Archive for May, 2015

(CTRP) Expedia Announces eLong Transaction

BELLEVUE, Wash., May 22, 2015 — Expedia, Inc. (NASDAQ: EXPE) today announced that Expedia has sold its 62.4% majority stake in eLong, Inc. (NASDAQ: LONG) to several purchasers based in China, including Ctrip.com International, Ltd. (NASDAQ: CTRP), Keystone Lodging Holdings Limited, Plateno Group Limited and Luxuriant Holdings Limited for a total purchase price of approximately $671 million.

In addition, Expedia and Ctrip have agreed to cooperate with each other to allow their respective customers to benefit from certain travel product offerings for specified geographic markets.

The transaction closed on May 22, 2015.

About Expedia, Inc.

Expedia, Inc. (NASDAQ: EXPE) is one of the world’s largest travel companies, with an extensive brand portfolio that includes leading online travel brands, such as:

  • Expedia.com®, a leading full service online travel agency with localized sites in 31 countries
  • Hotels.com®, the hotel specialist with localized sites in more than 60 countries
  • Hotwire®, a leading discount travel site that offers opaque deals in 12 countries throughout North America, Europe and Asia
  • Travelocity®, a pioneer in online travel and a leading online travel agency in the US and Canada
  • Egencia®, a leading corporate travel management company
  • Venere.com™, an online hotel reservation specialist in Europe
  • trivago®, a leading online hotel metasearch company with sites in 51 countries
  • Wotif Group, a leading operator of travel brands in the Asia-Pacific region, including Wotif.com®, lastminute.com.au®, travel.com.au, Asia Web Direct®, LateStays.com and GoDo.com.au
  • Expedia Local Expert®, a provider of online and in-market concierge services, activities, experiences and ground transportation in hundreds of destinations worldwide
  • Classic Vacations®, a top luxury travel specialist
  • Expedia® CruiseShipCenters®, a provider of exceptional value and expert advice for travelers booking cruises and vacations through its network of 180 franchise locations across North America
  • CarRentals.com™, the premier car rental booking company on the web

The company delivers consumers value in leisure and business travel, drives incremental demand and direct bookings to travel suppliers, and provides advertisers the opportunity to reach a highly valuable audience of in-market consumers through Expedia® Media Solutions. Expedia also powers bookings for some of the world’s leading airlines and hotels, top consumer brands, high traffic websites, and thousands of active affiliates through Expedia® Affiliate Network. For corporate and industry news and views, visit us at www.expediainc.com or follow us on Twitter @expediainc.

Trademarks and logos are the property of their respective owners.  © 2015 Expedia, Inc.  All rights reserved.  CST: 2029030-50

Forward-looking Statements.

This press release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements relating to the expected benefits of the Expedia/Ctrip agreements. These statements are based on the expectations of Expedia and Ctrip management as of the date hereof and assumptions which are inherently subject to uncertainties, risks and changes in circumstances that are difficult to predict. Actual results and the timing and outcome of events may differ materially from those expressed or implied in the forward-looking statements for a variety of reasons, including, among others, the ability of the parties to successfully implement the agreements, or meet forecasts and other expectations, as well as other risks detailed in Expedia, Inc. and Ctrip.com International, Ltd.’s public filings with the Securities and Exchange Commission, including Expedia, Inc.’s most recent Annual Report on Form 10-K and Ctrip.com International, Ltd’s most recent Annual report on Form 20-F. Except as required by law, Expedia and Ctrip undertake no obligation to update any forward-looking or other statements in this release, whether as a result of new information, future events or otherwise.

Friday, May 22nd, 2015 Uncategorized Comments Off on (CTRP) Expedia Announces eLong Transaction

(AAU) Ixtaca Infill Drilling Program, Hits 31.50 Meters of 0.39 G/T Au, 117.0 G/T Ag

VANCOUVER, BC–(May 21, 2015) – Almaden Minerals Ltd. (“Almaden” or “the Company”) (TSX: AMM) (NYSE MKT: AAU) is pleased to announce additional results from Almaden’s ongoing 2015 Ixtaca Zone exploration and development program at the Company’s 100% owned Tuligtic project, Mexico. Recently the company released a positive PEA on the Ixtaca deposit (see news release dated September 3rd, 2014). The mineral resources incorporated into the PEA mine plan were comprised of 29% Measured, 55% Indicated and 16% Inferred. The results reported today are from hole TU-15-453, drilled subsequent to the 2014 resource update and PEA and designed to upgrade the Chemalaco Zone resources remaining in the inferred category to the higher confidence measured and indicated categories. Hole TU-15-453 intersected multiple zones of greater than 100 g/t silver, including two beneath the current PEA pit: 6.30 meters of 0.55 g/t Au and 119.6 g/t silver and 12.00 meters of 0.62 g/t gold and 104.3 g/t silver. Infill drilling is now complete and the Company’s 2015 program is now focussed on engineering and environmental studies towards the completion of a Pre Feasibility Study (“PFS”) as described below. Geotechnical drilling is currently being conducted on the property and additional sample material is being collected for the ongoing metallurgical testing program. Highlights from hole TU-15-453 released today include the following intercepts:

Hole # From (m) To (m) Interval (m) Au (g/t) Ag (g/t) SECTION
TU-15-453 83.50 202.00 118.50 0.21 61.6 50200N
including 123.00 130.00 7.00 0.32 100.2
including 136.45 143.00 6.55 0.45 186.8
including 163.50 195.00 31.50 0.39 117.0
TU-15-453 218.00 268.00 50.00 0.35 54.8
including 228.50 234.80 6.30 0.55 119.6
including 246.00 258.00 12.00 0.62 104.3

J.D. Poliquin, chairman of Almaden, stated, “Today’s results once again show the potential to expand the Ixtaca deposit. We continue to focus on developing the Ixtaca deposit towards being a significant precious metals producer in Mexico and are currently busy on site with engineering related drilling.”

About the Ixtaca Deposit PFS Program
Development related activities are currently underway, including advanced engineering and environmental baseline studies to meet the requirements of a PFS and the submittal of an environmental permit application and risk assessment to the Mexican regulatory agency responsible for mine permitting. To date Almaden has completed or initiated the following studies:

  • Hydrologic studies including the drilling of water test wells and installation of hydrologic equipment for baseline monitoring of existing subsurface water flow and quality on the project site;
  • Baseline surface water quality and flow measurements;
  • Geochemical characterization of rock materials;
  • Condemnation drilling of areas where mine infrastructure is planned;
  • Geotechnical drilling to confirm foundation, footing and subsurface material quality;
  • Geomechanical drilling to confirm rock strength, hardness and pit slope parameters;
  • PFS level metallurgical test work;
  • Flora and fauna studies;
  • Installation of a weather station.

The Company has selected independent engineers Moose Mountain Technical Services and Knight Piesold Ltd. to prepare a PFS study.

About the Ixtaca Drilling Program and the Ixtaca Project
The 100% owned Ixtaca Zone is a blind discovery made by the Company in 2010 on claims staked by the Company. The deposit is an epithermal gold-silver deposit, mostly hosted by veins in carbonate units and crosscutting dykes (“basement rocks”) with a minor component of disseminated mineralisation hosted in overlying volcanic rocks.

The Ixtaca deposit is located in a developed part of Mexico in Puebla State, the location of significant manufacturing investments including Volkswagen and Audi plants. The project is accessed by paved road and is roughly 20 kilometres from an industrial park with rail service where significant manufacturers such as Kimberly Clarke have facilities. Any potential mining operation at Ixtaca would be located in an area previously logged or cleared with negligible to no current land usage.

The Company has access to the entire project area and works closely with local officials and residents. The Company has employed roughly 70 people in its exploration program who live local to the Ixtaca deposit. For example, local employees have made up virtually all the drilling staff and have been trained on the job to operate the Company’s wholly owned drills. The Company has implemented a comprehensive science based and objective community relations and education program for employees and all local stakeholders to transparently explain the exploration and development program underway as well as the potential impacts and benefits of any possible future mining operation at Ixtaca. The Company regards the local inhabitants to be major stakeholders in the Ixtaca deposit’s future along with the Company’s shareholders. Every effort is being made to create an open and clear dialogue with our stakeholders to ensure that any possible development scenarios that could evolve from the anticipated PFS are properly understood and communicated throughout the course of the Company’s exploration and development program. To better explain the impacts of a mining operation at Ixtaca the Company has conducted numerous tours for local residents to third party operated mines in Mexico so that interested individuals can witness the realities of mining personally. The Company invites all interested parties to visit www.almadenminerals.com to find out more about our community development, education and outreach programs.

Technical Details of the Ixtaca Drilling Program
The Main Ixtaca and Ixtaca North Zones of veining are interpreted to have a north-easterly trend. Holes to date suggest that the Main Ixtaca and Ixtaca North Zones are sub vertical with local variations. This interpretation suggests that true widths range from approximately 35% of intersected widths for a -70 degree hole to 94% of intersected widths for a -20 degree hole. The drilling completed to date has traced mineralisation over 1,000 meters along this northeast trend. The Chemalaco (Northeast Extension) Zone strikes roughly north-south (340 azimuth) and dips at 55 degrees to the west. This interpretation suggests that true widths range from approximately 82% of intersected widths for a -70 degree hole to 99% of intersected widths for a -40 degree hole.

Morgan J. Poliquin, Ph.D., P.Eng., a qualified person (“QP”) under the meaning of NI 43-101, the President CEO and a Director of the Company, reviewed the technical information in this news release. The analyses reported were carried out at ALS Chemex Laboratories of North Vancouver using industry standard analytical techniques. For gold, samples are first analysed by fire assay and atomic absorption spectroscopy (“AAS”). Samples that return values greater than 10 g/t gold using this technique are then re-analysed by fire assay but with a gravimetric finish. Silver is first analysed by Inductively Coupled Plasma – Atomic Emission Spectroscopy (“ICP-AES”). Samples that return values greater than 100 g/t silver by ICP-AES are then re analysed by HF-HNO3-HCLO4digestion with HCL leach and ICP-AES finish. Of these samples those that return silver values greater than 1,500 g/t are further analysed by fire assay with a gravimetric finish. Gold equivalent (“AuEq” or “Gold Eq.”) and silver equivalent (“AgEq” or “Silver Eq.”) values were calculated using silver to gold ratios of 50 to 1. The ratio of 50 to 1 was used for the sake of consistency with past news releases. Intervals that returned assays below detection were assigned zero values. Metallurgical recoveries and net smelter returns are assumed to be 100% for these calculations.

Blanks, field duplicates and certified standards were inserted into the sample stream as part of Almaden’s quality assurance and control program which complies with National Instrument 43-101 requirements.

Cautionary Note concerning estimates of Measured, Indicated and Inferred Mineral Resources
This news release uses terms that comply with reporting standards in Canada and certain estimates are made in accordance with Canadian National Instrument 43-101 (“NI 43-101”). NI 43-101 is a rule developed by the Canadian Securities Administrators that establishes Canadian standards for all public disclosure an issuer makes of scientific and technical information concerning mineral projects. These standards differ significantly from the requirements of the U.S. Securities and Exchange Commission (“SEC”), and mineral resource information contained herein may not be comparable to similar information disclosed by United States companies.

This news release uses the terms “measured mineral resources”, “indicated mineral resources” and “inferred mineral resources” to comply with reporting standards in Canada. We advise United States investors that while such terms are recognized and required by Canadian regulations, the SEC does not recognize them. United States investors are cautioned not to assume that any part or all of the mineral deposits in such categories will ever be converted into mineral reserves under SEC definitions. These terms have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. Therefore, United States investors are also cautioned not to assume that all or any part of the “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” exist. In accordance with Canadian rules, estimates of “inferred mineral resources” cannot form the basis of pre-feasibility or other economic studies. It cannot be assumed that all or any part of the “measured mineral resources”, “indicated mineral resources” or “inferred mineral resources” will ever be upgraded to a higher category.

About Almaden
Almaden is a well-financed mineral exploration company working in North America. The company has assembled mineral exploration projects, including the Ixtaca Zone and the Tuligtic project, through its grass roots exploration efforts. While the properties are largely at early stages of development they represent exciting opportunities for the discovery of significant gold, silver and copper deposits as evidenced at Ixtaca. Almaden’s business model is to find and acquire mineral properties and develop them by seeking option agreements with others who can acquire an interest in a project by making payments and exploration expenditures. Through this means the company has been able to expose its shareholders to discovery and capital gain without the funding and consequent share dilution that would be required if the company were to have developed these projects without a partner. The company intends to expand this business model, described by some as prospect generation, by more aggressively exploring several of its projects including the Ixtaca Zone.

On Behalf of the Board of Directors

“Morgan Poliquin”
Morgan J. Poliquin, Ph.D., P.Eng.
President, CEO and Director
Almaden Minerals Ltd.

Neither the Toronto Stock Exchange (TSX) nor the NYSE MKT have reviewed or accepted responsibility for the adequacy or accuracy of the contents of this news release which has been prepared by management. Except for the statements of historical fact contained herein, certain information presented constitutes “forward-looking statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and Canadian securities laws. Such forward-looking statements, including but not limited to, those with respect to potential expansion of mineralization, potential size of mineralized zone, and size and timing of exploration and development programs, estimated project capital and other project costs and the timing of submission and receipt and availability of regulatory approvals involve known and unknown risks, uncertainties and other factors which may cause the actual results, performance or achievement of Almaden to be materially different from any future results, performance or achievements expressed or implied by such forward-looking statements. Such factors include, among others, risks related to international operations and joint ventures, the actual results of current exploration activities, conclusions of economic evaluations, uncertainty in the estimation of mineral resources, changes in project parameters as plans continue to be refined, environmental risks and hazards, increased infrastructure and/or operating costs, labour and employment matters, and government regulation and permitting requirements as well as those factors discussed in the section entitled “Risk Factors” in Almaden’s Annual Information form and Almaden’s latest Form 20-F on file with the United States Securities and Exchange Commission in Washington, D.C. Although Almaden has attempted to identify important factors that could cause actual results to differ materially, there may be other factors that cause results not to be as anticipated, estimated or intended. There can be no assurance that such statements will prove to be accurate as actual results and future events could differ materially from those anticipated in such statements. Almaden disclaims any intention or obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise, other than as required pursuant to applicable securities laws. Accordingly, readers should not place undue reliance on forward-looking statements.

Contact
Morgan Poliquin, P.Eng., Ph.D.
President and CEO
604-689-7644

Thursday, May 21st, 2015 Uncategorized Comments Off on (AAU) Ixtaca Infill Drilling Program, Hits 31.50 Meters of 0.39 G/T Au, 117.0 G/T Ag

(ABTL) Acquires Dealix, a Top-Ranked Provider of Auto Sales Leads, for $25 Million

– Autobytel’s Full Suite of Award-Winning Car Buying Services Now Available to All Dealix Customers –

– Autobytel Management to Discuss Acquisition on Call Today at 5 p.m. ET –

IRVINE, Calif., May 21, 2015  — Autobytel Inc. (Nasdaq:ABTL), a leading provider of online automotive services connecting consumers with dealers, has acquired Dealix Corporation and Autotegrity, Inc. (wholly-owned subsidiaries of CDK Global, LLC), for $25 million.

The all-cash transaction, which includes a working capital adjustment, combines two prominent leaders in the automotive industry to help dealers and manufacturers improve their businesses and sell more cars.

Dealix provides new and used car leads to dealerships, dealer groups, and automotive manufacturers, and consistently ranks as a top auto sales lead provider in the industry. The company is also the operator of the highly successful car buying site, UsedCars.com – one of the first used car search engines to connect consumers with a nationwide inventory of quality used cars. This site now joins Autobytel’s consumer-facing family of websites, Autobytel.com and the soon to be re-launched Car.com.

This acquisition is expected to provide a variety of significant benefits to the automotive industry, including:

  • A greater commitment to delivering high converting, in-market consumers to industry partners by integrating Autobytel’s lead generation and customer acquisition processes across the entire combined network of customers;
  • Enhanced analytics, consumer acquisition strategies, and product development teams;
  • A more robust level of service and support for industry customers through expanded field teams, account management teams, and training groups; and
  • An expanded suite of products for dealers and manufacturers, including mobile, next generation video chat, direct-to-dealer website traffic programs, and expanded used car lead services, among others.

The acquisition adds approximately 600 retail new dealers and 300 retail used dealers to the Autobytel network, for a combined total of approximately 4,954 dealers. These dealer additions do not include the 450 retail new and 170 retail used overlap dealers that were receiving leads from both Dealix and Autobytel. Autobytel management expects the acquisition to be accretive to net income in 2015.

“This acquisition creates an even more dynamic and effective automotive marketing organization,” said Jeff Coats, President and CEO of Autobytel. “The addition of Dealix further expands our reach and influence in the automotive industry by increasing our lead generation capabilities and the size of our car dealer network, and also strengthens our relationships with auto manufacturers. Autobytel’s existing proprietary lead strategies and customer acquisition programs produce estimated buy rates of at least three times the industry average. As such, by combining these organizations, we expect to significantly improve the quality of leads and related services that members of the Dealix network are accustomed to receiving.”

“Developing a greater used car presence has been a key growth initiative for Autobytel,” continued Coats, “with the company’s commercial acquisition team launching a used car beta test platform earlier this year. Our internally-generated used car business has been ramping steadily as we collect the information that allows us to optimize for quality, volume and margin. However, UsedCars.com makes an immediate contribution to this initiative and will accelerate its development.”

In addition to UsedCars.com, Dealix brings to Autobytel a suite of products that help dealers grow their sales, backed by in-depth analytics. With offices in Cambridge and the Silicon Valley area, Dealix leverages its close proximity to both Massachusetts Institute of Technology (MIT) and the vast pool of tech personnel in Silicon Valley to hire some of the brightest minds in the industry to develop products that optimize the car sales process.

This includes proprietary analytics technology and precision targeting tools that allow dealers to launch more effective campaigns based on make and geography. These products will be added to Autobytel’s already expanding platform, including TextShield, SaleMove, AutoWeb and GoMoto, which have redefined the way customers interact with dealers.

Transaction Financing

The transaction was financed in part by Union Bank, N.A. through a newly established $15.0 million senior secured term loan and by drawing on the $2.8 million remaining balance of Autobytel’s $8.0 million working capital revolver. The remainder was funded by cash on hand. The term loan carries an interest rate of LIBOR plus 3.0% and is amortizable over a period of five years. The revolver carries an interest rate of LIBOR plus 2.5%.

Revised Business Outlook

Autobytel’s guidance for fiscal 2015 has been revised upward with revenues now expected to range between $128.0 million and $132.0 million, representing an increase of approximately 20% to 24% from 2014. The company also now expects non-GAAP diluted EPS in fiscal 2015 to range between $1.21 and $1.27, an increase of approximately 46% to 53%.

Conference Call

Autobytel will hold a conference call today at 5:00 p.m. Eastern time to discuss the transaction. The company’s president and CEO, Jeff Coats, and CFO, Kim Boren, will host the call, followed by a question and answer period.

Date: Thursday, May 21, 2015
Time: 5:00 p.m. Eastern time (2:00 p.m. Pacific time)
Toll-free dial-in number: 877-852-2929
International dial-in number: 404-991-3925
Conference ID: 52982324

The conference call will also be broadcast live at www.autobytel.com (click on “Investor Relations” and then click on “Events & Presentations”). Please visit the website at least 15 minutes prior to the start of the call to register and download any necessary software.

For those who will be joining the call by phone, please call the conference telephone number 5-10 minutes prior to the start time. If you have any difficulty connecting with the conference call, please contact Liolios Group at 1-949-574-3860.

A replay of the conference call will be available after 8:00 p.m. Eastern time on the same day through May 28, 2015. The call will also be archived in the Investor Relations section of Autobytel’s website for one year.

Toll-free replay number: 855-859-2056
International replay number: 404-537-3406
Replay ID: 52982324

Note about Non-GAAP Financial Measures

Autobytel has disclosed non-GAAP EPS in this press release, which is a non-GAAP financial measures as defined by SEC Regulation G, for fiscal 2015. The company defines non-GAAP EPS as GAAP net income before amortization of acquired intangibles, non-cash stock-based compensation, acquisition costs, severance costs, litigation settlements and income taxes, divided by weighted average diluted shares outstanding. The company’s management believes that presenting non-GAAP EPS provides useful information to investors regarding the underlying business trends and performance of the company’s ongoing operations and is a better metric for monitoring the company’s performance given the company’s net operating loss (NOL) tax credits. This non-GAAP financial measure is used in addition to and in conjunction with results presented in accordance with GAAP and should not be relied upon to the exclusion of GAAP financial measures. Management strongly encourages investors to review the company’s consolidated financial statements in their entirety and to not rely on any single financial measure.

About Autobytel

Autobytel Inc. provides high quality consumer leads and associated marketing services to automotive dealers and manufacturers throughout the United States. The company also provides consumers with robust and original online automotive content to help them make informed car-buying decisions. The company pioneered the automotive Internet in 1995 with its flagship website www.autobytel.com and has since helped tens of millions of automotive consumers research vehicles; connected thousands of dealers nationwide with motivated car buyers; and has helped every major automaker market its brand online.

Investors and other interested parties can receive Autobytel news alerts and special event invitations by accessing the online registration form at investor.autobytel.com/alerts.cfm.

