Uncategorized
(TGD) Addresses Sentry Investments Press Release
VANCOUVER, BRITISH COLUMBIA–(June 2, 2014) – Timmins Gold Corp. (TSX:TMM)(NYSE MKT:TGD) (“Timmins Gold” or the “Company”) is aware that Sentry Investments intends to run a dissident slate to replace six of the eight existing members of the Timmins Gold board of directors (the “Board”).
The Board is committed to considering the views of all of the shareholders of the Company and is confident that it can resolve this matter in a manner that is in the best interests of the Company and all of the Company’s shareholders.
The Board’s process will include working with an independent consultant to consider the qualifications of the nominees of Sentry Investments and other potential candidates.
Annual Meeting Date
Timmins Gold has applied to extend the date of its annual meeting of shareholders to September 23, 2014.
Neither the TSX nor its Regulation Services Provider (as that term is defined in the policies of the TSX) nor the New York Stock Exchange MKT accepts responsibility for the adequacy or accuracy of this news release.
Cautionary Note Regarding Forward-Looking Statements
Certain statements contained herein may constitute forward-looking statements and are made pursuant to the “safe harbor” provisions of the United States Private Securities Litigation Reform Act of 1995 and Canadian securities laws. Forward-looking statements are statements which relate to future events. Such statements include estimates, forecasts and statements as to management’s expectations with respect to, among other things, business and financial prospects, financial multiples and accretion estimates, future trends, plans, strategies, objectives and expectations, including with respect to production, exploration drilling, reserves and resources, exploitation activities and events or future operations. Information inferred from the interpretation of drilling results and information concerning mineral resource estimates may also be deemed to be forward-looking statements, as it constitutes a prediction of what might be found to be present when, and if, a project is actually developed.
In some cases, you can identify forward-looking statements by terminology such as “may”, “should”, “expects”, “plans, “anticipates”, believes”, “estimates”, “predicts”, “potential”, or “continue” or the negative of these terms or other comparable terminology. These statements are only predictions and involve known and unknown risks, uncertainties and other factors that may cause our or our industry’s actual results, level of activity, performance or achievements to be materially different from any future results, levels of activity, performance, or achievements expressed or implied by these forward-looking statements.
While these forward-looking statements, and any assumptions upon which they are based, are made in good faith and reflect our current judgment regarding the direction of our business, actual results will almost always vary, sometimes materially, from any estimates, predictions, projections, assumptions or other future performance suggestions herein. Except as required by applicable law, Timmins Gold does not intend to update any forward-looking statements to conform these statements to actual results.
Timmins Gold Corp.
Alex Tsakumis
Vice President, Corporate Development
604-604-682-4002
alex@timminsgold.com
www.timminsgold.com
(BRCM) to Explore Strategic Alternatives for Cellular Baseband Business
Company Accelerates Key Initiatives in Broadband, Infrastructure and Connectivity Markets Conference Call Webcasted at 6:00 a.m. PT / 9:00 a.m. ET www.broadcom.com/investors
IRVINE, Calif., June 2, 2014 — Broadcom Corporation (NASDAQ: BRCM), a global innovation leader in semiconductor solutions for wired and wireless communications, today announced it is exploring strategic alternatives for its cellular baseband business, including a potential sale or wind-down. The company has engaged investment bank JP Morgan in connection with its efforts.
The successful sale or wind-down of the cellular baseband business is currently expected to result in a roughly $700 million reduction in annualized GAAP research and development and selling, general and administrative expenses, of which approximately $100 million relates to estimated reductions in stock-based compensation. As such, non-GAAP research and development and selling, general and administrative expenses are currently expected to be reduced by roughly $600 million. These estimates do not reflect the impact of any potential impairment and/or restructuring charges that are likely to be recorded related to the successful sale or wind-down of Broadcom’s cellular baseband business.
Broadcom currently expects to organically reinvest roughly $50 million of these savings on an annualized basis into projects in the Broadband, Infrastructure and Connectivity businesses. This incremental spending is currently expected to strengthen and accelerate the company’s plans in the area of small cells, embedded processing and low-power connectivity.
Updated Business Outlook
Broadcom today also updated its business outlook for the three months ending June 30, 2014. Broadcom continues to expect revenue between $2.0 billion and $2.1 billion. Broadcom now expects both GAAP and non-GAAP product gross margin to be at or above the high end of the previously-guided range, driven principally by mix.
Conference Call Information
Broadcom will conduct a conference call with analysts and investors today at 6:00 a.m. PT (9:00 a.m. ET). Interested parties can call (800) 447-0521 US toll free or (847) 413-3238 US toll. The company will broadcast the conference call via webcast over the Internet. To listen to the webcast, please visit the Investors section of Broadcom’s website at www.broadcom.com/investors. The webcast will be recorded and available for replay, within 48 hours after the event, until 10:00 p.m. PT on July 2, 2014.
There can be no assurance that this exploration process will result in a sale. The company does not intend to discuss developments with respect to the exploration of strategic alternatives in cellular baseband unless or until its Board of Directors has approved a definitive transaction or the process is otherwise complete.
About Broadcom
Broadcom Corporation (NASDAQ: BRCM), a FORTUNE 500® company, is a global leader and innovator in semiconductor solutions for wired and wireless communications. Broadcom® products seamlessly deliver voice, video, data and multimedia connectivity in the home, office and mobile environments. With the industry’s broadest portfolio of state-of-the-art system-on-a-chip solutions, Broadcom is changing the world by Connecting everything®. For more information, go to www.broadcom.com.
Cautions Regarding Forward-Looking Statements
All statements included or incorporated by reference in this release and the related conference call for analysts and investors, other than statements or characterizations of historical fact, are forward-looking statements within the meaning of the federal securities laws, including the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based on our current expectations, estimates and projections about our industry and business, management’s beliefs, and certain assumptions made by us, all of which are subject to change. Forward-looking statements can often be identified by words such as “anticipates,” “expects,” “intends,” “plans,” “predicts,” “believes,” “seeks,” “estimates,” “may,” “will,” “should,” “would,” “could,” “potential,” “continue,” “ongoing,” similar expressions, and variations or negatives of these words. Examples of such forward-looking statements include, but are not limited to, the amount and timing of reduced research & development and selling, general & administrative expenses resulting from the exit of the cellular baseband business, the possibility of a sale or wind-down of such business, our ability to drive growth through our planned reinvestments in our Broadband, Infrastructure and Connectivity businesses, and guidance provided on future revenue, product gross margin and operating expenses for the second quarter of 2014 (on both a GAAP and non-GAAP basis). These forward-looking statements are not guarantees of future results and are subject to risks, uncertainties and assumptions that could cause our actual results to differ materially and adversely from those expressed in any forward-looking statement.
These risks and uncertainties include, but are not limited to the following:
- Our quarterly operating results may fluctuate significantly.
- We depend on a few significant customers for a substantial portion of our revenue.
- We face intense competition.
- We manufacture and sell complex products and may be unable to successfully develop and introduce new products.
- We may fail to appropriately adjust our operations in response to changes in our strategy or market demand.
- We are exposed to risks associated with our international operations.
- Our business is subject to potential tax liabilities.
- Our stock price is highly volatile.
- Our operating results may be adversely impacted by worldwide economic uncertainties and specific conditions in the markets we address.
- We may be required to defend against alleged infringement of intellectual property rights of others and/or may be unable to adequately protect or enforce our own intellectual property rights.
- We face risks associated with our acquisition strategy.
- We may be unable to attract, retain or motivate key personnel.
- We are subject to order and shipment uncertainties.
- We depend on third parties to fabricate, assemble and test our products.
- Our systems are subject to security breaches and other cyber security incidents.
- Government regulation may adversely affect our business.
- Our co-founders and their affiliates may strongly influence the outcome of matters that require the approval of our shareholders.
- Our articles of incorporation and bylaws contain anti-takeover provisions.
- There can be no assurance that we will continue to declare cash dividends.
- We may be unable to successfully sell or wind down the cellular baseband business or realize the expected reduction in annualized research and development and selling, general and administrative expenses.
- There can be no assurance that we will be able to successfully grow or maintain our Connectivity business independent of the cellular baseband business.
Broadcom’s Annual Report on Form 10-K for the year ended December 31, 2013, subsequent Quarterly Reports on Form 10-Q, recent Current Reports on Form 8-K, and other Securities and Exchange Commission filings discuss the foregoing risks as well as other important risk factors that could contribute to such differences or otherwise affect our business, results of operations and financial condition. The forward-looking statements in this release speak only as of this date. We undertake no obligation to revise or update publicly any forward-looking statement to reflect future events or circumstances.
BROADCOM CORPORATIONUpdated Guidance for the Three Months Ending June 30, 2014 | |||
ReportedThree Months Ended
March 31, 2014 |
Prior GuidanceThree Months Ending
June 30, 2014 |
Updated GuidanceThree Months Ending
June 30, 2014 |
|
Total net revenue | $1.984 billion | ~$2.0 to ~$2.1 billion | ~$2.0 to ~$2.1 billion |
Product gross margin (GAAP) | 49.4% | Up ~100 to ~200 bps | At or above the high end of the previously- guided range |
Product gross margin (Non-GAAP) | 52.2% | Up ~75 to ~175 bps | At or above the high end of the previously- guided range |
Research & development and selling, general, and administrative expenses (GAAP) | $821 million | Flat to up ~$20 million | Flat to up ~$20 million |
Research & development and selling, general, and administrative expenses (Non-GAAP) | $706 million | Down ~$5 to up ~$15 million | Down ~$5 to up ~$15 million |
Broadcom has based the preceding guidance for the three months ending June 30, 2014 on expectations, assumptions and estimates that we believe are reasonable given our assessment of historical trends and other information reasonably available as of June 2, 2014. Our guidance consists of predictions only, however, and is subject to a wide range of known and unknown business risks and uncertainties, many of which are beyond our control. The forecasts and projections contained in the table above should not be regarded as representations by Broadcom that the estimated results will be achieved. Projections and estimates are necessarily speculative in nature and actual results may vary materially from the guidance we provide today. The non-GAAP guidance presented above is calculated in a manner consistent with the presentation of non-GAAP results as reported in our April 24, 2014 press release covering Broadcom’s first quarter 2014 results.
The guidance set forth in the above table should be read together with the information under the caption, “Cautions Regarding Forward-Looking Statements” above, our Annual Report on Form 10-K for the year ended December 31, 2013, subsequent Quarterly Reports on Form 10-Q, recent Current Reports on Form 8-K, and our other Securities and Exchange Commission filings. We undertake no obligation to publicly update or revise any forward-looking statements, including the guidance set forth herein, to reflect future events or circumstances.
Note Regarding Use of Non-GAAP Financial Measures
Broadcom believes that the presentation of the non-GAAP measures included herein provides important supplemental information to management and investors regarding financial and business trends relating to our financial condition and results of operations. Broadcom’s management believes that the use of these non-GAAP financial measures provides consistency and comparability among and between results from prior periods or forecasts and future prospects, and also facilitates comparisons with other companies in our industry, many of which use similar non-GAAP financial measures to supplement their GAAP results. Broadcom’s management has historically used these non-GAAP financial measures when evaluating operating performance, because we believe that the inclusion or exclusion of the items in these measures provides insight into our core operating results, our ability to generate cash and underlying business trends affecting our performance. Broadcom has chosen to provide this information to investors to enable them to perform additional analysis of past, present and future operating performance and as a supplemental means to evaluate our ongoing core operations. The non-GAAP financial information presented herein should be considered supplemental to, and not as a substitute for, or superior to, financial measures calculated in accordance with GAAP.
Broadcom®, the pulse logo, Connecting everything®, the Connecting everything logo are among the trademarks of Broadcom Corporation and/or its affiliates in the United States, certain other countries and/or the EU. Any other trademarks or trade names mentioned are the property of their respective owners.
Contacts
PressKaren Kahn
Vice President, Communications 949-926-3139 |
InvestorsChris Zegarelli
Senior Director, Investor Relations 949-926-7567 |
(AQXP) xpansion of Ongoing Phase 2 Trials of AQX-1125
VANCOUVER, British Columbia, June 2, 2014 — Aquinox Pharmaceuticals, Inc. (Nasdaq:AQXP), a clinical-stage pharmaceutical company discovering and developing targeted therapeutics for inflammatory disease and cancer, today announced expansion of its ongoing Phase 2 clinical trials with its lead product candidate, AQX-1125.
The U.S. Food and Drug Administration (FDA) has accepted Aquinox’s Investigational New Drug (IND) application for the Phase 2 LEADERSHIP trial, which is investigating the safety and efficacy of AQX-1125 in reducing pain and urinary symptoms in patients with bladder pain syndrome/interstitial cystitis (BPS/IC). The LEADERSHIP trial has been enrolling patients at clinical sites across Canada and is now active at sites in the United States.
“The United States is an integral part of our development and commercialization plan for AQX-1125,” said David J. Main, President and Chief Executive Officer of Aquinox. “Expanding LEADERSHIP into the U.S. provided Aquinox with an important opportunity for the FDA to review our program while also broadening our access to patients for enrollment and engaging with leading U.S. clinicians.”
In addition, Aquinox announced that it is expanding its Phase 2 FLAGSHIP trial investigating the safety and efficacy of AQX-1125 in the treatment of exacerbations of chronic obstructive pulmonary disease (COPD) after having obtained regulatory clearance in Australia, where it is currently adding clinical sites. Aquinox is also seeking regulatory clearance to add clinical sites in New Zealand. FLAGSHIP has been enrolling patients at clinical sites across Northern and Central Europe.
“Australia and New Zealand have COPD prevalence and treatment practices that are similar to the countries where the FLAGSHIP trial is already underway and the added sites have contributed significantly to prior drug trials in COPD,” said Dr. Stephen Shrewsbury, Senior Vice President, Clinical Development and Chief Medical Officer of Aquinox. “Opening sites in the Southern Hemisphere will allow us to capitalize upon their winter season when patients typically experience an increase in COPD exacerbations.”
About Bladder Pain Syndrome/Interstitial Cystitis (BPS/IC)
BPS/IC is a chronic inflammatory bladder disease characterized by pelvic pain and increased urinary urgency and/or frequency. For many sufferers, these symptoms are severe and adversely affect all major aspects of their lives, including overall physical and emotional health, employment, social and intimate relationships, and leisure activities. While the cause of the disease remains largely unknown, erosion of the bladder lining is thought to be a significant contributor. BPS/IC currently affects an estimated 14 million people in the United States. Most BPS/IC patients continue to suffer this debilitating condition, despite treatment with existing therapies. Most current therapies and those in development are focused solely on symptomatic relief of BPS/IC. New and innovative therapies that target the underlying disease processes to reduce the chronic pain and urinary symptoms are needed.
About the LEADERSHIP Trial
The LEADERSHIP trial is a double-blind, placebo-controlled, Phase 2 clinical trial investigating AQX-1125‘s ability to reduce pain and urinary symptoms in approximately 70 female patients with BPS/IC. The primary objective is to measure the difference in the change from baseline in the mean daily bladder pain score based on an 11-point numeric rating scale (NRS) at six weeks recorded by eDiary. For more information on the LEADERSHIP trial, please visit www.clinicaltrials.gov.
About Chronic Obstructive Pulmonary Disease (COPD) & Related Exacerbations.
COPD is a lung disease frequently associated with cigarette smoking and air pollution and is characterized by progressive loss of lung function and chronic inflammation of the airways. COPD currently affects up to an estimated 600 million people worldwide, with up to 200 million suffering from the moderate and severe forms that most frequently require treatment. It is the third leading cause of death in the United States and the fourth leading cause of death worldwide. In the United States alone, the annual economic burden of treating COPD is estimated at $50 billion. COPD patients suffer periodic episodes with severe worsening of symptoms, known as exacerbations. Of COPD patients, 22-40% die within one year of a severe exacerbation and 66% die within three years. Since exacerbations involve severe increased airway inflammation, treatment with potent anti-inflammatories is a potentially promising strategy to reduce exacerbations.
About the FLAGSHIP Trial
The FLAGSHIP trial is a multinational, double-blind, placebo-controlled, Phase 2 clinical trial investigating AQX-1125‘s ability to reduce the effects of exacerbations in approximately 400 unstable patients with moderate to severe COPD. The primary endpoint is the change in the severity, duration and reoccurrence of exacerbations in patients treated with AQX-1125 versus placebo, as measured by EXACT-PRO, a patient-reported outcome tool that measures symptoms. For more information on the FLAGSHIP trial, please visit www.clinicaltrials.gov.
