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(IMDZ) to Present at Jefferies 2014 Global Healthcare Conference
SEATTLE and SOUTH SAN FRANCISCO, Calif., Nov. 13, 2014 — Immune Design Corp. (Nasdaq:IMDZ), a clinical-stage immunotherapy company, today announced that Carlos Paya, M.D., Ph.D., President and Chief Executive Officer of Immune Design, will present at the Jefferies 2014 Global Healthcare Conference in London on November 19, 2014 at 11:20 a.m. GMT/3:20 a.m. PST. A live audio webcast and archive of the presentation will be available on the company website at http://ir.immunedesign.com/events.cfm.
About Immune Design
Immune Design is a clinical-stage immunotherapy company employing next-generation in vivo approaches to enable the body’s immune system to fight disease. The company’s technologies are engineered to activate the immune system’s natural ability to create and/or expand antigen-specific cytotoxic T cells, while enhancing other immune effectors, to fight cancer and other chronic diseases. Immune Design’s three on-going immuno-oncology clinical programs are the product of its two synergistic discovery platforms: ZVexTM and GLAASTM. Immune Design has offices in Seattle and South San Francisco. For more information, visit www.immunedesign.com.
CONTACT: Media Contact Julie Rathbun Rathbun Communications julie@rathbuncomm.com 206-769-9219 Investor Contact Robert H. Uhl Westwicke Partners robert.uhl@westwicke.com 858-356-5932
(ISSC) FAA Awards STC for B737 NextGen Flight Deck & FMS
Innovative Solutions & Support, Inc.(IS&S) (NASDAQ: ISSC) announced today that it received Federal Aviation Administration (FAA) Supplemental Type Certification (STC) for its Flight Management System (FMS) for Boeing 737 Classic aircraft. As a result, IS&S now offers the most advanced Boeing 737-300/-400/-500 NextGen retrofit, including Required Navigational Performance/Radius to Fix (RNP/RF), Required Time of Arrival (RTA), Localizer Performance with Vertical guidance (LPV) and Wide Area Augmentation System / Global Positioning System (WAAS/GPS) capabilities. The IS&S cockpit upgrade opens a major new aircraft retrofit market worldwide, providing legacy air transport aircraft with navigational capability and performance equivalent to that of the newest production aircraft.
This latest certification is the culmination of a multi-year program to upgrade (2) 737-400 aircraft to full CNS/ATM compliance standards in which IS&S served as the systems integrator. This program included installation of new transponders, cockpit printers, ACARS and SATCOM systems. Relocation of the center console facilitated installation of this new equipment.
The IS&S B737 Classic cockpit upgrade is the first Air Transport retrofit to integrate RNP/RF, LPV and WAAS/GPS approaches supporting a worldwide navigational database, greatly increasing the utility of these aircraft and firmly establishing IS&S as a leader in this market. The RNP and WAAS/GPS capabilities will enable aircraft to fly shorter flight paths and optimum idle-thrust descents, thereby reducing fuel consumption, carbon emissions, and noise levels. LPV capability significantly improves access, with thousands of airports now benefitting from published WAAS LPV procedures.
The IS&S flight deck upgrade replaces legacy CRT and Flight Management avionics, leverages recently developed advanced display and computing technology, and provides the flexibility for functional evolution as NextGen requirements evolve. The IS&S upgrade package includes an advanced flight management system with global navigational database capability, primary & navigational flight displays, and a WAAS/GPS system, and seamlessly integrates DataComm and ADS-B capabilities.
The IS&S NextGen cockpit upgrade package provides further operational benefits, including increased operational flexibility and reliability, improved dispatch and on time arrival availability and simplified maintenance. In addition the system enhances safety through improved situational awareness and reduced crew workload.
The IS&S cockpit upgrade package is easily integrated with third party avionics systems, including the Mode S transponder, the ACARS system, SATCOM, and the cockpit printer. The MCDU acts as the crew interface for these systems through ARINC 739 AOC pages. The Flat Panel Display System installation was specifically designed to minimize aircraft down time due to rewiring. To convert from an EFIS airplane, no wiring modifications are required in the electronics bay, where shelf removal dramatically increases avionics modification complexity – the IS&S FMS Line Replaceable Units (LRUs) are plug-in replacements for the legacy FMS LRUs. Including installation of dual GPS antennas and receivers, the upgrade package installation can be completed in less than five days.
The FMS complements the IS&S Cockpit/IP® display and instrument systems that have been installed on nearly 300 air transport aircraft to-date. The Cockpit/IP® employs IS&S’s open architecture flat panel display system that allows operators to upgrade their aircraft to a glass flight deck while leaving third party avionics installed in the aircraft. The flight management system supports satellite-based operations, which result in improved efficiencies, related to RNAV, RNP, and LPV procedures.
About Innovative Solutions & Support, Inc.
Headquartered in Exton, Pa., Innovative Solutions & Support, Inc. (www.innovative-ss.com) is a systems integrator that designs and manufactures flight guidance and cockpit display systems for Original Equipment Manufacturers (OEM’s) and retrofit applications. The company supplies integrated Flight Management Systems (FMS) and advanced GPS receivers for precision low carbon footprint navigation. IS&S supplies Flight Management solutions to the commercial air transport market, the military aviation market for C-130, L-100 and the business aviation market for the Eclipse E500 and E550 aircraft.
Certain matters contained herein that are not descriptions of historical facts are “forward-looking” (as such term is defined in the Private Securities Litigation Reform Act of 1995). Because such statements include risks and uncertainties, actual results may differ materially from those expressed or implied by such forward-looking statements. Factors that could cause results to differ materially from those expressed or implied by such forward-looking statements include, but are not limited to, those discussed in filings made by the Company with the Securities and Exchange Commission. Many of the factors that will determine the Company’s future results are beyond the ability of management to control or predict. Readers should not place undue reliance on forward-looking statements, which reflects management’s views only as of the date hereof. The Company undertakes no obligation to revise or update any forward-looking statements, or to make any other forward-looking statements, whether as a result of new information, future events or otherwise.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20141112006410/en/
Innovative Solutions & Support, Inc.
Jason Zywalewski, +1-610-646-9800 ext 609
jzywalewski@innovative-ss.com
(ERII) Changes Investor and Analyst Day to Monday, December 8 in New York City
SAN LEANDRO, Calif., Nov. 12, 2014 — Energy Recovery Inc. (Nasdaq:ERII), the leader in capturing reusable energy from industrial fluid flows and pressure cycles, has announced a new date and location for its Investor and Analyst Day, now being held on Monday, December 8, 9:30am-2:30pm, at the Mandarin Oriental Hotel in New York City. The event will unveil a new, disruptive technology for an as-yet-unnamed major industry, and guide investors and analysts through a dynamic and new business strategy for 2015 and beyond.
Led by CEO Tom Rooney, this will be the first analyst-focused event Energy Recovery has hosted in more than five years. The forum will allow the management team to provide investors and potential shareholders critical information to help them make informed decisions about the Company.
In addition to announcing a disruptive new technology, the Company will provide significant detail on its new growth markets, including oil and gas and chemical processing, and will share details on new products, value propositions, total addressable markets and a comprehensive business strategy that will position Energy Recovery as the leading innovator in the field, tapping pressure energy to drive uptime and profitability in oil and gas, chemicals and water. The day will also include an update on the state of the desalination market.
Interested Parties
Individuals interested in attending can contact Adam Prior of The Equity Group Inc. at aprior@equityny.com or by calling (212) 836-9606.
About Energy Recovery Inc.
Energy Recovery (Nasdaq:ERII) develops award-winning innovations that make industrial processes more productive, more profitable and environmentally cleaner. Our solutions tap into pressure energy from fluid flows to drive uptime throughout industrial processes. By recycling otherwise lost pressure energy, we are able to make systems more efficient and reduce overall maintenance costs, with solutions customized to adapt to all conditions. Working in oil & gas, chemical and water industries, more than 15,000 solutions worldwide save clients over $1.4 Billion (USD). Headquartered in the San Francisco Bay Area, Energy Recovery has offices in Madrid, Shanghai, and Dubai. Learn more at www.energyrecovery.com
CONTACT: Adam Prior The Equity Group Inc. aprior@equityny.com (212) 836-9606
(MITK) Optimizes Mobile Web Photo Capture of Driver’s Licenses and Other IDs
New Browser-Based Image Capture to Drive Revenue by Speeding Consumer Enrollment and Improving Forms Completion
SAN DIEGO, Nov. 12, 2014 — Mitek (Nasdaq:MITK) (www.miteksystems.com), the leading innovator of mobile imaging for financial transactions and identification, today announced it will be optimizing photo capture of driver’s licenses and other IDs through mobile browsers. The addition of this capability to the Company’s awarding winning Mobile Photo Account Opening™ Suite will help financial brands drive revenue by speeding mobile enrollment process and improving forms completion rates for new accounts.
According to comScore, mobile devices accounted for 55% of Internet usage in the United States in January 2014. For this reason, digital strategists and marketers need to create a superior mobile web user experience to win new customers and drive new revenue. By adding the ability to evoke the camera via a browser to Mitek’s Mobile Photo Account Opening, marketers will be able to achieve higher conversions from targeted digital marketing campaigns as well as capture those shopping online for new financial services using mobile devices.
Mitek estimates an increase in form completion rates of 30% – 50% for new bank accounts, credit card applications and more. The data accuracy of photo pre-fill will significantly improve the ability of back-end systems to apply business rules for real-time decisioning increasing the number of new accounts opened and applications approved.
“Our customers asked us for an acquisition tool to help them drive new revenue from mobile web,” said James B. DeBello, president & CEO of Mitek. “We are responding to their needs by embedding advanced computer vision technology into mobile browsers to create a powerful tool that will help them achieve their goals.”
Mitek’s Mobile Photo Account Opening for Mobile Web is easy to implement. The mobile web team embeds the Mitek Mobile Web Capture SDK into their website which provides a turnkey image capture and enhancement capability while ensuring no images are saved to the device. Images are securely sent to and returned from Mitek’s mobile imaging server through simple web services calls. This approach allows financial services organizations to quickly configure to meet their needs and minimizes the IT resources required to deploy.
Mobile Photo Account Opening for Mobile Web will be generally available in Q2 2015. The server side can be deployed in Mitek Cloud or on-premise.
About Mitek
Headquartered in San Diego, CA, Mitek (Nasdaq:MITK) is the leading innovator of mobile imaging for financial transactions and identification. Mitek’s patented mobile photo technology automatically captures images of financial and personal documents and then extracts relevant data. This enables consumers to use the Camera as a Keyboard™ to reduce friction for mobile check deposit, account opening, bill payment, insurance quoting, and many other use cases. This innovative technology is licensed by more than 3,000 organizations and used by tens of millions of consumers enabling increased customer acquisition, retention and operational efficiency. www.miteksystems.com MITK-G
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CONTACT: Media Contacts: Ann Reichert Senior Director of Marketing pr@miteksystems.com Katherine Verducci MIX Public Relations pr@mix-pr.com
(ESCA) Announces Executive Management Change
EVANSVILLE, Ind., Nov. 12, 2014 — Escalade, Incorporated (NASDAQ: ESCA) announced today that it will be consolidating its finance and accounting department effective at the end of its fiscal year on December 27, 2014. At that time, Stephen R. Wawrin will assume the additional duties as Escalade’s Vice President, Finance and Chief Financial Officer. Since 2008, Mr. Wawrin has served as Vice President –Finance and Administration for Escalade’s Sporting Goods business. He joined Escalade in 2005, and previously served as Corporate Controller for Escalade, Inc. Mr. Wawrin will succeed Deborah J. Meinert, Escalade’s current Vice President Finance, Chief Financial Officer, and Secretary, who will be leaving Escalade at that time.
The decision to restructure Escalade’s finance and accounting department results from Escalade’s strategic decision to focus on its Sporting Goods business. With the divestiture of its Information Security and Print Finishing business, Escalade’s executive management and board of directors determined that certain functions could be consolidated. This management change does not impact or in any way relate to the financial statements or reporting of Escalade or its subsidiaries.
Robert J. Keller, Escalade’s President and Chief Executive Officer, said, “We thank Deborah for her service over the last seven years. Deborah has made many contributions to the success of Escalade, and we wish her the best in the future.” Mr. Keller continued, “Stephen is an integral part of our Sporting Goods team and we look forward to his continued leadership as we seek to grow our Sporting Goods business. We anticipate a smooth transition in the Company’s business and financial operations as Stephen assumes his expanded role.”
Escalade is a leading manufacturer and marketer of sporting goods products sold worldwide. To obtain more information on the Company and its products, visit our website at: www.EscaladeInc.com or contact Robert J. Keller, President and CEO at 812/467-1288.
FORWARD LOOKING STATEMENTS
Statements in this press release that are not historical facts are forward-looking statements that involve risks and uncertainties. These risks and uncertainties include, but are not limited to, risks relating to changes to our management team, the impact of competitive products and pricing, product demand and market acceptance, new product development, Escalade’s ability to achieve its business objectives, especially with respect to its Sporting Goods business on which it has chosen to focus, Escalade’s ability to successfully achieve the anticipated results of strategic transactions, including the integration of the operations of acquired assets and businesses and the divestiture of its Information Security and Print Finishing Segment, the continuation and development of key customer and supplier relationships, Escalade’s ability to control costs, general economic conditions, fluctuations in operating results, changes in foreign currency exchange rates, changes in the securities markets, Escalade’s ability to obtain financing and to maintain compliance with the terms of such financing, and other risks detailed from time to time in Escalade’s filings with the Securities and Exchange Commission. Copies of these filings are available from the Company and on the SEC’s website at www.sec.gov. Escalade’s future financial performance could differ materially from the expectations of management contained herein. Escalade undertakes no obligation to release revisions to these forward-looking statements after the date of this press release.
(BIOC) Launches Lung Cancer Offering
Blood-Based Liquid Biopsy Testing Launched for NSCLC Indications
SAN DIEGO, Nov. 12, 2014 — Biocept, Inc. (Nasdaq:BIOC), a molecular oncology diagnostics company specializing in biomarker analysis of circulating tumor DNA and Circulating Tumor Cells (CTCs), today announced the launch of its lung cancer liquid biopsy testing that will be performed at the Company’s CLIA-certified and CAP-accredited laboratory.
By launching blood-based biomarker testing for non-small cell lung cancer (NSCLC), along with the previously commercialized breast cancer offering, Biocept is providing options for health care providers and researchers when a tumor biopsy is not available, is unsafe to perform or when additional information is desired. For patients with recurrent or newly diagnosed metastatic lung cancer, accurate identification of genomic biomarker information is a key piece of information that clinicians need when making treatment decisions. A challenge for physicians has been availability of tissue from the surgical biopsy that is required to perform the biomarker testing. This limitation occurs as a result of tumor location or health of the patient. According to a recent study1, when lung biopsies are attempted, there is a 19.3% risk of complication such as a collapsed lung or an infection. Managing these complications quadruples the cost of care. In comparison, the cost of a simple blood draw is nominal, and poses little risk for patients, and the Company believes it has the potential to simultaneously save cost and improve outcomes for the health care system.
The Company’s first CLIA-validated assay for lung cancer will be testing for ALK fusions on CTCs captured in Biocept’s patented device. ALK is incorporated into the testing guidelines utilized by oncologists when making treatment decisions in NSCLC patients. ALK positive patients now have targeted treatment options with two key drugs that have been approved by the FDA: the first is Pfizer’s Xalkori (Crizotinib) and the second is Novartis’s Zykadia (ceritinib), and others are in development.
