Archive for December, 2017

$ARGX Positive Topline Results GMG Phase 2 Proof-Of-Concept Trial

  • Favorable tolerability profile consistent with Phase 1 data
  • ARGX-113 treatment resulted in a strong clinical improvement over placebo during the entire duration of the study
  • 75% of ARGX-113 treated patients had a clinically meaningful and statistically significant improvement through at least 6 consecutive study weeks versus 25% of patients on placebo
  • Management to host conference call today at 8:00 am EST

December 11, 2017

Breda, the Netherlands / Ghent, Belgium – argenx (Euronext & Nasdaq: ARGX), a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer, today announced positive topline results from its Phase 2 proof-of-concept clinical trial of ARGX-113 (efgartigimod) in myasthenia gravis (MG) patients with confirmed generalized muscle weakness. The data showed a clinically meaningful and statistically significant benefit of ARGX-113 over placebo. In addition, ARGX-113 was found to have a favorable tolerability profile consistent with that observed in the Phase 1 study.

The results will be discussed during a conference call and webcast presentation today at 2:00 pm CET/ 8:00 am EST. The conference call can be accessed by dialing 1-631-510-7498 in the U.S. or selecting from the numbers below if international. The confirmation code is 5472459. The webcast may be accessed on the homepage of the argenx website at www.argenx.com or by clicking here.

“There remains a clear unmet need for a safe and fast-acting treatment for patients with generalized MG, who continue to face serious, potentially life-threatening symptoms associated with their disease,” said Professor James F. Howard Jr., MD, Distinguished Professor of Neuromuscular Disease, professor of neurology, medicine and allied health, and chief of the Neuromuscular Disorders Section in the University of North Carolina School of Medicine, Chapel Hill, NC USA. “These data demonstrate a rapid and sustained benefit in disease score after treatment with ARGX-113, supporting further development of the drug as a potential new option to fill the current treatment gap for MG patients.”

Phase 2 Trial Design
The Phase 2 double-blind, placebo-controlled, proof-of-concept trial enrolled 24 MG patients with generalized muscle weakness, and a total Myasthenia Gravis Activity-of-Daily-Living (MG-ADL) score >= 5 with more than 50% of the score consisting of non-ocular items. Patients were randomized to receive four weekly doses of either standard of care plus 10 mg/kg of ARGX-113, or standard of care plus placebo. Standard of care therapies included corticosteroids and/or immunomodulatory agents. The primary endpoints of the study were safety and tolerability. Secondary endpoints included efficacy as measured by the change from baseline of the MG-ADL, Quantitative Myasthenia Gravis (QMG), and Myasthenia Gravis Composite (MGC) disease severity scores; impact on quality of life as measured by the Myasthenia Gravis Quality of Life (MGQoL) score; and an assessment of pharmacokinetics (PK) and pharmacodynamic (PD) markers. All 24 patients were evaluable.

Top-line Results
Primary endpoint analysis revealed ARGX-113 to be well tolerated in all patients, with most adverse events (AEs) characterized as mild and deemed unrelated to the study drug. No serious or severe AEs were reported. The observed tolerability profile is consistent with the Phase 1 healthy volunteer study.

The secondary endpoint measures relating to efficacy showed ARGX-113 treatment resulted in rapid onset of action and strong clinical improvement over placebo during the entire duration of the study.
Specifically, we observed that:

  • 75% of patients treated with ARGX-113 had a clinically meaningful and statistically significant improvement in MG-ADL scores (at least a 2-point reduction from baseline) for a period of at least 6 consecutive weeks versus 25% of patients on placebo (p = 0.0391).
  • Clinical benefit in the ARGX-113 treatment group maximized as of 1 week after the administration of the last dose, achieving statistical significance over the placebo group (p = 0.0356) on the MG-ADL score. Increasing differentiation was observed between the
    ARGX-113 treatment group versus placebo with increasing MG-ADL thresholds.
  • Patients in the treatment arm showed rapid disease improvement, with clear separation from placebo 1 week after the first infusion.
  • All patients in the treatment arm showed a rapid and deep reduction of their total IgG levels and disease improvement was found to correlate with reduction in pathogenic IgG levels.
  • ARGX-113 demonstrated strong clinical improvement over placebo as measured by all four predefined clinical efficacy scales – MG-ADL, QMG, MGC and MG-QoL15.

“These results strengthen our conviction that reducing pathogenic autoantibodies may offer an innovative approach to treat myasthenia gravis and could give rise to potential therapeutic benefits in other neuromuscular conditions that are similarly mediated. Further, through our deeper understanding of the drug’s mechanism, we see promise of its potential across other disease categories as well, including autoimmune blood disorders or skin blistering diseases which we are evaluating in our two ongoing Phase 2 studies in immune thrombocytopenia and pemphigus vulgaris,” commented Nicolas Leupin, Chief Medical Officer of argenx. “We look forward to refining our plan forward and optimizing the broad potential of ARGX-113.”

argenx plans to present the full data from the trial at the American Academy of Neurology annual meeting (Los Angeles, April 21-27, 2018).

argenx is conducting two additional ongoing Phase 2 clinical trials of ARGX-113 in immune thrombocytopenia (ITP) and pemphigus vulgaris (PV). Topline data for the ITP trial and interim data from the PV trial are both expected in the second half of 2018.

About ARGX-113
ARGX-113 (efgartigimod) is an investigational therapy for IgG-mediated autoimmune diseases and was designed to exploit the natural interaction between IgG antibodies and the recycling receptor FcRn. It consists of the Fc-portion of an antibody that has been modified by the argenx proprietary ABDEG(TM) technology. ARGX-113 blocks antibody recycling through FcRn binding and induces rapid depletion of the autoimmune disease-causing IgG autoantibodies. The development work on ARGX-113 is done in close collaboration with Prof. E. Sally Ward (University of Texas Southwestern Medical and Texas A&M University Health Science Center, a part of Texas A&M University).

About argenx
argenx is a clinical-stage biotechnology company developing a deep pipeline of differentiated antibody-based therapies for the treatment of severe autoimmune diseases and cancer. We are focused on developing product candidates with the potential to be either first-in-class against novel targets or best-in-class against known, but complex targets in order to treat diseases with a significant unmet medical need. Our ability to execute on this focus is enabled by our suite of differentiated technologies. Our SIMPLE Antibody(TM) Platform, based on the powerful llama immune system, allows us to exploit novel and complex targets, and our three antibody engineering technologies are designed to enable us to expand the therapeutic index of our product candidates.
www.argenx.com

Dial-in numbers:
Please dial in 5-10 minutes prior to 2:00 pm CET/ 8:00 am EST using the number and conference ID below.

Confirmation Code: 5472459

  • Standard International Dial-In Number:                 +44 (0) 1452 555566
  • Local Call Dial-In Numbers:

United States, New York                              16315107498
United Kingdom                                               08444933800
Belgium                                                                081700061

Austria                                                                  019286568
Finland                                                                 0923195187
France                                                                  0176742428
Germany                                                             06922224918
Italy                                                                       0236008146
Luxembourg                                                      20880695
Netherland                                                         0207176886
Spain                                                                     914143669
Sweden                                                                               0850336434
Switzerland                                                        0565800007

A question and answer session will follow the presentation of the results. Go to www.argenx.com to access the live audio webcast. The archived webcast will also be available (30 days) for replay shortly after the close of the call from the “Downloads” section of the argenx website.

For further information, please contact:
Joke Comijn, Corporate Communications Manager
+32 (0)477 77 29 44
+32 (0)9 310 34 19
info@argenx.com

Beth DelGiacco (US IR)
Stern Investor Relations
+1 212 362 1200
beth@sternir.com

Forward-looking Statements
The contents of this announcement include statements that are, or may be deemed to be, “forward-looking statements.” These forward-looking statements can be identified by the use of forward-looking terminology, including the terms “believes,” “estimates,” “anticipates,” “expects,” “intends,” “may,” “will,” or “should,” and include statements argenx makes concerning the encouraging clinical data of ARGX-113; argenx’s advancement of, and anticipated clinical development and regulatory milestones and plans related to ARGX-113; and the intended results of its strategy. By their nature, forward-looking statements involve risks and uncertainties and readers are cautioned that any such forward-looking statements are not guarantees of future performance. argenx’s actual results may differ materially from those predicted by the forward-looking statements as a result of various important factors, including argenx’s expectations regarding its the inherent uncertainties associated with competitive developments, preclinical and clinical trial and product development activities and regulatory approval requirements; argenx’s reliance on collaborations with third parties; estimating the commercial potential of argenx’s product candidates; argenx’s ability to obtain and maintain protection of intellectual property for its technologies and drugs; argenx’s limited operating history; and argenx’s ability to obtain additional funding for operations and to complete the development and commercialization of its product candidates. A further list and description of these risks, uncertainties and other risks can be found in argenx’s U.S. Securities and Exchange Commission (SEC) filings and reports, including in the final prospectus related to argenx’s initial U.S. public offering filed with the SEC pursuant to Rule 424(b) of the Securities Act of 1933, as amended, as well as subsequent filings and reports filed by argenx with the SEC. Given these uncertainties, the reader is advised not to place any undue reliance on such forward-looking statements. These forward-looking statements speak only as of the date of publication of this document. argenx undertakes no obligation to publicly update or revise the information in this press release, including any forward-looking statements, except as may be required by law.

Monday, December 11th, 2017 Uncategorized Comments Off on $ARGX Positive Topline Results GMG Phase 2 Proof-Of-Concept Trial

$PTI Positive Clinical Results PTI-428, PTI-801 and PTI-808 Cystic Fibrosis

Company to Host Conference Call and Webcast Today at 5:00 p.m. ET

CAMBRIDGE, Mass., Dec. 11, 2017 – Proteostasis Therapeutics, Inc. (NASDAQ:PTI), a clinical stage biopharmaceutical company dedicated to the discovery and development of groundbreaking therapies to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing, today announced positive study results across all three of the company’s CF pipeline programs.  These include a study in CF subjects for PTI-428, a cystic fibrosis transmembrane conductance regulator (CFTR) amplifier; interim data for a study in CF subjects for PTI-801, a new generation CFTR corrector; and studies in healthy volunteers for PTI-808, a CFTR potentiator, and the combination of PTI-428, PTI-801 and PTI-808.  The results support the goal of studying the Company’s novel CFTR modulators in doublet and triplet combinations in CF subjects.

Results of PTI-428 Meet Efficacy Endpoint in 28-day Study in CF Patients on Background Orkambi
Proteostasis announced that it has completed its Phase 2 study designed to evaluate the efficacy, safety, and tolerability of 50 mg once-a-day of PTI-428 over a 28-day treatment of CF patients on background Orkambi®1 (lumacaftor/ivacaftor).  The addition of PTI-428 to Orkambi® demonstrated mean absolute improvements in ppFEV1 of 5.2 percentage points from baseline compared to placebo (p<0.05), with mean relative improvements of 9.2 percent (p<0.05). This treatment effect was achieved by day 14 and sustained through 28 days of dosing.

“This is an important first step towards translating the scientific potential of the first and only genotype agnostic CFTR modulator in development, and its ability to enhance Orkambi by selectively increasing the production of the CFTR protein,” said Dr. Patrick Flume, a clinical investigator at the Medical University of South Carolina, a CFFT Therapeutics Development Network center, who is participating in the PTI-428 and PTI-801 clinical studies. “I look forward to seeing PTI-428 evaluated in further combination studies, with the goal of fully elucidating the potential of this unique CFTR amplifier.”

The two registrational phase 3 studies of Orkambi®, TRAFFIC and TRANSPORT, showed that magnitude of response to Orkambi® varied according to patient lung function at screening, suggesting that the overall efficacy was mainly driven by the subgroup with baseline ppFEV1 below 70% (+3.3 percentage points) while the changes in the group with FEV1 ≥70% were not statistically significant. A similar analysis was performed in the 28-day study with PTI-428 and it showed an average +6.6 percentage points increase (p<0.05) in absolute ppFEV1 compared to placebo for patients who had lower baseline ppFEV1 value (<70%). The results of the subgroup analysis are consistent with Phase 3 data with Orkambi®, suggesting that PTI-428 potentially amplifies the Orkambi® effect in the responder population.

Additional exploratory endpoints in the study included measurement of changes in sweat chloride and CFTR expression in nasal epithelia. In this study, a positive increase in CFTR protein from baseline was observed in PTI-428 treated subjects and the magnitude of change was consistent with the changes in CFTR protein levels observed in an in vitro human bronchial cell (HBE) model.  In contrast, changes in sweat chloride did not correlate with changes in lung function.

The 28-day study continues to confirm the safety profile of PTI-428 in that it was generally well tolerated and lacked clinically meaningful drug-drug interactions with ivacaftor and lumacaftor.   Fourteen of 20 subjects receiving PTI-428 and two of four subjects receiving placebo experienced at least one treatment emergent adverse event. There were no serious adverse events and there were 2 adverse events that led to study discontinuation. Both cases were thrombocytopenia of mild grade and comparable magnitude and value. One occurred while a subject was on Orkambi® only and one in a subject receiving PTI-428, with both subjects resolving spontaneously.

“The ability to capture an improvement in absolute ppFEV1 along with a targeted increase in the CFTR protein at 50 mg of PTI-428 indicates that we have been able to identify a starting dose that will guide us for future dose optimization in combination studies with our proprietary potentiator and corrector,” said Meenu Chhabra, president and CEO.

Preliminary Ad Hoc Analysis of PTI-801 in Ongoing 14-day Study in CF Patients on Background Orkambi
The Company has also shared initial data from the first five subjects (four PTI-801 treated and one placebo) of the first dose level tested in the 14-day dosing study of PTI-801 in CF patients on background Orkambi® therapy.  All four subjects who received once-a-day 100 mg of PTI-801 have completed two weeks of dosing. The pharmacokinetic (PK) profile observed from these four subjects is consistent with the PK profile observed for healthy volunteers. These initial data also showed no clinically meaningful drug-drug interactions with either lumacaftor or ivacaftor.  There were no serious adverse safety events reported that were considered as possibly drug related.  Mean absolute improvements in ppFEV1 of approximately 4 percentage points from baseline, with mean relative improvements of approximately 7 percent, were observed in the four PTI-801 subjects who have completed two weeks of dosing to date. The first cohort of up to 20 patients is still recruiting with enrollment expected to complete in Q1 2018.

“This initial data begins to validate the in vitro profile of PTI-801 and its potential to bolster efficacy for subjects on Orkambi®. We are eager to explore a dose response in the next planned cohort with 200 mg of once a day dosing,” said Ms. Chhabra.

PTI-808 Completes Safety and PK Profile from SAD and MAD Study in Healthy Volunteers
A total of 48 healthy volunteers have participated and completed the study of up to 300 mg of once-a-day, orally dosed PTI-808, a novel CFTR potentiator that was tested in single and multiple dose cohorts. PTI-808 was found to be generally well tolerated.  One subject experienced a serious adverse event from a pre-existing condition of transverse myelitis. This serious adverse event was considered unlikely to be related to the study drug. No adverse events leading to discontinuation of treatment were reported.  All other adverse events that have been reported to date were of mild or moderate severity. Preliminary PK assessment of PTI-808 suggest that it could potentially be suitable for once daily dosing.

Co-administration of PTI-428, PTI-808 and PTI-801 in Healthy Volunteers Completed
PTI completed a healthy volunteer co-administration study of its three proprietary CFTR modulators testing safety and tolerability in 20 subjects. Safety and PK profiles achieved with seven days of once-a-day oral dosing of PTI-428, PTI-801 and PTI-808 indicate these compounds were generally well-tolerated and could potentially be amenable for once a day dosing. No SAEs or AEs leading to discontinuation of treatment were reported.  The PK data demonstrated a lack of clinically meaningful drug-drug interactions.  Combination study protocols have been reviewed by key patient advocacy and regulatory authorities in US and Europe.

“The phase 2 data with PTI-428, along with initial clinical evidence with PTI-801 and the completion of co-administration safety and PK studies with all three CFTR modulators in healthy volunteers further cements our progress towards combination development with our proprietary compounds in the CF patient population,” said Ms. Chhabra.  “We look forward to initiating a doublet study of PTI-801 and PTI-808 in CF subjects and progressing towards a triple combination study in CF subjects in 2018.”

Conference Call and Webcast

Proteostasis will hold a conference call and accompanying webcast today, December 11, 2017, at 5:00 p.m. ET to discuss the data announced today.  The conference call can be accessed by dialing 1-844-534-7315 from the United States or 1-574-990-3007 from outside the United States and referring to conference ID 8786987. A live webcast and accompanying slide presentation will be available on the Event Calendar page in the Investors & Media section of the company’s website, www.proteostasis.com. A replay of the webcast will be available on the company’s website shortly after the conclusion of the conference call.

About Proteostasis Therapeutics, Inc.

Proteostasis Therapeutics, Inc. is a clinical stage biopharmaceutical company developing small molecule therapeutics to treat cystic fibrosis (CF) and other diseases caused by dysfunctional protein processing. Headquartered in Cambridge, MA, the Proteostasis Therapeutics team focuses on identifying therapies that restore protein function. In addition to its multiple programs in cystic fibrosis, Proteostasis Therapeutics has formed a collaboration with Astellas Pharma, Inc. to research and identify therapies targeting the Unfolded Protein Response (UPR) pathway. For more information, visit www.proteostasis.com.

Safe Harbor

To the extent that statements in this release are not historical facts, they are forward-looking statements reflecting the current beliefs and expectations of management made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995.  Words such as “aim,” “may,” “will,” “expect,” “anticipate,” “estimate,” “intend,” and similar expressions (as well as other words or expressions referencing future events, conditions or circumstances) are intended to identify forward-looking statements.  Examples of forward-looking statements made in this release include, without limitation, statements regarding the expected timing of the initiation of, patient enrollment in, data from, and the completion of, our clinical studies and cohorts for PTI-428, PTI-801, PTI-808 and our dual and triple combination therapy candidates.   Forward-looking statements made in this release involve substantial risks and uncertainties that could cause actual results to differ materially from those expressed or implied by the forward-looking statements, and we, therefore cannot assure you that our plans, intentions, expectations or strategies will be attained or achieved.  Such risks and uncertainties include, without limitation, the possibility final or future results from our drug candidate trials (including, without limitation, longer duration studies) do not achieve positive results or are materially and negatively different from or not indicative of the preliminary results reported by the Company (noting that these results are based on a small number of patients and small data set), uncertainties inherent in the execution and completion of clinical trials (including, without limitation, the possibility FDA requires us to run cohorts sequentially or conduct additional cohorts or pre-clinical or clinical studies), in the enrollment of CF patients in our clinical trials, in the timing of availability of trial data, in the results of the clinical trials, in possible adverse events from our trials, in the actions of regulatory agencies, in endorsement, if any, by therapeutic development arms of CF patient advocacy groups, and those set forth in our Quarterly Report on Form 10-Q for the quarter ended September 30, 2017 and our other SEC filings.  We assume no obligation to update or revise any forward-looking statements, whether as a result of new information, future events or otherwise.

1 Orkambi® is a registered trademark from Vertex Pharmaceuticals, Inc.

CONTACTS:

Investors:
David Pitts
Argot Partners
212.600.1902
david@argotpartners.com

Media:
Eliza Schleifstein
Argot Partners
973.361.1546
eliza@argotpartners.com

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$YTEN Grants Research License to Monsanto

WOBURN, Mass., Dec. 11, 2017 — Yield10 Bioscience, Inc. (NASDAQ:YTEN) announced today that it has granted a non-exclusive research license to Monsanto Company to evaluate its novel C3003 and C3004 yield traits in soybean. Under the license, Monsanto plans to research both traits within its soybean pipeline as a strategy to improve plant yields. Yield10 Bioscience is focused on “building better plants” by developing proprietary, breakthrough technologies that produce higher yields in major food and feed crops to enhance global food security using lower inputs of land, water and fertilizer.

Yield10’s “Smart Carbon Grid for Plants” advanced metabolic engineering technology platform incorporates sourcing of new metabolic functionality from non-plant systems with sophisticated models of carbon-flux pathways to identify gene targets that enhance carbon capture from photosynthesis and regulate the flow of carbon to seed. Derived from algae, C3003 represents the lead plant trait in this platform. C3004, another platform trait, is believed to play a role in carbon partitioning. Monsanto plans to conduct research with C3003 and C3004 individually and in combination to evaluate the effectiveness of the trait stack.