About Aquinox Pharmaceuticals
Aquinox Pharmaceuticals, Inc. is a clinical-stage pharmaceutical company discovering and developing novel drug candidates to treat inflammation and cancer. Aquinox’s primary focus is advancing anti-inflammatory product candidates targeting SHIP1, a key regulator of the PI3K immune cell-signaling pathway. Aquinox’s lead product candidate, AQX-1125, is a SHIP1 activator that has demonstrated broad anti-inflammatory properties and has successfully completed three clinical trials with over 100 subjects dosed with once daily oral therapy. Aquinox is currently investigating AQX-1125 in two Phase 2 trials for chronic obstructive pulmonary disease (COPD) exacerbations and bladder pain syndrome/interstitial cystitis (BPS/IC), both debilitating chronic inflammatory diseases affecting millions of people worldwide. For more information please visit www.aqxpharma.com.
Cautionary Note on Forward-looking Statements
Certain of the statements made in this press release are forward looking, such as those, among others, relating to: the success and timing of our Phase 2 clinical trials; the outcome of our interactions with the FDA and other regulatory authorities; and potential market opportunities for AQXP-1125. These statements are subject to risks and uncertainties that could cause actual results and events to differ materially from those anticipated, including, but not limited to, risks and uncertainties related to: our ability to enroll patients in our clinical trials at the pace that we project; the size and growth of the potential markets for AQX-1125 or any future product candidates and our ability to serve those markets; our ability to obtain and maintain regulatory approval of AQX-1125 or any future product candidates; and our expectations regarding the potential safety, efficacy or clinical utility of AQX-1125 or any future product candidates. Actual results or developments may differ materially from those projected or implied in these forward-looking statements. More information about the risks and uncertainties faced by Aquinox is contained in the company’s Quarterly Report on Form 10-Q for the quarter ended March 31, 2014 filed with the Securities and Exchange Commission. Aquinox disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: Brendan Payne, Senior Manager, Investor Relations Aquinox Pharmaceuticals, Inc. 604.629.9223 ir@aqxpharma.com Bianca Nery MacDougall Biomedical Communications 650.339.7533 aquinox@macbiocom.com
(GIGA) High Performance Filter Extended to Third Aircraft Platform
SAN RAMON, Calif., June 2, 2014 — Giga-tronics Incorporated announced today that it has completed a sole-source multi-year agreement with a major aerospace company to develop a variant of its high performance fast tuning YIG filters for a third aircraft platform. In connection with the agreement, the Company has received orders valued at approximately $6.9 million for the non-recurring engineering and for the delivery of a limited number of flight-qualified prototype hardware. The majority of the non-recurring engineering services are expected to be performed over the next twelve months. The Company is also anticipating an additional multi-year order later this year for approximately $10.0 million associated with the production units.
The award for developing the specialty filters based upon the Company’s fast switching YIG technology, will be fulfilled by Giga-tronics’ Microsource subsidiary co-located with the Company’s instrument division in San Ramon, California. John Regazzi, President and CEO of Giga-tronics, said “Engineers from our components group will produce a working filter in less than 12 months by leveraging Microsource’s F/A-18 and F-15E filter know-how. We are very proud to be chosen for this new program based upon our proven field performance on US Navy and US Air Force fighter jets.”
Giga-tronics Microsource has been supplying sole-sourced filters for a number of years. Ernie Nyiri, Microsource’s program manager, stated “The nature of sole sourced contracts requires Microsource to maintain the highest customer satisfaction as measured by on time delivery product quality & reliability, and price. At the conclusion of the development phase, Microsource will be a supplier of filter systems for all three of the US designed 4th generation fighters.”
Giga-tronics is a publicly held company, traded on the NASDAQ Capital Market under the symbol “GIGA”. Giga-tronics produces instruments, subsystems and sophisticated microwave components that have broad applications in defense electronics, aeronautics and wireless telecommunications.
This press release contains forward-looking statements concerning profitability, development of products, future growth, shareholder value, backlog and shipments. Actual results may differ significantly due to risks and uncertainties, such as future orders, cancellations or deferrals, disputes over performance, availability of capital and capital resources, the ability to collect receivables and general market conditions. For further discussion, see Giga-tronics’ most recent annual report on Form 10-K for the fiscal year ended March 30, 2013, Part I, under the heading “Risk Factors” and Part II, under the heading “Management’s Discussion and Analysis of Financial Condition and Results of Operations.”
CONTACT: Steven D. Lance Vice President of Finance/Chief Financial Officer slance@gigatronics.com (925) 302-1056
(HTBX) Green Lighted to Expand Enrollment, Phase 1/2 on HS-410 in Bladder Cancer
DURHAM, NC–(May 30, 2014) – Heat Biologics, Inc. (NASDAQ: HTBX), a clinical stage biopharmaceutical company focused on the development of novel cancer immunotherapies, announced today that its Dose Escalation Committee has approved the expansion of the first cohort to full enrollment in its ongoing Phase 1/2 study of HS-410 (Vesigenpumatucel-L) for the treatment of bladder cancer. The Committee unanimously agreed to expand the cohort to the full nine patients without delay.
The decision was based on pre-specified protocol criteria and was made after the initial three patients were dosed with Heat Biologic’s off-the-shelf product candidate designed to activate a T-cell mediated pan-antigen immune response for the treatment of non-muscle invasive bladder cancer.
There were no serious adverse events reported in the initial three patients, and all non-serious adverse events and injection site reactions reported were Grade 1.
“We are delighted about the early reports of the safety of HS-410,” said Jeff Wolf, CEO of Heat. “This early data appears to be consistent with the data from our successful Phase 1 lung cancer trial with our product candidate HS-110 (Viagenpumatucel-L) based on the same ImPACT platform.”
The multi-center Phase 1/2 bladder cancer study of HS-410 (Vesigenpumatucel-L) will enroll approximately 93 patients after transurethral resection of bladder tumor (TURBT) and bacillus Calmette-Guérin (BCG). The Phase 1 portion of the trial is designed to evaluate the safety of two doses of HS-410 in bladder cancer patients. In the Phase 2 portion, the trial is designed to evaluate whether vaccination with HS-410 extends the time to disease recurrence compared to placebo.
Heat’s proprietary Immune Pan Antigen Cytotoxic Therapy (“ImPACT“) reprograms live cancer cells from a single tumor source to continually secrete gp96, a chaperone protein found in all human cells. In turn, gp96 chaperones tumor antigens to T-cells to activate a robust, pan-antigen T-cell immune response and direct killer T-cells to attack the patient’s cancer. Heat’s ImPACT technology holds promise for treating a wide variety of different cancers.
According to the American Cancer Society, in 2012, there were 73,000 new cases of bladder cancer reported and 15,000 deaths from the disease in the U.S. alone. More than 500,000 people in the U.S. have been treated for bladder cancer. Importantly, the U.S. Food and Drug Administration “FDA” has not approved any new drugs to treat bladder cancer in more than 25 years. Heat’s HS-410 (Vesigenpumatucel-L) represents a viable opportunity to address a significant unmet medical need.
About Heat Biologics, Inc.
Heat Biologics, Inc. (www.heatbio.com) is a clinical-stage biopharmaceutical company focused on developing its novel, “off-the-shelf” ImPACT therapeutic vaccines to combat a wide range of cancers. Our ImPACT Therapy is designed to deliver live, genetically-modified, irradiated human cells which are reprogrammed to “pump out” a broad spectrum of cancer-associated antigens together with a potent immune adjuvant called “gp96” to educate and activate a cancer patient’s immune system to recognize and kill cancerous cells. Heat’s Viagenpumatucel-L (HS-110) will be entering Phase 2 trials against non-small cell lung cancer and its Vesigenpumatucel-L (HS-410) is being evaluated in an ongoing Phase 1/2 clinical trial against bladder cancer.
Forward Looking Statements
This press release includes forward-looking statements on our current expectations and projections about future events. In some cases forward-looking statements can be identified by terminology such as “may,” “should,” “potential,” “continue,” “expects,” “anticipates,” “intends,” “plans,” “believes,” “estimates,” and similar expressions. These statements are based upon current beliefs, expectations and assumptions and include statements regarding the potential for Heat’s ImPACT Therapy. These statements are subject to a number of risks and uncertainties, many of which are difficult to predict, including the ability for Heat’s ImPACT Therapy to perform as designed and ability to enroll patients as planned. The information in this release is provided only as of the date of this release, and we undertake no obligation to update any forward-looking statements contained in this release based on new information, future events, or otherwise, except as required by law.
Heat Biologics, Inc. Contact Information:
Matthew Czajkowski
Chief Financial Officer
(919) 240 7133
Email Contact
Jenene Thomas
Investor Relations and Corporate Communications Advisor
Jenene Thomas Communications, LLC
(908) 938-1475
Email Contact
(BTX) Subsidiary Announces a $14.3 Million Strategic Partnership
Asterias Biotherapeutics, Inc. (“Asterias”), a subsidiary of BioTime, Inc. (NYSE MKT: BTX), today announced that it has been awarded a $14.3 million Strategic Partnership III grant entitled “A Phase 1/2a Dose Escalation Study of AST-OPC1 in Patients with Cervical Sensorimotor Complete Cervical Spinal Cord Injury” from the California Institute for Regenerative Medicine (“CIRM”). The award provides funding for Asterias to reinitiate clinical development of AST-OPC1 in subjects with spinal cord injury and to expand clinical testing of escalating doses in the target population intended for future pivotal trials.
AST-OPC1 is a population of cells derived from human embryonic stem cells (hESCs) that contains oligodendrocyte progenitor cells (OPCs). OPCs and their mature derivatives called oligodendrocytes provide critical functional support for nerve cells in the spinal cord and brain. Asterias recently presented the results from phase 1 clinical trial testing of a low dose of AST-OPC1 in patients with neurologically-complete thoracic spinal cord injury. The results showed that AST-OPC1 was successfully delivered to the injured spinal cord site. Patients followed 2-3 years after AST-OPC1 administration showed no evidence of serious adverse events associated with the cells in detailed follow-up assessments including frequent neurological exams and MRIs. Immune monitoring of subjects through one year post-transplantation showed no evidence of antibody-based or cellular immune responses to AST-OPC1. In four of the five subjects, serial MRI scans performed throughout the 2-3 year follow-up period indicate that reduced spinal cord cavitation may have occurred and that AST-OPC1 may have had some positive effects in reducing spinal cord tissue deterioration. There was no unexpected neurological degeneration or improvement in the five subjects in the trial as evaluated by the International Standards for Neurological Classification of Spinal Cord Injury (ISNCSCI) exam.
The Strategic Partnership III grant from CIRM will provide funding to Asterias to support the next clinical trial of AST-OPC1 in subjects with spinal cord injury, and for Asterias’ product development efforts to refine and scale manufacturing methods to support later-stage trials and eventually commercialization. CIRM funding will be conditional on FDA approval for the trial, completion of a definitive agreement between Asterias and CIRM, and Asterias’ continued progress toward the achievement of certain pre-defined project milestones.
“These programs help bring together the most rigorous scientific research with companies that know how to do clinical trials and move therapies through the regulatory process. It’s a partnership with a simple goal, get the most promising therapies to patients as quickly as possible,” said Jonathan Thomas, Ph.D., J.D., Chair, Governing Board of CIRM. “If this therapy can achieve even very modest improvements for patients, it could have an enormous impact on the quality of their life, and the lives of their families.”
“We are preparing to initiate the dose escalation Phase 1/2a clinical trial of AST-OPC1 in patients with cervical injuries in 6-9 months subject to FDA clearance,” stated Edward Wirth III M.D., Ph.D., Asterias’ Chief Translational Officer. “Achievements in this CIRM-supported program could also help accelerate further development of AST-OPC1 in other neurodegenerative diseases such as stroke and multiple sclerosis. We are currently evaluating the function of AST-OPC1 in nonclinical models of these diseases.”
“This award provides significant non-dilutive funding to accelerate the development of AST-OPC1 for patients with spinal cord injury. Given the lack of any approved therapies for spinal cord injury and the high level of disability, substantial costs of care, and shorter life expectancy of injured individuals, AST-OPC1 has the potential to address a substantial unmet medical need in this condition,” stated Katharine Spink, Ph.D., Asterias’ Chief Operating Officer. “We look forward to working in partnership with CIRM to bring this important therapy to patients.”
More information about AST-OPC1 and Asterias is available on Asterias’ website, www.asteriasbiotherapeutics.com and in the company’s amended S-1 filed with the Securities and Exchange Commission.
About Spinal Cord Injury and AST-OPC1
Over 12,000 individuals suffer a spinal cord injury (SCI) each year in the United States alone, and approximately 1.3 million Americans are estimated to be living with a spinal cord injury. Traumatic SCI most commonly impacts individuals in their 20s and 30s, resulting in a high level of permanent disability in young and previously healthy individuals. Individuals with SCI not only have impaired limb function, but suffer from a wide range of additional disabilities which can each significantly impact quality of life, and can even be life threatening in some instances. According to the National Spinal Cord Injury Statistical Center, the life expectancy of an individual suffering a cervical spinal cord injury at age 20 is 20-25 years lower than that of a similarly aged individual with no SCI.
In addition to its dramatic impact on quality of life for patients and their families, SCI is responsible for tremendous costs to society. At one year post injury, only 11.8% of SCI patients are employed, and fewer than 35% are employed even at more than twenty years post-injury. Additionally, many patients require help with activities of daily living such as feeding and bathing. As a result, the lifetime cost of care for SCI patients are enormous; a recent paper estimated lifetime costs of care for a patient sustaining a cervical SCI at age 25 at $4.2 million. Overall, it has been estimated that SCIs cost the U.S. over $14.5 billion per year in direct medical costs and disability support, plus an additional $5.5 billion in lost productivity.
There are currently no approved therapies for the treatment of SCI, and the complex pathology of the injury is unlikely to be addressed by a traditional small molecule or protein therapeutic. AST-OPC1, an oligodendrocyte progenitor population derived from human embryonic stem cells, has been shown to have three potentially reparative functions which address the complex pathologies observed at the SCI injury site. These activities of AST-OPC1 include production of neurotrophic factors, stimulation of vascularization, and induction of remyelination of denuded axons, all of which are critical for survival, regrowth and conduction of nerve impulses through axons at the injury site. In preclinical animal testing, AST-OPC1 administration led to remyelination of axons, improved hindlimb and forelimb locomotor function, dramatic reductions in injury-related cavitation and significant preservation of myelinated axons traversing the injury site.
About Asterias Biotherapeutics
Asterias Biotherapeutics (“Asterias”) is a biotechnology company focused on the emerging field of regenerative medicine. Our core technologies center on stem cells capable of becoming all of the cell types in the human body, a property called pluripotency. We plan to develop therapies based on pluripotent stem cells to treat diseases or injuries in a variety of medical fields, with an initial focus on the therapeutic applications of oligodendrocyte progenitor cells (AST-OPC1) and antigen-presenting dendritic cells (AST-VAC1 and AST-VAC2) for the fields of neurology and oncology respectively. AST-OPC1 was tested for treatment of spinal cord injury in the world’s first Phase 1 clinical trial using human embryonic stem cell-derived cells. We plan to seek FDA clearance to reinitiate clinical testing of AST-OPC1 in spinal cord injury this year, and are also evaluating its function in nonclinical models of multiple sclerosis and stroke. AST-VAC1 and AST-VAC2 are dendritic cell-based vaccines designed to immunize cancer patients against telomerase, a protein abnormally expressed in over 95% of human cancer types. AST-VAC2 differs from AST-VAC1 in that the dendritic cells presenting telomerase to the immune system are produced from human embryonic stem cells instead of being derived from human blood.
In October of 2013, Asterias acquired the cell therapy assets of Geron Corporation. These assets included INDs for the clinical stage AST-OPC1 and AST-VAC1 programs, banks of cGMP-manufactured AST-OPC1 drug product, cGMP master and working cell banks of human embryonic stem cells, over 400 patents and patent applications filed worldwide including broad issued claims to fundamental platform technologies for the scalable growth of pluripotent stem cells and compositions of matter for several hESC-derived therapeutic cell types, research cell banks, customized reagents and equipment, and various assets relating to the AST-VAC2 program and preclinical programs in cardiology and orthopedics.
Asterias is a member of the BioTime family of companies.
Additional information about Asterias can be found at www.asteriasbiotherapeutics.com.
About CIRM
CIRM was established in November 2004 with the passage of Proposition 71, the California Stem Cell Research and Cures Act. The statewide ballot measure, which provided $3 billion in funding for stem cell research at California universities and research institutions, was overwhelmingly approved by voters, and called for the establishment of an entity to make grants and provide loans for stem cell research, research facilities, and other vital research.
About BioTime
BioTime is a biotechnology company engaged in research and product development in the field of regenerative medicine. Regenerative medicine refers to therapies based on stem cell technology that are designed to rebuild cell and tissue function lost due to degenerative disease or injury. BioTime’s focus is on pluripotent stem cell technology based on human embryonic stem (“hES”) cells and induced pluripotent stem (“iPS”) cells. hES and iPS cells provide a means of manufacturing every cell type in the human body and therefore show considerable promise for the development of a number of new therapeutic products. BioTime’s therapeutic and research products include a wide array of proprietary PureStem® progenitors, HyStem® hydrogels, culture media, and differentiation kits. BioTime is developing Renevia™ (a HyStem® product) as a biocompatible, implantable hyaluronan and collagen-based matrix for cell delivery in human clinical applications, and is planning to initiate a pivotal clinical trial around Renevia™, in 2014. In addition, BioTime has developed Hextend®, a blood plasma volume expander for use in surgery, emergency trauma treatment and other applications. Hextend® is manufactured and distributed in the U.S. by Hospira, Inc. and in South Korea by CJ HealthCare Corporation, under exclusive licensing agreements.
