Archive for September, 2015

(EZCH) Mellanox Announces Definitive Agreement to Acquire EZchip

  • Combines highly successful teams, technologies, and products
  • Addresses large, growing markets, and expands opportunity within customer bases
  • Provides advanced, intelligent end-to-end interconnect solutions and processing capabilities that enable superior performance for data-intensive applications in Web 2.0, cloud, Big Data, telecom, secure data center, and storage
  • Expects accretive non-GAAP EPS impact from day one

Mellanox® Technologies, Ltd. (NASDAQ:MLNX), a leading supplier of end-to-end interconnect solutions for servers and storage systems, and EZchip (NASDAQ:EZCH) (TASE:EZCH), a leader in high-performance processing solutions for carrier and data center networks, announced today that they have entered into a definitive merger agreement under which Mellanox shall acquire 100 percent of EZchip’s outstanding ordinary shares for a cash purchase price of $25.5 per share implying a transaction value of approximately $811 million (approximately $620 million net of cash). The terms of the transaction have been unanimously approved by both the Mellanox and EZchip Boards of Directors.

This Smart News Release features multimedia. View the full release here: http://www.businesswire.com/news/home/20150930005470/en/

The EZchip acquisition is a step in Mellanox’s strategy to become the leading broad-line supplier of intelligent interconnect solutions for the software-defined data centers. The addition of EZchip’s products and expertise in security, deep packet inspection, video, and storage processing enhances Mellanox’s leadership position, and ability to deliver complete end-to-end, intelligent 10, 25, 40, 50, and 100Gb/s interconnect and processing solutions for advanced data center and edge platforms. The combined company will have diverse and robust solutions to enable customers to meet the growing demands of data-intensive applications used in high-performance computing, Web 2.0, cloud, secure data center, enterprise, telecom, database, financial services and storage environments.

“The synergies between EZchip and Mellanox create attractive opportunities. We expect our combined technologies, and product portfolios to deliver leading end-to-end intelligent interconnect and processing solutions to data centers and wide area networks,” said Eyal Waldman, president and CEO of Mellanox Technologies. “The new and emerging Web 2.0 and cloud applications that influence our day-to-day lives depend on fast data movement and processing. Mellanox’s interconnect provides the fastest and most-scalable solution for moving data within the data center, allowing the continuous development, use and expansion of these applications. EZchip’s processing solutions allow users to process and analyze, at wire speed, data both within and outside the data center. The solutions from the combined company will enable data center customers to meet the growing demands of data-intensive applications. We expect that the acquisition of EZchip’s technologies and team will better position us to offer further capabilities for smarter interconnect and processing solutions at 100Gb/s and beyond. As our second significant acquisition in Israel, we are confident in our ability to effectively integrate the talented teams from EZchip and Mellanox. We are looking forward to work together to build a successful company.”

“Joining forces with Mellanox represents numerous synergies that create a true powerhouse for connectivity and processing. With Mellanox’s leading layer 1 – 3 connectivity solutions for data centers and EZchip’s leading layer 3 – 7 processing solutions for carrier networks, the two companies complement each other in technology, products, markets served and customers. Together, we enable a multitude of layer 1 through 7 solutions for data centers and carriers,” said Eli Fruchter, CEO of EZchip. “I want to thank our shareholders and customers for their trust in us and our outstanding employees for building a winning company, a company that started fifteen years ago with many competitors and no customers, and became a market leader with leading-edge technology and products. We are delighted to join the Mellanox team and look forward to working together to drive the combined company’s further growth.”

Mellanox and EZchip each believe that employees represent one of their most important assets. Mellanox looks forward to combining employees from both organizations. Mellanox intends to retain both companies’ existing product lines, and will ensure continuity for customers and partners of both companies.

The combined businesses currently have approximately 2,400 employees, and have generated combined revenues of $668 million for the twelve months ended June 30, 2015.

The transaction is projected to close in the first quarter of 2016, subject to the completion of certain closing conditions. Mellanox expects the transaction to be non-GAAP accretive from day one.

Under the terms of the definitive agreement, EZchip shareholders will receive $25.5 for each ordinary share of EZchip that they hold at the closing of the transaction. Mellanox intends to fund the transaction with cash on hand from the combined companies and $300 million in fully-committed debt financing. The proposed acquisition is subject to customary closing conditions, including the receipt of applicable regulatory approvals and the approval of EZchip’s shareholders.

In connection with the transaction, J.P. Morgan acted as exclusive financial adviser and provided a financing commitment to Mellanox and Herzog Fox & Neeman and Latham & Watkins LLP acted as Mellanox’s legal counsel. Barclays acted as exclusive financial adviser to EZchip and Naschitz, Brandes, Amir & Co. and Carter Ledyard & Milburn LLP acted as EZchip’s legal counsel.

Conference Call

Mellanox and EZchip will jointly conduct a conference call to discuss Mellanox’s agreement to acquire EZchip at 5:30 a.m. Pacific Time, today, September 30, 2015. To listen to the call, dial +1-785-424-1666 approximately ten minutes prior to the start time. Presentation slides along with a webcast of the live and archived call will be available on the investor relations section of the Mellanox website at http://ir.mellanox.com.

Press Conference

Mellanox and EZchip will hold a press briefing in the Mellanox Tel Aviv office, Thursday, October 1, 10:00 a.m. Israel Time. In order to listen to the briefing, please use the following registration link: https://cc.readytalk.com/r/tr97vnkpv2kx&eom. On the confirmation mail, please click “Join Meeting.” Transcripts will be available as soon as practical on the investor relations section of the Mellanox website at http://ir.mellanox.com.

About EZchip

EZchip is a fabless semiconductor company that provides high-performance processing solutions for a wide range of applications for the carrier, cloud and data center networks. EZchip’s broad portfolio of solutions scales from a few to hundreds of Gigabits-per-second, and includes network processors, multi-core processors, intelligent network adapters, high-performance appliances and a comprehensive software ecosystem. EZchip’s processing solutions excel at providing great flexibility and high performance coupled with superior integration and power efficiency.

About Mellanox

Mellanox Technologies is a leading supplier of end-to-end InfiniBand and Ethernet interconnect solutions and services for servers and storage. Mellanox interconnect solutions increase data center efficiency by providing the highest throughput and lowest latency, delivering data faster to applications and unlocking system performance capability. Mellanox offers a choice of fast interconnect products: adapters, switches, software, cables and silicon that accelerate application runtime and maximize business results for a wide range of markets including high-performance computing, enterprise data centers, Web 2.0, cloud, storage and financial services. More information is available at www.mellanox.com.

Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995

This press release contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995, including statements related to the acquisition of EZchip’s outstanding ordinary shares, the accretive non-GAAP earnings per share impact in fiscal 2016, the combined company’s technologies, product portfolios and markets, the synergies between Mellanox and EZchip, the growth of fast data movement and processing, the combined company’s capabilities for smarter interconnect and processing solutions at 100 Gb/s and beyond, the ability to effectively and efficiently integrate the team from EZchip, Mellanox’s intent to retain both companies’ existing product lines, the projected timing for closing of the acquisition and the intended source of funds for the acquisition. These forward-looking statements are based on Mellanox’s current expectations, estimates and projections about our industry and business, management’s beliefs and certain assumptions made by Mellanox, all of which are subject to change. Forward-looking statements can often be identified by words such as “projects,” “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions and variations or negatives of these words. These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement. More information about the risks, uncertainties and assumptions that may impact Mellanox, EZchip and the combined company’s business is set forth in Mellanox’s annual report on Form 10-K for the year ended December 31, 2014 filed with the Securities and Exchange Commission (SEC) on March 2, 2015 and in its quarterly report on Form 10-Q for the six months ended June 30, 2015, filed with the SEC on July 31, 2015, and in EZchip’s Annual Report on Form 20-F for the year ended December 31, 2014, filed with the Securities and Exchange Commission on March 31, 2015. Other risks, uncertainties and assumptions that could cause Mellanox, EZchip and the combined company’s actual results to differ materially from those projected may be described from time to time in reports Mellanox and EZchip file with the SEC, including reports Mellanox’s reports on Forms 10-Q and 8-K and EZchip’s reports on Form 6-K. Neither Mellanox nor EZchip undertake any obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Mellanox is a registered trademark of Mellanox Technologies, Ltd. All other trademarks are property of their respective owners.

Mellanox Press/Media Contact
McGrath/Power Public Relations and Communications
Allyson Scott, +1-408-727-0351
allysonscott@mcgrathpower.com
or
Mellanox Investor Contact
Mellanox Technologies
Gwyn Lauber, +1-408-916-0012
gwyn@mellanox.com
or
Mellanox Israel PR Contact
Gelbart Kahana Investor Relations
Sharon Levin, +972-3-6070567
sharonl@gk-biz.com
or
EZchip Investor Contact
EZchip
Jeffrey A Schreiner, +1-408-520-3676
jschreiner@ezchip.com
or
EZchip PR Contact
EZchip
Daureen Green, +972-4-959-6677
dgreen@ezchip.com

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(CLIR) Selected by Delek for Process Optimization

Company enters Texas market to support 75,000-barrel-per-day refinery operation

SEATTLE, Sept. 30, 2015  — ClearSign Combustion Corporation (NASDAQ: CLIR), an emerging leader in combustion and emissions control technology for industrial, commercial and utility markets, announced today it will install its Duplex™ technology at a Texas refinery owned by a subsidiary of Delek US Holdings, Inc. This agreement marks ClearSign’s entrance into the Texas market and the company’s fourth major refinery customer in recent months.

ClearSign will retrofit burners within a process heater at Delek’s 75,000-barrel-per-day refinery in Tyler, Texas. It is expected that ClearSign’s unique, patent-pending Duplex technology will eliminate potential flame impingement upon process tubes and reduce maintenance costs and downtime. Delek has expressed interest in retrofitting the Duplex technology into other process heaters if the initial installation proves the viability of ClearSign’s solution.

Lindale-based JLCC, Inc. will lead the contracting services for the project on behalf of ClearSign.

“The oil and gas industry has a need for practical, effective solutions that reduce impingement on process tubes which should improve utilization rates and operating conditions,” noted JLCC Founder Jerry Lang. “ClearSign’s Duplex technology offers the industry an economic, future-proof option to simultaneously remove operational bottlenecks while reducing NOx emissions.”

“We’ve gained considerable traction in recent months, and in two of the country’s leading oil and gas markets,” said Stephen Pirnat, CEO of ClearSign. “We look forward to demonstrating exceptional results in the field and further building on this momentum.”

About Delek US Holdings, Inc.

Delek US Holdings, Inc. is a diversified downstream energy company with assets in petroleum refining, logistics and convenience store retailing. The refining segment consists of refineries operated in Tyler, Texas and El Dorado, Arkansas with a combined nameplate production capacity of 155,000 barrels per day. Delek US Holdings, Inc. and its affiliates also own approximately 62 percent (including the 2 percent general partner interest) of Delek Logistics Partners, LP. Delek Logistics Partners, LP is a growth-oriented master limited partnership focused on owning and operating midstream energy infrastructure assets. The retail segment markets motor fuel and convenience merchandise through a network of approximately 360 company-operated convenience store locations operated under the MAPCO Express®, MAPCO Mart®, East Coast®, Fast Food and Fuel™, Favorite Markets®, Delta Express® and Discount Food Mart™ brand names. Delek US Holdings, Inc. also owns approximately 48 percent of the outstanding common stock of Alon USA Energy, Inc.