“The evaluation of biomarker status is the standard-of-care in determining the course of therapy for patients with lung cancer,” said Michael Nall, President and CEO of Biocept. “We are excited to be able to help physicians by providing actionable genomic information for lung cancer patients with a simple blood test.”
“A liquid biopsy, or blood based genomic test, has the advantage of being far less invasive than a surgical biopsy, therefore being appropriate for diagnostic and importantly, monitoring purposes. This gives physicians insight into the molecular status of the patient in real time so that therapeutic changes can be made for better patient outcomes,” says Lyle Arnold, SVP and Chief Scientific Officer of Biocept.
The Company currently plans to offer additional biomarkers for lung cancer that physicians use when making treatment decisions before the end of the year and during 2015, including EGFR mutations, Ros1 fusions, KRAS mutations, and EGFR and MET amplification. EGFR mutation status, like ALK, is a biomarker included in guidelines that oncologists follow to determine the best treatment plan for a patient. Patients who have EGFR mutations are eligible for Tyrosine Kinase Inhibitors such as TarcevaR from Genentech or IressaR from AstraZeneca. In addition, the Company is validating important resistance markers for these targeted therapies that they expect to be used most often when physicians are monitoring patients.
Biocept expects that some of these biomarkers will be performed on CTCs while others will be performed on circulating cell free DNA, which, if successful, has the potential to make Biocept one of the first to offer genomic analysis both on intact cells and plasma.
About Biocept, Inc.
Biocept, Inc., headquartered in San Diego, Calif., is a commercial-stage oncology diagnostics company focused on providing information on patients’ tumors to physicians using its proprietary technology platform to help improve individual patient treatment. Biocept has developed proprietary technology platforms for capture and analysis of circulating tumor DNA, both in circulating tumor cells (CTCs) and in plasma (cell free tumor DNA). A standard blood sample is utilized to provide physicians with important prognostic and predictive information to enhance individual treatment of their patients with cancer. Biocept currently offers its OncoCEE-BRTM test for breast cancer and OncoCEE-LUTM for non-small cell lung cancer and plans to introduce CLIA validated tests for colorectal, prostate and other solid tumors based on its proprietary technology platforms over the coming months.
Forward-Looking Statements Disclaimer Statement
This release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to have been correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this release are not strictly historical, including without limitation statements as to cost savings, improvement of outcomes, our impact on diagnostic strategies and planned future offerings, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our SEC filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the Securities and Exchange Commission, which can be accessed over the Internet at the SEC’s website located at www.sec.gov.
1Lokhandwala T, Dann R, Johnson M, et al. Costs of the Diagnostic Workup for Lung Cancer – A Medicare Claims Analysis. Presented at: 2014 Chicago Multidisciplinary Symposium in Thoracic Oncology; October 30-November 1, 2014; Chicago, Illinois. Presentation Number: 103.
CONTACT: Investor Contact: The Ruth Group David Burke (646) 536-7009 dburke@theruthgroup.com Media Contact: The Ruth Group Calvin Allen (646) 536-7002 callen@theruthgroup.com
(UAMY) Reports a Major Processing Agreement
United States Antimony Corporation (“USAC”, NYSE MKT “UAMY”) reported it has entered a major processing agreement with Hillgrove Mines Pty Ltd of Armidale, New South Wales, Australia for 200 metric tons per month of 60% antimony concentrates containing approximately 20 grams per ton (0.64 ounces) of gold. On a yearly basis, this would amount to approximately 3,000,000 pounds of antimony and 1,500 ounces of gold. The production should give USAC an attractive gross margin on the sale of the antimony and gold. Hillgrove will provide funding to USAC on favorable terms to expand its smelter capacity in Montana and Mexico. Construction will begin immediately and production is expected during Q1 2015. Should Hillgrove decide, the contract also provides for the further expansion of the plant for up to 9,000,000 pounds per year of antimony and 4,500 ounces of gold.
John Lawrence, CEO commented, “USAC has smelted for Hillgrove in the past and is happy to enter into an Agreement to increase USAC’s market share and enhance Hillgrove’s cash flow. USAC’s antimony production remains in a sold out condition.”
Forward Looking Statements:
This Press Release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934 that are based upon current expectations or beliefs, as well as a number of assumptions about future events, including matters related to the Company’s operations, pending contracts and future revenues, ability to execute on its increased production and installation schedules for planned capital expenditures and the size of forecasted deposits. Although the Company believes that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, it can give no assurance that such expectations and assumptions will prove to have been correct. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties. In addition, other factors that could cause actual results to differ materially are discussed in the Company’s most recent filings, including Form 10-KSB with the Securities and Exchange Commission.
United States Antimony Corporation
John Lawrence, 406-827-3523
tfl3543@blackfoot.net
(AKBA) Poster Presentations at the Upcoming American Society of Nephrology Kidney Week
Akebia Therapeutics, Inc. (NASDAQ:AKBA), a biopharmaceutical company focused on delivering innovative therapies to patients with kidney disease through the biology of hypoxia inducible factor (HIF), today announced that data from the AKB-6548 development program will be presented in two poster sessions at the upcoming American Society of Nephrology (ASN) Kidney Week 2014 annual meeting in Philadelphia, PA from November 11-16, 2014.
Poster session details:
Thursday, November 13 – Saturday, November 15, 2014
Title: Phase 2a Study of AKB-6548, a novel Hypoxia-Inducible Factor Prolyl-Hydroxylase Inhibitor (HIF-PHI) in Patients with End Stage Renal Disease (ESRD) Undergoing Hemodialysis (HD) (Poster Board #:INFO25)
Poster Times: 9:30 a.m. – 2:30 p.m. Eastern Time
Location: Exhibit Hall A
Friday, November 14, 2014
Title: Hemodialysis has Minimal Impact on the Pharmacokinetics of AKB-6548, a Once-Daily Oral Inhibitor of Hypoxia Inducible Factor Prolyl-Hydroxylases (HIFPHs) for the Treatment of Anemia Related to Chronic Kidney Disease (CKD) (Poster Board #:FR-PO952)
Session Title: Pharmacokinetics/Pharmacodynamics/Pharmacogenomics
Poster Time: 10:00 a.m. – 12:00 p.m. Eastern Time
Location: Exhibit Hall A
The clinical posters will be available on Akebia’s website (www.akebia.com) in the Media section under the Publications tab.
About AKB-6548
AKB-6548 is a once-daily, oral therapy currently in development for the treatment of anemia related to CKD. AKB-6548 is designed to stabilize HIF, a transcription factor that regulates the expression of genes involved with red blood cell (RBC) production in response to changes in oxygen levels, by inhibiting the hypoxia-inducible factor prolyl hydroxylase (HIF-PH) enzyme. AKB-6548 exploits the same mechanism of action used by the body to naturally adapt to lower oxygen availability associated with a moderate increase in altitude. At higher altitudes, the body responds to lower oxygen availability with increased production of HIF, which coordinates the interdependent processes of iron mobilization and erythropoietin (EPO) production to increase RBC production and, ultimately, improve oxygen delivery.
As a HIF stabilizer with best-in-class potential, AKB-6548 may raise hemoglobin levels and RBC count predictably and sustainably, with a positive safety profile and a dosing regimen that allows for a gradual and controlled titration. Furthermore, AKB-6548 may improve iron mobilization, potentially eliminating intravenous iron administration and reducing the overall need for iron supplementation.
About Anemia Related to CKD
Approximately 30 million people in the United States have CKD, with an estimated 1.8 million of these patients suffering from anemia. Anemia results from the body’s inability to coordinate RBC production in response to lower oxygen levels due to the progressive loss of kidney function, which occurs in patients with CKD. Left untreated, anemia significantly accelerates patients’ overall deterioration of health with increased morbidity and mortality. Renal anemia is currently treated with injectable rESAs, which are associated with inconsistent hemoglobin responses and well-documented safety risks.
About Akebia Therapeutics
Akebia Therapeutics, Inc. is a biopharmaceutical company headquartered in Cambridge, Massachusetts, focused on delivering innovative therapies to patients with kidney disease through HIF biology. Akebia’s lead clinical program, AKB-6548, is a once-daily, oral therapy, which has completed a Phase 2b study in non-dialysis patients with anemia related to CKD and is in Phase 2 development for the treatment of anemia in patients undergoing dialysis, serious medical conditions that lead to increased morbidity and mortality if left untreated. For more information on Akebia, please visit please visit www.akebia.com.
Investors:
Akebia Therapeutics, Inc.
Nicole P. Jones, +1-617-871-1210
Senior Director, Investor Relations and Corporate Communications
njones@akebia.com
or
Media:
Feinstein Kean Healthcare
Liz Falcone, +1-617-761-6727
liz.falcone@fkhealth.com
(MTEX) Announces Official Completion of the M5M℠ China Run
Mannatech®, Incorporated (NASDAQ: MTEX), the pioneer of nutritional glycobiology, leading innovator of naturally-sourced supplements based on Real Food Technology® solutions, and creator of the M5M (Mission 5 MillionSM) social entrepreneurial movement, announced today that on October 28, 2014, ultra-endurance athlete Jason Lester officially passed the finish line of the M5M China Run. Lester became the first person in history to complete a solo run of 2,500 miles across the Great Wall of China in 100 days or less to raise awareness of the global epidemic of childhood malnutrition.
The run officially began on August 8, 2014 in Jiayuguan, in the Gansu province of China. Around midday on day 83 of the run, Lester crossed the finish line at the Shanhaiguan District Old Dragons Head entrance in Qinhuangdao, Hebei province, officially completing the 2,500-mile journey. Lester’s goal was to finish the run within 100 days, requiring an average daily trek equivalent to almost a full marathon per day. After increasing his daily runs to double marathons at times, he was able to accomplish this feat with 17 days to spare.
Mannatech has partnered with Lester as the title sponsor of the M5M China Run as a part of their ongoing Mission 5 Million, or M5M, movement. The goal of M5M is to connect five million children in need of proper nutrition with five million consumers of Mannatech products. As a social entrepreneurial company, Mannatech donates servings of its proprietary PhytoBlend™ powder to at-risk children all over the world every time a consumer purchases product for themselves on automatic order. According to recent reports by the World Health Organization, approximately five million children under the age of 5 die every year due to causes linked to malnutrition. As the title sponsor, Mannatech is hoping to bring this catastrophic reality to the forefront and inspire the world to take action.
Lester has previously run 3,500 miles from San Francisco to New York in 2013 to raise awareness and support for the victims of Hurricane Sandy; and in 2011 he biked and ran 5,000 miles across the United States for Nike’s “Journey for a Better World” campaign. Lester is an endorser of Mannatech products and is “Powered by Ambrotose,” Mannatech’s uniquely patented immune system support product containing Manapol® powder with aloe vera gel extract. He credits glyconutrient technology and Ambrotose as being his “secret weapons” in competitions and training.
“We are very proud of Jason Lester for achieving such a monumental feat and are grateful for the impact he made on the M5M movement,” said Mannatech President Al Bala. “His ambitious drive to be better and make the world a better place matches Mannatech’s desire to see childhood malnutrition come to an end through perseverance and commitment to daily challenges such as Jason Lester’s 100-Day Challenge. Through his efforts in bringing awareness to this cause, we are able to tackle the great wall of malnutrition head on with hope of seeing it overcome.”
To learn more about Mannatech and the M5M China Run, visit Mannatech.com.
About Mannatech
Mannatech, Incorporated, develops high-quality health, weight and fitness, and skin care products that are based on the solid foundation of nutritional science and development standards. Mannatech is dedicated to its platform of Social Entrepreneurship based on the foundation of promoting, aiding and optimizing nutrition where it is needed most around the world. Mannatech’s proprietary products are available through independent sales Associates around the globe including the United States, Canada, South Africa, Australia, New Zealand, Austria, Denmark, Germany, Norway, Sweden, the Netherlands, the United Kingdom, Japan, Taiwan, Singapore, Estonia, Finland, the Republic of Ireland, Czech Republic, the Republic of Korea, Mexico, Namibia and Hong Kong. For more information, visit Mannatech.com.
Please note: This release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, as amended, Section 21E of the Securities Exchange Act of 1934, as amended, and the Private Securities Litigation Reform Act of 1995. These forward-looking statements generally can be identified by use of phrases or terminology such as “believe,” “intend” or other similar words or the negative of such terminology. Similarly, descriptions of Mannatech’s objectives, strategies, plans, goals or targets contained herein are also considered forward-looking statements. Mannatech believes this release should be read in conjunction with all of its filings with the United States Securities and Exchange Commission and cautions its readers that these forward-looking statements are subject to certain events, risks, uncertainties and other factors. Some of these factors include, among others, Mannatech’s inability to attract and retain Associates and Members, increases in competition, litigation, regulatory changes and its planned growth into new international markets. Although Mannatech believes that the expectations, statements and assumptions reflected in these forward-looking statements are reasonable, it cautions readers to always consider all of the risk factors and any other cautionary statements carefully in evaluating each forward-looking statement in this release, as well as those set forth in its latest Annual Report on Form 10-K and Quarterly Report on Form 10-Q, and other filings filed with the United States Securities and Exchange Commission, including its current reports on Form 8-K. All of the forward-looking statements contained herein speak only as of the date of this release.
Mannatech, Incorporated
Raquel Mooring, 972-471-1532
rmooring@mannatech.com
(FOSL) & Michael Kors Renew Global Licensing Agreement for Watches & Jewelry
LONDON and RICHARDSON, Texas, Nov. 11, 2014 — Michael Kors Holdings Limited (NYSE:KORS) and Fossil Group, Inc. (Nasdaq:FOSL) announced today that they have renewed their global licensing agreement through 2024.
Michael Kors, a global luxury lifestyle brand, first partnered with Fossil Group, a global design, marketing and distribution company specializing in fashion accessories, in 2004 to design, develop and distribute watches under the Michael Kors label. The relationship expanded to encompass jewelry in 2010 and the two companies are currently collaborating to grow the men’s watch business.
Kosta Kartsotis, Chief Executive Officer of Fossil Group, commented: “We are very proud of our partnership with the Michael Kors brand and our role in contributing to the brand’s explosive growth over the years. This global licensing agreement allows us to further grow the Michael Kors brand and extensive line of watches and jewelry and explore other opportunities in the accessories category. We are pleased to extend our partnership and look forward to collaborating for years to come.”
John D. Idol, Chairman and Chief Executive Officer of Michael Kors, said: “We are very pleased to continue our partnership with the Fossil Group. Accessories are central to the Michael Kors brand DNA, and we will continue to build on that positioning as we grow globally. Fossil’s position as a leader in the global watch market has made them an ideal partner in the design and development of innovative watches and jewelry that capture the sophistication, energy and style of the Michael Kors lifestyle. We have enormous confidence in the future growth of our relationship and the many opportunities that lie ahead.”
Forward-Looking Statements
This press release contains forward-looking statements about Michael Kors and Fossil Group. You should not place undue reliance on such statements because they are subject to numerous uncertainties and factors relating to the operations and business environment of each company, all of which are difficult to predict and many of which are beyond such company’s control. Forward-looking statements include information concerning each company’s possible or assumed future results of operations, including descriptions of its business strategy. These statements often include words such as “may,” “will,” “should,” “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions. The forward-looking statements contained in this press release are based on assumptions that each company has made in light of management’s experience in the industry as well as its perceptions of historical trends, current conditions, expected future developments and other factors that it believes are appropriate under the circumstances. You should understand that these statements are not guarantees of performance or results. They involve known and unknown risks, uncertainties and assumptions. Although each company believes that these forward-looking statements are based on reasonable assumptions, you should be aware that many factors could affect its actual financial results or results of operations and could cause actual results to differ materially from those in these forward-looking statements. Please refer to both companies respective annual filings with the U.S. Securities and Exchange Commission for a complete list of risk factors.
