Uncategorized

$AAL, $C, $BCS, $MA Announce New #CreditCard Agreements

Expanded partnerships continue benefits for AAdvantage® members

FORT WORTH, Texas, July 12, 2016  — American Airlines (NASDAQ:AAL) and its partners in the AAdvantage® credit card program announced new agreements today to extend their relationships and continue providing AAdvantage® miles and other benefits to customers.

American has entered into new agreements with both Citi and Barclaycard US. The agreements will allow Citi to continue offering its lineup of cards to new customers through multiple exclusive channels such as digital – including aa.com – mobile, direct mail, and Admirals Club lounges.

The agreements will also allow Barclaycard US, the payments business of Barclays in the United States, to offer its cards to new customers in airports and exclusively during flights beginning in January 2017.

Current cardholders will continue to see the same great benefits from both Citi and Barclaycard US as well as benefit from a new, long-term exclusive agreement with MasterCard.

“These long-term relationships with our innovative credit card partners provide our customers with the best ways to enhance their travel experience. From earning miles to boarding early and checking a bag for free, our customers tell us how much they value their AAdvantage®-affiliated cards,” said Andrew Nocella, chief marketing officer for American Airlines. “Our new dual-issuer arrangement is the first of its kind in the U.S. airline industry, and was enabled by the progressive partnership with Citi, Barclaycard US and MasterCard.”

“We are delighted to announce a multi-year extension of our nearly three-decade long partnership with American Airlines,” said Ralph Andretta, Head of U.S. Branded Cards, Citi. “This renewal reinforces our strong commitment to delivering exceptional value, benefits and service to our mutual customers today and for years to come.”

“We are thrilled to extend and expand upon our strategic partnership with American Airlines,” said Denny Nealon, Head of Partnerships, Barclaycard US. “We are proud to continue to help American Airlines grow its business and drive even greater loyalty and engagement with its customers. Together, we will offer consumers and American Airlines enthusiasts richly rewarding benefits, easy and convenient ways to earn their next award flight, and fantastic service.”

“We have enjoyed a long and successful partnership with American Airlines and the award-winning AAdvantage program and we are pleased to extend our relationship as the exclusive payment network for many years to come,” said Craig Vosburg, president North America, MasterCard. “We look forward to working with our bank partners – Citi and Barclaycard – to deliver seamless, safe and secure payments services through our global network, product innovations, and many Priceless experiences.”

About American Airlines Group
American Airlines and American Eagle offer an average of nearly 6,700 flights per day to nearly 350 destinations in more than 50 countries. American has hubs in Charlotte, Chicago, Dallas/Fort Worth, Los Angeles, Miami, New York, Philadelphia, Phoenix, and Washington, D.C. American is a founding member of the oneworld® alliance, whose members serve more than 1,000 destinations with about 14,250 daily flights to over 150 countries. Shares of American Airlines Group Inc. trade on Nasdaq under the ticker symbol AAL. In 2015, its stock joined the S&P 500 index. Connect with American on Twitter @AmericanAir and at Facebook.com/AmericanAirlines.

About Barclaycard US
Barclaycard is part of Barclays, a transatlantic consumer, corporate and investment bank that moves, lends, invests and protects money for customers and clients worldwide. Headquartered in Wilmington, Del., Barclaycard US is one of the fastest growing top-10 credit card issuers in the nation. The company creates customized, co-branded credit card programs for some of the country’s most successful travel, entertainment, retail, affinity and financial institutions. The business also issues its own Barclaycard branded credit cards and offers high-yield online savings accounts and CDs. For more information on Barclaycard please visit BarclaycardUS.com.

About Citi
Citi, the leading global bank, has approximately 200 million customer accounts and does business in more than 160 countries and jurisdictions. Citi provides consumers, corporations, governments and institutions with a broad range of financial products and services, including consumer banking and credit, corporate and investment banking, securities brokerage, transaction services, and wealth management.

Additional information may be found at www.citigroup.com | Twitter: @Citi | YouTube: www.youtube.com/citi | Blog: http://blog.citigroup.com | Facebook: www.facebook.com/citi | LinkedIn: www.linkedin.com/company/citi

About MasterCard
MasterCard, is a technology company in the global payments industry. We operate the world’s fastest payments processing network, connecting consumers, financial institutions, merchants, governments and businesses in more than 210 countries and territories. MasterCard products and solutions make everyday commerce activities – such as shopping, traveling, running a business and managing finances – easier, more secure and more efficient for everyone. Follow us on Twitter @MasterCardNews, join the discussion on the Beyond the Transaction Blog and subscribe for the latest news on the Engagement Bureau. 

American Airlines Corporate Communications
817-967-1577
mediarelations@aa.com

Barclaycard US
Matt Fields
302-255-7807
Mfields@barclaycardus.com

Citi
Liz Fogarty
212-559-0486

MasterCard
Jim Issokson
914-249-6286
james_issokson@mastercard.com
Tuesday, July 12th, 2016 Uncategorized Comments Off on $AAL, $C, $BCS, $MA Announce New #CreditCard Agreements

$SAGE Positive #Topline Results in Severe #PostpartumDepression

Primary endpoint achieved with statistical significance at 60 hours maintained through 30 days

70% remission achieved at 60 hours of SAGE-547 treatment and maintained at 30-day follow-up

Company expects to pursue further development of SAGE-547 and SAGE-217 for PPD in a global clinical program

Conference call scheduled for 8:00 AM ET today

Sage Therapeutics (NASDAQ:SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system disorders, today announced positive top-line results from its Phase 2 clinical trial of SAGE-547 for the treatment of severe postpartum depression (PPD). SAGE-547 achieved the primary endpoint of a significant reduction in the HAM-D score compared to placebo at 60 hours (p=0.008). This represented a greater than 20 point mean reduction in the depression scores of the SAGE-547 group at the primary endpoint of 60 hours through trial completion with a greater than 12 point difference from placebo. The statistically significant difference in treatment effect began at 24 hours, (p=0.006) with an effect that was maintained at similar magnitude through to the 30-day follow-up (p=0.01). Remission from depression, as determined by a HAM-D ≤7, measured at 60 hours, was seen in 7 of 10 of the SAGE-547 group compared with 1 of 11 in the placebo group (p=0.008). Similarly, at 30 days, 7 of 10 of the SAGE-547 group and 2 of 11 in the placebo group were in remission (p=0.03). SAGE-547 was found to be generally well-tolerated with no serious adverse events reported during the treatment and follow-up periods. A greater number of adverse events were reported in the placebo arm than in the treatment arm of the trial. There are no approved therapies specifically for PPD and therapeutic options in severe PPD are limited.

“This is potentially one of the most important clinical findings in the pharmacologic treatment of postpartum depression to date,” said Samantha Meltzer-Brody, M.D., M.P.H., Associate Professor and Director of the UNC Perinatal Psychiatry Program of the UNC Center for Women’s Mood Disorders and primary investigator for the PPD-202 Trial. “The rapid onset of action of this drug observed in the trial is unlike anything else available in the field to date. The data show the potential of the drug to provide relief from the debilitating symptoms of PPD, and to markedly decrease suffering in women who are severely affected.”

This was a Phase 2, multi-center, placebo-controlled, double-blind, 1:1 randomization trial that was designed to enroll up to 32 women. The population studied were women with severe PPD (HAM-D ≥26) who developed severe depression either in the third trimester or within four weeks of childbirth. At baseline, the mean HAM-D scores for both groups was greater than 28. The primary objective of the trial was to evaluate the effect of SAGE-547 on depression as measured by the HAM-D score, compared to placebo, at 60 hours. In addition, patients were monitored during a 30-day follow-up period to assess both safety and efficacy.

“These data speak for themselves. The unmet need in the PPD patient population cannot be overstated. Given the societal impact of this condition, and the possible identification of a biological basis for treating these women, we are hopeful these data will point to a new understanding of this disorder and the development of effective therapies” said Jeff Jonas, M.D., Chief Executive Officer of Sage. “Further, as the second positive placebo-controlled trial involving SAGE-547, the first being in essential tremor, this demonstrates the potential broad utility of our differentiated GABA mechanism and the candidate molecules in our pipeline, not only for neurological disorders, but now for mood and affective disorders as well. I am extremely proud of the great work from the Sage team and we are thankful to our patients and investigators.”

“There has been a long-standing need to find an effective treatment option for women with postpartum depression, not only to alleviate the suffering of those women struggling with the disease, but to mitigate the effect on their family and children. Based on our review of the literature, we believe these data represent an unprecedented opportunity for developing treatments for PPD, and believe that our findings will serve as a paradigm shift in how the disease is thought about and, if our development program is successful, how PPD might be treated in the future,” said Steve Kanes, M.D., Ph.D., Chief Medical Officer of Sage. “The results of this study replicate and extend the findings of our original, open-label probe study of PPD reported previously. Given the consistent activity signals seen in both our open-label and placebo-controlled trials, we also intend to examine the development pathways for several of our other proprietary pipeline compounds into the treatment of a variety of psychiatric disorders, such as major depression, bipolar disorder and panic disorder.”

Secondary endpoints, including the Montgomery–Åsberg Depression Rating Scale (MADRS), showed a similar pattern of significant difference (p=0.004) at 24 hours and maintained to 30 days (p=0.01). MADRS total scores at baseline were 37.5 and 37.0 for SAGE-547 and placebo groups, respectively. At 60 hours post-initiation of treatment, the mean change from baseline in MADRS total score for the SAGE-547 group was -27.9 compared with the placebo group mean change of -12.2; this treatment difference of 15.7 points was statistically significant (p=0.01). Presentation of more comprehensive data from the trial is expected at future medical meetings and in publications.

The company has initiated an expansion of this Phase 2 clinical program to determine optimal dosing of SAGE-547 in PPD. This expanded trial involves dose exploration in moderate as well as severe patients, in a multicenter, placebo-controlled trial of SAGE-547 with enrollment to begin before the end of the year. In addition, the company intends to move forward with a PPD program involving its oral molecule, SAGE-217, and to seek regulatory input to determine the appropriate pathways for developing both medications for this indication.

Summary of Top-line SAGE-547 Phase 2 Study Results

Effect on Depressive Symptoms

  • The 21 patients enrolled in the trial were required to have had a Major Depressive Episode that began no earlier than the third trimester and no later than the first four weeks following delivery, and to also be less than six months postpartum at the time of enrollment. Trial participants were also required to have a HAM-D score of 26 or above prior to treatment.
  • Patients were randomized one-to-one to either SAGE-547 or placebo, and were administered blinded IV inpatient treatment as a continuous infusion for 60 hours. Ten patients were randomized to SAGE-547 treatment, while 11 patients were randomized to placebo. Patients were allowed to remain on background medications that could not be adjusted during treatment. Only three patients in each group were on such medications.
  • The study was designed to titrate dosing based on body weight.
  • SAGE-547 achieved the primary endpoint with a significant reduction in the HAM-D scale compared to placebo at 60 hours (p=0.008).
  • SAGE-547 patients experienced a 19.0 point mean reduction in their HAM-D scores at 24 hours (p=0.006), achieving a greater than 10.6 point difference from placebo at that time point and was maintained at similar magnitude through to the 30-day follow-up (p=0.01).
  • Results from secondary efficacy endpoints, including other rating scales such as the MADRS, reinforced the overall efficacy observed with SAGE-547 in the trial.
  • Remission from depression, as determined by a HAM-D less than or equal to 7, measured at 60 hours, was seen in 7 of 10 SAGE-547 patients and 1 of 11 placebo patients (p=0.008). The remission finding in the SAGE-547 group was maintained out to 30 days (p=0.03), demonstrating a strong durability of effect from SAGE-547 for over three weeks following the end of treatment.

Safety and tolerability:

  • SAGE-547 was generally well tolerated in this study. There were no deaths, serious adverse events or discontinuations.
  • Overall, fewer patients who received SAGE-547 experienced adverse events compared with placebo: 4 of 10 on SAGE-547 and 8 of 11 on placebo.
  • Similar number of patients reported Nervous System Disorder Adverse Events: 3 of 10 on SAGE-547 and 4 of 11 on placebo.
  • Equal number of patients reported the cluster of dizziness, sedation or somnolence: 3 in each group.
  • Fewer SAGE-547 patients reported Psychiatric Disorder Adverse Events: 0 of 10 on SAGE-547 and 5 of 11 on placebo. Adverse events included abnormal dreams, insomnia and anxiety for placebo.

Conference Call Information
Sage will host a conference call and webcast today at 8:00 AM ET to discuss the SAGE-547 top-line Phase 2 results from the PPD-202 trial. The live webcast can be accessed on the investor page of Sage’s website at investor.sagerx.com. The conference call can be accessed by dialing 1-866-450-8683 (toll-free domestic) or 1-281-542-4847 (international) and using the conference ID 47918013. A replay of the webcast will be available on Sage’s website approximately two hours after the completion of the event and will be archived for up to 30 days.

About the Hamilton Rating Scale for Depression (HAM-D)
HAM-D is a validated rating scale used to provide an assessment of depression, and as a guide to evaluate recovery. This scale is an accepted regulatory endpoint for depression. The scale is used to rate the severity of their depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation, anxiety, weight loss, and somatic symptoms.

About Postpartum Depression
Postpartum depression (PPD) is an affective disorder impacting women after childbirth. PPD may have devastating consequences for a woman and for her family, which may include significant functional impairment, depressed mood and/or loss of interest in her newborn, and associated symptoms of depression such as loss of appetite, difficulty sleeping, motor challenges, lack of concentration, loss of energy and poor self-esteem. Women with severe PPD may be hospitalized to provide a safe and stable environment for recovery if they are severely ill or unable to function and care for themselves. Suicide is the leading cause of maternal death following childbirth. According to the Centers for Disease Control and Prevention, there were approximately four million live births in the US in 2014. We estimate that PPD affects 10%-15% of mothers. A subset of these are severe enough to require hospitalization. There are no approved therapies for severe PPD and there is a high unmet medical need for improved pharmacological therapy in PPD.

About SAGE-547
SAGE-547 is an allosteric modulator of both synaptic and extra-synaptic GABAA receptors. SAGE-547 is an intravenous agent evaluated in the PPD-202 trial, a multi-center, randomized, double-blind, parallel-group, placebo-controlled study evaluating the efficacy, safety and pharmacokinetics of SAGE-547 in the treatment of adult female subjects with severe postpartum depression requiring inpatient treatment. For more information about this trial please visit https://clinicaltrials.gov/show/NCT02614547.

SAGE-547 is also being developed as an adjunctive therapy for the treatment of super-refractory status epilepticus (SRSE) in the global Phase 3 STATUS Trial. For more information about the STATUS Trial, please visit www.statustrial.com. SAGE-547 has been granted both Fast Track and orphan drug designations by the FDA for the treatment of SRSE.

About SAGE-217
SAGE-217 is a next generation positive allosteric modulator that has been optimized for selectivity to synaptic and extrasynaptic GABA receptors and a pharmacokinetic profile intended for once-daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and CNS, and contributes significantly to regulating CNS function. In a recent Phase 1 clinical program, SAGE-217 was well-tolerated in single and multiple ascending doses and the results were consistent with the predicted pharmacokinetic and pharmacologic profile. Sage plans to develop SAGE-217 for PPD, essential tremor, and other GABA dysfunction-related disorders.

About Sage Therapeutics
Sage Therapeutics is a clinical-stage biopharmaceutical company committed to developing novel medicines to transform the lives of patients with life-altering central nervous system (CNS) disorders. Sage has a portfolio of novel product candidates targeting critical CNS receptor systems, GABA and NMDA. Sage’s lead program, SAGE-547, is in Phase 3 clinical development for super-refractory status epilepticus, a rare and severe seizure disorder, and is being developed for severe PPD. Sage is developing its next generation modulators, including SAGE-217, SAGE-689 and SAGE-718, with a focus on acute and chronic CNS disorders. For more information, please visit www.sagerx.com.

Forward-Looking Statements

Various statements in this release concern Sage’s future expectations, plans and prospects, including without limitation, our expectations regarding further development of SAGE-547 and SAGE-217 in the treatment of PPD; our plans to commence additional clinical trials of these product candidates, and the potential timing of such efforts; our view of the potential of SAGE-547 and SAGE-217 as a treatment for PPD; our view of the potential of the GABA mechanism and our product candidates in the treatment of other indications; our plans to pursue development of our product candidates in those indications, and in other diseases; and our views as to the unmet need for additional treatment options in PPD and estimated number of patients with PPD. These forward-looking statements are neither promises nor guarantees of future performance, and are subject to a variety of risks and uncertainties, many of which are beyond our control, which could cause actual results to differ materially from those contemplated in these forward-looking statements, including the risks that: we may not be able to successfully demonstrate the efficacy and safety of our product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies involving the same compound or other product candidates; and ongoing and future clinical results may not support further development of a product candidate or be sufficient to gain regulatory approval to market any product; decisions or actions of regulatory agencies may affect the initiation, timing, progress and cost of clinical trials, and our ability to proceed with further clinical trials of a product candidate in a particular indication or at all or our ability to obtain marketing approval; we may decide that a development pathway for one of our product candidates in one or more indications is no longer feasible or advisable or that the unmet need no longer exists; the number of patients with a particular disease or the unmet need for additional treatment options in a disease may be significantly smaller than we expect; and we may encounter technical and other unexpected hurdles in the development and manufacture of our product candidates; as well as those risks more fully discussed in the section entitled “Risk Factors” in our most recent Quarterly 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. In addition, any forward-looking statements represent our views only as of today, and should not be relied upon as representing our views as of any subsequent date. We explicitly disclaim any obligation to update any forward-looking statements.

 

Investor Contact:
Sage Therapeutics
Paul Cox, 617-299-8377
paul.cox@sagerx.com
or
Media Contact:
Suda Communications LLC
Maureen L. Suda, 585-387-9248
maureen.suda@sagerx.com

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$OTIV #SATURN8700 #ContactlessReader Achieves #FeliCa #Certification

Certification Provides oti With Early-Mover Advantage in Burgeoning Japanese Unattended Vending Market

ROSH PINA, ISRAEL–(Jul 11, 2016) – On Track Innovations Ltd. (oti) (NASDAQ: OTIV), a global provider of near field communication (NFC) and cashless payment systems, has achieved FeliCa™ certification for its new NFC-based cashless payment reader, the SATURN 8700.

Operated by Sony Corporation, FeliCa is a secure contactless smart card system and the primary settlement infrastructure used in Japan to make electronic money card payments. With nearly six million vending machines nationwide, the Japanese market represents the second largest opportunity globally for cashless payment solutions. The Japanese vending market is transitioning to cashless payments in order to support the demand from the 20 million foreign travelers annually, as well as the upcoming Rugby World Cup in 2019 and Tokyo Olympic Games in 2020.

In June 2015, oti partnered with Billing System Corporation to develop and distribute FeliCa-certified NFC-based cashless payment systems to the Japanese unattended market. The SATURN 8700 reader marks the first certified product under the partnership, and the companies plan to start marketing and selling the reader to leading Japanese companies immediately.

The SATURN 8700 reader’s unique form factor makes it the world’s smallest FeliCa- and EMVCo-certified reader, while also supporting other NFC contactless payments, like Mifare and P2P. With complete contactless connectivity and multiple mounting options, the SATURN 8700 is designed for unattended retail environments with self-service payment stations, including ATMs, ticket vending machines, toll roads, gaming machines, kiosks, access control, and mass transit.

“Being EMVCo- and now FeliCa-certified makes the SATURN 8700 an ideal payment solution for the Japanese market,” said oti CEO Shlomi Cohen. “This unique product and certification demonstrates the strength of our R&D capabilities and partnership with Billing System, and marks another important step in our expansion into new growth markets. We plan to leverage our early-mover advantage to fulfill the emerging demand for cashless vending solutions in Japan. In step with this, we are pursuing FeliCa-certification for our full line of products and systems to take advantage of this nationwide shift toward cashless payments.”

Toshihiko Eda, CEO of Billing System, added: “This is the first step in delivering oti’s industry-leading and field-proven solutions to the entire Japanese market. We believe that having FeliCa-certified products in the market will be very beneficial in enabling us to strengthen our product portfolio and increase our sales in the months and years ahead.”

About Billing System Corporation
Billing System Corporation provides total settlement and processing service in Japan including services related to payment gateway, mobile payment, remittance, billing, reconciliation, bank debit and finance.