About ClearSign Combustion Corporation

ClearSign Combustion Corporation designs and develops technologies that aim to improve key performance characteristics of combustion systems including energy efficiency, emissions control, fuel flexibility and overall cost effectiveness. Our patent-pending Duplex™ and Electrodynamic Combustion Control™ platform technologies improve control of flame shape and heat transfer and optimize the complex chemical reactions that occur during combustion in order to minimize harmful emissions. For more information about the Company, please visit www.clearsign.com.

Cautionary note on forward-looking statements

This press release includes forward-looking information and statements within the meaning of the Private Securities Litigation Reform Act of 1995 and the provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Except for historical information contained in this release, statements in this release may constitute forward-looking statements regarding our assumptions, projections, expectations, targets, intentions or beliefs about future events that are based on management’s belief, as well as assumptions made by, and information currently available to, management. While we believe that our expectations are based upon reasonable assumptions, there can be no assurances that our goals and strategy will be realized. Numerous factors, including risks and uncertainties, may affect our actual results and may cause results to differ materially from those expressed in forward-looking statements made by us or on our behalf. Some of these factors include the acceptance of existing and future products, the impact of competitive products and pricing, general business and economic conditions, and other factors detailed in our Quarterly Report on Form 10-Q and other periodic reports filed with the SEC. We specifically disclaim any obligation to update or revise any forward-looking statement whether as a result of new information, future developments or otherwise.

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(CXRX) Completes $520 Million Public Offering

OAKVILLE, ON, Sept. 30, 2015  – Concordia Healthcare Corp. (“Concordia” or the “Company”) (NASDAQ: CXRX) (TSX: CXR) today announced that, further to its September 24, 2015 press release, it has completed its underwritten public offering (the “Offering”) of 8,000,000 common shares of Concordia for aggregate gross proceeds of US$520 million.

The Offering was completed at a price per share of US$65.00 (the “Offering Price”) by a syndicate of underwriters led by Goldman, Sachs & Co. and RBC Capital Markets, as lead book running managers, and Credit Suisse Securities (USA) LLC and Jefferies LLC, as additional book running managers, together with the Canadian affiliates of certain of the book running managers (the “Underwriters”). The Company also has granted the Underwriters an option to purchase up to an additional 1,200,000 common shares of Concordia at the Offering Price, exercisable at any time, and from time to time, in whole or in part, up to 30 days after and including the closing date of the Offering.

The Company intends to use the net proceeds of the Offering to fund in part the purchase price and costs related to the acquisition of Amdipharm Mercury Limited (“AMCo”), which the Company expects to close during the fourth quarter of 2015. The Company expects to finance the balance of the purchase price through a combination of term loans and a private placement of non-convertible debt securities, and has committed financing from certain of the Underwriters to pay for the purchase price of AMCo, to refinance all outstanding term loans or indebtedness for borrowed money of AMCo, and to repay certain existing debt of Concordia.

As previously announced, the Company entered into an agreement to acquire London-based AMCo earlier this month. The purchase price for the acquisition will consist of cash consideration of approximately £800 million (approximately US$1.2 billion), a fixed amount of 8.49 million common shares of the Company, and the repayment of AMCo’s existing debt of approximately US$1.4 billion (senior secured facilities of £581 million and €440 million), plus accrued interest and related cross-currency swaps. In addition, Concordia will pay £272,801 (approximately US$414,000), and a maximum cash earn-out of £144 million (approximately US$220 million) based on AMCo’s future gross profit over a period of 12 months from October 1, 2015.

No securities regulatory authority has either approved or disapproved the contents of this press release. This press release does not constitute an offer to sell or a solicitation of an offer to buy any securities of the Company in any jurisdiction in which such offer, solicitation or sale would be unlawful.

About Concordia

Concordia is a diverse healthcare company focused on legacy pharmaceutical products and orphan drugs. Concordia’s legacy pharmaceutical division, Concordia Pharmaceuticals Inc., consists of a portfolio of branded products and authorized generic contracts, including branded products such as Nilandron®, for the treatment of metastatic prostate cancer; Dibenzyline®, for the treatment of pheochromocytoma; Lanoxin®, for the treatment of mild-to-moderate heart failure and atrial fibrillation; Plaquenil®, for the treatment of lupus and rheumatoid arthritis, Donnatal® for the treatment of irritable bowel syndrome and Zonegran® (zonisamide) for treatment of partial seizures in adults with epilepsy. Concordia’s orphan drugs division owns Photofrin®. Photofrin® is marketed by Pinnacle Biologics, Inc. in the United States.

Concordia operates out of facilities in Oakville, Ontario; Bridgetown, Barbados; Roanoke, Virginia and has a specialty healthcare distribution (SHD) division that operates out of Kansas City, Missouri. Pinnacle Biologics, Inc. is located in Chicago, Illinois.

Notice regarding forward-looking statements:

This news release includes forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and forward-looking information within the meaning of Canadian securities laws, regarding Concordia and its business, which may include, but are not limited to the exercise of the Underwriters’ Option, the use of proceeds of the Offering, the completion of the term loans and the private placement of notes and the completion of the acquisition of AMCo. Often, but not always, forward-looking statements can be identified by the use of words such as “plans”, “expects”, “scheduled”, “intends”, “contemplates”, “anticipates”, “believes”, “proposes” or variations (including negative and grammatical variations) of such words and phrases, or state that certain actions, events or results “may”, “could”, “would”, “might” or “will” be taken, occur or be achieved. Such statements are based on the current expectations of Concordia’s management, and are based on assumptions and subject to risks and uncertainties. Although Concordia’s management believes that the assumptions underlying these statements are reasonable, they may prove to be incorrect. The forward-looking events and circumstances discussed in this news release may not occur by certain dates or at all and could differ materially as a result of known and unknown risk factors and uncertainties affecting Concordia, including risks relating to Concordia’s securities, the Acquisition, the pharmaceutical industry and the regulation thereof, economic factors, the equity and debt markets generally, general economic and stock market conditions and many other factors beyond the control of Concordia. Although Concordia has attempted to identify important factors that could cause actual actions, events or results to differ materially from those described in forward-looking statements, there may be other factors that cause actions, events or results to differ from those anticipated, estimated or intended. No forward-looking statement can be guaranteed. Except as required by applicable securities laws, forward-looking statements speak only as of the date on which they are made and Concordia undertakes no obligation to publicly update or revise any forward-looking statement, whether as a result of new information, future events, or otherwise.

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(MDWD) Awarded BARDA Contract Valued Up to $112 Million

Contract Highlights Product’s Merit and Therapeutic Impact, as well as Potential Role in Mass Casualty Preparedness

YAVNE, Israel, Sept. 30, 2015  — MediWound Ltd. (Nasdaq:MDWD), a fully integrated biopharmaceutical company specializing in innovative therapies to address unmet needs in severe burn and wound management, announces that the U.S. Biomedical Advanced Research and Development Authority (BARDA) has awarded the Company a contract valued at up to $112 million. The contract is for the advancement of the development and manufacturing, as well as the procurement of NexoBrid®, the Company’s proprietary pharmaceutical product for enzymatic removal of eschar in adults with deep-partial and full-thickness thermal burns, as a medical countermeasure as part of BARDA preparedness for mass casualty events.

The five-year base contract includes $24 million of funding to support development activities to complete the U.S. Food and Drug Administration (FDA) approval process for NexoBrid for use in thermal burn injuries, as well as $16 million for procurement of NexoBrid, which is contingent upon FDA Emergency Use Authorization (EUA) and/or FDA marketing authorization for NexoBrid. In addition, the contract includes options for further funding of up to $22 million for expanding NexoBrid’s indications and of up to $50 million for additional procurement of NexoBrid.

“BARDA’s commitment underscores the important role NexoBrid might play in preparing for mass casualty events where subsequent surgical capacity is limited and rapid severity assessment and intervention are imperative,” stated Gal Cohen, President and Chief Executive Officer of MediWound. “This non-dilutive funding provides important recognition of the potential merits of NexoBrid and the therapeutic impact of our technology, as well as provides significant support for our ongoing clinical development and manufacturing programs. This contract frees up a portion of the Company’s proceeds raised during the IPO, which were initially intended for use in clinical development of NexoBrid and now can be used to further advance our pipeline.  We are very happy to join forces with the U.S. government in support of its preparedness programs for mass casualty events. We look forward to working with BARDA to have NexoBrid available for burn patients in the U.S.”

The challenges of providing definitive burn care are heightened when delivering treatment after a mass casualty event in a resource-strained environment. The Government Accountability Office reports that in a mass casualty event, more than 10,000 patients might require thermal burn care, which will create bottlenecks in the ability to provide quality treatment and care for victims. Effective and rapid non-surgical debridement would increase treatment capacity to provide definitive wound healing to burn injuries. The use of non-surgical means that are capable of providing fast debridement without harming healthy tissues, particularly during public health emergencies, could potentially reduce the time, labor and resource burdens associated with the current standard-of-care, thereby enabling the treatment of more patients.

NexoBrid represents a new paradigm in burn care management having demonstrated in clinical studies, with statistical significance, its ability to non-surgically and rapidly remove in a single, four-hour application the dead or the damaged tissue (eschar) earlier than other modalities, without harming viable tissue. In clinical studies NexoBrid has demonstrated a significant reduction in surgical burden with long-term outcomes that are comparable to the current surgical treatment. NexoBrid was granted marketing authorization from the European Medicines Agency and the Israeli Ministry of Health for the removal of eschar in adults with deep partial and full-thickness thermal burns, and has been launched in Europe and Israel. MediWound is currently conducting a Phase 3 clinical study with NexoBrid in the U.S. for the removal of eschar in adults with deep-partial and full-thickness thermal burns.

“In addition to the U.S. government’s interest in NexoBrid in preparing for burn mass casualty events, last fall the Disaster Committee of the International Society for Burn Injuries (ISBI) recommended inclusion of NexoBrid in their draft plan for mass casualty events, as they too see a role for NexoBrid in providing relief in the expected bottleneck in hospitals after such disasters. We look forward to working with various international agencies and with governments to advance the use of NexoBrid for mass casualty and disaster preparedness, as well as in military medicine,” added Mr. Cohen.

About BARDA

The Biomedical Advanced Research and Development Authority (BARDA), within the Office of the Assistant Secretary for Preparedness and Response in the U.S. Department of Health and Human Services, provides an integrated, systematic approach to the development and purchase of the necessary vaccines, drugs, therapies and diagnostic tools for public health medical emergencies.