BioTime is also developing stem cell and other products for research, therapeutic, and diagnostic use through its subsidiaries:
- Asterias Biotherapeutics, Inc. is a new subsidiary which has acquired the stem cell assets of Geron Corporation, including patents and other intellectual property, biological materials, reagents and equipment for the development of new therapeutic products for regenerative medicine.
- BioTime Asia, Ltd., a Hong Kong company, may offer and sell products for research use for BioTime’s ESI BIO Division.
- Cell Cure Neurosciences Ltd. is an Israel-based biotechnology company focused on developing stem cell-based therapies for retinal and neurological disorders, including the development of retinal pigment epithelial cells for the treatment of macular degeneration, and treatments for multiple sclerosis.
- ESI BIO is the research and product marketing division of BioTime, providing stem cell researchers with products and technologies to enable them to translate their work into the clinic, including PureStem® progenitors and HyStem® hydrogels.
- LifeMap Sciences, Inc. markets, sells, and distributes GeneCards®, the leading human gene database, as part of an integrated database suite that also includes the LifeMap Discovery® database of embryonic development, stem cell research, and regenerative medicine, and MalaCards, the human disease database.
- LifeMap Solutions, Inc. is a subsidiary of LifeMap Sciences focused on developing mobile health (mHealth) products.
- OncoCyte Corporation is developing products and technologies to diagnose and treat cancer, including PanC-Dx™, with three clinical trials currently underway.
- OrthoCyte Corporation is developing therapies to treat orthopedic disorders, diseases and injuries.
- ReCyte Therapeutics, Inc. is developing therapies to treat a variety of cardiovascular and related ischemic disorders, as well as products for research using cell reprogramming technology.
For more information, please visit www.biotimeinc.com or connect with the company on Twitter, LinkedIn, Facebook, YouTube, and Google+.
FORWARD-LOOKING STATEMENTS
Statements pertaining to future financial and/or operating results, future growth in research, technology, clinical development, and potential opportunities for BioTime and its subsidiaries, along with other statements about the future expectations, beliefs, goals, plans, or prospects expressed by management constitute forward-looking statements. Any statements that are not historical fact (including, but not limited to statements that contain words such as “will,” “believes,” “plans,” “anticipates,” “expects,” “estimates”) should also be considered to be forward-looking statements. Forward-looking statements involve risks and uncertainties, including, without limitation, risks inherent in the development and/or commercialization of potential products, uncertainty in the results of clinical trials or regulatory approvals, need and ability to obtain future capital, and maintenance of intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements and as such should be evaluated together with the many uncertainties that affect the business of BioTime and its subsidiaries, particularly those mentioned in the cautionary statements found in BioTime’s Securities and Exchange Commission filings. BioTime disclaims any intent or obligation to update these forward-looking statements.
(MOBI) Announces Change of Fiscal Year End and US$20 Million Share Repurchase Program
HANGZHOU, China, May 30, 2014 — Sky-mobi Limited (“Sky-mobi” or the “Company”) (Nasdaq:MOBI), a leading mobile application platform in China, today announced that the Company’s Board of Directors has approved a fiscal year-end change from March 31 to December 31, beginning in the calendar year ending December 31, 2014. Additionally, the Company also announced that its Board of Directors has approved a program to repurchase up to US$20 million of the Company’s American depositary shares (“ADSs”) over the next 12-month period, ending on May 30, 2015.
The Company’s decision to change its fiscal year end is intended to improve its comparability with industry peers on both a quarterly and annual basis, to align Company’s reporting cycle with the calendar year and to provide more consistent quarter-to-quarter comparisons.
Michael Tao Song, Chairman and Chief Executive Officer of Sky-mobi stated, “Sky-mobi has delivered robust growth both operationally and financially in the past few quarters. Through our well designed initiatives and dedicated efforts, we are confident of the strong growth momentum of our mobile gaming business and hope to effectively present the fast-changing business dynamics to our shareholders. By redefining our revenue breakdown, starting in the second quarter of 2014, and aligning our reporting periods with our peers, we believe investors will be able to better understand our business and develop growing confidence of our tremendous potential as a leading distribution platform in China’s mobile application market.”
The Company expects to purchase shares on the open market, in negotiated transactions or otherwise in compliance with all of the conditions of Rule 10b-18 and Rule 10b5-1 under the Securities Exchange Act of 1934, as amended. The timing of the shares repurchased will be at the discretion of management and will depend on a number of factors, including price, market conditions and regulatory requirements. The Company retains the right to limit, terminate or extend the share repurchase program at any time without prior notice.
John Bi, Chief Financial Officer of Sky-mobi stated, “We have experienced significant revenue growth in the past few quarters at our smartphone business and our growth momentum is back on track with our successful transition. Given our strong balance sheet, long-term growth prospects, and successful turnaround story, we believe that now is the right time to enhance shareholder value through share repurchases and continued investment in growth initiatives.”
Safe Harbor Statement
This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. In some cases, you can identify forward-looking statements by such terms as “may,” “will,” ”believes,” ”expects,” ”anticipates,” ”intends,” ”estimates,” “plans,” “continues” or other similar expressions, the negative of these terms, or other comparable terminology. Such statements, including statements relating to the Company’s business outlook, are subject to risks and uncertainties that could cause actual results to differ materially from those projected. Potential risks and uncertainties include the effectiveness, profitability and marketability of the Company’s solutions; the Company’s limited operating history; measures introduced by the PRC government and mobile network operators aimed at mobile applications-related services; the Company’s revenue projections for future periods; the Company’s ability to maintain relationships with handset companies, content providers and payment service providers; its dependence on mobile service providers and mobile network operators for the collection of a substantial majority of its revenues; billing and transmission failures, which are often beyond the Company’s control; its ability to compete effectively; its ability to capture opportunities in the growing smart phone market; its ability to obtain and maintain applicable permits and approvals; general economic and business conditions; the volatility of the Company’s operating results and financial condition; the Company’s ability to attract or retain qualified senior management personnel and research and development staff; and other risks described in the Company’s filings with the Securities and Exchange Commission, including its annual report on Form 20-F filed on June 28, 2013. These forward-looking statements are based on current expectations, assumptions, estimates and projections about the Company and its industry. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or changes in its expectations, except as may be required by law.
About Sky-mobi Limited
Sky-mobi Limited is a leading mobile application platform in China. The Company works with handset companies to pre-install its Maopao mobile application store on handsets and with content providers to provide users with applications and content titles. Users of its Maopao store can browse, download and enjoy a range of applications and content, such as single-player games, mobile music and books on various mobile handsets with different hardware and operating system configurations. The Company’s mobile social network community in China, the Maopao Community, offers mobile social games, as well as applications and content with social network functions to its registered users. The Company is based in Hangzhou, China. For more information, please visit: www.sky-mobi.com.
CONTACT: Investor Relations Contact: Sky-mobi Limited Mr. John Bi, Chief Financial Officer Phone: + (86) 571-8777 0978 (Hangzhou, China) Email: investor.relations@sky-mobi.com ICR, Inc. Qiyiana Tian Phone: + (1) (646) -915-1615 (US) Email: investor.relations@sky-mobi.com
(VGGL) Receives Notice of Allowance for Patent to Optimize Media Merchandising
Viggle Inc. (NASDAQ:VGGL) (“Viggle”), the entertainment marketing and rewards platform, today announced that it received a Notice of Allowance from the U.S. Patent and Trademark Office (“USPTO”) for U.S. Patent Application No. 13/802,722, titled “Portfolio Optimization for Media Merchandising.” The patent allowance protects Viggle Inc.’s proprietary technology that analyzes content distribution patterns over time to recommend the most optimal time and channel for distributing content to achieve higher levels of engagement. The technology enables networks and brands that utilize the Viggle Platform to execute more effective marketing campaigns around their content.
The allowed patent application strengthens Viggle Inc.’s Platform, a multi-channel portfolio that allows marketers to engage with entertainment fans. The Viggle Platform encompasses the Viggle mobile app, where users check-in and engage with TV shows and music, Wetpaint’s entertainment and social media publishing platform and the NextGuide mobile app and website that enables discovery of entertainment content such as linear TV, streaming and content available for download.
“This patent furthers our ability to work with partners to launch campaigns that achieve higher response rates,” said Greg Consiglio, President and COO of Viggle Inc. “Our technology helps networks and brands more effectively share their content across web, social and in-app channels while utilizing actionable audience engagement data to improve targeting and engagement rates.”
This allowed patent application is one part of Viggle Inc.’s growing worldwide patent portfolio. Viggle has recently been awarded another patent, U.S. Patent No. 8,732,739, titled “System and Method for Tracking and Rewarding Media and Entertainment Usage Including Substantially Real Time Rewards.” The patent is directed to Viggle Inc.’s proprietary technology that compares known audio segments to audio captured by a viewer’s activation of Viggle’s mobile app on their smartphone or tablet to identify the entertainment the viewer is experiencing and assigns loyalty points to the viewer associated with the identified entertainment. By doing so, Viggle users earn points that can be redeemed for real rewards such as music downloads, headphones, electronics, major brand discounts and gift cards.
About Viggle Inc.
Viggle is an entertainment marketing and rewards platform whose app rewards its members for watching TV shows and discovering new music. The Viggle mobile app has over 4 million users. Since its launch, Vigglers have redeemed over $18 million in rewards for watching their favorite TV programs and listening to music. In addition, Viggle operates Wetpaint, which offers entertainment and celebrity news online. Viggle also operates Dijit Media, maker of technology that helps consumers search for, find, and set reminders for TV shows and movies. For more information, visit www.viggle.com or follow us on Twitter @Viggle.
This press release may contain 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, and as defined in the U.S. Private Securities Litigation Reform Act of 1995. These forward-looking statements involve inherent risks and uncertainties that could cause actual results to differ materially from those projected or anticipated. All information provided in this press release is as of May 30, 2014. Except as required by law, Viggle Inc. undertakes no obligation to update or revise publicly any forward-looking statements, whether as a result of new information, future events or otherwise, after the date on which the statements are made or to reflect the occurrence of unanticipated events.
A notice of allowance is a written notification issued after the USPTO makes a determination that a patent can be granted from an application. The vast majority of patent applications that receive a notice of allowance will proceed to issue as a U.S. patent; however, a notice of allowance is not a guarantee of patent issuance.
(LNG) and Iberdrola Sign 20-Year LNG Sale and Purchase Agreement
— Cheniere and Iberdrola sign SPA for LNG sales from Corpus Christi — Iberdrola contracts for approximately 0.8 million tonnes per annum of LNG
HOUSTON, May 30, 2014 — Cheniere Energy, Inc. (“Cheniere”) (NYSE MKT: LNG) announced today that its subsidiary, Corpus Christi Liquefaction, LLC (“Corpus Christi Liquefaction”), has entered into a liquefied natural gas (“LNG”) sale and purchase agreement (“SPA”) with Iberdrola, S.A. (“Iberdrola”) under which Iberdrola has agreed to purchase approximately 0.4 million tonnes per annum (“mtpa”) of LNG upon the commencement of operations of Train 1 of the LNG export facility being developed near Corpus Christi, Texas (the “Corpus Christi Liquefaction Project”), and increasing to approximately 0.8 mtpa of LNG upon the commencement of operations of Train 2. The Corpus Christi Liquefaction Project is being designed and permitted for up to three trains, with aggregate design production capacity of 13.5 mtpa of LNG.
Under the SPA, Iberdrola will purchase LNG on a free on board (“FOB”) basis for a purchase price indexed to the monthly Henry Hub price plus a fixed component. LNG will be loaded onto Iberdrola’s vessels. The term of the SPA will extend for twenty years beyond the date of first commercial delivery of the second train of the Corpus Christi Liquefaction Project, with an extension option of up to ten years. Deliveries from Train 2 are expected to occur in 2019.
“Iberdrola is the first foundation customer on Train 2 of our Corpus Christi Liquefaction Project being developed in Texas. Iberdrola is a leading European power generation and distribution company with operations located in several countries around the Atlantic Basin,” said Charif Souki, Chairman and CEO. “To date we have entered into SPAs aggregating approximately 3.8 mtpa of LNG volumes. We are in advanced discussions with other counterparties and are working towards finalizing additional agreements. We expect to complete all necessary steps to reach a final investment decision and begin construction by early 2015.”
The SPA is subject to certain conditions precedent, including but not limited to Corpus Christi Liquefaction receiving regulatory approvals, securing necessary financing arrangements and making a final investment decision to construct Train 2 of the Corpus Christi Liquefaction Project (the “Corpus Christi FID”).
Iberdrola is a Spanish energy company which generates, distributes, trades and markets electricity and natural gas. The company is listed on the Bolsa de Madrid and is part of the IBEX 35 index. It employs approximately 28,200 people. It is Spain’s largest power company by installed capacity with total power generation capacity of 45,000 MW worldwide. Iberdrola has access to regasification capacity in Spain, UK and the US. Additional information about Iberdrola may be found on its website located at http://www.iberdrola.com.
Cheniere Energy, Inc. is a Houston-based energy company primarily engaged in LNG-related businesses, and owns and operates the Sabine Pass LNG terminal and Creole Trail Pipeline in Louisiana. Cheniere is pursuing related business opportunities both upstream and downstream of the Sabine Pass LNG terminal. Through its subsidiary, Cheniere Energy Partners, L.P., Cheniere is developing a liquefaction project at the Sabine Pass LNG terminal adjacent to the existing regasification facilities for up to six LNG trains, each of which will have a design production capacity of approximately 4.5 mtpa (“Sabine Pass Liquefaction Project”). Construction has begun on LNG Trains 1 through 4 at the Sabine Pass Liquefaction Project. Cheniere has also initiated a project to develop liquefaction facilities near Corpus Christi, Texas. The Corpus Christi Liquefaction Project is being designed and permitted for up to three LNG trains, with aggregate design production capacity of up to 13.5 mtpa of LNG and which would include three LNG storage tanks with capacity of 10.1 Bcfe and two LNG carrier docks. Commencement of construction for the Corpus Christi Liquefaction Project is subject, but not limited, to obtaining regulatory approvals, entering into long-term customer contracts sufficient to underpin financing of the project, obtaining financing, and Cheniere making a final investment decision. We believe LNG exports from the Corpus Christi Liquefaction Project could commence as early as 2018. Additional information about Cheniere Energy, Inc. may be found on its website located at http://www.cheniere.com.
Target Date | ||||||||
Sabine Pass Liquefaction | Corpus Christi Liquefaction |
|||||||
Milestone | Trains1 & 2 | Trains 3 & 4 | Trains 5 & 6 | |||||
DOE export authorization | Received | Received | T5: Received FTAPending Non-FTA | Received FTA Pending Non-FTA |
||||
Definitive commercial agreements | Completed7.7 mtpa | Completed 8.3 mtpa |
T5: CompletedT6: 2014 | 2014 | ||||
– BG Gulf Coast LNG, LLC | 4.2 mtpa | 1.3 mtpa | ||||||
– Gas Natural Fenosa | 3.5 mtpa | |||||||
– KOGAS | 3.5 mtpa | |||||||
– GAIL (India) Ltd. | 3.5 mtpa | |||||||
– Total Gas & Power N.A. | 2.0 mtpa | |||||||
– Centrica plc | 1.75 mtpa | |||||||
– PT Pertamina | 0.8 mtpa | |||||||
– Endesa, S.A. | 2.25 mtpa | |||||||
– Iberdrola, S.A. | 0.8 mtpa | |||||||
EPC contract | Completed | Completed | 2015 | Completed | ||||
Financing | 2015 | 2014 | ||||||
– Equity | Completed | Completed | ||||||
– Debt commitments | Received | Received | ||||||
FERC authorization | ||||||||
– FERC Order | Received | Received | 2015 | 2014/2015 | ||||
– Certificate to commence construction | Received | Received | ||||||
Issue Notice to Proceed | Completed | Completed | 2015 | 2015 | ||||
Commence operations | 2015/2016 | 2016/2017 | 2018/2019 | 2018/2019 |
This press release contains certain statements that may include “forward-looking statements” within the meanings of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, included herein are “forward-looking statements.” Included among “forward-looking statements” are, among other things, (i) statements regarding Cheniere’s business strategy, plans and objectives, including the construction and operation of liquefaction facilities, (ii) statements regarding our expectations regarding regulatory authorizations and approvals, (iii) statements expressing beliefs and expectations regarding the development of Cheniere’s LNG terminal and pipeline businesses, including liquefaction facilities, (iv) statements regarding the business operations and prospects of third parties, (v) statements regarding potential financing arrangements and (vi) statements regarding future discussions and entry into contracts. Although Cheniere believes that the expectations reflected in these forward-looking statements are reasonable, they do involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect. Cheniere’s actual results could differ materially from those anticipated in these forward-looking statements as a result of a variety of factors, including those discussed in Cheniere’s periodic reports that are filed with and available from the Securities and Exchange Commission. You should not place undue reliance on these forward-looking statements, which speak only as of the date of this press release. Other than as required under the securities laws, Cheniere does not assume a duty to update these forward-looking statements.