About oti
On Track Innovations Ltd. (oti) is a leader in contactless and NFC applications based on its extensive patent and IP portfolio. oti’s field-proven innovations have been deployed around the world to address NFC and other cashless payment solutions, petroleum payment and management, cashless parking fee collection systems and mass transit ticketing. oti markets and supports its solutions through a global network of regional offices and alliances. For more information, visit www.otiglobal.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995 and other Federal securities laws. Whenever we use words such as “believe,” “expect,” “anticipate,” “intend,” “plan,” “estimate” or similar expressions, we are making forward-looking statements. For example, we are using forward-looking statements when we discuss our expectations regarding our growth or profitability, reduction of costs and expenses, expected divestitures, plans for our existing and new products and services, penetration of new markets and securing new customers, contributions of our regions to our growth, resolution of our outstanding patent infringement claims, strengthening of our balance sheet and delivery long-term shareholder value. Because such statements deal with future events and are based on oti’s current expectations, they are subject to various risks and uncertainties and actual results, performance or achievements of oti could differ materially from those described in or implied by the statements in this press release. Forward-looking statements could be impacted by the effects of the protracted evaluation and validation periods in the U.S. and other markets for contactless payment cards, or new and existing products and our ability to execute production on orders, as well as other risks and uncertainties, including those discussed in the “Risk Factors” section and elsewhere in our Annual Report on Form 10-K for the year ended December 31, 2015, and in subsequent filings with the Securities and Exchange Commission. Although we believe that the expectations reflected in such forward-looking statements are based on reasonable assumptions, we can give no assurance that our expectations will be achieved. Except as otherwise required by law, oti disclaims any intention or obligation to update or revise any forward-looking statements, which speak only as of the date hereof, whether as a result of new information, future events or circumstances or otherwise.

oti Investor Contact:
Scott Liolios or Matt Glover
Liolios Group, Inc.
949-574-3860
Email Contact

oti Press Contact:
Neil Barr
Director of Marketing
+972-4-686-8004
Email Contact

Monday, July 11th, 2016 Uncategorized Comments Off on $OTIV #SATURN8700 #ContactlessReader Achieves #FeliCa #Certification

$CDOR Announces #CommonStock #Dividend

BETHESDA, MD–(July 11, 2016) – Condor Hospitality Trust, Inc. (NASDAQ: CDOR), a hotel-focused real estate investment trust (REIT) headquartered and incorporated in the state of Maryland, today announced that its board of directors has declared a common stock dividend of $0.01 per share for the second quarter. The dividend will be payable on August 3, 2016, to shareholders of record as of July 22, 2016.

“We are pleased to declare and pay a dividend to the holders of our common stock for the first time since 2009,” said Bill Blackham, Condor’s Chief Executive Officer. “The recent redemption of the Company’s Series A & B Preferred Stock combined with the declaration and payment of dividends through June 30, 2016 on the Company’s Series D Preferred Sock enables the board of directors to approve the resumption of common stock dividends at this time. The board of directors intends to continue to review all circumstances in the future and consider the payment of common stock dividends, if permitted and in amounts it deems appropriate,” Blackham continued.

About Condor Hospitality Trust, Inc.

Condor Hospitality Trust, Inc. (NASDAQ: CDOR) is a self-administered real estate investment trust incorporated in the state of Maryland that specializes in the investment and ownership of upper midscale and upscale, premium-branded select-service, extended stay and limited-service hotels. The company currently owns 31 hotels in 16 states. Condor’s hotels are franchises of a number of the industry’s most well-regarded brand families including Hilton, Marriott, InterContinental Hotels Group, Choice, and Wyndham. For more information or to make a hotel reservation visit www.condorhospitality.com.

Certain matters within this press release are discussed using forward-looking language as specified in the Private Securities Litigation Reform Act of 1995, and, as such, may involve known and unknown risks, uncertainties and other factors that may cause the actual results or performance to differ from those projected in the forward-looking statement. These risks are discussed in the company’s filings with the Securities and Exchange Commission.

Jonathan Gantt
Chief Financial Officer and Senior Vice President
jgantt@trustcondor.com
(402) 371-2520

Monday, July 11th, 2016 Uncategorized Comments Off on $CDOR Announces #CommonStock #Dividend

$KTOS Receives Low-Cost #UAS Demo #Contract Award

Base Cost-Share Contract Award of $40.8 Million, with Potential Additional Government Funded Technology Spirals of Approximately $100 Million

SAN DIEGO, July 11, 2016  — Kratos Defense & Security Solutions, Inc. (Nasdaq:KTOS), a leading National Security Solutions provider announced today that its Unmanned Systems Division (KUSD) recently received a competitive, $40.8 million single award, cost-share contract by the Air Force Research Laboratory (AFRL) for the Low-Cost Attritable Strike Unmanned Aerial System (UAS) Demonstration (LCASD). This contract award is the result of a competitive acquisition with seven competitors. Under the contract award, KUSD will design, develop, deliver, demonstrate and test a technical baseline for a high-speed, long-range, low-cost, limited life-strike UAS.  Additional elements of the LCASD program include the identification of key enabling technologies for future low-cost attritable aircraft demonstrations, and the provision of a vehicle for future capability and technology demonstrations.  Under the $40.8 million cost-share contract, Kratos will receive $7.3 million in Government funding, and invest up to $33.5 million over the approximate 30 month period of performance.  For the Company’s investment, Kratos will retain hard and other assets including aircraft, related support and other equipment, and important intellectual property, software, data, platform, and system rights.  Additionally, planning by AFRL includes a desire to further evolve the system via subsequent technology maturation Government funded spirals valued at approximately $100 million.

The LCASD system KUSD will provide represents a configurable design for multiple variants anticipated to perform various missions that could require Nap-of-The-Earth (NOE) Flight, Cruising at High Altitudes, Defensive Counter Air (DCA) Maneuvers, Offensive Counter Air (OCA) Maneuvers, the Suppression of Enemy Air Defenses (SEAD) and the Destruction of Enemy Air Defenses (DEAD).  Additionally, the System will also incorporate performance capability including extreme agility for missile avoidance maneuvers for improved survivability. The Kratos LCASD design will meet or in certain cases significantly exceed the following stated Air Force goals for the program:

  • UAS Acquisition Cost: $3 million or less for the first unit up to 99 units, and $2 million or less for 100 or greater unit quantity purchases.
  • 1,500 nautical mile mission radius with a 500 lb. payload.
  • Capable of Mach 0.9 Dash.
  • Maximum G load limits, maneuver rates, and subsystem environmental suitability.
  • Internal weapons capability; sized to carry and deliver at least two GBU-39 small diameter bombs.
  • Runway Independent Take-off and Landing capability.
  • Emphasis on the use of Commercial-Off-The-Shelf (COTS) materials, sub-systems, manufacturing processes, and open mission system architecture concepts.
  • Tactical consideration of the vehicle shape, elimination of gaps and mismatches, and aero-structural inlet integration.

Jerry Beaman, President of Kratos Unmanned Systems Division, said, “The LCASD program is another important step in establishing Kratos in the growing Tactical Unmanned Aerial Vehicle marketplace, with survivable, high performance, mission flexible, tactical platforms designed to counter the potential adversaries of today, and the future.”

Eric Demarco, President and CEO of Kratos Defense & Security Solutions, Inc., said, “The LCASD contract award is one of the most important Unmanned Tactical Aerial System awards for Kratos to date, and we are honored to have been selected in a very competitive process.  With this win, Kratos has now received each of the most recent high performance unmanned tactical or combat aerial system awards to date, including a DARPA Gremlins Prime win, and a separate Tactical UAS win, which we believe validates our strategy, technology, capabilities and cost effectiveness in the Combat UAS arena.  Additionally, and most importantly, we believe that this Government–Industry partnership will result in the demonstration of arguably the world’s most capable and affordable long-range strike UAV.”

Mr. DeMarco went on, “Similar to other Kratos unmanned drone systems, with LCASD, Kratos’ strategy includes an internally funded investment over the approximate three year initial contract period of performance, for which our Company will own and retain aircraft, support equipment, software, other assets, and intellectual property, all of which we believe will be critically important and valuable over the expected long term life of this platform, including future production.  We believe that the LCASD aircraft will be an incredibly important strategic platform for multiple users once developed, reflected by the production quantity purchase price targets of $3 million per aircraft for block order quantities below 99 units, and $2 million per aircraft for block quantity order buys of 100 units or more.  The potential multiple year revenue, profitability and cash flow opportunity of this program and platform is significant, and Kratos’ winning approach and technology resulted in success for this highly competed contract award.”

Mr. DeMarco continued, “Also importantly, investments we have been making in the manned-unmanned teaming technologies area will all play together as we work with U.S. DoD entities to shape future capability sets.  We believe that ever present budget pressures placed on the U.S. DoD, coupled with Kratos’ proven and affordable technologies which we have demonstrated we can field in very short time periods, including Kratos’ UTAP-22 Tornado UAS, positions the Company well for participation in this growing and new market space.”

Mr. DeMarco concluded, “Kratos’ award of LCASD is another significant milestone in our building a leading high performance tactical unmanned combat aerial system business.  With the success and progress we have made with AFRL LCASD, DARPA Gremlins, UTAP-22, an additional recent tactical UAS award, other opportunities, and the multiple new unmanned aerial target drone system production programs that we expect to begin later this year and in 2017, we expect increasing future revenues, Adjusted EBITDA profitability and cash flow.  Accordingly, we now have a very clear path for the business with significant near, mid and long term growth opportunities.”

Kratos will provide additional details on the LCASD award, Kratos’ investment and the related aircraft, other assets and intellectual property Kratos will retain during the Company’s second quarter earnings conference call.

About Kratos Defense & Security Solutions
Kratos Defense & Security Solutions, Inc. (Nasdaq:KTOS) is a mid-tier government contractor at the forefront of the Department of Defense’s Third Offset Strategy.  Kratos is a leading technology, intellectual property and proprietary product and solution company focused on the United States and its allies’ national security.  Kratos is the industry leader in high performance unmanned aerial drone target systems used to test weapon systems and to train the warfighter, and is a provider of high performance unmanned combat aerial systems for force multiplication and amplification.  Kratos is also an industry leader in satellite communications, microwave electronics, cyber security/warfare, missile defense and combat systems.  Kratos has primarily an engineering and technically oriented work force of approximately 2,700. Substantially all of Kratos’ work is performed on a military base, in a secure facility or at a critical infrastructure location. Kratos’ primary end customers are National Security related agencies. News and information are available at www.KratosDefense.com.

Notice Regarding Forward-Looking Statements
Certain statements in this press release may constitute “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are made on the basis of the current beliefs, expectations and assumptions of the management of Kratos and are subject to significant risks and uncertainty. Investors are cautioned not to place undue reliance on any such forward-looking statements. All such forward-looking statements speak only as of the date they are made, and Kratos undertakes no obligation to update or revise these statements, whether as a result of new information, future events or otherwise. Although Kratos believes that the expectations reflected in these forward-looking statements are reasonable, these statements involve many risks and uncertainties that may cause actual results to differ materially from what may be expressed or implied in these forward-looking statements. For a further discussion of risks and uncertainties that could cause actual results to differ from those expressed in these forward-looking statements, as well as risks relating to the business of Kratos in general, see the risk disclosures in the Annual Report on Form 10-K of Kratos for the year ended December 27, 2015, and in subsequent reports on Forms 10-Q and 8-K and other filings made with the SEC by Kratos.

 

Press Contact:
Yolanda White
858-812-7302 Direct

Investor Information:
877-934-4687
investor@kratosdefense.com
Monday, July 11th, 2016 Uncategorized Comments Off on $KTOS Receives Low-Cost #UAS Demo #Contract Award

$CHRS Positive Topline Results for CHS-1701 Study

BLA submission anticipated in the third quarter 2016

REDWOOD CITY, Calif., July 11, 2016  — Coherus BioSciences, Inc. (NASDAQ:CHRS), a leading global biosimilars company with late-stage clinical products, today reported topline results from its follow-on pharmacokinetic and pharmacodynamic (PK/PD) clinical study of CHS-1701, a pegfilgrastim (Neulasta®) biosimilar candidate. This study met all of its co-primary endpoints for PK, Cmax and Area Under the Curve (AUC), and PD, absolute neutrophil count, and ANC (ANCmax and ANC AUC). For both endpoints, the 90% Confidence Intervals (CI) for the Geometric Mean Ratio (GMR) were well contained within the pre-specified margins of 80% to 125%.

This randomized, single-blind, three-sequence, three-period crossover study in healthy subjects assessed PK, PD, and safety (including immunogenicity) of a 6 mg subcutaneous (SC) injection of CHS-1701 compared to 6 mg SC dose of Neulasta. A total of 122 healthy volunteer subjects were randomized to one of three treatment sequences, each with three treatments.  Subject inclusion criteria, procedures and study design, as well as other measures, reflected modifications addressing findings in the previous study CHS-1701-03, successfully decreasing subject variability and eliminating the extreme subject outliers previously observed.

“As has been seen, pegfilgrastim is a relatively biologically complex molecule.  Our novel and innovative study design allowed us to evaluate and successfully control for the contribution of subject variability to the PK/PD parameters, validating our hypothesis regarding the outliers seen in the earlier study.  Based on the totality of the data, including this clinical result as well as those from the previous PK/PD study and the successful immunogenicity study, we are confident that CHS-1701 is highly biosimilar to the reference product, Neulasta, and will produce the expected clinical effect in patients, said Barbara Finck, M.D., Chief Medical Officer of Coherus BioSciences.

Safety Summary
The safety profiles of CHS-1701 and Neulasta were very similar. There were no serious adverse events related to either study drug or clinical meaningful difference between CHS-1701 or Neulasta leading to study drug discontinuations.

“This PK/PD study represents continued strong scientific and technical execution in a transformative year for Coherus, enabling an anticipated third quarter BLA filing and the ultimate launch of our first oncology biosimilar to the largest selling oncology product in the U.S.,” said Denny Lanfear, Chairman and CEO of Coherus BioSciences. “Biosimilar pegfilgrastim clinical development has proven to be more difficult for many than initially thought, resulting in a favorable competitive dynamic for Coherus at this point. We anticipate CHS-1701 to be the first in a portfolio of oncology biosimilars we intend to commercialize and the cornerstone of our U.S. oncology franchise that also includes our Avastin biosimilar, currently moving forward as planned, as well as other product candidates.”

Commercial plans and preparations are expected to begin later this year.  Long-term agreements with our manufacturing partner for CHS-1701 to secure an ample and reliable high quality supply have already been established, as previously disclosed.

Coherus will hold a conference call on Monday, July 11, 2016 at 12:00 noon ET.

Conference Call Information
Dial-in: (844) 452-6826 (domestic) or (765) 507-2587 (international)
Conference ID:  46834647
Please join the conference call at least 10 minutes early to register.

A replay of this conference call will be available through July 18, 2016
Dial-in: (855) 859-2056 (domestic) or (404) 537-3406 (international)
Conference ID:  46834647

About Coherus BioSciences, Inc.
Coherus is a leading global biosimilar company that develops and commercializes high-quality therapeutics for major regulated markets. Biosimilars are intended for use in place of existing, branded biologics to treat a range of chronic and often life-threatening diseases, with the potential to reduce costs and expand patient access. Composed of a team of proven industry veterans with world-class expertise in process science, analytical characterization, protein production and clinical-regulatory development, Coherus is positioned as a leader in the global biosimilar marketplace. Coherus is advancing three late-stage clinical products towards commercialization, CHS-1701 (pegfilgrastim biosimilar), CHS-0214 (etanercept biosimilar) and CHS-1420 (adalimumab biosimilar), as well as developing a robust pipeline of future products in four therapeutic areas, oncology, immunology (anti-TNF), ophthalmology and multiple sclerosis. For additional information, please visit www.coherus.com.

Forward-Looking Statements
Except for the historical information contained herein, the matters set forth in this press release, including statements regarding Coherus’ plans, potential opportunities including market opportunities, expectations, goals, objectives, strategies, product pipeline, clinical studies, product development, and the potential benefits of its products under development are forward-looking statements within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including Coherus’ ability to further the clinical development of, obtain marketing approval for and commercialize CHS-1701. Such forward-looking statements involve substantial risks and uncertainties that could cause our 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, the uncertainties inherent in the clinical drug development process, including the regulatory approval process, the timing of our regulatory filings and other matters that could affect the availability or commercial potential of our biosimilar drug candidates, as well as possible patent litigation. Coherus 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 Coherus’ business in general, see Coherus’ Quarterly Report on Form 10-Q for the quarter ended March 31, 2016, filed with the Securities and Exchange Commission on May 9, 2016 and its future periodic reports to be filed with the Securities and Exchange Commission.

Neulasta® is a registered trademark of Amgen Inc.

CONTACT:
Patrick O’Brien
Senior Vice President, Investor Relations
Coherus BioSciences, Inc.
pobrien@coherus.com
+1 (650) 649-3527
Monday, July 11th, 2016 Uncategorized Comments Off on $CHRS Positive Topline Results for CHS-1701 Study

$TACOW to #Exchange #CommonStock for up to 6.75M Outstanding #Warrants

Del Taco Restaurants, Inc. (Nasdaq:TACO, TACOW) (the “Company,” “we” or “our”) today announced that it has commenced an offer to exchange (“Offer to Exchange”) 0.2780 shares of the Company’s common stock (“Shares”) for each outstanding Company warrant exercisable for Shares at an exercise price of $11.50 per Share (the “Warrants”) (approximately one Share for every 3.6 Warrants tendered), up to a maximum of 6,750,000 Warrants.

The Offer to Exchange commenced today and will expire, unless extended, at 11:59 p.m., Eastern Time, on Friday, August 5, 2016. Tenders of Warrants must be made prior to the expiration of the Offer to Exchange and may be withdrawn at any time prior to the expiration of the Offer to Exchange.

The purpose of the Offer to Exchange is to reduce the number of Shares that would become outstanding upon the exercise of Warrants. All outstanding Warrants are eligible to be tendered pursuant to the Offer (subject to proration as described below). The Company’s board of directors believes that by allowing holders of Warrants to exchange one Warrant for 0.2780 Shares, the Company can potentially reduce the substantial number of Shares that would be issuable upon exercise of the Warrants, thus providing investors and potential investors with greater certainty as to the Company’s capital structure. For example, if all of the 6,750,000 eligible Warrants were validly tendered in the Offer, the Company would issue 1,876,500 Shares in exchange for such tendered Warrants. However, if all of the 6,750,000 eligible Warrants were exercised for Shares pursuant to the terms of the Warrants, the Company would issue 6,750,000 Shares in such exercise.

The Offer to Exchange is not conditioned on the tender of any minimum number of Warrants. The Offer to Exchange is, however, subject to certain customary conditions.

The Company will exchange all Warrants properly tendered and not properly withdrawn prior to the expiration of the Offer to Exchange, subject to proration, as described in the Offer to Exchange Letter that was filed with the U.S. Securities and Exchange Commission (the “SEC”) and is being distributed to Warrant holders. Because of the proration provisions described in the Offer to Exchange Letter, the Company may exchange less than all of the Warrants tendered by a Warrant holder if more than an aggregate of 6,750,000 Warrants are properly tendered and not properly withdrawn.

All of our directors and executive officers who beneficially own Warrants have agreed to participate in the Offer and in aggregate have agreed to tender not less than 1,500,000 of their Warrants.

Levy Family Partners, LLC holds 1,769,652 Warrants. Lawrence F. Levy and Ari B. Levy, each a director of the Company, are two of the four managers of Levy Family Partners, LLC. The four managers of Levy Family Partners, LLC, acting by majority vote, exercise voting and dispositive control over the Warrants held by Levy Family Partners, LLC. Levy Family Partners, LLC has agreed to tender not less than 665,000 of its Warrants.

The Ari Levy 2003 Investment Trust, a trust established for the benefit of Ari B. Levy, a director of the Company, holds 1,792,095 Warrants. The Ari Levy 2003 Investment Trust has agreed to tender not less than 670,300 of its Warrants.

PW Acquisitions, LP holds 600,000 Warrants. Patrick Walsh, a director of the Company, is the chief executive officer and managing member of the General Partner of PW Acquisitions, LP and exercises voting and dispositive power over these Warrants. PW Acquisitions, LP has agreed to tender not less than 164,000 of its Warrants.

The R.J. Investment Trust, a trust established for the benefit of R.J. Melman, a director of the Company, holds 2,500 Warrants. The R.J. Investment Trust has agreed to tender not less than 700 of its Warrants.

None of the Company, its board of directors, officers or employees, nor the financial advisor, depositary or the information agent makes any recommendations to Warrant holders as to whether to tender or refrain from tendering their Warrants pursuant to the Offer to Exchange Letter. Warrant holders must decide how many Warrants they will tender, if any.

In March 2016, the Company’s board of directors authorized the Company to repurchase up to $25 million of the Company’s outstanding Shares and Warrants. The Company has repurchased 990,555 Shares and 476,806 Warrants under the repurchase program for an aggregate of $10.5 million, consisting of $9.5 million to repurchase Shares and $1.0 million to repurchase Warrants, with $14.5 million remaining for future repurchases of Shares and Warrants under this authorization. There has been no change to this program as a result of the Offer to Exchange. The timing, actual number and value of shares purchased will depend on the Company’s stock price, market conditions, and other factors. As of July 8, 2016, the Company had 37,976,206 outstanding Shares and 12,162,817 outstanding Warrants.