About Emergency Use Authorization (EUA)

The Emergency Use Authorization (EUA) allows FDA to help strengthen the U.S. public health protections against chemical, biological, radiological, and nuclear (CBRN) threats by facilitating the availability and use of medical countermeasures needed during public health emergencies. Under the Federal Food, Drug, and Cosmetic Act, the FDA Commissioner may allow unapproved medical products or unapproved uses of approved medical products to be used in an emergency to diagnose, treat, or prevent serious or life-threatening diseases or conditions caused by CBRN threat agents when there are no adequate, approved, and available alternatives.

About MediWound Ltd.

MediWound is a fully integrated biopharmaceutical company focused on developing, manufacturing and commercializing novel therapeutics based on its patented proteolytic enzyme technology to address unmet needs in the fields of severe burns, as well as chronic and other hard-to-heal wounds. MediWound’s first innovative biopharmaceutical product, NexoBrid, received marketing authorization from the European Medicines Agency and from the Israeli Ministry of Health for removal of dead or damaged tissue, known as eschar, in adults with deep partial- and full-thickness thermal burns. NexoBrid represents a new paradigm in burn care management, and clinical trials have demonstrated, with statistical significance, its ability to non-surgically and rapidly remove the eschar earlier and, without harming viable tissues. For more information, please visit www.mediwound.com.

Cautionary Note Regarding Forward-Looking Statements

This release includes forward-looking statements within the meaning of Section 27A of the U.S. Securities Act of 1933, as amended, Section 21E of the US Securities Exchange Act of 1934, as amended, and the safe harbor provisions of the U.S. Private Securities Litigation Reform Act of 1995. Forward-looking statements are statements that are not historical facts, such as statements regarding assumptions and results related to financial results forecast, commercial results, clinical trials and the regulatory authorizations. In some cases, you can identify forward-looking statements by terminology such as “believe,” “may,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “predict,” “potential,” or the negative of these terms or other similar expressions. Forward-looking statements are based on MediWound’s current knowledge and its present beliefs and expectations regarding possible future events and are subject to risks, uncertainties and assumptions. Actual results and the timing of events could differ materially from those anticipated in these forward-looking statements as a result of several factors including, but not limited to, unexpected results of clinical trials, delays or denial in the FDA or the EMA regulatory approval process, or additional competition in the market. In particular, you should consider the risks discussed under the heading “Risk Factors” in our annual report on Form 20-F for the year ended December 31, 2014 and information contained in other documents filed with or furnished to the Securities and Exchange Commission. You should not rely upon forward-looking statements as predictions of future events. Although we believe that the expectations reflected in the forward-looking statements are reasonable, we cannot guarantee that future results, levels of activity, performance and events and circumstances reflected in the forward-looking statements will be achieved or will occur. The forward-looking statements made herein speak only as of the date of this announcement and MediWound undertakes no obligation to update publicly such forward-looking statements to reflect subsequent events or circumstances, except as otherwise required by law.

Contacts: Anne Marie Fields
Sharon Malka Senior Vice President
Chief Financial & Operation Officer LHA
MediWound Ltd. 212-838-3777
ir@mediwound.co.il afields@lhai.com
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(BLPH) Announces Clinical Trial Functional Respiratory Imaging Data

HAMPTON, N.J., Sept. 30, 2015  — Bellerophon Therapeutics, Inc. (Nasdaq:BLPH), a clinical-stage biotherapeutics company, announced that an oral presentation of late-breaking data from a clinical trial sponsored by the Company was presented today at the European Respiratory Society (ERS) International Congress 2015 in Amsterdam. The data showed that INOpulse®, an inhaled treatment of nitric oxide entering phase 3 testing for the treatment of pulmonary arterial hypertension, improved vasodilation in patients with pulmonary hypertension associated with chronic obstructive pulmonary disease (COPD). The abstract titled “Pulmonary vascular effects after pulsed inhaled NO evaluated by functional respiratory imaging (FRI)” was presented by W. De Backer, M.D., Director Department of Pulmonary Medicine, University Hospital and University of Antwerp. The presentation was in the session: “Pulmonary hypertension: new treatment insights” chaired by Professor Marc Humbert and Professor H. Areschir Ghofrani. The abstract presentation may be viewed at www.bellerophon.com, under the Investors Tab.

In the trial, 6 subjects (3 male and 3 female between the ages of 65-79) with pulmonary hypertension associated with COPD on long-term oxygen therapy were given an acute dose of INOpulse inhaled nitric oxide. Following treatment, the subjects underwent functional respiratory imaging to determine the geometry of their lungs, airway and pulmonary vascular structures.

In all of the subjects, administration of inhaled nitric oxide resulted in increased blood volume in the blood vessels in the lungs while also preserving oxygen saturation following treatment. Anecdotally, all patients in the trial reported having felt better following the treatment.

Jonathan Peacock, Chairman and Chief Executive Officer of Bellerophon Therapeutics, stated, “We continue to be encouraged by the progress we are making in the development of INOpulse as a potential treatment for pulmonary hypertension. This late-breaker session at the ERS Congress builds on earlier studies indicating that INOpulse has the potential to reduce pulmonary hypertension in COPD patients. In the next several months, we plan to test the effect of reducing pulmonary hypertension on exercise capacity for these patients.”

About Pulmonary Hypertension

Pulmonary hypertension is a rare lung disorder in which the arteries that carry blood from the heart to the lungs become narrowed, making it difficult for blood to flow through the vessels. As a result, the blood pressure in these arteries — called pulmonary arteries — rises far above normal levels. This abnormally high pressure strains the right ventricle of the heart, causing it to expand in size. Overworked and enlarged, the right ventricle gradually becomes weaker and loses its ability to pump enough blood to the lungs. This could lead to the development of right heart failure.

About Bellerophon

Bellerophon Therapeutics is a clinical-stage biotherapeutics company focused on developing innovative therapies at the intersection of drugs and devices that address significant unmet medical needs in the treatment of cardiopulmonary and cardiac diseases. The Company is currently developing two product candidates under its INOpulse® program, a proprietary pulsatile nitric oxide delivery device. The first is for the treatment of pulmonary arterial hypertension (PAH), for which the Company intends to commence Phase 3 clinical trials in 2015, and the other for the treatment of pulmonary hypertension associated with chronic obstructive pulmonary disease (PH-COPD), which is in Phase 2 development. The Company’s plans also call for the completion of further work on the use of INOpulse to treat pulmonary hypertension associated with COPD and idiopathic pulmonary fibrosis during 2016. Additionally, management is reviewing alternative paths forward for its Bioabsorbable Cardiac Matrix program. For more information, please visit www.bellerophon.com.

Forward-looking Statements

Any statements in this press release about Bellerophon’s future expectations, plans and prospects, including statements about the clinical development of its product candidates and other statements containing the words “anticipate,” “believe,” “continue,” “could,” “estimate,” “expect,” “intend,” “may,” “plan,” “potential,” “predict,” “project,” “should,” “target,” “would,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors, including: the uncertainties inherent in the initiation of future clinical trials, availability and timing of data from ongoing and future clinical trials and the results of such trials, whether preliminary or interim results from a clinical trial will be predictive of the final results of that trial or whether results of early clinical trials will be indicative of the results of later clinical trials, and other factors discussed in the “Risk Factors” section of the Company’s most recent filings with the Securities and Exchange Commission. In addition, any forward-looking statements included in this press release represent Bellerophon’s views only as of the date of this release and should not be relied upon as representing the Company’s views as of any subsequent date. The Company specifically disclaims any obligation to update any forward-looking statements included in this press release.

CONTACT: At Bellerophon:
         Amy Edmonds, Vice President
         Head of Clinical Operations &
         Administration
         (908) 574-4765

         At Rx Communications Group:
         Melody Carey
         (917) 322-2571
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(ISCO) Develops Technology to Replace Cartilage

CARLSBAD, CA–(September 30, 2015) – International Stem Cell Corporation (OTCQB: ISCO)(www.internationalstemcell.com, ISCO or the Company), a California-based biotechnology company developing novel stem cell-based therapies, today announced that the Company’s scientific team has developed a robust innovative technology to generate functional articular cartilage from the patient’s own skin or adipose tissue to treat osteoarthritis. This breakthrough technology may allow ISCO to not only address the therapeutic needs of patients suffering from osteoarthritic knee joints, but to also treat those with shoulder joints and intervertebral spinal disk osteoarthritis.

“While we are working on obtaining regulatory approval for the Parkinson’s disease treatment in Australia, as well as in the US, we are also pursuing a number of other therapeutic indications including osteoarthritis, which can potentially be treated with the patient’s own cells,” commented ISCO’s chief scientific officer, Ruslan Semechkin, PhD.

Despite the high prevalence of osteoarthritis, currently there is a lack of an effective treatment for this disease. ISCO developed and successfully tested a scalable system that permits the generation of functional human cartilage tissue with superior mechanical properties and, more importantly, the capacity to provide greater stability than other tissue that is currently available for the treatment of osteoarthritis.

Osteoarthritis is a degenerative joint disease characterized by progressive erosion of the articular cartilage. Although osteoarthritis can damage any joint in the body, the disorder most commonly affects joints in the hands, knees, hips and spine. The erosion of articular cartilage leads to joint pain, stiffness, and impaired mobility. According to the Arthritis foundation osteoarthritis affects over 27 million Americans with an estimated medical costs of as much as $65 billion.

About International Stem Cell Corporation

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

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Safe harbor statement

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

Contact

International Stem Cell Corporation
Ruslan Semechkin, PhD
Phone: 760-940-6383
Email: ir@intlstemcell.com

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

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

Wednesday, September 30th, 2015 Uncategorized Comments Off on (ISCO) Develops Technology to Replace Cartilage

(APPS) Announces Pricing of Public Offering of Common Stock

AUSTIN, Texas, Sept. 29, 2015  — Digital Turbine, Inc. (Nasdaq: APPS), the company empowering mobile operators and Original Equipment Manufacturers (“OEMs”) around the globe with end-to-end mobile solutions, today announced the pricing of its public offering of 7,600,000 shares of common stock at a price to the public of $1.57 per share.

The net proceeds to Digital Turbine from this offering are expected to be approximately $11.2 million, after deducting underwriting discounts. In addition, Digital Turbine has also granted the underwriter a 30-day option to purchase up to 1,140,000 additional shares of common stock.

The Company expects to use the net proceeds from the offering for organic business opportunities, product development, general corporate purposes, working capital and capital expenditures.

B. Riley & Co., LLC is acting as the underwriter for the offering. The offering is expected to close on or about October 2, 2015, subject to customary closing conditions.

The public offering will be made pursuant to a shelf registration statement on Form S-3 filed with the Securities Exchange Commission (“SEC”). A prospectus supplement and accompanying base prospectus relating to and describing the terms of the offering will be filed with the SEC and when filed will be available on the SEC’s website located at http://www.sec.gov. The offering is being made only by means of a prospectus and related prospectus supplement, copies of which may be obtained from B. Riley & Co., LLC, 11100 Santa Monica Blvd., Suite 800, Los Angeles, California 90025.

This press release shall not constitute an offer to sell or a solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any state or other jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such state or other jurisdiction.

