Archive for July, 2016

$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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$ACLS Announces Completion Of #ReverseStockSplit

In the news release, Axcelis Announces Completion Of Reverse Stock Split, issued 01-Jul-2016 by Axcelis Technologies, Inc. over PR Newswire, we are advised by the company that the second paragraph, last sentence, should read “This reduced the number of outstanding shares of common stock from approximately 116 million to approximately 29 million” rather than “to approximately 39 million” as originally issued inadvertently. The complete, corrected release follows:

Axcelis Announces Completion Of Reverse Stock Split

BEVERLY, Mass., July 1, 2016  — Axcelis Technologies, Inc. (Nasdaq: ACLS), a leading supplier of enabling ion implantation solutions for the semiconductor industry, today announced the completion of its 1-for-4 reverse stock split of its common stock as of 6:00 p.m. Eastern Time on June 30, 2016.  As of the open of the market today, shares of Axcelis common stock will begin trading on a split-adjusted basis on the Nasdaq Global Select Market under its unchanged symbol “ACLS.” The Axcelis common stock will trade under a new CUSIP number (054540208).

The reverse stock split affects all issued and outstanding shares of the Company’s common stock, as well as common stock underlying stock-based compensation immediately prior to the effectiveness of the reverse stock split. As previously disclosed, at effectiveness of the reverse stock split, every four shares of outstanding Axcelis common stock were automatically combined into one share of common stock without any change in the par value per share. This reduced the number of outstanding shares of common stock from approximately 116 million to approximately 29 million.

No fractional shares were issued in connection with the reverse stock split. Instead, Axcelis’ transfer agent will aggregate all fractional shares that otherwise would have been issued as a result of the reverse stock split and those shares will be sold into the market. Stockholders who would otherwise hold a fractional share of Axcelis common stock will receive a proportional cash payment from the net proceeds of that sale in lieu of such fractional share.  Additional information on the treatment of fractional shares and other effects of the reverse stock split can be found in Axcelis’ definitive proxy statement filed with the Securities and Exchange Commission on March 14, 2016.

Computershare Trust Company, N.A. and Computershare Inc. will collectively act as the Company’s exchange agent for purposes of implementing the reverse stock split. Stockholders with certificated shares will soon receive an exchange form from Computershare which will contain instructions on how to surrender certificates representing pre-split shares. Stockholders should not send in their old stock certificates until they receive an exchange form from Computershare.  However, a stockholder may, if desired, sell shares by delivering an old stock certificate to a broker.  Stockholders of record as of June 30, 2016 who wish to ensure that the Company has their most current contact information should visit the Computershare Investor Center online at www.computershare.com/investor.

Stockholders who hold their shares in brokerage accounts or “street name” will not be required to take any action to effect the exchange of their shares.

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

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

Friday, July 1st, 2016 Uncategorized Comments Off on $ACLS Announces Completion Of #ReverseStockSplit