The financial advisor for the Offer to Exchange is Piper Jaffray & Co. The information agent for the Offer to Exchange is Morrow Sodali. The depositary for the Offer to Exchange is Continental Stock Transfer & Trust Company. The Offer to Exchange, Letter of Transmittal and related documents are being mailed to Warrant holders of record and will be made available for distribution to beneficial owners of the Warrants.

Additional Information. This press release is for informational purposes only and is not an offer to purchase or a solicitation of an offer to sell securities. The Offer to Exchange described above is made only pursuant to a Tender Offer Statement on Schedule TO and related exhibits, including the Offer to Exchange Letter, Letter of Transmittal and other related documents, filed with the SEC. Warrant holders should read the Tender Offer Statement on Schedule TO, Offer to Exchange Letter, Letter of Transmittal and related exhibits, as they contain important information about the Offer to Exchange. Warrant holders can obtain these documents free of charge from the SEC’s website at www.sec.gov, or by directing a request to the information agent for the Offer to Exchange, Morrow Sodali, toll-free (855) 291-6792 (banks and brokerage firms, please call (203) 658-9400).

About Del Taco Restaurants, Inc.

Founded in 1964 in Southern California, Del Taco (NASDAQ: TACO) is the nation’s second largest Mexican Quick Service Restaurant chain. Known for serving Mexican and American favorites prepared fresh in every restaurants’ working kitchen, Del Taco’s menu items taste better because they are made with fresh ingredients like cheddar cheese grated from 40-lb blocks, hand chopped pico de gallo, fresh sliced avocado, slow cooked beans made from scratch, and fresh-grilled marinated chicken and carne asada steak. In June 2016, Del Taco reinvigorated its UnFreshing Believable® marketing campaign to further communicate its commitment to serve guests everything that they love, including choosing not to choose between tacos and fries, fresh prep and fair price, or great tasting food and the convenience of a drive thru. With nearly 550 restaurants in 16 states, Del Taco serves more than three million guests each week. For more information, follow Del Taco on Twitter, Facebook and Instagram or visit www.deltaco.com.

Forward-Looking Statements

In addition to historical information, this release may contain a number of “forward-looking statements” as defined in the Private Securities Litigation Reform Act of 1995. Forward-looking statements include, without limitation, information concerning completion of the Offer to Exchange, the Company’s possible or assumed future results of operations, business strategies, competitive position, industry environment, potential growth opportunities and the effects of regulation. These statements are based on the Company’s management’s current expectations and beliefs, as well as a number of assumptions concerning future events. When used in this press release, the words “estimates,” “projected,” “expects,” “anticipates,” “forecasts,” “plans,” “intends,” “believes,” “seeks,” “target,” “may,” “will,” “should,” “future,” “propose,” “preliminary,” “guidance” and variations of these words or similar expressions (or the negative versions of such words or expressions) are intended to identify forward-looking statements. Such forward-looking statements are subject to known and unknown risks, uncertainties, assumptions and other important factors, many of which are outside the Company’s management’s control that could cause actual results to differ materially from the results discussed in the forward-looking statements. These risks include, without limitation, consumer demand, our inability to successfully open company-owned or franchised restaurants or establish new markets, competition in our markets, our inability to grow and manage growth profitably, adverse changes in food and supply costs, our inability to access additional capital, changes in applicable laws or regulations, food safety and foodborne illness concerns, our inability to manage existing and to obtain additional franchisees, our inability to attract and retain qualified personnel, our inability to profitably expand into new markets, changes in, or the discontinuation of, the Company’s stock and Warrant repurchase program, and the possibility that we may be adversely affected by other economic, business, and/or competitive factors. Additional risks and uncertainties are identified and discussed in the Company’s reports filed with the SEC and available at the SEC’s website at www.sec.gov and the Company’s website at www.deltaco.com.

Forward-looking statements included in this release speak only as of the date of this release. The Company undertakes no obligation to update its forward-looking statements to reflect events or circumstances after the date of this release or otherwise.

 

For Del Taco Restaurants, Inc.
Media:
Julia Young, 646-277-1280
julia.young@icrinc.com
or
Investor Relations:
Raphael Gross, 203-682-8253
investor@deltaco.com

Monday, July 11th, 2016 Uncategorized Comments Off on $TACOW to #Exchange #CommonStock for up to 6.75M Outstanding #Warrants

$BLFS Executes 10 Year #SupplyAgreement w/ #KitePharma for #CryoStor

BOTHELL, Wash., July 11, 2016  — BioLife Solutions, Inc. (NASDAQ: BLFS), a leading developer, manufacturer and marketer of proprietary clinical grade cell and tissue hypothermic storage and cryopreservation freeze media and a related cloud hosted biologistics cold chain management app for smart shippers (“BioLife” or the “Company”), today announced that it has entered into a ten year supply agreement with Kite Pharma, a leading developer of chimeric antigen receptor (CAR) and T cell receptor (TCR) products for various cancers.

The agreement provides for Kite’s supply of BioLife’s CryoStor clinical grade freeze media for cells and tissues, which is embedded in Kite’s manufacturing process for KTE-C19, a CAR T cell therapy currently in four clinical trials for various cancers.

Marc Better, Vice President, Product Sciences at Kite Pharma, noted, “Over the last several years we have worked to qualify and adopt CryoStor in our clinical manufacturing process. We are now securing long term supply continuity for this reagent as our cell therapy product candidate continues to progress through multiple clinical trials.”

Mike Rice, BioLife President & CEO, commented, “We are honored that Kite has adopted CryoStor in their production process for truly remarkable and potentially life-saving cellular therapies. We are committed to supporting Kite with great customer service and high quality products and look forward to the interim data readout from Kite’s first clinical trial later this year.”

About BioLife Solutions

BioLife Solutions develops, manufactures and markets biopreservation media products and smart shipping containers connected to a cloud hosted cold chain management app to improve the quality of delivery logistics for cells, tissues, and organs. The Company’s proprietary HypoThermosol® and CryoStor® platform of solutions are highly valued in the biobanking, drug discovery, and regenerative medicine markets. BioLife’s biopreservation media products are serum-free and protein-free, fully defined, and are formulated to reduce preservation-induced cell damage and death.  BioLife’s enabling technology provides commercial companies and clinical researchers significant improvement in shelf life and post-preservation viability and function of cells, tissues, and organs.

The biologistex cloud based cold chain management service is an integrated logistics and tracking and trace web app used by shippers of time and temperature sensitive biologic materials.  The evo Smart Shipper is a state of the art precision thermal shipping container with embedded payload monitoring, GPS location tracking, and cellular communication electronics that transmit critical shipment information to the cloud.  This SaaS app enables users to monitor high value shipments during transit and configure actionable alerts for downstream recipients for location, approaching destination, delivery, package open, and remaining shelf life or stability via the patent pending StableAlert™ countdown timer. For more information please visit www.biolifesolutions.com, and follow BioLife on Twitter.

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

Media & Investor Relations
Roderick de Greef
Chief Financial Officer
(425) 686-6003
rdegreef@biolifesolutions.com

Monday, July 11th, 2016 Uncategorized Comments Off on $BLFS Executes 10 Year #SupplyAgreement w/ #KitePharma for #CryoStor

$LVNTB Announces New Proposed Distribution Date for Spin-off of #CommerceHub

Liberty Interactive Corporation (“Liberty”) (Nasdaq: QVCA, QVCB, LVNTA, LVNTB), announced today a new proposed distribution date in connection with its upcoming spin-off (the “Spin-off”) of its subsidiary CommerceHub, Inc. (“CH Parent”). Because CH Parent’s registration statement for the Spin-Off is still under review with the Securities and Exchange Commission, the new proposed distribution date will be 5:00 p.m., New York City time, on July 22, 2016 (previously announced as July 13, 2016). The record date will remain 5:00 p.m., New York City time, on July 8, 2016.

In the Spin-off, Liberty will distribute, by means of a dividend (the “Distribution”), to holders of its Series A and Series B Liberty Ventures common stock (i) 0.1 of a share of the corresponding series of CH Parent common stock and (ii) 0.2 of a share of CH Parent Series C common stock, in each case, for each share of Liberty Ventures common stock held as of the record date.

Liberty expects that the CH Parent Series A and Series C common stock will begin trading in the “regular way” on the Nasdaq Global Select Market under the symbols “CHUBA” and “CHUBK,” and that the CH Parent Series B common stock will be quoted on the OTC Markets under the symbol “CHUBB,” in each case, beginning on July 25, 2016.

The completion of the Spin-off remains subject to the satisfaction or waiver, as applicable, of a number of conditions. Additional information relating to the Spin-off, including the ex-dividend date of the Distribution and when-issued trading, will be announced once available.

This press release includes certain forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995, including statements about the completion of the Spin-off. These forward-looking statements involve many risks and uncertainties that could cause actual results to differ materially from those expressed or implied by such statements, including, without limitation, Liberty’s ability to satisfy the conditions to the Spin-off. These forward-looking statements speak only as of the date of this press release, and Liberty expressly disclaims any obligation or undertaking to disseminate any updates or revisions to any forward-looking statement contained herein to reflect any change in Liberty’s expectations with regard thereto or any change in events, conditions or circumstances on which any such statement is based. Please refer to the publicly filed documents of Liberty, including the most recent Forms 10-K and 10-Q, for additional information about Liberty and about the risks and uncertainties related to Liberty’s business which may affect the statements made in this press release.

About Liberty Interactive Corporation

Liberty Interactive Corporation operates and owns interests in a broad range of digital commerce businesses. Those businesses are currently attributed to two tracking stock groups: the QVC Group and the Liberty Ventures Group. The businesses and assets attributed to the QVC Group (Nasdaq: QVCA, QVCB) consist of Liberty Interactive Corporation’s subsidiaries, QVC, Inc. and zulily, llc, and its interest in HSN, Inc., and the businesses and assets attributed to the Liberty Ventures Group (Nasdaq: LVNTA, LVNTB) consist of all of Liberty Interactive Corporation’s businesses and assets other than those attributed to the QVC Group, including its interest in Expedia, Interval Leisure Group and FTD, its subsidiaries Bodybuilding.com, CommerceHub and Evite, and minority interests in Time Warner, Liberty Broadband Corporation, Lending Tree and Charter Communications, Inc.

Friday, July 8th, 2016 Uncategorized Comments Off on $LVNTB Announces New Proposed Distribution Date for Spin-off of #CommerceHub

$FGEN Announces Receipt of $62 Million License Payment from $AZN

SAN FRANCISCO, July 08, 2016 — FibroGen, Inc. (Nasdaq:FGEN) (“FibroGen”), a research-based biopharmaceutical company, announced today that it has received a scheduled $62 million license payment pursuant to its collaboration agreement with AstraZeneca (“AstraZeneca”) for the United States and certain other territories.

AstraZeneca and FibroGen are collaborating on the development and commercialization of roxadustat (FG-4592) for the treatment of anemia in patients with CKD in the U.S., China, and other markets. Astellas and FibroGen are collaborating on the development and commercialization of roxadustat in Europe, Japan, the Commonwealth of Independent States, the Middle East, and Africa.

For information about roxadustat studies that are currently recruiting patients, please visit clinicaltrials.gov at this link: https://clinicaltrials.gov/ct2/results?term=roxadustat&Search=Search

About Roxadustat
Roxadustat is currently in Phase 3 development as a potential therapy for anemia associated with chronic kidney disease in both patients on dialysis and not on dialysis. Roxadustat is an orally administered small molecule inhibitor of hypoxia-inducible factor (HIF) prolyl hydroxylase activity. HIF is a protein transcription factor that induces the natural physiological response to conditions of low oxygen, “turning on” erythropoiesis (the process by which red blood cells are produced) and other protective pathways.

About Chronic Kidney Disease
Chronic kidney disease (CKD) affects more than 200 million people worldwide and more than 30 million adults in the U.S. Although the disease can occur at any age, it becomes more common in aging populations and its prevalence is increasing. Anemia is a common complication of CKD and is associated with significant morbidity and mortality in both the dialysis and non-dialysis populations. In addition, CKD can be both a cause and a consequence of cardiovascular disease and is now a critical worldwide healthcare issue that represents a large and growing unmet medical need.  Currently, no curative treatment or ability to stop kidney deterioration in patients with CKD exists, with the exception of kidney transplantation.

About FibroGen
FibroGen is a research-based biopharmaceutical company focused on the discovery, development, and commercialization of novel therapeutics to treat serious unmet medical needs. The company utilizes its extensive experience in fibrosis and hypoxia-inducible factor (HIF) biology to generate development programs in multiple therapeutic areas. Its most advanced product candidate, roxadustat, or FG-4592, is an oral small molecule inhibitor of HIF prolyl hydroxylases (HIF-PHs) in Phase 3 clinical development for the treatment of anemia in CKD.  A second product candidate, FG-3019, is a monoclonal antibody in Phase 2 clinical development for the treatment of idiopathic pulmonary fibrosis (IPF), pancreatic cancer, and Duchenne muscular dystrophy (DMD).  For more information please visit: www.fibrogen.com

About AstraZeneca

AstraZeneca is a global, science-led biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines, primarily for the treatment of diseases in three main therapy areas – Respiratory and autoimmunity, Cardiovascular and metabolic diseases, and Oncology. We are also active in inflammation, infection, and neuroscience through collaborations. AstraZeneca operates in over 100 countries and its innovative medicines are used by millions of patients worldwide. For more information please visit: www.astrazeneca.com

Forward-Looking Statements
This release contains forward-looking statements, including statements regarding the clinical and commercial potential of roxadustat. Our actual results may differ materially from these early data and any forward-looking statements due to risks and uncertainties that are described in our Annual Report on Form 10-K and our quarterly reports on Form 10-Q filed with the Securities and Exchange Commission, including the risk factors set forth therein. 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.

Contact information
FibroGen, Inc.
Leanne Price 1.415.978.1200
lprice@fibrogen.com
Friday, July 8th, 2016 Uncategorized Comments Off on $FGEN Announces Receipt of $62 Million License Payment from $AZN

$CXDC Announces Commissioning Ceremony, New Facility in #Sichuan

Sichuan Plant Launches Operations

HARBIN, China, July 8, 2016  — China XD Plastics Company Limited (NASDAQ: CXDC, “China XD Plastics” or the “Company”), one of China’s leading specialty chemical companies engaged in the development, manufacture and sale of polymer composite materials primarily for automotive applications, today announces that it held a commissioning ceremony on July 7, 2016 at its new Sichuan manufacturing facility.

“We are grateful for the tremendous support from the Nanchong municipal and Shunqing district authorities as our new production facility in Sichuan Province was completed in a little over a year since the company broke ground,” said Jie Han, Chairman of the Board of Directors and Chief Executive Officer. “The commissioning ceremony featured our new, high-tech facility which is fully automated, and plant tours showcased the culmination of the cooperative efforts between our project development team and officials in the region and many partners who understand the evolution of China’s Southwest region into a major high-tech and transportation manufacturing center to include automobiles, high-speed rail, shipping and aviation. With over 700 participants, we were able to showcase how our Sichuan campus will diversify our product platform into additional high-growth verticals such as advanced transportation, bio-degradable materials, medical-grade materials and food packaging.”

“Our plant has been designed at the highest production specifications with state-of-the-art equipment to facilitate product deployment into new growth verticals while maintaining the highest standards in quality control and batch consistency,” continued Mr. Han. “The new facility extends our geographical reach beyond our established Harbin base and new facilities in Dubai.”

“The Sichuan plant will solidify our company leadership position with effective market coverage and penetration. It was evident at the commissioning ceremony that our commitment to quality, new technologies and loyal customers has enabled us to achieve another corporate milestone,” concluded Mr. Han.

It is expected that extensive local and major Chinese media will be reporting on the event.

About China XD Plastics Company Limited

China XD Plastics Company Limited, through its wholly-owned subsidiaries, develops, manufactures and sells polymer composites materials, primarily for automotive applications. The Company’s products are used in the exterior and interior trim and in the functional components of 28 automobile brands manufactured in China, including without limitation, Audi, Mercedes Benz, BMW, Buick, Chevrolet, VW Passat, Golf and Jetta, Mazda, and Toyota. The Company’s wholly-owned research center is dedicated to the research and development of polymer composites materials and benefits from its cooperation with well-known scientists from prestigious universities in China. As of March 31, 2016, 369 of the Company’s products have been certified for use by one or more of the automobile manufacturers in China. For more information, please visit the Company’s English website at http://www.chinaxd.net, and the Chinese website at http://www.xdholding.com.

Safe Harbor Statement

This announcement contains forward-looking statements within the meaning of the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. All statements other than statements of historical fact in this announcement are forward-looking statements, including but not limited to, the Company’s growth potential in international markets; the effectiveness and profitability of the Company’s product diversification strategy; the impact of the Company’s product mix shift to more advanced products and related pricing policies; the volatility of the Company’s operating results and financial condition; the Company’s ability to raise additional capital to finance the Company’s activities; the Company’s and its subsidiaries’ ability to fully perform all of their obligations under the guaranteed senior notes transaction and other contractual obligations applicable to them; the effectiveness, profitability, and the marketability of its the ongoing mix shift to more advanced products; the prospect of the Company’s Dubai facility, and the associated expansion into Middle East, Europe and other parts of Asia; the prospect of the Company’s Southwest China facility, and its penetration into Southwest China; the impact of volatile crude oil prices on the Company’s efforts to diversify its product offers; market for plastic resins; legal and regulatory risks; the Company’s projections of its revenues for performance in fiscal in 2016; the Company’s ability to execute its growth strategy and the effectiveness of its marketing strategy; the future trading of the common stock of the Company; the Company’s ability to operate as a public company; the period of time for which its current liquidity will enable the Company to fund its operations; general economic and business conditions; the volatility of the Company’s operating results and financial condition; the Company’s ability to attract or retain qualified senior management personnel and research and development staff; and other risks detailed in the Company’s filings with the Securities and Exchange Commission and available on its website at http://www.sec.gov. These forward-looking statements involve known and unknown risks and uncertainties and are based on current expectations, assumptions, estimates and projections about the Company and the industry. The Company undertakes no obligation to update forward-looking statements to reflect subsequent occurring events or circumstances, or to changes in its expectations, except as may be required by law. Although the Company believes that the expectations expressed in these forward looking statements are reasonable, it cannot assure you that its expectations will turn out to be correct, and investors are cautioned that actual results may differ materially from the anticipated results.

Contacts:

China XD Plastics
Mr. Taylor Zhang, CFO (New York)
Phone: +1 (212) 747-1118
Email: cxdc@chinaxd.net

Investor Relations: Grayling Communications Inc.
Ms. Vivian Chen, Managing Director
US: +1 (347) 481-3711
Email: Vivian.chen@grayling.com

Friday, July 8th, 2016 Uncategorized Comments Off on $CXDC Announces Commissioning Ceremony, New Facility in #Sichuan

$ECTE Common Stock to Transition from #NASDAQ to #OTCQB

ISELIN, N.J., July 8, 2016  — Echo Therapeutics, Inc. (Nasdaq: ECTE), a medical device company focused on non-invasive continuous glucose monitoring (CGM) and associated technologies, today announced that the company has received notice on July 8, 2016 from the Nasdaq Stock Market (Nasdaq) that trading of the Company’s common stock will be suspended on Nasdaq at the opening of business on Tuesday, July 12, 2016, and Nasdaq will file a Form 25 Notification of Delisting with the Securities and Exchange Commission.

Effective July 12, 2016, Echo expects that its common stock will trade on the OTCQB® Venture Market, operated by OTC Markets Group Inc. under its current trading symbol “ECTE.” Echo anticipates that beginning Tuesday, July 12, 2016, investors will be able to view real-time best bid and ask quotes for “ECTE” at www.otcmarkets.com and through most online broker websites.

As stated in Nasdaq’s letter, the Company was before the Nasdaq Hearing Panel on February 25, 2016, for failing to meet the shareholders’ equity requirement. The Panel issued a decision on March 9, 2016, continuing the listing. The Company was required, by the terms of that decision and pursuant to applicable listing rules, to demonstrate compliance with the requirement of a minimum $2.5 million in stockholders’ equity by July 5, 2016. The Company was unable to meet the terms of the exception by July 5, 2016.

“The progress that we have made in the development of our NextGen CGM system has begun to make a positive difference in the performance and outlook of the Company, but other recent factors negatively impacting the stock price don’t currently make it possible to comply with Nasdaq continued listing criteria,” commented Scott W. Hollander, Echo’s President and CEO. “While we anticipate trading on the OTCQB, we remain focused on our R&D efforts to bring our technology to market.”

About Echo Therapeutics

Echo Therapeutics is developing its non-invasive, wireless, continuous glucose monitoring (CGM) system. A significant opportunity exists for the Company’s CGM to be used in the outpatient diabetes market and in the fitness, weight loss and personal lifestyle wearable-health space. A longer-term opportunity also exists in the hospital settings. Echo developed its needle-free skin preparation device as a platform technology that allows for enhanced skin permeation enabling extraction of analytes, such as glucose, and enhanced delivery of topical pharmaceuticals.