About Digital Turbine
Digital Turbine works at the convergence of media and mobile communications, delivering end-to-end products and solutions for mobile operators, app advertisers, device OEMs and other third parties to enable them to effectively monetize mobile content and acquire higher value users. The company’s products include DT Ignite™, a mobile device management solution with targeted app distribution capabilities, DT IQ™, a customized user experience and app discovery tool, DT Marketplace™, an application and content store, and DT Pay™, a content management and mobile payment solution. Offerings also include DT Media, an advertiser solution for unique and exclusive carrier inventory, and Appia, a leading worldwide mobile user acquisition network. Digital Turbine has delivered more than 100 million app installs for hundreds of advertisers. In addition, more than 31 million customers use Digital Turbine’s solutions each month across more than 20 global operators. The company is headquartered in Austin, Texas with global offices in Durham, Berlin, Singapore, Sydney and Tel Aviv.

Forward-Looking Statements
This news release includes “forward-looking statements” within the meaning of the U.S. federal securities laws. Statements in this news release that are not statements of historical fact, including but not limited to statements regarding the proposed public offering, the anticipated closing date and use of proceeds of the offering and any other statement that may be construed as a prediction of future performance or events, speak only as of the date made and involve known and unknown risks, uncertainties and other factors which may, should one or more of these risks uncertainties or other factors materialize, cause actual results to differ materially from those expressed or implied by such statements. Such risks and uncertainties include, among others, the risks identified in Digital Turbine’s filings with the SEC, including its most recent Form 10-K and Form 10-Q filings, the preliminary prospectus supplement related to the proposed public offering and subsequent filings with the SEC. You should not place undue reliance on these forward-looking statements. The company does not undertake to update forward-looking statements, whether as a result of new information, future events or otherwise, except as required by law.

For more information, contact:
Carolyn Capaccio/Sanjay M. Hurry
LHA
(212) 838-3777
digitalturbine@lhai.com

Tuesday, September 29th, 2015 Uncategorized Comments Off on (APPS) Announces Pricing of Public Offering of Common Stock

(XENT) FDA Submission to Seek Expanded Indication of PROPEL

Intersect ENT, Inc. (Nasdaq:XENT), a company dedicated to improving the quality of life for patients with ear, nose and throat conditions, today announced that the company has submitted a supplemental premarket approval (PMA-s) submission to the U.S. Food and Drug Administration (FDA) to seek approval to expand the indication of the PROPEL® mini steroid releasing sinus implant to the treatment of patients undergoing frontal sinus surgery.

An expanded indication would allow Intersect ENT to market placement of PROPEL mini in the frontal sinuses, which are located behind the eyebrows. PROPEL mini is currently indicated for placement in the ethmoid sinuses, located just behind the bridge of the nose.

At least one in four of the over 500,000 patients undergoing surgery for chronic sinusitis suffers from frontal sinus disease. The condition contributes greatly to the debilitating symptoms of chronic sinusitis, including severe headaches, and is known to be the most difficult sinus to manage.

“This is an exciting milestone for Intersect ENT,” said Lisa Earnhardt, president and CEO, Intersect ENT. “More than 75,000 patients have benefitted from PROPEL to date and we look forward to broadening access to sustained local steroid delivery to more patients suffering from chronic sinusitis.”

Last month, Intersect ENT announced preliminary results of PROGRESS, a prospective, randomized, blinded, multi-center trial to assess the safety and efficacy of PROPEL mini when used following frontal sinus surgery. The study met its primary efficacy endpoint, demonstrating a statistically significant 38% relative reduction in the need for post-operative interventions, such as the need for additional surgical procedures or need for oral steroid prescription, compared to surgery alone. The device placement success rate was 100% and there were no device-related adverse events.

About Intersect ENT

Intersect ENT, Inc. is dedicated to improving the quality of life for patients with ear, nose and throat conditions. The company markets two steroid releasing implants, PROPEL and PROPEL mini, clinically proven to improve surgical outcomes for patients with chronic sinusitis undergoing ethmoid sinus surgery. In addition, Intersect ENT is developing new steroid releasing implants designed to provide ENT physicians with even more customized options to treat patients with chronic sinusitis less invasively and more cost effectively. Chronic sinusitis is an inflammatory condition leading to debilitating symptoms and chronic infections, and is one of the most costly conditions to U.S. employers.

For additional information on the company or the products including risks and benefits please visit www.intersectENT.com.

Forward-Looking Statements

The statements in this press release regarding the potential expanded indication for PROPEL® mini and the ability for Intersect ENT to broaden access to its products by patients with chronic sinusitis are “forward-looking” statements. These forward-looking statements are based on Intersect ENT’s current expectations and inherently involve significant risks and uncertainties. These statements include those related to the review of data by and timing for approval by the FDA as well as the rate of patient adoption for Intersect ENT’s products, if approved. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of risks and uncertainties, which include, without limitation, the performance of PROPEL and PROPEL mini, the development of competitive products, the uncertain timing of completion of and the success of clinical trials and market competition. Additional factors that could cause results to differ materially from those described in the forward-looking statements can be found in Intersect ENT’s filings on Form 10-K, Form 10-Q and the company’s other filings with the Securities and Exchange Commission (SEC) available at the SEC’s Internet site (www.sec.gov). Intersect ENT does not undertake any obligation to update forward-looking statements and expressly disclaims any obligation or undertaking to release publicly any updates or revisions to any forward-looking statements contained herein.

XENT-G

 

for Intersect ENT, Inc.
Media Contact:
Nicole Osmer, 650-454-0504
nicole@nicoleosmer.com
Investor Contact:
Jeri Hilleman, 650-641-2105
ir@intersectent.com

Tuesday, September 29th, 2015 Uncategorized Comments Off on (XENT) FDA Submission to Seek Expanded Indication of PROPEL

(WGBS) to Commence Commercial Launch of ICELL8 Single-Cell System at ASHG 2015

System Isolates More Than 10,000 Single Cells Per Day and Automatically Selects Cells to Process

FREMONT, Calif., Sept. 29, 2015  — WaferGen Bio-systems (Nasdaq:WGBS) announced that the Company will commence the commercial launch of the ICELL8™ Single-Cell System at the American Society of Human Genetics (ASHG) Annual Meeting taking place October 6-8, 2015, in Baltimore, MD. The system will create a new standard for single-cell analysis, enabling unbiased isolation of up to 1,800 single cells on a single chip. The system includes an imaging station for rapid image capture and CellSelect™ software for automatic selection of cells of interest for further processing for RNA sequencing. The system also allows researchers to run multiple samples on a single chip, enabling applications that require investigation under uniform conditions.

“We are pleased that the ICELL8 Single-Cell System will now be available to deliver what the single-cell research community has requested: greater cell isolation capabilities, control over the selection of isolated cells and the ability to run multi-sample experiments,” said Rollie Carlson, CEO of WaferGen.

The ICELL8 Single-Cell System provides the following:

  • Power – Poisson distribution for isolation of up-to 1,800 single-cells on a single chip using multi-sample nano-liter dispense technology that accommodates cell sizes from 5-100um in a single sample. The rapid and simple cell isolation and imaging protocol ensures that multiple chips can be processed in a single 8-hour day.
  • Control – CellSelect software allows for complete user-guided selection, as well as automatic determination of wells having individual cells to select for down-stream applications.
  • Insight – By enabling the analysis of up-to 8 samples on a single chip, complex experimental designs can now be accomplished in single-cell research.

“In order to conduct as thorough an evaluation of the ICELL8 Single-Cell System as possible, we sought both world-class early access collaborators who were experienced single cell researchers, as well as those just embarking on this exciting new frontier. We invited these researchers to test the system using challenging cell types, including cells directly from human subjects, and we were quite pleased to see the robust performance of the system under these conditions,” said Dr. Maithreyan Srinivasan, WaferGen’s Chief Technology Officer.

Extensive results with early access partners and in-house WaferGen research and development initiatives presented at the Single Cell Genomics 2015 conference demonstrated the system’s performance and utility, successfully processing various cell types, including live single neurons, human tumor cells, mouse tumor cells and nuclei. Further, the system has been shown to detect rare cell types with minimal sequencing costs, allowing researchers to more accurately interrogate complex samples to find the genomic information critical to their research. The ICELL8 Single-Cell System is the first single-cell analysis system to offer the scale of isolation, the control of cell selection and the openness of study design to truly expand single-cell analysis.

Order information will be available at the ASHG conference.

About WaferGen

WaferGen Bio-systems, Inc. is a biotechnology company that offers innovative genomic technology solutions for single-cell analysis and clinical research. The single cell analysis platform is a revolutionary system which can isolate thousands of single cells and processes specific cells for analysis, including Next Generation Sequencing. The system can also enable processing of up to eight samples by partitioning the chip into 8 sections. The SmartChip platform can be used for profiling and validating molecular biomarkers, and can perform massively-parallel single-plex PCR for one-step target enrichment and library preparation for clinical NGS. These technologies offer a powerful set of tools for biological analysis at the molecular and single-cell level in the life sciences, pharmaceutical, and clinical laboratory industries.

Forward Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended that are intended to be covered by the “safe harbor” created by those sections. Forward-looking statements, which are based on certain assumptions and describe our future plans, strategies and expectations, can generally be identified by the use of forward-looking terms such as “believe,” “expect,” “may,” “will,” “should,” “could,” “seek,” “intend,” “plan,” “estimate,” “anticipate” or other comparable terms. Forward-looking statements in this press release may address the following subjects among others: statements regarding the sufficiency of our capital resources, expected operating losses, expected revenues, expected expenses, expected cash usage, our expectations regarding our development of future products including single cell analysis technologies and our expectations concerning our competitive position and business strategy. Forward-looking statements involve inherent risks and uncertainties which could cause actual results to differ materially from those in the forward-looking statements, as a result of various factors including those risks and uncertainties described in the Risk Factors and in Management’s Discussion and Analysis of Financial Condition and Results of Operations sections of our most recently filed Annual Report on Form 10-K and any subsequently filed Quarterly Reports on Form 10-Q. We urge you to consider those risks and uncertainties in evaluating our forward-looking statements. We caution readers not to place undue reliance upon any such forward-looking statements, which speak only as of the date made. Except as otherwise required by the federal securities laws, we disclaim any obligation or undertaking to publicly release any updates or revisions to any forward-looking statement contained herein (or elsewhere) to reflect any change in our expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based.

CONTACT: INVESTOR CONTACTS:
         LifeSci Advisors, LLC
         Brian Ritchie
         BRitchie@LifeSciAdvisors.com

         WaferGen Bio-systems, Inc.
         Rollie Carlson
         Rollie.Carlson@wafergen.com
Tuesday, September 29th, 2015 Uncategorized Comments Off on (WGBS) to Commence Commercial Launch of ICELL8 Single-Cell System at ASHG 2015

(ACLS) Multiple Orders For ‘Purion M’ Implanter

Company Reiterates Q3 Guidance and Remains Confident That Axcelis Will Exit 2015 With 17-20% Market Share

BEVERLY, Mass., Sept. 29, 2015  — Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry,  announced today that it has received orders for the Company’s Purion M™ medium current implanter from three leading specialty device chipmakers. The systems, ranging in wafer sizes from 150-300mm, will be used in high volume production of image sensors, power devices and specialty logic chips supporting automotive, mobile and the Internet of Things market spaces. The first system has shipped, with revenue expected in the fourth quarter.  The other tools will ship in the second half of 2016, upon completion of a R&D program funded by two customers.