Forward-Looking Statements Disclaimer

The statements contained in this press release that are not historical facts are forward-looking statements under the federal securities laws. These forward-looking statements, including, (i) the company’s statement that the acquisition is expected to provide a variety of significant benefits to the automotive industry, including (1) a greater commitment to delivering high converting, in-market consumers to industry partners by integrating Autobytel’s lead generation and customer acquisition processes across the entire combined network of customers; (2) enhanced analytics, consumer acquisition strategies, and product development teams; (3) a more robust level of service and support for industry customers through expanded field teams, account management teams, and training groups; and (4) an expanded suite of products for dealers and manufacturers, including mobile, next generation video chat, direct-to-dealer website traffic programs, and expanded used car lead services, among others; (ii) that with the addition of Dealix, the company expects to significantly improve the quality of leads and related services that members of the Dealix network are accustomed to receiving; (iii) management’s expectation that the acquisition will be accretive to net income in 2015; (iv) that the company’s guidance for fiscal 2015 has been revised upward with revenues to range between $128.0 million and $132.0 million, representing an increase of approximately 20% to 24% from 2014; and (v) that the company also expects non-GAAP diluted EPS in fiscal 2015 to range between $1.21 and $1.27, an increase of approximately 46% to 53%, are not guarantees of future performance and involve assumptions and risks and uncertainties that are difficult to predict. Actual outcomes and results may differ materially from what is expressed in, or implied by, these forward-looking statements. Autobytel undertakes no obligation to update publicly any forward-looking statements, whether as a result of new information, future events or otherwise. Among the important factors that could cause actual results to differ materially from those expressed in, or implied by, the forward-looking statements are changes in general economic conditions; the financial condition of automobile manufacturers and dealers; disruptions in automobile production; changes in fuel prices; the economic impact of terrorist attacks, political revolutions or military actions; failure of our internet security measures; dealer attrition; pressure on dealer fees; increased or unexpected competition; the failure of new products and services to meet expectations; failure to retain key employees or attract and integrate new employees; actual costs and expenses exceeding charges taken by Autobytel; changes in laws and regulations; costs of legal matters, including, defending lawsuits and undertaking investigations and related matters; and other matters disclosed in Autobytel’s filings with the Securities and Exchange Commission. Investors are strongly encouraged to review the company’s Annual Report on Form 10-K for the year ended December 31, 2014 and other filings with the Securities and Exchange Commission for a discussion of risks and uncertainties that could affect the business, operating results or financial condition of Autobytel and the market price of the company’s stock.

CONTACT: Company Contact:
         Kim Boren
         Chief Financial Officer
         949-862-1396
         kimb@autobytel.com

         Investor Relations:
         Liolios Group, Inc.
         Cody Slach or Sean Mansouri
         949-574-3860
         ABTL@liolios.com

         Autobytel Inc. Media Relations
         Splash Media
         Jennifer Lange
         949-916-4820
         jlange@getsplashmedia.com
Thursday, May 21st, 2015 Uncategorized Comments Off on (ABTL) Acquires Dealix, a Top-Ranked Provider of Auto Sales Leads, for $25 Million

(CFRXW) Announces First Healthy Volunteer Dosed With CF-301

YONKERS, NY–(May 21, 2015) – ContraFect Corporation (NASDAQ: CFRX) (NASDAQ: CFRXW) (NASDAQ: CFRXZ), a biotechnology company focused on the discovery and development of protein therapeutics and antibody products for life-threatening, drug-resistant infectious diseases, today announced that it has commenced dosing of healthy volunteers in its Phase 1 clinical trial of CF-301. CF-301 is being developed for use in combination with standard of care antibiotics for the treatment of Staph bloodstream infections, including infective endocarditis, caused by drug-sensitive and drug-resistant Staph aureus.

“ContraFect is pleased to announce that it has taken an important step in the development of CF-301, the first in a new class of medicines with the potential to transform the treatment paradigm for drug-sensitive and drug-resistant Staph infections, including the MRSA superbug,” said Julia P. Gregory, ContraFect’s Chief Executive Officer. “Novel approaches, like CF-301, with activity against drug-resistant bacteria and biofilms, offer great potential to successfully treat these current life-threatening infections.”

ContraFect is conducting a single Phase 1 randomized, double-blind, placebo-controlled, dose-ranging trial in healthy volunteers in the United States to evaluate the safety, tolerability and pharmacokinetics of CF-301 alone. A data safety monitoring board will review the safety and pharmacokinetic data for each dose level in order to recommend proceeding to the next higher dose. Additional information on the trial can be found at https://www.clinicaltrials.gov/ct2/show/NCT02439359

About CF-301

CF-301 is a bacteriophage lysin with potent activity against Staph aureus infections. CF-301 has the potential to be a first-in-class treatment for Staph bacteremia as it has a new mechanism of action for eliminating bacteria. It has specific and rapid bactericidal activity against Staph aureus and does not impact the body’s good bacteria. By targeting a conserved region of the cell wall that is vital to bacteria, resistance is less likely to develop to CF-301. In vitro and in vivo experiments have shown that CF-301 clears biofilm. Combinations of CF-301 with standard of care antibiotics increased survival significantly in animal models of disease when compared to treatment with antibiotics or CF-301 alone. CF-301 was licensed from The Rockefeller University and developed at ContraFect.

About Staph Bacteremia

Staphylococcus aureus (“S. aureus”) is a major cause of bacteremia, and Staph aureus bacteremia is associated with higher morbidity and mortality, compared with bacteremia caused by other pathogens. The burden of Staph aureus bacteremia, particularly methicillin-resistant Staph aureus bacteremia, in terms of cost and resource use is high. The risk of infective endocarditis and of seeding to other metastatic foci increases the risk of mortality and raises the stakes for early, appropriate treatment.

Staphylococcus (“Staph”) infections occur in both hospital and community settings, and in the United States there are approximately 120,000 cases annually of Staph bacteremia (a bloodstream infection), which causes approximately 30,000 deaths annually. Of further concern, drug-resistant strains of Staph are now evolving and developing additional resistance against standard-of-care antibiotics, which may ultimately result in increased number of cases and mortality from Staph bacteremia. A recent study commissioned by U.K. Prime Minister David Cameron found that without action, drug-resistant infections that already kill hundreds of thousands a year globally could exceed 10 million by 2050.

About ContraFect

ContraFect is a biotechnology company focused on discovering and developing therapeutic protein and antibody products for life-threatening, drug-resistant infectious diseases, particularly those treated in hospital settings. Due to drug-resistant and newly emerging pathogens, hospital acquired infections are currently the fourth leading cause of death in the United States, following heart disease, cancer and stroke. We intend to address drug-resistant infections using our therapeutic product candidates from our lysin and monoclonal antibody platforms to target conserved regions of either bacteria or viruses (regions that are not prone to mutation). ContraFect’s initial product candidates include new agents to treat antibiotic-resistant infections such as MRSA (methicillin-resistant staphylococcus bacteria) and influenza.

FORWARD-LOOKING STATEMENTS

This press release contains “forward-looking statements” within the meaning of the U.S. federal securities laws. Forward-looking statements can be identified by words such as “projects,” “may,” “will,” “could,” “would,” “should,” “believes,” “expects,” “anticipates,” “estimates,” “intend,” “plans,” “potential,” “transform,” “look forward to,” “novel” or similar references to future periods. Forward-looking statements are statements that are not historical facts, nor assurances of future performance. Instead, they are based on ContraFect’s current beliefs, expectations and assumptions regarding the future of its business, future plans, strategies, projections, anticipated events and trends, the economy and other future conditions. Because forward-looking statements relate to the future, they are subject to inherent risks, uncertainties and changes in circumstances that are difficult to predict and many of which are beyond ContraFect’s control, including those detailed in ContraFect’s filings with the Securities and Exchange Commission. Specific forward-looking statements in this release include, without limitation, statements regarding anticipated screening and enrollment of healthy volunteers in our Phase 1 clinical trial of CF-301, the data obtained throughout the trial regarding the safety, tolerability and pharmacokinetics of CF-301, our ability to develop therapies to combat life-threatening infections, CF-301’s activity against drug-resistant bacteria and biofilms, and the performance of our clinical development organization. Actual results may differ from those set forth in the forward-looking statements. Any forward looking statement made by ContraFect in this press release is based only on information currently available and speaks only as of the date on which it is made. Except as required by applicable law, ContraFect expressly disclaims any obligations to publicly update any forward-looking statements, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise.

Investor Relations Contact

Barbara Ryan
Clermont Partners
Tel: 203-274-2825
Email: Email Contact

Avonelle McLean
ContraFect Corporation
Email: Email Contact

Thursday, May 21st, 2015 Uncategorized Comments Off on (CFRXW) Announces First Healthy Volunteer Dosed With CF-301

(AMPE) Positive Study Results on Optina™In Diabetic Macular Edema

ENGLEWOOD, Colo., May 21, 2015  — Ampio Pharmaceuticals, Inc. (NYSE MKT: AMPE) today announced positive results of the OptimEyes trial for DME. The OptimEyes trial was a multiple site, randomized, placebo controlled, parallel, double masked study to evaluate the safety and efficacy of two doses of oral Optina (adjusted to body mass index-BMI) in adult patients with Diabetic Macular Edema (DME).

The OptimEyes trial, with FDA guidance, was designed to include a wide variety of DME patients, some of whom had no therapeutic options and were progressing to blindness. Intraocular injections may have been contraindicated in these patients (example-patients with glaucoma, prior vitrectomy etc…and were included in our trials). Including patients not accepted in other trials of intraocular injections allowed us to better understand the effect of oral Optina in improving visual acuity (measured as best corrected visual acuity-BCVA, eye chart) and reducing edema (as measured by optical coherence tomography-OCT) in all patients.

The goal of the study was to assess the safety and efficacy of oral Optina, identify the patients who respond and the ideal dose.

  • Orally administered Optina was extremely safe with no drug related serious adverse events. There were no differences in side effect rates between placebo and the Optina arms.

Furthermore, we successfully identified a subgroup of patients based on BMI (n= 106 eyes) in which treatment with the optimal Optina dose resulted in significant improvements in both vision and retinal swelling. Results for this group are as follows:

  • Overall, 53% of patients included in the trial were refractory (unresponsive) to the approved intraocular injection therapies. These refractory patients showed a significant +6.2 letter improvement in visual acuity over the three month period of the study (P< 0.001). In the remaining 47% patients who were unable or unwilling to have eye injections, they showed a significant +3.1 letter improvement over the same period (p=0.04). The placebo group failed to achieve a significant increase in visual acuity in either of the subgroup of patients who were and were not refractory to intraocular injections over the same time period (+2.0 letters, p=0.20, +0.7 letters, p=0.72 respectively).
  • In addition to showing significant improvements in visual acuity, the patients had a significant decrease in retinal swelling of 46 microns (p=0.003). Again, the placebo group failed to show a significant change in retinal swelling (-12 microns, p=0.47).

Our plan is to continue the analysis, present the data to the FDA and once regulatory guidance is received, detailed information through appropriate channels such as conferences and publications will be distributed.

About Ampio Pharmaceuticals
Ampio Pharmaceuticals, Inc. is a development stage biopharmaceutical company primarily focused on the development of therapies to treat prevalent inflammatory conditions for which there are limited treatment options. We are developing compounds that decrease inflammation by (i) inhibiting specific pro-inflammatory compounds by affecting specific pathways at the protein expression and at the transcription level; (ii) activating specific phosphatase or depletion of the available phosphate needed for the inflammation process; and (iii) decreasing vascular permeability.

Forward Looking Statements
Ampio’s statements in this press release that are not historical fact and that relate to future plans or events are forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements can be identified by use of words such as “plan,” “continue”, “present,” “will be,” and similar expressions. These forward-looking statements include statements regarding Ampio’s plans with respect to the OptimEyes trial, which are subject to the risks associated with clinical trials, regulatory approvals, and changes in business conditions and similar events.  These risks include the uncertainty of the regulatory response to the sufficiency of trial data and trial design, that regulatory approval may not be obtained or delayed, and the risks and uncertainties detailed from time to time in Ampio’s filings with the Securities and Exchange Commission, including without limitation, under Ampio’s Annual Report on Form 10-K and Quarterly Reports on Form 10-Q. Ampio undertakes no obligation to revise or update these forward-looking statements, whether as a result of new information, future events or otherwise.

Thursday, May 21st, 2015 Uncategorized Comments Off on (AMPE) Positive Study Results on Optina™In Diabetic Macular Edema

(NBS) Turning Cancer Against Itself: Major Grant Advances Pioneering Melanoma Therapy

Company on Leading Edge of Research With Experimental Therapy Targeting Specific Cancer Cells

NEW YORK, May 21, 2015  — NeoStem, Inc. (Nasdaq:NBS) announced Thursday that it will receive one of the largest research grants of its kind to support its pioneering treatment for patients with stage III recurrent or stage IV metastatic melanoma, a potentially breakthrough approach that teaches the immune system which cells to attack and kill.

The $17.7 million grant from the California Institute for Regenerative Medicine (CIRM), a distinguished and independent scientific body, is a significant endorsement of the potential for NeoStem’s novel approach for treating metastatic melanoma, the most deadly form of skin cancer. The sheer scope of the award has important implications as it is expected to fund a significant portion of the pivotal Phase 3 clinical trial investigating a personalized cancer treatment and currently enrolling patients at centers across the United States.

NeoStem’s therapeutic candidate, NBS20, uses a patient’s own cancer cells – in essence, turning the cancer against itself – in a way that is unique. Instead of attacking the bulk of cancer cells, NeoStem’s therapy targets a patient’s cancer-initiating cells, often called “cancer stem cells,” which are those that proliferate cancer cells, spreading the disease and forming new tumors throughout the body.

Trial results to date support the expectation that this novel approach will improve overall survival. In a Phase 2 randomized, controlled trial of the therapy, results showed a 72 percent two-year survival rate, compared with 31 percent in the control group.

NeoStem’s belief is that if the Phase 3 trial is successful, and the therapy is then approved by the FDA, it could be a breakthrough in the treatment of metastatic melanoma patients and available as early as 2018.

The product candidate has been granted both Fast Track and Orphan Drug designations from the FDA, and the protocol is the subject of a Special Protocol Assessment with FDA. Additionally, the European Medicines Agency has classified NBS20 as an Advanced Therapeutic Medicinal Product.

“We are grateful to CIRM and the cancer experts who reviewed and endorsed our application. We firmly believe that this therapy has the potential to help people survive cancer longer and this grant helps us advance towards bringing this treatment to market,” said Dr. David J. Mazzo, NeoStem’s Chief Executive Officer. “The grant substantiates our approach to identifying and securing non-dilutive funding for our development programs and helps position NeoStem as a leader among immuno-oncology therapy developers.”

The grant comes during National Melanoma Skin Cancer Awareness Month and just ahead of the summer outdoor season when preventing skin cancer – the most common type of cancer in the United States – is a priority.

Norm Beegun, a patient in one of the Phase 2 trials for NBS20 who lives in Los Angeles, California, commented, “After several years of receiving other treatments with limited long-term success, I have been disease-free for the past 11 years since the NeoStem treatment – and I remain so today. The medical need for those with late-stage melanoma is profound, but so is the potential of this therapy. It deserves attention and support. That’s why I am so glad that CIRM is funding the kind of research that can help so many people.”

NeoStem’s research has potentially widespread applications for people with cancers of various solid tumor types, including ovarian, lung, colon, liver, renal and brain cancers.

Other therapies may treat existing cancer, but they may not be as likely as NeoStem’s approach might be to prevent a recurrence of tumors. NeoStem is one of a small group of companies with an immunotherapy product actually in Phase 3 development.

NeoStem is a biopharmaceutical company developing novel personalized immuno-oncology medical treatments. CIRM, whose mission it is to accelerate the availability of stem cell treatments for patients with unmet medical needs, funds promising research programs involving all types of stem cells and across a wide range of diseases.

The grant is the largest CIRM has made since its Dec 31, 2014 official launch of CIRM 2.0 and one of the largest the organization has ever made to an industry sponsor. Use of any of the CIRM grant funds is subject to dollar-for-dollar match funding by NeoStem.

“CIRM 2.0 is designed to accelerate the development of treatments for people with unmet medical needs, and this project clearly fits that description,” says Dr. C. Randal Mills, President and CEO of CIRM. “With the Board’s approval today we will now get this work up and running within the next 45 days. But that’s just the start. We are not just providing financial support; we are also partnering with these groups to provide expertise, guidance and other kinds of support that these teams need to help them be successful. That’s the promise of CIRM 2.0. Faster funding, better programs and a more comprehensive approach to supporting their progress.”

Unlike many other immuno-oncology products, in order to work as hypothesized NBS20 does not depend on a low-level intrinsic immune response from the patient. The therapy is intended to induce an immune response by “teaching” the immune system what cells to attack and kill. Furthermore, because of its unique mechanism of action, the therapy will likely be complementary and potentially even synergistic with other available therapies. It is expected to be very well tolerated by patients because it uses their own immune system to create a specific therapy.

The Intus trial is supported by results from two Phase 2 trials conducted with dendritic cells loaded with antigens from autologous tumor stem cells, now known as NBS20. The more recent of the two trials was a randomized trial comparing subcutaneous injections of NBS20 versus injections of autologous irradiated (inactivated) tumor stem cells in patients with advanced melanoma. The two-year survival rate of 72 percent corroborated one of the findings of the previous Phase 2 trial, in which a 73 percent two-year survival rate was demonstrated along with a five-year survival rate of 50 percent.

The U.S. melanoma market is approximately $1 billion per year, which is predominantly spent to treat metastatic melanoma.

For more information on the Intus Study, which will be enrolling at approximately 50 sites across the U.S, Canada, Australia and New Zealand, please visit www.theintusstudy.com or www.clinicaltrials.gov/ct2/show/NCT01875653.

About Metastatic Melanoma

Melanoma, which originates in pigment-producing cells known as melanocytes, is the most lethal form of skin cancer. Melanoma is often caused by unrepaired DNA damage to skin cells from UV radiation. Patients who have progressed to stage IV melanoma have a cancer that has metastasized—or spread—to distant sites in the body such as the lymph nodes, lungs, liver or brain. As a result, advanced melanoma is exceedingly difficult to treat, with a 5-year survival rate of approximately 15%. There are 20,000 estimated new cases of metastatic melanoma, and an estimated 10,000 deaths from metastatic melanoma, each year in the United States.

Treatments for stage IV melanoma are typically directed at slowing the growth of the cancer and prolonging survival. Current treatment options include radiation, chemotherapy, surgical resection, immunotherapy, or a combination approach. Unfortunately, most current approaches provide only temporary relief, either halting the growth of tumors for an average of 6-10 months or eliminating all tumors in only 10-20% of patients. Administering certain anti-melanoma drugs at higher doses appears to be more effective, but often results in more severe side effects.

About CIRM

At CIRM, we never forget that we were created by the people of California to accelerate stem cell treatments to patients with unmet medical needs, and to act with a sense of urgency commensurate with that mission. To meet this challenge, our team of highly trained and experienced professionals actively partners with both academia and industry in a hands-on, entrepreneurial environment to fast track the development of today’s most promising stem cell technologies. With $3 billion in funding and over 280 active stem cell programs in our portfolio, CIRM is the world’s largest institution dedicated to helping people by bringing the future of medicine closer to reality.
https://www.cirm.ca.gov/

About NeoStem, Inc.

NeoStem is a biopharmaceutical company pursuing the preservation and enhancement of human health globally through the development of novel cell based individualized medicine therapeutics that prevent, treat or cure disease. The Company is developing therapies based on three platform technologies (immuno-oncology, ischemic repair and immunomodulation) with a focus on its lead, Phase 3 clinical program for NBS20 in immuno-oncology. The combination of a rich therapeutics pipeline and an externally recognized in-house center for cell therapy process development and manufacturing has created an organization with unique capabilities for accelerated and efficient product development. www.neostem.com

Forward-Looking Statements

This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the adequacy of the grant for funding a significant portion of the Company’s pivotal Phase 3 trial, the potential impact of NBS20 in the treatment of metastatic melanoma patients and the date NBS20 will be available, the efficacy of other cancer treatments as compared to NeoStem’s approach, the applications of NeoStem’s research to cancers of various solid tumor types, the degree to which NBS20 will be complementary to and synergistic with other therapies, successful execution of the Company’s business strategy, the Company’s ability to develop and grow its business, the successful development of cellular therapies with respect to the Company’s research and development and clinical evaluation efforts in connection with the Company’s Immuno-Oncology Program, Ischemic Repair Program, Immune Modulation Program and other cell therapies, the future of the regenerative medicine industry and the role of stem cells and cellular therapy in that industry. The Company’s further development is highly dependent on future medical and research developments and market acceptance, which is outside of its control. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of the Company in general, see the factors described under the heading, “Item 1A. Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on March 2, 2015 and those described in the Company’s other periodic filings with the SEC. The Company undertakes no obligation to update or revise any forward-looking statements.

CONTACT: NeoStem, Inc.
         Eric Powers
         Manager of Communications and Marketing
         Phone: +1-212-584-4173
         Email: epowers@neostem.com
Thursday, May 21st, 2015 Uncategorized Comments Off on (NBS) Turning Cancer Against Itself: Major Grant Advances Pioneering Melanoma Therapy

(GNCA) Positive Top-Line Phase 2 Data for Genital Herpes Immunotherapy GEN-003

Genocea Biosciences, Inc. (NASDAQ:GNCA), a biopharmaceutical company developing T cell-directed vaccines and immunotherapies, today announced positive top-line data from a Phase 2 dose optimization trial evaluating GEN-003 for the treatment of genital herpes. During the 28-day observation period immediately after completion of dosing, the best dose of 60 µg per protein / 75 µg of Matrix-M2TM adjuvant demonstrated a highly statistically significant (p<0.0001) 55 percent reduction from baseline in the viral shedding rate, the primary endpoint of the trial and a measure of anti-viral activity. All dose combinations tested, including the successful 30 µg per protein / 50 µg of adjuvant dose from the prior Phase 1/2a trial, demonstrated a statistically significant viral shedding rate reduction versus baseline and only the lowest dose combination did not demonstrate a statistically significant reduction versus placebo.

In a planned secondary analysis to assess impact on patient-reported genital lesion rates, a self-assessed measurement of clinical disease, all dose groups, including the placebo group, demonstrated a statistically significant reduction from baseline.

“We are extremely pleased with these positive top-line results which have successfully allowed us to identify the optimal dose to advance into further trials,” said Chip Clark, president and chief executive officer. “The results strengthen the product profile from our Phase 1/2a trial, which we have shown in market research to be highly clinically meaningful and commercially attractive, providing further evidence of the strong value proposition of GEN-003 for patients, physicians and payers.”

The Phase 2 study showed that GEN-003 was generally safe and well tolerated by patients, with no serious adverse events related to the vaccine. Safety data throughout the trial is monitored by an independent data safety monitoring board. Although reactogenicity increased with adjuvant dose, there was no difference in discontinuations in patient dosing due to adverse events across the different treatment arms.

“People living with genital herpes are seeking treatments that deliver on efficacy and provide them with peace of mind that they are at less risk of transmitting the infection to their sexual partners,” said Peter Leone, MD, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina, and an investigator in the GEN-003 dose optimization trial. “We know that asymptomatic viral shedding is the driver of herpes transmission and GEN-003’s demonstrated antiviral efficacy data reported to date suggest this immunotherapy can be an effective future treatment.”