“The early development work with C3003 and C3004 in oilseeds and the mechanisms are very interesting, and we are excited to have the opportunity to explore the potential of these yield traits in soybean,” said Janice Edwards, Ph.D., Director, Yield Traits and Disease, Monsanto. “We are also impressed by Yield10’s metabolic engineering and advanced carbon flux modeling capabilities, as Monsanto is committed to developing solutions that meet farmers’ important needs, while positively affecting modern agriculture’s carbon footprint and overall sustainability.”

“Monsanto is a worldwide leader in soybean research, and we are pleased that they have chosen Yield10 and our novel C3003 and C3004 traits for integration into their soybean program,” said Oliver Peoples, Ph.D., Chief Executive Officer of Yield10. “The Yield10 team looks forward to supporting Monsanto with further insights from our research to contribute to their R&D success with the technology.”

Soybean is an oilseed crop used for animal feed, food, and food additives. It is the second highest value agricultural crop in the United States with the 2016 harvest estimated at over 4.31 billion bushels (USDA1) and a value of approximately $41 billion. Soybeans are widely cultivated in North and South America where a majority of the seed that is grown is genetically modified for crop enhancements, such as increased yield or pest resistance. Demands for agriculture are growing and evolving with a growing global population, rising middle class and shifting diets. As a result, increases in commodity crop yields are needed to keep pace with growing global demand for food security as well as to increase crop yield on agriculture’s existing footprint.

Background on Novel Yield Gene Trait C3003 

Yield10’s C3003 novel yield gene trait is part of a system in algae that enables carbon fixation in low CO2 environments and appears to be a unique gene that impacts photorespiration, a biochemical pathway in C3 photosynthetic plants which is responsible for significant losses in yield. The purpose of increased seed yield is to enable farmers to increase the productivity of their land. Yield10 is progressing the introduction of C3003 as well as improvements to the C3003 trait, in Camelina, canola, soybean and rice, and expects to report additional results from a number of these activities throughout 2017 and 2018.

About Yield10 Bioscience

Yield10 Bioscience, Inc. is focused on developing new technologies to achieve step-change improvements in crop yield to enhance global food security. Yield10 has an extensive track record of innovation based around optimizing the flow of carbon in living systems.  Yield10 leverages its technology platforms and unique knowledge base to design precise alterations to gene activity and the flow of carbon in plants to produce higher yields with lower inputs of land, water or fertilizer. Yield10 is advancing several yield traits it has developed in crops such as Camelina, canola, soybean and rice. Yield10 is headquartered in Woburn, MA and has an Oilseeds center of excellence in Saskatoon, Canada.

For more information about the company, please visit www.yield10bio.com.

(YTEN-G)

Safe Harbor for Forward-Looking Statements

This press release contains forward-looking statements which are made pursuant to the safe harbor provisions of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. The forward-looking statements in this release do not constitute guarantees of future performance. Investors are cautioned that statements in this press release which are not strictly historical, including, without limitation, statements regarding the research license to Monsanto including producing new, higher yielding varieties of soybean, constitute forward-looking statements. Such forward-looking statements are subject to a number of risks and uncertainties that could cause actual results to differ materially from those anticipated, including the risks and uncertainties detailed in Yield10 Bioscience’s filings with the Securities and Exchange Commission. Yield10 assumes no obligation to update any forward-looking information contained in this press release or with respect to the announcements described herein.

Source: https://www.nass.usda.gov/Newsroom/2017/01_12_2017.php

Yield10 Contacts:
Lynne H. Brum, (617) 682-4693, LBrum@yield10bio.com

Investor Relations Contact:
Amato and Partners, LLC
90 Park Avenue, 17th Floor
New York, NY 10016
admin@amatoandpartners.com

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$STLHF Provides Development Update on California Lithium Project

VANCOUVER, British Columbia, Dec. 11, 2017 — Standard Lithium Ltd. (“Standard Lithium” or the “Company”) (TSX-V:SLL) (FRA:S5L) (OTCQX:STLHF) is pleased to provide an update on the development work taking place at the Company’s California Lithium Project; comprising the Bristol Dry Lake and the Cadiz Dry Lake lithium brine properties located in the Mojave Desert, California.

A total of six new separate evaporation ponds have been installed on the Bristol Dry Lake Property to further assess the role that short-duration passive solar evaporation may play in processing the lithium brines encountered at the project.  Previous work demonstrated that, owing to extremely high evaporation rates in the project area, it is possible to concentrate brines from initial lithium concentrations of 146 mg/L to concentrations of 686 mg/L in approximately 7 weeks (note, this average lithium concentration was previously reported as 556 mg/L in news release dated 10th Oct 2017, but has been revised upwards based on final QA/QC data).  Additional evaporation tests are now being conducted to assess seasonal variations in evaporation rates, and also to produce large volumes of pre-concentrated brine that can be shipped to Standard Lithium’s testing facilities across North America where it will be used in ongoing selective lithium extraction processing work.  A bulk raw-brine sample from the Cadiz Dry Lake Project will also be transported to the evaporation ponds over next several weeks so that pre-concentration of lithium brine from this project can also be assessed.

In addition, a sampling program of lithium brine from all surface pits operating on TETRA’s Bristol Dry Lake property has been approved and is ongoing, and it is expected that this work will be completed over the next month.  This shallow-brine data collection program will provide excellent additional exploration coverage and increase data density across the large land package.

Exploration drilling work is ongoing at the Bristol Dry Lake Project, and four exploration boreholes have been successfully drilled using air reverse-circulation techniques.  Exploration hole DH-1 was completed to the targeted depth of 700 ft below ground level (213 m); exploration hole DH-4 was drilled to a greater depth of 1,195 ft (364 m); exploration hole DH-1 reached the targeted depth of 700 ft (213 m); and exploration borehole DH-3 was extended to a greater total depth of 1,060 ft (323 m).  All exploration boreholes intersected similar sequences of interbedded halite (salt) and finer-grained clastic materials.  Highly conductive brine was encountered throughout the entire drilled interval in airlift samples from all four exploration boreholes drilled to date.  Field-measured conductivities in the brine samples were typically greater than 200 mS/cm, and initial results from an accredited laboratory demonstrate that lithium contents and general brine chemistry are consistent with, or better than, those previously reported in historical USGS boreholes.  All final data, following secondary laboratory analysis and full QA/QC, will be reported in the maiden resource estimate for the Bristol Dry Lake Project, projected for the first half of 2018.

Drilling work is ongoing, and two additional drill targets have been identified and agreed on patented mining claims owned by TETRA Technologies Inc. (Tetra) on the Bristol Dry Lake Project.  Inclusion of these two new targets will allow the brine deposits below the complete land package of 35,000+ acres to be evaluated, and as a result, a single resource statement for the total land package at Bristol Dry Lake will be produced.

Quality Assurance

Raymond Spanjers, Certified Professional Geologist (SME No. 3041730), is a qualified person as defined by NI 43-101, and has supervised the preparation of the scientific and technical information that forms the basis for this news release.  Mr. Spanjers is not independent of the Company as he is an officer in his role as Vice President, Exploration and Development.

About Standard Lithium Ltd.

Standard’s value creation strategy encompasses acquiring a diverse and highly prospective portfolio of large-scale domestic brine resources, led by an innovative and results-oriented management team with a strong focus on technical skills.  The Company is currently focused on the immediate exploration and development of the Bristol Dry Lake Lithium Project located in the Mojave region of San Bernardino County, California; the location has significant infrastructure in-place, with easy road and rail access, abundant electricity and water sources, and is already permitted for extensive brine extraction and processing activities.  The Company is also commencing resource evaluation on 30,000+ acres of brine leases located in the Smackover Formation.

Standard Lithium is listed on the TSX Venture under the trading symbol “SLL”; quoted on the OTCQX under the symbol “STLHF”; and on the Frankfurt Stock Exchange under the symbol “S5L”. Please visit the Company’s website at www.standardlithium.com.

On behalf of the Board,

Standard Lithium Ltd.

Robert Mintak, CEO & Director

Neither TSX Venture Exchange nor its Regulation Services Provider (as that term is defined in policies of the TSX Venture Exchange) accepts responsibility for the adequacy or accuracy of this release.

This news release may contain certain “Forward-Looking Statements” within the meaning of the United States Private Securities Litigation Reform Act of 1995 and applicable Canadian securities laws. When used in this news release, the words “anticipate”, “believe”, “estimate”, “expect”, “target, “plan”, “forecast”, “may”, “schedule” and other similar words or expressions identify forward-looking statements or information.  These forward-looking statements or information may relate to future prices of commodities, accuracy of mineral or resource exploration activity, reserves or resources, regulatory or government requirements or approvals, the reliability of third party information, continued access to mineral properties or infrastructure, fluctuations in the market for lithium and its derivatives, changes in exploration costs and government regulation in Canada and the United States, and other factors or information.  Such statements represent the Company’s current views with respect to future events and are necessarily based upon a number of assumptions and estimates that, while considered reasonable by the Company, are inherently subject to significant business, economic, competitive, political and social risks, contingencies and uncertainties.  Many factors, both known and unknown, could cause results, performance or achievements to be materially different from the results, performance or achievements that are or may be expressed or implied by such forward-looking statements.  The Company does not intend, and does not assume any obligation, to update these forward-looking statements or information to reflect changes in assumptions or changes in circumstances or any other events affections such statements and information other than as required by applicable laws, rules and regulations.

For further information, contact Anthony Alvaro at (604) 240 4793
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$ELON Reports Inducement Grant Under NASDAQ Listing Rules

SANTA CLARA, Calif., Dec. 8, 2017 — Echelon Corporation (Nasdaq: ELON), a leading independent control networking company for the Industrial Internet of Things (IIoT), today reported an equity inducement award grant to a newly hired key employee, as required by NASDAQ Stock Market Rules.

As an inducement to entering into employment with the Company, and in accordance with NASDAQ Listing Rule 5635(c)(4), the Compensation Committee of the Board of Directors of the Company granted an award, effective as of December 11, 2017, of 12,000 restricted stock units (the “RSU Award”) to a new key employee. The RSU Award was made outside of the Company’s current equity plan, but will be subject to terms and conditions generally consistent with those in the Company’s 2016 Equity Incentive Plan. The RSU Award will vest as to one-third of the shares on December 11, 2018 and one-third on each annual anniversary thereafter, subject to continued service by such employee through each applicable vesting date.

About Echelon Corporation

For 25 years Echelon (NASDAQ:ELON) has pioneered the development of open-standard networking platforms for connecting, monitoring and controlling devices in commercial and industrial applications. With more than 110 million devices installed worldwide, Echelon’s proven, scalable solutions host a range of applications enabling customers to reduce energy and operational costs, improve safety and comfort, and create efficiencies through optimizing physical systems. Echelon focuses today on two IoT (Internet of Things) market areas: creating smart cities and smart enterprises through connected outdoor lighting systems, and enabling device makers to bring connected products to market faster via a range of IoT-optimized embedded systems. More information about Echelon can be found at www.echelon.com.

Investor Relations Contact:
Annie Leschin
Streetsmart Investor Relations
(415) 775-1788
annie@streetsmartir.com

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$FATE First Subject Treated with FATE-NK100, Ovarian Cancer APOLLO Study

SAN DIEGO, Dec. 08, 2017 — Fate Therapeutics, Inc. (NASDAQ:FATE), a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders, announced today that the first subject has been treated in the APOLLO study of FATE-NK100 in women with ovarian cancer resistant to, or recurrent on, platinum-based treatment. The clinical trial is intended to evaluate the safety and determine the maximum dose of FATE-NK100, the Company’s first-in-class, donor-derived adaptive memory natural killer (NK) cell cancer therapy, as a monotherapy when administered intraperitoneally in the outpatient setting. A clinical assessment of patients with ovarian cancer has previously shown that endogenous NK cells within the peritoneal fluid exhibit an altered phenotype with reduced cytolytic function.

“Women today often are treated with intraperitoneal chemotherapy, and the administration of FATE-NK100 directly within the peritoneal cavity is an exciting therapeutic strategy to restore NK cell function, promote persistence and inhibit tumor growth,” said Melissa A. Geller, M.D., Associate Professor in the Department of Obstetrics, Gynecology and Women’s Health, Division of Gynecologic Oncology at the University of Minnesota and the lead investigator of the clinical trial at the Masonic Cancer Center. “Ovarian cancer is a disease of middle age women, and over 60% of women with ovarian cancer initially present with advanced disease. For these women, the rate of recurrence is around 70%, and there is an urgent need for novel therapeutic strategies since standard treatments in the recurrent setting provide dismal response rates especially in platinum resistant disease.”

The APOLLO study is an open-label, accelerated dose-escalation, Phase 1 clinical trial of FATE-NK100 in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer. Up to three dose levels of FATE-NK100 are intended to be assessed to evaluate safety and determine the maximum dose. Other endpoints to be evaluated include objective response rate at 28 days, and progression-free and overall survival at six months. Subjects with stable disease or better at Day 28 following infusion may be considered for retreatment with FATE-NK100.

Ovarian cancer is the fifth leading cause of cancer-related death among women, and is the deadliest of gynecologic cancers. The American Cancer Society estimates that in 2017, about 22,440 new cases of ovarian cancer will be diagnosed and 14,080 women will die of ovarian cancer in the United States. While a high proportion of women respond to initial platinum-based chemotherapy, around 70% of patients diagnosed with ovarian cancer will have a recurrence. While recurrent ovarian cancer is treatable, it is rarely curable and there is a significant need for more effective, better-tolerated therapies.

About FATE-NK100
FATE-NK100 is a first-in-class, donor-derived natural killer (NK) cell cancer immunotherapy comprised of adaptive memory NK cells, a highly specialized and functionally distinct subset of activated NK cells expressing the maturation marker CD57. Higher frequencies of CD57+ NK cells in the peripheral blood or tumor microenvironment in cancer patients have been linked to better clinical outcomes. In preclinical studies, FATE-NK100 has demonstrated enhanced anti-tumor activity across a broad range of hematologic and solid tumors, with augmented cytokine production, improved persistence and increased resistance to immune checkpoint pathways compared to other NK cell therapies that are being clinically administered today. FATE-NK100 is produced through a feeder-free, seven-day manufacturing process during which NK cells sourced from a healthy donor are activated ex vivo with pharmacologic modulators.

About APOLLO
APOLLO is an open-label, accelerated dose-escalation, Phase 1 clinical trial in subjects with recurrent ovarian, fallopian tube or primary peritoneal cancer designed to evaluate the safety and determine the maximum dose of a single infusion of FATE-NK100 as a monotherapy when administered via intraperitoneal catheter after out-patient chemotherapy followed by sub-cutaneous IL-2 administration. Up to three dose levels of FATE-NK100 are intended to be assessed (1×107 cells/kg, >1×107 cells/kg to ≤3×107 cells/kg, and up to 1×108 cells/kg). In the event a dose limiting toxicity is observed, the clinical trial will convert to a 3+3 design. A ten-subject expansion cohort is expected to be enrolled at the maximum dose level. Other endpoints include objective response rate at 28 days, and progression-free and overall survival at six months, post-infusion of FATE-NK100. The clinical trial is being conducted at the Masonic Cancer Center, University of Minnesota as an investigator-initiated study.

About Fate Therapeutics, Inc.
Fate Therapeutics is a clinical-stage biopharmaceutical company dedicated to the development of programmed cellular immunotherapies for cancer and immune disorders. The Company’s hematopoietic cell therapy pipeline is comprised of NK- and T-cell immuno-oncology programs, including off-the-shelf product candidates derived from engineered induced pluripotent cell lines, and immuno-regulatory programs, including product candidates to prevent life-threatening complications in patients undergoing hematopoietic cell transplantation and to promote immune tolerance in patients with autoimmune disease. Its adoptive cell therapy programs are based on the Company’s novel ex vivo cell programming approach, which it applies to modulate the therapeutic function and direct the fate of immune cells. Fate Therapeutics is headquartered in San Diego, CA. For more information, please visit www.fatetherapeutics.com.

Forward-Looking Statements 
This release contains “forward-looking statements” within the meaning of the Private Securities Litigation Reform Act of 1995, including statements regarding the safety and therapeutic potential of NK cells including FATE-NK100, the expected clinical development plans for FATE-NK100, and the potential of FATE-NK100 to treat patients with recurrent ovarian, fallopian tube or primary peritoneal cancer. These and any other forward-looking statements in this release are based on management’s current expectations of future events and are subject to a number of risks and uncertainties that could cause actual results to differ materially and adversely from those set forth in or implied by such forward-looking statements. These risks and uncertainties include, but are not limited to, the risk of cessation or delay of planned development and clinical activities for a variety of reasons (including any delay in enrolling patients in clinical trials, or the occurrence of any adverse events or other results that may be observed during development), the risk that results observed in prior preclinical studies and current clinical trials of FATE-NK100 may not be replicated in current or future clinical trials, and the risk that FATE-NK100 may not produce therapeutic benefits or may cause other unanticipated adverse effects. For a discussion of other risks and uncertainties, and other important factors, any of which could cause our actual results to differ from those contained in the forward-looking statements, see the risks and uncertainties detailed in the Company’s periodic filings with the Securities and Exchange Commission, including but not limited to the Company’s most recently filed periodic report, and from time to time the Company’s other investor communications. Fate Therapeutics is providing the information in this release as of this date and does not undertake any obligation to update any forward-looking statements contained in this release as a result of new information, future events or otherwise.

Contact:
Christina Tartaglia
Stern Investor Relations, Inc.
212.362.1200
christina@sternir.com

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$CDXC Nicotinamide Riboside Improves Mitochondrial Activity in Alzheimer’s Research

IRVINE, Calif., Dec. 08, 2017 — ChromaDex Corp. (NASDAQ:CDXC), a science-based, fully integrated nutraceutical company devoted to extending human healthspan, announced today that in research published in the journal Nature, Dr. Johan Auwerx showed that Alzheimer’s disease (AD) mice treated with nicotinamide riboside (NR) had lower levels of amyloid deposits, improved mitochondrial energy production and improved memory.

Alzheimer’s disease is a devastating age-related neurodegenerative condition with no known cure. Identifying early mechanisms of the disease and approaches to prevent AD are among the most important priorities of global biomedical research.

Dr. Auwerx and colleagues at the Ecole Polytechnique Federale de Lausanne in Switzerland, revealed that people with mild cognitive impairment and Alzheimer’s disease have characteristic changes in their brain mitochondria. Dr. Auwerx and colleagues demonstrated that in development of the disease, mitochondrial energy output is reduced and the mitochondrial stress response, which normally recycles damaged mitochondrial proteins, is inactivated. Reasoning that mitochondrial function might be restored by molecules such as NAD+ that are limiting to energy production, Dr. Auwerx tested NR, a recently discovered vitamin and effective NAD+ booster. Dr. Auwerx showed that AD mice treated with NR had lower degrees of amyloid deposits, improved mitochondrial energy production and improved memory.

Remarking on Dr. Auwerx’s discovery, Dr. Rudolph Tanzi, the Vice-Chair of Neurology and Director of the Genetics and Aging Research Unit at Massachusetts General Hospital, the Joseph P. and Rose F. Kennedy Professor of Neurology at Harvard Medical School, and a member of the Scientific Advisory Board of ChromaDex commented, “We’ve long been fascinated by mitochondrial changes in AD pathology and have been intrigued with the possibility of a bioenergetic deficit in AD. Work published today clearly justifies testing NR in the context of mild cognitive impairment.”

Dr. Charles Brenner, the Roy J. Carver Chair and Head of Biochemistry at the University of Iowa and the Chief Scientific Advisor of ChromaDex continued “given the preclinical data and the human safety data that are coming out, we’re thrilled to have additional well vetted applications where we can test NR to improve the human condition. By combining novel imaging modalities with NAD metabolomics, we expect to see multiple opportunities to test NR as a neuroprotective agent in people in coming years.”

NR is a vitamin discovered by Dr. Brenner and developed by ChromaDex.