(NPSP) Introduces Emergency Resources Kit for Patients
NPS Pharmaceuticals, Inc. (NASDAQ:NPSP), a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases, today announced its support for World Hypoparathyroidism Awareness Day by introducing a free Emergency Resources Kit designed to support accurate and more rapid diagnosis of Hypoparathyroidism symptoms in emergency care and other medical care settings. The annual global observance encourages the public to increase awareness of the disorder and the need for more education, improved diagnosis, and new treatment options.
The Hypoparathyroidism Emergency Resources Kit includes an ID bracelet, wallet card and key chain tag that indicate that someone is living with Hypoparathyroidism. By carrying any of these identifiers, patients and caregivers may be better able to alert healthcare providers when someone is affected by symptoms associated with Hypoparathyroidism including seizures, tetany (severe cramping), cardiac abnormalities or spasms that may lead to an obstructed airway. Emergency Resources Kits are available free of charge and can be ordered by visiting www.hypoparathyroidism.com, an NPS Pharma website.
“NPS Pharma is honored to be joining the global Hypoparathyroidism community in recognizing World Hypoparathyroidism Awareness Day by increasing awareness and understanding of this rare, complex endocrine disorder,” said Francois Nader, MD, president and chief executive officer of NPS Pharma. “We developed the Emergency Resources Kits based on feedback from patients living with Hypoparathyroidism to make it easier for healthcare providers to identify the symptoms of the disorder, especially in people who may be incapacitated or unable to clearly describe their symptoms.”
Hypoparathyroidism is a rare disorder in which the body produces insufficient levels of parathyroid hormone, the principal regulator of calcium and phosphorus. When the body has too little parathyroid hormone, blood calcium levels drop and phosphorus levels increase. The most common cause of hypoparathyroidism is injury to or removal of the parathyroid glands during surgery for thyroid cancer or other forms of neck surgery, but the disorder can also be genetic, and in some cases its cause is unknown.
In addition to making it easier for patients to indicate that they are afflicted by Hypoparathyroidism, NPS Pharma is also continuing its ongoing support for the Hypoparathyroidism community in many other ways. The company provides an informational web site called Hypoparathyroidism Answers, publishes a free e-book called Getting Clarity on Hypoparathyroidism, and has coordinated an ambassador program to help people affected by this disorder to educate and support others who may also be affected. These resources are available at www.hypoparathyroidism.com.
World Hypoparathyroidism Awareness Day was initiated in 2011 by the Hypoparathyroidism Association, the first non-profit group in the U.S. that advocates exclusively for patients living with Hypoparathyroidism. The 2014 edition of World Hypoparathyroidism Awareness Day coincides with the organization’s upcoming patient conference being held from June 5 – 7 in Sacramento, California.
About Hypoparathyroidism
PTH plays a central role in a variety of critical physiological functions, including closely modulating serum calcium and phosphate, regulating renal excretion of calcium and phosphate, activating vitamin D, and maintaining normal bone turnover. In patients with hypoparathyroidism, insufficient levels of PTH lead to low serum calcium, high serum phosphate, increased urinary calcium excretion, and decreased urinary phosphorus excretion. PTH deficiency can also disrupt skeletal homeostasis, leading to bone abnormalities. In addition, patients with insufficient levels of PTH are unable to convert native vitamin D into its active state to properly absorb dietary calcium.
Acute symptoms of hypoparathyroidism are largely due to hypocalcemia and include fatigue, muscle spasms and cramps, tingling, tetany, seizures, brain fog/mental lethargy, anxiety, and depression. In the absence of an approved parathyroid replacement therapy, the standard approach focuses on using therapeutic doses of calcium and active vitamin D to increase calcium levels in the blood and reduce the severity of hypocalcemic symptoms. However, balancing the administration of supplements is challenging due to calcium fluctuations and the long-term use of high doses of calcium and vitamin D may lead to serious complications, including long-term renal damage. In addition, because serum phosphate levels are elevated when PTH is missing, increasing serum calcium may lead to irreversible calcium-phosphate deposits in the kidneys, arteries or brain. Further, supplements do not correct the abnormal bone metabolism due to PTH deficiency or enable the activation of vitamin D.
About NPS Pharma
NPS Pharma is a global biopharmaceutical company pioneering and delivering therapies that transform the lives of patients with rare diseases. The company’s lead product, Gattex® (teduglutide [rDNA origin]) for injection is approved in the US for adult patients with Short Bowel Syndrome (SBS) who are dependent on parenteral support. In the EU, teduglutide (trade name: Revestive®) is approved for the treatment of adult patients with SBS; patients should be stable following a period of intestinal adaptation after surgery. Teduglutide is not approved for the treatment of pediatric SBS patients. The safety, pharmacokinetics, and pharmacodynamics of teduglutide in this population is currently being evaluated in a global trial.
A Biologics License Application is undergoing FDA review for Natpara® (rhPTH [1-84]) for the treatment of hypoparathyroidism, a rare endocrine disorder characterized by insufficient levels of parathyroid hormone. The Prescription Drug User Fee Act goal date for the Natpara application is October 24, 2014.
NPS Pharma’s earlier stage pipeline includes NPSP795, a calcilytic compound with potential application in rare disorders involving increased calcium sensing receptor activity, such as autosomal dominant hypocalcemia (ADH). NPS Pharma complements its proprietary programs with a royalty-based portfolio of products and product candidates that includes agreements with Amgen, GlaxoSmithKline, Janssen Pharmaceuticals, and Kyowa Hakko Kirin.
Additional information about NPS Pharma is available through its corporate website, http://www.npsp.com.
“NPS,” “NPS Pharma,” “NPS Pharmaceuticals,” “Gattex,” “Natpara,” “Natpar,” “Preotact,” and “Revestive” are the company’s trademarks.
Disclosure notice
Statements made in this press release, which are not historical in nature, constitute forward-looking statements for purposes of the safe harbor provided by the Private Securities Litigation Reform Act of 1995. These statements are based on the company’s current expectations and beliefs and are subject to a number of factors and uncertainties that could cause actual results to differ materially from those described in the forward-looking statements. Forward looking statements include, but are not limited to, statements concerning the company’s future financial performance and plans for the commercialization of its products, beliefs or expectations regarding our products in development, statements concerning the company’s plans for international expansion, beliefs or expectations regarding potential revenue and earnings from product sales, including beliefs regarding our ability to grow sales, expectations regarding the market size for our products, including those in development, and beliefs or expectations regarding our operating expenses. Risks associated to the company’s business include, but are not limited to, the risks associated with any failure by the company to successfully commercialize Gattex/Revestive (teduglutide [rDNA origin]) for injection, including the risk that physicians and patients may not see the advantages of Gattex/Revestive and may therefore be reluctant to utilize the product, the risk that private and public payers may be reluctant to cover or provide reimbursement for Gattex, risks related to regulatory approvals for recombinant human parathyroid hormone 1-84 (rhPTH [1-84]), the risks associated with the company’s strategy, global macroeconomic conditions, the impact of changes in management or staff levels, the effect of legislation effecting healthcare reform in the United States, as well as other risk factors described in the company’s periodic filings with the U.S. Securities and Exchange Commission, including its Annual Report on Form 10-K and Form 10-Qs. All information in this press release is as of the date of this press release and NPS undertakes no duty to update this information, whether as a result of new information, future events or otherwise.
(ARQL) to Present at Jefferies Global Healthcare Conference
ArQule, Inc. (Nasdaq: ARQL) today announced that the Company will present at the Jefferies 2014 Global Healthcare Conference on Thursday, June 5, 2014 at 10:30 a.m. The presentation will be web cast and may be accessed through the investor relations section of the Company’s website, http://investors.arqule.com/events.cfm.
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, designed to inhibit fibroblast growth factor receptor (FGFR). ArQule’s current discovery efforts, which are based on the ArQule Kinase Inhibitor Platform (AKIP™), are focused on the identification of novel kinase inhibitors that are potent and selective against their targets.
(TWER) Teams With Alcatel-Lucent for Small Cell Services Agreement
MIDDLETOWN, R.I., May 29, 2014 — Towerstream Corporation (Nasdaq:TWER), a leading 4G and Small Cell Rooftop Tower company, today announced a small cell services teaming agreement with Alcatel-Lucent (Euronext Paris:ALU) (NYSE:ALU) enabling a one-stop solution for carriers to deploy Small Cell wireless infrastructure.
The agreement, which leverages Towerstream’s Fixed Wireless and Small Cell assets (marketed under its HetNets Tower Corporation subsidiary) gives Alcatel-Lucent access to locations and services, including high-capacity backhaul, power, and mounting rights, to instantly meet its customers preferences and technical needs.
“Alcatel-Lucent’s expertise and relationship with carriers puts our real estate assets on a quick path to small cell deployments,” said Jeff Thompson, Chief Executive Officer. “Alcatel-Lucent has proven to be a leading designer of wireless networks. The combination of their market experience and customer base coupled with our 5000 plus locations, immediately available on-site high capacity backhaul, and pre-built infrastructure allows us the opportunity to instantly meet the needs of carriers whether it be an all encompassing build-out or a la carte solutions.”
“Scaling the deployment of metro cells requires that we simplify site acquisition, power accessibility, and backhaul connectivity. By adding Towerstream to our Metro Cell Express Site Certification program we have greatly expanded our ability to help our customers accelerate small cell sites on-air, helping them to build the ultra broadband wireless networks that their subscribers demand,” said Mike Schabel of Alcatel-Lucent.
Through this agreement, both Alcatel-Lucent and Towerstream will work together to support each other in preparing customer proposals and projects and either can sign up carriers as the general contractor while working with the other on a sub-contractor basis.
About Towerstream Corporation
Towerstream (Nasdaq:TWER) is a leading 4G and Small Cell Rooftop Tower company. The company owns, operates, and leases Wi-Fi and Small Cell rooftop tower locations to cellular phone operators, tower, Internet and cable companies and hosts a variety of customers on its network. Towerstream was originally founded in 2000 to deliver fixed-wireless high-speed Internet access to businesses and to date offers broadband services in 12 urban markets including New York City, Boston, Los Angeles, Chicago, Philadelphia, the San Francisco Bay area, Miami, Seattle, Dallas-Fort Worth, Houston, Las Vegas-Reno, and the greater Providence area. For more information on Towerstream services, please visit www.towerstream.com and/or follow us @Towerstream.
The Towerstream Corporation logo is available at: http://www.globenewswire.com/newsroom/prs/?pkgid=6570
About HetNets Tower Corporation
HetNets Tower Corporation (“HetNets”) was formed in January 2013 as a wholly owned subsidiary of Towerstream Corporation (Nasdaq:TWER), and offers a neutral host, shared wireless infrastructure solution, either independently or as a turnkey service. Its wireless communications infrastructure is available to wireless carriers, cable and Internet companies in major urban markets where the explosion in mobile data is creating significant demand for additional capacity and coverage. HetNets offers a carrier-class Wi-Fi network for Internet access and the offloading of mobile data. Its street level rooftop locations are ideal for the installation of customer owned small cells including DAS, Metro and Pico cells. Other solutions provided by HetNets include backhaul, power, and related small cell requirements. More information is available at http://www.hetnets.com.
Safe Harbor
Certain statements contained in this press release are “forward-looking statements” within the meaning of applicable federal securities laws, including, without limitation, anything relating or referring to future financial results and plans for future business development activities, and are thus prospective. Forward-looking statements are inherently subject to risks and uncertainties, some of which cannot be predicted or quantified based on current expectations. Such risks and uncertainties include, without limitation, the risks and uncertainties set forth from time to time in reports filed by the Company with the Securities and Exchange Commission, including, without limitation, risk related to our ability to deploy and expand small cell rooftop tower locations in the New York City and other key markets. Although the Company believes that the expectations reflected in such forward-looking statements are reasonable, it can give no assurance that such expectations will prove to be correct. Consequently, future events and actual results could differ materially from those set forth in, contemplated by, or underlying the forward-looking statements contained herein. The Company undertakes no obligation to correct or update any forward-looking statements, whether as a result of new information, future events or otherwise.
CONTACT: INVESTOR CONTACT: Monica Gould The Blueshirt Group 212-871-3927 monica@blueshirtgroup.com MEDIA CONTACT: Todd Barrish Indicate Media 917-861-0089 todd@indicatemedia.com
(AEHR) Announces ABTS(TM) System Shipments Into China Market
FREMONT, Calif., May 29, 2014 — Aehr Test Systems (Nasdaq:AEHR), a worldwide supplier of semiconductor test and burn-in equipment, today announced it has shipped ABTS Burn-in and Test Systems to two new customers in China, one to a Chinese semiconductor foundry to fill a previously announced order and the other to a Chinese government research institute.
“China is a rapidly growing market for semiconductor manufacturing and we are pleased to ship our systems to these customers in the region,” said Mark Allison, vice president of sales at Aehr Test Systems. “Increased reliability and quality needs for automotive and mobility devices are driving new requirements in the test and burn-in market, and the state-of-the-art systems we provide are designed to fill these requirements both today and for the foreseeable future, and at a compelling price.”
According to industry research firm TechNavio, the semiconductor market in China is forecast to grow at a CAGR of 24.4% over the period 2012-2016. The firm notes that one of the key factors contributing to this market growth is the globally increasing demand for smartphones and tablets, and their data also show that the semiconductor market in China has been witnessing large capital expenditures by global companies to set up a semiconductor manufacturing base in China.
Mr. Allison continued, “As part of this shipment, one of these systems also includes the capability to perform a low-temperature operating life (LTOL) test, in which the devices are subjected to temperatures as low as -40C for an extended period. In addition to being a more rigorous screen for various failure mechanisms, LTOL is important for identifying failure modes for automotive applications, since automobiles are often subjected to extremely low temperatures.”
The ABTS family of products is based on a new hardware and software platform that is designed to address not only today’s devices, but also future devices for many years to come. It can test and burn-in both logic and memory devices, including resources for high pin-count devices and configurations for high-power and low-power applications. The ABTS system can be configured with up to 72 burn-in boards with up to 320 I/O channels each and 32M of test vector memory per channel. The ABTS offers the option of high voltage Device Power Supplies configurable with programmable voltage ranges to 60 or 230 volts, which are needed for automotive and power-line applications. The ABTS system is optimized for use with the Sensata iSocket* and VTR Thermal Management Technologies, which provide a scalable cost-effective solution using individual device temperature control for ICs up to 75 watts or more. Individual temperature control enables higher-power devices with a broad range of power dissipation to be burned-in simultaneously in a single burn-in chamber while maintaining a precise device temperature. The ABTS system also uses N+1 redundancy technology and hot-swap capability for many key components in the system to maximize system uptime.
*iSocket is a trademark of Sensata Technologies, Inc.
About Aehr Test Systems
Headquartered in Fremont, California, Aehr Test Systems is a worldwide provider of test systems for burning-in and testing logic and memory integrated circuits and has an installed base of more than 2,500 systems worldwide. Increased quality and reliability needs of the Automotive and Mobility integrated circuit markets are driving additional test requirements, capacity needs and opportunities for Aehr Test products in package and wafer level test. Aehr Test has developed and introduced several innovative products, including the ABTS and FOXTM families of test and burn-in systems and the DiePak® carrier. The ABTS system is used in production and qualification testing of packaged parts for both lower-power and higher-power logic as well as all common types of memory devices. The FOX system is a full wafer contact test and burn-in system used for burn-in and functional test of complex devices, such as leading-edge memories, digital signal processors, microprocessors, microcontrollers and systems-on-a-chip. The DiePak carrier is a reusable, temporary package that enables IC manufacturers to perform cost-effective final test and burn-in of bare die. For more information, please visit the Company’s website at www.aehr.com.
Safe Harbor Statement
This press release contains certain forward-looking statements based on current expectations, forecasts and assumptions that involve risks and uncertainties. These statements are based on information available to Aehr Test as of the date hereof and actual results could differ materially from those stated or implied due to risks and uncertainties. Forward-looking statements include statements regarding expected shipping dates of our ABTS systems and uses of our ABTS systems. The risks and uncertainties that could cause our results to differ materially from those expressed or implied by such forward-looking statements include, without limitation, general world economic conditions and events, the state of the semiconductor equipment market, our ability to maintain sufficient cash to support operations, acceptance by customers of the ABTS technology, acceptance by customers of the ABTS systems shipped upon receipt of a purchase order and the ability of new products to meet customer needs or perform as described. See Aehr Test’s recent 10-K, 10-Q and other reports from time to time filed with the Securities and Exchange Commission for a more detailed description of the risks facing our business. Aehr Test disclaims any obligation to update information contained in any forward-looking statement to reflect events or circumstances occurring after the date of this press release.