“These wins highlight the advantages the Purion M provides for specialty device manufacturing, especially in the areas of energetic metals contamination control and advanced process control,” said Bill Bintz, executive vice president, engineering and marketing. “The Purion M’s innovative hybrid filtering technique is the only technology available today specifically designed to utilize both magnetic and electrostatic filtration to enable unmatched metals filtration, subsequently delivering significantly higher device yield for our customers.” He continued, “New investments in R&D for advanced process control technologies, specifically designed to address emerging device types and substrates, will enable fabrication of these structures at the highest levels of productivity and yield.”

John Aldeborgh, executive vice president, customer operations, commented, “We’re excited about the adoption of the Purion M in the very active specialty device market. Our customers in this space have seen a strong resurgence in business, and they are actively upgrading for technology and productivity reasons. This market has accounted for nearly half of our sales in 2015, and we look forward to expanding our footprint with the full Purion Platform, including the Purion M, Purion H, and Purion XE.”

President and CEO Mary Puma said, “We reiterate Q3 guidance and remain confident that Axcelis will exit 2015 with 17-20% market share of the implant market. We also expect continued market share growth in 2016 as the Purion product family enters volume production at additional memory and non-leading edge logic and foundry fabs.”

Safe Harbor Statement
This press release contains forward-looking statements under the SEC safe harbor provisions. These statements, which include our guidance for future financial performance and market share, are based on management’s current expectations and should be viewed with caution. They are subject to various risks and uncertainties, many of which are outside the control of the Company, including the timing of orders and shipments, the conversion of orders to revenue in any particular quarter, or at all, the continuing demand for semiconductor equipment, relative market growth, continuity of business relationships with and purchases by major customers, competitive pressure on sales and pricing, increases in material and other production costs that cannot be recouped in product pricing and global economic, political and financial conditions. These risks and other risk factors relating to Axcelis are described more fully in the most recent Form 10-K filed by Axcelis and in other documents filed from time to time with the Securities and Exchange Commission.

About Axcelis:
Axcelis (Nasdaq: ACLS), headquartered in Beverly, Mass., has been providing innovative, high-productivity solutions for the semiconductor industry for over 35 years. Axcelis is dedicated to developing enabling process applications through the design, manufacture and complete life cycle support of ion implantation systems, one of the most critical and enabling steps in the IC manufacturing process. Learn more about Axcelis at www.axcelis.com.

CONTACTS:

Maureen Hart (editorial/media) 978.787.4266
Doug Lawson (investor relations) 978.787.9552

Tuesday, September 29th, 2015 Uncategorized Comments Off on (ACLS) Multiple Orders For ‘Purion M’ Implanter

(CERE) Licenses Bioinformatics Technology to KWS

– Crop development group to evaluate Persephone for its global product segments

THOUSAND OAKS, Calif., Sept. 29, 2015  — Ceres, Inc. (NASDAQ: CERE), an agricultural biotechnology company, today announced that KWS SAAT SE, a global seed developer with operations in over 70 counties, will evaluate Ceres’ Persephone bioinformatics technology under a license agreement.

Originally developed for in-house use by Ceres, the Persephone system allows researchers to organize, store, access and explore a diverse array of DNA-related information in much the same way online mapping programs allow users to explore geographic regions and locations.

“We look forward to working with researchers at KWS to demonstrate how Persephone can help deliver complex genomic information directly to its diverse product development groups,” said Tim Swaller, Ceres Vice President of Genomic Technologies.

Swaller noted that next generation sequencing technologies have substantially increased the amount and complexity of information generated in crop research and development. Despite the power of this information, it is often difficult to access and fully utilize throughout a research organization. “Persephone’s capabilities and user experience is designed to allow more eyes on information that is often inaccessible today,” said Swaller.

KWS, which develops, produces and markets seed for corn, sugarbeet, cereals, potatoes, canola and sunflower, has more than 1,000 employees involved in research, including large-scale genomic research programs across its major products lines.

Dr. Andreas Menze, Head of Bioinformatics at KWS, noted that the company’s high-throughput bioinformatics platform generates continuously increasing volumes of data which must be made available for its research teams. “We plan to evaluate how Persephone can help disseminate data for the widest audience within KWS for discussion and discovery. We believe that broad accessibility to data will be a key driver of long-term novel discovery,” said Dr. Menze.

In addition to crop research, Ceres markets Persephone to companies and institutions in the human and biomedical fields, where DNA-related information is analyzed and used in a similar manner to plants. The Persephone platform can be installed either within a customer’s own IT infrastructure or in the cloud using Amazon Web Services. Ceres also offers a demo software version utilizing Amazon’s infrastructure.

About Persephone
Persephone is a genome visualization platform marketed by Ceres, Inc. The technology platform allows researchers to store, access and explore DNA databases in much the same way online mapping programs allow users to explore geographic regions and places. Driven by dramatically lower costs, DNA sequencing is one of the most commonly used technologies in biological and medical research laboratories. Persephone has been designed to more fully utilize what has become an overload of data by enabling the rapid and easy visualization of large amounts of genomics data by experts and non-experts alike. The software features a number of optimizations to quickly fetch and render very large datasets. Persephone can display diverse datasets such as genetic maps, genomic sequences, gene models, synteny, QTLs, SNPs, RNA-Seq, and gene expression, among others. Persephone is a trademark of Ceres, Inc.

About Ceres
Ceres, Inc. is an agricultural biotechnology company that develops and markets seeds and traits to produce crops for animal feed, sugar and other markets. The company’s advanced plant breeding and biotechnology technology platforms, which can increase crop productivity, improve quality, reduce crop inputs and improve cultivation on marginal land, have broad application across multiple crops, including food, feed, fiber and fuel crops. Ceres markets its seed products under its Blade brand.

Ceres Forward-Looking Statements
This press release may contain forward-looking statements. All statements, other than statements of historical facts, including statements regarding Ceres’ efforts to develop and commercialize its products and technologies, anticipated yields and product performance, status of crop plantings, short-term and long-term business strategies, market and industry expectations, future operating metrics, and future results of operations and financial position, including anticipated cost savings from the company’s restructuring plan and projected cash expenditures, are forward-looking statements. You should not place undue reliance on these forward-looking statements because they involve known and unknown risks, uncertainties and other factors that are, in some cases, beyond Ceres’ control. Factors that could materially affect actual results can be found in Ceres’ filings with the U.S. Securities and Exchange Commission. Ceres undertakes no obligation to update publicly, except to the extent required by law, any forward-looking statements for any reason after the date the company issues this press release to conform these statements to actual results or to changes in the company’s expectations.

Tuesday, September 29th, 2015 Uncategorized Comments Off on (CERE) Licenses Bioinformatics Technology to KWS

(OPXA) Announces Reverse Stock Split

Opexa Therapeutics, Inc. (NASDAQ: OPXA), a biopharmaceutical company developing personalized immunotherapies for autoimmune disorders including multiple sclerosis (MS) and neuromyelitis optica (NMO), today announced that its Board of Directors approved a 1-for-8 reverse stock split of its common stock which will become effective immediately following the close of trading September 28, 2015. The consolidated common shares will begin trading on a split-adjusted basis on September 29, 2015 on the NASDAQ Capital Market.

The Company’s shareholders approved the reverse stock split at its annual meeting of shareholders on August 28, 2015, as determined by the Board of Directors in its discretion, at a ratio of not less than 1-for-4 and not more than 1-for-8. The reverse stock split is being implemented by Opexa to maintain the listing of its common stock on the NASDAQ Capital Market. Opexa received a deficiency notice from NASDAQ in December 2014 and, following a 180-day cure period, received an additional 180 days from NASDAQ in June 2015 to regain compliance with the minimum bid price requirement. To regain compliance, the closing bid price of the Company’s common stock must be at least $1.00 per share for a minimum of ten consecutive business days (or such longer period of time as the NASDAQ staff may require) before November 30, 2015. There can be no assurance that the reverse stock split will have the desired effect of raising the closing bid price of Opexa’s common stock prior to such date to meet this requirement.

The reverse split reduced the number of shares of Opexa’s outstanding common stock from approximately 54.3 million shares to approximately 6.8 million shares. Fractional shares created as a result of the stock split will be settled in cash. Informational letters will be sent to all shareholders of record by Opexa’s transfer agent, Continental Stock Transfer & Trust Company. Additional information about the reverse stock split can be found in the Company’s Form 8-K filed with the Securities and Exchange Commission.

About Opexa

Opexa is a biopharmaceutical company developing a personalized immunotherapy with the potential to treat major illnesses, including multiple sclerosis (MS) as well as other autoimmune diseases such as neuromyelitis optica (NMO). These therapies are based on Opexa’s proprietary T-cell technology. The Company’s leading therapy candidate, Tcelna®, is a personalized T-cell immunotherapy that is in a Phase IIb clinical development program (the Abili-T trial) for the treatment of secondary progressive MS. Tcelna consists of myelin-reactive T-cells, which are expanded ex vivo from the patient’s peripheral blood and reintroduced into the patient in an attenuated form via subcutaneous injections. This process triggers a potent immune response against specific subsets of autoreactive T-cells known to attack myelin for each individual patient.

For more information, visit the Opexa Therapeutics website at www.opexatherapeutics.com or follow company news on Twitter via @OpexaCEO.

Cautionary Statement Relating to Forward-Looking Information for the Purpose of “Safe Harbor” Provisions of the Private Securities Litigation Reform Act of 1995

Statements contained in this release, other than statements of historical fact, constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. The words “expects,” “believes,” “may,” “intends,” “potential” and similar expressions are intended to identify forward-looking statements. These forward-looking statements do not constitute guarantees of future performance. Investors are cautioned that forward-looking statements, including without limitation statements regarding the effect of the reverse stock split on the trading price of our common stock, the safety, efficacy and projected development timeline of drug candidates such as Tcelna® and OPX-212, constitute forward-looking statements. These forward-looking statements are based upon our current expectations and involve assumptions that may never materialize or may prove to be incorrect. Actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of various risks and uncertainties, which include without limitation our ability to raise additional capital to continue our development programs, our ability to successfully develop potential products such as Tcelna and OPX-212, our ability to obtain, maintain and protect intellectual property rights (including for Tcelna and OPX-212), our ability to regain and maintain compliance with NASDAQ listing standards, as well as other risks associated with the process of discovering, developing and commercializing drug candidates that are safe and effective for use as human therapeutics. These and other risks are described in detail in our SEC filings, including our Annual Report on Form 10-K for the year ended December 31, 2014 and our Quarterly Report on Form 10-Q for the quarter ended June 30, 2015. All forward-looking statements contained in this release speak only as of the date on which they were first made by us, and we undertake no obligation to update such statements to reflect events that occur or circumstances that exist after such date.

