTure treatments), which is unproven; our ability to obtain regulatory approval as necessary for our internationally launched fertility treatment and our potential fertility treatments; our ability to develop our potential fertility treatments, including the AUGMENT treatment, OvaPrime treatment and OvaTure treatment, on the timelines we expect, if at all; our ability to commercialize our treatments, including the AUGMENT treatment and OvaPrime treatment, on the timelines we expect, if at all; as well as those risks more fully discussed in the “Risk Factors” section of our most recently filed Quarterly Report on Form 10-Q or Annual Report on Form 10-K. The forward-looking statements contained in this press release reflect our current views with respect to future events. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing our view as of any date subsequent to the date hereof.

 

Investors
OvaScience
Theresa McNeely, 617-299-7356
EVP, Chief Communications Officer
tmcneely@ovascience.com
or
Media
OvaScience
Cara Petralia, 617-714-9638
Director, Corporate Communications
cpetralia@ovascience.com
or
FleishmanHillard
Catherine Collier Kyroulis, 917-886-5586

Wednesday, December 17th, 2014 Uncategorized Comments Off on (OVAS) Advances All Three Fertility Treatment Options

(MBII) REGALIA(R) MAXX Biofungicide Receives Registration in Brazil

First Approved Plant Extract-Based Fungicide in Brazil Brings Growers New Solution for Protecting Against Disease, Resulting in Higher Quality and Yields

DAVIS, Calif., Dec. 17, 2014  — Marrone Bio Innovations, Inc. (MBI), (Nasdaq:MBII), a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets, today announced that its REGALIA® MAXX Biofungicide has received a product registration from Brazil’s Ministry of Agriculture (MAPA). Brazil now joins Peru, El Salvador, Guatemala, Honduras, Panama, Columbia, the Dominican Republic and Mexico as Latin American countries having approved the use of REGALIA MAXX to control a wide variety of bacterial and fungal diseases across an array of agricultural crops.

REGALIA MAXX is the first plant extract-based fungicide approved in Brazil and is the first biopesticide with Induced Systemic Resistance (ISR), a complex mode of action which creates a defense response in the treated plants and stimulates additional biochemical pathways that strengthen the plant structure and act against the pathogen. The newly approved uses for REGALIA MAXX in Brazil, include tomatoes, potatoes, and dried beans. MBI is working with its partner FMC to expand the label to include a broader array of crops and diseases, such as citrus and row crops.

“REGALIA MAXX brings Brazilian growers an environmentally responsible and effective solution for protecting against a variety of fungal and bacterial diseases, resulting in higher quality and improved yields,” said MBI, CEO Pam Marrone. “This registration is critical to our global expansion plan for MBI products and we believe it will fill a real need for growers in Brazil. REGALIA MAXX can be used as a standalone product or in combination with other fungicides to strengthen integrated pest management programs, improve plant health and boost yields.”

REGALIA MAXX is an advanced biofungicide that can minimize chemical residues by being used alone in a disease-control program, particularly for exported crops at the end of the season right before harvest or in rotation with synthetic fungicides or in a tank mix. The product induces a plant’s natural defenses to protect against a variety of fungal and bacterial diseases and features multiple modes of action, which helps to prevent or delay the development of disease resistance. It also provides a four-hour re-entry interval that increases operational flexibility and a zero-day post-harvest interval so crop quality can be protected right up to harvest. REGALIA MAXX is proven to control diseases such as powdery mildews on cucurbits (melons, cucumber, zucchini), cane berries, tomatoes (including tomatillo), eggplant, peppers, grapes and ornamentals; Alternaria on tomatoes and potatoes; anthracnose on avocado, mango, papaya and citrus.

About Marrone Bio Innovations

Marrone Bio Innovations, Inc. (Nasdaq:MBII) is a leading provider of bio-based pest management and plant health products for the agriculture, turf and ornamental and water treatment markets. Our effective and environmentally responsible solutions help customers operate more sustainably while controlling pests, improving plant health, and increasing crop yields. We have a proprietary discovery process, a rapid development platform, and a robust pipeline of pest management and plant health product candidates. At Marrone Bio Innovations we are dedicated to pioneering better biopesticides that support a better tomorrow for users around the globe. For more information, please visit www.marronebio.com.

Forward Looking Statements

Portions of this press release may constitute “forward-looking statements,” and assumptions underlying such forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995 (the “PSLRA”), Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Any such forward-looking statements are made within the “safe-harbor” protections of the PSLRA, should not be relied upon as representing our views as of any subsequent date, and we are under no obligation to, and expressly disclaims any responsibility to, update or alter these forward-looking statements, whether as a result of new information, future events or otherwise. Forward-looking statements in this filing include those regarding: the anticipated filing date of the Company’s Form 10-Q and the Company’s expectations regarding regaining full compliance with NASDAQ continued listing requirements. Such forward-looking statements are based on information available to us as of the date of this release and involve a number of risks and uncertainties, some beyond our control, that could cause actual results to differ materially from those anticipated by these forward-looking statements. Such risks include the uncertainty surrounding the timing and results of the Audit Committee’s independent investigation of accounting matters, the potential need for restatement of our prior period financial statements, how promptly the investigation of accounting matters can be completed and any results thereof can be resolved, and potential legal or regulatory action related to the matters under investigation. In addition, the Company faces other risks and uncertainties that could affect its ability to complete the filing of its Form 10-Q and to regain compliance with the NASDAQ listing requirements. Additional information that could lead to material changes in our performance is contained in our filings with the Securities and Exchange Commission.

CONTACT: Media Contact:

         Cory Ziskind
         ICR
         646-277-1232
         Cory.Ziskind@icrinc.com
Wednesday, December 17th, 2014 Uncategorized Comments Off on (MBII) REGALIA(R) MAXX Biofungicide Receives Registration in Brazil

(TTPH) Positive Top-line Results, Phase 3 IGNITE 1 Clinical Trial of Eravacycline

Eravacycline achieves primary endpoint in first of two pivotal trials– —Company to host conference call at 4:30 p.m. ET today

Tetraphase Pharmaceuticals, Inc. (NASDAQ:TTPH), a clinical stage biopharmaceutical company developing novel antibiotics to treat life-threatening multidrug-resistant (MDR) infections, today announced positive top-line results from IGNITE 1, the Company’s Phase 3 clinical trial of eravacycline for the treatment of complicated intra-abdominal infection (cIAI) compared to ertapenem. In the trial, eravacycline met the primary endpoint of statistical non-inferiority of clinical response at the test-of-cure (TOC) visit, under the guidance set by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA).

The primary analysis under the FDA guidance was conducted using a 10% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population. In the micro-ITT population, the lower and upper bounds of the 95% confidence interval were -7.1% and 5.5%, respectively. Under the EMA guidance, the primary analysis was conducted using a 12.5% non-inferiority margin of the clinically evaluable (CE) patient population. In the CE population, the lower and upper bounds of the 95% confidence interval were -6.3% and 2.8%, respectively. The secondary analyses were consistent with and supportive of the primary outcome.

There were no drug-related serious adverse events in the trial. The most commonly reported drug-related adverse events for eravacycline were gastrointestinal, including nausea (3.3%) and emesis (2.2%). This adverse event profile for eravacycline was consistent with that seen in the Phase 2 clinical trial of eravacycline in cIAI.

The spectrum of pathogens in this trial was similar to that seen in other pivotal trials in this patient population. The most common Gram-negative pathogens in the study included Escherichia coli, Klebsiella pneumonia, Pseudomonas and Bacteroides.

“The prevalence of potentially deadly, multi-drug-resistant bacterial infections has grown rapidly in recent years and is currently a major global public health concern, especially in resistant Gram-negative infections where many current antibiotic treatment options are increasingly ineffective,” commented Joseph Solomkin, M.D., Professor Emeritus in the Department of Surgery at the University of Cincinnati College of Medicine and advisor to the Company. “These IGNITE 1 trial results suggest that eravacycline has the potential to be a new treatment option for serious intra-abdominal infections, and possibly other serious bacterial infections, where new treatments are urgently needed for patients.”

“The positive results from IGNITE 1 underscore that treatment with eravacycline could help a significant number of cIAI patients achieve a clinical cure for their difficult-to-treat Gram-negative infections,” said Guy Macdonald, President and CEO of Tetraphase. “The success of this trial is an important milestone for the eravacycline pivotal program. These results, along with those from our ongoing Phase 3 IGNITE 2 trial in complicated urinary tract infections (cUTI) which are expected in mid-2015, would form the basis of regulatory submissions seeking approval for eravacycline in both indications. We continue to target a New Drug Application submission to the FDA by the end of 2015.”

Tetraphase plans to submit the data from the Phase 3 IGNITE 1 clinical trial for presentation at a scientific meeting in 2015.

Conference Call Information

Tetraphase will host a conference call today at 4:30 pm Eastern Time to discuss the top-line data from the IGNITE 1 Phase 3 clinical trial. The call can be accessed by dialing (844) 831-4023 (U.S. and Canada) or (731) 256-5215 (international). To access the live audio webcast, or the subsequent archived recording, visit the “Investors Relations — Events & Presentations” section of the Tetraphase website at www.tphase.com. The webcast will be recorded and available for replay on the Tetraphase website for 30 days following the call.

About IGNITE 1

IGNITE 1 is a randomized, multi-center, double-blind, double-dummy, global Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline, dosed intravenously 1.0 mg/kg every 12 hours, compared with ertapenem, dosed intravenously 1 g every 24 hours, in the treatment of cIAI. Per the trial design, 541 adult patients were enrolled in the trial in 66 centers worldwide. Under the guidance set by the Food and Drug Administration (FDA) and the European Medicines Agency (EMA), the primary endpoint of the trial is clinical response at the test-of-cure (TOC) visit in the two treatment arms. For the FDA, the primary analysis is conducted using a 10% non-inferiority margin in the microbiological intent-to-treat (micro-ITT) population. For the EMA, the primary analysis is conducted using a 12.5% non-inferiority margin of the clinically evaluable patient population. Secondary endpoints include the microbiologic response in the treatment arms at the end of treatment, TOC and follow-up visits in the micro-ITT and microbiologically evaluable populations. The TOC visit takes place 25 to 31 days after the initial dose of eravacycline. The follow-up visit takes place 38 to 50 days after the initial dose of eravacycline.

About IGNITE 2

IGNITE 2 is a two-part, randomized, multi-center, double-blind, Phase 3 clinical trial designed to assess the efficacy and safety of eravacycline compared with levofloxacin in the treatment of cUTI at approximately 150 clinical trial sites worldwide. The two-part trial features a recently completed lead-in portion which was designed to determine the dose regimen to be carried forward into the pivotal portion of the trial. For the pivotal portion, 720 patients are expected to be enrolled and randomized 1:1 to receive eravacycline or levofloxacin (1.5 mg/kg intravenously every 24 hours followed by 200 mg orally every 12 hours) or levofloxacin (750 mg intravenously every 24 hours followed by 750 mg orally every 24 hours). This pivotal portion of the trial is designed to be a non-inferiority (10% margin) study. The primary endpoint for the FDA is the responder outcome (a combination of clinical cure rate and microbiological response) in the Microbiological Intent-to-Treat (micro-ITT) Population at the Post-Treatment visit (defined as 6-8 days after the completion of therapy). For the EMA, the primary endpoint is the microbiological response in the micro-MITT and microbiologically evaluable populations at the Post Treatment visit. Top-line results from the pivotal portion of the study are expected to be available in mid-2015.

About Eravacycline

Tetraphase’s lead product candidate, eravacycline, is being developed as a broad-spectrum intravenous and oral antibiotic in the IGNITE program (Investigating Gram-negative Infections Treated with Eravacycline). Under this program, two Phase 3 clinical trials are ongoing: IGNITE 1 for the indication of complicated intra-abdominal infections (cIAI) and IGNITE 2 for complicated urinary tract infections (cUTI). Eravacycline has been designated by the U.S. Food and Drug Administration as a Qualified Infectious Disease Product (QIDP) for both the cIAI and cUTI indications. This designation, which is assigned to qualifying new antibiotic product candidates, makes eravacycline eligible to benefit from certain development and commercialization incentives, including priority review, and eligibility for both fast-track status and an additional five years of U.S. market exclusivity.

About Tetraphase Pharmaceuticals, Inc.

Tetraphase is a clinical-stage biopharmaceutical company using its proprietary chemistry technology to create novel antibiotics for serious and life-threatening multidrug-resistant (MDR) bacterial infections, including those caused by many of the MDR Gram-negative bacteria highlighted as urgent public health threats by the Centers for Disease Control and Prevention (CDC). Tetraphase has created more than 3,000 novel tetracycline analogs using its proprietary technology platform. Please visit www.tphase.com for more company information.

Forward-Looking Statements

Any statements in this press release about our future expectations, plans and prospects, including statements regarding our strategy, future operations, prospects, plans and objectives, and other statements containing the words “anticipates,” “believes,” “expects,” “plans,” “will” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: whether our cash resources will be sufficient to fund our continuing operations for the period we anticipate; whether the top line results from the lead in portion of IGNITE 2 will be predictive of the final results of the trial; whether eravacycline will advance through the clinical trial process on a timely basis or at all; whether enrollment for clinical trials will be achieved in the time frame expected; whether submissions will be made and approvals will be received from the United States Food and Drug Administration or equivalent foreign regulatory agencies on a timely basis or at all; whether, if eravacycline obtains approval, it will be successfully distributed and marketed; and other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q, filed with the Securities and Exchange Commission on November 10, 2014. In addition, the forward-looking statements included in this press release represent our views as of December 17, 2014. We anticipate that subsequent events and developments will cause our views to change. However, while we may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so.

