Archive for August, 2015

(DPRX) Announces Participation in Four Investor Conferences in September

NEW YORK, Aug. 31, 2015  — Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX), a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide, today announced plans to participate in four investor conferences in September.

  • Wednesday, September 2, 2015 at the Sidoti & Company, LLC Emerging Growth Conference in New York City. David P. Luci, President & Chief Executive Officer, will present a corporate overview at 8:00 a.m. ET.
  • Wednesday, September 9, 2015 at the Rodman & Renshaw 17th Annual Global Investment Conference in New York City. David P. Luci, President & Chief Executive Officer, will present a corporate overview at 9:10 a.m. ET. To access the live audio webcast of this presentation, please log on through a link located in the Investor Relations section of Dipexium’s website at www.dipexiumpharmaceuticals.com, under the IR Calendar tab. A replay of the webcast will be available for 30 days after the conclusion of the live event.
  • Wednesday, September 9, 2015 at the FBR Second Annual Healthcare Conference in Boston. David Garrett, Vice President, Finance & Corporate Development will attend and participate in institutional investor meetings.
  • Thursday, September 10, 2015 at the NewsMakers in the Biotech Industry in New York City. David Garrett, Vice President, Finance & Corporate Development will attend and participate in institutional investor meetings.

About Dipexium Pharmaceuticals, Inc.

Dipexium Pharmaceuticals, Inc. (NASDAQ: DPRX) is a late-stage pharmaceutical company focused on the development and commercialization of Locilex® (pexiganan cream 0.8%), a novel, broad spectrum, topical antibiotic peptide. Initially, Locilex® is targeted for the treatment of mild infections of diabetic foot ulcers. Based on a compilation of available clinical and microbiology data, Locilex® is also considered a promising product candidate to treat other mild and moderate skin and skin structure infections, including infected decubitus ulcers, infected burns, infected surgical wounds and nasal colonization of methicillin-resistant staphylococcus aureus (MRSA).

Cautionary Note on Forward-Looking Statements

This press release and any statements of representatives and partners of Dipexium Pharmaceuticals, Inc. (the “Company”) related thereto contain, or may contain, among other things, certain “forward-looking statements” within the meaning of the U.S. federal securities laws.  Such forward-looking statements involve significant risks and uncertainties.  Such statements may include, without limitation, statements with respect to the Company’s plans, objectives, projections, expectations and intentions and other statements identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intends,” “plans,” “potential” or similar expressions.  These statements are based upon the current beliefs and expectations of the Company’s management and are subject to significant risks and uncertainties, including those detailed in the Company’s filings with the Securities and Exchange Commission and those that relate to the Company’s ability to leverage the expertise of employees and partners to assist the Company in the execution of its strategy.  Actual results (including, without limitation, the timing for and results of the clinical trials and proposed NDA submission for Locilex®) may differ significantly from those set forth in the forward-looking statements.  These forward-looking statements involve certain risks and uncertainties that are subject to change based on various factors (many of which are beyond the Company’s control).  The Company undertakes no obligation to publicly update any forward-looking statements, whether as a result of new information, future events or otherwise, except as required by applicable law.

Company Contacts:

David P. Luci
President & Chief Executive Officer
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com

David Garrett
Vice President, Finance & Corporate Development
Dipexium Pharmaceuticals, Inc.
212-269-2834
info@dipexium.com

Investor Relations Contact:

Donna L. LaVoie or Kristina Coppola
LaVoie Health Science
617-374-8800 X107/105
kcoppola@lavoiehealthscience.com

Monday, August 31st, 2015 Uncategorized Comments Off on (DPRX) Announces Participation in Four Investor Conferences in September

(AST) Initial Cohort Secured for SCiStar Phase 1/2a Clinical Trial of AST-OPC1

Safety of the Injection Procedure Confirmed with No Reported Serious Adverse Events

MENLO PARK, Calif., Aug. 31, 2015  — Asterias Biotherapeutics, Inc. (NYSE MKT: AST), a biotechnology company focused on the emerging field of regenerative medicine, today announced that the third patient was successfully dosed at Chicago-based Rush University Medical Center in a Phase 1/2a clinical trial evaluating activity of escalating doses of AST-OPC1 (oligodendrocyte progenitor cells) in newly injured patients with sensory and motor complete cervical spinal cord injury (SCI). This represents the final patient treated at the initial low-dose (2 million cells) safety cohort.  The results of the study continue to support a robust safety profile for AST-OPC1, with no serious adverse events observed in any of the three treated patients to date.

The first patient in this cohort was dosed at Shepherd Center in Atlanta and has completed the 2-month post-injection assessment.  This patient has progressed from a complete ASIA Impairment Scale (AIS) A injury to an incomplete AIS B injury.  The principal investigator at Shepherd Center, Dr. Donald Peck Leslie, said,  “This progress in the first patient is very encouraging and is observed in less than 5 percent of our AIS A patients at this stage of their recovery.”

The lead neurosurgeon for the study, Dr. Richard Fessler from Rush University Medical Center, performed the AST-OPC1 injections in the second and third patients. Dr. Fessler stated, “The injection procedure went very smoothly for both patients and there were no complications.  Both patients recovered quickly from the injection surgery and were able to resume their rehabilitation programs soon afterward.”

The Company expects to begin enrollment of the second dose cohort following Data Monitoring Committee review of the 30-day post-injection safety data from all three patients.  The second cohort will enroll five patients who will receive 10 million AST-OPC1 cells.  “The safety data in this first cohort now paves the way for testing the higher doses of AST-OPC1 (10-20 million cells) that we believe correspond most closely to the doses that showed the greatest efficacy in animal studies,” commented Dr. Edward Wirth, Chief Medical Officer of Asterias.

The open-label, single-arm study is being conducted at three centers currently and will include up to twelve centers in the United States.  Enrollment in the trial has already begun to accelerate, with 7 weeks elapsed between dosing the first and second patients, and only 3 weeks between dosing the second and third patients.

“We are encouraged by this performance improvement and are confident in meeting our disclosed timelines,” commented Pedro Lichtinger, President and CEO of Asterias.  “We expect to provide updates as identified milestones are reached or when major events occur.”

About the SCi-STAR Trial

The SCi-STAR trial will test three sequential escalating doses of AST-OPC1 administered at up to 20 million AST-OPC1 cells in 13 patients with sub-acute, C-5 to C-7, neurologically complete cervical SCI. These individuals have essentially lost all sensation and movement below their injury site with severe paralysis of the upper and lower limbs. AST-OPC1 will be administered 14 to 30 days post-injury. Patients will be followed by neurological exams and imaging methods to assess the safety and activity of the product. Additional information on the Phase 1/2a study, including trial sites, can be found at www.clinicaltrials.gov, using Identifier NCT02302157, and at the SCiStar Study Website (www.scistarstudy.com).

Upon achievement of initial safety data from the first two cohorts of this study, Asterias plans to seek concurrence from the U.S. Food and Drug Administration to increase the robustness of the proof of concept in the Phase 1/2a clinical trial by expanding enrollment from 13 patients to up to 40 patients. The Company believes this change will increase the statistical confidence of the safety and efficacy readouts, reduce the risks of the AST-OPC1 program and position the product for potential accelerated regulatory approvals. Asterias has received a Strategic Partnerships Award grant from the California Institute for Regenerative Medicine, which provides $14.3 million of non-dilutive funding for the Phase 1/2a clinical trial and other product development activities for AST-OPC1.

More than 12,000 people sustain a spinal cord injury each year, but there are no FDA-approved therapeutics or devices that could potentially restore some function in individuals who have recently sustained a spinal cord injury.

About AST-OPC1

AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown to have three potentially reparative functions that address the complex pathologies observed at the injury site of a spinal cord injury. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.

In a previous Phase 1 clinical trial, five patients with neurologically complete, thoracic spinal cord injury were administered two million AST-OPC1 cells at the spinal cord injury site 7-14 days post-injury. The subjects received low levels immunosuppression for the next 60 days.  Delivery of AST-OPC1 was successful in all five subjects with no serious adverse events associated with the administration of the cells, with AST-OPC1 itself, or the immunosuppressive regimen.  No evidence of rejection of AST-OPC1 was observed in detailed immune response monitoring of all subjects.  In four of the five subjects, serial MRI scans indicated that reduced spinal cord cavitation may have occurred.  Based on the results of this study, Asterias received approval from FDA to progress testing of AST-OPC1 to subjects with complete cervical injuries, which represents the first targeted population for registration trials.

About Asterias Biotherapeutics

Asterias Biotherapeutics, Inc. (NYSE MKT: AST) is a leading biotechnology company in the emerging field of regenerative medicine. The Company’s proprietary, industry leading platforms are based on its pluripotent stem cell and dendritic cell immunotherapy technologies. Asterias is focused on developing therapies to treat conditions in several medical areas where there is high unmet medical need and inadequate available therapies. AST-OPC1 (oligodendrocyte progenitor cells) is currently in a Phase 1/2a dose escalation clinical trial in spinal cord injury. AST-VAC1 (antigen-presenting autologous dendritic cells) has demonstrated promise in a Phase 2 study in acute myelogenous leukemia. AST-VAC2 (antigen-presenting allogeneic dendritic cells) represents a second generation, allogeneic approach to dendritic cell vaccines. Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.

About Rush University Medical Center

Rush University, with nearly 2,300 students is a health sciences university offering more than 30 unique degree or certificate options in medicine, nursing, allied health and biomedical research. Rush University is comprised of Rush Medical College, the College of Nursing, the College of Health Sciences, and the Graduate College.

Rush University Medical Center is part of Rush, a not-for-profit enterprise that also includes Rush University, Rush Oak Park Hospital and Rush Health. The mission of Rush is to provide the best health care for the individuals and diverse communities we serve through the integration of outstanding patient care, education, research, and community partnerships.

Located one mile west of Chicago’s Loop, the medical center encompasses a 664-bed hospital serving adults and children. The 376-bed Tower building opened in 2012 as part of a major, ten-year campus redevelopment.  Rush has more than 9,300 employees and faculty.

About Shepherd Center

Shepherd Center, located in Atlanta, Ga., is a private, not-for-profit hospital specializing in medical treatment, research and rehabilitation for people with spinal cord injury, brain injury, multiple sclerosis and chronic pain. Founded in 1975 and now a 152-bed facility, Shepherd Center is ranked by U.S. News & World Report among the top 10 rehabilitation hospitals in the nation. Last year, Shepherd Center had 965 admissions to its inpatient programs and 571 to its day patient programs. In addition, Shepherd Center sees more than 6,600 people annually on an outpatient basis. For more information, visit Shepherd Center online at www.shepherd.org.

FORWARD-LOOKING STATEMENTS

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

Monday, August 31st, 2015 Uncategorized Comments Off on (AST) Initial Cohort Secured for SCiStar Phase 1/2a Clinical Trial of AST-OPC1

(AMSC) Receives $40 Million Follow-On Order From Inox Wind

Vast Majority of Order Expected to be Delivered by the End of the Fiscal Year

DEVENS, Mass., Aug. 31, 2015  — AMSC (NASDAQ:AMSC), a global solutions provider serving wind and power grid industry leaders, today announced that it has received an approximately $40 million order for wind turbine electrical control systems (ECS) from Inox Wind Limited, part of India’s Inox Group of Companies. AMSC expects to begin shipments under this new order during the second quarter of fiscal 2015 and expects to complete the vast majority of shipments by the end of fiscal year 2015.

“Over the next quarters, we expect to maintain the growth that we have achieved so far, while we expand our manufacturing capacities in preparation for achieving greater market share,” said Devansh Jain, director of Inox Wind Limited. “We continue to have a very strong relationship with AMSC. By using AMSC’s sophisticated technology and design, we produce wind turbines with a highly competitive cost of energy.”

AMSC’s ECS are an integrated, high-performance suite of power electronics systems that include the wind turbine power converter cabinet, internal power supply and various controls. Together, these systems serve as the “brains” of the wind turbine and enable reliable, high-performance operation by controlling power flows, regulating voltage, monitoring system performance, controlling the pitch of the wind turbine blades and the yaw of the turbines to maximize efficiency.

“This latest order from Inox demonstrates the strong growth in its business. We expect to complete deliveries under this order in approximately half the time of the previous order,” said Daniel P. McGahn, President and CEO, AMSC. “Inox has proven its commitment and ability to succeed, grow, and become a major player within one of the world’s largest wind markets.”

Industry experts expect new annual capacity to grow between 2.5 gigawatts (GW) and 3.6 GW per year for the next five years.

To learn more about AMSC’s product offerings for the wind industry, please visit: http://www.amsc.com/windtec/index.html.

About Inox Wind Limited

Inox Wind Limited is part of the Inox Group of Companies. Inox Group is a $2 billion+, professionally managed business group, with interests in diverse businesses including Industrial Gases, Refrigerants,

Engineering Plastics, Chemicals, Carbon Credits, Cryogenic Engineering, Renewable Energy and Entertainment. The INOX Group employs close to 9,000 people at more than 150 business units across the country and has a distribution network that is spread across more than 50 countries around the globe. Each INOX Group company is characterized by three distinct characteristics – early identification of a winning business idea, building it to a size of dominant market leadership in that segment, and attaining a profit leadership position through cutting-edge efficiency in operations. The Inox Group of Companies, besides Inox Wind Limited, includes Inox Air Products Limited, Gujarat Fluorochemicals Limited, Inox India Limited, Inox Renewables Limited, Inox Leisure Limited and Fame India limited. More information is available at www.inoxwind.com.