About the GEN-003 Phase 2 Clinical Trial

The Phase 2 study enrolled 310 subjects from 17 institutions in the United States. Subjects were randomized to one of six dosing groups of either 30 µg or 60 µg per protein paired with one of three adjuvant doses (25 µg, 50 µg, or 75 µg). A seventh group received placebo. Subjects received three doses of GEN-003 or placebo at 21-day intervals. Baseline viral shedding and genital lesion rates were established for each subject in a 28-day observation period prior to the commencement of dosing by collecting 56 genital swab samples (two per day), which were analyzed for the presence of HSV-2 DNA, and by recording the days on which genital lesions were present. This 28-day observation period was repeated immediately after the completion of dosing and will be repeated two more times over the course of this trial, at six and twelve months following dosing. No booster doses will be given.

A prior Phase 1/2a clinical trial demonstrated, at the corresponding immediate post dosing 28-day observation period, a highly statistically significant 52 percent reduction in the viral shedding rate and a highly statistically significant 48 percent reduction in the genital lesion rate compared to baseline at a dose of 30 µg per protein/50 µg of Matrix-M2TM adjuvant.

For more information about this clinical study of GEN-003 please visit www.clinicaltrials.gov.

Conference Call

Genocea management will host a conference call and webcast today, at 9 a.m. EDT. Peter A. Leone, MD, Professor of Medicine and Adjunct Professor of Epidemiology at the University of North Carolina, will also join management for the call. Dr. Leone is an expert in the surveillance, prevention, and control of sexually transmitted diseases and is an investigator in the GEN-003 dose optimization trial. The conference call may be accessed by dialing (844) 826-0619 for domestic participants and (315) 625-6883 for international callers (reference conference ID 52068310). A live webcast of the conference call will be available online from the investor relations section of the Company’s website at http://ir.genocea.com. A webcast replay of the conference call will be available on the Genocea website beginning approximately two hours after the event, and will be archived for 30 days.

About GEN-003

Inducing a T cell response against HSV-2 is critical to treating the clinical symptoms of disease and controlling transmission of the infection. GEN-003 is a first-in-class T-cell directed immunotherapy designed to elicit both a T cell and B cell (antibody) immune response. The immunotherapy was designed using Genocea’s ATLAS™ platform, which profiles the comprehensive spectrum of actual T cell responses mounted by humans in response to disease, to identify antigen targets that drive T cell response. GEN-003 includes the antigens ICP4 and gD2 along with Matrix-M2TM adjuvant, which Genocea licensed from Novavax, Inc.

For more information about GEN-003, please visit http://www.genocea.com/platform-pipeline/pipeline/gen003-for-genital-herpes/

About Genital Herpes

Genital Herpes affects more than 400 million people worldwide and causes recurrent, painful genital lesions. It can be transmitted to sexual partners, even when the disease is asymptomatic. Current genital herpes therapies only partially control clinical symptoms and viral shedding, a process which drives disease transmission. Incomplete control of genital lesions and transmission risk, expense and the perceived inconvenience of taking a daily medication are hurdles for long-term disease management. Immunity through T cells is believed to be particularly critical to the control and possible prevention of genital herpes infections.

About Genocea

Genocea is harnessing the power of T cell immunity to develop life-changing vaccines and immunotherapies. T cells are increasingly recognized as a critical element of protective immune responses to a wide range of diseases, but traditional discovery methods have proven unable to identify the targets of such protective immune response. Using ATLAS™, its proprietary technology platform, Genocea identifies these targets to potentially enable the rapid development of medicines to address critical patient needs. Genocea’s pipeline of novel clinical stage T cell-enabled product candidates includes GEN-003 for genital herpes, GEN-004 for the prevention of infection by all serotypes of pneumococcus, and earlier-stage programs in chlamydia, genital herpes prophylaxis, malaria and cancer immunotherapy. For more information, please visit the company’s website at www.genocea.com.

Forward Looking Statements

Statements herein relating to future business performance, conditions or strategies and other financial and business matters, including expectations regarding clinical developments, are forward-looking statements within the meaning of the Private Securities Litigation Reform Act. Genocea cautions that these forward-looking statements are subject to numerous assumptions, risks and uncertainties, which change over time. Factors that may cause actual results to differ materially from the results discussed in the forward-looking statements or historical experience include risks and uncertainties, including Genocea’s ability to progress any product candidates in preclinical or clinical trials; the scope, rate and progress of its preclinical studies and clinical trials and other research and development activities; anticipated clinical trial results; that current results may not be predictive of future results; even if the data from preclinical studies or clinical trials is positive, regulatory authorities may require additional studies for approval and the product may not prove to be safe and efficacious; Genocea’s ability to enter into future collaborations with industry partners and the government and the terms, timing and success of any such collaboration; risks associated with the manufacture and supply of clinical and commercial product; the cost of filing, prosecuting, defending and enforcing any patent claims and other intellectual property rights; Genocea’s ability to obtain rights to technology; competition for clinical resources and patient enrollment from drug candidates in development by other companies with greater resources and visibility; the rate of cash utilized by Genocea in its business and the period for which existing cash will be able to fund such operation; Genocea’s ability to obtain adequate financing in the future through product licensing, co-promotional arrangements, public or private equity or debt financing or otherwise; general business conditions; competition; business abilities and judgment of personnel; the availability of qualified personnel and other factors set forth under “Risk Factors” in Genocea’s Annual Report on Form 10-K for the fiscal year ended December 31, 2014 and other filings with the Securities and Exchange Commission (the “SEC”). Further information on the factors and risks that could affect Genocea’s business, financial conditions and results of operations is contained in Genocea’s filings with the SEC, which are available at www.sec.gov. These forward-looking statements speak only as of the date of this press release and Genocea assumes no duty to update forward-looking statements.

For media:
Spectrum Science Communications
Megan Lustig, 202-955-6222
mlustig@spectrumscience.com
or
For investors:
Genocea Biosciences
Jonathan Poole, 617-876-8191
jonathan.poole@genocea.com

Wednesday, May 20th, 2015 Uncategorized Comments Off on (GNCA) Positive Top-Line Phase 2 Data for Genital Herpes Immunotherapy GEN-003

(INS) Announces Preliminary Results of Its Tender Offer

ATLANTA, May 20, 2015  — Intelligent Systems Corporation (NYSE MKT:INS) (the “Company”) today announced the preliminary results of its modified “Dutch auction” tender offer, which expired at 12:00 Midnight, New York City Time, on May 19, 2015.

Based on the preliminary analysis by the depositary, an aggregate of 230,729 shares were properly tendered and not withdrawn, including shares that were tendered through notice of guaranteed delivery, at prices at or below $3.00 per share. Accordingly, pursuant to the terms of the Offer to Purchase, the Letter of Transmittal and applicable securities laws, the Company expects to accept for payment up to an aggregate of 230,729 shares of its common stock at a purchase price of $3.00 per share.

The tender offer was made pursuant to an Offer to Purchase and Letter of Transmittal, each dated April 22, 2015.

The number of shares to be purchased in the tender offer and the price per share are preliminary. The determination of the final number of shares to be purchased is subject to confirmation by the depositary of the proper delivery of the shares properly tendered and not withdrawn. The actual number and percentage of outstanding shares properly tendered and not withdrawn, the final price per share for shares purchased in the tender offer and the number of shares of the Company’s common stock that will be outstanding after payment for the tendered shares will be announced promptly following the completion of the confirmation process. Payment for the shares accepted for purchase will occur promptly thereafter. Payment for shares will be made in cash, without interest.

The information agent for the offer is D.F. King & Co., Inc. and the depositary for the offer is American Stock Transfer & Trust Company, LLC. All questions and requests for information about the offer should be directed to D.F. King & Co., Inc. at (800) 499-8541.

About Intelligent Systems Corporation

For over thirty-five years, Intelligent Systems Corporation (NYSE MKT:INS) has identified, created, operated and grown technology companies. The Company’s principal continuing operations include CoreCard Software, Inc. (www.corecard.com) and its affiliate companies. CoreCard designs, develops, and markets a comprehensive suite of software solutions to corporations, financial institutions, retailers and processors to manage their credit and debit cards, prepaid cards, private label cards, fleet cards, loyalty programs, and accounts receivable and small loan transactions. CoreCard also offers prepaid and credit card processing services using its proprietary software solutions. Further information is available on the Company’s website at http://www.intelsys.com or by calling the Company at 770/381-2900.

CONTACT: Bonnie Herron, CFO
         770-564-5504
         bherron@intelsys.com
Wednesday, May 20th, 2015 Uncategorized Comments Off on (INS) Announces Preliminary Results of Its Tender Offer

(NXTD) Announces Participation as Member of Team Battelle for TIES Contract Award

OXFORD, Conn., May 20, 2015  — NXT-ID, Inc. (NASDAQ:NXTD) (“NXT-ID” or the “Company”) announces that its wholly owned subsidiary, 3D-ID LLC, a company engaged in biometric identification is an official contractor under Team Battelle for the biometrics technology portion of the recently awarded TIES (Technical Information Engineering Services) Unrestricted Suite Contract from the Department of the Army.

3D-ID LLC has a suite of 3D facial recognition products developed for government, law enforcement and security agencies.

Gino Pereira, Chief Executive Officer said, “We are very proud to be part of Team Battelle and contributing our expertise in biometric technologies. This award is the culmination of 2 years hard work by many parties involved. Although the Company’s primary focus has been on our biometric smart wallet, the Wocket®, currently being shipped to our pre-order customers, we have continued to develop opportunities for our core biometric products. We look forward to supporting Battelle on future task orders. ”

The contracts were awarded on 08 May 2015, and include nine total awardees. The estimated total contract value of the entire TIES program is $994M. This IDIQ contract will be Task Order driven and Task Orders under the Unrestricted Suite will be issued on a Full and Open Competition Basis among all nine Awardees.

The work conducted under TIES will span multiple areas of interest supporting the Information and Intelligence (I2WD) mission including Biometric Enabled Intelligence (BEI). I2WD is the Intelligence and Information Warfare Directorate which is part of the US Army’s Communication’s-Electronics Research, Development and Engineering Center (CERDEC).

About Battelle

Every day, the people of Battelle apply science and technology to solving what matters most. At major technology centers and national laboratories around the world, Battelle conducts research and development, designs and manufactures products, and delivers critical services for government and commercial customers. Headquartered in Columbus, Ohio since its founding in 1929, Battelle serves the national security, health and life sciences, and energy and environmental industries. For more information, visit www.battelle.org.

See more at: http://www.battelle.org

 

About NXT- ID Inc. – Mobile Security for a Mobile World: (NXTD)

NXT-ID, Inc.’s innovative MobileBio® solution mitigates consumer risks associated with mobile computing, m-commerce and smart OS-enabled devices. The company is focused on the growing m-commerce market, launching its innovative MobileBio® suite of biometric solutions that secure consumers’ mobile platforms led by Wocket®; a next generation smart wallet designed to replace all the cards in your wallet, no smart phone required. Wocket was recognized as one of the top technology products at CES 2015 by multiple media outlets including Wired.com. The Wocket works anywhere credit cards are accepted and only works with your biometric stamp of approval. http://www.wocketwallet.com/

NXT-ID’ wholly owned subsidiary, 3D-ID LLC, is engaged in biometric identification and has 22 licensed patents in the field of 3D facial recognition http://www.nxt-id.com/, http://3d-id.net/

Forward-Looking Statements for NXT-ID: This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Forward-looking statements reflect management’s current expectations, as of the date of this press release, and involve certain risks and uncertainties. Forward-looking statements include statements herein with respect to the successful execution of the Company’s business strategy. The Company’s actual results could differ materially from those anticipated in these forward-looking statements as a result of various factors. Such risks and uncertainties include, among other things, our ability to establish and maintain the proprietary nature of our technology through the patent process, as well as our ability to possibly license from others patents and patent applications necessary to develop products; the availability of financing; the Company’s ability to implement its long range business plan for various applications of its technology; the Company’s ability to enter into agreements with any necessary marketing and/or distribution partners; the impact of competition, the obtaining and maintenance of any necessary regulatory clearances applicable to applications of the Company’s technology; and management of growth and other risks and uncertainties that may be detailed from time to time in the Company’s reports filed with the Securities and Exchange Commission.

NXT- ID Inc Contact:
Corporate info: info@nxt-id.com

Investors:
investors@nxt-id.com

Media:
D. Van Zant
800 665-0411
press@nxt-id.com

Wednesday, May 20th, 2015 Uncategorized Comments Off on (NXTD) Announces Participation as Member of Team Battelle for TIES Contract Award

(ATNM) linical Update on Actimab-A at Upcoming 2015 ASCO Annual Meeting

Clinical Advisory Board Chairman Dr. Joseph Jurcic to Present Data From Ongoing Actimab-A Phase I/II Clinical Trial

NEW YORK, NY–(May 20, 2015) – Actinium Pharmaceuticals, Inc. (NYSE MKT: ATNM) (“Actinium” or “the Company”), a biopharmaceutical Company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers, announced the upcoming poster and abstract at ASCO 2015, the 51st Annual Meeting of American Society of Clinical Oncology, to be held in Chicago on May 29 – June 2. Data will be presented from the Company’s ongoing multi-center Phase 1/2 Study for Actimab-A for the treatment of newly diagnosed Acute Myeloid Leukemia (AML) in elderly patients.

Clinical data from the first three cohorts will be discussed. Cohort 3, which included 3 additional patients, demonstrated no dose limiting toxicities in patients older than 60 and up to 87 years of age who were not eligible for currently approved therapies. Two out of three Actimab-A treated patients achieved complete remission with different degrees of hematological recovery (CRi). These responses were documented in the settings of high pre-treatment leukemia burdens of up to 88% in the bone marrow. In the previous cohort treated at a lower dose level of Actimab-A, one patient achieved CRi. The Company also recently announced that it began the fourth and last cohort (2.0 μCi/kg per dose) in the Phase I portion of this trial.

Title: Phase I trial of α-particle therapy with actinium-225 (225Ac)-lintuzumab (anti-CD33) and low-dose cytarabine (LDAC) in older patients with untreated acute myeloid leukemia (AML).
Lead Author: Dr. Joseph G. Jurcic, Columbia University Medical Center
Date/Time: Sunday May 31, 2015, 8:00 AM – 11:30 AM
Location: McCormick Place, Chicago, Illinois
Other: Poster Board #39 in S Hall A; Abstract #7050

Dr. Jurcic is Director of the Hematologic Malignancies Section of the Hematology/Oncology Division and Professor of Clinical Medicine at Columbia University Medical Center. He is a hematologist/oncologist focusing on the treatment of acute and chronic leukemias, myeloproliferative neoplasms, and myelodysplastic syndrome. His research interests include acute myeloid leukemia, radioimmunotherapy with alpha and beta particle-emitting radioisotopes, monoclonal antibody therapy for leukemia, development of novel small molecule inhibitors for leukemia and molecular monitoring of minimal residual disease. He is the primary investigator for the current Actimab-A clinical trial and Clinical Advisory Board Chairman. He received his medical degree from the University of Pennsylvania and completed his fellowship in Hematology-Oncology at Memorial Sloan-Kettering Cancer Center.

“The positive results on both safety and anti-leukemic effect demonstrated in the completed third cohort represents a significant achievement for the Actimab-A program, and support the advancement to a higher dose with the potential to further enhance the already strong results we have seen to date,” stated Dragan Cicic, MD, Chief Medical Officer of Actinium. “We believe the responses observed for Actimab-A, with minimal toxicity being reported, are impressive in this disease setting. These findings build upon those presented and published over the past year which demonstrated a clear survival benefit in secondary AML patients. We remain steadfast in our belief that Actimab-A could play an important role in the treatment regimen for newly diagnosed elderly AML patients who currently have limited treatment options.”

About Actimab-A

Actimab-A is a radiolabeled antibody being developed for newly diagnosed AML in patients over 60, and is currently in a multicenter Phase 1/2 clinical trial. Based on Actinium’s alpha-particle immunotherapy (APIT) platform, Actimab-A consists of the CD33 antibody lintuzumab linked to the actinium-225 payload. Actimab-A has attracted support from leading experts at the prestigious and high-volume cancer treatment hospitals due to the potential of its safety and efficacy profile, as well as its potential potency, specificity and ease of use. Clinical trials are being conducted at world-class cancer institutions such as Memorial Sloan Kettering Cancer Center, MD Anderson Cancer Center, Johns Hopkins Medicine, Columbia University Medical Center, University of Pennsylvania Health System, Fred Hutchinson Cancer Research Center, and the Texas Oncology-Baylor Charles A. Sammons Cancer Center. Actimab candidates are in early development for other cancers.

About Iomab-B

Iomab-B™ is being developed to prepare patients for hematopoietic stem cell transplantation (HSCT) and will enter a single, pivotal Phase 3 clinical study in relapsed/refractory AML. Iomab-B is a radioimmunoconjugate consisting of BC8, a novel murine monoclonal antibody, and iodine-131 radioisotope. BC8 has been developed by Fred Hutchinson Cancer Research Center to target CD45, a pan-leukocytic antigen widely expressed on white blood cells. This antigen makes BC8 potentially useful in targeting white blood cells in preparation for hematopoietic stem cell transplantation in a number of blood cancer indications, including acute myeloid leukemia (AML), chronic myeloid leukemia (CML), acute lymphoblastic leukemia (ALL), chronic lymphocytic leukemia (CLL), Hodgkin’s disease (HD), Non-Hodgkin lymphomas (NHL) and multiple myeloma (MM).

About Actinium Pharmaceuticals

Actinium Pharmaceuticals, Inc. (www.actiniumpharma.com) is a New York-based biopharmaceutical company developing innovative targeted payload immunotherapeutics for the treatment of advanced cancers. Actinium’s targeted radiotherapy products are based on its proprietary delivery platform for the therapeutic utilization of alpha-emitting actinium-225 and bismuth-213 and certain beta emitting radiopharmaceuticals in conjunction with monoclonal antibodies. The Company’s lead radiopharmaceutical product candidate Iomab-B is designed to be used, upon approval, in preparing patients for hematopoietic stem cell transplant, commonly referred to as bone marrow transplant. The Company plans to conduct a single, pivotal, multicenter Phase 3 clinical study of Iomab-B in refractory and relapsed AML patients over the age of 55 with a primary endpoint of durable complete remission. The Company’s second product candidate, Actimab-A, is continuing its clinical development in a Phase 1/2 trial for newly diagnosed AML patients over the age of 60 in a single-arm multicenter trial.

Forward-Looking Statement for Actinium Pharmaceuticals, Inc.

This news release contains “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. These statements are based on management’s current expectations and involve risks and uncertainties, which may cause actual results to differ materially from those set forth in the statements. The forward-looking statements may include statements regarding product development, product potential, or financial performance. No forward-looking statement can be guaranteed and actual results may differ materially from those projected. Actinium Pharmaceuticals undertakes no obligation to publicly update any forward-looking statement, whether as a result of new information, future events, or otherwise.

Contact:
David Gould, MD
SVP, Finance and Corporate Development
Actinium Pharmaceuticals, Inc.
dgould@actiniumpharma.com

Wednesday, May 20th, 2015 Uncategorized Comments Off on (ATNM) linical Update on Actimab-A at Upcoming 2015 ASCO Annual Meeting

(AVEO) Final Results of Extension Study 902, FDA Feedback On Tivozanib In Kidney Cancer

AVEO Oncology (NASDAQ:AVEO) announced today that final results from the TIVO-1 extension study, known as Study 902, in which patients with advanced renal cell carcinoma (RCC) received tivozanib as second-line treatment subsequent to disease progression on sorafenib in the Company’s Phase 3 TIVO-1 first-line RCC study, will be presented at the 2015 American Society of Clinical Oncology (ASCO) Annual Meeting. The Company previously reported interim median progression free survival (PFS) results of 8.4 months among the 163 patients enrolled in Study 902. Final results now show a median PFS in this setting of 11.0 months and median overall survival (OS) of 21.6 months, demonstrating the efficacy of tivozanib in a VEGF treatment refractory population.

AVEO also announced today that it has received a written response from the U.S. Food and Drug Administration (FDA) stating that a phase 3 study outlined by the Company, in patients with RCC who have failed at least two prior regimens, including VEGF therapy, “may support AVEO’s proposed indication for tivozanib in the 3rd line setting.” In response to whether the study, together with the TIVO-1 study, would be sufficient to support licensure of tivozanib as a treatment for advanced RCC, the FDA indicated: “whether the results from this [third line] study can support AVEO’s proposal for tivozanib in the first line setting is a review issue.”

The study design shared with the FDA is a randomized, controlled, multi-center, open-label Phase 3 study of approximately 314 subjects randomized 1:1 to receive either tivozanib or sorafenib. Subjects enrolled in the study may include those who have received prior immunotherapy, including immune checkpoint (PD-1) inhibitors, reflecting a potentially evolving treatment landscape. The primary objective of the study would be PFS. Secondary objectives would include OS and objective response rate (ORR) as well as safety and pharmacokinetic endpoints.

“Based on TIVO-1, where tivozanib led to a longer progression free survival than sorafenib in the first line, combined with the activity tivozanib demonstrated in patients who have progressed on a VEGF therapy, we are optimistic about the probability of a successful clinical outcome in a third line RCC study,” said Michael Bailey, president and chief executive officer of AVEO. “We are also encouraged by the FDA’s willingness to consider whether a refractory study can serve as a confirmatory study for TIVO-1 in first line RCC. Prior to committing to a new study, we will continue to evaluate all options, including partnerships, for the clinical and regulatory advancement for tivozanib in RCC as well as colorectal cancer.”

ASCO Presentation Details

Efficacy results from Study 902 and final results from the TIVO-1 trial will be presented at the 2015 ASCO Annual Meeting being held May 29 – June 2, at McCormick Place in Chicago, Illinois. Details of the presentation are as follows:

Date & Time: Monday June 1, 1:15 PM to 4:45 PM

Poster Title: Tivozanib vs sorafenib targeted therapy for advanced renal cell carcinoma: Final results of a phase III trial (901) and efficacy results of a 2nd line tivozanib extension study (902)

Abstract Number: 4557

Poster Board: #231

Session: Genitourinary (Nonprostate) Cancer

Location: S Hall A

The full abstract can be viewed here.