 

Investor:
Tetraphase
Teri Dahlman, 617-600-7040
tdahlman@tphase.com
or
Argot Partners
Susan Kim, 212-600-1902
susan@argotpartners.com
or
Media:
Sam Brown Inc.
Mike Beyer, 773-463-4211
beyer@sambrown.com

Wednesday, December 17th, 2014 Uncategorized Comments Off on (TTPH) Positive Top-line Results, Phase 3 IGNITE 1 Clinical Trial of Eravacycline

(VOLC) To Be Acquired By Royal Philips (PHG)

Philips to acquire Volcano for USD 18.00 per share; total transaction value of USD 1.2 billion (approx. EUR 1 billion), inclusive of Volcano’s cash and debt – Agreement to acquire Volcano, a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, advances Philips’ focused strategy in image guided therapy – Volcano provides proven clinical development and commercialization capabilities for Philips’ next generation of imaging and measurement technologies – Philips expects the transaction to accelerate sales growth as combined business is optimally positioned to address unmet needs in EUR 4 billion image-guided therapy market – Transaction expected to be accretive to Philips EPS by 2017 driven by revenue and cost synergies

AMSTERDAM and SAN DIEGO, Dec. 17, 2014 – Royal Philips (NYSE: PHG; AEX: PHIA) and Volcano Corporation (NASDAQ:VOLC), a global leader in catheter-based imaging and measurement solutions for cardiovascular applications, today announced that they have entered into a definitive merger agreement. Pursuant to the agreement, Philips will commence a tender offer to acquire all of the issued and outstanding shares of Volcano for USD 18.00 per share, or a total equity purchase price of USD 1 billion (approx. EUR 800 million), to be paid in cash upon completion. The board of directors of Volcano has unanimously approved the transaction and recommends the offer to its shareholders. The transaction is expected to close in the first quarter of 2015.

In the last few years, Philips has created a leading image-guided therapy business through strategic investments in R&D, partnerships and technology licenses. Today, Philips has a rich portfolio of interventional imaging equipment, navigation tools, and services, and a sizeable global customer base, including each of the top 50 U.S. Heart Surgery and Cardiology hospitals. One in every three interventional X-ray systems sold globally is a Philips system. These systems provide the visual maps that allow the clinician to guide thin, tube-shaped instruments called catheters through the body, to the area of interest and perform the minimally invasive treatment.

In image-guided treatments of the heart and blood vessels, there is an increasing trend to use advanced catheters that are capable of producing ultrasound images of the interior of blood vessels (intravascular ultrasound or IVUS) or perform blood flow measurements (fractional flow reserve or FFR). There is a growing body of clinical evidence that the use of such technologies in conjunction with interventional X-ray helps improve procedural outcomes.

With 2013 sales of approximately USD 400 million, San Diego, California-based Volcano is a leader in catheter–based imaging and measurements for minimally invasive diagnostics and treatment of coronary artery disease and peripheral vascular disease. Volcano is the only company in the industry with a leading position in both IVUS imaging and FFR measurements. In addition, the company possesses the broadest product portfolio around these two technologies, a leading IP position and a nascent peripheral vascular therapeutics business that targets a segment with a double-digit growth rate.

The combination of two industry leaders will create new sources of recurring revenue streams and increase sales growth for Philips in the EUR 4 billion image-guided therapy market opportunity. Sales growth will be accelerated through Volcano’s close customer relationships associated with its disposable products and channel synergies that will create cross-selling opportunities between both companies’ existing customer bases. Furthermore, the combination of Volcano’s proven clinical development and commercialization capabilities with Philips’ next generation of imaging and measurement technologies, will allow Philips to introduce new solutions in higher growth segments such as the minimally invasive treatment of heart rhythm disorders and structural heart diseases. These are promising segments growing at double-digit rates.

“The agreement to acquire Volcano significantly advances our strategy to become the leading systems integrator in image-guided therapies,” said Frans van Houten, Chief Executive Officer of Royal Philips. “Volcano’s impressive and unique product portfolio is highly complementary to our strong offering in live image-guidance solutions, creating an opportunity to accelerate the revenue growth for our image-guided therapy business to a high single-digit rate by 2017. Our combined sales forces will be able to capture immediate cross selling opportunities, while our joint R&D teams will be able to develop new solutions to address significant unmet needs in the minimally invasive treatment of cardiovascular diseases.”

Mr. Van Houten added: “Image-guided therapies provide significant benefits for healthcare systems and patients, including reduced patient trauma, shorter recovery times and hospital stays, and lower costs. As a result, our clinical partners and customers are asking for a tighter integration of imaging and measurement technologies to enable such therapies. This transaction allows us to provide our customers with an integrated solution to improve procedural outcomes at a decisive stage in the health continuum.”

“I am very excited that Volcano will become part of Philips and join forces with its leading image guided therapy business,” said Scott Huennekens, Volcano President and Chief Executive Officer. “This transaction will be beneficial for our shareholders, customers, partners and employees. There is a large and growing global market opportunity for image-guided therapies, and as part of Philips, we gain the scale and resources needed to accelerate our goals of improving patient outcomes on a global basis, lowering cost and delivering innovative diagnostics and therapies in the coronary and peripheral markets. In addition, our shared expertise in the image-guided therapy market will allow us to further globalize our leading IVUS and FFR product offerings and enter new product areas.  We look forward to working closely with Philips and ensuring a smooth transition and closing.”

Upon completion of the transaction, the Volcano business and its 1,800 employees will be part of a dedicated, new image-guided therapy business group within Philips, which will be led by Philips executive Bert van Meurs, an experienced leader in the health care industry with a proven track record in the image-guided therapy market.

Financials
The acquisition will create a strategically and financially compelling combination that will provide higher growth, additional operating leverage through more productive sales operations, and enhance commercialization opportunities in new, adjacent segments. Philips will drive operational performance improvements through cost synergies and the implementation of proven productivity improvement methodologies such as Lean.  As a result, the transaction is expected to be accretive to Philips’ reported earnings per share by 2017, and Philips targets an EBITA margin for its image-guided therapy business group of around 20% by 2017.

The transaction is structured as a cash tender offer by Philips for all of the issued and outstanding shares of Volcano, to be followed by a merger in which each share of Volcano not tendered in the tender offer will be converted into the USD 18.00 per share price paid in the tender offer. Pursuant to the merger agreement, the transaction is subject to customary closing conditions, including certain regulatory clearances in the US and in certain non-US jurisdictions. The tender offer is not subject to any financing conditions. Philips intends to finance the acquisition through a combination of cash on hand and the issuance of debt.

About Royal Philips
Royal Philips (NYSE: PHG, AEX: PHIA) is a diversified health and well-being company, focused on improving people’s lives through meaningful innovation in the areas of Healthcare, Consumer Lifestyle and Lighting. Headquartered in the Netherlands, Philips posted 2013 sales of EUR 23.3 billion and employs approximately 115,000 employees with sales and services in more than 100 countries. The company is a leader in cardiac care, acute care and home healthcare, energy efficient lighting solutions and new lighting applications, as well as male shaving and grooming and oral healthcare. News from Philips is located at www.philips.com/newscenter.

About Volcano Corporation
Through its multi-modality platform, Volcano is the global leader in intravascular imaging for coronary and peripheral therapeutic devices. The company’s broad range of technologies makes imaging and therapy simpler, more informative and less invasive and offers physicians and their patients around the world with industry-leading tools that aid diagnosis and guide and provide therapy. Founded in cardiovascular care and expanding into other specialties, Volcano is focused on improving patient and economic outcomes. For more information, visit the company’s website at www.Volcanocorp.com.

Forward-looking statements
This release may contain certain forward-looking statements with respect to the financial condition, results of operations and business of Philips and certain of the plans and objectives of Philips with respect to these items, including without limitation completion of the tender offer and merger and any expected benefits of the merger, and certain forward-looking statements regarding Volcano, including without limitation with respect to its business, the proposed tender offer and merger, the expected timetable for completing the transaction, and the strategic and other potential benefits of the transaction. Completion of the tender offer and merger are subject to conditions, including satisfaction of a minimum tender condition and the need for regulatory approvals, and there can be no assurance that those conditions can be satisfied or that the transactions described in this release (the “Transactions”) will be completed or will be completed when expected. Often, but not always, forward-looking statements can be identified by the use of words such as “plans,” “expects,” “expected,” “scheduled,” “estimates,” “intends,” “anticipates,” “projects,” “potential,” “continues” or “believes,” or variations of such words and phrases or state that certain actions, events, conditions, circumstances or results “may,” “could,” “should,” “would,” “might” or “will” be taken, occur or be achieved. By their nature, forward-looking statements involve risk and uncertainty because they relate to events and depend on circumstances that will occur in the future and there are many factors that could cause actual results and developments to differ materially from those expressed or implied by these forward-looking statements. These factors include, but are not limited to, (i) the risk that not all conditions of the Offer or the merger will be satisfied or waived; (ii) uncertainties regarding the two companies’ ability to successfully market both new and existing products; (iii) uncertainties relating to the anticipated timing of filings and approvals relating to the Transactions; (iv) uncertainties as to the timing of the tender offer and merger; (v) uncertainties as to how many of Volcano’s stockholders will tender their stock in the tender offer; (vi) the possibility that competing offers will be made; (vii) the failure to complete the tender offer or the merger in the timeframe expected by the parties or at all; (viii) the outcome of legal proceedings that may be instituted against Volcano and/or others relating to the Transactions; (ix) Volcano’s ability to maintain relationships with employees, customers, or suppliers; (x) domestic and global economic and business conditions; (xi) developments within the euro zone; (xii) the successful implementation of Philips’ strategy and the ability to realize the benefits of this strategy; (xiii) legal claims; (xiv) changes in exchange and interest rates; (xv) changes in tax rates, raw materials and employee costs; (xvi) the ability to successfully exit certain businesses or restructure the operations; (xvii) the rate of technological changes; (xviii) political, economic and other developments in countries where Philips operates; (xix) industry consolidation and competition; and (xx) other risk factors described in Volcano’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the United States Securities and Exchange Commission (“SEC”). Any forward-looking statements in this release are based upon information known to Philips on the date of this announcement. Neither Philips nor Volcano undertakes any obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

Additional Information

The tender offer described in this communication (the “Offer”) has not yet commenced, and this communication is neither an offer to purchase nor a solicitation of an offer to sell any shares of the common stock of Volcano or any other securities. On the commencement date of the Offer, a tender offer statement on Schedule TO, including an offer to purchase, a letter of transmittal and related documents, will be filed with the SEC by Philips and a Solicitation/Recommendation Statement on Schedule 14D-9 will be filed with the SEC by Volcano. The offer to purchase shares of Volcano common stock will only be made pursuant to the offer to purchase, the letter of transmittal and related documents filed as a part of the Schedule TO. INVESTORS AND SECURITY HOLDERS ARE URGED TO READ BOTH THE TENDER OFFER STATEMENT AND THE SOLICITATION/RECOMMENDATION STATEMENT REGARDING THE OFFER, AS THEY MAY BE AMENDED FROM TIME TO TIME, WHEN THEY BECOME AVAILABLE BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION. The tender offer statement will be filed with the SEC by Clearwater Merger Sub, Inc., a wholly owned subsidiary of Philips Holding USA Inc., which is a wholly owned subsidiary of Royal Philips, and the solicitation/recommendation statement will be filed with the SEC by Volcano. Investors and security holders may obtain a free copy of these statements (when available) and other documents filed with the SEC at the website maintained by the SEC at www.sec.gov or by directing such requests to the Information Agent for the Offer, which will be named in the tender offer statement.

Wednesday, December 17th, 2014 Uncategorized Comments Off on (VOLC) To Be Acquired By Royal Philips (PHG)

(BAGR) Grand Opening of Bagger Dave’s Burger Tavern in Birch Run, Michigan

SOUTHFIELD, Mich., Dec. 16, 2014  — Diversified Restaurant Holdings, Inc. (Nasdaq:BAGR) (“DRH” or the “Company”), the creator, developer and operator of the unique, full-service, ultra-casual restaurant and bar Bagger Dave’s Burger Tavern® (“Bagger Dave’s”) and one of the largest franchisees for Buffalo Wild Wings® (“BWW”), today announced the grand opening of a Bagger Dave’s in Birch Run, Michigan on Sunday, December 14, 2014, concurrent with the opening of a new co-located Buffalo Wild Wings. This opening marks the sixteenth Bagger Dave’s location in the state of Michigan.

The new Bagger Dave’s restaurant is located at 8827 Main Street and showcases refreshed interior and exterior design elements, including historical photos of the community as well an enclosed patio. The restaurant is located across from the Birch Run Premium Outlets, the largest outlet mall in the Midwestern United States.

“We are excited to have completed our development plans for 2014 with two restaurant openings in Birch Run. Their proximity to the largest and most frequently visited outlet mall in the Midwest makes for an ideal location and we believe that the prominent signage at the busy Interstate 75 exit should help generate strong traffic for both brands. We are particularly pleased to be introducing Bagger Dave’s high quality and differentiated menu offerings to Birch Run residents and visitors,” said Michael Ansley, President and CEO.

Regular restaurant hours will be Sunday and Monday, 11:00 AM to 10:00 PM, Tuesday through Thursday, 11:00 AM to 11:00 PM, and Friday and Saturday from 11:00 AM to 12:00 AM.

In 2014, DRH opened a total of nine new restaurants, including six Bagger Dave’s in Birch Run, Woodhaven, and Grand Blanc, Michigan; and Carmel, Fishers, and Schererville, Indiana; and three Buffalo Wild Wings in Birch Run, Michigan; Pinellas Park, Florida; and Hammond, Indiana.

About Diversified Restaurant Holdings

Diversified Restaurant Holdings, Inc. (Nasdaq:BAGR) (“DRH” or the “Company”) owns and operates Bagger Dave’s Burger Tavern, a full-service, family-friendly restaurant and full bar with a casual, comfortable atmosphere specializing in custom-built, proprietary, fresh prime rib recipe burgers, all-natural turkey burgers, hand-cut fries, locally crafted beers on draft, hand-dipped milk shakes, salads, black bean turkey chili, and much more. There are currently 24 company-owned Bagger Dave’s restaurants in Michigan and Indiana.  For more information, visit www.baggerdaves.com.

The Company also operates 42 Buffalo Wild Wings Grill & Bar franchised restaurants in Indiana, Illinois, Michigan, and Florida.

The Company routinely posts news and other important information on its website at www.diversifiedrestaurantholdings.com.

Safe Harbor Regarding Forward Looking Statements

The information made available in this news release contains forward-looking statements which reflect DRH’s current view of future events, results of operations, cash flows, performance, business prospects and opportunities. Wherever used, the words “anticipate,” “believe,” “expect,” “intend,” “plan,” “project,” “will continue,” “will likely result,” “may,” and similar expressions identify forward-looking statements as such term is defined in the Securities Exchange Act of 1934. Any such forward-looking statements are subject to risks and uncertainties and the Company’s actual growth, results of operations, financial condition, cash flows, performance, business prospects and opportunities could differ materially from historical results or current expectations. Some of these risks include, without limitation, the impact of economic and industry conditions, competition, food and drug safety issues, store expansion and remodeling, labor relations issues, costs of providing employee benefits, regulatory matters, legal and administrative proceedings, information technology, security, severe weather, natural disasters, accounting matters, other risk factors relating to our business or industry and other risks detailed from time to time in the Securities and Exchange Commission filings of DRH. Forward-looking statements contained herein speak only as of the date made and, thus, DRH undertakes no obligation to update or publicly announce the revision of any of the forward-looking statements contained herein to reflect new information, future events, developments or changed circumstances or for any other reason.