Cautionary Statement Regarding Forward Looking Statements

The statements in this press release that are not historical facts may constitute forward-looking statements that are based on current expectations and are subject to risks and uncertainties that could cause actual future results to differ materially from those expressed or implied by such statements. Those risks and uncertainties include, but are not limited to, risks related to regulatory approvals and the success of Echo’s clinical studies, the safety and efficacy of Echo’s CGM System, the failure of future development and preliminary marketing efforts related to Echo’s CGM System, Echo’s ability to secure additional commercial partnering arrangements, risks and uncertainties relating to Echo’s and its partners’ ability to develop, market and sell Echo’s CGM System, the availability of substantial additional equity or debt capital to support its research, development and product commercialization activities, and the success of its research, development, regulatory approval, marketing and distribution plans and strategies, including those plans and strategies related to its CGM System. These and other risks and uncertainties are identified and described in more detail in Echo’s filings with the Securities and Exchange Commission, including, without limitation, its Annual Report on Form 10-K for the year ended December 31, 2015, its Quarterly Reports on Form 10-Q, and its Current Reports on Form 8-K. Echo undertakes no obligation to publicly update or revise any forward-looking statements.

For More Information:
Christine H. Olimpio
Director, Investor Relations and Corporate Communications
(732) 201-4189                                                          

Connect With Us:
– Visit our website at www.echotx.com
– Follow us on Twitter at www.twitter.com/echotx
– Join us on Facebook at www.facebook.com/echotx

Friday, July 8th, 2016 Uncategorized Comments Off on $ECTE Common Stock to Transition from #NASDAQ to #OTCQB

$STXS #Niobe ES System Installed at #Texas Children’s Hospital

First pediatric institution in U.S. to offer magnetic navigation technology for cardiac ablation

ST. LOUIS, July 08, 2016  — Stereotaxis, Inc. (NASDAQ:STXS), a global leader in innovative technologies for the treatment of cardiac arrhythmias, today announced that Texas Children’s Hospital in Houston has installed the Company’s Niobe® ES system, making it the only pediatric hospital in the country to offer the latest generation remote magnetic navigation platform for ablation procedures. Texas Children’s is recognized as one of the top children’s hospitals in the nation, ranked #2 nationally in cardiology and heart surgery by U.S. News & World Report.

“We are privileged to provide this cutting-edge treatment for our patients with arrhythmias in whom cardiac ablations are deemed necessary,” said Dr. Jeffrey Kim, director of the Arrhythmia and Pacing Service at Texas Children’s. “With the Niobe system, we can more quickly and aggressively target and ablate abnormal electrical impulses in young children and patients with structurally complex anatomy. This is an important tool in our armamentarium for this highly specialized procedure and undoubtedly advances our approach to pediatric cardiac rhythm management.”

Kim is one of four physicians utilizing the Niobe system at the hospital, primarily for patients with congenital heart disease or Wolf-Parkinson-White syndrome, a type of supraventricular tachycardia. The Arrhythmia and Pacing Service at Texas Children’s, which is one of the highest volume pediatric centers in the country for invasive electrophysiology studies, first installed Stereotaxis technology in March 2009. In 2012, the hospital conducted a comparative study of the magnetic platform versus manual catheter navigation for ablation of accessory pathways in children, recording significantly reduced fluoroscopy times in the magnetic patient group, an essential benefit for vulnerable pediatric patients.

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

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

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

 

Company Contact:	
Martin C. Stammer	
Chief Financial Officer
314-678-6155

Investor Contact:		
Todd Kehrli / Jim Byers	
MKR Group, Inc.		
323-468-2300			
stxs@mkr-group.com
Friday, July 8th, 2016 Uncategorized Comments Off on $STXS #Niobe ES System Installed at #Texas Children’s Hospital

$CLWT Reports Contract Awarded to PACT

HONG KONG, July 8, 2016  — Euro Tech Holdings Company Limited (Nasdaq: CLWT) today announced that its subsidiary, PACT Environmental Technology Company Ltd. (“PACT”) has recently been awarded a contract worth about US$ 6 million by a foreign mobile phone company.

This contract covers design, supply, installation and the commissioning of industrial wastewater treatment and scrubber systems for its OEM plants in Shanghai, Shenzhen and Zhengzhou, China.

About PACT:

PACT Environmental Technology Co. Ltd., based in Shanghai, is a global provider of environmental solutions for industrial and municipal clients, focusing on water and wastewater treatment. Pact’s capabilities cover design, manufacturing, sourcing, installation and servicing of water/wastewater treatment, water desalination plants and equipment.

Certain statements in this news release regarding the Company’s expectations, estimates, present view of circumstances or events, and statements containing words such as estimates, anticipates, intends, or expects, or words of similar import, constitute forward looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. Such statements indicate uncertainty and the Company can give no assurance with regard to actual outcomes. Specific risk factors may include, without limitation, having the Company’s offices and operations situated in Hong Kong and mainland China, doing business in mainland China, competing with Chinese manufactured products, competing with the Company’s own suppliers, dependence on vendors, and lack of long term written agreements with suppliers and customers, development of new products, entering new markets, possible downturns in business conditions, increased competition, loss of significant customers, availability of qualified personnel, negotiating definitive agreements, new marketing efforts and the timely development of resources. See the “Risk Factor” discussions in the Company’s filings with the Securities and Exchange Commission, including its Annual Report on Form 20-F for its fiscal year ended December 31, 2015.

Website: http://www.euro-tech.com, PACT’s Website: http://www.pactchina.com

Friday, July 8th, 2016 Uncategorized Comments Off on $CLWT Reports Contract Awarded to PACT

$ALQA & #BSNmedical Announce #DefinitiveAgreement on #DistributionRights for #Sorbion

YARDLEY, Pa. and CHARLOTTE, N.C., July 07, 2016  — Alliqua BioMedical, Inc. (NASDAQ:ALQA) (“Alliqua”), a provider of advanced wound care products, today announced that Alliqua signed a definitive agreement with BSN medical, Inc. (“BSN”), a global integrated medical therapy provider for the sale to BSN of Alliqua’s exclusive distribution rights for SORBION®SACHET® and SORBION®SANA primary dressings in the United States, Canada and Latin America. Subject to the terms and conditions of the definitive agreement, BSN will pay Alliqua total consideration of up to $4.4 million for the purchase by BSN of all of the rights out of Alliqua’s existing distribution agreement with former Sorbion GmbH & Co KG (now owned by BSN medical).

“The sale of Alliqua’s exclusive distribution rights for the SORBION® dressing products represents an opportunity for us to add important growth capital to our balance sheet and to focus our future investments on commercializing our own highly differentiated advanced wound care and regenerative technologies in MIST® Therapy, BIOVANCE® and, later this year, Interfyl™,” said David Johnson, Chief Executive Officer of Alliqua.

“We believe our entire experience with the distribution rights for the SORBION® dressings is illustrative of the strong value creation that our organization can provide in the wound care space,” Johnson continued. “After identifying an unmet need in the U.S. market, we secured the distribution rights for the SORBION® dressings in late-2013, and leveraged our highly-focused wound care distribution infrastructure to establish the product franchise in the U.S. and ultimately grow it into a strong commercial line in just two and a half years.”

“BSN medical is one of the few research-based wound care companies that can offer a comprehensive portfolio of integrated therapeutic solutions. We are very excited that SORBION® products are now also part of our wound care and vascular franchise in the world´s largest markets, the U.S., Canada and Latin America. With their patent-protected design and best-in-class superabsorbent core built on Hydrokinetic® fibers and Hydration Response® technology, these products offer an innovative therapeutic choice for patients suffering from particularly challenging wounds with high levels of exudate,” Dr Guido Oelkers, Chief Executive Officer of BSN medical Group, stated.

“This agreement is a perfect strategic fit for BSN medical following our acquisition of SORBION, as we just recently announced the launch of two new wound care products in the U.S., including products featuring BSN´s DACC Technology, a powerful alternative to silver antimicrobial dressings. With this step we are fueling our growth plans in the American markets and will strengthen our position in the therapeutic area of advanced wound care,” Oelkers commented.

The above description of the definitive agreement does not purport to be complete and is qualified in its entirety by reference to the definitive agreement, which Alliqua will file as exhibit to its Securities and Exchange Commission filings.

Background:
In September, 2013, Alliqua Biomedical signed an agreement with Sorbion GmbH & Co KG, pursuant to which Alliqua became the exclusive distributor of SORBION SACHET® and SORBION® SANA in the United States, Canada and Latin America. In November 2014, BSN medical announced the acquisition of Sorbion GmbH & Co. KG, Germany, as a result of which all of the rights and obligations under Alliqua’s distribution agreement were assigned to BSN. The term of Alliqua’s distribution agreement was scheduled to end on December 31, 2018.

Alliqua Fiscal Year 2016 Revenue Outlook:
Alliqua is updating its revenue guidance for the fiscal year 2016 period, which was originally issued on February 23, 2016 and reaffirmed on May 10, 2016, to account for the anticipated impact of the transition of distribution rights for SORBION® products.

For the fiscal year ending December 31, 2016, Alliqua now expects total revenue of $20 million to $22 million. This updated guidance range compares to the prior range of $22 million to $24 million, and represents growth in the range of approximately 33% to 46% year-over-year and growth in the range of approximately 5% to 15% on a pro forma basis, assuming Alliqua had recorded a full year of MIST® Therapy revenue. Revenue on a pro forma basis for the fiscal year ended December 31, 2015 was approximately $19.1 million. Alliqua acquired MIST® Therapy through its acquisition of Celleration on May 29, 2015. Alliqua will use approximately $1.75 million of the proceeds of this transaction to reduce its outstanding debt balance in accordance with its Credit Agreement with Perceptive Credit Opportunities Fund, L.P.

About Alliqua BioMedical, Inc.

Alliqua is a provider of advanced wound care solutions, committed to restoring tissue and rebuilding lives. Through its sales and distribution network, together with its proprietary products, Alliqua provides a suite of technological solutions to enhance the wound care practitioner’s ability to deal with the challenges of healing both chronic and acute wounds. Alliqua’s Mist Therapy System® uses painless, noncontact low-frequency ultrasound to stimulate cells below the wound bed to promote the healing process. Alliqua markets the human biologic wound care product BIOVANCE® and its line of dressings for wound care under the SilverSeal® and Hydress® brands, as well as its TheraBond® 3D Antimicrobial Barrier Dressings which incorporates SilverTrak® technology.

In addition, Alliqua can provide a custom manufacturing solution to partners in the medical device and cosmetics industry, utilizing its hydrogel technology. Alliqua’s electron beam production process, located at its 16,500 square foot Good Manufacturing Practice (GMP) manufacturing facility, allows Alliqua to custom manufacture a wide variety of hydrogels. Alliqua’s hydrogels can be customized for various transdermal applications to address market opportunities in the treatment of wounds as well as the delivery of numerous drugs or other agents for pharmaceutical and cosmetic industries. Alliqua has locations in Yardley, PA, Langhorne, PA and Eden Prairie, MN.

For additional information, please visit http://www.alliqua.com. To receive future press releases via email, please visit http://ir.stockpr.com/alliqua/email-alerts.

About BSN medical

BSN medical is a global leader in wound care and related vascular diseases, lymphology and non-invasive orthopaedic products. Founded in 2001, BSN medical currently employs approximately 6,100 members of staff and generated revenues of € 861m in 2015. BSN aims to provide an integrated therapy-driven approach – grounded in a broad portfolio of products, enhanced by insights into current therapeutic areas and complemented by a progressive approach to partnerships. Its well-known brands such as Leukoplast®, Cutimed®, JOBST®/JOBST® Elvarex®, Delta Lite® and Delta Cast® and Actimove® are among the most trusted in healthcare. With its comprehensive product portfolio, BSN medical addresses patients’ needs in the most prevalent conditions in wound care and vascular diseases, and orthopaedic treatments. U.S. offices are headquartered in Charlotte, N.C.
For additional information please visit www.bsnmedical.com or www.bsnmedical.us

Legal Notice Regarding Forward-Looking Statements:

This release contains forward-looking statements. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend,” or “project” or the negative of these words or other variations on these words or comparable terminology. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous factors and uncertainties outside of our control that can make such statements untrue, including, but not limited to, the adequacy of Alliqua’s liquidity to pursue its complete business objectives; inadequate capital; Alliqua’s ability to obtain reimbursement from third party payers for its products; loss or retirement of key executives; adverse economic conditions or intense competition; loss of a key customer or supplier; entry of new competitors and products; adverse federal, state and local government regulation; technological obsolescence of Alliqua’s products; technical problems with Alliqua’s research and products; Alliqua’s ability to expand its business through strategic acquisitions; Alliqua’s ability to integrate acquisitions and related businesses;  price increases for supplies and components; and the inability to carry out research, development and commercialization plans.  In addition, other factors that could cause actual results to differ materially are discussed in Alliqua’s filings with the SEC, including Alliqua’s most recent Annual Report on Form 10-K filed with the SEC, and Alliqua’s most recent Form 10-Q filings with the SEC. Investors and security holders are urged to read these documents free of charge on the SEC’s web site at http://www.sec.gov. Alliqua undertakes no obligation to publicly update or revise its forward-looking statements as a result of new information, future events or otherwise.

CONTACT: Investor Relations Alliqua:
Westwicke Partners on behalf of Alliqua Biomedical, Inc.
Mike Piccinino, CFA +1-443-213-0500
AlliquaBiomedical@westwicke.com

CONTACT: Media Relations BSN medical:
Friederike Herrfurth, Director Corporate Communications & Press Relations Officer
+352 621 53 1674
friederike.herrfurth@bsnmedical.com
Thursday, July 7th, 2016 Uncategorized Comments Off on $ALQA & #BSNmedical Announce #DefinitiveAgreement on #DistributionRights for #Sorbion

$PZG Completes #Acquisition of #CalicoResources

WINNEMUCCA, NEVADA–(July 7, 2016) – Paramount Gold Nevada Corp. (NYSE MKT:PZG) (“Paramount” or the “Company”) announced today that Paramount has completed its acquisition of Calico Resources Corp. (“Calico”) pursuant to the Arrangement Agreement dated March 14, 2016 (the “Agreement”) after having received the approval of the Supreme Court of British Columbia to the transaction on July 5, 2016. Calico is now a wholly-owned subsidiary of Paramount.

Pursuant to the Agreement, Paramount issued 7,171,209 common shares to Calico shareholders as per the exchange ratio whereby Calico stockholders had the right to receive 0.07 of a share of common stock of Paramount for every common share of Calico.

At the special meeting of its stockholders held on June 29, 2016, Paramount stockholders owning approximately 97.8% of the shares present in person or represented by proxy at the Paramount meeting, voted in favor of the arrangement proposal. Calico stockholders owning approximately 97.4% of the shares present in person or represented by proxy, voted in favor of Calico’s proposal at a special meeting of its stockholders also held on June 29, 2016.

  • Glen Van Treek, Paramount’s President and CEO, said: “We are pleased with the overwhelming vote of support from Calico stockholders. The acquisition not only diversifies and improves our asset base but it also strengthens our stockholder composition. The addition of the Grassy Mountain project is a textbook fit to our corporate strategy and the Paramount team is looking forward to continuing its advancement towards a production decision.”

Key investment highlights of the Calico acquisition are as follows:

  • Adds a second advanced-stage asset which more than doubles the Company’s measured plus indicated contained ounces of precious metals;
  • Significantly improves the overall gold grade of the Company’s global resources;
  • Increases the Company’s exploration upside potential; and
  • Reduces shareholder risk by diversifying the Company’s assets.

The Grassy Mountain Gold Project consists of approximately 9,300 acres with its main deposit located on private land in Malheur County, Oregon. The Grassy Mountain gold-silver deposit has a completed Preliminary Economic Assessment (“PEA”) and key permitting milestones have been accomplished. Please refer to the amended technical report titled “Amended Preliminary Economic Assessment, Calico Resources Corp. Grassy Mountain Project, Malheur County, Oregon USA” and dated July 9, 2015.

The PEA contemplates a 10 year underground mining operation with low cash operating costs driven by a high average underground gold grade of 5.32 g/T gold. The annual average production of 53,000 ounces of gold and 82,000 of silver yield robust economics assuming a $1,300 gold price and silver at $17.50 per ounce. At a 5% discount rate, the project produces an estimated pre-tax NPV of $144 million and a 32.6% IRR. The PEA is preliminary in nature and includes inferred mineral resources that are considered too speculative geologically to have the economic considerations applied to them that would enable them to be categorized as mineral reserves. Consequently, there is no certainty that the PEA will be realized.

Paramount’s immediate action plans are to improve confidence in Grassy Mountain’s overall project design and development in preparation for completing a Pre-feasibility Study with the commencement of a core drilling program in 2016. The key aspects of the going forward plan are:

  • To improve metallurgical testing and to optimize the recovery process;
  • To generate the geotechnical information needed for optimal mine and infrastructure design and location;
  • To improve geological, geometallurgical and geotechnical models;
  • To better define and potentially reduce capital cost estimates for mine construction and operation; and
  • To continue with environmental data collection required for the mine operation permitting process.
Grassy Mountain Mineral Inventory (1,2,3,4,5)
MEASURED
tons (000s) Au opt Au g/T Ounces Au (000s) Ag opt Ag g/T Ounces Ag (000s)
Underground 3,157 0.155 5.33 491 0.263 9.0 829
Open Pit 52,645 0.020 0.67 1,027 0.072 2.5 3,784
Total 55,802 0.027 0.93 1,518 0.083 2.8 4,613
INDICATED
tons (000s) Au opt Au g/T Ounces Au (000s) Ag opt Ag g/T Ounces Ag (000s)
Underground 88 0.149 5.13 13 0.163 5.6 14
Open Pit 12,803 0.010 0.33 122 0.027 0.9 350
Total 12,891 0.010 0.36 135 0.028 1.0 364
MEASURED PLUS INDICATED
tons (000s) Au opt Au g/T Ounces Au (000s) Ag opt Ag g/T Ounces Ag (000s)
Underground 3,246 0.155 5.32 504 0.260 8.9 843
Open Pit 65,447 0.018 0.60 1,149 0.063 2.2 4,133
Total 68,693 0.024 0.82 1,653 0.072 2.5 4,977
INFERRED
tons (000s) Au opt Au g/T Ounces Au (000s) Ag opt Ag g/T Ounces Ag (000s)
Underground
Open Pit 221 0.007 0.24 2 0.010 0.3 2
Total 221 0.007 0.23 2 0.010 0.3 2
(1) Rounding may cause apparent discrepancies (2) Underground and Open Pit material are exclusive from each other (3) tons= imperial tonnes; T= metric Tonnes (4) Underground Cut-off grade = 0.065 opt Au (5) Open pit Cut-off grade = 0.005 opt Au

Mineral resources that are not mineral reserves do not have demonstrated economic viability.

For more information on the Grassy Mountain Gold Project including the Preliminary Economic Assessment, please visit our website. The technical and scientific information contained in this news release have been reviewed and approved by Scott Wilson, CPG, of Metal Mining Consultants, a “qualified person” as defined by National Instrument 43-101 Standards of Disclosure for Mineral Projects (“NI 43-101”). Mr. Wilson is independent of Paramount and has verified the data within this release.

The common shares of Calico have been halted for trading and are to be delisted from the TSX Venture Exchange as of the close of business today, July 7, and the Company will cause Calico to voluntarily surrender Calico’s reporting issuer status in British Columbia and will apply to the Alberta Securities Commission to terminate Calico’s reporting issuer status in Alberta.

About Paramount Gold Nevada Corp.

Paramount Gold Nevada is a U.S. based precious metals exploration company. Paramount’s strategy is to create shareholder value through the exploration and development of U.S. properties and then selling to, or entering into joint ventures with, producers for construction and operation. Paramount owns a 100% interest in the Sleeper Gold Project located in Northern Nevada. The Sleeper Gold Project, which includes the former producing Sleeper high-grade gold mine, totals 2,322 unpatented mining claims (approximately 60 square miles or 15,500 hectares). Paramount also holds a 100% interest in the Grassy Mountain Gold Project which consists of approximately 9,300 acres located on private land in Malheur County, Oregon. The Grassy Mountain project contains a gold-silver deposit for which a Preliminary Economic Assessment (“PEA”) has been prepared and key permitting milestones have been accomplished. With its substantial ownership of U.S. gold resources on a per share basis, Paramount offers its shareholders significant leverage to a rising gold price.