About ChromaDex:

ChromaDex leverages its complementary business units to discover, acquire, develop and commercialize patented and proprietary health and wellness consumer products and ingredient technologies that promote healthy longevity. In addition to our consumer product and ingredient technologies units, we also have business units focused on natural product fine chemicals (known as “phytochemicals”), and product regulatory and safety consulting. As a result of our relationships with leading universities and research institutions, we are able to discover and license early stage, IP-backed ingredient technologies. We then utilize our in-house chemistry, regulatory and safety consulting business units to develop commercially viable ingredients. Our consumer product and ingredient portfolio are backed with clinical and scientific research, as well as extensive IP protection. Our portfolio of patented ingredient technologies includes NIAGEN® nicotinamide riboside; pTeroPure® pterostilbene; PURENERGY®, a caffeine-pTeroPure® co-crystal; IMMULINA, a spirulina extract; AnthOrigin®, anthocyanins derived from a domestically-produced, water-extracted purple corn husk, and ChromaDex’s flagship consumer product TRU NIAGEN, found at truniagen.com. To learn more about ChromaDex, please visit
www.ChromaDex.com.

Forward-Looking Statements:

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 including statements related to results of the study and its significance related to Alzheimer’s disease and the possibilities as a neuroprotectant. 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 ChromaDex’s business. More detailed information about ChromaDex and the risk factors that may affect the realization of forward-looking statements is set forth in ChromaDex’s Annual Report on Form 10-K for the fiscal year ended December 31, 2016, ChromaDex’s Quarter Reports on Form 10-Q and other filings submitted by ChromaDex 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 ChromaDex undertakes no obligation to revise or update this release to reflect events or circumstances after the date hereof.

ChromaDex Investor Relations Contact:
Andrew Johnson, Director of Investor Relations
949-419-0288
andrewj@chromadex.com

ChromaDex Public Relations Contact:
Breah Ostendorf, Director of Marketing
949-537-4103
breaho@chromadex.com

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$SLNO JVA for Development and Commercialization of CoSense Monitoring Tech

REDWOOD CITY, Calif., Dec. 08, 2017 — Soleno Therapeutics, Inc. (NASDAQ:SLNO), a clinical-stage biopharmaceutical company developing novel therapeutics for the treatment of rare diseases, today announced that it, and its wholly-owned subsidiary, Capnia, Inc., have entered into a Joint Venture (JV) agreement with OptAsia Healthcare Limited (OAHL), a Hong Kong-based healthcare firm, for the development and commercialization of Capnia’s Sensalyze technology, which includes the CoSense End-Tidal Carbon Monoxide monitor that assists in the detection of excessive hemolysis in neonates, and other related products.

Under the terms of the JV agreement, OAHL will invest up to $2.2 million in tranches to purchase shares of our Capnia subsidiary and as a result of this investment, Capnia will no longer be a wholly-owned subsidiary of Soleno.  Going forward, OAHL will be responsible for funding the operations of Capnia. In addition, OAHL has the option to buy the remaining shares of Capnia at a prespecified future time, and at a value based on revenue.

“The completion of this transaction focuses our business solely on the development of rare disease therapeutics with diazoxide choline controlled-release being the lead asset,” said Anish Bhatnagar, M.D., Chief Executive Officer of Soleno Therapeutics. “This JV allows the financing of further development of CoSense and related assets by OAHL, while providing the possibility of delivering future value to Soleno.”

Soleno’s lead product candidate, diazoxide choline controlled-release (DCCR), is a once-daily oral tablet for the treatment of Prader-Willi syndrome (PWS).  Given the completion of this shift in focus, Soleno’s Board of Directors today accepted the resignations of Stephen N. Kirnon, Ed.D., Edgar Engleman, M.D., and Steinar J. Engelsen, M.D., as directors of Soleno, effective as of December 31, 2017.

“I would like to thank Drs. Kirnon, Engleman and Engelsen for their support and contributions to the Company during their respective Board tenures,” said Soleno’s Chairman of the Board, Ernest Mario, Ph.D.  “We wish them well in their future endeavors.”

About Soleno Therapeutics, Inc.

Soleno Therapeutics, Inc. is focused on the development and commercialization of novel therapeutics for the treatment of rare diseases.  The company is currently advancing its lead candidate, DCCR, a once-daily oral tablet for the treatment of PWS, into a Phase III clinical development program in early 2018.

For more information, please visit www.soleno.life.

Forward-Looking Statements

This press release contains forward-looking statements that are subject to many risks and uncertainties. Forward-looking statements include statements regarding our intentions, beliefs, projections, outlook, analyses or current expectations concerning, among other things, our ability to initiate the Phase III clinical development program of DCCR in PWS in early 2018.

We may use terms such as “believes,” “estimates,” “anticipates,” “expects,” “plans,” “intends,” “may,” “could,” “might,” “will,” “should,” “approximately” or other words that convey uncertainty of future events or outcomes to identify these forward-looking statements. Although we believe that we have a reasonable basis for each forward-looking statement contained herein, we caution you that forward-looking statements are not guarantees of future performance and that our actual results of operations, financial condition and liquidity, and the development of the industry in which we operate may differ materially from the forward-looking statements contained in this presentation. As a result of these factors, we cannot assure you that the forward-looking statements in this presentation will prove to be accurate. Additional factors that could materially affect actual results can be found in Soleno’s Form 10-Q filed with the Securities and Exchange Commission on November 14, 2017, including under the caption titled “Risk Factors.” Soleno expressly disclaims any intent or obligation to update these forward-looking statements, except as required by law.

Contact:
Brian Ritchie
LifeSci Advisors, LLC
212-915-2578

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$GLBR to Voluntarily Delist Common Shares from The NASDAQ Capital Market

NEW YORK, Dec. 08, 2017 – Global Brokerage, Inc. (NASDAQ:GLBR) (“Global Brokerage”), announced today that it has notified The NASDAQ Stock Market (“Nasdaq”) of its intention to voluntarily withdraw its Class A common stock, par value $0.01 (the “Common Stock”), from listing on The NASDAQ Capital Market (the “Exchange”).

Global Brokerage intends to file a Form 25, Notification of Removal from Listing under Section 12(b) of the Securities Exchange Act of 1934, with the Securities and Exchange Commission (the “SEC”) on or about December 19, 2017, notifying the SEC of its delisting from the Exchange.  The last day of trading on the Exchange will be December 28, 2017.  Global Brokerage has not arranged for listing or registration of its Common Stock on another national securities exchange.

As previously announced, on May 2, 2017, Nasdaq notified Global Brokerage that the market value of its publicly held Common Stock did not meet the requirement for continued listing under The NASDAQ Global Market’s listing standards. On November 6, 2017, Global Brokerage was notified that Nasdaq would remove Global Brokerage from The NASDAQ Global Market. Nasdaq approved Global Brokerage to transfer its stock to the Exchange, and the Common Stock began trading at the opening of business on November 13, 2017.

Global Brokerage’s Board of Directors intends to withdraw its Common Stock from listing on the Exchange as a result of several factors, including the intention to deregister its Common Stock under the Securities Exchange Act of 1934, as amended, and terminate its duty to file periodic reports with the SEC in order to reduce its costs of compliance with the rules of the SEC and of the Exchange.

Disclosure Regarding Forward-Looking Statements
In addition to historical information, this earnings release may contain “forward-looking statements” within the meaning of Section 27A of the Securities Act of 1933, Section 21E of the Exchange Act and/or the Private Securities Litigation Reform Act of 1995. Forward-looking statements include statements preceded by, followed by, or including the words “believes,” “expects,” “anticipates,” “plans,” “estimates,” “projects,” “forecasts,” or similar expressions. Examples of forward-looking statements in this news release are statements about the expected terms and timing of the Plan, the expected SEC deregistration and the financial impact on Global Brokerage, including reduced expenses, resulting from the restructuring transactions. These forward-looking statements are not historical facts and are based on current expectations, estimates and projections about Global Brokerage’s industry, business plans, management’s beliefs and certain assumptions made by management, many of which, by their nature, are inherently uncertain and beyond our control. Accordingly, readers are cautioned that any such forward-looking statements are not guarantees of future performance and are subject to certain risks, uncertainties and assumptions that are difficult to predict including, without limitation, risks associated with Global Brokerage’s strategy to focus on its operations outside the United States, risks associated with the events that took place in the currency markets on January 15, 2015 and their impact on Global Brokerage’s capital structure, risks associated with Global Brokerage’s ability to recover all or a portion of any capital losses, risks relating to the ability of Global Brokerage to satisfy the terms and conditions of or make payments pursuant to the terms of the finance agreements with Leucadia, as well as risks associated with Global Brokerage’s obligations under its other financing agreements, risks related to Global Brokerage’s dependence on FX market makers, market conditions, risks associated with the outcome of any potential litigation or regulatory inquiries to which Global Brokerage may become subject, risks associated with potential reputational damage to Global Brokerage resulting from its sale of US customer accounts, and those other risks described under “Risk Factors” in Global Brokerage’s Annual Report on Form 10-K, Global Brokerage’s latest Quarterly Report on Form 10-Q, and other reports or documents Global Brokerage files with, or furnishes to, the SEC from time to time, which are accessible on the SEC website at sec.gov. This information should also be read in conjunction with Global Brokerage’s Consolidated Financial Statements and the Notes thereto contained in Global Brokerage’s Annual Report on Form 10-K, Global Brokerage’s latest Quarterly Report on Form 10-Q, and in other reports or documents that Global Brokerage files with, or furnishes to, the SEC from time to time, which are accessible on the SEC website at sec.gov.

About Global Brokerage, Inc.

Global Brokerage, Inc. (NASDAQ:GLBR) is a holding company with an indirect effective ownership of FXCM Group, through its equity interest in Global Brokerage Holdings, of between 7.5 — 37.3% depending on the amount of distributions made by FXCM Group.

Investor Relations
investorrelations@globalbrokerage.info

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$IMMU Updated Results Sacituzumab Govitecan (IMMU-132) in #mTNBC

Objective Response Rate (ORR) = 31% (Centrally Reviewed); 34% (Locally Assessed)

Median Duration of Response (DOR) = 9.1 Months (Centrally Reviewed); 7.6 Months (Locally Assessed)

Clinical Benefit Rate at 6 Months = 45% (Locally Assessed)

Submission of Biologics License Application (BLA) for Accelerated Approval of Sacituzumab Govitecan as Third-Line Treatment for mTNBC Remains on Track for First Quarter of 2018

SAN ANTONIO, Dec. 06, 2017 –  Immunomedics, Inc. (NASDAQ:IMMU) (“Immunomedics” or the “Company”) today announced that a blinded, independent review by an adjudication team of radiologists has determined an ORR of 31%, including six complete responses (CRs) and 28 partial responses (PRs), in 110 patients with mTNBC after receiving treatment with sacituzumab govitecan, the Company’s lead investigational antibody-drug conjugate (ADC), in a Phase 2 study. The independent centrally-reviewed (ICR) median DOR was 9.1 months. These efficacy data are summarized in the table below.

Blinded ICR* Locally Assessed
ORR 31% (6 CRs, 28 PRs) 34% (3 CRs, 34 PRs)
Median DOR 9.1 months 7.6 months

* Scans from 56 patients with at least 20% tumor reduction based on local assessment were sent for blinded, independent central review. Reviewers were not informed patients had 20% tumor shrinkage or which lesions were target lesions by local reads.

“Given relapsed or refractory mTNBC is currently an unmet clinical need and standard therapies provide a very limited benefit of 10-15% ORR and about 2-3 months progression-free survival, we are very encouraged with the efficacy and safety data sacituzumab govitecan has consistently been showing in this late-stage setting,” commented Aditya Bardia, MD, MPH, Director of Precision Medicine and attending physician at Center for Breast Cancer, Massachusetts General Hospital, Harvard Medical School, Boston, MA, who presented the single-arm study in an oral presentation during the 2017 San Antonio Breast Cancer Symposium.

Michael Pehl, President and Chief Executive Officer-elect of Immunomedics, stated, “We believe the blinded independent adjudication affirms the significant clinical activity of sacituzumab govitecan as a single agent in the third-line setting for patients with relapsed or refractory mTNBC. We remain focused on bringing this important medicine to breast cancer patients expeditiously and on transforming Immunomedics into a fully integrated biopharmaceutical company, creating value for our stockholders. To that end, the completion of this Phase 2 study is the second major step in our preparation of a BLA to be submitted to the FDA for accelerated approval of sacituzumab govitecan in this very aggressive form of cancer.”

In addition to a robust median duration of response, nine responders were progression free for more than one year from start of sacituzumab govitecan treatment, four of which were longer than two years. As of data cutoff on June 30, 2017, twelve responding patients were still receiving sacituzumab govitecan.

Overall, patients benefit from sacituzumab govitecan treatment irrespective of age, onset of metastatic disease, or number of prior regimens. Most patients spent more time on sacituzumab govitecan treatment compared to the time spent on last prior therapy. These include 19 patients with prior checkpoint inhibitor therapies who reported an encouraging ORR of 47% (9 of 19) with sacituzumab govitecan. The table below summarizes the ORR of various subgroups.

Subgroups ORR
Age <55 37% (20/54)
>55 30% (17/56)
Onset of metastatic disease <1.5 years 29% (16/55)
>1.5 years 38% (21/55)
Prior regimens for metastatic disease 3rd line 36% (16/45)
>4th line 32% (21/65)
Visceral Involvement at study entry Yes 30% (26/88)
No 50% (11/22)
Trop-2 IHC (N = 62) 0-1 (weak, absent) 0% (0/5)
2-3 (moderate, strong) 40% (23/57)
No Trop-2 IHC 29% (14/48)
Prior checkpoint inhibitors 47% (9/19)

These encouraging results will be part of a BLA package anticipated to be submitted in the first quarter of 2018 to the FDA for accelerated approval of sacituzumab govitecan as a third-line treatment for patients with mTNBC.

Sacituzumab govitecan has a predictable and manageable safety profile. Grade 3 or 4 adverse events with more than 5% frequency include neutropenia (41%), leukopenia (14%), anemia (10%), diarrhea (8%), and febrile neutropenia (7%).  Side effects were managed with supportive medication or dose modifications. There were no treatment-related deaths.

Investor Event
At 8:00 pm Central Time today, Wednesday, December 6, 2017, Immunomedics will host an investor event at The Grand Hyatt, Room Republic B, San Antonio, TX. Leading the discussion on the current treatment landscape for mTNBC will be Harold J. Burstein, MD, PhD, Associate Professor of Medicine at Harvard Medical School, and medical oncologist at Dana-Farber Cancer Institute and Brigham & Women’s Hospital. Linda T. Vahdat, MD, MBA, medical oncologist at Memorial Sloan Kettering Cancer Center and Chief of Medical Oncology and Clinical Director of Cancer Services at Norwalk Hospital will review the Phase 2 results with sacituzumab govitecan in mTNBC. Michael Pehl, President and Chief Executive Officer-elect of Immunomedics will also be present to provide the Company’s strategic priorities. Audio and slides will be webcast live at https://immunomedics.com/investors/. Approximately two hours following the live event, a webcast replay will be available on the Company’s website for approximately 30 days.

About Immunomedics
Immunomedics is a clinical-stage biopharmaceutical company developing monoclonal antibody-based products for the targeted treatment of cancer, autoimmune disorders and other serious diseases. Immunomedics’ most advanced product candidate is sacituzumab govitecan (IMMU-132), an antibody-drug conjugate that has received Breakthrough Therapy Designation from the FDA for the treatment of patients with metastatic triple-negative breast cancer who have failed at least two prior therapies for metastatic disease. Immunomedics’ primary goal is to bring sacituzumab govitecan to market for the benefit of patients and the creation of stockholder value. For additional information on the Company, please visit its website at https://immunomedics.com/. The information on its website does not, however, form a part of this press release.

Cautionary note regarding forward-looking statements
This release, in addition to historical information, may contain forward-looking statements made pursuant to the Private Securities Litigation Reform Act of 1995. Such statements, including statements regarding clinical trials (including the funding therefor, anticipated patient enrollment, trial outcomes, timing or associated costs), regulatory applications and related timelines, out-licensing arrangements, forecasts of future operating results, potential collaborations, and capital raising activities, timing for bringing any product candidate to market, involve significant risks and uncertainties and actual results could differ materially from those expressed or implied herein. Factors that could cause such differences include, but are not limited to, the Company’s dependence on business collaborations or availability of required financing from capital markets, or other sources on acceptable terms, if at all, in order to further develop our products and finance our operations, new product development (including clinical trials outcome and regulatory requirements/actions), the risk that we or any of our collaborators may be unable to secure regulatory approval of and market our drug candidates, risks associated with the outcome of pending litigation and competitive risks to marketed products, and the Company’s ability to repay its outstanding indebtedness, if and when required, as well as the risks discussed in the Company’s filings with the Securities and Exchange Commission. The Company is not under any obligation, and the Company expressly disclaims any obligation, to update or alter any forward-looking statements, whether as a result of new information, future events or otherwise. 

For More Information:
Dr. Chau Cheng
Senior Director, Investor Relations & Corporate Secretary
(973) 605-8200, extension 123
ccheng@immunomedics.com

Media/Investor Contact:
Dan Zacchei / Josh Hochberg
Sloane & Company
212-486-9500
Dzacchei@sloanepr.com
Jhochberg@sloanepr.com

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$VTGN Soars on Patent Announcement, Pipeline Review, and Analysts Opinion

NEW YORK, NY / December 7, 2017 / Traders News Source, a leading independent equity research and corporate access firm focused on small and mid-cap public companies is issuing a comprehensive report with no obligation on VistaGen Therapeutics, Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other CNS disorders.

VistaGen’s lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD).

On Wednesday, December 6th, 2017 the company announced it had been granted a U.S. patent for AV-101. VTGN shares jumped over 200% during intra-day trading on the news.

Read about AV-101 developments, analysts opinion, and a current financial review READ MORE

Copy and paste to your browser may be required to view the report – http://bit.ly/2nAu22s-VTGN-Report

AV-101, is a new generation oral antidepressant drug candidate in Phase 2 development. AV-101’s mechanism of action is fundamentally differentiated from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat major depressive disorder (MDD), with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants.

The company recently announced that the European Patent Office (EPO) granted a European Patent for AV-101, the Company’s oral CNS drug candidate in Phase 2 development for major depressive disorder (MDD).

Get a pipeline review and read about all recent company developments here READ MORE

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Disclosure

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Thursday, December 7th, 2017 Uncategorized Comments Off on $VTGN Soars on Patent Announcement, Pipeline Review, and Analysts Opinion

$DPW Raises 2018 Revenue Guidance 50% from Prior Estimate

Company Raises Full Year Revenue Guidance 250% Over 2017

FREMONT, Calif., Dec. 07, 2017  — Digital Power Corporation (NYSE AMERICAN:DPW) (“Digital Power” or the “Company”), a company seeking to increase revenue through acquisitions and organic growth, stated today that it anticipates that its gross revenue for the year 2018 may increase from roughly $25M to between $36-$38M, on a consolidated basis.

The Company affirms its guidance of $4.2-$4.9M for the quarter ending December 31, 2017.

In addition, for the quarter ending December 31, 2017, Digital Power expects to report growth in comprehensive income due to significant appreciation of its marketable securities held for resale on its balance sheet.

Factors contributing to the upward revision include significant increases in orders from DPW’s defense and commercial businesses, particularly from Microphase Corporation, which received a large order from the U.S. Air Force and currently anticipates further such orders in 2018.

The Company is presently realizing improvement in all its divisions and is benefiting from synergies at Microphase Corporation and reported:

  • The production for the MTIX $50M purchase order over 3 years is progressing as planned;
  • Digital Power Lending, LLC believes approval of its California state lending license is imminent;
  • The development of its Hospitality division is proceeding as scheduled.

Cryptocurrency Product Suite

DPW expects to leverage its 48 years of high-density, advanced power supply design, development and manufacturing experience to deliver superior systems to the burgeoning and exceptionally power-intensive cryptocurrency mining sector, as evidenced by the recent launch of Coolisys’ first crypto hardware product under the brand Super Crypto Power.

DPW is, through its subsidiary Coolisys Technologies, developing a suite of branded cryptocurrency products and services based on its world-class power solutions on both the ACIS and GPU platforms.