CONTACT: For more information contact:

         Investor Relations Contacts:
         Sheryl Freeman / Raphael Gross
         ICR Inc.
         646.277.1284 / 203.682.8253
         sheryl.freeman@icrinc.com / raphael.gross@icrinc.com
Tuesday, December 16th, 2014 Uncategorized Comments Off on (BAGR) Grand Opening of Bagger Dave’s Burger Tavern in Birch Run, Michigan

(IESC) Highlighted as a Top Workplace and Announces Recent Management Appointments

HOUSTON, Dec. 16, 2014  — Integrated Electrical Services, Inc. (or “IES”) (Nasdaq:IESC) today announced new divisional appointments and its ranking as a top workplace in Houston based on a survey conducted by the Houston Chronicle.

Recent Management Appointments

IES is pleased to announce several recent divisional appointments, including the hiring of Ed Zeuch as Vice President, Finance of the Infrastructure Solutions segment and Todd Lovell as Vice President, Program Director of the Commercial & Industrial segment. Additionally, IES’s Communications segment has added Robert Gosse as Branch Manager of its recently established Dallas, TX branch.

Mr. Zeuch has over 15 years of experience in finance and operations with companies including Schneider Electric, Teradata Corporation, and NCR Corporation. Over the last six years, Mr. Zeuch served as Chief Operating Officer at Carat Security Group.

Mr. Lovell has over 20 years of construction project management and most recently served as Senior Projects Manager for six years with Jacobs Engineering Group Inc. and five years with Tetra Tech, Inc. Mr. Lovell will be focused on driving strategic initiatives to ensure Commercial & Industrial’s continued growth and success.

James Lindstrom, Chairman and Chief Executive Officer, continued, “We believe the strong new additions to our team validate IES as an employer of choice and our ability to attract the best employees possible. We remain committed to developing our employees and investing in talent to expand our capabilities and support our growth and backlog in 2015.”

Top Workplace by the Houston Chronicle

IES has been named a Top Workplace by the Houston Chronicle, placing second in the ranking of midsize businesses. The second place ranking is an improvement of 13 spots from a 15th-place ranking in 2013. The ranking is based on an annual survey of employees conducted for the Houston Chronicle by the research firm WorkplaceDynamics.

Sarah Kerrigan, head of Human Resources at IES, stated, “We are honored to be recognized as one of the top places to work in Houston. The results of these independent surveys confirm that our focus on creating an ownership mindset for all employees and developing an entrepreneurial environment differentiates IES.”

ABOUT INTEGRATED ELECTRICAL SERVICES, INC.

Integrated Electrical Services, Inc. is a holding company that owns and manages diverse operating subsidiaries, comprised of providers of industrial products and infrastructure services to a variety of end markets. Our 2,700 employees serve clients in the United States and abroad. For more information about IES, please visit www.ies-co.com.

Certain statements in this release may be deemed “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934, all of which are based upon various estimates and assumptions that the Company believes to be reasonable as of the date hereof. In some cases, you can identify forward-looking statements by terminology such as “may,” “will,” “could,” “should,” “expect,” “plan,” “project,” “intend,” “anticipate,” “believe,” “seek,” “estimate,” “predict,” “potential,” “pursue,” “target,” “continue,” the negative of such terms or other comparable terminology. These statements involve risks and uncertainties that could cause the Company’s actual future outcomes to differ materially from those set forth in such statements. Such risks and uncertainties include, but are not limited to, the ability of our controlling shareholder to take action not aligned with other shareholders; the sale or disposition of the shares of our common stock held by our controlling shareholder, which, under certain circumstances, would trigger change of control provisions in our severance plan or financing and surety arrangements; or any other substantial sale of our common stock, which could depress our stock price; relatively low liquidity levels of our common stock, which could depress our stock price; the possibility that we issue additional shares of common stock or convertible securities that will dilute the percentage ownership interest of existing stockholders and may dilute the book value per share of our common stock; the possibility that certain tax benefits of our net operating losses may be restricted or reduced in a change in ownership; the inability to carry out plans and strategies as expected, including our inability to identify and complete acquisitions that meet our investment criteria in furtherance of our corporate strategy; limitations on the availability of sufficient credit or cash flow to fund our working capital needs and capital expenditures and debt service; difficulty in fulfilling the covenant terms of our credit facilities; competition in the industries in which we operate, both from third parties and former employees, which could result in the loss of one or more customers or lead to lower margins on new projects; challenges integrating new businesses into the Company or new types of work, products or processes into our segments; fluctuations in operating activity due to downturns in levels of construction, seasonality and differing regional economic conditions; a general reduction in the demand for our services; a change in the mix of our customers, contracts or business; our ability to enter into, and the terms of, future contracts; our ability to successfully manage projects; the possibility of errors when estimating revenue and progress to date on percentage-of-completion contracts; closures or sales of facilities resulting in significant future charges, including potential warranty losses or other unexpected liabilities, or a significant disruption of our operations; inaccurate estimates used when entering into fixed-priced contracts; the cost and availability of qualified labor; an increased cost of surety bonds affecting margins on work and the potential for our surety providers to refuse bonding or require additional collateral at their discretion; increases in bad debt expense and days sales outstanding due to liquidity problems faced by our customers; the recognition of potential goodwill, long-lived assets and other investment impairments; credit and capital market conditions, including changes in interest rates that affect the cost of construction financing and mortgages, and the inability for some of our customers to retain sufficient financing which could lead to project delays or cancellations; accidents resulting from the physical hazards associated with our work and the potential for accidents; our ability to pass along increases in the cost of commodities used in our business, in particular, copper, aluminum, steel, fuel and certain plastics; potential supply chain disruptions due to credit or liquidity problems faced by our suppliers; loss of key personnel and effective transition of new management; success in transferring, renewing and obtaining electrical and construction licenses; backlog that may not be realized or may not result in profits; uncertainties inherent in estimating future operating results, including revenues, operating income or cash flow; disagreements with taxing authorities with regard to tax positions we have adopted; the recognition of tax benefits related to uncertain tax positions; complications associated with the incorporation of new accounting, control and operating procedures; the possibility that our internal controls over financial reporting and our disclosure controls and procedures may not prevent all possible errors that could occur; the effect of litigation, claims and contingencies, including warranty losses, damages or other latent defect claims in excess of our existing reserves and accruals; growth in latent defect litigation in states where we provide residential electrical work for home builders not otherwise covered by insurance; the possibility that our current insurance coverage may not be adequate or that we may not be able to obtain a policy at acceptable rates; future capital expenditures and refurbishment, repair and upgrade costs, and delays in and costs of refurbishment, repair and upgrade projects; and liabilities under laws and regulations protecting the environment.

You should understand that the foregoing, as well as other risk factors discussed in this document and in the Company’s annual report on Form 10-K for the year ended September 30, 2014, could cause future outcomes to differ materially from those experienced previously or those expressed in such forward-looking statements. The Company undertakes no obligation to publicly update or revise any information, including information concerning its controlling shareholder, net operating losses, borrowing availability, or cash position, or any forward-looking statements to reflect events or circumstances that may arise after the date of this release.

Forward-looking statements are provided in this press release pursuant to the safe harbor established under the Private Securities Litigation Reform Act of 1995 and should be evaluated in the context of the estimates, assumptions, uncertainties, and risks described herein.

General information about Integrated Electrical Services, Inc. can be found at http://www.ies-co.com under “Investors.” The Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and current reports on Form 8-K, as well as any amendments to those reports, are available free of charge through the Company’s website as soon as reasonably practicable after they are filed with, or furnished to, the SEC.

CONTACT: Robert Lewey, CFO
         Integrated Electrical Services, Inc.
         713-860-1500
Tuesday, December 16th, 2014 Uncategorized Comments Off on (IESC) Highlighted as a Top Workplace and Announces Recent Management Appointments

(BLRX) Teams Up With Novartis (NVS) In Strategic Collaboration

Global pharmaceutical company makes initial $10 million equity investment in BioLineRx – – BioLineRx to host conference call today, December, 16 at 10:00 a.m. EST

BioLineRx Ltd. (NASDAQ: BLRX) (TASE: BLRX), a clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates, today announced that it has entered into a multi-year strategic collaboration agreement with Novartis Pharma AG designed to facilitate development and commercialization of Israeli-sourced drug candidates.

Leveraging BioLineRx’s close and long-lasting ties with academic institutions, hospitals and biomedical companies in Israel, as well as its proven project screening process and development expertise, Novartis will evaluate projects identified and presented by BioLineRx for co-development and potential future licensing under the collaboration. The companies intend to co-develop a number of pre-clinical and early clinical therapeutic projects through clinical proof-of-concept. As part of the agreement, Novartis has made an initial equity investment in BioLineRx of $10 million for 12.8% of BioLineRx’s current shares outstanding.

Dr. Kinneret Savitsky, CEO of BioLineRx, said, “This is a transformative collaboration for BioLineRx. Recognition by Novartis, the global leader for innovative therapeutics, is a further validation of our drug development capabilities, our business model, and our strong track record of selecting the most promising innovative therapeutic programs stemming from Israel’s leading research institutions and biotech start-ups, and developing them towards commercialization. Working closely with Novartis at relatively early stages of project development will enable us to tailor our development processes to meet their needs and expectations, helping to ensure agreed upon clinical goals are met successfully.”

Under the terms of the agreement, Novartis acquired an initial 5,000,000 American Depositary Shares of BioLineRx in a private transaction at a price of $2.00 per share for a total equity investment of $10 million. Novartis will not have any governance rights and has agreed to certain standstill provisions. Novartis and BioLineRx will jointly evaluate both clinical and pre-clinical stage projects presented by BioLineRx via a Joint Steering Committee, which will determine which projects to advance further in development and on what terms. Projects at or reaching the clinical stage will be eligible for selection by Novartis. Upon selection of a project, Novartis will pay BioLineRx an option fee of $5 million, as well as fund 50% of the anticipated remaining development costs associated with establishing clinical proof-of-concept, in the form of an additional equity investment in BioLineRx. Novartis will have an exclusive right of first negotiation to license from BioLineRx each selected project upon establishment of clinical proof-of-concept. The companies intend to develop up to three programs pursuant to this collaboration.

Conference Call and Webcast Information

BioLineRx will hold a conference call today, December 16, 2014, at 10:00 a.m. EST. Dr. Kinneret Savitsky, Chief Executive Officer; Philip Serlin, Chief Financial and Operating Officer; and David Malek, Vice-President of Business Development, will present and provide more details on the collaboration with Novartis. To access the conference call, please dial 1-888-668-9141 from the U.S. or +972-3-918-609 internationally. The call will also be available via live webcast through BioLineRx’s website. A replay of the conference call will be available approximately two hours after completion of the live conference call. To access the replay, please dial 1-888-326-9310 from the U.S. or +972-3-925-5901 internationally. The replay will be available through December 19, 2014.

About BioLineRx

BioLineRx is a publicly-traded, clinical-stage biopharmaceutical company dedicated to identifying, in-licensing and developing promising therapeutic candidates. The Company in-licenses novel compounds primarily from academic institutions and biotech companies based in Israel, develops them through pre-clinical and/or clinical stages, and then partners with pharmaceutical companies for advanced clinical development and/or commercialization.

BioLineRx’s current portfolio consists of a variety of clinical and pre-clinical projects, including: BL-1040 for prevention of pathological cardiac remodeling following a myocardial infarction, which has been out-licensed to Bellerophon BCM (f/k/a Ikaria) and is in the midst of a pivotal CE-Mark registration trial; BL-8040, a cancer therapy platform, which is in the midst of a Phase 2 study for acute myeloid leukemia (AML) as well as a Phase 1 study for stem cell mobilization; and BL-7010 for celiac disease, which has completed a Phase 1/2 study.

For more information on BioLineRx, please visit www.biolinerx.com or download the investor relations mobile device app, which allows users access to the Company’s SEC documents, press releases, and events. BioLineRx’s IR app is available on the iTunes App Store as well as the Google Play Store.

Safe Harbor Statement

Various statements in this release concerning BioLineRx’s future expectations constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These statements include words such as “may,” “expects,” “anticipates,” “believes,” and “intends,” and describe opinions about future events. These forward-looking statements involve known and unknown risks and uncertainties that may cause the actual results, performance or achievements of BioLineRx to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Some of these risks are: changes in relationships with collaborators; the impact of competitive products and technological changes; risks relating to the development of new products; and the ability to implement technological improvements. These and other factors are more fully discussed in the “Risk Factors” section of BioLineRx’s most recent annual report on Form 20-F filed with the Securities and Exchange Commission on March 17, 2014. In addition, any forward-looking statements represent BioLineRx’s views only as of the date of this release and should not be relied upon as representing its views as of any subsequent date. BioLineRx does not assume any obligation to update any forward-looking statements unless required by law.

for BioLineRx
Tiberend Strategic Advisors, Inc.
Joshua Drumm, Ph.D.
+1-212-375-2664
jdrumm@tiberend.com
or
Andrew Mielach
+1-212-375-2694
amielach@tiberend.com
or
Tsipi Haitovsky
Public Relations
+972-3-6240871
tsipihai5@gmail.com

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(MRVC) Board Authorizes $8 Million Share Repurchase Plan

MRV Communications (NASDAQ:MRVC), a global provider in converged packet and optical solutions that empower the optical edge and network integration services for leading communications service providers, announced MRV‘s Board of Directors has authorized a share repurchase program for up to $8 million.

The stock repurchase program will be operated in accordance with the requirements of Rule 10b-18 under the Securities Exchange Act of 1934, as amended (the “Exchange Act”). In connection therewith, MRV is entering into a stock repurchase plan under Rule 10b5-1 of the Exchange Act to facilitate the repurchase of its Common Stock. Purchases of Common Stock will be subject to terms set forth in the Rule 10b5-1 plan and certain price, volume and timing constraints. Accordingly, there can be no assurance as to how many shares will be purchased.