Cautionary Note to U.S. Investors Concerning Estimates of Indicated and Inferred Resources

This news release uses the terms “measured and indicated resources” and “inferred resources”. We advise U.S. investors that while these terms are defined in, and permitted by, Canadian regulations, these terms are not defined terms under SEC Industry Guide 7 and not normally permitted to be used in reports and registration statements filed with the SEC. “Inferred resources” have a great amount of uncertainty as to their existence, and great uncertainty as to their economic and legal feasibility. It cannot be assumed that all or any part of an inferred mineral resource will ever be upgraded to a higher category. Under Canadian rules, estimates of inferred mineral resources may not form the basis of a feasibility study or prefeasibility studies, except in rare cases. The SEC normally only permits issuers to report mineralization that does not constitute SEC Industry Guide 7 compliant “reserves”, as in-place tonnage and grade without reference to unit measures. U.S. investors are cautioned not to assume that any part or all of mineral deposits in this category will ever be converted into reserves. U.S. investors are cautioned not to assume that any part or all of an inferred resource exists or is economically or legally minable.

Safe Harbor for Forward-Looking Statements

This release and related documents may include “forward-looking statements” and “forward-looking information” (collectively, “forward-looking statements”) pursuant to applicable United States and Canadian securities laws, including, but not limited to, the Company’s anticipated plans for the Grassy Mountain Project and the potential for any mining or production at the Grassy Mountain Project. These statements relate to analysis and other information that are based on expectations of future performance as set out in the PEA, including gold and silver production and planned work programs. In addition, forward-looking statements relate to, among other things, Paramount’s strategies and plans, the attractiveness of the Grassy Mountain Project as a development option; the exploration potential at the Grassy Mountain Project; development scenarios at the Grassy Mountain Project; timing of receipt of permits and regulatory approvals; the sufficiency of the Company’s capital to finance the Company’s operations; geological interpretations and potential mineral recovery processes. Forward-looking statements are subject to a variety of known and unknown risks, uncertainties and other factors that could cause actual events or results to differ from those reflected in the forward-looking statements including, without limitation, risks relating to: uncertainty as to actual capital costs, operating costs, production and economic returns, and uncertainty that development activities will result in a profitable mining operation at the Grassy Mountain Project; fluctuations in the spot and forward price of gold or certain other commodities; changes in national and local government legislation, taxation, controls, regulations and political or economic developments in the United States; the uncertainties involved in interpreting geological data; business opportunities that may be presented to, or pursued by, the Company; operating or technical difficulties in connection with mining activities; the speculative nature of gold exploration and development, including the risks of obtaining necessary licenses and permits, risks related to mineral exploration estimates being based on interpretations and assumptions which may result in less mineral production under actual conditions than is currently estimated and to diminishing quantities or grades of mineral resources as the Grassy Mountain Project is mined; and contests over title to properties, particularly title to undeveloped properties. In addition, there are risks and hazards associated with the business of gold exploration, development and mining, including environmental hazards, industrial accidents, unusual or unexpected formations, pressures, cave-ins, flooding and gold bullion losses (and the risk of inadequate insurance, or the inability to obtain insurance, to cover these risks.

Forward-looking statements are based on the reasonable assumptions, estimates, analyses and opinions of management made in light of its experience and its perception of trends, current conditions and expected developments, as well as other factors that management believes to be relevant and reasonable in the circumstances at the date that such statements are made, but which may prove to be incorrect. Management believes that the assumptions and expectations reflected in such forward-looking statements are reasonable. Assumptions have been made regarding, among other things: Paramount’s ability to carry on exploration and development activities, including construction; the timely receipt of required approvals; the price of silver, gold and other metals; prices for key mining supplies, including labor costs and consumables, remaining consistent with current expectations; production meeting expectations and being consistent with estimates and plant, equipment and processes operating as anticipated. Paramount’s future expectations, beliefs, goals, plans or prospects constitute forward-looking statements within the meaning of the United States Private Securities Litigation Reform Act of 1995 and other applicable securities laws. Words such as “believes,” “plans,” “anticipates,” “expects,” “estimates” and similar expressions should also be considered to be forward-looking statements.

Except as required by applicable law, Paramount disclaims any intention or obligation to update any forward-looking statements as a result of developments occurring after the date of this document.

Paramount Gold Nevada Corp.
Glen Van Treek
President, CEO and Director

Chris Theodossiou
Director of Corporate Communications
866-481-2233

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$PTCT NHS England Enables Access to #Translarna

–Important decision allows reimbursed access to Translarna, the first approved therapy to treat the underlying cause of Duchenne muscular dystrophy–

SOUTH PLAINFIELD, New Jersey, July 7, 2016  — PTC Therapeutics, Inc. (NASDAQ: PTCT) today announced that the company and NHS England have successfully negotiated a Managed Access Agreement (MAA) for Translarna (ataluren) for ambulatory patients aged five years and older with nonsense mutation Duchenne muscular dystrophy (nmDMD).  This decision provides reimbursed patient access to Translarna in England via a five-year MAA.  Translarna previously received a positive recommendation from the National Institute for Health and Care Excellence (NICE) in April of 2016, subject to PTC and NHS England finalizing the terms of the MAA. NICE is expected to issue final guidance later this month following execution of the MAA, with implementation soon after.

Primarily affecting males, Duchenne muscular dystrophy (DMD) is a progressive muscle disorder caused by the lack of functional dystrophin protein. Dystrophin is critical to the structural stability of skeletal, diaphragm, and heart muscles. Patients with DMD lose the ability to walk from as early as 10 years of age and experience life-threatening lung and heart complications in their late teens and early twenties.

“This is an important day in England for children and young adults suffering from DMD,” said Stuart W. Peltz, Ph.D., Chief Executive Officer, PTC Therapeutics, Inc. “We are extremely pleased to have reached a successful outcome with NHS England, which will provide long-awaited access to Translarna for patients with nonsense mutation DMD. We are grateful to the patients, families, advocacy groups and physicians for their tremendous effort in supporting PTC Therapeutics throughout this important and rigorous access process.”

PTC and NHS England have now finalized the outstanding aspects of the MAA which include a confidential financial arrangement and the collection of further data on the efficacy of Translarna for the treatment of nmDMD over a five-year period with NICE guidance to be reviewed again at the end of that period, before future funding decisions are taken.

Translarna received marketing authorization from the European Commission to treat nmDMD in August 2014, which is currently under annual review by the European Medicines Agency with an opinion on renewal expected mid-2016. Translarna is currently available to patients in more than 20 countries through either expanded access programs or commercial sales.

About Translarna™ (ataluren)
Translarna, discovered and developed by PTC Therapeutics, Inc., is a protein restoration therapy designed to enable the formation of a functioning protein in patients with genetic disorders caused by a nonsense mutation. A nonsense mutation is an alteration in the genetic code that prematurely halts the synthesis of an essential protein. The resulting disorder is determined by which protein cannot be expressed in its entirety and is no longer functional, such as dystrophin in Duchenne muscular dystrophy. Translarna is licensed in the European Economic Area for the treatment of nonsense mutation Duchenne muscular dystrophy in ambulatory patients aged five years and older. Translarna is an investigational new drug in the United States. The development of Translarna has been supported by grants from Cystic Fibrosis Foundation Therapeutics Inc. (the nonprofit affiliate of the Cystic Fibrosis Foundation); Muscular Dystrophy Association; FDA’s Office of Orphan Products Development; National Center for Research Resources; National Heart, Lung, and Blood Institute; and Parent Project Muscular Dystrophy.

Further information about Translarna, including the European Public Assessment Report, Summary of Product Characteristics and Patient Information Leaflet, is available on the European Medicines Association website.

This medicinal product is subject to additional monitoring. Healthcare professionals are asked to report any suspected adverse reactions via the national reporting system or to PTC at medinfo@ptcbio.com.

About PTC Therapeutics, Inc.
PTC is a global biopharmaceutical company focused on the discovery, development and commercialization of orally administered, proprietary small molecule drugs targeting an area of RNA biology we refer to as post-transcriptional control. Post-transcriptional control processes are the regulatory events that occur in cells during and after a messenger RNA is copied from DNA through the transcription process. PTC’s internally discovered pipeline addresses multiple therapeutic areas, including rare disorders and oncology. PTC has discovered all of its compounds currently under development using its proprietary technologies. PTC plans to continue to develop these compounds both on its own and through selective collaboration arrangements with leading pharmaceutical and biotechnology companies. For more information on the company, please visit our website www.ptcbio.com.

For More Information:

Investors:
Jane Baj
+1 (908) 912-9176
jbaj@ptcbio.com

Media:
Justine O’Malley
+1 (908) 912-9551
jomalley@ptcbio.com

Forward Looking Statements:
All statements, other than those of historical fact, contained in this press release, are forward-looking statements, including statements regarding the: future expectations, plans and prospects for PTC; timing and outcome of PTC’s regulatory strategy and process, including the execution of the MAA, issuance of final guidance from NICE with respect to Translarna, the implementation of such guidance in England, and the European Medicines Agency’s (EMA) opinion with respect to the potential renewal or approval of the marketing authorization for Translarna in nmDMD in the European Economic Area (EEA) and any restrictions or conditions that may be placed on any such renewal or approval; PTC’s ability to maintain its current marketing authorizations, including its ability to satisfy any obligations or conditions that may be placed on its marketing authorization in the EEA, or obtain and maintain additional marketing authorizations; the clinical utility and potential advantages of Translarna; PTC’s ability to continue to supply Translarna to patients across Europe and in other territories; PTC’s strategy, future operations, future financial position, future revenues or projected costs; and the objectives of management.  Other forward-looking statements may be identified by the words “plan,” “anticipate,” “believe,” “estimate,” “expect,” “intend,” “may,” “predict,” “target,” “potential,” “will,” “would,” “could,” “should,” “continue,” and similar expressions.

PTC’s actual results, performance or achievements could differ materially from those expressed or implied by forward-looking statements it makes as a result of a variety of risks and uncertainties, including those related to: expectations with respect to execution of the MAA, whether final guidance from NICE recommends Translarna for the treatment of nmDMD; actual reimbursement decisions by NHS England; PTC’s ability to maintain its marketing authorization of Translarna for the treatment of nmDMD in the EEA, including whether the EMA’s Committee for Medicinal Products for Human Use determines that the benefit-risk balance of Translarna supports renewal or approval of PTC’s marketing authorization in the EEA and any restrictions or conditions that may be placed on any such renewal or approval; the timing and outcome of future interactions PTC has with the FDA with respect to Translarna for the treatment of nmDMD, including whether PTC is required to perform additional clinical and non-clinical trials at significant cost and whether such trials, if successful, may enable FDA review of a NDA submission; whether other regulators agree with PTC’s interpretation of the results of ACT DMD; the EMA’s determinations with respect to PTC’s variation submission which seeks to add Translarna for the treatment of nonsense mutation cystic fibrosis to PTC’s marketing authorization in the EEA; the scope of regulatory approvals or authorizations for Translarna (if any), including labeling and other matters that could affect the availability or commercial potential of Translarna; PTC’s ability to commercialize and commercially manufacture Translarna in general and specifically as a treatment for nmDMD;  the outcome of pricing and reimbursement negotiations in those territories in which PTC is authorized to sell Translarna; whether patients and healthcare professionals may be able to access Translarna through alternative means if pricing and reimbursement negotiations in the applicable territory do not have a positive outcome; expectations for regulatory approvals, including PTC’s ability to make regulatory submissions in a timely manner (or at all), the period during which the outcome of regulatory reviews will become available, adverse decisions by regulatory authorities, other delay or deceleration of the regulatory process, and PTC’s ability to meet existing or future regulatory standards with respect to Translarna; PTC’s ability to fulfill any additional obligations, including with respect to further trials or studies relating to cost-effectiveness, obtaining licenses or satisfying requirements for labor and business practices, in the territories in which it may obtain regulatory approval, including the United States, EEA and other territories; the initiation, conduct and availability of data from clinical trials and studies; PTC’s scientific approach and general development progress; the eligible patient base and commercial potential of Translarna and PTC’s other product candidates; the outcome of ongoing or future clinical trials or studies; PTC’s ability to establish and maintain arrangements with manufacturers, suppliers, distributors and production and collaboration partners on favorable terms; the sufficiency of PTC’s cash resources and PTC’s ability to obtain adequate financing in the future for PTC’s foreseeable and unforeseeable operating expenses and capital expenditures; and the factors discussed in the “Risk Factors” section of PTC’s most recent Quarterly Report on Form 10-Q as well as any updates to these risk factors filed from time to time in PTC’s other filings with the SEC. You are urged to carefully consider all such factors.

As with any pharmaceutical under development, there are significant risks in the development, regulatory approval and commercialization of new products. There are no guarantees that Translarna will receive full regulatory approval in any territory or maintain its current marketing authorization in the EEA, or prove to be commercially successful in general, or specifically with respect to the treatment of nmDMD.

The forward-looking statements contained herein represent PTC’s views only as of the date of this press release and PTC does not undertake or plan to update or revise any such forward-looking statements to reflect actual results or changes in plans, prospects, assumptions, estimates or projections, or other circumstances occurring after the date of this press release except as required by law.

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$EVOK Advances Commercial Preparations for EVK-001 with inVentiv Agreement

SOLANA BEACH, Calif., July 07, 2016  — Evoke Pharma, Inc. (NASDAQ:EVOK), today announced that it has entered into a master service agreement with inVentiv Commercial Services LLC (“inVentiv”) in connection with Evoke’s preparation for commercial activities for EVK-001, its lead product candidate for the treatment of diabetic gastroparesis in women. Evoke recently completed its Phase 3 clinical trial for EVK-001, with data expected early in the third quarter.

Evoke’s partnership with inVentiv will enable Evoke to build its commercial infrastructure as it prepares for the potential commercialization of EVK-001, pending the filing of a New Drug Application (NDA) and U.S. Food and Drug Administration (FDA) approval. Under terms of the agreement, inVentiv may provide services including, but not limited to, sales representatives, sales management, marketing, account management, advertising, medical communications, distribution support, and overall commercial management.  Evoke and inVentiv will add commercial team members and capabilities on an as-needed basis over the coming months as certain development and regulatory milestones are met.  In the past five years, inVentiv has created more than 110 teams for clients, about 50 of which were created to launch new products.

“As we await pivotal phase 3 clinical trial data, we have begun to ramp up our efforts to prepare for commercialization, should we be in a position to move forward with the submission of our NDA,” commented Dave Gonyer, R.Ph., President and CEO of Evoke. “We estimate that the market opportunity for EVK-001 is very large given the significant unmet need within the gastroparesis community and the lack of FDA-approved treatments. Working with inVentiv, a leader in providing services to assist healthcare companies to effectively and efficiently commercialize their products, we have full confidence in successfully bringing EVK-001 to market following approval from the FDA.”

About Evoke Pharma, Inc.

Evoke is a specialty pharmaceutical company focused primarily on the development of drugs to treat GI disorders and diseases. The Company is developing EVK-001, a metoclopramide nasal spray for the relief of symptoms associated with acute and recurrent gastroparesis in women with diabetes mellitus. Diabetic gastroparesis is a GI disorder afflicting millions of sufferers worldwide, in which the stomach takes too long to empty its contents resulting in serious digestive system symptoms. Metoclopramide is the only product currently approved in the United States to treat gastroparesis, and is currently available only in oral and intravenous forms. EVK-001 is a novel formulation of this drug, designed to provide systemic delivery of metoclopramide through nasal administration. Visit www.EvokePharma.com for more information.

Safe Harbor Statement

Evoke cautions you that statements included in this press release that are not a description of historical facts are forward-looking statements. In some cases, you can identify forward-looking statements by terms such as “may,” “will,” “should,” , or expect,” “plan,” “anticipate,” “could,” “intend,” “target,” “project,” “contemplates,” “believes,” “estimates,” “predicts,” “potential” or “continue” or the negatives of these terms or other similar expressions. These statements are based on the company’s current beliefs and expectations. These forward-looking statements include statements regarding: the timing of data from the Phase 3 clinical trial of EVK-001; the sufficiency of such data and the other activities completed to data providing a basis for the submission of an NDA for EVK-001 to the FDA and the timing thereof; and the potential commercialization of EVK-001. The inclusion of forward-looking statements should not be regarded as a representation by Evoke that any of its plans will be achieved. Actual results may differ from those set forth in this press release due to the risk and uncertainties inherent in Evoke’s business, including, without limitation: the inherent risks of clinical development of EVK-001 as well as potential delays in any other clinical trials and studies; Evoke is entirely dependent on the success of EVK-001, for which it has completed a Phase 3 clinical trial and continues enrollment in a male companion trial, and Evoke cannot be certain that it will be able to obtain regulatory approval for, or successfully commercialize, EVK-001; the results observed in female patients with symptoms associated with acute and recurrent diabetic gastroparesis in Evoke’s Phase 2b clinical trial of EVK-001 may not be predictive of the safety and efficacy results in the Phase 3 clinical trial; Evoke will require substantial additional funding to potentially commercialize EVK-001 as well as to finance additional development requirements, and may be unable to raise capital when needed, including to fund ongoing operations; the potential for adverse safety findings relating to EVK-001 to delay or prevent regulatory approval or commercialization; Evoke may not be able to successfully commercialize EVK-001, if approved, as a result of risks associated with market acceptance, coverage and reimbursement and competing products; and other risks detailed in Evoke’s prior press releases and in the periodic reports it files with the Securities and Exchange Commission. You are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof, and Evoke undertakes no obligation to revise or update this press release to reflect events or circumstances after the date hereof. All forward-looking statements are qualified in their entirety by this cautionary statement. This caution is made under the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.

Investor Contact:
The Ruth Group
David Burke
Tel: 646-536-7009
dburke@theruthgroup.com

Media Contact:
The Ruth Group
Kirsten Thomas
Tel: 646-536-7014
kthomas@theruthgroup.com
Thursday, July 7th, 2016 Uncategorized Comments Off on $EVOK Advances Commercial Preparations for EVK-001 with inVentiv Agreement

$BLIN National Franchise Selects #iAPPS to Power Full Website Network

BURLINGTON, Mass., July 07, 2016  — Bridgeline Digital, Inc. (NASDAQ:BLIN) announced today that a leading national franchise serving the home remodeling and services market selected the iAPPS Digital Engagement Platform to power its network of websites. The company will use iAPPS’ distributed localization functionality to create microsites and marketing campaigns for its network of 180+ franchises.

The solution, built with the iAPPS Pro product line, utilizes a collection of pre-built building blocks to help the franchise quickly go to market with a fully revamped digital strategy. “iAPPS Pro is such a game changer for companies like this,” Ari Kahn, CEO of Bridgeline said. “With our set of flexible modules and building blocks, they can create enterprise-class websites and microsites quickly, without the substantial investment that often comes with that.”

With the inherent campaign distribution features built in iAPPS, the company will be able to create localized microsites for each franchise and enable individual management for hyperlocal experiences. “Our campaign distribution helps big brands maintain consistency while giving their local team capabilities to market at a hyperlocal level,” Kahn said. “We are excited to see companies like this take advantage of iAPPS’ localization capabilities – something that is central to their success.”

About Bridgeline Digital

Bridgeline Digital helps customers maximize the performance of their full digital experience – from websites and intranets to online stores and campaigns. Bridgeline’s iAPPS platform deeply integrates Web Content Management, eCommerce, eMarketing, Social Media management, and Web Analytics to help marketers deliver digital experiences that attract, engage and convert their customers across all channels. Headquartered in Burlington, Mass., Bridgeline has thousands of quality customers that range from small- and medium-sized organizations to Fortune 1000 companies. To learn more, please visit www.bridgeline.com or call (800) 603-9936.

 

Becki Dilworth
Bridgeline Digital, Inc.
Senior Vice President of Marketing
303.785.3858
bdilworth@bridgeline.com
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$TWER Announces #Reverse #StockSplit

MIDDLETOWN, R.I., July 06, 2016 — Towerstream Corporation (NASDAQ:TWER), a leading Fixed-Wireless Fiber Alternative company, announced today a reverse stock split of its shares of common stock at a ratio of 1-for-20.  The purpose of this reverse split is to allow the Company to regain and maintain compliance with the minimum closing bid price of $1.00 per share as required by NASDAQ Listing Rules.  At the market open on Thursday, July 7, 2016, Towerstream’s common stock will begin trading on a split-adjusted basis.

As a result of the reverse stock split, the Company’s issued and outstanding shares of common stock will decrease to approximately 4,517,000 post-split shares (prior to effecting the rounding of fractional shares into whole shares as described below) from approximately 90,333,000 pre-split shares.

As a result of the reverse stock split, the total number of shares of common stock held by each stockholder will be converted automatically into the number of whole shares of common stock equal to the number of shares of common stock held by such stockholder immediately prior to the reverse stock split, divided by 20.  No fractional shares will be issued, and no cash or other consideration will be paid.  Instead, any stockholder who otherwise would have received a fractional share as a result of the reverse stock split will receive one whole share of the post-split common stock.

Stockholders who hold their shares in electronic form at their brokerage firms need not take any action, as the shares held in brokerage accounts will be automatically adjusted to reflect the reverse stock split.  Stockholders holding paper certificates may (but are not required to) send the certificates to the Company’s transfer agent at the address given below.  The transfer agent will issue a new share certificate reflecting the terms of the reverse stock split to each requesting stockholder who submits its paper certificate.