 

Opexa Therapeutics, Inc.
Karthik Radhakrishnan, 281-775-0600
Chief Financial Officer

Tuesday, September 29th, 2015 Uncategorized Comments Off on (OPXA) Announces Reverse Stock Split

(BLDP) Inks $6M Deal in China For First Global Deployment of Fuel Cell-Powered Trams

VANCOUVER, Canada and QINGDAO & FOSHAN, China, Sept. 28, 2015  – At a ceremony held at the Company’s global headquarters, Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) signed a joint development agreement and a supply agreement to develop and commercialize a fuel cell engine specifically designed for integration into low floor trams manufactured by CRRC Qingdao Sifang Company, Ltd. (CRRC Sifang), a Chinese rolling stock manufacturer. The agreements include 2016 delivery of ten (10) customized FCvelocity® modules and the agreements have an initial value expected to be approximately $6 million.

Ballard plans to develop a new prototype configuration of its FCvelocity® fuel cell module to deliver 200 kilowatts (kW) of net power for use in powering trams in urban deployments. An initial deployment of eight (8) fuel cell-powered trams is planned by CRRC Sifang and the City of Foshan on the Gaoming Line starting in 2017.

“We are pleased with the strong relationship we are developing with CRRC Sifang, a company with a rich history of innovation in Chinese rail transit, to pursue the China market opportunity for fuel cell powered trams,” said Randy MacEwen, Ballard’s President and CEO.

CRRC Sifang, based in Qingdao, Shandong province was established more than 100-years ago, in 1900. CRRC Sifang has a yearly production capacity of 200 high-speed electric multiple units (EMUs), 1,000 mass transit vehicles and 300 high-grade passenger cars. In March 2015, a Ballard fuel cell module powered the world’s first hydrogen fuel cell powered fixed rail electric tram that was successfully demonstrated at a ceremonial event held at CRRC Sifang’s head office, production and testing facility.

Mr. Luo Bin, Deputy President of CRRC Qingdao Sifang Company stated, “Clean urban transportation is a high priority in China. Our collaboration with Ballard to develop a purpose-built engine for our low floor tram, and the initial planned deployments in Foshan, position us well for this attractive opportunity. Ballard is our chosen partner for fuel cell technology because they have leading fuel cell expertise, experience, capabilities and a focus on safety, reliability and quality.”

Mr. Xu Guo, Vice Mayor of the City of Foshan/Yunfu added, “Our planned move toward clean mass transit technology is being accelerated with this announcement of fuel cell-powered trams as well as our announcement of 300 fuel cell powered buses in Foshan/Yunfu. We have confidence that the consortium partners, including Ballard and CRRC Sifang, will effectively deliver ground-breaking solutions for the benefit of our Chinese citizens.”

Alfred Wong, Ballard’s Director – Sales for Asia Pacific said, “Our ground-breaking announcement a few days ago regarding a deal to support deployment of 300 fuel cell buses in the Cities of Foshan and Yunfu, together with today’s announcement of an initial order supporting deployment of 8 fuel cell trams in the City of Foshan provide concrete evidence that Ballard’s customer-centric China strategy is moving toward an unparalleled level of industry success.”

Further discussion of Ballard’s activities and plans in the heavy-duty mass transit market will take place during the Company’s Investor and Analyst Day, scheduled to be held on October 1, 2015 in New York City. Institutional investors wishing to attend are asked to register as soon as possible, as space is limited, by emailing Ballard at analystday@ballard.com. Ballard’s Investor and Analyst Day will also be webcast, with the live audio stream and presentation materials accessible through a link on Ballard’s homepage at www.ballard.com. Following the event, the webcast and presentation materials will be archived in the Investors section of Ballard’s website at www.ballard.com/investors.

About Ballard Power Systems

Ballard Power Systems (NASDAQ: BLDP; TSX: BLD) provides clean energy products that reduce customer costs and risks, and helps customers solve difficult technical and business challenges in their fuel cell programs. To learn more about Ballard, please visit www.ballard.com.

This release contains forward-looking statements concerning planned product development efforts, product deployments and anticipated market demand for our products. These forward-looking statements reflect Ballard’s current expectations as contemplated under section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any such forward-looking statements are based on Ballard’s assumptions relating to its financial forecasts and expectations regarding its product development efforts, manufacturing capacity, and market demand.

These statements involve risks and uncertainties that may cause Ballard’s actual results to be materially different, including risks related to our ability to develop and commercialize our products, risk of market acceptance of our products, general economic and regulatory changes, detrimental reliance on third parties, successfully achieving our business plans and achieving and sustaining profitability. For a detailed discussion of these and other risk factors that could affect Ballard’s future performance, please refer to Ballard’s most recent Annual Information Form. Readers should not place undue reliance on Ballard’s forward-looking statements and Ballard assumes no obligation to update or release any revisions to these forward looking statements, other than as required under applicable legislation.

This press release does not constitute an offer to sell or the solicitation of an offer to buy securities.  The Ballard Common Shares have not been registered under the United States Securities Act of 1933, as amended, or the securities laws of any other jurisdiction and may not be offered or sold in the United States absent registration or an applicable exemption from registration requirements.

Monday, September 28th, 2015 Uncategorized Comments Off on (BLDP) Inks $6M Deal in China For First Global Deployment of Fuel Cell-Powered Trams

(STXS) Extends Warrants Offering Subscription Period

Company CEO and CFO Fully Exercise Subscription Warrants

ST. LOUIS, Sept. 28, 2015  — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced it is extending its registered offering of subscription warrants to the holders of common shares, as described in its prospectus supplement filed with the Securities and Exchange Commission (SEC) on September 4, 2015 (the “Prospectus”). The warrants offering was originally scheduled to expire on Wednesday, September 30, 2015 and the Company is extending the warrants offering by two days in order to better ensure that its stockholders who hold shares in brokerage accounts receive the offering materials and have time to act on them. The subscription warrants will now be exercisable until 5:00 p.m. New York City time on Friday, October 2, 2015.

As previously announced, the Company is conducting a registered offering of subscription warrants to the holders of its common shares, which functions similarly to a rights offering. The Company declared the record date for determination of stockholders eligible to participate as September 9, 2015 at 5:00 p.m. New York City time, at which time, each holder was issued, at no charge, one subscription warrant for every four common shares held, entitling the holder to purchase one share of common stock at a price of $1.10 per share. As previously reported on Form 4 filings made with the SEC on September 24, 2015, Stereotaxis CEO William Mills and CFO Martin Stammer have fully exercised their allotted subscription warrants to purchase Stereotaxis common shares.

The warrants commenced being listed on the NASDAQ Capital Market under the symbol “STXSW” on September 14, 2015 and will continue through the new expiration date of October 2, 2015. In addition to being able to purchase their pro rata portion of the shares offered, based on their ownership as of the record date of the warrants offering, Stereotaxis stockholders who exercise all of their warrants may subscribe to purchase additional common shares pursuant to an over-subscription privilege, subject to certain limitations and subject to allotment, as described in the Prospectus. No fractional subscription warrants will be distributed and no fractional shares will be issued, pursuant to the warrants offering. Any fractional warrants issuable, pursuant to the warrants offering, resulting from the number of shares owned as of the record date or fractional shares issuable, pursuant to the over-subscription, resulting from prorations or other limitations, will be eliminated by rounding down to the nearest whole warrant or whole share.

This press release does not constitute an offer to sell or the solicitation of an offer to buy the securities described herein, nor shall there be any offer, solicitation, or sale of the securities in any state or jurisdiction in which such offer, solicitation or sale would be unlawful, prior to the registration or qualification of the securities under the securities law of such state or jurisdiction. A shelf registration statement on Form S-3, pursuant to which the warrants are being issued, was filed with the SEC on November 27, 2013 and declared effective on December 11, 2013. The warrants offering is being made only by means of the Prospectus together with a base prospectus filed with the registration statement. Copies of the Prospectus and base prospectus, which contain further details regarding the warrants offering, will be provided to all stockholders, as of the record date.

Holders of Stereotaxis’ shares who hold their shares in “street name” at a brokerage firm, bank or similar organization, like the vast majority of Stereotaxis stockholders, may direct any questions about the warrants offering to the broker or bank at the number identified in the offering materials mailed to the holders. Stockholders who hold their shares directly may contact the warrants agent, Broadridge Corporate Issuer Solutions, Inc. at (855) 300-4994.

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® ES remote magnetic navigation system, the Odyssey® portfolio of lab optimization, networking and patient information management systems, and the Vdrive™ robotic navigation system and consumables.

The core components of Stereotaxis’ systems have received regulatory clearance in the United States, 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 United States, 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 United States, 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
Monday, September 28th, 2015 Uncategorized Comments Off on (STXS) Extends Warrants Offering Subscription Period

(FLL) Resorts to Acquire Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado

– Purchase Price is Approximately 5.9x Adjusted EBITDA, as Defined in the Purchase Agreement

– Acquisition Will Diversify the Company’s Geographic Presence and Cash Flows

– Acquisition is Expected to Be Immediately Accretive

Full House Resorts (NASDAQ: FLL) has entered into a definitive agreement with privately-owned Pioneer Group, Inc. to acquire the operating assets of Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado for approximately $30.0 million. The transaction is expected to be accretive to Full House.

Believed to be one of the two market leaders in Cripple Creek, Bronco Billy’s is located on the north side of Bennett Avenue, along the key city block that accounts for the bulk of the town’s gaming activity. The casino comprises a majority of that block and has certain ownership rights to portions of the rest of the block. Bronco Billy’s also controls significant land and structures that adjoin this key city block.

Bronco Billy’s has approximately 830 slot and video poker machines, 13 table games, a 24-room hotel, a steakhouse, four casual dining outlets, and an outdoor amphitheater. The casino was expanded in May 2015, adding approximately 15% more slot machines, 14 guest rooms (to the ten that the property previously operated), and 2.3 acres of additional surface parking. The expansion extended the Bronco Billy’s footprint to an important street corner, whereas previously it was confined to the center of that key block of Cripple Creek’s prime “casino strip.”

Gaming in Colorado is limited to three historic mining towns: Black Hawk and Central City, which adjoin each other, and Cripple Creek. The first two towns are located about an hour west of Denver. Cripple Creek is located approximately one hour from Colorado Springs, Colorado’s second largest city. The Colorado Springs metropolitan statistical area (MSA) has a population of approximately 668,000 and has shown steady growth in recent years. Between 2000 and 2012, the MSA’s population grew approximately 22%. It is estimated that the population has continued to grow since 2012 at approximately 3.5% per year.

Cripple Creek has offered gaming for more than 20 years. It is near the center of the state and will not easily be affected by expanded gaming in neighboring states. Additionally, there are no federally- or state-recognized Native American tribes nearby which could potentially offer gaming. Efforts over the years to legalize additional casinos in Colorado outside of these historical mining towns, including one in 2014, have been soundly defeated by voters. Through August 2015, the Cripple Creek market has grown approximately 2.7% compared to the first eight months of 2014.