The plan expires on November 13, 2015 or may be suspended or discontinued at any time, without prior notice. The funding for the repurchase is available from existing cash on hand. A plan under Rule 10b5-1 of the Exchange Act allows a company to repurchase its shares at times when it otherwise might be prevented from doing so under insider trading laws or because of self-imposed trading blackout periods. A broker selected by MRV will have the authority under the terms and limitations specified in the plan to repurchase shares on MRV’s behalf in accordance with the terms of the plan.

About MRV Communications

MRV Communications is a global provider in converged packet and optical solutions that empower the optical edge and network integration services for leading communications service providers. For more than two decades, the most demanding service providers, Fortune 1000 companies and governments worldwide have trusted MRV to provide best-in-class solutions and services for their mission-critical networks. We help our customers overcome the challenge of orchestrating the ever-increasing need for capacity while improving service delivery and lowering network costs for critical applications such as cloud connectivity, high-capacity business services, mobile backhaul and data center connectivity. For more information please visit www.mrv.com.

Forward Looking Statements

This press release may contain statements regarding future financial and operating results of MRV, management’s assessment of business trends, and other statements about management’s future expectations, beliefs, goals, plans or prospects and those of the market segments in which MRV is engaged that are based on management’s current expectations, estimates, forecasts and projections about MRV and its consolidated businesses and the respective market segments in which MRV’s businesses operate, in addition to management’s assumptions. Statements in this press release regarding MRV’s future financial and operating results, which are not statements of historical facts, constitute forward-looking statements within the meaning of the U.S. Private Securities Litigation Reform Act of 1995. Words such as “expects,” “anticipates,” “envisions,” “estimates,” “targets,” “intends,” “plans,” “believes,” “seeks,” “should,” “could,” “forecasts,” “projects,” variations of such words and similar expressions, are intended to identify such forward-looking statements which are not statements of historical facts. These forward-looking statements are not guarantees of future performance nor guarantees that the events anticipated will occur or expected conditions will remain the same or improve. These statements involve certain risks, uncertainties and assumptions, the likelihood of which are difficult to assess and may not occur, including risks that each of its business segments may not make the expected progress in its respective market, or that management’s long-term strategy may not achieve the expected results. Therefore, actual outcomes, performance and results may differ from what is expressed or forecast in such forward-looking statements, and such differences may vary materially from current expectations.

For further information regarding risks and uncertainties associated with MRV’s businesses, please refer to the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” and “Risk Factors” sections of MRV’s SEC filings, including, but not limited to its annual report on Form 10-K for the year ended December 31, 2013, copies of which may be obtained by contacting MRV’s investor relations department or by visiting MRV’s website at http://www.mrv-corporate.com or the SEC’s EDGAR website at http://www.sec.gov.

 

IR Contact:
LHA
Kirsten Chapman or Monica Chang, 415-433-3777
ir@mrv.com

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(ATEA) Receives Positive NASDAQ Listing Determination

HORSHAM, Pa., Dec. 16, 2014  — Astea International Inc. (ATEA), the leader in service management and mobile workforce solutions, announced today that it has received a positive determination from the NASDAQ Listings Qualifications Panel (the “Panel”) advising it that the Company has been provided a further extension of time, subject to certain conditions, through March 16, 2015, to evidence compliance with the $2.5 million stockholders’ equity requirement for continued listing on The NASDAQ Capital Market. The Company is working to timely evidence compliance with the terms of the Panel’s decision; however, there can be no assurance that it will be able to do so.

About Astea International

Astea International (NASDAQ: ATEA) is a global provider of software solutions that offer all the cornerstones of service lifecycle management, including customer management, service management, asset management, forward and reverse logistics management and mobile workforce management and optimization. Astea’s solutions link processes, people, parts, and data to empower companies and provide the agility they need to achieve sustainable value in less time, and successfully compete in a global economy. Since 1979, Astea has been helping more than 600 companies drive even higher levels of customer satisfaction with faster response times and proactive communication, creating a seamless, consistent and highly personalized experience at every customer relationship touch point.

www.astea.com.   Service Smart.  Enterprise Proven.

© 2014 Astea International Inc. Astea and Astea Alliance are trademarks of Astea International Inc.  All other company and product names contained herein are trademarks of the respective holders.

Forward-looking Statements

Statements in this press release, other than statements of historical information, are forward-looking statements that are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements involve known and unknown risks which may cause the Company’s actual results in future periods to differ materially from expected results. Those risks include, among others, risks associated with increased competition, customer decisions, the successful completion of continuing development of new products, the successful negotiations, execution and implementation of anticipated new software contracts, the successful addition of personnel in technical areas, our ability to complete development and sell and license our products at prices which result in sufficient revenues to realize profits and other business factors beyond the Company’s control. These and other risks are described in the Company’s filings with the Securities and Exchange Commission (SEC), including but not limited to the Company’s Annual Report on Form 10-K and any subsequent Quarterly Reports on Form 10-Q.

Tuesday, December 16th, 2014 Uncategorized Comments Off on (ATEA) Receives Positive NASDAQ Listing Determination

(SYRG) Announces Closing on Acquisition of Wattenberg Field Assets

PLATTEVILLE, CO–(December 16, 2014) – Synergy Resources Corporation (NYSE MKT: SYRG) (Synergy), a U.S. oil and gas exploration and production company with operations focused in the Greater Wattenberg Area in the D-J Basin has closed on the purchase of certain assets from a private operator (“seller”) in the Wattenberg Field as previously disclosed on October 30th, 2014. The assets include leases that are all held by production covering 5,040 gross acres (4,053 net) with rights to the Codell and Niobrara formations. In addition, the acquisition includes 73 operated and 11 non-operated vertical wells and non-operated working interests in seventeen horizontal wells, ten of which are in production (including four mid-reach laterals) and seven which have been completed and are in the early stages of flow back. These seven are all extended reach two mile horizontal wells. Working interests in the non-operated horizontal wells ranges from 6% to 40%. Other assets purchased include 35 permits in process for operated horizontal wells (including 20 extended reach laterals), 3D seismic data and an additional 2,400 gross acres (1,739 net) with rights to other formations, including the Sussex, Shannon and J-Sand. The original purchase price for the assets of $125 million has been amended by increasing the stock component to 40% from 30%. Specifically, the seller will receive 4,648,136 restricted shares of Synergy’s common stock (based on $10.76 per share price) and $75 million in cash. SYRG will fund the cash portion of the purchase via its $230 million borrowing base. The acquisition has an effective date of October 1, 2014. SunTrust Bank is the Joint Lead Arranger/Administrative Agent and KeyBank, National Association is the Joint Lead Arranger/Syndication Agent of the borrowing base and six other banks have joined in the syndicated loan.

This purchase gives Synergy a total acreage position in the Wattenberg Field of approximately 35,000 net acres and adds 150 potential net horizontal Codell and Niobrara wells bringing its inventory of undrilled locations to over 1,250 based on 24 wells per 640 acres.

About Synergy Resources Corporation

Synergy Resources Corporation is a domestic oil and natural gas exploration and production company. Synergy’s core area of operations is in the Wattenberg Field of the Denver-Julesburg Basin. The Denver-Julesburg Basin encompasses parts of Colorado, Wyoming, Kansas, and Nebraska. The Wattenberg field in the D-J Basin ranks as one of the most productive fields in the U.S. The company’s corporate offices are located in Platteville, Colorado. More company news and information about Synergy Resources is available at www.SYRGinfo.com.

Important Cautions Regarding Forward Looking Statements

This press release may contain forward-looking statements, within the meaning of the Private Securities Litigation Reform Act of 1995. The use of words such as “believes”, “expects”, “anticipates”, “intends”, “plans”, “estimates”, “should”, “likely” or similar expressions, indicates a forward-looking statement. These statements are subject to risks and uncertainties and are based on the beliefs and assumptions of management, and information currently available to management. The actual results could differ materially from a conclusion, forecast or projection in the forward-looking information. Certain material factors or assumptions were applied in drawing a conclusion or making a forecast or projection as reflected in the forward-looking information. The identification in this press release of factors that may affect the company’s future performance and the accuracy of forward-looking statements is meant to be illustrative and by no means exhaustive. All forward-looking statements should be evaluated with the understanding of their inherent uncertainty. Factors that could cause the company’s actual results to differ materially from those expressed or implied by forward-looking statements include, but are not limited to: the success of the company’s exploration and development efforts; the price of oil and gas; worldwide economic situation; change in interest rates or inflation; willingness and ability of third parties to honor their contractual commitments; the company’s ability to raise additional capital, as it may be affected by current conditions in the stock market and competition in the oil and gas industry for risk capital; the company’s capital costs, which may be affected by delays or cost overruns; costs of production; environmental and other regulations, as the same presently exist or may later be amended; the company’s ability to identify, finance and integrate any future acquisitions; and the volatility of the company’s stock price.

Investor Relations Contact:
Jon Kruljac
Synergy Resources Corporation
jkruljac@syrginfo.com
Tel (303) 840-8166

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(NVGN) Announces Breakthrough Discovery in the Treatment of Melanoma

SYDNEY, Dec. 16, 2014  — Novogen Limited (ASX:NRT; NASDAQ:NVGN), Australian/US biotechnology company, today announces that it has confirmed that its lead candidate product, TRXE-009, originally developed for the treatment of brain cancers, has been shown in pre-clinical studies also to be highly active against melanoma.

The Company believes this is an important breakthrough discovery for two reasons. The first is that it confirms that TRXE-009 is an important new potential treatment for melanoma, including for the treatment of secondary brain cancers due to melanoma, for which there currently are no effective therapies. The second is that it offers evidence for the first time of an hypothesized link between brain cancer and melanoma.

The link has long been considered a possibility because nerve cells and melanocytes (the melanin pigment-bearing cells in skin that lead to melanoma) have a common origin in the embryo known as the neural crest. This primitive tissue gives rise to the neural cells that go on to form the brain, spinal cord, and peripheral nerves, as well as cells that form the structures of the skull; melanocytes also come from this embryonic tissue. Up till now, no functional link has been found between brain cells and melanocytes, or between brain cancer and melanoma. TRXE-009 is the first compound to demonstrate the possibility of a common link, suggesting that is the first drug with the ability to identify cancers arising in cells that have the neural crest as their common origin.

TRXE-009 has been confirmed as a potential new treatment for both adult and paediatric neural cancers. TRXE-009 previously has been announced as a world-first in having exceptionally high killing activity against adult brain cancer (glioblastoma multiforme) stem cells, and against the paediatric brain cancers – medulloblastoma and DIPG (diffuse interstitial pontine glioma) – all tumors that are highly resistant to known chemotherapies. That same high potency is now confirmed against melanoma cells, with activity unaffected by the tumor’s BRAF gene status.

Dr Graham Kelly, Novogen Group CEO, said, “This latest finding brings the value of TRXE-009 into true perspective for us. We initially developed the compound for brain cancer. We saw it as the first chemotherapy with the potential to make a meaningful difference to the survival prospects of patients, both adult and children, with primary brain cancer.”

“From there we looked at its ability to kill other cancers of neural origin, and discovered that the same potency against brain cancer cells extended to neuroblastoma cells, a potential deadly cancer in children that arises in peripheral nerve tissue outside of the brain.”

“With the realisation that we arguably had the first anti-cancer drug capable of recognising cancers arising in tissues with a common neural crest origin, it was an obvious next step to look at melanoma, with the outcome that we are announcing today,” Kelly explained.

Novogen will be delivering TRXE-009 as a proprietary construct known as Trilexium. Trilexium has been developed to maximise the bio-availability of the drug to cancer cells in the body. Animal xenograft studies of human cancer have confirmed the efficacy of Trilexium.

Kelly said, “This finding completely changes the outlook for this drug candidate. From a drug that was due to come into the clinic specifically for the treatment of adult and childhood neural cancers, we now are presented with a prospective treatment for malignant melanoma, including the treatment of secondary brain cancers due to melanoma for which there currently is no effective therapy.”

“We naturally are keen to bring Trilexium into the clinic as soon as possible,” said Kelly. “But our entire focus at the moment in terms of a clinical program is the product candidate, Cantrixil. That is where our efforts are centred and where our current financial resources are committed, with the objective of achieving the key inflection point of transiting into a clinical-stage company as a firm strategy. Trilexium will enter the clinic only when we have been successful in raising funds specifically ear-marked for this project. Those discussions are current with interested stakeholders.”

About Novogen Limited

Novogen is a public, Australian drug-development company whose shares trade on both the Australian Securities Exchange (‘NRT’) and NASDAQ (‘NVGN’). The Novogen group includes US-based, CanTx Inc, a joint venture company with Yale University.

Novogen has two main drug technology platforms: super-benzopyrans (SBPs) and anti-tropomyosins (ATMs). SBP compounds have been designed to kill the full heterogeneity of cells within a tumor, including the cancer stem cells. The molecular target is a trans-membrane electron-transfer pump mechanism oncogene that is common to all cancer cells. Cells die by respiratory distress and mitochondrial disintegration.

The ATM compounds target the micro-filament component of the cancer cell’s cytoskeleton and have been designed to combine with anti-microtubular drugs (taxanes, vinca alakaloids) to produce comprehensive and fatal destruction of the cancer cell cytoskeleton.

The Company pipeline comprises three SBP drug candidates (TRXE-002, TRXE-009, TRXE-0025) and one ATM drug candidate (‘Anisina’).

About TRXE-009

TRXE-009 is an SBP compound generated by the Company’s VAL-ID (Versatile Approach to Library-based Iterative Design) drug discovery process, with structure-activity relationship driving design based on activity against brain cancer stem cells and the known required chemical criteria to facilitate passage across the blood-brain barrier.

About Trilexium

Trilexium is a construct of drug candidate, TRXE-009, in a proprietary oil-based formulation selected for its ability to maximize passage of drug across the cancer cell plasma membrane.

About Melanoma

Malignant melanoma (Stage 4), where the cancer has spread away from the site of origin, remains a major unmet clinical need with limited effective treatment options. Main sites of metastasis are lungs, liver, brain, bones, and distant lymph nodes and skin. Immunotherapies (ipilumumab, vemurafenib, vaccines), chemotherapy (dacarbazine, vinblastine), radiotherapy and surgery are used to prolong life in Stage 4 disease, but these modalities provide little benefit where metastases has occurred to the brain.