Continental Stock Transfer & Trust Company
Attn: Reorganization Department – 8th Floor
17 Battery Park Place
New York, NY 10004
Telephone number: 917-262-2378

About Towerstream Corporation

Towerstream Corporation (NASDAQ:TWER) is a leading Fixed-Wireless Fiber Alternative company delivering high-speed Internet access to businesses.  The Company offers broadband services in 12 urban markets including New York City, Boston, Los Angeles, Chicago, Philadelphia, the San Francisco Bay area, Miami, Seattle, Dallas-Fort Worth, Houston, Las Vegas-Reno, and the greater Providence area.

Safe Harbor

This release contains forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities and Exchange Act of 1934, as amended.  Statements that are not a description of historical facts constitute forward-looking statements and may often, but not always, be identified by the use of such words as “expects”, “anticipates”, “intends”, “estimates”, “plans”, “potential”, “possible”, “probable”, “believes”, “seeks”, “may”, “will”, “should”, “could” or the negative of such terms or other similar expressions.  Actual results may differ materially from those set forth in this release due to the risks and uncertainties inherent in Towerstream’s business.  More detailed information about Towerstream and the risk factors that may affect the realization of forward-looking statements is set forth in Towerstream’s Annual Report on Form 10-K for the fiscal year ended December 31, 2015, Towerstream’s Quarterly Reports on Form 10-Q and other filings submitted by Towerstream to the SEC, copies of which may be obtained from the SEC’s website at www.sec.gov.  Readers are cautioned not to place undue reliance on these forward-looking statements, which speak only as of the date hereof.  All forward-looking statements are qualified in their entirety by this cautionary statement and Towerstream undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

INVESTOR CONTACT:

Terry McGovern
Vision Advisors
415-902-3001
mcgovern@visionadvisors.net
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$OCLS Announces Record Monthly and Quarterly Prescription Data

May 2016: Highest Monthly Prescriptions Filled in Oculus’ History

Quarter Ended March 31, 2016: Highest Quarterly Number of Prescriptions

  • 34% over prior December quarter
  • 25% average “quarter over quarter” growth in number of prescriptions for last four quarters

PETALUMA, Calif., July 06, 2016  — Oculus Innovative Sciences, Inc. (NASDAQ: OCLS, OCLSW), a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care, today announced record monthly and quarterly prescriptions filled in the company’s dermatology products.

The average “quarter over quarter” growth of Oculus’ number of prescriptions was 25% for the last four quarters ended March 31, 2016.  More specifically, the number of prescriptions filled of all dermatology products were 3,767 for the March 2015 quarter, 5,666 for the June 2015 quarter, 7,162 for September 2015 quarter, 6,736 for December 2015 quarter and 8,624 for the March 2016 quarter.

For the month of May 2016, the number of prescriptions was 3,917, or 36% above the average monthly rate of 2,874 for the March 2016 quarter. The number of prescriptions filled for April 2016 and May 2016 collectively totaled 7,304, compared to 8,624 for the total March 2016 quarter. Part of the May increase is attributed to higher prescriptions filled for Ceramax, a state-of-the-art skin repair product that was launched in April 2016.

“U.S. dermatology growth has continued to be strong in the first quarter of our new fiscal year,” said Bob Miller, Oculus CFO. “Our dermatology sales and marketing team has done a stellar job in growing this business from zero with a limited budget beginning in the fall of 2014.  Following the old adage, the key to our business success is the people and the team at Oculus. Our progress further validates the wisdom of placing our primary corporate focus on growing the U.S. dermatology markets with our own experienced sales force.  We anticipate our best dermatology prescription quarter ending June 30, 2016.  As we continue to execute on our four-pronged growth strategy to launch one new product per quarter, grow existing products, add new sales people in new territories and increase prices gradually, we believe this strong sales ramp will continue.”

Oculus announced a new strategic direction for the company two years ago, focused on launching products into the U.S. dermatology market with the company’s own direct sales force. This initiative is led by dermatology veterans and boasts a seasoned direct sales force—totaling more than 20 professionals—that market a strong portfolio of seven effective, branded and innovative products.

About Oculus Innovative Sciences, Inc.
Oculus Innovative Sciences is a specialty pharmaceutical company that develops and markets unique and effective solutions for the treatment of dermatological conditions and advanced tissue care. The company’s products, which are sold throughout the United States and internationally, have improved outcomes for more than five million patients globally by reducing infections, itch, pain, scarring and harmful inflammatory responses. The company’s headquarters are in Petaluma, California, with manufacturing operations in the United States and Latin America. European marketing and sales are headquartered in Roermond, Netherlands. More information can be found at www.oculusis.com

Forward-Looking Statements
Except for historical information herein, matters set forth in this press release are forward-looking within the meaning of the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995, including statements about the commercial and technology progress and future financial performance of Oculus Innovative Sciences, Inc. and its subsidiaries (the “Company”). These forward-looking statements are identified by the use of words such as “continue,” “anticipate,” “execute,” and “market,” among others. Forward-looking statements in this press release are subject to certain risks and uncertainties inherent in the Company’s business that could cause actual results to vary, including such risks that regulatory clinical and guideline developments may change, scientific data may not be sufficient to meet regulatory standards or receipt of required regulatory clearances or approvals, clinical results may not be replicated in actual patient settings, protection offered by the Company’s patents and patent applications may be challenged, invalidated or circumvented by its competitors, the available market for the Company’s products will not be as large as expected, the Company’s common stock and warrants may be delisted from NASDAQ, the Company’s products will not be able to penetrate one or more targeted markets, revenues will not be sufficient to fund further development and clinical studies, the Company may not meet its future capital needs, the Company may not be able to obtain additional funding, as well as uncertainties relative to varying product formulations and a multitude of diverse regulatory and marketing requirements in different countries and municipalities, and other risks detailed from time to time in the Company’s filings with the Securities and Exchange Commission including its annual report on Form 10-K for the fiscal year ended March 31, 2016. The Company disclaims any obligation to update these forward-looking statements, except as required by law.

Oculus and Microcyn® Technology are trademarks or registered trademarks of Oculus Innovative Sciences, Inc. All other trademarks and service marks are the property of their respective owners.

 

Media and Investor Contact:

Oculus Innovative Sciences, Inc.

Dan McFadden
VP of Public and Investor Relations
(425) 753-2105
dmcfadden@oculusis.com
Wednesday, July 6th, 2016 Uncategorized Comments Off on $OCLS Announces Record Monthly and Quarterly Prescription Data

$EMKR to Issue Special #Dividend of $1.50 per share

Company completes return of approximately $85M to shareholders with special dividend

ALHAMBRA, Calif., July 06, 2016  — EMCORE Corporation (NASDAQ:EMKR), a leading provider of Indium Phosphide (InP) optical chips, components, subsystems and systems for the broadband and specialty fiber optics market, announced today that it has completed its strategic review and will distribute $1.50 per share via a special dividend payable on July 29, 2016 to shareholders of record as of July 18, 2016.

With this action, EMCORE’s Board of Directors will have returned approximately $85M of cash to its shareholders since June 2015, representing approximately 50% of the cash received from operations sold in the prior fiscal year.

“The return of cash to shareholders will strongly improve the Return on Assets of the business by reducing our overall capitalization, while maintaining flexibility to invest in new market opportunities to accelerate earnings growth,” says Jeffrey Rittichier, President and CEO.  “As previously stated, we’re encouraged by the performance of our CATV and Fiber Optic Gyro businesses and see strong growth opportunities in these and other areas to continue improving our financial performance,” added Rittichier.

“During my first year at EMCORE, we grew revenues 47% and improved gross margins 13 points from FY14 to FY15, positioning the company for profitable growth.  Building on this progress, we returned $45M to shareholders in June 2015 and began executing a strategic re-alignment of the manufacturing operations to drive margins higher.  With the core operations of the business on improved footing, in December 2015 the Board and management began a comprehensive strategic review to strike the right balance between returning assets to shareholders and investing in growth opportunities.  During this review period, we actively worked to eliminate risks to our balance sheet posed by the Sumitomo arbitration and other lingering liabilities.  Given the recent successful outcome of the Sumitomo arbitration and the completion of our strategic review, we are pleased to announce this return of capital to our shareholders,” continued Rittichier.

As part of the strategic review process, the company evaluated its growth opportunities in existing and adjacent markets, analyzed its products, technologies and production capabilities, and concluded that it could fully leverage its core competency in Mixed-Signal Optics in both existing and new markets.  As Mixed-Signal devices have both analog and digital circuits on multiple chips, or even a single chip, the value of these solutions are often far greater than traditional digital applications, and as a result require a specialized expertise which is unique in the optics industry.

“Given EMCORE’s existing leadership in Mixed-Signal Optic products such as DOCSIS 3.1 transmission devices, and emerging position in new products such as Fiber Optic Gyros and 5G Distributed Antenna System components for wireless applications, it became clear there is an opportunity to leverage our core Mixed-Signal competencies to penetrate new markets.  EMCORE is uniquely positioned as a supplier of advanced Mixed-Signal solutions given our design expertise and our captive wafer fabrication facility,” continued Rittichier.  “Mixed-Signal technology is at the heart of all of our products, and is shared between Fiber Optic Gyros (Sensor) and our CATV (Transmission) products alike.  As a matter of fact, if one were to open up one of our Fiber Gyros, one would see a miniature communication link that requires the same technologies, chip designs and production assets as our CATV products, giving us the ability to leverage our high volume infrastructure against lower volume, higher value added product,” concluded Rittichier.

The Company is currently in a quiet period until it reports its fiscal third quarter results at which time the Company will host its regularly scheduled quarterly conference call.  For more information regarding the special cash dividend please visit the investors section of the Company’s website at http://investor.emcore.com/downloads.cfm for a copy of the Question and Answer document.

About EMCORE

EMCORE Corporation designs and manufactures Indium Phosphide (InP) optical chips, components, subsystems and systems for the broadband and specialty fiber optics market. EMCORE was the pioneer in linear fiber optic transmission technology, and today is a leader in optical components, as well as a provider of complete end-to-end solutions for high-speed communications network infrastructures, enabling systems and service providers to meet growing demand for bandwidth and connectivity.  EMCORE’s advanced optical technologies are designed for cable television (CATV) and fiber-to-the-premise (FTTP) networks, telecommunications and data centers, satellite communications, aerospace and defense, wireless networks, and broadcast and professional audio/video systems. With its world-class InP semiconductor wafer fabrication facility, EMCORE has fully vertically-integrated manufacturing capability and also provides contract design, foundry and component packaging services. EMCORE is headquartered in Alhambra, California, USA with InP wafer fabrication operations in Alhambra, and ISO 9001 certified manufacturing in Alhambra and Langfang, China. For further information, please visit http://www.emcore.com.

Forward-looking statements:

The information provided herein may include 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, as amended. Such forward-looking statements include, in particular, statements about our plans, strategies, business prospects, changes and trends in our business and expansion into new markets. These forward-looking statements are based on management’s current expectations, estimates, forecasts and projections about EMCORE and are subject to risks and uncertainties that could cause actual results and events to differ materially from those stated in the forward-looking statements, including without limitation, the following: (a) the rapidly evolving markets for the Company’s products and uncertainty regarding the development of these markets; (b) the Company’s historical dependence on sales to a limited number of customers and fluctuations in the mix of products and customers in any period; (c) delays and other difficulties in commercializing new products; (d) the failure of new products: (i) to perform as expected without material defects, (ii) to be manufactured at acceptable volumes, yields, and cost, (iii) to be qualified and accepted by our customers, and (iv) to successfully compete with products offered by our competitors; (e) uncertainties concerning the availability and cost of commodity materials and specialized product components that we do not make internally; (f) actions by competitors; and (g) other risks and uncertainties discussed under Item 1A – Risk Factors in our Annual Report on Form 10-K for the fiscal year ended September 30, 2015, as updated by our subsequent periodic reports.  Forward-looking statements contained in this press release are made only as of the date hereof, and EMCORE undertakes no obligation to update or revise the forward-looking statements, whether as a result of new information, future events or otherwise.

Contact:
EMCORE Corporation

Jikun Kim
Chief Financial Officer
(626) 293-3400
investor@emcore.com

Media
Joel Counter
Manager, Corporate Marketing Communications
(626) 999-7017
media@emcore.com

Investors
Erica Mannion
Sapphire Investor Relations, LLC 
(617) 542-6180 
investor@emcore.com
Wednesday, July 6th, 2016 Uncategorized Comments Off on $EMKR to Issue Special #Dividend of $1.50 per share

$SMED Acquires Citiwaste, LLC; Route-Based Medical Waste Solution Provider

– Complements Recent Pennsylvania-based Acquisitions and Northeast Treatment Facility
– Expands Coverage to New York, New Jersey, Massachusetts and Connecticut
– Significantly Expands Customer Base in Core Healthcare, Professional and Assisted Living/Long Term Care Markets

HOUSTON, July 06, 2016  — Sharps Compliance Corp. (NASDAQ:SMED) (“Sharps” or the “Company”), a leading full-service national provider of comprehensive waste management solutions including medical, pharmaceutical and hazardous, today announced the acquisition of Citiwaste, LLC, located in Brooklyn, NY.  Citiwaste is a full service, route-based provider of medical, pharmaceutical and hazardous waste solutions to over 5,500 customer locations in New York, New Jersey, Connecticut and Massachusetts.

Citiwaste has annual revenue of approximately $3 million, serving small to medium size waste generators primarily in the healthcare, professional, and assisted living/long-term care markets.  Revenue at Citiwaste has grown by approximately 30% – 40% annually over the past 4 years.

The purchase price consists of $7 million in cash and 456,760 shares of Sharps Compliance unregistered stock for a total consideration of $9 million.

David P. Tusa, President and Chief Executive Officer of Sharps, commented, “We are very excited to expand our Northeast route-based business operations with the acquisition of the highly-respected and well run Citiwaste organization. With this acquisition, Sharps becomes a leading provider of route-based services in the Northeast serving a ten (10) contiguous state region and increasing our Northeast customer base from approximately 1,800 to over 7,400, with locations in attractive and densely populated areas. Furthermore, the acquired customer base comprises many disciplines of healthcare professionals, healthcare facilities and assisted living/long-term care providers which is well aligned with our core capabilities and our largest growth market opportunities.  In addition to expanding the reach of our pick-up service capabilities, the acquisition also enables us to efficiently leverage our existing route-based business infrastructure as well as our Northeast-based treatment facility which is expected to be operational in August 2016. The Citiwaste acquisition, when combined with our two previous Northeast-based acquisitions, our route-based operations in Texas and Louisiana and the pending treatment facility in the Northeast, provides Sharps with the operations and infrastructure to service areas which encompass about 100 million people or 31% of the U.S.A. population.

Mr. Tusa concluded, “The growth of our Company through the acquisition of route-based businesses is an important component of our strategic growth plans which also include organic growth in all key markets from the sale of our mailback solutions and the launching of new products and services designed to increase efficiencies and save money in healthcare such as the MedSafe and the TakeAway Recycle System.”

About Sharps Compliance Corp.

Headquartered in Houston, Texas, Sharps Compliance is a leading full-service national provider of comprehensive waste management services including medical, pharmaceutical and hazardous. Its key markets include healthcare facilities, pharmaceutical manufacturers, home healthcare providers, assisted living / long-term care, retail pharmacies and clinics, and the professional market which is comprised of physicians, dentists and veterinary practices. The Company’s flagship product, the Sharps Recovery System, is a comprehensive solution for the containment, transportation, treatment and tracking of medical waste and other used healthcare materials. The Company also offers its route-based pick-up service in a ten (10) state region of the Northeast portion of the United States as well as Texas and Louisiana.

More information on the Company and its products can be found on its website at: www.sharpsinc.com

Safe harbor statement

The information made available in this news release contains certain forward-looking statements which reflect Sharps Compliance Corp.’s current view of future events and financial performance.  Wherever used, the words “estimate,” “expect,” “plan,” “anticipate,” “believe,” “may” and similar expressions identify forward-looking statements.  Any such forward-looking statements are subject to risks and uncertainties and the Company’s future results of operations could differ materially from historical results or current expectations.  Some of these risks include, without limitation, the Company’s ability to educate its customers, development of public awareness programs to educate the identified consumer, customer preferences, the Company’s ability to scale the business and manage its growth, the degree of success the Company has at gaining more large customer contracts, managing regulatory compliance and/or other factors that may be described in the Company’s annual report on Form 10-K, quarterly reports on Form 10-Q and/or other filings with the Securities and Exchange Commission.  Future economic and industry trends that could potentially impact revenue and profitability are difficult to predict.  The Company assumes no obligation to publicly update or revise its forward-looking statements even if experience or future changes make it clear that any projected results, express or implied therein, will not be realized.

 

For more information contact:

Diana P. Diaz
Sharps Compliance Corp.
Vice President and Chief Financial Officer
Phone: (713) 660-3547
Email: ddiaz@sharpsinc.com

John Nesbett/Jennifer Belodeau
Institutional Marketing Services (IMS)
Phone: (203) 972-9200
Email: jnesbett@institutionalms.com
Wednesday, July 6th, 2016 Uncategorized Comments Off on $SMED Acquires Citiwaste, LLC; Route-Based Medical Waste Solution Provider

$RLJE Engages Universal Screen Arts To Administer Its Direct-To-Consumer Catalog

Acorn Mail-Order Catalog and Website to be managed by the owners of Signals Catalog

STILLWATER, Minn., July 6, 2016  — RLJ Entertainment (NASDAQ: RLJE) today announced that its catalog and online direct-to-consumer business division has entered into a licensing agreement with Universal Screen Arts, Inc., a leading Internet retailer and mail order catalog company to manage the day-to-day catalog, website operations, and fulfillment under the Acorn brand.

Miguel Penella, President and CEO of RLJ Entertainment said, “We believe there is a strong alignment between our brands, our customer base, and the products we sell both online and in our catalog. Acorn and Signals catalogs are synergistic and Universal Screen Arts, Inc. is the ideal company to manage the promotion and fulfillment of our products because of their breadth and experience in the direct-to-consumer space.”

Kenneth Harris, CEO of Universal Screen Arts said, “We look forward to being able to offer our eclectic assortment of unique gifts to the Acorn customers and the Acorn DVD’s to our customer base.  We expect to leverage our capabilities in digital and catalog marketing to increase the Acorn Direct revenues and customer file.”

About RLJ Entertainment: RLJ Entertainment, Inc. (NASDAQ: RLJE) is an entertainment content distribution company in primarily North America, the United Kingdom, and Australia. RLJE’s titles are distributed in multiple formats including broadcast television (including satellite and cable), theatrical and non-theatrical, DVD, Blu-Ray, digital download, and digital streaming. With its popular OTT branded channels, Acorn TV (British TV) and UMC (Urban Movie Channel), RLJE targets distinct, premium audiences and urban niche audiences. The company grows its proprietary digital channels through development, acquisition, and distribution of exclusive rights of program franchises and feature film content. Through Acorn Media Enterprises, its UK development arm, RLJE owns all rights to the hit UK mystery series Foyle’s War and is developing new programs. RLJE owns 64% of Agatha Christie Limited, which manages the intellectual property and publishing rights to some of the greatest works of mystery fiction, including stories of the iconic sleuths Miss Marple and Poirot. Through its proprietary e-commerce web sites for the Acorn brand in North America and the UK, the company also has direct contacts and billing relationships with millions of consumers. For more information visit: www.rljentertainment.com

About Universal Screen Arts: Universal Screen Arts markets a wide range of exclusive and unique high quality consumer products direct to the consumer via catalogs, websites, digital marketing and internet Marketplaces. Universal’s collection of products span from apparel, home decor, fine jewelry, footwear, books, accessories to health and beauty products. Universal’s portfolio of exclusive brands includes Signals, What on Earth, Catalog Classics, Bas Bleu, Support Plus and Universal Direct Brands. Universal distributes over 40 million catalogs and 300 million e mails to its 17 million customers annually. Universal was founded in 1983 by Jared Florian and is based in Hudson, Ohio.

Media Inquiries: RLJ Entertainment, Traci Otey Blunt, 301.830.6204; tblunt@rljentertainment.com
Universal Screen Arts/Signals, David Beckwith, 323.845.9836; david@thebeckwithcompany.com

Wednesday, July 6th, 2016 Uncategorized Comments Off on $RLJE Engages Universal Screen Arts To Administer Its Direct-To-Consumer Catalog

$FORD Signs New Three Year Supplier Agreement With Global Healthcare Provider

WEST PALM BEACH, Fla., July 06, 2016  — Forward Industries, Inc. (NASDAQ:FORD), a designer and distributor of custom carry and protective solutions, today announced that they have signed a three and a half year extension to their existing  supply agreement with a Global Healthcare provider to supply Global custom carry cases for their diabetic products through January 2020.