Balance Sheet

We expect a significant improvement to our balance sheet due to receipt of proceeds from the exercise of warrants and a reduction of liabilities from the conversion of a significant portion of our debt.

Digital Power’s attendance at 10th Annual LD Micro Conference and its presentation on December 7, 2017 was pre-empted by the wildfires in Southern California. Moreover, the investor presentation has been deferred and its release will be announced at a later date. The Company said it appreciated the acute focus on safety and caution was appreciated by all the attendees.

About Digital Power

Headquartered in Fremont, CA, Digital Power Corporation, through its subsidiaries, designs, manufactures and sells high-grade customized and off-the-shelf power system solutions. Our products are used in the most demanding communications, industrial, medical and military applications where customers demand high density, high efficiency and ruggedized power solutions. The Company’s wholly owned subsidiary, Coolisys Technologies, Inc., is dedicated to providing world-class technology-based solutions where innovation is the main driver for mission-critical applications and lifesaving services. Coolisys’ growth strategy targets core markets that are characterized by “high barriers to entry” and include specialized products and services not likely to be commoditized.  Coolisys, a developer and manufacturer that services the defense, aerospace, medical and industrial sectors, has three subsidiaries: Digital Power Limited, a wholly owned manufacturer based in Salisbury, UK.; Microphase Corporation, a majority owned subsidiary, with its headquarters in Shelton, CT 1-203-866-8000; and Power-Plus Technical Distributors, a wholly owned wholesale distributor based in Sonora, CA 1-800-963-0066. Digital Power Lending, LLC, is a wholly owned subsidiary of the Company, is based in Fremont, CA, and is a California private lending company dedicated to strategically providing capital to small and middle size businesses for an equity interest in addition to loan fees and interest. Excelo, LLC is a national search firm specializing in fulfilling strategic executive, professional and hi-tech placements for businesses delivering world-class services. Digital Power Corporation‘s headquarters is located at 48430 Lakeview Blvd., Fremont, California, 94538; 1-877-634-0982.

For Investor Relations inquiries: IR@digipwr.comwww.digitalpowercorp.com or 1-888-753-2235.

Forward-Looking Statements

The foregoing release contains “forward looking statements” regarding future events or results within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended, including statements concerning the Company’s current expectations regarding revenues for the remaining 2017 and thereafter from contracts and operations on a consolidated basis, that the Company and its subsidiaries will be able to complete and fulfill orders pending completion and fulfilment to the U.S. Air Force, the ability of the Company to develop or complete the manufacturing of its new product line for the digital mining community or the ability of the Company to sell digital mining power systems, the ability of the Company to earn in full the deferred revenues that may be recorded, that the Company will be able to meet its production for the MTIX product and develop a new line of accepted products and services targeting the textile marketplace. The Company cautions readers that such “forward looking statements” are, in fact, predictions that are subject to risks and uncertainties and that actual events or results may differ materially from those anticipated events or results expressed or implied by such forward- looking statements. The Company disclaims any current intention to update its “forward looking statements,” and the estimates and assumptions within them, at any time or for any reason. More information about potential risk factors that could affect the Company’s business and financial results are included in the Company’s most recent filings with the U.S. Securities and Exchange Commission, including, but not limited to, the Company’s Forms 10-K, 10-Q and 8-K. All filings are available on the Company’s website at www.digipwr.com.

Thursday, December 7th, 2017 Uncategorized Comments Off on $DPW Raises 2018 Revenue Guidance 50% from Prior Estimate

$ENTL Definitive Agreement to be Acquired by $SYK

PLYMOUTH, Minn., Dec. 07, 2017 — Entellus Medical, Inc. (NASDAQ:ENTL) announced today a definitive merger agreement by which Stryker Corporation (NYSE:SYK) will acquire Entellus in an all cash transaction for $24.00 per share, or an equity value of approximately $662 million.  The Entellus Board of Directors unanimously approved entering into the agreement.

“Entellus is a leader in the ENT segment and offers a comprehensive portfolio of products that enable physicians to conveniently and comfortably perform a broad range of ENT procedures,” stated Timothy J. Scannell, Group President, MedSurg and Neurotechnology at Stryker.

“The combination of Stryker’s established commitment to making healthcare better and Entellus’ innovative products within the ENT segment will continue to provide our customers the tools they need for cost effective solutions,” said Robert S. White, President and Chief Executive Officer of Entellus Medical.  “I look forward to the additional progress we will make together.”

The closing of this transaction is subject to approval by Entellus’ stockholders, expiration or termination of the applicable waiting period under the Hart-Scott-Rodino Antitrust Improvements Act and other customary closing conditions.

Piper Jaffray & Co. served as financial advisor and Latham & Watkins LLP and Fox Rothschild LLP served as outside legal counsel for Entellus in connection with this transaction.

Forward-looking statements

This press release contains forward-looking statements within the meaning of the federal securities law that are subject to various risks and uncertainties that could cause our actual results to differ materially from those expressed or implied in such statements. Such factors include, but are not limited to: (i) Entellus may be unable to obtain stockholder approval as required for the merger; (ii) conditions to the closing of the merger may not be satisfied; (iii) the merger may involve unexpected costs, liabilities or delays; (iv) the effect of the announcement of the merger on the ability of Entellus to retain and hire key personnel and maintain relationships with customers, suppliers and others with whom Entellus does business, or on Entellus’ operating results and business generally; (v) Entellus’ business may suffer as a result of uncertainty surrounding the merger and disruption of management’s attention due to the merger; (vi) the outcome of any legal proceedings related to the merger; (vii) Entellus may be adversely affected by other economic, business, and/or competitive factors; (viii) the occurrence of any event, change or other circumstances that could give rise to the termination of the merger agreement; (ix) risks that the merger disrupts current plans and operations and the potential difficulties in employee retention as a result of the merger; and (x) other risks to consummation of the merger, including the risk that the merger will not be consummated within the expected time period or at all. Additional factors that may affect the future results of Entellus are set forth in its filings with the Securities and Exchange Commission (SEC), including Entellus’ most recently filed Annual Report on Form 10-K, subsequent Quarterly Reports on Form 10-Q, Current Reports on Form 8-K and other filings with the SEC, which are available on the SEC’s website at www.sec.gov. See in particular Item 1A of Entellus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2016 and Item 1A of Part II of Entellus’ Quarterly Report on Form 10-Q for the fiscal quarter ended September 30, 2017 under the headings “Risk Factors.” The risks and uncertainties described above and in Entellus’ most recent Annual Report on Form 10-K and most recent Quarterly Report on Form 10-Q are not exclusive and further information concerning Entellus and its business, including factors that potentially could materially affect its business, financial condition or operating results, may emerge from time to time. Readers are urged to consider these factors carefully in evaluating these forward-looking statements. Readers should also carefully review the risk factors described in other documents that Entellus files from time to time with the SEC. The forward-looking statements in this press release speak only as of the date of this press release. Except as required by law, Entellus assumes no obligation to update or revise these forward-looking statements for any reason, even if new information becomes available in the future.

About Entellus

Entellus is a medical technology company focused on delivering superior patient and physician experiences through products designed for less invasive treatments. Entellus products are used for the treatment of adult and pediatric patients with chronic and recurrent sinusitis, patients with nasal airway obstruction, as well as adult patients with persistent Eustachian tube dysfunction. The Entellus platform of products provides safe, effective and easy-to-use solutions intended to enable treatment of patients in more cost-effective sites of care. Entellus’ product lines including the XprESS™ ENT Dilation System, Latera™ Absorbable Nasal Implant, MiniFESS™ Surgical Instruments, XeroGel Nasal Dressing and FocESS™ Imaging & Navigation combine to enable ENT physicians to conveniently and comfortably perform a broad range of procedures in the most cost effective and efficient site of care. Entellus is committed to broadening its product portfolio with high-quality and purposeful innovations for the global ENT market.

Additional Information and Where to Find It

In connection with the proposed merger, Entellus plans to file with the SEC and mail or otherwise provide to its stockholders a proxy statement regarding the proposed transaction. BEFORE MAKING ANY VOTING DECISION, ENTELLUS’ STOCKHOLDERS ARE URGED TO READ THE PROXY STATEMENT IN ITS ENTIRETY WHEN IT BECOMES AVAILABLE AND ANY OTHER DOCUMENTS FILED WITH THE SEC IN CONNECTION WITH THE PROPOSED MERGER OR INCORPORATED BY REFERENCE THEREIN BECAUSE THEY WILL CONTAIN IMPORTANT INFORMATION ABOUT THE PROPOSED TRANSACTION AND THE PARTIES TO THE PROPOSED TRANSACTION. Investors and security holders may obtain a free copy of the proxy statement and other documents that Entellus files with the SEC (when available) from the SEC’s website at www.sec.gov and Entellus’ website at www.entellusmedical.com. In addition, the proxy statement and other documents filed by Entellus with the SEC (when available) may be obtained from Entellus free of charge by directing a request to Entellus Medical, Inc., 3600 Holly Lane North, Suite 40, Plymouth, Minnesota 55447.

Participants in the Solicitation

This press release does not constitute a solicitation of proxy, an offer to purchase or a solicitation of an offer to sell any securities. Entellus and its directors, executive officers and certain employees may be deemed to be participants in the solicitation of proxies from Entellus’ stockholders in connection with the proposed merger. Security holders may obtain information regarding the names, affiliations and interests of such individuals in Entellus’ Annual Report on Form 10-K for the fiscal year ended December 31, 2016, which was filed with the SEC on February 22, 2017, and its definitive proxy statement for the 2017 annual meeting of stockholders, which was filed with the SEC on April 26, 2017. To the extent the holdings of Entellus securities by Entellus’ directors and executive officers have changed since the amounts set forth in Entellus’ proxy statement for its 2017 annual meeting of stockholders, such changes have been or will be reflected on Statements of Change in Ownership on Form 4 filed with the SEC. Additional information regarding the interests of such individuals in the proposed merger will be included in the proxy statement relating to the proposed merger when it is filed with the SEC. These documents (when available) may be obtained free of charge from the SEC’s website at www.sec.gov and Entellus’ website at www.entellusmedical.com.

Contact: Lynn Pieper Lewis
415-937-5402
ir@entellusmedical.com

Thursday, December 7th, 2017 Uncategorized Comments Off on $ENTL Definitive Agreement to be Acquired by $SYK

$SAGE Positive Top-line Results Phase 2 of SAGE-217 in #MDD

CAMBRIDGE, Mass.

– SAGE-217 met primary endpoint and provided rapid, profound and durable effects through 2-week treatment period and additional 4-week follow-up –

– Well-tolerated and demonstrated highly statistically significant mean reduction in the HAM-D score compared to placebo at 15 days (p<0.0001) beginning after one dose and maintained through Week 4 with numerical superiority though Week 6 –

– All secondary endpoints were consistent with primary endpoints at Day 15, including remission in 64% of SAGE-217 patients versus 23% of placebo patients (p=0.0005) –

– Data support further development of SAGE-217 for MDD and related disorders –

– Conference call scheduled today at 8:00 A.M. ET –

Sage Therapeutics (NASDAQ: SAGE), a clinical-stage biopharmaceutical company developing novel medicines to treat life-altering central nervous system (CNS) disorders, today announced positive top-line results from the Phase 2, double-blind, placebo-controlled clinical trial of SAGE-217 in the treatment of 89 adult patients with moderate to severe major depressive disorder (MDD). In the trial, treatment for 14 days with SAGE-217 was associated with a statistically significant mean reduction in the Hamilton Rating Scale for Depression (HAM-D) 17-Item total score from baseline to Day 15 (the time of the primary endpoint) of 17.6 points for SAGE-217, compared to 10.7 for placebo (p<0.0001). Statistically significant improvements were observed in the HAM-D compared to placebo by the morning following the first dose through Week 4 and the effects of SAGE-217 remained numerically greater than placebo through the end of follow-up at Week 6. At Day 15, 64 percent of patients who received SAGE-217 achieved remission, defined as a score of 7 or less on the HAM-D scale, compared with 23 percent of patients who received placebo (p=0.0005). Other secondary endpoints were all similarly highly significant at Day 15 (p≤0.002).

SAGE-217 was generally well-tolerated with no serious or severe adverse events; the most common adverse events (AEs) in the SAGE-217 group were headache, dizziness, nausea, and somnolence. A low rate of discontinuations due to AEs was reported; overall reports of AEs were similar between drug (53%) and placebo (46%), with a safety profile consistent with that seen in earlier trials. SAGE-217 was granted Fast Track Designation by the U.S. Food and Drug Administration (FDA) in May 2017.

“These very encouraging data suggest the potential of SAGE-217 in the treatment of MDD as well as other mood-related disorders that we may pursue,” said Jeff Jonas M.D., chief executive officer of Sage Therapeutics. “There has been little innovation in the discovery and development of treatments for depression in the last two decades. Coupled with our recent positive Phase 3 data read-out evaluating brexanolone for the treatment of postpartum depression, the findings in this study suggest our pipeline of proprietary GABAA modulators may impact novel and fundamental brain mechanisms, offering potential development opportunities in a variety of indications. The positive activity and safety findings of SAGE-217 in MDD support advancing the program into later stage clinical development and we will work with the FDA to determine next steps in the further development of SAGE-217.”

The GABA system is the major inhibitory signaling pathway of the central nervous system (CNS), and contributes significantly to regulating CNS function. SAGE-217 is a novel, highly potent and selective, next generation GABAA receptor positive allosteric modulator that is being developed as a once-daily, oral therapy for the treatment of various CNS disorders. SAGE-217 was discovered by Sage, and the Company maintains worldwide rights to the compound.

“There are currently significant gaps in the disease management of depression and our development goal at Sage is to change patients’ expectations by transforming the treatment landscape for MDD,” said Steve Kanes, M.D., Ph.D., chief medical officer of Sage Therapeutics. “If successfully developed, SAGE-217 has the potential to offer the first truly new mechanism of action in the pharmacologic treatment of depression in more than 20 years. If the results from this trial are replicated in Phase 3 trials, SAGE-217 may meet the needs of patients with MDD for a once-daily oral treatment that potentially provides a rapid, well-tolerated and durable response with a high rate of remission.”

Summary of Top-line Results from the Placebo-Controlled Phase 2 Trial
Effect on Depressive Symptoms through end of Treatment (Day 15):

  • Treatment with SAGE-217 was associated with a statistically significant mean reduction from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score at Day 15 of 17.6 points compared with a 10.7 point mean reduction associated with placebo (p<0.0001).
  • The majority of patients (64%) who received SAGE-217 achieved remission at Day 15 as determined by a HAM-D total score less than or equal to 7 (compared with 23% of patients who received placebo, p=0.0005).
  • Other secondary endpoints (e.g., MADRS, CGI-I) were similarly highly significant at Day 15 (p≤0.002).

Effect on Depressive Symptoms over Time:

  • Statistically significant mean reductions from baseline in the Hamilton Rating Scale for Depression (HAM-D) total score were observed following the first dose (Day 2) and maintained through Week 4, two weeks after end of treatment (p<0.0318).
  • At Week 4, the mean reduction from baseline in HAM-D total score was 15.6 for the SAGE-217 group and 11.9 for the placebo group (p=0.0243).
  • At Week 6, the mean reduction in HAM-D total score for the SAGE-217 group was 15.0 and numerically, but not statistically improved compared to the placebo group reduction of 13.0.
  • Rates of remission at Week 4 and Week 6 for patients treated with SAGE-217 were 52 percent and 45 percent compared to 28 percent and 33 percent for placebo, with statistical significance maintained at Week 4 (p=0.0221) but not Week 6.

Safety and Tolerability:

  • SAGE-217 was generally well tolerated in the trial. The overall incidence of patients who experienced adverse events was 53 percent for the SAGE-217 treatment group and 46 percent for the placebo group.
  • There were no deaths, serious or severe adverse events.
  • Rates of discontinuation from dosing of study drug due to adverse events were low; two patients (4.4%) treated with SAGE-217 and none treated with placebo.
  • The most common adverse events in the SAGE-217 group were headache, dizziness, nausea and somnolence.
  • There was no signal for increased risk for patients treated with SAGE-217 as measured by structured assessments of suicidality and sedation.

Conference Call Information
Sage will host a conference call and webcast today at 8:00 A.M. ET to discuss the top-line results from the Phase 2 SAGE-217 trial in MDD. 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 866-450-8683 (toll-free domestic) or 281-542-4847 (international) and using the conference ID 2675527. 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 Placebo-controlled Phase 2 trial of SAGE-217 in MDD:
In the randomized, double-blind, parallel-group, placebo-controlled trial, 89 eligible patients (with a minimum total score of 22 on the Hamilton Rating Scale for Depression) were stratified based on use of antidepressant treatment (current/stable or not treated/withdrawn ≥30 days) and randomized in a 1:1 ratio to receive SAGE-217 Capsules (30mg) (n=45) or matching placebo (n=44). All doses of study drug were administered at night with food. The study consisted of a 14-day treatment period, and a 4-week follow-up period. The mean HAM-D total scores at baseline were 25.2 for the SAGE-217 group and 25.7 for the placebo group (overall range 22-33), representing patients with moderate to severe MDD. Approximately 90 percent of patients in each group completed the study.

About Major Depressive Disorder
Major depressive disorder (MDD) is a common but serious mood disorder in which patients exhibit depressive symptoms, such as a depressed mood or a loss of interest or pleasure in daily activities consistently for at least a two-week period, and demonstrate impaired social, occupational, educational or other important functioning. It is estimated that approximately 16 million people in the U.S. suffer from MDD each year. While antidepressants are widely used for treatment, large scale studies have demonstrated the need for additional therapies.

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 in clinical research to rate the severity of a patient’s depression by probing mood, feelings of guilt, suicide ideation, insomnia, agitation, anxiety, weight loss, and somatic symptoms.

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 daily oral dosing. The GABA system is the major inhibitory signaling pathway of the brain and CNS, and contributes significantly to regulating CNS function. SAGE-217 is currently being developed for MDD and certain other mood and movement 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, a proprietary IV formulation of brexanolone (SAGE-547), is in Phase 3 clinical development for postpartum depression. Sage is developing its next generation modulators, including SAGE-217 and SAGE-718, in various 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 the potential for SAGE-217 in the treatment of MDD and related disorders; our statements regarding plans for further development of SAGE-217 and related regulatory activities and the potential for successful development; our view of the potential of the GABA mechanism and our product candidates, including SAGE-217, in the treatment of CNS diseases and disorders; our views as to the unmet need for additional treatment options in MDD and the potential of SAGE-217 to meet the unmet need, and our estimates as to the number of patients with MDD. 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 SAGE-217 or any of our other product candidates at each stage of development; success in early stage clinical trials may not be repeated or observed in ongoing or future studies of SAGE-217 or any of our other product candidates; ongoing and future clinical results may not support further development or be sufficient to gain regulatory approval to market SAGE-217 or any of our other product candidates; 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; decisions or actions of the FDA or other regulatory agencies may affect the initiation, timing, design, size, progress and cost of clinical trials and our ability to proceed with further development; we may encounter unexpected safety or tolerability issues with SAGE-217 or any of our other product candidates in ongoing or future development; the actual size of the MDD patient population may be significantly lower than our estimates and, even if SAGE-217 is successfully developed and approved for MDD, it may only be approved or used to treat a subset of the MDD population; and we may encounter technical and other unexpected hurdles in the development and manufacture of SAGE-217 or any of our other 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, and 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, 585-355-1134
maureen.suda@sagerx.com

Thursday, December 7th, 2017 Uncategorized Comments Off on $SAGE Positive Top-line Results Phase 2 of SAGE-217 in #MDD

$IGC Launches New Sites Highlighting Canna-Pharmaceutical Compound Portfolio

BETHESDA, Md., Dec. 07, 2017 — India Globalization Capital, Inc. (NYSE American:IGC), today announced that it has launched two new websites to detail the Company’s cannabinoid pipeline for the indications of pain, seizures, eating disorders and Alzheimer’s. Investors are encouraged to visit www.igcpharma.com and www.Hyalolex.com for the latest information on IGC’s initiatives and development timeline.

www.Hyalolex.com

It is believed that in Alzheimer’s disease two types of legions in the cerebral cortex and hippocampus: 1) senile plaque composed of amyloid beta peptides (Aβ plaque), and 2) neurofibrillary tangles, composed of highly phosphorylated Tau protein, are implicated in the pathogenesis of the disease. Amyloid Precursor Protein (APP), on the surface of neurons, is normally cleaved by enzymes to free up Aβ peptide composed of 36-43 amino acids that is then cleared by the body. In patients with Alzheimer’s, an imbalance causes Aβ to be unregulated, resulting in the abnormal buildup into insoluble fibroles depositing as senile plaques. Aβ monomers aggregate to form oligomers and then into fibril Aβ. It is believed that extracellular misfolded oligomers are toxic to nerve cells. IGC’s Alzheimer’s drug candidate, IGC-AD1 (Hyalolex), works through a molecular pathway that allows low doses of IGC-AD1 to: 1) modulate Aβ protein production, 2) inhibit Aβ protein aggregation 3) reduce Tau phosphorylation, 4) enhance mitochondria function, and 5) help redirect the immune system, with none of the side effects commonly associated with cannabis. Based on these and other studies we expect to bring IGC-AD1 to market in early 2018, with the hope of bringing much needed relief to Alzheimer’s patients.