CONTACT: Aehr Test Systems Carl Buck V.P. of Marketing (510) 623-9400 x381 cbuck@aehr.com MKR Group Inc. Todd Kehrli or Jim Byers Analyst/Investor Contact (323) 468-2300 aehr@mkr-group.com
(ICLD) to Present at the LD Micro Invitational on June 4th
SHREWSBURY, N.J., May 29, 2014 — InterCloud Systems, Inc. (the “Company” or “InterCloud”) (Nasdaq:ICLD), a single source provider of end-to-end IT technology and next-generation network solutions to the service provider and corporate enterprise markets through professional services and cloud platforms, today announced it will present at the LD Micro Invitational on Wednesday June 4, 2014 at the Luxe Sunset Boulevard Hotel in Los Angeles.
Chairman and CEO of InterCloud Systems, Mark Munro, is scheduled to present at 2:30pm Pacific Time on Track 4.
In addition to presenting information on the Company, management will be available for one-on-one meetings. For more information about the conference or to schedule a one-on-one meeting with InterCloud’s management, please contact an LD Micro representative or visit www.ldmicro.com.
About InterCloud Systems, Inc.
InterCloud Systems, Inc. is a single-source provider of end-to-end information technology (IT) and next-generation network solutions to the telecommunications service provider (carrier) and corporate enterprise markets through cloud platforms and professional services. InterCloud offers cloud and managed services, professional consulting and staffing services, and voice, data and optical solutions to assist its customers in meeting their changing technology demands. Additional information regarding InterCloud may be found on InterCloud’s website at www.intercloudsys.com.
About LD Micro
LD Micro is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published an annual list of recommended stocks, as well as comprehensive reports on select companies throughout the year. The firm also hosts the LD Micro Micro-Cap Growth Conference for investors in December of each year. It is a non-registered investment advisor. For more information, please contact 408-457-1042 or visit www.ldmicro.com.
CONTACT: Investor Relations Mike Bowdoin RedChip Companies, Inc. Tel: +1-800-733-2447, ext. 110 mike@redchip.com http://www.redchip.com
(XGTI) Second New U.S. Patent Award for Interference Mitigation Techniques
Invention Helps Improve Performance of Wireless Systems by Overcoming Impairments to Transmission Quality
SARASOTA, Fla., May 29, 2014 — xG Technology, Inc. (“xG” or the “Company”) (Nasdaq: XGTI, XGTIW), a developer of wireless communications and spectrum sharing technologies, has announced that it has been awarded a new patent for interference mitigation techniques. This is the second new patent grant announced by xG Technology this week. On May 27, xG announced a cognitive radio patent award that enables enhanced interference mitigation for devices in shared spectrum.
The new patent, “OFDM Symbol Diversity Combiner for Burst Interference Mitigation” (U.S.P.T.O. #13/486,331) covers a method of diversity combining that operates on individual OFDM (Orthogonal Frequency Division Multiplexing) symbols, allowing efficient mitigation of burst interference typical to many devices operating on unlicensed bands. More specifically, this invention describes a diversity combiner that operates as a maximal ratio combiner (MRC) or selection combiner, depending on operation conditions.
Interference is a major impediment to reliable and efficient wireless transmissions, and can negatively impact performance and coverage in high-capacity mobile systems. While interference has been an issue in unlicensed spectrum bands for years, mobile carriers are now also experiencing unprecedented levels of interference in their licensed spectrum-based mobile networks, due to skyrocketing demand for mobile data. This latest xG innovation describes advanced techniques for detecting and reducing unwanted transmissions that lead to harmful interference, thus improving system performance.
“This new patent enhances xG’s position as a leader in developing innovative approaches to overcoming the challenges faced by today’s wireless networks,” said John Coleman, CEO of xG Technology. “The company continues to invest in our xMax cognitive radio technology foundation in ways that enable us to offer compelling mobile broadband communications solutions. These solutions are unencumbered by many of the costs and limitations associated with traditional wireless options, and this key value proposition is driving interest from prospective clients in a broad range of industries.”
With this patent award, xG Technology’s intellectual property portfolio now stands at 60 U.S. patent matters (51 issued) and 145 international patent matters (65 issued).
xMax is a comprehensive fixed and mobile broadband solution that is designed for rapid deployment and low operating costs. It offers a carrier-grade user experience and can serve as a network backbone or last-mile solution for a number of markets and applications. xMax leverages software defined radio (SDR) and cognitive radio access network technology that enable efficient sharing of both licensed and unlicensed spectrum.
About xG Technology
xG Technologyhas created a broad portfolio of intellectual property that makes wireless networks more intelligent, accessible, affordable and reliable. The company has created xMax, a patented all-IP cognitive radio technology that enables robust mobile broadband communications for private, consumer and government networks. xMax can solve the crisis facing the wireless industry caused by data-hungry devices and applications that are straining network capacity. It eliminates the need to acquire scarce and expensive licensed spectrum, thus lowering the total cost of ownership for wireless broadband access. xG’s goal is to help wireless broadband networks deliver voice, video and data services to fixed and mobile users. The xMax cognitive radio system incorporates advanced optimizing technologies that include spectrum sharing, interference mitigation, multiple-input multiple-output (MIMO) and software defined radio (SDR). These and other technologies make xMax ideal for wide area, as well as rapid emergency communication deployment. xG offers solutions for numerous industries worldwide, including urban and rural wireless broadband, utilities, defense, emergency response and public safety.
Based in Sarasota, Florida, xG has 60 U.S. and over 140 international patents and pending patent applications, and its products have been sold in both domestic and foreign markets. xG is a publicly traded company listed on the NASDAQ Capital Market where xG common stock is traded under the symbol XGTI and xG warrants are traded under the symbol XGTIW. For more information, please visit www.xgtechnology.com.
Free Writing Prospectus Disclosure
On April 3, 2014, the issuer, xG Technology, Inc., filed a Registration Statement on Form S-1/A Amendment No. 1 (Registration No. 333-194810) with the Securities and Exchange Commission (the “SEC”) with respect to the offering to which this press release relates. A copy of the preliminary prospectus for the offering is included in that registration statement. Before you invest, you should read the prospectus in that registration statement and other documents the issuer has filed with the SEC for more complete information about the issuer and this offering. You may obtain these documents for free by visiting EDGAR on the SEC web site at www.sec.gov. Alternatively, copies of the preliminary prospectus and, when available, the final prospectus relating to the offering may be obtained from Roth Capital Partners, LLC, Prospectus Department, 888 San Clement Drive, Newport Beach, CA 92660, telephone: 800-678-9147, e-mail: prospectus@roth.com; or Feltl and Company, Inc., Prospectus Department, 800 LaSalle Avenue, Suite 2100, Minneapolis, MN, 55402, telephone: 612-492-8800, e-mail: prospectus@feltl.com.
Cautionary Statement Regarding Forward Looking Statements
Statements contained herein that are not based upon current or historical fact are forward-looking in nature and constitute 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 forward-looking statements reflect the Company’s expectations about its future operating results, performance and opportunities that involve substantial risks and uncertainties. These statements include but are not limited to statements regarding the intended terms of the offering, closing of the offering and use of any proceeds from the offering. When used herein, the words “anticipate,” “believe,” “estimate,” “upcoming,” “plan,” “target”, “intend” and “expect” and similar expressions, as they relate to xG Technology, Inc., its subsidiaries, or its management, are intended to identify such forward-looking statements. These forward-looking statements are based on information currently available to the Company and are subject to a number of risks, uncertainties, and other factors that could cause the Company’s actual results, performance, prospects, and opportunities to differ materially from those expressed in, or implied by, these forward-looking statements.
For More Information:
Media and Analyst Relations
David Worthington
Fusion PR
www.fusionpr.com
(212) 651-4200
Investor Relations
James Woodyatt
xG Technology
www.xGtechnology.com
(954) 572-0395
Jody Burfening/Carolyn Capaccio
LHA
ccapaccio@lhai.com
(212) 838-3777
(ASTC) $61M Sale of Astrotech Space Operations to Lockheed Martin
AUSTIN, Texas, May 29, 2014 — Astrotech Corporation (Nasdaq:ASTC) today announced a major step in its strategic evolution with the signing of a definitive agreement to sell the assets constituting its Astrotech Space Operations business (ASO) to Lockheed Martin Corporation, including the assets of its wholly owned subsidiary, Astrotech Space Operations, for $61 million.
“We are very excited about what this transaction means for our shareholders,” stated Thomas B. Pickens III, Chairman and Chief Executive Officer of Astrotech Corporation. “This represents the beginning of a new era for Astrotech Corporation as the company can now concentrate our efforts on high growth business opportunities while having the needed resources to develop and fulfill the potential of our 1st Detect mass spectrometer product line.”
Subject to the satisfaction of customary closing conditions, including the approval by the Astrotech Corporation shareholders, the transaction is expected to close in the third quarter of 2014. Upon closing, ASO will be operated as a wholly-owned subsidiary of Lockheed Martin and managed by the corporation’s Space Systems business area.
About Astrotech Corporation
Astrotech is one of the first space commerce companies and remains a strong entrepreneurial force in the aerospace industry. We are leaders in identifying, developing and marketing space technology for commercial use. Our ASO business unit serves our government and commercial satellite and spacecraft customers with pre-launch services on the eastern and western range. 1st Detect Corporation is developing what we believe is a breakthrough miniaturized mass spectrometer, the MMS-1000™, while Astrogenetix, Inc. is a biotechnology company utilizing microgravity as a research platform for drug discovery and development.
This press release contains forward-looking statements that are made pursuant to the Safe Harbor provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements are subject to risks, trends, and uncertainties that could cause actual results to be materially different from the forward-looking statement. These factors include, but are not limited to, continued government support and funding for key space programs, product performance and market acceptance of products and services, as well as other risk factors and business considerations described in Astrotech’s Securities and Exchange Commission filings including the annual report on Form 10-K. Any forward-looking statements in this document should be evaluated in light of these important risk factors. Astrotech assumes no obligation to update these forward-looking statements.
CONTACT: FOR MORE INFORMATION: Eric Stober Astrotech Corporation 512.485.9530
(SYNA) ClearPad® In-Cell Technology Powers Huawei’s Latest Flagship Smartphone
Deployment Underscores Display Integration Adoption and Emphasizes Synaptics Position as a Leading Touch Solution Provider to Major China OEM
SAN JOSE, Calif., May 28, 2014 — Synaptics Inc. (NASDAQ: SYNA), the leading developer of human interface solutions, today announced that Huawei has once again selected the ClearPad® family of capacitive touchscreen solutions to power the touch interface of its latest flagship smartphone device, the Ascend P7. By leveraging the ClearPad S3350 In-Cell solution, Huawei is able to offer Ascend P7 users glove input, passive pen and moisture-proofing support, while providing seamless touch performance on the first 5-inch full high-definition (FHD) In-Cell touchscreen device from the Chinese market. This design win further highlights Synaptics’ strong relationship with leading Chinese OEMs, like Huawei, who have a global market presence and growing customer base.
Huawei’s implementation of Synaptics’ ClearPad solution in its flagship device demonstrates the strong trend of display integration technology adoption by OEMs. By integrating touch functionality directly into a device’s display, versus an additional discrete sensor layer, OEMs are able to deliver best-in-class touch experience and an excellent display, while providing high-quality design and functionality. Many industry reports indicate that display integration adoption is expected to grow over the next few years as OEMs seek highly integrated solutions and supply chain efficiencies.
ClearPad S3350 Key Benefits:
- Brighter Displays: Increases the brightness by 10% by eliminating sensor transmitters on the color filter glass.
- Ultra-thin Designs: Provides the thinnest solution available today by reducing up to ~1mm in thickness, depending on the stack-up used.
- Total System Cost Savings: Reduces total system cost through supply chain efficiencies and complete removal of a discrete sensor stack up.
- Display Noise Immunity: Provides highest display noise immunity by performing touch sensing during display blanking periods.
- User Interaction Features: Provides features like glove operation and stylus tracking by utilizing advanced trans-capacitance sensing in the display integrated systems.
“As the world’s third largest smartphone maker, Huawei has continued to push the boundaries of design and innovation and we’re excited to see our industry-leading ClearPad In-Cell technology deployed in the Ascend P7,” said Brian Daly, vice president of marketing, Smart Display Division for Synaptics. “Our partnership with Huawei further underscores Synaptics’ leadership in the Chinese market. We are uniquely positioned to offer our OEM partners the latest innovations in display integration technology aimed at delivering the ultimate touch experience for consumers around the world.”
Synaptics will showcase its entire portfolio of human interface products at Computex Taipei from June 3rd through June 5th, by appointment only. Customers and suppliers are encouraged to contact their Synaptics partner to arrange a meeting time at Computex. Media are encouraged to contact synaptics@text100.com to arrange a meeting time.
For up-to-the-minute Synaptics news, follow @SynaCorpon Twitter. For more information on Synaptics’ products and solutions please visit www.synaptics.com.
About Synaptics
The leading developer of human interface solutions which enhance the user experience, Synaptics provides the broadest solutions portfolio in the industry. The ClearPad® family supports touchscreen solutions for devices ranging from entry-level mobile phones to flagship premium smartphones, tablets and notebook PCs. The TouchPad™ family, including ClickPad™ and ForcePad®, is integrated into the majority of today’s notebook PCs. Natural ID™ fingerprint sensor technology enables authentication, mobile payments, and touch-based navigation for smartphones, tablets, and notebook computers. Synaptics’ wide portfolio also includes ThinTouch® supporting thin and light keyboard solutions, as well as key technologies for next generation touch-enabled video and display applications. (NASDAQ: SYNA) www.synaptics.com.
Synaptics, TouchPad, ClearPad, ClickPad, ForcePad, ThinTouch, NaturalID, TypeGuard and the Synaptics logo are trademarks of Synaptics in the United States and/or other countries. All other marks are the property of their respective owners.
For further information, please contact:
Nick Rottler
Synaptics
408-904-1820
nrottler@synaptics.com
Starlayne Meza
Text 100 Global Communications
415-593-8431
synaptics@text100.com
(DWCH) Joins Industrial Internet Consortium
CHELMSFORD, Mass., May 28, 2014 — Datawatch Corporation, (NASDAQ-CM: DWCH), a leading global provider of visual data discovery solutions, announced today that it has joined the Industrial Internet Consortium (IIC), a non-profit partnership of industry, government and academia formed to advance the wide-spread use of interconnected machines, intelligent analytics and people at work.
Datawatch will bring its vast expertise in real-time data analytics and visualization to help develop best practices, reference architectures, case studies and interoperability standards for Industrial Internet applications. The “Industrial Internet” is the integration of complex physical machinery and devices with networked sensors and software, used to predict, control and plan for better business and societal outcomes.
“As a leading visual data discovery solution provider, Datawatch is already very much involved with Industrial Internet technologies,” said Dr. Richard Soley, executive director of the Industrial Internet Consortium. “We’re excited to have Datawatch as a member and look forward to their contributions to IIC working group activities.”
“Datawatch brings unique insight on how to handle the massive analytic challenges, through the use of visual data discovery, from the explosion of real-time data from interconnected machines, sensors and people,” said Dan Potter, vice president, product marketing for Datawatch. “We are honored to participate in influencing the development of global standards and technologies for next-generation internet and industrial systems.”
For more information about the Industrial Internet Consortium, visit www.iiconsortium.org.
About the Industrial Internet Consortium
The Industrial Internet Consortium TM (IIC) is the open membership, not-for-profit organization that catalyzes and coordinates the priorities and enabling technologies of industry, academia and the government around the Industrial Internet. Announced in March 2014, the IIC will systematically address the complexities of the Industrial Internet, leading to faster adoption, deployments and transformational business outcomes across the globe.
About Datawatch Corporation
Datawatch Corporation (NASDAQ-CM: DWCH) provides visual data discovery software that optimizes any data – regardless of its variety, volume, or velocity – delivering next generation analytics to reveal valuable insights for improving business. Its unique ability to integrate structured, unstructured, and semi-structured sources like reports, PDF files and EDI streams with real-time streaming data into visually rich analytic applications allows users to dynamically discover key factors that impact any operational aspect of their business. This ability to perform visual discovery against any data sets Datawatch apart in the big data and visualization markets. Organizations of every size, worldwide use Datawatch products, including 99 of the Fortune 100. Datawatch is headquartered in Chelmsford, Massachusetts with offices in New York, London, Munich, Stockholm, Singapore, Sydney and Manila, and with partners and customers in more than 100 countries worldwide. See the Whole Story for yourself by downloading the free trial at www.datawatch.com/trial.