“We look forward to adding Bronco Billy’s Casino and Hotel to the Full House portfolio,” said Daniel R. Lee, President and Chief Executive Officer of Full House Resorts. “In addition to diversifying our geographic presence and cash flows, we are acquiring Bronco Billy’s at an attractive EBITDA multiple and price. It is well-run and well- maintained, and a stable leader within its market. We expect that its management team will remain at the property and we look forward to welcoming them and all of the Bronco Billy’s employees to the Full House family.”

Mr. Lee continued, “We see potential for growth at Bronco Billy’s as the property benefits from a full year of its recently-completed expansion. Over the long term, there may be opportunities to develop the property’s excess surrounding acreage. Bronco Billy’s will significantly increase our Company’s EBITDA, without any significant increase in corporate overhead. In fact, there may be corporate cost savings related to economies of scale. We look forward to completing this transaction as quickly as possible, potentially in the fourth quarter of 2015 or early in 2016.”

The $30.0 million purchase price, exclusive of working capital and other adjustments, is subject to reduction to $28.5 million if Bronco Billy’s twelve-month Adjusted EBITDA, as defined, falls below $4.7 million in certain periods prior to closing. If Bronco Billy’s twelve-month Adjusted EBITDA, as defined, further falls below $4.5 million in certain periods prior to closing, Full House Resorts may terminate the purchase agreement without penalty. Strictly for purposes of the Adjusted EBITDA definition contained in the purchase agreement, Pioneer Group advised us that, for the twelve-month period ended August 31, 2015, the amount would have been $5.1 million.

The Company will make a $2.5 million deposit to secure its performance under the purchase agreement. As stated above, the deposit will be returned if Bronco Billy’s twelve-month Adjusted EBITDA, as defined, is less than $4.5 million.

Full House Resorts intends to finance the acquisition concurrent with the refinancing of its outstanding first and second lien debt, much of which comes due in 2016. Management expects to complete the refinancing of the Company’s debt simultaneous with the close of the Bronco Billy’s transaction in late 2015 or early 2016, subject to obtaining regulatory approvals and completion of other customary closing conditions.

“This transaction significantly increases the scope and diversity of Full House,” concluded Mr. Lee. “While there is no ‘financing contingency’ in the purchase agreement, we believe the Company’s credit statistics, including the cost of the acquisition, will be within the norm for regional casino companies. While nothing is certain, our bankers have expressed confidence that the Company’s debt can be refinanced, including the entire cost of the acquisition, on terms that are better than the cost of our existing debt.”

Bronco Billy’s Casino and HotelSupplemental Information

Reconciliation of Adjusted EBITDA, as Defined in the Purchase Agreement, to Operating Income

(In Thousands, Unaudited)

Twelve month period endedAugust 31, 2015
Adjusted EBITDA, as defined in the purchase agreement $ 5,069
Pre-opening expenses (124 )
Gaming campaign expenses (40 )
Lost profits due to temporary July closure (150 )
Non-recurring consulting fees (173 )
Expenses related to sale process (134 )
Depreciation and amortization (1,738 )
Operating Income $ 2,710

Note: The amounts in the above table were provided by Pioneer Group, Inc.

Forward-looking Statements
Some of the statements made in this release are forward-looking statements. These forward-looking statements are based upon Full House’s current expectations and projections about future events and generally relate to Full House’s plans, objectives and expectations for Full House’s business. Although Full House’s management believes that the plans and objectives expressed in these forward-looking statements are reasonable, the outcome of such plans, objectives and expectations involve risks and uncertainties including, without limitation, regulatory approvals, compliance with conditions precedent under the purchase agreement, review of negotiated financial terms in the definitive agreement, the ability to refinance indebtedness, financing sources and terms, the increase in Full House’s indebtedness if the acquisition closes, the risk that the acquisition does not close, and general macroeconomic conditions. Additional information concerning potential factors that could affect Full House’s financial condition and results of operations is included in the reports that Full House files with the Securities and Exchange Commission, including, but not limited to, its Form 10-K for the most recently ended fiscal year, Forms 10-Q and other periodic filings. The Company is under no obligation to (and expressly disclaims any such obligation to) update or revise its forward-looking statements as a result of new information, future events or otherwise.

About Full House Resorts, Inc.
Full House Resorts owns, develops and operates gaming facilities throughout the country. The Company’s properties include Rising Star Casino Resort in Rising Sun, Indiana; Silver Slipper Casino and Hotel in Hancock County, Mississippi; and Stockman’s Casino in Fallon, Nevada. The Company also operates the Grand Lodge Casino at the Hyatt Regency Lake Tahoe Resort, Spa and Casino in Incline Village, Nevada on the north shore of Lake Tahoe under a lease agreement with the Hyatt organization. The Company recently announced its intent to purchase Bronco Billy’s Casino and Hotel in Cripple Creek, Colorado and has proposed American Place, a major development in Indianapolis, Indiana. Further information about Full House Resorts can be viewed on its website at www.fullhouseresorts.com.

 

Full House Resorts, Inc.
Lewis Fanger, Chief Financial Officer
(702) 221-7800
www.fullhouseresorts.com

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(GVP) $35 Million of Nuclear Operations Support for Major US Utility

GSE Systems, Inc. (NYSE MKT: GVP) (“GSE”), the global energy industry performance improvement company, today announced that its Hyperspring LLC subsidiary has been awarded a contract for the continuation of Nuclear Operations support services in the form of providing Nuclear Operations Instructors at a major nuclear utility in the southern United States. The on-call services contract allows for total payment up to $35 million to GSE over the three-year contract term. Instructor tasks include leading the development, maintenance and conduct of training and qualification activities to ensure operators and shift technical advisor qualifications meet regulatory and accreditation requirements.

For the year ended December 31, 2014 and the six-month period ended June 30, 2015, Hyperspring generated revenues from this utility of $11.1 million and $5.3 million, respectively.

Paul Abbott, President of Hyperspring LLC said, “This contract is a continuation of a long standing relationship with the utility customer and reflects their satisfaction with the quality of services we have provided. We are honored to serve this customer, are proud of the value we have provided, and are excited for the opportunity to continue the relationship, serving the customer’s needs well into the future.”

Hyperspring LLC was acquired by GSE Systems in November of 2014 and provides professional plant support services to a variety of power generation facilities throughout the United States. Services include: instruction, procedure writing, work management, corrective action, training program development and accreditation, self-assessments and equipment reliability. In addition, Hyperspring offers turn-key courses for Senior Reactor Operator (SRO) Instructor Certification, SRO Management Certifications, and NRC Generic Fundamentals exam preparation.

ABOUT GSE SYSTEMS, INC.

GSE Systems, Inc. provides performance improvement solutions to the energy and process industries. We improve human performance though turnkey training, unique visualization and simulation applications, and our staff of instructors, as well as plant improvement through our engineering expertise and use of technology to improve plant design, commissioning and operations. The Company has more than 340 employees and over four decades of experience as well as more than 1,100 installations and hundreds of customers in over 50 countries spanning the globe. GSE Systems is headquartered in Sykesville (Baltimore), Maryland, with offices in St. Marys, Georgia; Cary, North Carolina; Huntsville, Alabama; Chennai, India; Nyköping, Sweden; Stockton-on-Tees, UK; Glasgow, UK; Manama, Bahrain; and Beijing, China. Information about GSE Systems is available at www.gses.com.

Forward-Looking Statements

We make statements in this press release that are considered 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. These statements reflect our current expectations concerning future events and results. We use words such as “expect,” “intend,” “believe,” “may,” “will,” “should,” “could,” “anticipates,” and similar expressions to identify forward-looking statements, but their absence does not mean a statement is not forward-looking. These statements are not guarantees of our future performance and are subject to risks, uncertainties, and other important factors that could cause our actual performance or achievements to be materially different from those we project. For a full discussion of these risks, uncertainties, and factors, we encourage you to read our documents on file with the Securities and Exchange Commission, including those set forth in our periodic reports under the forward-looking statements and risk factors sections. We do not intend to update or revise any forward-looking statements, whether as a result of new information, future events, or otherwise.

 

GSE Systems, Inc.
Kyle J. Loudermilk, 410-970-7950
Chief Executive Officer
or
The Equity Group Inc.
Devin Sullivan, 212-836-9608
Senior Vice President
dsullivan@equityny.com
or
Kalle Ahl, CFA, 212-836-9614
Senior Associate
kahl@equityny.com

Monday, September 28th, 2015 Uncategorized Comments Off on (GVP) $35 Million of Nuclear Operations Support for Major US Utility

(PSDV) Announces NDA for Medidur™

Top-Line Data from First Trial Expected December 2015

pSivida Corp. (NASDAQ:PSDV) (ASX:PVA), a leader in the development of sustained release drug delivery products for treating eye diseases, announced that the Company now plans to file a New Drug Application (NDA) for Medidur for posterior uveitis based on six-month efficacy data for both Phase III trials. The U.S. Food & Drug Administration (FDA) has advised pSivida that this data will be acceptable for review by the agency. pSivida previously planned to utilize 12-month efficacy data from the first trial and six-month efficacy data from the second trial. As six-month visits in the first trial will be completed this month, top-line results from the first Phase III trial are now anticipated to be reported in December 2015. Enrollment in the second Phase III trial continues and is expected to be completed during the first half of 2016, with an NDA anticipated in the first half of 2017.

“We are very pleased that the FDA has agreed to review an NDA for posterior uveitis based on six-month efficacy data,” said Dr. Paul Ashton, president and CEO of pSivida. “The primary end-point of the Phase III trials is recurrence of disease, which in the majority of patients occurs typically within six months. Our analysis of the masked data from our first trial is consistent with this. We believe therefore that six-month data from our two trials will show safety and efficacy. We look forward to being able to announce the top-line results from the first trial at the end of this year.”

About Medidur. Medidur is an injectable micro-insert designed to treat posterior uveitis that provides sustained release of flucinolone acetonide (a corticosteroid) for three years. Medidur comprises the same micro-insert (same design, same polymers, same drug, same dose) as ILUVIEN® for DME. ILUVIEN has been approved in the U.S. and 17 EU countries and is sold in the U.S., the U.K., Germany and Portugal.

About Posterior Uveitis. Posterior uveitis is a chronic, non-infectious inflammatory disease affecting the posterior segment of the eye, often involving the retina, which is a leading cause of blindness in the developed and developing countries. It afflicts people of all ages, producing swelling and destroying eye tissues, which can lead to severe vision loss and blindness. In the U.S. posterior uveitis is estimated to affect approximately 175,000 people, resulting in approximately 30,000 cases of blindness and making it the third leading cause of blindness in the U.S.

Patients with posterior uveitis are typically treated with systemic steroids but over time frequently develop serious side effects that can limit effective dosing. Patients then often progress to steroid-sparing therapy with systemic immune suppressants or biologics, which themselves can have severe side effects including an increased risk of cancer. Medidur is designed to provide improved outcomes compared to standard of care but with a significant reduction in side effects.