About Michael Kors
Michael Kors is a world-renowned, award-winning designer of luxury accessories and ready-to-wear. His namesake company, established in 1981, currently produces a range of products through his Michael Kors and MICHAEL Michael Kors labels, including accessories, footwear, watches, jewelry, men’s and women’s ready-to-wear, and a full line of fragrance products. Michael Kors stores are operated, either directly or through licensing partners, in some of the most prestigious cities in the world, including New York, Beverly Hills, Chicago, London, Milan, Paris, Munich, Istanbul, Dubai, Seoul, Tokyo and Hong Kong.
About Fossil Group, Inc.
Fossil Group, Inc. is a global design, marketing and distribution company that specializes in consumer lifestyle and fashion accessories. The Company’s principal offerings include an extensive line of men’s and women’s fashion watches and jewelry sold under a diverse portfolio of proprietary and licensed brands, handbags, small leather goods, accessories and clothing. The Company’s products are sold to department stores, specialty retail stores and specialty watch and jewelry stores in the U.S. and in approximately 150 countries worldwide through approximately 25 Company-owned foreign sales subsidiaries and a network of over 60 independent distributors. The Company also distributes its products in over 580 Company-owned and operated retail stores, through its international e-commerce websites and through the Company’s U.S. e-commerce website at www.fossil.com. Certain press release and SEC filing information concerning the Company is also available at www.fossilgroup.com.
CONTACT: Investor Relations: Eric M. Cerny FOSSIL GROUP, Inc. (855) 336-7745 Allison Malkin ICR, Inc. (203) 682-8225 Krystyna Lack VP, Treasurer Michael Kors (201) 691-6133 InvestorRelations@MichaelKors.com Jean Fontana ICR, Inc. (646) 277-1214 Public Relations: Theresa Palermo FOSSIL GROUP, Inc. (469) 730-7065 Alecia Pulman ICR, Inc. (203) 682 8224
(JRJC) Announces New Partnership with Great Wall Securities
BEIJING, Nov. 11, 2014 — China Finance Online Co. Limited (“China Finance Online”, or the “Company”) (NASDAQ GS: JRJC), a leading web-based financial services company that provides Chinese retail investors online access to securities, commodities and wealth management products, today announced that it has entered into a strategic partnership agreement with Great Wall Securities Co. Limited (“Great Wall Securities”), to integrate Great Wall Securities’ backend systems with China Finance Online’s web-based trading platform, “Securities Master,” or “Zhengquantong.” Along with the Company’s partnerships with CITIC Securities Co., Ltd. and Zhongshan Securities Co., Ltd., each of which has already gone live, the strategic partnership with Great Wall Securities will allow China Finance Online to continue to enhance its platform’s depth by providing more comprehensive products and services and to further expand its broad user base.
Great Wall Securities was founded in 1995 and is one of the oldest nation-wide comprehensive securities firms in China. In 2013, it was awarded, among others, the “Best Investment Advisory Brand of China” and “Research Institution with Highest Potential.”
China Finance Online’s new partnership with Great Wall Securities will allow customers to open online accounts and to trade real-time. In addition, Great Wall Securities will be able to provide its new users from the Company’s Securities Master platform with several high-quality financial advisory services.
“We are happy to announce this new partnership at this encouraging moment where the well-anticipated Shanghai-Hong Kong Stock Connect will soon be launched,” stated Zhiwei Zhao, Chairman and CEO of China Finance Online. “With Chinese government’s accelerated opening of capital markets, our Company will take advantage of waves of regulatory change and keep standing at the forefront of financial innovations.”
About China Finance Online
China Finance Online Co. Limited is a leading web-based financial services company that provides Chinese retail investors access to stocks, commodities and wealth management products. The Company’s two prominent flagship portal sites, www.jrj.com and www.stockstar.com, are ranked as top financial websites in China. Through Securities Master and Yinglibao platforms, China Finance Online is a pioneer in China in providing integrated online securities trading and wealth management services.
In addition to the web-based securities trading platform, the Company offers financial software, information services and securities investment advisory services to retail investors in China. Through its subsidiary, Shenzhen Genius Information Technology Co. Ltd., the Company provides financial database and analytics to institutional customers including domestic financial, research, academic and regulatory institutions. China Finance Online also provides brokerage services in Hong Kong.
Safe Harbor Statement
This press release contains forward-looking statements. These statements constitute “forward-looking” statements within the meaning of Section 21E of the Securities Exchange Act of 1934, as amended, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements can be identified by terminology such as “will,” “expects,” “anticipates,” “future,” “intends,” “plans,” “believes,” “estimates” and similar statements. Among other things, this release contains the following forward-looking statements regarding:
- our prospect on the web-based stock trading platform, Securities Master, and its integration with Great Wall Securities’ backend systems;
- our prospect on the growth of our financial platform and online trading capabilities;
- our prospect on enhancing the depth of the Securities Master platform by providing more comprehensive products and services and expanding its user base;
- our prospect on our partnership with Great Wall Securities;
- our prospect on continuing to create financial innovations; and
- the market prospect of the business of internet finance.
Such statements involve certain risks and uncertainties that could cause actual results to differ materially from those in the forward-looking statements, which risks and uncertainties include, among others, the following:
- the changing customer needs, regulatory environment and market condition that we are subject to;
- the uneven condition of the world and Chinese economy that could lead to volatility in the equity markets and affect our operating results in the coming quarters;
- the impact of the changing conditions of the Chinese stock market, Hong Kong stock market and global financial market on our future performance;
- the degree to which our strategic collaborations with partners will yield successful outcome;
- the prospect of integrating our newly launched web-based securities trading platform with our strategic partners’ trading and settlement and backend system(s);
- the prospect for China’s high-net-worth and middle-class households;
- the prospect of equipping our customer specialists with new technology, tools and financial knowledge;
- the competition we are facing in the new business of internet finance and online securities trading;
- wavering investor confidence that could impact our business; and
- possible non-cash goodwill, intangible assets and investment impairment may adversely affect our net income.
Further information regarding these and other risks is included in the Company’s filings with the U.S. Securities and Exchange Commission, including its annual report on Form 20-F under “Forward-Looking Information” and “Risk Factors”. The Company does not undertake any obligation to update any forward-looking statement as a result of new information, future events or otherwise, except as required under applicable law.
Contact:
China Finance Online Co. Limited
Julie Zhu
+86-10-5832-5288
ir@jrj.com
(NETE) Releases New Version of Aptito POS Platform
Newly Released Platform Adds Offline Mode, Business Management and Analytics
MIAMI, Nov. 11, 2014 — Net Element, Inc. (NASDAQ: NETE) (“Net Element” or the “Company”), a technology-driven group specializing in mobile payments and value-added transactional services in emerging countries and in the United States, today announced a new version of Aptito (“Aptito 2.0”). This cloud based, point of sale (POS) platform for the hospitality industry has been optimized for iOS 8.1 and upgraded to add many new features, including business management and analytics.
Aptito 2.0 represents a significant overall improvement over previous versions and includes the following upgrades:
- Offline Mode. This hybrid architecture allows merchants to always remain online, even if the Internet connection is lost to the cloud. Net Element’s local server solution is synchronized with Amazon cloud, providing 99.99% uptime.
- Interactive Ordering Kiosk. Aptito’s stand-alone kiosks put the eye-catching digital menu in front of customers and helps them avoid waiting in line during busy peak hours.
- Digital Menu Module. Aptito’s digital menus make self-ordering fun and easy while streamlining operations. The intuitive interface improves the overall “Customer Experience” for guests while saving money on labor costs at the same time.
- Tableside Ordering. Orders placed tableside by customers directly speed up the process and improve overall efficiency. Aptito’s next generation mobile POS system provides portability to your staff while performing all the same functions as a traditional POS system, and more.
- Business management and Analytics. Business management functions of Aptito 2.0 alongside with Unified Insights, which was announced earlier this year, cover many different business management, market sales and revenue analytics required by the most demanding business owners and historically available only to large national merchants.
“We are proud to introduce this innovative platform, which supports the latest technologies and state-of–the-art business analytics and management tools historically not available to SME sector,” said Oleg Firer, Chief Executive Officer of Net Element. “All of our packages can be configured individually to suit virtually any business owner and are significantly cheaper than conventional PC-based POS packages while offering a stable Apple iOS platform.”
About Net Element
Net Element (NASDAQ: NETE) is a global technology-driven group specializing in mobile payments and value-added transactional services. The Company owns and operates a global mobile payments and transaction processing provider, TOT Group. TOT Group companies include Unified Payments, recognized by Inc. Magazine as the #1 Fastest Growing Private Company in America in 2012; Aptito, a next generation cloud-based point of sale payments platform; and TOT Money, which has a leading position in Russia and has been ranked as the #1 SMS content provider by Beeline, Russia’s second largest telecommunications operator. Together with its subsidiaries, Net Element enables ecommerce and adds value to mobile commerce environments. Its global development centers and high-level business relationships in the United States, Russia and Commonwealth of Independent States strategically position the Company for continued growth. More information is available at www.netelement.com.
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 Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element or its business continues to grow, whether the release of the new version of the Aptito product will have a positive effect on the Company’s business and whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element ‘s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element ‘s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element ‘s ability to successfully expand in existing markets and enter new markets; (iv) Net Element ‘s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element ‘s business; (viii) changes in government licensing and regulation that may adversely affect Net Element ‘s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element ‘s business; (x) Net Element ‘s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.
(ARQL) Positive Top-Line Results of NIH-Sponsored Phase 2 Trial of Tivantinib in Prostate Cancer
ArQule, Inc. (NASDAQ: ARQL) today announced positive top-line results from a randomized, double-blind, placebo-controlled Phase 2 clinical trial of tivantinib as a single agent in metastatic prostate cancer. This trial (clinicaltrials.gov identifier NCT01519414) was conducted under a Cooperative Research and Development Agreement (CRADA) with the National Cancer Institute’s Cancer Therapy Evaluation Program (CTEP) (“A Randomized, Double-Blind, Placebo-Controlled Phase 2 Study of ARQ 197 (tivantinib) in Men with Asymptomatic or Minimally Symptomatic Metastatic Castrate Resistant Prostate Cancer,” NCI Protocol # 8986). The principal investigator was J. Paul Monk, M.D. of The Ohio State University, Arthur G. James Cancer Hospital and Solove Research Institute.
In this trial, 78 patients were randomized 2 to 1 to receive either tivantinib as a single agent or placebo. During a pre-planned analysis, it was found that the trial met its primary endpoint of improving median progression-free survival (PFS) with tivantinib alone as compared to placebo. The results were highly statistically significant. Safety data were consistent with those observed in other trials of tivantinib.
The results of the trial are the subject of ongoing analyses and will be submitted by the investigators for presentation at a future medical conference. As final data emerge from this trial, ArQule and its partner, Daiichi Sankyo Company, Limited, will discuss with the National Institutes of Health (NIH) the potential for additional trials in this indication.
“We are pleased that these significant findings from the NIH trial in prostate cancer add to the body of clinical evidence of the anti-cancer activity of tivantinib across multiple tumor types,” said Paolo Pucci, chief executive officer of ArQule.
“Our CRADA reflects our shared commitment with the NCI to continue to explore the clinical potential of tivantinib in tumor types beyond the compound’s lead indication, hepatocellular carcinoma (HCC), currently in Phase 3 clinical trials,” said Mr. Pucci.
Uncontrolled, signal generation data from additional NIH-sponsored trials with tivantinib in breast cancer and multiple myeloma did not meet their primary endpoint of response rate. As a result, the Company does not plan to prioritize development in these indications at this time.
About the NCI Protocol # 8986 Trial
This study is a randomized Phase 2 trial in which men with asymptomatic or minimally symptomatic metastatic castrate resistant, chemotherapy-naïve prostate cancer were randomized 2 to 1 to receive tivantinib 360 milligrams BID or placebo. The primary objective of the trial is PFS. Secondary objectives include PSA response rate at 12 weeks, radiographic response rate at 12 weeks, proportion of patients who are progression-free at 12 weeks, and safety and tolerability.
The study is designed to detect an improvement in the median PFS from 3 months to 6 months with tivantinib treatment. The proposed sample of 78 patients (26 in the placebo arm, 52 in the tivantinib arm) provides 90 percent power to detect an improvement from 3 months median PFS with placebo to a median PFS of at least 6 months with tivantinib. This design is based on the assumption of having 58 cumulative events (progressions or deaths).
About Tivantinib and the MET pathway
Tivantinib is an orally administered, selective inhibitor of MET, a receptor tyrosine kinase. Tivantinib is currently in Phase 3 development and has not yet been approved in any market. In healthy adult cells, MET is present in normal levels to support natural cellular function, but in cancer cells MET is inappropriately and continuously activated for unknown reasons. When abnormally activated, MET plays multiple roles in aspects of human cancer, including cancer cell growth, survival, angiogenesis, invasion and metastasis.
About ArQule and Daiichi Sankyo Co., Ltd.
In December 2008, ArQule and Daiichi Sankyo signed a license, co-development and co-commercialization agreement for tivantinib (ARQ 197) in the U.S., Europe, South America and the rest of the world, excluding Japan, China (including Hong Kong), South Korea and Taiwan.
About ArQule
ArQule is a biotechnology company engaged in the research and development of next-generation, small-molecule cancer therapeutics. The Company’s targeted, broad-spectrum products and research programs are focused on key biological processes that are central to human cancers. ArQule’s lead product, in Phase 2 and Phase 3 clinical development, is tivantinib (ARQ 197), an oral, selective inhibitor of the c-MET receptor tyrosine kinase. The Company’s pipeline includes: ARQ 092, designed to inhibit the AKT serine/threonine kinase, and ARQ 087, a multi-kinase inhibitor designed to preferentially inhibit the fibroblast growth factor receptor (FGFR) family. ArQule’s current discovery efforts are focused on the identification of novel kinase inhibitors, leveraging the Company’s proprietary library of compounds.
This press release contains forward-looking statements regarding the Company’s clinical trials with tivantinib (ARQ 197), including clinical trials in prostate cancer, and as well as its ability to fund operations with current cash and marketable securities. These statements are based on the Company’s current beliefs and expectations, and are subject to risks and uncertainties that could cause actual results to differ materially. Positive information about pre-clinical and early stage clinical trial results, including in prostate cancer, does not ensure that later stage or larger scale clinical trials will be successful. For example, tivantinib may not demonstrate promising therapeutic effect; in addition, it may not demonstrate appropriate safety profiles in current or later stage or larger scale clinical trials as a result of known or as yet unanticipated side effects. The results achieved in later stage trials may not be sufficient to meet applicable regulatory standards or to justify further development. Problems or delays may arise during clinical trials or in the course of developing, testing or manufacturing these compounds that could lead the Company or its partners, including the National Institutes of Health, to discontinue development. Even if later stage clinical trials are successful, unexpected concerns may arise from subsequent analysis of data or from additional data. Obstacles may arise or issues may be identified in connection with review of clinical data with regulatory authorities. Regulatory authorities may disagree with the Company’s view of the data or require additional data or information or additional studies. In addition, the planned timing of initiation and completion of clinical trials for tivantinib is subject to the ability of the Company as well as Daiichi Sankyo, Inc. and Kyowa Hakko Kirin, a licensee of tivantinib, to enroll patients, enter into agreements with clinical trial sites and investigators, and overcome technical hurdles and other issues related to the conduct of the trials for which each of them is responsible. There is a risk that these issues may not be successfully resolved. In addition, we and our partners are utilizing a companion diagnostic to identify MET-high patients in the METIV-HCC and JET-HCC trials, and we may encounter difficulties in developing and obtaining approval for companion diagnostics, including issues relating to selectivity/specificity, analytical validation, reproducibility, or clinical validation. Any delay or failure by our collaborators to develop or obtain regulatory approval of the companion diagnostics could delay or prevent approval of our product candidates. Drug development involves a high degree of risk. Only a small number of research and development programs result in the commercialization of a product. Positive pre-clinical data may not be supported in later stages of development. Furthermore, ArQule may not have the financial or human resources to successfully pursue drug discovery in the future. Moreover, with respect to partnered programs, even if certain compounds show initial promise, Daiichi Sankyo or Kyowa Hakko Kirin may decide not to license or continue to develop them, as the case may be. In addition, Daiichi Sankyo and Kyowa Hakko Kirin have certain rights to unilaterally terminate their agreements with ArQule. If either company were to do so, the Company might not be able to complete development and commercialization of the applicable licensed products on its own. For more detailed information on the risks and uncertainties associated with the Company’s drug development and other activities, see the Company’s periodic reports filed with the Securities and Exchange Commission. The Company does not undertake any obligation to publicly update any forward-looking statements.