Safe Harbor Statement under the Private Securities Litigation Reform Act of 1995
Any statements contained in this press release that do not describe historical facts may constitute forward-looking statements as that term is defined in the Private Securities Litigation Reform Act of 1995. Any such statements, including but not limited to those relating to results of operations, contained herein are based on current expectations, but are subject to a number of risks and uncertainties that may cause actual results to differ materially from expectations. The factors that could cause actual future results to differ materially from current expectations include the following: risks associated with the continuing weak global economy; risks associated with fluctuations in quarterly operating results due, among other factors, to the size and timing of large customer orders; risks associated with acquisitions, including the recent acquisition of intellectual property from Math Strategies and the acquisition of Panopticon; the volatility of Datawatch’s stock price; limitations on the effectiveness of internal controls; rapid technological change; Datawatch’s dependence on the introduction of new products and possible delays in those introductions; competition in the software industry generally, and in the markets for next generation analytics in particular; Datawatch’s dependence on its principal products, proprietary software technology and software licensed from third parties; risks associated with international sales and operations; risks associated with indirect distribution channels and co-marketing arrangements, many of which were only recently established; the adequacy of Datawatch’s sales returns reserve; risks associated with a subscription sales model; Datawatch’s dependence on its ability to hire and retain skilled personnel; disruption or failure of Datawatch’s technology systems that may result from a natural disaster, cyber-attack or other catastrophic event; and uncertainty and additional costs that may result from evolving regulation of corporate governance and public disclosure. Further information on factors that could cause actual results to differ from those anticipated is detailed in various publicly-available documents, which include, but are not limited to, filings made by Datawatch from time to time with the Securities and Exchange Commission, including but not limited to, those appearing in the Company’s Annual Report on Form 10-K for the year ended September 30, 2013 and Form 10-Q for the quarter ended December 31, 2013. Any forward-looking statements should be considered in light of those factors.
© 2014 Datawatch Corporation. Datawatch and the Datawatch logo are trademarks or registered trademarks of Datawatch Corporation in the United States and/or other countries. All other names are trademarks or registered trademarks of their respective companies.
Investor Contact:
Datawatch Investor Relations
investor@datawatch.com
Phone: (978) 441-2200 ext. 8323
Media Contact:
Sarah Bernardi
Datawatch Corporation
Sarah_Bernardi@datawatch.com
Phone: (978) 441-2200 ext. 8387
Twitter: @datawatch
(IDRA) to Present at the Jefferies 2014 Global Healthcare Conference
Idera Pharmaceuticals, Inc. (NASDAQ: IDRA), a clinical stage biopharmaceutical company developing novel nucleic acid therapeutics for orphan diseases, today announced that Company management will present at the Jefferies 2014 Global Healthcare Conference on Wednesday, June 4, 2014 at 8:30 a.m. EDT in New York City.
A live audio webcast of the presentation will be available in the Investors and Media section of Idera’s website at www.iderapharma.com or at the link http://wsw.com/webcast/jeff82/IDRA. An archived version will also be available on the Company’s website after the event for 90 days.
About Idera Pharmaceuticals, Inc.
Idera Pharmaceuticals is a clinical-stage biopharmaceutical company developing a novel therapeutic approach for the treatment of genetically defined forms of B-cell lymphoma and orphan autoimmune diseases. Idera’s proprietary technology involves creating novel nucleic acid therapeutics designed to inhibit over-activation of Toll-like Receptors (TLRs). In addition to its TLR programs, Idera is developing gene silencing oligonucleotides (GSOs) that it has created using its proprietary technology to inhibit the production of disease-associated proteins by targeting RNA.
(XXII) to Present at Institutional Investor Conference
22nd Century Group, Inc. (NYSE MKT:XXII) today announced that Henry Sicignano III, President, will present at the LD MICRO Invitational Conference at the Luxe Sunset Hotel, Los Angeles, California, on Wednesday, June 4th, 2014 at 9:00am PDT.
22nd Century Group’s presentation at the LD Micro Invitational Conference is part of a one-week non-deal road show. The Company will also be conducting private meetings at the conference over the course of the day.
Starting June 2, 2014, Joseph Pandolfino, CEO, and Henry Sicignano, President, will visit five cities across the United States to introduce 22nd Century Group to institutional investors, retail brokers, and the business press. This initiative represents the Company’s first major effort to specifically target institutional investors since uplisting to the NYSE MKT exchange in March 2014.
Though the Company’s shareholder base has increased from fewer than 100 shareholders in early 2011 to more than 2,000 shareholders today, it is clear that 22nd Century Group remains “well under the radar” of most of Wall Street. It is management’s intention that the Company’s road show increases awareness of 22nd Century Group’s technology and investment potential.
About LD Micro
LD MICRO is an investment newsletter firm that focuses on finding undervalued companies in the micro-cap space. Since 2002, the firm has published an annual list of recommended stocks, as well as comprehensive reports on select companies throughout the year. The firm also hosts the LD MICRO Micro-Cap Growth Conference for investors in December of each year. It is a non-registered investment advisor. For more information, please call 408-457-1042 or visit www.LDmicro.com.
About 22nd Century Group, Inc.
22nd Century is a plant biotechnology company whose proprietary technology allows for the levels of nicotine and other nicotinic alkaloids (e.g., nornicotine, anatabine and anabasine) in the tobacco plant to be decreased or increased through genetic engineering and plant breeding. 22nd Century owns or is the exclusive licensee of 116 issued patents in 78 countries plus an additional 42 pending patent applications. Goodrich Tobacco Company, LLC and Hercules Pharmaceuticals, LLC are wholly-owned subsidiaries of 22nd Century. Goodrich Tobacco is focused on commercial tobacco products and potentially less harmful cigarettes. Hercules Pharmaceuticals is focused on X-22, a prescription smoking cessation aid in development.
For additional information, please visit: www.xxiicentury.com
Cautionary Note Regarding Forward-Looking Statements: This press release contains forward-looking information, including all statements that are not statements of historical fact regarding the intent, belief or current expectations of 22nd Century Group, Inc., its directors or its officers with respect to the contents of this press release. The words “may,” “would,” “will,” “expect,” “estimate,” “anticipate,” “believe,” “intend” and similar expressions and variations thereof are intended to identify forward-looking statements. We cannot guarantee future results, levels of activity or performance. You should not place undue reliance on these forward-looking statements, which speak only as of the date that they were made. These cautionary statements should be considered with any written or oral forward-looking statements that we may issue in the future. Except as required by applicable law, including the securities laws of the United States, we do not intend to update any of the forward-looking statements to conform these statements to reflect actual results, later events or circumstances, or to reflect the occurrence of unanticipated events. You should carefully review and consider the various disclosures made by us in our annual report on Form 10-K for the fiscal year ended December 31, 2013, filed on January 30, 2014, including the section entitled “Risk Factors,” and our other reports filed with the U.S. Securities and Exchange Commission which attempt to advise interested parties of the risks and factors that may affect our business, financial condition, results of operation and cash flows. If one or more of these risks or uncertainties materialize, or if the underlying assumptions prove incorrect, our actual results may vary materially from those expected or projected.
(LIVE) Addition to Morgan Stanley Capital International Global Index
NEW YORK, NY–(May 28, 2014) – LiveDeal (NASDAQ: LIVE) just landed an incredible opportunity to gain worldwide recognition in the global financial markets when it became one of the newly named companies added to Morgan Stanley Capital International’s (MSCI) exclusive Global Index. The company’s addition to the list will be effective by close of market on Friday, May 30, 2014. In a rebalancing of MSCI’s global indices, LiveDeal is being added to the MSCI US Micro Cap Index, and with it, investors should see greater liquidity, and price appreciation.
MSCI indices are widely used as the benchmark indices by which the performance of global equity portfolios are measured, and MSCI’s flagship product offerings are its global indices with close to $7 trillion estimated to be benchmarked to the indices on a worldwide basis.
With this kind of exposure on a global scale, LiveDeal should benefit greatly from being added to the exclusive list of companies that will garner worldwide attention from large pension plans, hedge funds, asset managers, and banks.
The MSCI US Micro Cap Index is designed to measure the performance of the Micro Cap segment of the US equity market. With 932 constituents, the index represents approximately 1% of the free float-adjusted market capitalization in the US. With the company’s inclusion in the well-followed MSCI index, it is proof that LiveDeal’s progress over the last eight months has been recognized and rewarded.
MSCI is headquartered in New York, with research and commercial offices around the world. The firm is a leading provider of investment decision support tools to over 6,000 investment institutions worldwide.
A list of companies added to the MSCI Global Micro Cap Index can be found at: http://www.msci.com/eqb/gimi/stdindex/MSCI_May14_MicroPublicList.pdf.
About Stock Market Media Group
SMMG is a Research and Content Development IR firm offering a platform for corporate stories to unfold in the media with Reports, Interviews and Articles. This article is SMMG’s opinion and was written based upon publicly available information. LiveDeal hasn’t endorsed or compensated SMMG for this article. SMMG is compensated for LiveDeal content by a third party who reserves the right to buy, sell or remain neutral on securities after the publication of this article. SMMG has received total compensation of $52,230 for LiveDeal content. For information visit: www.stockmarketmediagroup.com.
Contact:
Stock Market Media Group
Email Contact
(VSTM) Publishes Scientific Data on Targeting Mesothelioma Cancer Stem Cells
Verastem, Inc. (NASDAQ:VSTM), focused on discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells, today announced that a paper, entitled “Merlin Deficiency Predicts FAK Inhibitor Sensitivity: A Synthetic Lethal Relationship,” has been published by Verastem scientists in the latest issue of the journal Science Translational Medicine (Vol. 6, Issue 237, p. 237ra68).
The paper describes the finding that loss of the tumor suppressor merlin predicts for increased responsiveness to drugs targeting cancer stem cells through inhibition of focal adhesion kinase (FAK). Since merlin loss is particularly prevalent in mesothelioma (approximately 50% of patients), the efficacy of FAK inhibition was demonstrated in several cellular and in vivo mesothelioma models. The publication further describes the strong tumor-initiating capability of mesothelioma cancer stem cells and the observation that the standard of care agents pemetrexed and cisplatin augment cancer stem cells. In contrast, FAK inhibition effectively reduces cancer stem cells in preclinical models of mesothelioma.
“These data demonstrate that FAK inhibition is particularly effective in models of merlin-negative mesothelioma,” said Jonathan Pachter, Ph.D., Verastem Head of Research. “These results build upon key findings published earlier this year by our collaborators at Fox Chase Cancer Center which demonstrated that merlin loss drives the development of highly aggressive malignant mesothelioma which is enriched for cancer stem cells. Accordingly, in a merlin-negative mesothelioma patient-derived tumor model, FAK inhibitor treatment as maintenance therapy prolonged the inhibition of tumor growth following treatment with pemetrexed and cisplatin.”
Collectively, these observations provide the scientific basis for Verastem’s ongoing registration-directed clinical trial of the FAK inhibitor VS-6063 in patients with mesothelioma following treatment with pemetrexed (Alimta®) plus platinum (ClinicalTrials.gov NCT01870609).
The Science Translational Medicine paper can be accessed at http://bit.ly/RWbTH9
The Cancer Research paper from Fox Chase Cancer Center can be accessed at http://bit.ly/1bnjwiS
About Malignant Pleural Mesothelioma
Malignant pleural mesothelioma is an aggressive form of cancer that occurs in the mesothelium, the thin layer of tissue that covers the lungs. Mesothelioma is associated with exposure to asbestos in most cases. According to the World Health Organization, there are a total of 59,000 cases of mesothelioma worldwide each year. Most mesotheliomas begin as one or more nodules that progressively grow to form a solid coating of tumor surrounding the lung leading to eventual suffocation and death. A high percentage of mesotheliomas contain cancer stem cells which are generally resistant to the currently available treatment options for mesothelioma.
About VS-6063
VS-6063 (defactinib) is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). Cancer stem cells are an underlying cause of tumor resistance to chemotherapy, recurrence and ultimate disease progression. Research by Robert Weinberg, Ph.D., scientific cofounder and chair of Verastem’s Scientific Advisory Board, and Verastem has demonstrated that the FAK pathway is critical for the growth and survival of cancer stem cells. VS-6063 is currently being studied in the registration-directed COMMAND trial in mesothelioma (www.COMMANDmeso.com), a Phase 1/1b study in combination with paclitaxel for patients with ovarian cancer and a Phase 2 trial in patients with KRas-mutated non-small cell lung cancer. VS-6063 has been granted orphan drug designation in the U.S. and E.U. for use in mesothelioma.
About COMMAND
COMMAND is a registration-directed, double-blind, placebo-controlled trial of VS-6063 with Progression Free Survival (PFS) and Overall Survival (OS) as the primary endpoints. VS-6063 targets cancer stem cells. Cancer stem cells are an underlying cause of tumor progression and recurrence. The design of COMMAND allows the opportunity to enrich for patients with tumors low in the biomarker, merlin. Preclinical and early clinical research has demonstrated that low merlin levels may be predictive of increased effectiveness of FAK inhibitors such as VS-6063. The COMMAND study stratifies patients to evaluate the effect of VS-6063 in both the overall patient population and the subgroup of patients whose tumors are low in merlin.
COMMAND is expected to enroll approximately 350-400 patients at clinical sites in 12 countries, including the US, UK, Japan, Australia, Canada, South Africa, New Zealand and countries in mainland Europe. Eligible patients who had a partial response or stable disease following standard first-line therapy with platinum/pemetrexed will be stratified to merlin low or high and then randomized to receive either placebo or 400 mg of defactinib. For more information visit www.COMMANDmeso.com
About VS-4718
VS-4718 is an orally available compound designed to target cancer stem cells through the potent inhibition of focal adhesion kinase (FAK). VS-4718 is currently being studied in a Phase 1 dose escalation study in patients with advanced cancers.
About Verastem, Inc.
Verastem, Inc. (NASDAQ:VSTM) is discovering and developing drugs to treat cancer by the targeted killing of cancer stem cells. Cancer stem cells are an underlying cause of tumor recurrence and metastasis. Verastem is developing small molecule inhibitors of signaling pathways that are critical to cancer stem cell survival and proliferation: FAK, PI3K/mTOR and Wnt. For more information, please visit www.verastem.com.
Forward-looking statements:
This press release includes forward-looking statements about the Company’s strategy, future plans and prospects, including statements regarding the development of the Company’s compounds, including VS-6063, or defactinib, and the Company’s FAK inhibition program, the timeline for clinical development and regulatory approval of the Company’s compounds, the expected timing for the reporting of data from ongoing trials, and the structure of the Company’s planned or pending clinical trials, and potential indications for clinical development. The words “anticipate,” “appear,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Each forward-looking statement is subject to risks and uncertainties that could cause actual results to differ materially from those expressed or implied in such statement. Applicable risks and uncertainties include the risks that the preclinical testing of the Company’s compounds and preliminary data from clinical trials may not be predictive of the results or success of ongoing or later clinical trials, that data may not be available when we expect it to be, that enrollment of clinical trials may take longer than expected, that the Company will be unable to successfully complete the clinical development of its compounds, including VS-6063, that the development of the Company’s compounds will take longer or cost more than planned, and that the Company’s compounds will not receive regulatory approval or become commercially successful products. Other risks and uncertainties include those identified under the heading “Risk Factors” in the Company’s Annual Report on Form 10-K for the year ended December 31, 2013 and in any subsequent SEC filings. The forward-looking statements contained in this presentation reflect the Company’s current views with respect to future events, and the Company does not undertake and specifically disclaims any obligation to update any forward-looking statements.
(TKMR) Initiating Phase I/II Clinical Trial in Patients with Hepatocellular Carcinoma
VANCOUVER, British Columbia, May 27, 2014 — Tekmira Pharmaceuticals Corporation (Nasdaq:TKMR) (TSX:TKM), a leading developer of RNA interference (RNAi) therapeutics, today announced they have met all regulatory requirements to initiate a Phase I/II clinical trial of TKM-PLK1 in patients with Hepatocellular Carcinoma (HCC). Tekmira is also conducting a separate Phase I/II clinical trial evaluating TKM-PLK1 in patients with Gastrointestinal Neuroendocrine Tumors (GI-NET) or Adrenocortical Carcinoma (ACC).
“Hepatocellular carcinoma is associated with one of the poorest survival rates in oncology, and clearly new therapies are needed. We are encouraged with the positive data from our GI-NET and ACC clinical studies with TKM-PLK1 and there is sound rational for evaluating this agent in HCC,” said Dr. Mark J. Murray, Tekmira’s President and CEO.
“We are excited about reaching another important milestone for Tekmira by launching this new clinical trial, and also remain on track to share results from our GI-NET/ACC trial in the second half of this year,” added Dr. Murray.
This trial is an open-label, multi-center, Phase I/II dose escalation study in patients with advanced hepatocellular carcinoma. The study is designed to determine the safety, tolerability and clinical benefit of TKM-PLK1. The study will be conducted at sites in North America and Asia.