Further information is available on our websites www.novogen.com

For more information please contact:

Corporate Contact

Dr. Graham Kelly
Executive Chairman & CEO Novogen Group
Graham.Kelly@novogen.com
+61-2-9472-4100

Media Enquiries

Cristyn Humphreys
Operations Manager Novogen Group
Cristyn.Humphreys@novogen.com
+61-2-9472-4111

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(ISIG) Announces Preliminary Expectations for Fourth Quarter 2014 Results

Insignia Systems, Inc. (Nasdaq:ISIG) (“Insignia” or “the Company”) today provided certain preliminary information regarding its expected financial results for the fourth quarter of 2014. As discussed in Insignia’s press release, dated October 29, 2014, announcing financial results for the third quarter of 2014 (the “third quarter 2014 release”), the Company’s business currently faces increasing challenges in the market, driven primarily by recent overall cost reduction efforts among consumer packaged goods (CPG) manufacturers and changes in promotional spending by two of the Company’s larger CPG customers. In the third quarter release, the Company disclosed that, as of the date of that release, its year-over-year bookings for the fourth quarter of 2014 were down by approximately 12%. Insignia now expects net sales for the fourth quarter of 2014 will range from $5.8 million to $6.1 million, down 12% to 16% compared to the fourth quarter of 2013. Given the Company’s investments in sales and marketing thus far in 2014 to sustain and grow Insignia’s core products and launch The Like Machine™, the Company now expects a net loss for the fourth quarter of 2014 ranging from $300,000 to $500,000, including certain restructuring costs described below. Fourth quarter 2014 expected results are preliminary and are subject to the Company’s management and independent auditor completing their customary closing and audit procedures following the quarter, among other factors.

A restructuring plan has been approved and will be implemented to reduce costs moving forward. The Company anticipates a pre-tax restructuring charge of approximately $130,000, primarily consisting of an office lease reserve, which will be reflected in its fourth quarter 2014 results. Current backlog for programs running in 2015 is $8.3 million, while the backlog one year ago for programs running in 2014 was $7.4 million.

Glen Dall, President and CEO, commented, “We are disappointed in our fourth quarter 2014 results. While we are encouraged by the increase in backlog, it is too early to predict 2015 sales levels. Moving forward, we are committed to aligning our expenses to revenue, while continuing efforts to grow our core business, and successfully launch The Like Machine. We have confidence in our team and remain dedicated to focusing on delivering long-term value.”

About Insignia Systems, Inc.

Insignia Systems, Inc. is a developer and marketer of innovative in-store products, programs, and services that help consumer goods manufacturers and retail partners drive sales at the point of purchase. Insignia provides at-shelf media solutions in approximately 13,000 retail supermarkets, 2,000 mass merchants and 8,000 dollar stores. With a client list of over 200 major consumer goods manufacturers, including General Mills, Kellogg Company, Kraft Foods, Nestlé, and P&G, Insignia helps major brands deliver on their key engagement, promotion, and advertising objectives right at the point-of-purchase. For additional information, contact (888) 474-7677, or visit the Insignia website at www.insigniasystems.com.

Cautionary Statement for the Purpose of Safe Harbor Provisions of the Private Securities Litigation Reform Act of 1995

Statements in this press release which are not statements of historical or current facts are considered forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, as amended. The words “believes,” “expects,” “anticipates,” “seeks” and similar expressions identify forward-looking statements. Readers are cautioned not to place undue reliance on these or any forward-looking statements, which speak only as of the date of this press release. Statements made in this press release regarding, for instance: current expectations as to fourth quarter 2014 or future financial performance; backlog; ability to implement and achieve benefits from restructuring efforts; benefits of sales and marketing investments; and ability to sustain and grow core products and launch new products, are forward-looking statements. These forward-looking statements are based on current information, which we have assessed and which by its nature is dynamic and subject to rapid and even abrupt changes. As such, actual results may differ materially from the results or performance expressed or implied by such forward-looking statements. Forward-looking statements involve known and unknown risks, uncertainties and other factors, including: (i) the risk that management may be unable to fully or successfully implement its business plan, including restructuring efforts, to achieve and maintain profitability in the future; (ii) the risk that backlog will not result in actual sales; (iii) the risk that the Company will not be able to sustain and grow core product offerings or to develop, implement and grow new product offerings in a successful manner, including our ability to gain retailer acceptance of new product offerings; (iv) the unexpected loss of a major consumer packaged goods manufacturer relationship or retailer agreement or termination of our relationship with News America; (v) prevailing market conditions in the in-store advertising industry, including intense competition for agreements with retailers and consumer packaged goods manufacturers and the effect of any delayed or cancelled customer programs; (vi) potentially incorrect assumptions by management with respect to the financial effect of cost containment or reduction initiatives, current strategic decisions, current sales trends for fiscal year 2015; and (vi) other economic, business, market, financial, competitive and/or regulatory factors affecting the Company’s business generally, including those set forth in our Annual Report on Form 10-K for the year ended December 31, 2013 and additional risks, if any, identified in our Quarterly Reports on Form 10-Q and our Current Reports on Forms 8-K filed with the SEC. Such forward-looking statements should be read in conjunction with the Company’s filings with the SEC. The Company assumes no responsibility to update the forward-looking statements contained in this press release or the reasons why actual results would differ from those anticipated in any such forward-looking statement, other than as required by law.

Insignia Systems, Inc.
John Gonsior, 763-392-6200
CFO

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(AIRT) Adopts Stockholder Rights Plan with Stockholder Protections

Rights Plan Will Expire at 2015 Annual Meeting Unless Ratified by Stockholders; Does Not Apply to Qualifying Offer Made for All Shares that Treats All Shareholders Equally

MAIDEN, N.C., Dec. 15, 2014  — Air T, Inc. (Nasdaq Capital Market: AIRT) announced today that its Board of Directors (the “Board”) adopted a Rights Agreement, pursuant to which one preferred stock purchase right will be distributed as a dividend on each share of the Company’s common stock held of record as of the close of business on December 26, 2014 (the “Rights”).  Initially, the Rights will be represented by the Company’s common stock certificates, or by the registration of uncertificated shares of common stock in the Company’s share register, and will not be exercisable.

The Board adopted the Rights Agreement in response to what it believes are recent rapid accumulations of significant portions of the Company’s outstanding common stock.  It is intended to protect the Company and its stockholders from efforts to obtain control that are inconsistent with the best interests of the Company and its stockholders.  The Rights Agreement provides several recognized stockholder protections:

  • expires at the 2015 annual meeting of stockholders unless the stockholders vote to approve the Rights Agreement at that meeting (in which case it will expire in three years);
  • has procedures for exempting offers made for all shares of the Company that treat all stockholders equally, that result in the bidder owning a majority of the Company’s shares and require the offeror to promptly complete a second-step transaction in which all shares not purchased in the offer will be acquired at the same consideration per share paid in the offer;
  • guards against coercive tactics to gain control without paying all stockholders a premium for that control; and
  • facilitates the ability of all shareholders to realize the full long-term value of their investment in the Company.

Under the Rights Agreement, with certain exceptions, if any person or group becomes the beneficial owner of 20% or more of the Company’s common stock, then each Right not beneficially owned by such beneficial owner will entitle its holder to purchase, at the Rights’ then-current exercise price, shares of the Company’s common stock having a market value of twice the Rights’ then-current exercise price.  In addition, with certain exceptions, if, after any person or group has become a beneficial owner of 20% or more of the Company’s common stock, the Company becomes involved in a merger or other business combination, each Right will entitle its holder (other than such 20% or more beneficial owner) to purchase, at the Rights’ then-current exercise price, common shares of the acquiring company having a value of twice the Rights’ then-current exercise price.

Further details about the Rights Agreement will be contained in a Current Report on Form 8-K to be filed with the Securities and Exchange Commission by the Company.

About Air T
Air T, through its subsidiaries, provides overnight air freight service to the express delivery industry, manufactures and sells aircraft deicers and other special purpose industrial equipment, and provides ground support equipment and facilities maintenance to airlines.  Air T is one of the largest, small-aircraft air cargo operators in the United States.  Air T’s Mountain Air Cargo and CSA Air subsidiaries currently operate a fleet of single and twin-engine turbo-prop aircraft daily in the eastern half of the United States, Puerto Rico and the Caribbean Islands.  Air T’s Global Ground Support subsidiary manufactures deicing and other specialized military and industrial equipment and is one of the largest providers of deicers in the world.  The Global Aviation Services subsidiary provides ground support equipment and facilities maintenance to domestic airline customers.

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(QTWW) Delivers Hydrogen Dispensing System to Linde for a Retail Fueling Station

LAKE FOREST, Calif., Dec 15, 2014  — Quantum Fuel Systems Technologies Worldwide, Inc. (NASDAQ: QTWW), a global leader in natural gas storage systems, integration and vehicle system technologies, in partnership with Linde North America, announces the first hydrogen dispensing system that measures hydrogen mass with connectivity to retail interface and user friendly payment features. The system was installed in West Sacramento and was unveiled at a grand opening hosted by the California Fuel Cell Partnership, Ramos Oil and Linde.

“For over a decade of development and prototyping, we have achieved the breakthrough of measuring and dispensing hydrogen fuel for commercial use in fuel-cell vehicles,” said Brian Olson, CEO of Quantum Technologies. “We are pleased with the results of our agreement with Linde and can expect further joint development efforts to the changing industry and standards,” continued Mr. Olson.

In partnership with Linde, Quantum has developed a highly specialized Hydrogen Dispenser system for 35 and 70 MPa service. For the first time, measuring the mass of hydrogen from a dispensing unit was successful and has received conditional approval for commercial service in California by the Department of Measurements and Standards. This is the first public accessible Hydrogen refueling station that has demonstrated SAE compliant fast fill performance with accurate mass flow measurement.

In addition to the development of dispensers, Quantum’s flag ship type IV tank, Q-Lite™, takes full advantage of maximizing gas and reducing storage weight not only experienced with CNG but also hydrogen.

About Quantum: Quantum Fuel Systems Technologies Worldwide, Inc. is a leader in the innovation, development and production of  hydrogen and natural gas fuel storage systems and the integration of vehicle system technologies including engine and vehicle control systems and drivetrains. Quantum produces one of the most innovative, advanced, and light‐weight hydrogen and compressed natural gas storage tanks in the world and supplies these tanks, in addition to fully‐integrated gas storage systems, to truck and automotive OEMs and aftermarket and OEM truck integrators. Quantum provides low emission and fast‐to‐market solutions to support the integration and production of natural gas fuel and storage systems, hybrid, fuel cell, and specialty vehicles, as well as hydrogen refueling stations. Quantum is headquartered in Lake Forest, California, and has operations and affiliations in the United States, Canada, and India.

About Linde: In the 2013 financial year, The Linde Group generated revenue of USD 23.1 bn (EUR 16.655 bn), making it the largest gases and engineering company in the world with approximately 63,500 employees working in more than 100 countries worldwide. The strategy of The Linde Group is geared towards long-term profitable growth and focuses on the expansion of its international business with forward-looking products and services. Linde acts responsibly towards its shareholders, business partners, employees, society and the environment – in every one of its business areas, regions and locations across the globe. The company is committed to technologies and products that unite the goals of customer value and sustainable development.

Forward Looking Statements: This press release contains forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. All statements included in this report, other than those that are historical, are forward looking statements and can generally be identified by words such as “may,” “could,” “will,” “should,” “assume,” “expect,” “anticipate,” “plan,” “intend,” “believe,” “predict,” “estimate,” “forecast,” “outlook,” “potential,” or “continue,” or the negative of these terms, and other comparable terminology. Various risks and other factors could cause actual results, and actual events that occur, to differ materially from those contemplated by the forward looking statements. Risk factors include the growth of the CNG market and acceptance of the Company’s product. The Company undertakes no obligation to update the information in this press release to reflect events or circumstances after the date hereof or to reflect the occurrence of anticipated or unanticipated events.

More information about the products and services of Quantum can be found at http://www.qtww.com/ or you may contact:

Quantum Investor Relations
Phone: 949-399-4555
Email: ir@qtww.com

For more information, see The Linde Group online at www.linde.com.

Contact:
Amy Ficon
Linde corporate communications
908-771-1491
email: amy.ficon@linde.com

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(CJJD) Completed the Acquisition of Hangzhou Sanhao Grand Pharmacy

HANGZHOU, China, Dec. 15, 2014  — China Jo-Jo Drugstores, Inc. (NASDAQ CM: CJJD) (the “Company” or “China Jo-Jo”), a leading China-based retail and wholesale distributor of pharmaceutical and health care products through its own online and retail pharmacies, today announce that it has completed the acquisition of Hangzhou Sanhao Grand Pharmacy Chain Co., Ltd. (“Sanhao Drugstores”), a Hangzhou-based pharmacy chain with 11 stores.

Founded in 2006, Sanhao Drugstores is a well-known local drugstore chain and owns 11 drugstores in Hangzhou. Among the 11 stores, four have the qualification of “Designated Medical Institutions for Social Health Insurance (“SHI”),” and four others have passed the qualification tests. SHI Program is China’s national health insurance plan aimed to provide universal health insurance coverage to Chinese citizens. Only pharmacies with SHI qualification can serve SHI participants, thus acquiring SHI qualification would substantially enhance a pharmacy’s revenue and profitability. For example, the sales related to SHI accounted for about 55% of China Jo-Jo’s total sales in fiscal 2014.

The Company plans to relocate or remodel the majority of the acquired pharmacies in the upcoming months. After the restructuring of Sanhao Drugstores, the management expects it to generate about RMB 30 million (or $4.8 million) revenue in the calendar year of 2015.

Mr. Lei Liu, Chairman of the Company, stated, “The synergistic acquisition of Sanhao Drugstores will increase our total store count to over 60, from our current level of 51 drugstores. We also set our eyes on some key geographic locations in Hangzhou which allow us to expand our store penetration. We believe the investment will bring satisfactory economic benefits to our shareholders in the coming years.”About China Jo-Jo Drugstores, Inc.

China Jo-Jo Drugstores, Inc., through its own retail drugstores, wholesale distributor and online pharmacy, is a leading retailer and wholesale distributor of pharmaceutical and health care products in China. As of September 30, 2014, the Company had 51 retail pharmacies in Hangzhou. The Company’s wholesale subsidiary not only supplies its retail stores, but also distributes drug and other health care products to other drugstores and drug vendors. The Company routinely posts important information on its corporate websites at www.jiuzhou-drugstore.com (Chinese) and www.chinajojodrugstores.com (English).