About AMSC (NASDAQ:AMSC)

AMSC generates the ideas, technologies and solutions that meet the world’s demand for smarter, cleaner … better energy. Through its Windtec™ Solutions, AMSC provides wind turbine electronic controls and systems, designs and engineering services that reduce the cost of wind energy. Through its Gridtec™ Solutions, AMSC provides the engineering planning services and advanced grid systems that optimize network reliability, efficiency and performance. The company’s solutions are now powering gigawatts of renewable energy globally and enhancing the performance and reliability of power networks in more than a dozen countries. Founded in 1987, AMSC is headquartered near Boston, Massachusetts with operations in Asia, Australia, Europe and North America. For more information, please visit www.amsc.com.

AMSC, Windtec, Gridtec, and Smarter, Cleaner … Better Energy are trademarks or registered trademarks of American Superconductor Corporation. All other brand names, product names, trademarks or service marks belong to their respective holders.

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). Any statements in this release about expectations regarding Inox’s expected growth, new annual wind capacity in India, when shipments will begin under the new order and when the vast majority of shipments will be completed under this new order, completing this order in approximately half the time of the previous order, and other statements containing the words “believes,” “anticipates,” “plans,” “expects,” “will” and similar expressions, constitute forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements represent management’s current expectations and are inherently uncertain. There are a number of important factors that could materially impact the value of our common stock or cause actual results to differ materially from those indicated by such forward-looking statements. Such factors include: We have a history of operating losses, which may continue in the future. Our operating results may fluctuate significantly from quarter to quarter and may fall below expectations in any particular fiscal quarter; we have a history of negative operating cash flows, and we may require additional financing in the future, which may not be available to us; Our Term Loans include certain covenants and other events of default. Should we not comply with these covenants or incur an event of default, we may be required to repay our obligation in cash, which could have an adverse effect on our liquidity; We may be required to issue performance bonds or provide letters of credit, which restricts our ability to access any cash used as collateral for the bonds or letters of credit; Changes in exchange rates could adversely affect our results from operations; If we fail to maintain proper and effective internal controls over financial reporting, our ability to produce accurate and timely financial statements could be impaired and may lead investors and other users to lose confidence in our financial data; Our financial condition may have an adverse effect on our customer and supplier relationships; Our success in addressing the wind energy market is dependent on the manufacturers that license our designs; A significant portion of our revenues are derived from a single customer, Our success is dependent upon attracting and retaining qualified personnel and our inability to do so could significantly damage our business and prospects; We may not realize all of the sales expected from our backlog of orders and contracts; Our business and operations would be adversely impacted in the event of a failure or security breach of our information technology infrastructure; We may not be able to ramp up production at our newly leased manufacturing facility in Romania, and, if we are able to do so, we may have manufacturing quality issues, which would negatively affect our revenues and financial position; We rely upon third-party suppliers for the components and subassemblies of many of our Wind and Grid products, making us vulnerable to supply shortages and price fluctuations, which could harm our business; Many of our revenue opportunities are dependent upon subcontractors and other business collaborators; If we fail to implement our business strategy successfully, our financial performance could be harmed; Problems with product quality or product performance may cause us to incur warranty expenses and may damage our market reputation and prevent us from achieving increased sales and market share; New regulations related to conflict-free minerals may force us to incur significant additional expenses; Our contracts with the U.S. government are subject to audit, modification or termination by the U.S. government and include certain other provisions in favor of the government. The continued funding of such contracts remains subject to annual congressional appropriation which, if not approved, could reduce our revenue and lower or eliminate our profit; Many of our customers outside of the United States, particularly in China, are, either directly or indirectly, related to governmental entities, and we could be adversely affected by violations of the United States Foreign Corrupt Practices Act and similar worldwide anti-bribery laws outside the United States; We have limited experience in marketing and selling our superconductor products and system-level solutions, and our failure to effectively market and sell our products and solutions could lower our revenue and cash flow; We may acquire additional complementary businesses or technologies, which may require us to incur substantial costs for which we may never realize the anticipated benefits; Our success depends upon the commercial use of high temperature superconductor (HTS) products, which is currently limited, and a widespread commercial market for our products may not develop; Growth of the wind energy market depends largely on the availability and size of government subsidies and economic incentives; We have operations in and depend on sales in emerging markets, including India and China, and global conditions could negatively affect our operating results or limit our ability to expand our operations outside of these countries. Changes in India’s or China’s political, social, regulatory and economic environment may affect our financial performance; Our products face intense competition, which could limit our ability to acquire or retain customers; Our international operations are subject to risks that we do not face in the United States, which could have an adverse effect on our operating results; Adverse changes in domestic and global economic conditions could adversely affect our operating results; We may be unable to adequately prevent disclosure of trade secrets and other proprietary information; Our patents may not provide meaningful protection for our technology, which could result in us losing some or all of our market position; There are a number of technological challenges that must be successfully addressed before our superconductor products can gain widespread commercial acceptance, and our inability to address such technological challenges could adversely affect our ability to acquire customers for our products; Third parties have or may acquire patents that cover the materials, processes and technologies we use or may use in the future to manufacture our Amperium products, and our success depends on our ability to license such patents or other proprietary rights; Our technology and products could infringe intellectual property rights of others, which may require costly litigation and, if we are not successful, could cause us to pay substantial damages and disrupt our business; We have filed a demand for arbitration and other lawsuits against our former largest customer, Sinovel, regarding amounts we contend are overdue. We cannot be certain as to the outcome of these proceedings; We have been named as a party in various legal proceedings, and we may be named in additional litigation, all of which will require significant management time and attention, result in significant legal expenses and may result in an unfavorable outcome, which could have a material adverse effect on our business, operating results and financial condition; and Our common stock has experienced, and may continue to experience, significant market price and volume fluctuations, which may prevent our stockholders from selling our common stock at a profit and could lead to costly litigation against us that could divert our management’s attention.

These and the important factors discussed under the caption “Risk Factors” in Part 1. Item 1A of our Form 10-K for the fiscal year ended March 31, 2015, and our other reports filed with the SEC, among others, could cause actual results to differ materially from those indicated by forward-looking statements made herein and presented elsewhere by management from time to time. Any such forward-looking statements represent management’s estimates as of the date of this press release. While we may elect to update such forward-looking statements at some point in the future, we disclaim any obligation to do so, even if subsequent events cause our views to change. These forward-looking statements should not be relied upon as representing our views as of any date subsequent to the date of this press release.

CONTACT: AMSC Contact:
         Kerry Farrell
         Phone: 978-842-3247
         Email: kerry.farrell@amsc.com
Monday, August 31st, 2015 Uncategorized Comments Off on (AMSC) Receives $40 Million Follow-On Order From Inox Wind

(GST) Announces Borrowing Base Maintained At $200 Million

HOUSTON, Aug. 31, 2015  — Gastar Exploration Inc. (NYSE MKT: GST) (“Gastar”) today announced that it has completed its second scheduled borrowing base redetermination of its revolving credit facility for 2015 and, as a result, the borrowing base has been reaffirmed by the lending participants at $200.0 million. Currently, Gastar has drawn $65.0 million under its revolving credit facility, resulting in $135.0 million of unused borrowing capacity. The next scheduled borrowing base redetermination is to occur by May 1, 2016.

Michael A. Gerlich, Gastar’s Chief Financial Officer, commented, “Our successful drilling activity in 2015 combined with our strong hedging program allowed us to maintain our borrowing base in a difficult commodity price environment.  The available borrowings under this credit facility, along with our cash on hand and internally generated cash flow, will give Gastar more than adequate liquidity to fund our recently expanded 2015 capital expenditures budget and provide for a strong liquidity position as we enter 2016.”

About Gastar

Gastar Exploration Inc. is an independent energy company engaged in the exploration, development and production of oil, condensate, natural gas and natural gas liquids in the United States. Gastar’s principal business activities include the identification, acquisition, and subsequent exploration and development of oil and natural gas properties with an emphasis on unconventional reserves, such as shale resource plays. In Oklahoma, Gastar is developing the primarily oil-bearing reservoirs of the Hunton Limestone horizontal play and expects to test other prospective formations on the same acreage, including the Meramec Shale (middle Mississippi Lime) and the Woodford Shale, which Gastar refers to as the STACK Play. In West Virginia, Gastar is developing liquids-rich natural gas in the Marcellus Shale and has drilled and completed its first two successful dry gas Utica Shale/Point Pleasant wells on its acreage.  For more information, visit Gastar’s website at www.gastar.com.

Safe Harbor Statement

This news release includes “forward looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  Forward looking statements give our current expectations, opinion, belief or forecasts of future events and performance.  A statement identified by the use of forward looking words including “may,” “expects,” “projects,” “anticipates,” “plans,” “believes,” “estimate,” “will,” “should,” and certain of the other foregoing statements may be deemed forward-looking statements.  Although Gastar believes that the expectations reflected in such forward-looking statements are reasonable, these statements involve risks and uncertainties that may cause actual future activities and results to be materially different from those suggested or described in this news release.  These include risks inherent in natural gas and oil drilling and production activities, including risks of fire, explosion, blowouts, pipe failure, casing collapse, unusual or unexpected formation pressures, environmental hazards, and other operating and production risks, which may temporarily or permanently reduce production or cause initial production or test results to not be indicative of future well performance or delay the timing of sales or completion of drilling operations; delays in receipt of drilling permits; risks with respect to natural gas and oil prices, a material decline in which could cause Gastar to delay or suspend planned drilling operations or reduce production levels; risks relating to the availability of capital to fund drilling operations that can be adversely affected by adverse drilling results, production declines and declines in natural gas and oil prices; risks relating to unexpected adverse developments in the status of properties; borrowing base redeterminations by our banks; risks relating to the absence or delay in receipt of government approvals or fourth party consents; risks relating to our ability to integrate acquired assets with ours and to realize the anticipated benefits from such acquisitions; and other risks described in Gastar’s Annual Report on Form 10-K and other filings with the U.S. Securities and Exchange Commission (“SEC”), available at the SEC’s website at www.sec.gov.  Our actual sales production rates can vary considerably from tested initial production rates depending upon completion and production techniques and our primary areas of operations are subject to natural steep decline rates. By issuing forward looking statements based on current expectations, opinions, views or beliefs, Gastar has no obligation and, except as required by law, is not undertaking any obligation, to update or revise these statements or provide any other information relating to such statements.

Contacts:

Gastar Exploration Inc.

Michael A. Gerlich, Chief Financial Officer

713-739-1800 / mgerlich@gastar.com

 

Investor Relations Counsel:

Lisa Elliott, Dennard-Lascar Associates

713-529-6600 / lelliott@DennardLascar.com

Monday, August 31st, 2015 Uncategorized Comments Off on (GST) Announces Borrowing Base Maintained At $200 Million

(TRVN) Announces Positive Results from Phase 2b Study of TRV130

– Novel mu-opioid receptor modulator TRV130 achieved primary endpoint –

– Superior safety and tolerability profile of TRV130 compared to morphine –

– Company to host conference call at 5:00 PM EDT –

Trevena, Inc. (NASDAQ: TRVN), a clinical stage pharmaceutical company focused on the discovery and development of biased ligands targeting G protein coupled receptors (GPCRs), today announced positive data from its randomized, double-blind, placebo- and active-controlled Phase 2b trial of TRV130 in moderate to severe acute postoperative pain after abdominoplasty surgery. The study achieved its primary endpoint of statistically greater pain reduction than placebo over 24 hours. In addition, TRV130 was superior to morphine in pre-specified secondary measures, exhibiting significantly reduced nausea, vomiting, and hypoventilation events.

“The data from this trial showed that TRV130, when given on-demand, matched morphine efficacy for pain relief with a markedly improved safety and tolerability profile,” said Neil Singla, M.D., chief scientific officer of Lotus Clinical Research and lead investigator of the study. “The challenges of safely and adequately titrating morphine are well recognized, and these data suggest that, if approved, TRV130 may provide a better option than currently available opioid analgesics.”

In the trial, two regimens of TRV130 were tested: the first consisted of a 1.5 mg intravenous loading dose with 0.1 mg self-administered on-demand doses as often as every 6 minutes (together referred to here as “TRV130 0.1 mg”) using a patient controlled analgesia (PCA) device; the second consisted of a 1.5 mg loading dose with 0.35 mg on-demand doses (together referred to here as “TRV130 0.35 mg”) using a PCA device. A commonly used morphine PCA regimen was also tested, consisting of a 4 mg loading dose with 1 mg on-demand doses. Placebo was administered as a loading dose and on-demand doses that were volume-matched to the active regimens.

Study Results
Efficacy
TRV130 demonstrated statistically significant pain reduction compared to placebo and comparable efficacy to morphine.  The TRV130 0.1 mg regimen reduced average pain scores (LS mean change in time-weighted average over 24 hours) by 2.3 points (p<0.0001 vs. placebo).  The TRV130 0.35 mg regimen reduced average pain scores by 2.1 points (p=0.0003 vs. placebo), similar to morphine, which reduced average pain scores by 2.1 points (p=0.0001 vs. placebo).
TRV130 provided rapid reduction in average pain scores, consistent with the previous Phase 2 trial where TRV130 showed more rapid onset of meaningful pain relief than morphine.
Rescue analgesic use was similar for both TRV130 and morphine, and less than half the rate of rescue analgesic use for placebo.  The proportion of patients using rescue analgesic was 64% with placebo, 31% with TRV130 0.1 mg, 21% with TRV130 0.35 mg, and 25% with morphine (post hoc p<0.0005 for all three active arms vs. placebo).
Safety and tolerability
In this study, the TRV130 groups had a significantly lower prevalence (percentage of patients) of hypoventilation events (a measure of respiratory safety), nausea, and vomiting than the morphine group (post hoc p<0.05 for both TRV130 regimens vs. morphine).
Placebo TRV130 0.1 mg TRV130 0.35 mg Morphine
Hypoventilation 10% 15% 31% 53%
Vomiting 8% 15% 15% 42%
Nausea 18% 41% 46% 72%
Adverse events associated with TRV130 were largely opioid-related; the most frequently reported events were nausea, vomiting, hypoventilation and headache. Opioid-related AEs were generally less frequent in the TRV130 groups compared to morphine. No drug-related serious adverse events were reported in the study.