ArQule, Inc.
William B. Boni, 781-994-0300
VP, Investor Relations/
Corp. Communications
www.ArQule.com
(PCMI) Announces Launch of New Websites
PCM, Inc. (NASDAQ:PCMI) today announced the launch of its new websites for the PCM and PCMG brands. The PCM.com and PCMG.com websites went live recently, replacing the previous sites with a fresh and newly streamlined look and more user-friendly functionality. The new sites have been designed to be clean, simple to navigate and deliver a faster browsing experience.
The PCM and PCMG websites have been rebuilt from the inside out. Customers are able to enjoy enhanced search options and improved product pages, all while browsing in a clean, easy to follow format. Among the newly redesigned features are: a new directory menu, quick and easy navigation, enhanced product search and a new blog featuring a constant stream of relevant IT news topics.
PCMG’s customers in Federal, state and local government agencies and educational institutions will now be able to more easily identify content and solutions designed to address their segment specific requirements. Additionally, through streamlined site segmentation, public sector customers will be able to better leverage the power of PCMG contracts available to them with more robust filters to vehicles and cooperative partnerships.
“The new PCM redesign allows us to better promote our products, solutions and services to our different market segments. We’ve simplified our navigation menu so our customers can quickly identify portions of the site relevant to their organization’s needs. We’ve also enhanced the UI of our search results page – It’s now much easier for our customers to find, filter, compare and get the products they are looking for. This first phase of the redesign was to build the foundation for all the new and innovative features we plan on implementing in the near future. The second phase of the redesign will include a more robust shopping funnel that will provide intelligent and relevant product, solutions and services recommendations. We’re really excited about this launch and can’t wait to get started on the second phase of the redesign,” said Anthony Layug, VP Advertising & Creative of PCM Logistics.
PCM also makes available to its Commercial and Public Sector customers customized extranets that allow them the flexibility to have custom catalogs and pricing, as well as secure work flow to support e-procurement, invoicing and a host of other features.
About PCM, Inc.
PCM, Inc., through its wholly-owned subsidiaries, is a leading technology solutions provider to small and medium sized businesses, mid-market and enterprise customers, government and educational institutions and individual consumers. In the 12 months ended September 30, 2014, we generated approximately $1.4 billion in revenue and now have approximately 2,800 employees, 64% of which are in sales or service positions. For more information please visit investor.pcm.com or call (310) 354-5600.
Genesis Select Corporation
Budd Zuckerman, 303-415-0200
(LIOX) To Acquire CLS Communication
Market-Leading Translation Solutions Company with $85 Million of Recurring Revenue in Financial Services, Industrial, and Public Sector Markets Accelerates Lionbridge End Market Diversification
WALTHAM, Mass., Nov. 10, 2014 — Lionbridge Technologies, Inc. (Nasdaq: LIOX) today announced a definitive agreement to acquire CLS Communication, a privately-held provider of translation solutions to clients in the financial services, industrial, public sector and life sciences markets. The combination of Lionbridge and CLS will address growing demand for integrated, technology-enabled translation solutions that allow organizations to create, translate and manage digital content worldwide.
Lionbridge expects to purchase CLS Communication for approximately 74 million Swiss Francs, or approximately $77 million US Dollars in cash, subject to estimated cash and debt adjustments at closing and certain post-closing adjustments. The acquisition is being funded using Lionbridge’s existing cash and a new credit facility through its long-standing banking partner, HSBC, who is acting as the leading syndicator.
“As organizations continue to expand their online engagement across geographies and channels, the demand for integrated, global-scale translation services is accelerating,” said Rory Cowan, CEO, Lionbridge. “CLS is the ideal partner for Lionbridge with a proven track record of providing high-quality professional solutions to clients in diverse, highly-regulated industries. With highly complementary geographic reach and vertical market expertise, we believe this business combination positions Lionbridge as the clear market leader in global translation and content solutions worldwide.”
Headquartered in Zurich, Switzerland, with operations in 10 countries in Europe, North America and Asia, CLS provides Lionbridge with complementary geographic coverage and several long-standing, multi-million dollar relationships with clients in the financial services, industrial, public sector and life sciences markets. The Company has approximately 600 professionals including global program managers, linguists and language technology experts who create, optimize and translate highly complex technical, marketing and regulatory content for world leading brands.
“CLS realizes significant benefits by joining forces with Lionbridge,” said Matthias Trumpy, CEO of CLS Communication. “We expect to gain additional market presence and a proven global delivery platform to complement our existing operations. Our employees and clients will benefit from becoming part of a larger organization with a broader suite of solutions that span the full lifecycle of global content.”
Details about the announcement can be found on the announcement page on Lionbridge.com here.
Lionbridge expects the acquisition to close in the first quarter of 2015.
“As we focus on deploying our language technology, optimizing our combined operations, and reducing redundant overhead costs, we expect rapid synergies of the combined business. This allows us to accelerate our path to double digit EBITDA margin in 2016 as a combined business and accelerate our end market diversification,” continued Cowan.
The acquisition is expected to be accretive to non-GAAP earnings by approximately $0.07 to $0.12 per share in 2015 and accretive to non-GAAP earnings by approximately $0.17 to $0.22 per share in 2016 depending on tax and timing of synergies. The Company defines non-GAAP adjusted earnings as net income excluding merger, restructuring and acquisition-related charges, amortization of acquisition-related intangible assets, and stock-based compensation. The financial impact of the acquisition is presented on a non-GAAP basis, as GAAP acquisition-related charges, including, but not limited to, amortization of purchased intangible assets and potential restructuring charges, are not currently determinable.
Union Square Advisors LLC is serving as exclusive financial advisor, and VISCHER Ltd. is serving as legal advisor to Lionbridge. William Blair & Company is serving as financial advisor, and Wenger & Vieli AG is serving as legal advisor to CLS.
Purchase price is based on based on CHF/USD exchange rate of 1.035.
Non-GAAP Financial Measures
In this release, the Company’s adjusted earnings and adjusted earnings per share are not presented in accordance with generally accepted accounting principles (GAAP) and are not intended to be used in lieu of GAAP presentations of results of operations. These measures are presented because management believes they provide additional information to investors with respect to the performance of our fundamental business activities. “Adjusted earnings” and “Adjusted Earnings per Share (EPS)” are Non-GAAP financial measures and should not be viewed as alternatives to GAAP measures of performance. Management believes the most directly comparable GAAP financial measure for these measures are net income and diluted net income per share.
About Lionbridge
Lionbridge enables more than 800 world-leading brands to increase international market share, speed adoption of products and effectively engage their customers in local markets worldwide. Using our innovative cloud technology platforms and our global crowd of more than 100,000 professional cloud workers, we provide translation, online marketing, global content management and application testing solutions that ensure global brand consistency, local relevancy and technical usability across all touch points of the customer lifecycle. Based in Waltham, Mass., Lionbridge maintains solution centers in 26 countries. To learn more, visit http://www.lionbridge.com.
Forward-Looking Statements
This press release contains forward-looking statements that involve risks and uncertainties, including expectations for growing demand for the combined companies, Lionbridge’s leadership position after the CLS acquisition, expected sales channels and delivery platform for CLS after the transaction, the expected purchase price and timing to complete the acquisition of CLS, expected synergies of the combined companies, expected revenue for 2015 and earnings 2015 and 2016 related to the acquisition of CLS and expected EBITDA of the combined company in 2016. Lionbridge’s actual experiences, actions, financial and operating results may differ materially from those discussed in the forward-looking statements. Factors that might cause such a difference include the termination of customer contracts prior to the end of their term; integration expense; reorganization or restructuring initiatives of one or more major clients or customers, which may impact such customer’s demand or requirements for Lionbridge’s services; the ability of Lionbridge to integrate acquisitions and expand its customer relationships and the timing and success of such activities; the impact of foreign currency fluctuations on revenue, margins, costs, operating results and profitability Lionbridge’s dependence on clients’ product releases and production schedules to generate revenues; the loss of a major client or customer; the size, timing and recognition of revenue from major clients; customer delays or postponements of services; risks associated with management of growth, transition and integration; the failure to keep pace with the rapidly changing requirements of its clients; Lionbridge’s ability to attract and retain key personnel; costs associated with and consequential to the acquisition and integration of CLS Communications and benefits realized from the acquisition; risks associated with competition and competitive pricing pressures; and Lionbridge’s ability to forecast revenue and operating results. For a more detailed description of the risk factors associated with Lionbridge, please refer to the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and subsequent filings with the SEC (copies of which may be accessed through the SEC’s website at http://www.sec.gov).
Contacts:
Sara Buda
Lionbridge Technologies
sara.buda@lionbridge.com
Tel. +1-978-964-1404
Matthias Trumpy
CLS Communication
Mai: info-ch@cls-communication.com
Tel. +41 44 206 68 68
(XENE) Announces Closing of IPO
BURNABY, British Columbia, Nov. 10, 2014 — Xenon Pharmaceuticals Inc. (Nasdaq:XENE), a clinical-stage biopharmaceutical company, today announced the closing of its previously announced initial public offering of 4,600,000 of its common shares at a price to the public of $9.00 per share. The common shares sold include 600,000 common shares sold pursuant to the option to purchase additional shares granted by Xenon Pharmaceuticals to the underwriters, which was exercised in full.
Jefferies LLC and Wells Fargo Securities, LLC acted as joint book-running managers for the offering. Canaccord Genuity Inc. acted as co-manager.
A registration statement relating to this offering of common shares was declared effective by the Securities and Exchange Commission on November 4, 2014, and the offering was also qualified by a prospectus filed in each of British Columbia, Alberta and Ontario.
The offering of these securities was made only by means of a prospectus, copies of which may be obtained from Jefferies LLC, Equity Syndicate Prospectus Department, 520 Madison Avenue, 2nd Floor, New York, NY 10022, or by telephone at (877) 547-6340, or by email at Prospectus_Department@Jefferies.com; or Wells Fargo Securities, LLC, Equity Syndicate Department, 375 Park Avenue, New York, NY 10152, or by telephone at (800) 326-5897, or by email at cmclientsupport@wellsfargo.com, and a Canadian prospectus, a copy of which may be obtained from Canaccord Genuity Corp. Attn: Syndication, 161 Bay Street, Suite 3000 Toronto, ON M5J 2S1, or by telephone at (416) 869-7398 or by email at ecm@canaccordgenuity.com.
This press release shall not constitute an offer to sell or the solicitation of an offer to buy, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such jurisdiction.
CONTACT: Xenon Pharmaceuticals Contact Information: Ian Mortimer Chief Financial Officer Xenon Pharmaceuticals Inc. Phone: 604.484.3300 Email: investors@xenon-pharma.com
(OREX) Reports Q3 Results
SAN DIEGO, Nov. 10, 2014 — Orexigen® Therapeutics, Inc. (Nasdaq: OREX), a biopharmaceutical company focused on the treatment of obesity, today announced results for the third quarter ended September 30, 2014.
“We are thrilled that Contrave® (naltrexone HCl / bupropion HCl extended release) is now available to patients,” said Michael Narachi, CEO of Orexigen. “In addition to strong commercial resourcing, Takeda is bringing innovative approaches to the Contrave launch, by supporting the patient’s complete approach to weight management with companion programs such as a weight loss program called Scale Down as well as Contrave Direct Save.”
Narachi continued: “Regarding the European Marketing Authorization Application for Mysimba™ (naltrexone HCl / bupropion HCl prolonged release) for chronic weight management, we are pleased with the progress of the review. We met recently with the European reviewers to discuss a final list of issues, all of which we believe are addressable. We will submit our responses later this month and expect the CHMP opinion by year end.”
Financial results for the three months ended September 30, 2014
For the three months ended September 30, 2014, Orexigen reported net income of $11.3 million, or $0.09 per share, as compared to a net loss of $18.6 million, or $0.19 per share, for the third quarter of 2013.
Total revenues for the third quarter of 2014 were $30.9 million compared to $857,000 for the same quarter in 2013. This increase in 2014 was due to recognition of two regulatory/development milestones, consisting of $20.0 million due upon regulatory approval in the U.S. and $10.0 million due upon the delivery of Contrave launch supplies to Takeda.
Total operating expenses for the third quarter of 2014 were $17.8 million compared to $19.4 million for the third quarter of 2013. This overall decrease in operating expenses primarily reflects a decrease in research and development expenses associated with the conduct of the Light Study, the Contrave cardiovascular outcomes trial.
As of September 30, 2014, Orexigen had $68.4 million in cash and cash equivalents and an additional $50.3 million in marketable securities, for a total of $118.7 million. As previously announced, Orexigen received milestone payments totaling $30 million and expects to receive another milestone payment of $70 million from Takeda this week. The Company expects to end 2014 with cash, cash equivalents and marketable securities of approximately $190 million.
Naltrexone HCl / bupropion HCl program update:
- In September 2014, the United States Food and Drug Administration (FDA) approved Contrave (naltrexone HCl / bupropion HCl) extended-release tablets as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of 30 kg/m2 or greater (obese), or 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition.
Orexigen has licensed North American Contrave rights to partner, Takeda Pharmaceuticals. Takeda has launched Contrave in the United States with a sales force of 900 representatives and companion program offerings to support a patient’s complete approach to weight management. These programs include Contrave Direct Save, which provides the lowest cost available for both commercially insured and cash-paying patients, with one-on-one pharmacy support and the convenience of home delivery, and the Scale Down program, which provides weight management support with a wireless scale that triggers personalized messages based on weigh-ins. The Scale Down program is a product from Scale Down LLC, a company that is independent from both Takeda and Orexigen and is solely responsible for its content.
- Orexigen has filed a Marketing Authorization Application (MAA) with the European Medicines Agency (EMA) seeking European approval for Mysimba® for chronic weight management in adults who are obese or overweight with certain weight related comorbidities. Mysimba is the brand name granted in Europe for NB32 (naltrexone HCl / bupropion HCl prolonged release). In September, Orexigen submitted answers to the EMA’s Committee for Medicinal Products for Human Use (CHMP) Day 180 List of Outstanding Issues (LOI) and the application was discussed at the CHMP meeting in October. Following the meeting, Orexigen received a revised and final LOI for the Company’s written response. No major objections remain in the CHMP assessment. The Company believes the remaining issues are addressable. Orexigen intends to submit written responses in November and expects a CHMP opinion in December.
Orexigen owns Mysimba/NB32 rights outside of North America and will seek a commercial partner in those territories.