Forward Looking Statement

Statements in this press release regarding the Company that are not historical facts are forward-looking statements and are subject to risks and uncertainties that could cause actual future events or results to differ materially from such statements. Any such forward-looking statements, including, but not limited to, financial guidance, are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements can be identified by the use of forward-looking terminology such as “believe,” “expect,” “may,” “will,” “should,” “project,” “plan,” “seek,” “intend,” “anticipate,” the negatives thereof, or comparable terminology. Such statements typically involve risks and uncertainties and may include financial projections or information regarding the progress of new product development. It is routine for the Company’s internal projections and expectations to change as the quarter and year progresses, and therefore it should be clearly understood that the internal projections and beliefs upon which the Company bases its expectations may change. Although these expectations may change, the Company is under no obligation to inform you if they do. Actual results could differ materially from the expectations reflected in such forward-looking statements as a result of numerous factors, including the risks associated with the effect of changing economic conditions in the People’s Republic of China, variations in cash flow, reliance on collaborative retail partners and on new product development, variations in new product development, risks associated with rapid technological change, and the potential of introduced or undetected flaws and defects in products. Readers are referred to the reports and documents filed from time to time by the Company with the Securities and Exchange Commission for a discussion of these and other important risk factors that could cause actual results to differ from those discussed in forward-looking statements.

Contacts

China Jo-Jo Drugstores, Inc.
Ming Zhao
Chief Financial Officer
Tel: (561) 372-5555
Email: frank.zhao@jojodrugstores.com

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(DAKP) Issues Open Letter To The Board Of Dakota Plains

Gratified to See Board Act to Exit Joint Ventures but Believes More Remains to be Done States Significant Additional Value Can Be Created with MLP Structure for the Pioneer Transloading Facility Calls on the Board to Take the Second Step of Creating Value and Initiate Strategic Alternatives Review Process

OLD GREENWICH, Conn., Dec. 15, 2014 — Lone Star Value Management, LLC (together with its affiliates, “Lone Star Value”), the largest shareholder of Dakota Plains Holdings, Inc. (NYSEMKT: DAKP) (“Dakota Plains” or the “Company”) with aggregate ownership of approximately 7.3% of the outstanding common stock, today issued an open letter to the Company’s Board of Directors.  The full text of the letter is included below:

December 15, 2014

Board of Directors
Dakota Plains Holdings, Inc.

Members of the Board:

Lone Star Value Investors, LP (“Lone Star Value”, “LSV”, “we” or “us”) currently owns 4,000,000 shares of Dakota Plains Holdings, Inc. (“Dakota Plains”, “DAKP” or the “Company”), making us DAKP’s largest shareholder.  At Lone Star Value, our goal is to invest in undervalued securities and engage with our portfolio companies to improve performance and maximize value for all shareholders.

We originally invested in the shares of Dakota Plains based on our valuation analysis which indicated that DAKP shares were materially undervalued versus our estimate of the Company’s net asset value per share and our belief that opportunities existed within the control of the Board and management to unlock value and close the valuation gap.  Our research on the Company’s Pioneer transloading facility uncovered a number of strategic strengths that, in our opinion, make Dakota Plains an attractive long-term investment, including:

  • Strategic location in the core of the Bakken oil field; the core of the Bakken oil field has very low breakeven pricing levels ensuring continued growth in oil production volumes from the core area of the field leading to growing demand for access to DAKP’s transloading facility
  • Oil production in North Dakota is expected to continue to exceed pipeline capacity creating long-term demand for crude-by-rail as an offtake solution
  • Crude-by-rail is safe and cost-effective and will always be a key transportation mechanism for product to get to market from the Bakken
  • Access to key rail line offtake systems and good relationships with railroads
  • Pricing is based on a fixed fee per unit transported, not on commodity prices, making DAKP’s transloading asset perform more like a pipeline asset than an oil & gas asset
  • In addition to exporting oil volumes out of the basin, DAKP’s transloading facility can also be used to import needed raw materials into the basin such as frac sand (as evidenced by DAKP’s JV with Unimin)

At Lone Star Value, whenever we discover an undervalued security, we examine why the security is undervalued and if the factors leading to the undervaluation are temporary and fixable.  When we originally invested in DAKP, we believed the Company’s complicated structure, whereby all assets were held in three different joint ventures, was causing a discount in DAKP’s stock price versus its underlying asset value per share.  DAKP’s multiple joint ventures presented a confusing picture for investors and unclear financial statements.  In addition to the Company’s core asset (the Pioneer transloading facility) being owned in a joint venture, the Company was also in two other non-core businesses via joint ventures: the Trucking business and the Marketing business.  Further, the Marketing business was once profitable, but began generating losses which created more volatility in DAKP’s earnings than is typical for a pipeline-type asset like the Pioneer transloading facility.

We were convinced that the best and critical first step to create value for all DAKP shareholders was unwinding the Company’s complicated joint venture structures and we sought to engage with the Board and management team to help the Company achieve this goal.  We invested significantly in DAKP, ultimately owning more than 5% of all outstanding shares and, upon your invitation, a representative of Lone Star Value joined the Dakota Plains Board.  We made it clear to you that in order for shareholder value to be maximized, DAKP needed to urgently become a pure play company owning 100% of a single asset — the strategic Pioneer transloading facility.

Accordingly, we were gratified to see Dakota Plains announce on November 10, 2014 that it had exited the Trucking joint venture as we suggested.  The Company also announced on that day the construction of a third storage tank at Pioneer allowing the facility to transport approximately 80,000 barrels of oil per day upon its completion in Q3 2015.  We were further pleased to see the Company announce on December 8, 2014 the unwinding of the Marketing joint venture and the purchase of its partner’s 50% share of the Transloading joint venture, thus exiting all joint ventures and owning 100% of the Pioneer transloading facility.

We have been disappointed, however, with the Board and management’s poor decision to wait so long to unwind its joint ventures and simplify the Company’s business structure.  This delay damaged shareholder value in our opinion based on our belief that the cost of unwinding of both the Marketing and Transloading joint ventures would have been lower had they been done sooner.  In addition, these value-creating steps were not undertaken until the Company was pressured to do so by shareholders.

We believe the Board needs to take further steps to maximize shareholder value.  For example, Dakota Plains’ Pioneer transloading facility would be far more attractive inside an MLP structure and an MLP is the ultimate natural owner of this asset similar to other pipelines and pipeline-type assets in the energy business.  Our analysis indicates that DAKP’s assets inside an MLP structure could be valued at $3.55-4.85 per share based on DAKP’s earnings potential by year-end 2015 once the tank 3 construction is complete and the facility is transporting 80,000 barrels of oil per day (see Exhibit A).  In addition, if further capital investment is made so that the Pioneer transloading facility can transport its full facility capacity of 160,000 barrels of oil per day, we believe DAKP’s potential future value in a few years could approach $7.70-10.20 per share inside an MLP structure (see Exhibit B).

We strongly believe that remaining a small cap C-corp will cause DAKP stock to continue to trade at a material discount to its intrinsic asset value.  An MLP structure is the optimal ownership structure for DAKP’s transloading asset and will generate the highest value for DAKP shareholders.  Given that Dakota Plains is now a pure-play Transloading company, we believe the time is right to initiate a Strategic Alternatives process whereby the Company would be sold in a competitive auction to the highest bidder, most likely to an MLP.

In summary, we are pleased to see the Board has finally made the strategic moves this year to convert Dakota Plains into a pure play business owning 100% of the Pioneer transloading facility.  As we have clearly stated in the past, we believe unwinding the Company’s joint venture structure was an important first step to generate value for shareholders.  However, we believe more remains to be done to fully capitalize on the value of the Company’s assets and strategic advantages.  In our view, the Pioneer transloading facility is more valuable to a larger company, particularly inside an MLP, and now is the right time to start the second step of creating value for shareholders by initiating a strategic alternatives process to sell the Company.

Sincerely,

Jeffrey E. Eberwein, Managing Member
Lone Star Value Management, LLC

 

Exhibit A
Valuation in Connection with a Master Limited Partnership (MLP) Structure1
Phase 3 (80 TBD)
Low Mid High Notes
Pioneer Transloading Facility
Throughput (TBD) 80.0 80.0 80.0 Thousands of barrels per day
Income/bbl $1.10 $1.10 $1.10 JV income = $0.55/bbl per 6-24-14presentation at 50% ownership
Implied EBIT ($mm) $32.1 $32.1 $32.1
DD&A expense ($mm) $4.8 $4.8 $4.8 LSV estimate including Tank 3
Implied EBITDA ($mm) $36.9 $36.9 $36.9 Run rate by 2015 year-end
Unimin EBITDA ($mm) $1.0 $1.0 $1.0 LSV estimate
Total EBITDA ($mm) $37.9 $37.9 $37.9
EBITDA Multiple 8.0 9.0 10.0 MLPs trade at 8-10x EBITDA
Implied Asset Value ($mm) $304 $341 $379
Debt ($mm)
New Notes $48.5 Slide 22 of 12-12-14 presentation
Contingent Payments 47.1 Slide 22 of 12-12-14 presentation
Capex 5.5 Cost of Tank 3
Total Debt $101
Equity Value ($mm) $203 $240 $278
Equity Value per share $3.55 $4.20 $4.85 Fully diluted
1 Our Analysis contains forward-looking statements that reflect the current views of Lone Star Value, including, but not limited to, statements regarding speculations of future growth and business, operational capacities and plans within Dakota Plains. These statements involve uncertainties, as actual results could differ materially from those anticipated, but such numbers are supported by certain known verifiable facts and in depth strategic due diligence.

 

Exhibit B
Valuation in Connection with a Master Limited Partnership (MLP) Structure2
Phase 4-6 (160 TBD)
Low Mid High Notes
Pioneer Transloading Facility
Throughput (TBD) 160 160 160 Thousands of barrels per day
Income/bbl $1.10 $1.10 $1.10 JV income = $0.55/bbl per 6-24-14presentation at 50% ownership
Implied EBIT ($mm) $64.2 $64.2 $64.2
DD&A expense ($mm) $7.6 $7.6 $7.6 LSV estimate
Implied EBITDA ($mm) $71.8 $71.8 $71.8 Run rate by 2016 year-end
Unimin EBITDA ($mm) $1.0 $1.0 $1.0 LSV estimate
Total EBITDA ($mm) $72.8 $72.8 $72.8
EBITDA Multiple 8.0 9.0 10.0 MLPs trade at 8-10x EBITDA
Implied Asset Value ($mm) $583 $655 $728
Debt ($mm)
New Notes $48.5 Slide 22 of 12-12-14 presentation
Contingent Payments 47.1 Slide 22 of 12-12-14 presentation
Capex 41.5 Cost of Tank 3 + Cost of Phases 4-6as shown on Slide 19 of 12-12-14 presentation
Total Debt $137
Equity Value ($mm) $445 $518 $591
Equity Value per share $7.70 $8.90 $10.20 Fully diluted
2 Our Analysis contains forward-looking statements that reflect the current views of Lone Star Value, including, but not limited to, statements regarding speculations of future growth and business, operational capacities and plans within Dakota Plains. These statements involve uncertainties, as actual results could differ materially from those anticipated, but such numbers are supported by certain known verifiable facts and in depth strategic due diligence.

 

About Lone Star Value Management:

Lone Star Value Management, LLC (“Lone Star Value”) is an investment firm that invests in undervalued securities and engages with its portfolio companies in a constructive way to help maximize value for all shareholders.  Lone Star Value was founded by Jeff Eberwein who was formerly a Portfolio Manager at Soros Fund Management and Viking Global Investors.  Lone Star Value is based in Old Greenwich, CT.

Jeffrey E. Eberwein
203.489.9500
je@lonestarvm.com

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(SRNE) Strategic Investment By And Collaboration With Nantworks Founder

SAN DIEGO, Dec. 15, 2014  — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), an oncology company developing new treatments for cancer and associated pain, announced today that it has entered into a binding agreement with NantWorks founder, physician scientist, and biotechnology entrepreneur Dr. Patrick Soon-Shiong.

Under the terms of the agreement, NantWorks and Sorrento will establish a global strategic collaboration to jointly develop next generation immunotherapies for the treatment of cancer and auto-immune diseases. NantWorks, through a subsidiary, and Sorrento intend to establish the first joint venture – “The Immunotherapy Antibody JV” – as an independent biotechnology company with $20 million initial joint funding. As part of a strategic investment, Dr. Soon-Shiong’s affiliated entity will acquire a 19.9% equity stake in Sorrento by purchasing common stock priced at $5.80 per share, Sorrento’s closing sale price on Friday, December 12, 2014. In addition, Sorrento granted the purchaser a 3-year warrant to purchase 1,724,138 shares of common stock at an exercise price of $5.80 per share.

The Immunotherapy Antibody JV will focus on accelerating the development of multiple immuno-oncology monoclonal antibodies (mAbs) for the treatment of cancer, including but not limited to anti-PD-1, anti-PD-L1, anti-CTLA4 mAbs, and other immune-check point antibodies as well as antibody drug conjugates (ADCs) and bispecific antibodies. The immuno-oncology field has emerged as the one of most exciting and fastest developing pharmaceutical market. Immunomodulatory antibodies help the cancer patient’s own immune system to fight the disease and are being developed for the treatment of a number of solid tumors. They have demonstrated therapeutic potential in difficult-to-treat cancers, such as metastatic melanoma and non-small cell lung cancer (NSCLC). A recent forecast by Citigroup predicts this market to become the biggest blockbuster drug class in history with potential sales of up to $35 billion a year over the next 10 years.

“We are extremely pleased to be working with Dr. Patrick-Soon Shiong and NantWorks. The investment into Sorrento and future formation of the JV with NantWorks further validate our G-MAB antibody technology and underscore Sorrento’s commitment to seeking strategic alliances in bringing its diverse portfolio of fully human monoclonal antibodies, ADCs, and bispecific antibodies into the clinic,” said Dr. Henry Ji, President and CEO of Sorrento. “Our innovative collaboration will unite Sorrento’s capability to develop complex biologics with NantWorks proprietary genomic and personalized medicine technologies. We share NantWorks’ enthusiasm for the potential of our JV to produce a pipeline of immuno-oncology products to address unmet needs of cancer treatment.”