About Hepatocellular Carcinoma (HCC)
Hepatocellular carcinoma (HCC) is one of the most common cancers worldwide and the third most common cause of cancer-related death worldwide. HCC is overwhelmingly related to chronic liver disease, particularly hepatitis B and hepatitis C. Patients with HCC usually are asymptomatic until later stages. The prognosis of HCC generally is very poor, with a median survival of six to 20 months and less than five percent of symptomatic patients surviving more than two years. 350,000 to 1 million cases of HCC occur every year worldwide. (source: www.clinicalkey.com)
About TKM-PLK1
Tekmira’s lead oncology product candidate, TKM-PLK1, targets polo-like kinase 1 (PLK1), a protein involved in tumor cell proliferation and a validated oncology target. Inhibition of PLK1 expression prevents the tumor cell from completing cell division, resulting in cell cycle arrest and death of the cancer cell. PLK1 has been a target of interest for years, and evidence that patients with elevated levels of PLK1 in their tumors exhibit poorer prognosis and survival rates has been documented in the medical literature. By using an RNAi approach and exploiting its naturally occurring mechanism of action, Tekmira can potentially overcome the limitations of other approaches and effectively silence PLK1.
About RNAi and Tekmira’s LNP
RNAi therapeutics have the potential to treat a broad number of human diseases by “silencing” disease causing genes. The discoverers of RNAi, a gene silencing mechanism used by all cells, were awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi therapeutics, such as “siRNAs,” require delivery technology to be effective systemically. Tekmira believes its LNP technology represents the most widely adopted delivery technology for the systemic delivery of RNAi therapeutics. Tekmira’s LNP platform is being utilized in multiple clinical trials by both Tekmira and its partners. Tekmira’s LNP technology (formerly referred to as stable nucleic acid-lipid particles or SNALP) encapsulates siRNAs with high efficiency in uniform lipid nanoparticles that are effective in delivering RNAi therapeutics to disease sites in numerous preclinical models. Tekmira’s LNP formulations are manufactured by a proprietary method which is robust, scalable and highly reproducible, and LNP-based products have been reviewed by multiple FDA divisions for use in clinical trials. LNP formulations comprise several lipid components that can be adjusted to suit the specific application.
About Tekmira
Tekmira Pharmaceuticals Corporation is a biopharmaceutical company focused on advancing novel RNAi therapeutics and providing its leading lipid nanoparticle delivery technology to pharmaceutical partners. Tekmira has been working in the field of nucleic acid delivery for over a decade and has broad intellectual property covering LNPs. Further information about Tekmira can be found at www.tekmirapharm.com. Tekmira is based in Vancouver, B.C.
Forward-Looking Statements and Information
This news release contains “forward-looking statements” or “forward-looking information” within the meaning of applicable securities laws (collectively, “forward-looking statements”). Forward-looking statements in this news release include statements about the initiation of a Phase I/II Clinical Trial with TKM-PLK1 in patients with HCC; a separate Phase I/II Clinical Trial with TKM-PLK1 evaluating TKM-PLK1 in patients with GI-NET or ACC and expected results of this trial in the second half of this year; the effectiveness of Tekmira’s products over other approaches in silencing PLK1; and Tekmira’s strategy, future operations, clinical trials, prospects and the plans of management; RNAi (ribonucleic acid interference) product development programs.
With respect to the forward-looking statements contained in this news release, Tekmira has made numerous assumptions regarding, among other things: LNP’s status as a leading RNAi delivery technology; the effectiveness of Tekmira’s products as therapeutic treatments for diseases; and mRNA is efficiently delivered using Tekmira’s LNP. While Tekmira considers these assumptions to be reasonable, these assumptions are inherently subject to significant business, economic, competitive, market and social uncertainties and contingencies.
Additionally, there are known and unknown risk factors which could cause Tekmira’s actual results, performance or achievements to be materially different from any future results, performance or achievements expressed or implied by the forward-looking statements contained herein. Known risk factors include, among others: the Phase I/II Clinical Trial with TKM-PLK1 in patients with HCC may not complete as expected, or at all; the Phase I/II Clinical Trial with TKM-PLK1 evaluating TKM-PLK1 in patients with GI-NET or ACC may not complete as expected, or at all; Tekmira’s products may not prove to be effective as therapeutic treatments for diseases; Tekmira’s LNP may not be as efficient of a delivery system for mRNA as currently believed; Tekmira may not obtain and protect intellectual property rights, and operate without infringing on the intellectual property rights of others; Tekmira may face competition from other pharmaceutical or biotechnology companies and the possibility that other organizations have made advancements in RNAi delivery technology that Tekmira is not aware of; pre-clinical and clinical trials may be more costly or take longer to complete than anticipated and may not generate results that warrant future development of the tested drug candidate; Tekmira’s development partners and licensees conducting clinical trial, development programs and joint venture strategic alliances may not result in expected results on a timely basis, or at all; future operating results are uncertain and likely to fluctuate; economic and capital market conditions; Tekmira may become subject to product liability or other legal claims for which Tekmira has made no accrual in its financial statements; and the possibility that Tekmira may not have sufficiently budgeted for expenditures necessary to carry out planned activities.
A more complete discussion of the risks and uncertainties facing Tekmira appears in Tekmira’s annual report on Form 10-K for the year ended December 31, 2013 (Annual Report), as well as Tekmira’s continuous disclosure filings, which are available at www.sedar.com or at www.sec.gov. All forward-looking statements herein are qualified in their entirety by this cautionary statement, and Tekmira disclaims any obligation to revise or update any such forward-looking statements or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except as required by law.
CONTACT: Investors Bruce Cousins, Executive VP & CFO Investor Relations Phone: 604-419-3200 Email: ir@tekmira.com Media Alan Bayless Longview Communications Inc. Phone: 604-694-6035 Email: abayless@longview.ca
(SPEX) Patent Reform Bill Removed from Senate Consideration
BETHESDA, Md., May 27, 2014 — Spherix Incorporated (NASDAQ: SPEX) — an intellectual property development company committed to the fostering and monetization of intellectual property, today noted that the United States Senate, and Senate Judiciary Committee Chairman Patrick Leahy (D-Vermont), removed the patent reform bill from the committee’s calendar.
Senator Leahy cited the lack of broad bipartisan support for the bill, and also stated that many of the proposals would overly burden “legitimate patent holders who employ thousands of Americans.”
Anthony Hayes, Chief Executive Officer of Spherix, stated, “The removal of this bill from the Senate Judiciary Committee schedule should remove some of the uncertainty which has been clouding our industry. Spherix is committed to responsibly protecting the patents it owns, and we remain eager to work with companies large and small to reach fair agreements.”
About Spherix
Spherix Incorporated was launched in 1967 as a scientific research company. Spherix is committed to advancing innovation by active participation in the patent market. Spherix draws on portfolios of pioneering technology patents to partner with and support product innovation.
Forward Looking Statements
Certain statements in this press release constitute “forward-looking statements” within the meaning of the federal securities laws. Words such as “may,” “might,” “will,” “should,” “believe,” “expect,” “anticipate,” “estimate,” “continue,” “predict,” “forecast,” “project,” “plan,” “intend” or similar expressions, or statements regarding intent, belief, or current expectations, are forward-looking statements. While the Company believes these forward-looking statements are reasonable, undue reliance should not be placed on any such forward-looking statements, which are based on information available to us on the date of this release. These forward looking statements are based upon current estimates and assumptions and are subject to various risks and uncertainties, including without limitation those set forth in the Company’s filings with the Securities and Exchange Commission (the “SEC”), not limited to Risk Factors relating to its patent business contained therein. Thus, actual results could be materially different. The Company expressly disclaims any obligation to update or alter statements whether as a result of new information, future events or otherwise, except as required by law.
Contact:
Investor Relations Contact:
Hayden/ MS-IR
Brett Mass
Phone: (646) 536-7331
Email: brett@haydenir.com
www.haydenir.com
Spherix Contact:
Phone: (703) 992-9325
Email: info@spherix.com
www.spherix.com
(INVE) Explains How to Establish Trust in a Connected World
FREMONT, Calif., May 27, 2014 — Identiv (Nasdaq:INVE), a leading global security technology company for integrated physical and logical IT security, will hold a webinar discussion on how companies can establish trust in the connected world. Jason Hart, Identiv CEO, will discuss the trends behind the massive growth of the Internet of Things (IoT), how this impacts security, and how organizations can use trust solutions to reduce risk, achieve compliance and protect brand identity.
WHAT: | “How to Establish Trust in the Connected World” Webinar |
WHEN: | Thursday, May 29, 2014, 10:00 AM PDT |
WHO: | Jason Hart, Identiv CEO |
REGISTER: | http://l.identive-group.com/webinar/trust/ |
The rise of IoT, in which physical objects are connected through the Internet, has created a heightened risk environment as it is increasingly embedded within our personal and corporate lives. With the growing adoption of IoT, information security is a growing priority in protecting identity for many organizations.
In the webinar, Hart will address the connectivity of everything from premises, information, identities, devices and even everyday items such as cars, medicines and toys. He will share best practices and provide solutions to lower security risk associated with identification and authentication, data access, legislative boundary restrictions and integrated two-factor security solutions.
Identiv provides physical access control solutions for customers in the enterprise, government, education, healthcare and consumer markets. Its integrated IT security ensures both the physical facilities and digital assets of organizations are protected. Please feel free to visit Identiv’s blog, “From the Desk of Jason Hart”, to read more on Jason Hart’s insight into physical access control at ceo.identiv.com.
About Identiv
Identiv is a global security technology company that establishes trust in the connected world, including premises, information and everyday items. CIOs, CSOs and product departments rely upon Identiv’s trust solutions to reduce risk, achieve compliance and protect brand identity. Identiv’s trust solutions are implemented using standards-driven products and technology, such as digital certificates, mobility and cloud services. For more information, visitidentiv.com.
CONTACT: Identiv Media Contacts: Lesley Sullivan/Joann Wardrip MSLGROUP 781-684-0770 identivgroup@mslgroup.com
(MEIL) Announces Closing of Public Offering of Common Stock
LAS VEGAS, NV–(May 27, 2014) – Methes Energies International Ltd. (NASDAQ: MEIL), a renewable energy company that produces and sells biodiesel fuel and biodiesel processing equipment, today announced the closing of its previously announced underwritten public offering of 2,500,000 registered shares of its common stock, par value $0.001 per share, at a price to the public of $2.00 per share. In connection with the offering, the Company has also granted the underwriter a 30-day option to purchase up to an additional 375,000 shares of common stock from the Company to cover over-allotments, if any.
The Company intends to use the net proceeds of the offering primarily to perform the preparatory work necessary to increase the production capacity and for other improvements at its Sombra plant, and for working capital and general corporate purposes.
National Securities Corporation, a wholly owned subsidiary of National Holdings, Inc. (OTCBB: NHLD), acted as sole book-running manager for the offering. The Company offered and sold these securities pursuant to its existing shelf registration statement (File No. 333-195271), including a base prospectus, as declared effective by the Securities and Exchange Commission (the “SEC”) on May 14, 2014.
A final prospectus supplement describing the terms of the offering was filed with the SEC and formed a part of the effective registration statement. Copies of the prospectus supplement and the accompanying base prospectus may be obtained by contacting the book-running manager at the following address:
National Securities Corporation
410 Park Ave, 14th Floor
New York, NY 10022
Attn: Kim Addarich
Telephone: (212)-417-8164
Email: prospectusrequest@nationalsecurities.com
This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities of the Methes Energies International Ltd., and shall not constitute an offer, solicitation or sale of any security in any state or jurisdiction in which such offer, solicitation or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.
About Methes Energies International Ltd.
Methes Energies International Ltd. is a renewable energy company that offers a variety of products and services to biodiesel fuel producers. Methes also offers biodiesel processors that are unique, truly compact, fully automated state-of-the-art and continuous flow that can run on a wide variety of feedstocks. Methes markets and sells biodiesel fuel produced at its showcase production facility in Mississauga, Ontario, Canada, and at its 13 MGY facility in Sombra, Ontario, to customers in the U.S. and Canada, as well as providing multiple biodiesel fuel solutions to its clientele. Among its services are selling commodities to its network of biodiesel producers, selling their biodiesel production and providing clients with proprietary software to operate and control their processors. Methes also remotely monitors the quality and characteristics of its clients’ production, upgrades and repairs their processors and advises clients on adjusting their processes to use varying feedstock to improve the quality of their biodiesel. For more information, please visit www.methes.com.
Forward-looking Statements
This press release contains forward-looking statements regarding future events and financial performance. In some cases, you can identify these statements by words such as “may,” “might,” “will,” “should,” “except,” “plan,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” or “continue,” the negative of these terms and other comparable terminology. These statements involve a number of risks and uncertainties and are based on numerous assumptions involving judgments with respect to future economic, competitive and market conditions and future business decisions, all of which are difficult or impossible to predict accurately and many of which are beyond the Company’s control. There are or may be important factors that could cause our actual results to materially differ from our historical results or from any future results expressed or implied by such forward looking statements. These factors include, but are not limited to, those discussed under the section entitled “Risk Factors” in our Annual Report on Form 10-K for the year ended November 30, 2013, filed on February 25, 2014, as amended, which is available at the U.S. Securities and Exchange Commission website at www.sec.gov. The forward-looking statements in this press release are based upon management’s reasonable belief as of the date hereof. The Company undertakes no obligation to revise or update publicly any forward-looking statements for any reason.
Contacts:
Methes Energies International Ltd.
Michel G. Laporte
Chairman and CEO
702-932-9964
(GALE) to Present at the Marcum MicroCap Conference
PORTLAND, Ore., May 23, 2014 — Galena Biopharma (Nasdaq:GALE), a biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care, today announced that Ryan Dunlap, Vice President and Chief Financial Officer, will present a corporate update at the Marcum MicroCap Conference. The presentation will take place on Thursday, May 29, 2014 at 10:00 a.m. ET at The Grand Hyatt Hotel in New York City.
The presentation will be webcast and available on the Investors section of the Company’s website at www.galenabiopharma.com.
About Galena Biopharma
Galena Biopharma, Inc. (Nasdaq:GALE) is a Portland, Oregon-based biopharmaceutical company developing and commercializing innovative, targeted oncology treatments that address major unmet medical needs to advance cancer care. For more information please visit: www.galenabiopharma.com.
CONTACT: Remy Bernarda Vice President, Marketing & Communications (503) 405-8258 rbernarda@galenabiopharma.com
(AMRS) Prices $75 Million Convertible Senior Notes Due 2019
EMERYVILLE, Calif., May 23, 2014 — Amyris, Inc. (Nasdaq:AMRS) today announced that it has priced $75 million aggregate principal amount of 6.50% Convertible Senior Notes due 2019 (the “notes”). The notes will be sold to qualified institutional buyers pursuant to Rule 144A under the Securities Act of 1933, as amended. Amyris also granted the initial purchaser of the notes an option to purchase up to an additional $15 million aggregate principal amount of the notes. The sale is expected to close on May 29, 2014, subject to customary closing conditions.
Morgan Stanley & Co. LLC is acting as initial purchaser and sole book-running manager for the offering of the notes.
Prior to the close of business on the business day immediately preceding the maturity date of the notes, the notes will be convertible at any time at the option of holders. Upon conversion, the notes will be settled in shares of Amyris common stock.
The notes will have an initial conversion rate of 267.0370 shares of Amyris common stock per $1,000 principal amount of notes (which is subject to adjustment in certain circumstances). This represents an initial effective conversion price of approximately $3.74 per share. The initial conversion price represents a premium of approximately 24% to the $3.02 per share closing price of Amyris common stock on May 22, 2014.
With respect to any conversion on or after May 15, 2015, in the event that the last reported sale price of Amyris’s common stock for 20 or more trading days (whether or not consecutive) in a period of 30 consecutive trading days ending within five trading days immediately prior to the date Amyris receives a notice of conversion exceeds the conversion price in effect on each such trading day, the holders, in addition to the shares deliverable upon conversion, will be entitled to receive a cash payment equal to the present value of the remaining scheduled payments of interest that would have been made on the notes being converted from the earlier for the date that is three years after the date Amyris receive such notice of conversion and maturity.
The notes will be unsecured and unsubordinated obligations of Amyris, and interest will be payable semi-annually in cash at a rate of 6.50% per annum on each on May 15 and November 15, beginning on November 15, 2014. The notes will mature on May 15, 2019, unless purchased or converted in accordance with their terms prior to such date. Amyris may not redeem the notes prior to their maturity.