“Our initial focus on the canna-pharmaceutical front is on Alzheimer’s, America’s most expensive disease.  In 2017, the direct cost of treatment for Alzheimer’s and other dementias is projected to cost the U.S. approximately $259 billion. Roughly 5.3 million individuals in the U.S. alone suffer from the disease, and the number is expected to double over the next 20 years. As such, we believe the market for Alzheimer’s disease represents tremendous potential for our cannabis-extract-based compounds.  Our longer-term goal, based on adequate funding, is to move our Alzheimer’s formulation through FDA registered pre-clinical and clinical trials.  Independent of the FDA process, our near-term goal is to commercialize our liquid formulation for Alzheimer’s as a Complimentary and Alternative Medicine (CAM) sold through licensed medical cannabis dispensaries in the U.S., and internationally in Canada and Germany,” stated Ram Mukunda, CEO of IGC.

www.igcpharma.com

We have six provisional patent filings in the phytocannabinoid-based combination therapy space for the indications of pain, medical refractory epilepsy, and cachexia. In addition, in May 2017, we acquired exclusive rights to a patent filed by the University of South Florida Research Foundation entitled “THC as a Potential Therapeutic Agent for Alzheimer’s Disease.”  The table below provides a status of the patent filings:

Indication Provisional Filing PCT Filing Subsequent Activity
Pain (IGC-501) 9/16/14 9/16/15 US National Case Filed – 6/15/16
Seizures (IGC-502) 6/15/15 6/14/16 US National Case Filed – 6/15/16
Seizures (IGC-503) 4/1/15 4/1/16 PCT Application Published- 10/6/16
Eating Disorders (IGC-504) 8/12/15 8/11/16 US and National Filing Anticipated 2/12/18
Seizures (IGC-505) 6/15/16 6/15/16 US National Filing Anticipated 12/15/18
Eating Disorders (IGC-506) 2/28/17 Anticipated- 2/28/18 US and National Filing Anticipated 8/28/19
Alzheimer’s (IGC-AD1) 7/30/2015 Anticipated -2018 US and National Filing Anticipated in 2018

About IGC:
IGC is engaged in the development of cannabis based combination therapies to treat Alzheimer’s, pain, nausea, eating disorders, several end points of Parkinson’s, and epilepsy in dogs and cats. IGC has assembled a portfolio of patent filings and four lead product candidates addressing these conditions. The company is based in Maryland, USA.

For more information please visit www.igcinc.us
Follow us on Twitter @IGCIR and Facebook.com/IGCIR/

Forward-looking Statements:
Please see forward-looking statements and risk factors as discussed in detail in IGC’s Form 10K for fiscal year ended March 31, 2017, and in other reports filed with the U.S. Securities and Exchange Commission.

Contact:

Claudia Grimaldi

301-983-0998

Thursday, December 7th, 2017 Uncategorized Comments Off on $IGC Launches New Sites Highlighting Canna-Pharmaceutical Compound Portfolio

$MYO Full Exercise of Over-Allotment Option in Follow-On Public Offering

CAMBRIDGE, Mass.

Myomo, Inc. (NYSE American: MYO), a commercial stage medical robotics company, today announced that Roth Capital Partners, the underwriter of Myomo’s follow-on offering, exercised in full its option to purchase 626,250 shares of common stock and accompanying warrants to purchase 626,250 shares of common stock, at a combined price to the public of $2.40 per share of common stock and accompanying warrant, for gross proceeds of approximately $1.5 million. After giving effect to the full exercise of the over-allotment, the Company sold an aggregate of 4,801,250 shares of common stock and accompanying warrants to purchase up to an aggregate of 4,801,250 shares of common stock in the public offering, and gross proceeds were approximately $11.5 million.

Roth Capital Partners acted as sole manager.

Net proceeds from the full exercise of the over-allotment option, after underwriting discounts and commissions and payment of other transaction fees and expenses payable by Myomo, will be approximately $1.4 million.

Myomo intends to use the net proceeds of the offering for debt repayment and working capital and other general corporate purposes.

A registration statement on Form S-1 (File No. 333-221053) relating to this offering was declared effective by the Securities and Exchange Commission (SEC) on November 29, 2017, and an additional registration statement on Form S-1 (File No. 333-221817) relating to this offering was filed and became effective immediately upon filing under Rule 462(b) under the Securities Act of 1933, as amended. The securities may be offered only by means of a prospectus. A copy of the final prospectus is available on the SEC’s website located at www.sec.gov. Electronic copies of the final prospectus also may be obtained from Roth Capital Partners, LLC, Equity Capital Markets, 888 San Clemente Drive, Newport Beach, CA 92660, at 800-678-9147 and Rothecm@roth.com.

This press release shall not constitute an offer to sell or the solicitation of an offer to buy these securities, nor shall there be any sale of these securities in any jurisdiction in which such offer, solicitation or sale would be unlawful prior to the registration or qualification under the securities laws of any such jurisdiction.

About Myomo

Myomo, Inc. is a commercial stage medical robotics company that offers expanded mobility for those suffering from neurological disorders and upper limb paralysis. Myomo develops and markets the MyoPro product line. MyoPro is a powered upper limb orthosis designed to restore function to the weakened or paralyzed arms of patients suffering from CVA stroke, brachial plexus injury, traumatic brain or spinal cord injury, ALS or other neuromuscular disease or injury.

Forward Looking Statements

This press release contains forward-looking statements, including statements about the offering and the proceeds therefrom, which are subject to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. These forward-looking statements are only predictions and may differ materially from actual results due to a variety of factors. Our actual results could differ materially from those anticipated in these forward looking statements for many reasons, including, without limitation, the risk factors contained in our filings made with the Securities and Exchange Commission. The Company cautions readers not to place undue reliance on any such forward-looking statements, which speak only as of the date made. The Company disclaims any obligation subsequently to revise any forward-looking statements to reflect events or circumstances after the date of such statements or to reflect the occurrence of anticipated or unanticipated events.

 

For Myomo:
ir@myomo.com
or
Investor Relations:
PCG Advisory
Vivian Cervantes, 646-863-6274
vivian@pcgadvisory.com
or
Public Relations:
Greenough
Rachel Robbins, 617-275-6521
rrobbins@greenough.biz

Wednesday, December 6th, 2017 Uncategorized Comments Off on $MYO Full Exercise of Over-Allotment Option in Follow-On Public Offering

$SEAC Liberty Global Selects SeaChange for Next-Generation Cloud-Based Video Offering

ACTON, Mass., Dec. 06, 2017  — Video solutions innovator SeaChange International Inc. (NASDAQ:SEAC) today announced its Adrenalin multiscreen video solution has been selected as a key element of Liberty Global plc’s next-generation video platform supporting its Horizon 4 services.

Liberty Global, the world’s largest international TV and broadband company, provides video services to viewers across Europe, the Caribbean and Latin America‎. Deploying a common, fully virtualized video platform architecture for its Horizon services allows for a faster pace of service innovation and development.

The SeaChange Adrenalin software, running as part of Liberty Global’s video service platform, will provide the content information and transaction support for Liberty’s viewers across both broadcast and IP video delivery networks on Liberty’s latest Horizon set-top boxes (STBs). Adrenalin’s flexibility also supports each affiliate’s need to independently deploy and control their own multi-vendor platform and editorial catalogues, while at the same time gaining the operational efficiencies of shared, visualized resources.

“We are pleased to be chosen as a key contributor to Liberty Global’s next-generation video platform,” said Ed Terino, SeaChange’s CEO. “SeaChange’s Adrenalin video solution enables video delivery at the massive scale needed to support customers such as Liberty Global.  As video platforms transition to virtualized cloud infrastructure and enable advanced capabilities such as replay TV and network DVR to multiple devices, SeaChange will continue to support customers like Liberty Global to monetize their video assets and modernize their video delivery platforms.”

Olivier Philippe, Vice President of Entertainment within Liberty Global stated, “We have had a long relationship with SeaChange as a key technology provider within our video ecosystem.  As the industry continues to evolve its video platforms to support advanced consumer experiences that are truly device agnostic, we need solution providers who can provide a rich set of capabilities and stay relevant in those platform ecosystems. This helps us to continue to innovate and rapidly evolve our video services so that they truly resonate with our customers.”

“Our selection of SeaChange as a key part of our video platform reflects their continued development of leading video delivery technologies and their relentless commitment to operational excellence.”

About SeaChange International
Enabling our customers to deliver billions of premium video streams across a matrix of pay-TV and OTT platforms, SeaChange (Nasdaq:SEAC) empowers service providers, broadcasters, content owners and brand advertisers to entertain audiences, engage consumers and expand business opportunities. As an Emmy winning organization with nearly 25 years of experience, we give media businesses the content management, delivery and monetization capabilities they need to craft an individualized branded experience for every viewer that sets the pace for quality and value worldwide. For more information, please visit www.schange.com.

About Liberty Global

Liberty Global is the world’s largest international TV and broadband company, with operations in more than 30 countries across Europe, Latin America and the Caribbean. We invest in the infrastructure that empowers our customers to make the most of the digital revolution. Our scale and commitment to innovation enable us to develop market-leading products delivered through next-generation networks that connect our over 24 million customers who subscribe to over 50 million television, broadband internet and telephony services. We also serve over 10 million mobile subscribers and offer WiFi service across 10 million access points. Liberty Global’s businesses are comprised of two stocks: the Liberty Global Group (NASDAQ:LBTYA) (Nasdaq:LBTYB) (Nasdaq:LBTYK) for our European operations, and the LiLAC Group (NASDAQ:LILA) (Nasdaq:LILAK) (OTC Link:LILAB), which consists of our operations in Latin America and the Caribbean. The Liberty Global Group operates in 12 European countries under the consumer brands Virgin Media, Unitymedia, Telenet and UPC. The Liberty Global Group also owns 50% of VodafoneZiggo, a Dutch joint venture, which has 4 million customers, 10 million fixed-line subscribers and 5 million mobile subscribers. The LiLAC Group operates in over 20 countries in Latin America and the Caribbean under the consumer brands VTR, Flow, Liberty, Más Móvil and BTC. In addition, the LiLAC Group operates a sub-sea fiber network throughout the region connecting over 40 markets. For more information, please visit www.libertyglobal.com

Safe Harbor Provision

Any statements contained in this press release that do not describe historical facts, including regarding future operations of SeaChange and Liberty Global, are neither promises nor guarantees and may constitute “forward-looking statements” as that term is defined in the U.S. Private Securities Litigation Reform Act of 1995. Such forward-looking statements may include words such as “may,” “might,” “will,” “should,” “expects,” “plans,” “anticipates,” “believes,” “estimates,” “predicts,” “potential” or “continue,” the negative of these terms and other comparable terminology. Any such forward-looking statements contained herein are based on current assumptions, estimates and expectations, but are subject to a number of known and unknown risks and significant business, economic and competitive uncertainties that may cause actual results to differ materially from expectations. Numerous factors could cause actual future results to differ materially from current expectations expressed or implied by such forward-looking statements, including the risks and other risk factors detailed in various publicly available documents filed by the Company from time to time with the Securities and Exchange Commission (SEC), which are available at www.sec.gov, including but not limited to, such information appearing under the caption “Risk Factors” in the Company’s Annual Report on Form 10-K filed with the SEC on April 17, 2017. Any forward-looking statements should be considered in light of those risk factors. The Company cautions readers not to rely on any such forward-looking statements, which speak only as of the date they are made. The Company disclaims any intent or obligation to publicly update or revise any such forward-looking statements to reflect any change in Company expectations or future events, conditions or circumstances on which any such forward-looking statements may be based, or that may affect the likelihood that actual results may differ from those set forth in such forward-looking statements.

 

Contact:
Investors
Mary T. Conway
Conway Communications
1-781-772-1679
marytconway@comcast.net

Media
Kurt Michel
VP, Marketing
1-978-889-3001
kurt.michel@schange.com

Wednesday, December 6th, 2017 Uncategorized Comments Off on $SEAC Liberty Global Selects SeaChange for Next-Generation Cloud-Based Video Offering

$CLIR Announces Request to Withdraw S-1 Registration Statement

Company to review alternate funding and strategic options

SEATTLE, Dec. 6, 2017  — ClearSign Combustion Corporation (NASDAQ: CLIR), an emerging leader in industrial combustion technologies that reduce emissions and improve efficiency, today announced that the company has submitted a request to the Securities and Exchange Commission to withdraw its S-1 Registration Statement (File No. 333-221467) (the “Registration Statement”) on file with the U.S. Securities and Exchange Commission (the “SEC”).  The Registration Statement has not been declared effective by the SEC, and no securities have been sold in connection with the offering described in the Registration Statement.  The company will be reviewing alternate funding and strategic options.

“In light of the recent stock price decline the company feels that it is in the best interests of shareholder value to withdraw the registration statement. Our board is continuing to go through a thorough review process to consider alternative funding and strategic options, and to pursue the best possible path for shareholders and the company,” said Stephen Pirnat, Chairman and Chief Executive Officer of ClearSign. “We remain optimistic about the direction of the company, specifically our recent announcements regarding a new multi-unit Plug and Play order, successful testing with a supermajor, and the launch of our Hong Kong subsidiary.”

For more information about ClearSign visit:  www.clearsign.com.

About ClearSign Combustion Corporation

ClearSign Combustion Corporation designs and develops products and technologies for the purpose of improving key performance characteristics of combustion systems, including emissions and operational performance, energy efficiency and overall cost-effectiveness. Our patented Duplex™, Duplex Plug & Play™ and Electrodynamic Combustion Control™ platform technologies enhance the performance of combustion systems in a broad range of markets, including the energy (upstream oil production and down-stream refining), commercial/industrial boiler, chemical, petrochemical, and power industries. For more information, please visit www.clearsign.com.

Cautionary note on forward-looking statements

All statements in this press release that are not based on historical fact are “forward-looking statements.” While management has based any forward-looking statements included in this press release on its current expectations, the information on which such expectations were based may change. These forward-looking statements rely on a number of assumptions concerning future events and are subject to a number of risks, uncertainties and other factors, many of which are outside of our control, which could cause actual results to materially differ from such statements. Such risks, uncertainties and other factors include, but are not limited to, general business and economic conditions, the performance of management and our employees, our ability to obtain financing, competition, whether our technology will be accepted and other factors identified in our Annual Report on Form 10-K filed with the Securities & Exchange Commission and available at www.sec.gov and other factors that are to be detailed in our periodic and current reports available for review at www.sec.gov. Furthermore, we operate in a competitive environment where new and unanticipated risks may arise. Accordingly, investors should not place any reliance on forward-looking statements as a prediction of actual results. We disclaim any intention to, and undertake no obligation to, update or revise forward-looking statements to reflect events or circumstances that subsequently occur or of which we hereafter become aware.

Wednesday, December 6th, 2017 Uncategorized Comments Off on $CLIR Announces Request to Withdraw S-1 Registration Statement

$MDG LMGL-3196 Achieves Primary Endpoint in NASH Study

Statistically significant improvement in the relative decrease in liver fat in patients treated with MGL-3196 compared with placebo, determined by magnetic resonance imaging-estimated proton density fat fraction (MRI-PDFF) at 12-weeks, the primary end point in this Phase 2 proof-of-concept trial

— Statistically significantly more MGL-3196 than placebo treated patients achieved clinically relevant (at least 30%) liver fat reduction at 12 weeks relative to baseline MRI-PDFF–

— Statistically significant improvements in drug-treatment group compared to placebo in low-density lipoprotein cholesterol (LDL-C), triglycerides and lipoprotein (a) (Lp(a)); these lipids when elevated are associated with increased cardiovascular risk

— Statistically significant improvements in liver enzymes in drug-treatment group, with very good all subject tolerability, few serious adverse events, none related to MGL-3196–

— Clinical trial continues blinded with potential for correlating improvement in non-invasive imaging test (MRI-PDFF at 12 and 36 weeks) with improvement in repeat liver biopsy obtained at 36 weeks

– Conference call scheduled for 8:30 AM Eastern Time today –

CONSHOHOCKEN, Pa., Dec. 06, 2017 — Madrigal Pharmaceuticals, Inc. (Nasdaq:MDGL) today announced positive top-line results from a Phase 2 clinical trial in patients with biopsy-proven non-alcoholic steatohepatitis (NASH). In this trial, MGL-3196, a first-in-class, oral, once-daily, liver-directed, thyroid hormone receptor (THR) β -selective agonist, demonstrated statistically significant results for the primary endpoint, the percent change in hepatic fat versus placebo as measured by MRI-PDFF, a non-invasive imaging test. Recent published data have shown a high correlation of the reduction of liver fat of 30% or more as measured by MRI-PDFF to improvement in NASH on liver biopsy.

ALL MGL-3196 HIGH MGL-3196** Placebo
Numbers of patients 78 44 38
Relative change in MRI-PDFF (% change from baseline, median)
Significance relative to placebo
-36.3%
p<0.0001
-42.0%
p<0.0001
-9.6%
Percentage of patients attaining ≥30% liver fat reduction
Significance relative to placebo
60.3%
p<0.0001
75.0%
p<0.0001
18.4%

**Prespecified group of patients (44/78) with relatively higher MGL-3196 drug levels

Statistically significant reductions in ALT and AST were observed in MGL-3196 treated patients; greater reductions in ALT and AST, statistically significant relative to placebo, were observed in the prespecified group of 44/78 patients with relatively higher MGL-3196 drug levels. In drug-treated relative to placebo patients, statistically significant improvements were also seen in multiple secondary endpoints considered to be potentially clinically relevant in patients with NASH including LDL-C, triglycerides, apolipoprotein B (ApoB), and Lp(a).

MGL-3196 has been well-tolerated with mostly mild AEs, and a few moderate AEs, the numbers of which are balanced between placebo and drug-treatment groups. There are no adverse effects of MGL-3196 on safety laboratory or vital sign parameters. There have been three serious adverse effects in the study, all considered unrelated to MGL-3196.

The on-going study remains blinded. Safety, efficacy of NASH resolution by biopsy, and repeat MRI-PDFF will be assessed at 36 weeks. Multiple inflammatory and fibrosis serum biomarkers at 12 and 36 weeks are being and will be assessed.

“NASH is a common liver disease in the United States, with a growing prevalence, for which no FDA approved treatment is yet available,” said Dr. Stephen Harrison, M.D., Principal Investigator of the study as well as Medical Director for Pinnacle Clinical Research, San Antonio, Texas, and Visiting Professor of Hepatology, Oxford University. “These results suggest that a highly selective liver-directed, thyroid hormone receptor-β agonist may be able to effectively and safely treat patients with NASH. Importantly, the study is designed to allow correlations between efficacy in a non-invasive imaging test, MRI-PDFF at 12 and 36 weeks, and improvement in NASH on liver biopsy at 36 weeks.”

Rebecca Taub, M.D., Chief Medical Officer and Executive VP, Research & Development of Madrigal added, “Results from this study confirm what we have seen in both our preclinical and earlier clinical studies and support our long-standing confidence in the safety and potential therapeutic value of MGL-3196. We fully expect data at 36 weeks to confirm results seen at 12 weeks, and potentially show improvement in NASH on liver biopsy. We look forward to the presentation of the 12-week, Phase 2 results to the scientific and clinical community, and further development of MGL-3196 for treatment of patients with NASH.”