Total TRV130 use in the study was similar for the two TRV130 regimens with mean cumulative doses of 7.6 mg and 5.4 mg for the TRV130 0.1 mg and TRV130 0.35 mg regimens, respectively. The mean cumulative dose of morphine was 26.3 mg.

Full results will be presented at a future scientific conference or in a journal publication.

“The positive data from this study continue the impressive accumulation of evidence suggesting meaningful differentiation of TRV130 from morphine,” said Maxine Gowen, Ph.D., chief executive officer of Trevena. “The goal of new analgesic drug discovery has long been the provision of more powerful pain relief with reduced opioid-related adverse effects. We believe the Trevena biased ligand platform has delivered this profile in TRV130 and we look forward to starting Phase 3 development in early 2016.”

Study Design

The Phase 2b study was a randomized, double-blind, placebo- and active-controlled, multiple dose, adaptive study in 200 patients undergoing abdominoplasty surgery at a single center in the United States. At baseline, patients had a mean baseline pain score on the numerical pain rating scale (NPRS) of 7.7 out of 10, which is considered severe pain. Pain intensity was measured using validated numeric rating scales at multiple time points up to 24 hours.

All study arms used a flexible dose, PCA administration regimen intended to optimize treatment and reflect the as-needed dosing most commonly used with post-operative opioid analgesics. All regimens were blinded and volume-matched, and consisted of intravenous loading doses followed by patient-controlled intravenous doses with a 6 minute lockout period after every on-demand dose. Patients were assigned randomly to post-operative regimens of TRV130, placebo, or morphine, in a 2:1:2 ratio respectively, beginning when post-operative pain became moderate or severe in intensity and continuing for 24 hours thereafter.

Rescue analgesics were available as necessary for patients whose pain was not adequately treated by TRV130, morphine, or placebo; first line rescue was oral ibuprofen and second line rescue was oral oxycodone. A standard methodology was used to avoid including effects of rescue analgesics on pain intensity measures: an unscheduled pain intensity assessment was made before rescue analgesic dosing, and this value was used instead of the scheduled pain intensity values until the end of the study.

In this trial, respiratory safety was measured as hypoventilation events, defined as clinically apparent and persistently decreased respiratory rate, respiratory effort or oxygen saturation. In practice, such events can result in interruption of opioid analgesic administration or, if unrecognized and if additional opioids are administered, to more serious consequences.

A pre-specified interim analysis was conducted after enrollment of 100 patients to evaluate opportunities for studying additional regimens of TRV130, after which the on-demand dose of TRV130 was increased to 0.35 mg for the remaining portion of the study.

Conference Call and Webcast
Date: Monday, August 31, 2015
Time: 5:00 p.m. (EDT)
Telephone Access: (855) 465-0180
International: (484) 756-4313
Conference ID: 26412950

To access the live audio webcast of the presentation and the slides, please visit the Investor Presentation section of the Company’s website. The webcast will be available for replay for 7 days.

About moderate-to-severe acute pain

Mu opioid receptor agonists such as morphine and fentanyl are the most effective class of analgesics currently available and are the standard of care in postoperative pain; however, in published national surveys, a significant proportion of surgical patients have reported inadequate pain relief despite use of opioid analgesics. Opioid-related adverse effects such as respiratory depression, nausea and vomiting, are frequently dose-limiting, which complicates pain management and increases the burden of care.

About TRV130

TRV130 was designed to optimize opioid receptor pharmacology to deliver an improved analgesic profile. TRV130 is a biased mu opioid receptor ligand which in preclinical studies activated analgesic signals while avoiding signals that can interfere with analgesia and promote respiratory depression and gastrointestinal dysfunction. In late 2014, the Company reported data from a Phase 2a/b trial comparing TRV130 to placebo and morphine following bunionectomy surgery. In this trial, TRV130 3 mg demonstrated superior efficacy to a standard dose of morphine, with average reduction in numeric pain rating scale up to 6 points from a baseline of 7 points. This efficacy was achieved without any serious adverse events and without significant respiratory depression as measured by oxygen desaturation. A previous study in healthy volunteers showed that TRV130, in a series of experimental models, elicited analgesia superior to that of morphine with less respiratory depression and vomiting and lower severity of nausea. Trevena believes that TRV130 may have an improved profile compared to currently used opioid analgesics and could offer enhanced pain relief with a reduced burden of opioid-related adverse events. Trevena anticipates that the initial market opportunity for TRV130, if approved, will be in the acute care settings, with a focus on postoperative pain in the hospital.

About Trevena

Trevena, Inc. is a clinical stage biopharmaceutical company that discovers, develops and intends to commercialize therapeutics that use a novel approach to target G protein coupled receptors, or GPCRs. Using its proprietary product platform, Trevena is developing four biased ligand product candidates it has identified – TRV027 to treat acute heart failure (Phase 2b), TRV130 to treat moderate to severe acute pain intravenously (completed Phase 2), TRV734 to treat moderate to severe acute and chronic pain orally (Phase 1), and TRV250 for treatment-refractory migraine and other CNS disorders (preclinical).

Cautionary Note on Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the company, including statements about the company’s strategy, future operations, clinical development of its therapeutic candidates, plans for potential future product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “suggest,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the status, timing, costs, results and interpretation of the company’s clinical trials, including the Company’s interpretation of the efficacy, safety and tolerability results from the Phase 2b study of TRV130 as compared to placebo and morphine and whether TRV130 ultimately will provide a better treatment option than existing opioids for patients with moderate to severe acute pain; the uncertainties inherent in conducting clinical trials; whether interim results from a clinical trial will be predictive of the final results of the trial or results of completed clinical trials will be indicative of the results of future trials, including with respect to whether the results of this Phase 2b study of TRV130 as well as prior clinical studies of this molecule will be consistent with the results obtained in any future Phase 3 studies; expectations for regulatory approvals; availability of funding sufficient for the company’s foreseeable and unforeseeable operating expenses and capital expenditure requirements; other matters that could affect the viability or commercial potential of the company’s therapeutic candidates; the inherent uncertainties associated with intellectual property; and other factors discussed in the Risk Factors set forth in the company’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings the company makes with the SEC from time to time. In addition, the forward-looking statements included in this press release represent the company’s views only as of the date hereof. The company anticipates that subsequent events and developments may cause the company’s views to change. However, while the company may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so, except as may be required by law.

 

Investor Contacts:
Trevena, Inc.
Jonathan Violin
Director of investor relations
610-354-8840 x231
jviolin@trevenainc.com
or
Argot Partners
Andrea Rabney
President and chief executive officer
212-600-1902
andrea@argotpartners.com
or
Media Contact:
Argot Partners
Eliza Schleifstein
917-763-8106
eliza@argotpartners.com

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(BLFS) Customer TiGenix Phase 3 Clinical Trial Meets Primary Endpoint

HypoThermosol® Cell Storage/Shipping Media to be Used in Commercial Manufacturing of Allogeneic Expanded Stem Cells for Complex Perianal Fistula in Crohn’s Disease Patients

BOTHELL, Wash., Aug. 31, 2015  — BioLife Solutions, Inc. (NASDAQ: BLFS), the leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers (“BioLife” or the “Company”), today announced that its customer TiGenix NV, an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic expanded stem cells, recently disclosed that its lead compound Cx601 met the primary endpoint in the Phase III ADMIRE-CD trial of complex perianal fistula in Crohn’s Disease patients. Cx601 is a suspension of allogeneic expanded adipose-derived stem cells (eASC) injected intra-lesionally. A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24, in patients with inadequate response to previous therapies, including anti-TNFs. The study results confirm the favorable safety and tolerability profile of Cx601. Key results include:

  • A single injection of Cx601 was statistically superior to placebo in achieving combined remission at week 24 of complex perianal fistulas in Crohn’s disease patients with inadequate response to previous therapies, including anti-TNFs
  • More than 50% of patients treated with Cx601 achieved combined remission at week 24
  • A higher number of Cx601-treated patients had their fistulas closed by week 6
  • The results confirm the favorable safety and tolerability profile of Cx601

These positive data allow for European filing in the first quarter of 2016 and moving forward in the US with the SPA-approved pivotal study.

Mike Rice, BioLife’s President & CEO, said, “We congratulate the entire TiGenix team on this outstanding accomplishment.  All of us at BioLife are pleased to be a critical biopreservation tools supplier to TiGenix and are proud to know that our clinical grade HypoThermosol cell storage and shipping media is helping to commercialize another novel cellular therapy.”

BioLife managements estimates that HypoThermosol and the Company’s companion CryoStor® clinical grade freeze media are incorporated into at least 200 pre-clinical validation projects and clinical trials of new cell and tissue based products and therapies.

In July 2015, Frost & Sullivan forecasted that the stem cell therapy market is expected to be worth $40 billion by 2020 and $180 billion by 2030.

About TiGenix

TiGenix NV (Euronext Brussels: TIG) is an advanced biopharmaceutical company focused on developing and commercializing novel therapeutics from its proprietary platforms of allogeneic, or donor-derived, expanded stem cells. Two products from the adipose-derived technology platform are currently in clinical development. Cx601 is in Phase III for the treatment of complex perianal fistulas in Crohn’s disease patients. Cx611 has completed a Phase I/II trial in rheumatoid arthritis, as well as a Phase I sepsis challenge trial. Effective as of July 31, 2015,

TiGenix acquired Coretherapix, whose lead cellular product (AlloCSC-01) is currently in a Phase II clinical trial in acute myocardial infarction (AMI). Coretherapix is planning to initiate the clinical evaluation of AlloCSC-01 in the chronic setting as well and is also involved in the pre-clinical development of a pharmaceutical formulation of growth factors to treat AMI.

Finally, TiGenix also developed ChondroCelect, an autologous cell therapy product for cartilage repair of the knee, which was the first Advanced Therapy Medicinal Product (ATMP) to be approved by the European Medicines Agency (EMA). From June 2014, the marketing and distribution rights of ChondroCelect were exclusively licensed to Sobi for the European Union (except for Finland, where it is distributed by the Finnish Red Cross Blood Service), Norway, Russia, Switzerland and Turkey, and the countries of the Middle East and North Africa. TiGenix is headquartered in Leuven (Belgium) and has operations in Madrid (Spain).

See more at: www.tigenix.com

About BioLife Solutions

BioLife Solutions develops, manufactures and markets hypothermic storage and cryopreservation solutions and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. BioLife also performs contract aseptic media formulation, fill, and finish services. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs.  For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

This press release contains forward-looking statements, including, but not limited to, statements concerning new products, the company’s anticipated business and operations, the potential utility of and market for its products and services, potential revenue growth and market expansion, and, projected financial results and liquidity. All statements other than statements of historical fact are statements that could be deemed forward-looking statements. These statements are based on management’s current expectations and beliefs and are subject to a number of risks, uncertainties and assumptions that could cause actual results to differ materially from those described in the forward-looking statements, including among other things, uncertainty regarding market adoption of products; uncertainty regarding third party market projections; market volatility; competition; litigation; and those other factors described in our risk factors set forth in our filings with the Securities and Exchange Commission from time to time, including our Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. We undertake no obligation to update the forward-looking statements contained herein or to reflect events or circumstances occurring after the date hereof, other than as may be required by applicable law.

Media & Investor Relations
Daphne Taylor
Senior Vice President, Chief Financial Officer
(425) 402-1400
dtaylor@biolifesolutions.com

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(ATVI) Call of Duty: Black Ops III Beta Biggest Ever on PlayStation 4

Treyarch’s Black Ops III Beta Sets New Standard as the #1 Beta on PlayStation 4

Activision Publishing, Inc., a wholly owned subsidiary of Activision Blizzard (Nasdaq: ATVI), today confirmed that Treyarch’s Call of Duty®: Black Ops III Multiplayer Beta, which began on August 19 and ran through August 23, has become the largest beta in PlayStation®4 (PS4™) history.

Millions of gamers downloaded and played the beta, which provided critical feedback and technical data at scale for the Treyarch development team to further fine-tune and polish in preparation for the November 6 launch of Call of Duty: Black Ops III.

“This is about making sure we deliver to our fans the best possible game at launch,” said Rob Kostich, senior vice president and general manager of Call of Duty®, Activision Publishing. “Becoming the biggest beta on PS4 speaks to the excitement felt by gamers and the quality of work by Treyarch. And remember, this beta is just a fraction of the overall multiplayer experience and a portion of what’s coming on November 6 when the full game – spanning campaign, multiplayer and Zombies hits worldwide.”

“We’ve been looking forward to getting the game into the hands of the people that matter most – the fans,” said Mark Lamia, studio head of Treyarch. “We can’t thank them all enough for participating and providing us with invaluable feedback and data that Treyarch is already hard at work incorporating into the game for launch. Our goal is to deliver the best Day One experience possible and this beta – along with the input from our passionate community of fans – has helped position us to do just that.”

“Played by millions of PlayStation fans around the world, the response to the beta was massive and shows the strength when bringing together the best-selling console franchise with the best-selling game console,” said Adam Boyes, VP of Publisher and Developer Relations, Sony Computer Entertainment America. “Signaling an impressive start of a new era for PlayStation and this famed franchise, there was no better way to welcome Call of Duty to its new home on PlayStation 4.”

The Call of Duty: Black Ops III beta set new marks on PS4 delivering the most downloads, gameplay sessions and hours of gameplay to date, according to Activision and Sony PlayStation.

Call of Duty: Black Ops III is in development at Treyarch for PlayStation®4 computer entertainment system, Xbox One, the all-in-one games and entertainment system from Microsoft and PC. The Call of Duty: Black Ops III multiplayer beta is available now on Xbox One and PC.

For the latest intel, check out: www.callofduty.com, www.youtube.com/callofduty or follow @Treyarch and @CallofDuty on Twitter and Instagram and Facebook. Call of Duty: Black Ops III is not yet rated.