Amyris estimates that the net proceeds from the offering will be approximately $71.5 million (or approximately $85.9 million if the initial purchaser exercises its option to purchase additional notes in full) after deducting the estimated initial purchaser’s discount and estimated offering expenses payable by Amyris. Amyris expects to use the net proceeds from the offering of the notes, including any proceeds from the initial purchaser’s exercise of its option to purchase additional notes, for general corporate purposes, including for potential collaboration opportunities and other strategic transactions or acquisitions. In addition, under a preexisting right, Total Energies Nouvelle Activités USA may exchange up to approximately $9.7 million of outstanding convertible promissory notes currently held by Total for new securities issued by Amyris. As a result, Amyris will repay, from the proceeds of the offering, $9.7 million of the outstanding convertible notes held by Total, which amount represents the principal amount of notes that Total has agreed to purchase in the offering.
This announcement is neither an offer to sell nor a solicitation of an offer to buy any of these securities (including the shares of Amyris common stock, if any, into which the notes are convertible) and shall not constitute an offer, solicitation or sale in any jurisdiction in which such offer, solicitation or sale is unlawful. Any offers of the notes will be made only by means of a private offering memorandum.
The notes and any shares of common stock issuable upon conversion of the notes have not been registered under the Securities Act of 1933, as amended, or any state securities laws and may not be offered or sold in the United States absent registration or an applicable exemption from such registration requirements.
Forward Looking Statements
This press release contains forward-looking statements including, among other things, statements relating to the expected use of proceeds from the offering. These forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These statements involve risks and uncertainties that could cause actual results to differ materially, including, but not limited to, whether or not Amyris will consummate the offering, prevailing market conditions, the anticipated use of the proceeds of the offering, which could change as a result of market conditions or for other reasons, and the impact of general economic, industry or political conditions in the United States or internationally.
Amyris assumes no obligation to, and does not currently intend to, update any such forward-looking statements after the date of this release.
CONTACT: Amyris, Inc. Media & Investor Relations Joel Velasco info@amyris.com
(PTCT) Receives Positive Opinion from CHMP for Translarna™ (ataluren)
The first treatment for the underlying cause of Duchenne muscular dystrophy –
SOUTH PLAINFIELD, New Jersey, May 23, 2014 — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that following its request for re-examination, the Committee for Medicinal Products for Human Use (CHMP) of the European Medicines Agency (EMA) has adopted a positive opinion regarding the company’s application for a conditional marketing authorization of TranslarnaTM (ataluren) for the treatment of nonsense mutation Duchenne muscular dystrophy (nmDMD) in ambulatory patients aged five years and older.
“We are very pleased with the outcome of the CHMP review of Translarna’s marketing authorization application (MAA) and the level of engagement we experienced with CHMP members throughout the review process,” said Robert J. Spiegel, M.D., Chief Medical Officer of PTC Therapeutics, Inc. “We are grateful to the patients, families, advocacy groups and physicians who have supported PTC Therapeutics through many years of research and development of Translarna. It is important to note that this journey continues through the completion of our Phase 3 Translarna confirmatory trial in nmDMD (ACT DMD) which is a high priority for PTC and the DMD community.”
Dr. Craig McDonald, Professor of Physical Medicine and Rehabilitation at the University of California, Davis, who developed and validated the 6-minute walk test as a primary clinical endpoint in Duchenne muscular dystrophy (DMD) stated, “This is a historic day for the DMD community. Translarna is the first treatment for the underlying cause of nonsense mutation DMD to receive a positive opinion from the CHMP. The Phase 2b clinical trial provided strong evidence that Translarna slows disease progression as measured by the 6-minute walk test. A clinically meaningful 31.3 meter benefit in 6-minute walk distance, relative to placebo, was achieved in 48 weeks of treatment in patients five years and older and this was supported by positive trends in multiple secondary efficacy endpoints. In addition, in the prespecified group of patients with less than a 350 meter baseline 6-minute walk distance, a 68 meter benefit was observed in patients treated with 40 mg/kg Translarna given daily, relative to placebo. A conditional approval by the European Commission based on this positive opinion would allow children with nmDMD in the European Union to gain access to Translarna while PTC Therapeutics completes its ongoing confirmatory trial.”
The CHMP opinion will form the basis for a European Commission (EC) decision as to whether to formally grant the conditional marketing authorization. The European Commission will review the positive opinion from the CHMP and generally delivers its final decision within three months. The conditional marketing authorization would authorize the company to market Translarna with unified labeling in the 28 countries that are Member States of the European Union, as well as European Economic Area members Iceland, Liechtenstein and Norway.
“We congratulate PTC Therapeutics on this landmark decision by the CHMP,” stated Elizabeth Vroom, Chair of United Parent Project Muscular Dystrophy (UPPMD). “We applaud PTC for its dedication to the community and its perseverance in pursuing regulatory options to provide Translarna to patients as rapidly as possible. The company’s pioneering work has paved the way and encouraged the scientific community to develop new therapies for DMD,” she continued. “The EMA is to be commended for recognizing the great unmet need for novel treatments for this relentlessly progressive disease.”
Filippo Buccella, President of Parent Project Italy and UPPMD board member, commented, “After thirty years since the discovery of the dystrophin gene, we are finally beginning to see a change in the landscape. For the first time in the history of Duchenne, we see the path to approval for a drug to treat the underlying cause of DMD. This positive result rewards the efforts of a company that has always believed in collaboration with patients and with clinicians. The perseverance of this community made it possible to realize a dream that can give hope to the boys affected with nmDMD in Europe. Our work as a community of patients is not yet finished and we will stand ready to participate with PTC in the ensuing stages of this process and, we hope, with many other companies with new therapies for Duchenne.”
PTC requested a re-examination of the CHMP’s negative opinion received in January 2014. The positive opinion is based on data and subsequent analysis submitted from a 48-week, 174-patient Phase 2b double-blind, placebo controlled trial which demonstrated that nmDMD patients treated with Translarna (40 mg/kg given daily) walked on average 31.3 meters farther than patients on placebo, as measured by the change in six-minute walk distance (6MWD) from baseline to Week 48. Patients receiving Translarna also demonstrated a slower rate of decline in ambulation, based on an analysis of time to 10 percent worsening in 6MWD. Safety results showed that Translarna was generally well tolerated. Serious adverse events were infrequent and none were considered to be related to Translarna. PTC’s global Phase 3 ACT DMD clinical trial is ongoing with full enrollment expected mid-2014.
“The positive opinion from the CHMP recommending the conditional approval of Translarna in nonsense mutation Duchenne muscular dystrophy is a major milestone for the DMD community and we are extremely proud of this joint achievement in accelerating the access to Translarna for patients with nonsense mutation DMD,” stated Stuart W. Peltz, Ph.D., CEO of PTC Therapeutics, Inc. “DMD is a progressive disease for which there are currently no approved treatment options. As previously disclosed, we expect to have all patients enrolled in our global Phase 3 ACT DMD by mid-2014. The outcome of this trial is critical for achieving full approval in the EU as well as the US. Assuming that the EC approves a conditional marketing authorization for Translarna in nmDMD, today’s decision means that in parallel to this effort, we will be able to provide patients access to Translarna with the immediacy that DMD deserves.”
About Conditional Approval
Conditional approval is granted based on a positive benefit/risk ratio in the available data which, while not yet comprehensive, indicate that the public health benefits of immediate availability of a medicine outweigh its risks. The company is given obligations to fulfill by the EC, such as the performance of further studies. The approval is renewed on a yearly basis until all obligations have been fulfilled, and is then converted from a conditional approval into a full approval. Conditional approvals can only be granted for medicines that satisfy an unmet medical need, meaning the medicine is intended to be used for a disease or condition for which no treatment is readily available, and it is therefore important that patients have early access to the medicine concerned.
About TranslarnaTM (ataluren)
Translarna, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy. The development of Translarna has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); Muscular Dystrophy Association; FDA’s Office of Orphan Products Development; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.
About Duchenne Muscular Dystrophy (DMD)
Primarily affecting males, Duchenne muscular dystrophy (DMD) is a progressive muscle disorder caused by the lack of functional dystrophin protein. Dystrophin is critical to the structural stability of skeletal, diaphragm, and heart muscles. Patients with DMD, the more severe form of the disorder, lose the ability to walk as early as age 10 and experience life-threatening lung and heart complications in their late teens and twenties. It is estimated that a nonsense mutation is the cause of DMD in approximately 13% of patients, or approximately 2,000 patients in the United States and 2,500 patients in the European Union. More information about DMD is available through the Muscular Dystrophy Association (www.mdausa.org), Parent Project Muscular Dystrophy (www.parentprojectmd.org), Action Duchenne (www.actionduchenne.org), United Parent Projects Muscular Dystrophy (uppmd.org), Muscular Dystrophy Campaign (www.muscular-dystrophy.org) and AFM (l’Association francaise contre les myopathies), (www.afm-telethon.fr).
About PTC Therapeutics, Inc.
PTC is a biopharmaceutical company focused on the discovery and development of orally administered, proprietary small molecule drugs that target post-transcriptional control processes. Post-transcriptional control processes regulate the rate and timing of protein production and are essential to proper cellular function. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare disorders, oncology and infectious diseases. PTC has developed proprietary technologies that it applies in its drug discovery activities and in collaborations with leading biopharmaceutical companies. For more information on the company, please visit our website www.ptcbio.com.
Forward Looking Statements:
All statements, other than those of historical fact, contained in this press release, including statements regarding the future expectations, plans and prospects for PTC, the timing of regulatory approvals, including any determination (whether positive or negative) by the European Commission with respect to conditional marketing authorization for Translarna in nmDMD, the development of and potential market for Translarna, including our estimates regarding the size of the nmDMD patient population, our Phase 3 clinical trial for Translarna in nmDMD, including the timing of enrollment for such trial, our ability to satisfy the obligations necessary to obtain full approval for Translarna in nmDMD, and the objectives of management, are forward-looking statements. Other forward-looking statements may be identified by the words “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “plan” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions.
Our actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements we make as a result of a variety of risks and uncertainties, including among others, those related to our expectations for regulatory approvals, including the European Commission’s determination with respect to conditional marketing authorization for Translarna in nmDMD, the initiation and conduct of clinical trials, availability of data from clinical trials, our scientific approach and general development progress, the availability or commercial potential of our product candidates, market acceptance by physicians, patients, third-party payors and others in the medical community necessary for commercial success, and the other factors discussed in the “Risk Factors” section of our most recent Quarterly Report on Form 10-Q, which is on file with the Securities and Exchange Commission. You are urged to carefully consider all such factors. In addition, the forward-looking statements included in this press release represent our views only as of the date of this release. We anticipate that subsequent events and developments will cause our views to change. However, while PTC may elect to update these forward-looking statements at some point in the future, we specifically disclaim any obligation to do so. These forward-looking statements should not be relied upon as representing PTC’s views as of any date subsequent to the date of this press release.
(LIVE) Has Enough Cash on Hand to Continue Expansion Through Acquisition
NEW YORK, NY–(May 23, 2014) – LiveDeal, Inc. (NASDAQ: LIVE) released its Quarterly numbers this week from the period ending March 31, 2014, and while much of what was presented had to be expected from a company that is growing predominantly in a new direction, there was good news in the 22 percent revenue increase, the dramatic 70 percent improvement in losses, and a strong cash position and access to cash that should allow for continued growth.
LiveDeal’s main focus is now squarely on competing in the online/mobile deal space and building a framework for success around its real-time and instant offers platform, www.livedeal.com. According to the numbers, LiveDeal has a current cash position of almost $10 million which should help greatly with the company’s expected growth through acquisition.
After entering the instant deal space late in 2013 with the launch of its geo-location based mobile marketing platform that enables restaurants to publish “real-time” and “instant offers” to nearby consumers, LiveDeal expanded into the goods and services industry by acquiring and already established online goods deal platform. The company’s CEO seems confident that LiveDeal can be a leader in the space with continued expansion.
Jon Isaac said in this week’s release, “What we believe separates LiveDeal from others in the industry is that we are focused on creating an ongoing, long-term stainable revenue stream that will position us to be an industry leader in the instant deal space.”
LiveDeal is offering merchants free subscriptions to join the site giving up a small amount of short term revenue in order to attract long term, quality subscribers, with the intent to ultimately establish a long-term sustainable revenue model.
The CEO added, “With LiveDeal’s long-term philosophy we believe we can increase the number of merchant subscribers to our database, enabling us to aggressively build our database and then begin to market our sites as an advertising medium, similar to the strategy followed by Groupon and Facebook.”
And, while the process may be frustrating to those investors who want to grow from nothing to Groupon-sized overnight, it seems LiveDeal has embarked upon a methodical plan that has its numbers drastically improving, a platform growing quickly, an expansion into other verticals, and cutting losses so deep that they should soon turn into profits.
About Stock Market Media Group
SMMG is a Research and Content Development IR firm offering a platform for corporate stories to unfold in the media with Reports, Interviews and Articles. This article is SMMG’s opinion and was written based upon publicly available information. LiveDeal hasn’t endorsed or compensated SMMG for this article. SMMG is compensated for LiveDeal content by a third party who reserves the right to buy, sell or remain neutral on securities after the publication of this article. SMMG has received total compensation of $50,880 for LiveDeal content. For information visit: www.stockmarketmediagroup.com.
Contact:
Stock Market Media Group
Email Contact
TraderPower Featured Companies
Top Small Cap Market News
- $SOBR InvestorNewsBreaks – SOBR Safe Inc. (NASDAQ: SOBR) Closes on $8.2M Private Placement
- $CLNN InvestorNewsBreaks – Clene Inc. (NASDAQ: CLNN) Announces Participation at Two Upcoming Investor Conferences
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
Recent Posts
- $EAWD IEA Hosts G20 Ministers, Influential Personalities to Discuss Clean and Affordable Energy Transition
- $SFWJ InvestorNewsBreaks – Software Effective Solutions Corp. (d/b/a MedCana) (SFWJ) Releases Report on Series of Acquisitions, Multiple Cannabis Licenses
- $RFLXF JPMorgan Executive Says US Backlash Against ESG Is Exaggerated
- $TMET.V Gold Stutters as Strong US Jobs Data Dampens Expectations of Large Rate Cuts
- $FSTTF InvestorNewsBreaks – First Tellurium Corp. (CSE: FTEL) (OTC: FSTTF) Shares Additional Information on the PyroDelta Thermoelectric Generator, Relationship with Subsidiary
- $LEXX InvestorNewsBreaks – Lexaria Bioscience Corp. (NASDAQ: LEXX) Begins Subject Dosing in Human Pilot Study #3 Evaluating Oral DehydraTECH-Processed Tirzepatide
- $LGVN InvestorNewsBreaks – Longeveron Inc. (NASDAQ: LGVN) to Present at This Month’s Congenital Heart Surgeons’ Society Annual Meeting
- $ATBHF Aston Bay Holdings Ltd. (TSX.V: BAY) (OTCQB: ATBHF) Releases Updated Report on Storm Copper Project Drilling Program
Recent Comments
Archives
- October 2024
- January 2023
- June 2022
- December 2021
- September 2021
- August 2021
- July 2021
- June 2021
- May 2021
- April 2021
- March 2021
- February 2021
- January 2021
- December 2020
- November 2020
- October 2020
- September 2020
- August 2020
- July 2020
- June 2020
- May 2020
- April 2020
- March 2020
- February 2020
- January 2020
- December 2019
- November 2019
- October 2019
- September 2019
- August 2019
- July 2019
- June 2019
- May 2019
- April 2019
- March 2019
- February 2019
- January 2019
- December 2018
- November 2018
- October 2018
- September 2018
- August 2018
- July 2018
- June 2018
- May 2018
- April 2018
- March 2018
- February 2018
- January 2018
- December 2017
- November 2017
- October 2017
- September 2017
- August 2017
- July 2017
- June 2017
- May 2017
- April 2017
- March 2017
- February 2017
- January 2017
- December 2016
- November 2016
- October 2016
- September 2016
- August 2016
- July 2016
- June 2016
- May 2016
- April 2016
- March 2016
- February 2016
- January 2016
- December 2015
- November 2015
- October 2015
- September 2015
- August 2015
- July 2015
- June 2015
- May 2015
- April 2015
- March 2015
- February 2015
- January 2015
- December 2014
- November 2014
- October 2014
- September 2014
- August 2014
- July 2014
- June 2014
- May 2014
- April 2014
- March 2014
- February 2014
- January 2014
- December 2013
- November 2013
- October 2013
- September 2013
- August 2013
- July 2013
- June 2013
- May 2013
- April 2013
- March 2013
- February 2013
- January 2013
- December 2012
- November 2012
- October 2012
- September 2012
- August 2012
- July 2012
- June 2012
- May 2012
- April 2012
- March 2012
- February 2012
- January 2012
- December 2011
- November 2011
- October 2011
- September 2011
- August 2011
- July 2011
- June 2011
- May 2011
- April 2011
- March 2011
- February 2011
- January 2011
- December 2010
- November 2010
- October 2010
- September 2010
- August 2010
- July 2010
- June 2010
- May 2010
- April 2010
- March 2010
- February 2010
- January 2010
- December 2009
- November 2009
- October 2009
- September 2009
- August 2009
- July 2009
- June 2009