Paul Friedman, M.D., Chief Executive Officer of Madrigal, stated, “We are gratified to see clinical results that strongly suggest MGL-3196 has the potential to provide clinically meaningful improvement of NASH by targeting lipotoxicity and inflammation as well as by reduction of cardiovascular risk by lowering atherogenic lipids. These pleiotropic actions, coupled with the excellent safety profile we have seen in this trial, continue to suggest that MGL-3196 has the potential to address the root causes of the underlying disease process in NASH.”

Conference Call and Webcast Information
Madrigal will hold a conference call and webcast this morning at 8:30 a.m. ET. To access the conference call, please dial 833-660-2754 for domestic callers or 409-350-3497 for international callers. When prompted, provide the conference identification number, 5577478.

The conference call will also be webcast live and can be accessed at http://www.madrigalpharma.com/newsroom/presentations/ in the “Events and Presentations” section of the Madrigal website.

If you are unable to participate, a replay of the conference call will be available on the website under http://www.madrigalpharma.com/newsroom/presentations/.

About the Phase 2 NASH Study
The randomized, double-blind, placebo-controlled, multi-center Phase 2 study enrolled 125 patients 18 years of age and older with liver biopsy-confirmed NASH and included approximately 25 clinical sites in the United States. Patients were randomized to receive either placebo or MGL-3196 with twice as many patients receiving MGL-3196 as placebo. The starting dose in 3196-treated patients was 80 mg once a day. The study employed an adaptive dosing design whereby, in a blinded fashion, the dose could be adjusted by small amounts (i.e. 20 mg up or down) or remain at 80 mg in each 3196-treated patient based on a pharmacokinetic analysis of drug level performed in each patient at 2 weeks.

The primary endpoint of the study is the reduction of liver fat at 12 weeks compared with baseline (relative change), assessed by MRI-PDFF, with efficacy confirmed at the end of the trial (36 weeks) by repeat MRI-PDFF and conventional liver biopsy to examine histological evidence for the resolution of NASH. A total of 116 patients completed the 12 week MRI-PDFF; the 9 discontinuations were balanced between placebo and drug treated; 2/9 discontinuations were AE-related.

Other secondary endpoints include changes in clinically relevant biomarkers at 12 and 36 weeks, improvement in fibrosis by at least one stage with no worsening of steatohepatitis, and safety and tolerability. Results at 36-weeks are expected in the second quarter of 2018.  Additional information about the study [NCT02912260] can be obtained at www.ClinicalTrials.gov.

About MGL-3196
Among its many functions in the human body, thyroid hormone, through activation of its beta receptor, plays a central role in controlling lipid metabolism, impacting a range of health parameters from levels of serum cholesterol and triglycerides to the pathological buildup of fat in the liver. Attempts to exploit this pathway for therapeutic purposes in cardio-metabolic and liver diseases have been hampered by the lack of selectivity of older compounds for the thyroid hormone receptor (THR)-β, chemically-related toxicities and undesirable distribution in the body.

Madrigal recognized that greater selectivity for thyroid hormone receptor (THR)-β and liver targeting might overcome these challenges and deliver the full therapeutic potential of THR-β agonism. Madrigal believes that MGL-3196 is the first orally administered, small-molecule, liver-directed, truly β-selective THR agonist. MGL-3196 has demonstrated the potential for a broad array of therapeutically beneficial effects, improving components of both metabolic syndrome, such as insulin resistance and dyslipidemia, and fatty liver disease, including lipotoxicity and inflammation. These pleiotropic actions, coupled with an excellent safety profile, suggest that MGL-3196 could be the preferred treatment option for NASH.

About Madrigal Pharmaceuticals
Madrigal Pharmaceuticals, Inc. (Nasdaq:MDGL) is a clinical-stage biopharmaceutical company pursuing novel therapeutics that target a specific thyroid hormone receptor pathway in the liver, which is a key regulatory mechanism common to a spectrum of cardio-metabolic and fatty liver diseases with high unmet medical need. Madrigal’s lead candidate, MGL-3196, is a first-in-class, orally administered, small-molecule, liver-directed, thyroid hormone receptor (THR)  β-selective agonist that is currently in Phase 2 development for NASH and HeFH. For more information, visit www.madrigalpharma.com.

Forward-Looking Statements
This communication contains “forward-looking statements” made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. Such statements contain words such as “expect,” “could,” “may,” “will,” “believe,” “estimate,” “continue,” “future,” or the negative thereof or comparable terminology and the use of future dates. Forward-looking statements reflect management’s current knowledge, assumptions, judgment and expectations regarding future performance or events. Although management believes that the expectations reflected in such statements are reasonable, they give no assurance that such expectations will prove to be correct and you should be aware that actual results could differ materially from those contained in the forward-looking statements. Forward-looking statements are subject to a number of risks and uncertainties including, but not limited to, the company’s clinical development of MGL-3196, the timing and outcomes of clinical studies of MGL-3196, and the uncertainties inherent in clinical testing. Undue reliance should not be placed on forward-looking statements, which speak only as of the date they are made. Madrigal undertakes no obligation to update any forward-looking statements to reflect new information, events or circumstances after the date they are made, or to reflect the occurrence of unanticipated events. Please refer to Madrigal’s filings with the U.S. Securities and Exchange Commission for more detailed information regarding these risks and uncertainties and other factors that may cause actual results to differ materially from those expressed or implied.

Investor Contact:
Marc Schneebaum, Madrigal Pharmaceuticals, Inc.
IR@madrigalpharma.com
Media Contact:
Mike Beyer, Sam Brown Inc.
mikebeyer@sambrown.com
312 961 2502

Wednesday, December 6th, 2017 Uncategorized Comments Off on $MDG LMGL-3196 Achieves Primary Endpoint in NASH Study

$VTGN Granted U.S. Patent regarding Methods of Production for AV-101

SOUTH SAN FRANCISCO, CA–(December 06, 2017) – VistaGen Therapeutics Inc. (NASDAQ: VTGN), a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other central nervous system (CNS) disorders, today announced the U.S. Patent and Trademark Office (USPTO) has issued U.S. Patent No. 9,834,801 related to certain methods of production for AV-101, VistaGen’s lead CNS product candidate.

“The issuance of this U.S. patent by the USPTO advances our intellectual property strategy for AV-101 at this vital period in its clinical development. This issued U.S. patent, in conjunction with the potential issuance of additional AV-101 patent applications currently under review worldwide, provides VistaGen with added long-term intellectual property protection for AV-101 and enhances its commercial potential,” stated Shawn Singh, Chief Executive Officer of VistaGen.

About VistaGen

VistaGen Therapeutics, Inc. (NASDAQ: VTGN) is a clinical-stage biopharmaceutical company focused on developing new generation medicines for depression and other CNS disorders. VistaGen’s lead CNS product candidate, AV-101, is in Phase 2 development, initially as a new generation oral antidepressant drug candidate for major depressive disorder (MDD). AV-101’s mechanism of action is fundamentally different from all FDA-approved antidepressants and atypical antipsychotics used adjunctively to treat MDD, with potential to drive a paradigm shift towards a new generation of safer and faster-acting antidepressants. AV-101 is currently being evaluated by the National Institute of Mental Health (NIMH) in a small Phase 2 monotherapy study in MDD being fully funded by the NIMH and conducted by Dr. Carlos Zarate Jr., Chief, Section on the Neurobiology and Treatment of Mood Disorders and Chief of Experimental Therapeutics and Pathophysiology Branch at the NIMH. VistaGen is preparing to launch a 180-patient Phase 2 study of AV-101 as an adjunctive treatment for MDD patients with an inadequate response to standard, FDA-approved antidepressants, with Dr. Maurizio Fava of Harvard University as Principal Investigator. AV-101 may also have the potential to treat multiple CNS disorders and neurodegenerative diseases in addition to MDD, including neuropathic pain, epilepsy, Huntington’s disease, Parkinson’s disease levodopa-induced dyskinesia and other disorders where modulation of the NMDA receptors, activation of the AMPA neurotransmitter pathways and/or key active metabolites of AV-101 may achieve therapeutic benefit.

For more information, please visit www.vistagen.com and connect with VistaGen on Twitter, LinkedIn and Facebook.

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 securing sufficient funding for, and the launch, continuation and results of the NIMH’s Phase 2 (monotherapy) and/or the Company’s planned Phase 2 (adjunctive treatment) clinical studies of AV-101 in MDD, and other CNS diseases and disorders, including neuropathic pain and PD LID, allowance of patent applications and continued protection of its intellectual property, and the availability of substantial additional capital to support its operations, including the AV-101 Phase 2 adjunctive treatment study and other potential AV-101 clinical development activities described above. These and other risks and uncertainties are identified and described in more detail in VistaGen’s filings with the Securities and Exchange Commission (SEC). These filings are available on the SEC’s website at www.sec.gov. VistaGen undertakes no obligation to publicly update or revise any forward-looking statements.

Company Contact
Mark A. McPartland
VistaGen Therapeutics Inc.
Phone: +1 (650) 577-3600
Email: IR@vistagen.com

Investor Contact:

Valter Pinto / Allison Soss
KCSA Strategic Communications
Phone: +1 (212) 896-1254/+1 (212) 896-1267
Email: VistaGen@KCSA.com

Wednesday, December 6th, 2017 Uncategorized Comments Off on $VTGN Granted U.S. Patent regarding Methods of Production for AV-101

$AGFS to Participate in UBS 2017 Agriculture Day, 5th Annual ROTH IG & Cleanteach Conferences

PHILADELPHIA

AgroFresh Solutions, Inc. (NASDAQ: AGFS) (the “Company”), a global leader in produce freshness solutions, today announced that the Company will be participating at two upcoming investor conferences hosted by UBS and ROTH Capital Partners.

  • The UBS 2017 Agriculture Day. This event will be held at the UBS offices in Chicago on Wednesday, December 6, 2017. The 2017 “Ag Day” will give investors unique access to the management of key companies in the agriculture sector. The format of the event is one-on-one and small group meetings. Katherine Harper, Executive Vice President and Chief Financial Officer will attend on behalf of the Company.
  • 5th Annual ROTH Industrial Growth and Cleantech 1×1 Event. This invitation-only event will be held at the Lotte New York Palace in New York, NY on Tuesday, December 12, 2017. The event will provide investors the opportunity to meet with senior management teams of a select group of small and mid-cap companies. Ms. Harper will attend on behalf of the Company and will take part in a series of one-on-one and small group meetings.

These events will not be webcast as the conferences do not include formal presentations. To schedule a meeting with Ms. Harper at these events please contact your UBS or ROTH Capital Partners representative.

About AgroFresh

AgroFresh Solutions, Inc. (AGFS) is a global industry leader in providing innovative data-driven specialty solutions aimed at enabling growers and packers of fresh produce to preserve and enhance the freshness, quality and value of fresh produce and to maximize the percentage of produce supplied to the market relative to the amount of produce grown. Its flagship product is the SmartFresh™ Quality System, a freshness protection technology proven to maintain firmness, texture and appearance of fruits during storage and transport. SmartFresh is currently commercialized in over 40 countries worldwide. Additionally the Company has a number of different solutions and application technologies that have either been launched (Harvista™, RipeLock™, LandSpring™) or will be launched in the future that will extend its footprint to other crops and steps of the global produce supply chain. For more information, please visit www.agrofresh.com.

Gregory FCA
Joe Hassett, 610-228-2110
joeh@gregoryfca.com

Tuesday, December 5th, 2017 Uncategorized Comments Off on $AGFS to Participate in UBS 2017 Agriculture Day, 5th Annual ROTH IG & Cleanteach Conferences

$KELYA $KELYB Research Findings Indicate Strong Public Support for Teachers

Survey from Kelly Services(R) shows changes are needed in the teaching profession

TROY, MI–(December 05, 2017) – Kelly Services® (NASDAQ: KELYA) (NASDAQ: KELYB), a global leader in providing workforce solutions, today announced the findings of its Education Pulse Survey, conducted to gauge the public’s perception of the state of education in the U.S.

The fourth quarter survey, conducted online in October of 2017 for Kelly Services’ educational practice group by Harris Poll, reveals strong support for teachers. Findings show that 85 percent of U.S. adults with or without dependent children in grades K-12, support pay increases for teachers to address teacher shortages. In addition, 75 percent support a change in requirements to make it easier for people with bachelor’s degree to become certified as a teacher.

“The Education Pulse Survey results validate our observations of how deeply Americans care about our education system,” said Nicola Soares, Vice President and Managing Director Kelly Educational Staffing. “It’s encouraging to see that parents and non-parents alike continue to have solid respect and esteem for educators and expect them to be qualified and fairly compensated.”

Compensation could be a top reason why professionals leave the field. Roughly six in 10 U.S. adults (62 percent) feel a main reason teachers leave the profession is due to being underpaid/low salary. This sentiment is most prominent in the West and South (67 percent each) followed by the Midwest (60 percent) with fewer in the Northeast (49 percent) feeling the same.

But what about the growing teacher shortage? In a recently released research brief, the Learning Policy Institute found that currently there are not enough qualified teachers applying for teaching jobs to meet the demands in all locations and field.

One in four U.S. adults believe teachers exit their chosen field due to:

  • Challenging work environment (29%)
  • Lack of or difficult parent support/partnership (27%)
  • Ineffective district/school leadership (26%)
  • Heavy workload (25%)

Perhaps surprisingly, three in four U.S. adults would encourage a young person to go into teaching as a career today and support a change in requirements to make it easier for people with bachelor’s degrees to become certified as a teacher (both 75 percent).

The Education Pulse Survey gauges the top issues and concerns among those with and without children or dependents in grades K-12. The survey provided an opportunity for adults to convey their thoughts on teacher compensation, retention, and why they believe educators are leaving the field.

About Kelly Educational Staffing

Kelly Educational Staffing® (KES®), a specialty service of Kelly Services® (NASDAQ: KELYA) (NASDAQ: KELYB), is the first staffing provider to develop a comprehensive education talent management solution. Launched in 1997, KES partners with 7,000+ public, private and charter schools across 35 states. KES provides schools with quality substitute teacher staffing and management, in addition to after school program staffing, and the staffing of non-instructional positions such as custodians, cafeteria employees, administrative assistants, and school nurses. More than 2.8 million classrooms are filled by a KES substitute teacher each school year. Visit www.kellyeducationalstaffing.com for more information.

This survey was conducted online within the United States by Harris Poll on behalf of Kelly Services from October 6-10, 2017 among 2,150 U.S. adults ages 18 and older. This online survey is not based on a probability sample and therefore no estimate of theoretical sampling error can be calculated.

Media Contact:

Jane Stehney
Kelly Services
stehnja@kellyservices.com
248-574-9800

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$RVNC RT002 Meets Primary and All Secondary Endpoints

NEWARK, Calif.

– Highly statistically significant results on primary composite endpoint achieved at Week 4 –

– RT002 delivered highly statistically significant reduction in severity of glabellar lines at Week 24 –

– If approved, RT002 could represent a new, next-generation, long-acting neuromodulator –

– Revance to host conference call at 8:00 am ET today –

Revance Therapeutics, Inc. (NASDAQ:RVNC), a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, today announced its next-generation neuromodulator DaxibotulinumtoxinA for Injection (RT002) delivered positive top-line results in alleviating moderate-to-severe glabellar lines in two pivotal SAKURA Phase 3 trials. RT002 appeared generally safe and well-tolerated in both studies.

If approved by the U.S. Food and Drug Administration (FDA), Revance believes RT002 would be the first neuromodulator with a long-acting duration of six months. Marketed neuromodulators have demonstrated duration of three to four months in treating glabellar lines.

Both SAKURA 1 and SAKURA 2 met the primary composite endpoint by delivering highly statistically significant improvement against placebo in reducing the severity of glabellar lines, i.e., the frown lines or wrinkles between the brows. The percent of RT002-treated patients who had none or mild wrinkles and achieved at least a two-point improvement from baseline on both validated physician and patient assessments were 73.6 percent in SAKURA 1 and 74.0 percent in SAKURA 2 compared to placebo (p<0.0001) at Week 4. Also at that time point, 88 percent of RT002-treated patients in SAKURA 1 and 91 percent of RT002 patients in SAKURA 2 said they were very satisfied or satisfied with their treatment experience.

All secondary endpoints measuring reduction in severity of glabellar lines with RT002 compared to placebo were highly statistically significant at every time point evaluated to 24 weeks. On an additional key secondary endpoint, median duration for patients treated with RT002 to return to baseline wrinkle severity was nearly 27 weeks (SAKURA 1: 27.7 weeks and SAKURA 2: 26.0 weeks) as assessed by both physicians and patients.

“We are extremely pleased with these positive SAKURA top-line results, which reinforce the findings from the BELMONT Phase 2 active-comparator study. These results demonstrate it is scientifically and clinically possible to create a significantly longer-acting neuromodulator with a duration of six months, compared to three to four months observed with currently available products,” said Dan Browne, Co-Founder, President and Chief Executive Officer of Revance Therapeutics. “We look forward to providing patients and healthcare professionals with what we believe is a new, next-generation, long-acting neuromodulator for the treatment of glabellar lines.”

In addition to SAKURA 1 and SAKURA 2, a long-term safety trial, SAKURA 3, is fully enrolled and is expected to be completed in the second half of 2018. Assuming successful completion of SAKURA 3, the company plans to submit a Biologics License Application in the first half of 2019 and, pending approval by the FDA, launch RT002 in the U.S. in 2020.

“Both SAKURA 1 and SAKURA 2 show RT002 delivers consistent long-acting performance, which is unprecedented for a neuromodulator given what we have seen over the last 30 years,” said Jean D. Carruthers, M.D., a SAKURA lead investigator and pioneer in the use of botulinum toxin for both aesthetic and therapeutic conditions, and Clinical Professor, University of British Columbia. “The data confirm the enhanced effect of this new neuromodulator both in its longevity and patient response. With just two treatments a year, RT002 has the potential to change the landscape in neuromodulator therapy.”

Treatment of glabellar lines is the most popular aesthetic procedure for an injectable neuromodulator, accounting for nearly a third of the $3.6 billion in global neuromodulator sales in 2016. Patients and physicians alike identify duration as the most important attribute of an injectable aesthetic treatment, market research shows. 1

“Patients in my practice are very savvy – not only do they want their neuromodulator treatment to give them great results, they also want the look to last as long as possible,” said Joely Kaufman-Janette, M.D., Skin Associates of South Florida, and a SAKURA investigator. “I am very excited about the results of the SAKURA trials since RT002 appears to provide the look my patients desire over a six-month period, which is remarkable and will fulfill a significant need among my patients.”

TOP-LINE 36-WEEK RESULTS

PRIMARY ENDPOINT

The primary efficacy measurement was a composite of the proportion of patients who achieved a score of 0 or 1 (none or mild) and at least a two-point improvement from baseline at maximum contraction (frown) in glabellar line severity on both the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales at Week 4.

  • Percent of patients who achieved the primary composite endpoint:
    • SAKURA 1: 73.6 percent of patients vs. 0 percent for placebo (p<0.0001)
    • SAKURA 2: 74.0 percent vs. 1.0 percent for placebo (p<0.0001)

SECONDARY DURATION ENDPOINTS

There were several secondary endpoints used to evaluate duration of effect, including the proportion of patients achieving none or mild response on IGA-FWS compared to placebo, median duration for time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS, and median duration for time to return to baseline on both IGA-FWS and PFWS.

  • The percent of patients treated with RT002 who achieved a none or mild response on IGA-FWS at Week 24:
    • SAKURA 1: 35.3 percent vs. 2.0 percent for placebo (p<0.0001)
    • SAKURA 2: 29.4 percent vs. 2.0 percent for placebo (p<0.0001)
  • Median duration for time to loss of none or mild wrinkle severity on both IGA-FWS and PFWS for patients treated with RT002:
    • SAKURA 1: 24.0 weeks
    • SAKURA 2: 23.9 weeks
  • Median duration for time to return to baseline wrinkle severity on both IGA-FWS and PFWS for patients treated with RT002:
    • SAKURA 1: 27.7 weeks
    • SAKURA 2: 26.0 weeks

For comparison, an additional exploratory duration endpoint was evaluated, which mirrors the duration measure used in the BELMONT Phase 2 study.