About Treyarch

Treyarch is a video game studio, driven by the desire to create epic gameplay experiences that are enjoyed by as many video game fans as possible. It is an approach that has helped to make the studio an industry-leading game developer, whose Call of Duty: Black Ops II set world-wide launch day records, and whose previous game Call of Duty: Black Ops set an entertainment launch opening record upon its release in 2010 and continues to be one of the best-selling games of all time, according to NPD and GfK Chart-Track. Treyarch is wholly owned by Activision Publishing, Inc.

About Activision Publishing, Inc.

Headquartered in Santa Monica, California, Activision Publishing, Inc. is a leading global producer and publisher of interactive entertainment. Activision maintains operations throughout the world. More information about Activision and its products can be found on the company’s website, www.activision.com or by following @Activision.

Cautionary Note Regarding Forward-looking Statements: Information in this press release that involves Activision Publishing’s expectations, plans, intentions or strategies regarding the future, including statements about the expected Call of Duty: Black Ops III release date of November 6, 2015, are forward-looking statements that are not facts and involve a number of risks and uncertainties. Factors that could cause Activision Publishing’s actual future results to differ materially from those expressed in the forward-looking statements set forth in this release include unanticipated product delays and other factors identified in the risk factors sections of Activision Blizzard’s most recent annual report on Form 10-K and any subsequent quarterly reports on Form 10-Q. The forward-looking statements in this release are based upon information available to Activision Publishing and Activision Blizzard as of the date of this release, and neither Activision Publishing nor Activision Blizzard assumes any obligation to update any such forward-looking statements. Forward-looking statements believed to be true when made may ultimately prove to be incorrect. These statements are not guarantees of the future performance of Activision Publishing or Activision Blizzard and are subject to risks, uncertainties and other factors, some of which are beyond its control and may cause actual results to differ materially from current expectations.

ACTIVISION, CALL OF DUTY, CALL OF DUTY BLACK OPS, and stylized roman numeral III are trademarks of Activision Publishing, Inc. All other trademarks and trade names are the properties of their respective owners.

“PlayStation” is a registered trademark and “PS4” is a trademark of Sony Computer Entertainment Inc.

 

Activision Publishing, Inc.
Kyle Walker, 424-744-5677
PR Director
kyle.walker@activision.com

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(NVEE) Wins Green Infrastructure Design Services Contract With the City of New York

HOLLYWOOD, FL–(Aug 28, 2015) – NV5 Holdings, Inc. (the “Company”) (NASDAQ: NVEE), a provider of professional and technical engineering and consulting solutions, announced today that it was recently awarded a contract for more than $10 million for the siting and design of right-of-way green infrastructure practices throughout 1,561 acres of Bayside, Queens, New York. The contract was won by the infrastructure and environmental services team at The RBA Group and is one of several green infrastructure projects awarded to RBA under the city-wide NYCDEP green infrastructure program. The project includes a comprehensive site selection process, with site investigations, historical data analysis, surface and subsurface drainage analysis, geotechnical investigation, site survey, and structural analysis followed by green infrastructure design and construction management support services.

Dickerson Wright, PE, Chairman and CEO of NV5, said, “In the mere month that has elapsed since RBA joined the NV5 family, we have learned of several new large-scale planning and design contract wins with prominent public clients and agencies in the Northeast. We are looking forward to sharing the news with our shareholders and also to realizing opportunities for cross-selling between RBA and our existing Northeastern operations.”

David Lapping, PTP, President of RBA, and Linda Reardon, PE, Senior Vice President and Director of New York City, Long Island, Connecticut and Pennsylvania Operations at RBA, added, “This is a great opportunity for us to expand our growing Green Infrastructure practice in New York City and we hope it will be a springboard towards generating additional opportunities in other geographic markets.”

“The City’s Green Infrastructure program matches our philosophy of incorporating sustainable strategies into all of our design projects. In particular, this project will help mitigate combined sewer overflows by capturing and infiltrating stormwater before it enters the combined sewer system, reducing the amount of traditional grey infrastructure required and simultaneously greening the City in which we work and live,” said David Ksyniak, PE, Project Manager at RBA.

About NYCDDC
The New York City Department of Design and Construction (NYCDDC) is the City’s primary capital construction project manager with a portfolio valued at $10 billion. NYCDDC frequently partners with other city agencies such as the New York City Department of Environmental Protection (NYCDEP) to achieve its goal of providing New Yorkers with buildings and services that are socially responsible, progressively designed, and environmentally sound. Over the last decade, NYCDDC’s staff of 1,200 has completed more than 745 miles of new roadway, 735 miles of water mains, 588 miles of storm and sanitary sewers, and 42,000 sidewalk pedestrian ramp installations in all five boroughs. To learn more about NYCDDC and NYCDEP, visit www.NYC.gov.

About NV5
NV5 Holdings, Inc. (NASDAQ: NVEE) is a provider of professional and technical engineering and consulting solutions to public and private sector clients in the infrastructure, energy, construction, real estate and environmental markets. NV5 primarily focuses on five business verticals: construction quality assurance, infrastructure, engineering and support services, energy, program management, and environmental solutions. The Company operates 42 offices in Arizona, California, Colorado, Connecticut, Florida, Massachusetts, Maryland, New Jersey, New Mexico, New York, Ohio, Pennsylvania, Utah, Washington and Wyoming, and is headquartered in Hollywood, Florida. For additional information, please visit the Company’s website at www.NV5.com. Also visit the Company on Twitter, LinkedIn, Facebook, and Vimeo.

Contact
NV5 Holdings, Inc.
Lauren Wright, Ph.D.
Director of Investor Relations
Tel: +1-408-392-7233
Email: ir@nv5.com

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(TIL) Announces Loan to Silver Predator and Novation of Reinsurance Contracts

HAMILTON, Bermuda, Aug. 28, 2015  — Till Capital Ltd. (NASDAQ:TIL) (TSX.V:TIL) (the “Company” or “Till“), a Bermuda domiciled company and the majority shareholder of Silver Predator Corp. (TSX.V:SPD) (“Silver Predator“), announces that it has signed a Promissory Note (the “Note“) issued by Silver Predator to Till, in conjunction with which Till will advance US$100,000 of the Note principal to Silver Predator on August 28, 2015. The principal on the Note is US$275,000, which amount represents the maximum that Silver Predator may borrow, but is not obligated to do so. The annual interest rate on any balance on the Note is 12%.

Till also announces that it has novated two reinsurance contracts held by its wholly-owned subsidiary Resource Re Ltd. to Multi-Strat Re, a Bermuda-based reinsurance company. The total dollar value of the novated agreements is $5.3 million. The novation releases Resource Re from its liabilities under these reinsurance contracts.

Till Capital Ltd.

Till Capital Ltd. is a Bermuda-domiciled company with two wholly-owned subsidiaries, Omega Insurance Holdings Inc. and Resource Re Ltd.  Omega Insurance Holdings Inc. owns Omega General Insurance Company, a Canadian insurance company offering innovative and customized insurance industry solutions, including fronting and run-off services for insurers/reinsurers, within the Canadian marketplace. Omega Insurance Holdings Inc. also operates Focus Group Inc., a consulting and project management company servicing the local and international needs of its Property Casualty Insurance clients. Resource Re Ltd. is a Bermuda-domiciled reinsurance company regulated by the Bermuda Monetary Authority with a Class 3A insurance license directed to underwrite reinsurance policies within a long term investment strategy. Through its regulated subsidiaries, the Company has been structured to produce underwriting profits as well as above average returns on assets under management.

Cautionary Note

At this time, the Company has no current plans to provide earnings guidance due to the volatility of investment returns.

The Till Capital shares are restricted voting shares, whereby no single shareholder of Till Capital is able to exercise voting rights for more than 9.9% of the voting rights of the total issued and outstanding Till Capital shares (the “9.9% Restriction“). However, if any one shareholder of Till Capital beneficially owns, or exercises control or direction over, more than 50% of the issued and outstanding Till Capital shares, the 9.9% Restriction will cease to apply to the Till Capital shares.

This news release shall not constitute an offer to sell or a solicitation of an offer to buy any securities of Till Capital or any other securities, and shall not constitute an offer, solicitation or sale in any state or jurisdiction in which such an offer, solicitation or sale would be unlawful. Trading in the securities of Till Capital should be considered speculative.

Neither the TSX Venture Exchange nor its Regulatory Service Provider (as that term is defined in the policies of the TSX Venture Exchange) nor the Bermuda Monetary Authority accepts responsibility for the adequacy or accuracy of this release.

Cautionary Statement Regarding Forward Looking Information

Except for statements of historical fact, this news release contains certain “forward-looking information” within the meaning of applicable securities laws. These forward-looking statements are intended to qualify for the safe harbor from liability established by the Private Securities Litigation Reform Act of 1995, and generally can be identified by phrases such as “plan”, “except”, “project”, “intend”, “believe”, “anticipate”, “estimate”, “will”, “could” and other similar words, or statements that certain events or conditions “may” occur.   Such forward-looking statements are subject to risks and uncertainties that may cause actual results, performance or developments to differ materially from those contained in the statements. These and all subsequent written and oral forward-looking information are based on estimates and opinions of management on the dates they are made and are expressly qualified in their entirety by this notice. Except as required by law, Till Capital assumes no obligation to update forward-looking information should circumstances or management’s estimates or opinions change.

CONTACT: For additional information:

         Till Capital Ltd.
         John T. Rickard
         Director
         (208) 635-5415
         info@tillcap.com
         www.tillcap.com
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(TUBE) to Present at Citi 2015 Global Technology Conference

EMERYVILLE, Calif., Aug. 28, 2015  — TubeMogul, Inc. (NASDAQ:TUBE), a leading enterprise software company for brand advertising, today announced that members of the management team will present to the investment community at the following investor conference:

Citi 2015 Global Technology Conference
Date: Wednesday, September 9, 2015
Time: 2:45 p.m. ET
Location: Hilton New York Hotel, New York, NY

A webcast will be accessible on the investor relations section of the TubeMogul website (http://investor.tubemogul.com). An archived replay of the webcast will be available following the live presentation.

About TubeMogul

TubeMogul (NASDAQ:TUBE) is an enterprise software company for brand advertising. By reducing complexity, improving transparency and leveraging real-time data, our platform enables advertisers to gain greater control of their global advertising spend and achieve their brand advertising objectives. TubeMogul was incorporated in 2007 and is based in Emeryville, California with operations in Kyiv, London, Mexico City, New York, Paris, Sao Paulo, Shanghai, Singapore, Sydney, Tokyo, Toronto and offices across the United States.

TubeMogul and the TubeMogul logo are trademarks or registered trademarks of TubeMogul, Inc. in the United States and other countries.

CONTACT: Media Contact:
         David Burch
         press@tubemogul.com

         Investor Relations Contact:
         Alex Wellins
         The Blueshirt Group
         investor@tubemogul.com
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(KTOS) Receives $49 Million Contract Award to Support U.S. Government Satellite Communications

SAN DIEGO, Aug. 28, 2015  — Kratos Defense & Security Solutions, Inc. (Nasdaq:KTOS), a leading National Security Solutions provider, announced today that its RT Logic subsidiary has received a $49 million firm fixed price, IDIQ, single contract award from a U.S. Government Agency for Satellite and Communication System hardware, equipment and products. The period of performance on the contract is five years with funding to be determined with each respective hardware order under the contract vehicle. The first delivery orders under the contract, totaling more than $8 million, have been received by the Company.

The dual-use technology being deployed in support of this contract has also been sold to major commercial Satellite Communications (SATCOM) operators to support their new multi-billion dollar investments in High Throughput Satellite (HTS) SATCOM fleets.

“This technology supports the new, next-generation wideband digital SATCOM payloads that are now coming on line and will dominate the growth of SATCOM for years to come. Kratos’ overarching strategy and related R&D investments in next-generation SATCOM payload monitoring is already paying dividends,” said John Monahan, President of RT Logic.

RT Logic is part of Kratos’ Technology & Training Solutions Division (KTTS) which specializes in providing systems products, solutions, and services for satellite communications command and control, signal monitoring and communications network management, as well as intelligence, cyber security and training products, solutions and services.

Phil Carrai, President of KTTS Division, said, “KTTS’s satellite and communications products and services have supported more than 85% of U.S. government space missions and are used by more than 75% of commercial satellite operators around the globe, making Kratos a leading provider of end-to-end ground segment solutions including satellite systems command and control, monitoring, signal processing and intelligence products and technologies, We are proud to support this important national security customer in its mission.”

Due to customer related and other considerations, no additional information will be provided related to this contract award.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (Nasdaq:KTOS) is a specialized Technology Company providing mission critical products, solutions and services for United States National Security. Kratos’ core capabilities are sophisticated engineering, manufacturing and system integration offerings for National Security platforms and programs. Kratos’ areas of expertise include Command, Control, Communications, Computing, Combat and Intelligence, Surveillance and Reconnaissance (C5ISR) systems, satellite communications, electronic warfare, unmanned systems, hypersonic systems, directed and high power energy systems, electromagnetic railgun, missile defense, cyber warfare, cybersecurity, information assurance, and critical infrastructure security. Kratos has primarily an engineering and technically oriented work force of approximately 3,100. Substantially all of Kratos’ work is performed on a military base, in a secure facility or at a critical infrastructure location. Kratos’ primary end customers are National Security related agencies. News and information are available at www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty, including risks related to product failure, general economic conditions and cutbacks in spending. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 28, 2014, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

 

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com
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(EXEL) Announces First Regulatory Approval of Cobimetinib in Switzerland

— The Second Product Discovered by Exelixis to Receive Regulatory Approval —- Additional Regulatory Applications in the U.S. and EU Currently under Review —

Exelixis, Inc. (NASDAQ:EXEL) today announced that Swissmedic, the Swiss licensing and supervisory authority of Switzerland, has approved cobimetinib for use in combination with vemurafenib as a treatment for patients with advanced melanoma. Cobimetinib is a selective inhibitor of MEK that was discovered by Exelixis and is the subject of a worldwide collaboration agreement between Exelixis and Genentech, a member of the Roche Group. The trade name for cobimetinib in Switzerland is Cotellic™.