About AVEO

AVEO Oncology (AVEO) is a biopharmaceutical company committed to developing targeted therapies through biomarker-driven insights to provide improvements in patient outcomes where significant unmet medical needs exist. AVEO’s proprietary Human Response Platform™ has delivered unique insights into cancer and related disease biology that AVEO is seeking to leverage in the clinical development strategy of its therapeutic candidates. For more information, please visit the Company’s website at www.aveooncology.com.

Cautionary Note Regarding Forward-Looking Statements

This press release contains forward-looking statements of AVEO within the meaning of The Private Securities Litigation Reform Act of 1995 that involve substantial risks and uncertainties. All statements, other than statements of historical facts, contained in this press release are forward-looking statements. The words “anticipate,” “expect,” “intend,” “may,” “plan,” “could,” “should,” “seek,” or the negative of these terms or other similar expressions, are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. These forward-looking statements include, among others, statements about: the probability of licensure for tivozanib by the FDA as a treatment for advanced RCC; the probability of successful outcomes for a study in third line RCC; and the Company’s plans to continue to assess its options for the regulatory and clinical advancement of tivozanib in renal cell cancer and colorectal cancer. Actual results or events could differ materially from the plans, intentions and expectations disclosed in the forward-looking statements that AVEO makes due to a number of important factors, including risks relating to: AVEO’s ability to successfully implement its restructuring and strategic plans; AVEO’s ability to successfully enroll and complete clinical trials of its product candidates; AVEO’s ability to demonstrate to the satisfaction of the FDA, EMA or other equivalent foreign regulatory agencies, the safety, efficacy and clinically meaningful benefit of its product candidates; AVEO’s ability to achieve and maintain compliance with all regulatory requirements applicable to its product candidates; AVEO’s ability to obtain and maintain adequate protection for intellectual property rights relating to its product candidates and technologies; developments and expenses related to AVEO’s ongoing shareholder litigation and SEC inquiry; AVEO’s ability to raise the substantial additional funds required to achieve its goals; unplanned capital requirements; adverse general economic and industry conditions; competitive factors; and those risks discussed in the section titled “Risk Factors” included in AVEO’s most recent Annual Report on Form 10-K, its quarterly reports on Form 10-Q and in its other filings with the SEC. The forward-looking statements in this press release represent AVEO’s views as of the date of this press release. AVEO anticipates that subsequent events and developments will cause its views to change. However, while AVEO may elect to update these forward-looking statements at some point in the future, it specifically disclaims any obligation to do so. You should, therefore, not rely on these forward-looking statements as representing AVEO’s views as of any date subsequent to the date of this press release.

Company, Media and Investors:
Argot Partners
David Pitts, 212-600-1902
aveo@argotpartners.com

Wednesday, May 20th, 2015 Uncategorized Comments Off on (AVEO) Final Results of Extension Study 902, FDA Feedback On Tivozanib In Kidney Cancer

(ISR) Cesium-131 Lung Cancer Treatment Reports 96% Success

Cesium-131’s Outstanding Lung Cancer Results Take on Other Treatment Forms Including Stereotactic Radiation

RICHLAND, WA–(May 20, 2015) – IsoRay, Inc. (NYSE MKT: ISR), a medical technology company and innovator in seed brachytherapy and medical radioisotope applications, today announced the on-line publication of the first major peer reviewed study showing improved results using IsoRay’s Cesium-131 seeds in the treatment of lung cancer.

IsoRay CEO Dwight Babcock commented, “We are extremely excited to have our Cesium-131 isotope seeds and mesh used in the treatment of non-small cell lung cancers with such outstanding patient outcomes. Notable physicians, including the authors of this study, are seeking better solutions and outcomes for their patients. We are continuing to develop our product offerings internally with support from these industry leaders. With every success that has been reported, the medical community is rapidly becoming aware of the innovative alternative our Cesium-131 products offer to cancer patients.”

Dr. Bhupesh Parashar MD, of Weill Cornel Medical College, is lead author of the publication titled: ‘Analysis of Stereotactic Radiation vs. Wedge Resection vs Wedge Resection Plus Cesium-131 Brachytherapy in Early-stage Lung Cancer’. The study noted that the survival rate at 5 years was exceptional for the Cesium-131 group, which included many high risk patients, and Cesium-131 added no noticeable side effects. Treatment with Cesium-131 was performed at the time of the surgery as a single treatment, in contrast to another treatment option, external radiation, which requires numerous hospital visits. To review the report as published online as of May 19, 2015, please follow the link provided here: http://www.sciencedirect.com/science/article/pii/S1538472115004559

Babcock said, “Published studies are the final step to commercialization as leaders in the medical arena recognize the important need for a new powerful weapon in the battle against cancer. This latest publication, in conjunction with other recent published reports on metastatic brain cancer and gynecological cancers, are proving Cesium-131’s time is now. Not only does Cesium-131 work but it is a single application providing improved quality of life for the patient.”

IsoRay’s various products, including Cesium-131 seeds, sutured seeds, stranded mesh and the GliaSite® radiation therapy system, give physicians the ability to directly place a specified dosage of radiation in areas where cancer is most likely to remain after completion of a tumor removal or by placing seeds within the prostate. The ability to precisely place a specified dose of radiation means there is less likelihood for damage to occur to healthy surrounding tissue compared to other alternative treatments. IsoRay’s cancer fighting products diminish the ability of the tumor to recur, resulting in important benefits for patients in longevity as well as quality of life.

IsoRay is the exclusive manufacturer of Cesium-131. The pioneering brachytherapy therapy is one of the most significant advances in internal radiation therapy in 20 years. Cesium-131 allows for the precise treatment of many different cancers because of its unrivaled blend of high energy and its 9.7 day half-life (its unequaled speed in giving off therapeutic radiation).

In addition to its CMS codes, Cesium-131 is FDA-cleared and holds a CE mark for international sales in seed form for the treatment of brain cancer, prostate cancer, lung cancer, ocular melanoma cancer, colorectal cancer, gynecologic cancer, head and neck cancer and other cancers throughout the body. The treatment can be deployed using several delivery methods including single seed applicators, implantable strands and seed sutured mesh. IsoRay also sells several new implantable devices, including the GliaSite® radiation therapy system.

About IsoRay
IsoRay, Inc., through its subsidiary, IsoRay Medical, Inc. is the sole producer of Cesium-131 brachytherapy seeds, which are expanding brachytherapy options throughout the body. Learn more about this innovative Richland, Washington company and explore the many benefits and uses of GliaSite® and Cesium-131 by visiting www.isoray.com. Join us on Facebook/Isoray. Follow us on Twitter @Isoray.

Safe Harbor Statement
Statements in this news release about IsoRay’s future expectations, including: the advantages of our products and their delivery systems, whether IsoRay will be able to continue to expand its base beyond prostate cancer, whether sales of our products will continue at historic levels or increase, whether the use of our products will increase or continue, whether we will continue to receive support from industry leaders, whether awareness of our products in the medical community will continue or increase, timing of commercialization of our products, and all other statements in this release, other than historical facts, are “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995 (“PSLRA”). This statement is included for the express purpose of availing IsoRay, Inc. of the protections of the safe harbor provisions of the PSLRA. It is important to note that actual results and ultimate corporate actions could differ materially from those in such forward-looking statements based on such factors as physician acceptance, training and use of our products, our ability to successfully manufacture, market and sell our products, our ability to manufacture our products in sufficient quantities to meet demand within required delivery time periods while meeting our quality control standards, our ability to enforce our intellectual property rights, whether additional studies are released and support the conclusions of past studies, patient results achieved with our products, successful completion of future research and development activities, our ability and the ability of our distributors and customers to receive and maintain all required regulatory approvals in the U.S. and internationally, continued compliance with ISO standards as audited by BSI, the success of our sales and marketing efforts, changes in reimbursement rates, changes in laws and regulations applicable to our products, and other risks detailed from time to time in IsoRay’s reports filed with the SEC. The Company undertakes no obligation to publicly update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
IsoRay Medical
Info@Isoray.com
(509) 375-1202
Or
Worldwide Financial
Info@wwfinancial.com
(954) 360-9998

Wednesday, May 20th, 2015 Uncategorized Comments Off on (ISR) Cesium-131 Lung Cancer Treatment Reports 96% Success

(NETE) Presenting at New York Investor Conferences Thursday, May 28th

MIAMI, FL–(May 20, 2015) – Net Element, Inc. (NASDAQ: NETE) (the “Company”) today announced its CEO Oleg Firer and CFO Jonathan New will be presenting at the following investor conferences on May 28th.

2015 Marcum MicroCap Conference
Date: May 28, 2015
Time: 11:00am Eastern Time
Location: Grand Hyatt, 109 E 42nd St, New York, NY

SeeThru Equity 4th Annual Microcap Investor Conference
Date: May 28, 2015
Time: 2:00pm Eastern Time
Location: Convene Grand Central, 101 Park Ave, New York, NY

In the presentations Mr. Firer and Mr. New will describe and update Net Element’s global payments business and will be available for questions and answers.

To arrange one-on-one meetings with management during the conferences, please contact Melissa Rios at 305-507-8808 ext. 333 or mrios@netelement.com.

About Net Element
Net Element (NASDAQ: NETE) is a global payments-as-a-service, technology provider with an integrated mobile and transactional services platform. Its wholly owned subsidiary, TOT Group operates Aptito providing transaction processing and value-added services utilizing a next generation, cloud-based, point of sale payments platform. The Company also operates TOT Money, a leading mobile payments service provider that has been ranked in the Top 3 mobile payments providers by Beeline, Russia’s second largest telecommunications operator. Further information is available at www.netelement.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. Any statements contained in this press release that are not statements of historical fact may be deemed forward-looking statements. Words such as “continue,” “will,” “may,” “could,” “should,” “expect,” “expected,” “plans,” “intend,” “anticipate,” “believe,” “estimate,” “predict,” “potential,” and similar expressions are intended to identify such forward-looking statements. These forward-looking statements include, without limitation, whether Net Element can secure any additional financing and if such additional financing will be adequate to meet the Company’s objectives. All forward-looking statements involve significant risks and uncertainties that could cause actual results to differ materially from those expressed or implied in the forward-looking statements, many of which are generally outside the control of Net Element and are difficult to predict. Examples of such risks and uncertainties include, but are not limited to: (i) Net Element’s ability (or inability) to obtain additional financing in sufficient amounts or on acceptable terms when needed; (ii) Net Element’s ability to maintain existing, and secure additional, contracts with users of its payment processing services; (iii) Net Element’s ability to successfully expand in existing markets and enter new markets; (iv) Net Element’s ability to successfully manage and integrate any acquisitions of businesses, solutions or technologies; (v) unanticipated operating costs, transaction costs and actual or contingent liabilities; (vi) the ability to attract and retain qualified employees and key personnel; (vii) adverse effects of increased competition on Net Element’s business; (viii) changes in government licensing and regulation that may adversely affect Net Element’s business; (ix) the risk that changes in consumer behavior could adversely affect Net Element’s business; (x) Net Element’s ability to protect its intellectual property; (xi) local, industry and general business and economic conditions; (xii) adverse effects of potentially deteriorating U.S.-Russia relations, including, without limitation, over a conflict related to Ukraine, including a risk of further U.S. government sanctions or other legal restrictions on U.S. businesses doing business in Russia. Additional factors that could cause actual results to differ materially from those expressed or implied in the forward-looking statements can be found in the most recent annual report on Form 10-K and the subsequently filed quarterly reports on Form 10-Q and current reports on Form 8-K filed by Net Element with the Securities and Exchange Commission. Net Element anticipates that subsequent events and developments may cause its plans, intentions and expectations to change. Net Element assumes no obligation, and it specifically disclaims any intention or obligation, to update any forward-looking statements, whether as a result of new information, future events or otherwise, except as expressly required by law.

Media Contact:
Net Element, Inc.
info@netelement.com
(786) 923-0502

Wednesday, May 20th, 2015 Uncategorized Comments Off on (NETE) Presenting at New York Investor Conferences Thursday, May 28th

(BLUE) Global Regulatory Strategy for LentiGlobin BB305 in Beta-Thalassemia Major

bluebird bio, Inc. (Nasdaq: BLUE), a clinical-stage company committed to developing potentially transformative gene therapies for severe genetic and rare diseases and T cell-based immunotherapies, today announced that it has met with regulatory authorities in Europe and the United States to discuss potential approval pathways for its LentiGlobin BB305 product candidate for the treatment of beta-thalassemia major. These discussions have resulted in general agreement from both agencies regarding bluebird bio’s development plans, which could potentially result in accelerated approvals.

“We are very pleased with the outcome of these recent regulatory interactions,” commented David Davidson, M.D., chief medical officer. “We look forward to advancing our beta-thalassemia major program based on data both from our ongoing studies as well as two planned open-label studies with a sample size of 15 patients each. The EMA Adaptive Pathways pilot program will allow us to pursue conditional approval for the treatment of beta-thalassemia major on the basis of clinical data from our ongoing HGB-204 and HGB-205 studies. This feedback brings us closer to achieving our vision of delivering one-time, potentially transformative gene therapy to patients.”

EMA Registration Strategy: Participate in Adaptive Pathways Pilot Program

bluebird bio is one of the first companies to participate in the European Medicines Agency’s (EMA) Adaptive Pathways (formerly referred to as Adaptive Licensing) pilot program, which is part of the EMA’s efforts to improve timely access for patients to new medicines. Based on several discussions involving the EMA, European Health Technology Assessment (HTA) agencies and patient advocacy organizations as part of this program, bluebird bio believes it is possible to seek conditional approval for the treatment of adults and adolescents with beta-thalassemia major on the basis of the totality of clinical data, in particular reduction in transfusion need, from the ongoing Northstar Study and supportive HGB-205 study. Conversion to full approval will be subject to the successful completion of the HGB-207 and HGB-208 clinical trials discussed below, supportive long-term follow-up data and “real-life” post-approval monitoring data.

FDA Registration Strategy: Pursue Accelerated Approval Based on HGB-207 (n=15) and HGB-208 (n=15)

In addition, bluebird bio has reached general agreement with the U.S. Food and Drug Administration (FDA) on the design of its planned clinical trials HGB-207 and HGB-208. Based on its discussions with the FDA, bluebird bio believes that data from these trials, together with data from the ongoing beta-thalassemia major clinical studies (Northstar and HGB-205), could form the basis for a Biologics License Application (BLA) submission for LentiGlobin BB305. HGB-207 and HGB-208 share similar trial designs and are differentiated primarily by patient age. HGB-207 will enroll adult and adolescent patients; HGB-208 will enroll pediatric patients.

bluebird bio has also reached general agreement with the FDA on:

  • Sample size: 15 patients per trial
  • Duration: 24 months of follow-up per patient
  • Primary endpoint: 12 months of transfusion independence

In the United States, if the LentiGlobin BB305 product candidate demonstrates acceptable efficacy and safety in these patient populations, these planned clinical trials could support an accelerated approval, with post-approval confirmatory evidence to be provided with longer-term follow-up of these trials. As a result of this regulatory feedback and as required of all gene therapy clinical trials, bluebird bio has filed both clinical study protocols with the National Institutes of Health (NIH) Recombinant DNA Advisory Committee (RAC). The RAC has notified bluebird bio that HGB-207 does not require an in-depth review or public RAC discussion. The RAC has also notified bluebird bio that the HGB-208 study protocol is scheduled for public review on June 9, 2015.

“We are grateful for the collaborative regulatory feedback from the FDA and EMA on the design of our pivotal studies, as well as feedback from the European HTA agencies and patient advocacy organizations that are participating in our Adaptive Pathways pilot project,” stated Anne-Virginie Eggimann, vice president of regulatory science. “We are looking forward to continuing our engagement with all of these stakeholders in the coming months to support the potential acceleration of the LentiGlobin BB305 program.”

Background on the EMA’s Adaptive Pathways Program

In establishing the Adaptive Pathways program, the EMA stated the following:

“The concept of Adaptive Pathways foresees either an initial approval in a well-defined patient subgroup with a high medical need and subsequent widening of the indication to a larger patient population, or an early regulatory approval (e.g. conditional approval), which is prospectively planned, and where uncertainty is reduced through the collection of post-approval data on the medicine’s use in patients. This approach is particularly relevant for medicines with the potential to treat serious conditions with an unmet medical need and may reduce the time to a medicine’s approval or to its reimbursement for targeted patient groups. It involves balancing the importance of timely patient access with the need for adequate, evolving information on a medicine’s benefits and risks. The Adaptive Pathways approach builds on regulatory processes already in place within the existing European Union legal framework.”

The pilot was initiated in March 2014 and was called “Adaptive Licensing” at the time. EMA changed the name to Adaptive Pathways “to better reflect the idea of a life-span approach to bring new medicines to patients with clinical drug development, licensing, reimbursement, and utilization in clinical practice, and monitoring viewed as a continuum.”

Background on the FDA Process and NIH’s RAC

FDA approval must be obtained before clinical testing of biological products. Each clinical study protocol for a gene therapy product is reviewed by the FDA and the NIH, through its Recombinant DNA Advisory Committee (RAC). Within the FDA, the Center for Biologics Evaluation and Research (CBER) regulates gene therapy products. CBER works with the NIH and its RAC, which makes recommendations to the NIH on gene therapy issues and engages in a public discussion of scientific, safety, ethical and societal issues related to proposed and ongoing gene therapy protocols.

The NIH is responsible for convening the RAC to discuss protocols that raise novel or particularly important scientific, safety or ethical considerations at one of its quarterly public meetings. The Office of Biotechnology Activities (OBA) notifies the FDA of the RAC’s decision regarding the necessity for full public review of a gene therapy protocol. RAC proceedings and reports are posted to the OBA web site and may be accessed by the public.

Investor Conference Call and Webcast Information

bluebird bio will host a conference call and webcast on May 19, 2015 at 8:00 AM ET to review its LentiGlobin regulatory strategy. The event will be webcast live and can be accessed under “Calendar of Events” in the Investors and Media section of the company’s website at www.bluebirdbio.com. Alternatively, investors may listen to the call by dialing (844) 825-4408 from locations in the United States and (315) 625-3227 from outside the United States.

About bluebird bio, Inc.

With its lentiviral-based gene therapy and gene editing capabilities, bluebird bio has built an integrated product platform with broad potential application to severe genetic diseases and T cell-based immunotherapy. bluebird bio’s clinical programs include Lenti-D™, currently in a Phase 2/3 study, called the Starbeam Study, for the treatment of childhood cerebral adrenoleukodystrophy, and LentiGlobin®, currently in three clinical studies: a global Phase 1/2 study, called the Northstar Study, for the treatment of beta-thalassemia major; a single-center Phase 1/2 study in France (HGB-205) for the treatment of beta-thalassemia major or severe sickle cell disease; and a separate U.S. Phase 1 study for the treatment of sickle cell disease (HGB-206). bluebird bio also has a preclinical CAR T immuno-oncology program in collaboration with Celgene Corporation, as well as discovery research programs utilizing megaTALs/homing endonuclease gene editing technologies.

bluebird bio has operations in Cambridge, Massachusetts, Seattle, Washington, and Paris, France. For more information, please visit www.bluebirdbio.com.

Forward-Looking Statements

This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s global regulatory strategy for LentiGlobin BB305, including the expected protocols for planned clinical trials and the timing of these clinical trials, whether these planned clinical trials will be sufficient to support regulatory submissions for marketing approval and the expected timing of any such submissions and decisions. In particular, it should be noted that the FDA normally requires two pivotal clinical studies to approve a drug or biologic product. Whether the planned HGB-207 and HGB-208 trials will be sufficient to support submission of a BLA for LentiGlobin BB305 will likely be a review issue to be discussed with FDA following completion of the trials. In addition, it should be noted that the EMA Adaptive Pathways program is a pilot program, and as such there is limited information and precedent regarding the potential outcomes for sponsors that participate in this program. Any forward-looking statements are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of cessation or delay of any of the ongoing or planned clinical studies and/or our development of our product candidates, the risk of a delay in the enrollment of patients in the Company’s clinical studies, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials and regulatory submissions, the risk that the results of previously conducted studies involving similar product candidates will not be repeated or observed in ongoing or future studies involving current product candidates, the risk that our collaboration with Celgene will not continue or will not be successful, and the risk that any one or more of our product candidates will not be successfully developed and commercialized. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the section entitled “Risk Factors” in our most recent annual report on Form 10-Q, as well as discussions of potential risks, uncertainties, and other important factors in our subsequent filings with the Securities and Exchange Commission. All information in this press release is as of the date of the release, and bluebird bio undertakes no duty to update this information unless required by law.

Availability of other information about bluebird bio

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

Investor Relations:
bluebird bio, Inc.
Jim DeTore, 339-499-9355
Chief Financial Officer
or
Media:
Pure Communications, Inc.
Dan Budwick, 973-271-6085

Tuesday, May 19th, 2015 Uncategorized Comments Off on (BLUE) Global Regulatory Strategy for LentiGlobin BB305 in Beta-Thalassemia Major

(ARDX) Positive Results From Tenapanor Phase 2b Clinical In IBS-C Digestive Disease

FREMONT, Calif., May 19, 2015  — Ardelyx, Inc. (NASDAQ: ARDX), a clinical-stage biopharmaceutical company focused on cardio-renal, gastrointestinal, and metabolic diseases, today presented Phase 2b clinical trial results that demonstrated statistically significant and clinically meaningful improvement in IBS-C symptoms for tenapanor-treated patients compared to patients receiving placebo. As previously reported, at the 50 mg dose of tenapanor, the study met its primary efficacy endpoint of an increase in the complete spontaneous bowel movement (CSBM) responder rate. Most secondary endpoints, including abdominal pain and other abdominal and IBS-C symptoms, demonstrated clinically meaningful improvements. Tenapanor was well-tolerated, and the safety results were consistent with those observed in previous tenapanor trials.

The findings were presented today in an oral presentation entitled, “Efficacy and Safety of Tenapanor in Patients with Constipation Predominant Irritable Bowel Syndrome: A 12-Week, Double-Blind, Placebo-Controlled, Randomized Phase 2b Trial” at the Digestive Disease Week (DDW) 2015 conference being held in Washington, D.C. from May 16-19, 2015.

“IBS-C impacts the quality of life of millions of patients yet is still one of the most enigmatic diseases of the gut,” said William Chey, MD, Professor of Internal Medicine at University of Michigan. “Tenapanor, if successfully developed, would represent an entirely new mechanism of action for the treatment of IBS-C that could give patients important options for their disease.”