Terry Wise, Chief Executive Officer of Forward Industries, stated, “This agreement from another major player in the industry emphatically reflects Forward’s ability to consistently provide a quality compliant product on a timely basis. I am extremely delighted that we continue to uphold our extremely high quality performance ratings from all our multi-national clients – and despite a very challenging, highly regulated and competitive market landscape we continue to be the preferred supplier of choice within the diabetics’ custom cases industry.”

About Forward Industries
Incorporated in 1962, and headquartered West Palm Beach, Florida, Forward Industries is a global designer and distributor of mobile device cases and accessories. Forward’s products can be viewed online at www.forwardindustries.com.

Contact:                                                
Forward Industries, Inc.                                         
Michael Matte, CFO                                               
(561) 465-003
Wednesday, July 6th, 2016 Uncategorized Comments Off on $FORD Signs New Three Year Supplier Agreement With Global Healthcare Provider

$VSR Awarded New Contract For Critical Environmental Work On Behalf Of Air Force

SPRINGFIELD, Va., July 6, 2016  — Versar, Inc. (NYSE MKT: VSR) announced today that its wholly-owned subsidiary, J.M. Waller Associates, was competitively awarded the Architect-Engineer 2013 Environmental Services (A-E13ES) multiple-award contract with a combined contract ceiling totaling $500 million for continued work on behalf of Air Force Civil Engineer Center (AFCEC). The contract provides for the performance of Title I and Title II architectural-engineering (A-E) and other A-E services, primarily for multidisciplinary environmental projects, including planning and programming, environmental restoration, quality (environmental compliance and pollution prevention), and environmental conservation services.  Specifically, this contract is the follow-on to the former AFCEC 4PA-E08 contract and is intended to provide support for AFCEC’s worldwide environmental program. The contract vehicle has a five (5) year period of performance, during which time additional work may be awarded/performed; work may also be performed for two (2) additional years following the base period.

Tony Otten, Chief Executive Officer of Versar, said: “We are very pleased to assist AFCEC in addressing such important environmental issues at many of its facilities worldwide. This contract will enable the Company to continue to serve a long-standing customer and accomplish several critical tasks on its behalf.”

VERSAR, INC., headquartered in Springfield, Virginia, is a publicly-traded global project management company providing sustainable value oriented solutions to government and commercial clients in the construction management, environmental services, and professional services market areas.

VERSAR operates the following websites: www.versar.com and www.versarpps.com.

This news release contains forward-looking information. The forward-looking statements are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Forward-looking statements may be significantly impacted by certain risks and uncertainties described herein and in Versar’s Annual Report on Form 10-K filed with the Securities and Exchange Commission for the fiscal year ended June 26, 2015, as updated from time to time in the Company’s periodic filings. The forward-looking statements are made as of the date hereof and Versar does not undertake to update its forward-looking statements.

Contact: Karin Weber Robert Ferri
M&A, Investor Relations Manager Robert Ferri Partners
Versar, Inc. (415) 575-1589
(703) 642-6706 robert.ferri@robertferri.com
kweber@versar.com
Wednesday, July 6th, 2016 Uncategorized Comments Off on $VSR Awarded New Contract For Critical Environmental Work On Behalf Of Air Force

$NEON Distribution Agreement for #AirBar Devices w/ #IngramMicro Asia

STOCKHOLM, Sweden, July 01, 2016  — Neonode Inc. (NASDAQ:NEON), the Optical Interactive Sensing Technology Company, has signed a distribution agreement with Ingram Micro Asia for the distribution of AirBar devices.

AirBar brings displays to life, adding touch and gesture sensing to both new and existing PCs. AirBar works with Windows® and ChromeOS™ operating systems as a “Plug and Touch” solution anywhere: simply plug AirBar into the USB port and interact with the display immediately.

Ingram Micro is a Fortune 100 company that delivers a full spectrum of global technology and supply chain services to businesses around the world. The agreement covers a territory of 12 countries including Singapore, Malaysia, Korea, Japan, Hong Kong, the Philippines, Cambodia, Vietnam, Myanmar, Taiwan, Thailand and Indonesia. With Ingram Micro’s unmatched footprint throughout Asia, Neonode will have access to leading retailers, online stores and resellers in the education and enterprise markets. Furthermore, Ingram Micro’s strong global alliances with major PC brands, including HP®, Lenovo®, Dell®, Asus® and Acer®, makes it easier for Ingram Micro channel partners to   attach AirBar together with these leading client systems as an offering to meet the customers’ demands.

“Ingram Micro Asia plays a key part in our global expansion plans. Dealing with the leading global technology distributor means Neonode can focus on running a streamlined business, yet have access to numerous markets that have been demanding AirBar,” said Remo Behdasht, SVP AirBar Devices at Neonode Inc. “Ingram Micro’s enthusiasm and cooperation in bringing AirBar to Asia further solidifies our global relationship setting the stage for many more products to come under the AirBar brand.”

“We are pleased to expand our portfolio of options and accessories offerings with the addition of AirBar which complements our wide range of client systems,” said Francis Choo, ASEAN & HK Vice President, Ingram Micro.

About Neonode
Neonode Inc. (NASDAQ:NEON) develops and licenses optical interactive sensing technologies. Neonode’s patented optical interactive sensing technology is developed for a wide range of devices like automotive systems, printers, PC devices, monitors, mobile phones, tablets and e-readers. NEONODE and the NEONODE logo are trademarks of Neonode Inc. registered in the United States and other countries. AIRBAR is a trademark of Neonode Inc. All other trademarks are the property of their respective owners.

For more information please visit www.neonode.com.

About Ingram Micro

Ingram Micro helps businesses Realize the Promise of Technology™. It delivers a full spectrum of global technology and supply chain services to businesses around the world. Deep expertise in technology solutions, mobility, cloud, and supply chain solutions enables its business partners to operate efficiently and successfully in the markets they serve. Unrivaled agility, deep market insights and the trust and dependability that come from decades of proven relationships, set Ingram Micro apart and ahead. More at www.ingrammicro.com.

Forward-Looking Statements
This press release contains forward-looking statements within the meaning of the Private Securities Litigation Reform Act of 1995. These include, but are not limited to, statements relating to expectations, future performance or future events, and product cost, performance, and functionality matters. These statements are based on current assumptions, expectations and information available to Neonode management and involve a number of known and unknown risks, uncertainties and other factors that may cause Neonode’s actual results, levels of activity, performance or achievements to be materially different from any expressed or implied by these forward-looking statements.

These risks, uncertainties, and factors are discussed under “Risk Factors” and elsewhere in Neonode’s public filings with the U.S. Securities and Exchange Commission from time to time, including Neonode’s annual report on Form 10-K, quarterly reports on Form 10-Q, and current reports on Form 8-K. You are advised to carefully consider these various risks, uncertainties and other factors. Although Neonode management believes that the forward-looking statements contained in this press release are reasonable, it can give no assurance that its expectations will be fulfilled. Forward-looking statements are made as of today’s date, and Neonode undertakes no duty to update or revise them.

© Copyright Neonode Inc. 2001 – 2016. All rights reserved.

For more information:

AirBar Sales Contact:
hello@air.bar

AirBar Press Contact:
Oscar Ritzén Praglowski 
Email: oscar.praglowski@neonode.com

Investors relations contact:
David Brunton
E-mail: david.brunton@neonode.com
Friday, July 1st, 2016 Uncategorized Comments Off on $NEON Distribution Agreement for #AirBar Devices w/ #IngramMicro Asia

$MESO Update on Heart Failure Trial and Funding of Clinical Operations

Highlights

  • Interim Analysis to assess heart failure Phase 3 trial’s primary endpoint to read-out meaningful data in Q1 2017
  • The anticipated trial costs to this Interim Analysis are approximately US$13 million
  • Annualized cash burn to be materially reduced through cost reductions and a strategic prioritization of core assets
  • Existing cash reserves of approximately US$80 million will provide operational runway for 12-15 months
  • Funds in place to maintain momentum in additional Tier 1 programs for degenerative disc disease, graft versus host disease, and biologic-refractory rheumatoid arthritis
  • A fully discretionary equity facility has been established for up to $A120 million/$US90 million over 36 months to provide additional funds as required

NEW YORK and MELBOURNE, Australia, July 01, 2016  — Mesoblast Limited (ASX:MSB); (Nasdaq:MESO) today announced plans for an early data readout on its Phase 3 chronic heart failure trial, materially reduced projections for annualized cash burn, and the establishment of an equity facility to provide funding at the Company’s discretion for up to three years.

Mesoblast Chief Executive Silviu Itescu said: “We believe we can obtain meaningful data by performing a blinded Interim Analysis to assess the heart failure trial’s primary endpoint in Q1 2017. The results will inform our subsequent strategic decisions regarding the program.

“Importantly, we are implementing a series of material cost-cutting measures and have realigned existing company resources to focus on our key value drivers. This will ensure we maintain momentum in our key Tier 1 programs: Phase 3 programs for degenerative disc disease, graft versus host disease and chronic heart failure, as well as the Phase 2 program in biologic refractory rheumatoid arthritis.

“To ensure financial flexibility, we have established an equity facility which may be used at our sole discretion over the next three years, as needed.”

Chronic Heart Failure Program

Approximately 240 patients have already been enrolled in the Phase 3 heart failure trial to date. The trial’s primary endpoint is a comparison of recurrent Heart Failure-Related Major Adverse Cardiovascular Events (HF-MACE) in high-risk heart failure patients receiving either Mesoblast’s product candidate MPC-150-IM or control.

Based on observed HF-MACE event rates in the trial, the Company believes meaningful data will be generated by bringing forward to Q1 2017 a scheduled Interim Analysis to assess the trial’s primary endpoint between cell-treated and control patients. The results will be used to provide evidence based support for strategic decisions regarding the Phase 3 program, ongoing cardiovascular partnering discussions, and informed use of funds. The anticipated costs incurred to this Interim Analysis will be approximately US$13 million.

Cash Management

To ensure prudent use of cash reserves given the additional expenditure on the Phase 3 heart failure trial, the Company will significantly reduce projected cash burn for FY17 through re-prioritization of certain projects and operational streamlining. Consequently, Mesoblast’s existing cash reserves of approximately US$80 million will provide operational runway for 12 to 15 months, including costs related to the heart failure trial.

During this period the Company anticipates key data readouts from each of its Tier 1 programs. In parallel, Mesoblast will continue discussions with potential strategic partners to deliver non-dilutive funding.

Details of implemented cost reductions will be provided in the upcoming full year financial results.

Key Terms of the Equity Facility Agreement

The Company has entered into an equity facility with Kentgrove Capital which may be used by Mesoblast to meet additional funding requirements over the next three years, as they arise.

  1. Equity facility for up to $A60 million available to be used over 18 months, with Mesoblast having the option to increase the facility to A$120 million over 36 months.
  2. For each placement, Mesoblast determines when the placement occurs, the placement period, the maximum amount of the placement, and the minimum share issue price.
  3. For each placement, Mesoblast will receive funds from Kentgrove Capital via the issue of shares at a volume weighted average price (VWAP) based on the sale of Mesoblast shares by Kentgrove Capital over the placement period less 4.5%, which cannot be less than the minimum issue price determined by Mesoblast.
  4. The issuance of shares under the facility will be made in compliance with Mesoblast’s available placement capacity.
  5. Kentgrove Capital will be granted 1,500,000 incentive rights with a three year exercise period at an exercise price equivalent to 200% of the average daily VWAP of Mesoblast shares sold on-market on ASX during the 10 trading days before the date of the facility.
  6. Mesoblast may terminate the facility on 14 days’ notice. Kentgrove Capital may only terminate the facility in certain limited circumstances, such as a material breach of the facility by Mesoblast which is not remedied.

About Kentgrove Capital
Kentgrove Capital is an Australian-based, privately-held investment management firm with an objective of generating strong returns for their investors over the medium and long term. Kentgrove Capital invests in Australian equities across all industries with a primary strategy to invest in companies they consider to be significantly undervalued and have high growth potential.

About Mesoblast
Mesoblast Limited (ASX: MSB); (Nasdaq: MESO) is a global leader in developing innovative cell-based medicines. The Company has leveraged its proprietary technology platform, which is based on specialized cells known as mesenchymal lineage adult stem cells, to establish a broad portfolio of late-stage product candidates. Mesoblast’s allogeneic, ‘off-the-shelf’ cell product candidates target advanced stages of diseases with high, unmet medical needs including cardiovascular conditions, orthopedic disorders, immunologic and inflammatory disorders and oncologic/hematologic conditions.

Forward-Looking Statements
This press release includes forward-looking statements that relate to future events or 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 differ materially from any future results, levels of activity, performance or achievements expressed or implied by these forward-looking statements. We make such forward-looking statements pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995 and other federal securities laws. Forward-looking statements should not be read as a guarantee of future performance or results, and actual results may differ from the results anticipated in these forward-looking statements, and the differences may be material and adverse. You should read this press release together with our risk factors, in our most recently filed reports with the SEC or on our website. Uncertainties and risks that may cause Mesoblast’s actual results, performance or achievements to be materially different from those which may be expressed or implied by such statements, and accordingly, you should not place undue reliance on these forward-looking statements. We do not undertake any obligations to publicly update or revise any forward-looking statements, whether as a result of new information, future developments or otherwise.

 

For further information, please contact:

Michael Schuster
Investor Relations
Mesoblast Limited
T: +1 212 880-2060  
E:  michael.schuster@mesoblast.com

Julie Meldrum
Corporate Communications
Mesoblast Limited
T: +61 3 9639 6036        
E: julie.meldrum@mesoblast.com
Friday, July 1st, 2016 Uncategorized Comments Off on $MESO Update on Heart Failure Trial and Funding of Clinical Operations

$ALNY Reports New Results from Investigational RNAi Therapeutic Programs

– At 24 Months, Patisiran Shows a Mean 6.7 Point Decrease in Modified Neuropathy Impairment Score (mNIS+7), Comparing Favorably with an Expected Mean 26-30 Point Increase Estimated from Historical Data –

– In New Individual Patient Analysis, Over 70 Percent of Patisiran Patients Show Improvement or No Change in mNIS+7 at 24 Months, Supportive of Therapeutic Hypothesis that Patisiran can Potentially Halt or Improve Neuropathy Progression –

– In APOLLO Phase 3 Study of Patisiran, Baseline Demographics Reveal Enrollment of a Globally Representative Patient Population with a Wide Range of Disease Severity and TTR Mutations, Including 54 Percent with Cardiac Involvement, Enabling Assessment of Patisiran Effects on Broad Range of Disease Manifestations –

– At 12 Months, Revusiran Achieves Generally Stable 6-Minute Walk Distance Results in Majority of Evaluable Patients with hATTR-CM –

– Alnylam also Guides that ENDEAVOUR Phase 3 Study of Revusiran will Complete Enrollment by End of Summer, Ahead of Schedule, with Data Now Expected in Early 2018 –

– Company to Host Conference Call Today, Friday, July 1, at 8:30 am ET to Discuss Results –

 

Alnylam Pharmaceuticals, Inc. (Nasdaq: ALNY), the leading RNAi therapeutics company, announced today preliminary results from its ongoing Phase 2 open-label extension (OLE) studies with patisiran and revusiran, both investigational RNAi therapeutics targeting transthyretin (TTR) for the treatment of hereditary TTR-mediated amyloidosis (hATTR amyloidosis). These new clinical data are being presented at the XV International Symposium on Amyloidosis held July 3 – 7, 2016 in Uppsala, Sweden. Data from the patisiran Phase 2 OLE study provided evidence of improvement or no change in the mean neuropathy impairment score (mNIS+7) following 24 months of dosing in hATTR patients with polyneuropathy (hATTR-PN, also known as Familial Amyloidotic Polyneuropathy, or FAP). These results support the therapeutic hypothesis that TTR knockdown with patisiran can potentially halt or improve neuropathy progression in patients with hATTR-PN. The Company also presented baseline demographics from its APOLLO Phase 3 study of patisiran in hATTR-PN patients, showing, among other things, that the majority of patients have evidence of cardiac disease, which should allow the evaluation of patisiran’s potential effects on cardiac manifestations of hATTR amyloidosis. In addition, initial 12-month data from the revusiran Phase 2 OLE study continued to show robust and sustained knockdown of serum TTR, and 6-minute walk distance (6-MWD) results were found to be generally stable in the majority of evaluable hATTR patients with cardiomyopathy (hATTR-CM, also known as Familial Amyloidotic Cardiomyopathy, or FAC). Alnylam also announced today that it expects to complete enrollment in the ENDEAVOUR Phase 3 study of revusiran this summer, ahead of schedule, with data readout now expected in early 2018.

“We believe that data from these ongoing Phase 2 OLE studies further support the potential of patisiran and revusiran as innovative investigational medicines for the treatment of hereditary ATTR amyloidosis. With patisiran, we believe the mean 6.7 point decrease in mNIS+7 seen over 24 months is a promising result in light of the rapid increase in neuropathy impairment scores that would have been anticipated based on analyses of other historical data sets. Moreover, we’re encouraged to see that individual patient mNIS+7 responses show evidence for halting of or improvement in neuropathy progression in over 70 percent of patients,” said Eric Green, Vice President, General Manager, TTR Program. “Accordingly, we look forward to reporting data from the APOLLO Phase 3 trial with patisiran in mid-2017, where, in addition to evaluating the effect on neuropathy progression, we also expect to evaluate patisiran’s impact on other aspects of the disease, including cardiac manifestations, given the significant number of patients enrolled in the trial with cardiac involvement.”

Patisiran Results Show Potential to Halt or Improve Neuropathy Progression
In the patisiran single-arm Phase 2 OLE study, new results for patients (N=24) who reached the 24-month endpoint as of a data cutoff date of May 12, 2016, showed a mean decrease of 6.7 points from baseline in mNIS+7 after 24 months of treatment. This compares favorably to an estimated mean increase in mNIS+7 of 26 to 30 points at 24 months based upon analyses of historical data sets in untreated hATTR-PN patients with similar baseline neurologic impairment (Adams et al., Neurology, 2015;85:675-682; Berk et al., JAMA, 2013;310:2658-67). Similar results were seen in patients with or without concomitant use of TTR tetramer stabilizers. In a new analysis, over 70 percent of patients showed either improvement or no change in mNIS+7 at 24 months. The maximal improvement achieved was a robust 34.6 point decrease in mNIS+7. In addition, patisiran administration was associated with statistically significant mean improvements in nerve fiber density from sweat gland biopsy samples from both the distal thigh and distal leg (p less than 0.01 for both), as read histologically in a blinded manner by a central lab. Over the 24-month period, hATTR-PN patients with associated cardiac involvement (N=11) showed stability in their cardiac biomarkers, echocardiographic measures, and 10-meter walk test (i.e., gait speed). Serum TTR levels were also measured throughout the OLE study, and showed TTR knockdown of up to 97 percent, a mean maximal knockdown of 93 percent, and a mean knockdown of 84 percent at 24 months.

In addition, Alnylam also presented the results of an exploratory analysis examining the relationship between the degree of TTR knockdown with subsequent changes in mNIS+7. In the analysis, the degree of TTR knockdown on Day 17 after the first dose of patisiran was compared to changes in mNIS+7 at 6, 12, 18, and 24 months. There was a positive correlation between the degree of serum TTR knockdown and changes in mNIS+7. Specifically, greater degrees of TTR knockdown resulted in greater levels of mNIS+7 improvement; the strongest correlations were observed at 6 and 12 months (p less than 0.01), and a trend was observed at 18 and 24 months (p equal to 0.055 and 0.15, respectively). Over 24 months, patients with lesser degrees of initial TTR knockdown also had improvements in mNIS+7, suggesting that there may be an accrual of clinical benefit to even those patients with lesser degrees of TTR knockdown if treated over longer periods of time. Altogether the Company believes these data support the therapeutic hypothesis that reduction of mutant and wild-type TTR with patisiran has the potential to halt or improve neuropathy progression in patients with hATTR-PN.

Patisiran administration was also found to be generally well tolerated in hATTR-PN patients out to 25 months, with no drug-related serious adverse events (SAEs) reported through the data transfer date. The most common drug-related or possibly drug-related adverse events (AEs) were flushing (22.2 percent) and infusion-related reactions (18.5 percent), all of which were mild in severity and did not result in any discontinuations. There were nine reports of SAEs in six patients, all of which were unrelated to study drug, including two deaths as previously reported. There were no clinically significant changes in liver function tests, renal function, or hematologic parameters, including platelet counts.