Roche’s Swiss regulatory submission for cobimetinib was based on data from coBRIM, the phase 3 pivotal trial of cobimetinib and vemurafenib conducted in 495 patients with previously untreated unresectable, locally advanced or metastatic melanoma with a BRAF V600 mutation. The resulting approval is the first for cobimetinib worldwide, and additional regulatory applications are under review in other territories. Genentech filed its New Drug Application (NDA) for cobimetinib with the U.S. Food and Drug Administration (FDA) in December 2014 and the Prescription Drug User Fee Act date is November 11, 2015. Separately, Roche filed a Marketing Authorization Application with the European Medicines Agency in late 2014, and Roche anticipates a regulatory decision before the end of 2015.

“The Swiss regulatory approval of cobimetinib is an important advance for melanoma patients, physicians, and caregivers,” said Michael M. Morrissey, Ph.D., president and chief executive officer of Exelixis. “Exelixis congratulates our partner Roche on this first approval for the product, and we look forward to additional regulatory decisions in the United States and European Union, which are anticipated later this year.”

After discovering cobimetinib internally, Exelixis advanced the product to investigational new drug (IND) status. In late 2006, the company entered into its worldwide collaboration with Genentech, under which Exelixis received initial upfront and milestone payments for signing the agreement and submitting the IND. Following the determination of the maximum tolerated dose in phase 1 by Exelixis, Genentech exercised its option to further develop cobimetinib. Under the terms of the collaboration, Exelixis is eligible to receive royalties on sales of cobimetinib outside the United States. If cobimeitnib is approved in the United States, Exelixis is entitled to an initial equal share of U.S. profits and losses, which will decrease as sales increase, and will share in U.S. marketing and commercialization costs. In November 2013, Exelixis exercised its option to co-promote cobimetinib in the United States and, under the terms of the agreement, the company is prepared to field up to 25 percent of the U.S. sales force.

Dr. Morrissey continued: “As the second approved product to have been discovered at Exelixis, cobimetinib represents a major achievement for our company and for all of the employees, past and present, who contributed to the program since its inception. Our agreement with Genentech and Roche enables Exelixis to participate meaningfully in the product’s commercialization. This includes receiving royalties on ex-U.S. sales and sharing in the profits in the U.S., where our team is fully prepared to co-promote cobimetinib with Genentech pending regulatory approval. Exelixis is excited to be working with Genentech and Roche to ensure that the commercialization phase of our cobimetinib partnership mirrors the productivity and success seen during the compound’s discovery and clinical development.”

About the coBRIM study

The pivotal coBRIM study is an international, randomized, double-blind, placebo-controlled, phase 3 study evaluating the safety and efficacy of the combination therapy. A total of 495 patients with unresectable, locally advanced or metastatic melanoma with a BRAF V600 mutation were randomized to receive vemurafenib once daily at the approved dosage and either cobimetinib or a placebo for 3 weeks followed by one week off cobimetinib/placebo. Treatment was continued until disease progression, unacceptable toxicity or withdrawal of consent. Investigator-assessed progression-free survival (PFS) was the primary endpoint. Secondary endpoints include PFS by independent review committee, objective response rate, overall survival, duration of response and other safety, pharmacokinetic and quality of life measures.1

The Swissmedic approval was based on an updated analysis of the coBRIM study data that showed that patients with previously untreated BRAF V600 mutation-positive advanced melanoma live a median of more than a year (12.3 months) without progression of their disease (progression-free survival, PFS) on combination therapy with cobimetinib and vemurafenib, and 7.2 months on vemurafenib monotherapy.2,3 Patients responded better to treatment with cobimetinib and vemurafenib than those given vemurafenib alone. In this updated analysis, the objective response rate (ORR) of the cobimetinib and vemurafenib combination was 70 percent (compared to 50 percent for vemurafenib monotherapy).2 With further follow-up from the primary analysis, the complete response rate was 15 percent. The safety profile of cobimetinib and vemurafenib was consistent with safety data previously reported from the phase 1b BRIM7 study. The most common adverse events in the combination arm were diarrhea, rash, nausea, fever, sun sensitivity, liver lab abnormalities, elevated creatine phosphokinase (CPK, an enzyme released by muscles) and vomiting.

About the cobimetinib and vemurafenib Combination

Cobimetinib is a selective inhibitor that blocks the activity of MEK, a protein kinase that is part of a key pathway (the RAS-RAF-MEK-ERK pathway) that promotes cell division and survival. This pathway is frequently activated in human cancers including melanoma, where mutation of one of its components (BRAF) causes abnormal activation in about 50 percent of tumors. About 50 percent of patients with BRAF mutation positive melanoma experience a tumor response when treated with a BRAF inhibitor, however development of resistance and subsequent tumor progression limits treatment benefit. Clinical and preclinical analyses indicated that reactivation of the MEK-ERK pathway may underlie development of resistance to BRAF inhibitors in many progressing tumors, and that co-treatment with a BRAF and MEK inhibitor delays the emergence of resistance in the preclinical setting, providing the rationale for testing the combination of vemurafenib and cobimetinib in clinical trials. In addition to the combination with vemurafenib in melanoma, cobimetinib is also being investigated in combination with several investigational medicines, including an immunotherapy, in several tumor types, including non-small cell lung cancer, colorectal cancer, triple-negative breast cancer and melanoma.

About Melanoma and its BRAF V600 Mutation-Positive Form

Melanoma is the less common, but more serious category of skin cancer that starts in the skin’s pigment producing cells known as melanocytes. According to the American Cancer Society, approximately five percent of skin cancer diagnoses are melanoma, but melanoma accounts for a large majority of skin cancer deaths. In recent years, there have been significant advances in treatment for metastatic melanoma and people with the disease have more options. However, it continues to be a serious health issue with a high unmet need and a steadily increasing incidence over the past 30 years. It is projected that approximately half of all melanomas, and eight percent of solid tumors, contain a mutation of the BRAF protein. BRAF is a key component of the RAS-RAF-MEK-ERK pathway involved in normal cell growth and survival. However, mutations that keep the BRAF protein in an active state may cause excessive signaling in the pathway, leading to uncontrolled cell growth and survival. The BRAF V600 mutation-positive form of melanoma is associated with high-risk characteristics of the disease, including early onset, the absence of chronic skin damage, and decreased survival.

About Exelixis

Exelixis, Inc. is a biopharmaceutical company committed to developing small molecule therapies for the treatment of cancer. Exelixis is focusing its development and commercialization efforts primarily on cabozantinib, its wholly-owned inhibitor of multiple receptor tyrosine kinases. Another Exelixis-discovered compound, cobimetinib, a selective inhibitor of MEK, received its first regulatory approval and is being evaluated by Roche and Genentech (a member of the Roche Group) in a broad development program under a collaboration with Exelixis. For more information, please visit the company’s web site at www.exelixis.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, without limitation, statements related to: the potential for additional regulatory approvals for cobimetinib in other territories by the end of 2015, including by the FDA in the U.S. and EMA in the EU; the potential for cobimetinib to advance melanoma treatment; Exelixis’ preparedness to support U.S. co-promotion efforts for cobimetinib in the U.S.; the plan of Genentech and Exelixis to share U.S. profits and losses and U.S. marketing and commercialization costs for cobimetinib; and, Exelixis’ potential receipt of royalties on sales of cobimetinib products outside the U.S. Words such as “anticipate,” “look forward,” “if,” “entitled,” “eligible,” “will,” “prepared,” or other similar expressions, identify forward-looking statements, but the absence of these words does not necessarily mean that a statement is not forward-looking. In addition, any statements that refer to expectations, projections or other characterizations of future events or circumstances are forward-looking statements. These forward-looking statements are based upon Exelixis’ current plans, assumptions, beliefs, expectations, and projections. Exelixis’ actual results and the timing of events could differ materially from those anticipated in the forward-looking statements as a result of risks and uncertainties, which include, without limitation: risks related to: the clinical, therapeutic and commercial value of cobimetinib; Exelixis’ dependence on its relationship with Genentech/Roche with respect to cobimetinib and Exelixis’ ability to maintain its rights under the collaboration; risks and uncertainties related to regulatory review and approval processes and Exelixis’ compliance with applicable legal and regulatory requirements; market competition; changes in economic and business conditions; and other factors discussed under the caption “Risk Factors” in Exelixis’ quarterly report on Form 10-Q filed with the Securities and Exchange Commission (SEC) on August 11, 2015 and in Exelixis’ other filings with the SEC. The forward-looking statements made in this press release speak only as of the date of this press release. Exelixis expressly disclaims any duty, obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein to reflect any change in Exelixis’ expectations with regard thereto or any change in events, conditions or circumstances on which any such statements are based.

Exelixis and the Exelixis logo are registered U.S. trademarks.

1 Larkin J et al., Combined Vemurafenib and Cobimetinib in BRAF-Mutated Melanoma. N Engl J Med. 2014;371(20):1867-76.

2 Larkin J et al., Update of progression-free survival and correlative biomarker analysis from coBRIM: cobimetinib plus vemurafenib in advanced BRAF-mutated melanoma. Abstract presented at ASCO, Chicago, IL, USA, 29 May – 2 June 2015; abstract #9006.

3 The NDA submitted to the FDA was based on data from the primary analysis of the coBRIM study.

Investors Contact:
Exelixis, Inc.
Susan Hubbard, 650-837-8194
Investor Relations and Corporate Communications
shubbard@exelixis.com
or
Media Contact:
For Exelixis, Inc.
Hal Mackins, 415-994-0040
hal@torchcommunications.com

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(NGD) Announces Sale of El Morro Interest for $90 Million Cash and a 4% Gold Stream

(All dollar figures are in US dollars unless otherwise indicated)

TORONTO, Aug. 27, 2015  – New Gold Inc. (“New Gold”) (TSX:NGD) (NYSE MKT:NGD) today announces that the company has entered into an agreement with Goldcorp Inc. (“Goldcorp”) to sell New Gold’s 30% interest in the El Morro project to Goldcorp in exchange for $90 million in cash, a 4% stream on gold production from the El Morro property and the cancellation of New Gold’s $93 million carried funding loan (the “Transaction”). The Transaction provides New Gold with increased financial flexibility, strengthens the balance sheet and enables the company to maintain exposure to El Morro’s significant 8.9 million ounce gold reserve and ongoing exploration potential.

KEY TRANSACTION HIGHLIGHTS

$90 million cash consideration

  • $90 million, less applicable withholding taxes, to be paid at closing of the Transaction, expected to be in the fourth quarter of 2015

4% stream on gold production from the El Morro property

  • 4% stream on life-of-project gold production from the 417 square kilometre El Morro property
  • El Morro’s currently estimated gold mineral reserves – 599 million tonnes at an average gold grade of 0.46 grams per tonne, totalling 8.9 million ounces
    • Measured and Indicated mineral resources (exclusive of reserves) – 92 million tonnes at an average gold grade of 0.41 grams per tonne, totalling 1.2 million ounces
    • Inferred mineral resources (including open pit and underground resources) – 678 million tonnes at an average gold grade of 0.30 grams per tonne, totalling 6.5 million ounces
  • New Gold to pay fixed $400 per ounce on the first 217,000 ounces of gold delivered as part of the stream

$93 million carried funding loan cancelled

  • New Gold will no longer be obligated to repay the $93 million in debt that Goldcorp (and previous joint venture partners) funded on the company’s behalf

In conjunction with the Transaction, Goldcorp and Teck Resources Limited (“Teck”) today announced that they plan to combine their respective El Morro and Relincho projects into a 50/50 joint venture with the interim name of Project Corridor.

“This transaction makes strategic sense for all of the parties involved,” stated Randall Oliphant, Executive Chairman of New Gold. “We believe Goldcorp and Teck have developed a creative and thoughtful approach to bring their projects together. It is logical for two large, well-capitalized, proven operators to carry Project Corridor forward. At the same time, New Gold has taken this opportunity to further enhance our financial flexibility and strengthen our balance sheet while retaining a meaningful, low-cost stream on El Morro’s significant gold reserves and ongoing potential.”

“Goldcorp has been an excellent partner at El Morro over the last five years and we look forward to Goldcorp and Teck progressing Project Corridor for the benefit of all stakeholders,” added Mr. Oliphant.

Additional Transaction Details

Based on the results of the Project Corridor Preliminary Economic Assessment, when ore is sourced from El Morro, gold production is expected to average over 400,000 ounces per year which would enable New Gold to purchase over 16,000 ounces of gold per year at $400 per ounce.

The cash purchase price for gold delivered under the stream is fixed at $400 per ounce for the first 217,000 ounces of gold, where 217,000 ounces reflects 4% of El Morro’s currently estimated recoverable gold production. Thereafter, the cash purchase price will be $400 per ounce plus an annual 1% inflation adjustment.

Goldcorp and Teck are expecting to commence a Pre-Feasibility Study in early 2016 which should be completed 12 to 18 months thereafter.

El Morro has generated a significant return for the company since it was originally brought into the portfolio by one of New Gold’s predecessor companies in 1996. Including the costs associated with optioning into the property and subsequent exploration expenditures, the company has spent less than $7 million for its interest in El Morro. In return for this investment, New Gold received a $50 million payment from Goldcorp in 2010 when Goldcorp became the company’s 70% joint venture partner, as well as the cash proceeds related to today’s Transaction. Importantly, beyond these two cash payments, New Gold continues to maintain meaningful exposure to the El Morro project through the 4% gold stream. From an accounting perspective, the company expects to realize a non-cash loss of approximately $100 million on the sale of its 30% interest in El Morro, primarily related to the purchase accounting value assigned to the project at the time of the New Gold’s three-way merger in 2008.