  • Median duration of ≥ 1 point improvement from baseline on IGA-FWS for patients treated with RT002:
    • SAKURA 1: 24.1 weeks
    • SAKURA 2: 24.1 weeks
    • BELMONT: 23.6 weeks2

SAFETY

RT002 appeared to be generally safe and well-tolerated through the end of study at Week 36. Adverse events were mild, localized and transient. There were no treatment-related serious adverse events. The most common adverse events for RT002 in both studies combined were headache (6.4 percent) and injection site pain (3.7 percent). The incidence of eyelid ptosis and brow ptosis were 2.2 percent and 0.7 percent, respectively.

About SAKURA Phase 3 Clinical Program

The SAKURA clinical program includes SAKURA 1 and SAKURA 2 – two randomized, double-blind, placebo-controlled pivotal trials that were identical in design to evaluate the safety and efficacy of a single administration of RT002 for the treatment of moderate-to-severe glabellar lines in adults from 18 to 75 years of age. The SAKURA 1 and SAKURA 2 trials enrolled a total of 609 patients at 30 sites in the U.S. and Canada. In both trials, patients were randomized 2:1 to receive either RT002 (40U) or placebo. Post-treatment, patients were followed for at least 24 weeks and up to 36 weeks.

The primary efficacy endpoint was the composite of the proportion of patients who achieved a score of 0 or 1 (none or mild) and at least two-point improvement from baseline in glabellar line severity on both the Investigator Global Assessment-Facial Wrinkle Severity (IGA-FWS) and Patient Facial Wrinkle Severity (PFWS) scales, at maximum contraction (frown), at Week 4. Duration of the reduction of severity of glabellar lines was assessed as secondary efficacy endpoints.

The program also includes an open-label trial designed to evaluate the long-term safety of RT002 in glabellar lines following both single and repeat treatment administration. The long-term safety trial enrolled more than 2,500 patients at 66 sites in the U.S. and Canada and is expected to be completed in the second half of 2018.

About Glabellar Lines

The glabella is the skin between the eyebrows and above the nose. Glabellar lines, often called “frown lines,” are vertical lines that develop between the eyebrows and may appear as a single vertical line or as two or more lines and may also appear angled toward the inner corners of the eyebrows. When you frown, the muscles of the lower forehead contract in a downward direction, causing the skin between the eyebrows to crease. Lines are formed by the repeated action of frowning due to the lack of elasticity in the skin. Age, sun exposure, and genetics are contributing factors. Botulinum toxin is used to block the nerve impulses, temporarily inhibiting movement of the muscles that cause the frown lines, giving the skin a smoother, more refreshed appearance.

Based on data from Global Industry Analysts, Inc., the global market for aesthetic treatments with neuromodulators represented about $1.6 billion in revenue in 2016, and according to the American Society for Aesthetic Plastic Surgery, botulinum toxin treatment is the No.1 nonsurgical cosmetic procedure in the U.S. Management estimates glabellar line treatment represents nearly $1 billion of the global market.

About RT002

DaxibotulinumtoxinA for Injection (RT002) is an investigational product. It is a novel, next-generation neuromodulator in development for the treatment of aesthetic and therapeutic conditions, including glabellar lines, cervical dystonia and plantar fasciitis. Created using Revance’s proprietary peptide technology, RT002 has the potential to become the first neuromodulator with long-acting duration of six months. This proprietary, stabilizing excipient peptide technology eliminates the need for human- and animal-based components, which carry a potential risk of transmitting pathogens.

Revance has three active clinical programs for RT002 injectable under way. With the SAKURA 1 and SAKURA 2 Phase 3 pivotal trials to treat glabellar lines now completed, Revance plans to complete the SAKURA 3 open-label, long-term safety study in the second half of 2018. For cervical dystonia, the company was recently granted orphan drug designation and plans to initiate a Phase 3 program in 2018. A Phase 2 trial for RT002 for the management of plantar fasciitis is fully enrolled, and the company plans to share results by year end 2017.

Conference Call

Individuals interested in listening to the conference call today, December 5, at 5:00am PT/8:00am ET, may do so by dialing (855) 453-3827 for domestic callers, or (484) 756-4301 for international callers and reference conference ID: 9076999; or from the webcast link in the investor relations section of the Company’s website at: http://investors.revance.com/index.cfm.

A replay of the call will be available beginning today at 8:00am PT/11:00am ET through 8:00am PT/11:00am ET on December 6, 2017. To access the replay, dial (855) 859-2056 or (404) 537-3406 and reference conference ID: 9076999. The webcast will be available in the investor relations section on the Company’s website for 30 days following the completion of the call.

About Revance Therapeutics, Inc.

Revance Therapeutics is a biotechnology company developing neuromodulators for use in treating aesthetic and underserved therapeutic conditions, including muscle movement disorders and pain. The company’s lead drug candidate, DaxibotulinumtoxinA for Injection (RT002), is currently in development for the treatment of glabellar lines, cervical dystonia and plantar fasciitis, with the potential to be the first long-acting neuromodulator. Revance has developed a proprietary, stabilizing excipient peptide technology designed to create novel, differentiated therapies. The company has a comprehensive pipeline based upon its peptide technology, including injectable and topical formulations of daxibotulinumtoxinA. More information on Revance may be found at www.revance.com.

“Revance Therapeutics” and the Revance logo are registered trademarks of Revance Therapeutics, Inc.

Forward-Looking Statements

This press release contains forward-looking statements, including statements related to our business strategy, timeline and other goals and market for our anticipated products, plans and prospects; statements about our ability to obtain regulatory approval; and statements about potential benefits of our drug product candidates and our technologies.

Forward-looking statements are subject to risks and uncertainties that could cause actual results to differ materially from our expectations. These risks and uncertainties include, but are not limited to: the outcome, cost, and timing of our product development activities and clinical trials; the uncertain clinical development process; our ability to obtain and maintain regulatory approval of our drug product candidates; our ability to obtain funding for our operations; our plans to research, develop, and commercialize our drug product candidates; our ability to achieve market acceptance of our drug product candidates; unanticipated costs or delays in research, development, and commercialization efforts; the applicability of clinical study results to actual outcomes; the size and growth potential of the markets for our drug product candidates; our ability to successfully commercialize our drug product candidates and the timing of commercialization activities; the rate and degree of market acceptance of our drug product candidates; our ability to develop sales and marketing capabilities; the accuracy of our estimates regarding expenses, future revenues, capital requirements and needs for financing; our ability to continue obtaining and maintaining intellectual property protection for our drug product candidates; and other risks. Detailed information regarding factors that may cause actual results to differ materially from the results expressed or implied by statements in this press release may be found in Revance’s periodic filings with the Securities and Exchange Commission (the “SEC”), including factors described in the section entitled “Risk Factors” of our quarterly report on Form 10-Q filed November 3, 2017. These forward-looking statements speak only as of the date hereof. Revance disclaims any obligation to update these forward-looking statements.

References:

1. Data on file
2. Carruthers, J., et al. Injectable DaxibotulinumtoxinA for the Treatment of Glabellar Lines: A Phase 2, Randomized, Dose-Ranging, Double-Blind, Multicenter Comparison with OnabotulinumtoxinA and Placebo. Dermatol. Surg. 2017; 43: 1321 – 1331

 

INVESTORS
Revance Therapeutics, Inc.
Jeanie Herbert, 714-325-3584
jherbert@revance.com
or
Burns McClellan, Inc.
Ami Bavishi, 212-213-0006
abavishi@burnsmc.com
or
MEDIA
General Media:
TOGORUN
Mariann Caprino, 917-242-1087
m.caprino@togorun.com
or
Trade Media:
Nadine Tosk, 504-453-8344
nadinepr@gmail.com

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$BIOC First U.S. Patent Issued for Key ctDNA Tech

Expands Biocept’s intellectual property portfolio to 21 issued patents for its highly sensitive methods of detecting cancer biomarkers on circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA)

SAN DIEGO, Dec. 5, 2017  — Biocept, Inc. (NASDAQ: BIOC), a leading commercial provider of liquid biopsy tests designed to provide physicians with clinically actionable information to improve the outcomes of patients diagnosed with cancer, announces the issuance of U.S. Patent No. 9,834,817, entitled METHODS FOR DETECTING NUCLEIC ACID SEQUENCE VARIANTS. The patent is core to Biocept’s Target Selector™ assays for ctDNA analysis using real-time PCR, Sanger sequencing and next generation sequencing (NGS).

The patent encompasses Biocept’s proprietary “switch-blocker” technology, which enriches patient specimens for oncogene mutations of interest, resulting in ultra-high sensitivity and specificity for the detection of cancer-associated mutations. The switch blocker technology is designed to improve detection rates for these oncogenes, allowing physicians to make informed decisions for the selection of therapy and monitoring of treatment response over time for patients with cancer.

“The issuance of this patent signals what we believe is the first in a series of worldwide patents protecting our proprietary, highly sensitive ctDNA platform technology,” said Lyle Arnold, Ph.D., Biocept’s Chief Scientific Officer. “When combined with our patents and technology related to CTC capture and analysis as well as our blood transport tubes, Biocept has significant coverage protecting all three of its core liquid biopsy technology platforms.”

Michael Nall, Biocept’s President and CEO, added, “Biocept remains differentiated in the liquid biopsy field by using both ctDNA and CTC analysis on patient samples to detect and monitor actionable cancer biomarkers that are listed in the NCCN guidelines. Both of our platform technologies offer specialized enrichment methods that can aid physicians in making more informed decisions in the treatment of their patients with cancer. Obtaining this new intellectual property provides additional patent protection for the unique and novel features of our Target Selector™ dual platform approach.”

About ctDNA Target Selector™ Technology

The “switch-blocker” technology covered by U.S. Patent No. 9,834,817 is applicable to a broad range of molecular genomic platforms, including real-time PCR, digital PCR, Sanger sequencing, NGS, arrays, mass-spec, and capillary detection systems.  This technology allows normal (wild-type) nucleic acid material such as normal DNA to be significantly blocked from amplification, while genetic alterations associated with cancer are able to be amplified. This method greatly increases the detection sensitivity of genetic alterations such as cancer mutations in low abundance, as the “noise” associated with normal genetic sequences is largely eliminated.

Biocept’s switch-blocker technology also has the advantage of reducing the cost of running assays, like NGS assays, by approximately 100-1,000-fold, since the expense of sequencing large amounts of uninformative wild-type nucleic acid is eliminated.

In clinical validation studies, Biocept has demonstrated, with a high degree of correlation, the ability to detect the same biomarkers in blood that were identified from tissue biopsy of solid tumors. Using a blood specimen to provide information on biomarkers found on solid tumors offers the benefits of reducing the risks and costs of biopsy relative to tissue, has convenience advantages, and can enable the ability to non-invasively conduct serial monitoring of patient specimens over time.

About Biocept
Biocept, Inc. is a molecular diagnostics company with commercialized assays for lung, breast, gastric, colorectal and prostate cancers, and melanoma.  The Company leverages its proprietary liquid biopsy technology to provide physicians with clinically actionable information for treating and monitoring patients diagnosed with cancer.  Biocept’s patented Target Selector™ liquid biopsy technology platforms capture and analyze tumor-associated molecular markers on circulating tumor cells (CTCs) and in circulating tumor DNA (ctDNA). With thousands of tests performed, the platform has demonstrated the ability to identify cancer mutations and alterations to inform physicians about a patient’s disease and therapeutic options. For additional information, please visit www.biocept.com.

Forward-Looking Statements Disclaimer Statement
This news release contains forward-looking statements that are based upon current expectations or beliefs, as well as a number of assumptions about future events. Although we believe that the expectations reflected in the forward-looking statements and the assumptions upon which they are based are reasonable, we can give no assurance that such expectations and assumptions will prove to be correct. Forward-looking statements are generally identifiable by the use of words like “may,” “will,” “should,” “could,” “expect,” “anticipate,” “estimate,” “believe,” “intend” or “project,” or the negative of these words or other variations on these words or comparable terminology. To the extent that statements in this news release are not strictly historical, including, without limitation, statements as to our ability to improve the outcomes of cancer patients, the utility and effectiveness of our intellectual property protections, our ability to obtain additional patents in the future covering our proprietary liquid biopsy technology, and the perceived benefits of our proprietary liquid biopsy technology, such statements are forward-looking, and are made pursuant to the safe harbor provisions of the Private Securities Litigation Reform Act of 1995. The reader is cautioned not to put undue reliance on these forward-looking statements, as these statements are subject to numerous risk factors as set forth in our Securities and Exchange Commission (SEC) filings. The effects of such risks and uncertainties could cause actual results to differ materially from the forward-looking statements contained in this news release. We do not plan to update any such forward-looking statements and expressly disclaim any duty to update the information contained in this press release except as required by law. Readers are advised to review our filings with the SEC at www.sec.gov

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$CUR Positive Updated Data from Phase 2 Study of NSI-189 in MDD

40 mg dose showed statistically significant improvement on Cogscreen objective cognitive measures of attention and memory

Two additional self-rated secondary endpoints (CPFQ and QIDS) showed statistically significant improvements in depressive symptoms with procognitive benefits, reinforcing the benefit with SDQ endpoint reported previously

NSI-189 appeared to be safe and well tolerated with no serious adverse events

The Company will be hosting a conference call today, Tuesday, December 5th at 8:30 a.m. ET

GERMANTOWN, Md., Dec. 05, 2017 — Neuralstem, Inc. (Nasdaq:CUR), a biopharmaceutical company developing novel treatments for nervous system diseases, today announced that additional safety, efficacy and tolerability data from its exploratory Phase 2 clinical trial examining the efficacy of NSI-189 at 40 mg once daily (QD) and 40 mg twice daily (BID) compared to placebo for the treatment of major depressive disorder (MDD) were presented at the 56th American College of Neuropsychopharmacology (ACNP) Annual Meeting in a poster entitled, “A Phase 2, Double-Blind, Placebo-Controlled Study of NSI-189 Phosphate, a Neurogenic Compound, Among Out-Patients with Major Depressive Disorder.”  These additional results suggest that NSI-189 has antidepressant effects with cognitive benefits shown on both objective and subjective measures.

“NSI-189 appears to be a broad-acting antidepressant, with effects in both core symptoms of depression and in aspects of cognition where standard antidepressants typically show very modest effects.  These results warrant the continued study of this compound among MDD patients who are inadequately managed by current antidepressant therapies,” said Maurizio Fava, MD, Director of the Division of Clinical Research of the MGH Research Institute and Executive Vice Chair, Department of Psychiatry at Massachusetts General Hospital, and the principal investigator of the trial.

In the Phase 2 trial, 220 subjects were randomized to: NSI-189 40mg daily (n=44), NSI-189 80mg daily (n=44), or placebo (n=132) for 6 weeks (Stage 1). At the end of 6 weeks, placebo-treated subjects who were non-responders (defined as less than 50% reduction in Montgomery-Asberg Depression Rating Scale (MADRS)) with a MADRS score greater than 15 were re-randomized to 6 weeks treatment with NSI-189 40 mg daily (n=22), NSI-189 80 mg daily (n=22), or placebo (n=22) (Stage 2).  Patients on NSI-189 who completed Stage 1 continued the same dose for another 6 weeks.  The primary outcome measure was the MADRS.  Secondary outcome measures included the 17-item Hamilton Depression Rating (HAMD-17), the Symptoms of Depression Questionnaire (SDQ), the Cognitive and Physical Functioning Scale (CPFQ), the patient-rated version of the Quick Inventory of Depressive Symptomatology Scale (QIDS-SR), and CogScreen and CogState objective cognitive tests. Efficacy results concerning all patients randomized in Stage 1 were pooled (50:50 weighted average) with the Stage 2 results of all re-randomized patients who had been non-responders to placebo in Stage 1.

Using the Sequential Parallel Comparison Design (SPCD) pooled analysis approach, MADRS score reduction from baseline with 40mg or 80mg NSI-189 versus placebo did not reach statistical significance (mean difference -1.8, p=0.22, mean difference -1.4, p=0.34, respectively).  However, the 40 mg dose resulted in a statistically significant reduction in SDQ (mean difference -8.2, p=0.04), and CPFQ scores (mean difference -1.9, p=0.03) versus placebo in the pooled SPCD analyses. There was also a statistically greater reduction in QIDS-SR scores versus placebo for patients treated with 40 mg of NSI-189 in Stage 2 (-2.5, p=0.04), but not Stage 1.  Differences for the 80 mg dose versus placebo on these three self-report measures were not statistically significant.

In addition, the 40mg dose also showed statistical advantages on objective measures of attention and memory as per the Cogscreen test, but not the Cogstate test:  Simple Attention (SATADRTC, p=0.034; Complex Attention (SATACACC, p = 0.048) and Memory (SDCDRACC, p = 0.002; also seen with 80mg dose, p = 0.015).

Both doses were well-tolerated with 0, 0 and 7 subjects discontinuing treatment with 40mg, 80mg and placebo, respectively, due to intolerance in Stage 1, and 1,0 and 1 subjects discontinuing treatment with 40mg, 80mg and placebo, respectively, due to intolerance in Stage 2.  Furthermore, no subjects treated with NSI-189 experienced a serious adverse event during the study.

“We are extremely pleased that the novel, neurogenic, neurotrophic mechanism of action of NSI-189 has shown both antidepressant and pro-cognitive activity in depressed patients, and which appears to result in meaningful benefit as reported both by the patients themselves and by objective computerized measurements. These results further support  those from the previous Phase 1b in subjects with MDD, which demonstrated potential efficacy on both depression and cognition scales. We look forward to meeting with the Food and Drug Administration (FDA) in the first half of 2018 to further define the clinical development and regulatory paths for NSI-189, as well as to submit the results of this study to a peer reviewed publication by the end of this year,” said Rich Daly, Chairman and CEO, Neuralstem.

Conference Call and Webcast
In connection with this announcement, Neuralstem will host a conference call today, Tuesday, December 5, at 8:30 a.m. ET. The call can be accessed by dialing 1 (833) 584-0034 (U.S. and Canada) or 1 (409) 350-3602 (international). The conference ID number is 4382159. To access the live webcast, or the subsequent archived recording, visit the “Events” section of the Neuralstem website at www.neuralstem.com. An archived presentation will be available for 90 days.

About NSI-189

NSI-189, a benzylpiperazine-aminopyridine, is a small molecule in clinical development for MDD and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke. NSI-189 is a novel compound developed for the treatment of MDD. Data suggest that NSI-189 works by promoting synaptogenesis or neurogenesis in the hippocampus; a different mechanism of action than currently marketed antidepressants.  Based on preclinical studies, NSI-189 has shown to stimulate neurogenesis of human hippocampus-derived neural stem cells in vitro and stimulates neurogenesis in mouse hippocampus in vivo. These studies suggest that NSI-189 may have broad utility as a neuroregenerative drug.  NSI-189 was discovered using the Company’s stem cell-based screening platform. The Company’s portfolio of small molecule compounds, which includes NSI-189, are covered by 10 U.S. exclusively owned issued and pending patents and over 60 exclusively owned foreign issued and pending patents.

About Neuralstem
Neuralstem is a clinical-stage biopharmaceutical company developing novel treatments for nervous system diseases of high unmet medical need.  NSI-189 is a small molecule in clinical development for major depressive disorder (MDD) and in preclinical development for Angelman syndrome, irradiation-induced cognitive impairment, Type 1 and Type 2 diabetes, and stroke.  NSI-566 is a stem cell therapy being tested for treatment of paralysis in stroke, chronic spinal cord injury (cSCI) and Amyotrophic Lateral Sclerosis (ALS).  Neuralstem’s diversified portfolio of product candidates is based on its proprietary neural stem cell technology.