“More than 14 million people worldwide are estimated to suffer from IBS-C, many of whom are not effectively treated by current marketed therapies,” said Mike Raab, President & Chief Executive Officer of Ardelyx. “Based on tenapanor’s clinical results through the Phase 2b program, we believe that it has the potential to offer a best-in-class treatment for this underserved population.”

Phase 2b Clinical Trials for Tenapanor in IBS-C

The Phase 2b clinical trial was a randomized, double blind, placebo-controlled, multi-center study to evaluate the safety and efficacy of three dose levels of tenapanor in 356 subjects with IBS-C as defined by the Rome III criteria and who had active disease as determined during a two-week screening period. Subjects who qualified and who were randomized into the study received 5, 20, or 50 mg of tenapanor or placebo twice daily for 12 consecutive weeks. At the end of this treatment period, subjects were followed for an additional 4 weeks. The primary endpoint, overall CSBM responder rate, was achieved in 60.7 percent of patients receiving tenapanor 50 mg twice daily versus 33.7 percent receiving placebo (p < 0.001).  A responder was defined as a patient who had an increase of greater than or equal to one CSBM from baseline during 6 out of 12 weeks.  The results are reported on an intent-to-treat basis.

The overall abdominal pain responder rate was achieved in 65.5 percent of patients receiving tenapanor 50 mg twice daily versus 48.3 percent receiving placebo (p = 0.026).  An overall abdominal pain responder was defined as a patient who experienced at least a 30 percent decrease in abdominal pain from baseline for 6 of 12 weeks.

The overall responder rate, or dual composite endpoint percent, was achieved in 50.0 percent of patients receiving tenapanor 50 mg twice daily versus 23.6 percent receiving placebo (p < 0.001).  An overall responder was defined as a patient who was both an overall CSBM responder and an overall abdominal pain responder in the same week for 6 of 12 weeks.

As shown in the table, other key secondary endpoints that exhibited significant improvements for patients receiving 50 mg tenapanor twice daily compared to placebo-treated patients included abdominal discomfort, abdominal bloating, straining, stool consistency, CSBM per week and SBM per week.

Phase 2b Primary and Key Secondary Endpoints

Endpoint Placebo Tenapanor 50mg twice daily p-value
Primary Endpoint: responder analysis ≥6 of 12 weeks*
≥1 CSBM increase 33.7% 60.7% p<0.001
Secondary Endpoints: responder analysis ≥6 of 12 weeks*
≥30% abdominal pain reduction 48.3% 65.5% p=0.026
≥30% abdominal pain reduction and ≥1 CSBM increase in same week 23.6% 50.0% P<0.001
Secondary Endpoints: LS mean change from baseline to week 12**
Abdominal pain (0-10) -2.3 -3.1 P=0.014
Abdominal discomfort (0-10) -2.0 -3.0 P=0.004
Abdominal bloating (0-10) -1.6 -2.6 P=0.023
Straining (0-5) -0.7 -1.2 P=0.006
Stool consistency BSFS*** 1.0 2.2 P<0.001
CSBM/week 0.9 2.7 P<0.001
SBM/week 1.6 3.4 P=0.006
* P-value uses Cochran-Mantel-Haenszel analysis
** P-Value Uses Analysis of covariance analysis
*** BSFS is the Bristol Stool Form Scale with 1 = hard and 7 = watery

A dose response relationship among all doses was observed in the primary endpoint, as well as in most secondary endpoints, although statistical significance was not achieved at the 5 mg or 20 mg doses.  Additionally, the activity of tenapanor was maintained throughout the entire 12-week treatment period.

Tenapanor was well-tolerated in these patients, and the safety results were consistent with those observed in previous tenapanor trials. The most common adverse events at 50 mg twice daily (greater than or equal to 5 percent) that occurred more frequently in tenapanor-treated patients compared to placebo-treated patients were diarrhea at 11.2 percent vs. 0 percent, and urinary tract infections at 5.6 percent vs. 4.4 percent.  Overall rates of discontinuation due to adverse events were 4.5 percent (3.3 percent due to diarrhea) for the tenapanor-treated patients (50 mg twice daily) and 3.3 percent for the placebo-treated patients.  Based on the analysis of plasma samples tested as part of the study, the minimally systemic nature of tenapanor was confirmed.

The abstract for oral presentation is available in Gastroenterology, Vol. 148, Issue 4, S-191–S-192, 2015.  Please refer to Ardelyx’s website for a copy of the DDW slide presentation at http://ir.ardelyx.com.

Ardelyx formed a partnership with AstraZeneca in October 2012 to develop and commercialize tenapanor.  Under the terms of the agreement, AstraZeneca is obligated to communicate to Ardelyx, on or before June 29, 2015, whether it will continue the development of tenapanor.  Should AstraZeneca decide to pursue the development of only the IBS-C indication, Ardelyx will be entitled to a milestone payment of $10 million. Should AstraZeneca decide to pursue the development of any other indication or multiple indications, Ardelyx will be entitled to receive a $20 million milestone payment. Ardelyx is scheduled for an end of phase 2 meeting with the FDA scheduled in June. If AstraZeneca decides to return the program to Ardelyx, the Company seeks to be in a position to initiate a Phase 3 clinical program for tenapanor in IBS-C in the fourth quarter of 2015.

About Irritable Bowel Syndrome with Constipation (IBS-C)
IBS-C is a gastrointestinal disorder in which abdominal pain or discomfort is associated with constipation, significantly affecting health and quality of life. It is unknown what causes IBS-C. There is no specific test or biomarker for IBS-C and therefore, its presence is diagnosed by symptoms and by eliminating other disorders. IBS-C is very similar to chronic constipation but is clinically distinguished by its significant pain component.

Based on reports in the literature regarding the prevalence of IBS in the U.S. population and the percentage of individuals who have IBS-C as opposed to other forms of IBS, Ardelyx estimates that approximately 1.4 percent of the U.S. population has IBS-C, or about 4.4 million individuals. Of those, approximately 1.0 million patients have been diagnosed with IBS-C. Additionally, there are about 6.6 million IBS-C patients in Europe and about 3.4 million in Japan.

About Ardelyx, Inc.

Ardelyx is a clinical-stage biopharmaceutical company focused on the discovery, development and commercialization of innovative, minimally-systemic, small molecule therapeutics that work exclusively in the gastrointestinal tract to treat cardio-renal, gastrointestinal and metabolic diseases. Ardelyx has developed a proprietary drug discovery and design platform enabling it, in a rapid and cost-efficient manner, to discover and design novel drug candidates. Utilizing this platform, the Company has discovered and designed tenapanor.  Ardelyx formed a partnership with AstraZeneca in October 2012 to develop and commercialize tenapanor.  In addition to tenapanor, Ardelyx has discovered small molecule NaP2b inhibitors for the treatment of hyperphosphatemia in patients on dialysis, a program licensed to Sanofi, and independently is advancing several additional research programs focused in cardio-renal, gastrointestinal and metabolic diseases. Ardelyx is located in Fremont, California. For more information, please visit Ardelyx’s website at www.ardelyx.com

Forward Looking Statements

To the extent that statements contained in this press release are not descriptions of historical facts regarding Ardelyx, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor of the Private Securities Reform Act of 1995, including statements regarding the potential for tenapanor in treating IBS-C patients, the timing of AstraZeneca’s decisions regarding its future plans for tenapanor, the potential receipt and timing of milestone payments from AstraZeneca in connection with any decision by it to continue the development of tenapanor and our future development plans and the timing thereof, if the rights to tenapanor are returned to us.  Such forward-looking statements involve substantial risks and uncertainties that could cause the development of tenapanor, or Ardelyx’s future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements.  Such risks and uncertainties include, among others, the uncertainties inherent in the clinical development process, AstraZeneca’s right under the license agreement to choose which indication or indications for which tenapanor will be developed, and AstraZeneca’s right under the license agreement to terminate the agreement upon written notice to Ardelyx. Ardelyx undertakes no obligation to update or revise any forward-looking statements.  For a further description of the risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to Ardelyx’s business in general, please refer to Ardelyx’s quarterly report filed on Form 10-Q with the Securities and Exchange Commission on May 12, 2015.

Tuesday, May 19th, 2015 Uncategorized Comments Off on (ARDX) Positive Results From Tenapanor Phase 2b Clinical In IBS-C Digestive Disease

(QBAK) Announces the Promotion of Daniel K. Jan to President

Qualstar Corporation (NASDAQ:QBAK), a publicly traded company and manufacturer of data storage solutions and high-efficiency power supplies, announced today that as of May 15, 2015, Daniel K. Jan has been promoted to President of the Company after having served as Executive Vice President since April 2014. Steven N. Bronson stepped down as President and shall remain the Chief Executive Officer of the Company.

“In the past year, Qualstar has demonstrated success in increasing revenue and decreasing expenses while refreshing our product portfolio, creating relevant technologies that are extremely well received by our customers,” said Steven N. Bronson, Chief Executive Officer. “Dan brings years of diverse technology and management experience that has helped Qualstar focus and deliver on our mission. We are committed to growing Qualstar, and Dan’s thought leadership will be critical as we continue to execute our long-term growth plans.”

Prior to joining Qualstar, Dan was most recently President of BDT Products, Inc., the US subsidiary of BDT Media Automation GmbH, one of the world’s largest OEM designers and manufacturers of tape library systems. Dan also spent many years in Silicon Valley working in various management positions in companies ranging from high-performance blade server startups, optical storage designers, to IBM in their storage and peripheral devices groups who were deeply involved in HDD, tape, and RAID subsystem technologies.

About Qualstar Corporation

Qualstar, founded in 1984, is a diversified electronics manufacturer specializing in data storage and power supplies. Qualstar is a leading provider of high-efficiency and high density power supplies marketed under the N2Power™ brand, and of data storage systems marketed under the Qualstar™brand. Our N2Power power supply products provide compact and efficient power conversion for a wide variety of industries and applications including, but not limited to, telecom, networking, broadcast, industrial, lighting, gaming and test equipment. Our Qualstar data storage products are used to provide highly scalable and reliable solutions to store and retrieve very large quantities of electronic data. Qualstar’s products are known throughout the world for high quality and Simply Reliable™designs that provide years of trouble-free service. More information is available at www.qualstar.com or www.n2power.com or by phone at 805-583-7744.

Cautionary Statement Concerning Forward-Looking Statements

Statements used in this press release that relate to future plans, events, financial results, prospects or performance are forward-looking statements as defined under the Private Securities Litigation Reform Act of 1995. These forward-looking statements are based upon the current expectations and beliefs of Qualstar’s management and are subject to certain risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such forward-looking statements. Notwithstanding changes that may occur with respect to matters relating to any forward looking statements, Qualstar does not expect to, and disclaims any obligation to, publicly update any forward-looking statements whether as a result of new information, future events or otherwise. Qualstar, however, reserves the right to update such statements or any portion thereof at any time for any reason. In particular, the following factors, among others, could cause actual or future results to differ materially from those suggested by the forward-looking statements: Qualstar’s ability to successfully execute on its strategic plan and meet its long-term financial goals; Qualstar’s ability to successfully implement and recognize cost savings; Qualstar’s ability to develop and commercialize new products; industry and customer adoption and acceptance of Qualstar’s new products; Qualstar’s ability to increase sales of its products; the rescheduling or cancellation of customer orders; unexpected shortages of critical components; unexpected product design or quality problems; adverse changes in market demand for Qualstar’s products; increased competition and pricing pressure on Qualstar’s products; and the risks related to actions of activist shareholders, including the amount of related costs. For further information on these and other and other cautionary statements, please refer to the risk factors discussed in Qualstar’s filings with the U.S. Securities and Exchange Commission including, but not limited to, Qualstar’s Annual Report on Form 10-K for the fiscal year ended June 30, 2014, the “Management’s Discussion and Analysis of Financial Condition and Results of Operations” sections of such Form 10-K, and any subsequently filed reports. All of Qualstar’s filings are available without charge through the SEC’s website (www.sec.gov) or from Qualstar’s website (www.qualstar.com).

Qualstar Corporation
Steven N. Bronson, 805-416-7004
Chief Executive Officer

Tuesday, May 19th, 2015 Uncategorized Comments Off on (QBAK) Announces the Promotion of Daniel K. Jan to President

(RRGB) Honors Military Guests this Memorial Day Weekend

The Gourmet Burger Authority™ to Offer Free Appetizer, with Purchase, to our Nation’s Heroes and Their Families

GREENWOOD VILLAGE, Colo., May 19, 2015 — In celebration of Memorial Day, Red Robin Gourmet Burgers, Inc. is proud to offer all veterans, retired, active duty and military spouses, who are also Red Robin Royalty members, a FREE appetizer with any purchase of at least $10 between Saturday, May 23 and Monday, May 25, at participating Red Robin restaurants nationwide. Red Robin’s support for its military guests also extends beyond Memorial Day Weekend with special surprise and delight offers throughout the year in its Red Robin Royalty rewards program.

“Red Robin is committed to honoring the courageous men and women who serve our country,” said Lee Dolan, Red Robin’s chief marketing officer. “This Memorial Day offer is a small token of our appreciation for their bravery and service. We look forward to seeing all of our distinguished military guests and having a chance to serve them this Memorial Day weekend.”

Select appetizers included in Red Robin’s Memorial Day Weekend promotion for qualifying military guests include Baja Dip ‘n’ Chips, The O-Ring Shorty, Pretzel Bites, Guac, Salsa & Chips, Classic Mini Wedge Salad, half order of Bar Wings ‘n’ Yukon Chips and a half order of Red’s Bold Boneless Wings. Appetizer availability may vary by restaurant location.

Military is ‘Royalty’ at Red Robin
As part of its year-round commitment to giving back to those who serve their country, Red Robin offers additional rewards through its Red Robin Royalty national military program. By signing up for the program, veteran, retired, active duty and military spouses can take advantage of exclusive offers redeemable at Red Robin restaurants.

For more information on Red Robin or to find the nearest restaurant, visit www.redrobin.com. To become eligible to receive additional benefits from Red Robin throughout the year, visit royalty.redrobin.com.

About Red Robin Gourmet Burgers, Inc. (NASDAQ: RRGB)
Red Robin Gourmet Burgers, Inc. (www.redrobin.com), a casual dining restaurant chain founded in 1969 that operates through its wholly-owned subsidiary, Red Robin International, Inc., is the Gourmet Burger Authority, famous for serving more than two dozen craveable, high-quality burgers with Bottomless Steak Fries® in a fun environment welcoming to guests of all ages.  In addition to its many burger offerings, Red Robin serves a wide variety of salads, soups, appetizers, entrees, desserts and signature Mad Mixology® Beverages. Red Robin offers a variety of options behind the bar, including its extensive selection of local and regional beers, and innovative adult beer shakes and cocktails, earning the restaurant the 2014 VIBE Vista Award for Best Beer Program in a Multi-Unit Chain Restaurant. There are more than 500 Red Robin restaurants across the United States and Canada, including Red Robin Burger Works® locations and those operating under franchise agreements. Red Robin… YUMMM®! Connect with Red Robin on Facebook and Twitter.

Tuesday, May 19th, 2015 Uncategorized Comments Off on (RRGB) Honors Military Guests this Memorial Day Weekend

(SRPT) To Submit Rolling NDA for Eteplirsen After Today’s Pre-NDA Meeting w/ FDA

Sarepta Therapeutics, Inc. (NASDAQ: SRPT), a developer of innovative RNA-targeted therapeutics, today announced that the Company held a pre-New Drug Application (NDA) meeting with the U.S. Food and Drug Administration (FDA) regarding its lead product candidate, eteplirsen, for the treatment of Duchenne muscular dystrophy (DMD). Sarepta has agreed with the Agency to initiate a rolling NDA submission and will submit the non-clinical and CMC components of the NDA by the end of this week. As previously announced, Sarepta plans to submit the final component of the NDA by mid-year 2015.

“We will initiate a rolling NDA submission to facilitate the regulatory review of the NDA,” said Edward Kaye, M.D., Sarepta’s interim chief executive officer and chief medical officer. “The initiation of our NDA submission for eteplirsen marks a significant milestone for the Duchenne community and we look forward to completing the submission by the middle of the year and to continuing to work with the Agency towards the goal of providing treatments to patients as quickly as possible.”

About Sarepta Therapeutics
Sarepta Therapeutics is a biopharmaceutical company focused on the discovery and development of unique RNA-targeted therapeutics for the treatment of rare, infectious and other diseases. The Company is primarily focused on rapidly advancing the development of its potentially disease-modifying DMD drug candidates, including its lead DMD product candidate, eteplirsen, designed to skip exon 51. Sarepta is also developing therapeutics for the treatment of drug-resistant bacteria and infectious, rare and other human diseases. For more information, please visit us at www.sarepta.com.

Forward-Looking Statements
This press release contains statements that are forward looking. Any statements contained in this press release that are not statements of historical fact may be deemed to be forward-looking statements. Words such as “believes,” “anticipates,” “plans,” “expects,” “will,” “may,” “intends,” “prepares,” “looks,” “potential,” “possible” and similar expressions are intended to identify forward-looking statements. These forward-looking statements include statements relating to Sarepta’s plans to initiate a rolling NDA for eteplirsen, facilitate the regulatory review process, submit the non-clinical and CMC components of the NDA by end of this week, complete the final component of the NDA by mid-year 2015 and the Company’s plans to continue working with the Agency towards the goal of providing treatments to patients as quickly as possible.

These forward-looking statements involve risks and uncertainties, many of which are beyond Sarepta’s control. Actual results could materially differ from those stated or implied by these forward-looking statements as a result of such risks and uncertainties. Known risk factors include the following: we may be delayed in or may not be able to complete our planned NDA submission for eteplirsen; even if we complete our eteplirsen NDA submission we may not be able to comply with all FDA requests in a timely manner or at all and the FDA may determine that the submission does not qualify for filing or approval; the additional information and data we collect or have collected for the eteplirsen NDA submission may not be consistent with prior data or results or may not support an eteplirsen NDA filing or approval; there may be delays in our projected timelines and our expectations may not be accurate with respect to a potential commercialization of eteplirsen for various reasons, including possible limitations of Company resources and regulatory or agency decisions, scale-up of manufacturing may not be successful, we may lack the funding necessary to commercialize eteplirsen or any of our product candidates, the results of the additional eteplirsen trials the Company conducts may not support an NDA filing or approval for eteplirsen and those risks identified under the heading “Risk Factors” in Sarepta’s most recent Annual and Quarterly Reports on Forms 10-K and 10-Q, respectively, filed with the Securities and Exchange Commission (SEC) as well as other SEC filings made by Sarepta, which you are encouraged to review.

Any of the foregoing risks could materially and adversely affect the Company’s business, results of operations and the trading price of Sarepta’s common stock. You should not place undue reliance on forward-looking statements. Sarepta does not undertake any obligation to publicly update its forward-looking statements based on events or circumstances after the date hereof, except to the extent required by applicable law or SEC rules.

Internet Posting of Information
We routinely post information that may be important to investors in the ‘For Investors’ section of our web site at www.sarepta.com. We encourage investors and potential investors to consult our website regularly for important information about us.

Media and Investors:
Sarepta Therapeutics, Inc.
Ian Estepan, 617-274-4052
iestepan@sarepta.com
or
W2O Group
Ryan Flinn, 415-946-1059
Mobile: 510-207-7616
rflinn@w2ogroup.com

Tuesday, May 19th, 2015 Uncategorized Comments Off on (SRPT) To Submit Rolling NDA for Eteplirsen After Today’s Pre-NDA Meeting w/ FDA

(PBMD) CVac Shows Clear Overall Survival Benefit In Ovarian Cancer Study

SYDNEY, AUSTRALIA–(May 19, 2015) – Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD)

  • Final Data from the CAN-003 Phase II trial after 5 years of data collection
  • Final Overall Survival data provided at least 16 months benefit for second remission ovarian cancer patients (“second remission patients”) using CVac
  • Follows Progression Free Survival data showing 8 month benefit for second remission patients 

Prima BioMed Ltd (ASX: PRR) (NASDAQ: PBMD) (“Prima” or the “Company”) is pleased to announce that the final CVac data from the Phase II CAN-003 ovarian cancer clinical trial has shown a trend for a clinically meaningful improvement in Overall Survival (“OS”) over standard of care (“SOC”) in second remission patients.

In the group of second remission patients (n=20), the median for standard of care (“SOC”) patients was 25.53 months, which is consistent with current literature. By comparison, for patients treated with CVac a median has still not yet been reached after 42 months with study completion and closure. This suggests a striking improvement with a hazard ratio1 = 0.17 (95%CI: 0.02, 1.44; p=0.07). This implies at least a 16 months median survival advantage for second remission patients when treated with CVac.

Lucy Turnbull, Chairman of Prima BioMed, commented: “This final clinical data for CVac is most encouraging for cancer patients in second remission. We sincerely thank all patients and medical staff who have participated in the trial over the last five years. Our concerted focus will now be to find a development partner to make CVac widely available to cancer sufferers around the world.”

This data is consistent with the statistically significant Progression Free Survival (“PFS”) data for second remission patients from CAN-003 announced in May 2014 with a median PFS for CVac of greater than 12.91 months, compared to a median PFS of 4.94 months for the control group (hazard ratio=0.32; p=0.04). This implies an eight month median PFS advantage for second remission patients treated with CVac.

For first remission patients, the final CAN-003 data suggests a positive trend in favour of CVac patients with no median reached in either the CVac or SOC group (current hazard ratio= 0.65 (95%CI: 0.17, 2.42); p=0.52).

Marc Voigt, Prima’s Chief Executive Officer, said: “The CAN-003 data has shown a consistent and sustained trend for improvement over the years in Progression Free Survival and also Overall Survival. The positive effect of cellular therapies and the high quality of life of treated patients support the potential for further developing CVac under license through an industry partner.”

About the CAN-003 clinical trial

CAN-0032 is a 63-patient phase 2 study evaluating the effects of CVac, as compared to an observational standard of care arm (SOC), in epithelial ovarian cancer patients in complete remission after first or second line treatment. In accordance with the protocol design, the first seven patients on the trial were all assigned to receive CVac in order to test the comparability of product manufacturing in a new facility.