Closing of the Transaction is conditional upon the closing of the El Morro-Relincho joint venture between Goldcorp and Teck as well as other customary conditions. The Transaction is expected to close in the fourth quarter of 2015.

ABOUT NEW GOLD INC.

New Gold is an intermediate gold mining company. The company has a portfolio of four producing assets and three significant development projects. The New Afton Mine in Canada, the Mesquite Mine in the United States, the Peak Mines in Australia and the Cerro San Pedro Mine in Mexico, provide the company with its current production base. In addition, New Gold owns 100% of the Rainy River and Blackwater projects, both in Canada, as well as an interest in the El Morro project located in Chile. New Gold’s objective is to be the leading intermediate gold producer, focused on the environment and social responsibility. For further information on the company, please visit www.newgold.com.

CAUTIONARY NOTE REGARDING FORWARD-LOOKING STATEMENTS

Certain information contained in this news release, including any information relating to New Gold’s future financial or operating performance are “forward looking”. All statements in this news release, other than statements of historical fact, which address events, results, outcomes or developments that New Gold expects to occur are “forward-looking statements”. Forward-looking statements are statements that are not historical facts and are generally, but not always, identified by the use of forward-looking terminology such as “plans”, “expects”, “is expected”, “budget”, “scheduled”, “targeted”, “estimates”, “forecasts”, “intends”, “anticipates”, “projects”, “potential”, “believes” or variations of such words and phrases or statements that certain actions, events or results “may”, “could”, “would”, “should”, “might” or “will be taken”, “occur” or “be achieved” or the negative connotation of such terms. Forward-looking statements in this news release include, among others, statements with respect to the anticipated benefits and effects of the Transaction, including the ability of the parties to satisfy the conditions of and complete Transaction; the ability of Teck and Goldcorp to satisfy the conditions of and complete the El Morro-Relincho joint venture (“Project Corridor”); the estimation of mineral reserves and mineral resources and metallurgical recoveries; the timing and amount of estimated future production from the El Morro property; and the completion of a pre-feasibility study for Project Corridor.

All forward-looking statements in this news release are based on the opinions and estimates of management as of the date such statements are made and are subject to important risk factors and uncertainties, many of which are beyond New Gold’s ability to control or predict. Certain material assumptions regarding such forward-looking statements are discussed in this news release. In addition to, and subject to, such assumptions discussed in more detail elsewhere, the forward-looking statements in this news release are also subject to assumptions regarding: (1) conditions to closing of the Transaction being satisfied in a timely manner; (2) conditions to closing of Project Corridor being satisfied in a timely manner; (3) the future business strategies and the environment in which Goldcorp and Teck will operate, including the price of commodities and anticipated costs of developing Project Corridor; (4) political and legal developments in Chile being consistent with the parties’ current expectations; (5) the accuracy of current mineral reserve and resource estimates; (6) all required permits, licenses and authorizations being obtained from the relevant governments and other relevant stakeholders within the expected timelines; and (7) the results of the conceptual design of Project Corridor being realized.

Forward-looking statements are necessarily based on estimates and assumptions that are inherently subject to known and unknown risks, uncertainties and other factors that may cause actual results, level of activity, performance or achievements to be materially different from those expressed or implied by such forward-looking statements. Such factors include, without limitation: the Transaction not closing when planned; delay or failure to receive regulatory approvals or the failure to satisfy other closing conditions to the Transaction or Project Corridor; future mineral prices; discrepancies between actual and estimated production, mineral reserves and resources and metallurgical recoveries; estimated mine life and sequencing of ore from the El Morro property and the Relincho property; conclusions of economic evaluations; litigation risks; mining operational and development risks; general business, economic, competitive, political and social uncertainties; currency exchange rate fluctuations; not realizing the potential benefits of the Transaction or Project Corridor; changes in parameters as plans continue to be refined; as well as those risks identified in New Gold’s filings with Canadian securities regulators, which may be viewed at www.sedar.com.

Although New Gold has attempted to identify important factors that could cause actual results to differ materially from those contained in forward-looking statements and information, there may be other factors that cause results not to be as anticipated, estimated or intended.

Forward-looking statements are not guarantees of future performance, and actual results and future events could materially differ from those anticipated in such statements. All of the forward-looking statements contained in this news release are qualified by these cautionary statements. New Gold expressly disclaims any intention or obligation to update or revise any forward-looking statements whether as a result of new information, events or otherwise, except in accordance with applicable securities laws.

CAUTIONARY NOTE TO U.S. READERS CONCERNING ESTIMATES OF MINERAL RESERVES AND MINERAL RESOURCES

Information concerning the properties and operations of New Gold has been prepared in accordance with Canadian standards under applicable Canadian securities laws, and may not be comparable to similar information for United States companies. The terms “Mineral Resource”, “Measured Mineral Resource”, “Indicated Mineral Resource” and “Inferred Mineral Resource” used in this news release are Canadian mining terms as defined in the Canadian Institute of Mining, Metallurgy and Petroleum (“CIM”) Definition Standards for Mineral Resources and Mineral Reserves adopted by CIM Council on May 10, 2014 and incorporated by reference in National Instrument 43-101 (“NI 43-101”).  While the terms “Mineral Resource”, “Measured Mineral Resource”, “Indicated Mineral Resource” and “Inferred Mineral Resource” are recognized and required by Canadian securities regulations, they are not defined terms under standards of the United States Securities and Exchange Commission.  As such, certain information contained in this news release concerning descriptions of mineralization and mineral resources under Canadian standards is not comparable to similar information made public by United States companies subject to the reporting and disclosure requirements of the United States Securities and Exchange Commission.

An “Inferred Mineral Resource” has a great amount of uncertainty as to its existence and as to its economic and legal feasibility.  Under Canadian rules, estimates of inferred mineral resources may not form the basis of feasibility or pre-feasibility studies.  It cannot be assumed that all or any part of an “Inferred Mineral Resource” will ever be upgraded to a higher confidence category through additional exploration drilling and technical evaluation.   Readers are cautioned not to assume that all or any part of an “Inferred Mineral Resource” exists or is economically or legally mineable.

Under United States 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 estimation is made.  Readers are cautioned not to assume that all or any part of the measured or indicated mineral resources will ever be converted into mineral reserves. In addition, the definitions of “Proven Mineral Reserves” and “Probable Mineral Reserves” under CIM standards differ in certain respects from the standards of the United States Securities and Exchange Commission.

EL MORRO MINERAL RESERVES AND RESOURCES (ON A 100% BASIS)

EL MORRO MINERAL RESERVES AND RESOURCES SUMMARY TABLE AS AT DECEMBER 31, 2014 (100% basis)
Metal grade Contained metal
Tonnes
000s
Gold
g/t
Silver
g/t
Copper
%
Gold
Koz
Silver
Koz
Copper
Mlbs
MINERAL RESERVES
Proven 321,814 0.56 0.55 5,820 3,877
Probable 277,240 0.35 0.43 3,097 2,627
Total El Morro P&P 599,054 0.46 0.49 8,917 6,503
MEASURED AND INDICATED MINERAL RESOURCE
Measured 19,790 0.53 0.51 340 223
Indicated 72,563 0.38 0.39 883 630
Total El Morro M&I 92,353 0.41 0.42 1,220 853
INFERRED RESOURCE
El Morro – Open Pit 564,217 0.16 0.26 2,903 3,233
El Morro – Underground 113,840 0.97 0.78 3,550 1,957

NOTES TO MINERAL RESERVE AND RESOURCE ESTIMATES

  1. New Gold’s mineral reserves have been estimated in accordance with the Canadian Institute of Mining, Metallurgy and Petroleum (“CIM”) Definition Standards for Mineral Resources and Mineral Reserves adopted by CIM Council on May 10, 2014 and incorporated by reference in National Instrument 43-101 (“NI 43-101”).
  2. For year-end 2014 mineral reserves for the El Morro property have been estimated based on the following metal prices and lower cut-off criteria:
    Mineral Property Gold ($/oz) Silver ($/oz) Copper ($/lb) Lower Cut-off
    El Morro $1,300 $3.00 0.20% CuEq
  3. New Gold reports its Measured and Indicated mineral resources exclusive of mineral reserves. Measured and Indicated mineral resources do not have demonstrated economic viability. Inferred mineral resources have a greater amount of uncertainty as to their existence, economic and legal feasibility, do not have demonstrated economic viability, and are likewise exclusive of mineral reserves.
  4. For year-end 2014 mineral resources for the El Morro property have been estimated based on the following metal prices and lower cut-off criteria:
    Mineral Property Gold ($/oz) Silver ($/oz) Copper ($/lb) Lower Cut-off
    El Morro $1,500 $3.50 0.20% CuEq
  5. Mineral resources are classified as Measured, Indicated and Inferred resources and are reported based on technical and economic parameters consistent with the methods most suitable for their potential commercial exploitation. Where different mining and/or processing methods might be applied to different portions of a mineral resource, the designators ‘open pit’ and ‘underground’ have been applied to indicate envisioned mining method. Mineral reserves and mineral resources may be materially affected by environmental, permitting, legal, title, taxation, sociopolitical, marketing and other risks and relevant issues. Additional details regarding mineral reserve and mineral resource estimation, classification, reporting parameters, key assumptions and associated risks for the El Morro property are provided in the NI 43-101 Technical Report for the El Morro Project, Region III, Chile, dated March 26, 2012 which is available under New Gold’s profile at www.sedar.com.
  6. The preparation of the mineral reserve and mineral resource estimates for the El Morro property has been done by Qualified Persons as defined under NI 43-101, under the oversight and review of Mr. Mark A. Petersen, a Qualified Person under NI 43-101.
Thursday, August 27th, 2015 Uncategorized Comments Off on (NGD) Announces Sale of El Morro Interest for $90 Million Cash and a 4% Gold Stream

(TBPH) to Present at the Baird 2015 Healthcare Conference

DUBLIN, IRELAND–(Aug 27, 2015) – Theravance Biopharma, Inc. (NASDAQ: TBPH) announced today that Rick E Winningham, Chairman and Chief Executive Officer and other members of the management team will participate in a fireside chat at the Baird 2015 Healthcare Conference on Wednesday, September 9, 2015, at 9:40 a.m. ET. The conference will be held from September 9-10 at The New York Palace Hotel, New York, NY.

The presentation will be webcast live and can be reached by visiting the Investor Relations section of Theravance Biopharma’s website at www.theravance.com, under the Presentations & Events tab. Listeners are encouraged to visit the site at least 15 minutes prior to the scheduled presentation to register, download and install any necessary audio software.

About Theravance Biopharma

The mission of Theravance Biopharma (NASDAQ: TBPH) is to create value from a unique and diverse set of assets: an approved product; a development pipeline of late-stage assets; and a productive research platform designed for long-term growth.

Our pipeline of internally discovered product candidates includes potential best-in-class opportunities in underserved markets in the acute care setting, representing multiple opportunities for value creation. VIBATIV® (telavancin), our first commercial product, is a once-daily dual-mechanism antibiotic approved in the U.S., Europe and certain other countries for certain difficult-to-treat infections. TD-4208 is an investigational long-acting muscarinic antagonist (LAMA) being developed as a potential once-daily, nebulized treatment for COPD. Axelopran (TD-1211) is an investigational potential once-daily, oral treatment for opioid-induced constipation (OIC). Our earlier-stage clinical assets represent novel approaches for potentially treating diseases of the lung and gastrointestinal tract and infectious disease. In addition, we have an economic interest in future payments that may be made by GlaxoSmithKline plc pursuant to its agreements with Theravance, Inc. relating to certain drug development programs, including the combination of fluticasone furoate, umeclidinium and vilanterol and (the “Closed Triple”).

With our successful drug discovery and development track record, commercial infrastructure, experienced management team and efficient corporate structure, we believe that we are well positioned to create value for our shareholders and make a difference in the lives of patients.

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

THERAVANCE®, the Cross/Star logo, MEDICINES THAT MAKE A DIFFERENCE® and VIBATIV® are registered trademarks of the Theravance Biopharma group of companies.

Contact Information:

Renee Gala
Chief Financial Officer
650-808-4045
investor.relations@theravance.com

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(AMRN) Announces Encore Presentation of Results of the Apolipoprotein C-III Post-Hoc Analysis

EDMINSTER, NJ and DUBLIN, IRELAND–(August 27, 2015) – Amarin Corporation plc (NASDAQ: AMRN) today announced the encore presentation of findings from a post-hoc analysis examining the effects of icosapent ethyl (Vascepa®) on Apolipoprotein C-III (ApoC-III) levels in both very high triglyceride (VHTG) and high triglyceride (HTG) patient populations. The poster titled, “Icosapent Ethyl (eicosapentaenoic acid ethyl ester): Effects on Apolipoprotein C-III in Patients from the MARINE and ANCHOR Studies,” will be on display at the European Society of Cardiology 2015 Annual Congress in London, England, Session 302 Poster Session #2. The results will be presented by lead investigator, Dr. Christie Ballantyne, Baylor College of Medicine and the Methodist DeBakey Heart and Vascular Center on Sunday, August 30 at 10:00 AM GMT.

“This analysis extends the findings to date of the potential lipid and lipoprotein modifying benefits Vascepa possesses in patients with elevated triglyceride (TG) levels,” said Dr. Ballantyne. “It also extends our understanding of the effects Vascepa® has on top of statin therapy.”