Conference Call Today at 8:30 a.m. Eastern Time (5:30 a.m. Pacific Time)
The Orexigen management team will host a teleconference and webcast to discuss the third quarter 2014 financial results and recent business highlights. The live call may be accessed by calling (800) 708-4539 (domestic) or (847) 619-6396 (international), participant code 38402718. The webcast can be accessed live on the Investors section of the Orexigen web site at www.orexigen.com and will be archived for 14 days following the call.
Important Safety Information for Contrave (naltrexone HCl and bupropion HCl)
WARNING: SUICIDAL THOUGHTS AND BEHAVIORS; AND NEUROPSYCHIATRIC REACTIONS
SUICIDALITY AND ANTIDEPRESSANT DRUGS
CONTRAVE is not approved for use in the treatment of major depressive disorder or other psychiatric disorders. CONTRAVE contains bupropion, the same active ingredient as some other antidepressant medications (including, but not limited to, WELLBUTRIN, WELLBUTRIN SR, WELLBUTRIN XL and APLENZIN). Antidepressants increased the risk of suicidal thoughts and behavior in children, adolescents, and young adults in short-term trials. These trials did not show an increase in the risk of suicidal thoughts and behavior with antidepressant use in subjects over age 24; there was a reduction in risk with antidepressant use in subjects aged 65 and older. In patients of all ages who are started on CONTRAVE, monitor closely for worsening, and for the emergence of suicidal thoughts and behaviors. Advise families and caregivers of the need for close observation and communication with the prescriber. CONTRAVE is not approved for use in pediatric patients.
NEUROPSYCHIATRIC REACTIONS IN PATIENTS TAKING BUPROPION FOR SMOKING CESSATION
Serious neuropsychiatric reactions have occurred in patients taking bupropion for smoking cessation. The majority of these reactions occurred during bupropion treatment, but some occurred in the context of discontinuing treatment. In many cases, a causal relationship to bupropion treatment is not certain, because depressed mood may be a symptom of nicotine withdrawal. However, some of the cases occurred in patients taking bupropion who continued to smoke. Although CONTRAVE is not approved for smoking cessation, observe all patients for neuropsychiatric reactions. Instruct the patient to contact a healthcare provider if such reactions occur.
Contraindications: CONTRAVE is contraindicated in patients with uncontrolled hypertension, seizure disorder, or current or prior diagnosis of anorexia nervosa or bulimia; in patients undergoing abrupt discontinuation of alcohol, benzodiazepines, barbiturates, and antiepileptic drugs; with use of other bupropion-containing products; for use with chronic opioids or opiate agonists (eg, methadone) or partial agonists (eg, buprenorphine) or acute opiate withdrawal; during/within 14 days following treatment with monoamine oxidase inhibitors (MAOIs); in patients with known allergy to any other component of CONTRAVE—anaphylactoid/anaphylactic reactions and Stevens-Johnson syndrome have been reported; in pregnancy.
Warnings and Precautions
Suicidal Behavior and Ideation: All patients being treated with antidepressants for any indication should be monitored appropriately and observed closely for clinical worsening, suicidality, and unusual changes in behavior, especially during the initial few months of a course of drug therapy or at times of dose changes, either increases or decreases. Consider changing the therapeutic regimen or discontinuing in patients whose depression is persistently worse, or who are experiencing emergent suicidality or symptoms of anxiety, agitation, panic attacks, insomnia, irritability, hostility, aggressiveness, impulsivity, akathisia (psychomotor restlessness), hypomania, or mania, especially if these symptoms are severe, abrupt in onset, or were not part of the patient’s presenting symptoms. Alert families and caregivers of patients being treated with antidepressants about the need to monitor patients for the emergence of above mentioned symptoms, as well as the emergence of suicidality, daily and to report such symptoms immediately. Prescriptions for CONTRAVE should be written for the smallest quantity of tablets consistent with good patient management in order to reduce the risk of overdose.
Neuropsychiatric Symptoms and Suicide Risk in Smoking Cessation Treatment: CONTRAVE is not approved for smoking cessation treatment, but serious neuropsychiatric symptoms have been reported in patients taking bupropion for smoking cessation, including changes in mood (including depression and mania), psychosis, hallucinations, paranoia, delusions, homicidal ideation, hostility, agitation, aggression, anxiety and panic, as well as suicidal ideation, suicide attempt, and completed suicide. Observe patients for the occurrence of neuropsychiatric reactions. Instruct patients to contact a healthcare professional if such reactions occur.
Seizures: CONTRAVE can cause seizures. The risk of seizure is dose-related. Discontinue treatment and do not restart CONTRAVE in patients who experience a seizure. Use caution and consider the risk when prescribing CONTRAVE to patients with predisposing factors, clinical situations, and concomitant medications that may lower seizure threshold. Risk of seizure may be minimized by adhering to the recommended dosing schedule and avoiding co-administration with a high-fat meal.
Patients Receiving Opioid Analgesics: CONTRAVE should not be administered to patients receiving chronic opioids. Patients may be vulnerable to opioid overdose and/or precipitated opioid withdrawal.
Increase in Blood Pressure (BP) and Heart Rate (HR): CONTRAVE can cause an increase in systolic BP, diastolic BP, and/or resting HR. Monitor BP and HR especially in patients with cardiac or cerebrovascular disease and/or with controlled hypertension.
Allergic Reactions: Anaphylactoid/anaphylactic reactions and symptoms suggestive of delayed hypersensitivity have been reported in clinical trials with bupropion, as well as rare spontaneous reports of erythema multiforme, Stevens-Johnson syndrome, and anaphylactic shock.
Hepatotoxicity: Cases of hepatitis, clinically significant liver dysfunction, and transient asymptomatic hepatic transaminase elevations have been observed with naltrexone exposure. Use of CONTRAVE should be discontinued in the event of symptoms/signs of acute hepatitis.
Activation of Mania: Prior to initiating CONTRAVE, screen patients for history of bipolar disorder and the presence of risk factors for bipolar disorder (eg, family history of bipolar disorder, suicide, or depression).
Angle-Closure Glaucoma: The pupillary dilation that occurs following use of many antidepressant drugs, including bupropion, a component of CONTRAVE, may trigger an angle-closure attack in a patient with anatomically narrow angles who does not have a patent iridectomy.
Use of Antidiabetic Medications: Weight loss may increase the risk of hypoglycemia in patients with type 2 diabetes mellitus treated with insulin and/or insulin secretagogues (eg, sulfonylureas). Monitor blood glucose levels.
Adverse Reactions: Most common adverse reactions (≥5%) include: nausea (32.5%), constipation (19.2%), headache (17.6%), vomiting (10.7%), dizziness (9.9%), insomnia (9.2%), dry mouth (8.1%), and diarrhea (7.1%).
Drug Interactions: Increased risk of hypertensive reactions can occur when CONTRAVE is used concomitantly with MAOIs. Use caution and consider dose reduction of drugs metabolized by CYP2D6 when using with CONTRAVE. Avoid concomitant use with CYP2B6 inducers. Reduce CONTRAVE dose when taken with CYP2B6 inhibitors. Dose CONTRAVE with caution when used with drugs that lower seizure threshold. Use caution and monitor for CNS toxicity when using CONTRAVE concomitantly with dopaminergic drugs (levodopa and amantadine). CONTRAVE can cause false positive urine test results for amphetamines.
Indication
CONTRAVE is indicated as an adjunct to a reduced-calorie diet and increased physical activity for chronic weight management in adults with an initial body mass index (BMI) of:
- 30 kg/m2 or greater (obese) or
- 27 kg/m2 or greater (overweight) in the presence of at least one weight-related comorbid condition (eg, hypertension, type 2 diabetes mellitus, or dyslipidemia)
Limitations of Use
The effect of CONTRAVE on cardiovascular morbidity and mortality has not been established. The safety and effectiveness of CONTRAVE in combination with other products intended for weight loss, including prescription drugs, over-the-counter drugs, and herbal preparations, have not been established.
Please see full Prescribing Information, including Medication Guide, for Contrave.
More information is also available at www.ContraveHCP.com and www.Contrave.com.
Contrave® is a trademark of Orexigen Therapeutics, Inc. registered with the U.S. Patent and Trademark Office. Scale Down is a program designed and sold by Scale Down, LLC. Scale Down, LLC is an independent company and not part of Orexigen Therapeutics, Inc. Orexigen does not control the content developed and presented by the Scale Down program. All other trademarks are the property of their respective owners.
About Orexigen Therapeutics
Orexigen Therapeutics, Inc. is a biopharmaceutical company focused on the treatment of obesity. Orexigen developed Contrave® (naltrexone HCl and bupropion HCl extended-release), which is approved in the United States. Orexigen’s strategy for Contrave is to pursue marketing authorizations worldwide and pharmaceutical partnerships for global commercialization. Orexigen’s partner for North America, Takeda Pharmaceuticals, will commercialize Contrave in the United States, Canada and Mexico. Orexigen has submitted an application for marketing authorization for Mysimba® (naltrexone HCl/ bupropion HCl prolonged release) in Europe, with an opinion from the European Medicines Agency’s Committee for Medicinal Products for Human Use (CHMP) expected in December 2014. Further information about the Company can be found at http://www.orexigen.com/.
Forward-Looking Statements
Orexigen cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “indicates,” “will,” “should,” “intends,” “potential,” “suggests,” “assuming,” “designed” and similar expressions are intended to identify forward-looking statements. These statements are based on the Company’s current beliefs and expectations. These forward-looking statements include statements regarding: the timing of an opinion for MySimba by year end by the CHMP; the timing of Orexigen’s response to the final Day 180 List of Outstanding Issues; the use by Takeda of 900 sales representatives focusing on primary care physicians in the U.S.; the success of a U.S. primary care launch of Contrave; and Takeda’s use of companion programs such as Scale Down and Contrave Direct Save. The inclusion of forward‐looking statements should not be regarded as a representation by Orexigen that any of its plans will be achieved. Actual results may differ materially from those expressed or implied in this release due to the risk and uncertainties inherent in the Orexigen business, including, without limitation: the potential that Takeda will not successfully launch Contrave; the possibility that public disclosure of the results of the interim analysis of the Light Study would later be deemed to jeopardize the integrity of ongoing cardiovascular outcomes trials resulting in the requirement to conduct additional, costly studies; additional analysis of the interim results or new data from the continuing Light Study, including safety-related data, may produce negative or inconclusive results, or may be inconsistent with the conclusion that the interim analysis was successful; the potential that the interim analysis may not be predictive of future results in the Light Study or another cardiovascular outcomes trial; the possibility that the CHMP determines to not approve Contrave; the potential for early termination of Orexigen’s North American collaboration agreement with Takeda; the possibility that Orexigen is unable to find a partner for Contrave in territories outside of North America, the final results of the Light Study or another cardiovascular outcomes trial may not support continued approval of Contrave; the therapeutic and commercial value of Contrave; and other risks described in Orexigen’s filings with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward‐looking statements, which speak only as of the date hereof, and Orexigen undertakes no obligation to revise or update this news release to reflect events or circumstances after the date hereof. Further information regarding these and other risks is included under the heading “Risk Factors” in Orexigen’s Annual Report on Form 10-Q filed with the Securities and Exchange Commission on August 8, 2014 and its other reports, which are available from the SEC’s website (www.sec.gov) and on Orexigen’s website (www.orexigen.com) under the heading “Investor Relations.” All forward‐looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995.
Orexigen Contact: | Media Contact: |
McDavid Stilwell | David Walsey |
VP, Corporate Communications and Business Development | BrewLife |
(858) 875-8629 | (858) 617-0772 |
Orexigen Therapeutics, Inc. | |||||
Balance Sheets | |||||
(In thousands, except share and par value amounts) | |||||
September 30, | December 31, | ||||
2014 | 2013 | ||||
(Unaudited) | |||||
Assets | |||||
Current assets: | |||||
Cash and cash equivalents | $ 68,358 | $ 98,121 | |||
Accounts receivable | 32,014 | 77 | |||
Investment securities, available-for-sale | 50,277 | 78,875 | |||
Inventory | 754 | – | |||
Prepaid expenses and other current assets | 1,757 | 1,209 | |||
Total current assets | 153,160 | 178,282 | |||
Property and equipment, net | 718 | 630 | |||
Other long-term assets | 426 | 1,032 | |||
Restricted cash | 177 | 177 | |||
Total assets | $ 154,481 | $ 180,121 | |||
Liabilities and stockholders’ equity | |||||
Current liabilities: | |||||
Accounts payable | $ 4,743 | $ 4,787 | |||
Accrued clinical trial expenses | 6,932 | 7,886 | |||
Accrued expenses | 6,631 | 6,751 | |||
Deferred revenue, current portion | 3,429 | 3,429 | |||
Total current liabilities | 21,735 | 22,853 | |||
Long term convertible debt | 82,911 | 80,031 | |||
Deferred revenue, less current portion | 32,572 | 35,143 | |||
Other long-term liabilities | 378 | 232 | |||
Commitments and contingencies | |||||
Stockholders’ equity: | |||||
Preferred stock, $.001 par value, 10,000,000 shares | |||||
authorized at September 30, 2014 and December 31, 2013; no | |||||
shares issued and outstanding at | |||||
September 30, 2014 and December 31, 2013 | – | – | |||
Common stock, $.001 par value, 300,000,000 | |||||
shares authorized at September 30, 2014 and | |||||
December 31, 2013 and; | |||||
123,073,090 and 104,970,200 shares issued and outstanding | |||||
at September 30, 2014 and December 31, 2013, respectively | 123 | 105 | |||
Additional paid-in capital | 569,357 | 556,235 | |||
Accumulated other comprehensive income (loss) | 12 | (3) | |||
Accumulated deficit | (552,607) | (514,475) | |||
Total stockholders’ equity | 16,885 | 41,862 | |||
Total liabilities and stockholders’ equity | $ 154,481 | $ 180,121 |
Orexigen Therapeutics, Inc. | |||||||||||||
Statements of Operations | |||||||||||||
(In thousands, except per share amounts) | |||||||||||||
(Unaudited) | |||||||||||||
Three Months Ended | Nine Months Ended | ||||||||||||
September 30, | September 30, | ||||||||||||
2014 | 2013 | 2014 | 2013 | ||||||||||
Revenues: | |||||||||||||
Collaborative agreement | $ | 30,857 | $ | 857 | $ | 32,571 | $ | 2,571 | |||||
Total revenues | 30,857 | 857 | 32,571 | 2,571 | |||||||||
Operating expenses: | |||||||||||||
Research and development | 10,719 | 13,027 | 44,446 | 41,276 | |||||||||
General and administrative | 7,097 | 6,411 | 21,040 | 17,537 | |||||||||
Total operating expenses | 17,816 | 19,438 | 65,486 | 58,813 | |||||||||
Income (loss) from operations | 13,041 | (18,581) | (32,915) | (56,242) | |||||||||
Interest and other (expense) income, net: | |||||||||||||
Interest income | 16 | 9 | 68 | 57 | |||||||||
Interest expense | (1,784) | – | (5,285) | (1) | |||||||||
Total interest and other (expense) income, net | (1,768) | 9 | (5,217) | 56 | |||||||||
Net income (loss) | $ | 11,273 | $ | (18,572) | $ | (38,132) | $ | (56,186) | |||||
Basic and diluted net income (loss) per share | $ | 0.09 | $ | (0.19) | $ | (0.33) | $ | (0.59) | |||||
Shares used in computing basic net income (loss) per share | 122,583 | 98,737 | 116,655 | 94,717 | |||||||||
Shares used in computing diluted net income (loss) per share | 130,140 | 98,737 | 116,655 | 94,717 |
(DVAX) Independent DSMB Recommendation to Continue Phase 3 Study of HEPLISAV-B™
BERKELEY, CA–(Nov 10, 2014) – Dynavax Technologies Corporation (NASDAQ: DVAX) today announced that the independent Data and Safety Monitoring Board (DSMB) charged with periodically reviewing safety data from the ongoing phase 3 clinical trial of HEPLISAV-B, its investigational adult hepatitis B vaccine, has completed its first prespecified review and has recommended that the study continue unchanged.