The subsequent 56 patients were randomized 1:1 to either the CVac group or observational standard of care (SOC) and included in the intent-to-treat analysis. 36 patients were in first remission (19 patients were assigned to CVac and 17 to SOC) and 20 patients were in second remission (10 patients were each assigned to CVac or SOC). Final PFS data was analysed after thorough quality control reviews of investigator-evaluated progression and appropriate censoring of data from patients who had not progressed during the study.

The primary objectives of the trial were to determine the safety of CVac administration and to determine CVac’s effect on progression-free survival. Secondary objectives of the trial were to determine CVac’s effect on overall survival and to evaluate host immunologic responses to CVac.

1 The ratio of survival in one group as compared with survival in another. A hazard ratio of 0.17 means that the risk of death at a specific timepoint is reduced by 83% for patients receiving CVac compared to those receiving SOC.

2 See NCT01068509 at www.clinicaltrials.gov.

About CVac

CVac, an autologous cancer vaccine in which a patient’s dendritic cells are primed ex vivo with a mannan+MUC1 fusion protein, was Prima BioMed’s original lead product between 2001 and 2015. Prima BioMed announced in February 2015 that it had ceased recruiting into outstanding CVac clinical trials. The company is currently seeking partnership arrangements for further development.

About Prima BioMed

Prima BioMed is a globally active biotechnology company that is striving to become a leader in the development of immunotherapeutic products for the treatment of cancer. Prima BioMed is dedicated to leveraging its technology and expertise to bring innovative treatment options to market for patients and to maximize value to shareholders.

Prima’s pipeline of products includes IMP321 based on the LAG-3 immune control mechanism which plays a vital role in the regulation of the T cell immune response. IMP321 is its most clinically advanced product, a T cell immunostimulatory factor (APC activator) for cancer chemoimmunotherapy which has completed early Phase II trials. A number of additional LAG-3 products including antibodies for immune response modulation in autoimmunity and cancer are being developed by large pharmaceutical partners.

Prima BioMed is listed on the Australian stock exchange, on the NASDAQ in the US. For further information please visit www.primabiomed.com.au

For further information please contact:

Prima BioMed Ltd:
Stuart Roberts
+61 (0) 447 247 909
Email Contact

USA Investor/Media:
Adam Holdsworth
PCG Advisory
+1 (646) 862 4607
Email Contact

Australia Investor/Media:
Matthew Gregorowski
Citadel Communications
+61 (0) 422 534 755
Email Contact

Europe Investor/Media:
Axel Muhlhaus
edicto GmbH
+49 (0) 69 905505-52
Email Contact

Tuesday, May 19th, 2015 Uncategorized Comments Off on (PBMD) CVac Shows Clear Overall Survival Benefit In Ovarian Cancer Study

(IDRA) Development Update on IMO-9200, an Antagonist of Toll-like Receptors

Company Completed Phase 1 Trial in Healthy Subjects Which Demonstrated IMO-9200 Safe and Well-tolerated Across All Dose Regimens

Pre-Clinical Data Supporting IMO-9200 as an Oral Therapeutic Option to Treat Inflammatory Bowel Disease Presented at 2015 Digestive Disease Week Conference

CAMBRIDGE, Mass. and EXTON, Pa., May 18, 2015  — Idera Pharmaceuticals, Inc. (Nasdaq:IDRA), a clinical-stage biopharmaceutical company developing toll-like receptor and RNA therapeutics for patients with cancer and rare diseases, today announced the achievement of key development milestones for its product candidate IMO-9200, an antagonist of Toll-like receptors (TLRs) 7, 8 and 9. Specifically, the company today reported top-line data from a Phase 1 clinical trial of IMO-9200 in healthy subjects and announced the presentation of new preclinical data for IMO-9200 in models of inflammatory bowel disease (IBD) at the 2015 Digestive Disease Week Conference (DDW) in Washington, DC.

In the placebo-controlled Phase 1 clinical trial in 30 healthy subjects, IMO-9200 was administered by subcutaneous injection at escalating single-dose levels of 0.1, 0.3, and 0.5 mg/kg. In the multiple dose cohort, a dose of 0.5 mg/kg/week for four weeks was also evaluated. All dose regimens were well tolerated, with no serious adverse events related to IMO-9200 treatment reported. There were no patterns of laboratory or other safety parameters suggestive of any related adverse treatment effect.

Additionally, new preclinical data for IMO-9200 were presented on Saturday, May 16 at the 2015 Digestive Disease Week Conference (DDW). The poster presentation, entitled “Targeting Innate Immune Receptors to Treat Inflammatory Bowel Disease: Activity of Oral IMO-9200, an Antagonist of TLRs 7, 8, and 9 in Mouse Models of Colitis,” (Abstract #Sa1757) provided results from two mouse models of colitis. These results demonstrated the potential of orally dosed IMO-9200 as a treatment for inflammatory bowel disease (IBD), which includes Crohn’s disease (CD) and ulcerative colitis (UC). Crohn’s disease and UC are severe and debilitating autoimmune disorders characterized by chronic inflammation in the gastrointestinal tract. A copy of the poster can be found on Idera’s corporate website: http://www.iderapharma.com/our-science/key-presentations-and-publications.

Presented data showed orally-delivered IMO-9200 treatment improved body weight and survival, with corresponding improvements in colon weight, length and histology, in a TNBS-induced Crohn’s disease model. In addition, data showed that IMO-9200 treatment improved pro-inflammatory cytokine gene expression and levels in the colon and serum, and restored the TGF-β/SMAD3 signaling pathway. Comparable results for IMO-9200 were observed in a separate DSS-induced UC model, including a reduction on the Colitis Disease Activity Index (CDAI).

Collectively, these data demonstrate that TLRs are an important therapeutic target in IBD, and specific blocking of TLRs 7, 8 and 9 with oral IMO-9200 has the potential to disrupt the autoimmune cycle, reduce chronic intestinal inflammation, and improve disease symptoms.

Previously conducted preclinical studies have demonstrated the activity of IMO-9200 in mouse models of other autoimmune diseases, including the MRL/lpr model of lupus, the collagen antibody-induced arthritis model of rheumatoid arthritis, and the IL-23-induced dermal inflammation model of psoriasis.

“These data demonstrating the potential activity of IMO-9200 delivered either orally or subcutaneously as a novel therapeutic option for patients suffering from autoimmune diseases are encouraging and provide strong support for advancement into further clinical development,” stated Vincent Milano, Chief Executive Officer of Idera Pharmaceuticals. “As we noted at the outset of this year, the strategic focus of Idera is directed towards oncology and rare diseases and as such, we are currently reviewing our various strategic options for the future of the IMO-9200 development program.”

About Toll-Like Receptors (TLRs) and Idera’s Proprietary TLR Antagonist Technology Platform

Toll-like receptors (TLRs) play a central role in the innate immune system and in regulating inflammation, and published data have implicated TLR dysfunction across a broad range of autoimmune diseases and genetically defined forms of B-cell lymphoma.

In autoimmune diseases, endogenous nucleic acids released from damaged or dying cells initiate signaling cascades through TLRs, inducing multiple cytokines. Subsequent inflammation causes further damage to the body’s own tissues and organs and the release of more self-nucleic acids. Thus, a pathological amplification cycle is established, promoting disease progression.

In B-cell lymphomas characterized by the MYD88 L265P genetic mutation, an oncoprotein is produced that over activates TLR-initiated signaling, thereby activating transcription factors that promote the survival and proliferation of tumor cells.

Based on the company’s proprietary chemistry-based discovery platform, Idera designed and developed two synthetic oligonucleotide-based TLR antagonists, IMO-8400 and IMO-9200. These clinical-stage candidates have demonstrated activity in multiple preclinical models of autoimmune disease and cancer, including psoriasis, lupus, arthritis, and MYD88 L265P-positive B-cell lymphoma.

About Idera Pharmaceuticals            

Idera Pharmaceuticals is a clinical-stage patient-focused, biopharmaceutical company developing novel therapeutic approaches for the treatment of cancer and rare diseases. Idera’s proprietary technology involves creating novel nucleic acid therapeutics. Idera’s immunotherapy approach is based on the modulation of Toll-like receptors (TLRs).  In addition to its TLR modulation programs, Idera is developing gene silencing oligonucleotides (GSO) technology that it has created to inhibit the production of disease-associated proteins by targeting RNA. To learn more about Idera, visit www.iderapharma.com.

Forward- Looking Statements

This press release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. All statements, other than statements of historical fact, included or incorporated in this press release, including statements regarding the company’s strategy, future operations, collaborations, intellectual property, prospects, plans, and objectives of management, are forward-looking statements. The words “believes,” “anticipates,” “estimates,” “plans,” “expects,” “intends,” “may,” “could,” “should,” “potential,” “likely,” “projects,” “continue,” “will,” and “would” and similar expressions are intended to identify forward-looking statements, although not all forward-looking statements contain these identifying words. Idera cannot guarantee that it will actually achieve the plans, intentions or expectations disclosed in its forward-looking statements and you should not place undue reliance on the company’s forward-looking statements. There are a number of important factors that could cause Idera’s actual results to differ materially from those indicated or implied by its forward-looking statements. Factors that may cause such a difference include: whether results obtained in preclinical studies and clinical trials such as the results described in this release with respect to IMO-9200 will be indicative of the results that will be generated in future clinical trials; whether products based on Idera’s technology will advance into or through the clinical trial process when anticipated or at all or warrant submission for regulatory approval; whether such products will receive approval from the U.S. Food and Drug Administration or equivalent foreign regulatory agencies; whether, if the company’s products receive approval, they will be successfully distributed and marketed; whether the company’s collaborations will be successful; and such other important factors as are set forth under the caption “Risk Factors” in the company’s Quarterly Report on Form 10-Q for the period ended March 31, 2015. Although Idera may elect to do so at some point in the future, the company does not assume any obligation to update any forward-looking statements and it disclaims any intention or obligation to update or revise any forward-looking statement, whether as a result of new information, future events or otherwise.

CONTACT: Investor and Media Contact
         Robert Doody
         Vice President, Investor Relations and
         Corporate Communications
         484-639-7235
         rdoody@iderapharma.com
Monday, May 18th, 2015 Uncategorized Comments Off on (IDRA) Development Update on IMO-9200, an Antagonist of Toll-like Receptors

(PTBI) Closes Abeona Therapeutics Acquisition

Executing on Strategy to Become a Leader in Gene Therapy and Cell Therapy for Rare Diseases Two Phase 1/2 Clinical Trials for ABX-101 (MPS IIIB) and ABX-102 (MPS IIIA) for Sanfilippo Syndrome to Commence This Year

NEW YORK, NY–(May 18, 2015) – PlasmaTech Biopharmaceuticals, Inc. (NASDAQ: PTBI), a biopharmaceutical company focused on gene therapy and cell therapy products for severe and life- threatening rare diseases announced today that it had closed its previously announced acquisition of Abeona Therapeutics, a company engaged in the development and commercialization of therapies for patients with lysosomal storage diseases. The Company will issue to Abeona Therapeutic members a total of 3,979,761 common shares, and up to an additional $9 million in performance milestones, in common stock or cash, at the Company’s option. Additionally, Tim Miller, Ph.D. is appointed President & CEO of PlasmaTech Biopharmaceuticals and joins the Company’s Board of Directors.

“We are excited about closing this transaction, and plan to further build our gene and cell therapy pipeline with additional rare disease programs that will be synergistic with our current programs,” stated Steven H. Rouhandeh, PlasmaTech’s Executive Chairman. “With the closing of this acquisition and recent financings, the Company has added over $20 million to the balance sheet since the end of the first quarter. We welcome Tim Miller, his team and his scientific partners, and look forward to building the portfolio and Company together.”

“This is a very important step in the development of a comprehensive product pipeline in the rare disease space,” said Tim Miller, Ph.D., PlasmaTech’s President & CEO. “I want to again thank all of Abeona’s stakeholders, especially the supporting foundations, patient advocates, and the expanded scientific teams, for the past support and their continued voice in accelerating the Sanfilippo programs.” Abeona stakeholders and supporting foundations include U.S.-based Cure Sanfilippo Foundation, Sanfilippo Research Foundation, Team Sanfilippo, the Abby Grace Foundation, the National MPS Society, The Children’s Medical Research Foundation, Inc., and the Ryan Foundation. Strong overseas support comes from the international Sanfilippo community, with investments from Spain-based Stop Sanfilippo and Sanfilippo B Foundation, Geneva, Switzerland-based Fondation Sanfilippo, Australian-based Sanfilippo Children’s Foundation and Mexico-based Red Sanfilippo Foundation. Support for our programs has also been provided by the Canadian led Sanfilippo Children’s Research Foundation (SCRF).

About PlasmaTech Biopharmaceuticals: PlasmaTech Biopharmaceuticals is focused on advancing gene therapy and cell therapy for rare diseases. PlasmaTech’s lead program is a gene therapy for Sanfilippo syndrome (MPS IIIA and IIIB) in collaboration with patient advocate groups, researchers and clinicians. Clinical trials for Sanfilippo types A and B are anticipated to begin in 2015. In addition, the company is pursuing two additional proprietary platforms, Salt Diafiltration (SDF™) Process and Polymer Hydrogel Technology (PHT™), and is active in the development and commercialization of human plasma-derived therapeutics, including its proprietary alpha-1 protease inhibitor, SDF Alpha™. The company has developed a robust product pipeline that includes two commercial stage products, MuGard® and ProctiGard™, with additional follow-on products in development. For more information, visit www.plasmatechbio.com and www.abeonatherapeutics.com.

This press release contains certain statements that are forward-looking within the meaning of Section 27a of the Securities Act of 1933, as amended, and that involve risks and uncertainties. These statements include, without limitation, those relating to: the Company’s proposed acquisition of Abeona, anticipated acceleration in the development and internationalization of clinical programs, information regarding the future performance of the combined company, the outlook on medical needs, future pipeline expectations, management plans for the Company, the anticipated closing of the transaction, and general business outlook. These statements are subject to numerous risks and uncertainties, including but not limited the satisfaction of closing conditions for the transaction, the parties’ ability to successfully integrate and operate the new company, and achieve expected synergies and other benefits; the impact of competition; the ability to develop products and technologies; the ability to achieve or obtain necessary regulatory approvals; the impact of changes in the financial markets and global economic conditions; and other risks as may be detailed from time to time in the Company’s Annual Reports on Form 10-K and other reports filed by the Company with the Securities and Exchange Commission. The Company undertakes no obligations to make any revisions to the forward-looking statements contained in this release or to update them to reflect events or circumstances occurring after the date of this release, whether as a result of new information, future developments or otherwise.

Company and Media Contact:
Andre’a Lucca
Director of Communications
PlasmaTech Biopharmaceuticals, Inc.
212-786-6208
alucca@plasmatechbio.com

Monday, May 18th, 2015 Uncategorized Comments Off on (PTBI) Closes Abeona Therapeutics Acquisition

(ERN) Announces Production Rate from the Oyo Field

Oyo-8 exceeds 7,000 barrels of oil per day

Erin Energy Corporation (“Erin Energy” or the “Company”) (NYSE MKT:ERN) announced today that the Oyo-8 well (“Oyo-8”) located in OML 120 offshore Nigeria has exceeded expectations and is currently producing at a stabilized rate of 7,080 barrels of oil per day. Erin Energy is the operator and has a 100% interest in the well.

Erin Energy is currently engaged in drilling and completion operations on the Oyo-7 development well and expects to achieve first oil production from the well in a few weeks.

Additionally, in preparation for the planned drilling of one of its Miocene exploration prospects later this year, the Company has completed site survey of three of its top prospect drilling locations. Erin Energy announced last year that it had identified, and high-graded to drill-ready status, four Miocene exploration prospects. The four prospects have a combined 2.4 billion barrels of recoverable P50 prospective resources.

Segun Omidele, Senior Vice-President of Exploration and Production commented: “We are pleased with the Oyo-8 well’s performance and delighted that well parameters are stable. We plan to continue this very cautious well management approach and expect to bring Oyo-7 on production in a similar manner. We are advancing both our development and exploration work offshore Nigeria and look forward to an exciting second half of 2015.”

About Erin Energy

Erin Energy Corporation is an independent oil and gas exploration and production company focused on energy resources in sub-Saharan Africa. Its asset portfolio consists of 9 licenses across 4 countries covering an area of 43,000 square kilometers (10 million acres), including current production and other exploration projects offshore Nigeria, as well as exploration licenses offshore Ghana, Kenya and Gambia, and onshore Kenya. Erin Energy is headquartered in Houston, Texas, and is listed on the New York and Johannesburg Stock Exchanges under the ticker symbol ERN.

Resource Estimates

This press release refers to prospective resources, including recoverable resources. The Securities and Exchange Commission (“SEC”) permits oil and gas companies, in their filings with the SEC, to disclose only “reserves,” as that term is defined under SEC rules. Prospective resources are those quantities of petroleum estimated, as at a given date, to be potentially recoverable from undiscovered accumulations by application of future development projects. Prospective resources have both an associated chance of discovery and a chance of development. Investors should not assume there will be any discovery associated with prospective resources, or that any discovery will be economically drillable or ever be upgraded into reserves.

Forward-Looking Statements

This news release contains “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933 and Section 21E of the Securities Exchange Act of 1934. All statements, other than statements of historical fact, concerning activities, events or developments that the Company expects, believes or anticipates will or may occur in the future are forward-looking statements. Although the Company believes the expectations reflected in these forward-looking statements are reasonable, they involve assumptions, risks and uncertainties, and these expectations may prove to be incorrect.

The Company’s actual results could differ materially from those anticipated or implied in these forward-looking statements due to a variety of factors, including the Company’s ability to successfully finance, drill, produce and/or develop the wells and prospects identified in this release, and risks and other risk factors discussed in the Company’s periodic reports filed with the Securities and Exchange Commission. All forward-looking statements are expressly qualified in their entirety by this cautionary statement. You should not place undue reliance on forward-looking statements, which speak only as of their respective dates. The Company undertakes no duty to update these forward-looking statements.

Source: Erin Energy Corporation

Erin Energy Corporation
Investors:
Chris Heath, +1 713-797-2945
chris.heath@erinenergy.com
or
Media:
Lionel McBee, +1 713-797-2960
lionel.mcbee@erinenergy.com

Monday, May 18th, 2015 Uncategorized Comments Off on (ERN) Announces Production Rate from the Oyo Field

(LTBR) Formal Expression of Interest in Lightbridge Metallic Fuel Submitted To NRC

MCLEAN, Va., May 18, 2015  — The U.S. Nuclear Regulatory Commission (NRC) disclosed today that four U.S. electric utility companies representing nearly 50% of the nation’s nuclear generation have formally asked the Commission to prepare to review the patented metallic fuel design of Lightbridge Corporation (Nasdaq:LTBR), citing opportunities for this fuel product to “significantly improve safety and fuel cycle economics” of nuclear power plants. The NRC relies on communications from U.S. utilities to adjust Commission staffing levels and budgets in anticipation of regulatory review of licensing applications.

The utilities said their joint letter was being submitted in advance of an expected application to the NRC in 2017 for use of Lightbridge fuel lead test assemblies in an “operating U.S. pressurized water reactor as early as 2020.” The Commission posted the utilities’ expression of interest in Lightbridge’s fuel and supporting documents on its official web site at http://pbadupws.nrc.gov/docs/ML1513/ML15134A092.pdf

“Lightbridge is developing the first truly next generation commercial fuel design that can provide significant fuel performance and economic benefits to nuclear utilities,” said Seth Grae, Lightbridge President and Chief Executive Officer. “This expression of interest by major U.S. utilities is the strongest endorsement to date of Lightbridge fuel by potential customers. The Company believes it remains well positioned to realize high-margin revenue streams from technology licensing fees and royalties from a growing $25 billion annual global market for nuclear fuel.”

The advantages of Lightbridge’s metallic fuel design were confirmed in independent third-party analyses published in 2012 and 2013, he added. These reports, which include a peer-reviewed article published in Nuclear Technology, are available for download at http://ir.ltbridge.com/. Grae said the indicated benefits of Lightbridge’s fuel include:

  • A 1,000°C reduction in average fuel operating temperature, compared to conventional uranium dioxide pellet fuel, resulting in dramatic safety improvements;
  • Improved heat transfer and fluid flow, increased structural strength, and improved performance during transients and accidents;
  • 10% more power and longer fuel cycles or up to 17% more power with the same fuel cycle length for existing pressurized water reactors (PWRs);
  • Up to 30% more power with the same fuel cycle length for new build PWRs;
  • Increased revenue and improved profit margins for existing nuclear power units;
  • Lower total levelized cost per kilowatt-hour for new build reactors;
  • Increased competitiveness of nuclear power versus fossil or renewable energy sources;

The commercial nuclear energy industry is projected to grow rapidly at a time of rising global demand for reliable, carbon-free, base load electric power. There are currently 437 operable civil nuclear reactors in 30 countries around the world, with 65 reactors under construction and 481 on order, planned or proposed, according to the World Nuclear Association. By 2040, the International Energy Agency projects a 58% increase in nuclear capacity from a combination of power uprates and reactor construction.

“Lightbridge staff and capital are keenly focused on the Company’s nuclear fuel development program,” Grae said. “We are confident that this focus on near-term catalysts in fuel technology development will lead to long-term value creation for Lightbridge shareholders.”

The nuclear fuel managers at Dominion Generation (NYSE:D), Duke Energy (NYSE:DUK), Exelon Generation (NYSE:EXC) and Southern Company (NYSE:SO) comprise the Nuclear Utility Fuel Advisory Board (NUFAB). The board told the Commission that it intends to advise Lightbridge throughout its remaining, ongoing fuel tests and the regulatory review process.

About Lightbridge Corporation

Lightbridge is a nuclear energy company based in McLean, Virginia. The Company develops proprietary next generation nuclear fuel technologies for current and future nuclear reactor systems. Lightbridge’s breakthrough fuel technology is establishing new global standards for safe and clean nuclear power and leading the way to a sustainable energy future. The Company also provides comprehensive advisory services for established and emerging nuclear programs based on a philosophy of transparency, non-proliferation, safety and operational excellence. Lightbridge consultants provide integrated strategic advice and expertise across a range of disciplines including regulatory affairs, nuclear reactor procurement and deployment, reactor and fuel technology and international relations. The Company leverages those broad and integrated capabilities by offering its services to commercial entities and governments with a need to establish or expand nuclear industry capabilities and infrastructure.