The analysis evaluated the effects of EPA-only prescription Vascepa, alone or in combination with statin therapy, on ApoC-III levels in 148 patients with VHTG levels in the MARINE study of Vascepa and 612 patients with HTG levels in the ANCHOR study of Vascepa. In MARINE, Vascepa 4 g/day statistically significantly reduced ApoC-III levels by 25.1% (P < 0.0001) versus placebo. In ANCHOR, Vascepa 4 g/day statistically significantly reduced ApoC-III levels by 19.2% (P < 0.0001) versus placebo. The findings, originally presented at the National Lipid Association Annual Scientific Sessions in 2014, show that at both 4g/day and 2g/day compared to placebo, Vascepa, alone or in combination with statin therapy, significantly reduced ApoC-III levels in adult patients in the MARINE and ANCHOR studies, in which Vascepa also significantly lowered TG levels without raising LDL-C.

Further study is needed to determine if the effects of Vascepa, including those on ApoC-III, in patients with hypertriglyceridemia would have clinically meaningful benefit in the human body.

About VASCEPA® (icosapent ethyl) capsules

VASCEPA® (icosapent ethyl) capsules, known in scientific literature as AMR101, is a highly pure-EPA omega-3 prescription product in a 1 gram capsule.

Indications and Usage

  • VASCEPA (icosapent ethyl) is indicated as an adjunct to diet to reduce triglyceride (TG) levels in adult patients with severe (≥500 mg/dL) hypertriglyceridemia.
  • The effect of VASCEPA on the risk for pancreatitis and cardiovascular mortality and morbidity in patients with severe hypertriglyceridemia has not been determined.

Important Safety Information for VASCEPA

  • VASCEPA is contraindicated in patients with known hypersensitivity (e.g., anaphylactic reaction) to VASCEPA or any of its components.
  • Use with caution in patients with known hypersensitivity to fish and/or shellfish.
  • The most common reported adverse reaction (incidence > 2% and greater than placebo) was arthralgia (2.3% for Vascepa, 1.0% for placebo). There was no reported adverse reaction > 3% and greater than placebo.
  • Patients receiving treatment with VASCEPA and other drugs affecting coagulation (e.g., anti-platelet agents) should be monitored periodically.
  • In patients with hepatic impairment, monitor ALT and AST levels periodically during therapy.
  • Patients should be advised to swallow VASCEPA capsules whole; not to break open, crush, dissolve, or chew VASCEPA.
  • Adverse events and product complaints may be reported by calling 1-855-VASCEPA or the FDA at 1-800-FDA-1088.

FULL VASCEPA PRESCRIBING INFORMATION CAN BE FOUND AT WWW.VASCEPA.COM.

Vascepa has been approved for use by the United States Food and Drug Administration (FDA) as an adjunct to diet to reduce triglyceride levels in adult patients with severe (≥ 500 mg/dL) hypertriglyceridemia. Vascepa is under various stages of development for potential use in other indications that have not been approved by the FDA. Nothing in this press release should be construed as promotion the use of Vascepa in any indication that has not been approved by the FDA.

About Amarin

Amarin Corporation plc is a biopharmaceutical company focused on the commercialization and development of therapeutics to improve cardiovascular health. Amarin’s product development program leverages its extensive experience in lipid science and the potential therapeutic benefits of polyunsaturated fatty acids. Amarin’s clinical program includes commitment to an ongoing outcomes study. Vascepa® (icosapent ethyl), Amarin’s first FDA approved product, is a highly-pure, EPA-only, omega-3 fatty acid product available by prescription. For more information about Vascepa visit www.vascepa.com. For more information about Amarin visit www.amarincorp.com.

Forward-looking statements

This press release contains forward-looking statements, including statements about the potential efficacy, safety and therapeutic benefits of EPA, including statements about the potential clinical importance of the findings presented. These forward-looking statements are not promises or guarantees and involve substantial risks and uncertainties. Among the factors that could cause actual results to differ materially from those described or projected herein include uncertainties associated generally with in vitro research, research and development and clinical trials, including the risk that such study results may not be predictive of future results or replicated in study in man and that studied parameters may not have clinically meaningful effect. A list and description of these risks, uncertainties and other risks associated with an investment in Amarin can be found in Amarin’s filings with the U.S. Securities and Exchange Commission, including its most recent quarterly report on Form 10-Q. Existing and prospective investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof. Amarin undertakes no obligation to update or revise the information contained in this press release, whether as a result of new information, future events or circumstances or otherwise.

Availability of other information about Amarin

Investors and others should note that we communicate with our investors and the public using our company website (www.amarincorp.com), our investor relations website (http://www.amarincorp.com/investor-splash.html), including but not limited to investor presentations and investor FAQs, Securities and Exchange Commission filings, press releases, public conference calls and webcasts. The information that we post on these channels and websites could be deemed to be material information. As a result, we encourage investors, the media, and others interested in Amarin to review the information that we post on these channels, including our investor relations website, on a regular basis. This list of channels may be updated from time to time on our investor relations website and may include social media channels. The contents of our website or these channels, or any other website that may be accessed from our website or these channels, shall not be deemed incorporated by reference in any filing under the Securities Act of 1933.

Investor Relations:
Michael Farrell
Investor Relations and Corporate Communications
Amarin Corporation plc
In U.S.: +1 (908) 719-1315
investor.relations@amarincorp.com

Graham Morrell
Trout Group
In U.S.: +1 (646) 378-2954
gmorrell@troutgroup.com

Media Inquiries:
Lee Davies
Makovsky
In U.S.: +1 (212) 508-9651
ldavies@makovsky.com

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(STXS) Ablation Effectiveness of Magnetic Navigation Highlighted By Westmead

ST. LOUIS, Aug. 27, 2015  — Stereotaxis, Inc. (NASDAQ:STXS) and Westmead Hospital in Australia today announced findings of a recent study comparing the stability of a Niobe® remote magnetic navigation system catheter group and a manually controlled catheter group in a validated cardiac wall motion simulator.

“The Niobe system has long demonstrated an enhanced safety profile in comparison to conventional ablations, but its efficacy with lesion creation in highly mobile cardiac regions has not been adequately studied,” said Pramesh Kovoor, M.D., Ph.D., Director of Cardiac Services at Westmead Hospital and Associate Professor at the University of Sydney. “We were pleasantly surprised with the results of our research, which provided strong evidence of faster, deeper lesion formation utilizing the Niobe system, due to constant catheter contact in the presence of simulated heart wall motion. As a practitioner, this translates into the potential for more precise, effective ablations in unstable regions of the heart, which could lead to improved patient outcomes and shorter procedure times.”

During the study, the research team performed a total of 60 ablations in a myocardial phantom (gel tank), which was previously validated in animal studies. Radiofrequency ablations were delivered both by an irrigated catheter controlled by the Niobe magnetic navigation system as well as a manually controlled irrigated catheter, and catheter position was confirmed by real-time visualization. The ablation surface of the phantom was put into motion in order to simulate cardiac wall movement. Researchers observed lateral sliding (5.2mm) in the manual catheter group during surface movement, while the magnetically guided catheter group maintained stable focal contact with no lateral movement (0mm). As a result, lesion dimensions using the Niobe system were larger, deeper and formed sooner compared to manual control. Complete study results are available online in the Journal of Interventional Cardiac Electrophysiology (DOI: 10.1007/s10840-015-0023-3). Additional study details as well as a video of the study can be found at www.stereotaxis.com/lesion_westmead/.

About Stereotaxis

Stereotaxis is a healthcare technology and innovation leader in the development of robotic cardiology instrument navigation systems designed to enhance the treatment of arrhythmias and coronary disease, as well as information management solutions for the interventional lab. Over 100 issued patents support the Stereotaxis platform, which helps physicians around the world provide unsurpassed patient care with robotic precision and safety, improved lab efficiency and productivity, and enhanced integration of procedural information. Stereotaxis’ core Epoch® Solution includes the Niobe® magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management solutions, and the Vdrive® robotic navigation system and consumables.

The core components of Stereotaxis’ systems have received regulatory clearance in the U.S., European Union, Canada, China, Japan, and elsewhere. The V-Sono™ ICE catheter manipulator, V-Loop™ variable loop catheter manipulator, and V-CAS™ catheter advancement system have received clearance in the U.S., Canada, and the European Union. For more information, please visit www.stereotaxis.com.

This press release includes statements that may constitute “forward-looking” statements, usually containing the words “believe”, “estimate”, “project”, “expect”, or similar expressions. Forward-looking statements inherently involve risks and uncertainties that could cause actual results to differ materially from the forward-looking statements. Factors that would cause or contribute to such differences include, but are not limited to, the Company’s ability to raise additional capital on a timely basis and on terms that are acceptable, its ability to continue to manage expenses and cash burn rate at sustainable levels, its ability to continue to work with lenders to extend, repay or refinance indebtedness on acceptable terms, continued acceptance of the Company’s products in the marketplace, the effect of global economic conditions on the ability and willingness of customers to purchase its systems and the timing of such purchases, competitive factors, changes resulting from the recently enacted healthcare reform in the U.S., including changes in government reimbursement procedures, dependence upon third-party vendors, timing of regulatory approvals, and other risks discussed in the Company’s periodic and other filings with the Securities and Exchange Commission. By making these forward-looking statements, the Company undertakes no obligation to update these statements for revisions or changes after the date of this release. There can be no assurance that the Company will recognize revenue related to its purchase orders and other commitments in any particular period, or at all, because some of these purchase orders and other commitments are subject to contingencies that are outside of the Company’s control. In addition, these orders and commitments may be revised, modified, delayed or canceled, either by their express terms, as a result of negotiations, or by overall project changes or delays.

CONTACT: STXS Company Contact:
         Martin Stammer
         Chief Financial Officer
         314-678-6155

         STXS Investor Contact:
         Todd Kehrli / Jim Byers
         MKR Group, Inc.
         323-468-2300
         stxs@mkr-group.com
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(ENG) Announces the Addition of Key Professionals

HOUSTON, Aug. 27, 2015  — ENGlobal (NASDAQ:ENG), a leading provider of automation and engineering services, today announced the addition of two key professionals to its management team in newly created positions. These actions support the Company’s strategic commitment to further strengthen its midstream project execution and automation engineering businesses.

Mr. John Offutt has joined ENGlobal to serve in a newly created position – General Manager, Midstream Projects, with responsibility over the Company’s Tulsa and Houston midstream operations. Mr. Offutt brings his knowledge and experience in managing all phases of large transportation-related projects, with the majority of his 30 year career having been with a major midstream operating company.

In his most recent assignment, Mr. Offutt managed a $700 million capital budget including 280 miles of pipeline and associated facilities. Mr. Offutt has directed teams of project managers, engineers, construction managers and support functions, being responsible for the successful execution of a lengthy list of both large and small diameter pipeline projects.

Additionally, Mr. Robert Sammons has joined the Company as General Manager – Automation Engineering. In this role, Mr. Sammons has the responsibility of expanding the Company’s automation capabilities, in addition to supervising several of the Company’s existing projects and technologies.

Mr. Sammons has gained extensive automation experience during his 25 year career, with senior level responsibilities focused on both business development and operations. Most recently he has been active in his own business providing Process Hazard Analysis and Burner Management Safety systems to midstream processing, refining and petrochemical clients.

“ENGlobal is privileged to include both John and Robert as senior professionals and members of the ENGlobal Team,” stated William A. Coskey, P.E., ENGlobal’s Chairman and Chief Executive Officer. “Our intent in the current market is to remain dynamic and proactive as a Company, building upon our many project execution skills and thereby demonstrating our continuous commitment to better serve our valued clients.”

About ENGlobal

ENGlobal (NASDAQ:ENG) is a provider of engineering and related project services primarily to the energy sector throughout the United States and internationally. ENGlobal operates through two business segments: Automation and Engineering. ENGlobal’s Automation segment provides services related to the design, fabrication and implementation of advanced automation, control, instrumentation and process analytical systems. The Engineering segment provides consulting services for the development, management and execution of projects requiring professional engineering, construction management, and related support services. Within the Engineering segment, ENGlobal’s Government Services group provides engineering, design, installation and operation and maintenance of various government, public sector and international facilities, and specializes in the turnkey installation and maintenance of automation and instrumentation systems for the U.S. Defense industry worldwide. Further information about the Company and its businesses is available at www.ENGlobal.com.

Safe Harbor for Forward-Looking Statements

The statements above regarding the Company’s expectations regarding its operations and certain other matters discussed in this press release may constitute forward-looking statements within the meaning of the federal securities laws and are subject to risks and uncertainties For a discussion of additional risks and uncertainties, which could cause actual results to differ from those contained in the forward-looking statements, see ENGlobal’s filings with the Securities and Exchange Commission, including the Company’s most recent reports on Form 10-K and 10-Q, and other SEC filings.

Click here to join our email list:http://www.b2i.us/irpass.asp?BzID=702&to=ea&s=0.

CONTACT: Mark A. Hess
         (281) 878-1040
         ir@ENGlobal.com
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(DGLY) Ally Receives Body Camera, In-Car Video and VuLink Order

More Than 200 Agencies in State of Missouri Have Chosen Company’s Digital Video Solution

LENEXA, KS–(Aug 26, 2015) – Digital Ally, Inc. (NASDAQ: DGLY) (“Digital” or the “Company”), which develops, manufactures and markets advanced video surveillance products for law enforcement, homeland security and commercial applications, today announced that it has received a follow-on order for its DVM-800 in-car video systems, FirstVu HD body-worn video cameras and VuLink automatic activation systems from the Ferguson, Missouri Police Department.

“From the beginning of this process Digital Ally has repeatedly gone above and beyond for the Ferguson Police Department,” stated Assistant Police Chief Alan Eickhoff. “Our officers have been using Digital Ally equipment in the field for the last year, and the equipment has performed without failure and has aided our officers in their activities. Deploying this type of technology to all of our officers will increase transparency between our department and the public as we work to rebuild trust between the department and our community.”