About Medidur’s Phase III Trials. pSivida’s two Phase III trials for Medidur are double-masked studies comparing injections of Medidur to sham injections on a two-to-one basis. The primary end point of both trials is recurrence of uveitis within six months. The first trial is fully enrolled with 129 patients in 16 centers in the U.S. and 17 centers outside the U.S. The last scheduled visit for the last patient in this trial is in September 2015, and top-line data is expected in December 2015. The second trial will enroll up to 150 patients in approximately 15 centers in India. Patients in both trials will be followed for three years. pSivida plans to seek approval for Medidur for posterior uveitis based on six-month data from the two trials and data from a utilization study of pSivida’s redesigned proprietary inserter together with data referenced from the Phase III trials of ILUVIEN® for DME. With favorable results, pSivida expects to file a New Drug Application in the first half of 2017.

About pSivida Corp. pSivida Corp., headquartered in Watertown, MA, is a leader in the development of sustained release, drug delivery products for treating eye diseases. pSivida has developed three of only four FDA-approved treatments for back-of-the-eye diseases. The most recent, ILUVIEN, a micro-insert for diabetic macular edema, is licensed to Alimera Sciences and sold in the U.S. and three EU countries. Retisert®, an implant for posterior uveitis, is licensed to and sold by Bausch & Lomb. pSivida’s lead product candidate, Medidur™, a micro-insert for posterior uveitis, is currently in pivotal Phase III clinical trials with an NDA anticipated in the first half of 2017. pSivida’s pre-clinical development program is focused on using its core platform technologies, Durasert™ and/or Tethadur™, to deliver drugs and biologics to treat wet and dry age-related macular degeneration (AMD), glaucoma, osteoarthritis and other diseases. To learn more about pSivida please visit www.psivida.com and connect on Twitter, LinkedIn, Facebook and Google+.

SAFE HARBOR STATEMENTS UNDER THE PRIVATE SECURITIES LITIGATION REFORM ACT OF 1995: Various statements made in this release are forward-looking, and are inherently subject to risks, uncertainties and potentially inaccurate assumptions. All statements that address activities, events or developments that we intend, expect or believe may occur in the future are forward-looking statements. Some of the factors that could cause actual results to differ materially from the anticipated results or other expectations expressed, anticipated or implied in our forward-looking statements include uncertainties with respect to: our ability to achieve profitable operations and access to capital; further impairment of our intangible assets; fluctuations in our operating results; declines in Retisert royalties; successful commercialization of, and receipt of revenues from, ILUVIEN for DME; the effect of pricing and reimbursement decisions on sales of ILUVIEN for DME; consequences of flucinolone acetonide side effects; safety and efficacy results of Medidur Phase III trials, timing of filing and acceptance of the Medidur NDA, if at all; fluctuations in our operating results; ability to use of data in a U.S. NDA from trials outside the U.S.; any exercise by Pfizer of its option with respect to the latanoprost product; our ability to develop Tethadur to successfully deliver large biologic molecules and develop products using it; our ability to successfully develop product candidates, initiate and complete clinical trials and receive regulatory approvals; our ability to market and sell products; the success of current and future license agreements; termination or breach of current license agreements; effects of competition and other developments affecting sales of products; market acceptance of products; effects of guidelines, recommendations and studies; protection of intellectual property and avoiding intellectual property infringement; retention of key personnel; product liability; industry consolidation; compliance with environmental laws; manufacturing risks; risks and costs of international business operations; legislative or regulatory changes; volatility of stock price; possible dilution; absence of dividends; and other factors described in our filings with the SEC. You should read and interpret any forward-looking statements in light of these risks. Should known or unknown risks materialize, or should underlying assumptions prove inaccurate, actual results could differ materially from past results and those anticipated, estimated or projected in the forward-looking statements. You should bear this in mind as you consider any forward-looking statements. Our forward-looking statements speak only as of the dates on which they are made. We do not undertake any obligation to publicly update or revise our forward-looking statements, even if experience or future changes makes it clear that any projected results expressed or implied in such statements will not be realized.

 

Martin E. Janis & Company, Inc.
Beverly Jedynak, 312-943-1123
President
M: 773-350-5793
bjedynak@janispr.com

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(RJET) Teamsters Local 357, Republic Airways Reach Tentative Agreement on New Contract

Three-year agreement provides overall industry-leading pay, job protections, and work rules

Teamsters Local 357 and Republic Airways Holdings Inc. (NASDAQ/NM: RJET) announced today that they have reached a consensual tentative agreement on the terms of a new three-year contract for the 2,100 Republic pilots represented by the International Brotherhood of Teamsters.

“This milestone is long overdue,” said Captain Jim Clark, Teamsters Local 357 president. “Our members are extraordinary aviators and safety professionals who come to work every day ready to do the job asked of them. They deserve pay, job security, benefits and work rules that match their leadership position in our industry. The Executive Board of Local 357 recommends this tentative agreement to our members for ratification. We were able to reach this positive outcome because of the support of our members who stayed united even in the face of constant challenges.”

“This is a positive outcome,” said Matt Koscal, Republic vice president of human resources. “This consensual agreement respects the role our pilots play in our airline’s success and it puts them at the forefront of our industry. We are pleased that we could reach a consensual agreement with the leadership of Local 357 that allows us to make a significant investment in our Pilots and our future.”

The parties are preparing the document for publication, at which point Local 357 will distribute copies of the tentative agreement to its members. The union plans to hold a series of road shows and other forums to afford its members the opportunity to review the tentative agreement and to ask questions. Ratification voting is scheduled to conclude in late October. Further details on this process will be provided to our Pilots by the union in the coming days.

The company will post a copy of the tentative agreement on www.myrjetcontract.com for the convenience of Local 357 members and has agreed to host an FAQ and other content on the site as requested by the union.

Both parties wish to express their thanks to the National Mediation Board, and specifically to board member Linda Puchala and to senior mediator Terri Brown, for their ongoing guidance and assistance during this process. The parties also express their appreciation to the staff and specifically, Director, Captain David Bourne of the Teamster’s Airline Division for their assistance.

 

Republic Airways Holdings Inc.
Bob Birge, 317-471-2808
Corporate Communications
Bob.Birge@rjet.com
or
IBT Local 357
Natalie Rodriguez
Communications Specialist
Communications@local357.org

Monday, September 28th, 2015 Uncategorized Comments Off on (RJET) Teamsters Local 357, Republic Airways Reach Tentative Agreement on New Contract

(RENT) Acquires SponsorHub

-SponsorHub’s Proprietary Measurement Platform, Specializing in Social Media and Mega Events, Enhances Rentrak’s Unsurpassed Position in Precisely Measuring Movies and TV Everywhere-

PORTLAND, Ore., Sept. 25, 2015  — Rentrak (NASDAQ: RENT), the leader in precisely measuring movies and TV everywhere, today announced it has acquired SponsorHub, the premiere Big Data platform for the sports and entertainment industry, offering proprietary social media measurement for sports, political and advertising brands.

SponsorHub offers the most trusted industry benchmarking for top brands in the sports technology and entertainment space. Its tools measure and track brand engagement in sports and branded entertainment initiatives, ranging from the Olympics and World Cup, to TV and movies.

Rentrak’s acquisition of SponsorHub advances its mission of providing unprecedented audience measurement and targeting to enable marketers to reach the right audience at the right time. Through its acquisition of SponsorHub, Rentrak will offer products that measure the effect of social media on television, dynamic ad insertion, online video advertising, movies and branded content integration.

“TV continues to be more social and our industry-leading analytics greatly complement Rentrak’s services,” said SponsorHub Chief Executive Officer, Robert Johnston. “The combination of Rentrak’s current products with SponsorHub’s social media SaaS platform will provide the most precise set of tools to measure the effect of social media. We’re looking forward to the new products that will be developed through this acquisition.”

“We are excited to add social media measurement to our TV Everywhere products, as it will give additional transparency and purchasing flexibility for brands and agencies through SponsorHub’s social media products,” said Rentrak’s Vice Chairman & Chief Executive Officer, Bill Livek.

SponsorHub has pioneered social media analytics in sports, across multiple platforms. Its X-Stream product helps advertisers better appropriate the billions of dollars spent on sports and entertainment campaigns. X-Stream provides a real-time consumer impact index and key emotional metrics derived from billions of social conversations around athletes, celebrities, teams, leagues and brands.

About Rentrak

Rentrak (NASDAQ: RENT) is the entertainment and marketing industries’ premier provider of worldwide consumer viewership information, precisely measuring actual viewing behavior of movies and TV everywhere. Using our proprietary intelligence and technology, combined with Advanced Demographics, only Rentrak is the census currency for VOD and movies. Rentrak provides the stable and robust audience measurement services that movie, television and advertising professionals across the globe have come to rely on to better deliver their business goals and more precisely target advertising across numerous platforms including box office, multiscreen television and home video. For more information on Rentrak, please visit www.rentrak.com.

About SponsorHub

SponsorHub provides elegant yet powerful enterprise-grade software tools to help brands measure their most important sports and entertainment campaigns. SponsorHub’s proprietary technology provides a dynamic mover board of public sentiment towards brands, products, mega events, teams, leagues, athletes and celebrities. For more information, please visit www.sponsorhub.com

RENTM

Contact for Rentrak:
Antoine Ibrahim
646.722.1561
aibrahim@rentrak.com

Contact for SponsorHub:
Katie Campisano
908 247 8678
katie.campisano@CodeMorris.com

Friday, September 25th, 2015 Uncategorized Comments Off on (RENT) Acquires SponsorHub

(GLBL) GPM Announces Investigation on Behalf of TerraForm Global, Inc. Investors

Glancy Prongay & Murray LLP (“GPM”) announces that it is investigating potential claims on behalf of investors of TerraForm Global, Inc. (“TerraForm” or the “Company”) (NASDAQ:GLBL) concerning the Company’s and its officers’ possible violations of federal securities laws. GPM is preparing a lawsuit to recover damages on behalf of TerraForm investors.

TerraForm owns and operates renewable energy generation assets worldwide, and operates as a subsidiary of SunEdison, Inc. On August 4, 2015, the Company completed its initial public offering of 45 million shares at an offering price of $15 per share. However, over the course of several disclosures in the past two months, regarding SunEdison, Inc.’s and TerraForm’s poor performance the Company’s stock price has fallen nearly 50% below its IPO price, thereby damaging investors. GPM is investigating whether investors were misled by the Company and its officers and directors during the course of the initial public offering.

If you purchased TerraForm securities, have information or would like to learn more about these claims including whether you qualify to serve as a class representative, or have any questions concerning this announcement or your rights or interests with respect to these matters, please contact Lesley F. Portnoy, Esquire, of GPM, 1925 Century Park East, Suite 2100, Los Angeles, California 90067 at 310-201-9150, Toll-Free at 888-773-9224, by email to shareholders@glancylaw.com, or visit our website at http://www.glancylaw.com. If you inquire by email please include your mailing address, telephone number and number of shares purchased.

This press release may be considered Attorney Advertising in some jurisdictions under the applicable law and ethical rules.

 

Glancy Prongay & Murray LLP, Los Angeles
Lesley F. Portnoy, 310-201-9150 or 888-773-9224
shareholders@glancylaw.com
www.glancylaw.com

Friday, September 25th, 2015 Uncategorized Comments Off on (GLBL) GPM Announces Investigation on Behalf of TerraForm Global, Inc. Investors