Important milestones achieved by Lightbridge in 2014 include U.S. Patent and Trademark Office (USPTO) approval and issuance in February of the key patent (#8,654,917) covering the Company’s multi-lobed metallic fuel rod design and fuel assemblies. In July, the Company was issued its first international patent on its fuel rod design by the Commonwealth of Australia Patents Office.  A provisional patent application was filed in the U.S. relating to use of the Company’s metallic fuel in CANDU-type power reactors.

Lightbridge is on Twitter. Sign up to follow @LightbridgeCorp at http://twitter.com/lightbridgecorp.

Forward Looking Statements

This news release contains statements that are forward-looking in nature within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the Company’s competitive position and product and service offerings. These statements are based on current expectations on the date of this news release and involve a number of risks and uncertainties that may cause actual results to differ significantly from such estimates. The risks include, but are not limited to, the degree of market adoption of the Company’s product and service offerings; market competition; dependence on strategic partners; and the Company’s ability to manage its business effectively in a rapidly evolving market. Certain of these and other risks are set forth in more detail in Lightbridge’s filings with the Securities and Exchange Commission. Lightbridge does not assume any obligation to update or revise any such forward-looking statements, whether as the result of new developments or otherwise.

CONTACT: Gary Sharpe
         Investor Relations and Corporate Communications
         Lightbridge Corporation
         1-571-730-1213
         gsharpe@ltbridge.com
Monday, May 18th, 2015 Uncategorized Comments Off on (LTBR) Formal Expression of Interest in Lightbridge Metallic Fuel Submitted To NRC

(RGSE) 1-for-20 Reverse Stock Split Effective Today

LOUISVILLE, Colo., May 18, 2015  — RGS Energy (Nasdaq:RGSE), one of the nation’s leading rooftop installers of solar equipment, announced that the 1-for-20 reverse split of its Class A common stock will be effective today at the open of the U.S. markets.

Shares of RGS Energy Class A common stock will begin trading on a split-adjusted basis today on the NASDAQ Capital Market under the same symbol, RGSE. However, it will receive a new CUSIP number: 75601N203.

The effect of the reverse stock split will be to combine each 20 shares of outstanding common stock into one new share, with no change in par value per share, and to reduce the number of shares outstanding from approximately 96 million to 4.8 million.

No fractional shares will be issued in connection with the reverse split. Shareholders who would otherwise hold a fractional share of Real Goods Class A common stock will have their shares rounded up to the nearest whole share.

Holders of shares of Real Goods Class A common stock held in book-entry form or through a bank, broker or other nominee do not need to take any action in connection with the reverse split, and will see the result of the reverse split automatically reflected in their accounts. Beneficial holders may contact their bank, broker or nominee for more information.

For those few shareholders who hold physical stock certificates, the company’s transfer agent, Computershare, Inc., will send instructions for exchanging those certificates for new certificates that represent the post-split number of shares. Computershare can be contacted at (855) 396-2084.

About RGS Energy

RGS Energy (Nasdaq:RGSE) is one of the nation’s leading rooftop installers of solar equipment, serving residential and small business customers in the mainland U.S. and Hawaii. Beginning with one of the very first photovoltaic panels sold in 1978, the company has installed tens of thousands solar power systems. RGS Energy makes it very convenient for customers to save on their energy bill by providing a comprehensive solar solution, from design, financing, permitting and installation to ongoing monitoring, maintenance and support.

For more information, visit RGSEnergy.com, on Facebook at www.facebook.com/rgsenergy and on Twitter at www.twitter.com/rgsenergy. RGS Energy is a trade name and RGS Energy makes filings with the Securities and Exchange Commission under its official name “Real Goods Solar, Inc.” For more information about the company, visit www.rgsenergy.com.

Forward-Looking Statements and Cautionary Statements

This press release may contain forward-looking statements that involve risks and uncertainties. Forward-looking statements are neither historical facts nor assurances of future performance. Instead, they provide our current beliefs, expectations, assumptions and forecasts about future events. The words “may,” “will” and similar expressions as they relate to us are intended to identify such forward-looking statements. Because forward-looking statements relate to the future, they are subject to inherent uncertainties, risks and changes in circumstances that are difficult to predict and many of which are outside of our control. Our actual results and financial condition may differ materially from those indicated in the forward-looking statements. Therefore, you should not rely on any of these forward-looking statements. Important factors that could cause actual results and financial condition to differ materially from those indicated in the forward-looking statements include, without limitation, the factors discussed throughout Part I, Item 1A, Risk Factors and Part II, Item 7, Management’s Discussion and Analysis of Financial Conditions and Results of Operations of our Annual Report on Form 10-K for the year ended December 31, 2014.

Any forward-looking statement made by us in this press release is based only on information currently available to us and speaks only as of the date on which it is made. We undertake no obligation to publicly update any forward-looking statement, whether written or oral, that may be made from time to time, whether as a result of new information, future developments or otherwise. These documents are available on both the EDGAR section of the SEC’s website at www.sec.gov and the Investor Relations section of the company’s website at www.rgsenergy.com

CONTACT: Media and Investor Relations Contact
         Ron Both
         Liolios Group, Inc.
         Tel 1-949-574-3860
         RGSE@liolios.com
Monday, May 18th, 2015 Uncategorized Comments Off on (RGSE) 1-for-20 Reverse Stock Split Effective Today

(INFU) Announces Gregg Lehman Elected Chairman of the Board of Directors

MADISON HEIGHTS, Mich., May 15, 2015  — InfuSystem Holdings, Inc. (NYSE MKT: INFU), a leading national provider of infusion pumps and related services for the healthcare industry in the United States and Canada, announced today the Board of Directors has elected Gregg O. Lehman, PhD., as Chairman of the Board of Directors, effective May 13, 2015.  Dr. Lehman, a member of the InfuSystem Board since 2014, succeeds Ryan J. Morris, who had served as Chairman since 2012 and will continue to serve on InfuSystem’s Board.

“I am honored to be elected Chairman and look forward to serving InfuSystem in that capacity,” said Dr. Lehman.  “We appreciate Ryan Morris’ leadership since 2012, which brought stability and a new executive leadership team during a period of transition and look forward to his ongoing contribution as a member of our Board. With the leadership of Chief Executive Officer Eric Steen and his management team, I believe InfuSystem is well positioned for the future.  I look forward to working with management by providing Board leadership during this exciting phase in the development of InfuSystem.”

Mr. Steen, also a member of the InfuSystem Board, added, “We are pleased that Gregg Lehman has accepted the responsibilities of Board chairman and we look forward to his public company management experience and healthcare industry expertise to move the Company forward in the coming years. All of us at InfuSystem, as well as our shareholders, recognize and appreciate Ryan’s significant contributions to the business transformation that has taken place at InfuSystem these past three years. We look forward to the future with great enthusiasm.”

Gregg O. Lehman, Ph.D., is a nationally recognized leader in population health management and brings more than 28 years’ experience in the health care industry to the Company. Dr. Lehman has served as Chief Executive Officer of EB Employee Solutions, LLC since May 2014. Mr. Lehman was previously President and Chief Executive Officer of MGC Diagnostics Corporation, a leading cardiorespiratory diagnostic company from July 2011 until May 2014. Dr. Lehman served as President and Chief Executive Officer of Health Fitness Corporation, a population health management company based in Minneapolis, MN, from 2007 through 2010. Dr. Lehman has held numerous senior-level executive and governance positions in the medical and education industries including President and Chief Executive Officer of INSPIRIS, Inc., a Nashville-based specialty care medical management company. Dr. Lehman also was President and Chief Executive Officer of Gordian Health Solutions, Inc., a health management company, and President and Chief Executive Officer of the National Business Coalition on Health (NBGH) in Washington, D.C., and as President of Taylor University in Indiana. Dr. Lehman currently serves on the Executive Committee of the Washington D.C. based Care Continuum Alliance and has worked with the Health Care Purchasing Institute through Academy Health, the eHealth Initiative, the National Quality Forum, the National Patient Safety Foundation, and other purchasing/quality organizations that promote value-based purchasing and market-based reform. Dr. Lehman has a Doctorate and a Master of Science degree in higher education administration, with a minor in finance and economics from Purdue University and a Bachelor of Science in business management and marketing from Indiana University.

About InfuSystem Holdings, Inc.

InfuSystem Holdings, Inc. is a leading provider of infusion pumps and related services to hospitals, oncology practices and other alternate site healthcare providers.  Headquartered in Madison Heights, Michigan, the Company delivers local, field-based customer support and also operates Centers of Excellence in Michigan, Kansas, California, Texas and Ontario, Canada.  The Company’s stock is traded on the NYSE MKT under the symbol INFU.  Additional information about InfuSystem Holdings, Inc. is available at www.infusystem.com

Forward-Looking Statements

Certain statements contained in this press release are forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended (the “Securities Act”) and Section 21E of the Securities Exchange Act of 1934, as amended (the “Exchange Act”). The words “believe,” “may,” “will,” “estimate,” “continue,” “anticipate,” “intend,” “should,” “plan,” “expect,” “strategy,” “future,” “likely,” variations of such words, and other similar expressions, as they relate to the Company, are intended to identify forward-looking statements.  However, the absence of these words or similar expressions does not mean that a statement is not forward-looking.  In connection with the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, the Company is identifying certain factors that could cause actual results to differ, perhaps materially, from those indicated by these forward-looking statements. Those factors, risks and uncertainties include, but are not limited to, potential changes in overall healthcare reimbursement, including rates, payor mix and CMS competitive bidding, sequestration, concentration of customers, increased focus on early detection of cancer, competitive treatments, dependency on our Medicare Supplier Number, availability of chemotherapy drugs, global financial conditions, changes and enforcement of state and federal laws, natural forces, competition, dependency on suppliers, risks in acquisitions & joint ventures, U.S. regulatory changes and healthcare reform, relationships with healthcare professionals and organizations, technological changes related to infusion therapy, dependency on websites and intellectual property, the ability of the Company to successfully integrate acquired businesses, dependency on key personnel, dependency on banking relations and covenants, and other risks associated with our common stock, as well as any litigation to which the Company may be involved in from time to time; and other risk factors as discussed in the Company’s annual report on Form 10-K for the year ended December 31, 2014.  Our annual report on Form 10-K is available on the SEC’s EDGAR website at www.sec.gov, and a copy may also be obtained by contacting the Company.  All forward-looking statements made in this press release speak only as of the date hereof.  We do not intend, and do not undertake any obligation, to update any forward-looking statements to reflect future events or circumstances after the date of such statements.

CONTACT:

Joe Dorame, Joe Diaz & Robert Blum
Lytham Partners, LLC
602-889-9700

Friday, May 15th, 2015 Uncategorized Comments Off on (INFU) Announces Gregg Lehman Elected Chairman of the Board of Directors

(ALDR) Positive Clinical Data for ALD403 To Be Presented At Major Headache Conference

Single IV Dose of ALD403 Demonstrates Efficacy Over Six Months for the Preventive Treatment of Migraine

BOTHELL, Wash., May 15, 2015  — Alder BioPharmaceuticals, Inc. (“Alder”) (Nasdaq:ALDR), a clinical-stage biopharmaceutical company developing monoclonal antibody therapeutics for the treatment of migraine, announced that six-month follow-up data from its Phase 2 proof-of-concept clinical trial of ALD403, its anti-calcitonin gene-related peptide (CGRP) antibody for the prevention of frequent episodic migraine, were presented today by Jeffrey T.L. Smith, M.D., FRCP, Senior Vice President, Translational Medicine at Alder, in an oral presentation at the 17th Congress of the International Headache Society in Valencia, Spain.

Key Points from Oral Session: Migraine Pathophysiology and CGRP as a Therapeutic Target:

  • A single intravenous dose of ALD403 1000mg demonstrated prolonged efficacy over six months for the preventive treatment of migraine.
  • Over three months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 61% vs 33% (p < 0.001); 33% vs 9% (p < 0.001); and 16% vs 0% (p < 0.001), respectively.
  • Over six months, the proportion of patients with a 50%, 75%, and 100% reduction in migraine days for ALD403 and placebo was 53% vs 28% (p < 0.001); 26% vs 7% (p < 0.002); and 11% vs 0% (p <0.002), respectively.
  • ALD403 was well tolerated and there were no differences from placebo in terms of adverse events or laboratory safety data.
  • The migraine prevention proof-of-concept trial was conducted in 163 patients with frequent episodic migraine who had on average nine headache days per month. Patients were given a single intravenous dose of 1000mg of ALD403 or placebo. The primary endpoint was the mean change in migraine headache days from baseline to weeks 5-8, and patients were followed for 24 weeks for additional safety and efficacy analyses.

Alder also presented a poster with Phase 1 data for ALD403 titled, “A Single Dose Placebo-Controlled, Randomized, Ascending Dose Study of ALD403, a Humanized Anti-Calcitonin Gene-Related Peptide Monoclonal Antibody Administered IV or SC – Pharmacokinetic and Pharmacodynamic Results.”

ALD403 is Alder’s transformative novel monoclonal antibody that targets CGRP for prevention of migraine. CGRP is a small protein involved in the transmission of and heightened sensitivity to pain experienced in migraine.

Quote:

Randall C. Schatzman, Ph.D., President and Chief Executive Officer of Alder, said, “We believe that ALD403 has the potential to transform migraine prevention. These data presented today demonstrate the durable efficacy of ALD403 over six months, and we are now focused on identifying the optimal once-quarterly dose of ALD403 for both infusion and self-administration formulations. To this end, we plan to initiate two additional dose-ranging clinical trials in the second half of this year. We believe that providing patients and physicians the choice between these two routes of administration will allow a customized treatment paradigm that best suits each individual patient’s preference and circumstances.”

About Alder BioPharmaceuticals

Alder BioPharmaceuticals, Inc. is a clinical-stage biopharmaceutical company that discovers, develops and seeks to commercialize therapeutic antibodies with the potential to meaningfully transform current treatment paradigms. Alder’s lead clinical candidate, ALD403, inhibits a well-validated molecule shown to trigger migraine attacks, calcitonin gene-related peptide (CGRP), and is currently undergoing Phase 2b clinical testing for the treatment of chronic migraines. Alder plans to initiate additional advanced clinical studies for ALD403 in frequent episodic and chronic migraines in the second half of 2015. Alder’s second program, ALD1613, which targets adrenocorticotropic hormone (ACTH) is undergoing Investigational New Drug (IND)-enabling preclinical studies with the initiation of clinical studies in Cushing’s disease planned for 2016. Finally, clazakizumab, previously known as ALD518, is designed to block the pro-inflammatory cytokine IL-6 and has completed a Phase 2b clinical trial. For more information, please visit http://www.alderbio.com.

Forward-Looking Statements

This press release contains forward-looking statements, including statements regarding the further development of ALD403 and ALD1613, our expectations for the initiation of future clinical trials and studies, availability of clinical trial data, patient enrollment and the potential of ALD403, ALD1613 and clazakizumab to address the unmet medical needs of patients. All forward-looking statements included in this press release are based on our management’s beliefs and assumptions and on information currently available to our management, and we assume no obligation to update any such forward-looking statements. Any or all of our forward-looking statements in this press release may turn out to be wrong and actual events or results may differ materially. Our forward-looking statements can be affected by inaccurate assumptions we might make or by known or unknown risks, uncertainties and other factors. In evaluating these statements, you should specifically consider various factors, including the risks outlined under the caption “Risk Factors” set forth in our Quarterly Report on Form 10-Q for the quarter ended March 31, 2015, which was filed with the Securities and Exchange Commission (SEC) on May 7, 2015, and is available on the SEC’s website at www.sec.gov. Additional information will also be set forth in our other reports and filings we will make with the SEC from time to time. We caution investors that our business and financial performance are subject to substantial risks and uncertainties.

CONTACT: Media Contacts:
         David Schull or Lena Evans
         Russo Partners
         (212) 845-4271
         (212) 845-4262
         david.schull@russopartnersllc.com
         lena.evans@russopartnersllc.com

         Investor Relations Contact:
         Sarah McCabe
         Stern Investor Relations, Inc.
         (212) 362-1200
         sarah@sternir.com
Friday, May 15th, 2015 Uncategorized Comments Off on (ALDR) Positive Clinical Data for ALD403 To Be Presented At Major Headache Conference

(OCUL) to Proceed with NDA Submission for Post-Surgical Ocular Pain Indication OTX-DP

Ocular Therapeutix, Inc. (NASDAQ:OCUL), a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye, today announced financial results for the first quarter ended March 31, 2015 and provided an update on its clinical and preclinical programs for its proprietary hydrogel platform technology. Following a meeting with the Food and Drug Administration (FDA) in April 2015, the Company now plans to submit a New Drug Application (NDA) for OTX-DP for the treatment of post-surgical ocular pain. The Company also received conditional acceptance of the name DEXTENZA™ from the FDA for its OTX-DP product candidate. A request for a proprietary name review is planned as part of the NDA submission.

“We are pleased with the overall progress of our pipeline of sustained release drug delivery products in clinical and preclinical development. We continue to advance our clinical programs for the treatment of post-surgical ocular inflammation and pain, allergic conjunctivitis, inflammatory dry eye disease and glaucoma, with several anticipated milestones in the near-term. Furthermore, last week we presented preclinical data on our sustained release hydrogel depot for the delivery of anti-vascular endothelial growth factors (anti-VEGF) for the treatment of wet age-related macular degeneration at the recent annual ARVO meeting in Denver. This is a promising platform for a condition that is one of the leading causes of blindness,” said Amar Sawhney, Ph.D., President and Chief Executive Officer.

Dr. Sawhney further commented, “We remain confident about our program for post-surgical ocular inflammation and pain, and our plans for the regulatory and clinical pathway for this product candidate. We intend to submit an NDA for a post-surgical ocular pain indication and conduct an additional Phase 3 clinical trial. Our goal is to subsequently submit an NDA supplement to expand the labeling for the inflammation indication, subject to favorable results from the additional trial and the initial approval of the NDA for the pain indication.”

Clinical Update for DEXTENZA for the Treatment of Post-Surgical Ocular Inflammation and Pain

Following a Pre-NDA Clinical meeting held with FDA in April 2015, Ocular Therapeutix is charting a path forward for DEXTENZA for the treatment of post-surgical ocular inflammation and pain. The Company’s plan now includes:

  • Submission of an NDA for DEXTENZA for a post-surgical ocular pain indication in the second half of 2015.
  • Initiation of an additional Phase 3 clinical trial for DEXTENZA for post-operative ocular inflammation and pain with modifications to the trial design based on learnings from the previously completed second Phase 3 trial, including the exclusion of patients on high-dose nonsteroidal anti-inflammatory drugs (NSAIDs), randomizing patients in a 1:1 ratio into treatment and placebo groups and providing more protocol specificity regarding the administration of rescue medications.
  • Submission of an NDA supplement for DEXTENZA to broaden the indication to include treatment of post-operative ocular inflammation, subject to favorable results from the additional Phase 3 clinical trial and the approval of the NDA for DEXTENZA for the pain indication.

Recent Highlights for Other Key Development Programs

Sustained release depots for treatment of retinal diseases

At the recent Association for Research in Vision and Ophthalmology (ARVO) annual meeting in Denver, Ocular Therapeutix presented a total of eight posters, three of which highlighted the company’s sustained release hydrogel depot platform technology.

The data presented on back-of-the-eye depots focused on demonstrating the viability of the platform for treating retinal diseases using bevacizumab and other anti-VEGF agents as model proteins. In preclinical studies, data showed in-situ formed bioresorbable anti-VEGF hydrogel depots maintain their structure and bioactivity within the company’s hydrogel. Data further showed tolerability and drug release of clinically meaningful concentration and duration.

Decreasing the frequency of intravitreal injections with a sustained release modality remains a major clinical challenge in treating chronic diseases such as age-related macular degeneration (AMD) and diabetic macular edema (DME).

A multi-pronged strategy is being pursued to seek to maximize the potential of this technology for back-of-the-eye diseases. The Company is pursuing ongoing collaborations with several different pharmaceutical companies using protein based anti-VEGF agents and internal development efforts using bevacizumab. Additionally, the delivery of small molecule drugs, such as tyrosine-kinase inhibitors, or TKIs, in the Company’s hydrogel depot are being evaluated. The Company believes this class of drugs is well suited to the Company’s hydrogel depot platform given its high potency, multiple targeting capability, and low water solubility. The Company plans to continue evaluating these multiple pathways as additional preclinical milestones are achieved.

OTX-TP product candidate for the treatment of glaucoma

  • The Company’s OTX-TP product candidate for the treatment of glaucoma and ocular hypertension is now in a Phase 2b clinical trial at multiple sites in the United States, which is more than 80% enrolled and remains on track to report topline efficacy data in the fourth quarter of 2015.

DEXTENZA product candidate for the treatment of allergic conjunctivitis and inflammatory dry eye disease

  • The DEXTENZA product candidate is being investigated for the treatment of allergic conjunctivitis, for which two Phase 3 trials are to be conducted beginning in the middle of 2015.
  • DEXTENZA is also being investigated for the treatment of inflammatory dry eye disease and is currently nearing enrollment completion in an exploratory Phase 2 clinical trial, with topline efficacy data to be released in the fourth quarter of 2015.

First Quarter 2015 Financial Results

  • Ocular Therapeutix reported a net loss of approximately $7.6 million, or $(0.35) per share, for the quarter ended March 31, 2015, compared to a net loss of $7.0 million, or $(2.45) per share, for the quarter ended March 31, 2014. The first quarter 2015 results include $0.9 million in non-cash charges for stock-based compensation compared to $2.9 million in non-cash charges for stock-based compensation and licensing and consultant fees paid in common stock in the first quarter of 2014.
  • Total operating expenses for the quarter ended March 31, 2015 were $7.5 million as compared to $6.9 million for the quarter ended March 31, 2014. Research and development (R&D) expenses for the quarter ended March 31, 2015 were $4.7 million, compared to $4.9 million for the quarter ended March 31, 2014. In the quarter ended March 31, 2014, there was $1.7 million in non-cash licensing fees paid in common stock relating to the Company’s intellectual property rights. This was partially offset by increases in personnel costs and clinical trials of DEXTENZA and OTX-TP product candidates.
  • Ocular Therapeutix generated $0.4 million in revenue during the three months ended March 31, 2015 from product sales of ReSure® Sealant and from collaborations with corporate partners.
  • As of March 31, 2015, cash and cash equivalents and marketable securities totaled $67.4 million. Cash used in operating activities was $6.9 million for the three months ended March 31, 2015.
  • There was $15.0 million in outstanding debt as of March 31, 2015, with an interest only period through September 30, 2015.
  • As of May 3, 2015, there were approximately 21.4 million shares issued and outstanding.