This large safety and immunogenicity study (known as HBV-23) is observer-blinded, randomized, and active-controlled. Adult subjects were randomized in a 2:1 ratio to receive a 2-dose series of HEPLISAV-B or a 3-dose series of the control vaccine, Engerix-B®. The DSMB for HBV-23 is an independent panel of physicians otherwise unaffiliated with the study that is charged with performing at least three comprehensive reviews of interim safety data at predetermined time points.
The first DSMB review included safety data for all enrolled subjects collected through the data cut-off in October. As of the cut-off, over 50% of subjects had reached 12 weeks follow-up after the first immunization. The DSMB reviewed unblinded tables and listings presenting safety data for HEPLISAV-B and Engerix-B immunized subjects. Based on this review, the panel recommended continuing HBV-23 with no change to the study protocol, patient consent or other study materials.
Two additional prespecified DSMB reviews will occur during the conduct of HBV-23. Safety observation is scheduled to continue for 12 months following each subject’s second immunization and all study visits are expected to be completed by October, 2015.
About HEPLISAV-B
HEPLISAV-B is an investigational adult hepatitis B vaccine that combines hepatitis B surface antigen with a proprietary Toll-like Receptor 9 agonist to enhance the immune response. Dynavax has worldwide commercial rights to HEPLISAV-B.
About Dynavax
Dynavax, a clinical-stage biopharmaceutical company, uses TLR biology to discover and develop novel vaccines and therapeutics in the areas of infectious and inflammatory diseases and oncology. Dynavax’s lead product candidate is HEPLISAV-B, a Phase 3 investigational adult hepatitis B vaccine. For more information visit www.dynavax.com.
Forward-Looking Statements
This press release contains “forward-looking” statements, including expectations for the conduct, timing and sufficiency of any additional clinical trials for HEPLISAV-B and whether the DSMB will identify safety issues or concerns that could result in changes to or stoppage of the ongoing phase 3 clinical study. Actual results may differ materially from those set forth in this press release due to the risks and uncertainties inherent in our business, including whether successful clinical and regulatory development and review and approval of HEPLISAV-B and our process for its manufacture can occur without significant delay or additional studies and other risks detailed in the “Risk Factors” section of our current periodic reports with the SEC. We undertake no obligation to revise or update information herein to reflect events or circumstances in the future, even if new information becomes available. Information on Dynavax’s website at www.dynavax.com is not incorporated by reference in our current periodic reports with the SEC.
Contact:
Michael S. Ostrach
Vice President, Chief Business and Principal Financial Officer
510-665-7257
Email Contact
(CNDO) Raises $3.5M Through Restricted Stock Private Placement
Shares were sold at the closing price on November 6, 2014
Participating in the transaction were DAK Capital and Officers and Directors, Dr. Lindsay A. Rosenwald, Michael S. Weiss and Malcolm Hoenlein
BURLINGTON, Mass., Nov. 7, 2014 — Coronado Biosciences, Inc. (Nasdaq:CNDO) announced today that it raised $3,501,750 through the sale of restricted common stock. The shares were priced at the closing price on November 6, 2014. Participating in the financing were DAK Capital, Dr. Lindsay A. Rosenwald, Chairman and CEO of the Company, Michael S. Weiss, Executive Vice Chairman and Malcolm Hoenlein, Director.
About Coronado Biosciences
Coronado Biosciences is a biopharmaceutical company dedicated to investing in, acquiring, developing and commercializing novel pharmaceutical products. The Company’s portfolio currently includes novel immunotherapy agents for the treatment of autoimmune diseases and cancer. As part of its growth strategy, the company plans to leverage its biopharmaceutical business and drug development expertise to acquire rights to, or to finance, innovative pharmaceutical and biotechnology products, technologies and/or companies, using a variety of approaches including licensing, partnerships, joint ventures, direct financings and/or public and private spin-outs. For more information, visit www.coronadobiosciences.com.
Forward-Looking Statements
This press release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. Such statements include, but are not limited to, any statements relating to our growth strategy and product development programs and any other statements that are not historical facts. Forward-looking statements are based on management’s current expectations and are subject to risks and uncertainties that could negatively affect our business, operating results, financial condition and stock price. Factors that could cause actual results to differ materially from those currently anticipated are: risks related to our growth strategy; our ability to obtain, perform under and maintain financing and strategic agreements and relationships; risks relating to the results of research and development activities; uncertainties relating to preclinical and clinical testing; our dependence on third party suppliers; our ability to attract, integrate, and retain key personnel; the early stage of products under development; our need for substantial additional funds; government regulation; patent and intellectual property matters; competition; as well as other risks described in our SEC filings. We expressly disclaim any obligation or undertaking to release publicly any updates or revisions to any forward looking statements contained herein to reflect any change in our expectations or any changes in events, conditions or circumstances on which any such statement is based, except as required by law.
CONTACT: Lucy Lu, MD, Executive Vice President & Chief Financial Officer Coronado Biosciences, Inc. 781-652-4525; ir@coronadobio.com
(AIRT) Reports Unaudited Second Quarter Earnings
MAIDEN, N.C., Nov. 7, 2014 — Air T, Inc. (Air T) (NASDAQ: AIRT) today reported consolidated net earnings of $1,818,000 ($0.77 per diluted share) for fiscal 2015’s second quarter ended September 30, 2014 compared to consolidated net earnings of $456,000 ($0.18 per diluted share) for the similar fiscal 2014 period.
Consolidated revenue increased $10,435,000 (43%) to $34,625,000 for the quarter ended September 30, 2014 compared to the same quarter in the prior fiscal year. Consolidated operating income increased $1,844,000 (245%) for the quarter ended September 30, 2014 compared to the same quarter in the prior fiscal year. Ground equipment sales revenue increased $10,044,000 (127%) this quarter compared to the prior year comparable quarter. Approximately $4,800,000 of the increase in revenue is attributable to the shipment of deicing units that had been delayed at June 30, 2014 as noted in the June 30, 2014 Form 10-Q. Ground equipment sales operating income increased by $2,471,000 from the prior year comparable quarter as a result of the impact of the delay in shipment into the second quarter, efficiencies in production, and increased parts and service volume as customers experience some early winter weather. At September 30, 2014, ground equipment sales backlog was $15.3 million, compared to $11.9 million at September 30, 2013. The ground support services segment reported a $541,000 (13%) increase in revenue this quarter, driven by continuing growth in locations and in services offered to new and existing customers; operating income decreased by $217,000 (70%) principally due to infrastructure changes to help position the segment for further growth. Overnight air cargo revenues reported a $150,000 (1%) decrease this quarter compared to the same quarter in the prior fiscal year, and the segment’s operating income decreased by $287,000 (51%) this quarter as a result of a variety of factors including a reduction in revenue aircraft and maintenance labor costs.
Nick Swenson commented, “GGS completed an outstanding first half of the fiscal year, converting backlog into shipments and delivering strong top-line and bottom-line growth. Our inventories at mid-year are the lowest they’ve been in six years. Simply put, Mike Moore and his management team have been executing on their business plan. GGS is delivering high quality products on time and within budget. While the harsh winter is part of the demand story at GGS, we believe that GGS management has enhanced operations in many incremental ways, thereby strengthening the franchise.”
FINANCIAL HIGHLIGHTS | |||||||
(In thousands, except per share data) | |||||||
Three Months Ended | Six Months Ended | ||||||
9/30/2014 | 9/30/2013 | 9/30/2014 | 9/30/2013 | ||||
Operating Revenues | $ 34,625 | $ 24,190 | $56,403 | $45,470 | |||
Net Earnings | $ 1,818 | $ 456 | $1,891 | $595 | |||
Net Earnings Per Share- Diluted | $0.77 | $0.18 | $0.80 | $0.24 | |||
Average Common Shares Outstanding | 2,375 | 2,485 | 2,376 | 2,477 |
Air T, through its subsidiaries, provides overnight air freight service to the express delivery industry, manufactures and sells aircraft deicers and other special purpose industrial equipment, and provides ground support equipment and facilities maintenance to airlines. Air T is one of the largest, small-aircraft air cargo operators in the United States. Air T’s Mountain Air Cargo and CSA Air subsidiaries currently operate a fleet of single and twin-engine turbo-prop aircraft daily in the eastern half of the United States, Puerto Rico and the Caribbean Islands. Air T’s Global Ground Support subsidiary manufactures deicing and other specialized military and industrial equipment and is one of the largest providers of deicers in the world. The Global Aviation Services subsidiary provides ground support equipment and facilities maintenance to domestic airline customers.
For a more detailed presentation and discussion of the Company’s results of operations and financial condition, please read the Company’s Quarterly Report on Form 10-Q for the quarter ended September 30, 2014 filed today with the Securities and Exchange Commission. Copies of the Form 10-Q may be accessed on the Internet at the SEC’s website, http://www.sec.gov.
Statements in this press release, which contain more than historical information, may be considered forward-looking statements (as such term is defined in the Private Securities Litigation Reform Act of 1995), which are subject to risks and uncertainties. Actual results may differ materially from those expressed in the forward-looking statements because of important potential risks and uncertainties, including but not limited to the risk that contracts with major customers will be terminated or not extended, uncertainty regarding legal actions against the Company, future economic conditions and their impact on the Company’s customers, the timing and amounts of future orders under our contract with the United States Air Force, inflation rates, competition, changes in technology or government regulation, and the impact of future terrorist activities in the United States and abroad. A forward-looking statement is neither a prediction nor a guarantee of future events or circumstances, and those future events or circumstances may not occur. We are under no obligation, and we expressly disclaim any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise.
(ACFN) to Host 2014 Third Quarter Conference Call on Thursday, Nov13
WILMINGTON, Del., Nov. 7, 2014 — Acorn Energy, Inc. (NASDAQ: ACFN) today announced that John A. Moore, President & CEO of Acorn Energy, will host an investor call on Thursday, November 13, 2014 at 11am ET to discuss its third quarter 2014 results and developments. The Company will release financial results for the third quarter the afternoon of Wednesday November 12th, after the market closes.
Participants can pre-register for the conference call by accessing this link http://dpregister.com/10056088 Pre-registering gives one immediate entry into the call, zero wait time and will automatically populate your Outlook calendar with an invitation.
Participants that would like to join the conference call, but have not registered, can do so by dialing US Toll Free (866) 652-5200, International Dial in (412) 317-6060 and asking for the “Acorn Energy Conference Call” (no pass code required). If you are unable to participate in the live call, a digital replay of the call will be available two hours after the end of the live call through 9:00am ET December 13, 2014 by dialing (877) 344-7529 or International (412) 317-0088 and entering access code 10056088.
About Acorn Energy, Inc.
Acorn Energy, Inc. is a holding company whose four portfolio companies help their customers achieve greater productivity, reliability, security, and efficiency—factors which can lead to greater profitability. GridSense® provides monitoring for all critical points along the electricity delivery system. OmniMetrix™ remotely monitors emergency back-up power generation systems to increase their reliability. US Seismic Systems® supplies fiber optic sensing solutions to increase oil/gas production and lower costs. DSIT provides security solutions from underwater threats to naval and marine based energy assets. For more information visit: http://www.acornenergy.com.
Safe Harbor Statement
This press release includes forward-looking statements, which are subject to risks and uncertainties. There is no assurance that Acorn Energy, Inc. or its operating companies will continue to grow their respective businesses, or that any of them will meet the expectations or execute the initiatives described or referred to above. A complete discussion of the risks and uncertainties which may affect Acorn Energy’s business generally and the businesses of its subsidiaries is included in “Risk Factors” in the Company’s Form 10-K filed by the Company with the Securities and Exchange Commission.
Investor & Press Contact:
F. Kent Leacock
Acorn Energy
(925) 698-1431
kleacock@acornenergy.com
(ANV) Files NI 43-101 Technical Report for Hycroft Mill Expansion Feasibility Study
RENO, NEVADA–(Nov. 7, 2014) – Allied Nevada Gold Corp. (“Allied Nevada”, “us”, “we”, “our” or the “Company”) (TSX:ANV)(NYSE MKT:ANV) announces the filing on SEDAR of a National Instrument (“NI”) 43-101 Technical Report representing the qualifying report for the recently announced feasibility study for the Hycroft mill expansion project (see Allied Nevada press release dated October 15, 2014).
A copy of the report titled Hycroft Mine, NI 43-101 Technical Report, Mill Expansion Feasibility Study, Winnemucca, Nevada, USA, and dated November 3, 2014, can be obtained from www.SEDAR.com or on the company’s website at www.alliednevada.com.
Allied Nevada Gold Corp.
Tracey Thom
Vice President, Investor Relations
(775) 789-0119
www.alliednevada.com
(URRE) Adds Properties in Texas and Plans 2015 Drilling Program
Uranium Resources, Inc. (NASDAQ: URRE) today closed on the previously announced non-cash asset exchange agreement with Rio Grande Resources Corporation.
Christopher M. Jones, President and Chief Executive Officer, said, “This land exchange was a strategic accomplishment that strengthens our project development pipeline. We acquired mid-term in situ recovery projects, including the Alta Mesa Este, Butler Ranch and Sejita Dome properties located near our temporarily idled processing facilities in South Texas. In 2015, we will commence drilling at the Alta Mesa Este Project and also plan test holes at the Butler Ranch Project.”
Mr. Jones continued, “We have reprioritized and rescheduled the technical report for the Churchrock Project in favor of advancing the Alta Mesa Este Project exploration program to build value for our shareholders. We are excited about the potential for the Alta Mesa Este Project to reach production within three to five years.”
2015 Exploration Program
The Company is planning an exploration program of approximately $825,000 in 2015 for drilling and geophysical logging at the Alta Mesa Este and Butler Ranch projects. The majority of the planned investment will be at the Alta Mesa Este Project for drilling up to 27,000 feet and geophysical work. (Please refer to the location maps in the Appendix.)
The 2,841-acre Alta Mesa Este Project is located 56 miles southwest of URRE’s Kingsville Dome processing facility and northeast of Mesteña Uranium’s Alta Mesa processing plant and well fields. The Company has been analyzing historical information from drilling in the 1980s and identified a target area approximately 1.5 miles along the east-west strike of mineralization hosted in the Goliad Formation.
An initial exploration program at the 2,592-acre Butler Ranch project is designed to test the mineral potential in parallel trending sandstone units and the continuation of the Turner-Garcia mineral system. Butler Ranch is located in the prolific Karnes County mining district, which has some of the largest uranium deposits in the South Texas uranium province, and 75 miles north-northeast of the URRE’s Rosita processing plant. This area saw historic uranium mining in the 1950s through the 1970s.
Further details about the acquired properties covering 8,000 acres in the uranium belts of South Texas are described in the Company’s news release of September 8, 2014.
As described in URRE’s 3Q 2014 news release issued earlier today, the total cash budget for 2015 is expected to be less than $10.0 million and includes funding of the exploration program. The expected cash spend for 2015 is approximately 20% lower than the estimated total spend in 2014.
About Uranium Resources
Uranium Resources, Inc. was incorporated in 1977 to explore, develop and recover uranium. Uranium Resources has two licensed and currently idled processing facilities and over 16,000 acres of prospective in situ recovery (ISR) projects in Texas. In New Mexico, the Company holds a federal Nuclear Regulatory Commission license to recover up to three million pounds of uranium per year using the ISR process at certain properties and controls minerals rights encompassing approximately 200,000 acres in the prolific Grants Mineral Belt in New Mexico, which holds one of the largest known concentrations of sandstone-hosted uranium deposits in the world. The Company acquired these properties over the past 25 years, along with an extensive uranium information database of historic drill hole logs, assay certificates, maps and technical reports for the Western United States.