“Ferguson is one of more than two hundred law enforcement agencies in the State of Missouri that have chosen Digital Ally as their provider for a digital video solution,” stated Stanton E. Ross, the Company’s Chief Executive Officer. “Immediately after the first wave of unrest began in Ferguson last year, Digital Ally was on the ground with the Ferguson Police Department, equipping and training its officers on our systems. As a company focused on public safety, we feel a moral obligation to assist communities during periods of crisis and to do anything within our power to help protect law enforcement officers and the citizens of such communities. This order represents the continuation of a partnership forged during a very tumultuous period of time. With this purchase, Ferguson has strengthened the relationship between Digital Ally, the Police Department and members of the community for many years to come.”

Digital Ally is proud to design and assemble its products in the United States. The DVM-800 is Digital Ally’s “flagship” in-car video system. It is smaller, more powerful and easier to use than its predecessors and represents a continuation of the highly successful digital video rear-view mirror platform. Digital Ally’s FirstVu HD body-worn video systems offer multiple camera and mounting options, and when combined with the Company’s in-car video systems and patented VuLink™ technology, the FirstVu HD allows for hands-free activation of an officer’s in-car and body-worn camera systems.

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About Digital Ally, Inc.

Digital Ally, Inc. develops, manufactures and markets advanced technology products for law enforcement, homeland security and commercial applications. The Company’s primary focus is digital video imaging and storage. For additional information, visit www.digitalallyinc.com.

The Company is headquartered in Lenexa, Kansas, and its shares are traded on The NASDAQ Capital Market under the symbol “DGLY”.

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Act of 1934. These forward-looking statements are based largely on the expectations or forecasts of future events, can be affected by inaccurate assumptions, and are subject to various business risks and known and unknown uncertainties, a number of which are beyond the control of management. Therefore, actual results could differ materially from the forward-looking statements contained in this press release. A wide variety of factors that may cause actual results to differ from the forward-looking statements include, but are not limited to, the following: whether sales to law enforcement departments such as the Ferguson Police Department will help to generate sales of our products to additional law enforcement agencies; whether the Company will be able to compete successfully in the marketplace to generate additional sales of its products in side-by side comparisons with other companies’ products; and whether the Company will be able to adapt its technology to new and different uses. These cautionary statements should not be construed as exhaustive or as any admission as to the adequacy of the Company’s disclosures. The Company cannot predict or determine after the fact what factors would cause actual results to differ materially from those indicated by the forward-looking statements or other statements. The reader should consider statements that include the words “believes”, “expects”, “anticipates”, “intends”, “estimates”, “plans”, “projects”, “should”, or other expressions that are predictions of or indicate future events or trends, to be uncertain and forward-looking. The Company does not undertake to publicly update or revise forward-looking statements, whether as a result of new information, future events or otherwise. Additional information respecting factors that could materially affect the Company and its operations are contained in its annual report on Form 10-K for the year ended December 31, 2014, and its Form 10-Q for the three and six months ended June 30, 2015, as filed with the Securities and Exchange Commission. 

Image Available: http://www2.marketwire.com/mw/frame_mw?attachid=2878414

For Additional Information, Please Contact:

Stanton E. Ross
CEO
(913) 814-7774
or
RJ Falkner & Company, Inc.
Investor Relations Counsel
(800) 377-9893
info@rjfalkner.com

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(OVAS) Publication of AUGMENT Fertility Treatment Shows Statistically Significant Improvements

Real-World Experience from International IVF Clinics Reported in Peer-Reviewed Journal

OvaScienceSM (NASDAQ:OVAS), a global fertility company focused on the discovery, development and commercialization of new treatment options, announced today the first published analysis of real-world patient experience comparing the AUGMENTSM fertility treatment to standard in vitro fertilization (IVF). In the same woman within the same IVF cycle, AUGMENT-treated eggs had statistically significant higher rates of embryo selection and transfer based on standard embryo quality measures, which resulted in statistically significant higher rates of pregnancy, compared to standard IVF.

The report, published today in the peer-reviewed, Journal of Fertilization: In Vitro– IVF-Worldwide Reproductive Medicine, Genetic & Stem Cell Biology, includes a previously described subset of 25 patients at Fakih IVF in the United Arab Emirates (UAE) whose eggs were prospectively allocated to two treatment groups – one that received the AUGMENT treatment and the other that received standard IVF only. The publication also includes the combined experience of more than 90 patients from Fakih IVF and TCART Fertility Partners in Canada that showed substantial improvements in pregnancy rates with the AUGMENT treatment compared to the patients’ prior IVF histories. The publication is available at http://www.ovascience.com/technology/publications. A presentation describing the findings is available on the Investors page at www.ovascience.com. The AUGMENT treatment is designed to improve egg health and is not available in the United States.

“This first publication of AUGMENT experience from different IVF clinics shows that AUGMENT treatment resulted in higher ongoing clinical pregnancy rates and healthy births when compared to standard IVF,” said Robert F. Casper, M.D., F.R.C.S.(C), Medical Director of TCART Fertility Partners. “In addition, the new analysis by Fakih IVF demonstrated statistically significant higher rates of embryo selection and transfer with the AUGMENT treatment. This provides further evidence that the AUGMENT treatment has the potential to improve egg health and embryo quality, and may offer a new treatment option to improve IVF success.”

The eggs retrieved from a group of 25 patients at Fakih IVF were prospectively allocated into two treatment groups: one group received the AUGMENT treatment and the other group received standard IVF with ICSI (intracytoplasmic sperm injection). All 25 patients met the inclusion criteria for the retrospective analysis that required embryo transfer be limited to only one treatment group, as including embryos from both treatment groups would prevent an accurate assessment of treatment benefit. Embryos that were transferred were selected from the one treatment group that had the highest quality embryo(s) for transfer. Accordingly, in patients where more than one embryo was transferred, embryos were only selected from the one treatment group that included overall highest quality embryos. Embryos were selected based on standard morphogenetic analysis, which is composed of two measures. The first is an objective analysis to identify genetic disorders (e.g., cystic fibrosis) and chromosomal abnormalities (e.g., aneuploidy). This is called preimplantation genetic diagnosis (PGD) or preimplantation genetic screening (PGS). The second is an analysis of morphology performed by the embryologist. There is a standard grading system used to evaluate the embryos.

Following the PGD/PGS assessment, there were 9 patients for whom no embryos met the criteria for transfer. The majority of embryos were chosen based on PGD/PGS, an objective measure of embryo quality. The remaining embryos underwent morphological assessment. The morphogenetic analysis resulted in 14 embryo transfers from the AUGMENT group and 2 from the IVF-only group, which was statistically significant and suggestive of improved embryo quality with the AUGMENT treatment.

Ongoing clinical pregnancy rates in these women, who previously had a 0 percent live birth rate, were higher in the AUGMENT treatment group, with 8 women out of 14 with embryo transfers resulting in ongoing clinical pregnancies that are expected to result in live births (and include the births of two sets of twins). There were 0 women with ongoing clinical pregnancies out of 2 with embryo transfers in the IVF-only group. In the intent-to-treat (ITT) analysis of all 25 patients, there was a statistically significant improvement in pregnancy rates with the AUGMENT treatment compared to the IVF-only group. (See Figure 1, pg. 5 of publication)

“Evaluating the AUGMENT treatment in the same woman during the same IVF cycle eliminates many variables and provides clinically meaningful insight into the positive impact the treatment can have for patients,” said Michael Fakih, M.D., Co-Founder and Medical Director of Fakih IVF. “As IVF success typically decreases with increasing cycle number and increasing maternal age, we were pleased to see with the AUGMENT treatment that ongoing clinical pregnancy rates per embryo transfer were similar to the success rates of young, donor eggs. This was particularly encouraging given that these results were observed in patients who had poor embryo quality and prior IVF failures.”

The publication also included a summary of patients treated at TCART (n=34) and Fakih IVF (n=59), demonstrating improvements in pregnancy rates above the patients’ historic IVF success rates. Prior to the AUGMENT treatment, patients collectively underwent 328 IVF cycles, and had a 2 and 1.4 percent live birth rate per IVF cycle initiated in Canada and the UAE, respectively. After the AUGMENT treatment, there was an 11- and 18-fold increase in ongoing clinical pregnancy rate per initiated cycle in the UAE and Canada, respectively, which includes the births of six babies. Patient experience in the publication is inclusive of all patients up to a certain point in time.

Patient History Live Birth Rate per
Initiated Cycle
Clinical
Pregnancy Rate
per Initiated
AUGMENT Cycle
Ongoing Clinical
Pregnancy
Rate/Live Birth
Rate per Initiated
AUGMENT Cycle
Canada(n=34)
  • Average age: 36.0
  • 1-5 prior IVF cycles
  • 71 total prior IVF cycles
1% 35% 26%
9 patients with 23 frozen embryos
remaining for transfer
United ArabEmirates(n=59)
  • Average age: 37.3
  • 1-16 prior IVF cycles
  • 257 total prior IVF cycles
2% 22% 18%
Canada and UAE Have Reported Six Babies Born with the AUGMENT Treatment

“As with the introduction of other new fertility technologies, we anticipated that IVF clinics would gain experience using the AUGMENT treatment by taking various approaches to demonstrate benefit,” said Michelle Dipp, M.D., Ph.D., Chief Executive Officer of OvaScience. “We are pleased that the approaches used to date have shown marked and significant improvement with the AUGMENT treatment compared to standard IVF. We believe that egg allocation offers a more controlled approach in a real-world setting. We look forward to additional patient experiences and publications that demonstrate the benefits of the AUGMENT treatment.”

IVF is the standard treatment for infertility, yet it fails the majority of the time. Poor egg health is a major cause of IVF failure, and data has demonstrated that the decline in egg health is largely due to a reduction in energy production. The AUGMENT treatment is designed to improve egg health by supplementing the energy in mature eggs during IVF.

About OvaScience

OvaScience (NASDAQ: OVAS) is a global fertility company dedicated to improving treatment options 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 www.augmenttreatment.com and connect with us on Twitter and Facebook.

Forward-Looking Statements

This press release includes forward-looking statements about the Company’s plans 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 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 commercial ramp up of the AUGMENT treatment, which we expect will depend upon continued use of the AUGMENT treatment in our partner clinics in new and existing regions, significant uptake in the UAE as a result of the recent coverage, and other programs that include driving first-line use of the AUGMENT treatment, and further results from ACE clinic experience as they become available; 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 where necessary for our potential treatments; our ability to develop our potential treatments, including the OvaPrime and OvaTure treatments, on the timelines we expect, if at all; our ability to commercialize the AUGMENT treatment and our potential treatments, including the 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 and/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.

 

For OvaScience:
Theresa McNeely, 617-299-7356
EVP, Chief Communications Officer
tmcneely@ovascience.com
or
Media:
Cara Mayfield, 617-714-9638
Director, Corporate Communications
cmayfield@ovascience.com

Wednesday, August 26th, 2015 Uncategorized Comments Off on (OVAS) Publication of AUGMENT Fertility Treatment Shows Statistically Significant Improvements

(LOAN) Announces the Buy-Back of up to 150,000 of Its Common Shares

LONG ISLAND, N.Y., Aug. 26, 2015  — Manhattan Bridge Capital, Inc. (NASDAQ:LOAN) announced that its Board of Directors has authorized a common stock repurchase allowing the buyback of up to 150,000 common shares in market or off-market transactions at prevailing prices over the next twelve months.

The manner, timing and number of shares purchased will be at the Company’s discretion.

Assaf Ran, Chairman of the Board and CEO stated, “The Company and its Board have decided to approve this stock buy-back program in order to be able to take advantage of unpredictable and volatile market conditions as occurred recently, and buy its own shares at what Management believes could be significantly undervalued prices.”

About Manhattan Bridge Capital, Inc.

Manhattan Bridge Capital, Inc. offers short-term secured, non–banking loans (sometimes referred to as ‘‘hard money’’ loans) to real estate investors to fund their acquisition, renovation, rehabilitation or improvement of properties located in the New York metropolitan area. We operate the web site: http://www.manhattanbridgecapital.com

This report contains forward-looking statements within the meaning of section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”).  Forward-looking statements are typically identified by the words “believe,” “expect,” “intend,” “estimate” and similar expressions.  Those statements appear in a number of places in this report and include statements regarding our intent, belief or current expectations or those of our directors or officers with respect to, among other things, trends affecting our financial condition and results of operations and our business and growth strategies.  These forward-looking statements are not guarantees of future performance and involve risks and uncertainties.  Actual results may differ materially from those projected, expressed or implied in the forward-looking statements as a result of various factors (such factors are referred to herein as “Cautionary Statements”), including but not limited to the following: (i)we may not qualify as a REIT; (ii) we have no operating history as a REIT;(iii) our loan origination activities, revenues and profits are limited by available funds (iv)we operate in a highly competitive market and competition may limit our ability to originate loans with favorable interest rates; (v) our chief executive officer is critical to our business and our future success may depend on our ability to retain him; (vi) if we overestimate the yields on our loans or incorrectly value the collateral securing the loan, we may experience losses; (vii) we may be subject to “lender liability” claims; (viii) our loan portfolio is illiquid; (ix) our due diligence may not uncover all of a borrower’s liabilities or other risks to its business; (x) borrower concentration could lead to significant losses; (xi) our management has no experience managing a REIT; and (xii) we may choose to make distributions in our own stock, in which case you may be required to pay income taxes in excess of the cash dividends you receive.   The accompanying information contained in this report, including the information set forth under “Management’s Discussion and Analysis of Financial Condition and Results of Operations”, identifies important factors that could cause such differences.  These forward-looking statements speak only as of the date of this report, and we caution potential investors not to place undue reliance on such statements.  We undertake no obligation to update or revise any forward-looking statements.  All subsequent written or oral forward-looking statements attributable to us or persons acting on our behalf are expressly qualified in their entirety by the Cautionary Statements.

 

Contacts: 
Assaf Ran, CEO
(516) 444-3400
Wednesday, August 26th, 2015 Uncategorized Comments Off on (LOAN) Announces the Buy-Back of up to 150,000 of Its Common Shares