Conference Call & Webcast Information

Members of the Ocular Therapeutix management team will host a live conference call and webcast today at 8:00 am Eastern Time to discuss the Company’s financial results and provide a general business update.

The live webcast can be accessed by visiting the investor section of the Company’s website at investors.ocutx.com. Please connect at least 15 minutes prior to the live webcast to ensure adequate time for any software download that may be needed to access the webcast. Alternatively, please call 844-464-3934 (U.S.) or 765-507-2620 (International) to listen to the conference call. The conference ID number for the live call will be 34331440. An archive of the webcast will be available until May 29, 2015 on the company’s website.

About Ocular Therapeutix, Inc.

Ocular Therapeutix, Inc. (NASDAQ: OCUL) is a biopharmaceutical company focused on the development and commercialization of innovative therapies for diseases and conditions of the eye using its proprietary hydrogel platform technology. Ocular Therapeutix’s lead product candidates are in Phase 3 clinical development for post-surgical ocular inflammation and pain, and Phase 2 clinical development for glaucoma, allergic conjunctivitis and inflammatory dry eye disease. The Company is also evaluating sustained-release injectable anti-VEGF drug depots for back-of-the-eye diseases. Ocular Therapeutix’s first product, ReSure® Sealant, is FDA-approved to seal corneal incisions following cataract surgery.

Forward Looking Statements

Any statements in this press release about future expectations, plans and prospects for the Company, including statements about the development of the Company’s product candidates, such as the Company’s plans for regulatory submissions and the design, initiation and conduct of a third clinical trial of OTX-DP for post-surgical inflammation and pain, the ongoing development of the Company’s sustained release hydrogel depot technology, the timing and conduct of the Company’s Phase 2b clinical trial of OTX-TP for the treatment of glaucoma and ocular hypertension, the Company’s Phase 3 clinical trials of OTX-DP for allergic conjunctivitis and the Company’s Phase 2 clinical trial of OTX-DP for the treatment of inflammatory dry eye disease, the advancement of the Company’s other product candidates and other statements containing the words “anticipate,” “believe,” “estimate,” “expect,” “intend”, “goal,” “may”, “might,” “plan,” “predict,” “project,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions, constitute forward-looking statements within the meaning of The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by such forward-looking statements as a result of various important factors. Such forward-looking statements involve substantial risks and uncertainties that could cause the Company’s clinical development programs, future results, performance or achievements to differ significantly from those expressed or implied by the forward-looking statements. Such risks and uncertainties include, among others, those related to the timing and costs involved in commercializing ReSure® Sealant, the initiation and conduct of clinical trials, availability of data from clinical trials and expectations for regulatory submissions and approvals, the Company’s scientific approach and general development progress, the availability or commercial potential of the Company’s product candidates, the sufficiency of cash resources and need for additional financing or other actions and other factors discussed in the “Risk Factors” section contained in the Company’s Annual Report on Form 10-K for the year ended December 31, 2014 on file with the Securities and Exchange Commission. In addition, the forward-looking statements included in this press release represent the Company’s views as of the date of this release. The Company anticipates that subsequent events and developments will cause the Company’s views to change. However, while the Company may elect to update these forward-looking statements at some point in the future, the Company specifically disclaims any obligation to do so. These forward-looking statements should not be relied upon as representing the Company’s views as of any date subsequent to the date of this release.

OCULAR THERAPEUTIX, INC.
STATEMENTS OF OPERATIONS
(In thousands, except share and per share data)
(Unaudited)
Three Months ended
March 31,
2015 2014
Product revenue $ 238 $ 27
Collaboration revenue 188
Total revenue 426 27
Operating Expenses:
Cost of product revenue 56 9
Research and development 4,719 4,958
Selling and marketing 870 310
General and administrative 1,894 1,575
Total operating expenses 7,539 6,852
Loss from operations (7,113) (6,825)
Other income (expense):
Interest income 40 1
Interest expense (505) (43)
Other (expense) income, net (141)
Total other expense, net (465) (183)
Net loss and comprehensive loss (7,578) (7,008)
Accretion of redeemable convertible preferred stock to redemption value (6)
Net loss attributable to common stockholders $ (7,578) $ (7,014)
Net loss per share attributable to common stockholders per share, basic and diluted $ (0.35) $ (2.45)
Weighted average shares outstanding, basic and diluted 21,362,731 2,859,752
OCULAR THERAPEUTIX, INC.
BALANCE SHEETS
(In thousands, except share and per share data)
(Unaudited)
March 31,
2015
December 31,
2014
Assets
Current assets:
Cash and cash equivalents $ 12,523 $ 37,393
Marketable securities 54,900 37,435
Accounts receivable 352 329
Inventory 158 133
Prepaid expenses and other current assets 1,537 893
Total current assets 69,470 76,183
Property and equipment, net 1,799 1,782
Restricted cash 228 228
Total assets $ 71,497 $ 78,193
Liabilities and Stockholders’ Equity
Current liabilities:
Accounts payable $ 2,195 $ 1,316
Accrued expenses 1,922 3,016
Deferred revenue 250 188
Notes payable, net of discount, current 2,860 1,354
Total current liabilities 7,227 5,874
Deferred rent, long-term 103 112
Notes payable, net of discount, long-term 12,094 13,511
Total liabilities 19,424 19,497
Commitments and contingencies
Stockholders’ equity:
Preferred stock, $0.0001 par value; 5,000,000 authorized at March 31, 2015 and December 31, 2014; no shares issued or outstanding at March 31, 2015 and December 31, 2014
Common stock, $0.0001 par value; 100,000,000 shares authorized at March 31, 2015 and December 31, 2014; 21,428,571 and 21,333,507 shares issued and outstanding at March 31, 2015 and December 31, 2014, respectively 2 2
Additional paid-in capital 149,077 148,122
Accumulated deficit (97,006) (89,428)
Total stockholders’ equity 52,073 58,696
Total liabilities and stockholders’ equity $ 71,497 $ 78,193

Investors:
Ocular Therapeutix, Inc.
Brad Smith
Chief Financial Officer
bsmith@ocutx.com
or
Burns McClellan on behalf of Ocular Therapeutix
Kimberly Minarovich, 212-213-0006
kminarovich@burnsmc.com
or
Media:
Ocular Therapeutix, Inc.
Scott Corning
Vice President of Sales and Marketing
scorning@ocutx.com

Friday, May 15th, 2015 Uncategorized Comments Off on (OCUL) to Proceed with NDA Submission for Post-Surgical Ocular Pain Indication OTX-DP

(MNGA) US Navy Purchases First Order of MagneGas

MagneGas Demonstration at US Navy Results in MagneGas 2 Cutting 100% Faster Than Acetylene

TAMPA, Fla., May 15, 2015  — MagneGas Corporation (“MagneGas” or the “Company”) (NASDAQ: MNGA), a technology company that counts among its inventions a patented process that converts liquid waste into a MagneGas Fuel, announced today that following a specific request from the US Navy, it has successfully completed a demonstration using its MagneGas2® cutting fuel at a designated US Navy facility.  Following an initial demonstration, the US Navy contacted MagneGas and purchased their first order of MagneGas 2. Subsequently MagneGas was invited to perform a two-day “hands-on” demonstration and testing session that concluded on May 12th.

In various customer and independent tests, MagneGas2® has repeatedly been lauded for it’s ability to cut faster than acetylene as well as for its overall safety advantages due to its lighter than air characteristics, reduced slag and reduced oxygen consumption. This particular US Navy facility is interested in improving productivity and discussions with them have been on-going for several months regarding demonstrating MagneGas 2 to their team.

While at the US Navy yard, the MagneGas team performed “head to head” travel speed demonstrations against acetylene and achieved a 100% faster cutting speed on 2″ plate using a track torch. The demonstration showed that the use of MagneGas 2 would dramatically increase the productivity of their cutting operation resulting in a verbal commitment to purchase additional MagneGas. MagneGas has already been invited back to demonstrate to the demolition function of this particular yard that is a completely new opportunity within the US Navy.

“We are proud to see solid progress in our penetration of the important armed forces markets through our initial order from the US Navy,” commented Ermanno Santilli CEO of MagneGas Corp. “Providing hands-on testing, training and demonstrations underscores this US Navy facility’s interest in improving productivity. The opportunity to help the US Navy turn ships around faster so that our Armed Forces can protect US interests around the globe makes the whole MagneGas team very proud.”

The MagneGas IR App is now available for free in Apple’s App Store for the iPhone or iPad http://bit.ly/AfLYww and at Google Play http://bit.ly/Km2iyk for Android mobile devices.

To be added to the MagneGas investor email list, please email pcarlson@kcsa.com with MNGA in the subject line.

About MagneGas Corporation
Founded in 2007, Tampa-based MagneGas Corporation (NASDAQ: MNGA) is a technology Company that counts among its inventions, a patented process that converts liquid waste into hydrogen based fuels.  The Company currently sells MagneGas® into the metal working market as a replacement to acetylene.  It is also selling equipment for the sterilization of bio-contaminated liquid waste for various industrial and agricultural markets.  In addition, the Company is developing a variety of ancillary uses for MagneGas® fuels utilizing its high flame temperature for co-combustion of hydrocarbon fuels and other advanced applications.  For more information on MagneGas®, please visit the Company’s website at www.MagneGas.com.

FORWARD-LOOKING STATEMENTS

This press release contains forward-looking statements as defined within Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended.  These statements relate to future events, including our ability to raise capital, or to our future financial performance, and involve known and unknown risks, uncertainties and other factors that may cause our actual results, levels 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. You should not place undue reliance on forward-looking statements since they involve known and unknown risks, uncertainties and other factors which are, in some cases, beyond our control and which could, and likely will, materially affect actual results, levels of activity, performance or achievements. Any forward-looking statement reflects our current views with respect to future events and is subject to these and other risks, uncertainties and assumptions relating to our operations, results of operations, growth strategy and liquidity. We assume no obligation to publicly update or revise these forward-looking statements for any reason, or to update the reasons actual results could differ materially from those anticipated in these forward-looking statements, even if new information becomes available in the future. The Company is currently using new ethylene glycol to produce fuel until proper permits to process used liquid waste have been obtained.

For a discussion of these risks and uncertainties, please see our filings with the Securities and Exchange Commission. Our public filings with the SEC are available from commercial document retrieval services and at the website maintained by the SEC at http://www.sec.gov.

Friday, May 15th, 2015 Uncategorized Comments Off on (MNGA) US Navy Purchases First Order of MagneGas

(SRNE) NantWorks Acquires Cynviloq™ For Up To $1.3+ Billion

–$90 million+ up-front payment and $1.2 billion+ milestone payments
–Sorrento retains option for co-development and/or co-marketing of Cynviloq™SAN DIEGO, May 15, 2015  — Sorrento Therapeutics, Inc. (NASDAQ: SRNE; Sorrento), announced today that NantPharma, founded by Dr. Patrick Soon-Shiong and a member of the NantWorks ecosystem of companies, agreed to acquire the rights to Cynviloq through the acquisition of Igdrasol, Inc., a wholly-owned subsidiary of Sorrento, which has been developing Cynviloq (paclitaxel nanoparticle polymeric micelle) in a bio-equivalence trial. Dr. Soon-Shiong was the founder of Abraxis BioScience and inventor and developer of the blockbuster drug Abraxane® (albumin-bound paclitaxel), currently approved for the treatment of breast, lung, and pancreatic cancers. Under the terms of the agreement, Sorrento will receive more than $90 million in an up-front cash payment plus the potential for more than $600 million in regulatory and $600 million in sales milestone payments. Sorrento will also receive additional transfer pricing payments from total unit sales. Furthermore, Sorrento has the option to co-develop and/or co-market Cynviloq on terms to be negotiated.”We are extremely pleased with the recent Cynviloq TRIBECA™ study results and excited that Dr. Patrick Soon-Shiong and his NantPharma team plan to expand Cynviloq into multiple cancer indications, as well as combine it with immunomodulatory antibodies and cell therapies from Sorrento’s pipeline,” said Dr. Henry Ji, President and CEO. “This major transaction will enhance Sorrento’s mission of bringing innovative therapies to patients in need quickly and efficiently. It puts our lead program into the hands of a team that has the experience, commitment and resources to develop and launch a major cancer drug. This transaction not only validates our prior Igdrasol acquisition, it also delivers significant financial return, while potentially offering much more in the long run to our shareholders. Moving forward, Sorrento plans to focus on truly innovative immuno-oncology and cellular therapies and position us as the leader in the emerging immunotherapy space.”

“Precision cancer medicine will require a multi-faceted treatment approach involving chemotherapy, immunotherapy, adoptive cellular therapy and next-generation precision medicine technologies, including such as genomics and proteomics diagnostics which NantWorks is developing,” said Dr. Soon-Shiong. “We are committing significant resources to the development of novel cancer therapies, including combination therapies, an area of significant unmet need. Chemotherapy is an important pillar to the combination with immunotherapy and natural killer cells, and the opportunity to develop combination regimens of low-dose metronomic use of this active drug is an important step in transforming cancer care as we know it today.”‎

About Sorrento Therapeutics, Inc.

Sorrento is an oncology company developing new treatments for cancer and associated pain.  In addition to Cynviloq, Sorrento has clinical stage asset resiniferatoxin, a non-opiate TRPV1 agonist currently in a Phase 1/2 study at the NIH to treat terminal cancer patients suffering from intractable pain.

In December 2014, Sorrento and NantWorks formed a global joint venture, called NANTibody, to focus on immunotherapies for cancer. Also in December 2014, Sorrento and Conkwest, Inc., a privately-held immuno-oncology company developing proprietary Neukoplast®, a Natural Killer (NK) cell-line based therapy, entered into an agreement to jointly develop CAR.TNK™ (Chimeric Antigen Receptor Tumor-attacking Neukoplast) immunotherapies for the treatment of cancer and infectious diseases. In March 2015, Sorrento entered into a global collaboration with NantCell, a NantWorks company, to discover and develop immunotherapies against tumor neo-epitopes.

About NantWorks

NantWorks, LLC, founded by renowned physician scientist and inventor of the first human nanoparticle chemotherapeutic agent Abraxane®, Dr. Patrick Soon-Shiong, is the umbrella organization for the following entities: NantHealth, NantMobile, NantMedia, NantOmics, NantBioScience, NantCell, NantPharma, NantCapital and NantCloud. Fact-based and solution-driven, each of NantWorks’ division entities operates at the nexus of innovation and infrastructure. The core mission of NantWorks is convergence: to develop and deliver a diverse range of technologies that accelerates innovation, broadens the scope of scientific discovery, enhances groundbreaking research, and improves healthcare treatment for those in need. NantWorks is building an integrated fact-based, genomically-informed, personalized approach to the delivery of care and the development of next generation diagnostics and therapeutics.

Forward-Looking Statements

This press release contains forward-looking statements related to Sorrento Therapeutics, Inc. under the safe harbor provisions of Section 21E of the Private Securities Litigation Reform Act of 1995 and subject to risks and uncertainties that could cause actual results to differ materially from those projected. Forward-looking statements include statements about whether Sorrento will receive any or all of the milestone, profit share or other payments under the agreement with NantPharma; whether Cynviloq may be approved by the FDA; and the potential for co-development or co-marketing that may be agreed pursuant to the agreement with NantPharma; and other matters that are described in Sorrento’s Annual Report on Form 10-K for the year ended December 31, 2014, and subsequent Quarterly Reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth in those filings. Investors are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date of this release and we undertake no obligation to update any forward-looking statement in this press release except as required by law.

Cynviloq™, TRIBECA™, CAR.TNK™ and the Sorrento logo are trademarks owned by Sorrento Therapeutics, Inc.

All other trademarks and trade names are the property of their owners.

Friday, May 15th, 2015 Uncategorized Comments Off on (SRNE) NantWorks Acquires Cynviloq™ For Up To $1.3+ Billion

(ACRX) Awarded Contract from Department of Defense to Advance ARX-04

REDWOOD CITY, Calif., May 14, 2015  — AcelRx Pharmaceuticals, Inc. (Nasdaq: ACRX), (AcelRx), a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute pain, today announced it has entered into Contract No. W81XWH-15-C-0046 worth up to $17.0 million, supported by the United States Army Medical Research and Materiel Command (USAMRMC) within the U.S. Department of Defense (DoD). The contract provides partial funding for ongoing development of ARX-04, including Phase 3 clinical, manufacturing and regulatory activities. ARX-04 is in development as a non-invasive, single-use 30 mcg sufentanil sublingual tablet in a disposable, pre-filled, single-dose applicator (SDA), for the anticipated treatment of moderate-to-severe acute pain in a medically supervised setting.

“We recently announced the initiation of the pivotal Phase 3 study of ARX-04 and are now very pleased to announce the DoD’s continued support of ARX-04. The funding, together with our existing resources, will allow us to complete the Phase 3 development program, continue with manufacturing activities, and ready the product for the potential submission of a New Drug Application (NDA). We are excited to continue our relationship with the DoD, which began in 2011 through a $5.6 million grant to fund Phase 2 development. We believe ARX-04 can potentially provide great benefit to our servicemen and women in the armed forces and presents promising commercial opportunities in a wide range of medically-supervised settings such as emergency rooms, and following short-stay surgeries,” stated Howie Rosen, AcelRx interim Chief Executive Officer.

Under the terms of the contract, commencing in Q2 2015, the DoD will reimburse AcelRx for costs incurred for development, manufacturing and clinical costs outlined in the contract, including reimbursement for certain personnel and overhead expenses. These development activities are intended to include completion of the Phase 3 clinical program and manufacturing development activities over the next 18-months.

About ARX-04

ARX-04 consists of a 30 mcg sufentanil sublingual tablet, in a pre-filled single-dose applicator (SDA). ARX-04 is non-invasive, single-use and disposable, allowing healthcare professionals to administer a sufentanil tablet under a patient’s tongue to manage their moderate-to-severe acute pain. AcelRx’s proprietary tablet formulation enables sublingual sufentanil absorption when a tablet is placed under the tongue, thereby providing analgesia with a consistent pharmacokinetic profile, due to a high percentage of drug being absorbed sublingually instead of through the gastrointestinal tract. We believe ARX-04 may be a candidate for use in a variety of medically supervised settings to manage moderate-to-severe pain, including in emergency room patients; post-operative patients who are transitioning from the operating room to the recovery floor; patients who are recovering from either short-stay or ambulatory surgery and do not require more long-term patient-controlled analgesia; treatment of battlefield casualties; and patients being transported by paramedics. According to the National Emergency Department Sample, there were more than 104 million adult emergency room visits in the U.S. during 2011, of which it is estimated that more than 48 million were associated with moderate-to-severe acute pain; while in the five largest markets in Europe there were more than 91 million adult emergency room visits during 2011, of which it is estimated more than 34 million were associated with moderate-to-severe acute pain.

About USAMRMC

The USAMRMC is the Army’s medical materiel developer, with responsibility for medical research, development, and acquisition and medical logistics management. The USAMRMC manages and executes research in five basic areas: military infectious diseases, combat casualty care, military operational medicine, chemical biological defense, and clinical and rehabilitative medicine.

About AcelRx Pharmaceuticals, Inc.

AcelRx Pharmaceuticals, Inc. is a specialty pharmaceutical company focused on the development and commercialization of innovative therapies for the treatment of acute and breakthrough pain. AcelRx has initiated a Phase 3 clinical trial for ARX-04 and is actively recruiting for that trial. In addition to ARX-04, AcelRx’s lead product candidate, Zalviso, is designed for the management of moderate-to-severe acute pain in adult patients in the hospital setting by utilizing a high therapeutic index opioid, through a non-invasive delivery route via a pre-programmed, patient-controlled analgesia device. AcelRx has submitted an NDA to the FDA seeking approval for Zalviso in the treatment of moderate-to-severe acute pain in adult patients in the hospital setting and on July 25, 2014, received a Complete Response Letter (CRL) from the FDA. In March 2015, AcelRx received correspondence from the FDA stating that in addition to the bench testing and two Human Factors studies AcelRx has performed to address dispensing issues raised in the CRL, an additional clinical trial is needed to assess the risk of inadvertent dispensing and overall risk of dispensing failures. AcelRx submitted a formal meeting request to the FDA and this request has been denied. AcelRx is currently evaluating its next steps to seek a pathway forward towards gaining approval of Zalviso in the U.S., including potential additional clinical studies, additional Human Factors studies, or the dispute resolution processes provided for by the FDA. The Company has two additional pain treatment product candidates, ARX-02 and ARX-03, which have completed Phase 2 clinical development. For additional information about AcelRx’s clinical programs, please visit www.acelrx.com.

Forward-Looking Statements

This press release contains forward-looking statements, including, but not limited to, statements related to the process and timing of anticipated future development of AcelRx’s product candidates, including Zalviso and ARX-04; statements related to the completion of enrollment in  ARX-04’s Phase 3 trial and anticipated timing of the trial’s top line results; availability and amount of funding to support ARX-04’s development including potential filing of an NDA; and the therapeutic and commercial potential of AcelRx Pharmaceuticals’ product candidates, including Zalviso and ARX-04.

These forward-looking statements are based on AcelRx Pharmaceuticals’ current expectations and inherently involve significant risks and uncertainties. AcelRx Pharmaceuticals’ actual results and the timing of events could differ materially from those anticipated in such forward-looking statements as a result of these risks and uncertainties, which include, without limitation, risks related to: AcelRx Pharmaceuticals’ ability to complete Phase 3 development for ARX-04, file an NDA and to receive regulatory approval for ARX-04; the success, cost and timing of all product development activities and clinical trials, including the Phase 3 ARX-04 trial; the market potential for its product candidates, including Zalviso and ARX-04; the ability to maintain compliance with contractual compliance matters and requirements; and other risks detailed in the “Risk Factors” and elsewhere in AcelRx Pharmaceuticals’ U.S. Securities and Exchange Commission filings and reports, including its Quarterly Report on Form 10-Q filed with the SEC on May 5, 2015. AcelRx Pharmaceuticals undertakes no duty or obligation to update any forward-looking statements contained in this release as a result of new information, future events or changes in its expectations.

Thursday, May 14th, 2015 Uncategorized Comments Off on (ACRX) Awarded Contract from Department of Defense to Advance ARX-04