Cautionary Statement
This news release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements are subject to risks, uncertainties and assumptions and are identified by words such as “expects,” “estimates,” “projects,” “anticipates,” “believes,” “could,” and other similar words. All statements addressing operating performance, events or developments that the Company expects or anticipates will occur in the future, including but not limited to statements relating to (i) the timing or occurrence of production at the Company’s properties, (ii) future improvements in the demand for and price of uranium, (iii) the adequacy of funding for the Company through 2015, (iv) expected reductions in the Company’s operating expenses and burn rate, and total cash budget for 2015, (v) the occurrence and extent of any future exploration program, and (vi) additions of reserves and resources or acquisitions are forward-looking statements. Because they are forward-looking, they should be evaluated in light of important risk factors and uncertainties. These risk factors and uncertainties include, but are not limited to, (a) the Company’s ability to raise additional capital in the future; (b) spot price and long-term contract price of uranium; (c) the Company’s ability to reach agreements with current royalty holders; (d) operating conditions at the Company’s projects; (e) government and tribal regulation of the uranium industry and the nuclear power industry; (f) world-wide uranium supply and demand; (g) maintaining sufficient financial assurance in the form of sufficiently collateralized surety instruments; (h) unanticipated geological, processing, regulatory and legal or other problems the Company may encounter; and other factors which are more fully described in the Company’s Annual Report on Form 10-K, Quarterly Reports on Form 10-Q, and other filings with the Securities and Exchange Commission. Should one or more of these risks or uncertainties materialize, or should any of the Company’s underlying assumptions prove incorrect, actual results may vary materially from those currently anticipated. In addition, undue reliance should not be placed on the Company’s forward-looking statements. Except as required by law, the Company disclaims any obligation to update or publicly announce any revisions to any of the forward-looking statements contained in this news release.
Photos/Multimedia Gallery Available: http://www.businesswire.com/multimedia/home/20141107005110/en/
Uranium Resources, Inc.
Wendy Yang, Investor Relations
303-531-0478
info@uraniumresources.com
www.uraniumresources.com
(URG) to Present at the Cowen and Company 5th Annual Conference
LITTLETON, Colo., Nov. 7, 2014 — Ur-Energy Inc. (NYSE MKT: URG, TSX: URE) (“Ur-Energy” or the “Company”) will be featured as a presenting company at the Cowen and Company 5th Annual Global Metals, Mining and Materials Conference. The conference is being held November 11-12, 2014, at the Sheraton New York Times Square Hotel in New York City.
Jeff Klenda, Board Chairman, will provide an overview of the Company’s business during his presentation and will be available to participate in one-on-one meetings with investors who are registered to attend the conference.
Event: Cowen and Company 5th Annual Global Metals, Mining and Materials Conference
Date: Tuesday, November 11, 2014
Presentation Time: 10:10 AM
Location: Riverside Ballroom, 3rd Floor, Sheraton New York Times Square Hotel
Conference attendees are invited to contact Christy Nolan at christy.nolan@cowen.com in advance to set up one-on-one meetings.
About Ur-Energy
Ur-Energy is a dynamic junior mining company operating the Lost Creek in-situ recovery (ISR) uranium facility in south-central Wyoming. The Lost Creek processing facility will have a two million pounds per year nameplate capacity. Ur-Energy engages in the identification, acquisition, exploration, development, and operation of uranium projects in the United States and Canada. Shares of Ur-Energy trade on the NYSE MKT under the symbol “URG” and the Toronto Stock Exchange under the symbol “URE.” In addition, Ur-Energy’s project pipeline is supported by an extensive, exploration database, providing for exploration and development potential. Ur-Energy’s corporate office is located in Littleton, Colorado; its registered office is in Ottawa, Ontario. Ur-Energy’s website is www.ur-energy.com.
FOR FURTHER INFORMATION, PLEASE CONTACT | ||
Rich Boberg, Senior Director IR/PR | Wayne Heili, President and CEO | |
303-269-7707 | 307-265-2373 | |
866-981-4588 | 866-981-4588 | |
rich.boberg@ur-energy.com | wayne.heili@ur-energy.com |
(LFVN) Announces New $7 Million Share Repurchase Program
SALT LAKE CITY, Nov. 6, 2014 — LifeVantage Corporation (Nasdaq:LFVN) announced today that its Board of Directors has approved up to $7 million in stock repurchases. The Company expects to fund the repurchase program through cash on hand and future cash flow from operations. In October 2014, LifeVantage completed its previous $4 million share repurchase program announced in June 2014, having repurchased a total of approximately 3 million shares.
Douglas C. Robinson, President and Chief Executive Officer of LifeVantage stated, “With our healthy cash balance and ability to consistently generate solid cash flow from operations, we have the financial flexibility to make strategic investments in our business while enhancing shareholder value through share repurchases.”
The repurchase program permits LifeVantage to purchase shares from time to time through a variety of methods, including in the open market, through privately negotiated transactions or other means as determined by the company’s management, in accordance with applicable securities laws. As part of the repurchase program, the Company anticipates entering into a pre-arranged stock repurchase plan which will operate in accordance with guidelines specified under Rule 10b5-1 of the Securities Exchange Act of 1934. Accordingly, transactions, if any, under the pre-arranged repurchase plan would be completed in accordance with the terms of the stock repurchase plan, including specified price, volume and timing conditions.
About LifeVantage Corporation
LifeVantage Corporation (Nasdaq:LFVN), is a leader in Nrf2 science and the maker of Protandim®, the Nrf2 Synergizer® patented dietary supplement, the TrueScienceTM Anti-Aging Skin Care Regimen, Canine Health and the AXIOTM energy product line. The company is a science based network marketing company that is dedicated to visionary science that looks to transform health, wellness and anti-aging internally and externally at the cellular level. LifeVantage was founded in 2003 and is headquartered in Salt Lake City, Utah.
Forward-Looking Statements
This document contains forward-looking statements made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Words and expressions reflecting optimism, satisfaction or disappointment with current prospects, as well as words such as “believe,” “hopes,” “intends,” “estimates,” “expects,” “projects,” “plans,” “anticipates,” “look forward to” and variations thereof, identify forward-looking statements, but their absence does not mean that a statement is not forward-looking. Examples of forward-looking statements include, but are not limited to, statements we make regarding our future revenue, operating income, operating margins, earnings per share, cash flow from operations, share repurchase activity and future investment and growth. Such forward-looking statements are not guarantees of performance and the Company’s actual results could differ materially from those contained in such statements. These forward-looking statements are based on the Company’s current expectations and beliefs concerning future events affecting the Company and involve known and unknown risks and uncertainties that may cause the Company’s actual results or outcomes to be materially different from those anticipated and discussed herein. These risks and uncertainties include, among others, those discussed in greater detail in the Company’s Annual Report on Form 10-K and the Company’s Quarterly Report on Form 10-Q under the caption “Risk Factors,” and in other documents filed by the Company from time to time with the Securities and Exchange Commission. The Company cautions investors not to place undue reliance on the forward-looking statements contained in this document. All forward-looking statements are based on information currently available to the Company on the date hereof, and the Company undertakes no obligation to revise or update these forward-looking statements to reflect events or circumstances after the date of this document, except as required by law.
CONTACT: Investor Relations Contact: Cindy England (801) 432-9036 Director of Investor Relations -or- John Mills (646) 277-1254 Partner, ICR INC
(HCKT) Credit Card Fees: Avoidable Burden For B2B Companies
Credit card processing fees present a growing burden for many U.S. business-to-business (B2B) companies, according to new research from REL Consulting, a division of The Hackett Group, Inc. (NASDAQ:HCKT), and companies can significantly improve their profit margin by changing acceptance policies for credit cards.
REL’s research estimates that B2B companies in the U.S. now incur an average of $2.2 million in credit card processing fees per billion of revenue. Credit cards usage for B2B payments has increased dramatically over the past few years, and are expected to represent 10 percent of all payments in 2014. REL estimates that approximately 60 to 85 percent of credit card fees can be avoided by making changes to credit card acceptance policies keyed to the organizations business model, customer base, customer risk, and competitive landscape.
“It’s not hard to understand why B2B customers have doubled their use of credit cards over the past few years, even for five and six figure payments,” said REL Customer-to-Cash Practice Leader Veronica Wills. “It’s an easy way to extend time to payment, and transaction processing cost to the purchaser is low. In addition, companies can often accrue rebates and rewards.
“But for B2B sellers, the cost of accepting credit cards far outweighs the benefits,” Ms. Wills explained. “Visa, MasterCard and other credit card companies have tripled their U.S. swipe fees in the past decade, and they are now the highest in the world. As a result, the spiraling cost of allowing credit card payments can easily cut into bottom-line profitability. Any company that is not actively reviewing how and when it accepts credit cards is willingly squandering away margin.”
Many B2B companies have been slow to respond to the problem for a variety of reasons. “Companies are afraid of losing customers, and don’t want to give their competitors an edge,” said Ms. Wills. “Accounts receivable staff can also be indifferent, because to them, a payment is a payment…and sales staff are often unsupportive, because their compensation is generally tied to simple revenue.”
REL encourages U.S. companies to carefully evaluate what forms of payment they accept from clients, and consider both incentives and disincentives to encourage customers to use other electronic payment methods that benefit both the payer and the payee. A comprehensive analysis should evaluate the impact of payment methods on cash flow, cost, risk, and service.
REL recommends that companies consider multiple strategies to reduce the use of credit cards by their customers. Through a strategic analysis of the customer base, companies can develop a stratified payment method acceptance plan that takes into account payment terms optimization, migration to other forms of payment, and trade-offs, modeling to evaluate concessions such as discounts in lieu of payment by credit card.
Cost is the first thing companies that should be considered. Electronic payment methods are significantly less expensive, labor-intensive, and error-prone than checks, which remain the most popular form of payment for B2B companies. But some forms of electronic payment – in particular electronic funds transfer and automated clearinghouse, or direct debit – are clearly preferable to the seller, as they offer lower processing costs than credit card acceptance, faster turnaround times than traditional checks, and are less labor intensive to process.
Other alternative options to consider include renegotiating credit card fees, considering alternative payment processors, surcharging credit card transactions, establishing convenience charges, and implementing multi-tier pricing. And lastly, the simplest solution may be to no longer permit settlement of receivables by credit card where credit terms are offered. This ensures total mitigation of credit card fees and other processing costs.
“Companies are understandably cautious when making changes like they ones we’re proposing. They need help understanding how and when they can apply new regulations to their credit card policies, because there’s a lot of room for interpretation, and not a lot of guidance out there for B2B companies. There’s also concern that policy changes may spark customer discontent. But we are not aware of any B2B company in our database ever reporting a loss of business due to a strict credit card acceptance policy,” said REL Associate Rob Crowder. “Still, communication is a critical element of success here. Internal staff need to understand policy changes and why they’re being made, and how to answer questions. Customers need to be told what’s happening, and how they can potentially benefit by changing their payment procedures. There’s potential for a win/win. But it takes careful analysis, thoughtful planning, and real cooperation.”
A complimentary version of this Research Insight, “Credit Card Payments a Growing Burden on Business-to-Business Organizations,” is available with registration at this link: http://www.thehackettgroup.com/research/2014/creditcard/.
About REL
REL, a division of The Hackett Group, Inc. (NASDAQ:HCKT), is a world-leading consulting firm dedicated to delivering sustainable cash flow improvement from working capital and across business operations. REL’s tailored working capital management solutions balance client trade-offs between working capital, operating costs, service performance and risk. REL’s expertise has helped clients free up billions of dollars in cash, creating the financial freedom to fund acquisitions, product development, debt reduction and share buy-back programs. In-depth process expertise, analytical rigor and collaborative client relationships enable REL to deliver an exceptional return on investment in a short timeframe. REL has delivered work in over 60 countries for Fortune 500 and global Fortune 500 companies.
More information on REL is available: by phone at (770) 225-3600; by e-mail at info@relconsultancy.com; or on the Web at www.relconsultancy.com.
REL
Gary Baker, 917-796-2391
Global Communications Director
gbaker@relconsultancy.com
(AAWW) Places Third 747 Freighter with Etihad Airways
Atlas Air Worldwide Holdings, Inc. (Nasdaq:AAWW), a leading global provider of outsourced aircraft and aviation operating services, today announced the placement of a third Boeing 747 Freighter into ACMI service for Etihad Airways, the national carrier of the United Arab Emirates.
The 747-400 freighter will be operated by Atlas Air, Inc. on behalf of Etihad Cargo, the cargo arm of the airline, through an aircraft, crew, maintenance and insurance agreement. The new 747 service is scheduled to begin this month and will increase the number of Atlas aircraft operated for Etihad Airways to three.
William J. Flynn, President and Chief Executive Officer, Atlas Air Worldwide, said, “We are continuing to expand our strategic partnership with Etihad Cargo and are delighted to support the sustained strong growth of its global network.”
James Hogan, Etihad Airways President and Chief Executive Officer, said, “Our partnership with Atlas Air is an important part of our success and we are confident that it will continue to deliver the operational excellence, outstanding customer service and security that will help us achieve our goal.”
About Atlas Air Worldwide:
Atlas Air Worldwide is the parent company of Atlas Air, Inc. (Atlas) and Titan Aviation Holdings, Inc. (Titan), and is the majority shareholder of Polar Air Cargo Worldwide, Inc. (Polar). Through Atlas and Polar, Atlas Air Worldwide operates the world’s largest fleet of Boeing 747 freighter aircraft.
Atlas, Titan and Polar offer a range of outsourced aircraft and aviation operating services that include ACMI service – in which customers receive an aircraft, crew, maintenance and insurance on a long-term basis; CMI service, for customers that provide their own aircraft; express network and scheduled air cargo service; military cargo and passenger charters; commercial cargo and passenger charters; and dry leasing of aircraft and engines.
Atlas Air Worldwide’s press releases, SEC filings and other information can be accessed through the Company’s home page, www.atlasair.com.
About Etihad Airways:
Etihad Airways began operations in 2003, and in 2013 carried 11.5 million passengers. From its Abu Dhabi base Etihad Airways flies to 111 existing or announced passenger and cargo destinations in the Middle East, Africa, Europe, Asia, Australia and the Americas. The airline has a fleet of 105 Airbus and Boeing aircraft, and more than 200 aircraft on firm order, including 71 Boeing 787s, 25 Boeing 777-X, 62 Airbus A350s and 10 Airbus A380s. Etihad Airways holds equity investments in airberlin, Air Seychelles, Virgin Australia, Aer Lingus, Air Serbia and Jet Airways, and is in the process of formalising equity investments in Alitalia and Swiss-based Etihad Regional*. For more information, please visit: www.etihad.com.
*Operated by Darwin Airline
Atlas Air Worldwide Holdings, Inc.
Media:
Bonnie Rodney, 914-701-8580
or
Investors:
Dan Loh, 914-701-8200
(KPTI) Data Presentations at American Society of Hematology Annual Meeting
Published Abstracts Include Clinical Data on Selinexor (KPT-330) as Single-Agent in Non-Hodgkin’s Lymphoma and in Combination With Dexamethasone in Multiple Myeloma
NEWTON, Mass., Nov. 6, 2014 — Karyopharm Therapeutics Inc. (Nasdaq:KPTI), a clinical-stage pharmaceutical company, today announced that clinical and pre-clinical data for its lead drug candidate, Selinexor (KPT-330), a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound, will be presented at the 56th American Society of Hematology (ASH) Annual Meeting, which is being held from December 6-9, 2014 in San Francisco.