APOLLO Phase 3 Study with Patisiran is Largest Controlled Study of Patients with hATTR-PN to Date and Represents Global Patient Population
Alnylam also presented baseline demographics from the APOLLO Phase 3 study of patisiran. A total of 225 patients with hATTR-PN were enrolled at 44 sites in 19 countries around the world between December 2013 and January 2016. Ninety-five patients (42 percent) have the Val30Met TTR mutation, the most prevalent genotype known to be associated with hATTR-PN; the remaining 130 patients (58 percent) span 57 other mutations. In terms of disease severity, 104 patients (46 percent) were FAP Stage 1 at baseline, and 119 (53 percent) patients were Stage 2; only 2 patients (1 percent) were Stage 3. The mean baseline mNIS+7 score was 78.8 (range 8.0 – 165.0). Additionally, baseline mNIS+7 and quality of life (QOL) scores were found to correlate with FAP Stage and polyneuropathy disability (PND) score, underscoring the clinical relevance of specific endpoints in the APOLLO Phase 3 study. A significant number of patients (N=122, 54 percent) had cardiac involvement at baseline. The Company believes this patient subset should allow for a controlled evaluation of effects of patisiran on cardiac parameters, including cardiac biomarkers NT-proBNP and troponin, left ventricular wall thickness, ejection fraction, and 10-meter walk test, all included as secondary or exploratory endpoints in the Phase 3 study protocol. Alnylam expects to report data from the APOLLO trial in mid-2017.

12-Month Data with Revusiran Show Generally Stable 6-Minute Walk Distance Results in Majority of Evaluable Patients with hATTR-CM
“With revusiran, we are pleased to see the robust and durable knockdown of TTR for up to eighteen months, representing our longest human dosing experience with a GalNAc-siRNA conjugate. We’re also encouraged to see generally stable 6-minute walk distance results in the majority of evaluable hATTR-CM patients,” said Eric Green. “Nevertheless, given the highly advanced patient population in the revusiran Phase 2 OLE study, we continue to believe that further assessment of clinical activity in hATTR-CM will need to await placebo-controlled results from the cardiac subgroup in APOLLO and from ENDEAVOUR. To this end, we are pleased to announce today that we expect to complete enrollment in the ENDEAVOUR Phase 3 study of revusiran later this summer, ahead of schedule, which should position us to report out data from this study in early 2018.”

Preliminary results were presented for patients (N=16) who reached the 12-month endpoint as of a data cutoff of May 26, 2016. At 12 months, the majority of hATTR-CM patients evaluable for 6-MWD (5 of 9) showed generally stable results, with a mean change of -14 ± 8 meters in those patients. On average, all evaluable patients with hATTR-CM (N=9) exhibited a mean change of -73 ± 26 meters, and those with wild-type ATTR amyloidosis (wtATTR, also known as Senile Systemic Amyloidosis, or SSA) (N=6) exhibited a mean change of -152 ± 36 meters over 12 months. These results are generally in line with natural history data at 12 months. Finally, repeat dosing with revusiran achieved robust and sustained TTR knockdown out to 18 months, with an up to 98 percent maximal and 88 percent mean maximal knockdown of TTR.

Baseline demographics for patients in the revusiran Phase 2 OLE revealed a study population with advanced disease, with a mean time from diagnosis to first dose of 35 months. This compares with a nearly three-times shorter, 13-month mean time from diagnosis to first dose for hATTR-CM patients (N=139) enrolled in the ongoing ENDEAVOUR trial to date. All safety data from the revusiran Phase 2 OLE are through the data transfer date of May 26, 2016. Fourteen patients (56 percent) in the Phase 2 OLE presented with SAEs. One event, a case of lactic acidosis, was deemed possibly related to study drug. There were a total of seven deaths, all of which were unrelated to study drug. Time from ATTR diagnosis to first dose in the Phase 2 OLE study was found to be significantly correlated with death or disease progression, where patients who died or experienced disease progression (N=8) had a mean time of 48 months compared with patients (N=11) who remained on study who had a mean time of 25 months (p less than 0.05). The majority of AEs were mild or moderate in severity, and included injection site reactions (ISRs) in 12 patients (48 percent); the majority of reported ISRs were mild in severity. Beyond the three cases previously reported, there were no further discontinuations due to ISRs. There were no other notable changes in liver function tests, renal function or hematologic parameters, including platelets.

To view all the results presented by Alnylam at the ISA meeting, please visit www.alnylam.com/capella.

Conference Call Information
Alnylam management will discuss these data in a webcast conference call on Friday, July 1 at 8:30 a.m. ET. A slide presentation will also be available on the Investors page of the company’s website, www.alnylam.com, to accompany the conference call. To access the call, please dial 877-312-7507 (domestic) or 631-813-4828 (international) five minutes prior to the start time and refer to conference ID 36431889. A replay of the call will be available beginning at 10:30 a.m. ET. To access the replay, please dial 855-859-2056 (domestic) or 404-537-3406 (international), and refer to conference ID 36431889.

About the Patisiran Phase 2 OLE Study
The ongoing patisiran OLE study is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of patisiran administration in patients with hereditary ATTR amyloidosis with polyneuropathy (hATTR-PN) that were previously enrolled in a Phase 2 study. Patisiran is being administered once every 3 weeks at a dose of 0.3 mg/kg by intravenous infusion. The study is measuring a number of clinical endpoints every six months, including mNIS+7, which is an evaluation of muscle weakness, sensory and autonomic function, and nerve conductance, where neuropathy progression leads to an increased score over time. The change in the mNIS+7 measurement from baseline to 18 months is the primary endpoint in the Company’s APOLLO Phase 3 trial of patisiran in patients with hATTR-PN.

About the Revusiran Phase 2 OLE Study
The ongoing revusiran OLE study is an open-label, multi-center trial designed to evaluate the long-term safety and tolerability of revusiran administration in TTR cardiac amyloidosis patients that were previously enrolled in a Phase 2 study. Patients receive a fixed subcutaneous dose of 500 mg of revusiran once daily for five days, followed by once-weekly dosing. The study is measuring a number of clinical endpoints every six months, including effects on serum TTR and on mortality, hospitalization, and 6-minute walk distance (6-MWD). The changes in 6-MWD and serum TTR from baseline to 18 months are the co-primary endpoints in the Company’s ENDEAVOUR Phase 3 trial of revusiran in patients with hereditary ATTR amyloidosis with cardiomyopathy (hATTR-CM).

About the APOLLO Phase 3 Study
The APOLLO Phase 3 trial is a randomized, double-blind, placebo-controlled, global study designed to evaluate the efficacy and safety of patisiran in patients with hATTR-PN. The primary endpoint of the study is the difference in the change in mNIS+7 between patisiran and placebo at 18 months. Secondary endpoints include: the Norfolk Quality of Life-Diabetic Neuropathy (QOL-DN) score; NIS-weakness; modified BMI; timed 10-meter walk; and the COMPASS-31 autonomic symptom score. The trial enrolled 225 hATTR-PN patients that were randomized 2:1, patisiran:placebo, with patisiran administered at 0.3 mg/kg once every three weeks for 18 months. The study was designed with 90% power to conservatively detect as little as a 37.5% difference in change in mNIS+7 between treatment groups, with a two-sided alpha of 0.05. The placebo mNIS+7 progression rate was derived from an Alnylam analysis of natural history data from 283 hATTR-PN patients. All patients completing the APOLLO Phase 3 study are eligible to screen for the APOLLO-OLE study, in which they have the opportunity to receive patisiran on an ongoing basis.

Sanofi Genzyme Alliance
In January 2014, Alnylam and Sanofi Genzyme, the specialty care global business unit of Sanofi, formed an alliance to accelerate and expand the development and commercialization of RNAi therapeutics across the world. The alliance is structured as a multi-product geographic alliance in the field of rare diseases. Alnylam retains product rights in North America and Western Europe, while Sanofi Genzyme obtained the right to access certain programs in Alnylam’s current and future Genetic Medicines pipeline in the rest of the world (ROW) through the end of 2019, together with certain broader co-development/co-commercialization rights and global rights for certain products. In the case of patisiran, Alnylam will advance the product in North America and Western Europe, while Sanofi Genzyme will advance the product in the ROW. In the case of revusiran, Alnylam and Sanofi Genzyme will co-develop/co-commercialize the product in North America and Western Europe, while Sanofi Genzyme will advance the product in the ROW.

About hATTR Amyloidosis
Hereditary transthyretin (TTR)-mediated amyloidosis (hATTR) is an inherited, progressively debilitating, and often fatal disease caused by mutations in the TTR gene. TTR protein is produced primarily in the liver and is normally a carrier of vitamin A. Mutations in TTR cause abnormal amyloid proteins to accumulate and damage body organs and tissue, such as the peripheral nerves and heart, resulting in intractable peripheral sensory neuropathy, autonomic neuropathy, and/or cardiomyopathy. hATTR represents a major unmet medical need with significant morbidity and mortality; hATTR with polyneuropathy (hATTR-PN) – also known as familial amyloidotic polyneuropathy (FAP) – affects approximately 10,000 people worldwide and hATTR with cardiomyopathy (hATTR-CM) – also known as familial amyloidotic cardiomyopathy (FAC) – is estimated to affect at least 40,000 people worldwide. hATTR-PN patients have a life expectancy of 5 to 15 years from symptom onset, and the only approved treatment options for early stage disease are liver transplantation and tafamidis (approved in Europe, Japan, and certain countries in Latin America). hATTR-CM is fatal within 2.5 to 5 years of diagnosis and treatment is currently limited to supportive care. Wild-type amyloidosis (wtATTR) – also called senile systemic amyloidosis (SSA) – is a non-hereditary form of TTR cardiac amyloidosis caused by idiopathic deposition of wild-type TTR; its prevalence is generally unknown, but is associated with advanced age. There is a significant need for novel therapeutics to treat patients with hATTR.

About LNP Technology
Alnylam has licenses to Arbutus Biopharma LNP intellectual property for use in RNAi therapeutic products using LNP technology.

About GalNAc Conjugates and Enhanced Stabilization Chemistry (ESC)-GalNAc Conjugates
GalNAc-siRNA conjugates are a proprietary Alnylam delivery platform and are designed to achieve targeted delivery of RNAi therapeutics to hepatocytes through uptake by the asialoglycoprotein receptor. Alnylam’s Enhanced Stabilization Chemistry (ESC)-GalNAc-conjugate technology enables subcutaneous dosing with increased potency and durability and a wide therapeutic index. This delivery platform is being employed in nearly all of Alnylam’s pipeline programs, including programs in clinical development.

About RNAi
RNAi (RNA interference) is a revolution in biology, representing a breakthrough in understanding how genes are turned on and off in cells, and a completely new approach to drug discovery and development. Its discovery has been heralded as “a major scientific breakthrough that happens once every decade or so,” and represents one of the most promising and rapidly advancing frontiers in biology and drug discovery today which was awarded the 2006 Nobel Prize for Physiology or Medicine. RNAi is a natural process of gene silencing that occurs in organisms ranging from plants to mammals. By harnessing the natural biological process of RNAi occurring in our cells, the creation of a major new class of medicines, known as RNAi therapeutics, is on the horizon. Small interfering RNA (siRNA), the molecules that mediate RNAi and comprise Alnylam’s RNAi therapeutic platform, target the cause of diseases by potently silencing specific mRNAs, thereby preventing disease-causing proteins from being made. RNAi therapeutics have the potential to treat disease and help patients in a fundamentally new way.

About Alnylam Pharmaceuticals
Alnylam is a biopharmaceutical company developing novel therapeutics based on RNA interference, or RNAi. The company is leading the translation of RNAi as a new class of innovative medicines. Alnylam’s pipeline of investigational RNAi therapeutics is focused in 3 Strategic Therapeutic Areas (STArs): Genetic Medicines, with a broad pipeline of RNAi therapeutics for the treatment of rare diseases; Cardio-Metabolic Disease, with a pipeline of RNAi therapeutics toward genetically validated, liver-expressed disease targets for unmet needs in cardiovascular and metabolic diseases; and Hepatic Infectious Disease, with a pipeline of RNAi therapeutics that address the major global health challenges of hepatic infectious diseases. In early 2015, Alnylam launched its “Alnylam 2020” guidance for the advancement and commercialization of RNAi therapeutics as a whole new class of innovative medicines. Specifically, by the end of 2020, Alnylam expects to achieve a company profile with 3 marketed products, 10 RNAi therapeutic clinical programs – including 4 in late stages of development – across its 3 STArs. The company’s demonstrated commitment to RNAi therapeutics has enabled it to form major alliances with leading companies including Ionis, Novartis, Roche, Takeda, Merck, Monsanto, The Medicines Company, and Sanofi Genzyme. In addition, Alnylam holds an equity position in Regulus Therapeutics Inc., a company focused on discovery, development, and commercialization of microRNA therapeutics. Alnylam scientists and collaborators have published their research on RNAi therapeutics in over 200 peer-reviewed papers, including many in the world’s top scientific journals such as Nature, Nature Medicine, Nature Biotechnology, Cell, New England Journal of Medicine, and The Lancet. Founded in 2002, Alnylam maintains headquarters in Cambridge, Massachusetts. For more information about Alnylam’s pipeline of investigational RNAi therapeutics, please visit www.alnylam.com.

Alnylam Forward Looking Statements
Various statements in this release concerning Alnylam’s future expectations, plans and prospects, including without limitation, Alnylam’s views with respect to the potential for RNAi therapeutics, including patisiran and revusiran, the potential implications of reported results from its ongoing Phase 2 OLE studies of patisiran and revusiran, its expectations regarding the timing of clinical studies and presentation of clinical data, including for the APOLLO Phase 3 trial of patisiran and the ENDEAVOUR Phase 3 trial of revusiran, its expectations regarding its STAr pipeline growth strategy, and its plans regarding commercialization of RNAi therapeutics, constitute forward-looking statements for the purposes of the safe harbor provisions under The Private Securities Litigation Reform Act of 1995. Actual results may differ materially from those indicated by these forward-looking statements as a result of various important factors, including, without limitation, Alnylam’s ability to discover and develop novel drug candidates and delivery approaches, successfully demonstrate the efficacy and safety of its drug candidates, the pre-clinical and clinical results for its product candidates, which may not be replicated or continue to occur in other subjects or in additional studies or otherwise support further development of product candidates, actions of regulatory agencies, which may affect the initiation, timing and progress of clinical trials, obtaining, maintaining and protecting intellectual property, Alnylam’s ability to enforce its patents against infringers and defend its patent portfolio against challenges from third parties, obtaining regulatory approval for products, competition from others using technology similar to Alnylam’s and others developing products for similar uses, Alnylam’s ability to manage operating expenses, Alnylam’s ability to obtain additional funding to support its business activities and establish and maintain strategic business alliances and new business initiatives, Alnylam’s dependence on third parties for development, manufacture, marketing, sales and distribution of products, the outcome of litigation, and unexpected expenditures, as well as those risks more fully discussed in the “Risk Factors” filed with Alnylam’s most recent Quarterly Report on Form 10-Q filed with the Securities and Exchange Commission (SEC) and in other filings that Alnylam makes with the SEC. In addition, any forward-looking statements represent Alnylam’s views only as of today and should not be relied upon as representing its views as of any subsequent date. Alnylam explicitly disclaims any obligation to update any forward-looking statements.

Alnylam Pharmaceuticals, Inc.
Investors and Media
Christine Regan Lindenboom, 617-682-4340
or
Investors
Josh Brodsky, 617-551-8276

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$AEZS & Orient EuroPharma Sign Exclusive #LicenseAgreement for #Zoptrex

Aeterna Zentaris Inc. (NASDAQ: AEZS) (TSX: AEZ) (the “Company”) and Orient EuroPharma Co., Ltd. (“OEP”) today announced the signing of an exclusive license agreement between the Company and Cyntec Co., Ltd., an affiliate of OEP (“Cyntec”), for the Company’s lead anti-cancer compound, Zoptrex™ (zoptarelin doxorubicin), for the initial indication of endometrial cancer, for Taiwan and nine countries in Southeast Asia (the “Territory”). Zoptrex™, a novel synthetic peptide carrier linked to doxorubicin as a New Chemical Entity (NCE), is currently in a fully-enrolled Phase 3 clinical trial in endometrial cancer. The Company expects to complete the Phase 3 clinical trial in the third quarter of 2016 and, if the results of the trial warrant doing so, to file a new drug application for Zoptrex™ in the first half of 2017.

Under the terms of the License Agreement, Aeterna Zentaris will be entitled to receive a non-refundable upfront payment in consideration for the license to Cyntec of the Company’s intellectual property related to Zoptrex™ and the grant to Cyntec of the right to commercialize Zoptrex™ in the Territory. Cyntec has also agreed to make additional payments to the Company upon achieving certain pre-established regulatory and commercial milestones. Furthermore, the Company will receive royalties on future net sales of Zoptrex™ in the Territory. Cyntec will be responsible for the development, registration, reimbursement and commercialization of the product in the Territory.

David Dodd, President and CEO of the Company, stated, “We are very excited about this arrangement with OEP. It is an important step in our strategy of leveraging our pipeline to secure future revenues with strategic development and commercial licensees for specific regions of the world. We are very pleased that OEP’s affiliates will commercialize Zoptrex™ in the Territory, providing women with advanced endometrial cancer a significant treatment option. Their experience and commitment to ensuring the success of Zoptrex™ in their Territory is most assuring. We look forward to similar, additional agreements as we progress towards the completion of the pivotal Phase 3 trial and the subsequent reporting of top-line results later this year.”

Commenting on the signing of the agreement, Peter Tsai, Chairman and CEO of OEP stated, “With our advantage of the comprehensive sales network and operation over Southeast Asia market which we have cultivated for years, we successfully signed the partnership with Aeterna Zentaris and the outstanding endometrial cancer treatment. The exclusive license agreement gives us more confidence in exploring the Asian market with a stronger product portfolio.”

About Zoptrex™

Zoptrex™ is a complex molecule that combines a synthetic peptide carrier with doxorubicin, a well-known chemotherapy agent. The synthetic peptide carrier is [D-Lys6]-LHRH, a modified natural hormone believed to have a strong affinity for the LHRH receptor. The design of the compound allows for the specific binding and selective uptake of the cytotoxic conjugate by LHRH receptor-positive tumors. Potential benefits of this targeted approach include enhanced efficacy and a more favorable safety profile with lower incidence and severity of side effects as compared to doxorubicin.

About Orient EuroPharma Co., Ltd.

Founded in 1982, Orient EuroPharma Co., Ltd (OEP) was officially listed in the Gre-Tai Securities market in 2003, and consolidated net sales exceeded $5 billion in the 2014 financial year. Currently, OEP has more than 800 staffs worldwide, in which over 40% are overseas employees. OEP’s products include pharmaceuticals, cancer drugs, cosmeceutical, infant & adult nutrition and healthcare products. OEP also established a subsidiary company focused on developing and manufacturing new drugs. OEP is one of multinational pharmaceutical companies able to integrate pharmaceutical research & development, clinical trial, manufacture and marketing in Taiwan.

About Aeterna Zentaris Inc.

Aeterna Zentaris is a specialty biopharmaceutical company engaged in developing and commercializing novel treatments in oncology, endocrinology and women’s health. We are engaged in drug development activities and in the promotion of products for others. We are now conducting Phase 3 studies of two internally developed compounds. The focus of our business development efforts is the acquisition or license of products that are relevant to our therapeutic areas of focus. We also intend to license out certain commercial rights of internally developed products to licensees in territories where such out-licensing would enable us to ensure development, registration and launch of our product candidates. Our goal is to become a growth-oriented specialty biopharmaceutical company by pursuing successful development and commercialization of our product portfolio, achieving successful commercial presence and growth, while consistently delivering value to our shareholders, employees and the medical providers and patients who will benefit from our products. For more information, visit www.aezsinc.com.

Forward-Looking Statements

This press release contains forward-looking statements made pursuant to the safe harbor provisions of the US Securities Litigation Reform Act of 1995. Forward-looking statements may include, but are not limited to statements preceded by, followed by, or that include the words “expects,” “believes,” “intends,” “anticipates,” and similar terms that relate to future events, performance, or our results. Forward-looking statements involve known and unknown risks and uncertainties that could cause the Company’s actual results to differ materially from those in the forward-looking statements. Such risks and uncertainties include, among others, the availability of funds and resources to pursue R&D projects and clinical trials, the successful and timely completion of clinical studies, the risk that safety and efficacy data from any of our Phase 3 trials may not coincide with the data analyses from previously reported Phase 1 and/or Phase 2 clinical trials, the rejection or non-acceptance of any new drug application by one or more regulatory authorities and, more generally, uncertainties related to the regulatory process, the ability of the Company to efficiently commercialize one or more of its products or product candidates, the degree of market acceptance once our products are approved for commercialization, the ability of the Company to take advantage of business opportunities in the pharmaceutical industry, the ability to protect our intellectual property, the potential of liability arising from shareholder lawsuits and general changes in economic conditions. Investors should consult the Company’s quarterly and annual filings with the Canadian and US securities commissions for additional information on risks and uncertainties relating to forward-looking statements. Investors are cautioned not to place undue reliance on these forward-looking statements. The Company does not undertake to update these forward-looking statements. We disclaim any obligation to update any such factors or to publicly announce the result of any revisions to any of the forward-looking statements contained herein to reflect future results, events or developments, except if required to do so.

Aeterna Zentaris Inc.
Philip A. Theodore, 843-900-3223
Senior Vice President
IR@aezsinc.com

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