“Combining NantWorks’ cutting edge expertise in genomic and molecular profiling of cancer patients and Sorrento’s industry-leading G-MAB antibody technology, we believe will enable us to develop multiple novel therapies for malignant disorders where there is currently a significant unmet need. Through this partnership, it is our goal to provide relief for millions of people who today have limited treatment options. This will be a model relationship aligned to accelerate development and production of novel cancer immunotherapies. We look forward to working closely with Sorrento’s team,” said Dr. Patrick Soon-Shiong, CEO and Founder of NantWorks.

About NantWorks

NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane®, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobile, NantMedia, NantOmics, NantBioScience, NantBioCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks’ division entities operates at the nexus of innovation and infrastructure.

The core mission of NantWorks is convergence: to develop and deliver a diverse range of
technologies that accelerates innovation, broaden the scope of scientific discovery, enhance
groundbreaking research, and improve healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically-informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics.

About Sorrento Therapeutics, Inc. 

Sorrento is an oncology company developing new treatments for cancer and associated pain. Sorrento’s most advanced asset Cynviloq™, the next-generation nanoparticle paclitaxel, commenced its registrational trial in March 2014 and is being developed under the abbreviated 505(b)(2) regulatory pathway. Sorrento is also developing RTX, a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the NIH to treat terminal cancer patients suffering from intractable pain. The Company has made significant advances in developing human monoclonal antibodies, complemented by a comprehensive and fully integrated ADC platform that includes proprietary conjugation chemistries, linkers, and toxic payloads. Sorrento’s strategy is to enable a multi-pronged approach to combating cancer with small molecules, mono- and bi-specific therapeutic antibodies, and ADCs.

Forward-Looking Statements

This press release contains forward-looking statements under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about its Cynviloq registrational trial; and the advances made in developing RTX and human monoclonal antibodies, if any; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2013, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

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(FLXN) Announces Pricing of Public Offering of Common Stock

BURLINGTON, Mass., Dec. 12, 2014  — Flexion Therapeutics, Inc. (Nasdaq:FLXN) today announced the pricing of its underwritten public offering of 5,040,000 shares of common stock at a price to the public of $17.00 per share. Flexion has also granted the underwriters a 30-day option to purchase up to an additional 756,000 shares of common stock. The offering is expected to close on December 17, 2014, subject to customary closing conditions.

BMO Capital Markets Corp. and RBC Capital Markets, LLC are acting as joint book-running managers. Needham & Company, LLC is acting as lead manager and Janney Montgomery Scott and Summer Street Research Partners are acting as co-managers.

Registration statements relating to the shares to be sold in the offering have become effective. The offering is being made only by means of a prospectus. A copy of the prospectus relating to the offering may be obtained from BMO Capital Markets Corp., 3 Times Square, 27th Floor, New York, NY 10036, Attention: Equity Syndicate Department, Telephone: (800) 414-3627, Email: bmoprospectus@bmo.com; or from RBC Capital Markets, LLC, 200 Vesey Street, 8th Floor, New York, NY 10281; Attention: Equity Syndicate Department, Telephone: (877) 822-4089, Fax: (212) 428-6260.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy any of Flexion’s securities. No offer, solicitation or sale will be made in any jurisdiction in which such offer, solicitation or sale is unlawful.

About Flexion Therapeutics

Flexion is a clinical-stage specialty pharmaceutical company focused on the development and commercialization of novel pain therapies. The company is currently advancing a portfolio of injectable drug candidates that have the potential to provide better and more persistent analgesia compared with existing therapy. The company’s lead program, FX006, is an intra-articular sustained release steroid in development for patients with moderate to severe OA pain. The company also has two additional product candidates, FX007, a locally administered TrkA receptor antagonist for post-operative pain, and FX005, an intra-articular, sustained-release p38 MAP kinase inhibitor for end-stage OA patients.

Forward-Looking Statements

Statements in this press release regarding matters that are not historical facts, including expectations regarding the completion and timing of Flexion’s proposed public offering, are forward-looking statements. These forward-looking statements are based on management’s expectations and assumptions as of the date of this press release and are subject to numerous risks and uncertainties, which could cause actual results to differ materially from those expressed or implied by such statements. These risks and uncertainties include, without limitation, risks and uncertainties associated with market conditions and the satisfaction of customary closing conditions related to the proposed offering, as well as other risks and uncertainties described in Flexion’s filings with the Securities and Exchange Commission (SEC), including under the heading “Risk Factors” in Flexion’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC. You are encouraged to read Flexion’s filings with the SEC, available at www.sec.gov, for a discussion of these and other risks and uncertainties. The forward-looking statements in this press release speak only as of the date of this press release, and Flexion undertakes no obligation to update or revise any of the statements.

CONTACT: Media Contact
         Jamie Lacey-Moreira
         PressComm PR, LLC
         T: 410-299-3310
         jamielacey@presscommpr.com

         Corporate Contact
         Lisa Davidson, MBA
         Vice President, Finance and Administration
         Flexion Therapeutics, Inc.
         T: 781-305-7765
         ldavidson@flexiontherapeutics.com
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(CISG) to Expand New Share Issue to Employees

GUANGZHOU, China, Dec. 12, 2014  — CNinsure Inc. (“CNinsure” or the “Company”) (Nasdaq:CISG), a leading independent insurance intermediary company in China, today announced that it has obtained approval from the Board of Directors to increase the new share issue to employees from up to 100,000,000 ordinary shares to 150,000,000 ordinary shares, representing approximately 15% of the Company’s current total outstanding share capital. The purchase price for the 100,000,000 ordinary shares is $0.27 per ordinary share or $5.4 per ADS, while that for the additional 50,000,000 ordinary shares is $0.29 per ordinary share or $5.8 per ADS, both of which are the average closing prices for the 20 trading days prior to the board approvals. Completion of the share issuances to the employees is subject to customary closing conditions.

“The new share issue was enthusiastically received by our employees, as reflected by the significant oversubscription. Therefore, we have decided to expand the size of the new share issue to meet the excess demand.” Mr. Chunlin Wang, the chief executive officer of CNinsure commented, “the strong demand shows a strong vote of confidence in the Company. We reaffirm our commitment to delivering long term sustainable growth for the benefit of all our shareholders.”

About CNinsure Inc.

CNinsure is a leading independent intermediary company operating in China. CNinsure’s distribution network reaches many of China’s most economically developed regions and affluent cities. The Company distributes a wide variety of property and casualty and life insurance products underwritten by domestic and foreign insurance companies operating in China, and provides insurance claims adjusting as well as other insurance-related services.

Forward-looking Statements

This press release contains statements of a forward-looking nature. These statements are made under the “safe harbor” provisions of the U.S. Private Securities Litigation Reform Act of 1995. You can identify these forward-looking statements by terminology such as “will,” “expects,” “believes,” “anticipates,” “intends,” “estimates” and similar statements. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about CNinsure and the industry. Potential risks and uncertainties include, but are not limited to, those relating to CNinsure’s limited operating history, especially its limited experience in selling life insurance products, its ability to attract and retain productive agents, especially entrepreneurial agents, its ability to maintain existing and develop new business relationships with insurance companies, its ability to execute its growth strategy, its ability to adapt to the evolving regulatory environment in the Chinese insurance industry, its ability to compete effectively against its competitors, and macroeconomic conditions in China and their potential impact on the sales of insurance products. All information provided in this press release is as of the date hereof, and CNinsure undertakes no obligation to update any forward-looking statements. Although CNinsure believes that the expectations expressed in these forward-looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results. Further information regarding risks and uncertainties faced by CNinsure is included in CNinsure’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F.

CONTACT: For more information, please contact:
         Oasis Qiu
         Investor Relations Manager
         Tel: +86 (20) 6122-2731
         Email: qiusr@cninsure.net
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(NAVB) Data Supporting Potential for Breakthrough with Manocept™ in Immunotherapy

Macrophage Therapeutics, a newly created business unit of Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB), is pleased to present at a conference data generated by independent academic collaborators that it believes represent a pathway to a potential major scientific breakthrough in disease therapy, and more specifically, immunotherapy. Data will be presented to members of the scientific and investment communities both live in New York City and via webinar (details below).

Data will be presented that demonstrates that the Manocept™ backbone of tilmanocept, a component of an FDA-approved diagnostic agent, when attached to selected active therapeutic agents, can modulate over-active macrophages in clinically meaningful ways. To date, immunotherapy targeting the innate immune system has been limited to selectively blocking certain of the chemokines and cytokines produced by over-active macrophages. As a result of the high affinity of the Manocept platform compounds to CD206, which is only found in activated macrophage stages, one can now target the cell directly and modulate all of the activities of the overactive cell. This breakthrough has potential implications for radically new approaches to treatment in a broad array of diseases including infectious diseases, cancer, cardiovascular, autoimmune and central nervous system diseases.

Presenting at the webinar will be Frederick O. Cope, Ph.D., who will provide the technology overview covering the basic aspects of tilmanocept interactions with macrophages. Dr. Cope will also present data on the tuberculosis/macrophage relationships and the tilmanocept/CD206 relationship in the pathology of tuberculosis, as well as findings in rheumatoid arthritis. These studies have been generated in collaboration with researchers at The Ohio State University.

In the area of Kaposi’s sarcoma (KS), Michael McGrath, M.D., Ph.D., Professor, University of California, San Francisco, School of Medicine, will cover work done with tilmanocept in KS, HIV, and HVC.

Lastly, Steven Grinspoon, M.D., Professor of Medicine at Harvard Medical School, will discuss the ongoing work with vulnerable plaque and atherosclerosis and the role of CD206, macrophages and tilmanocept’s potential interactions in this pathology.

“We are humbled to be entrusted with this scientific breakthrough that has the potential to help so many patients. Our priority is to develop additional data in order to advance products utilizing this technology into clinical testing and then to the market. We are fortunate that we already have an FDA-approved indication with this technology as a diagnostic. As a result, we believe we have addressed many of the key commercialization issues for the technology and can now focus on the individual therapeutic applications. We are in the process of creating a Scientific Advisory Board of leading macrophage-focused immunologists as well as therapeutic area experts to assist us in prioritization within major disease categories,” said Navidea director Michael M. Goldberg, M.D., who is leading Navidea’s Macrophage Therapeutics efforts.

The conference and webinar will be held at 10:00 am (EST) this coming Monday, December 15th, at 109 West 39th Street, New York, NY 10019.

The conference will also be available streaming online via webinar at: https://www3.gotomeeting.com/register/264506806, or by dialing Toll-free: 1 866 952 8437, Access Code: 622 843 441

About Macrophage Therapeutics

Macrophage Therapeutics, a newly created business unit of Navidea Biopharmaceuticals, Inc., is developing new therapeutics based on its proprietary CD206 targeting technology platform. This will represent a new paradigm in the treatment of disease. Depending on the active agent(s) attached to the Manocept™ backbone as well as other core molecule permutations, it may be possible to approach immunotherapy in a completely novel manner. This approach has the potential to provide for management and modification of diseases that include the immediate involvement of macrophages, the biological products of macrophages, or the effective impact of macrophages or their progenitor and/or daughter elements. Thus, Macrophage Therapeutics’ Manocept platform is designed to specifically address a key element, macrophage interactions, in the natural progression of clinically significant diseases that impact the lives of patients around the globe.

About Navidea Biopharmaceuticals Inc.

Navidea Biopharmaceuticals, Inc. (NYSE MKT: NAVB) is a biopharmaceutical company focused on the development and commercialization of precision diagnostics and radiopharmaceutical agents. For more information, please visit www.navidea.com.

The Private Securities Litigation Reform Act of 1995 (the Act) provides a safe harbor for forward-looking statements made by or on behalf of the Company. Statements in this news release, which relate to other than strictly historical facts, such as statements about the Company’s plans and strategies, expectations for future financial performance, new and existing products and technologies, anticipated clinical and regulatory pathways, and markets for the Company’s products are forward-looking statements within the meaning of the Act. The words “believe,” “expect,” “anticipate,” “estimate,” “project,” and similar expressions identify forward-looking statements that speak only as of the date hereof. Investors are cautioned that such statements involve risks and uncertainties that could cause actual results to differ materially from historical or anticipated results due to many factors including, but not limited to, the Company’s continuing operating losses, uncertainty of market acceptance of its products, reliance on third party manufacturers, accumulated deficit, future capital needs, uncertainty of capital funding, dependence on limited product line and distribution channels, competition, limited marketing and manufacturing experience, risks of development of new products, regulatory risks and other risks detailed in the Company’s most recent Annual Report on Form 10-K and other Securities and Exchange Commission filings. The Company undertakes no obligation to publicly update or revise any forward-looking statements.

 

Macrophage Therapeutics
Michael M. Goldberg, M.D. 201-608-5218
or
Navidea Biopharmaceuticals
Brent Larson, 614-822-2330
Executive VP & CFO

Friday, December 12th, 2014 Uncategorized Comments Off on (NAVB) Data Supporting Potential for Breakthrough with Manocept™ in Immunotherapy

(ONTY) Exclusive License Agreement With Array BioPharma for ONT-380

SEATTLE, Dec. 12, 2014  — Oncothyreon Inc. (Nasdaq:ONTY) today announced that Array BioPharma Inc. (Nasdaq:ARRY) has granted Oncothyreon an exclusive license to develop, manufacture and commercialize ONT-380 (ARRY-380), an orally active, reversible and selective small molecule HER2 inhibitor. The license agreement replaces the prior Development and Collaboration Agreement under which Oncothyreon and Array were jointly developing ONT-380.

As part of the agreement, Oncothyreon will pay Array $20 million as an upfront fee. In addition, Oncothyreon will pay Array a significant portion of any payments received from sublicensing ONT-380 rights. If Oncothyreon is acquired within three years of the effective date of the current agreement, Array will be eligible for up to $280 million in commercial milestone payments. Array is also entitled to receive up to a double-digit royalty based on net sales of ONT-380.

“We are encouraged by the positive preliminary evidence of efficacy and tolerability seen in patients with advanced metastatic breast cancer in our ongoing Phase 1b trials of ONT-380, as will be reported today at the San Antonio Breast Cancer Symposium,” said Robert L. Kirkman, M.D., President and Chief Executive Officer of Oncothyreon. “We are pleased, therefore, to obtain the exclusive rights to develop and commercialize ONT-380.”