“We are excited that our growing body of data in hematologic malignancies for our lead drug candidate, Selinexor, will be presented at ASH, including promising clinical data of Selinexor in patients with heavily pretreated, relapsed and refractory aggressive non-Hodgkin’s lymphoma and additional preclinical and clinical data demonstrating synergistic activity of Selinexor when combined with dexamethasone in multiple myeloma,” said Sharon Shacham, PhD, MBA, President and Chief Scientific Officer of Karyopharm. “We are committed to uncovering the potential of our SINE™ compounds, in particular the broad anti-cancer activity in hematologic and solid tumor malignancies demonstrated by our first-in-class agent, oral Selinexor.”
Oral Presentation (Selinexor):
Title: | The Oral Selective Inhibitor of Nuclear Export (SINE) Selinexor (KPT-330) Demonstrates Broad and Durable Clinical Activity in Relapsed / Refractory Non-Hodgkin’s Lymphoma (NHL) | |
Author: | Kuruvilla | |
Publication #: | 396 | |
Session: | 623. Lymphoma: Chemotherapy, excluding Pre-Clinical Models: Adjusting Induction Therapy in Large Cell Lymphoma | |
Date/Time: | Monday, December 8, 2014 11:45 AM PT | |
Location: | Moscone Center, South Building, Esplanade 304-306-308 | |
Highlights of topline abstract data: Overall response rate (partial response or better) of 40% and disease control rate (stable disease or better) of 80% in 10 patients with relapsed and refractory aggressive non-Hodgkin’s lymphoma treated with single-agent Selinexor dosed twice weekly at ≥60mg/m2 (equivalent to approximately 100mg doses). A 33% response rate was observed in 27 patients dosed at 35-50mg/m2 (equivalent to approximately 60-85mg doses), along with a 25% response rate at lower doses. These data are current through August 5, 2014, and will be updated in detail at ASH. |
Poster Presentations (Selinexor):
TITLE: | Selinexor Demonstrates Marked Synergy with Dexamethasone (Sel-Dex) in Preclinical Models and in Patients with Heavily Pretreated Refractory Multiple Myeloma (MM) | |
Author: | Chen | |
Publication #: | 4773 | |
Session: | 653. Myeloma: Therapy, excluding Transplantation: Poster III | |
Date/Time: | Monday, December 8, 2014, 6:00 PM – 8:00 PM PT | |
Location: | Moscone Center, West Building, Level 1 | |
Highlights of topline abstract data: Overall response rate (partial response or better) of 60% and clinical benefit rate (minimal response or better) of 80% in 10 patients with heavily pretreated and refractory multiple myeloma treated with Selinexor in combination with low-dose dexamethasone, each dosed twice weekly at 45mg/m2 and 20mg, respectively. These data are current through August 5, 2014, and will be updated in detail at ASH. | ||
TITLE: | Anti-Myeloma Activity of Combined Inhibition of the Proteasome with Carfilzomib (CFZ) and XPO1/CRM1-Dependent Nuclear Export by Selinexor (KPT-330) Via a Novel Mechanism of Intracellular Activation of Caspase 10-Dependent Apoptosis | |
Author: | Rosebeck | |
Publication #: | 3443 | |
Session: | 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II | |
Date/Time: | Sunday, December 7, 2014, 6:00 PM – 8:00 PM PT | |
Location: | Moscone Center, West Building, Level 1 | |
TITLE: | Selinexor-Induced Thrombocytopenia Results from the Inhibition of Megakaryocyte Progenitor Cells in the Early Stage of Megakaryopoiesis | |
Author: | Machlus | |
Publication #: | 1458 | |
Session: | 311. Disorders of Platelet Number or Function: Poster I | |
Date/Time: | Saturday, December 6, 2014, 5:30 PM – 7:30 PM PT | |
Location: | Moscone Center, West Building, Level 1 | |
TITLE: | Gene Expression and Transcription Factor (TF) Activation Profiling Identifies Suppression of Multiple Myeloma (MM) Cell Survival and Chemoresistance Pathways by Inhibition of XPO1/CRM1-Dependent Nuclear Export with Selinexor | |
Author: | Rosebeck | |
Publication #: | 3444 | |
Session: | 652. Myeloma: Pathophysiology and Pre-Clinical Studies, excluding Therapy: Poster II | |
Date/Time: | Sunday, December 7, 2014, 6:00 PM – 8:00 PM PT | |
Location: | Moscone Center, West Building, Level 1 |
Additional posters detailing preclinical data from Karyopharm’s PAK4 inhibitor program, as well as preclinical data of Selinexor in acute myeloid leukemia (AML), will also be presented.
About Selinexor
Selinexor (KPT-330) is a first-in-class, oral Selective Inhibitor of Nuclear Export / SINE™ compound. Selinexor functions by inhibiting the nuclear export protein XPO1 (also called CRM1), leading to the accumulation of tumor suppressor proteins in the cell nucleus, which subsequently reinitiates and amplifies their tumor suppressor function. This is believed to lead to the selective induction of apoptosis in cancer cells, while largely sparing normal cells. Over 450 patients have been treated with Selinexor in Phase 1 and Phase 2 clinical trials in advanced hematologic malignancies and solid tumors. Karyopharm has initiated a registration-directed clinical trial of Selinexor in older patients with acute myeloid leukemia and two additional registration-directed clinical trials in hematological indications are expected to begin enrollment during 2014. Additional Phase 1 and Phase 2 studies are ongoing or currently planned, including multiple investigator-sponsored studies of Selinexor in combination with one or more approved therapies. The latest clinical trial information for Selinexor is available at www.clinicaltrials.gov.
About Karyopharm Therapeutics
Karyopharm Therapeutics Inc. (Nasdaq:KPTI) is a clinical-stage pharmaceutical company focused on the discovery and development of novel drugs directed against nuclear transport targets for the treatment of cancer and other major diseases. Karyopharm’s SINE™ compounds function by binding with and inhibiting the nuclear export protein XPO1 (or CRM1). SINE™ compounds have also shown biological activity in models of autoimmune disease, certain viruses, and wound-healing. Karyopharm was founded by Dr. Sharon Shacham and is located in Newton, Massachusetts. For more information, please visit www.karyopharm.com.
Forward-Looking Statements
This press release contains forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Such forward-looking statements include those regarding the therapeutic potential of and potential clinical development plans for Karyopharm’s drug candidates, including the timing of initiation of certain trials and of the reporting of data from such trials. Such statements are subject to numerous important factors, risks and uncertainties that may cause actual events or results to differ materially from the company’s current expectations. For example, there can be no guarantee that any of Karyopharm’s SINE™ compounds, including Selinexor (KPT-330) or any PAK4 inhibitor, or any other drug candidate that Karyopharm is developing will successfully complete necessary preclinical and clinical development phases or that development of any of Karyopharm’s drug candidates will continue. Further, there can be no guarantee that any positive developments in Karyopharm’s drug candidate portfolio will result in stock price appreciation. Management’s expectations and, therefore, any forward-looking statements in this press release could also be affected by risks and uncertainties relating to a number of other factors, including the following: Karyopharm’s results of clinical trials and preclinical studies, including subsequent analysis of existing data and new data received from ongoing and future studies; the content and timing of decisions made by the U.S. Food and Drug Administration and other regulatory authorities, investigational review boards at clinical trial sites and publication review bodies; Karyopharm’s ability to obtain and maintain requisite regulatory approvals and to enroll patients in its clinical trials; unplanned cash requirements and expenditures; development of drug candidates by Karyopharm’s competitors for diseases in which Karyopharm is currently developing its drug candidates; and Karyopharm’s ability to obtain, maintain and enforce patent and other intellectual property protection for any drug candidates it is developing. These and other risks are described under the caption “Risk Factors” in Karyopharm’s Annual Report on Form 10-K for the year ended December 31, 2013, which is on file with the Securities and Exchange Commission (SEC), and in other filings that Karyopharm may make with the SEC in the future. Any forward-looking statements contained in this press release speak only as of the date hereof, and Karyopharm expressly disclaims any obligation to update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Investor / Company Contact: Justin Renz (617) 658-0574 jrenz@karyopharm.com Media Contact: Ryan Flinn 415.946.1059 rflinn@w2ogroup.com
(BTN) Adopts One-Year Stockholder Rights Plan
Ballantyne Strong, Inc. (NYSE MKT: BTN) today announced that its board of directors has unanimously adopted a stockholder rights plan (the “Rights Plan”) and declared a dividend of one right on each outstanding share of its common stock. The Rights Plan has a 12-month duration and thus is expected to fit within ISS voting guidelines that would not result in negative vote recommendations in the election of directors.
The board of directors adopted the Rights Plan in response to the recent accumulation of approximately 13% of the Company’s outstanding common stock. The Rights Plan has not been adopted in response to a takeover bid or other proposal to acquire control of the Company. The Rights Plan is designed to assure that all of the Company’s stockholders receive fair and equal treatment in the event of a proposed takeover of the Company and to guard against tactics to gain control of the Company without paying a premium for that control. The Rights Plan is intended to enable all of the Company’s stockholders to realize the long-term value of their investment in the Company. In addition, the Company believes that this would not be an opportune time to pursue a sale of the Company because of the stockholder value expected to be generated from execution of the Company’s strategy, including complimentary acquisitions being pursued with its available cash. The Rights Plan will not prevent a takeover, but should encourage anyone seeking to acquire the Company to negotiate with the board of directors prior to attempting a takeover.
Pursuant to the Rights Plan, Ballantyne Strong is issuing one preferred stock purchase right for each current share of common stock outstanding at the close of business on November 16, 2014. Initially these rights will not be exercisable and will trade with the common stock of the Company.
Under the Rights Plan, the rights generally will become exercisable only if a person (including such person’s affiliates, associates, and persons acting in concert with such person), or group acquires beneficial ownership of 15% or more of the Company’s common stock (as determined in the manner specified in the Rights Plan) without the approval of the board of directors of the Company. If the rights become exercisable, they will entitle stockholders, other than the person (including such person’s affiliates and associates and persons acting in concert with such person or group of which it is a member) or group that has exceed the 15% ownership limit and their transferees (whose rights will become void and will not be exercisable), to purchase, at the then-current exercise price, additional shares of common stock having a value that is twice the exercise price of the right. In addition, if the Company were acquired in a merger or other business combination after an unapproved party acquires more than 15% of the Company’s common stock, each holder of the rights (other than the acquiring person) would then be entitled to purchase, at the then-current exercise price, shares of the acquiring Company’s stock, having a value that is twice the exercise price of the right.
If a stockholder’s beneficial ownership (as determined in the manner specified in the Rights Plan) as of the time of the adoption of the Rights Plan is at or above the threshold applicable to it (including through entry into certain derivative positions), that stockholder’s existing ownership percentage is grandfathered, but the rights would generally become exercisable if such stockholder becomes the beneficial owner of one or more additional shares of the Company’s common stock.
In addition to the board of directors’ authority to amend the Rights Plan, it may redeem the rights for a nominal amount before an event triggering the exercisability of the rights.
A more detailed summary of the Rights Plan will be contained in a Form 8-K to be filed by the Company with the U.S. Securities and Exchange Commission.
Forward-Looking Statements
Except for the historical information in this press release, it includes forward-looking statements that involve risks and uncertainties, including but not limited to, quarterly fluctuations in results; customer demand for the Company’s products; the development of new technology for alternate means of motion picture presentation; domestic and international economic conditions; the management of growth; and other risks detailed from time to time in the Company’s Securities and Exchange Commission filings. Actual results may differ materially from management’s expectations.
About Ballantyne Strong, Inc. (www.strong-world.com)
Ballantyne Strong is a provider of digital equipment, screens and managed services as well as specialty lighting equipment. The Company supplies major and independent theater chains, top arenas, theme parks and architectural sites around the world. Through its subsidiary, Convergent Media Systems, the Company is also a leading player in digital signage and content creation and distribution systems for the retail, hospitality, financial services, cinema and government markets.
Financial Profiles, Inc.
Tony Rossi, 310-622-8221
trossi@finprofiles.com
(RPRX) Holds Constructive Meeting With FDA Regarding Androxal(R) NDA Filing
- No New Clinical Studies Requested
- Environmental Impact Assessment Plan Will be Discussed With FDA Prior to NDA Submission
- Company to Host Conference Call on Friday, November 7, 2014, at 9 AM Eastern
THE WOODLANDS, Texas, Nov. 6, 2014 — Repros Therapeutics Inc.® (Nasdaq:RPRX) today reported the outcome from its meeting with the FDA to discuss the Company’s expected NDA submission.
Based on the data compiled to date, the FDA did not identify any additional clinical studies that would be required for filing the NDA. Although no specific request was made, the FDA stated that as a result of the recent Advisory Committee Meeting, cardiovascular risk is of particular interest and that additional safety studies could be required in the future.
The FDA advised that the Company’s environmental assessment of Androxal® planned for the NDA should be discussed with appropriate Agency personnel prior to NDA submission. The Agency stated that due to their evolving interest in this class of chemicals this would be important to avoid late cycle approval delays, and the Company plans to engage in those discussions promptly.
Repros does not anticipate that an additional meeting will be held before submission of its NDA given the detailed guidance received and the subsequent response the Company will provide the Agency. Repros is confident that it will be able to address all concerns noted in the meeting and believes the discussions provided constructive guidance for the NDA filing. The Company will reassess submission timelines once it has discussed the environmental assessment requirements with appropriate Agency personnel.
Conference Call Details:
Time: | Friday, November 7, 2014 – 9:00 AM Eastern |
Participant Dial-In Number | (Domestic): 877-407-8629; International: 201-493-6715 |
It is recommended that participants call in approximately 15 minutes prior to the start time of the conference call.
Replay Call Details:
Conference ID Number: | 13595473 |
Replay Dial-In (Toll Free): | 877-660-6853 |
Replay Dial-In (International): | 201-612-7415 |
About Repros Therapeutics Inc. ®
Repros Therapeutics focuses on the development of small molecule drugs for major unmet medical needs that treat male and female reproductive disorders.
Any statements made by the Company that are not historical facts contained in this release are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and are subject to various risks, uncertainties and other factors that could cause the Company’s actual results, performance or achievements to differ materially from those expressed or implied by such forward-looking statements. These statements often include words such as “may,” “will,” “expect,” “anticipate,” “continue,” “estimate,” “project,” “intend,” “believe,” “plan,” “seek,” “could,” “can,” “should” or similar expressions. These statements are based on assumptions that the Company has made in light of the Company’s experience in the industry, as well as the Company’s perceptions of historical trends, current conditions, expected future developments and other factors the Company believes are appropriate in these circumstances. Forward-looking statements include, but are not limited to, those relating to planned clinical studies and the timing and nature of the results thereof, the impact of the studies on the Androxal® label and the commercial potential of Androxal® and the timing of the Company’s expected filing of an NDA for Androxal®. Such statements are based on current expectations that involve a number of known and unknown risks, uncertainties and other factors that may cause actual events to be materially different from those expressed or implied by such forward-looking statements, including the ability to have success in the clinical development of the Company’s technologies, the reliability of interim results to predict final study outcomes, the ability to protect the Company’s intellectual property rights and such other risks as are identified in the Company’s most recent Annual Report on Form 10-K and in any subsequent quarterly reports on Form 10-Q. These documents are available on request from Repros Therapeutics or at www.sec.gov. Repros disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
For more information, please visit the Company’s website at http://www.reprosrx.com
CONTACT: Investor Relations: Thomas Hoffmann The Trout Group (646) 378-2931 thoffmann@troutgroup.com
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