Cautionary Statement Regarding Forward Looking Information
This news release contains “forward-looking statements” made pursuant to the “safe harbor” provisions of the Private Securities Litigation Reform Act of 1995. Such forward-looking statements relate to future, not past, events and may often be identified by words such as “expect,” “anticipate,” “intend,” “plan,” “believe,” “seek” or “will.” Forward-looking statements by their nature address matters that are, to different degrees, uncertain. Specific risks and uncertainties that could cause our actual results to differ materially from those expressed in our forward-looking statements include risks inherent in the development and commercialization of potential products, uncertainty of clinical trial results or regulatory approvals or clearances, need for future capital, dependence upon collaborators and maintenance of our intellectual property rights. Actual results may differ materially from the results anticipated in these forward-looking statements. Additional information on potential factors that could affect our results and other risks and uncertainties are detailed from time to time in Neuralstem’s periodic reports, including the Annual Report on Form 10-K for the year ended December 31, 2016, and Form 10-Q for the three and nine months ended September 30, 2017, filed with the Securities and Exchange Commission (SEC), and in other reports filed with the SEC. We do not assume any obligation to update any forward-looking statements.

Contact:

Kimberly Minarovich
Argot Partners (Investor Relations)
212-600-1902
kimberly@argotpartners.com

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$CIIX Enters Into an Agreement With Blockchain BT to Host a #Bitcoin ATM

SAN GABRIEL, California, December 5, 2017  —

ChineseInvestors.com, Inc. (OTCQB: CIIX) (“CIIX” or the “Company”), the premier financial information website for Chinese-speaking investors, announced today that it has entered into an agreement with Blockchain BTM, LLC to host a Bitcoin ATM at its San Gabriel, California office with plans to expand to serve other Chinese Communities throughout the United States. The Bitcoin ATM, located in the lobby of the Company’s offices in the highly trafficked San Gabriel Hilton Plaza, is open from 9 a.m. to 6 p.m., Monday through Friday, making it convenient and easy to purchase Bitcoin. Purchasers will have access to on site customer service representatives available to provide instruction regarding the Bitcoin ATM in both Chinese and English. The machine however offers translation into five languages including traditional and simplified Chinese, English, Spanish, French and Korean.

Cryptocurrency enthusiasts can purchase up to $7,000 worth of Bitcoin daily from the ATM. If the purchaser does not already have a digital wallet to hold the cryptocurrency, the ATM is able to digitally print a wallet. Alternatively, there are many digital wallet smartphone apps available for download for Android and iPhone. For those that wish to make a more significant investment, over $7,000, the Company can provide information on how to facilitate much larger transactions.

In recent weeks the Company unveiled its new cryptocurrency education and information services, including the first Chinese Daily Video Newscast, Bitcoin Multimillionaire, broadcast from the NYSE covering Cryptocurrency and Blockchain Technology. In November the Company launched a free bitcoin news and education website in the Chinese language under the domain name newcoins168.com to serve Chinese cryptocurrency investors globally. In addition, the Company will launch new cryptocurrency subscription products in January 2018.

“Although there has been some volatility in the cryptocurrency market, Bitcoin’s price resilience is impressive, reaching over $11,000.00 in the last week, with a Friday close of $10,814. With each rebound in price relative to news, we see more evidence that the concept of digital currency is taking root with investors and the general public alike,” says Warren Wang, Founder and CEO of CIIX. “In addition to providing skilled investors with news about digital currency, ChineseInvestors.com, Inc. hopes to satisfy the average person’s curiosity about cryptocurrency, including how to purchase Bitcoin. Moreover, the underlying Blockchain Technology is extremely compelling and we expect to see many interesting developments in this area. Bitcoin ATMs are just one example of how this area is moving forward. We are excited to make this service available to the Chinese community.”

About ChineseInvestors.com (OTCQB: CIIX)

Founded in 1999, ChineseInvestors.com endeavors to be an innovative company providing: (a) real-time market commentary, analysis, and educational related services in Chinese language character sets (traditional and simplified); (b) advertising and public relation related support services; and (c) retail, online and direct sales of hemp-based products and other health related products.

For more information visit ChineseInvestors.com

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Forward-Looking Statements

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 Exchange Act of 1934, as amended. All forward-looking statements are inherently uncertain as they are based on current expectations and assumptions concerning future events or future performance of the company. Readers are cautioned not to place undue reliance on these forward-looking statements, which are only predictions and speak only as of the date hereof. In evaluating such statements, prospective investors should review carefully various risks and uncertainties identified in this release and matters set in the company’s SEC filings. These risks and uncertainties could cause the company’s actual results to differ materially from those indicated in the forward-looking statements.
Contact:
ChineseInvestors.com, Inc.
227 W. Valley Blvd, #208 A
San Gabriel, CA 91776

Investor Relations:
Alan Klitenic
+1-214-636-2548

Corporate Communications:
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Editor@NetworkNewsWire.com

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$BGNE to Webcast an Analyst and Investor Event from the American Society of Hematology

CAMBRIDGE, Mass., and BEIJING, China, Dec. 04, 2017 — BeiGene, Ltd. (NASDAQ:BGNE), a commercial-stage biopharmaceutical company focused on developing and commercializing innovative molecularly targeted and immuno-oncology drugs for the treatment of cancer, today announced that the company will webcast an analyst and investor event being held at the 59th American Society of Hematology (ASH) Annual Meeting to discuss updated data and the development program for its BTK inhibitor zanubrutinib (BGB-3111). ASH will take place December 9-12, 2017 in Atlanta, GA.

Dial-in Information

Date & Time: Saturday, December 9, 2017, 8:00pm EST (Sunday, December 10, 2017, 9:00am China Standard Time)

Dial-In Numbers: 1-844-461-9930 or 1-478-219-0535 (US), 400-682-8609 or 800-870-0169 (China), 852-30114522 (Hong Kong), 65-66221010, 61-282239773, or 1-478-219-0535 (International)

Conference ID Number: 9086588

A live webcast and replay of the event will be available on BeiGene’s investor website, http://ir.beigene.com/. The dial-in replay will be available approximately two hours after the conference and will be available for two days following the event. It can be accessed by dialing 1-855-859-2056 or 1-404-537-3406 (US), 400-683-7185 (China), 852-30114541 (Hong Kong), 65-31583682, 61-282239792, or 1-855-859-2056 (International).

About BeiGene

BeiGene is a global, commercial-stage, research-based biotechnology company focused on molecularly targeted and immuno-oncology cancer therapeutics. With a team of over 700 employees in China, the United States, and Australia, BeiGene is advancing a pipeline consisting of novel oral small molecules and monoclonal antibodies for cancer. BeiGene is also working to create combination solutions aimed to have both a meaningful and lasting impact on cancer patients. BeiGene markets ABRAXANE® (nanoparticle albumin–bound paclitaxel), REVLIMID® (lenalidomide), and VIDAZA® (azacitidine) in China under a license from Celgene Corporation.1

Investor/Media Contact

Lucy Li, Ph.D.
+1 781-801-1800
ir@beigene.com
media@beigene.com

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$EXAC and TPG Capital Announce Amended Merger Agreement

GAINESVILLE, Fla.

  • Merger with TPG Capital Now Valued at $737 Million

Exactech, Inc. (Nasdaq: EXAC), a leading developer and producer of orthopaedic implant devices and surgical instrumentation for extremities and large joints, announced today that it has entered into an amendment to its merger agreement with TPG Capital and certain of its affiliates which was previously announced on October 23, 2017. Pursuant to the amended merger agreement, the Company’s common stock outstanding immediately prior to the effective time of the merger (other than certain shares held by the Company’s founders and certain management shareholders) will be converted into the right to receive $49.25 per share in cash. This represents an increase of approximately 17.3% over the $42.00 of per share merger consideration previously agreed to by Exactech and TPG Capital. TPG Capital has also increased its equity financing commitment to $737 million for purposes of consummating the merger.

Pursuant to a rollover and voting support agreement entered into at the time of the amended merger agreement, the Company’s founders, CEO and certain other management shareholders have agreed with TPG to exchange a portion of their shares in the transaction, representing approximately 18.8% of the Company’s outstanding common stock, for new equity securities in the post-closing ownership of the Company at a valuation equal to or less than $49.25 per share. Such founding and management shareholders have previously agreed to vote all of their shares for the approval of the amended merger agreement.

Exactech’s Board has approved the amended merger agreement with TPG and has determined that it is advisable, fair to and in the best interests of Exactech and its shareholders. Exactech’s Board hereby recommends to Exactech’s shareholders that they vote to approve the merger agreement and the merger with TPG.

TPG has arranged fully committed equity financing for the transaction and there is no financing condition to consummation of the merger with the Company. Early termination of the statutory waiting period under the Hart-Scott-Rodino Act was obtained on November 17, 2017 and, accordingly, there are no anti-competition or other regulatory approvals needed to consummate the merger with TPG Capital’s affiliate. The merger is expected to close during the first quarter of 2018, subject to customary closing conditions.

Advisors

J.P. Morgan Securities LLC is acting as financial advisor to Exactech. Greenberg Traurig, P.A. (Miami) and Greenberg Traurig, LLP (NYC) are acting as Exactech’s legal advisor. Ropes & Gray LLP is acting as legal advisor to TPG Capital.

About Exactech

Exactech was founded in 1985 by orthopedic surgeon Dr. Bill Petty, his wife Betty and biochemical engineer Gary Miller, PhD, with the purpose of improving the quality of care for patients suffering from joint injury or disease, such as arthritis. The company employs more than 700 individuals including engineers, researchers, manufacturing professionals and sales representatives, and distributes its products to more than 35 countries around the world.

Based in Gainesville, Fla., Exactech develops and markets orthopaedic implant devices, related surgical instruments and biologic materials and services to hospitals and physicians. The company manufactures many of its orthopaedic devices at its Gainesville facility. Exactech’s orthopaedic products are used in the restoration of bones and joints that have deteriorated as a result of injury or diseases such as arthritis. Exactech markets its products in the United States, in addition to more than 30 markets in Europe, Latin America, Asia and the Pacific. Additional information about Exactech can be found at http://www.exac.com.

About TPG

TPG is a leading global alternative asset firm founded in 1992 with more than $73 billion of assets under management and offices in Austin, Beijing, Boston, Dallas, Fort Worth, Hong Kong, Houston, London, Luxembourg, Melbourne, Moscow, Mumbai, New York, San Francisco, Seoul, and Singapore. TPG’s investment platforms are across a wide range of asset classes, including private equity, growth venture, real estate, credit, and public equity. TPG aims to build dynamic products and options for its investors while also instituting discipline and operational excellence across the investment strategy and performance of its portfolio. For more information, visit www.tpg.com.

Forward-Looking Statements

This press release includes forward-looking statements within the meaning of Section 27A of the Securities Act of 1933, as amended, and Section 21E of the Securities Exchange Act of 1934, as amended. These forward-looking statements include, but are not limited to, statements regarding Exactech’s proposed business combination transaction with TPG Capital, all statements regarding Exactech’s expected future financial position, results of operations, cash flows, dividends, financing plans, business strategy, budgets, capital expenditures, competitive positions, growth opportunities, plans and objectives of management, and statements containing the words such as “anticipate,” “approximate,” “believe,” “plan,” “estimate,” “expect,” “project,” “could,” “would,” “should,” “will,” “intend,” “may,” “potential,” “upside,” and other similar expressions. All Statements in this press release that are not historical facts, are forward-looking statements that reflect the best judgment of Exactech based upon currently available information.

Such forward-looking statements are inherently uncertain, and shareholders and other potential investors must recognize that actual results may differ materially from Exactech’s expectations as a result of a variety of factors, including, without limitation, those discussed below. Such forward-looking statements are based upon management’s current expectations and include known and unknown risks, uncertainties and other factors, many of which Exactech is unable to predict or control, that may cause its actual results, performance or plans to differ materially from any future results, performance or plans expressed or implied by such forward-looking statements. These statements involve risks, uncertainties and other factors discussed below and detailed from time to time in Exactech’s filings with the Securities and Exchange Commission (the “SEC”).

Risks and uncertainties related to the proposed merger include, but are not limited to, the risk that Exactech’s shareholders do not approve the merger, potential adverse reactions or changes to business relationships resulting from the announcement of the amendment to the merger agreement or completion of the merger, uncertainties as to the timing of the merger, adverse effects on Exactech’s stock price resulting from the announcement of the merger or the failure of the merger to be completed, competitive responses to the announcement of the merger, the risk that regulatory, licensure or other approvals required for the consummation of the merger are not obtained or are obtained subject to terms and conditions that are not anticipated, litigation relating to the merger, the inability to retain key personnel, and any changes in general economic and/or industry-specific conditions.

In addition to the factors set forth above, other factors that may affect Exactech’s plans, results or stock price are set forth in its most recent Annual Report on Form 10-K and in its subsequently filed reports on Forms 10-Q and 8-K.

Many of these factors are beyond Exactech’s control. Exactech cautions investors that any forward-looking statements made by it are not guarantees of future performance. Exactech disclaims any obligation to update any such factors or to announce publicly the results of any revisions to any of the forward-looking statements to reflect future events or developments.

Additional Information and Where to Find It

All references below to the “merger”, the “proposed merger” or the “merger agreement” refer to the Company’s previously announced merger and merger agreement with TPG Capital, as amended or supplemented from time to time.

The Company previously filed with the SEC a report on Form 8-K regarding the proposed transaction with TPG Capital, which included the amendment to the merger agreement. All parties desiring details regarding the merger are urged to review these documents, which are available at the SEC’s website (http://www.sec.gov).

This press release does not constitute an offer to sell or the solicitation of an offer to buy any securities or a solicitation of any vote or approval. This communication may be deemed to be solicitation material in respect of the proposed merger. In connection with the merger, the Company will prepare and mail a proxy statement to its shareholders. In addition, certain participants in the merger will prepare and file with the SEC a Schedule 13E-3 transaction statement. These documents will be filed with or furnished to the SEC. Investors and shareholders are urged to read carefully and in their entirety these materials and other materials filed with or furnished to the SEC when they become available, as they will contain important information about the Company, the merger and related matters. In addition to receiving the proxy statement by mail, shareholders also will be able to obtain these documents, as well as other filings containing information about the Company, the merger and related matters, without charge, from the SEC’s website (http://www.sec.gov). In addition, these documents can be obtained, without charge, by sending an e-mail to investors@exac.com, along with complete contact details and a mailing address.

Participants in Solicitation

The Company and certain of its directors, executive officers and other members of management and employees may, under SEC rules, be deemed to be “participants” in the solicitation of proxies from shareholders with respect to the merger. Information regarding the persons or entities who may be considered “participants” in the solicitation of proxies will be set forth in the proxy statement and Schedule 13E-3 transaction statement relating to the merger when it is filed with the SEC. Information regarding the directors and executive officers of the Company is set forth in the proxy statement for the Company’s 2017 Annual Meeting of Shareholders, which was filed with the SEC on March 24, 2017. Additional information regarding the interests of such potential participants will be included in the proxy statement and Schedule 13E-3 transaction statement and the other relevant documents filed with the SEC when they become available.

 

TPG
Luke Barrett, 415-743-1550
media@tpg.com
or
Exactech, Inc.
Donna Edwards, 352-377-1140
Donna.Edwards@exac.com

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$CPSH HybridTech Armor® Strike Plates Undergoing U.S. Navy Sea Trials

NORTON, Mass., Dec. 04, 2017  — CPS Technologies Corporation (Nasdaq:CPSH) is pleased to announce that a jointly-developed integrated armor solution incorporating CPS’ HybridTech Armor® is now undergoing sea trials for a key U.S. Navy requirement.

After several years of joint development, with original funding from a Navy SBIR, prime contractor Kinetic Protection has delivered an integrated armor solution to the U.S. Navy, incorporating and based upon CPS’ HybridTech Armor strike faces, which meets the exacting requirements of ballistic protection, light weight, cost and durability for this Navy application.  The primary objective of the current sea trials, which will last into 2018, is to confirm environmental durability.

The Kinetic Protection partnership is a primary example of CPS’ strategy of teaming with multiple armor integrators worldwide to develop integrated armor solutions which are enabled by the remarkable properties of CPS’ HybridTech Armor. These solutions are comprised of several layers of material integrated together with HybridTech Armor strike faces. The HybridTech Armor itself consists of ceramic tiles completely enveloped and mechanically and chemically bonded to lightweight and stiff aluminum metal matrix composites.

Tom Breen, CPS Technologies Senior VP of Sales and Marketing, commented, “CPS Technologies HybridTech Armor components result in a remarkably lighter armor than traditional steel offerings. Using our patented, metal-encapsulated solution enhances state of the art ceramic performance while also providing superior, yet cost effective environmental durability that is measured in decades instead of years. Our modular designs have been field tested and proven to defeat threats as high as STANAG 6. CPS has an excellent track record supporting multiple branches of the US Military as well as domestic and international prime contractors and armor integrators. Working with technology innovators such as Kinetic Protection, LLC., continues that long string of successes.”

Kinetic Protection’s President Erik Crawford adds, “Kinetic Protection has been identifying and delivering real-world anti-terror/force-protection solutions for our customers through the years and the demands are high.  We in part have been able to achieve this through valued and vital partnerships with the likes of CPS Technologies.  This is very much a contact sport, and we are thrilled to take the field with CPS on our team!”

About CPS Technologies Corporation:
CPS is a global leader in producing metal-matrix composite components used to improve the reliability and performance of various armor and electrical systems. CPS products are used to defeat the most advanced threats to ground, airborne and naval platforms. They are also used in motor controllers for hybrid and electric vehicles, high-speed trains, subway cars and wind turbines, as well as heat spreaders in internet switches, routers and high-performance microprocessors.

About Kinetic Protection, LLC.:
Based in Stillwater, MN, Kinetic Protection develops and manufactures advanced defense systems for the US military. The company offers its customers a diversified array of innovative solutions at the leading edge of global technology.  With over 20 years of peacetime and wartime experience, Kinetic Protection has hand-selected former operators and decision-makers in several disciplines to leverage current and emerging technology and combine the understanding of operational procedures and needs.

CPS Technologies Corporation
Ralph Norwood, Chief Financial Officer
111 South Worcester Street
Norton, MA 02766
Telephone: (508) 222-0614
Web Site:  www.alsic.com

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$RETO Announces Full Exercise of the Underwriter’s Over-Allotment Option

BEIJING

ReTo Eco-Solutions, Inc. (NASDAQ:RETO) (“ReTo” or the “Company”), a manufacturer and distributor of eco-friendly construction materials as well as equipment used for the production of these eco-friendly construction materials, and consultation, design, project implementation and construction of urban ecological environments including those for the purpose of capturing, controlling and reusing rainwater, commonly called “sponge cities”, today announced that ViewTrade Securities, Inc., who acted as the managing underwriter and sole book-runner of the Company’s initial public offering (“IPO”), has exercised the full over-allotment option to purchase an additional 420,000 common shares at the IPO price of $5.00 per share. As a result, the Company has raised gross proceeds of approximately $2,100,000, in addition to the previously announced IPO gross proceeds of approximately $14 million, before underwriting discounts and commissions and offering expenses.

A registration statement relating to the securities being sold in this offering was declared effective by the Securities and Exchange Commission on November 28, 2017. The offering has been made only by means of a prospectus. A copy of the final prospectus related to the offering may be obtained, when available, from ViewTrade Securities, via email: IB@Viewtrade.com or standard mail at ViewTrade Securities, 7280 W Palmetto Park Rd, #310, Boca Raton, FL 33433, Attn: Prospectus Department. In addition, a copy of the final prospectus relating to the offering may be obtained via the SEC’s website at www.sec.gov.

This press release shall not constitute an offer to sell, or the solicitation of an offer to buy, nor shall there be any sale of these securities in any state or jurisdiction in which such offer, solicitation, or sale would be unlawful prior to registration or qualification under the securities laws of any such state or jurisdiction.

About Reto Eco-Solutions, Inc.

Founded in 1999 and headquartered in Beijing, ReTo is a manufacturer and distributor of eco-friendly construction materials (aggregates, bricks, pavers and tiles), made from mining waste (iron tailings) and fly-ash, as well as equipment used for the production of these eco-friendly construction materials. The Company also provides a full range of eco-friendly project solutions, including consultation, design, project implementation and construction, relating to all stages of sponge-city projects for customers. The Company’s clients are located in mainland China, and internationally, including Canada, the United States, Mongolia, Middle East, India, South Asia, North Africa and Brazil.

 

ReTo Eco-Solutions, Inc.
ir@retoeco.com
or
Investor Relations:
Weitian Group LLC
Tony Tian, CFA
tony.tian@weitian-ir.com
+1-732-910-9692

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