About ONT-380

ONT-380 is an orally active, reversible and selective HER2 inhibitor invented at Array. In multiple preclinical tumor models, ONT-380 was well tolerated and demonstrated significant dose-related tumor growth inhibition that was superior to Herceptin® (trastuzumab) and Tykerb® (lapatinib). Additionally, in these models, ONT-380 demonstrated synergistic or additive tumor growth inhibition when dosed in combination with the standard-of-care therapeutics Herceptin or Taxotere® (docetaxel). ONT-380 has also demonstrated superior activity, based on overall survival, compared to Tykerb® and to the investigational drug, neratinib, in an intracranial HER2 positive breast cancer xenograft model.

A Phase 1 trial of ONT-380, with both dose-escalation and expansion components, has been completed in 50 patients, 43 of whom had HER2 positive metastatic breast cancer. All HER2 positive breast cancer patients had progressed on a Herceptin-containing regimen. In addition, over 80 percent had been treated with Tykerb, with many having progressed on therapy. In this study, ONT-380 demonstrated an acceptable safety profile; treatment-related adverse events were primarily Grade 1. Because ONT-380 is selective for HER2 and does not inhibit EGFR, there was a low incidence and severity of treatment-related diarrhea, rash and fatigue. Additionally, there were no treatment-related cardiac events or Grade 4 treatment-related adverse events reported. Twenty-two HER2 positive breast cancer patients with measurable disease were treated with ONT-380 at doses greater than or equal to 600 mg BID. In this heavily pretreated patient population, there was a clinical benefit rate (partial response [n = 3] plus stable disease for at least 6 months [n = 3]) of 27 percent.

Oncothyreon is currently conducting two Phase 1b trials of ONT-380 in combination with other agents. The first trial (ClinicalTrials.gov Identifier NCT02025192) is a parallel dose-escalation study of ONT-380 in combination with Xeloda® (capecitabine) and/or Herceptin® (trastuzumab) in patients who have been previously treated with Herceptin and Kadcyla® (ado-trastuzumab emtansine or TDM-1) for metastatic breast cancer.  The second trial (ClinicalTrials.gov Identifier NCT01983501) is a dose-escalation study of ONT-380 in combination with Kadcyla in patients who have been previously treated with Herceptin and a taxane for metastatic breast cancer. Preliminary data from both trials will be presented today at the San Antonio Breast Cancer Symposium and are summarized in an accompanying press release.

About Oncothyreon

Oncothyreon is a clinical-stage biopharmaceutical company specializing in the development of innovative therapeutic products for the treatment of cancer. Our goal is to discover, develop and commercialize novel compounds that have the potential to improve the lives and outcomes of cancer patients. Our current clinical-stage product candidates include ONT-380, an orally active and selective small molecule HER2 inhibitor, and ONT-10, a therapeutic vaccine targeting MUC1. We are developing preclinical product candidates in oncology, and potentially certain rare diseases, using our recently acquired protocell technology. For more information, visit www.oncothyreon.com.

Oncothyreon Forward-Looking Statements

In order to provide Oncothyreon’s investors with an understanding of its current results and future prospects, this release contains statements that are forward-looking. 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 “believes,” “anticipates,” “plans,” “expects,” “will,” “intends,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include Oncothyreon’s expectations regarding clinical development activities.

Forward-looking statements involve risks and uncertainties related to Oncothyreon’s business and the general economic environment, many of which are beyond its control. These risks, uncertainties and other factors could cause Oncothyreon’s actual results to differ materially from those projected in forward-looking statements, including those predicting the timing, duration and results of clinical trials, the timing and results of regulatory reviews, the safety and efficacy of our product candidates, and the indications for which our product candidates might be developed. There can be no guarantee that the results of preclinical studies or clinical trials will be predictive of either safety or efficacy in future clinical trials. Although Oncothyreon believes that the forward-looking statements contained herein are reasonable, it can give no assurance that its expectations are correct. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. For a detailed description of Oncothyreon’s risks and uncertainties, you are encouraged to review the documents filed with the securities regulators in the United States on EDGAR and in Canada on SEDAR. Oncothyreon does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof.

Additional Information

Additional information relating to Oncothyreon can be found on EDGAR at www.sec.gov and on SEDAR at www.sedar.com.

CONTACT: Oncothyreon Investor and Media Relations Contact:	

         Julie Rathbun
         Rathbun Communications
         206-769-9219
         ir@oncothyreon.com
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(CCXI) Positive Results in Phase II Diabetic Nephropathy Trial CCR2 Inhibitor CCX140

Primary Endpoint Achieved; Statistically Significant Reduction in Urinary Protein Over 52 Weeks

Improved Estimated Glomerular Filtration Rate Profile versus Standard of Care

Favorable Safety Profile for CCX140

Company to Host Conference Call and Webcast Today at 8:30a.m. ET

MOUNTAIN VIEW, Calif., Dec. 12, 2014  — ChemoCentryx, Inc., (Nasdaq:CCXI), a clinical-stage biopharmaceutical company focused on autoimmune diseases, inflammatory disorders and cancer, today announced positive top-line 52-week data from its Phase II clinical trial in diabetic nephropathy with CCX140, an inhibitor of the chemokine receptor known as CCR2.

The trial met its primary endpoint by demonstrating that treatment with 5 mg of CCX140 given orally once daily added to a standard of care regimen (SOC) of angiotensin converting enzyme (ACE) inhibitor or angiotensin receptor II blocker (ARB) treatment resulted in a statistically significant (p=0.0148) reduction in urinary albumin creatinine ratio (UACR), beyond that achieved with SOC alone. High UACR is known to predict poor renal outcome. The maximum treatment effect (24 percent reduction) was reached at 12 weeks, and sustained reduction in albuminuria induced by CCX140 relative to SOC alone was observed over the full year, i.e., UACR at each one of the 10 time points over the 52-week treatment period in the patients who received 5 mg CCX140 continuously for 52 weeks, were below those of the SOC alone group. A dose of 10 mg CCX140 per day did not provide more improvement in albuminuria as compared to the 5 mg dose.

In addition, estimated glomerular filtration rate (eGFR) changes were assessed. Measuring eGFR is important in assessing long-term kidney function (over many months to years), and provides the basis for Phase III clinical trial registration endpoints. Numerous clinical trials with the current SOC (ACE inhibitors and ARBs) show that these attenuate the slope of decline of eGFR, and that this translates into a beneficial effect on clinical outcome parameters such as time to dialysis, with chronic multi-year treatment. Treatment with CCX140 improved the eGFR profile. Initial analysis showed that after an acute effect in eGFR in the CCX140 treatment groups in the first 12 weeks, there was a sustained attenuation in the slope of annual decline in eGFR. Such eGFR profiles have been associated with successful long-term clinical benefit in kidney outcomes with approved diabetic nephropathy drugs. The treatment group receiving 5 mg of CCX140 in addition to SOC showed an attenuated annual slope decline of 1.3 mL/min/1.73 m2, compared to SOC alone group, 2.3 mL/min/1.73 m2. The magnitude of slope improvement seen for CCX140 is consistent with drugs that have been previously approved for diabetic nephropathy.

CCX140 did not affect systemic blood pressure, suggesting that the beneficial effect of CCX140 is mediated locally in the kidney micro-environment, possibly through a beneficial reduction in renal inflammation. CCX140 appeared to be well tolerated with a low overall dropout rate over the 52-week treatment period (10 percent). No safety issues were observed that would prevent further clinical development of CCX140 in diabetic nephropathy.

“These positive data suggest that treatment with CCX140 may result in clinically meaningful improvements in kidney function when added to standard of care in patients with chronic kidney disease,” said Thomas J. Schall, Ph.D., President and Chief Executive Officer, ChemoCentryx. “Given the positive improvements in albuminuria and eGFR observed in this clinical trial, we believe we have an effective dose of CCX140 to take forward into a Phase III clinical trial in diabetic nephropathy, and that we are well positioned to advance partnering discussions as well as an end of Phase II meeting with the FDA.”

“Even with optimal current care, the residual risk in diabetic nephropathy patients for further decrease in renal function is still extremely high,” said Prof. Dick de Zeeuw, M.D., Ph.D., in the Department of Clinical Pharmacy and Pharmacology at the University Medical Center in Groningen, The Netherlands. “The search for new drugs that add to standard of care ACE inhibitor and ARB treatment is therefore of utmost importance. To date, no great successes of new drugs on surrogates like blood pressure, albuminuria, or estimated glomerular filtration rate have been reported. These robust results with CCX140, in this context, are extremely relevant and promising, particularly if translated into preservation of renal function. CCX140 should definitely be tested in a Phase III trial.”

The Company plans to present the full results of this clinical trial at upcoming medical meetings.

Study Design

The objectives of the Phase II study, which took place at more than 90 sites across six European countries, were to determine the safety, tolerability and signs of clinical effect of CCX140 in patients with diabetic nephropathy. CCX140 was studied in a randomized, double-blind, placebo controlled clinical trial in 332 patients with residual albuminuria, despite having received an ACE inhibitor or ARB for at least eight weeks prior to screening for this trial. The original protocol had a 12-week treatment period that was extended to 52 weeks by protocol amendment. Of the 332 patients enrolled in the study initially, 102 patients were ineligible to re-enroll after the protocol amendment approval due to the length of time off treatment. As such 196 patients participated in the study extension to receive treatment for 52 weeks. The primary safety objective was evaluation of the safety profile of CCX140 based on the incidence of adverse events. The primary efficacy endpoint was the evaluation of the effect of CCX140 treatment over 52 weeks on first morning urinary albumin:creatinine ratio. Secondary objectives included evaluation of the effect of CCX140 on eGFR and HbA1c. At baseline, the mean age of the study population was 63 years, the median duration of type 2 diabetes was 14.5 years and the median duration of nephropathy was 3.3 years. The baseline mean urinary ACR for the population overall was 636 mg/g creatinine and baseline mean eGFR was 63 mL/min/1.73 m2. Baseline mean arterial blood pressure was 98 mm Hg.

About Diabetic Nephropathy

Diabetic nephropathy is a progressive kidney disease characterized primarily by proteinuria in patients with diabetes. Diabetic nephropathy is the leading cause of end-stage renal disease (ESRD) in the United States, resulting in the need for dialysis or kidney transplantation. Of the 26 million patients with chronic kidney disease, approximately 35 percent of those are patients with diabetes.

About CCX140

CCX140 is an inhibitor of the chemokine receptor known as CCR2. CCR2 is found on subsets of monocytes and macrophages, which are cells of the immune system believed to play an important role in inflammatory processes. Blocking CCR2 is intended to reduce the abnormal monocyte- and macrophage-driven inflammatory response implicated in renal diseases such as diabetic nephropathy. CCR2 may also have a direct role in the function of other specialized cells in the kidney, where its inhibition would correlate with a positive therapeutic effect.

Conference Call Information

The Company will host a conference call and webcast today, December 12, 2014 at 8:30 a.m. Eastern Time to discuss Phase II trial results and to answer questions. The live event will be accessible on the ChemoCentryx website beginning at 8:30 a.m. ET at www.ChemoCentryx.com, under the Investors section, or by calling 877-303-8028 (domestic) or 760-536-5167 (international). The conference ID number is 52903154

An archived webcast will be accessible via the Investors section of the Company’s website at www.ChemoCentryx.com. The webcast will remain available for thirty (30) days following the live call.

About ChemoCentryx

ChemoCentryx, Inc. is a clinical-stage biopharmaceutical company focused on discovering, developing and commercializing orally-administered therapeutics that target the chemokine and chemoattractant systems in order to treat autoimmune diseases, inflammatory disorders and cancer. The chemokine system is a biological network that regulates inflammation via a collection of secreted chemokine molecules, or ligands, and their specific cell surface receptors. Based on its proprietary drug discovery and drug development platform, ChemoCentryx has generated multiple clinical and preclinical-stage programs, each targeting distinct chemokine and chemoattractant receptors with different small molecule compounds. CCX140, a CCR2 inhibitor, successfully completed a Phase II clinical trial where it was shown to be safe and well tolerated while demonstrating statistically significant improvements in kidney function in patients with diabetic nephropathy. CCX168, a C5aR inhibitor, is in Phase II development for the treatment of anti-neutrophil cytoplasmic antibody-associated vasculitis (AAV). CCX168 appears to be safe, well tolerated and successful in allowing both reduction and elimination of high-dose corticosteroids, part of standard of care for AAV patients, without compromising efficacy or safety during a 12-week treatment period. Vercirnon (also known as Traficet-EN or CCX282) is a specific CCR9 inhibitor for the treatment of inflammatory bowel disease. Other clinical programs include CCX872, a next generation CCR2 inhibitor, currently in Phase I clinical development, CCX507, a next generation CCR9 inhibitor, which has successfully completed Phase I development and CCX354, a CCR1 inhibitor which successfully completed a Phase II clinical trial for the treatment of rheumatoid arthritis. ChemoCentryx also has several programs in advanced preclinical development.

Forward-Looking Statements

ChemoCentryx cautions that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “may,” “could,” “will,” “would,” “should,” “expect,” “plan,” “anticipate,” “believe,” “estimate,” “intend,” “predict,” “seek,” “contemplate,” “potential” or “continue” or the negative of these terms or other comparable terminology are intended to identify forward-looking statements. These statements include statements regarding whether CCX140 will be shown to be effective in Phase III clinical trials or obtain regulatory approval or the speed with which such approval might be obtained and statements regarding the ability of ChemoCentryx to successfully partner the development of CCX140. The inclusion of forward-looking statements should not be regarded as a representation by ChemoCentryx that any of its plans will be achieved. Actual results may differ from those set forth in this release due to the risks and uncertainties inherent in the ChemoCentryx business and other risks described in the Company’s filings with the Securities and Exchange Commission (“SEC”). Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and ChemoCentryx undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in ChemoCentryx’s periodic reports filed with the SEC, including ChemoCentryx’s Quarterly Report on Form 10-Q filed with the SEC November 6, 2014 and its other reports which are available from the SEC’s website (www.sec.gov) and on ChemoCentryx’s website (www.chemocentryx.com) under the heading “Investors.” All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.

Source: ChemoCentryx (CCXI-G)

CONTACT: Susan M. Kanaya
         Senior Vice President, Finance and
         Chief Financial Officer or
         Markus J. Cappel, Ph.D.
         Chief Business Officer
         650.210.2900
         investor@chemocentryx.com

         Media:
         Denise Powell
         510.703.9491
         denise@redhousecomms.com

         Investors:
         Angeli Kolhatkar
         Burns McClellan
         212.213.0006
         akolhatkar@burnsmc.com
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